이상반응 보고
| VAERS ID | 1826949 |
|---|---|
| 성별 | 알 수 없음 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FF0688 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-17 |
| 발병일 | 2021-09-10 |
| 상태 |
증상
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 조산아(Premature baby)
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임상 검사
증상 상세
Maternal Exposure During Pregnancy, second trimester; Birth premature; This is a spontaneous report from a contactable consumer (parent).
This is the second of two reports.
The first report is a report downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00695732.
This consumer reported information for both mother and fetus.
This is a fetus report.
A neonate patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 2 transplacental on 17Jul2021 (Lot Number: FF0688) as DOSE 2, SINGLE for COVID-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (BOOSTRIX POLIO), transplacental on 08Jul2021 (Lot Number: AC37B381AC), at unspecified dose for pertussis immunisation.
The patient medical history and concomitant medications were not reported.
The patient's mother received the first dose of COMIRNATY on 08Jun2021 with no adverse reactions.
The patient's mother was not diagnosed with COVID-19 prior to vaccination.
The patient experienced maternal exposure during pregnancy, second trimester on an unspecified date.
The diphtheria vaccination took place at a pregnancy duration of 22 weeks, the covid-19 vaccination took place at a pregnancy duration of 27 weeks.
On 10Sep2021, the patient's mother had a birth premature, 5 weeks early.
The patient's mother was supposed to be due on 14Oct2021, but the water broke and had birth premature.
The events were assessed as serious (medically significant).
Outcome of the events was unknown.
Sender's comment: Since the nature of the reported reaction does imply seriousness according to one of the resource criteria, the reaction birth premature (5 weeks early) was considered as serious by the Regulatory Authority.
Reporter's comments: Past drug therapy: BioNTech/Pfizer vaccine (Comirnaty): ADRs: No.
No follow-up attempts are possible.
No further information is expected.
; Reporter's Comments: Past drug therapy: BioNTech/Pfizer vaccine (Comirnaty): ADRs: No.
; Sender's Comments: Linked Report(s) : NL-PFIZER INC-202101370256 maternal case