이상반응 보고
| VAERS ID | 1847124 |
|---|---|
| 성별 | 알 수 없음 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 1 |
| 접종일 | |
| 발병일 | |
| 상태 |
증상
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 대동맥 협착증(Aortic stenosis)
- 태아 심장 장애(Foetal cardiac disorder)
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임상 검사
증상 상세
Vitium cordis(Double outlet right ventricle with large VSD, aortic isthmus stenosis); Vitium cordis(Double outlet right ventricle with large VSD, aortic isthmus stenosis); patient's mother received the 1st vaccination in the 23rd week of pregnancy; This is a spontaneous report from a non-contactable physician based on information received by regulatory authority [manufacturer control number: 94206, license party for COMIRNATY.
This physician reported information for both mother and fetus/baby.
This is a fetus/baby report.
This is the second of two reports.
A fetus patient of an unspecified gender received the first dose bnt162b2 (COMIRNATY, solution for injection) transplacental on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.
The patient's medical history and concomitant medications were not reported.
Patient's mother received the 1st vaccination 1 week before ovulation and is in the 23rd week of pregnancy at the time of report.
On an unspecified date, the patient (fetus) had severe Vitium cordis (Double outlet right ventricle with large VSD, aortic isthmus stenosis).
The outcome of the events was unknown.
No follow-up attempts are possible, information about lot/batch number cannot be obtained.
No further information is expected.
; Sender's Comments: Based on the information in the case report, a possible causal relationship between fetal cardiac disorder, aortic stenosis , maternal exposure during pregnancy and suspect drug BNT162B2 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.
,Linked Report(s) : DE-PFIZER INC-202101438376 mother case