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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

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Case Details (Sorted by Onset Date)

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VAERS ID: 1671524 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / 1 - / OT

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Miscarriage; This case was received via a regulatory authority (Reference number: FR-AFSSAPS-RS20212724) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a pharmacist and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. The patient''s last menstrual period was on 14-May-2021 and the estimated date of delivery was 18-Feb-2022. On 05-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization and medically significant). The patient received mRNA-1273 (Spikevax) beginning around the sixteenth week of the pregnancy. The delivery occurred on 05-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product use was provided by the reporter. No treatment medication was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter''s Comments: Treatment - Non; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1679628 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-05
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: There is not reported any other health issues.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202101095311

Write-up: 3 weeks after the first vaccination she experienced a spontaneous abortion; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0084180. A 37-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jul2021 (Batch/Lot Number: FD0932) as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history (no reported any other health issues), past drug therapy and concomitant medications were not reported. On 05Aug2021, the patient found out that she was 8 weeks pregnant and 3 weeks after the first vaccination she experienced a spontaneous abortion with outcome of not recovered. The mother reported she became pregnant while taking bnt162b2. The mother was 8 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. No treatment due to the ADRs was reported and/or medical procedure was performed. There is no information regarding test results. The second dose of bnt162b2 was given on 12Aug2021 (batch number FE9174). The event was assessed as serious and medically significant. No follow up attempts possible. No further information is expected.


VAERS ID: 1747096 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-08-05
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101207657

Write-up: Pregnancy; Abortion spontaneous; GENERAL INVESTIGATION TARGETING THE VACCINES (HEALTH CARE PROVIDERS HCPS) WHO ARE VACCINATED IN EARLY POST-APPROVAL PHASE (FOLLOW-UP STUDY) This is a report from a Non-Interventional Source from an investigator via a contactable other health professional. A 31-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in upper arm left on 15Mar2021 15:00 (Batch/Lot Number: EP2163; Expiration Date: 31May2021) as 0.3 ml single for COVID-19 immunisation. The subject had no medical history. The subject was not receiving concomitant medications. Her last menstrual period was on 05Jun2021. The patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered left upper arm on 25Feb2021 (Batch/Lot Number: EP2163; Expiration Date: 31May2021) as 0.3 ml single for covid-19 immunisation. The patient experienced abortion spontaneous (medically significant) on 05Aug2021 with outcome of unknown, pregnancy/vaccine exposure before pregnancy (non-serious) on an unknown date with outcome of unknown. The course of events was as follows: On an unspecified date (after the vaccination), the subject took an antipyretic (oral acetoaminophene 500 mg). On an unspecified date, the subject became pregnant. The mother reported she became pregnant while taking bnt162b2. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver on 12Mar2022. On 05Aug2021, the subject had abortion spontaneous. (The outcome of the pregnancy was abortion spontaneous.). The gestation at the time of exposure to the study drug was not applicable. The subject did not smoke during pregnancy. The subject did not drink alcohol during pregnancy. The subject did not use any illegal drugs during pregnancy. Gravidity: None. Information on the father was not applicable. The investigator commented as follows: As above mentioned, as pregnancy and its clinical course were found, this case was reported. The investigator classified the events of pregnancy and abortion spontaneous as non-serious. The causality assessment was not provided. The reporter''s assessment of the causal relationship of the events with the suspect product COMIRNATY was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Abortion spontaneous, Maternal exposure before pregnancy can be considered related. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1789087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-05
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aborted pregnancy, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History Concurrent Conditions: COVID-19 (no info if symptomatic or not); Pregnancy (1 previous pregnancy without problem, delivery at term)
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: ultrasound/echo; Result Unstructured Data: Test Result:nothing to report; Test Date: 20210722; Test Name: ultrasound/echo; Result Unstructured Data: Test Result:everything was perfect
CDC Split Type: FRPFIZER INC202101291508

Write-up: Aborted pregnancy; Pregnancy loss <20 weeks gestation; A pregnant 38-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 27Jul2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunisation. Relevant medical history includes COVID-19 (no info if symptomatic or not) and 1 previous pregnancy without problem, delivery at term. Patient''s last period was on 28May2021. The patient''s concomitant medications were not reported. On 22Jul2021, ultrasound: nothing to report; and everything was perfect. On 27Jul2021, at 8 week, vaccination with Comirnaty. On 05Aug2021 or 06Aug2021, aborted pregnancy/termination of pregnancy, pregnancy loss <20 weeks gestation. Also reported on 26Aug2021, spontaneous hemorrhagic miscarriage. The outcome of the event was recovering. Reporter comment: pregnancy stopped on 05Aug2021 or 06Aug2021 (had an echo on 22Jul2021 and everything was perfect) spontaneous bleeding miscarriage on 26Aug2021 No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: pregnancy stopped on 05Aug2021 or 06Aug2021 (had an echo on 22Jul2021 and everything was perfect) spontaneous bleeding miscarriage on 26Aug2021


VAERS ID: 1828135 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Immunisation reaction, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Miscarriage; Maternal exposure during pregancy; Reactogenicity event; This case was received via European Medicines Agency (Reference number: FR-AFSSAPS-AM20212755) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a pharmacist and describes the occurrence of REACTOGENICITY EVENT (Reactogenicity event) and ABORTION SPONTANEOUS (Miscarriage) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Aug-2021, the patient experienced REACTOGENICITY EVENT (Reactogenicity event) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregancy). On 07-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred on 07-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 05-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregancy) had resolved. On 07-Aug-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved. On 08-Aug-2021, REACTOGENICITY EVENT (Reactogenicity event) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. COMPANY COMMENT: This case concerns a 29 year old pregnant female with no reported history nor LMP, EDC and weeks gestation who experienced the serious, unlisted events of Abortion spontaneous and Reactogenicity event 2 days after and non-serious event of Maternal exposure during pregnancy the day of dose 2 of Spikevax. Re-challenge is not applicable for dose 2. Benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translation document was received on 23-Oct-2021: event verbatims were updated to English and anatomical location of administration of vaccine was updated.; Sender''s Comments: This case concerns a 29 year old pregnant female with no reported history nor LMP, EDC and weeks gestation who experienced the serious, unlisted events of Abortion spontaneous and Reactogenicity event 2 days after and non-serious event of Maternal exposure during pregnancy the day of dose 2 of Spikevax. Re-challenge is not applicable for dose 2. Benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1874810 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-08-05
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Magnetic resonance imaging, Ultrasound foetal
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: MRI; Result Unstructured Data: Test Result:the examination is affected by fetal movements.; Comments: the examination is affected by fetal movements. Bilateral, asymmetric ventriculomegaly with measurement of ventricular hubs at 33 mm and 27 mm. Inside the larger ventricle there is T2 hypointense and T1 hypersignal in favor of intraventricular hemorrhage. Hemorrhage of the homolateral germinal zone. There are also partitions within this ventricle which has irregular walls. the third ventricle also appears to be enlarged. Sign abnormality and thinning of the parenchyma adjacent to ventricular dilation. the corpus callosum is present. no anomaly of the posterior fossa. gyraton appears to be related to gestational age subject to limited analysis with regard to ventricular dilation.; Test Name: Ultrasound; Result Unstructured Data: Test Result:reveals a ventriculomegaly with irregular ventricu
CDC Split Type: FRPFIZER INC202101464546

Write-up: fetal demise; This is a spontaneous report from a contactable consumer, downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TO20218502. This is the maternal case . The 29-year-old mother of the fetus is vaccinated via intramuscular in left arm against COVID 19 on 21May2021. During the examination at the gynecologist of the 3rd trimester ultrasound reveals a ventriculomegaly with irregular ventricular walls. A fetal MRI performed on 23Jul2021 shows the following results: the examination is affected by fetal movements. Bilateral, asymmetric ventriculomegaly with measurement of ventricular hubs at 33 mm and 27 mm. Inside the larger ventricle there is T2 hypointense and T1 hypersignal in favor of intraventricular hemorrhage. Hemorrhage of the homolateral germinal zone. There are also partitions within this ventricle which has irregular walls. The third ventricle also appears to be enlarged. Sign abnormality and thinning of the parenchyma adjacent to ventricular dilation, the corpus callosum is present, no anomaly of the posterior fossa, gyraton appears to be related to gestational age subject to limited analysis with regard to ventricular dilation. Conclusion: Bilateral, asymmetric, severe ventriculomegaly with the presence of a clot hemorrhage within a ventricle and hemorrhage from the ipsilateral germinal zone. Parenchyma signal abnormalities adjacent to ventricular dilation, analysis of the placenta reveals a preterm placenta without noticeable histological lesion. Evolution: Death of the fetus on 05Aug2021 by medical termination of the pregnancy. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101454831 fetus


VAERS ID: 1540744 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-27
Onset:2021-08-06
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: paracetamol (occasionallly), omeprazol (occasionally), multivitamin complex (gestacare gestacao), iron+folic acid, magnesium
Current Illness: None
Preexisting Conditions: None
Allergies: Allergic to metamisole
Diagnostic Lab Data:
CDC Split Type:

Write-up: Gave birth on the 6th of August, 10 days after the vaccination at 37 weeks 0 days.


VAERS ID: 1782734 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-03-17
Onset:2021-08-06
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 2 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: N/A
Current Illness: None
Preexisting Conditions: None
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage at around 7 weeks (I found out at 9 weeks pregnant). No symptoms were present. I found out about the miscarriage because of a routine ultrasound- the fetus did not have a heartbeat and was measuring at 7 weeks.


VAERS ID: 1791333 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Exposure during pregnancy, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre natal biotin
Current Illness: No
Preexisting Conditions: Diabetes
Allergies: Sulfa and kenolog
Diagnostic Lab Data:
CDC Split Type:

Write-up: Bleeding lower back pain, miscarriage of my baby in 3 days of shot.


VAERS ID: 1632108 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-08-06
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101038065

Write-up: Dizziness; 2 weeks later miscarriage; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the regulatory authority-WEB BE-FAMHP-DHH-N2021-103683. A 28-years-old pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot Number: unknown) via unspecified route of administration on 23Jul2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. Gestation period 1 trimester. On 06Aug2021 (2 weeks later), patient had miscarriage. On an unspecified date, patient had dizziness. The outcome of events was unknown. Reporter comment: Treatment - Evolution of the ADR - Time relationship - ADR description - Dizzy - 5 weeks pregnant during first vaccine administration. 2 weeks later miscarriage. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1680759 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-08-06
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6984 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC202101095207

Write-up: Abortion spontaneous/ miscarriage; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-773502. A 35-year-old pregnant female patient received bnt162b2 (COMIRNATY, Lot Number: FC6984; Expiration Date: 30Sep2021), dose 1 intramuscular, administered in right arm (also reported as right shoulder) on 14Jun2021 (at the age of 35-year-old) as dose 1, single (also reported as 300 ul) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Last menstrual period on 14May2021. On 06Aug2021, the patient experienced miscarriage/ abortion spontaneous. Measures taken for the event miscarriage/ abortion spontaneous included scraping. The mother reported she became pregnant while taking bnt162b2. The mother was 12 Weeks pregnant at the onset of the event. The mother was due to deliver on 18Feb2022. Impact on quality of life (10/10). The outcome of the events was recovered with sequelae. Sender''s comment: On 19Aug2021, the reporter was contacted by telephone regarding information on: - batch, date, area and time of administration of the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1686814 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-06
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Molar pregnancy; Termination of pregnancy - medical (trisomy 21); Widal syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101107791

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LY20219952. A 35-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscular on 29Jul2021 (Batch/Lot Number: FE8244) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history Widal syndrome from an unknown date and unknown if ongoing, medical termination of pregnancy for trisomy 21 in Dec2020, and molar pregnancy in Apr2021. Date of last menstrual period was on 21Jul2021. Concomitant medication included paracetamol taken for unspecified indication on unspecified date. The patient was taking paracetamol for 48 hours on the advice of the gynecologist. No side effects. The patient experienced early miscarriage (also reported as spontaneous miscarriage) (medically significant) on 06Aug2021. It was reported that note a blur at the time of vaccination, the doctor initially refusing the vaccination of a pregnant woman at T1. Called back the patient after information and accepted as a woman over 35 years old (pending clarification). The mother reported she became pregnant while taking bnt162b2. The mother was 2 weeks pregnant at the onset of the event. The mother was due to deliver on 27Apr2022. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The outcome of the event was recovered on unspecified date.


VAERS ID: 1710470 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Ultrasound scan, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week)
Allergies:
Diagnostic Lab Data: Test Name: Ultrasound scan; Result Unstructured Data: Test Result:At the first ultrasound there was not much to see,; Comments: At the first ultrasound there was not much to see, but at the moment of reporting it was clear that she had a miscarriage.
CDC Split Type: NLPFIZER INC202101150037

Write-up: Miscarriage; Abdominal pain/stomach pain; Vaginal haemorrhage; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB NL-LRB-00674389, Safety Report Unique Identifier NL-LRB-00681254, received from Regulatory Authority. This first of two reports, regarding the second dose. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 28-year-old pregnant female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FF2752), via an unspecified route of administration on 06Aug2021 (at the age of 28-years-old) as dose 2, 0.3 ml single for COVID-19 immunisation. Medical history included maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: she was not pregnant with the first one the 2nd one she was 5 weeks pregnant). The patient''s concomitant medications were not reported. The patient previously received the first dose of COMIRNATY on 02Jul2021 for COVID-19 immunisation and experienced pain in arm and muscle pain in arm. The patient experienced miscarriage (9 hours after administration of covid-19 vaccine pfizer injectable solution), abdominal pain and vaginal haemorrhage on 06Aug2021. Drugs and latency for covid-19 vaccine pfizer injectable solution: abdominal pain, vaginal haemorrhage and miscarriage: 9 hours after start. The miscarriage occurred at a pregnancy duration of about 5 weeks. This was after the second Covid vaccination. The first vaccination took place before the pregnancy. When having the second vaccination the reporter just found out she was pregnant. The night after the vaccination she had stomach pain and the day after she started bleeding. At the first ultrasound there was not much to see, but at the moment of reporting it was clear that she had a miscarriage. The mother reported she became pregnant while taking bnt162b2. The mother was 5 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included ultrasound scan: at the first ultrasound there was not much to see on an unspecified date. Treatment: Abdominal pain, miscarriage is treated and vaginal haemorrhage were treated with medication to induce the miscarriage. Therapeutic measures were taken as a result of miscarriage, abdominal pain and vaginal haemorrhage. The outcome of abdominal pain and vaginal haemorrhage was not recovered, while of miscarriage was unknown. Sender''s comments: Since the nature of the reported reaction does imply seriousness according to one of the RA critera, the reaction was considered as serious by the regulatory authority. Seriousness of miscarriage was changed from "Congenital anomaly / birth defect" to "other medically important condition" Reporter''s Comments Text: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Muscle pain in arm Date: 02Jul2021 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Muscle pain in arm Date: 02Jul2021


