(107) Reports of Spontaneous Abortion In The VAERS Database, Under Reported 100 to 1, SO THIS IS 10,700 Dead Babies

Adverse Event Description

I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.  The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.   On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor’s office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.

went through a miscarriage on 23APR2021, after receiving the first dose; feeling abdomen pain lightly two to three days later; could not left her arm after the injection; injection site was sore,could not lift her arm after the injection; found pregnant on 07MAR2021,first vaccine dose 11APR2021; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 20-Nov-2021. On 11-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021). On 13-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection). On 14-Apr-2021, the patient experienced ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later). On 23-Apr-2021, the patient experienced ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, miscarriage on 23-Apr-2021. On 11-Apr-2021, EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021) had resolved. On 23-Apr-2021, ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) had resolved. At the time of the report, ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later), VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that his wife was found pregnant on 07Mar2021. She had normal back pain and normal pregnancy pain during her pregnancy. My wife could not left her arm after the injection and the injection site was sore on 13-Apr-2021.  After taking the Moderna vaccine she started to have abdomen pain lightly for two to three days on 14-Apr-2021. On 22-Apr-2021, she started to feel unbearable pain. On Friday 23-Apr-2021 she had a miscarriage.   No treatment product information was not provided  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up had NNI; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Received first dose without knowing I was pregnant. I have a high risk pregnancy and the baby is at risk of a spontaneous abortion I?ve being in bed since I knew I was pregnant.  I have intense abdominal pain, no hemorrhage just unknown pain.  Doctors told me to keep resting and just wait for a spontaneous abortion, I was given the fist dose and was advised to not take the second dose . I am know 11 weeks of painful pregnancy just waiting for something to occur. I recommend that woman who are in reproduction ages should first take a pregnancy exam before the vaccine so that nothing like what I am passing happens to someone else. Doctors say that if the pregnancy concludes at its last term the baby will have birth defects because of the vaccine. They recommend and abortion or just wait for a spontaneous abortion.

Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed.  Confirmed Spontaneous abortion.  blood type of B-, patient received dose of RhoGam.  Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.  The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.   On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor’s office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.

Last menstrual period either Nov 1-8 (light, abnormal, pregnancy symptoms) or Nov 29-12/2 (light, abnormal, pregnancy symptoms).  Possible dates of conception 10/16, 10/18, 10/19, 11/14, 11/15.  Negative pregnancy test on 11/26 & 11/29.  +Pregnancy test 12/10.   Estimated delivery dates were either 7/8/21 or 8/8/21. First covid vaccine received on 12/30.  First OB ultrasound on 1/5/21, estimated to be 6 weeks + 3 days gestation, with no heartbeat.  Repeat ultrasound on 1/13/21, continued to measure 6 weeks + 3 days gestation, again with no heartbeat. Spontaneous miscarriage did not occur, 1 time dose of intravaginal Cytotec was taken and medical abortion completed.

I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown.  Follow-up attempts are completed. No further information is expected.; Sender’s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case)

Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN’S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn’s disease.    The patient’s past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN’S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date.  At the time of the report, CROHN’S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect.  No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Patient received dose 2/2 of Pfizer vaccine on 2/25/2021. She had an IUI procedure done in (country) on 12/14/2020, which was confirmed to be successful at her follow up OB/Gyn visit- then returned to (country) . Patient returned to (country) on Feb 8, 2021 for 10 week US and was found to have no fetal heart tone, missed spontaneous abortion at approximately 7w5d. This timing would draw into question the timing of the vaccine administration.

My pregnancy symptom s started disappearing gradually and after a week I didn’t feel pregnant at all/missed abortion; My arm was sore; I felt mild fatigue; This is spontaneous report from contactable consumer.  A 28 year-old female consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8735), on 03May2021 (at the age of 28-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of vaccine on 13Apr2021 (lot EW0164). The patient had no known allergies and had not other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that she got her 2nd dose of vaccination when she was 7 weeks pregnant. The LMP was on 21Mar2021. Her arm was sore and she felt mild fatigue. Her pregnancy symptoms started disappearing gradually and after a week she didn’t feel pregnant at all. When she went in for her first ultrasound appointment at 9 weeks, the doctor said that the growth stopped at 7 weeks 4 days and there was no heartbeat. She declared it missed abortion.  Information on Lot/Batch number was available. Additional information has been requested.

This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABORTION OF ECTOPIC PREGNANCY (Miscarriage) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Hypospadias on 15-Jun-2019 and Pregnancy (one). Concurrent medical conditions included Subfertility (Treated since 2018).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 29-Oct-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 05-Mar-2021, the patient experienced ABORTION OF ECTOPIC PREGNANCY (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Ectopic pregnancy. On 04-Mar-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, ABORTION OF ECTOPIC PREGNANCY (Miscarriage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.; Sender’s Comments: This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.

Miscarriage; patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; This is a spontaneous report from a contactable Other Health Professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on 22Dec2020 06:00 AM at single dose at Arm Right at Hospital for COVID.  Medical history included ongoing sleep apnoea. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage on 29Dec2020 13:00.  The patient was pregnant while taking BNT162B2. The patient was 4 Weeks pregnant at the onset of the event.  Patient last menstrual period date was 24Nov2020. The Pregnancy due to deliver was on 07Sep2021. The pregnancy resulted in spontaneous abortion. Since the vaccination, the patient has been tested for COVID-19 on an unknown date with unknown results. Nasal Swab on 28Dec2020 was Negative. There was no treatment received for the adverse event. The outcome of event was recovering.; Sender’s Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, Ethics Committees, and Investigators, as appropriate.

I was about 3 weeks pregnant at time of vaccination (Due date 9/3/2021). I experienced spontaneous abortion at 6 weeks gestation.  Uncomplicated, no doctors visits or hospitalization required (though I am a physician so tracked HCG levels throughout). G3P1, one prior missed spontaneous abortion  2017, one live birth 2019.

Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna’s COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage).  The patient’s medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine.   On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided.  The patient’s prior positive pregnancy test, last menstrual period, conception and due dates were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event,  pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter’s Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested

Miscarried at 6 weeks; Vaccine exposure during pregnancy; A spontaneous  report was received from a healthcare professional concerning a 32 year old female patients who received Moderna’s  Covid 19 vaccine(mRNA1273) and experienced vaccine exposure during pregnancy and miscarried at 6 weeks.  The patient’s medical history was not provided. Concomitant product use was not provided.    The patient received second of two planned dose of mRNA-1273  for prophylaxis of Covid 19 infection approximately 2.5 weeks before the miscarriage.  The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of Moderna vaccine.  The patient received both scheduled doses of mRNA-1273 prior to the events ; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event, miscarriage spontaneous  was considered as unknown. The outcome for the event of Vaccine exposure during pregnancy was recovered/resolved.; Reporter’s Comments: This case concerns a 32 year old, female subject, who experienced a spontaneous abortion and drug exposure during  pregnancy. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested.

Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient’s medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient’s last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter’s Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.

Pregnant patient miscarried; got pregnant in between the first and second dose; A spontaneous report was received from a pharmacist ,concerning a 38-year-old, female patient , who received Moderna’s COVID-19 vaccine(mRNA-1273) and experienced getting pregnant in between the first and second doses (Exposure during pregnancy) and miscarried/abortion spontaneous.  The patient’s medical history was not reported. Concomitant medications were not reported.  On 15 Jan 2021, patient received the first of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine intramuscularly for prophylaxis of COVID-19 infection.  Between an unknown date and 17 Mar 2021, the patient become pregnant and experienced a miscarriage.  On March 17 2021, the patient received the second of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine for prophylaxis of COVID-19 infection.  The event, miscarriage, was medically significant.  Laboratory details were not reported. Treatment information was not reported.  Action taken with mRNA-1273  in response to the events was not applicable.  At the time of report , the outcome of events; got pregnant in between first and second dose and pregnant patient miscarried were, were not reported.; Reporter’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

spontaneous abortion at approximately 8 weeks gestation, 10 days after vaccine administration

Miscarriage; Pregnancy; well past the 42 day mark; A Spontaneous report was received from a Healthcare Professional concerning a  female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) and the patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  The patients medical history was not provided.No concomitant medication information was provided.  On an unknown date in JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly  for prophylaxis of COVID-19 infection.  On an unknown date, The patient The patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  Laboratory details was not provided.No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Pregnancy and Miscarriage was resolved.  The outcome of the event  well past 42 days was unknown.; Reporter’s Comments: This is a case of product exposure during pregnancy with spontaneous abortion for this female (age unknown).  Patient missed her second dose. She will continue to be contacted for further monitoring of AEs post abortion. .

I had a miscarriage (spontaneous abortion) on March 14, 2021. I was 12 weeks pregnant at the time of miscarriage.

miscarriage/spontaneous abortion; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  intramuscular, administered in Arm Right on 17Feb2021 15:30 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing herpes simplex 2 and sulfa allergy. Patient previously received the first dose of bnt162b2 for covid-19 immunisation. Concomitant medication included acyclovir) taken for an unspecified indication, start and stop date were not reported. The mother was 7 Weeks pregnant at the onset of the event. The patient experienced miscarriage/spontaneous abortion on 25Feb2021 16:45.   The patient was supposedly due to deliver on 18Oct2021. The with outcome of event was recovered with sequelae.  No follow-up attempts are possible, information about batch/lot number has already been obtained.

Patient had two previous live births and two spontaneous abortions at 10 and 8 weeks prior.  Reported lack of fetal movement in the last few days (not quantified).  Provider note ruled as a pregnancy loss at 19 weeks of gestation.

Miscarriage/spontaneous abortion

spontaneous miscarriage; conceived following second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder, Drug allergy (sulfa), Drug allergy (cephalosporins) and Drug allergy (codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication.   On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, PREGNANCY (conceived following second dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (spontaneous miscarriage) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of last menstrual period was 29Jan2021 This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder and Drug allergy (sulfa, cephalosporins, codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication.   On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, ABORTION SPONTANEOUS (spontaneous miscarriage) and PREGNANCY (conceived following second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of last menstrual period was 29 Jan 2021.  This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender’s Comments: This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Had a early pregnancy loss at 7th week gestation, Spontaneous abortion, Having regular check ups and follow up with the doctors

Spontaneous Abortion. Miscarriage started on it’s own at home.  Bleeding lasted 14 days, then turned to excessive hemorrhaging and ended up getting an emergency D&C. Was 10 weeks pregnant at time of miscarriage. EDD was 10/23/2021.

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

Spontaneous abortion at 7 weeks LMP 2/18/21

Late-term miscarriage; This is a spontaneous report from a contactable consumer (patient). A 31-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization in a hospital. The patient’s medical history was not reported. There were no concomitant medications. The patient had no other vaccines in four weeks and no other medications in two weeks. The patient has not had COVID prior to vaccination and has not been tested for COVID post vaccination. The patient experienced late-term miscarriage on 22Mar2021 that required physician clinic visit and hospitalization for 1 day. The mother was 15 weeks pregnant at the onset of the event. Gestation period at exposure was not reported. Pregnancy due date was reported to be scheduled on 07Sep2021. The pregnancy resulted in spontaneous abortion. Fetal outcome was not reported. Therapeutic measures were taken as a result of late-term miscarriage which includes dilation and evacuation (D&E). The outcome of the event was unknown.

Miscarriage; Patient was unaware that she was pregnant; This spontaneous case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Pregnancy test (Negative home pregnancy test.) on 02-Mar-2021.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant). On 19-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment or concomitant mediation were reported.

MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; BODY ACHES; FEVER; This spontaneous report received from a consumer (company representative) concerned an female of unspecified age. The patient’s height, and weight were not reported. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient experienced body aches and fever. On 10-APR-2021, the patient was pregnant when she had vaccine. On 12-APR-2021, the patient experienced hemorrhage, miscarriage (spontaneous abortion) and was hospitalized (date unspecified). The duration of hospitalization was not reported. The date of patient’s last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). .; Sender’s Comments: V0: -covid-19 vaccine ad26.cov2.s-miscarriage, vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Spontaneous abortion, hives, headache

miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient’s husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room  visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage  was unknown while for all other events was not recovered.

had a natural miscarriage; This is a spontaneous report from a contactable consumer (patient). A 40-year-old pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: G06026), via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:00 as single dose for COVID-19 immunization in an public health clinic. The patient’s medical history was not reported. No known allergies. The patient’s concomitant medication includes an unspecified multivitamin. The patient previously received the first dose of bnt162b2 (lot number: not reported) on an unspecified date for COVID-19 immunization. No other vaccinations in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. The patient’s last menstrual period was on 25Jan2021 with gestation age at exposure reported as 6 weeks. Expected due date was on 08Nov2021. On 09Apr2021, the patient visited  the emergency room and physicians office and it was reported that the patient had a natural miscarriage, do not know if it was related to the vaccine. Baby stopped developing around time of vaccination at 10 weeks of gestation. The pregnancy resulted in spontaneous abortion. It was unknown if the patient received any treatment. The fetal outcome is intrauterine death. The outcome of the patient was recovering.   No follow-up attempts are possible. No further information is expected.

Spontaneous abortion (miscarriage) on April 15th, approximately 8 weeks pregnant (was due in November). No previous miscarriages and I have 2 healthy children.

went through a miscarriage on 23APR2021, after receiving the first dose; feeling abdomen pain lightly two to three days later; could not left her arm after the injection; injection site was sore,could not lift her arm after the injection; found pregnant on 07MAR2021,first vaccine dose 11APR2021; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 20-Nov-2021. On 11-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021). On 13-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection). On 14-Apr-2021, the patient experienced ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later). On 23-Apr-2021, the patient experienced ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, miscarriage on 23-Apr-2021. On 11-Apr-2021, EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021) had resolved. On 23-Apr-2021, ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) had resolved. At the time of the report, ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later), VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that his wife was found pregnant on 07Mar2021. She had normal back pain and normal pregnancy pain during her pregnancy. My wife could not left her arm after the injection and the injection site was sore on 13-Apr-2021.  After taking the Moderna vaccine she started to have abdomen pain lightly for two to three days on 14-Apr-2021. On 22-Apr-2021, she started to feel unbearable pain. On Friday 23-Apr-2021 she had a miscarriage.   No treatment product information was not provided  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up had NNI; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

The patient was pregnant at the time of vaccination; The patient was pregnant at the time of vaccination; Miscarriage; This is a spontaneous report from a contactable consumer (patient, self-reported). The patient reported information for both herself and fetus/baby. This is a maternal report. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not provided. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination. The patient was not tested for COVID post vaccination. The patient was pregnant at the time of vaccination. The Patient’s last menstrual date was 09Jan2021 and delivery date was 16Oct2021. The mother reported she became pregnant while taking BNT162B2. The mother was 14 weeks pregnant at the onset of the event. It was reported that on 21Apr2021, the pregnancy resulted in spontaneous abortion- miscarriage and resulted in emergency room and physician visit. Outcome of the event miscarriage was reported as not recovered and for all other events, it was unknown.  Information on the lot/batch number has been requested.

spontaneous abortion; This is spontaneous report from a contactable nurse. A 27 year old female patient who was not pregnant at the time of vaccination received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot Number: EL3247) dose 1 intramuscular administered on Arm left on 15Feb2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Seriousness criteria was reported by the patient that it was not serious, no death life-threatening or cause of prolonged hospitalisation. It was not disabling and did not have any congenital birth defect. COVID-19 vaccine was administered at the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. 12Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test negative. On 29Mar2021, the patient had spontaneous abortion and was taken to emergency room in hospital. On 25Apr2021, the device date given. vaccine facility, race and ethnicity information was available. The outcome of the event was recovered.; Sender’s Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, spontaneous abortion cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021458221 mother/baby case

Patient Miscarried; vaccine exposure during pregnancy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030m20a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) (seriousness criterion medically significant). On 30-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Patient Miscarried) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Company Comment:  This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use.  Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking.  Additional information has been requested.; Sender’s Comments: This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use.  Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking.  Additional information has been requested.

Miscarriage; This is a spontaneous report from a contactable consumer (patient herself). A 30-year-old female patient. A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right deltoid on 14Apr2021 (Batch/Lot Number: Ew0162) as 2nd dose, single for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS) received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She received an unspecified vaccine on 14Apr2021 (same date) in right arm. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced miscarriage on 27Apr2021. At 6 weeks there was a heartbeat detected. Patient received her second dose and at 8 weeks there was no heartbeat. Abortion pill was reported as treatment. Event result in Doctor or other healthcare professional office/clinic visit. Patient had not been tested for COVID-19 since the vaccination. Outcome of event was recovering.

Miscarriage / pregnancy loss; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report.  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 30-years-old), administered in Arm Left on 23Apr2021 10:00 (Lot Number: ER8735) as 2nd dose, single for COVID-19 immunization. The patient’s medical history was not reported. Concomitant medication included Nature Made Pre-Natal Vitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:00 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Confirmed pregnancy on 22Apr2021 at OBGYN via blood test, urine test, and ultrasound. Pfizer 2nd dose COVID vaccine administered on 23Apr2021. Began miscarriage on 28Apr2021. On 28Apr2021, OGBYN medical professionals detected NO GROWTH since 22Apr2021 ultrasound. Identical imagining in size. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient experienced miscarriage / pregnancy loss on 28Apr2021 15:30.No treatment received for the event. The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 20Dec2021. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovering. The event was considered as serious (disability, congenital anomaly).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.; Sender’s Comments: Linked Report(s) : US-PFIZER INC-2021497434 fetal case

Miscarriage; Electing not to receive second Moderna dose after learning she was pregnant; Pregnant when she received her first Moderna dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient’s past medical history included Polycystic ovarian syndrome and Hypothyroidism. Concomitant products included LEVOTHYROXINE and METFORMIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose). On 05-Feb-2021, the patient experienced INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant). On 27-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose) had resolved. On 05-Feb-2021, INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant) had resolved. On 27-Apr-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information regarding treatment was provided.  Nurse reported she was unaware she was pregnant when she received her first Moderna dose on 08-Jan-2021. Nurse reported that she discovered she was pregnant a week 29-Jan-2021 prior to her scheduled second Moderna dose on 05-Feb-2021. Testing was performed on the fetus and physicians determined the baby was a normal healthy girl with no genetic abnormalities or findings. Reportedly, she stopped metformin during her pregnancy so glucose testing could be performed.

First trimester miscarriage; Received the Moderna COVID-19 Vaccine while pregnant; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (First trimester miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (First trimester miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion.  At the time of the report, ABORTION SPONTANEOUS (First trimester miscarriage) outcome was unknown and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  No treatment details were provided.  Company Comment : This is a case of product exposure during pregnancy with associated AEs for this female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.

Caused misscarrage; Vaccine exposure during pregnancy; Based on the current case data, this case has been classified as invalid. This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Caused misscarrage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Caused misscarrage) (seriousness criteria medically significant and congenital anomaly) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Caused misscarrage) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  This is a case of product exposure during pregnancy with associated AE.   Reporter did not allow further contact; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  This is a case of product exposure during pregnancy with associated AE .

Spontaneous miscarriage; Spontaneous miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Spontaneous miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Spontaneous miscarriage. Gestation period not reported. At the time of the report, ABORTION SPONTANEOUS (Spontaneous miscarriage) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.  Company Comment: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender’s Comments: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.

Received first dose of vaccine on May 6th and had a miscarriage on May 18th.; This is a spontaneous report received from a contactable consumer (patient).   A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06May2021 15:45 (Lot Number: ER 8735) as single dose (at the age of 33-years-old) for COVID-19 immunization. The patient’s medical history was not reported. Concomitant medications included unspecified prenatal vitamins. The patient received first dose of vaccine on 06May2021 and had a miscarriage on 18May2021 00:00 (reported as 12:00 AM). The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 12Jan2022. Patient’s last menstrual period date was on 07Apr2021. The pregnancy resulted in spontaneous abortion. No treatment received for the event. The outcome of the event was recovering. The event was considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was in Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Device Date: 28May2021  No follow-up attempts are needed. No further information is expected.

had a miscarriage; had vaccine during the first 10 weeks and had a miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (had a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (had a miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (had a miscarriage) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment drug was reported.  It was reported that the baby died  Company comment: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.; Sender’s Comments: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.

This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (lost the pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (lost the pregnancy) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, ABORTION SPONTANEOUS (lost the pregnancy) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.  Moderna Customer Care agent attempted a warm transfer but when retrieving the caller the caller was no longer on the line. But the agent informed that  the caller received the first dose of the Moderna COVID-19 vaccine in March. At  the time of vaccination the caller did not know they were pregnant and did not get second dose once they found out for safety reasons. The caller lost the pregnancy and now wants to know if they can get the second dose.  This is a case of product exposure during pregnancy with associated AEs for this female patient of unknown age. Patient declined further contact no further details is expected.; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this female patient of unknown age. Patient declined further contact no further details is expected.

Spontaneous abortion at 7weeks gestational age.

Amenorrhoea; Abortion spontaneous; Ovulation disorder; Pregnancy; Uterine spasm; This case was received via  VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy) and UTERINE SPASM (Uterine spasm). On an unknown date, the patient experienced AMENORRHOEA (Amenorrhoea). At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy), UTERINE SPASM (Uterine spasm) and AMENORRHOEA (Amenorrhoea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the provided. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender’s Comments: This is a case of product exposure during pregnancy which resulted in Abortion spontaneous, for this 29 years old female. Very limited information has been provided at this time.

5 days after receiving the Pfizer vaccination I ended up in the ER due to me having a miscarriage that had started approximately 4 days after the vaccination was given.; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05May2021 13:00 (Batch/Lot Number: EW0171) (at age of 36 years) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was pregnant at time of vaccination. Last menstrual date was on 09Apr2021. Medical history included known allergies (unspecified) and other unspecified medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other unspecified medications the patient received within 2 weeks of vaccination. 5 days after receiving the Pfizer vaccination, patient ended up in the ER due to having a miscarriage that had started approximately 4 days after the vaccination was given, on 08May2021 08:00 (as reported). The mother was 4 weeks pregnant at the onset of the event (also reported as 5 with unspecified unit). The mother was due to deliver on 14Jan2022. The mother delivered the pregnancy (as reported, pending clarification). The pregnancy resulted in spontaneous abortion. Adverse event resulted in Emergency room/department or urgent care. Treatment for event was unknown. The outcome of event was recovered on May2021.

Miscarriage shortly after the 1st dose; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date.  At the time of the report, ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was not given.  No treatment information was given.; Sender’s Comments: This is a case of exposure of product during pregnancy with the vaccine mRNA -1273 with reported AE of spontaneous abortion. There is very limited information regarding this events  has been provided at this time.  Further information has been requested.

Pregnancy resulted in a miscarriage; Did not receive 2nd dose; Found out she was pregnant after receiving 1st dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 22-Mar-2021, EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) had resolved and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was reported that the patient received first shot and then found out she was pregnant.  The pregnancy resulted in a miscarriage and patient wanted to knowif she should now get her 2nd shot, or restart the vaccination series.    This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected.   Reporter did not allow further contact; Sender’s Comments: This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected.

Miscarriage; she received first moderna vaccine while pregnant; Nausea; Headache; Vomiting; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 15-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred  on 15-May-2021. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Mar-2021, EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  In about a period of two weeks, the ultrasound indicated that the baby’s heart beat was non-existent and on 15 May 2021, the patient had a spontaneous miscarriage.  Date of last menstrual period and estimated due date were not provided.  No treatment was given.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226308 (Parent-Child Link).   See case MOD-2021-226308 for details regarding the child case.; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed.  Confirmed Spontaneous abortion.  blood type of B-, patient received dose of RhoGam.  Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.

Miscarriage at 8 weeks pregnant; Unevaluable event; This case was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20a and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) (seriousness criterion medically significant). 14-May-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) and UNEVALUABLE EVENT (Unevaluable event) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On  05/14/2021 and 05/17/2021 unknown lab tests were done ,results not provided. No Concomitant medications were  reported. No treatment information was provided.  This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified.   Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender’s Comments: This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified.  Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.

Pfizer COVID19 vaccinations given on 5/5/21 and 5/26/2021.  Patients last menstrual period 4/27/2021 prior to pregnancy.  Spontaneous abortion/miscarriage at 7 weeks gestation on 6/24/21.

