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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: 1265469 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Virginia  
Vaccinated:2020-12-01
Onset:2020-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
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? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
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 received the first dose the the pizer vaccine on december 18th and did not know I was pregnant at the time. A couple weeks later I found out I was pregnant and due date was September 7th. Hence, my conception was likely within a week of receiving my first dose. We later found out our baby had turners syndrome and have since lost the baby. Obviously it is unclear the cause but I wanted to report it .


VAERS ID: 906529 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Texas  
Vaccinated:2020-12-18
Onset:2020-12-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Claritin, Prenatal Vitamins, Flonase
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: When I got the vaccination I was 32weeks pregnant and on Saturday I had spontaeous rupture of the amnotic fluids and went immediately to the hospital and was immediately given steroid, magnesium for the baby. And on Sunday around 3:45PM I got a second round of the steroids and was transferred for observation. On Monday, at 8:06am I went into early labor I delivered my baby at 33weeks gestation and she weighed 3lb 11oz. Expected Date of Delivery-2/8/2021. I was a high risk patient d/t Fibroids but have experienced no issues the entire pregnancy and my last ultrasound was 12/17 and baby was healthy with no complications at that time.


VAERS ID: 953086 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2020-12-19
Onset:2020-12-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJI685 / 1 RA / OT

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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021014948

Write-up: I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; This is a spontaneous report from a contactable Physician (patient). A 31-year-old female patient received BNT162B2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJI685) intramuscular at arm right on 19Dec2020 06:30 at single dose for covid-19 immunization. Facility type vaccine was hospital. Medical history was none. The patient had no known allergies or other medical history. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient experienced a very early miscarriage at five weeks on 01Jan2021. The event result in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event miscarriage was recovered in Jan2021. No covid prior vaccination and no covid tested post vaccination.; Sender''s Comments: All pregnancies have a risk of birth defect, loss, or other adverse outcomes. The data on BNT162B2 administered to pregnant women is insufficient to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 932028 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: California  
Vaccinated:2020-12-18
Onset:2020-12-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Private       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: Oats, scallops
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage at 6 weeks pregnant


VAERS ID: 965558 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2020-12-20
Onset:2020-12-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 LA / OT

Administered by: Work       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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021025914

Write-up: Miscarriage; pregnant patient received the vaccine; pregnant patient received the vaccine; This is a spontaneous report from a contactable nurse (patient). This pregnant 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK5730), intramuscular at single dose in the left arm on 20Dec2020 for COVID-19 immunisation. Medical history included none. Concomitant medication included venlafaxine. The patient experienced miscarriage (medically significant) on 09Jan2021 with outcome of recovering. Treatment unknown. The event required a visit to the emergency room. The patient was pregnant while taking BNT162B2. The patient was 4 weeks pregnant at the onset of the event. Patient last menstrual period date was 27Nov2020. The pregnancy due to deliver was on 03Sep2021. The vaccine was administered at Workplace Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. She received the second dose of BNT162B2 (Lot number EL0142), intramuscular in the left arm on 13Jan2021.; Sender''s Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be complete 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: 1106171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-01-26
Onset:2020-12-21
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041L20A / 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: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: no fetal heartbeat; pregnant and received vaccine; A spontaneous report was received from a 37-year old, female patient who received Moderna''s COVID-19 Vaccine (mRNA-1273) while pregnant, and there was not fetal heartbeat. The patient''s medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins. The consumer received the second of the two planned doses of mRNA-1273 on 26-JAN-2021 (Batch# 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 02-MAR-2021, the patient stated her fetus had no heartbeat. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events was considered recovered.; Reporter''s Comments: This is a case of product exposure during pregnancy for this 37 year old woman with associated event of absent fetal heartbeat. The patient will continue to be contacted for follow-up.


VAERS ID: 925639 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Idaho  
Vaccinated:2020-12-22
Onset:2020-12-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0140 / 1 RA / OT

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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sleep apnoea
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: tested for COVID-19; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201228; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2021000238

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


VAERS ID: 950562 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Georgia  
Vaccinated:2020-12-22
Onset:2020-12-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Human chorionic gonadotropin negative
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: Migraines Eczema Seasonal allergies
Allergies: Sulfa, eggs
Diagnostic Lab Data:
CDC Split Type:

Write-up: 9 days after vaccine, I had a miscarriage. I was 5 weeks pregnant at that time. I had confirmation lab test 2 weeks prior of pregnancy and had labs with bhcg lower at time of bleeding to confirm miscarriage


VAERS ID: 1505744 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Oregon  
Vaccinated:2020-12-22
Onset:2020-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 1 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal heart rate abnormal, Pregnancy, Surgery
SMQs:, 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal medicine
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: surgery and medicine
CDC Split Type: vsafe

Write-up: got pregnant in February after the second dose and in April the doctor said the baby didn''t have any heart beat and may i had the surgery and miscarriage.


VAERS ID: 1534010 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Arizona  
Vaccinated:2020-12-23
Onset:2020-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Dizziness, Influenza like illness, Maternal exposure during pregnancy, Muscle spasms, Nausea, Vaccination complication, Vaccination site hypoaesthesia
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? 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: Mischarge; arm went numb; dizzy; crampy; flu symptoms; felt like she was hit by a bus; nausea; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Mischarge) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043Lv0A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 21-Jan-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (arm went numb), DIZZINESS (dizzy), MUSCLE SPASMS (crampy), INFLUENZA LIKE ILLNESS (flu symptoms), VACCINATION COMPLICATION (felt like she was hit by a bus) and NAUSEA (nausea). In March 2021, the patient experienced ABORTION SPONTANEOUS (Mischarge) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg. On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Mischarge) outcome was unknown and VACCINATION SITE HYPOAESTHESIA (arm went numb), DIZZINESS (dizzy), MUSCLE SPASMS (crampy), INFLUENZA LIKE ILLNESS (flu symptoms), VACCINATION COMPLICATION (felt like she was hit by a bus) and NAUSEA (nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product information was provided. Company Comment This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, vaccination site hypoaesthesia, dizziness, muscle spams, influenza-like symptoms, vaccination related malaise and nausea. Based on the current available information and temporal association between the use of the product and the start date of the events vaccination site hypoaesthesia, dizziness, muscle spams, influenza-like symptoms, vaccination related malaise and nausea, a causal relationship cannot be excluded. For the event abortion spontaneous, very limited information have been provided at this time. Further information regarding temporal association has been requested.; Sender''s Comments: This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, vaccination site hypoaesthesia, dizziness, muscle spams, influenza-like symptoms, vaccination related malaise and nausea. Based on the current available information and temporal association between the use of the product and the start date of the events vaccination site hypoaesthesia, dizziness, muscle spams, influenza-like symptoms, vaccination related malaise and nausea, a causal relationship cannot be excluded. For the event abortion spontaneous, very limited information have been provided at this time. Further information regarding temporal association has been requested.


VAERS ID: 978398 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2020-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Off label use, Product use issue
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021048674

Write-up: Miscarriage of pregnancy; Patient was exposed to the medicine first-trimester (1-12 weeks); Patient was exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer. This report was received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-20210107214717, Safety Report Unique Identifier GB-MHRA-ADR 24570946. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not known), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. Patient was exposed to the medicine first-trimester (1-12 weeks) on 23Dec2020. Patient suffered a miscarriage on 06Jan2021. They wanted to report this as read that there isn''t a lot if research on the effects in pregnancy. Patient has not tested positive for COVID-19 since having the vaccine. It''s unsure if the medicine have an adverse effect on any aspect of the pregnancy. Patient did not take folic acid supplement during pregnancy. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 918034 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Michigan  
Vaccinated:2020-12-23
Onset:2020-12-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Foetal hypokinesia, Premature delivery, Stillbirth, Ultrasound Doppler, Ultrasound foetal
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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Advair, Pulmocort, levothyroxine, pepcid, prenatal vitamins, singulair, aspirin
Current Illness: None
Preexisting Conditions: Asthma
Allergies: None
Diagnostic Lab Data: Fetal doppler and fetal ultrasound on 12/26/2020
CDC Split Type:

Write-up: I was 28 weeks and 5 days pregnant when I received the first dose of the COVID19 vaccine. Two days later (12/25/2020 in the afternoon), I noticed decreased motion of the baby. The baby was found to not have a heartbeat in the early am on 12/26/2020 and I delivered a 2lb 7oz nonviable female fetus at 29 weeks gestation. I was 35 years old at the time of the fetal demise and the only pregnancy history for this pregnancy included a velamentous cord insertion that was being closely monitored by a high risk OB. My estimated due was March 12, 2021.


VAERS ID: 926723 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Oregon  
Vaccinated:2020-12-19
Onset:2020-12-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Over the counter
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound.
CDC Split Type: vsafe

Write-up: I suffered from a miscarriage. 12 weeks along. It had been a healthy pregnancy otherwise.


VAERS ID: 917350 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2020-12-26
Onset:2020-12-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Dizziness, Exposure during pregnancy, Fatigue, Foetal heart rate abnormal, Impaired work ability, Injection site discomfort, Injection site swelling, Malaise, Pregnancy test positive, Ultrasound scan
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (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), 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Blood work and ultrasound - emergency dept.
CDC Split Type:

Write-up: 27Dec2020 - patient developed some swelling (went about 1 inch out from injection site) and discomfort at the injection site - had taken Advil and was using a cool compress. 29Dec2020 - patient had to leave work early since she was not feeling well - very fatigued and a little dizzy (able to eat/drink) - denied any COVID illness s/s (no cough, fever, loss of taste/smell, etc). She ended up going to the local ED - since she was still very fatigued and was feeling like she was going to pass out - blood work and U/S done - this is where she found out she had been pregnant but had lost the pregnancy (no heart beat). Per her report - all other blood work was unremarkable. No other medications given to her during this visit and was just told that she would be ''passing the products of conception within this next week''.


VAERS ID: 1004202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2020-12-28
Onset:2020-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026L20A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin abnormal, Ultrasound 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), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOLOFT; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Term birth
Allergies:
Diagnostic Lab Data: Test Name: hCG; Result Unstructured Data: 0; Test Date: 20210119; Test Name: hCG; Test Result: Inconclusive ; Result Unstructured Data: Started to climb back up again; Test Date: 20201227; Test Name: USG; Result Unstructured Data: Got it done, but it was too early so it didn''t show anything.
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Presumed miscarriage; human chorionic gonadotropin decreased; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 31-years-old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) who experienced vaccine exposure during pregnancy, human chorionic gonadotropin decreased and presumed miscarriage. The patient''s medical history was not provided. The patient''s prior history of pregnancies were two miscarriages (2013 and 2015) and two full term births (2017 and 2019) were reported. The patient''s last menstrual period was 25 Nov 2021. The estimated due date was 1 Sep 2021. Concomitant medications included sertraline hydrochloride and vitamins. On 27 Dec 2020, the patient found out she was pregnant, but she already had some bleeding. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On undisclosed date, after receiving the vaccine her human chorionic gonadotropin (hCG) levels went down to 0. Her health care professional presumed it was a miscarriage. Treatment for the event was not reported. On 19th Jan 2021, her hCG levels started to climb back up again. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, presumed miscarriage, and human chorionic gonadotropin decreased was unknown. The outcome of the event, vaccine exposure during pregnancy, was resolved on 28 Dec 2020.; Reporter''s Comments: This spontaneous report concerns a 31-years-old, G5P2 female patient who experienced vaccine exposure during pregnancy and presumed miscarriage. The patient''s last menstrual period was 25-Nov-2020 with estimated date of delivery as 01-Sep-2021. One day after the patient discovered she was pregnant; she received the first dose of mRNA-1273 vaccine (lot # 026L20A expiration date unknown). The event of presumed miscarriage (human chorionic gonadotropin (hCG) levels went down to 0) was diagnosed on an unknown date after vaccine administration. The HCG level began to climb up again 22 days after the vaccine administration. Based on the information provided which includes, the patient''s obstetric history, vaginal bleeding the day prior to mRNA-1273 vaccination and without definitive confirmation of pregnancy loss, there is not enough evidence to assess that that there was a miscarriage and is also unlikely to be associated with mRNA-1273 administration. The event of vaccine exposure during pregnancy is considered not applicable


VAERS ID: 1021340 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2020-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Off label use, Product use issue
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021083018

Write-up: 3 weeks after first vaccination: abortion; Accidental vaccination with unknown pregnancy; Accidental vaccination with unknown pregnancy; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory authority-WEB DE-PEI-CADRPEI-2021013163. A 23-year-old female patient (1 week pregnant at time of vaccination) received BNT162B2 (COMIRNATY, lot number: EM0477), intramuscular on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced abortion on 17Jan2021 (3 weeks after first vaccination). The mother reported she became pregnant while taking BNT162B2. The mother was 1 month pregnant at the onset of the event. The patient outcome of the event was recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 924247 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2020-12-30
Onset:2020-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain lower, Abortion spontaneous, Exposure during pregnancy, Fatigue, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was 5.5 weeks pregnant when I revived the Pfizer Covid Vaccine. Everything was seemingly going fine with my pregnancy until about 4 hours after receiving the vaccine when I went to the bathroom nd wiped and saw pink discharge on the toilet paper. I then began to have mild low abdominal cramping. The abdominal cramping and vaginal bleeding steadily increased in severity over the next 24 hours until I eventually had an obvious miscarriage the evening of 12/31/2020. I cant help but think the vaccine in some way caused my body to reject the pregnancy. Along with the miscarriage, I also had extreme tiredness with GI upset 12/31/20 - 1/02/2021.