VAERS ID: 1730006 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Foetal death, Foetal growth restriction, Foetal heart rate abnormal, Maternal exposure during pregnancy, Vaccination complication
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: the fetus stopped growing; Intrauterine fetal death; had adverse reactions after receiving Moderna vaccine; Maternal exposure during pregnancy, first trimester; no FHB for 1 week; This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of FOETAL DEATH (Intrauterine fetal death), VACCINATION COMPLICATION (had adverse reactions after receiving Moderna vaccine), FOETAL HEART RATE ABNORMAL (no FHB for 1 week), FOETAL GROWTH RESTRICTION (the fetus stopped growing) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Aug-2021, the patient experienced VACCINATION COMPLICATION (had adverse reactions after receiving Moderna vaccine) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced FOETAL DEATH (Intrauterine fetal death) (seriousness criterion medically significant). On an unknown date, the patient experienced FOETAL HEART RATE ABNORMAL (no FHB for 1 week) (seriousness criterion medically significant) and FOETAL GROWTH RESTRICTION (the fetus stopped growing) (seriousness criterion medically significant). The delivery occurred on 24-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On August 24, the patient received induced labor operation in National Taiwan University Hospital, and the subsequent operation of judicial necropsy was followed up. On 06-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) had resolved. At the time of the report, FOETAL DEATH (Intrauterine fetal death) had resolved and VACCINATION COMPLICATION (had adverse reactions after receiving Moderna vaccine), FOETAL HEART RATE ABNORMAL (no FHB for 1 week) and FOETAL GROWTH RESTRICTION (the fetus stopped growing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered FOETAL DEATH (Intrauterine fetal death), VACCINATION COMPLICATION (had adverse reactions after receiving Moderna vaccine), FOETAL HEART RATE ABNORMAL (no FHB for 1 week) and FOETAL GROWTH RESTRICTION (the fetus stopped growing) to be possibly related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester). Concomitant product use was not provided by the reporter. On 21 August 2021, it is found that there was no FHB for 1 week and on an unknown date it was found through prenatal examination that the fetus has stopped growing and has died. Treatment information was not provided. This is a RA report of Maternal exposure during pregnancy and the serious unexpected event of foetal death (and other related events), in a 37 years old female whose medical history and concomitant medication were not provided. As per maternal age, this pregnancy is a High risk pregnancy. Fetal death occurred approximately 19 days after an unknown dose of the product. The events were considered related to the product per the reporter''s assessment. Although there is temporal relationship between the events and the product, maternal age is a potentially confounder/co-suspect for fetal adverse outcome.; Sender''s Comments: This is a RA report of Maternal exposure during pregnancy and the serious unexpected event of foetal death (and other related events), in a 37 years old female whose medical history and concomitant medication were not provided. As per maternal age, this pregnancy is a High risk pregnancy. Fetal death occurred approximately 19 days after an unknown dose of the product. The events were considered related to the product per the reporter''s assessment. Although there is temporal relationship between the events and the product, maternal age is a potentially confounder/co-suspect for fetal adverse outcome.


VAERS ID: 1739587 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Intermenstrual bleeding, Pregnancy test
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood human chorionic gonadotropin; Result Unstructured Data: Test Result:Misscarriage; Test Date: 2021; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NOPFIZER INC202101193829

Write-up: MISCARRIAGE; an unusual bleeding a little earlier than normal menstruation; This is a spontaneous report from a non-contactable consumer (patient) reported different events for each dose of drug. This is the first of two reports. This is a spontaneous report received from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Urqy7p. This is the first report, for the second dose of COMIRNATY. A 37-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 04Aug2021 08:45 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on an unknown date for COVID-19 immunisation and experienced shortening of menstrual cycle. The patient experienced miscarriage on 06Aug2021 and an unusual bleeding a little earlier than normal menstruation in 2021. The reactions/case was considered to be Serious due to (Other Serious (Important Medical Events)). The clinical course was reported as follows: The patient developed miscarriage (dose no. 2), bleeding intermenstrual (dose no. 1), bleeding intermenstrual (dose no. 2). The patient reported to take a positive pregnancy test, but when measuring hcg (human chorionic gonadotropin) it was found that she had a miscarriage. The patient reported that she had never had a miscarriage before, and never previously had an irregular menstrual cycle since as a teenager. The patient underwent lab tests and procedures which included Blood human chorionic gonadotropin: misscarriage in 2021 and pregnancy test: positive in 2021. The outcome of the event ''miscarriage'' was recovering and event ''an unusual bleeding a little earlier than normal menstruation'' was unknown. Sender Comment: The patient reports side effects for both dose no. 1 and 2. No individual report found for dose no 1. The case was upgraded from non-serious to serious ("Other Serious (Important Medical Events)"). The patient reported the date for dose no. 2 as 04Aug2021, and Onset date for side effect MISSCARRIAGEa as 06Aug2021. The patient also reported that she had two abnormal bleedings after dose no. 2 with 1 week apart, and that she found out that she had been pregnant but miscarried after the second bleeding. Latency for the side effect MISSCARRIAGE is therefor not necessarily 2 days. Maybe she meant Latency 2 days for the side effect BLEEDING INTERMENSTRUAL (DOSE NO. 2). Reporter''s comment: Contact with healthcare professionals: Physician. The patient reported to take a positive pregnancy test, but when measuring hcg it was found that she had misscarried. The patient reported that she had never misscarried before, and never previously had an irregular menstrual cycle since as a teenager. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Physician. The patient reported to take a positive pregnancy test, but when measuring hcg it was found that she had misscarried. The patient reported that she had never misscarried before, and never previously had an irregular menstrual cycle since as a teenager.; Sender''s Comments: Linked Report(s) : NO-PFIZER INC-202101257182 same patient/drug, different dose


VAERS ID: 1746276 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / 1 - / OT

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

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

Write-up: Early miscarriage; maternal exposure during pregnancy; This case was received via a regulatory authority (Reference number: FR-AFSSAPS-LY202110426) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS (Early miscarriage) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Early miscarriage in May 2012. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 23-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 06-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Early miscarriage) had resolved with sequelae. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided. This case concerns a 39 year- old, female patient with relevant medical history of miscarriage, who experienced the unexpected events of vaccine exposure during pregnancy and spontaneous abortion. The last menstrual period and estimated date of delivery were not provided. Spontaneous abortion occurred approximately 17 days after the first dose of Moderna covid-19 vaccine. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna covid-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 39 year- old, female patient with relevant medical history of miscarriage, who experienced the unexpected events of vaccine exposure during pregnancy and spontaneous abortion. The last menstrual period and estimated date of delivery were not provided. Spontaneous abortion occurred approximately 17 days after the first dose of Moderna covid-19 vaccine. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna covid-19 vaccine is not affected by this report.


VAERS ID: 1755150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-06
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, SARS-CoV-2 test, Ultrasound foetal, Uterine contractions during pregnancy, Vaginal discharge
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scans; Result Unstructured Data: Test Result:normal; Comments: had three scans, including the 12 weeks and were all normal
CDC Split Type: GBPFIZER INC202101265181

Write-up: Miscarriage; abdominal cramps; Uterine contractions during pregnancy; Vaginal discharge/light pink discharge; This is a spontaneous report received from a contactable consumer (patient) from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109231333426060-KD3OH. Safety Report Unique Identifier GB-MHRA-ADR 25984094. A 37-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: FE1510) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Folic acid supplementation. The patient was a healthy individual. Patient has not had symptoms associated with COVID-19. This was her third low risk pregnancy. Concomitant medication included folic acid taken for vitamin supplementation. The patient experienced abdominal cramps on 10Aug2021, miscarriage on 10Aug2021 23:30, Vaginal discharge/light pink discharge on 06Aug2021, uterine contractions during pregnancy on 10Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative covid-19 test on 22Jul2021. The patient had three scans, including the 12 weeks and were all normal. The patient was hospitalized. The outcome of abdominal cramps and miscarriage was not recovered, outcome of other events was unknown. The clinical course was reported as: The patient received the first dose of vaccine on Thursday 29Jul2021 (14 weeks pregnant). The patient did not have any side effects but on Friday 06Aug2021 (8 days after the vaccination) she started to experience light pink discharge. On Tuesday 10Aug2021, she started to have abdominal cramps and then contractions and miscarriage at 11:30 pm. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101275587 baby


VAERS ID: 1807179 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-08-06
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Ultrasound uterus, Uterine spasm, 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: METOPROLOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ultrasound of the uterus; Result Unstructured Data: Test Result:saw a beating heart; Test Name: Ultrasound of the uterus; Result Unstructured Data: Test Result:heart stopped beating
CDC Split Type: NLPFIZER INC202101339703

Write-up: vaccine exposure during pregnancy week: 5; Miscarriage at 10.5 weeks; uterine cramps during periods; daily bleeding; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00693941. A 37-year-old pregnant female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Jun2021 (Batch/Lot Number: FC5089) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. On 06Aug2021, the patient experienced miscarriage at 10.5 weeks, uterine cramps during periods, daily bleeding and vaccine exposure during pregnancy week: 5. The mother was 10 Weeks pregnant at the onset of the event. The first Covid vaccination took place at a pregnancy duration of about 5 weeks. The miscarriage occurred at a pregnancy duration of about 10.5 weeks. Since the miscarriage, the patient suffers from vaginal bleeding and uterine cramps. The pregnancy resulted in spontaneous abortion. It was further reported that on 25 June she had a positive pregnancy test and on 16 July she saw a beating heart on the ultrasound, but on 06 August the heart stopped beating and the miscarriage was initiated with the help of medication. Miscarriage was treated, initiated with medication and vaginal bleeding was treated with medication to promote ovulation and hopefully get a good menstrual period. Since then (until today) Patient have been bleeding daily and have uterine cramps at times, which means no normal miscarriage and no normal menstruation either. The outcome of the events uterine cramps during periods and daily bleeding was not reported, and unknown outcome for the other events. No follow-up attempts are possible; Information about batch number already obtained.; Reporter''s Comments: Since the nature of the reported reaction does imply seriousness according to one of the agency critera, the reaction (Miscarriage) was considered as serious by the Centre.


VAERS ID: 1632591 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-13
Onset:2021-08-07
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006M20A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001B21A / 2 LA / SYR

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

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

Write-up: miscarriage - 6 weeks


VAERS ID: 1651401 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-06
Onset:2021-08-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain lower, Abortion spontaneous, Back pain, Dizziness, Exposure during pregnancy, Fallopian tube operation, Haematosalpinx, Migraine, Ovarian operation, Ovarian rupture, Surgery, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zyrtec, Flonase, Prenatal Vitamin, Prozac, Metoprolol ER Succinate 25mg
Current Illness: N/A
Preexisting Conditions: High blood pressure
Allergies: No known allergies
Diagnostic Lab Data: Please refer to the information above in item 18.
CDC Split Type:

Write-up: I was having migraine?s the day after the injection (8/7) along with lightheadedness and dizziness for the next several weeks. I was pregnant during the first dose of the injection but didn?t know until a week later after the injection. I went to the emergency room on 8/24/2021 for bleeding, right side abdomen cramps and low back pain. I ended up having emergency surgery that afternoon for a ruptured fallopian tube and ovary on my right side which resulted in a miscarriage at 5 and a half weeks pregnant. This was my second pregnancy as I had a healthy and normal first pregnancy with no issues.


VAERS ID: 1669307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-07
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy (type I)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101055152

Write-up: Bleeding; Miscarriage in week 16 of pregnancy; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is SE-MPA-2021-071253. A 42-year-old pregnant female patient received BNT162B2 (COMIRNATY; solution for injection), via an unspecified route of administration on 14Jul2021 (lot number: FE6208) as dose 1, single for COVID-19 immunization. Medical history included ongoing penicillin allergy type I from 2013. The patient''s concomitant medications were not reported. On 14Jul2021, patient received the first dose of BNT162B2 in week 13 of pregnancy. On 07Aug2021, the suffered a miscarriage in week 16 of pregnancy. The patient sought acute medical attention on 08Aug2021 and was admitted due to bleeding. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1671668 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Miscarriage; maternal exposure during pregnancy; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25856335) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. the patient seven weeks pregnant and the baby was shown to have stopped growing at 7 weeks and miscarried at 11 weeks. On 26-Aug-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was seven weeks pregnant and the baby was shown to have stopped growing at 7 weeks and I miscarried at 11 weeks. "2 scans, one at facility, one private " Company Comment This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded; Sender''s Comments: This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded


VAERS ID: 1755415 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-08-07
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion missed, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Pregnancy
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMOTRIGINE; LURASIDONE HYDROCHLORIDE
Current Illness: Bipolar disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Abortion missed; Inappropriate schedule of product administration; Maternal exposure during pregnancy; Pregnancy; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP097349) on 22-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This case, initially reported to the Regulatory Authority by a pharmacist, was received via the Regulatory Authority (Ref, v21128359). The patient had received lamotrigine tablet 100 mg, lurasidone hydrochloride tablet 20 mg, and keisi-ka-ryukotuboreito for bipolar disorder. On 29-Jun-2021, the patient had the last menstrual period. On 12-Jul-2021, the patient received the 1st dose of the vaccine. On 29-Jul-2021, the patient tested positive by a home pregnancy test. On 07-Aug-2021, pregnancy was confirmed at the reporting hospital. On 21-Aug-2021, Crown-rump length (CRL) 3.7? and fetal heart beat (FHB) +. On 27-Aug-2021, the patient received the 2nd dose of the vaccine. On 04-Sep-2021, a diagnosis of abortion missed was made. On 11-Sep-2021, the patient underwent an abortion procedure. The outcome of pregnancy and abortion missed was resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 37-year-old female patient with medical history of bipolar disease, who experienced the unexpected, serious event of abortion missed. Maternal exposure during pregnancy and inappropriate schedule of product administration are also reported. The event abortion missed occurred 8 days after second dose of Spikevax. The rechallenge was not applicable. Use of concomitant lamotrigine and lurasidone hydrochloride remains as confounders. The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document.; Sender''s Comments: This case concerns a 37-year-old female patient with medical history of bipolar disease, who experienced the unexpected, serious event of abortion missed. Maternal exposure during pregnancy and inappropriate schedule of product administration are also reported. The event abortion missed occurred 8 days after second dose of Spikevax. The rechallenge was not applicable. Use of concomitant lamotrigine and lurasidone hydrochloride remains as confounders. The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document.