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

miscarried her baby; This is a spontaneous report from a contactable other HCP. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jun2021 (Batch/Lot number was not reported) at age of 33-year-old as DOSE NUMBER UNKNOWN, SINGLE for prevention of COVID. Medical history included the patient had exposure to COVID before but she tested negative, this occurred 31Oct2020. She also has history of pneumonia, on 31Dec2020. Obstetrical History: Number of previous pregnancies None that the caller is aware of. The patient’s concomitant medications were not reported. The patient became pregnant while taking bnt162b2. The due date was on 25Feb2022. The patient miscarried her baby on 26Jun2021. First Day of Last Menstrual Period was unknown. Caller said the patient thought she was right around 8 weeks when she called her on 16Jun2021 so by the callers calculations it would have been right around 21May2021 (as reported). She confirmed patient did not know but the date was provided by the callers calculation. Risk factors for adverse pregnancy outcomes including environmental or occupational exposures, e.g. hypertension, diabetes, etc. Family history of congenital abnormality/genetic diseases, consanguinity (or any family relation or lineage) between parents (specify degree): None. It was noted in the emergency room note that she had been trying to conceive for 15 years with her spouse, so she was having trouble getting pregnant. Caller was calling from a clinic about the Pfizer COVID vaccine. She has a patient who got the COVID vaccine 15Jun2021 and the patient miscarried her baby on 26Jun2021. She was looking for a place that was taking repots on stuff like that she did not feel that it was really a VAERS report. Dose: She did not have any record of the administration of her having it, she got it in a completely different town. The patient did not smoke during this pregnancy. The patient did not drink alcohol during this pregnancy. The patient did not use illicit drugs during this pregnancy. Caller added the patients blood type was O negative. She saw that Pfizer may be looking at information regarding blood type. Outcome of pregnancy was spontaneous abortion/miscarriage on 26Jun2021. No investigation assessment. The outcome of event was unknown. Seriousness: Caller stated this event was serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender’s Comments: Miscarriages/spontaneous abortion occurred 11 days after the vaccination with BNT 162B2.  Given that the patient with her spouse had trouble getting pregnancy for many years, the event more likely is associated with their underlying contributory factors.  More information including genetic, immunological and endocrine workups are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage; At the time of the shot she was 7 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) in a 39-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jul-2021, the patient experienced EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant). On 08-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) (seriousness criteria medically significant, life threatening and congenital anomaly). On 07-Jul-2021, EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant) had resolved. On 09-Jul-2021, ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  The laboratory exams performed to further understand the event included were ultrasound a week prior to the shot to show the babies heart rate. Treatment medication use information was not provided by reporter.; Sender’s Comments: This case concerns a 39-year-old female patient gravida 1 who received mRNA-1273 at 7 weeks of pregnancy and experienced spotting one day post vaccination and spontaneous abortion 2 days post vaccination.  Last menstrual period and estimated date of delivery were not provided. Spontaneous abortion show temporal association with product use and a causal relationship cannot be excluded.  The event of exposure during pregnancy is assessed not applicable

Spontaneous abortion. Pt was 9w1d at time of first Moderna COVID vaccine (EDD 8/9/2021). Two weeks later she began bleeding and was found to have an incomplete abortion with embryo measuring 9w1d. Proceeded to bleed heavily and D&C performed. Uncomplicated recovery. Genetic studies in process.  Unknown if SAB is related to vaccine, though it appears embryonic demise occurred within a few days of vaccine administration.

Amenorrhoea; Abortion spontaneous; Ovulation disorder; Pregnancy; Uterine spasm; This case was received via  VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy) and UTERINE SPASM (Uterine spasm). On an unknown date, the patient experienced AMENORRHOEA (Amenorrhoea). At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy), UTERINE SPASM (Uterine spasm) and AMENORRHOEA (Amenorrhoea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the provided. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender’s Comments: This is a case of product exposure during pregnancy which resulted in Abortion spontaneous, for this 29 years old female. Very limited information has been provided at this time.

I tested positive for pregnancy in 17Mar2021. In 24Mar2021 I got my first covid vaccine from Pfizer; feel cold (really cold) all the time; feel weak; This is a spontaneous report from contactable consumer female (patient, mother reported for herself). A 41-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on right arm on 24Mar2021 at 07:15 hours, as 1st single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included dementia, patient was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. Patient had one previous pregnancy and no previous maternal pregnancy compilations. Concomitant medication included patient was taking Throne dietary supplement for prenatal supplement from 18Mar2021, daily and ongoing. First day of last Menstrual period was 14Feb2021. Estimated delivery of patient was 21Nov2021. Gestation period at the time of initial exposure was 2 weeks, 1st trimester. Patient had no problems before delivery. No drugs were taken by father (patient’s husband) during the mother’s pregnancy, father was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. The patient tested positive for pregnancy in 17Mar2021. On 24Mar2021, she got her first COVID vaccine from Pfizer. Patient first appointment with her OB/GYN was in 05Apr2021. Her doctor did an ultrasound and checked the baby’s vital signs. She confirmed that the baby was the right size, and the baby heartbeat was good. She said everything was ok with the baby. On 14Apr2021 she got her second Covid vaccine from Pfizer. Her vaccine was schedule at 10:00 AM. After she got the vaccine, she started to have cramps. About 1:00 PM she started bleeding (light red). She called her doctor and she told her to go to her office. About 1:45 PM She had a new ultrasound. Her doctor said that she did not find any heartbeat in the baby and that she was having an abortion.  On 10May2021, it was reported that on unspecified date of 2021, after she got the vaccine, patient had some different symptoms like feel cold (really cold) all the time and feel weak. During all this time she was taking just Thorne-Dietary supplement. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on left arm on 14Apr2021 at 10:15 hours, as 2nd single dose (at the age of 41-years-old) for COVID-19 immunization. Patient called her doctor at 14:00 to 14:30 hours on 14Apr2021, during physician office visit, the doctor did a sonogram and she said that she was having a spontaneous abortion/miscarriage with 7 weeks (2 months) of gestational age. During the sonogram/ultrasound, no heartbeat was detected for fetal. Patient stated that it was the first time that she had miscarriage, her first pregnancy was normal, and her son was born. Patient got the 2 vaccines but wasn’t informed about the Lot number. The outcome of feel cold (really cold) all the time and feel weak was unknown and not recovered for rest of the event.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.  Follow up attempts are completed. No further information is expected.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. This Consumer reported in response to EDP follow-up questionnaire which included that: New events was added. Pregnancy details, medical history and concomitant medication was added. Clinical course and text were amended accordingly.

Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed.  Confirmed Spontaneous abortion.  blood type of B-, patient received dose of RhoGam.  Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.

Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed.  Confirmed Spontaneous abortion.  blood type of B-, patient received dose of RhoGam.  Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.

Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient’s medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient’s last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter’s Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.

Spontaneous Abortion. Miscarriage started on it’s own at home.  Bleeding lasted 14 days, then turned to excessive hemorrhaging and ended up getting an emergency D&C. Was 10 weeks pregnant at time of miscarriage. EDD was 10/23/2021.

Spontaneous abortion, hives, headache

miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient’s husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room  visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage  was unknown while for all other events was not recovered.

Miscarriage / pregnancy loss; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report.  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 30-years-old), administered in Arm Left on 23Apr2021 10:00 (Lot Number: ER8735) as 2nd dose, single for COVID-19 immunization. The patient’s medical history was not reported. Concomitant medication included Nature Made Pre-Natal Vitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:00 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Confirmed pregnancy on 22Apr2021 at OBGYN via blood test, urine test, and ultrasound. Pfizer 2nd dose COVID vaccine administered on 23Apr2021. Began miscarriage on 28Apr2021. On 28Apr2021, OGBYN medical professionals detected NO GROWTH since 22Apr2021 ultrasound. Identical imagining in size. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient experienced miscarriage / pregnancy loss on 28Apr2021 15:30.No treatment received for the event. The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 20Dec2021. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovering. The event was considered as serious (disability, congenital anomaly).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.; Sender’s Comments: Linked Report(s) : US-PFIZER INC-2021497434 fetal case

Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed.  Confirmed Spontaneous abortion.  blood type of B-, patient received dose of RhoGam.  Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.

miscarried her baby; This is a spontaneous report from a contactable other HCP. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jun2021 (Batch/Lot number was not reported) at age of 33-year-old as DOSE NUMBER UNKNOWN, SINGLE for prevention of COVID. Medical history included the patient had exposure to COVID before but she tested negative, this occurred 31Oct2020. She also has history of pneumonia, on 31Dec2020. Obstetrical History: Number of previous pregnancies None that the caller is aware of. The patient’s concomitant medications were not reported. The patient became pregnant while taking bnt162b2. The due date was on 25Feb2022. The patient miscarried her baby on 26Jun2021. First Day of Last Menstrual Period was unknown. Caller said the patient thought she was right around 8 weeks when she called her on 16Jun2021 so by the callers calculations it would have been right around 21May2021 (as reported). She confirmed patient did not know but the date was provided by the callers calculation. Risk factors for adverse pregnancy outcomes including environmental or occupational exposures, e.g. hypertension, diabetes, etc. Family history of congenital abnormality/genetic diseases, consanguinity (or any family relation or lineage) between parents (specify degree): None. It was noted in the emergency room note that she had been trying to conceive for 15 years with her spouse, so she was having trouble getting pregnant. Caller was calling from a clinic about the Pfizer COVID vaccine. She has a patient who got the COVID vaccine 15Jun2021 and the patient miscarried her baby on 26Jun2021. She was looking for a place that was taking repots on stuff like that she did not feel that it was really a VAERS report. Dose: She did not have any record of the administration of her having it, she got it in a completely different town. The patient did not smoke during this pregnancy. The patient did not drink alcohol during this pregnancy. The patient did not use illicit drugs during this pregnancy. Caller added the patients blood type was O negative. She saw that Pfizer may be looking at information regarding blood type. Outcome of pregnancy was spontaneous abortion/miscarriage on 26Jun2021. No investigation assessment. The outcome of event was unknown. Seriousness: Caller stated this event was serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender’s Comments: Miscarriages/spontaneous abortion occurred 11 days after the vaccination with BNT 162B2.  Given that the patient with her spouse had trouble getting pregnancy for many years, the event more likely is associated with their underlying contributory factors.  More information including genetic, immunological and endocrine workups are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the Vaccine Adverse Event Reporting System (VAERS), and other data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021513072 Pfizer;US-PFIZER INC-2021513093 Pfizer;US-PFIZER INC-2021513094 Pfizer;US-PFIZER INC-2021513095 Pfizer;US-PFIZER INC-2021513097 Pfizer;US-PFIZER INC-2021513098 Pfizer;US-PFIZER INC-2021513099 Pfizer;US-PFIZER INC-2021513096 Pfizer

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the Vaccine Adverse Event Reporting System (VAERS) and other data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from 2021, pages 1-10 entitled Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons in the are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : PFIZER INC-2021480902 Pfizer;PFIZER INC-2021480902 Pfizer”"

This is a literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from a publication. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons in the are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

This is a literature report from The New England Journal of Medicine, 2021, pages 1-10 entitled Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from a Journal of Medicine, 2021, pages 1-10 entitled Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : PFIZER INC-2021480902 Pfizer;PFIZER INC-2021480902 Pfizer”"

This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN’S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn’s disease.    The patient’s past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN’S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date.  At the time of the report, CROHN’S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect.  No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Pregnancy dated by LMP consistent with 7 week ultrasound. Received first dose before pregnancy was known, received second dose at 7 weeks gestation. Started prenatal care, and had normal labs, euthyroid state, negative/normal fetal cell free DNA (non-invasive prenatal testing) done at 11 weeks with normal fetal nuchal translucency and nasal bone present. Missed spontaneous abortion discovered at 12 weeks 6 days (no fetal heart beat), D&C done, awaiting cytogenetics now.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the Vaccine Adverse Event Reporting System (VAERS), and other data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021513072 Pfizer;US-PFIZER INC-2021513093 Pfizer;US-PFIZER INC-2021513094 Pfizer;US-PFIZER INC-2021513095 Pfizer;US-PFIZER INC-2021513097 Pfizer;US-PFIZER INC-2021513098 Pfizer;US-PFIZER INC-2021513099 Pfizer;US-PFIZER INC-2021513096 Pfizer

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the Vaccine Adverse Event Reporting System (VAERS) and other data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from 2021, pages 1-10 entitled Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons in the are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : PFIZER INC-2021480902 Pfizer;PFIZER INC-2021480902 Pfizer”"

This is a literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from a publication. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons in the are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

This is a literature report from The New England Journal of Medicine, 2021, pages 1-10 entitled Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from a Journal of Medicine, 2021, pages 1-10 entitled Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : PFIZER INC-2021480902 Pfizer;PFIZER INC-2021480902 Pfizer”"

This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the “”safe after vaccination health checker”" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender’s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer”"

Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN’S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn’s disease.    The patient’s past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN’S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date.  At the time of the report, CROHN’S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect.  No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.

