이상반응 보고
| VAERS ID | 2578434 |
|---|---|
| 성별 | 알 수 없음 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 5 |
| 접종일 | |
| 발병일 | |
| 상태 | 사망 |
증상
- 죽음(Death)
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임상 검사
증상 상세
a patient died the next day after received Comirnaty bivalent BA.
4-5 as dose 5; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.
A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.
4-5 (COMIRNATY RTU FOR BA.
4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.
The patient's relevant medical history and concomitant medications were not reported.
Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunisation.
The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "a patient died the next day after received Comirnaty bivalent BA.
4-5 as dose 5".
The date and cause of death for the patient were unknown.
The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.
4-5 has been requested and will be submitted if and when received.
; Sender's Comments: Based on the limited available information in the case, the causal association between death of the patient and the suspect drug cannot be completely excluded.
The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
; Reported Cause(s) of Death: a patient died the next day after received Comirnaty bivalent BA.
4-5 as dose 5