VAERS ID: 1796042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-07
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no other reported health issues.
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result: No results reported; Test Date: 20210830; Test Name: Ultrasound uterus; Result Unstructured Data: Test Result: Fetal tissue not visible; Test Date: 20210830; Test Name: Ultrasound uterus; Result Unstructured Data: Test Result: Confirmation of missed abortion.
CDC Split Type: DKPFIZER INC202101314280

Write-up: Missed abortion (Abnormal cell division in early stage of pregnancy); This is a spontaneous report from a contactable consumer or other non HCP (patient) and a physician downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0088833. This consumer or other non HCP reported information for both mother and fetus/baby. This is a maternal report. A 39-year-old female patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FD0932; Expiration Date: 30Sep2021), via an unspecified route of administration on 28Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had no other reported health issues. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FE2083; Expiration Date: 31Oct2021), via an unspecified route of administration on 30Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced missed abortion (abnormal cell division in early stage of pregnancy) on 07Aug2021. Missed abortion was by the Regulatory Medicines Agency assessed medically significant due to Abortion missed being on the RA list. Patient''s clinical course was as follows: The mother reported she became pregnant while taking bnt162b2. The patient was treated with a medically induced abortion. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included blood test with result of ''no result reported'' on Aug2021; ultrasound uterus with results of ''Fetal tissue not visible'' and ''Confirmation of missed abortion'' on 30Aug2021. Outcome of the event was not recovered. Sender Comment: REGULATORY AUTHORITY COMMENT: Version 002: Created because the second reporter, the physician, mistakely was placed under other contacts in version 001. No follow up attempts possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101358184 baby case


VAERS ID: 1553818 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-08-08
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Full blood count, Premature baby, Premature delivery, Pyrexia, Ultrasound scan normal, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: prenatal vitamin
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: penicillin
Diagnostic Lab Data: 8/9/21 CBC WBC 19, unremarkable sonogram
CDC Split Type:

Write-up: Uncomplicated first pregnancy, due Oct 12, 2021. Second Pfizer vaccine 7/30/21, began contracting on 8/8/21, admitted to hospital 8/9/21, and delivered 31wk viable infant on 8/10/21. Pt states had high fever after second vaccine.


VAERS ID: 1675140 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-07-26
Onset:2021-08-08
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Autoimmune disorder, Condition aggravated, Delivery, Exposure during pregnancy, Foetal heart rate abnormal, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (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), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vyvanse; Lamictal; Adderall; AMBIEN; Propranolol; Prenatal vitamin; Vitamin D
Current Illness: Pregnancy was perfect
Preexisting Conditions: Anxiety, adhd & migraines, infertility
Allergies:
Diagnostic Lab Data: underway
CDC Split Type:

Write-up: Due date: 10/7/2020; Second Pfizer dose on July 26th; Aug 5: prenatal check up. Good heartbeat, active. Doc said feet swelling was normal; Aug 8: began experiencing severe foot and joint pain similar to pain experienced during autoimmune flair back in 2015. Planned to discuss at next appt. Aug 26th: prenatal appt; no heartbeat, estimated baby had been dead for some time. Aug 27: delivered baby, skin was peeling?which happens when baby dies days ago. It takes 2 weeks for second dose to fully kick in- which would be Aug 9th?around the time my symptoms appeared. 2.5 weeks before I learned my baby boy was dead. Stillborn baby boy dead within 2.5 weeks of second Pfizer vaccination. Autopsy results still not back but current results show nothing. The only thing was the vaccine. Birth weight 4lb 15oz 17.5 inches.


VAERS ID: 1638361 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Haemorrhage, Hypoaesthesia, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Pregnancy, Scan
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (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), Medication errors (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:5.5 weeks progressed; Comments: 10 week scan revealed pregnancy was only 5.5 weeks progressed
CDC Split Type: GBPFIZER INC202101069218

Write-up: pregnant; abdominal pain; bleeding; Maternal exposure during pregnancy; Miscarriage; vaccine is administered outside of the range 19 - 42 days after the first dose; Numbness of upper arm; This is a spontaneous report from a contactable consumer (Patient) received from a regulatory authority. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 08Aug2021 (at the age of 38-Year-old) as dose 2, single for Covid-19 immunization. Medical history included pregnancy, Patient no longer pregnant at the time of reporting, vitamin supplementation from an unknown date and unknown if ongoing. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient has not had symptoms associated with COVID-19. Not had a Covid-19 test. Patient was not currently breastfeeding. The patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW3143) via an unspecified route of administration on 15May2021 as a dose 1, single for COVID-19 immunization. Concomitant medications included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. On an unspecified date the patient experienced pregnant, abdominal pain, bleeding, maternal exposure during pregnancy, numbness of upper arm on 08Aug2021, miscarriage on 12Aug2021, vaccine is administered outside of the range 19 - 42 days after the first dose on 08Aug2021. The events were assessed as hospitalization, medically significant, congenital anomaly. The patient underwent lab tests and procedures which included scan: 5.5 weeks progressed on 10 week scan revealed pregnancy was only 5.5 weeks progressed. The patient had her first dose before she knew she was pregnant. She postponed second dose when she found out. On reading that it was strongly advised to get vaccinated she had my second dose on 8th August. She thought she was 10 weeks pregnant (since first day of last period). Four days later she started getting abdominal pain and bleeding so was taken for a scan. The scan showed a 5.5 week pregnancy not a 10 week pregnancy but couldn''t confirm whether it was alive or a missed miscarriage. She then had more severe pains/bleeding and miscarried over the weekend 13-15 Aug. The possibilities were that she was 10 weeks pregnant but that it stopped developing after 5.5 weeks (missed misscarriage). In which case it was likely nothing to do with the vaccine. Or she was in fact only 5.5 weeks pregnant, which was possible according to dates. In which case she miscarried very soon after having the vaccine and it could have been associated. Patient has not tested positive for Covid-19 since having the vaccine. Patient is not enrolled in clinical trial. The clinical outcome of the events pregnant, abdominal pain, bleeding was resolved, numbness of upper arm was resolved on 09Aug2021, miscarriage was resolved with sequelae, maternal exposure during pregnancy and vaccine is administered outside of the range 19 - 42 days after the first dose was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101077606 Same patient and Inappropriate schedule of vaccine administered.


VAERS ID: 1657263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Investigation, Maternal exposure during pregnancy, Pregnancy, SARS-CoV-2 test, Scan
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), 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: Specular Exam, Internal Exam.; Result Unstructured Data: Test Result:Results: Unknown; Comments: Unknown; Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210812; Test Name: Scan and investigation; Result Unstructured Data: Test Result:miscarriage; Comments: suffered the miscarriage at 7am.
CDC Split Type: GBPFIZER INC202101064546

Write-up: Miscarriage; bleeding; Maternal exposure during pregnancy; pregnancy; This is a spontaneous report from a contactable consumer (patient), received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108162111525600-L9YW2.[Safety Report Unique Identifier: GB-MHRA-ADR 25806556]. A 24-years-old female pregnant patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot number: FD8813), via an unspecified route of administration on 08Aug2021 as dose 2, single for COVID-19 immunization. Medical history included pregnancy (Patient no longer pregnant at the time of reporting), lactation decreased and folic acid supplementation. Concomitant medications included folic acid (FOLIC ACID) as folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since had the vaccine. She was previously received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection; Batch/Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and no reaction reported for dose 1. It was reported patient was 11 weeks pregnant, she had zero problems with the pregnancy prior to the second vaccine, she even had an 8 week scan in which they showed me the baby was healthy and had a regular heartbeat. On an unspecified date in 2021, the patient had pregnancy, maternal exposure during pregnancy and on 09Aug2021, day after vaccination, patient experienced slight bleeding, and had a miscarriage. It was reported light bleeding leading up to the 12Aug2021, it got heavier, she had been offered a scan on the 12Aug2021 at 18:00 due to this bleeding but unfortunately suffered the miscarriage at 07:00. Did the medicine had an adverse effect on any aspect of the pregnancy was unsure; Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: She had a scan booked in on the 12th which was my dating scan. The patient''s hospitalization was prolonged as a result of adverse events. The patient underwent lab tests and procedures which included on 03Aug2021, sars-cov-2 test (COVID-19 test) resulted negative (No-Negative COVID-19 test), on 12Aug2021, scan and investigation resulted miscarriage (suffered the miscarriage at 07:00) and on an unspecified date, investigation (relevant investigations or tests conducted was specular exam and internal exam) results were unknown. The outcome of the event maternal exposure during pregnancy was unknown, event pregnancy, bleeding was recovering and event miscarriage was resolved on 10Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1668066 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-08
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101068890

Write-up: vaccine exposure during pregnancy; early miscarriage; This is a spontaneous report from a contactable pharmacist. This pharmacist reported information for both mother and fetus/baby. This is a maternal report. A 36-year-old pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration at arm left on 01Jun2021 as a single dose 1, for COVID-19 immunization. And second dose of bnt162b2 (COMIRNATY, solution for injection, lot Number: J07BX03 expiry date was unknown) via an unspecified route of administration dose 2 via an unspecified route of administration at arm on right on 10Jul2021 as a single dose 2, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other medications the patient received within 2 weeks of vaccination. On 08Aug2021 the patient experienced early miscarriage (abortion spontaneous), on an unspecified date vaccine exposure during pregnancy. The mother reported she became pregnant while taking bnt162b2. Last menstrual period date was reported on 21Jun2021. The mother was 7 Weeks pregnant at the onset of the event. The mother was due to deliver on 28Mar2022. Outcome of the event early miscarriage was not recovered, exposure during pregnancy was unknown. Follow up attempts are completed. No further information is expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be 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: 1676489 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-08
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Intrauterine device removal; Miscarriage (miscarriage at 10 weeks pregnant in 2009 between my 2 other pregnancies); Pregnancy (miscarriage at 10 weeks pregnant in 2009 between my 2 other pregnancies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101088640

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number is FR-AFSSAPS-BX20217537. A 42-year-old pregnant female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left arm on 29Jul2021 (Batch/Lot Number: FF4213) as dose 1, single for COVID-19 immunisation. Medical history included miscarriage at 10 weeks pregnant in 2009 between 2 other pregnancies and IUD discontinuation in Mar2021. The patient''s concomitant medications were not reported. On 08Aug2021, the patient experienced miscarriage at 5 gestation weeks. This mother reported her last menstrual period was on 08Jul2021. The mother reported she became pregnant while taking BNT162B2. The mother was due to deliver on 14Apr2022. The pregnancy resulted in spontaneous abortion on 08Aug2021. The fetal outcome is intrauterine death. Outcome of event was not recovered. The reporter assessed the events as serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1698318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
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; Latex allergy; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: ECHO; Result Unstructured Data: Test Result:non-progressive intrauterine pregnancy; Comments: non-progressive intrauterine pregnancy, measurements correspond to a term of 8 WA (based on the HA (1700 and gestational sac (33 mm) instead of expected 11 WA, average examination conditions.
CDC Split Type: FRPFIZER INC202101131384

Write-up: Miscarriage; blood loss; mild abdominal pain; Estimated date of conception 16Jun2021/received first dose on on 08Aug2021; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20215909. A 29-years-old female patient (pregnant, last period was 02Jun2021) received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 08Aug2021 (Batch/Lot Number: FE8244), as single dose, for covid-19 immunisation. Medical history included hypersensitivity, rubber sensitivity, pregnancy estimated on 16Jun2021. Patient did not have history of COVID. Patient had not been tested. The patient''s concomitant medications were not reported. The patient previously took josamycin (JOSACINE) and clarithromycin (ZECLAR) both had allergy. On 18Aug2021, the patient experienced miscarriage (hospitalization, medically significant), blood loss (non-serious), and mild abdominal pain (non-serious). It was reported on 18Aug2021 onset of miscarriage with slight blood loss following the week of the vaccine then profuse blood loss on 18Aug2021 and mild abdominal pain. Required a visit to the Emergency Room. Additional information obtained by the regulatory authority: Date of last period 02Jun2021. Estimated date of conception 16Jun2021. Echo on 18Aug2021: non-progressive intrauterine pregnancy, measurements correspond to a term of 8 week of amenorrhea (WA) (based on the LCC (1700 and gestational sac (33 mm) instead of expected 11 WA, average examination conditions. The outcome of events was recovering. Reporter comment: Sender comment: Case Summary: COVID vaccine portal reporting number 20210820114051499. Person considered at risk included Person having had COVID was No. Person having been tested was No. No follow-up attempts possible. No further information expected.


VAERS ID: 1541906 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-05-09
Onset:2021-08-09
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Gynaecological examination abnormal, 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), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Viactove calcium chews, prenatal vitamins, vitamin d3 chews and fortify probiotic
Current Illness: None
Preexisting Conditions: Ibs
Allergies: Food allergy mushrooms, penicillin allergy
Diagnostic Lab Data: August 10 A exam on cervix was done by midwife and ultrasound confirming miscarriage had taken place.
CDC Split Type:

Write-up: I received my second Covid vaccine on May 9, had a period starting on May 22 it resulted in pregnancy, miscarried pregnancy. No known documentation for pregnancy except for miscarriage there?s no pregnancy symptoms arose so I test was never taken. Not sure if these are related but wanted to report just in case. This would be my fourth pregnancy and first miscarriage, my other three pregnancies resulted in live births.


VAERS ID: 1722796 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-09
Onset:2021-08-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 062E21A / 2 - / IM

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

Life Threatening? No
Birth Defect? 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: One a day prenatal pills
Current Illness: Na
Preexisting Conditions: Na
Allergies: Na
Diagnostic Lab Data: August 30, 2021 - ultrasound
CDC Split Type:

Write-up: I was pregnant, due date was March 31,2022. I got the vaccine on August 9, 2021 when I was almost 7 weeks pregnant. I felt no symptoms, just tired. Then a few days later I no longer felt pregnant. I had lost all of my pervious pregnancy symptoms. My first prenatal appointment was August 30, 2021. The midwife performed an ultrasound to determine approximately how far along I was and discovered that the sack was empty. It appeared that based on the size of the sack the baby stopped growing at approximately 7 weeks. I had had a silent miscarriage.


VAERS ID: 1654740 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-08-09
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101056720

Write-up: Miscarriage 6 weeks after jab; This is a spontaneous report from a contactable consumer (patient). A 30-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 10Jun2021 15:00 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient had no medical history. The patient''s concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 09Aug2021 the patient experienced miscarriage 6 weeks after jab. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of event was recovered with sequelae on an unspecified date in Aug2021.


VAERS ID: 1663674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Abortion spontaneous, Headache
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness:
Preexisting Conditions: Comments: Aucun
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101072999

Write-up: Miscarriage; Headache; Pain in the lower abdomen; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. This is a report received from AFSSAPS Regulatory authority report number FR-AFSSAPS-CN20212671. A 27-year-old pregnant female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 06Aug2021 (Batch/Lot Number: FF0688) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 09Aug2021 patient experienced miscarriage, headache, pain in the lower abdomen. Onset of a miscarriage at 1 month of pregnancy with headache and pain in the lower abdomen at Day 4 after vaccination. Went to Emergency Room, not hospitalized. The outcome of event was recovered. Case was reported as serious due to other medically important condition.