VAERS ID: 1065910 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2020-12-30
Onset:2020-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 1 - / 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: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; BONJESTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage (18 May 2021); Pregnancy (live birth on 21 Feb 2016); Pregnancy (live birth on 08 Mar 2018)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Miscarriage; Received vaccine when pregnant; A spontaneous report was received from a 34-year old female patient who received Moderna''s COVID-19 Vaccine (mRNA-1273) when pregnant and experienced a miscarriage. The patient''s medical history included three prior pregnancies, with two live births and one miscarriage. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins and doxylamine succinate/pyridoxine hydrochloride. The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 30 Dec 2020. On 27 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. At 7 weeks gestation, the fetus had a normal heart beat. She reported that she had no complications with the pregnancy. On 08 Feb 2021, the patient had a miscarriage. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The events received vaccine when pregnant and miscarriage were considered recovered.; Reporter''s Comments: This report concerns a 34-year-old, P2G4 who experienced miscarriage 1 month 9 days post administration of first dose and 12 days after the last dose of mRNA-1273 vaccine. There is not enough information such as the last menstrual period, estimated date of conception and delivery and gestational age at the time of miscarriage. In addition, the patient''s detailed medical history including any trauma and reason for previous miscarriage is lacking. Vaccine exposure during pregnancy is assessed as not applicable.


VAERS ID: 922289 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2020-12-17
Onset:2020-12-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Human chorionic gonadotropin decreased, Ultrasound antenatal screen abnormal, Uterine 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), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (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: Pre natal vitamins
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Falling HCG level Transactional ultrasound confirmed miscarriage
CDC Split Type:

Write-up: I suffered a miscarriage on 12/31/2020. I was at 5 weeks gestation. This was my first pregnancy. I had uterine bleeding and abdominal cramps on 12/31/2020 and underwent evaluation by my Obstetrician and was diagnosed with a miscarriage after ultrasound.


VAERS ID: 1010528 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New York  
Vaccinated:2020-12-31
Onset:2020-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 1 LA / -

Administered by: Private       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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IRON; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2020; Test Name: pregnancy test; Test Result: Negative ; Test Date: 202101; Test Name: pregnancy test; Test Result: Positive ; Comments: she had a negative pregnancy test before getting the first vaccine dose, but then had a positive pregnancy test a few days after the first dose.
CDC Split Type: USPFIZER INC2021062785

Write-up: unfortunately she had a miscarriage about 5-6 days before her second dose; positive pregnancy test a few days after the first dose.; positive pregnancy test a few days after the first dose.; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (3 weeks pregnant at time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included iron and minerals nos, vitamins nos (PRENATAL VITAMINS). The patient had a negative pregnancy test in 2020 before getting the first vaccine dose, but then had a positive pregnancy test in Jan2021 a few days after the first dose, but unfortunately she had a miscarriage in Jan2021, about 5-6 days before her second dose. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the miscarriage was recovering.; Sender''s Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be completely 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: 1041373 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2020-12-21
Onset:2020-12-31
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Breast feeding, Human chorionic gonadotropin increased, Pregnancy, Ultrasound antenatal screen abnormal
SMQs:, Tumour markers (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)

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: prenatal
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: Cipro
Diagnostic Lab Data: I had HCG level on 1/8/2021 which was 17,500 and US at 10 weeks which confirmed miscarriage at 5 weeks. At 10.5 weeks but body naturally miscarried without medical intervention. I am 37 yrs old and healthy. I have no way of knowing if the vaccine played a part in this as my odds are 20% to have a miscarriage.
CDC Split Type:

Write-up: I was 4 weeks pregnant when I received the vaccine and had a miscarriage at 5 weeks 3 days. I had one healthy pregnancy to 41 weeks in 2019 and I was and still am breastfeeding.


VAERS ID: 1245491 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Texas  
Vaccinated:2020-12-31
Onset:2020-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032L20A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Exposure during pregnancy, Fatigue, Glucose tolerance test, Headache, Induced labour, Premature delivery, Ultrasound scan, Umbilical cord prolapse
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; METHYLPHENIDATE
Current Illness: ADHD (Stable); Depression (Stable, medication Wellbutrin discontinued due to pregnancy.); Lactose intolerance (Mild)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: Blood pressure; Result Unstructured Data: abnormal; Test Date: 20210129; Test Name: Blood pressure; Result Unstructured Data: abnormal, sent for induction.; Test Date: 20201130; Test Name: GTT; Result Unstructured Data: Normal; Test Date: 20200710; Test Name: Ultrasound; Result Unstructured Data: normal-8-week ultrasound.; Test Date: 20200810; Test Name: Ultrasound; Result Unstructured Data: normal; Test Date: 20201002; Test Name: Ultrasound; Result Unstructured Data: normal
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Induction via balloon catheter due to elevated blood pressure; Cord prolapse / Hand presentation; Premature delivery; Headache; Chills; Fatigue; Elevated blood pressure; Exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UMBILICAL CORD PROLAPSE (Cord prolapse / Hand presentation), INDUCED LABOUR (Induction via balloon catheter due to elevated blood pressure), PREMATURE DELIVERY (Premature delivery) and BLOOD PRESSURE INCREASED (Elevated blood pressure) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lactose intolerance (Mild), ADHD (Stable) and Depression (Stable, medication Wellbutrin discontinued due to pregnancy.). Concomitant products included METHYLPHENIDATE from 01-Feb-2018 to an unknown date for ADHD, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2019 to an unknown date for Nutritional support. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient''s last menstrual period was on 14-Apr-2020 and the estimated date of delivery was 18-Feb-2021. On 31-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). On 27-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure) (seriousness criterion medically significant). On 28-Jan-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). On 29-Jan-2021 at 5:30 PM, the patient experienced INDUCED LABOUR (Induction via balloon catheter due to elevated blood pressure) (seriousness criterion hospitalization). On 30-Jan-2021, the patient experienced PREMATURE DELIVERY (Premature delivery) (seriousness criterion hospitalization prolonged). On 30-Jan-2021 at 6:00 AM, the patient experienced UMBILICAL CORD PROLAPSE (Cord prolapse / Hand presentation) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 29-Jan-2021 due to INDUCED LABOUR. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the forty-first week of the pregnancy. The cesarean delivery occurred on 30-Jan-2021, which was reported as Premature. For neonate 1, with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Pre-Term Birth NOS. The baby, female, was delivered at 37.2 weeks and therefore it is considered pre-term. Cord prolapse/hand presentation was discovered at cervical check post-induction by balloon catheter, therefore an immediate C-section delivery was performed. No abnormalities/complications for the infant, currently breastfeeding. On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) outcome was unknown. On 29-Jan-2021, HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. On 30-Jan-2021, UMBILICAL CORD PROLAPSE (Cord prolapse / Hand presentation), INDUCED LABOUR (Induction via balloon catheter due to elevated blood pressure) and PREMATURE DELIVERY (Premature delivery) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (Elevated blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2020, Ultrasound abdomen: normal (normal) normal-8-week ultrasound.. On 10-Aug-2020, Ultrasound abdomen: normal (normal) normal. On 02-Oct-2020, Ultrasound abdomen: normal (normal) normal. On 30-Nov-2020, Glucose tolerance test: normal (normal) Normal. On 27-Jan-2021, Blood pressure measurement: 142/94 (High) abnormal. On 29-Jan-2021, Blood pressure measurement: 142/98 (High) abnormal, sent for induction.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient reports she had an unwanted/unplanned induction 2 days after her second Moderna vaccine dose. Her blood pressure was found to be elevated on 27-Jan-2021 at her 36 weeks prenatal visit and she was informed she will be admitted for induction if the blood pressure does not return to normal. Between 28-29 of January, 2021 she experienced mild side effects, which she managed with ibuprofen and rest. On 29-Jan-2021 her blood pressure was re-checked and confirmed to be elevated so she was admitted for induction at 5:30pm via balloon catheter. Approximately at 6:00am on 30-Jan-2021, the patient was found to have a cord prolapse/hand presentation and was immediately scheduled for C-section delivery. She delivered at 6:10AM. No family history of congenital abnormalities/genetic diseases. Besides the mild lactose intolerance, no allergies reported. Treatment medications were not reported. This is a case of drug exposure during pregnancy with associated AEs (elevated blood pressure, umbilical cord prolapse, induced labor, premature delivery) for this 29-year-old female. Patient delivered a female child at 37 wks. 2 days. Based on the current available information and temporal association between the use of the product and the start date of these events (headache, chills, fatigue), a causal relationship cannot be excluded. Further information is requested to monitor the newborn. This case was linked; Sender''s Comments: This is a case of drug exposure during pregnancy with associated AEs (elevated blood pressure, umbilical cord prolapse, induced labor, premature delivery) for this 29-year-old female. Patient delivered a female child at 37 wks. 2 days. Based on the current available information and temporal association between the use of the product and the start date of these events (headache, chills, fatigue), a causal relationship cannot be excluded. Further information is requested to monitor the newborn.


VAERS ID: 1025810 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2020-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, COVID-19, Cough, Diarrhoea, Drug ineffective, Off label use, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Vitamin supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021091148

Write-up: cough; diarrhoea; Fevers; SARS-CoV-2 infection; SARS-CoV-2 infection; Early miscarriage; exposed to the medicine first-trimester (1-12 weeks); exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report received from a contactable consumer (patient) received by Pfizer from the Regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202101281017216470 and GB-MHRA-ADR 24658790. A 37-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 31Dec2020 at a single for covid-19 vaccination. Medical history included mild asthma and vitamin supplementation. Patient is not enrolled in clinical trial. Concomitant medication included folic acid (FOLIC ACID) for vitamin supplementation. On an unspecified date, the patient experienced cough, diarrhea and fever. The patient reported being exposed to the medicine first-trimester (1-12 weeks). Details of scans and investigations included early pregnancy loss 4 days following vaccine. On 15Jan2021, the patient also tested positive for SARS-CoV-2 infection (reported 13 days) post the vaccine. The patient husband and son tested positive following isolation with her. The events were assessed serious, medically significant. The outcome of event early miscarriage was recovered on 10Jan2021, SARS-CoV-2 infection was recovering; all other events was unknown. No follow-up attempts are possible. Information about batch number cannot be obtained.


