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From the 11/19/2021 release of VAERS data:

Found 2,686 cases where Vaccine is COVID19 and Symptom is Aborted pregnancy or Abortion or Abortion complete or Abortion early or Abortion incomplete or Abortion induced or Abortion late or Abortion missed or Abortion of ectopic pregnancy or Abortion spontaneous or Abortion spontaneous complete or Abortion spontaneous incomplete or Foetal cardiac arrest or Foetal death or Premature baby death or Premature delivery or Stillbirth

Government Disclaimer on use of this data



Case Details (Sorted by Onset Date)

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VAERS ID: 1389387 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Miscarriage even though my child was healthy; Vaccine exposure during pregnancy; This regulatory authority pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage even though my child was healthy) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 16-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage even though my child was healthy) (seriousness criterion medically significant). On 09-May-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage even though my child was healthy) outcome was unknown. Concomitant medications were not provided. Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event Abortion spontaneous, a causal relationship cannot be excluded. Causality for the event Exposure during pregnancy is assessed as not applicable.; 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 Abortion spontaneous, a causal relationship cannot be excluded. Causality for the event Exposure during pregnancy is assessed as not applicable.


VAERS ID: 1698192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-05-09
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101125291

Write-up: Miscarriage/Early miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20214193. A pregnant 27-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 18Apr2021 (Batch/Lot number was not reported) as dose 1, single; and via an unspecified route of administration in Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included asthma. Concomitant medications included folic acid and colecalciferol (VITAMIN D). The patient experienced miscarriage/early miscarriage on 09May2021. Early miscarriage approximately 1 week after each vaccine dose. Both pregnancies were at weeks 6 to 8. Asthma as an underlying condition. No other medications, the patient only uses folic acid and vitamin D supplements. The patient is recovering from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1303316 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-02-26
Onset:2021-05-10
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Inappropriate schedule of product administration, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole Pre Natal vitamin Vitamin D Heather?s tummy tamers Cranberry Valcycolvir
Current Illness: None
Preexisting Conditions: HSV
Allergies: Zithromax
Diagnostic Lab Data: Obgyn appointment: 4/28/21. Ultrasound: 4/30/21. Ultrasound: 5/10/21.
CDC Split Type:

Write-up: Vaccine 1: 1/29/21. Vaccine 2: 2/26/21. Found out I was pregnant: 3/25/21. Miscarriage: 5/10/21. First OBGYN appointment baby was smaller than expected and had to get vaginal ultrasound. Baby was measuring at 6 weeks with no heartbeat. 10 days later repeated ultrasound and baby had not grown and still no heart beat. Baby never developed longer than 6 weeks. Adverse event: miscarriage.


VAERS ID: 1317821 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-11
Onset:2021-05-10
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040A21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0HB21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Ovarian cyst, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatals
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Bloodwork and ultrasounds. All resulting in the diagnosis of a miscarriage.
CDC Split Type:

Write-up: 3 days of ovulation resulting in pregnancy. And then a corpus literal cyst and a miscarriage.


VAERS ID: 1360487 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-01-10
Onset:2021-05-10
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: COVID-19 Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2021548022

Write-up: My second dose of the vaccine was 10Jan2021. I conceived around 24Jan2021. I suffered a missed miscarriage detected 10May2021, then an incomplete miscarriage 14May2021.; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 10Jan2021 10:00 (lot number not reported), as 2nd dose, single dose, at age 34 years old, for covid-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications (other medications received within 2 weeks of vaccination: no). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, on 20Dec2021 at 10:00 (lot number not reported), at age 34 years old, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, "My second dose of the vaccine was 10Jan2021. I conceived around 24Jan2021. I suffered a missed miscarriage detected 10May2021, then an incomplete miscarriage 14May2021." The event resulted to emergency room and physician office visits, and hospitalization (date not reported, duration: 1 day). Treatment was reported as "incomplete miscarriage, hemorrhaged, D&C". The patient tested negative to COVID-19 via nasal swab on 14May2021. The outcome of the event was recovered with sequel in May2021. Information on batch/lot number has been requested.; Sender''s Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be fully excluded. 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.


VAERS ID: 1520464 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-03
Onset:2021-05-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Arrhythmia, Asthenia, Blood iron normal, Blood magnesium normal, Blood phosphorus normal, Blood thyroid stimulating hormone normal, Condition aggravated, Dizziness, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory, Feeling abnormal, Full blood count normal, HIV test negative, Heart rate irregular, Hepatitis C test negative, Impaired quality of life, Iron binding capacity total normal, Lipids normal, Maternal exposure before pregnancy, Metabolic function test normal, Palpitations, Serum ferritin normal, Sinus arrhythmia, Temperature intolerance, Thyroxine free normal
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Multivitamin, fish oil
Current Illness: None
Preexisting Conditions: Heart palpitations only when exposed to extreme heat. (95*F or more)
Allergies: Pseudoephedrine - induced heart palpitations
Diagnostic Lab Data: EKG - sinus arrhythmia 9:15am 7/1/21 Labs: CBC, Ferratin, Iron + TIBC, CMP, TSH, T4 Free, Lipid Panel, Hep C, HIV, Magnesium, phosphorus all normal 10am 7/1/21 EKG- sinus arrhythmia 11:26pm 7/24/21 EKG- sinus arrhythmia 1:29am 7/25/21 Echo- normal 7/28/21 Halter- awaiting results 8/4/21
CDC Split Type:

Write-up: Baseline heart arrhythmia significantly affecting quality of life at temperatures exceeding 75*F. (Dizzy, weak, brain fog, pounding irregular heart beat). Lost pregnancy 6/5/21 due to heart irregularity. I became pregnant after being vaccinated, but I was only in my first trimester when I lost my baby.


VAERS ID: 1723373 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2020-12-23
Onset:2021-05-10
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J202A / 1 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 029L20A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Menstruation irregular, Oedema peripheral, Ultrasound scan abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multi-vitamin
Current Illness: None
Preexisting Conditions: Left knee arthritis, 4 left knee surgeries
Allergies: Ceclor, Rocephin, Menocin
Diagnostic Lab Data: Various lab work completed post ultrasound that detected the miscarriage (5/10/21) until end of June 2021.
CDC Split Type:

Write-up: I had my first Moderna vaccine on 12/23/20 and my second Moderna vaccine on 1/19/21. On 5/10/21 I found out I had a miscarriage when the fetus was approximately 9 weeks gestation- no heart beat was detectable at 10.5 weeks during my ultrasound. It should be noted that I have had two other healthy pregnancies and no miscarriages prior. It took my body 4 weeks to remove all tissues naturally; however, bleeding continued so my physician scraped the inside of my uterus to remove more tissues. My cycle is still not regular. Also since June 2021, I have had pitting edema of my bilateral lower extremities with my left lower extremity being worse than my right lower extremity. This is not normal for me. I do get pitting edema when further along in pregnancies which is currently not the case due to the above stated miscarriage. There has also been some incidences of abnormal resting, high heart rate.


VAERS ID: 1798726 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-04-27
Onset:2021-05-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Confirmed pregnancy HCG levels at 21 during miscarriage.
CDC Split Type:

Write-up: I conceived my baby the day I got the second dose of Pfizer. I miscarried 13 days later. I went to my local ER to confirm pregnancy as well as to receive the Rogham shot.


VAERS ID: 1586105 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-10
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Discharge, Exposure during pregnancy, Pregnancy test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: Pregnancy test; Test Result: Negative ; Result Unstructured Data: Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Exposure during pregnancy; Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino; Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino; This case was received via regulatory authority (Reference number: IT-MINISAL02-766060) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino) and DISCHARGE (Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino) in a 36-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced ABORTION SPONTANEOUS (Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino) (seriousness criteria medically significant and congenital anomaly) and DISCHARGE (Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino) (seriousness criterion congenital anomaly). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino) and DISCHARGE (Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino) had resolved with sequelae and EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Pregnancy test: negative (Negative) Test di gravidanza 10/04 Negative. Vaccino Moderna fotto il 20/04. Non veniva il ciclo. Faccio ecogafia ero incinta. Innzio ad avere perdite. Abprto spontaneo a due settimane dal vaccino. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. This is a case of product exposure during pregnancy of unknown gestational age with spontaneous abortion for this 36-year-old female, 20 days after vaccination. No follow up is possible. The serious criteria CA (congenital anomaly is not appropriate but left it as reported because it is RA case. Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up document received, contain no new information.; Sender''s Comments: This is a case of product exposure during pregnancy of unknown gestational age with spontaneous abortion for this 36-year-old female, 20 days after vaccination. No follow up is possible. The serious criteria CA (congenital anomaly is not appropriate but left it as reported because it is RA case.


VAERS ID: 1657366 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-05-10
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting. 2 healthy pregnancies prior. Multiple chemical pregnancies prior.)
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101097009

Write-up: Miscarriage; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202108222153021380-OBC5E, Safety Report Unique Identifier GB-MHRA-ADR 25833873. A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Apr2021 (Lot Number: ER1749) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included pregnancy (Patient no longer pregnant at the time of reporting). Concomitant medication included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced miscarriage (death, medically significant) on 10May2021. Clinical course reported as: The date patient would have conceived, is the date she had her second vaccine, she didn''t discover she was pregnant until after the vaccine had been administered. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Pregnancy adverse effects details: Miscarriage. Details of previous pregnancies: 2 healthy pregnancies prior. Multiple chemical pregnancies prior. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on unknown date. The patient died on 12May2021, blood test: unknown results on unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1325371 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-21
Onset:2021-05-11
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Pregnancy test positive, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lamotrigine, prenatal vitamin, fish oil
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: May 12, 2021: U/S obstetric, 1st trim, single - IMPRESSION: There is no intrauterine gestational sac. May 12, 2021: HCG 5,520 MIU/ML
CDC Split Type:

Write-up: I want to report a miscarriage. I got the vaccine when I was 5 weeks and 1 day pregnant. I didn''t know I was pregnant when I got the vaccine, but I got a positive pregnancy test 2 days after. It was a "missed miscarriage" because I had my 10 week ultrasound on May 10 and it showed that the embryo had died at 6 weeks and 2 days. I started miscarrying that day on May 10.


VAERS ID: 1329420 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-22
Onset:2021-05-11
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Laboratory test, Pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft, prenatal vitamins
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Fluoride
Diagnostic Lab Data: Bloodwork taken on 5/18/2021. Have not received results yet.
CDC Split Type:

Write-up: Miscarried on may 13, 2021, exactly 3 weeks later. I was 6 weeks at the time of miscarriage. I have one healthy child and no history of miscarriage.


VAERS ID: 1330837 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-16
Onset:2021-05-11
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6202 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Complication of pregnancy, Exposure during pregnancy, Foetal death
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin B12, Prenatal Vitamins, Sertraline , Albuterol Sulfate
Current Illness: Pregnancy
Preexisting Conditions: Asthma, Endometriosis
Allergies: Shellfish
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had an intrauterine fetal demise at 36 4/7 weeks. Most likely unrelated but want it reported that she had vaccine during pregnancy.


VAERS ID: 1360595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-05-11
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: NP and rapid; Test Result: Negative
CDC Split Type: USPFIZER INC2021571248

Write-up: Late miscarriage at 18 weeks gestation. Fetal demise.; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced late miscarriage at 18 weeks gestation. fetal demise on 11May2021 12:00. The mother was 18 weeks pregnant at the onset of the event. The mother was due to deliver on 10Oct2021. The mother delivered the pregnancy on 11May2021. Patient had Nasal swab (NP and rapid) on 17May2021 and the result was negative. Treatment: Delivery of fetus, D&C of remaining undelivered placenta. Event resulted to doctor or other healthcare professional office/clinic visit, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event). The outcome of the event was recovering. Information about the Lot/batch number has been requested.; Sender''s Comments: A contributory role of BNT162B2 to event late miscarriage at 18 weeks gestation. fetal demise cannot be excluded based on temporal association and available information. 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 Authorities, Committees and Investigators, as appropriate.