VAERS ID: 1668374 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-09
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting but was pregnant when vaccinated)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111679

Write-up: miscarriage/Early miscarriage; This is a spontaneous report from a contactable consumer. This is the first of 2 reports, for the second dose. The first report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108251608055360-GGIM4, Safety Report Unique Identifier GB-MHRA-ADR 25848396. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 (Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included previous miscarriage and pregnancy (Patient no longer pregnant at the time of reporting but was pregnant when vaccinated). Patient had not had symptoms associated with COVID-19. Concomitant medication included folic acid taken for folic acid supplementation. Historical Vaccine included the first dose of BNT162B2 on an unknown date as single dose for COVID-19 immunisation and caused shift to mensural cycle by about 3 days. The patient experienced miscarriage/early miscarriage (medically significant) on 09Aug2021. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. Unknown if this was an effect from the vaccine but data can only help. Early miscarriage post second vaccine. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test on an unspecified date: No - Negative COVID-19 test. The event outcome was recovered on 15Aug2021 No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101116009 Same patient/reporter/drug, different dose number and event.


VAERS ID: 1754989 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ectopic pregnancy, Haemorrhage, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Hyperthyroidism; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result:ectopic pregnancy
CDC Split Type: GBPFIZER INC202101226964

Write-up: ectopic pregnancy; missed miscarriage; Bleeding; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer. This report was received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-202109171006007140-BTZDB. Safety Report Unique Identifier GB-MHRA-ADR 25957879. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Aug2021 (Lot Number: FE3380) as DOSE 2, SINGLE (at the age of 38 years old) for COVID-19 immunisation. Medical history included hyperthyroidism from an unknown date, endometriosis from an unknown date, pregnancy from an unknown date (Patient no longer pregnant at the time of reporting). Concomitant medication included folic acid taken for folic acid supplementation at 400ug, start and stop date were not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID 19 immunization. The patient experienced ectopic pregnancy on an unspecified date with outcome of recovering, missed miscarriage on an unspecified date with outcome of recovering, maternal exposure during pregnancy on 09Aug2021 with outcome of unknown, and bleeding on 10Aug2021 with outcome of recovering. The mother reported she became pregnant while taking BNT162B2. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Apr2021 and Scan: ectopic pregnancy on an unspecified date. Details we reported as follows: Was a few weeks pregnant and started to bleed one day after having my second vaccine. Resulting in ectopic pregnancy. Patient is not enrolled in clinical trial. Details of previous pregnancies: Missed miscarriage in March. Patient was exposed to the medicine Before pregnancy. No follow-up attempts are needed; No further information is expected.


VAERS ID: 1764159 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-09
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004218 / UNK - / OT

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

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

Write-up: Maternal exposure during pregnancy; This case was received via Regulatory Authority (Reference number: SE-MPA-2021-083809) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004218) for COVID-19 vaccination. The patient''s past medical history included Missed abortion in February 2021. On 24-Jul-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 09-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Missfall) (seriousness criterion medically significant). The delivery occurred on 09-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. ? No treatment information was provided. This case concerns a 35-year-old, pregnant female with a history of missed abortion, who experienced the unexpected serious events of maternal exposure during pregnancy and abortion spontaneous. The events occurred approximately 17 days after one dose of mRNA-1273 Moderna vaccine (Spikevax) (unknown number). The rechallenge was not applicable. The medical history of previous missed abortion could be a potentially confounder. Seriousness of the event maternal exposure during pregnancy was adjudicated by RA. The Benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation document received on 30-Sep-2021 contains no new information; Sender''s Comments: This case concerns a 35-year-old, pregnant female with a history of missed abortion, who experienced the unexpected serious events of maternal exposure during pregnancy and abortion spontaneous. The events occurred approximately 17 days after one dose of mRNA-1273 Moderna vaccine (Spikevax) (unknown number). The rechallenge was not applicable. The medical history of previous missed abortion could be a potentially confounder. Seriousness of the event maternal exposure during pregnancy was adjudicated by RA. The Benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report


VAERS ID: 1583357 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-27
Onset:2021-08-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PA7485 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PC3182 / 2 LA / SYR

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

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

Write-up: I was 10 weeks and 3 days pregnant. Estimated due date was 3/6/22. I had a miscarriage with no history of miscarriages.


VAERS ID: 1651444 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-02
Onset:2021-08-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: I found out I was pregnant late July. This was my third pregnancy, I had never miscarried before. Relieved the vaccine 8/2. I started bleeding heavily 8/9 and continued thru 8/17. Test confirmed pregnancy was lost.


VAERS ID: 1665687 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-07
Onset:2021-08-10
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E40584 / 1 LA / -

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

Life Threatening? No
Birth Defect? 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative
CDC Split Type: USPFIZER INC202101068376

Write-up: Missed Miscarriage at 8 weeks; This is a spontaneous report from a non-contactable consumer or other non HCP (Patient reported for self). A 36-years-old (pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: E40584), via an unspecified route of administration, administered in Arm Left on 07Jul2021 14:00 (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. Patient did not receive other medications in two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 10Aug2021 17:00, the patient experienced missed miscarriage (also reported as ?gestational period: 1''). The mother reported she became pregnant while taking bnt162b2. The mother was pregnant at the onset of the event. Last menstrual date was 20May2021. The mother was due to deliver soon after. The pregnancy resulted in spontaneous abortion. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. COVID tested post vaccination, the patient underwent lab tests and procedures which included sars-cov-2 test (covid test type post vaccination=Nasal swab): Negative on 13Aug2021. Patient was received treatment for event. Adverse event was treated with D and C. The event was serious (Congenital anomaly or birth defect). The outcome of the event was reported as recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1732587 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-01-10
Onset:2021-08-10
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Culture tissue specimen, Delivery, Exposure during pregnancy, Foetal death, Laboratory test, Single umbilical artery, Ultrasound antenatal screen abnormal
SMQs:, Congenital, familial and genetic disorders (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pre-natal vitamin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: 8/10/21- US showing demise, fetal demise lab panel. 8/11/21- fetal chromosomes, placental cultures
CDC Split Type:

Write-up: Pregnancy related outcome. EDD 9/12/21. Single umbilical artery found at 20 week US. IUFD at 35w 2d on 8/10/21. Delivered 8/11/21. weight 5 lbs 6.7 oz.


VAERS ID: 1657387 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-10
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101069810

Write-up: miscarriage; This is a spontaneous report from a contactable consumer or other non hcp. This is second report of two reports. The first report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108152044031750-DNMG4. Safety Report Unique Identifier GB-MHRA-ADR 25802057. A female patient of an unspecified age received the second dose of BNT162B2 via an unspecified route of administration in Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Historical Vaccine included first does of BNT162B2 on an unspecified date for covid-19 immunization and the patient experienced Stress, Menstrual cycle abnormal and Heavy periods. The patient''s concomitant medications were not reported. The patient experienced miscarriage on 10Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. The outcome of event was not recovered. The clinical course was reported as follows: 3 weeks after the second vaccine miscarriage on an 8 week pregnancy. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Additional information: No other treatment. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1667599 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-08-10
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D015A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnant
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101079366

Write-up: unborn child (11+4 pregnancy week) was diagnosed with trisomy 18; This is as spontaneous report received from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021162112 with Safety report unique identifier DE-PEI-202100167154. This consumer reported information for both mother and fetus. This is the maternal report. A 34-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Jul2021 (also reported as 02Jun2021, pending clarification) (Batch/Lot Number: 1D015A) as a single dose (dose number unknown) for COVID-19 immunization. Medical history included pregnancy. The patient''s concomitant medications were not reported. On 10Aug2021, the patient had an abortion, her unborn child (11+4 pregnancy week, pending clarificaton) was diagnosed with trisomy 18. She has previously given birth to 4 healthy children, never from complications or genetic defects. The mother reported she became pregnant while taking bnt162b2. The mother was 1 month pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome is congenital anomaly. This report is serious - other. Outcome of the event was unknown. Sender Comment: Information on risk factors or previous illnesses: None known Relatedness Assessment: Abortion: D. Unclassifiable. Source of assessment: HA; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101126767 fetus case


VAERS ID: 1702577 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal exposure during pregnancy, first trimester
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101125594

Write-up: Miscarriage; Headache; Not feeling well; Nausea; maternal exposure during pregnancy; This is as spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00672883. The same reporting consumer reported events after both vaccine doses for the mother and the fetus. This is the first report for the second dose, for the mother report. A 24-year-old female pregnant patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Aug2021 (at the age of 24-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included maternal vaccine exposure (first vaccination took place at a pregnancy duration of about 1 week). No Previous COVID-19 infection. Concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (COMIRNATY), on 06Jul2021 as single dose for COVID-19 immunisation and patient experienced abdominal pain, diarrhea, back pain, maternal exposure during pregnancy. The patient experienced miscarriage (other medically important condition) on 13Aug2021, headache on 11Aug2021, nausea on 10Aug2021, malaise/not feeling well on 11Aug2021, maternal exposure during pregnancy following administration of covid-19 vaccine Pfizer injection solution. Headache was treated with Paracetemol. The miscarriage occurred at a pregnancy duration of about 6 weeks. This was after the second Covid vaccination. The first vaccination took place at a pregnancy duration of about 1 week. 2 days after the second vaccination there was a heart beat visible at the ultrasound. The day after the ultrasound the patient started bleeding, which was still present at the moment of the report. The heart of the embryo stopped beating and a miscarriage had occurred. The clinical course was reported as follows: On Friday, 13Aug2021, patient started losing blood after seeing a heartbeat on 12Aug2021. So far blood loss. On the 10Aug2021, patient had 2nd vaccination and now two weeks later unfortunately the baby had no heartbeat and patient ended up having a miscarriage. Confounding factors with COVID-19 vaccine exposure during pregnancy week was 1 week. The outcome of headache was recovered on 13Aug2021, outcome of malaise was recovered on 12Aug2021, outcome of nausea was recovered on 11Aug2021, while of the other events was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction was considered as serious by the regulatory authority. Seriousness of miscarriage was changed from Congenital Anomaly / Birth Defect to "other medically important condition". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101182998 Fetal case


VAERS ID: 1717593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-08-10
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       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? 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: 20210810; Test Name: Ultrasound; Result Unstructured Data: Test Result:miscarriage
CDC Split Type: NLPFIZER INC202101155425

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00675463. A 28-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: Unknown and expiration date was not reported), via an unspecified route of administration on 06Jul2021 at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no past drug history and had no previous COVID-19 infection. It was reported that patient had miscarriage and was seen in echo on 10Aug2021 and was induced with medication. It occurred at a pregnancy duration of about 8.5 weeks. It was estimated that the pregnancy stopped developing at around the time of the first Covid vaccination, which occurred at a pregnancy duration of about 3.5 weeks. The reaction was considered as serious by health authority. The outcome of the event was recovered on 11Aug2021. Sender comment: Since the nature of the reported reaction does imply seriousness according to one of the RA critera, the reaction was considered as serious by the regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101206294 Duplicate case


VAERS ID: 1723664 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F036A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion early, Inappropriate schedule of product administration
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101167048

Write-up: Abortion early; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable physician, downloaded from the Regulatory Agency (RA)-WEB, Regulatory authority number DE-PEI-202100182760. A 26-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Aug2021 (Batch/Lot Number: 1F036A) as dose 2, 0.3 ml single (at the age of 26-years-old) for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Jun2021 (Batch/Lot Number: unknown) as dose 1, 0.3 ml single (at the age of 25-years-old) for Covid-19 immunisation. The patient experienced abortion early on 19Aug2021. The mother reported she became pregnant while taking bnt162b2. The event outcome was unknown. Source of assessment was reported as Agency and the Result of Assessment was reported as D. Unclassifiable. This report is non-serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1750663 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4509 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101228593

Write-up: Miscarriage; Patient was 7 weeks pregnant; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FI-FIMEA-20214749. A 32-year-old pregnant female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 10Aug2021 (Batch/Lot Number: FG4509) (at the age of 32 years old) dose number was unknown, single for Covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient''s last menstruation was on 21Jun2021. The patient was 7 weeks pregnant when she received the vaccine on 10Aug2021. In Sep2021, the patient experienced miscarriage corresponding to H 6 + 2. The mother was supposed to be due to deliver on 28Mar2022. However, the pregnancy resulted in spontaneous abortion. According to the reporter, the menstrual history was inaccurate, but if they count according to menstrual period, it was possible that the miscarriage occurred a few days before the vaccination (as reported), however, it was impossible to say in retrospect. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1778107 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-08-10
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Benign hydatidiform mole, Blood test, Malaise, Menstruation irregular, SARS-CoV-2 test, Scan
SMQs:, Reproductive premalignant disorders (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), 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: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation;
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown Results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210810; Test Name: Scan; Result Unstructured Data: Test Result:having a molar pregnancy
CDC Split Type: GBPFIZER INC202101294539