VAERS ID: 917595 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2020-12-26
Onset:2021-01-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test abnormal, Exposure during pregnancy, Ultrasound pelvis abnormal
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre-natal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 1/1/21 - emergency room visit at Hospital. Bloodwork and ultrasound confirmed miscarriage.
CDC Split Type:

Write-up: I was about 6 weeks pregnant when I received the vaccine on 12/26/20. I had a miscarriage on 1/1/21. I have a pregnancy history of one prior healthy full term pregnancy in 2019.


VAERS ID: 923743 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Texas  
Vaccinated:2020-12-26
Onset:2021-01-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037K20A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin negative, Laboratory test, Progesterone normal
SMQs:, 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: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Follow blood work HCG- negative Progesterone level -Normal
CDC Split Type: vsafe

Write-up: I had a miscarriage on 01/01/2021 Estimated date of Delivery 09/7/ 2021


VAERS ID: 949729 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2020-12-23
Onset:2021-01-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 1 LA / IM

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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness:
Preexisting Conditions: bicornuate uterus
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage. Expected due date in August 2021. No prior pregnancy history.


VAERS ID: 950091 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2020-12-28
Onset:2021-01-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Fatigue, Hunger, Injection site pain, Muscle spasms, Pregnancy test negative, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Dystonia (broad), 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), Hypoglycaemia (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:
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Positive pregnancy test 12/26/2020 & 12/28/2020 with associated fatigue, hunger & pregnancy symptoms. Vaginal bleeding & cramping for 2 days starting 1/1/2021 with a negative pregnancy test 1/2/2021
CDC Split Type:

Write-up: I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days later. I do not know if the vaccine contributed to my miscarriage but wanted to contribute to the existing data. I had no other side effects or symptoms other than soreness at the injection site. There were no complications with the miscarriage.


VAERS ID: 1035009 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-01-12
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1284 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Heart rate, Human chorionic gonadotropin, Off label use, Product use issue, Uterine dilation and curettage
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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Cold urticaria (gets hives from anything cold (fluid, food, air) that touches her)
Allergies:
Diagnostic Lab Data: Test Name: heartbeat; Result Unstructured Data: Test Result:didn''t see a fetal heartbeat at 6 week on u/s; Comments: 7 weeks still no heartbeat on u/s; Test Name: HCG; Result Unstructured Data: Test Result:didn''t go down until second u/s, so fetal demise; Comments: occurred between 6 -7 weeks; Test Name: D & C; Result Unstructured Data: Test Result:no geneticabnormalities were found in fetal tissue
CDC Split Type: USPFIZER INC2021106680

Write-up: embryonic demise/loss of pregnancy; patient was pregnant at the time of vaccination of the second dose; patient was pregnant at the time of vaccination of the second dose; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284), intramuscular in the left arm on 12Jan2021 at 08:00 at a single dose, received in the Doctor''s office/urgent care for covid-19 immunisation. Medical history included anxiety and allergies: gets hives from anything cold (fluid, food, air) that touches her. Concomitant medication included venlafaxine for anxiety. The patient was pregnant at the time of vaccination of the second dose, last menstrual date was 23Nov2020, delivery date was 30Aug2021, gestation period was 7 weeks. The patient experienced embryonic demise/loss of pregnancy in Jan2021, patient was hospitalized for 1 day and treatment was received for the event. The patient underwent lab tests and procedures which included didn''t see a fetal heartbeat at 6 week on u/s, and 7 weeks still no heartbeat on u/s, HCG didn''t go down until second u/s, so fetal demise occurred between 6 -7 weeks, D&C performed and no genetic abnormalities were found in fetal tissue. Doctor and patient, who is a nurse, do not think the fetal demise is related to the vaccine, but wanted to document the loss for data in case they would start to see a trend. The patient does not intend to pursue further investigation into the vaccine as a cause. After the first dose (received on 21Dec2020 at 08:00, the patient had a sore arm and then two days later found out she was pregnant. The doctor discussed with patient and pharmacist whether to get second dose. Patient is a nurse and decided to get second dose. No major symptoms were reported after second dose until the miscarriage. The patient recovered from the event with lasting effects/sequel.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1051018 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

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: Medical History/Concurrent Conditions: Pregnancy (full term live birth via vaginal birth with epidural at 40 weeks and 1 day)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021153606

Write-up: After the vaccine the patient miscarried the baby; This is a spontaneous report from Pfizer-sponsored program via a contactable pharmacist. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), 0.3 ml via an unspecified route of administration on 15Jan2021 at 10:00-11:30am as a single dose for COVID-19 immunization, administered in the right arm. Patient has no past medical history. Concomitant medication includes One-a-day vitamin, Ongoing. No prior Vaccinations within 4 weeks prior. First Day of Last menstrual period: 6-13 Dec2020. Patient reports one previous pregnancy: full term live birth via vaginal birth with epidural at 40 weeks and 1 day. The father used marijuana, at an unspecified frequency. Patient was unaware that she was pregnant, guesses she was about 3 weeks when she got the first shot of the vaccine. Ten days after the vaccine, the patient miscarried the baby. The clinical outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Miscarriage of pregnancy cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1293942 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Florida  
Vaccinated:2020-12-28
Onset:2021-01-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 AR / IM

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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: methylphenidate levothyroxine
Current Illness:
Preexisting Conditions: Patient had early pregnancy loss in January 2021.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Early pregnancy loss 1/2021


VAERS ID: 1590942 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Arizona  
Vaccinated:2020-12-22
Onset:2021-01-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EH9899 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Menstruation irregular
SMQs:, 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: Compounded thyroid medication
Current Illness:
Preexisting Conditions:
Allergies: Hydrocodone, latex
Diagnostic Lab Data: HCG 4/17/2021
CDC Split Type:

Write-up: Irregular menstrual cycle, miscarriage


VAERS ID: 1590946 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-01-12
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0142 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Menstruation irregular
SMQs:, 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: Compounded thyroid medication
Current Illness:
Preexisting Conditions:
Allergies: Hydrocodone, latex
Diagnostic Lab Data: HCG
CDC Split Type:

Write-up: Irregular menstrual cycles, miscarriage


VAERS ID: 1067800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Asthenia, Body temperature, Impaired quality of life, Investigation, Myalgia, Pregnancy test, Pyrexia, Somnolence, Ultrasound scan, Vaccination site pain, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Food allergy; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: fever; Result Unstructured Data: Test Result:fever; Test Name: Impact on quality of life; Result Unstructured Data: Test Result:7/10; Test Date: 20210123; Test Name: pregnancy; Test Result: Positive ; Test Name: ultrasound; Result Unstructured Data: Test Result:onset 26Jan2021 abortion documented by ultrasound; Comments: onset 26Jan2021 abortion documented by ultrasound report at the 5th week
CDC Split Type: ITPFIZER INC2021169082

Write-up: Spontaneous abortion; severe asthenia; sleepiness; muscle pain; Fever chills; impact on quality of life 7/10; pain and swelling at the injection site; pain and swelling at the injection site; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB regulatory authority IT-MINISAL02-674646. A 36-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot EL1484) via intramuscular in the right arm, on 15Jan2021 at single dose for covid-19 immunisation. Medical history included allergy to nuts, dogs, pollen, peaches. The patient''s concomitant medications were not reported. The patient experienced spontaneous abortion, severe asthenia, sleepiness, muscle pain, fever chills, all on 26Jan2021 requiring hospitalization, pain and swelling at the injection site on an unspecified date in Jan2021. Patient received Paracetamol for fever chills. Went to emergency room for spontaneous abortion. The impact on quality of life scored 7/10 (undated). The abortion which onset on 26Jan2021 was documented by ultrasound report at the 5th week (undated), positive pregnancy test dated 23Jan2021, however patient was not aware of the pregnancy at the time of receiving first dose. She became pregnant while receiving the first dose and was 5-week pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Patient received second dose of BNT162B2 (lot EL0725) on 05Feb2021. Outcome of spontaneous abortion, severe asthenia, sleepiness, muscle pain, fever chills was recovered, outcome of other events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1158630 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Anembryonic gestation, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; TEMAZEPAM; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor; Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week:)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021297561

Write-up: Miscarriage/found out at 8 weeks of pregnancy that the fetus probably stopped growing at a very early stage, a so-called blighted ovum; Miscarriage/found out at 8 weeks of pregnancy that the fetus probably stopped growing at a very early stage, a so-called blighted ovum; Myalgia; This is a spontaneous report downloaded from the Agency -WEB NL-LRB-00472449. This consumer (patient) reported information for both mother and fetus. This is the mother report. A 36-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number: EJ6795), via an unspecified route of administration on 29Jan2021 as a single dose for COVID-19 immunization. Medical history included disease risk factor and maternal vaccine exposure during pregnancy week (as reported). The patient did not have COVID-19 prior to the vaccination. Concomitant medications included paracetamol (manufacturer unknown); temazepam (manufacturer unknown) and ibuprofen (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 08Jan2021 for COVID-19 immunization and did not experience any adverse reactions. On an unspecified date in Jan2021, 12 hours after receiving the second dose, the patient experienced myalgia. It was reported that shortly after the vaccination of the second dose the patient turned out to be pregnant. The conception date was 28Jan2021 so 1 day before the second vaccine. On 09Mar2021, at 8 weeks of pregnancy, the patient found out that the fetus probably stopped growing at a very early stage (also reported as ''1 month after start''), a so-called blighted ovum. It is not known exactly when it occurred. The gynecologist thinks in the first week. The patient personally thinks that the miscarriage was not the result of the vaccination but cannot rule it out. The blighted ovum will be treated with an induced miscarriage with misoprostol. The outcome of the event myalgia was recovered on 01Feb2021 while the outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021352904 maternal/fetus case


VAERS ID: 1173212 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Off label use, Product use issue
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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Missed abortion
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021358753

Write-up: Missed abortion at week 7; pregnant patient received the vaccine; pregnant patient received the vaccine; This is a spontaneous report from a contactable physician (patient). This physician only reported information for the mother (herself). This is the maternal report. A 33-year-old pregnant female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 21Jan2021 (at the age of 33-years old) (Batch/Lot Number: EL1484) as SINGLE DOSE, and dose 1 intramuscular, administered in Arm Right on 20Jan2021(as reported) (Batch/Lot Number: EJ6796) as SINGLE DOSE for COVID-19 immunisation. Medical history included prior missed abortion from an unknown date and unknown if ongoing. The last menstrual period was on 23Dec2020. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The pregnant patient received the vaccine on 21Jan2021 and experienced missed abortion at week 7 on 01Feb2021. The patient was hospitalized for missed abortion at week 7 for 2 days. The patient did not receive any treatment for the event missed abortion. The mother reported she became pregnant while taking bnt162b2. The mother was 4 Weeks pregnant at the onset of the event. The mother was due to deliver on 29Sep2021. The clinical outcome of the event missed abortion at week 7 was unknown.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of missed abortion due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1181171 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal death, Polymerase chain reaction, SARS-CoV-2 test, Ultrasound antenatal screen, Viral 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: FOLIC ACID; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Penicillin allergy; Prolactinoma
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result:Unknown Results; Test Name: Lateral flow; Result Unstructured Data: Test Result:Unknown Results; Test Date: 202102; Test Name: nuchal scan; Result Unstructured Data: Test Result:no heartbeat; Comments: It was estimated the baby had stopped growing at approx 8+6 weeks.; Test Date: 20210218; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210308; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210312; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210317; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210320; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: GBPFIZER INC2021327816