VAERS ID: 1368525 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-13
Onset:2021-05-11
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6208 / 1 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 2 AR / SYR

Administered by: Other       Purchased by: ?
Symptoms: Caesarean section, Exposure during pregnancy, Ocular hyperaemia, Pain in extremity, Premature delivery, Premature separation of placenta
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Glaucoma (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins Natural Made, probiotics, fiber, B6 and unisom
Current Illness:
Preexisting Conditions:
Allergies: Erythromycin
Diagnostic Lab Data: 5/11/2021: placental abruption
CDC Split Type:

Write-up: I ended up giving birth early after my second vaccine dose (first dose of Pfizer was on 3/13/21, second dose was on 4/3/21). My expected due date was 9/1/2021. My baby was 23 weeks 6 days when he was born. He weighed 720 grams. My OB diagnosed that I have placental abruption. I ended up having C section. For the first dose of Pfizer vaccine, I have red eye (blood in one of my eyes) and my arm hurt. I only feel my arm hurts after the second dose but then ended up giving birth early.


VAERS ID: 1368795 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-19
Onset:2021-05-11
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Inappropriate schedule of product administration, Red blood cell count decreased, Ultrasound scan abnormal
SMQs:, Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins, colace
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: See Item 18
CDC Split Type:

Write-up: My first vaccine was: Monday, March 22 My second dose was: Monday, April 19 A blood test at the doctor confirmed we were expecting a baby on: Friday, April 16 2 previous full term deliveries, no other miscarriages My blood count was lower than expected based off of my last period date (March 3, 2021). A second blood test was done Thursday, April 29. An ultrasound was done Monday, May 10 which showed a fetal heartbeat and measurement of 5wks 5days. A second ultrasound was done Wednesday, May 19 and showed an irregular heartbeat and less growth than was expected by that point. Bleeding began on Tuesday May 11. An ultrasound on Wednesday, May 19 showed the baby had stopped growing or moving and no heartbeat was detected. On Wednesday, May 26 a D&C was performed.


VAERS ID: 1389119 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-03-20
Onset:2021-05-11
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006M20A / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Chills, Exposure during pregnancy, Fatigue, Headache, Malaise, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Shell fish
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: I had a miscarriage on 05-11-2021. At the time of my miscarriage I was 4 weeks pregnant. After my vaccine I was also sick for a week and a half, developed fatigued, chills, fever, headaches, left arm soreness, these symptoms lasted for nine days.


VAERS ID: 1407061 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-01
Onset:2021-05-11
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin 500mg 2x per day
Current Illness: None
Preexisting Conditions: Type 2 Diabetes - well controlled with diet and medication
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received vaccination on or about date of conception Miscarried at 3 weeks 6 days


VAERS ID: 1415194 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-02
Onset:2021-05-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001C21A / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Blood test 5/20/2021
CDC Split Type:

Write-up: started a menstrual cycle a few days later than usual, had significant loss of blood on the 8th day, which turned out to be a spontaneous miscarriage and not a menstrual cycle, tested through blood test.


VAERS ID: 1487394 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-17
Onset:2021-05-11
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Abortion spontaneous, Antibody test positive, Autoimmune thyroiditis, Exposure during pregnancy, Pregnancy test positive, Thrombosis, Ultrasound uterus abnormal
SMQs:, Acute pancreatitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Vasculitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins; Vitamin D; Claritin.
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: Shellfish.
Diagnostic Lab Data: May 20, 2021, lab work, confirmed pregnancy; July 13, 2021, lab work, elevated antibodies; May 28, 2021, ultrasound, no fetus.
CDC Split Type: vsafe

Write-up: Ok so well on May 15 I had a confirmed pregnancy test however on May 27, 2021 I had sharp pains in my stomach. I passed blood clots. I went to the ER and they confirmed there was no fetus, and they did testing. It came back that I had passed the embryo. They performed some blood work, which included a test for antibodies and that came back elevated so therefore I was told to have Hashimoto''s Disease. Prior to the vaccine I was not diagnosed, so this is the information that I have. The time of miscarriage, I would have been 5 weeks pregnant so it was considered an early pregnancy loss. So I have had one pregnancy three years ago and since then, I have been trying to get pregnant and through IVF. My estimated date of delivery would have been January 27, 2022.


VAERS ID: 1490317 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-19
Onset:2021-05-11
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0169 / 2 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre-natal vitamin.
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was administered by 2nd dose of the Pfizer COVID-19 vaccine on April 19, 2021, while I was approximately 3 months pregnant. I was instructed by the CDC and my medical providers that the COVID-19 vaccine was safe notwithstanding my pregnancy status. At my next OBGYN pregnancy appointment on May 11, it was discovered that I had suffered from a late-term miscarriage. It was estimated by my medical team that the miscarriage occurred at approximately 14 weeks of gestation (or the week of April 28th), approximately one week after I received the 2nd dose of the Pfizer vaccine.


VAERS ID: 1756549 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-04-20
Onset:2021-05-11
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: I was approximately 5 weeks pregnant and had a miscarriage after I got the first Covid vaccine.


VAERS ID: 1352338 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Maternal exposure during pregnancy, Ultrasound foetal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: ultrasound; Result Unstructured Data: baby''s heart stopped at 7 weeks.
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: Baby''s heart stopped at 7 weeks; Tiredness; Maternal exposure during pregnancy; This regulatory authority pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), ABORTION SPONTANEOUS (Baby''s heart stopped at 7 weeks) and FATIGUE (Tiredness) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Allergy. On 11-May-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 11-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion congenital anomaly) and FATIGUE (Tiredness) (seriousness criterion congenital anomaly). On 12-May-2021, the patient experienced ABORTION SPONTANEOUS (Baby''s heart stopped at 7 weeks) (seriousness criteria medically significant and congenital anomaly). On 11-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 12-May-2021, ABORTION SPONTANEOUS (Baby''s heart stopped at 7 weeks) had resolved. At the time of the report, FATIGUE (Tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Ultrasound foetal: baby''s heart stopped at 7 weeks (abnormal) baby''s heart stopped at 7 weeks.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. On 12 May 2021, the patient went for a scan and baby''s heart stopped at seven weeks. Patient was exposed to the medicine first-trimester (1-12 weeks). The concomitant medications on use were not provided. No treatment information was provided. Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 42-year-old female. Patient will continue to be contacted for further monitoring of AEs.; Sender''s Comments: This is a case of product exposure during pregnancy with no associated AEs for this 42-year-old female. Patient will continue to be contacted for further monitoring of AEs.


VAERS ID: 1401406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-05-11
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021628290

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number NL-LRB-00548392. A 30-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 29Jan2021 (Lot Number: EJ6795) as second dose, single dose for COVID-19 immunisation. Medical history included disease risk factor from 07Jan2001 to an unknown date. The patient''s concomitant medications were not reported. The patient took her first dose of BNT162B2 on 07Jan2021 for COVID-19 immunisation. On 11May2021, patient had a miscarriage reported as serious, other medically important condition, following administration of COVID-19 vaccine Pfizer. This was the second vaccination. This vaccination was not given during pregnancy but about 5 weeks before start of pregnancy. The heartbeat of the fetus stopped at a pregnancy duration of 9 weeks. The outcome of miscarriage is unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction (miscarriage) was considered as serious by the Netherlands Pharmacovigilance Centre Lareb. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1453364 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-11
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 4)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210702716

Write-up: MISCARRIAGE; VACCINATION DURING THE 4TH WEEK OF PREGNANCY; This spontaneous pregnancy report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00592417] concerned a 31 year old female of unknown race and ethnicity. The patient''s weight was 77 kilograms, and height was 170 centimeters. The patient''s past medical history included maternal vaccine exposure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C10-02, expiry: UNKNOWN) 1 dosage forms, total dose 0.5 ml administered on 11-MAY-2021 for covid-19 immunisation. No concomitant medications were reported. On 11-MAY-2021, the patient had vaccination during the 4th week of pregnancy. On 09-JUN-2021, the patient experienced miscarriage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination during the 4th week of pregnancy and miscarriage was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210702716- covid-19 vaccine ad26.cov2.s -miscarriage. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210702716- covid-19 vaccine ad26.cov2.s -vaccination during the 4th week of 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


VAERS ID: 1458641 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Injection site erythema, Injection site reaction, Maternal exposure during pregnancy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 4
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS in a 31-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week On 11-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY and INJECTION SITE ERYTHEMA. On an unknown date, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. On 22-May-2021, INJECTION SITE REACTION and INJECTION SITE ERYTHEMA had resolved. At the time of the report, ABORTION SPONTANEOUS and MATERNAL EXPOSURE DURING PREGNANCY outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. This is a case of product exposure during pregnancy with associated adverse events of Abortion spontaneous, Injection site reaction and Injection site erythema. Based on temporal association a causal relationship cannot be excluded. This case was linked to NL-MODERNATX, INC.-MOD-2021-243770 (E2B Linked Report).; Sender''s Comments: This is a case of product exposure during pregnancy with associated adverse events of Abortion spontaneous, Injection site reaction and Injection site erythema. Based on temporal association a causal relationship cannot be excluded. NL-MODERNATX, INC.-MOD-2021-243770:Child''s case (miscarriage)


VAERS ID: 1480220 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Injection site erythema, Injection site reaction, Maternal exposure during pregnancy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority prospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS in a 31-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Maternal vaccine exposure. On 11-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 11-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY, INJECTION SITE REACTION and INJECTION SITE ERYTHEMA. On an unknown date, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). On 11-May-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved. On 22-May-2021, INJECTION SITE REACTION and INJECTION SITE ERYTHEMA had resolved. At the time of the report, ABORTION SPONTANEOUS outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter. This is a case of product exposure during pregnancy with associated adverse event for this 31-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. This case was linked to MOD-2021-243719/NL-LRB-00561816, NL-MODERNATX, INC.-MOD-2021-243719 (Linked Report).; Sender''s Comments: This is a case of product exposure during pregnancy with associated adverse event for this 31-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. MOD-2021-243719/NL-LRB-00561816:Mother''s case NL-MODERNATX, INC.-MOD-2021-243719:Child''s case (miscarriage)


VAERS ID: 1739524 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Injection site reaction, Maternal exposure before pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding (Borstvoeding); Disease risk factor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: in a 27-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Disease risk factor and Breast feeding On 11-May-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-May-2021, the patient experienced INJECTION SITE REACTION (Reactie op of rond de injectieplaats linkerarm: zwelling, ontstaan binnen een week na de vaccinatie, blauwe plek) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). On 08-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Late miskraam bij 12-13 weken) (seriousness criterion medically significant). 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 not resolved and INJECTION SITE REACTION (Reactie op of rond de injectieplaats linkerarm: zwelling, ontstaan binnen een week na de vaccinatie, blauwe plek) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment drugs were reported. No concomitant drugs were reported. Company Comment: This case concerns a 27-year-old female patient with no previous relevant medical history, who experienced the unexpected events of Maternal exposure during pregnancy and Spontaneous abortion after Spikevax (mRNA- 1273 vaccine). The event occurred approximately 2 months and 25 days after Spikevax, dose number unknown. Spontaneous abortion occurred at week 12-13 of pregnancy, hence the patient received the dose of vaccine preconceptionally. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Added new event and updated seriousness from non serious to serious. On 17-Sep-2021: Translation received on 21-Sep-2021 with no new information.; Sender''s Comments: This case concerns a 27-year-old female patient with no relevant medical history, who experienced the unexpected events of Maternal exposure before pregnancy and Spontaneous abortion after Spikevax (mRNA- 1273 vaccine). The event Spontaneous abortion occurred approximately 2 months and 25 days after Spikevax, dose number unknown and occurred at week 12-13 of pregnancy, hence the patient received the dose of vaccine preconceptionally. The benefit-risk relationship of Spikevax vaccine is not affected by this report.


