이상반응 보고
| VAERS ID | 2088638 |
|---|---|
| 성별 | 알 수 없음 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FE8405 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-30 |
| 발병일 | 2021-06-18 |
| 상태 |
증상
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- Arnold-Chiari 기형(Arnold-Chiari malformation)
- 태아 기형(Foetal malformation)
- 수막척수류(Meningomyelocele)
이환 중 질병
지병
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임상 검사
증상 상세
Diagnosis at 21 weeks gestation: Chiari II malformations.
; Further diagnostics revealed a complex malformation syndrome.
; Diagnosis at 21 weeks gestation: large cystic fetal lumbosacral myeleomeningocele; Maternal exposure during pregnancy, first trimester (2nd week of pregnancy); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority.
Regulatory number: DE-PEI-CADR2021201195 (Agency).
Other Case identifier(s): DE-CADRPEI-2021201195 (Agency Webportal), DE-PEI-202100225507 (Agency).
A patient (no qualifiers provided) was exposed to bnt162b2 (COMIRNATY, solution for injection, strength: 0.
3ml), transplacental, administration date 30Jul2021 (Lot number: FE8405) as dose 2, single and transplacental, administration date 18Jun2021 (Lot number: FD9234) as dose 1, single for covid-19 immunisation.
The mother of the patient was 33 year-old.
The mother was 1 months pregnant at the event onset.
The mother's relevant medical history and concomitant medications were not reported.
The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant) with onset 18Jun2021, outcome "unknown", described as "Maternal exposure during pregnancy, first trimester (2nd week of pregnancy)"; ARNOLD-CHIARI MALFORMATION (congenital anomaly, medically significant), outcome "unknown", described as "Diagnosis at 21 weeks gestation: Chiari II malformations.
"; FOETAL MALFORMATION (congenital anomaly, medically significant), outcome "unknown", described as "Further diagnostics revealed a complex malformation syndrome.
"; MENINGOMYELOCELE (congenital anomaly, medically significant), outcome "unknown", described as "Diagnosis at 21 weeks gestation: large cystic fetal lumbosacral myeleomeningocele".
Diagnosis at 21 weeks gestation: large cystic foetal lumbosacral myeleomeningocele + Chiari II malformations.
Further diagnostics revealed a complex malformation syndrome.
1st vaccination: week 2 of pregnancy; 2nd vaccination: week 8 of pregnancy.
Relatedness of Comirnaty to Myelomeningocele, Foetal malformation, Arnold-Chiari malformation type II was assessed by Agency as D.
unclassifiable.
The reporter's assessment of the causal relationship of the Myelomeningocele, Foetal malformation, Arnold-Chiari malformation type II with BNT162B2 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; information about lot/batch number cannot be obtained.
No further information is expected.
; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202200172887 mother/foetus case