Write-up: Miscarriage; vaccine administered at 7+4 weeks gestation/became pregnant while taking BNT162B2; there was no heartbeat/ the miscarriage then started 2 days later which was 4 weeks after the baby had died and 5 weeks after administration of the vaccine; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK1768), via an unspecified route of administration, administered in Arm Left on 13Jan2021 at the age of 32 years old at single dose for COVID-19 immunisation. Medical history included Macroprolactinoma, mild asthma, Allergies to medications, food, or other products: Penicillin. Concomitant medications included folic acid; colecalciferol (VITAMIN D [COLECALCIFEROL]). Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported the Vaccine administered at 7+4 weeks gestation. In Feb2021, at the nuchal scan at 12+3 weeks it was confirmed that there was no heartbeat and it was estimated the baby had stopped growing at approx. 8+6 weeks, a week after the vaccine had been administered. In Feb2021, the miscarriage then started 2 days later which was 4 weeks after the baby had died (Jan2021) and 5 weeks after administration of the vaccine. The mother reported she became pregnant while taking BNT162B2. The mother was 12 Weeks pregnant at the onset of the event. The patient last menstrual period date was 21Nov2020. The mother was due to deliver on 28Aug2021. The adverse events result in Doctor or other healthcare professional office/clinic visit. Treatment was not received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR): Unknown results on an unspecified date; Lateral flow: unknown results on an unspecified date; nuchal scan: no heartbeat in Feb2021, it was estimated the baby had stopped growing at approx 8+6 weeks; Nasal Swab: negative on 18Feb2021, negative on 08Mar2021, negative on 12Mar2021, negative on 17Mar2021, negative on 20Mar2021. The outcome of the event "there was no heartbeat/ the miscarriage then started 2 days later which was 4 weeks after the baby had died and 5 weeks after administration of the vaccine" was unknown, of the other events was Recovered/Resolved with Sequel.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. 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: 1187269 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker (I don''t smoke.)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy (In 2019, I went through an appendectomy.); COVID-19 (In November 2020, I overcame Covid 19 infection with mild clinical symptoms (2 days of fever).); First pregnancy
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:pregnant
CDC Split Type: HRPFIZER INC2021375457

Write-up: Spontaneous abortion at 8 weeks of gestation (about 2-3 weeks per ultrasound)/Early miscarriage; got pregnant in between the doses (natural way); This is a spontaneous report from a contactable consumer (patient) who reported events for both vaccination doses. The is the report for the second dose. The first report was downloaded from the Medicines Agency (MA) WEB regulatory authority number HR-HALMED-300044977. A 35-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number: EJ6136), intramuscular on 29Jan2021 as a single dose as protection against Covid 19 infection. Medical history included appendectomy in 2019, COVID-19 infection with mild clinical symptoms (2 days of fever) in from an unspecified date in 2020 to Nov2020. The patient did not have any other comorbidities, is a non-smoker and does not consume alcohol. The patient does not have allergies and has not given birth or had an abortion so far. The patient was not taking any permanent therapy. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EJ1491) on 04Jan2021 for COVID-19 immunization and experienced pain in her arm at the application site that lasted for 48 hours. Between the two doses the patient got pregnant the natural way in Jan2021. On 23Feb2021, the patient had an early miscarriage/spontaneous abortion at 8 weeks of gestation (about 2-3 weeks per ultrasound). The patient was hospitalized due to the event. The outcome of the event was recovering. Considering the lack of data in pregnant women from clinical trials and high incidence of spontaneous miscarriages in the first trimester of pregnancy, causal relationship between vaccine administration and spontaneous miscarriage cannot be assessed. Early miscarriage was assessed by the regulatory authority as "Unassessable/Unclassifiable" using WHO-UMC Causality method. Sender''s comments: Additional information received on 23Mar2021. Vaccination site pain lasting 48 hours after administration of the first dose is reported. The reporter stated the following: "I have reported early miscarriage as ADR since clinical trials were not performed in pregnant women, although I completely understand that miscarriage could be or does not have to be related with vaccination." No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-01
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
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? 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; 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 INC2021657213

Write-up: Early miscarriage; Maternal exposure during pregnancy/exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer, received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106050618450020-A3V8E, Safety Report Unique Identifier GB-MHRA-ADR 25425060. This consumer reported different events for different vaccine doses for the same patient. This is one of the two reports. This is also a maternal report. A 31-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included suppressed lactation, pregnancy (patient was no longer pregnant at the time of reporting), and folic acid supplementation. The patient has not had symptoms associated with COVID-19, was not enrolled in a clinical trial, and was not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation. The patient experienced maternal exposure during pregnancy in Jan2021 and an early miscarriage on 06Feb2021. The patient was exposed to the medicine first-trimester (1-12 weeks). It was reported that the vaccination was received at "2+5", miscarried at "4+3". The patient was subsequently pregnant again, currently at "9+1" (since had the second vaccination on 29Mar2021). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unspecified date (No - Negative COVID-19 test). The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events was unknown. They were unsure if the medicine had an adverse effect on any aspect of the pregnancy. The case was reported as serious (medically significant). No follow-up attempts are possible, information about the batch/lot number cannot be obtained.


VAERS ID: 985993 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Texas  
Vaccinated:2020-12-22
Onset:2021-01-02
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Pregnancy test positive, Progesterone decreased, 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), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (narrow), Sexual dysfunction (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: omega 3 fatty acids 1gm PO BID NP thyroid 60 mg PO QAM
Current Illness: None
Preexisting Conditions: Hypothyroidism
Allergies: Egg ovalbumin, raw - rash/hives
Diagnostic Lab Data: Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021.
CDC Split Type:

Write-up: Previously G1P1, delivered normal healthy baby July 20, 2020. Second pregnancy conception 12/15/2020. First vaccine dose 12/22/2020. Vaginal bleeding started 1/2/2021 and tapered down 1/4/2021. Light bleeding continued 1/4/2021 - 1/18/2021. Second vaccine dose administered 1/12/2021. Bleeding increased from light/none to medium flow on 1/19/2021 - 1/22/2021. Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021. Bleeding decreased to light flow 1/22-1/25 and gone 1/26/2021. Dr. diagnosed as early pregnancy loss/miscarriage.


VAERS ID: 1093231 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Blood test, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (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? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Akinesia (3 years ago; completely resolved); Lactation decreased; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:unknown results; Test Name: blood tests; Result Unstructured Data: Test Result:unknown results; Test Date: 20201206; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210202; Test Name: X2 tv ultrascans; Result Unstructured Data: Test Result:all okay; Comments: had an early scan at 5 weeks; Test Date: 20210216; Test Name: X2 tv ultrascans; Result Unstructured Data: Test Result:showed a non viable pregnancy and no growth or hea; Comments: showed a non viable pregnancy and no growth or heartbeat
CDC Split Type: GBPFIZER INC2021217007

Write-up: shoulder pain; Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202102271322335360, Safety Report Unique Identifier GB-MHRA-ADR 24848082. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 02Jan2021 at a single dose for Covid-19 immunisation. Medical history included suppressed lactation, abortion spontaneous, pregnancy (patient was no longer pregnant at the time of reporting), and akinesia (3 years ago; completely resolved). Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication included folic acid (FOLIC ACID). The patient experienced shoulder pain on an unspecified date (reported as end of January beginning of February). The patient did not realize she was pregnant (maternal exposure during pregnancy) when vaccinated on 02Jan2021. Patient had miscarriage on 16Feb2021. The mother was 8 weeks pregnant at the time. The mother was supposed due to deliver on 25Sep2021. All events were reported as medically significant. Patient understand that there was no known link with the vaccine and miscarriage, and it may well be that it was unrelated, however she was shocked that when reflecting on the matter she had not been asked if she had the vaccine. She would have thought data would be being collected for future analysis to ensure no links between increased early miscarriage and the vaccine. Patient was exposed to the medicine first-trimester (1-12 weeks). Relevant investigations or tests conducted: 2 blood tests (unknown results) and X2 tv ultrascans: (had an early scan at 5 weeks) all okay on 02Feb2021, showed a non-viable pregnancy and no growth or heartbeat on 16Feb2021. The patient underwent lab tests which included COVID-19 virus test: no - negative covid-19 test on 06Dec2020. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event shoulder pain was unknown while for the other events was recovering. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender''s Comments: A possible role oof the vaccine in the onset of shoulder pain cannot be excluded, conversely there is is not a reasonable possibility that the reported miscarriage is related to vaccine.


VAERS ID: 968006 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-01-02
Onset:2021-01-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8982 / 2 LA / SYR

Administered by: Senior Living       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, 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)

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: Labetalol Sertraline
Current Illness: None
Preexisting Conditions: Hypertension
Allergies: Penicillin and all cousins Suprax Cipro Percocet Tetracycline
Diagnostic Lab Data: Ultrasound to confirm 01/04/21
CDC Split Type:

Write-up: Miscarriage on 01/03/21 (due date 08/08/21) 2 previous pregnancies with live births (2006,2010)


VAERS ID: 1026685 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Oregon  
Vaccinated:2020-12-29
Onset:2021-01-04
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Fatigue, Immediate post-injection reaction, Laboratory test, Pain in extremity
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (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: Prenatal vitamins; vit d
Current Illness: no
Preexisting Conditions: no
Allergies: No
Diagnostic Lab Data: Laboratory - confirmed
CDC Split Type: vsafe

Write-up: Arm pain and fatigue right away; January 4th I noticed I was bleeding - I had a miscarriage. Went to doctor the next day and they did lab tests and confirmed I had a miscarriage. Pregnancy - 3rd pregnancy; and it was my second miscarriage. I was about seven weeks pregnant.


VAERS ID: 979951 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Washington  
Vaccinated:2020-12-18
Onset:2021-01-05
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin positive
SMQs:, Tumour markers (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Oral typhoid, in mid-20s, severe abdominal pain
Other Medications: Prenatal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfonamides
Diagnostic Lab Data: HCG positive 1/4, 1/3, 1/2
CDC Split Type:

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


VAERS ID: 1063971 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Chromosomal analysis, Exposure during pregnancy, Headache, Immediate post-injection reaction, Neck pain, Pain, Pain in extremity, Ultrasound abdomen, 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), Hypersensitivity (narrow), Arthritis (broad), 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: Topical - Metronidazole; Multi-Vitamin
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: I had a DNC surgery on February 12, 2021. They did do chromosome testing and those results are still pending.
CDC Split Type: vsafe

Write-up: Sudden onset: Sore arm - really sore. Whole body aches. Headache and neckache. I did not have a fever. 24 hours later they all disappeared. I found out I was pregnant on the 8th. I had a normal ultrasound and a heartbeat at the end of January (the 29th) and February 8, there was no heartbeat anymore. I miscarried. This was my fifth pregnancy. I had one other miscarriage. I had a pregnancy where I had twins and one of the twins miscarried. So I have miscarried three babies. The expected date of delivery for this pregnancy was September 13, 2021.


VAERS ID: 1086384 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 02L20A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Erythema, Exposure during pregnancy, Mobility decreased, Pain, Pain of skin, Peripheral swelling, Thrombosis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (broad), 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: Supplements: Vitamin D3 k2 Iron Prescriptions: Adderall 20mg Adderall 30mg
Current Illness: None
Preexisting Conditions: NONE
Allergies: Mushroom allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: On the following day after receiving my first dose of the vaccination, my arm was throbbing, completely swollen, decreased ROM and skin was RED and severely tender to the touch. Took OTC Tylenol (2) po and had no signs of relief. Pain , swelling, and skin redness lasted for 3 days. On February 10th, 2021 I had a positive pregnancy test (confirmed by bloodwork and urine) which indicated I was 6-7 weeks pregnant and had a miscarriage on March 2021, after giving live births 3 prior times. The cause of the miscarriage is unknown. I also developed a blood clot on the arm that was inserted for an IV. I have no family history or personal history of needing blood thinners.