VAERS ID: 1772683 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood grouping, HIV test, Hepatitis B surface antibody, Hepatitis C virus test, Investigation, Maternal exposure during pregnancy, Premature delivery, Rubella antibody test, SARS-CoV-2 test, Sexually transmitted disease test, Toxoplasma serology
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amniocentesis; Blood group O (Rh negative); Metrorrhagia (first trimester); Pregnancy (40 weeks delivery by c-section for stagnation or stopping of dilation of the cervix during labour); Premature separation of placenta (first trimester); Uterine contractions during pregnancy (no threat of premature delivery diagnosed by doctors)
Allergies:
Diagnostic Lab Data: Test Name: blood group; Result Unstructured Data: Test Result:O; Comments: Rh negative; Test Name: Hepatitis B immunisation; Test Result: Negative ; Test Name: Hepatitis C immunisation; Test Result: Negative ; Test Name: HIV; Test Result: Negative ; Test Name: Check for irregular agglutinins; Result Unstructured Data: Test Result:unknown results; Test Name: Rubella serology; Result Unstructured Data: Test Result:immune; Test Date: 20210513; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Name: Venereal Disease Research Laboratory; Test Result: Negative ; Test Name: Toxoplasmic serology; Result Unstructured Data: Test Result:immune
CDC Split Type: FRPFIZER INC202101272378

Write-up: Premature delivery; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FR-AFSSAPS-PC20213879. This consumer reported information for both mother and baby. This is a maternal report. A 36-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 11May2021 (Batch/Lot Number: FC3143) at the age of 36 years old as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included first pregnancy completed in 2017 (40 weeks) and delivery by caesarean section for stagnation or stopping of dilation of the cervix during labour. Patient 3rd gesture-primiparous. Note that during pregnancy: first trimester: placental abruption and metrorrhagia, in Mar2021: amniocentesis, many contractions but no threat of premature delivery diagnosed by doctors. No medical history of COVID-19. Blood group: 0, Rh negative. Serology included Check for irregular agglutinins: unknown results, Rubella serology and Toxoplasmic serology: immune, Venereal Disease Research Laboratory: negative, HIV: negative, Hepatitis B immunisation: Hepatitis B surface negative, Hepatitis C immunisation: negative, Cytomegalovirus immunisation: unknown. The patient''s concomitant medications were not reported. On 11May2021, first injection of COMIRNATY vaccine, the patient was in her 2nd trimester of pregnancy (as reported, maternal exposure during pregnancy, second trimester). On 14May2021, the patient experienced premature delivery. On 13May2021, water loss and delivery the same evening on 14May2021 at 12:37 am (as reported). The patient was at 31 weeks of amenorrhoea + 2 days. The patient was hospitalized for premature delivery from 13May2021 to 22May2021. (As reported, "the end date retained was 21Jul2021.") The mother was pregnant while taking bnt162b2. The mother was 31 weeks pregnant at the onset of the event (as reported). The mother delivered the pregnancy on 14May2021. The baby was delivered premature. The fetal outcome is normal. At the time of the report, the baby has no particular problem apart from prematurity. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 13May2021. In conclusion, premature delivery at 31 week + 2 days on Day 4 of the Dose 1 of the COMIRNATY vaccine. The outcome of event premature delivery was recovered on 14May2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1777854 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Premature delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101304495

Write-up: Premature delivery; maternal Exposure During Pregnancy, second trimester; This is a spontaneous report received from a contactable consumer and other HCP. This is second of two reports. The first report is a report downloaded from the Agency WEB; regulatory authority report number is FR-AFSSAPS-PC20213879. This consumer reported information for both mother and baby. This is the baby report. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Solution for injection; lot number: FC3143 and expiration date: not reported), via transplacental, on 11May2021, as dose 1, 0.3 mL, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The mother was vaccinated with a single dose for COVID-19 immunization on 11may2021 and had premature delivery on 14May2021. The patient was hospitalized for premature delivery from 13May2021 to 22May2021.The outcome of the event premature delivery was recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101272378 mother case


VAERS ID: 1859867 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Twin pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: LUPFIZER INC202101455115

Write-up: In utero death of a twin; fetal death in utero; Maternal exposure during pregnancy at around 31 weeks; This is a spontaneous report from a contactable consumer downloaded from The regulatory authority report number is LU-ALMPS-202103108. This consumer reported events for both mother and baby. This is the maternal report. A 35-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EW6126), intramuscular, on 11May2021 (at the age of 35 years), as dose 1, single, for COVID-19 immunization. The patient''s medical history included twin pregnancy. The patient''s concomitant medications were not reported. The patient was pregnant with twins with due date of Jul2021. On 11May2021, the patient had the first vaccination BNT162B2. The patient experienced in utero death of a twin (fetal death in utero) at around 31 weeks (11May2021), the estimated date of death being that of the vaccination (maternal exposure during pregnancy). The event required hospitalization from 2021. The patient had continuation of pregnancy and premature birth of second twin at 35 weeks, baby well. The patient underwent second vaccination with BNT162B2 (Lot Number: FE2083) on 22Jun2021 after delivery. The pregnancy for the first baby resulted in spontaneous abortion and fetal outcome is intrauterine death. Baby two was delivered premature and the fetal outcome is normal. The patient recovered from the event in May2021. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : LU-PFIZER INC-202101472940 Child report


VAERS ID: 1322483 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-05-04
Onset:2021-05-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21L / 1 AR / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 2 AR / SYR

Administered by: Public       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: EDD=11/8/2021, IUFD diagnosed 5/12/2021


VAERS ID: 1342256 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-27
Onset:2021-05-12
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ED7533 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Pain in extremity, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: sertraline 50mg
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Ultrasound on May 18th revealed the embryo had already miscarried (I stopped experiencing pregnancy symptoms about a week prior). In the ultrasound on May 4, there was a heartbeat and the embryo measured at 6 weeks 5 days.
CDC Split Type:

Write-up: I received the first Pfizer dose on 4/6/21 and the second on 4/27/21. My only side effects at the time were a sore arm (both times) and tiredness/fatigue after the second dose. On May 18, I found out I had a missed miscarriage (probably in the prior week) at around 8 weeks pregnant.


VAERS ID: 1355547 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-23
Onset:2021-05-12
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042B21A / 2 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046A21A / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pyrexia, Ultrasound scan
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Claritin taken the day before the vaccine, No other medications taken on the day of the vaccine
Current Illness:
Preexisting Conditions: Thyroid condition- Hashimoto disease
Allergies: Gluten, sesame seeds, banana, NKDA
Diagnostic Lab Data: radiology ultrasound
CDC Split Type: vsafe

Write-up: I was pregnant when I got my second dose vaccine. I was on my first trimester when I had a miscarriage. I also had high fever which I took Tylenol for pain medication even though I had hard time bringing my fever down, I also do not know if it was related to the Modena vaccine or my miscarriage. On 05-12-2021 I found out I was 11 weeks pregnant. I underwent a radiology ultrasound where it showed my fetus died at 8 and half weeks.


VAERS ID: 1374321 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 2 LA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Back pain, Exposure during pregnancy, Headache, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol after vaccination
Current Illness: none
Preexisting Conditions: lower back issues
Allergies: none
Diagnostic Lab Data: Lab work Friday, May 21, 2021 Doctor suggested doing a DNC or getting medication to induce at home on May 24th I was given medication to induce labor at home. May 28th started having a lot of pain my miscarriage was not complete. I was told to do another dose of medication to induce at home. I did that miscarriage still not complete. Last week on Tuesday and the miscarriage is still not complete. I was advised to either do surgery or another dose of medication. I go back to the doctor next week.
CDC Split Type: vsafe

Write-up: headache pain in hip and legs pain from the waist down back pain Miscarriage (7 weeks 5-6 days pregnant) went to OB clinic Ultrasound no heartbeat 7 weeks 5-6 days Determined that the baby stop growing at 7 weeks and 5 days, which is the day I received my 2 dose of my vaccine. Friday, May 21st suggested doing a DNC of getting medication to induce at home 24th gave medication to induce problems that 28 having alot of pain miscarriage was not complete told to do another dose of medication to induce at home last week on tuesday and the miscarrige is still not complete advise to surgery of anotehr dose of medication go back next week .misscariage is not complete.


VAERS ID: 1379297 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-29
Onset:2021-05-12
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Blood test, Exposure during pregnancy, Ultrasound abdomen, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness:
Preexisting Conditions:
Allergies: Yes, aspirin and penicillins.
Diagnostic Lab Data: Yes, on 05/11/21 and 05/12/21 at Clinic Urgent Care and Hospital Emergency.
CDC Split Type:

Write-up: First shot was on 03/29.21, I didn''t know but I was already pregnant about 7 weeks. Second shot was taken on 04/21/21. On 05/11/21 and 05/12/21, I checked in on Emergency Care with craps and light bleeding. A ultrasound and blood tests were done and I was informed I had had a miscarriage. We don''t know if it was just a coincidence or if there is any link to the Covid19 vaccine but I was oriented by CDC to report the finding if I would like to.


VAERS ID: 1457466 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-08
Onset:2021-05-12
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion induced, Ectopic pregnancy, Fallopian tube disorder, Fallopian tube operation, Maternal exposure before pregnancy, Pregnancy test positive, Surgery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Pregnancy test. Emergency Surgery.
CDC Split Type:

Write-up: I received the vaccine and within the next few days became pregnant about 1 month later - I found out I was pregnant on 5/10. I was hospitalized with an ectopic pregnancy and had emergency surgery to remove the pregnancy and the entire Fallopian tube on 5/12. I would have only been 5.5 weeks pregnant but was showing all other signs of a healthy early pregnancy when I went in for the test on 5.10. When I see the date of conception and date of covid vaccine - they are within a day of one another. I would have died had I not gone into the hospital the day of the pain - the Fallopian tube was rupturing.


VAERS ID: 1478309 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-03-06
Onset:2021-05-12
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Cytogenetic analysis normal, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Foetal hypokinesia, Induced labour, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal Vitamin
Current Illness: No illnesses prior to vaccination
Preexisting Conditions: No known health conditions
Allergies: No known allergies
Diagnostic Lab Data: Autopsy and Genetic Testing performed and revealed no known cause for fetal demise
CDC Split Type:

Write-up: Previous healthy pregnancy with healthy live childbirth Jan 22nd, 2019. Healthy pregnancy, no complications, due May 23rd, 2021. 38 week check-up with OB on Mon May 10th, 2021 - normal, healthy, heard heartbeat ER visit on Wed May 12th, 2021 due to reduced fetal movement detected and ER OB confirmed no fetal heartbeat Stillborn baby girl delivered via induction on Fri May 14th, 2021 Autopsy and Genetic Testing performed and revealed no known cause for fetal demise


VAERS ID: 1826304 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-08
Onset:2021-05-12
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamin
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data: I was seen at Kaiser for the second miscarriage
CDC Split Type:

Write-up: I had a miscarriage within 2 weeks of receiving the second dose. I was likely was "pregnant" at the time of vaccine, dose 2. 1st miscarriage was 5/12/21 (4.5 weeks pregnant) 2nd miscarriage was 7/16/21 (8 weeks pregnant)


VAERS ID: 1385676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-12
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601151

Write-up: Abortion spontaneous; Petechiae; This is a spontaneous report from a contactable healthcare professional via the RA. The regulatory authority report number is 555461. A 39-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 12May2021, the patient experienced abortion spontaneous and petechiae. Outcome of the events was not recovered/ not resolved No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1445572 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 6)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Miskraam; Maternal exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miskraam) in a 37-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 6). On 12-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage form. The patient''s last menstrual period was on an unknown date and the estimated date of delivery was 05-Jan-2022. On 12-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 15-May-2021, the patient experienced ABORTION SPONTANEOUS (Miskraam) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Unknown. On 12-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 21-May-2021, ABORTION SPONTANEOUS (Miskraam) had resolved. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment 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: 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.


