이상반응 보고
| VAERS ID | 2294304 |
|---|---|
| 성별 | 여성 |
| 나이 | 38세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EY0581 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-08-24 |
| 발병일 | 2021-08-24 |
| 상태 |
증상
- 부적절한 제품 관리 일정(Inappropriate schedule of product administration)
- 사산(Stillbirth)
- 주사(Scan)
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임상 검사
Test Date: 20211206; Test Name: Scan; Result Unstructured Data: Test Result:12 weeks pregnant; Comments: conception began Sep2021
증상 상세
Still born baby.
Baby delivered at 25 weeks pregnant; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).
The reporter is the patient.
A 38-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 24Aug2021 as dose 2, single (Lot number: EY0581) at the age of 38 years for covid-19 immunisation.
The patient was 25 weeks pregnant at the event onset.
The patient's relevant medical history and concomitant medications were not reported.
Vaccination history included: comirnaty (Dose number: 1, Batch/Lot no: FE2090), administration date: 30Jun2021, for COVID-19 immunisation, reaction(s): "Drug ineffective", "Suspected COVID-19".
The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; STILLBIRTH (medically significant), outcome "unknown", described as "Still born baby.
Baby delivered at 25 weeks pregnant".
The event "still born baby.
baby delivered at 25 weeks pregnant" required physician office visit.
The pregnancy resulted in still birth.
The fetal outcome is neonatal death.
The patient underwent the following laboratory tests and procedures: Scan: (06Dec2021) 12 weeks pregnant, notes: conception began Sep2021.
The patient reported that this was her fourth pregnancy, 4th child and at 20 weeks pregnant, doctors picked up fatal abnormalities with baby and at 25 weeks baby was delivered stillborn.
The patient conceived 2 weeks after the 2nd Pfizer dose.
Sender's Comments: Linked Report(s) : ZA-PFIZER INC-202200748105 Fetus Case;ZA-PFIZER INC-202200748104 Same Reporter/Patient, different Dose/Events.