VAERS ID: 1140309 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2020-12-30
Onset:2021-01-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3249 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion induced, Exposure during pregnancy, 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: As stated above. OB ultrasound 1/5/21. OB ultrasound 1/13/21.
CDC Split Type:

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


VAERS ID: 1162341 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Body temperature, Body temperature increased, Human chorionic gonadotropin, Myalgia, Pregnancy test, Vaccination site inflammation, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), 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? 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: 20210106; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Test Date: 20210118; Test Name: human chorionic gonadotropin; Result Unstructured Data: Test Result:Result indicated 5 - 6th week of pregnancy; Comments: human chorionic gonadotropin was increased (result indicated 5 - 6th week of pregnancy); Test Date: 20210105; Test Name: Pregnancy test; Test Result: Negative ; Test Date: 20210116; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: LVPFIZER INC2021298073

Write-up: Missed abortion; Injection site inflammation; Muscle pain (injection site and neck, patient had trouble moving their muscles due to the pain); Injection site pain; Body temperature 37,3 C; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number [LV-SAM-2021035059]. A 27-year-old female patient received BNT162B2 (COMIRNATY), dose intramuscular, on 05Jan2021 (Lot number: EJ6796) as 0.3mL, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Jan2021, patient started experiencing injection site pain and body temperature 37,3 c. On 06Jan2021, the patient experienced injection site inflammation, muscle pain (injection site and neck, patient had trouble moving their muscles due to the pain). On 28Feb2021, it was noted that the patient had had a missed abortion. The patient underwent lab tests and procedures which included body temperature showed 37.3 centigrade on 06Jan2021, human chorionic gonadotropin showed increased (result indicated 5 - 6th week of pregnancy) on 18Jan2021, pregnancy test was negative on 05Jan2021, pregnancy test was positive on 16Jan2021.The patient consulted their obstetrician and decided not to receive the 2nd vaccination dose while pregnant. The outcome of the missed abortion was unknown and injection site inflammation, muscle pain, injection site pain, body temperature 37,3 c were recovered on 09Jan2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1325348 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Human chorionic gonadotropin, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? 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: 20210105; Test Name: body temperature; Result Unstructured Data: Test Result:less than 39 Centigrade; Test Date: 20210118; Test Name: HGC total; Result Unstructured Data: Test Result:2603 MiU/mL
CDC Split Type: ITPFIZER INC2021491523

Write-up: Abortion deemed/ suspected miscarriage; Fever below 39; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number IT-MINISAL02-721986. A 31-year-old pregnant female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: EL1484), intramuscular on 04Jan2021 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Jan2021, the patient experienced fever below 39. The patient had abortion deemed/ suspected miscarriage on 10Feb2021. The patient was 2 weeks pregnant at the onset of the event and was due to deliver on 23Sep2021. The pregnancy resulted in spontaneous abortion. The patient underwent Total HCG: 2603 miu/ml on 18Jan2021. The patient recovered from the event "abortion deemed/ suspected miscarriage" on 18Feb2021, and unknown outcome for "fever below 39". On 18Mar2021, the patient received her 2nd dose of COMIRNATY. Sender''s Comment: 30April2021: request for follow-up information from the reporter regarding clinical documentation. the form is updated with the additional information provided by the reporter and the clinical report is attached. No follow-up attempts are possible. No further information is expected.


VAERS ID: 967274 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: New York  
Vaccinated:2021-01-01
Onset:2021-01-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Malaise, 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? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Covid19
CDC Split Type:

Write-up: I was pregnant and my baby died two days after I took it and I got really sick


VAERS ID: 1063650 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / -

Administered by: Public       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Pain in extremity, Ultrasound abdomen
SMQs:, 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)

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: No
Current Illness: No
Preexisting Conditions: No
Allergies: I am allergic to penicillin, clindamycin and tree nuts.
Diagnostic Lab Data: I had an US ABD and Transvaginal.
CDC Split Type: vsafe

Write-up: I had a soreness in my arm. The two weeks later on the 21st of January, I had a routine OB appointment and we did an US only to find out that the fetus was no longer alive. I had to have a DNC the following week. Participant is not sure if it is vaccine related but wanted to file a report anyway.


VAERS ID: 947745 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2020-12-29
Onset:2021-01-07
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Exposure during pregnancy, Impaired work ability, Pregnancy test negative, Pregnancy test positive, 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), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: no known allergies
Diagnostic Lab Data: Pregnancy Test #1: Positive 1-11-2021 Pregnancy Test #2: Negative 1-13-2021
CDC Split Type:

Write-up: When this individual received her Moderna Covid-19 vaccine (Dose #1) on 12-29-2020 she did not know her pregnancy status. She did not think she was pregnant. On Thursday 1-7-2021 around 4 AM she started experiencing severe abdominal pain. She did not go to work that day but did go in on Friday 1-8-2021. On Saturday 1-9-2021 she woke up with significant vaginal bleeding. On Monday 1-11-2021 she went to the OB/GYN and there she had a positive pregnancy test. The diagnosis of miscarriage was made at that time. A couple of days later, a repeat pregnancy test resulted in a negative reading.


VAERS ID: 992848 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027L20A / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion missed, Ultrasound foetal, Ultrasound foetal abnormal, Uterine dilation and curettage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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? No
Previous Vaccinations:
Other Medications: prenatal vitamins
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Pathology of products of conception sent 2/1. Results pending. Microarray genetic testing sent 2/1. Results pending.
CDC Split Type:

Write-up: Pt is G1P0. EDD was 8/15 by LMP. The patient had an ultrasound on 1/6 showing a live intrauterine pregnancy with crown rump length measuring 8 weeks 0 days. She had covid vaccine 1/7. Came in with vaginal bleeding 1/29 and found to have missed abortion on ultrasound (no heart tones, crown rump length measuring 8 weeks 3 days). Underwent D&C 2/1.


VAERS ID: 1641652 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Michigan  
Vaccinated:2020-12-31
Onset:2021-01-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin
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; Amlodipine 2.5mg
Current Illness: N/A
Preexisting Conditions: High blood pressure
Allergies: N/A
Diagnostic Lab Data: HCG draws
CDC Split Type:

Write-up: Miscarriage.


VAERS ID: 1381580 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4245 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Drug exposure before pregnancy, Extra dose administered, Inappropriate schedule of product administration, Pregnancy on contraceptive
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), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control (for the last 15 years); Penicillin allergy; Sulfonamide allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021592732

Write-up: ended up pregnant the two week after my second dose; ended up pregnant the two week after my second dose; 1 dose 7JAN 2021 and 2 dose 7JAN2021; 1 dose 7JAN 2021 and 2 dose 7JAN2021; miscarried at 7 weeks; This is a spontaneous report from a contactable healthcare professional (patient) and physician. A 29-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER/BIONTECH COVID-19 VACCINE), dose 1 on 07Jan2021 14:45 (Lot Number: Eh4241) as 1st dose, 0.3 mL single dose; and dose 2 on 07Jan2021 (Lot Number: Ek4245) as 2nd dose, 0.3 mL single dose; both intramuscularly administered in the left arm for covid-19 immunisation. Medical history included on birth control for the last 15 years (2005), and allergies to penicillin and sulfa. The patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included unspecified birth control for the last 15 years (2005). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received the first dose and second dose of Pfizer/Biontech Covid-19 Vaccine on 07Jan2021. The patient reported that she was on birth control and has been on for the last 15 years (2005) never had a pregnancy scare. She reported that she ended up pregnant the two week (28Feb2021) after her second dose and also miscarried at 7 weeks (2021). She feels these two are related as she was not trying, not planning to be pregnant. The patient did not require hospitalization but received treatment included miscarriage procedure. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient has not been tested for COVID-19 since vaccination. The outcome of the event pregnancy on contraceptive was recovered/resolved in 2021 with sequel (lasting effects) while the outcome of the other events was unknown.; Sender''s Comments: The association between the event "she ended up pregnant" and "miscarried at 7 weeks" with BNT162b2 can not be fully excluded based on the temporal relationship. 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: 1389689 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8492 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Lactation decreased; Miscarriage; 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; Test Date: 202101; Test Name: scan; Result Unstructured Data: Test Result:Normal looking scan
CDC Split Type: GBPFIZER INC2021606577

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; Early miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID 202105251245329250-HFGCL, Safety Report Unique Identifier GB-MHRA-ADR 25356127. A 34-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 07Jan2021 (Lot Number: ee8492) as SINGLE DOSE for covid-19 immunisation. Medical history included abortion spontaneous from an unknown date, suppressed lactation from an unknown date , Patient no longer pregnant at the time of reporting. No medical conditions, no medications, fit and well. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 07Jan2021 with outcome of unknown , sars-cov-2 infection on 24Jan2021 with outcome of recovered in 2021, early miscarriage on 13Jan2021 with outcome of recovered with sequelae in 2021. All of the events were assessed as medically significant. The patient experienced Early miscarriage after first dose of vaccine. Vaccine at 7 weeks, normal scan at 7 weeks, miscarriage at 8 weeks. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date; scan in Jan2021: Normal looking scan. The patient received the second dose via an unspecified route of administration on 24Mar2021 (Lot Number: er1749) as SINGLE DOSE for covid-19 immunisation. No follow-up attempts are possible. No further information is expected.


VAERS ID: 928892 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Georgia  
Vaccinated:2020-12-20
Onset:2021-01-08
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre-natal MVI, Iron supplement, B6 50mg BID
Current Illness: None
Preexisting Conditions: None
Allergies: amoxicillin-clavulanate
Diagnostic Lab Data: Ultrasound 12/18 Pregnant, Estimated 6w3d Ultrasound 01/08 No pregnancy observed
CDC Split Type:

Write-up: I was approximately six weeks pregnant at time of my first vaccine. At subsequent OB visit three weeks later I had miscarried. It may not be related to the vaccine at all, but given this is a new vaccine and not studied in pregnant women I thought it was best to report it.


VAERS ID: 930916 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Exposure during pregnancy, Premature baby, Premature delivery, 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), Neonatal disorders (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: prenatal vitamin calcium supplement 1200 mg vitamin d3 1000 iu Aspirin 81 mg
Current Illness: none
Preexisting Conditions: none
Allergies: NKA
Diagnostic Lab Data: see above
CDC Split Type:

Write-up: Patient is a 32 yo G2P1001 with EDD 5/2/2021 by 7w US. She had the first dose of the Pfizer Covid 19 vaccination on 12/17/2020 at the Health Clinic and the second dose on 1/7/2021 at 1115 am. She began having abdominal pain and vaginal bleeding at 315 sm on 1/8/2021 progressing to a previable (22w2d) preterm birth at 739pm on 1/8/2021.