VAERS ID: 1474128 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0193 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021820126

Write-up: miscarriage 1 week after vaccine; miscarriage 1 week after vaccine; This is a spontaneous report from a contactable consumer (patient). A 31-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0193) via an unspecified route of administration in left arm on 05May2021 at 18:00 (age at vaccination 31-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021, patient experienced miscarriage 1 week after vaccination. Adverse events resulted into Emergency room/department or urgent care. Patient did not receive any treatment for the event. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1498817 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Lactose intolerance
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:Result not provided; Comments: After vaccination; Test Date: 20210626; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: DEPFIZER INC2021859416

Write-up: gestational week 8 the embryo was too small, corresponded to only gestational week 6 plus 2/missed abortion in gestational week 7 plus 2, drug-induced abortion; BNT162B2 exposure during pregnancy/first trimester; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 32-year-old pregnant female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EY2172), via an unspecified route of administration, administered in arm left on 12May2021 at 01:15 (at the age of 32-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing bronchial asthma, lactose intolerance on an unknown date. The patient was pregnant at the time of vaccination. The mother reported she became pregnant while taking bnt162b2. The mother was 1 week pregnant at the time of bnt162b2 administration. The mother was due to deliver on 06Feb2022. The patient''s last menstrual period date was reported as 02May2021. The patient''s concomitant medication was reported as mama plus from doppelherz taken for an unspecified indication, start and stop date were not reported. The patient experienced ''gestational week 8 the embryo was too small, corresponded to only gestational week 6 plus 2/missed abortion in gestational week 7 plus 2, drug-induced abortion'' on 22Jun2021 and BNT162B2 exposure during pregnancy/first trimester on 12May2021 at 01:15. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: result not provided on an unspecified date (after vaccination) and negative on 26Jun2021. Therapeutic measures were taken as a result of in gestational week 8 the embryo was too small and corresponded to only gestational week 6 plus 2/ followed by missed abortion in gestational week 7 plus 2 and drug-induced abortion. The outcome of the events was not recovered.


VAERS ID: 1589126 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Foetal death, Maternal exposure during pregnancy
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101046535

Write-up: fetal death in utero which constituted a congenital anomaly / birth defect; Cardiac arrest of the fetus at 10 weeks of pregnancy; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable consumer or other non-healthcare professional (parent). This is a second of two reports, for the fetus. The first report is a report from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NY20213108. A fetus patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY), via transplacental (Parent Route of Administration: intramuscular) on 12May2021 (Lot Number: EX7389) as single dose for COVID-19 immunisation. The mother is a 34-year-old female, date of last menstrual period: 26Apr2021. Pregnancy Information: due date reported as 31Jan2022. The patient medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy, first trimester on 12May2021, fetal death in utero which constituted a congenital anomaly / birth defect on 15Jul2021, cardiac arrest of the fetus at 10 weeks of pregnancy on 15Jul2021. Seriousness of the events reported as death and congenital anomaly. The outcome of the events was fatal. The patient died on 15Jul2021. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101003844 Maternal case; Reported Cause(s) of Death: fetal death in utero which constituted a congenital anomaly / birth defect; Cardiac arrest of the fetus at 10 weeks of pregnancy; Maternal Exposure During Pregnancy, first trimester


VAERS ID: 1321443 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-12
Onset:2021-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Haemorrhage, Muscle spasms, Ultrasound ovary
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamins, albuterol, pulmacort
Current Illness:
Preexisting Conditions:
Allergies: sulfa, latex, marijuana
Diagnostic Lab Data: DNC
CDC Split Type:

Write-up: Miscarriage at 5 weeks pregnant. Had first appointment, ultrasound and blood work on 5/11/2021. Covid vaccine on 05/12/2021, first signs of miscarriage on 05/13/2021. Bleeding was followed by cramps. I saw Dr. on 05/14/2021 for miscarriage. Due date was January 10, 2022. Fourth pregnancy. Once previous miscarriage.


VAERS ID: 1373782 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-02
Onset:2021-05-13
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021602163

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient). This is the mother case. A 34-year-old female patient received the 1st single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in left arm on 18Apr2021 (Batch/Lot Number: Ew161), and the 2nd single dose, always in the left arm, on 02May2021 (Batch/Lot Number: Ew0171), for COVID-19 immunisation. First and second dose were administered at the age of 34 years old. Relevant medical history was reported as none. The patient''s last menstrual period was on 18Feb2021 and pregnancy due date was 26Dec2021. Concomitant medications included unspecified pre-natal vitamins. Relevant past drug history included sulfa. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was never diagnosed with COVID-19, and since the vaccination the patient had not been tested for COVID-19. The patient reported having miscarriage on 13May2021, diagnosed after the 2nd shot of BNT162b2. A doctor or other healthcare professional office/clinic visit was needed. The fetus had died sometime between the 1st and 2nd shot based on gestational age. Gestation period when the event was observed was reported as 4 weeks. The patient had to undergo dilation and curettage from which the patient was recovering. The seriousness criterion was reported as ''Congenital anomaly/birth defect'' (no further information reported about the congenital anomaly). Follow-up attempts completed. No further information expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-2021602308 mother/baby case


VAERS ID: 1392742 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-03-12
Onset:2021-05-13
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004M20A / 1 RA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026AZ1A / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal heart rate abnormal, Ultrasound foetal abnormal, Uterine dilation and curettage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin C, vitamin D, prenatal vitamin
Current Illness:
Preexisting Conditions:
Allergies: allergic to nickel
Diagnostic Lab Data: Exam and ultrasound on 5/13/2021. D&C surgery on 5/18/2021. Additional exam and ultrasound due to complications on 5/21/2/2021.
CDC Split Type:

Write-up: Miscarriage at 16 weeks was found on 05/13/2021. Due date was 10/31/2021. Ultrasound at 16 weeks showed baby with no heartbeat at approximately 12-13 weeks growth.


VAERS ID: 1414646 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016C21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Fatigue, Malaise
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Progestin Pill; Norethindrone
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: June 5, 2021 lab of blood test. June 3, 2021 regular Dr. appt with OBGYN for missed period. Appt. June Discovered after June 5, 2021 lab for pregnancy hormone.
CDC Split Type: vsafe

Write-up: That evening felt unwell the night of the vaccination and into the next day was feeling very fatigue and 05/14/2021, 05/15/2021 until June 1, 2021 felt fine. Then on June 02, 2021, miscarriage. June 3, 2021 regular Dr. appt with OBGYN for missed period. Appt. June Discovered after June 5, 2021 lab for pregnancy hormone.


VAERS ID: 1428542 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (1 previous full term pregnancy); Vitamin supplementation
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:No heartbeat detected at 13 week
CDC Split Type: GBPFIZER INC2021683688

Write-up: Early miscarriage; Maternal exposure during pregnancy/received in week 9 of pregnancy (first trimester); This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106100508256360-MH05H. Safety Report Unique Identifier GB-MHRA-ADR 25449045. A 38-year-old female patient received BNT162B2 via an unspecified route of administration on 13May2021, at the age of 38 years (lot number: EW4109) as dose 1, single for COVID-19 immunization. Medical history included pregnancy (1 previous full term pregnancy) and vitamin supplementation. Patient no longer pregnant at the time of reporting. Concomitant medication included folic acid taken for vitamin supplementation. The patient had a maternal exposure during pregnancy on 13May2021 and early miscarriage, medically significant on 08Jun2021. Events were described as follows: vaccine was received in week 9 of pregnancy (first trimester). Estimated age that fetus stopped developing was 9 weeks. No heartbeat detected at 13 week scan. Patient has not tested positive for COVID-19 since having the vaccine. The patient has not recovered from early miscarriage. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1491671 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-05-13
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8493 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vaccination site mass
Allergies:
Diagnostic Lab Data: Test Name: bloods; Result Unstructured Data: Test Result:ok; Comments: Bloods also ok; Test Name: ultrasound; Result Unstructured Data: Test Result:no issues affecting fertility detected
CDC Split Type: GBPFIZER INC2021853081

Write-up: Early miscarriage; Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202107022117500760-GZEQB], Safety Report Unique Identifier [GB-MHRA-ADR 25588264]. A 31-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EE8493), via an unspecified route of administration on 13Jan2021 as dose 1, single for COVID-19 immunisation. Medical history included vaccination site mass. The patient''s concomitant medications were not reported. The patient experienced miscarriage on 13May2021 and early miscarriage on 10Jun2021. The outcome of the events was recovered on an unspecified date. The clinical course was reported as follows: Two consecutive miscarriages. Patient has not tested positive for COVID-19 since having the vaccine. Additional information: Have had an ultrasound with no issues affecting fertility detected. Bloods also ok. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1337712 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-04-14
Onset:2021-05-14
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multi-vitamin; folic acid
Current Illness: no
Preexisting Conditions: no
Allergies: penicillin
Diagnostic Lab Data: Ultrasound last Friday, 5/14/2021
CDC Split Type: vsafe

Write-up: I have miscarriage - they aren''t sure when it happened. The heart beat had stopped when they did an ultra sound last Friday. Pregnancy history - first; Estimated date of delivery - 12/31/2021


VAERS ID: 1361041 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-24
Onset:2021-05-14
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Pathology test, Premature delivery, Preterm premature rupture of membranes
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zoloft, prenatal, Synthroid
Current Illness:
Preexisting Conditions: Under active thyroid
Allergies: Penicillin
Diagnostic Lab Data: Pathology on placenta - 5/15/21
CDC Split Type:

Write-up: Preterm birth at 33 weeks and 5 days. Date of birth 5/15/21. Due date June 28, 2021. Water broke on 5/14. Birth weight 4 lbs 8oz. Only pregnancy complication was bleeding at 6 weeks. Baby in NICU for 12 days.


VAERS ID: 1364666 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-01
Onset:2021-05-14
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion missed, Foetal cardiac arrest, Foetal heart rate abnormal, Full blood count abnormal, Haematocrit decreased, Haemoglobin decreased, Pregnancy test urine positive, Primiparous, Red blood cell count decreased, Retained products of conception, Ultrasound antenatal screen abnormal, Ultrasound scan vagina abnormal, Vaginal haemorrhage, White blood cell count decreased
SMQs:, Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Congenital and neonatal arrhythmias (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D drops - 1000 IU daily
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin allergy
Diagnostic Lab Data: 5/17/21 - ultrasound impression reported above; 5/25/21 - CBC (low WBC and RBC, reduced Hbg and Htc compared to patient baseline drawn on 3/5/21); 5/27/21 - ultrasound impression reported above
CDC Split Type:

Write-up: Patient''s first day of last menstrual period was 3/23/2021. Patient has a predictable monthly cycle with an average length of 30 days. Patient reports two positive at home urine pregnancy tests on 4/30/21 and 5/1/21. Conception likely occurred on or around 4/6/21. Patient reports vaginal bleeding that started on 5/14/21. Patient had transvaginal ultrasound on 5/17/21. Impression: FIRST TRIMESTER ULTRASOUND, SINGLETON An early intrauterine singleton pregnancy is visualized. A fetal pole is visualized but fetal cardiac activity is NOT present. The fetal biometry is appropriate for gestational age. Anatomic survey is precluded by early gestational age. As the CRL <7mm (measures 2.6mm) a definitive diagnosis of a missed miscarriage can not be made I would recommend a follow up ultrasound in 10-14d. Follow up ultrasound on 5/27/21 could not visualize pregnancy. Impression: The endometrium measures 14.39 mm, with heterogenous echotexture suggestive of retained products. The right and left ovaries appear normal.


