이상반응 보고
| VAERS ID | 2293013 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FJ5973 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-12-01 |
| 발병일 | 2021-12-01 |
| 상태 | 입원 |
증상
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 태반의 조기 분리(Premature separation of placenta)
- 임신 중 출혈(Haemorrhage in pregnancy)
이환 중 질병
지병
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
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임상 검사
증상 상세
I immediately had to have an emergency surgery in order not to bleed out; On 01Dec2021 I was vaccinated for the first time BioNTech during my pregnancy and on 25Dec2021 my placenta completely separated; I was vaccinated in the 7th month; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB.
The reporter is the patient.
Regulatory number: DE-PEI-CADR2022274624.
Other Case identifier(s): DE-CADRPEI-2022274624 (web portal), DE-PEI-202200075781.
A 41-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 01Dec2021 as dose 1, 0.
3 ml single (Lot number: FJ5973) for covid-19 immunisation.
The patient had no relevant medical history.
The patient was 7 months pregnant at the time of exposure to BNT162b2.
The patient was 7 months pregnant at the event onset.
The patient did not had any known allergies.
The patient's concomitant medications were not reported.
The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization) with onset 01Dec2021, outcome "unknown", described as "I was vaccinated in the 7th month"; PREMATURE SEPARATION OF PLACENTA (hospitalization, medically significant) with onset 25Dec2021, outcome "unknown", described as "On 01Dec2021 I was vaccinated for the first time BioNTech during my pregnancy and on 25Dec2021 my placenta completely separated"; HAEMORRHAGE IN PREGNANCY (hospitalization, medically significant) with onset 25Jan2022, outcome "unknown", described as "I immediately had to have an emergency surgery in order not to bleed out".
Therapeutic measures were taken as a result of premature separation of placenta, haemorrhage in pregnancy.
Clinical course: It was reported that on 01Dec2021 patient was vaccinated in the 7th month and on 25Dec2021 the placenta completely separated so that patient immediately had to have an emergency surgery in order not to bleed out.
Before that patient had no complaints and the pregnancy was uneventful.
Event assessment: Comirnaty/event /The Regulatory Authority/Result of Assessment: D.
Unclassifiable for event: Premature placental detachment.
No follow-up attempts are possible.
No further information is expected.