VAERS ID: 932107 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: New York  
Vaccinated:2021-01-06
Onset:2021-01-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-10
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, Muscle spasms
SMQs:, Dystonia (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? 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: Fluticasone, azelastine, prenatal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pfizer-BioNTech COVID-19 Vaccine EUA Miscarriage - (date of vaccination 1/6/21, miscarriage symptoms (cramping) started 1/8/21, confirmed 1/10/21; estimated date of delivery 8/30/21)


VAERS ID: 941086 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: California  
Vaccinated:2020-12-31
Onset:2021-01-08
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / -

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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamins
Current Illness: none
Preexisting Conditions: none
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage


VAERS ID: 1015666 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Georgia  
Vaccinated:2020-12-28
Onset:2021-01-08
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0142 / 1 LA / -

Administered by: Work       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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Eosinophilic esophagitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021092594

Write-up: patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; Miscarriage 11 days post vaccine; This is a spontaneous report from a contactable Nurse. A 39-year-old female nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 28Dec2020 at 07:30 AM at single dose for COVID-19 immunization. Medical history included asthma and eosinophilic esophagitis and allergies to Keflex ASA. Concomitant drugs were none. At the time of vaccination the patient was pregnant, her last menstrual date was on 20Nov2020, gestational period 6. The patient reported that on 08Jan2021 at 12:00 PM she had miscarriage 11 days post vaccine. The patient was seen at Doctor or other healthcare professional office/clinic visit. At the time of reporting the patient was recovering.; Sender''s Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported miscarriage. However, information is limited, and miscarriage is multifactorial event. In the general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. 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: 1363993 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20-2A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Intentional dose omission
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: LEVOTHYROXINE; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Polycystic ovarian syndrome; Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20211

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


VAERS ID: 1429381 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-01-06
Onset:2021-01-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4176 / 2 LA / -

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Dyspnoea, SARS-CoV-2 test, Ultrasound uterus
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: Nasal Swab; Test Result: Negative ; Comments: (PCP Nasal Swab); Test Date: 20210323; Test Name: Nasal Swab; Test Result: Negative ; Comments: (PCP Nasal Swab); Test Name: ultrasound.; Result Unstructured Data: Test Result:Viable pregnancy with heartbeat at 6 week; Comments: Viable pregnancy with heartbeat at 6 week
CDC Split Type: USPFIZER INC2021689430

Write-up: Became pregnant 7 days after 2nd dose of the vaccine (13Jan2021). Viable pregnancy with heartbeat at 6 week ultrasound. Ended in miscarriage; Difficulty breathing; This is a spontaneous report from a contactable nurse (patient). A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on (at the age of 31-years-old) 06Jan2021 14:30 (Batch/Lot Number: EK4176) as DOSE 2, SINGLE for covid-19 immunisation. Facility in which the vaccine was given was a Workplace clinic. The patient had no known medical history or allergies. Concomitant medications were not reported. Historical Vaccine includes bnt162b2 dose 1, Lot Number EH9899, On 16Dec2020 at 14:00 in Left arm. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient Became pregnant 7 days after 2nd dose of the vaccine (13Jan2021). Viable pregnancy with heartbeat at 6 week ultrasound. Ended in miscarriage on 23Mar2021. (medically significant). On 08Jan2021 at 20:00, 2 days after 2nd dose, sudden difficulty breathing, no personal history of asthma. Needed Primary Care Physician to order Albuterol inhaler, which I needed daily for 4 weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: (PCP Nasal Swab) negative on 19Jan2021, sars-cov-2 test (PCP Nasal Swab): negative on 23Mar2021.Events difficulty breathing and Miscarriage of pregnancy required Emergency Room Visit and Physician Office visit. Treatment was given for the events which included Albuterol for difficulty breathing, D+C on 25Mar2021 for miscarriage. The clinical outcome of the events was unknown.


VAERS ID: 1149580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       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: ESPFIZER INC2021283149

Write-up: Abortion spontaneous; Exposure during pregnancy; This is a spontaneous report from a contactable healthcare professional, downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-784945. A 38-years-old female patient received bnt162b2 (COMIRNATY), on 08Jan2021 (Batch/Lot Number: EJ6796) as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. APer the HCP, a 38-year-old woman, vaccinated with COMIRNATY on 08Jan2021 without knowing she was pregnant, suffered a spontaneous abortion on 26Feb2021, at 9 weeks of gestation. The outcome of the event was recovered, No follow-up attempts possible. No further information expected.


VAERS ID: 1057062 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Chest pain, Exposure during pregnancy, Fatigue, Headache, Laboratory test, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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)

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, vit D, magnesium
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Bactrum
Diagnostic Lab Data: blood panel; confirmed pregnancy 1/21 miscarriage
CDC Split Type: vsafe

Write-up: 1/8 vaccination 1/9 I woke up with severe HA, muscle aches, and fatigue. That evening I got chest pains. 1/10 CP resolved. Everything resolved. 1/17 positive pregnancy test 1/22 miscarriage. First pregnancy. 2/10 finally able to see dr.


VAERS ID: 1757767 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Oregon  
Vaccinated:2020-12-20
Onset:2021-01-09
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin
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: Flecainide, vitamin d, magnesium, potassium, melatonin
Current Illness: None
Preexisting Conditions: PVCs
Allergies: Sulfa, doxycycline
Diagnostic Lab Data: Hcg quant showing decreasing levels
CDC Split Type:

Write-up: Pregnant at the time of vaccination. Miscarriage occurred 20 days after vaccination at around 5 weeks along.


VAERS ID: 971477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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? Yes
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: Comments: No PMH Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021054141

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202101171454477130, Safety Report Unique Identifier GB-MHRA-ADR 24605669. A 26-years-old pregnancy female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. The patient medical history was none. Patient had not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included folic acid at 400 mcg for folic acid supplementation. Patient was exposed to the medicine first-trimester (1-12 weeks). The pregnancy female patient received bnt162b2 on 08Jan2021, experienced miscarriage on 09Jan2021. The events were considered to be serious for hospitalization (Jan2021), life threatening. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 11Jan2021. The event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 999562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2021-01-09
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / 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? 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: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021059255

Write-up: Maternal exposure during pregnancy; Spontaneous abortion; This is a spontaneous report downloaded from the Regulatory Agency-WEB, GB-MHRA-WEBCOVID-20210112103038 and GB-MHRA-ADR 24582782. This is a report received from the Regulatory Agency and Healthcare products Regulatory Agency. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. Lot number was EK1768. Medical history included pregnancy in 2003. Periods have been irregular and sparse for some time. The concomitant medications were not reported. Patient did not take folic acid supplement during pregnancy. Contraception was not being used for some time. Patient was unaware of pregnancy at time of first Covid vaccination on 22Dec2020 (patient no longer pregnant at the time of reporting). Patient was exposed to vaccine first-trimester (6 weeks, also reported 1-12 weeks). Spontaneous abortion was diagnosed on 09Jan2021 (also reported 17 days after vaccination administration). Patient has not been tested/ or has had an inconclusive test for COVID-19. It was unsure if patient was enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient recovered from spontaneous abortion on 10Jan2021. It was reported that the vaccine did not have an adverse effect on any aspect of the pregnancy. No follow-up attempts are possible. No further information expected.


VAERS ID: 1007832 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Virginia  
Vaccinated:2020-12-21
Onset:2021-01-10
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Military       Purchased by: ?
Symptoms: Abortion spontaneous, Anembryonic gestation, Exposure during pregnancy, Immune system disorder, Swelling, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: no
CDC Split Type: vsafe

Write-up: I developed swelling and hives over 75% of my body and was given a shot of Epi shot because my throat closed. I developed a weakened immune system from the vaccine. I am 8 week pregnant and developed a Blighted Ovum and I am currently going through a miscarriage to date. Rather not release any info regarding the pregnancy


VAERS ID: 1038034 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:2021-01-10
Onset:2021-01-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011LZ0A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound 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)

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: MAGNESIUM; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; VITAMIN B [VITAMIN B NOS]; VITAMIN C [ASCORBIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: ultrasound; Result Unstructured Data: No heartbeat at 15 weeks and 5 days
CDC Split Type: USMODERNATX, INC.MOD20210

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


VAERS ID: 1742384 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2020-12-27
Onset:2021-01-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Menstruation irregular
SMQs:, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Changes in menstrual cycles for several months after vaccination. Miscarriage occurred June 2021.


VAERS ID: 1434169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage in pregnancy, Maternal exposure during pregnancy
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699158

Write-up: Heavy bleeding abortion; Heavy bleeding abortion; Maternal Exposure during pregnancy; This is a spontaneous report from a non-contactable consumer downloaded from the WEB. The regulatory authority report number is DE-PEI-CADR2021098412, Sender''s (Case) Safety Report Unique Identifier is DE-PEI-202100090938. Additional referenced number includes: DE-CADRPEI-2021098412. A 31-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: Unknown), via an unspecified route of administration on 10Jan2021, as dose 2, 0.3 mL single for COVID-19 immunisation. Medical history included ongoing pregnancy. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY; Batch/Lot Number: Unknown) as 1st dose 0.3 mL, on unspecified date, for COVID-19 immunization, and experienced exposure during pregnancy. On 05Jun2021, it was reported that the patient experienced heavy bleeding abortion. The patient also experienced maternal exposure during pregnancy. The outcome of the event Heavy bleeding abortion was not recovered, while for the other event was unknown. Sender Comment: First vaccination took place during the unnoticed pregnancy. The second vaccination was done consciously pregnancy. From then on, heavy bleeding and constant finally abortion in pregnancy calendar week 16. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 936919 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2021-01-07
Onset:2021-01-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Progesterone, Vaginal haemorrhage
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: Prenatal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa
Diagnostic Lab Data: 1/11/21 Blood HCG: positive 1/11/21 Blood progesterone: 0.7
CDC Split Type:

Write-up: G3 P1 mother, estimated gestational age of baby = 4 weeks. On day 4 post-vaccine (1/11/21) started with heavy bleeding and labs confirmed miscarriage.


VAERS ID: 962952 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-01-10
Onset:2021-01-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0255202A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin
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: Herbal remedy from acupuncturist
Current Illness: None
Preexisting Conditions: None
Allergies: Allergy to doxycycline
Diagnostic Lab Data: HCG test 1/11 and 1/13
CDC Split Type:

Write-up: Miscarriage


VAERS ID: 1011050 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-01-08
Onset:2021-01-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Dizziness, Exposure during pregnancy, Nausea, Ultrasound antenatal screen abnormal
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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? 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, acetaminophen, B12, Vitamin D, VSL#3 Probiotic
Current Illness: None
Preexisting Conditions: Celiac disease, acne
Allergies: Benzoyl peroxide, gluten
Diagnostic Lab Data:
CDC Split Type:

Write-up: Positive pregnancy test 1/10/21. EDD 9/18/21 based on LMP (12/12/21). Woke up extremely dizzy and could not get out of bed without almost falling over and very nauseated. Symptoms eventually subsided around 10:00 am. Did not have dizziness again. Had a confirmatory Ultrasound on 2/4/21 which measured 5weeks, 5 days and no yolk sac. Was supposed to be 7 weeks, 5 days. Determined that I miscarried.


VAERS ID: 1070733 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-01-08
Onset:2021-01-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

Administered by: Private       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? 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 INC2021182471

Write-up: miscarriage; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose on 08Jan2021 in right arm and 1st dose on 15Dec2020 in left arm, both via intramuscular at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously took amoxicillin and experienced allergy. Concomitant medication included prenatal vitamins. The patient experienced miscarriage on 11Jan2021 with outcome of recovered. The event resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was 11 weeks pregnant at the onset of the event. The mother was due to deliver on 07Aug2021. Date of LMP was 26Oct2020. Therapeutic measures were taken as a result of miscarriage included misoprostol (CYTOTEC). Information of lot/batch number has been requested.; Sender''s Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported ''miscarriage'' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1189070 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dizziness, Illness, Inner ear disorder, Maternal exposure before pregnancy, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (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), 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: Clinical trial participant (doorstep testing); Hypertension; Lactation decreased; Miscarriage; Pregnancy; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021336316

Write-up: miscarriage; patient was exposed to the medicine before pregnancy; Inner ear disorder; Sickness; Dizziness/Light headedness; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202103251414585270. This is a Maternal report. A 37-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included suppressed lactation, pregnancy, pulmonary embolism, abortion spontaneous, hypertension, clinical trial participant (doorstep testing). Details of previous pregnancies included: second pregnancy, first one had PE so classed as high risk. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medications included folic acid (FOLIC ACID) taken for pregnancy, vitamin supplementation from 01Sep2020 to 18Mar2021. It was reported that the patient was exposed to the medicine before pregnancy. The patient experienced miscarriage on an unspecified date, dizziness on 11Jan2021, light headedness on 12Jan2021, inner ear disorder on 12Jan2021 and sickness on 12Jan2021. It was reported that symptoms were present at the time of conception. Miscarriage occurred at 6 weeks and 2 days. The symptoms above meant she was off work for a few days. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 13Jan2021. Patient has not tested positive for COVID-19 since having the vaccine. It was unsure whether the medicine have an adverse effect on any aspect of the pregnancy. The events were repored as other medically important condition. The outcome of the events miscarriage was recovering, maternal exposure during pregnancy was unknown and other events recovered on 20Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 943837 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-01-07
Onset:2021-01-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Human chorionic gonadotropin negative, Ultrasound scan vagina abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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)

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: Levetiracetam 500mg , Folic acid 4mg, prenatal vitamin, vitamin C 500mg, Zinc 50mg, Omega 3 fatty acids
Current Illness:
Preexisting Conditions: Seizure disorder
Allergies: Amoxicillin
Diagnostic Lab Data: 1/13/2021: Intravaginal ultrasound showing no gestational sac or embryo which would have been expected for gestation 1/13/2021: Hcg, Total, Quantitative 971 mIU/mL
CDC Split Type:

Write-up: Approximately 5 days after administration at 6 weeks pregnant, I began bleeding. The following day (6 days after administration) miscarriage was confirmed via ultrasound


VAERS ID: 981360 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-01-08
Onset:2021-01-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 1 RA / IM

Administered by: Work       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: Patient is an IVF patient. Embryo transfer was 12/18/2020. She approximately 5 weeks pregnant based upon HCG levels obtained by her specialists the same day of her vaccination - 1/8/21. Her IVF physician, Dr. supported her decision to be va
Current Illness: None reported
Preexisting Conditions: Undergoing IVF treatment
Allergies: None reported
Diagnostic Lab Data: None by this facility.
CDC Split Type:

Write-up: Patient reported history as noted above. She relayed a coincident IVF cycle pregnancy loss. Further clinical details unknown by this facility. Submitted for consideration of possible association and further discussion with treating providers.