Write-up: Molar pregnancy; caused my period to come early; feeling very unwell; miscarriage; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109291411408070-SA2SH, Safety Report Unique Identifier GB-MHRA-ADR 26009387. This consumer or other non hcp reported information for both mother and fetus/baby. This is a maternal report. Only this case is serious. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Jun2021 at the age of 29 years old as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy and vitamin supplementation from an unknown date. Patient had two previous, healthy, full term babies. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. The patient experienced miscarriage on an unspecified date in 2021 and molar pregnancy on 10Aug2021. The events were reported as serious (medically significant). Clinical course was reported as follows: I am a healthy 29-year-old. Who has had two healthy, full term babies - now aged 9 and 12. I had my first dose of the vaccine on the 30Jun2021. The vaccine caused my period to come early - i then conceived my third child on the 17Jul2021. After feeling very unwell for the first few weeks of the ''pregnancy'' i then began to bleed at 7 weeks - under the impression that i was having a miscarriage. At an emergency scan, they advised me that i was in fact having a molar pregnancy and i would have to have an operation to remove the pregnancy immediately. As a result of this i am now having blood tests on a two weekly basis. I strongly believe that the vaccination i had is linked to this result of a molar pregnancy. Patient is not enrolled in clinical trial. Details of previous pregnancies: I have had two previous, healthy, full term babies. I had my first vaccine on the 30Jun, and conceived my third baby on the 17Jul. On the 27Aug after assuming i was having a miscarriage, i was told i was having a molar pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included sars-cov-2 test with No - Negative COVID-19 test result on an unspecified date. The patient recovered from miscarriage on an unspecified date while outcome for molar pregnancy recovered with sequelae on 10Sep2021. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1828147 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Chest pain, Dyspnoea, Fatigue, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Menstruation irregular, Pyrexia, SARS-CoV-2 test, Thrombosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness: Allergy; Polycystic ovarian syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Stomach ulcer; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Chest pain; Inappropriate schedule of vaccine administered; Clot blood; Irregular periods; Early miscarriage; maternal exposure during pregnancy; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26099354) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot blood), ABORTION SPONTANEOUS (Early miscarriage), MENSTRUATION IRREGULAR (Irregular periods), FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath) and the first episode of CHEST PAIN (Chest pain) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3004668) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped) and Stomach ulcer. Previously administered products included for Stomach ulcer: LANSOPRAZOLE; for Allergy: FEXOFENADINE. Concurrent medical conditions included Polycystic ovarian syndrome and Allergy. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-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 10-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 27-Aug-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criterion medically significant). On 10-Sep-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular periods) (seriousness criterion medically significant). On 25-Sep-2021, the patient experienced THROMBOSIS (Clot blood) (seriousness criterion medically significant). On 08-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 15-Oct-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 02-Sep-2021, ABORTION SPONTANEOUS (Early miscarriage) had resolved. On 05-Oct-2021, THROMBOSIS (Clot blood) had resolved with sequelae. On 08-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, MENSTRUATION IRREGULAR (Irregular periods) had not resolved, FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), PYREXIA (Fever) and DYSPNOEA (Shortness of breath) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medication were provided Patient reported LMP was on 28-SEP-2021. Patient had significant blood loss and clotting and also has possible inflammation of the heart. COMPANY COMMENT: This case concerns a 30 year old female with relevant medical history of Polycystic ovarian syndrome , suspected Covid19, who experienced Serious, unexpected events of Abortion Spontaneous which occurred 17 days after vaccination with the 1st dose of mRNA -1273 (Moderna) . Other Serious unexpected events of Menstruation irregular occurred after 31 days after , thrombosis, 46 days after vaccination with the 1st dose. Inappropriate Schedule of product adminstration. was coded as an event non-serious, unexpected. On an unknown date after vaccination with the first dose unexpected events of fatigue, chest pain , pyrexia and dyspnea. Additional non-serious unexpected event of Maternal exposure during pregnancy was coded, however the AOG at the time of exposure during the pregnancy cannot be totally determined since the date reported for the event of Abortion Spontaneous was earlier than the date of the reported LMP hence, this needs clarification. The re-challenge for this case is not applicable. The medical condition of Polycystic Ovarian Syndrome may be considered as a confounder for this case. The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report. This case is captured as Serious : Medically Significant per RA report, and as mentioned above this case has conflicting dates of reporting for events since the Spontaneous abortion event occurred before the reported LMP of the patient.; Sender''s Comments: This case concerns a 30 year old female with relevant medical history of Polycystic ovarian syndrome , suspected Covid19, who experienced Serious, unexpected events of Abortion Spontaneous which occurred 17 days after vaccination with the 1st dose of mRNA -1273 (Moderna) . Other Serious unexpected events of Menstruation irregular occurred after 31 days after , thrombosis, 46 days after vaccination with the 1st dose. Inappropriate Schedule of product adminstration. was coded as an event non-serious, unexpected. On an unknown date after vaccination with the first dose unexpected events of fatigue, chest pain , pyrexia and dyspnea. Additional non-serious unexpected event of Maternal exposure during pregnancy was coded, however the AOG at the time of exposure during the pregnancy cannot be totally determined since the date reported for the event of Abortion Spontaneous was earlier than the date of the reported LMP hence, this needs clarification. The re-challenge for this case is not applicable. The medical condition of Polycystic Ovarian Syndrome may be considered as a confounder for this case. The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report. This case is captured as Serious : Medically Significant per RA report, and as mentioned above this case has conflicting dates of reporting for events since the Spontaneous abortion event occurred before the reported LMP of the patient.


VAERS ID: 1602591 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-06
Onset:2021-08-11
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Pharmacy       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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Sonogram performed on August 21, 2021 confirmed the fetus?s estimated gestational age and lack of heartbeat or blood flow.
CDC Split Type:

Write-up: Suffered a miscarriage at 8 weeks gestation on August 11, 2021 after receiving the Moderna COVID-19 vaccine. Miscarriage was confirmed at Hospital on August 20, 2021. I was unaware that I was pregnant when I received the vaccine.


VAERS ID: 1640737 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-04-23
Onset:2021-08-11
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, 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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: NKDA
Diagnostic Lab Data: Ultrasound
CDC Split Type:

Write-up: Patient found that she had a miscarriage/intrauterine fetal demise at estimated 9wks gestational age, diagnosed by ultrasound performed 8/11/2021.


VAERS ID: 1688374 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-11
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:unknown; Comments: done twice
CDC Split Type: NLPFIZER INC202101115172

Write-up: Miscarriage; This spontaneous report from a contactable consumer or other non-HCP reported different events for each dose of drug. This is the first of two reports. This is a spontaneous report received from the regulatory authority-WEB NL-LRB-00670221. A 28-years-old female patient received second dose of bnt162b2 (COMIRNATY, Strength: 0.3 ml, Solution for injection, Lot Number: FF2752, Expiry Date: not reported), via an unspecified route of administration on 06Aug2021 as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No previous Covid-19 infection. The patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 02Jul2021 as dose 1, single for covid-19 immunisation and had vaccine exposure during pregnancy week: 5. She had miscarriage and maternal exposure during pregnancy 5 days after administration of second dose of Covid-19 Pfizer vaccine injection. The miscarriage occurred at a pregnancy duration of about 10/11 weeks. The gestation weeks was 11 at time of report. An ultrasound was made twice. Stop date for event miscarriage: 18Aug2021. The outcome of the event was resolved. No follow-up attempts possible. No further information expected. ; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101167380 same patient, same drug, different event


VAERS ID: 1717595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-11
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / -

Administered by: Other       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Internal ultrasound; Result Unstructured Data: Test Result: unknown result
CDC Split Type: NLPFIZER INC202101155430

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00675496. A 32-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: FE4728) as dose 2, 0.3 ml single for covid-19 immunisation. The first dose was received on 24Jun2021. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage on 11Aug2021 and maternal exposure during pregnancy. The miscarriage occurred at a pregnancy duration of about 12 weeks. The first and second Covid vaccination took place at a pregnancy duration of about 5 and 10 weeks, respectively. The patient underwent lab tests and procedures which included internal ultrasound: unknown result. Outcome of the event was unknown. Patient was not previously diagnosed with covid. No follow-up attempts are possible. No further information is expected; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101206396 Same patient different dose


VAERS ID: 1786883 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (vaccine exposure during pregnancy week: 5 weeks)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101291360

Write-up: Miscarriage at 5 weeks; vaccine exposure during pregnancy week: 5 weeks; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00688787. This first of two reports, regarding the second dose. A 35-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 11Aug2021(at the age of 35 years) as single dose for COVID-19 immunization. Medical history included maternal exposure timing unspecified from an unknown date and unknown if ongoing vaccine exposure during pregnancy week: 5 weeks.The patient''s concomitant medications were not reported. Previously patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 07Jul2021 as single dose for COVID-19 immunization. on 07Jul2021 and the patient experienced headache. On 11Aug2021 the patient experienced miscarriage at 5 weeks, vaccine exposure during pregnancy week: 5 weeks. The outcome of the events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101299078 the same patient/product, a different dose


VAERS ID: 1789669 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-11
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion missed, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (vaccine exposure during pregnancy week: 0); Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority(Reference number: NL-LRB-00695111) on 11-Oct-2021 and was forwarded to Moderna on 11-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS and ABORTION MISSED ( in a 32-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Maternal vaccine exposure (vaccine exposure during pregnancy week: 0) and Suspected COVID-19 on 15-Mar-2020. Previously administered products included for an unreported indication: Moderna vaccinCOVID-19 VACCIN MODERNA INJVLST 0,5MLCOVID-19 VACCIN MODERNA INJVLST on 22-Jun-2021, Moderna vaccinCOVID-19 VACCIN MODERNA INJVLST 0 and5MLCOVID-19 VACCIN MODERNA INJVLST on 22-Jun-2021. Past adverse reactions to the above products included Fatigue with Moderna vaccinCOVID-19 VACCIN MODERNA INJVLST 0 and5MLCOVID-19 VACCIN MODERNA INJVLST; and Headache with Moderna vaccinCOVID-19 VACCIN MODERNA INJVLST 0 and5MLCOVID-19 VACCIN MODERNA INJVLST. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). On 28-Sep-2021, the patient experienced ABORTION MISSED (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE TIMING UNSPECIFIED. At the time of the report, ABORTION SPONTANEOUS and MATERNAL EXPOSURE TIMING UNSPECIFIED outcome was unknown. No concomitant medication was given. No treatment medication was given. This case concerns a 32 year old presumably pregnant female, LMP, EDC and weeks gestation unknown, with a history of suspected COVID-19 five months earlier who experienced the serious, unlisted events of Abortion spontaneous and Abortion missed and non-serious event of Maternal exposure timing unspecified 2 weeks after presumably the first dose of Spikevax. Re-challenge is unknown a no information about a second dose is reported. The history of COVID-19 remains a confounder as it may have enhanced the reaction to the vaccine. Benefit -risk relationship of Spikevax is not affected by this report. The events of Abortion spontaneous and Abortion missed cannot co-exist as it is one or the other and the source document does not distinguish. Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Significant follow up appended On 11-Oct-2021: Translation received date 13-OCT-2021 for initial On 11-Oct-2021: Translation received date 13-OCT-2021 for Follow Up; Reporter''s Comments: Seriousness of miscarriage was changed from "death" to "other medically important condition".; Sender''s Comments: This case concerns a 32 year old presumably pregnant female, LMP, EDC and weeks gestation unknown, with a history of suspected COVID-19 five months earlier who experienced the serious, unlisted events of Abortion spontaneous and Abortion missed and non-serious event of Maternal exposure timing unspecified 2 weeks after presumably the first dose of Spikevax. Re-challenge is unknown a no information about a second dose is reported. The history of COVID-19 remains a confounder as it may have enhanced the reaction to the vaccine. Benefit -risk relationship of Spikevax is not affected by this report. The events of Abortion spontaneous and Abortion missed cannot co-exist as it is one or the other and the source document does not distinguish.


VAERS ID: 1806876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Human chorionic gonadotropin, Pregnancy test, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: pregnancy test; Test Result: Positive ; Test Date: 20210803; Test Name: ultrasound; Result Unstructured Data: Test Result:Confirmation of pregnancy by imaging method; Comments: Confirmation of pregnancy by imaging method; Test Date: 20210811; Test Name: ultrasound; Result Unstructured Data: Test Result:Missed abortion; Test Date: 20210811; Test Name: ?- hcg; Result Unstructured Data: Test Result:highlighting low values
CDC Split Type: GRPFIZER INC202101339820

Write-up: Missed abortion; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-20218344. A 33-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 02Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient''s mother has a history of missed abortion. On 12Jul2021 she received first dose of bnt162b2 for COVID-19 immunisation. The patient experienced missed abortion, medically significant on 11Aug2021. Additional information reported as follows: more specifically, the pregnancy test was positive on 02Aug2021 (possible start day of pregnancy from 12Jul2021) and then on 03Aug2021 an ultrasound was performed confirming the pregnancy by imaging method. On 11Aug2021 a second ultrasound was performed with ?- hcg (highlighting low values), from which missed abortion was confirmed. No missed abortion in the past. No previous childbirth prior to termination of pregnancy/palindromic pregnancy. The patient has recovered from the event on 11Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GR-PFIZER INC-202101373299 same patient/drug, different event/dose number


VAERS ID: 1659226 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Abortion, Anxiety, Bundle branch block, Electrocardiogram abnormal, Oropharyngeal blistering, Palpitations
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: EKG shows:Incomplete bundle branch block. Pt reports no cardiac problems prior to vaccination, more testing to be ordered
CDC Split Type:

Write-up: Pt presented to ER with C/o palpitations, abdominal pain, and throat pain since first Moderna vaccine on 8/12/21. Pt states the palpitations/dizziness was so severe she pulled over in the car and summoned help. Pt states she sought medical treatment and was discharged with Anxiety as the diagnosis, and states she has never been diagnosed with Anxiety before and feels "something is wrong."


VAERS ID: 1709671 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-07
Onset:2021-08-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

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

Life Threatening? No
Birth Defect? 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My wife had a miscarriage 6 days after she received the first dose. She was 9 weeks pregnant. My wife was 142 lbs. healthy. Baby had a normal ultrasound 3 weeks prior.


VAERS ID: 1759012 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-05
Onset:2021-08-12
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

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

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

Write-up: I had a miscarriage at 5 weeks pregnancy. Conception on July 18-20, positive pregnancy test August 5, miscarriage August 12-13.


VAERS ID: 1657176 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Heart rate, Heart rate increased, Scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Termination of pregnancy and risk of abortion (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: heart beat; Result Unstructured Data: Test Result:increased; Test Name: emergency scan; Result Unstructured Data: Test Result:there was still a heart beat
CDC Split Type: GBPFIZER INC202101064574

Write-up: miscarriage; heart beat; Bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108161026099210-SEDLC, Safety Report Unique Identifier GB-MHRA-ADR 25803324. This consumer or other non hcp reported information for both mother and fetus/baby. This is a maternal report. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380), on 11Aug2021 as dose 1, single for COVID-19 immunization. Medical history included Miscarriage and Pregnancy. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. The patient''s concomitant medications were not reported. Reporter stated that, she was 13 weeks pregnant at the time of having the Covid vaccine. Within 24 hours she suffered a heavy bleed. She was sent for an emergency scan as she believed she was suffering a miscarriage. The scan confirmed there was still a heart beat. She also had to have an Anti D shot as she had bled during pregnancy. She believed the bleed was caused as a direct result of having the Pfizer vaccine. On an unspecified date, the patient experienced heart beat and miscarriage; bleeding on 12Aug2021. The mother reported she became pregnant while taking bnt162b2. The mother was 13 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included emergency scan: there was still a heart beat on an unspecified date and heart rate: increased. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101069818 For fetus


VAERS ID: 1657194 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-08-12
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101064629

Write-up: miscarriage; Early miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108161249376770-P1A7D, Safety Report Unique Identifier GB-MHRA-ADR 25804077. A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown), dose 1 via an unspecified route of administration on 10Jun2021 as dose 1, single for COVID-19 immunization. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient experienced miscarriage on an unspecified date, early miscarriage on 12Aug2021. Early miscarriage 8 weeks after COVID injection given. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No- Negative COVID-19 test). The outcome of the event miscarriage was reported as unknown. The outcome of the event early miscarriage was recovered on 16Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1686951 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-12
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101114838

Write-up: Miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20214484. This is a maternal report. A 19-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in the arm (left/right arm) on 29Jul2021 (Batch/Lot Number: FE7051) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient concomitant medications were not reported. The patient had no history of COVID19. No medical history. Date of last menstrual period 05Jun2021. The patient received the vaccine at 7 pregnancy week and 5 days. On 12Aug2021, at 9 pregnancy week + 6 day, the patient experienced miscarriage. The event was assessed as serious (medically significant). The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. The outcome of the event was not recovered. No follow-up attempts are possible, no information is expected.


