이상반응 보고
| VAERS ID | 2247406 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FM3289 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-12-15 |
| 발병일 | 2021-12-16 |
| 상태 | 입원 중증 회복 |
증상
- 병(Illness)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 전자간증(Pre-eclampsia)
이환 중 질병
지병
기타 의료
MULTIVITAMINS [VITAMINS NOS]; OMEGA 3 [FISH OIL;VITAMIN E NOS]
이전 예방접종
알레르기
임상 검사
증상 상세
Pre-eclampsia; maternal exposure during pregnancy, third trimester; ILLNESS; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Medicines Agency () -WEB.
Regulatory number: NO-NOMAADVRE-PASRAPP-2022-Vgr7g7 ().
A 28-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 15Dec2021 as dose 1, single (Lot number: FM3289) intramuscular, in left arm for covid-19 immunisation.
The patient's relevant medical history was not reported.
The patient was 3 trimester pregnant at the time of exposure to BNT162b2.
The patient was 3 trimester pregnant at the event onset.
Concomitant medication(s) included: MULTIVITAMINS [VITAMINS NOS]; OMEGA 3 [FISH OIL;VITAMIN E NOS].
The following information was reported: PRE-ECLAMPSIA (hospitalization, life threatening) with onset 16Dec2021, outcome "recovered" (31Dec2021); MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "maternal exposure during pregnancy, third trimester"; ILLNESS (non-serious), outcome "unknown".
The events "pre-eclampsia" and "illness" required physician office visit.
Clinical course: The reactions/case was considered to be Serious due to Life Threatening and Hospitalization Required.
The Center did not provide a causality assessment.
Reporter Comment: The patient reports contact with physician.
The patient reported sick leave due to the events.
The patient wrote that it's hard to know if there is any relation of the event with the vaccine, but she shares her personal knowledge about people who had a sudden PRE-ECLAMPSIA within 1-3 days after the vaccine.
The patient didn't have any symptoms prior to vaccination.
She got suddenly ILL and had to give birth by EMERGENCY CAESAREAN SECTION on 31Dec2021.
She reports being HOSPITALIZED for about 14 days due to the event.
No follow-up attempts are possible.
No further information is expected.
; Reporter's Comments: The patient reports contact with physician.
patient reported sick leave due to the events.
patient wrote that it's hard to know if there is any relation of the event with the vaccine, but she shares her personal knowledge about people who had sudden pre-eclampsia within 1-3 dys after the vaccine.
patient didn't have any symptoms prior to vaccination.
She got suddenly ILL & had to give birth by emergency Csection on 31Dec2021.
She reports being hospitalized for about 14 days due to the event.
; Sender's Comments: Linked Report(s) : NO-NOMAADVRE-E2B_00081150 NOMA;NO-NOMAADVRE-PASRAPP-2022-Vgr7g7