VAERS ID: 1265524 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021462034

Write-up: Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report downloaded from the Healthcare Products Regulatory Agency. Regulatory authority number: IE-HPRA-2021-064934. A contactable physician reported that a 28-year-old female patient received first dose bnt162b2 (COMIRNATY; Lot/Batch Number: EM0477) intramuscularly on 12Jan2021 as single dose for COVID-19 immunisation. The patient''s medical history was not reported. The patient was not taking any concomitant medication. On 12Jan2021, the patient was vaccinated with first dose of Comirnaty. The patient deferred second dose offered on 02Feb2021 as she had found out she was pregnant in the interim. She was noted to be in her 1st trimester at the time of exposure. This event was noted to be serious by the reporter due to being a medically important condition. As of 12Apr2020, it was reported that the patient had a miscarriage on 29Mar2021. The fetal outcome is neonatal death. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Follow-up (12Apr2020): New information from a contactable physician downloaded from the Regulatory Authority-WEB IE-HPRA-2021-064934 includes: new event (miscarriage), reporter details and correct world wide identifier was reflected. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1061033 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2020-12-03
Onset:2021-01-13
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Ultrasound abdomen, 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: Prenatal
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultra sound labs
CDC Split Type: vsafe

Write-up: I was 6 weeks pregnant at the vaccine, two weeks later I started bleeding and had a miscarriage. Exactly 2 weeks after the vaccine. I left work that day to see the OB , had ultra sound, labs and a follow up a week later.


VAERS ID: 1505800 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2020-12-27
Onset:2021-01-13
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol inhaler
Current Illness:
Preexisting Conditions: Mild asthma
Allergies: None
Diagnostic Lab Data: Ultrasound to confirm absence of heartbeat February 4, 2021.
CDC Split Type:

Write-up: I received dose 1 of the Moderna vaccine on the day of my missed period, around week 4 of pregnancy. I had a miscarriage at about 6.5 weeks. No previous history of miscarriage/adverse pregnancy outcomes for myself, or history of miscarriage/adverse pregnancy outcomes in my family.


VAERS ID: 1185801 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound 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), 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
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: US scan; Result Unstructured Data: Test Result:showed no foetal heart beat, confirmed miscarriage
CDC Split Type: GBPFIZER INC2021333967

Write-up: Early miscarriage; Maternal exposure during pregnancy; vaginal bleed; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202103241056547250, Safety Report Unique Identifier GB-MHRA-ADR 25011822. This physician reported information for the mother. A 30-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: ER1749), dose 1 via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included lactation decreased and miscarriage, both from unknown date. Patient was pregnant at time of vaccination. No other medical information is known. 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 taken for folic acid supplementation. Patient knew she was pregnant when counselled for vaccination but in high risk work group (anesthetics) and decided to have vaccine. Approx four hours after vaccination (13Jan2021) started vaginal bleed. Patient miscarried overnight. Obstetrician felt foetal heart beat would have ben lost up to 2 weeks prior to symptoms of miscarriage. So not likely to be related to vaccination. Did the medicine have an adverse effect on any aspect of the pregnancy: No. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures on an unknown date which included Negative COVID-19 virus test, ultrasound scan: showed no foetal heart beat, confirmed miscarriage. The outcome of Early miscarriage was recovered on 14Jan2021. The outcome of other events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 953737 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Ohio  
Vaccinated:2020-12-21
Onset:2021-01-14
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin
SMQs:, 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: N/A
Preexisting Conditions: Mitral valve prolapse
Allergies: N/A
Diagnostic Lab Data: Hcg on 01/07/2021 was 1224 Hcg on 01/14/2021 was 596
CDC Split Type:

Write-up: 3 weeks pregnant at time of first dose on 12/21/2020. Due date would have been 09/09/2021. Miscarriage on 01/14/2021 at 6 weeks.


VAERS ID: 955432 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-01-10
Onset:2021-01-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Activated partial thromboplastin time, Exposure during pregnancy, Ultrasound scan abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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)

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: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Ultra sound and ACT level
CDC Split Type: vsafe

Write-up: I had vaginal bleeding and receive a Ultra sound. Which I had a miscarriage. My estimated delivery was August 25,2021.


VAERS ID: 1010028 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2020-12-30
Onset:2021-01-14
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 1 LA / SYR

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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Aspirin and Peninsilin
Diagnostic Lab Data:
CDC Split Type:

Write-up: The day I got the first shot of Moderna Covid19 vaccine I was 4 weeks pregnant. Starting week 6 I start to have symptoms of miscarriage (January 14 2021). This continued until January 18 when I lost the baby. I was due in September 2, 2021.


VAERS ID: 1086871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042L20A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Human chorionic gonadotropin, Sexually transmitted disease test, Ultrasound abdomen, Urine analysis
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: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; LEXAPRO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Cosmetic allergy (an allergy to an unknown beauty product); Endometriosis; Environmental allergy (environmental allergies); Kidney stone; Paroxysmal supraventricular tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: Blood Test; Result Unstructured Data: Normal test results; Test Date: 20210222; Test Name: HCG; Result Unstructured Data: 21297 (expected to be); Test Date: 20210222; Test Name: HIV/ Chlamydia /gonorrhea; Test Result: Negative ; Result Unstructured Data: HIV/ Chlamydia /gonorrhea; Test Date: 20210222; Test Name: Ultrasound; Result Unstructured Data: no fetal heart beat; Test Date: 20210222; Test Name: Urine; Result Unstructured Data: Tested normal/negative
CDC Split Type: USMODERNATX, INC.MOD20210

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


VAERS ID: 1175464 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011L20A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030M20A / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Loss of consciousness, Pulseless electrical activity, Surgery, Transfusion
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiac arrhythmia terms, nonspecific (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lovenox Prenatal vitamins
Current Illness: None
Preexisting Conditions: PVC Right bundle branch block Hx TBI Hx DVT Asthma
Allergies: Dilaudid Tramadol
Diagnostic Lab Data: Yes fetus was sent to pathology miscarriage occurred 2/5/21. Required EMT services. Passed out twice and flatlined for 4 seconds. Blood transfusion on 2/6/21. D AND C surgery on 2/7/21. All at hospital.
CDC Split Type:

Write-up: At the time of my first vaccine on 1/14/21 I was 9 weeks pregnant and on lovenox for DVT and progesterone for pregnancy maintenance. On 2/5/21 I miscarried the baby and ended up hemmoraging thus requiring a blood transfusion. The fetus was sent to pathology and I was informed that at 12 weeks when I miscarried that the baby had termed at 9 weeks which was the time of my first vaccine injection.


VAERS ID: 1417285 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-01-12
Onset:2021-01-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Maternal exposure before pregnancy, Menstruation irregular, Oligomenorrhoea
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), Fertility 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: Lexapro, adderall xr, Zyrtec, prenatal vitamin, acyclovir, turmeric
Current Illness: None
Preexisting Conditions: Asthma, migraines, spondylarthropathy
Allergies: Indomethacin, moxifloxacin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Period was 4 days early (Jan 14 instead of Jan 18) and lasted 9 days instead of 5 days. Bleeding was a lot heavier than normal. Ovulated 10 days later than normal in next cycle. I had been keeping track because we were trying to get pregnant. My periods are always very regular. I became pregnant with EDD 10/31/21 and suffered miscarriage on 3/21/21. Genetic screening from fetal tissue showed digynic triploidy. I do not necessarily think vaccine caused miscarriage however I am just stating what happened with my cycle immediately prior to getting pregnant.


VAERS ID: 1064862 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Abortion spontaneous, Diarrhoea, Fatigue, Migraine, SARS-CoV-2 test, Scan, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Noninfectious diarrhoea (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Polycystic ovaries; Pregnancy (has 3 children)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210211; Test Name: scans; Result Unstructured Data: Test Result:showing gestional sac, had stopped development at; Comments: about 5 weeks. Growth of sack measurements coincides of a fetus of 5 weeks.
CDC Split Type: GBPFIZER INC2021170072

Write-up: Diarrhea; Stomach cramps; Vomiting; Miscarriage of pregnancy/Stop of fetus growth leading to miscarrage/gestional sac, had stopped development; Migraine; Fatigue; This is a spontaneous report received from the RA. The regulatory authority report number is GB-MHRA-WEBCOVID-202102160524241370. Safety Report Unique Identifier is GB-MHRA-ADR 24769816. A contactable consumer reported that a 34-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included migraine, polycystic ovaries, and pregnancy (has 3 children) from an unknown date. Concomitant medication included paracetamol from an unspecified date for pain relief. On 14Jan2021, within hours of vaccination, the patient experienced migraine which recovered on 16Feb2021 and fatigue which recovered on 17Jan2021. On 16Jan2021 at 06:30 it was reported that the patient had diarrhea, stomach cramps, and vomiting which recovered on 16Jan2021 at 15:30. The patient fell pregnant around the middle of December. The patient was reported to have had a miscarriage of pregnancy on 16Jan2021. Stop of fetus growth leading to miscarriage which was reported to be recovering. Gestional sac, had stopped development at about 5 weeks. Patient did not take folic acid supplement during pregnancy. Details of scans or investigations included: Growth of sack measurements coincides that of a fetus of 5 week. Gestional sac, had stopped development at about 5 weeks on 11Feb2021. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient would of been 5 weeks pregnant at time of taking vaccination. It was reported that the vaccine had an effect with the pregnancy. The reporter assessed all the events as serious for medically significant events. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1072046 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Gynaecological examination, Investigation, Maternal exposure during pregnancy, Ultrasound uterus
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: ACFOL
Current Illness: Abortion spontaneous (history of abortion, repeated miscarriage)
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Name: Vaginal examination; Result Unstructured Data: Test Result:cervix permeable; Test Date: 20210202; Test Name: Vaginal examination; Result Unstructured Data: Test Result:uterus in anteversion with endometrial line of 12; Comments: uterus in anteversion with endometrial line of 12 mm, no intrauterine gestational sac is observed. Intracavitary coagulation is observed; Test Name: External popliteal sciatic; Result Unstructured Data: Test Result:cervix and vagina well epithelialised with active; Comments: cervix and vagina well epithelialised with active bleeding less than a period; Test Name: Gastroenterology macroscopically; Result Unstructured Data: Test Result:normal; Test Name: ultrasound; Result Unstructured Data: Test Result:6 mm embryo with AC+.; Comments: Last ultrasound: 6 mm embryo with AC+. Exploration Good general condition , conscious, oriented and collaborative, well-nourished, well-hydrated, and well-perfused.
CDC Split Type: ESPFIZER INC2021181628

