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VAERS Report 2157028

Case Report Section

Vaer Report Details

Age: NA

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: fn3543


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-12-21
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

maternal drug exposure; mhra yellow card vaccine monitor this is a solicited report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory agency for a sponsored program. a 36 year-old female patient (pregnant) received bnt162b2 (comirnaty), administration date 21dec2021 (lot number: fn3543) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "pregnancy" (unspecified if ongoing), notes: estimated due date: 07dec2021; "folic acid supplementation" (unspecified if ongoing). date of last menstrual period: 02mar2021. the patient was 42 weeks pregnant at the time of exposure to bnt162b2. the patient is expected to deliver a baby(s) on 07dec2021. concomitant medication(s) included: folic acid taken for vitamin supplementation. vaccination history included: bnt162b2 (dose 1, batch/lot number: fa1027), administration date: 11jun2021, for covid-19 immunization, reaction(s): "maternal exposure during pregnancy, second trimester"; bnt162b2 (dose 2, batch/lot number: ff3319), administration date: 06aug2021, for covid-19 immunization, reaction(s): "maternal exposure during pregnancy, second trimester"; bnt162b2 (dose 2, batch/lot number: ff3319), administration date: 06aug2021, for covid-19 immunisation, reaction(s): "inappropriate schedule of vaccine administered". the following information was reported: maternal exposure timing unspecified (congenital anomaly), described as "maternal drug exposure". clinical course: patient has not had symptoms associated with covid-19 not had a covid-19 test. the reporters assessment of the causal relationship of the event with the suspect product 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 in the case report, a possible causal relationship between the reported event and the suspect drug bnt162b2 cannot be completely excluded. the impact of this report on the benefit/risk profile of the pfizer drug is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.,linked report(s) : gb-pfizer inc-202200342346 same patient, same product, different dose and different events;gb-pfizer inc-202200342345 same patient, same product, different dose and different events;gb-pfizer inc-202200329245 mother case;gb-pfizer inc-202200342345 same patient, same product, different dose and different events;gb-pfizer inc-202200329245 mother case

Lab Data
na
List of symptoms
maternal exposure timing unspecified
Patient Died?
No
Date Died
NA
Birth defect
true
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na