이상반응 보고
| VAERS ID | 1576496 |
|---|---|
| 성별 | 알 수 없음 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FD8813 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-31 |
| 발병일 | 2021-07-31 |
| 상태 |
증상
- 태아 운동저하증(Foetal hypokinesia)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
이환 중 질병
지병
기타 의료
ASPIRIN (E.C.); CITALOPRAM; ESOMEPRAZOLE; FOLIC ACID
이전 예방접종
알레르기
임상 검사
증상 상세
Maternal exposure during pregnancy; Fetal movements decreased; YELLOW CARD VACCINE MONITOR This is a solilcited report from the regulatory authority from a contactable consumer.
This is the second of two reports.
The first report was downloded from the regulatory authority.
Regulatory authority report number { GB-MHRA-YCVM-202108010809315380-IJHYY }, Safety Report Unique Identifier GB-MHRA-ADR 25737819.
This consumer reported information for both mother and fetus.
This is a fetus report.
A 29 year old pregnant consumer received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), on 31Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation.
The consumer's concomitant medications included acetylsalicylic acid (ASPIRIN (E.
C.
)) taken for an unspecified indication, citalopram taken for an unspecified indication,; esomeprazole taken for an unspecified indication, and folic acid taken for vitamin supplementation.
The pregnancy estimated due date is 21Oct2021.
The consumer experienced fetal movements decreased on 31Jul2021.
The event was consdered medically significant.
The outcome was not recovered.
The reporter's 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 available information in the case, the causal association between the events foetal hypokinesia, maternal exposure during pregnancy and the suspect drug BNT162B2 cannot be excluded.
The case will be reassessed once new information is available.
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.
,Linked Report(s) : GB-PFIZER INC-202100984741 Maternal Case