VAERS ID: 1469584 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Texas  
Vaccinated:2020-12-31
Onset:2021-05-14
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037K20A / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Unevaluable event
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: 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.


VAERS ID: 1364424 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ELTROXIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021555778

Write-up: Miscarriage; This is a spontaneous received from a contactable consumer (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11May2021 19:15 (Batch/Lot Number: Unknown) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Relevant medical history was not reported. The patient had no history of miscarriage, 1 prior successful pregnancy, full term. 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. Concomitant medication(s) included ongoing levothyroxine sodium (ELTROXIN). The patient experienced miscarriage 14May2021 06:00, 3 days following vaccine. The adverse event resulted in Emergency room/department or urgent care. No treatment received. The mother reported she became pregnant while taking bnt162b2. The mother was 7 Weeks pregnant at the onset of the event. The mother was due to deliver on 01Jan2022. Patient last menstrual period date was 26Mar2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovering. Information on the lot/batch number has been requested.


VAERS ID: 1398608 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Maternal exposure during pregnancy, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding; Pregnancy (3 previous pregnancies ongoing pregnancy (patient is pregnant at first trimester)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021622090

Write-up: Miscarriage/ Missed Miscarriage/ Heartbeat stopped around date of vaccine; Maternal exposure during breast feeding/ ongoing breast feeding; Maternal exposure during breast feeding/ ongoing breast feeding; Patient received the vaccine on the first-trimester (1-12 weeks) of pregnancy; This is a spontaneous report from a contactable consumer. This is first of the two reports. This first report was received from the Regulatory Agency; the Regulatory Authority report number is GB-MHRA-WEBCOVID-202105292122203980-M7XCM and the Safety Report Unique Identifier is GB-MHRA-ADR 25387516. This consumer reported information for both mother and baby. This is the maternal case. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14May2021 (batch/lot number was not reported) at 40 years old as 1ST DOSE, SINGLE for COVID-19 immunization. The patient''s medical history included miscarriage, three (3) previous pregnancies and ongoing pregnancy (patient is pregnant at first trimester), ongoing breast feeding, and folic acid supplementation. The patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Concomitant medication included folic acid (manufacturer unknown) taken for folic acid supplementation, start and stop dates were not reported. On 14May2021, the patient received the vaccine on the first-trimester (1-12 weeks) of pregnancy. On an unspecified date, the patient experienced miscarriage reported as missed miscarriage and heartbeat stopped around the date of vaccine. It was unsure if the suspect drug had an adverse effect on any aspect of the pregnancy. No relevant investigations or tests were conducted. It was also reported that the patient experienced "maternal exposure during breast feeding/ ongoing breast feeding" on 14May2021. The patient recovered from the event "miscarriage/ missed miscarriage/ heartbeat stopped around date of vaccine" on an unspecified date. Outcome of the rest of the events was unknown. The events were reported as serious, medically significant. The patient has not tested positive for COVID-19 since having the vaccine; patient tested no - negative for COVID-19 virus test on an unspecified date. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021639754 Baby case


VAERS ID: 1399703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-05-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021635370

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 559771. A 34-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Apr2021 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced abortion spontaneous on 14May2021 with outcome of recovered on unspecified date. The mother reported she is pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1419041 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Seizure, Ultrasound scan
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Government scheme with monthly swabs and antibody checks); Lactation decreased (not currently breastfeeding); Pregnancy (previous pregnancies: Pregnacare taken till 12 week scan and 2 other successful pregnancies)
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210606; Test Name: SCAN; Result Unstructured Data: Test Result:abs confirmed baby passed away; Comments: 18+1 no heartbeat detected; measuring approximately 16 weeks which would have been a week after vaccine
CDC Split Type: GBPFIZER INC2021671664

Write-up: Late miscarriage; Maternal exposure during pregnancy, second trimester; had vaccine 14th may at 15 weeks; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106072058214860-1MVMN. Safety Report Unique Identifier GB-MHRA-ADR 25433834. A 30-year-old female patient (pregnant) receivedfirst dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Not known) via an unspecified route of administration on 14May2021 (at 30 years) as single dose for covid-19 immunisation. Medical history included lactation decreased, pregnancy (previous pregnancies: Pregnacare taken till 12 week scan and 2 other successful pregnancies;Patient no longer pregnant at the time of reporting) , clinical trial participant (Study details: Government scheme with monthly swabs and antibody checks). Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Concomitant medication included folic acid taken as folic acid supplementation, start and stop date were not reported. Patient had vaccine on 14May2021 at 15 weeks (exposed to the medicine Second-trimester: 13-28 weeks), felt flitters etc as expected with 3rd child. Patient had seizure on an unknown date in 2021 . All symptoms subsided over next week but convinced herself all was ok. Patient had late miscarriage on 06Jun2021: she went for a scan on 06Jun2021 "abs" confirmed baby had passed away around 16 weeks according to measurements (details of scans or investigations: 18+1 no heartbeat detected; measuring approximately 16 weeks which would have been a week after vaccine, as reported). Hospital running bloods. Placenta to be screened and depending on baby condition post mortem maybe done. COVID-19 virus test was negative on 24May2021. Unsure if vaccine had an adverse effect on any aspect of the pregnancy. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1464938 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: Scan; Result Unstructured Data: Test Result:complete miscarriage
CDC Split Type: GBPFIZER INC2021787241

Write-up: Miscarriage; Maternal exposure during pregnancy/ exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106251020483710-QA9S4.Safety Report Unique Identifier GB-MHRA-ADR 25542205. A 35-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH),dose 1 via an unspecified route of administration on 14May2021 (Lot number was not reported) as dose 1,single for COVID-19 immunization (35-year-old at vaccination). Medical history included abortion spontaneous from an unknown date, suppressed lactation from an unknown date and unknown if ongoing , pregnancy from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy (maternal exposure during pregnancy) (medically significant) on 14May2021 with outcome of unknown, miscarriage (abortion spontaneous) (medically significant) on 24May2021 with outcome of recovered. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient stated there was of course no clear evidence that the vaccine in any way caused a miscarriage. She was unaware that she was pregnant at the time the vaccine was given so did not have any discussion with a medical professional regarding whether to continue with vaccination. Indicators of miscarriage started within about 2 weeks of vaccine administration and miscarriage was shown to be complete within about 4 weeks. Details of scans or investigations: Scan showed complete miscarriage. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent COVID-19 test on unknown date with negative result. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1469968 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021759117

Write-up: ABORTION in the 7th week of pregnancy, the pregnancy was not known; This is a spontaneous report downloaded from the regulatory authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-32328. A contactable physician reported that a 32-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route on 23Apr2021 (Batch/Lot Number: ET7205) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion in the 7th week of pregnancy, the pregnancy was not known on 14May2021 with outcome of not recovered. The mother was 7 Weeks pregnant at the onset of the event. Sender''s comments: The patient was pregnant. The report is for a patient. No mail was sent to reporter. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1472279 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-14
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021772767

Write-up: Miscarriage; This is a spontaneous report from a consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is, GB-MHRA-WEBCOVID-202106212010229750-HVUJ2. Safety Report Unique Identifier GB-MHRA-ADR 25515081. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as second dose, single for COVID-19 immunization. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken as folic acid supplementation, start and stop date were not reported. The patient experienced miscarriage (assessed as medically significant) on 14May2021 with outcome of recovered on 20May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown dare. Patient has not tested positive for COVID-19 since having the vaccine. Bleeding started day after the 2nd dose of vaccine.Patient was exposed to the medicine first-trimester (1-12 weeks). No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1526806 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Investigation, Maternal exposure during pregnancy, Mucosal haemorrhage, Off label use, Pain in extremity, Product use issue, SARS-CoV-2 test, Scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: Examination; Result Unstructured Data: Test Result:concluded 6+2 developmental stage; Test Date: 20210708; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210622; Test Name: Scan; Result Unstructured Data: Test Result:fully miscarried
CDC Split Type: GBPFIZER INC202100928624

Write-up: Maternal exposure during breast feeding; Maternal exposure during breast feeding; Miscarriage; spot bleeding; Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester (1-12 weeks); Sore arm to touch and move; This is a spontaneous report from a contactable consumer (patient). This is the first of three reports. The first report is a report downloaded from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107201002150600-IBMZF, Safety Report Unique Identifier: GB-MHRA-ADR 25679285. This consumer reported information for both mother and baby. This is a mother report. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14May2021 (Lot number was not known) as dose 1, single for COVID-19 immunisation. Medical history included miscarriage, pregnancy (patient no longer pregnant at the time of reporting), ongoing breast feeding, and folic acid supplementation. Patient has not had symptoms associated with COVID-19. Concomitant medication included folic acid at 400 mcg taken for folic acid supplementation. The patient experienced spot bleeding (coded to ''Mucosa bleeding spot'' as reported), maternal exposure during breast feeding on an unspecified date; maternal exposure during pregnancy (14May2021); miscarriage on 19Jun2021. Clinical course reported: spot bleeding 19Jun2021 through to 21Jun2021 then full miscarriage. Scanned on 22Jun2021 to confirm. Doctor and midwife examined miscarriage confirmed developmental stage of baby. The medicine had an adverse effect on any aspect of the pregnancy. Pregnancy adverse effects details: received vaccination while 6+1 day (6 weeks and 1 day) pregnant. No unexpected reactions. Sore arm to touch and move from the evening (unspecified date) and next day then fine. Then at 11+2 (11 weeks and 2 days), she miscarried. Through examination by doctor and midwife, they concluded baby was 6+2 (6 weeks and 2 days) developmental. Details of previous pregnancies: 3 previous perfect no complications pregnancies and home births. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: doctor and nurse examined baby, concluded 6+2 developmental stage. Scan to firmed she had fully miscarried. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 08Jul2021. The outcome of the events miscarriage and spot bleeding was recovered on 21Jun2021; and of event sore arm to touch and move was recovered on an unspecified date. Regulatory authority assessed the events as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100940168 same reporter/patient/suspect drug; different vaccine dose and events;GB-PFIZER INC-202100940169 baby case


VAERS ID: 1576977 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Interchange of vaccine products
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202100973290

Write-up: Spontaneous abortion; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority-WEB NO-NOMAADVRE-PASRAPP-2021-Uq49wp. A 20-year-old female patient received bnt162b2 (COMIRNATY), dose 2 at the age of 20-years-old intramuscular, administered in Arm Left on 14May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included folic acid taken for an unspecified indication, start and stop date were not reported. The patient experienced spontaneous abortion 03Jul2021 and revaccination with different covid-19 vaccine on 14May2021 with outcome of unknown. The mother reported she became pregnant while taking bnt162b2, covid-19 vaccine nrvv ad (chadox1 ncov-19). The pregnancy resulted in spontaneous abortion. The outcome of the events was unknown. The regulatory authority did not provide a causality assessment. Reporter Comment: Contact with healthcare professionals: Physician, Nurse. The patient reports a latency for SPONTANEOUS ABORTION being 2-3 months (Comirnaty). Sender Comment: Upgraded to serious due to SPONTANEOUS ABORTION (Important Medical Events). Reporter reported 2 separate incidents related to 2 different suspect products in same report. Original report is therefore split into 2 ICSRs (NO-NOMAADVRE-PASRAPP-2021-Uq49wp and NO-NOMAADVRE-PASRAPP-2021-Uq49wp-2) and linked. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Contact with healthcare professionals: Physician, Nurse. The patient reports a latency for SPONTANEOUS ABORTION being 2-3 months (Comirnaty).