VAERS ID: 1702639 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-12
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLATE; OMEGA-3 [SALMO SALAR OIL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Positive pregnancy test; Test Result: Positive
CDC Split Type: NOPFIZER INC202101125727

Write-up: SPONTANEOUS ABORTION; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Ug9en3. A 32-year-old female patient received the second dose of bnt162b2 (COMIRNATY), via intramuscular on 02Aug2021 09:20 (Lot Number: FE3065) as single dose for covid-19 immunisation. Medical history was not reported. Concomitant medications included folic acid (FOLATE) taken for an unspecified indication, start and stop date were not reported; salmo salar oil (OMEGA-3) taken for an unspecified indication, start and stop date were not reported. The mother reported she became pregnant while taking bnt162b2. Date of end of event Spontaneous abortion on 12Aug2021. The patient developed spontaneous abortion on 12Aug2021, absence of menstruation on 02Aug2021. The reactions/case was considered to be serious due to hospitalization required and other serious (important medical event). The patient had choosed death as serious criteria. The patient didn''t die, but her fetus. The cross is therefore removed, but it is probable that she had to go to hospital, so hospitalization was choosed instead, so the report stays serious. The patient underwent lab tests and procedures which included pregnancy test positive on 03Aug2021. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823029 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4509 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101415065

Write-up: This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority, regulatory authority number NL-LRB-00699821. This is the first of two mother''s reports for the 2nd dose. This consumer reported information for both mother and fetus/baby. This is a mother report. A 34-years-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Aug2021 (Lot Number: FG4509) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. No previous COVID-19 infection. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 07Jul2021 for COVID-19 immunisation and experienced rigid arm. The mother reported she became pregnant while taking BNT162B2. The miscarriage occurred at a pregnancy duration of about 9 weeks. The fetus stopped growing when it was about 6.5 weeks old. This was the second Covid vaccination, which took place around the time of conception. Pregnancy occurred in cycle in which vaccine was administered. Ovulation and conception were around the date of vaccination. On 12Aug2021, the patient (mother) had reaction at or around the injection site: hardening, occurring later than one week after vaccination. Spontaneous miscarriage/abortion spontaneous occurred on 14Oct2021. In the cycle in which the patient had the 2nd vaccination, a spontaneous miscarriage occurred after 9 weeks of pregnancy. The patient recovered from injection site hardening on 29Sep2021, while outcome for other events was unknown. Sender''s comment: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction (Miscarriage) was considered as serious by the Regulatory Authority. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101423066 fetus case, maternal EDP


VAERS ID: 1666947 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-05
Onset:2021-08-13
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Depression, Exposure during pregnancy, Foetal death, Stillbirth
SMQs:, Depression (excl suicide and self injury) (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: The patient had a mostly uneventful pregnancy. She was treated at one point for depression, but stopped the medication and coped well. She received the vaccine on 8/5 and reported a very active baby that day. Five days later, she felt the baby move for the last time, and came in for evaluation the next day, and the baby had passed away. I am uncertain if the vaccine had anything to do with the stillbirth, but I wanted to report it as everything was healthy and normal leading up to it.


VAERS ID: 1776840 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-01
Onset:2021-08-13
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abnormal cord insertion, Blood creatine increased, Blood pressure increased, Blood test, Caesarean section, Exposure during pregnancy, Foetal monitoring, Liver function test abnormal, Pre-eclampsia, Premature delivery, Prolonged labour, Protein urine present, Urine analysis
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: I was taking a pre-natal vitamin (nature made) and Claritin.
Current Illness: I was not experiencing any illness.
Preexisting Conditions: I''m obese and have IBS.
Allergies: I am allergic to sulfa drugs, Wellbutrin and ibuprofen.
Diagnostic Lab Data: I had a lot of blood work, a fetal monitor attached to my stomach, urinalysis. My urine protein was 49mg per dl on 08/13. The stable number is less than 12.
CDC Split Type: vsafe

Write-up: My Estimated due date was 09/04/2021. My sons birth weight was 5lbs 14oz. I was classified as low risk. I had marginal cord insertion, but it was not severe enough to impact my sons development. My blood pressure was increasing throughout pregnancy. On 08/06/2021, it was over the threshold, so I had blood work completed. At my next appointment on 08/13, my blood pressure was very high again. My creatine levels were above the normal amount as well. I had pre-eclampsia. I was admitted to the hospital and I was told that I would not be released until my son was born. My liver protein levels were high. I was not dilating very fast and I suggested a C-Section, to which the doctors agreed. My son is doing well, but we are keeping an eye on certain things. He has chordee and penile torsion. They are both mild, but they will require corrective surgery when he is 9 months old. He also has an umbilical hernia. I''m hoping that he will not need surgery for his umbilical hernia because it usually corrects itself.


VAERS ID: 1800567 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-03
Onset:2021-08-13
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes)
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: USPFIZER INC202101360385

Write-up: A miscarriage took place; I experienced a significant release of tissue; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received bnt162b2 (BNT162B2, Brand: Pfizer, solution for injection, Lot Number: FA7485, expiry date not reported), via an unspecified route of administration, administered in right arm on 03Aug2021 (at the age of 26 years old as reported) as dose 2, single for covid-19 immunisation. Medical history included covid-19 (prior to vaccination) from an unknown date and unknown if ongoing. Patient had nasal swab on 31May2021 (unknown results). The patient had no known allergies and other medical history. The patient had no concomitant medications and no other medications in two weeks. Patient received dose 1 of bnt162b2 (BNT162B2, Brand: Pfizer) on 26Jun2021 (Lot number: EW0181) on 26Jun2021 administered in the right arm as COVID-19 immunization (at the age of 26 years old as reported). It was reported that a miscarriage took place on 13Aug2021. Patient experienced a significant release of tissue, and went to three different OBGYN''s, two of which confirmed that the photos she presented were a miscarriage. Patient did not know that she was pregnant yet. The patient was pregnant at the time of the vaccination and of the events reported. The events was reported as serious as results in death (fetus). The event resulted in doctor or other healthcare professional office/clinic visit. It was reported that no treatments were received. The events recovered with lasting effects on an unknown date in 2021. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1699408 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, 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? 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: 202105; Test Name: Blood test; Result Unstructured Data: Test Result:normal
CDC Split Type: IEPFIZER INC202101131470

Write-up: suspected very early miscarriage; passed blood clots from vagina; This is a spontaneous report from a contactable consumer received by HPRA from a member of the public reporting and downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-082480. Safety Report Unique Identifier: IE-HPRA-2021-082480. A 35-year-old female patient received bnt162b2 (COMIRNATY; Solution for injection; Lot Number: FE0900), dose 2 via an unspecified route of administration on 11Aug2021 at 12:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No previous history of heavy clots from vagina. The patient historical vaccine includes first dose bnt162b2 (COMIRNATY; batch details: unknown) on 16Jul2021 for Covid-19 immunisation. The patient experienced vaginal haemorrhage and suspected abortion spontaneous following vaccination with Comirnaty. On 08Aug2021, the patient''s menstrual period ended. 09Aug2021, the patient had intercourse (without contraception barrier or hormone). On 11Aug2021, at 12:00, the patient was vaccinated with second dose of Comirnaty. On 13Aug2021, at 12:30, the patient passed heavy clots from vagina. The patient reported suspected very early miscarriage.The events were assessed as serious medically significant. The patient underwent lab tests which included unspecified blood test done about 3 months ago in May2021 and results came back normal. The outcome of the events recovered on an unspecified date in 2021 at the time of the report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702570 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Inappropriate schedule of product administration, Ultrasound foetal
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Ultrasound; Result Unstructured Data: Test Result:embryo appeared too small and there was no heart b; Comments: embryo appeared too small and there was no heart beat
CDC Split Type: NLPFIZER INC202101125600

Write-up: Miscarriage (Missed Abortion); First dose on 28Jun2021, second dose on 13Aug2021 (47 days apart); This is as spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00672339. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 28-year-old female patient received bnt162b2 (COMIRNATY), dose 2 at the age of 28-years-old via an unspecified route of administration on 13Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY) on 28Jun2021 (batch/lot number: Unknown) for covid-19 immunisation and experienced Maternal Exposure During Pregnancy, first trimester (at 1 week of pregnancy). The patient experienced miscarriage (missed abortion) on 18Aug2021, 5 days after vaccination. The miscarriage occurred at a pregnancy duration of about 7-8 weeks. This was after the second Covid vaccination. During the first vitality ultrasound around 7-8 weeks, the embryo appeared too small and there was no heart beat. Classified as a missed abortion. The event was considered to cause congenital anomaly. The pregnancy resulted in spontaneous abortion with fetal outcome of intrauterine death. The patient underwent lab tests and procedures which included ultrasound foetal: embryo appeared too small and there was no heart beat on Aug2021. The outcome of the event was unknown. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101182270 Fetal case


VAERS ID: 1738332 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCDD2 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Cough, Diarrhoea, Influenza like illness, Myalgia, Nasopharyngitis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Noninfectious diarrhoea (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? 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: 20210816; Test Name: Body temperature; Result Unstructured Data: Test Result:fever(40?C)
CDC Split Type: FRPFIZER INC202101194710

Write-up: Influenza like illness; Diarrhoea; Cough; Fever (40?C); Muscles aches; cold; Miscarriage; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BX20218422. A 28-years-old pregnant female patient (Date of last period 14Jul2021) received bnt162b2 (COMIRNATY), dose 1 intramuscular on 10Aug2021 (Batch/Lot Number: SCDD2) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage (medically significant) on 13Aug2021, influenza like illness on an unspecified date, diarrhoea on 16Aug2021, cough on 16Aug2021, fever (40?C) on 16Aug2021, muscles aches on 16Aug2021, cold on 16Aug2021. The outcome of event Influenza like illness was recovering, of other events was recovered. Sender comment: CaseSummary: Comirnaty, Dose 1 on 10Aug2021, batch SCDD2 Pregnant female patient, Date of last period 14Jul2021 Adverse reaction 3days after miscarriage (3 weeks pregnant), and had symptoms for 15 days: - diarrhoea -cough -fever(40?C) -muscle aches -cold general condition still fragile after 4 weeks No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746354 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-13
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: Pregnancy ultrasound; Result Unstructured Data: Test Result:8 weeks of gestation
CDC Split Type: FRPFIZER INC202101215550

Write-up: Miscarried (pregnancy loss <20 weeks gestation); This is a spontaneous report from a contactable consumer and a healthcare professional downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-PC20213402. A pregnant 34-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: FE7051), intramuscular in left arm, on 30Jul2021 (at the age of 34 years), as dose 1, 0.3 mL, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had no history of COVID-19 and COVID-19 test was not performed. On 27Jul2021, the patient underwent pregnancy ultrasound: 8 weeks of gestation. On 30Jul2021 (first trimester), injection of BNT162B2 vaccine was administered to the patient. On 13Aug2021, the patient was informed that she had miscarried (pregnancy loss <20 weeks gestation), the embryo would have been dead for 1 week and a few days. In total, discovery of a miscarriage at 11.5 weeks of amenorrhea (first trimester), at day 15 of the first dose of BNT162B2 vaccine. The event was considered serious as important medical event. The patient recovered from the event in 2021.


VAERS ID: 1747301 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Inappropriate schedule of product administration
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: NLPFIZER INC202101216211

Write-up: Miscarriage; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB [NL-LRB-00682429]. This reporter reported events for the same patient after two doses of the vaccine. This reports for the second dose. A 29-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 13Aug2021 (Batch/Lot Number: FE8235) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included COMIRNATY dose 1 on 01Jul2021 for covid-19 immunisation and experienced vaccine exposure during pregnancy week: 5. The patient had no previous COVID-19 infection. The patient experienced miscarriage on 19Aug2021 with outcome of unknown and inappropriate schedule of vaccine administered on 13Aug2021 with outcome of unknown. The miscarriage occurred at a pregnancy duration of about 12 weeks. It was reported that the patient lived a healthy life and have done everything possible for the fetus to grow optimally. The corona vaccine was the only thing she can think of, about which she have grave doubts, whether she should have taken it. The mother reported she became pregnant while taking bnt162b2. The mother was 12 Weeks pregnant at the onset of the event. The mother delivered the pregnancy on 19Aug2021. The pregnancy resulted in spontaneous abortion. Sender''s Comment: Since the nature of the reported reaction does imply seriousness according to one of the regulatory authority critera, the reaction was considered as serious by the regulatory authority. Reporter''s comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes; ADRs: Unclear Date: 01Jul2021. Miscarriage. Additional information ADR: I suffered a miscarriage. I have always lived a healthy life and have done everything possible for the fetus to grow optimally. The corona vaccine is the only thing I can think of, about which I have grave doubts, whether I should have taken it. Confounding factors, vaccine exposure during pregnancy week: 5. COVID19- Previous COVID-19 infection: No. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes; ADRs: Unclear Date: 01Jul2021. Miscarriage. Additional information ADR: I suffered a miscarriage. I have always lived a healthy life and have done everything possible for the fetus to grow optimally. The corona vaccine is the only thing I can think of, about which I have grave doubts, whether I should have taken it. Confounding factors, vaccine exposure during pregnancy week: 5. COVID19- Previous COVID-19 infection: No.