Miscarriage; patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; This is a spontaneous report from a contactable Other Health Professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on 22Dec2020 06:00 AM at single dose at Arm Right at Hospital for COVID.  Medical history included ongoing sleep apnoea. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage on 29Dec2020 13:00.  The patient was pregnant while taking BNT162B2. The patient was 4 Weeks pregnant at the onset of the event.  Patient last menstrual period date was 24Nov2020. The Pregnancy due to deliver was on 07Sep2021. The pregnancy resulted in spontaneous abortion. Since the vaccination, the patient has been tested for COVID-19 on an unknown date with unknown results. Nasal Swab on 28Dec2020 was Negative. There was no treatment received for the adverse event. The outcome of event was recovering.; Sender’s Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, Ethics Committees, and Investigators, as appropriate.

I was about 3 weeks pregnant at time of vaccination (Due date 9/3/2021). I experienced spontaneous abortion at 6 weeks gestation.  Uncomplicated, no doctors visits or hospitalization required (though I am a physician so tracked HCG levels throughout). G3P1, one prior missed spontaneous abortion  2017, one live birth 2019.

Spontaneous abortion. Pt was 9w1d at time of first Moderna COVID vaccine (EDD 8/9/2021). Two weeks later she began bleeding and was found to have an incomplete abortion with embryo measuring 9w1d. Proceeded to bleed heavily and D&C performed. Uncomplicated recovery. Genetic studies in process.  Unknown if SAB is related to vaccine, though it appears embryonic demise occurred within a few days of vaccine administration.

Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna’s COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage).  The patient’s medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine.   On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided.  The patient’s prior positive pregnancy test, last menstrual period, conception and due dates were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event,  pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter’s Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested

Miscarried at 6 weeks; Vaccine exposure during pregnancy; A spontaneous  report was received from a healthcare professional concerning a 32 year old female patients who received Moderna’s  Covid 19 vaccine(mRNA1273) and experienced vaccine exposure during pregnancy and miscarried at 6 weeks.  The patient’s medical history was not provided. Concomitant product use was not provided.    The patient received second of two planned dose of mRNA-1273  for prophylaxis of Covid 19 infection approximately 2.5 weeks before the miscarriage.  The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of Moderna vaccine.  The patient received both scheduled doses of mRNA-1273 prior to the events ; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event, miscarriage spontaneous  was considered as unknown. The outcome for the event of Vaccine exposure during pregnancy was recovered/resolved.; Reporter’s Comments: This case concerns a 32 year old, female subject, who experienced a spontaneous abortion and drug exposure during  pregnancy. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested.

Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient’s medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient’s last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter’s Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.

Pregnancy dated by LMP consistent with 7 week ultrasound. Received first dose before pregnancy was known, received second dose at 7 weeks gestation. Started prenatal care, and had normal labs, euthyroid state, negative/normal fetal cell free DNA (non-invasive prenatal testing) done at 11 weeks with normal fetal nuchal translucency and nasal bone present. Missed spontaneous abortion discovered at 12 weeks 6 days (no fetal heart beat), D&C done, awaiting cytogenetics now.

Last menstrual period either Nov 1-8 (light, abnormal, pregnancy symptoms) or Nov 29-12/2 (light, abnormal, pregnancy symptoms).  Possible dates of conception 10/16, 10/18, 10/19, 11/14, 11/15.  Negative pregnancy test on 11/26 & 11/29.  +Pregnancy test 12/10.   Estimated delivery dates were either 7/8/21 or 8/8/21. First covid vaccine received on 12/30.  First OB ultrasound on 1/5/21, estimated to be 6 weeks + 3 days gestation, with no heartbeat.  Repeat ultrasound on 1/13/21, continued to measure 6 weeks + 3 days gestation, again with no heartbeat. Spontaneous miscarriage did not occur, 1 time dose of intravaginal Cytotec was taken and medical abortion completed.

Pregnant patient miscarried; got pregnant in between the first and second dose; A spontaneous report was received from a pharmacist ,concerning a 38-year-old, female patient , who received Moderna’s COVID-19 vaccine(mRNA-1273) and experienced getting pregnant in between the first and second doses (Exposure during pregnancy) and miscarried/abortion spontaneous.  The patient’s medical history was not reported. Concomitant medications were not reported.  On 15 Jan 2021, patient received the first of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine intramuscularly for prophylaxis of COVID-19 infection.  Between an unknown date and 17 Mar 2021, the patient become pregnant and experienced a miscarriage.  On March 17 2021, the patient received the second of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine for prophylaxis of COVID-19 infection.  The event, miscarriage, was medically significant.  Laboratory details were not reported. Treatment information was not reported.  Action taken with mRNA-1273  in response to the events was not applicable.  At the time of report , the outcome of events; got pregnant in between first and second dose and pregnant patient miscarried were, were not reported.; Reporter’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

spontaneous abortion at approximately 8 weeks gestation, 10 days after vaccine administration

I had a miscarriage (spontaneous abortion) on March 14, 2021. I was 12 weeks pregnant at the time of miscarriage.

This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABORTION OF ECTOPIC PREGNANCY (Miscarriage) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Hypospadias on 15-Jun-2019 and Pregnancy (one). Concurrent medical conditions included Subfertility (Treated since 2018).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 29-Oct-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 05-Mar-2021, the patient experienced ABORTION OF ECTOPIC PREGNANCY (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Ectopic pregnancy. On 04-Mar-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, ABORTION OF ECTOPIC PREGNANCY (Miscarriage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.; Sender’s Comments: This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.

Patient had two previous live births and two spontaneous abortions at 10 and 8 weeks prior.  Reported lack of fetal movement in the last few days (not quantified).  Provider note ruled as a pregnancy loss at 19 weeks of gestation.

Had a early pregnancy loss at 7th week gestation, Spontaneous abortion, Having regular check ups and follow up with the doctors

Spontaneous Abortion. Miscarriage started on it’s own at home.  Bleeding lasted 14 days, then turned to excessive hemorrhaging and ended up getting an emergency D&C. Was 10 weeks pregnant at time of miscarriage. EDD was 10/23/2021.

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

Spontaneous abortion at 7 weeks LMP 2/18/21

Vaginal bleeding in 1st trimester (LMP 2/27/21); suspect spontaneous abortion

Miscarriage; Patient was unaware that she was pregnant; This spontaneous case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Pregnancy test (Negative home pregnancy test.) on 02-Mar-2021.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant). On 19-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment or concomitant mediation were reported.

MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; BODY ACHES; FEVER; This spontaneous report received from a consumer (company representative) concerned an female of unspecified age. The patient’s height, and weight were not reported. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient experienced body aches and fever. On 10-APR-2021, the patient was pregnant when she had vaccine. On 12-APR-2021, the patient experienced hemorrhage, miscarriage (spontaneous abortion) and was hospitalized (date unspecified). The duration of hospitalization was not reported. The date of patient’s last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). .; Sender’s Comments: V0: -covid-19 vaccine ad26.cov2.s-miscarriage, vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Patient was a 45 y/o,  G2P0, 39.3 weeks gestation, IVF pregnancy with Gestational Diabetes that was controlled with diet and gestational hypertension. Pt had history of 1 spontaneous abortion.  EDD 4/30/21. Pt received her second dose of Pfizer COVID 19 Vaccine on 4/23/21, on that same day she had an ultrasound to check on fetus and fetus received a Biophysical Profile Score of 8/8. On Monday, 4/26/21, pt went to hospital complaining of decreased fetal movement, ultrasound confirmed an intrauterine fetal demise.  Pt delivered via C-Section on 4/27/21, birth weight of baby was 8 pounds 12oz.

Spontaneous abortion (miscarriage) on April 15th, approximately 8 weeks pregnant (was due in November). No previous miscarriages and I have 2 healthy children.

went through a miscarriage on 23APR2021, after receiving the first dose; feeling abdomen pain lightly two to three days later; could not left her arm after the injection; injection site was sore,could not lift her arm after the injection; found pregnant on 07MAR2021,first vaccine dose 11APR2021; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 20-Nov-2021. On 11-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021). On 13-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection). On 14-Apr-2021, the patient experienced ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later). On 23-Apr-2021, the patient experienced ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, miscarriage on 23-Apr-2021. On 11-Apr-2021, EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021) had resolved. On 23-Apr-2021, ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) had resolved. At the time of the report, ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later), VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that his wife was found pregnant on 07Mar2021. She had normal back pain and normal pregnancy pain during her pregnancy. My wife could not left her arm after the injection and the injection site was sore on 13-Apr-2021.  After taking the Moderna vaccine she started to have abdomen pain lightly for two to three days on 14-Apr-2021. On 22-Apr-2021, she started to feel unbearable pain. On Friday 23-Apr-2021 she had a miscarriage.   No treatment product information was not provided  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up had NNI; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

The patient was pregnant at the time of vaccination; The patient was pregnant at the time of vaccination; Miscarriage; This is a spontaneous report from a contactable consumer (patient, self-reported). The patient reported information for both herself and fetus/baby. This is a maternal report. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not provided. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination. The patient was not tested for COVID post vaccination. The patient was pregnant at the time of vaccination. The Patient’s last menstrual date was 09Jan2021 and delivery date was 16Oct2021. The mother reported she became pregnant while taking BNT162B2. The mother was 14 weeks pregnant at the onset of the event. It was reported that on 21Apr2021, the pregnancy resulted in spontaneous abortion- miscarriage and resulted in emergency room and physician visit. Outcome of the event miscarriage was reported as not recovered and for all other events, it was unknown.  Information on the lot/batch number has been requested.

Patient Miscarried; vaccine exposure during pregnancy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030m20a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) (seriousness criterion medically significant). On 30-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Patient Miscarried) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Company Comment:  This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use.  Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking.  Additional information has been requested.; Sender’s Comments: This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use.  Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking.  Additional information has been requested.

Miscarriage; Electing not to receive second Moderna dose after learning she was pregnant; Pregnant when she received her first Moderna dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient’s past medical history included Polycystic ovarian syndrome and Hypothyroidism. Concomitant products included LEVOTHYROXINE and METFORMIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose). On 05-Feb-2021, the patient experienced INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant). On 27-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose) had resolved. On 05-Feb-2021, INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant) had resolved. On 27-Apr-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information regarding treatment was provided.  Nurse reported she was unaware she was pregnant when she received her first Moderna dose on 08-Jan-2021. Nurse reported that she discovered she was pregnant a week 29-Jan-2021 prior to her scheduled second Moderna dose on 05-Feb-2021. Testing was performed on the fetus and physicians determined the baby was a normal healthy girl with no genetic abnormalities or findings. Reportedly, she stopped metformin during her pregnancy so glucose testing could be performed.

First trimester miscarriage; Received the Moderna COVID-19 Vaccine while pregnant; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (First trimester miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (First trimester miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion.  At the time of the report, ABORTION SPONTANEOUS (First trimester miscarriage) outcome was unknown and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  No treatment details were provided.  Company Comment : This is a case of product exposure during pregnancy with associated AEs for this female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.

Caused misscarrage; Vaccine exposure during pregnancy; Based on the current case data, this case has been classified as invalid. This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Caused misscarrage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Caused misscarrage) (seriousness criteria medically significant and congenital anomaly) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Caused misscarrage) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  This is a case of product exposure during pregnancy with associated AE.   Reporter did not allow further contact; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  This is a case of product exposure during pregnancy with associated AE .

Spontaneous miscarriage; Spontaneous miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Spontaneous miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Spontaneous miscarriage. Gestation period not reported. At the time of the report, ABORTION SPONTANEOUS (Spontaneous miscarriage) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.  Company Comment: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender’s Comments: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.

had a miscarriage; had vaccine during the first 10 weeks and had a miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (had a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (had a miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (had a miscarriage) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment drug was reported.  It was reported that the baby died  Company comment: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.; Sender’s Comments: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.

