이상반응 보고
| VAERS ID | 1633670 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FD4555 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-31 |
| 발병일 | 2021-07-31 |
| 상태 | 입원 |
증상
- 태아 모니터링(Foetal monitoring)
- 태아 사망(Foetal death)
- 초음파 태아(Ultrasound foetal)
- 오프 라벨 사용(Off label use)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 배아 생존력 감소(Decreased embryo viability)
- 태반 기능 부전(Placental insufficiency)
이환 중 질병
지병
Medical History/Concurrent Conditions: Asthma; Obsessive-compulsive disorder
기타 의료
SERTRALIN ACCORD; INNOVAIR
이전 예방접종
알레르기
임상 검사
Test Date: 20210803; Test Name: Cardiotocography; Result Unstructured Data: Test Result:gave suspicion of affected fetus; Test Date: 20210803; Test Name: Ultrasound fetal; Result Unstructured Data: Test Result:shows severely affected blood flow
증상 상세
Dead fetus; Severe impact on the blood supply to the fetus; Feels less life from the fetus; Maternal exposure during pregnancy; off-label; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0082469.
This is the first of two reports, only this one is serious.
A 31-year-old pregnant female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: FD4555, pregnant at the time of vaccination) via intramuscular route of administration on 31Jul2021 (age at the time of vaccination was not provided) as DOSE 2, SINGLE for covid-19 immunisation.
The patient's medical history included was obsessive-compulsive disorder from 2017 to an unspecified stop date and asthma from an unspecified date to an unspecified date and unknown if ongoing.
The concomitant medications included sertraline hydrochloride (SERTRALIN ACCORD, 100mg) 100mg 1x/day, taken for obsessive-compulsive disorder from 2017 to an unspecified stop date, beclomethasone dipropionate, formoterol fumarate (INNOVAIR, beclomethasone dipropionate 200 ug, formoterol fumarate 6 ug) at 2 DF, 1x/day, taken for asthma from 2018 to an unspecified stop date.
The historical vaccine included as received bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6134 and Expiration date: 30Apr2021) dose 1, via an unspecified route of administration on 15Jan2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced maternal exposure during pregnancy and off label use on 15Jan2021.
On 02Aug2021, the patient experienced dead fetus, severe impact on the blood supply to the fetus, feels less life from the fetus.
On 31Jul2021, the patient had maternal exposure during pregnancy, and off-label use.
The mother reported she became pregnant while taking bnt162b2.
The mother was 30 Weeks pregnant (Gestation Period 30 weeks) at the onset of the event.
The patient underwent lab tests and procedures which included foetal monitoring: gave suspicion of affected fetus on 03Aug2021, ultrasound foetal: shows severely affected blood flow on 03Aug2021.
The ADRs were by the reporter reported as resulting in hospitalisation.
The ADRs were by the reporter reported as resulting in hospitalisation and it was unknown if any treatment due to the ADRs was reported.
The outcome of the events dead fetus, Severe impact on the blood supply to the fetus, and feels less life from the fetus was not recovered and event maternal exposure during pregnancy was recovered on 31Jul2021 and while for off-label use it was unknown.
No follow-up attempts possible.
No further information expected.
; Sender's Comments: Linked Report(s) : DK-PFIZER INC-202101053823 1st/2nd dose