VAERS ID: 1669721 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001945 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroidectomy NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Miscarriage; Maternal exposure during pregnancy; This case was received via regulatory authority (Reference number: FR-AFSSAPS-NT20213389) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3001945) for SARS-CoV-2 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Thyroidectomy NOS. On 14-May-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. The patient''s last menstrual period was on 01-May-2021 and the estimated date of delivery was 05-Feb-2022. On 14-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 23-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Spikevax) beginning around the first week of the pregnancy. 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 (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-NT20213389. Concomitant product was not provided. Treatment medication was not reported. Company comment: 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.; 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


VAERS ID: 1705999 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Investigation, Maternal exposure before pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eating disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: GS; Result Unstructured Data: Test Result:24.0mm; Comments: GS (gestational sac): 24.0mm
CDC Split Type: JPPFIZER INC202101134558

Write-up: Abortion missed; the patient was pregnant confirmed by previous doctor on 03Aug2021(the patient received the first single dose on 14May2021 ); This is a spontaneous report from a contactable physician received via a Regulatory Authority. A 29-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EY2173; Expiration Date: 31Aug2021), intramuscular, in left arm on 14May2021 13:45 (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received FOLIC ACID supplement within 2 weeks of vaccination. 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 had eating disorder. On 14May2021 at 13:45, the patient received the first single dose of BNT162B2 (COMIRNATY). On 03Aug2021, the patient was pregnant confirmed by previous doctor. On 26Aug2021 at 08:45 (3 months 11 days 19 hours after the vaccination), the patient experienced abortion missed. The clinical course was reported as follows: The last menstrual period was 16Jun2021 to 7 days after. Pregnancy is confirmed by using an ovulation inducer. On 03Aug2021, the patient was pregnant confirmed by previous doctor. On 17Aug2021, the patient was referred to the hospital (equivalent to 8w6d from the last menstrual period). GS (gestational sac): 24.0mm (equivalent to 6w4d). On 26 Aug2021, the outline of the fetus is blurred and there was no fetal heartbeat. Abortion missed was confirmed. The outcome of the event was recovered on an unspecified date with treatment including miscarriage surgery (dilation and evacuation). The outcome of the patient was pregnant confirmed by previous doctor on 03Aug2021(the patient received the first single dose on 14May2021 ) was not provided. The reporter classified the events as non-serious.; Sender''s Comments: Based on plausible dose- event relationship post-vaccination and the causal role of BNT162B2 vaccine cannot be excluded for the reported events. Underlying hypertension could be contributory to the reported events. 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) : JP-PFIZER INC-202101163799 same reporter/drug, different patient/AE


VAERS ID: 1783894 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion, Asthenia, Dyspnoea, Hormone level abnormal, Menstrual disorder, Skin mass
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101299256

Write-up: total chaos in period; breathing problems; hormonal disturbance; abortion; nodule on surface of skin and below; weakness; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the a regulatory authority-WEB, regulatory authority number HU-OGYI-756421. Sender''s (Case) Safety Report HU-OGYI-756421. A 39-years-old pregnant female patient received BNT162B2 (COMIRNATY, formulation: solution for injection, Lot number: not provided, Expiration date: not provided), via an intramuscular route of administration on 13May2021 as dose 1, 0.3 mL, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. On 14May2021, 1 day after vaccination, the patient experienced weakness, total chaos in period, breathing problems, hormonal disturbance, abortion, nodule on surface of skin and below. Events were medically significant. Patient reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion; the patient reported that she had abortion few hours after vaccination. Gestation week was not reported. The fetal outcome was intrauterine death. The outcome of all events was not recovered. Sender Comment: Abortion, hormonal imbalance, menstrual disorder, nodules on- and below the surface of skin, and breathing difficulties are not expected adverse events of COMIRNATY. Weakness is expected for COMIRNATY. TTO was few hours for the start of the symptoms. Based on the above, in lack of detailed information, causality between the events and COMIRNATY is not assessable. The case is serious because of abortion. Further information is expected. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1320533 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-24
Onset:2021-05-15
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient sustained miscarriage. G1P0, Due Date 11/1/2021


VAERS ID: 1358839 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-14
Onset:2021-05-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Exposure during pregnancy, Fatigue, Foetal heart rate normal, Nausea, Night sweats, Pain, Ultrasound scan vagina, Vaginal haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: prenatal medicines
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: 5/17, 5/25 & 5/26 vaginal ultrasounds
CDC Split Type:

Write-up: Received second shot at 10 weeks pregnant (due 12/6/21). The night of 5/14 - started having night sweats, extreme lower back pain, nausea, and spotting from the vagina. All of these symptoms were new and none were experienced during pregnancy otherwise. (After the first shot at 7 weeks pregnant, only had a sore arm at injection site) On 5/15 - multiple episodes of vomiting, excessive exhaustion, and bleeding continued. 5/16-5/25 - bleeding increased Went to OBGYN 5/17 & 5/25 to get checked and both times they were able to locate a heartbeat, but were unsure why bleeding continued to occur. 5/25 11:30pm woke up in excessive pain and bleeding, resulting in a miscarriage. 5/26 2:00am ER confirmed miscarriage.


VAERS ID: 1432016 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-04-12
Onset:2021-05-15
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Hyperthyroidism, Thyroid function test, Ultrasound scan
SMQs:, Hyperthyroidism (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Thyroid labs, ultrasound
CDC Split Type:

Write-up: Was diagnosed with hyperthyroid 1 month after vaccine. Had miscarriage 1 month after vaccine. Had been healthy and no thyroid issue prior.


VAERS ID: 1701520 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Antiphospholipid antibodies negative, Exposure during pregnancy, Foetal death, Foetal hypokinesia, Labour induction, Pathology test, Placental disorder, Placental infarction
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins Protonix
Current Illness: None
Preexisting Conditions: GERD Iron deficiency anemia History of adenocarcinoma in situ of the cervix
Allergies: Keflex
Diagnostic Lab Data: See above
CDC Split Type:

Write-up: The patient is a 38 year old, with an estimated due date of 7/24/2021 whose pregnancy was notable for suspected Trisomy 21, based on duodenal atresia, nuchal thickening, echogenic bowel, and transient left renal pyelectasis. Cell free DNA screening indicated a high risk of Trisomy 21, and the patient declined amniocentesis. From a maternal health standpoint, her pregnancy was notable for Gastroesophageal reflux disease, iron deficiency anemia, and a history of cold knife conization. The patient had a sonographic assessment of the fetus two days prior to receiving the vaccine at 30 weeks gestation, which demonstrated new development of polyhydramnios. Given the patients multiple risk factors for stillbirth, it was recommended that antenatal testing commence by 32 weeks gestation. The patient reported that she stopped feeling her baby moving the day she received the COVID vaccine (two days after the ultrasound report demonstrating the above findings). She had reassuring antenatal testing two days subsequent to vaccination, but then had intrauterine fetal demise confirmed 9 days after vaccination. She underwent a labor induction. Her postnatal workup including chromosomal analysis which confirmed the Trisomy 21 diagnosis and a 2.8Mb 2q32.1 duplication thought to be a variant of unknown significance. The placental pathology report demonstrated a umbilical cord stricture with significant clot burden within the stricture. There was also evidence of meconium staining, and some scattered infarctions in the placenta but no large infarction. Maternal antiphospholipid screening was normal. Our clinical impression was that the fetal loss was most likely secondary to Trisomy 21, but given the temporal association between vaccination and change in fetal movement, we have submitted this report as a possible vaccine complication.


VAERS ID: 1385675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-15
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601149

Write-up: spontaneous abortion; This is a spontaneous report from a contactable healthcare professional via regulatory authority, report number is 555392. A 33-year-old female patient received bnt162b2 (COMIRNATY reported as COMIRNATY COVID-19 vaccine [BNT162b2 (mRNA)]), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. On 15May2021, the patient experienced spontaneous abortion. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1409292 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:unknown result
CDC Split Type: NLPFIZER INC2021645730

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00556129. A 30-year-old female patient received the 1st dose of BNT162B2 (COMIRNATY) via an unspecified route of adminsitration on 15May2021 at age of 30 years old as 0.3 ml single for COVID-19 immunisation. Medical history was unknown. Concomitant medications were unknown. The patient had a miscarriage (other medically important condition), on the same day she was treated with the Covid-19 vaccine on 15May2021. The miscarriage occurred at a pregnancy duration of about 5 weeks. This was the first covid vaccination. Outcome of the event was unknown. Sender comment: Since the nature of the reported reaction does imply seriousness according to one of the public health criteria, the reaction (Miscarriage) was considered as serious by the reporting system. Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty): Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no; confounding factors: COVID-19 vaccine exposure during pregnancy week: 5; COVID19: Previous COVID-19 infection: No; Other: diagnostic procedures: Blood tests. No follow-up attempts are possible, information on lot number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty): Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no; confounding factors: COVID-19 vaccine exposure during pregnancy week: 5; COVID19: Previous COVID-19 infection: No; Other: diagnostic procedures: Blood tests.


VAERS ID: 1415912 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Folic acid supplementation; Lactation decreased; Miscarriage (1997 at 12 weeks, 2003 at 6 weeks, Dec2020 at 6 weeks, Mar2021 at 6 weeks); Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210515; Test Name: Scan; Result Unstructured Data: Test Result:9 weeks 4 days, baby healthy with heartbeat; Comments: Scan on day of vaccine; Test Date: 20210530; Test Name: Scan; Result Unstructured Data: Test Result:baby had died at 10+6; Comments: Scan at 11+5
CDC Split Type: GBPFIZER INC2021657848

Write-up: Miscarriage of pregnancy; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer, received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202106051628359480-IICAH, Safety Report Unique Identifier GB-MHRA-ADR 25426125. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Not known), via an unspecified route of administration on 15May2021 (43-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history included miscarriages from 1997 (1997 at 12 weeks, 2003 at 6 weeks, Dec2020 at 6 weeks, Mar2021 at 6 weeks), lactation decreased, pregnancy (Patient no longer pregnant at the time of reporting), folic acid supplementation, and anxiety. Concomitant medications included folic acid taken for folic acid supplementation; sertraline taken for anxiety from Jun2017. The patient experienced maternal exposure during pregnancy on 15May2021, miscarriage of pregnancy on 24May2021. Events were assessed as serious with criteria of Caused/prolonged hospitalization, Congenital anomaly/birth defect, and Other medically important condition. Clinical course: The medicine has an adverse effect on aspect of pregnancy. Pregnancy adverse effects details were miscarriage at 11 weeks. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Scan on day of Pfizer vaccine (15May2021) at 9 weeks 4 days, baby healthy with heartbeat. Scan at 11+5 (30May2021) found baby had died at 10+6 (24May2021). Details of previous pregnancies: 3 living children aged 22, 17, 15; 5 miscarriages- 1997 at 12 weeks, 2003 at 6 weeks, Dec2020 at 6 weeks, Mar2021 at 6 weeks, 02Jun2021 at 10+6. The patient underwent COVID-19 virus test with result "no - negative COVID-19 test" on 02Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1877869 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Malaise, Maternal exposure during pregnancy, Post abortion haemorrhage, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise; At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise; At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise; At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise; At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise; Maternal exposure during pregnancy; This case was received via regulatory authority (Reference number: DE-PEI-202100116868) on 09-Nov-2021 and was forwarded to Moderna on 09-Nov-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise) and POST ABORTION HAEMORRHAGE (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise) in a 38-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 16-May-2021, the patient experienced ABORTION SPONTANEOUS (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise) (seriousness criterion medically significant), POST ABORTION HAEMORRHAGE (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise), MALAISE (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise) and PYREXIA (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise). The delivery occurred on 16-May-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 27-Jun-2021, ABORTION SPONTANEOUS (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise), POST ABORTION HAEMORRHAGE (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise), HEAVY MENSTRUAL BLEEDING (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise), MALAISE (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise) and PYREXIA (At the first vaccination, miscarriage and three weeks of bleeding. With the second vaccination, bleeding again without pregnancy. Fever, malaise) was resolving. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were reported No treatment medications were reported Company comment: This regulatory authority case concerns a 38-year-old female patient with no relevant medical history who experienced serious unexpected events of post abortion haemorrhage and miscarriage .The patient was also exposed to the vaccine during pregnancy. The events occurred after the first dose of the Moderna COVID-19 vaccine (mRNA-1273) . Rechallenge was not applicable since no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of product is not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Translated document received on 10-Nov-2021, contains translated event verbatim and sender''s comment; Reporter''s Comments: No D&C was necessary.; Sender''s Comments: This regulatory authority case concerns a 38-year-old female patient with no relevant medical history who experienced serious unexpected events of post abortion haemorrhage and miscarriage .The patient was also exposed to the vaccine during pregnancy. The events occurred after the first dose of the Moderna COVID-19 vaccine (mRNA-1273) . Rechallenge was not applicable since no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of product is not affected by this report


VAERS ID: 1347515 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-27
Onset:2021-05-16
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Beta hcg (x3) No ultrasound
CDC Split Type:

Write-up: I believe I was very early on in my pregnancy (as in, implantation or first week after conception) when I received the second dose of the vaccine. EDD was January 9th, 2022. I had brown spotting every day for the duration of my pregnancy, obviously concerning and something I paid attention to (though not altogether unusual in early pregnancy). I ended up miscarrying naturally at 6 weeks. I am strongly in favor and appreciative of this vaccine and would be surprised if there was a direct link, but I do know there is a growing conversation about its impact on women''s menstrual cycles. I wanted to submit my experience just in case it was in fact a trend for other trying-to-conceive or early pregnant females.