This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (lost the pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (lost the pregnancy) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, ABORTION SPONTANEOUS (lost the pregnancy) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.  Moderna Customer Care agent attempted a warm transfer but when retrieving the caller the caller was no longer on the line. But the agent informed that  the caller received the first dose of the Moderna COVID-19 vaccine in March. At  the time of vaccination the caller did not know they were pregnant and did not get second dose once they found out for safety reasons. The caller lost the pregnancy and now wants to know if they can get the second dose.  This is a case of product exposure during pregnancy with associated AEs for this female patient of unknown age. Patient declined further contact no further details is expected.; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this female patient of unknown age. Patient declined further contact no further details is expected.

Spontaneous abortion at 7weeks gestational age.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Received first dose without knowing I was pregnant. I have a high risk pregnancy and the baby is at risk of a spontaneous abortion I?ve being in bed since I knew I was pregnant.  I have intense abdominal pain, no hemorrhage just unknown pain.  Doctors told me to keep resting and just wait for a spontaneous abortion, I was given the fist dose and was advised to not take the second dose . I am know 11 weeks of painful pregnancy just waiting for something to occur. I recommend that woman who are in reproduction ages should first take a pregnancy exam before the vaccine so that nothing like what I am passing happens to someone else. Doctors say that if the pregnancy concludes at its last term the baby will have birth defects because of the vaccine. They recommend and abortion or just wait for a spontaneous abortion.

Miscarriage shortly after the 1st dose; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date.  At the time of the report, ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was not given.  No treatment information was given.; Sender’s Comments: This is a case of exposure of product during pregnancy with the vaccine mRNA -1273 with reported AE of spontaneous abortion. There is very limited information regarding this events  has been provided at this time.  Further information has been requested.

Pregnancy resulted in a miscarriage; Did not receive 2nd dose; Found out she was pregnant after receiving 1st dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 22-Mar-2021, EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) had resolved and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was reported that the patient received first shot and then found out she was pregnant.  The pregnancy resulted in a miscarriage and patient wanted to knowif she should now get her 2nd shot, or restart the vaccination series.    This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected.   Reporter did not allow further contact; Sender’s Comments: This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected.

Miscarriage; she received first moderna vaccine while pregnant; Nausea; Headache; Vomiting; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 15-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred  on 15-May-2021. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Mar-2021, EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  In about a period of two weeks, the ultrasound indicated that the baby’s heart beat was non-existent and on 15 May 2021, the patient had a spontaneous miscarriage.  Date of last menstrual period and estimated due date were not provided.  No treatment was given.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226308 (Parent-Child Link).   See case MOD-2021-226308 for details regarding the child case.; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Pfizer COVID19 vaccinations given on 5/5/21 and 5/26/2021.  Patients last menstrual period 4/27/2021 prior to pregnancy.  Spontaneous abortion/miscarriage at 7 weeks gestation on 6/24/21.

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage; At the time of the shot she was 7 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) in a 39-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jul-2021, the patient experienced EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant). On 08-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) (seriousness criteria medically significant, life threatening and congenital anomaly). On 07-Jul-2021, EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant) had resolved. On 09-Jul-2021, ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  The laboratory exams performed to further understand the event included were ultrasound a week prior to the shot to show the babies heart rate. Treatment medication use information was not provided by reporter.; Sender’s Comments: This case concerns a 39-year-old female patient gravida 1 who received mRNA-1273 at 7 weeks of pregnancy and experienced spotting one day post vaccination and spontaneous abortion 2 days post vaccination.  Last menstrual period and estimated date of delivery were not provided. Spontaneous abortion show temporal association with product use and a causal relationship cannot be excluded.  The event of exposure during pregnancy is assessed not applicable

Unexplainable second trimester vaginal bleeding without spontaneous abortion.

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient’s husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room  visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage  was unknown while for all other events was not recovered.

My pregnancy symptom s started disappearing gradually and after a week I didn’t feel pregnant at all/missed abortion; My arm was sore; I felt mild fatigue; This is spontaneous report from contactable consumer.  A 28 year-old female consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8735), on 03May2021 (at the age of 28-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of vaccine on 13Apr2021 (lot EW0164). The patient had no known allergies and had not other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that she got her 2nd dose of vaccination when she was 7 weeks pregnant. The LMP was on 21Mar2021. Her arm was sore and she felt mild fatigue. Her pregnancy symptoms started disappearing gradually and after a week she didn’t feel pregnant at all. When she went in for her first ultrasound appointment at 9 weeks, the doctor said that the growth stopped at 7 weeks 4 days and there was no heartbeat. She declared it missed abortion.  Information on Lot/Batch number was available. Additional information has been requested.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

I tested positive for pregnancy in 17Mar2021. In 24Mar2021 I got my first covid vaccine from Pfizer; feel cold (really cold) all the time; feel weak; This is a spontaneous report from contactable consumer female (patient, mother reported for herself). A 41-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on right arm on 24Mar2021 at 07:15 hours, as 1st single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included dementia, patient was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. Patient had one previous pregnancy and no previous maternal pregnancy compilations. Concomitant medication included patient was taking Throne dietary supplement for prenatal supplement from 18Mar2021, daily and ongoing. First day of last Menstrual period was 14Feb2021. Estimated delivery of patient was 21Nov2021. Gestation period at the time of initial exposure was 2 weeks, 1st trimester. Patient had no problems before delivery. No drugs were taken by father (patient’s husband) during the mother’s pregnancy, father was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. The patient tested positive for pregnancy in 17Mar2021. On 24Mar2021, she got her first COVID vaccine from Pfizer. Patient first appointment with her OB/GYN was in 05Apr2021. Her doctor did an ultrasound and checked the baby’s vital signs. She confirmed that the baby was the right size, and the baby heartbeat was good. She said everything was ok with the baby. On 14Apr2021 she got her second Covid vaccine from Pfizer. Her vaccine was schedule at 10:00 AM. After she got the vaccine, she started to have cramps. About 1:00 PM she started bleeding (light red). She called her doctor and she told her to go to her office. About 1:45 PM She had a new ultrasound. Her doctor said that she did not find any heartbeat in the baby and that she was having an abortion.  On 10May2021, it was reported that on unspecified date of 2021, after she got the vaccine, patient had some different symptoms like feel cold (really cold) all the time and feel weak. During all this time she was taking just Thorne-Dietary supplement. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on left arm on 14Apr2021 at 10:15 hours, as 2nd single dose (at the age of 41-years-old) for COVID-19 immunization. Patient called her doctor at 14:00 to 14:30 hours on 14Apr2021, during physician office visit, the doctor did a sonogram and she said that she was having a spontaneous abortion/miscarriage with 7 weeks (2 months) of gestational age. During the sonogram/ultrasound, no heartbeat was detected for fetal. Patient stated that it was the first time that she had miscarriage, her first pregnancy was normal, and her son was born. Patient got the 2 vaccines but wasn’t informed about the Lot number. The outcome of feel cold (really cold) all the time and feel weak was unknown and not recovered for rest of the event.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.  Follow up attempts are completed. No further information is expected.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. This Consumer reported in response to EDP follow-up questionnaire which included that: New events was added. Pregnancy details, medical history and concomitant medication was added. Clinical course and text were amended accordingly.

Spontaneous abortion at 7weeks gestational age.

Patient was a 45 y/o,  G2P0, 39.3 weeks gestation, IVF pregnancy with Gestational Diabetes that was controlled with diet and gestational hypertension. Pt had history of 1 spontaneous abortion.  EDD 4/30/21. Pt received her second dose of Pfizer COVID 19 Vaccine on 4/23/21, on that same day she had an ultrasound to check on fetus and fetus received a Biophysical Profile Score of 8/8. On Monday, 4/26/21, pt went to hospital complaining of decreased fetal movement, ultrasound confirmed an intrauterine fetal demise.  Pt delivered via C-Section on 4/27/21, birth weight of baby was 8 pounds 12oz.

Unexplainable second trimester vaginal bleeding without spontaneous abortion.

Pregnancy dated by LMP consistent with 7 week ultrasound. Received first dose before pregnancy was known, received second dose at 7 weeks gestation. Started prenatal care, and had normal labs, euthyroid state, negative/normal fetal cell free DNA (non-invasive prenatal testing) done at 11 weeks with normal fetal nuchal translucency and nasal bone present. Missed spontaneous abortion discovered at 12 weeks 6 days (no fetal heart beat), D&C done, awaiting cytogenetics now.

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

Patient received dose 2/2 of Pfizer vaccine on 2/25/2021. She had an IUI procedure done in (country) on 12/14/2020, which was confirmed to be successful at her follow up OB/Gyn visit- then returned to (country) . Patient returned to (country) on Feb 8, 2021 for 10 week US and was found to have no fetal heart tone, missed spontaneous abortion at approximately 7w5d. This timing would draw into question the timing of the vaccine administration.

Pfizer COVID19 vaccinations given on 5/5/21 and 5/26/2021.  Patients last menstrual period 4/27/2021 prior to pregnancy.  Spontaneous abortion/miscarriage at 7 weeks gestation on 6/24/21.

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

Vaginal bleeding in 1st trimester (LMP 2/27/21); suspect spontaneous abortion

Spontaneous abortion. Pt was 9w1d at time of first Moderna COVID vaccine (EDD 8/9/2021). Two weeks later she began bleeding and was found to have an incomplete abortion with embryo measuring 9w1d. Proceeded to bleed heavily and D&C performed. Uncomplicated recovery. Genetic studies in process.  Unknown if SAB is related to vaccine, though it appears embryonic demise occurred within a few days of vaccine administration.

Vaginal bleeding in 1st trimester (LMP 2/27/21); suspect spontaneous abortion

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

Unexplainable second trimester vaginal bleeding without spontaneous abortion.

I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.  The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.   On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor’s office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.

Spontaneous abortion. Pt was 9w1d at time of first Moderna COVID vaccine (EDD 8/9/2021). Two weeks later she began bleeding and was found to have an incomplete abortion with embryo measuring 9w1d. Proceeded to bleed heavily and D&C performed. Uncomplicated recovery. Genetic studies in process.  Unknown if SAB is related to vaccine, though it appears embryonic demise occurred within a few days of vaccine administration.

Spontaneous Abortion. Miscarriage started on it’s own at home.  Bleeding lasted 14 days, then turned to excessive hemorrhaging and ended up getting an emergency D&C. Was 10 weeks pregnant at time of miscarriage. EDD was 10/23/2021.

Vaginal bleeding in 1st trimester (LMP 2/27/21); suspect spontaneous abortion

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

Spontaneous abortion, hives, headache

Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.

Miscarriage; she received first moderna vaccine while pregnant; Nausea; Headache; Vomiting; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 15-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred  on 15-May-2021. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Mar-2021, EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  In about a period of two weeks, the ultrasound indicated that the baby’s heart beat was non-existent and on 15 May 2021, the patient had a spontaneous miscarriage.  Date of last menstrual period and estimated due date were not provided.  No treatment was given.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226308 (Parent-Child Link).   See case MOD-2021-226308 for details regarding the child case.; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.

Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient’s medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient’s last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter’s Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.

Spontaneous Abortion. Miscarriage started on it’s own at home.  Bleeding lasted 14 days, then turned to excessive hemorrhaging and ended up getting an emergency D&C. Was 10 weeks pregnant at time of miscarriage. EDD was 10/23/2021.

Spontaneous abortion, hives, headache

Unexplainable second trimester vaginal bleeding without spontaneous abortion.

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

Miscarriage/spontaneous abortion

Spontaneous abortion at 7weeks gestational age.

I was about 3 weeks pregnant at time of vaccination (Due date 9/3/2021). I experienced spontaneous abortion at 6 weeks gestation.  Uncomplicated, no doctors visits or hospitalization required (though I am a physician so tracked HCG levels throughout). G3P1, one prior missed spontaneous abortion  2017, one live birth 2019.

