이상반응 보고
| VAERS ID | 1843971 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FE2083 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-06-23 |
| 발병일 | |
| 상태 |
증상
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- SARS-CoV-2 테스트 양성(SARS-CoV-2 test positive)
- 코로나 바이러스 감염증 -19 : 코로나 19(COVID-19)
- 약물 효과 없음(Drug ineffective)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
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임상 검사
Test Name: COVID-19 PCR test; Test Result: Positive
증상 상세
Drug ineffective; COVID-19 PCR test positive; COVID-19; Maternal exposure during pregnancy, third trimester; This is a spontaneous report from a contactable other health professional downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number BE-FAMHP-DHH-N2021-108078.
This is the first of two reports.
Spontaneous COVID-19 report received by the regulatory authorities on 22Oct2021.
A 28-year-old pregnant female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: FE2083), dose 2 via an unspecified route of administration on 23Jun2021 as dose 2, single for COVID-19 immunization.
The patient medical history and concomitant medications were not reported.
The patient was 3 Trimester pregnant at the onset of the event.
Historical vaccine included COVID-19 vaccine (manufacturer unknown) dose 1 via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization.
On an unspecified date, the patient experienced drug ineffective, COVID-19 PCR test positive, COVID-19 and maternal exposure during pregnancy, third trimester.
The mother reported she became pregnant while taking bnt162b2.
The outcome of the events was unknown.
The complaint for ''PFIZER-BIONTECH COVID-19 mRNA VACCINE'' was investigated.
The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type.
The final scope was determined to be the associated lot(s) of the reported lot FE2083.
A complaint sample was not returned.
No related quality issues were identified during the investigation.
There is no impact on product quality, regulatory, validation and stability.
Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable.
The NTM process determined that no regulatory notification was required.
The reported defect could not be confirmed.
No root cause or CAPA were identified as the complaint was not confirmed.
No follow-up attempts possible.
No further information expected.
; Sender's Comments: Linked Report(s) : BE-PFIZER INC-202101503261 same patient, different drug dose, different event