VAERS ID: 1371270 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-27
Onset:2021-05-16
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Chills, Exposure during pregnancy, Headache, Influenza like illness, Pain, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: When I was 4 months old (43 years ago), I had a reaction to the MMR shot. I was very cranky and ran a fever, but when I received
Other Medications: I was taking prenatal vitamins and 27 mg of Iron.
Current Illness: I did not have any other illnesses.
Preexisting Conditions: I do not have any chronic or long-standing health conditions.
Allergies: I am allergic to penicillin, Keflex and amoxicillin.
Diagnostic Lab Data: I had blood work and an ultrasound done.
CDC Split Type: vsafe

Write-up: I miscarried on 05/16/2021. The baby was due 12/23/2021. I currently have 2 children and had 1 miscarriage before in my life. I was at 5 weeks of pregnancy when I received my 2nd dose and 8 weeks into my pregnancy when I miscarried. After I received my 2nd dose of the vaccine, the second night I experienced chills, had a minor headache and felt very achy. They felt like flu symptoms.


VAERS ID: 1458152 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-05-15
Onset:2021-05-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / 1 LA / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dovato
Current Illness: None
Preexisting Conditions: HIV
Allergies: None
Diagnostic Lab Data: Miscarriage
CDC Split Type:

Write-up: I was 7 weeks pregnant and very okay prior to taking the covid-19 vaccine on 05/15/21 and my weight at the time was 70.76


VAERS ID: 1458358 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-05-15
Onset:2021-05-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Dovato
Current Illness: None
Preexisting Conditions: HIV
Allergies: None
Diagnostic Lab Data: Miscarriage
CDC Split Type:

Write-up: I was 7 weeks pregnant and very okay prior to taking the covid-19 vaccine and my weight was 70.76 Daily medication taking Dovato


VAERS ID: 1478554 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-03-09
Onset:2021-05-16
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802072 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Pregnancy, Uterine dilation and curettage
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: Fructose
Diagnostic Lab Data: D&C surgery
CDC Split Type:

Write-up: I got pregnant the month after that resulted in a miscarriage (after having a normal pregnancy in the past). At week 6 the baby stopped developing and the pregnancy was lost at week 9. After having a D&C my Doctor, notified me of the amount of miscarriages he?s been seeing in vaccinated women just at his office and asked that I report it.


VAERS ID: 1393181 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-05-16
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243; EAN: 05 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; LUTEINE [PROGESTERONE]; PROGESTERONE; DROTAVERINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021616744

Write-up: abdomen pain; Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105261342361520-JLZ5Q,Safety Report Unique Identifier GB-MHRA-ADR 25364390. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EW2243; EAN: 05909991445492) at first dose, single for COVID-19 immunization. Medical history included abort Miscarriage and pregnancy (Patient no longer pregnant at the time of reporting). Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test; Patient is not enrolled in clinical trial; Patient is not currently breastfeeding. Concomitant medications included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported; luteine [progesterone] (LUTEINE [PROGESTERONE]) taken for an unspecified indication from 16May2021 to an unspecified stop date; progesterone taken for an unspecified indication, start and stop date were not reported; drotaverine taken for an unspecified indication, start and stop date were not reported; and dydroprogesterone. The patient experienced miscarriage on 16May2021 that recovered on 23May2021; abdomen pain on an unspecified date with outcome of unknown; and maternal exposure during pregnancy on an unspecified date with outcome of unknown. The events caused prolonged hospitalization. It was reported that bleeding started at 8th week of being pregnant. Drugs prescribed: folic acid, drotaverine, progesterone, dydroprogesterone, resting and being in beg. After the bleeding finished the strong abdomen pain happened within a few days and finished with miscarriage in 9th week. Patient has not tested positive for COVID-19 since having the vaccine. The patient didn''t know about being pregnant at the time then vaccine was administered. Patient was exposed to the medicine first-trimester (1-12 weeks). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1401403 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal exposure during pregnancy, first trimester (COVID-19 vaccine exposure during pregnancy week: 4)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021627697

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB NL-LRB-00547221, Safety Report Unique Identifier NL-LRB-00555685. A 34-year-old pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: ET6956), via an unspecified route of administration on 06May2021 as first dose, single dose for COVID-19 immunization. The mother was pregnant when she was administered BNT162B2, at 4 weeks. Medical history included maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 4). Concomitant medication included cetirizine 10 mg tablet taken from 2016. The patient experienced miscarriage on 16May2021, 10 days after administration of BNT162B2. The miscarriage occurred at a pregnancy duration of about 5 weeks. The event was reported as serious, other medically important condition. The pregnancy resulted in spontaneous abortion. The patient recovered from the event on 19May2021. Sender Comment: Since the nature of the reported reaction does imply seriousness according to criteria, the reaction (miscarriage) was considered as serious by the health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1472986 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Off label use, Product use issue, SARS-CoV-2 test, Scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage (Details of previous pregnancies: 2 previous miscarriages and 2 previous successful pregnancies.); Pregnancy (Details of previous pregnancies: 2 previous miscarriages and 2 previous successful pregnancies.); Vitamin supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210624; Test Name: Scan; Result Unstructured Data: Test Result:foetus stopped growing at 8w+4
CDC Split Type: GBPFIZER INC2021809113

Write-up: Miscarriage; Miscarriage bleed; Maternal exposure during pregnancy; Maternal exposure during breast feeding; Maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106281642588190-5T1R8. Safety Report Unique Identifier GB-MHRA-ADR 25556040. A 38-year-old pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16May2021 (Batch/Lot Number: EW2245) at the age of 38 years old, as single dose for covid-19 immunisation. Medical history included pregnancy and miscarriage (details of previous pregnancies: 2 previous miscarriages and 2 previous successful pregnancies. Patient no longer pregnant at the time of reporting), ongoing breast feeding, and vitamin supplementation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included folic acid, 400 ug, taken for vitamin supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy and maternal exposure during breast feeding on 16May2021; she had miscarriage and miscarriage bleed on 03Jun2021. Additional information: Vaccine was given at 6 weeks of pregnancy. Foetus heart stopped at 8 weeks +4. Body reacted to start miscarriage bleed at 11weeks +4. The mother reported she was pregnant when she has been vaccinated with BNT162B2. Patient was exposed to the vaccine during first trimester (1-12 weeks). The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 10Jun2021, and scan: foetus stopped growing at 8w+4 on 24Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events miscarriage, miscarriage bleed was recovered on 28Jun2021, while outcome of the other events was unknown. The regulatory authority assessed the events as medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1484439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-16
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Gynaecological examination, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: Pelvic exam; Result Unstructured Data: Test Result:Unknown result; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC2021843391

Write-up: inappropriate schedule of vaccine administered; Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number GB-MHRA-WEBCOVID-202106281712381910-YY26L. Safety Report Unique Identifier is GB-MHRA-ADR 25556359. A 30-year-old female patient (non-pregnant and not currently breastfeeding) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 29Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. Patient relevant medical history included pregnancy, Patient no longer pregnant at the time of reporting, abortion spontaneous, Folic acid supplementation. The patient concomitant medication(s) included folic acid, 400 ug taken for Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient was unsure, medicine have an adverse effect on any aspect of the pregnancy. Patient has not tested positive for COVID-19 since having the vaccine. The patient previously received first dose of BNT162B2 (Lot Number: Not Known) on 18Feb2021 for COVID-19 immunisation with reaction of prolonged periods. It was reported on 16May2021, the patient experienced miscarriage. On an unspecified date, maternal exposure during pregnancy. Prolonged and irregular periods after 1st vaccine ($g3 in 1 month). ongoing investigations. Unknown very early pregnancy after second vaccine. Miscarriage at 5.5 weeks. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included pelvic exam was unknown result, ultrasound scan was unknown result. The patient died on 16May2021. It was not reported if an autopsy was performed. Suspect Reactions. Please provide details of any relevant investigations or tests conducted: "Pelvic ex-am and referral for pelvic ultrasound for irreg periods. NAD " No follow up required. Information about Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1359724 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-08
Onset:2021-05-17
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage on 5/17/2021 10 days after second shot


VAERS ID: 1368206 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014B21A / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Intermenstrual bleeding, Ultrasound antenatal screen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sulfasalazine, Azathioprine, Folic Acid, Prenatal vitamin
Current Illness: None
Preexisting Conditions: Ulcerative colitis
Allergies: None
Diagnostic Lab Data: I had a spotting on 5/29/21 and again on 6/1/21. I called my OB both times and they brought my in for an ultrasound on 6/1/21. On 6/1/21, it was determined via ultrasound that my baby passed away on the exact day that I received my first Moderna vaccine.
CDC Split Type:

Write-up: I was 14 weeks, 4 days pregnant when I received the vaccine. My due date was November 11, 2021. I had three ultrasounds prior to my shot and all showed that the baby was normal and healthy. We also had normal genetic testing results with this pregnancy. We found out in 6/1/2021 that we lost the baby and based on the size of the baby when it passed, it was determined that the baby passed on 5/17/21 - the date I received my first Moderna vaccine.


VAERS ID: 1368613 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-07
Onset:2021-05-17
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: I take a anit depression meds Wellbutrin and prenatal vitamins.
Current Illness: No
Preexisting Conditions: I have Celiac and IBS.
Allergies: No
Diagnostic Lab Data: They did a ultra sound, full blood work and my HCG hormone tested and a physical done as well.
CDC Split Type: vsafe

Write-up: I was 6 weeks along and I was suppose to deliver in January 2022. I missed carried May 17, 2021. It can take upto 4 weeks with the miscarried.


VAERS ID: 1498040 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-04
Onset:2021-05-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Bed rest, Haemorrhage in pregnancy, Human chorionic gonadotropin, Maternal exposure during pregnancy, Urine analysis, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data: 5/15/21 HCG blood and urine test 5/17/21
CDC Split Type:

Write-up: I was vaccinated for my 2nd dose of Moderna Vaccine on 5/4/21. We have been trying to get pregnant for months and I found out on 5/14/21 that I was pregnant. Confirmed with a hcg blood test at the urgent care on 5/15/21. Monday 5/17/21 at around noon, I just started spotting and went to MD right away. He ordered bedrest for the whole week but my bleeding didnt stopped and led to miscarriage.