VAERS ID: 1754623 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Foetal death, Gene mutation identification test
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness: Endometriosis; Hashimoto''s thyroiditis; Hypertension; Myxoedema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Autopsy; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: Gene mutation identification test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DKPFIZER INC202101229275

Write-up: Dead fetus gestation week 20+0; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0085019. Safety Report Unique Identifier: DK-DKMA-ADR 25804245. A 42-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Aug2021 (Batch/Lot Number: FE9174; Expiration Date: 31Oct2021) as dose 1, single for covid-19 immunisation. Medical history included ongoing Hashimoto''s thyroiditis, ongoing endometriosis, ongoing hypertension and ongoing myxoedema. There is no information regarding past medication. Concomitant medications included nifedipine (NIFENOVA) taken for hypertension from 15Mar2021; levothyroxine sodium (EUTHYROX) taken for myxoedema from 01Jan2019; acetylsalicylic acid (ACETYLSALICYLSYRE TEVA) taken for pregnancy from 05Jun2021 to 15Aug2021. The patient experienced maternal exposure during pregnancy, second trimester on 01Aug2021 and dead fetus gestation week 20+0 on 13Aug2021. The clinical course was reported as follows: on 01Aug2021, it was gestation week 19 and the patient received the first dose of COMIRNATY (Batch number: FE9174) for Covid-19 immunisation. On 13Aug2021, 12 days after the first vaccination, the patient experienced dead fetus. The ADR was by the patient reported as resulting in hospitalisation (date unknown). The patient was treated with induced abortion. The scheduled test of fetus in 2021 included autopsy and gene mutation identification test: unknown results. The outcome of dead fetus was not recovered. No follow up attempts possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DK-DKMA-WBS-0085455


VAERS ID: 1778501 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214019 / 1 - / OT

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

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

Write-up: maternal exposure during pregnancy; This case was received via the RA (Reference number: IT-MINISAL02-791991) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214019) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 13-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 21-Sep-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criteria medically significant and congenital anomaly). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. 1, The outcome was reported as Spontaneous Abortion NOS. On 13-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS had resolved with sequelae. No concomitant medications were reported No treatment medications were reported Company Comment: This case involves a 39-year-old female subject with no medical history provided who experienced the unexpected adverse events of maternal exposure during pregnancy on the day of her first vaccination and spontaneous abortion (serious, congenital abnormality and medically significant) 1 month and 9 days after this vaccination. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Date of vaccine administration & batch number are reported in the followup; Sender''s Comments: This case involves a 39-year-old female subject with no medical history provided who experienced the unexpected adverse events of maternal exposure during pregnancy on the day of her first vaccination and spontaneous abortion (serious, congenital abnormality and medically significant) 1 month and 9 days after this vaccination. A re-challenge is not applicable since the patient had received only one vaccination dose. No confounding factors were known at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1799324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-13
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Intermenstrual bleeding, Intrapartum haemorrhage, Pelvic pain, Ultrasound scan, Vomiting
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), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: beta HCG; Result Unstructured Data: Test Result: results unknown; Test Date: 20210815; Test Name: echo; Result Unstructured Data: Test Result: Pregnancy Start Date (according to echo of 15Aug); Comments: Pregnancy Start Date (according to echo of 15Aug) 12Jul2021; Test Date: 20210815; Test Name: ultrasound; Result Unstructured Data: Test Result:27mm decidual hematoma in progressive pregnancy at; Comments: 6 + 6 amenorrhea weeks; Test Date: 20210902; Test Name: ultrasound; Result Unstructured Data: Test Result: the diagnosis of an arrested pregnancy made during; Comments: an ultrasound in town at about 8 amenorrhea weeks.; Test Date: 20210919; Test Name: ultrasound; Result Unstructured Data: Test Result: the presence of the gestational sac in the cervix.
CDC Split Type: FRPFIZER INC202101313928

Write-up: profuse, active bleeding with clots; Pregnancy loss <20 weeks gestation; vomiting; Metrorrhagia; Pain pelvic; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20214455. This report is for the second dose of bnt162b2. Only this case is serious. A 30-year-old female patient received bnt162b2 (COMIRNATY), intramuscular administered in left arm on 03Aug2021 (Batch/Lot Number: FF4213) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included pregnancy (G3P2). The patient had no known allergy. The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY) on 13Jul2021 (Batch/Lot Number: FE2296) for covid-19 immunisation where patient experienced exposure during pregnancy. The patient experienced metrorrhagia and pain pelvic on 13Aug2021; vomiting and profuse, active bleeding with clots on 15Aug2021; and pregnancy loss <20 weeks gestation on 02Sep2021. The events caused hospitalization from 19Sep2021 to 20Sep2021. The mother reported she became pregnant while taking bnt162b2. The date of last menstrual period was on 13Jun2021. Pregnancy start date (according to date of last period) was 27Jun2021 while pregnancy start date (according to echo of 15Aug) was 12Jul2021. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver on 20Mar2022. The pregnancy resulted in spontaneous abortion. Gestation period at exposure was 7 weeks. Clinical signs and chronology of facts: On 13Aug, 13 days after dose 2 of the Comirnaty vaccine, metrorrhagia and pelvic pain type contraction. Consultation in the gynecological emergency department diagnosis of spontaneous miscarriage. On 15Aug2021: persistence of pelvic pain symptoms, brown metrorrhagia and vomiting, consultation in emergencies in the gynecological emergency department, ultrasound discovery of a 27mm decidual hematoma in progressive pregnancy at 6 + 6 amenorrhea weeks. On 02Sep: consultation in the gynecological emergency room following the diagnosis of an arrested pregnancy made during an ultrasound in town at about 8 amenorrhea weeks. Prescription of misoprostol. On 18Sep2021: moderately profuse bleeding, failure of MisoOne treatment, programming of curettage on 21Sep2021. On 19Sep2021: Present to the emergency room for intense pelvic pain and profuse, active bleeding with clots. In the speculum, active metrorrhagia filling the speculum on placement. On ultrasound, the presence of the gestational sac in the cervix. Decision to curettage for hemorrhagic miscarriage, curettage under general anesthesia, simple consequences, return home on 20Sep2021. (Information collected by the regional center of Regulatory Authority) Biology / additional examinations / etiological research: Monitoring Beta HCG result not found on file; Ultrasound monitoring. Summary of management: Emergency medical consultations on 13Sep, 15Sep, 02Sep and 19Sep. Spontaneous miscarriage treated by MisoOne on 03Sep, treatment failure. Curettage scheduled for 21Sep2021. On 19Sep2021, hospitalization for hemorrhagic miscarriage and curettage, the operative consequences were simple. Return to home on 20Sep2021. Conclusion: Metrorrhagia and pelvic pain 13 days post vaccination leading to miscarriage. Therapeutic measures were taken as a result of metrorrhagia, pain pelvic, profuse, active bleeding with clots, and pregnancy loss <20 weeks gestation. The patient was recovering from metrorrhagia, pelvic pain, vomiting, and profuse, active bleeding with clots; and recovered from pregnancy loss <20 weeks gestation. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101332681 same patient, same drug of different dose, different events


VAERS ID: 1819110 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-08-13
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Ultrasound foetal
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Retroplacental haematoma (In a previous pregnancy without incidence); Unspecified disorder of thyroid
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: early echo; Result Unstructured Data: Test Result:discrepancy between the theoretical and ultrasound; Comments: discrepancy between the theoretical and ultrasound terms; Test Date: 20210806; Test Name: early echo; Result Unstructured Data: Test Result:discrepancy between the theoretical and ultrasound; Comments: discrepancy between the theoretical and ultrasound terms
CDC Split Type: FRPFIZER INC202101356562

Write-up: Miscarriage; bleeding; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PB20216490. A 33-year-old pregnant female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 16Jul2021 (Lot Number: FE2707) as dose 2, single for COVID-19 immunization. Medical history included Unspecified thyroid disorder and Retroplacental hematoma (in a previous pregnancy without incidence). The patient''s concomitant medications were not reported. Date of last menstrual period is on 18Jun2021. On 13Aug2021 the patient experienced miscarriage and bleeding. Course of evets: Patient at 4 weeks of pregnancy during her 2nd injection of the vaccine. She presented a discrepancy between the theoretical and ultrasound terms during the early echoes (29Jul2021 and 06Aug2021) then a miscarriage 1 month after her vaccination (on 13Aug2021) with bleeding and incomplete spontaneous expulsion, supported by instrumental method on 26Aug2021. The mother was 4 Weeks pregnant at the onset of the event. The mother was due to deliver on 25Mar2022. The pregnancy resulted in spontaneous abortion. The patient was hospitalized on unspecified date in 2021 due to the reported events. Therapeutic measure was taken as a result of the events. The patient recovered from the events on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1578231 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-28
Onset:2021-08-14
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 LA / SYR

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

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

Write-up: First pregnancy, Est. Due Date April 11th At time of injection, patient felt rush in lower abdomen/uterus Pregnancy symptoms diminished over the next few days after injection Miscarriage began on August 14, confirmed by physician on 8/16/21. Pregnancy loss


VAERS ID: 1665702 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-08-14
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: pregnancy test; Test Result: Positive
CDC Split Type: USPFIZER INC202101070476

Write-up: Miscarriage; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, NDC number, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date in Jun2021 (Age at vaccination: 37- years-old) as dose 2, single (patient partner got both doses) for COVID-19 immunization. No medical history was not reported. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS; VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine which the patient partner took was BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that the stated that she was not sure if it was a reportable event, but her partner got both doses of the vaccination and she got pregnant after he was fully vaccinated (03Jul2021) and she miscarried (14Aug2021), she did not get the Pfizer COVID-19 vaccine but her partner got both doses, she did not have her partners vaccine card to provide the NDC/LOT/EXP or dates of vaccination from it. She says she believes her partner got both doses of the vaccine and was fully vaccinated in Jun (unspecified date). She was experiencing the miscarriage/miscarrying now (14Aug2021), which started Saturday, and she just left the doctor''s today (unspecified date) and she confirmed that it was dead. The patient underwent lab tests and procedure which included pregnancy test: positive on 03Jul2021. The event miscarriage was considered as serious (Medically Significant). The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1711801 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-13
Onset:2021-08-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Maternal exposure during pregnancy, Pyrexia, SARS-CoV-2 test, Ultrasound scan, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: Temperature; Result Unstructured Data: Test Result:103; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:COVID-19; Comments: prior to vaccination; Test Name: Ultrasound; Result Unstructured Data: Test Result:complete miscarriage
CDC Split Type: USPFIZER INC202101162580

Write-up: Miscarriage; Vomiting; 103 fever (2 consecutive); Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Aug2021 (at the age of 28-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient was pregnant at the time of vaccination and had maternal exposure during pregnancy. On 14Aug2021, the patient experienced 103 fever (2 consecutive), vomiting and had miscarriage. The patient received ultrasound-complete miscarriage and treatment for other events. The adverse events resulted in doctor or other health care professional office/clinic visit. The outcome of the events was recovered with sequel. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1715357 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-06-05
Onset:2021-08-14
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood test normal, Exposure during pregnancy, Foetal death, Pathology test, Stillbirth
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? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Autopsy (fetal), Placenta pathology, Various blood work for different viruses, etc. All results of tests were normal, unremarkable.
CDC Split Type: vsafe

Write-up: Estimated delivery Nov. 10, 2021. Intrauterine fetal death was diagnosed August 13, stillbirth delivered August 14th. As of now there is no known cause despite the tests that have been run.


VAERS ID: 1660094 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? 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; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: Na; Result Unstructured Data: Test Result:unknown results; Test Date: 20210814; Test Name: pregnancy test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101064890

Write-up: Miscarriage; Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108161749477870-P8NDX. Safety Report Unique Identifier: GB-MHRA-ADR 25806180 A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration at the age of 32-year-old on 14Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included miscarriage, pregnancy from an unknown date and not ongoing (Patient no longer pregnant at the time of reporting), Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for Folic acid supplementation, start and stop date were not reported; pregnacare drug (unspecified). The patient previously took first dose bnt162b2 for COVID-19 immunization and patient missed a period completely. The patient experienced maternal exposure during pregnancy/patient was exposed to the medicine first-trimester (1-12 weeks) on 14Aug2021, miscarriage (medically significant) on 15Aug2021. The patient underwent lab tests and procedures which included pregnancy test: positive on 14Aug2021, blood sodium: unknown results on unknown date. The outcome of event miscarriage was recovering. The outcome of event Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester (1-12 weeks) was unknown. The clinical course was reported as follows: Patient had a miscarriage exactly 24 hours after receiving the vaccine. With patient''s first dose patient missed a period completely which shows to patient that this has an affect on the menstrual cycle. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. The medicine had an adverse effect on any aspect of the pregnancy. Patient had a miscarriage 24 hours after having the covid jab. Patient was taking pregnacare and had a positive pregnancy test and felt like a normal pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701410 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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 INC202101138358

Write-up: Miscarriage/miscarried; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108310836077660-DAASA, safety report unique identifier is GB-MHRA-ADR 25872635. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided), via an unspecified route of administration on 04Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included lactation decreased, folic acid supplementation, and pregnancy (also reported as ''patient no long pregnant at the time of reporting'') from unspecified dates and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for vitamin supplementation from unspecified dates and unknown if ongoing. The patient experienced ''miscarriage/miscarried'' on 14Aug2021. Patient''s clinical course is as follows: Patient reported that she had the vaccine at 4 weeks pregnant. At 6 weeks (10 days after the vaccine), patient miscarried. Patient was not sure if this was coincidence or related to the vaccine but wanted to report it in case others were also experiencing this. It was reported that patient was exposed to the medicine first-trimester (1-12 weeks). The event was assessed as serious (medically significant). The patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test with result of ''negative; No - Negative COVID-19 test'' on an unspecified date. At the time of reporting, outcome of the event was recovered/resolved with sequel on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1739865 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-08-14
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Foetal hypokinesia, Stillbirth
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amniocentesis (Fetus had a normal chromosome variant (Chromosome 15 satellite variation))
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Stillbirth; Fetal movements decreased; This regulatory authority case was reported by an other health care professional and describes the occurrence of STILLBIRTH (Stillbirth) and FOETAL HYPOKINESIA (Fetal movements decreased) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): The mother''s past medical history included Amniocentesis (Fetus had a normal chromosome variant (Chromosome 15 satellite variation)). MEDICAL HISTORY (Patient): The patient''s past medical history included Amniocentesis (Fetus had a normal chromosome variant (Chromosome 15 satellite variation)). On 12-Jul-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-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 14-Aug-2021, the patient was diagnosed with FOETAL HYPOKINESIA (Fetal movements decreased) (seriousness criteria death and medically significant). On 25-Aug-2021, the patient was diagnosed with STILLBIRTH (Stillbirth) (seriousness criteria death and medically significant). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred on 25-Aug-2021, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth NOS. Labor was induced. The patient died on 25-Aug-2021. The reported cause of death was Fetal hypokinesia. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Mother of the patient regularly went for prenatal check-ups, After experiencing decreased fetal movement and increase of uterine contractions, labor was induced and patient had a stillbirth. Company Comment: This case concerns an unknown age and gender patient with medical history of Chromosome 15 satellite variation, who experienced the unexpected serious event of FOETAL HYPOKINESIA, within 1 day after the mother received the second dose of mRNA-1273 vaccine and experienced the unexpected serious event of STILLBIRTH, within 12 days after the mother received the second dose of mRNA-1273 vaccine. The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. Limited information regarding the events have been provided at this time. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns an unknown age and gender patient with medical history of Chromosome 15 satellite variation, who experienced the unexpected serious event of FOETAL HYPOKINESIA, within 1 day after the mother received the second dose of mRNA-1273 vaccine and experienced the unexpected serious event of STILLBIRTH, within 12 days after the mother received the second dose of mRNA-1273 vaccine. The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. Limited information regarding the events have been provided at this time. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.; Reported Cause(s) of Death: Fetal Hypokinesia


VAERS ID: 1855974 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-08-14
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure before 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; Pregnancy (Patient no longer pregnant at the time of reporting. have had a healthy pregnancy in 2017.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101449779

Write-up: Maternal exposure during pregnancy; Pregnancy loss; This is a spontaneous report from a contactable consumer. This is the first of 2 reports. The first report is a report download from the regulatory authority report number is [GB-MHRA-WEBCOVID-202110251504112850-3W10O], Safety Report Unique Identifier [GB-MHRA-ADR 26117820]. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FC9001), via an unspecified route of administration on 21Jun2021 as dose 1, single for COVID-19 immunization. The medical history included pregnancy from an unknown date and unknown if ongoing the patient no longer pregnant at the time of reporting. Had a healthy pregnancy in 2017, vitamin supplementation from an unknown date and unknown if ongoing. The patient concomitant medications included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. The patient experienced maternal exposure before pregnancy on an unspecified date, pregnancy loss on 14Aug2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test was negative on an unspecified date (No - Negative COVID-19 test). The patient last menstrual period date: 14Oct2021. The patient not had symptoms associated with COVID-19. The patient was not currently breastfeeding. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Unsure the medicine had an adverse effect on any aspect of the pregnancy. 2 misscariges in 4 months after have both jabs of COVID. When the patient had a healthy pregnancy in 2017. The patient was exposed to the medicine Before pregnancy. It was reported that " report does not relate to possible myocarditis or pericarditis. The events were reported as medically significant and non-serious. The outcome of the events was unknown. No follow up attempts are needed. No further information is expected; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101466582 For same patient, same drug and different dose


