이상반응 보고
| VAERS ID | 1829604 |
|---|---|
| 성별 | 남성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EY0579 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-06-18 |
| 발병일 | |
| 상태 |
증상
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 출생 시 길이(Length at birth)
- 신생아 황달(Jaundice neonatal)
- 출생 체중 정상(Birth weight normal)
- 머리 둘레 보통(Head circumference normal)
이환 중 질병
지병
기타 의료
PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]
이전 예방접종
알레르기
임상 검사
Test Name: Head circumference at birth; Result Unstructured Data: Test Result:within normal limit; Test Name: Length at birth; Result Unstructured Data: Test Result:within normal limit; Test Name: Weight at birth; Result Unstructured Data: Test Result:within normal limit
증상 상세
mother received BNT162B2; jaundice; This is a spontaneous report from a contactable physician.
This physician reported information for both mother and fetus/baby.
This is a fetus/baby report.
A neonate male patient of an unspecified age was exposed to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via transplacental when its 39-year-old mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 39 years old) intramuscular administered in the left deltoid on 18Jun2021 (Batch/Lot Number: EY0579) as dose 2, single for covid-19 immunization.
The patient's medical history was not reported.
The mother's medical history included 2 previous pregnancies (2 newborn in previous pregnancies), shingles from Nov2020 to Dec2020 with treatment with acyclovir and ongoing thyroid nodule from 2017.
Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).
The mother previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in left deltoid on 11Apr2021 (Lot: EW 3344) for covid-19 immunization.
The patient experienced jaundice requiring phototherapy on an unspecified date.
The events were assessed as medically significant.
The patient's weight at birth, length at birth and head circumference at birth were all within normal limit.
The outcome of the events was unknown.
No follow-up attempts are needed.
No further information is expected.
; Sender's Comments: Based on possible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events.
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) : PFIZER INC-2021422189 mother case; PFIZER INC-202101138943 mother case