Write-up: Abortion spontaneous; Pregnant woman (7+5); This is a spontaneous report from a contactable other HCP (frontline healthcare worker, patient) downloaded from the WEB manufacturer report number ES-AEMPS-742705. A 41-year-old female patient received first dose bnt162b2 (COMIRNATY, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in left deltoid on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included asthma bronchial, ongoing abortion spontaneous (history of abortion, repeated miscarriage). Concomitant medication included folic acid (ACFOL, Tablet, Strength: 5 mg). The patient experienced abortion spontaneous (medically significant) on 02Feb2021. Patient was pregnant at the time of vaccine administration. Reported as follows: ''''I am a frontline healthcare worker. When I received the first dose of the Comirnaty vaccine, I was unaware that I could be pregnant. I do not know if there could be a causal relationship, but I think it is advisable to report it. Follow-up 15Feb2021 through consultation of emergency medical history on 03feb2021. Patient with a history of repeated miscarriage. Pregnant woman (7+5) who attended for bleeding less than a menstrual period and pain in the hypogastrium. Last ultrasound: 6 mm embryo with AC+. Exploration Good general condition, conscious, oriented and collaborative, well-nourished, well-hydrated, and well-perfused. Soft and depressible abdomen, slightly painful on palpation in the hypogastrium. No signs of peritonism. Gastroenterology macroscopically normal. External popliteal sciatic: cervix and vagina well epithelialised with active bleeding less than a period. Vaginal examination: cervix permeable. Vaginal examination (on 02Feb2021): uterus in anteversion with endometrial line of 12 mm, no intrauterine gestational sac is observed. Intracavitary coagulation is observed. Pouch of Douglas free.'''' The outcome of event abortion spontaneous was reported as recovering. The outcome of other event was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1112873 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Off label use, Product use issue
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021240446

Write-up: Miscarriage at 9week pregnancy (on March 3rd).; Received vaccine around time of conception; Received vaccine around time of conception; This is a spontaneous report from a contactable physician (who is also the patient). A 34 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), via an unspecified route of administration in left arm on 14Jan2021 06:15 PM at age of 34 years old at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not had allergies to medications, food, or other products. Patient was pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced adverse event included miscarriage at 9 week pregnancy (on March 3rd). Received vaccine around time of conception. Patient did not receive treatment for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event miscarriage at 9 week pregnancy was recovered in Mar2021, for others was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "Miscarriage at 9week pregnancy" secondary to "Received vaccine around time of conception" cannot be completely excluded based on temporal association. 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 959645 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-01-07
Onset:2021-01-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Muscle spasms
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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: I was unaware I was pregnant at time of vaccine. Turns out I was, I had a miscarriage a week later at about 4-5 weeks.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I started having cramps Friday night and Saturday morning I started bleeding, by Saturday evening I was passing clots and tissue. ER doctor and nurses did tests and found I was having a miscarriage.


VAERS ID: 960019 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-01-04
Onset:2021-01-15
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / IM

Administered by: Work       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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: atomoxetine, guanfacine, trazodone, fish oil, vitamin d, probiotic, iron
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: miscarriage, estimated 5 weeks


VAERS ID: 1775636 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Utah  
Vaccinated:2020-12-24
Onset:2021-01-15
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037K20A / 1 LA / UN
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030L20A / 2 LA / UN

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Dizziness, Human chorionic gonadotropin, Maternal exposure before pregnancy, Nausea, Pyrexia, Ultrasound scan
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: levothyroxine
Current Illness: no
Preexisting Conditions: scleroderma and hypothyroidism
Allergies: no
Diagnostic Lab Data: HCG testing and seen at a hospital for the second miscarriage where I received an HCG test and ultra sound.
CDC Split Type:

Write-up: I conceived and became pregnant between Dec 25-December 29th, the days following getting the first dose of the covid vaccine. I found out I was miscarrying January 15th via lab results from my primary care doctor. I became pregnant again in late February 2021 after having my second covid shot on January 26th 2021 where I had 2 weeks of a low fever, nausea and dizziness. I had a confirmed pregnancy test and a week later miscarried at 5 weeks. Prior to this I have had a successful pregnancy with no complications and no hx or miscarriage.


VAERS ID: 1081407 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1768 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Maternal exposure before pregnancy, 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), Tendinopathies and ligament disorders (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 400mg
Current Illness: Pregnancy; patient no longer pregnant at the time of report.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021193653

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202102210838192890; safety report unique identifier: GB-MHRA-ADR 24806513). A 32-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# ER1768), via an unspecified route of administration, on Jan 14, 2021, single dose, for COVID-19 vaccination. Medical history included pregnancy. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient is not enrolled in a clinical trial. Concomitant medication included folic acid 400mg for supplementation. The patient conceived 3 days after having the vaccine, by mistake. Then miscarried at 5.5 weeks pregnant. Patient was exposed to the medicine before pregnancy. Patient experienced, ''exposed to the medicine before pregnancy'' (reported as maternal exposure during pregnancy); and had a miscarriage (unspecified date) with outcome of unknown. The patient thought this was a normal reaction to the vaccination. The patient miscarried a baby at 5.5 weeks, which was conceived 3 days after receiving the vaccine. The patient also experienced backache and arm pain on Jan 15, 2021. The outcome of the backache and painful arm were recovered; while the outcome of other events was unknown. Patient has not tested positive for COVID-19 since the vaccination. The events were considered serious (other medically important condition). No follow-up attempts are possible. No further information expected.


VAERS ID: 1180938 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Maternal exposure during pregnancy, Ultrasound 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)

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: 2021; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:Confirmation of pregnancy; Comments: Confirmation of pregnancy Units not specified
CDC Split Type: DKPFIZER INC2021316354

Write-up: Missed abortion; Vaginal bleeding; Maternal exposure during pregnancy/ patient received the first vaccine in gestation week 3+0; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority- DK-DKMA-WBS-0053197, Safety Report Unique Identifier-DK-DKMA-ADR 24928703. A 31-year-old female patient received BNT162B2 (COMIRNATY), dose 1, intramuscular on 15Jan2021 (batch/lot number: EJ6134) (at the age of 31-years-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. There is no information regarding past medication. On 15Jan2021, the patient received the first vaccine in gestation week 3+0. On 04Mar2021, the patient developed missed abortion and vaginal bleeding. The events were assessed medically significant. The patient underwent ultrasound scan on an unspecified date in 2021 which revealed confirmation of pregnancy. No treatment due to the events was reported. The outcome of the event missed abortion was not recovered and the outcome for vaginal bleeding was unknown. It was also reported that the patient received the second dose of COMIRNATY (batch /lot number: EP9605) on 10Mar2021 for COVID-19 immunisation. No follow-up attempts possible. No further information expected. COMIRNATY batch already obtained.


VAERS ID: 1211747 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484-01-006 / 1 RA / 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUNOX; CITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021342984

Write-up: Miscarriage at 5th week (not aware of pregnancy status)/Spontaneous abortion; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number IT-MINISAL02-704039. A 36-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: EL1484-01-006, expiration date: 30Apr2021), intramuscular, administered in arm right on 15Jan2021 as 0.3 mL, single (at the age of 36-years-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included flurazepam hydrochloride (FLUNOX) and citalopram both were taken for an unspecified indication, start and stop date were not reported. The patient experienced miscarriage at 5th week (not aware of pregnancy status) on 15Jan2021. The outcome of the event was recovered (as reported). The patient received the second dose of bnt162b2 (COMIRNATY, lot number: EL0725-60-013, expiration date: 31Mar2021) administered in left deltoid on 05Feb2021. Reporter''s comments: the patient was unaware of her pregnancy status Sender''s comments: 2nd dose: 05Feb2021 with lot EL0725-60-013 with expiry date 31Mar2021 left deltoid. No follow-up attempts possible. No further information expected.; Reporter''s Comments: the patient was unaware of her pregnancy status; Sender''s Comments: A causal association between BNT162B2 and the reported event cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1378622 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure timing unspecified
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: ESPFIZER INC2021590375

Write-up: Spontaneous abortion; Drug exposure during pregnancy; This is a spontaneous report from a contactable other hcp downloaded from the WEB, regulatory authority number ES-AEMPS-724882. A 30-year-old female patient receive bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 15Jan2021 (Lot Number: EJ6796) at age of 30-year-old, as 1ST DOSE, 0.3 ML, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Unknown if the patient has been infected by COVID-19. The patient experienced spontaneous abortion on 18Jan2021, drug exposure during pregnancy on 15Jan2021. The event seriousness was reported as medically significant. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. Additional information about the adverse drug reactions: On the day of the vaccination, patient was unaware that she was pregnant when she was informed of the vaccination and signed an informed consent form. The outcome of the event spontaneous abortion was recovered on 18Jan2021. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 958501 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-01-14
Onset:2021-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026L20A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abdominal pain upper, Abortion spontaneous, Exposure during pregnancy, Pregnancy, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 8 weeks 5 days, estimated due date august 22, 2021, prenatel mvi qd
Current Illness: none
Preexisting Conditions: none
Allergies: NKA
Diagnostic Lab Data: OBGYN examined client not sure what tests were performed. PHN collected all information from client on 1/21/21.
CDC Split Type:

Write-up: Client was pregnant at time of vaccination. She had consulted with 2 OBGYNS that are following her concerning if she should receive the covid vaccine. They both stated yes. She received her 1st covid vaccination to her left deltiod between 12pm - 1300 on 1/14/21. She did not experience any complications or feel any side effects immediately after vaccination. She was monitored by nursing staff for over 30 min to be prudent. On 1/16/21 the Sat following vaccination she began experiencing cramping in her stomach and began to bleed vaginally. She consulted w her OBGYN and was monitored. She miscarried on 1/19/21.


VAERS ID: 966887 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Iowa  
Vaccinated:2020-12-24
Onset:2021-01-16
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J20-2A / 1 RA / IM

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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa medication
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Miscarried at 7.5 weeks between vaccination #1 and #2. I do not believe the vaccine was a cause, however, it was recommended to report just in case. This was a second pregnancy, first miscarriage. EDD was 9-1-2021. First pregnancy was uncomplicated. Pregnancy tests were negative prior to receiving the first vaccine and then turned positive on 12-29-2020 (5 days after getting first vaccine.)


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https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=3&PERPAGE=100&ESORT=ONSET-DATE&SYMPTOMS[]=Aborted_pregnancy_%2810000209%29&SYMPTOMS[]=Abortion_%2810000210%29&SYMPTOMS[]=Abortion_complete_%2810061614%29&SYMPTOMS[]=Abortion_early_%2810052846%29&SYMPTOMS[]=Abortion_incomplete_%2810000217%29&SYMPTOMS[]=Abortion_induced_%2810000220%29&SYMPTOMS[]=Abortion_late_%2810052847%29&SYMPTOMS[]=Abortion_missed_%2810000230%29&SYMPTOMS[]=Abortion_of_ectopic_pregnancy_%2810066266%29&SYMPTOMS[]=Abortion_spontaneous_%2810000234%29&SYMPTOMS[]=Abortion_spontaneous_complete_%2810061616%29&SYMPTOMS[]=Abortion_spontaneous_incomplete_%2810061617%29&SYMPTOMS[]=Foetal_cardiac_arrest_%2810084280%29&SYMPTOMS[]=Foetal_death_%2810055690%29&SYMPTOMS[]=Premature_baby_death_%2810076700%29&SYMPTOMS[]=Premature_delivery_%2810036595%29&SYMPTOMS[]=Stillbirth_%2810042062%29&VAX=COVID19


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