Vaginal bleeding in 1st trimester (LMP 2/27/21); suspect spontaneous abortion

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

First shot felt like I had flu for 2 to 3 days; This is a spontaneous report from a contactable consumer (patient). An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 as dose 1, single for COVID-19 immunization. Medical history included post-traumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD), depression, anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, caesarean section, asthma from an unknown date and unknown if ongoing. The patient’s concomitant medications were not reported. The patient had known allergies to amoxicillin, morphine, cantaloupe others unknown and experienced allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received 3 other prescriptions daily in two weeks prior to the vaccination. The patient stated that after first shot felt like she had flu for 2 to 3 days on 30Mar2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient received Therapy and possible change in medication as treatment for the adverse events. The outcome of the event was not recovered.  Follow-up attempts are needed. Further information is expected.

Miscarriage; Electing not to receive second Moderna dose after learning she was pregnant; Pregnant when she received her first Moderna dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient’s past medical history included Polycystic ovarian syndrome and Hypothyroidism. Concomitant products included LEVOTHYROXINE and METFORMIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose). On 05-Feb-2021, the patient experienced INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant). On 27-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose) had resolved. On 05-Feb-2021, INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant) had resolved. On 27-Apr-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information regarding treatment was provided.  Nurse reported she was unaware she was pregnant when she received her first Moderna dose on 08-Jan-2021. Nurse reported that she discovered she was pregnant a week 29-Jan-2021 prior to her scheduled second Moderna dose on 05-Feb-2021. Testing was performed on the fetus and physicians determined the baby was a normal healthy girl with no genetic abnormalities or findings. Reportedly, she stopped metformin during her pregnancy so glucose testing could be performed.

Pregnancy dated by LMP consistent with 7 week ultrasound. Received first dose before pregnancy was known, received second dose at 7 weeks gestation. Started prenatal care, and had normal labs, euthyroid state, negative/normal fetal cell free DNA (non-invasive prenatal testing) done at 11 weeks with normal fetal nuchal translucency and nasal bone present. Missed spontaneous abortion discovered at 12 weeks 6 days (no fetal heart beat), D&C done, awaiting cytogenetics now.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN’S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn’s disease.    The patient’s past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN’S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date.  At the time of the report, CROHN’S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect.  No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown.  Follow-up attempts are completed. No further information is expected.; Sender’s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case)

Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN’S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn’s disease.    The patient’s past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN’S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date.  At the time of the report, CROHN’S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect.  No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

I tested positive for pregnancy in 17Mar2021. In 24Mar2021 I got my first covid vaccine from Pfizer; feel cold (really cold) all the time; feel weak; This is a spontaneous report from contactable consumer female (patient, mother reported for herself). A 41-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on right arm on 24Mar2021 at 07:15 hours, as 1st single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included dementia, patient was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. Patient had one previous pregnancy and no previous maternal pregnancy compilations. Concomitant medication included patient was taking Throne dietary supplement for prenatal supplement from 18Mar2021, daily and ongoing. First day of last Menstrual period was 14Feb2021. Estimated delivery of patient was 21Nov2021. Gestation period at the time of initial exposure was 2 weeks, 1st trimester. Patient had no problems before delivery. No drugs were taken by father (patient’s husband) during the mother’s pregnancy, father was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. The patient tested positive for pregnancy in 17Mar2021. On 24Mar2021, she got her first COVID vaccine from Pfizer. Patient first appointment with her OB/GYN was in 05Apr2021. Her doctor did an ultrasound and checked the baby’s vital signs. She confirmed that the baby was the right size, and the baby heartbeat was good. She said everything was ok with the baby. On 14Apr2021 she got her second Covid vaccine from Pfizer. Her vaccine was schedule at 10:00 AM. After she got the vaccine, she started to have cramps. About 1:00 PM she started bleeding (light red). She called her doctor and she told her to go to her office. About 1:45 PM She had a new ultrasound. Her doctor said that she did not find any heartbeat in the baby and that she was having an abortion.  On 10May2021, it was reported that on unspecified date of 2021, after she got the vaccine, patient had some different symptoms like feel cold (really cold) all the time and feel weak. During all this time she was taking just Thorne-Dietary supplement. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on left arm on 14Apr2021 at 10:15 hours, as 2nd single dose (at the age of 41-years-old) for COVID-19 immunization. Patient called her doctor at 14:00 to 14:30 hours on 14Apr2021, during physician office visit, the doctor did a sonogram and she said that she was having a spontaneous abortion/miscarriage with 7 weeks (2 months) of gestational age. During the sonogram/ultrasound, no heartbeat was detected for fetal. Patient stated that it was the first time that she had miscarriage, her first pregnancy was normal, and her son was born. Patient got the 2 vaccines but wasn’t informed about the Lot number. The outcome of feel cold (really cold) all the time and feel weak was unknown and not recovered for rest of the event.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.  Follow up attempts are completed. No further information is expected.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. This Consumer reported in response to EDP follow-up questionnaire which included that: New events was added. Pregnancy details, medical history and concomitant medication was added. Clinical course and text were amended accordingly.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

Vaginal bleeding in 1st trimester (LMP 2/27/21); suspect spontaneous abortion

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

Patient was a 45 y/o,  G2P0, 39.3 weeks gestation, IVF pregnancy with Gestational Diabetes that was controlled with diet and gestational hypertension. Pt had history of 1 spontaneous abortion.  EDD 4/30/21. Pt received her second dose of Pfizer COVID 19 Vaccine on 4/23/21, on that same day she had an ultrasound to check on fetus and fetus received a Biophysical Profile Score of 8/8. On Monday, 4/26/21, pt went to hospital complaining of decreased fetal movement, ultrasound confirmed an intrauterine fetal demise.  Pt delivered via C-Section on 4/27/21, birth weight of baby was 8 pounds 12oz.

Miscarriage; she received first moderna vaccine while pregnant; Nausea; Headache; Vomiting; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 15-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred  on 15-May-2021. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Mar-2021, EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  In about a period of two weeks, the ultrasound indicated that the baby’s heart beat was non-existent and on 15 May 2021, the patient had a spontaneous miscarriage.  Date of last menstrual period and estimated due date were not provided.  No treatment was given.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226308 (Parent-Child Link).   See case MOD-2021-226308 for details regarding the child case.; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown.  Follow-up attempts are completed. No further information is expected.; Sender’s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case)

The patient was pregnant at the time of vaccination; The patient was pregnant at the time of vaccination; Miscarriage; This is a spontaneous report from a contactable consumer (patient, self-reported). The patient reported information for both herself and fetus/baby. This is a maternal report. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not provided. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination. The patient was not tested for COVID post vaccination. The patient was pregnant at the time of vaccination. The Patient’s last menstrual date was 09Jan2021 and delivery date was 16Oct2021. The mother reported she became pregnant while taking BNT162B2. The mother was 14 weeks pregnant at the onset of the event. It was reported that on 21Apr2021, the pregnancy resulted in spontaneous abortion- miscarriage and resulted in emergency room and physician visit. Outcome of the event miscarriage was reported as not recovered and for all other events, it was unknown.  Information on the lot/batch number has been requested.

Amenorrhoea; Abortion spontaneous; Ovulation disorder; Pregnancy; Uterine spasm; This case was received via  VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy) and UTERINE SPASM (Uterine spasm). On an unknown date, the patient experienced AMENORRHOEA (Amenorrhoea). At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy), UTERINE SPASM (Uterine spasm) and AMENORRHOEA (Amenorrhoea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the provided. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender’s Comments: This is a case of product exposure during pregnancy which resulted in Abortion spontaneous, for this 29 years old female. Very limited information has been provided at this time.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.

MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; BODY ACHES; FEVER; This spontaneous report received from a consumer (company representative) concerned an female of unspecified age. The patient’s height, and weight were not reported. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient experienced body aches and fever. On 10-APR-2021, the patient was pregnant when she had vaccine. On 12-APR-2021, the patient experienced hemorrhage, miscarriage (spontaneous abortion) and was hospitalized (date unspecified). The duration of hospitalization was not reported. The date of patient’s last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). .; Sender’s Comments: V0: -covid-19 vaccine ad26.cov2.s-miscarriage, vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient’s husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room  visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage  was unknown while for all other events was not recovered.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient’s husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room  visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage  was unknown while for all other events was not recovered.

Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.

My pregnancy symptom s started disappearing gradually and after a week I didn’t feel pregnant at all/missed abortion; My arm was sore; I felt mild fatigue; This is spontaneous report from contactable consumer.  A 28 year-old female consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8735), on 03May2021 (at the age of 28-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of vaccine on 13Apr2021 (lot EW0164). The patient had no known allergies and had not other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that she got her 2nd dose of vaccination when she was 7 weeks pregnant. The LMP was on 21Mar2021. Her arm was sore and she felt mild fatigue. Her pregnancy symptoms started disappearing gradually and after a week she didn’t feel pregnant at all. When she went in for her first ultrasound appointment at 9 weeks, the doctor said that the growth stopped at 7 weeks 4 days and there was no heartbeat. She declared it missed abortion.  Information on Lot/Batch number was available. Additional information has been requested.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Miscarriage; Pregnancy; well past the 42 day mark; A Spontaneous report was received from a Healthcare Professional concerning a  female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) and the patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  The patients medical history was not provided.No concomitant medication information was provided.  On an unknown date in JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly  for prophylaxis of COVID-19 infection.  On an unknown date, The patient The patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  Laboratory details was not provided.No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Pregnancy and Miscarriage was resolved.  The outcome of the event  well past 42 days was unknown.; Reporter’s Comments: This is a case of product exposure during pregnancy with spontaneous abortion for this female (age unknown).  Patient missed her second dose. She will continue to be contacted for further monitoring of AEs post abortion. .

spontaneous miscarriage; conceived following second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder, Drug allergy (sulfa), Drug allergy (cephalosporins) and Drug allergy (codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication.   On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, PREGNANCY (conceived following second dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (spontaneous miscarriage) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of last menstrual period was 29Jan2021 This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder and Drug allergy (sulfa, cephalosporins, codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication.   On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, ABORTION SPONTANEOUS (spontaneous miscarriage) and PREGNANCY (conceived following second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of last menstrual period was 29 Jan 2021.  This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender’s Comments: This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Amenorrhoea; Abortion spontaneous; Ovulation disorder; Pregnancy; Uterine spasm; This case was received via  VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy) and UTERINE SPASM (Uterine spasm). On an unknown date, the patient experienced AMENORRHOEA (Amenorrhoea). At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy), UTERINE SPASM (Uterine spasm) and AMENORRHOEA (Amenorrhoea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the provided. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender’s Comments: This is a case of product exposure during pregnancy which resulted in Abortion spontaneous, for this 29 years old female. Very limited information has been provided at this time.

spontaneous miscarriage; conceived following second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder, Drug allergy (sulfa), Drug allergy (cephalosporins) and Drug allergy (codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication.   On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, PREGNANCY (conceived following second dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (spontaneous miscarriage) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of last menstrual period was 29Jan2021 This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder and Drug allergy (sulfa, cephalosporins, codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication.   On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, ABORTION SPONTANEOUS (spontaneous miscarriage) and PREGNANCY (conceived following second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of last menstrual period was 29 Jan 2021.  This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender’s Comments: This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Had a early pregnancy loss at 7th week gestation, Spontaneous abortion, Having regular check ups and follow up with the doctors

I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.  The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.   On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor’s office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Miscarriage / pregnancy loss; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report.  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 30-years-old), administered in Arm Left on 23Apr2021 10:00 (Lot Number: ER8735) as 2nd dose, single for COVID-19 immunization. The patient’s medical history was not reported. Concomitant medication included Nature Made Pre-Natal Vitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:00 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Confirmed pregnancy on 22Apr2021 at OBGYN via blood test, urine test, and ultrasound. Pfizer 2nd dose COVID vaccine administered on 23Apr2021. Began miscarriage on 28Apr2021. On 28Apr2021, OGBYN medical professionals detected NO GROWTH since 22Apr2021 ultrasound. Identical imagining in size. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient experienced miscarriage / pregnancy loss on 28Apr2021 15:30.No treatment received for the event. The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 20Dec2021. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovering. The event was considered as serious (disability, congenital anomaly).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.; Sender’s Comments: Linked Report(s) : US-PFIZER INC-2021497434 fetal case

Miscarriage; Pregnancy; well past the 42 day mark; A Spontaneous report was received from a Healthcare Professional concerning a  female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) and the patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  The patients medical history was not provided.No concomitant medication information was provided.  On an unknown date in JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly  for prophylaxis of COVID-19 infection.  On an unknown date, The patient The patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  Laboratory details was not provided.No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Pregnancy and Miscarriage was resolved.  The outcome of the event  well past 42 days was unknown.; Reporter’s Comments: This is a case of product exposure during pregnancy with spontaneous abortion for this female (age unknown).  Patient missed her second dose. She will continue to be contacted for further monitoring of AEs post abortion. .

Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.

This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (lost the pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (lost the pregnancy) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, ABORTION SPONTANEOUS (lost the pregnancy) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.  Moderna Customer Care agent attempted a warm transfer but when retrieving the caller the caller was no longer on the line. But the agent informed that  the caller received the first dose of the Moderna COVID-19 vaccine in March. At  the time of vaccination the caller did not know they were pregnant and did not get second dose once they found out for safety reasons. The caller lost the pregnancy and now wants to know if they can get the second dose.  This is a case of product exposure during pregnancy with associated AEs for this female patient of unknown age. Patient declined further contact no further details is expected.; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this female patient of unknown age. Patient declined further contact no further details is expected.

Pregnancy resulted in a miscarriage; Did not receive 2nd dose; Found out she was pregnant after receiving 1st dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 22-Mar-2021, EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) had resolved and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was reported that the patient received first shot and then found out she was pregnant.  The pregnancy resulted in a miscarriage and patient wanted to knowif she should now get her 2nd shot, or restart the vaccination series.    This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected.   Reporter did not allow further contact; Sender’s Comments: This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected.

I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown.  Follow-up attempts are completed. No further information is expected.; Sender’s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case)

Unexplainable second trimester vaginal bleeding without spontaneous abortion.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.

MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; BODY ACHES; FEVER; This spontaneous report received from a consumer (company representative) concerned an female of unspecified age. The patient’s height, and weight were not reported. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient experienced body aches and fever. On 10-APR-2021, the patient was pregnant when she had vaccine. On 12-APR-2021, the patient experienced hemorrhage, miscarriage (spontaneous abortion) and was hospitalized (date unspecified). The duration of hospitalization was not reported. The date of patient’s last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). .; Sender’s Comments: V0: -covid-19 vaccine ad26.cov2.s-miscarriage, vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown.  Follow-up attempts are completed. No further information is expected.; Sender’s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case)

miscarried her baby; This is a spontaneous report from a contactable other HCP. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jun2021 (Batch/Lot number was not reported) at age of 33-year-old as DOSE NUMBER UNKNOWN, SINGLE for prevention of COVID. Medical history included the patient had exposure to COVID before but she tested negative, this occurred 31Oct2020. She also has history of pneumonia, on 31Dec2020. Obstetrical History: Number of previous pregnancies None that the caller is aware of. The patient’s concomitant medications were not reported. The patient became pregnant while taking bnt162b2. The due date was on 25Feb2022. The patient miscarried her baby on 26Jun2021. First Day of Last Menstrual Period was unknown. Caller said the patient thought she was right around 8 weeks when she called her on 16Jun2021 so by the callers calculations it would have been right around 21May2021 (as reported). She confirmed patient did not know but the date was provided by the callers calculation. Risk factors for adverse pregnancy outcomes including environmental or occupational exposures, e.g. hypertension, diabetes, etc. Family history of congenital abnormality/genetic diseases, consanguinity (or any family relation or lineage) between parents (specify degree): None. It was noted in the emergency room note that she had been trying to conceive for 15 years with her spouse, so she was having trouble getting pregnant. Caller was calling from a clinic about the Pfizer COVID vaccine. She has a patient who got the COVID vaccine 15Jun2021 and the patient miscarried her baby on 26Jun2021. She was looking for a place that was taking repots on stuff like that she did not feel that it was really a VAERS report. Dose: She did not have any record of the administration of her having it, she got it in a completely different town. The patient did not smoke during this pregnancy. The patient did not drink alcohol during this pregnancy. The patient did not use illicit drugs during this pregnancy. Caller added the patients blood type was O negative. She saw that Pfizer may be looking at information regarding blood type. Outcome of pregnancy was spontaneous abortion/miscarriage on 26Jun2021. No investigation assessment. The outcome of event was unknown. Seriousness: Caller stated this event was serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender’s Comments: Miscarriages/spontaneous abortion occurred 11 days after the vaccination with BNT 162B2.  Given that the patient with her spouse had trouble getting pregnancy for many years, the event more likely is associated with their underlying contributory factors.  More information including genetic, immunological and endocrine workups are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

spontaneous abortion; This is spontaneous report from a contactable nurse. A 27 year old female patient who was not pregnant at the time of vaccination received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot Number: EL3247) dose 1 intramuscular administered on Arm left on 15Feb2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Seriousness criteria was reported by the patient that it was not serious, no death life-threatening or cause of prolonged hospitalisation. It was not disabling and did not have any congenital birth defect. COVID-19 vaccine was administered at the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. 12Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test negative. On 29Mar2021, the patient had spontaneous abortion and was taken to emergency room in hospital. On 25Apr2021, the device date given. vaccine facility, race and ethnicity information was available. The outcome of the event was recovered.; Sender’s Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, spontaneous abortion cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021458221 mother/baby case

I tested positive for pregnancy in 17Mar2021. In 24Mar2021 I got my first covid vaccine from Pfizer; feel cold (really cold) all the time; feel weak; This is a spontaneous report from contactable consumer female (patient, mother reported for herself). A 41-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on right arm on 24Mar2021 at 07:15 hours, as 1st single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included dementia, patient was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. Patient had one previous pregnancy and no previous maternal pregnancy compilations. Concomitant medication included patient was taking Throne dietary supplement for prenatal supplement from 18Mar2021, daily and ongoing. First day of last Menstrual period was 14Feb2021. Estimated delivery of patient was 21Nov2021. Gestation period at the time of initial exposure was 2 weeks, 1st trimester. Patient had no problems before delivery. No drugs were taken by father (patient’s husband) during the mother’s pregnancy, father was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. The patient tested positive for pregnancy in 17Mar2021. On 24Mar2021, she got her first COVID vaccine from Pfizer. Patient first appointment with her OB/GYN was in 05Apr2021. Her doctor did an ultrasound and checked the baby’s vital signs. She confirmed that the baby was the right size, and the baby heartbeat was good. She said everything was ok with the baby. On 14Apr2021 she got her second Covid vaccine from Pfizer. Her vaccine was schedule at 10:00 AM. After she got the vaccine, she started to have cramps. About 1:00 PM she started bleeding (light red). She called her doctor and she told her to go to her office. About 1:45 PM She had a new ultrasound. Her doctor said that she did not find any heartbeat in the baby and that she was having an abortion.  On 10May2021, it was reported that on unspecified date of 2021, after she got the vaccine, patient had some different symptoms like feel cold (really cold) all the time and feel weak. During all this time she was taking just Thorne-Dietary supplement. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on left arm on 14Apr2021 at 10:15 hours, as 2nd single dose (at the age of 41-years-old) for COVID-19 immunization. Patient called her doctor at 14:00 to 14:30 hours on 14Apr2021, during physician office visit, the doctor did a sonogram and she said that she was having a spontaneous abortion/miscarriage with 7 weeks (2 months) of gestational age. During the sonogram/ultrasound, no heartbeat was detected for fetal. Patient stated that it was the first time that she had miscarriage, her first pregnancy was normal, and her son was born. Patient got the 2 vaccines but wasn’t informed about the Lot number. The outcome of feel cold (really cold) all the time and feel weak was unknown and not recovered for rest of the event.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.  Follow up attempts are completed. No further information is expected.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. This Consumer reported in response to EDP follow-up questionnaire which included that: New events was added. Pregnancy details, medical history and concomitant medication was added. Clinical course and text were amended accordingly.

Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient’s medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient’s last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter’s Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient’s medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient’s last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter’s Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.

Patient was a 45 y/o,  G2P0, 39.3 weeks gestation, IVF pregnancy with Gestational Diabetes that was controlled with diet and gestational hypertension. Pt had history of 1 spontaneous abortion.  EDD 4/30/21. Pt received her second dose of Pfizer COVID 19 Vaccine on 4/23/21, on that same day she had an ultrasound to check on fetus and fetus received a Biophysical Profile Score of 8/8. On Monday, 4/26/21, pt went to hospital complaining of decreased fetal movement, ultrasound confirmed an intrauterine fetal demise.  Pt delivered via C-Section on 4/27/21, birth weight of baby was 8 pounds 12oz.

I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.  The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.   On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor’s office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.

Pregnancy dated by LMP consistent with 7 week ultrasound. Received first dose before pregnancy was known, received second dose at 7 weeks gestation. Started prenatal care, and had normal labs, euthyroid state, negative/normal fetal cell free DNA (non-invasive prenatal testing) done at 11 weeks with normal fetal nuchal translucency and nasal bone present. Missed spontaneous abortion discovered at 12 weeks 6 days (no fetal heart beat), D&C done, awaiting cytogenetics now.

Spontaneous abortion at 7 weeks LMP 2/18/21

Spontaneous abortion. Pt was 9w1d at time of first Moderna COVID vaccine (EDD 8/9/2021). Two weeks later she began bleeding and was found to have an incomplete abortion with embryo measuring 9w1d. Proceeded to bleed heavily and D&C performed. Uncomplicated recovery. Genetic studies in process.  Unknown if SAB is related to vaccine, though it appears embryonic demise occurred within a few days of vaccine administration.

Last menstrual period either Nov 1-8 (light, abnormal, pregnancy symptoms) or Nov 29-12/2 (light, abnormal, pregnancy symptoms).  Possible dates of conception 10/16, 10/18, 10/19, 11/14, 11/15.  Negative pregnancy test on 11/26 & 11/29.  +Pregnancy test 12/10.   Estimated delivery dates were either 7/8/21 or 8/8/21. First covid vaccine received on 12/30.  First OB ultrasound on 1/5/21, estimated to be 6 weeks + 3 days gestation, with no heartbeat.  Repeat ultrasound on 1/13/21, continued to measure 6 weeks + 3 days gestation, again with no heartbeat. Spontaneous miscarriage did not occur, 1 time dose of intravaginal Cytotec was taken and medical abortion completed.

Spontaneous Abortion. Miscarriage started on it’s own at home.  Bleeding lasted 14 days, then turned to excessive hemorrhaging and ended up getting an emergency D&C. Was 10 weeks pregnant at time of miscarriage. EDD was 10/23/2021.

Miscarriage / pregnancy loss; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report.  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 30-years-old), administered in Arm Left on 23Apr2021 10:00 (Lot Number: ER8735) as 2nd dose, single for COVID-19 immunization. The patient’s medical history was not reported. Concomitant medication included Nature Made Pre-Natal Vitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:00 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Confirmed pregnancy on 22Apr2021 at OBGYN via blood test, urine test, and ultrasound. Pfizer 2nd dose COVID vaccine administered on 23Apr2021. Began miscarriage on 28Apr2021. On 28Apr2021, OGBYN medical professionals detected NO GROWTH since 22Apr2021 ultrasound. Identical imagining in size. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient experienced miscarriage / pregnancy loss on 28Apr2021 15:30.No treatment received for the event. The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 20Dec2021. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovering. The event was considered as serious (disability, congenital anomaly).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.; Sender’s Comments: Linked Report(s) : US-PFIZER INC-2021497434 fetal case

I tested positive for pregnancy in 17Mar2021. In 24Mar2021 I got my first covid vaccine from Pfizer; feel cold (really cold) all the time; feel weak; This is a spontaneous report from contactable consumer female (patient, mother reported for herself). A 41-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on right arm on 24Mar2021 at 07:15 hours, as 1st single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included dementia, patient was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. Patient had one previous pregnancy and no previous maternal pregnancy compilations. Concomitant medication included patient was taking Throne dietary supplement for prenatal supplement from 18Mar2021, daily and ongoing. First day of last Menstrual period was 14Feb2021. Estimated delivery of patient was 21Nov2021. Gestation period at the time of initial exposure was 2 weeks, 1st trimester. Patient had no problems before delivery. No drugs were taken by father (patient’s husband) during the mother’s pregnancy, father was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. The patient tested positive for pregnancy in 17Mar2021. On 24Mar2021, she got her first COVID vaccine from Pfizer. Patient first appointment with her OB/GYN was in 05Apr2021. Her doctor did an ultrasound and checked the baby’s vital signs. She confirmed that the baby was the right size, and the baby heartbeat was good. She said everything was ok with the baby. On 14Apr2021 she got her second Covid vaccine from Pfizer. Her vaccine was schedule at 10:00 AM. After she got the vaccine, she started to have cramps. About 1:00 PM she started bleeding (light red). She called her doctor and she told her to go to her office. About 1:45 PM She had a new ultrasound. Her doctor said that she did not find any heartbeat in the baby and that she was having an abortion.  On 10May2021, it was reported that on unspecified date of 2021, after she got the vaccine, patient had some different symptoms like feel cold (really cold) all the time and feel weak. During all this time she was taking just Thorne-Dietary supplement. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on left arm on 14Apr2021 at 10:15 hours, as 2nd single dose (at the age of 41-years-old) for COVID-19 immunization. Patient called her doctor at 14:00 to 14:30 hours on 14Apr2021, during physician office visit, the doctor did a sonogram and she said that she was having a spontaneous abortion/miscarriage with 7 weeks (2 months) of gestational age. During the sonogram/ultrasound, no heartbeat was detected for fetal. Patient stated that it was the first time that she had miscarriage, her first pregnancy was normal, and her son was born. Patient got the 2 vaccines but wasn’t informed about the Lot number. The outcome of feel cold (really cold) all the time and feel weak was unknown and not recovered for rest of the event.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.  Follow up attempts are completed. No further information is expected.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. This Consumer reported in response to EDP follow-up questionnaire which included that: New events was added. Pregnancy details, medical history and concomitant medication was added. Clinical course and text were amended accordingly.