VAERS ID: 1683293 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-01-10
Onset:2021-05-17
   Days after vaccination:127
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0142 / 2 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1625 / 1 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Uterine dilation and curettage
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Effexor Linzess
Current Illness:
Preexisting Conditions: Depression OSA constipation
Allergies: No known allergies
Diagnostic Lab Data: Had d&c x2 may 20,2021 and aug 30, 2021
CDC Split Type:

Write-up: Two miscarriages since administered. First on May 17. Second on August 30. No prior history of miscarriage or pregnancy issues. Previously had 2 healthy, normal pregnancies


VAERS ID: 1700643 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-26
Onset:2021-05-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound scan, Ultrasound uterus, Uterine dilation and curettage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Sonogram and Ultrasound 6/22/21 Ultrasound 6/24/21 D&C 7/9/21
CDC Split Type:

Write-up: I was 2 weeks pregnant for the first shot and 5 weeks pregnant for the second. I didn''t realize I was pregnant at the time but we are trying, so I knew it was a possibility. I found out at the first ultrasound a few weeks later that the baby had died at 8 weeks 4 days. The due date was January 20. This is my first and only miscarriage. I had an uncomplicated pregnancy in 2019 with my son who is now 20 months.


VAERS ID: 1382777 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-05-17
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound antenatal screen
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: ultrasound; Result Unstructured Data: Test Result:The fetus was found to be dead
CDC Split Type: FIPFIZER INC2021597636

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB FI-FIMEA-20212731. A 30-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 09Mar2021, at the age of 30 years, (Lot Number: Unknown) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17May2021 the patient experienced miscarriage. The verbatim clinical course was reported as follows: I was unaware of being pregnant when I received the first Pfizer covid vaccine comirnaty on 09Mar2021. The fetus was found to be dead in the ultrasound on 17May2021. It is the case of miscarriage. Fetus died approximately in weeks 9+3. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1428397 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-05-17
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021683542

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106091353463350-POADS, Safety Report Unique Identifier GB-MHRA-ADR 25444405. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26Mar2021 (lot number: EL1749; expiry date: unknown) as dose 2, single, for COVID-19 immunisation. Medical history included lactation decreased and pregnancy (patient no longer pregnant at the time of reporting). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medications included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunisation. Patient was exposed to the medicine first-trimester (1-12 weeks). The vaccine did not have an adverse effect on any aspect of the pregnancy. On 17May2021, the patient experienced miscarriage. The event was considered serious due to hospitalization on unspecified date in May2021, and due to other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1429185 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Culture throat, Maternal exposure during pregnancy, Ultrasound scan vagina, Vaginal discharge
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombophilia
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Throat swab; Test Result: Negative ; Test Date: 20210519; Test Name: vaginal ultrasound; Result Unstructured Data: Test Result:found out that there was a gestational sac with no; Comments: found out that there was a gestational sac with no fetal heartbeat
CDC Split Type: SAPFIZER INC2021679421

Write-up: miscarriage; brownish discharge for few days then it increased; last menstrual period was on 05Apr2021/patient received first dose on 17May2021; This is spontaneous report received from contactable physician (patient). A 39-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. Medical history included thrombophilia on the seventh month of her previous pregnancy. The patient''s last menstrual period was on 05Apr2021. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19. The patient''s concomitant medications were not reported. The patient reported that she had a late menstrual period before taking the vaccine but was unable to visit a doctor or check for pregnancy and patient was expecting a pregnancy. The patient added that in another country, they were telling that the vaccine is safe for pregnancy and even for preparing for it and so the patient took it. On 17May2021 the patient encountered the normal side effects but on 19May2021 15:00, the patient started to have brownish discharge for few days then it increased. The patient checked with the doctor and did a vaginal ultrasound and told found out that there was a gestational sac with no fetal heartbeat and most probably a miscarriage. The patient was hospitalized for 10 days due to the miscarriage. The patient received unspecified treatment for the events. The patient underwent a throat swab on 04Jun2021 with negative result. The outcome of the event ''miscarriage'' was not recovered and unknown for event ''brownish discharge for few days then it increased''.


VAERS ID: 1504984 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002184 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Injection site pain, Maternal exposure during pregnancy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN [SALBUTAMOL]; BECLOMETASON; FLIXONASE; LIVOCAB; LEVOCETIRIZINE; ALVESCO
Current Illness: Allergy (allergy: pinda, noten, banaan, kersen, perzik, dieren, huisstofmijt); Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy round vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 28-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002184) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy round vaccination). Concurrent medical conditions included Allergy and Asthma. Concomitant products included SALBUTAMOL (VENTOLIN [SALBUTAMOL]), BECLOMETASONE DIPROPIONATE (BECLOMETASON), FLUTICASONE PROPIONATE (FLIXONASE), LEVOCABASTINE HYDROCHLORIDE (LIVOCAB), LEVOCETIRIZINE and CICLESONIDE (ALVESCO) for an unknown indication. On 17-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY and INJECTION SITE PAIN. On 12-Jul-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). 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 , MATERNAL EXPOSURE DURING PREGNANCY and INJECTION SITE PAIN had resolved. The treatment information was not provided. Sender''s comment: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS criteria, the reaction was considered as serious by the Centre. This is a case of product exposure during pregnancy of unknown gestational age with spontaneous abortion 26 days after vaccination, for this 28-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 of unknown gestational age with spontaneous abortion 26 days after vaccination, for this 28-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.


VAERS ID: 1632127 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 2752336 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:everything was fine; Test Date: 20210523; Test Name: ultrasound; Result Unstructured Data: Test Result:baby''s heart stopped
CDC Split Type: BRPFIZER INC202101075284

Write-up: after the vaccine, the baby''s heart stopped; after the vaccine, the baby''s heart stopped; This is a spontaneous report from a contactable consumer (patient''s parent/mother) This consumer reported information for both mother and fetus/baby. This is a fetus/baby report. Only this case is serious. A fetus patient of an unspecified gender received first dose of bnt162b2 (COMIRNATY), transplacental on 17May2021 08:00 (Batch/Lot Number: 2752336) at single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Mother was 42-year-old and was pregnant at the time of vaccination (at the age of 42-year-old), with due date 18Dec2021. The mother was pregnant with 1 baby. Mother''s medical history included hypothyroidism. Mother did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, mother was not diagnosed with COVID-19. Since the vaccination, mother had not been tested for COVID-19. Mother was not allergic to any medications, food or other products. Mother had done an ultrasound the day before and everything was fine. On 23May2021 17:00 (also reported as "5 days after the vaccine"), the baby''s heart stopped. Events resulted in doctor or other healthcare professional office/clinic visit; emergency room/department or urgent care; and hospitalization (for 2 days). Therapeutic measures were taken as a result of events. The outcome of events was unknown.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202101063851 mother report


VAERS ID: 1766414 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Anxiety, Dizziness, Dyspnoea, Fatigue, Feeling hot, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gestational hypertension (Gestational hypertension during previous pregnancies)
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Ultrasonography; Result Unstructured Data: Ultrasonography performed at 12 weeks, result that the fetus died at 8 weeks.
CDC Split Type: ISMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy; This case was initially received via regulatory authority (Reference number: IS-IMA-4807) on 27-Sep-2021. The most recent information was received on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of the first episode of ABORTION SPONTANEOUS (F?sturl?t) and the second episode of ABORTION SPONTANEOUS (F?sturl?t) in a 33-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Gestational hypertension (Gestational hypertension during previous pregnancies). On 17-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 14-Jun-2021, the patient experienced the first episode of ABORTION SPONTANEOUS (F?sturl?t) (seriousness criterion medically significant) and the second episode of ABORTION SPONTANEOUS (F?sturl?t) (seriousness criterion medically significant). On 29-Jul-2021, the patient experienced DIZZINESS (Svimi), ANXIETY (Hr??ilegur kv??i), FEELING HOT (Hita tilfinning undir h??, fingrum, t?m og klof), DYSPNOEA (m??i) and FATIGUE (s??reyta). 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, last episode of ABORTION SPONTANEOUS (F?sturl?t) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and DIZZINESS (Svimi), ANXIETY (Hr??ilegur kv??i), FEELING HOT (Hita tilfinning undir h??, fingrum, t?m og klof), DYSPNOEA (m??i) and FATIGUE (s??reyta) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, Ultrasound scan: abnormal (abnormal) Ultrasonography performed at 12 weeks, result that the fetus died at 8 weeks.. NO concomitant medications were reported. NO treatment medications were reported. Company Comment: This case of maternal exposure during pregnancy, concerns a 33-year-old female patient (gestational age unknown when she received the vaccine) with a medical history of gestational hypertension, who experienced the unexpected serious event of spontaneous abortion and unexpected non-serious events of dizziness, dyspnea, feeling hot and anxiety. The abortion occurred 28 days after receiving the first dose and the other events occurred the next day after receiving the Moderna mRNA-1273 vaccine (Spikevax). The rechallenge is not applicable. The reporter did not provide the causality assessment. The medical history of gestational hypertension remains as confounder for the event spontaneous abortion. The benefit-risk relationship of mRNA vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains additional events (Miscarriage of pregnancy, shortness of breath),lab data was added (ultrasonography) and patient medical history was updated (gestational hypertension). On 28-Sep-2021: Translation document received with TCERT attached on 30-09-2021 contains no new information; Sender''s Comments: This case of maternal exposure during pregnancy, concerns a 33-year-old female patient (gestational age unknown when she received the vaccine) with a medical history of gestational hypertension, who experienced the unexpected serious event of spontaneous abortion and unexpected non-serious events of dizziness, dyspnea, feeling hot and anxiety. The abortion occurred 28 days after receiving the first dose and the other events occurred the next day after receiving the Moderna mRNA-1273 vaccine (Spikevax). The rechallenge is not applicable. The reporter did not provide the causality assessment. The medical history of gestational hypertension remains as confounder for the event spontaneous abortion. The benefit-risk relationship of mRNA vaccine is not affected by this report.


VAERS ID: 1354261 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-26
Onset:2021-05-18
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion induced, Amniorrhoea, Exposure during pregnancy, Multigravida, Preterm premature rupture of membranes
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: Nothing
Preexisting Conditions: No
Allergies: Aspirins (G6PD deficiency)
Diagnostic Lab Data: Medical tests all available at birth centre
CDC Split Type:

Write-up: Sudden Pprom and leakage at 23week and made me do a pregnancy termination. Due date was determined sep 11,2021 and no related complication detected at 20 week ultrasound and examination It was my 2nd pregnancy ( 1 st pregnancy in 2017 with no complication , vaginal delivery full term)


VAERS ID: 1358329 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-05-06
Onset:2021-05-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Site: Pain at Injection Site-Mild, Systemic: miscarriage-Mild, Additional Details: patient had miscarraige


VAERS ID: 1394096 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-05-06
Onset:2021-05-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER 8735 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021619622

Write-up: 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.


VAERS ID: 1394674 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-02-19
Onset:2021-05-18
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M204 / UNK - / -

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Full bloodwork and fetal DNA.
CDC Split Type:

Write-up: First dose received 1/22/2021 (lot 026L20A). 2nd dose received 2/19/2021. Become pregnant between doses 1 and 2. Pregnancy was confirmed 4/1/2021 and viable with due date of 11/14/2021. On 5/18/2021, pregnancy was confirmed as missed miscarriage (at approx 8wks 4 days). All DNA tests came back negative for genetic abnormalities up to that point.


VAERS ID: 1735919 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-05-11
Onset:2021-05-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal growth restriction, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Viable pregnancy with strong symptoms before second covid vax 5/11. Viable pregnancy on ultrasound 5/18. As of 6/14, pregnancy shown to have stopped growing and ended via miscarriage on or around 5/19, about 8 days post covid shot.


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