VAERS ID: 1582668 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-13
Onset:2021-08-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage


VAERS ID: 1866329 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-06-01
Onset:2021-08-15
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 2 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: Flu vaccine
Other Medications: Lantus Novolog Lisinopril Levothyroxene Atoravastatin
Current Illness:
Preexisting Conditions: Type 1 diabetes Hashimotos Celiacs
Allergies: Metformin Torradol
Diagnostic Lab Data:
CDC Split Type:

Write-up: I had a miscarriage


VAERS ID: 1660389 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? 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
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Result Unstructured Data: Test Result:Pregnant 4-5
CDC Split Type: GBPFIZER INC202101092548

Write-up: Foetal exposure during pregnancy; Pregnancy loss; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108201335212490-CVUJP. Safety Report Unique Identifier is GB-MHRA-ADR 25829330. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported, Solution for injection), via an unspecified route of administration, on 08Aug2021, as a dose 2, single for COVID-19 immunization. Medical history included vitamin supplementation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiration date were not reported) unspecified route of administration, on an unspecified date as single dose for COVID-19 immunization. Concomitant medication(s) included FOLIC ACID taken for vitamin supplementation. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced foetal exposure during pregnancy and on 15Aug2021, had pregnancy loss. All events were reported as medically significant. The mother reported she became pregnant while taking BNT162B2. The mother was in her first trimester (1-12 weeks) of pregnancy at exposure. Child and patient was exposure to the medicine in first trimester (1-12 weeks). The patient had test where resulted that patient was pregnant for 4-5 weeks and week later, she has miscarriage. Details of scans or investigations was miscarriage. The patient underwent lab tests and procedures which included pregnancy test: pregnant 4-5. The outcome of pregnancy loss was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1667772 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-08-15
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003602 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Intermenstrual bleeding
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROGEFFIK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: This case was received via Medicines Agency (Reference number: ES-AEMPS-977118) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS and INTERMENSTRUAL BLEEDING in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3004672 and 3003602) for COVID-19 vaccination. Concomitant products included PROGESTERONE (PROGEFFIK) from 15-Jul-2021 to 16-Aug-2021 for In vitro fertilization. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Aug-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant) and INTERMENSTRUAL BLEEDING (seriousness criterion medically significant). The delivery occurred on 15-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 15-Aug-2021, INTERMENSTRUAL BLEEDING had resolved. On 16-Aug-2021, ABORTION SPONTANEOUS had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 12-Jul-2021. Treatment information was not provided by the reporter. Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected (Translation).; Sender''s Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected (Translation).


VAERS ID: 1688382 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Heart rate, 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: Test Name: heart action; Result Unstructured Data: Test Result:positive heart action; Comments: At 15+6 weeks there has been a check-up where there was a positive heart action.
CDC Split Type: NLPFIZER INC202101115106

Write-up: 18 weeks pregnant, Intrauterine fetal demise was diagnosed on 22Aug2021 at 19 weeks and 2 days; vaccination during 18th week of pregnancy; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00672260. A 30-years-old pregnant female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number, Expiry date was not reported), dose 2 via an unspecified route of administration on 15Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation (maternal vaccine exposure). The miscarriage occurred at a pregnancy duration of about 19 weeks 7 days after administration. This was after the second Covid vaccination at 18 weeks on 15Aug2021. The time of gestation at the first vaccination is unknown. At 15+6 weeks there has been a check-up where there was a positive heart action. At 19+2 weeks the unborn child died. Patient didn''t want any further diagnostics into the cause of the miscarriage. Patient was 18 weeks pregnant, Intrauterine fetal demise was diagnosed on 22Aug2021 at 19 weeks and 2 days. At Ad 15+6 last check, then positive cardiac action. At Ad19+2 unborn child died, in accordance with 18 weeks. The patient does not want further diagnosis into the cause of intrauterine fetal death. The patient underwent lab tests and procedures which included heart rate: positive heart action on an unspecified date at 15+6 weeks there has been a check-up where there was a positive heart action. Miscarriage is treated with initiation of the birth. Therapeutic measures were taken for the events. The outcome of events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reporter''s Comments: Summary of reporter''s comments: Past drug therapy Pfizer vaccine (Comirnaty): yes , ADRs: no confounding factors COVID-19 vaccine exposure during pregnancy week: Previous COVID-19 infection: No diagnostic procedures: no; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101167417 same patient, different events after 1/2 dose


VAERS ID: 1709543 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-15
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       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? 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: 20210815; Test Name: ultrasound scan; Result Unstructured Data: Test Result:size of the foetus is around week 8; Comments: (size of the foetus is around week 8. No pulse)
CDC Split Type: FIPFIZER INC202101149675

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The Regulatory Authority report number is FI-FIMEA-20214347. A 38-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date in Jun2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage on 15Aug2021. The mother reported she was 3 weeks pregnant when she received BNT162B2. The mother was 11 Weeks pregnant at the onset of the event. At week 11 (15Aug2021), an ultrasound scan revealed that the size of the foetus is around week 8. No pulse. The outcome of the event was recovering. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1816263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-15
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 1 LA / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101350872

Write-up: Miscarriage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NC20214595. A 33-year-old pregnant female patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly, administered in Arm Left on 14Jul2021 (Lot Number: FD0168) as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage (hospitalization) on 15Aug2021. The patient reported she became pregnant while taking BNT162B2. The patient was 7 Weeks pregnant at the onset of the event. The date of last menstrual period 26Jun2021. Clinical course: On 15Aug2021 or 32 days after vaccination spontaneous miscarriage at 7 (SA) weeks of amenorrhea+1. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1875445 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-08-15
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Maternal exposure during pregnancy, Ultrasound scan vagina
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: Allergy (unspecified.); Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: vaginal ultrasound; Result Unstructured Data: Test Result:6 weeks old fetus
CDC Split Type: SEPFIZER INC202101531391

Write-up: Missed abortion; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency WEB, regulatory authority number SE-MPA-2021-091668. This consumer or other non hcp reported information for mother. This is a maternal report. A 30-year-old pregnant female patient received bnt162b2 (COMIRNATY, solution for injection) via an unspecified route of administration on 16Jun2021 (Batch/Lot Number: FA4632) as dose 2, single for covid-19 immunisation. Medical history included ongoing asthma, ongoing unspecified allergy. The patient''s concomitant medications were not reported. Patient previously took first dose of covid-19 vaccine (manufacturer unknown) on an unspecified date for covid-19 immunisation. It was reported that the patient experienced the events which was described as missed abortion on 15Aug2021 and maternal exposure during pregnancy, first trimester on an unspecified date in 2021. Where the patient was then pregnant at week 3. In gestational week 12+1, the patient suffered a missed miscarriage. The foetus was assessed by vaginal ultrasound to be approximately 6 weeks old. According to the reporter assessed by the gynaecologist as foetal remains or a very malformed foetus. The missed miscarriage then started on its own. The next day, the patient took two Cytotec tablets and then experienced bleeding that lasted for two weeks. Patient received treatment for missed abortion and the treating medication was Cytotec. The patient underwent lab tests and procedures which included ultrasound scan vagina resulted 6 weeks old foetus on an unspecified date in 2021. Outcome of the event was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-202101555742 same reporter, mother/baby case


VAERS ID: 1738230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body mass index, Ultrasound uterus, Vaccination site pain
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High weight (IMC = 29.9)
Allergies:
Diagnostic Lab Data: Test Name: IMC; Result Unstructured Data: Test Result:29.9; Test Date: 20210816; Test Name: ultrasound; Result Unstructured Data: Test Result:not make it possible to see heart activity
CDC Split Type: FRPFIZER INC202101195140

Write-up: Miscarriage; injection was pain in the arm.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-AM20212389. A 27-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left deltoid on 12Aug2021 (Batch/Lot Number: FE8244) as single dose for covid-19 immunisation. Medical history included High weight (IMC = 29.9). The patient''s concomitant medications were not reported. The patient experienced miscarriage (seious as hospitalization from 20Aug2021) on 16Aug2021 with outcome of recovered with sequelae on 16Aug2021, injection was pain in the arm (non-serious) on an unspecified date with outcome of unknown. The patient became pregnant while taking bnt162b2. The patient was 7 Weeks pregnant at the onset of the event. The clinical course was reported as follows: "On 16Aug2021 (over 4 days after) follow-up ultrasound set for this pregnant female patient at a little over 7 weeks of amenorrhea. The ultrasound does not make it possible to see heart activity and the pregnancy is reported ended at 7 weeks. Hospitalization and medication-induced expulsion of the embryo on 20Aug2021. This was the female patient''s first pregnancy. No febrile syndrome was linked to administration of the vaccine given that the only reaction to the injection was pain in the arm. Conclusion: miscarriage reported 4 days after dose 1 of the COMIRNATY. Interventions during the regulatory authority analysis: Contact with the reporting party. Additional information obtained regarding: Patient, reactions, biological tests, other treatments, medical history. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746260 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101222427

Write-up: Miscarriage; brown discharges; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-LL20216164. A 25-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route administered in left arm on 12Aug2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had no medical history of COVID and no risk factors for miscarriage. The patient previously received BNT162B2 (COMIRNATY) in Jul2021 for COVID-19 vaccination and experienced vaccine exposure before pregnancy. On 21Aug2021, the patient experienced miscarriage nine days after the injection, when the pregnancy was 3 weeks old. She had brown discharges 4 days after the injection on 16Aug2021. Outcome of brown discharges was unknown, and of miscarriage was not recovered. Patient had not been tested since the vaccination. NOTE: Accountability without prejudice to the elements of investigation which could be carried out as part of legal or amicable compensation procedures. No follow-up attempts are possible. No information about batch/lot number can be obtained.


VAERS ID: 1747463 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-16
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC202101221824

Write-up: Spontaneous abortion in the 7/8 week of pregnancy/miscarriage; Administration site pain/pain at the injection site; Headache; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is SI-JAZMP-NCPHV-2021SI0874_0874. A 44-year-old pregnant female patient received BNT162b2 (COMIRNATY), intramuscular on 15Jul2021 (Batch/Lot Number: FD8274; Expiration Date: 31Oct2021) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Aug2021, the patient experienced headache (lasted 3 days) and administration site pain/pain at the injection site (lasted 3 days). On 19Aug2021, the patient experienced spontaneous abortion in the 7/8 week of pregnancy. (Also reported as, on the fourth day after the 2nd vaccination, she had a miscarriage at 7/8 weeks of pregnancy.) The patient was hospitalised. The final outcome was not reported. This case report was assessed as medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1852318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Drug hypersensitivity (NSAIDs); Polyps nasal; Surgery; Widal syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210916; Test Name: ultrasound; Result Unstructured Data: Test Result:results below; Comments: at almost 11 weeks of amenorrhea, after brown discharge, ultrasound performed which revealed that the embryo was 3mm and had no cardiac activity; Test Date: 20210923; Test Name: ultrasound; Result Unstructured Data: Test Result:results below; Comments: 23Sep2021 a second ultrasound confirmed the fact that the embryo had stopped its development at 6 weeks of amenorrhea
CDC Split Type: FRPFIZER INC202101436699

Write-up: misscarriage; Termination of pregnancy; This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20214727. This consumer reported information for both mother and fetus. This is maternal report. A 35-year-old female patient received second dose of BNT162b2 (COMIRNATY), intramuscular on 13Aug2021 (Lot Number: FE8235) as single dose for COVID-19 immunisation. Medical history included drug hypersensitivity (NSAIDs), asthma, Widal''s disease and nasal polyp surgery, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162b2 (COMIRNATY) on 23Jul2021 for COVID-19 immunization. The clinical course was reported as follows: on 16Aug2021 (as reported): occurrence of spontaneous abortion. On 02Aug2021, between doses, pregnancy was diagnosed. Date of last menstruation 05Jul2021. At this time, vaccination in the first trimester was already authorized. On 16Sep2021 (as reported), at almost 11 weeks of amenorrhea, after brown discharge, ultrasound performed which revealed that the embryo was 3mm and had no cardiac activity. On 23Sep2021 a second ultrasound confirmed the fact that the embryo had stopped its development at 6 weeks of amenorrhea. Following the ultrasound on 23Sep2021 which confirmed the diagnosis, a first medical pregnancy termination on 25Sep2021 then another on 28Sep2021 since the first was not enough to expel the sac were carried. On 12Oct2021, persistence of some brown discharge. The mother reported she became pregnant while taking BNT162b2. The mother was 6 weeks pregnant at the onset of the event. The mother was due to deliver on 11Apr2022. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 17Jul2021. The patient outcome of the events was recovering.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101453139 same patient, events after 1st dose;FR-PFIZER INC-202101453140 fetal case


VAERS ID: 1871106 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Inappropriate schedule of product administration, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (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: Test Date: 20210917; Test Name: ultrasound; Result Unstructured Data: Test Result:with heart rate weeks 6 + 0; Test Date: 20211005; Test Name: ultrasound; Result Unstructured Data: Test Result:Found already killed on 18Sep2021
CDC Split Type: FIPFIZER INC202101490082

Write-up: Miscarriage; patient received the second dose of Comirnaty on 16Aug2021 but the first dose was on 24May2021; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number FI-FIMEA-20215929. A pregnant female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 intramuscular on 16Aug2021 (Batch/Lot Number: UNKNOWN) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Aug2021, the patient received the second dose of Comirnaty but the first dose was on 24May2021. On 18Sep2021, the patient experienced miscarriage. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. It was further reported that she got pregnant about another dose of the vaccine. On 17Sep2021, a fetus detected in early ultrasound with heart rate weeks 6 + 0. However, this ended in a miscarriage. It was reported that the fetus was found in ultrasound. On 05Oct2021, already killed on 18Sep2021 ie 6 + 2. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1670419 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-26
Onset:2021-08-17
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH O23D21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test abnormal, Erythema, Exposure during pregnancy, Tenderness
SMQs:, Anaphylactic reaction (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Redness in arm and tenderness in arm for 2 weeks after - Miscarriage happened in pregnancy.


VAERS ID: 1689792 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-02-18
Onset:2021-08-17
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6208 / 2 LA / IM

Administered by: Unknown       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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: ultrasounds identified early pregnancy loss; bHCG levels were followed until negative result (<5) on 9/9/21
CDC Split Type:

Write-up: Early pregnancy loss at ~10 weeks since LMP, expectant management, treated with methylergonovine


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