My pregnancy symptom s started disappearing gradually and after a week I didn’t feel pregnant at all/missed abortion; My arm was sore; I felt mild fatigue; This is spontaneous report from contactable consumer.  A 28 year-old female consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8735), on 03May2021 (at the age of 28-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of vaccine on 13Apr2021 (lot EW0164). The patient had no known allergies and had not other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that she got her 2nd dose of vaccination when she was 7 weeks pregnant. The LMP was on 21Mar2021. Her arm was sore and she felt mild fatigue. Her pregnancy symptoms started disappearing gradually and after a week she didn’t feel pregnant at all. When she went in for her first ultrasound appointment at 9 weeks, the doctor said that the growth stopped at 7 weeks 4 days and there was no heartbeat. She declared it missed abortion.  Information on Lot/Batch number was available. Additional information has been requested.

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

Received first dose without knowing I was pregnant. I have a high risk pregnancy and the baby is at risk of a spontaneous abortion I?ve being in bed since I knew I was pregnant.  I have intense abdominal pain, no hemorrhage just unknown pain.  Doctors told me to keep resting and just wait for a spontaneous abortion, I was given the fist dose and was advised to not take the second dose . I am know 11 weeks of painful pregnancy just waiting for something to occur. I recommend that woman who are in reproduction ages should first take a pregnancy exam before the vaccine so that nothing like what I am passing happens to someone else. Doctors say that if the pregnancy concludes at its last term the baby will have birth defects because of the vaccine. They recommend and abortion or just wait for a spontaneous abortion.

Pfizer COVID19 vaccinations given on 5/5/21 and 5/26/2021.  Patients last menstrual period 4/27/2021 prior to pregnancy.  Spontaneous abortion/miscarriage at 7 weeks gestation on 6/24/21.

spontaneous abortion at approximately 8 weeks gestation, 10 days after vaccine administration

Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna’s COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage).  The patient’s medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine.   On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided.  The patient’s prior positive pregnancy test, last menstrual period, conception and due dates were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event,  pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter’s Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested

I had a miscarriage (spontaneous abortion) on March 14, 2021. I was 12 weeks pregnant at the time of miscarriage.

Had a early pregnancy loss at 7th week gestation, Spontaneous abortion, Having regular check ups and follow up with the doctors

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

Spontaneous abortion, hives, headache

miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient’s husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room  visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage  was unknown while for all other events was not recovered.

Patient received dose 2/2 of Pfizer vaccine on 2/25/2021. She had an IUI procedure done in (country) on 12/14/2020, which was confirmed to be successful at her follow up OB/Gyn visit- then returned to (country) . Patient returned to (country) on Feb 8, 2021 for 10 week US and was found to have no fetal heart tone, missed spontaneous abortion at approximately 7w5d. This timing would draw into question the timing of the vaccine administration.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient’s last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0.         Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-011644, MOD-2021-011644 (Patient Link).; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed.  Confirmed Spontaneous abortion.  blood type of B-, patient received dose of RhoGam.  Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.

Unexplainable second trimester vaginal bleeding without spontaneous abortion.

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

Miscarriage at 8 weeks pregnant; Unevaluable event; This case was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20a and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) (seriousness criterion medically significant). 14-May-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) and UNEVALUABLE EVENT (Unevaluable event) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On  05/14/2021 and 05/17/2021 unknown lab tests were done ,results not provided. No Concomitant medications were  reported. No treatment information was provided.  This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified.   Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender’s Comments: This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified.  Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.

Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient’s medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient’s last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter’s Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.

Spontaneous abortion, hives, headache

Spontaneous abortion. Pt was 9w1d at time of first Moderna COVID vaccine (EDD 8/9/2021). Two weeks later she began bleeding and was found to have an incomplete abortion with embryo measuring 9w1d. Proceeded to bleed heavily and D&C performed. Uncomplicated recovery. Genetic studies in process.  Unknown if SAB is related to vaccine, though it appears embryonic demise occurred within a few days of vaccine administration.

Pregnancy dated by LMP consistent with 7 week ultrasound. Received first dose before pregnancy was known, received second dose at 7 weeks gestation. Started prenatal care, and had normal labs, euthyroid state, negative/normal fetal cell free DNA (non-invasive prenatal testing) done at 11 weeks with normal fetal nuchal translucency and nasal bone present. Missed spontaneous abortion discovered at 12 weeks 6 days (no fetal heart beat), D&C done, awaiting cytogenetics now.

Spontaneous Abortion. Miscarriage started on it’s own at home.  Bleeding lasted 14 days, then turned to excessive hemorrhaging and ended up getting an emergency D&C. Was 10 weeks pregnant at time of miscarriage. EDD was 10/23/2021.

Patient received dose 2/2 of Pfizer vaccine on 2/25/2021. She had an IUI procedure done in (country) on 12/14/2020, which was confirmed to be successful at her follow up OB/Gyn visit- then returned to (country) . Patient returned to (country) on Feb 8, 2021 for 10 week US and was found to have no fetal heart tone, missed spontaneous abortion at approximately 7w5d. This timing would draw into question the timing of the vaccine administration.

Amenorrhoea; Abortion spontaneous; Ovulation disorder; Pregnancy; Uterine spasm; This case was received via  VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy) and UTERINE SPASM (Uterine spasm). On an unknown date, the patient experienced AMENORRHOEA (Amenorrhoea). At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy), UTERINE SPASM (Uterine spasm) and AMENORRHOEA (Amenorrhoea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the provided. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender’s Comments: This is a case of product exposure during pregnancy which resulted in Abortion spontaneous, for this 29 years old female. Very limited information has been provided at this time.

went through a miscarriage on 23APR2021, after receiving the first dose; feeling abdomen pain lightly two to three days later; could not left her arm after the injection; injection site was sore,could not lift her arm after the injection; found pregnant on 07MAR2021,first vaccine dose 11APR2021; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 20-Nov-2021. On 11-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021). On 13-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection). On 14-Apr-2021, the patient experienced ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later). On 23-Apr-2021, the patient experienced ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, miscarriage on 23-Apr-2021. On 11-Apr-2021, EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021) had resolved. On 23-Apr-2021, ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) had resolved. At the time of the report, ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later), VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that his wife was found pregnant on 07Mar2021. She had normal back pain and normal pregnancy pain during her pregnancy. My wife could not left her arm after the injection and the injection site was sore on 13-Apr-2021.  After taking the Moderna vaccine she started to have abdomen pain lightly for two to three days on 14-Apr-2021. On 22-Apr-2021, she started to feel unbearable pain. On Friday 23-Apr-2021 she had a miscarriage.   No treatment product information was not provided  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up had NNI; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

went through a miscarriage on 23APR2021, after receiving the first dose; feeling abdomen pain lightly two to three days later; could not left her arm after the injection; injection site was sore,could not lift her arm after the injection; found pregnant on 07MAR2021,first vaccine dose 11APR2021; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient’s last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 20-Nov-2021. On 11-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021). On 13-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection). On 14-Apr-2021, the patient experienced ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later). On 23-Apr-2021, the patient experienced ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, miscarriage on 23-Apr-2021. On 11-Apr-2021, EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021) had resolved. On 23-Apr-2021, ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) had resolved. At the time of the report, ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later), VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that his wife was found pregnant on 07Mar2021. She had normal back pain and normal pregnancy pain during her pregnancy. My wife could not left her arm after the injection and the injection site was sore on 13-Apr-2021.  After taking the Moderna vaccine she started to have abdomen pain lightly for two to three days on 14-Apr-2021. On 22-Apr-2021, she started to feel unbearable pain. On Friday 23-Apr-2021 she had a miscarriage.   No treatment product information was not provided  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up had NNI; Sender’s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender’s Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna’s COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage).  The patient’s medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine.   On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided.  The patient’s prior positive pregnancy test, last menstrual period, conception and due dates were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event,  pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter’s Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient’s past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient’s last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a “”genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender’s Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.”"

Spontaneous abortion at 7weeks gestational age.

after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; migraine; after second shot of vaccination patient felt absolutely horrible. On 30Mar2021, patient immediately started vaginal bleeding heavily for 7 to 9 days; Severe body pain especially the left arm where I received shot; Severe body pain especially the left arm where I received shot; Was sick and down for 7 to 9 days.; Could not communicate to anyone that I felt like I had to go to emergency room.; Because I could not wake up and could not even speak when I did wake up briefly just to go to urinate.; Cannot think straight at all.; My memory is horrible. I forget things even minutes after they happen or I say or I heard.; severe debilitating depression; Personality changes either daily or weekly; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history of the patient included PTSD (Post-traumatic stress disorder), ADHD (Attention deficit hyperactivity disorder), depression, severe anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, C-section and asthma. Patient has allergy to cantaloupe. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications or any other medications the patient received within 2 weeks of vaccination included 3 prescriptions that patient take daily (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient previously took amoxicillin and morphine for unspecified indications and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization and had flu for 2 to 3 days. On 30Mar2021, a few hours after second shot of vaccination patient felt absolutely horrible and experienced vaginal bleeding for 7 to 9 days then every other week sometimes just a few days a part 2 to 3 days heavy to light, migraines, severe body pains especially in the left arm where patient was administered vaccination shot, patient was sick and down for 7 to 9 days, could not communicate to anyone that she felt like she had to go to emergency room because she could not wake up and could not even speak when she did wake up briefly just to go to urinate, cannot think straight, memory was horrible, forget things even minutes after they happen or she said or heard, this happened even while driving. Four weeks maybe only six days of severe debilitating depression for no reason almost committed herself to hospital due to the severity of it. When patient was going to get herself checked she could not even get a hold of her therapist or psychologist due to it being a holiday. Personality changes either daily or weekly. The events resulted in healthcare professional office/clinic visit [Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Reporter considered the events as serious. Therapeutic measures taken in response to the events included therapy and possible change in medication. Outcome of the events were not recovered.

Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed.  Confirmed Spontaneous abortion.  blood type of B-, patient received dose of RhoGam.  Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

Unexplainable second trimester vaginal bleeding without spontaneous abortion.

Miscarriage; she received first moderna vaccine while pregnant; Nausea; Headache; Vomiting; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 15-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred  on 15-May-2021. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Mar-2021, EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  In about a period of two weeks, the ultrasound indicated that the baby’s heart beat was non-existent and on 15 May 2021, the patient had a spontaneous miscarriage.  Date of last menstrual period and estimated due date were not provided.  No treatment was given.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226308 (Parent-Child Link).   See case MOD-2021-226308 for details regarding the child case.; Sender’s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history – Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient’s second dose of vaccine for Covid.