이상반응 보고
| VAERS ID | 1466143 |
|---|---|
| 성별 | 여성 |
| 나이 | 66세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | SD0927 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-06-24 |
| 발병일 | 2021-06-25 |
| 상태 | 사망 |
증상
- 혼란 상태(Confusional state)
- 발열(Pyrexia)
- 의식 소실(Loss of consciousness)
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- 복통(Abdominal pain)
- 근육 약화(Muscular weakness)
- 코로나 바이러스 감염증 -19 : 코로나 19(COVID-19)
- 죽음(Death)
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임상 검사
Test Date: 20210625; Test Name: COVID PCR swab; Test Result: Positive
증상 상세
Abdominal pain; Fever; Weakness of lower limbs; Confusion; COVID polymerase chain reaction (PCR) swab: positive; died; Collapsed / Falling; This is a spontaneous report from a contactable other hcp.
A 66-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration on 24Jun2021 12:47 (Lot Number: SD0927; Expiration Date: Sep2021) as dose 1, single (at the age of 66-year-old) for COVID-19 immunisation.
The patient medical history and concomitant medications were not reported.
On 25Jun2021, the patient experienced abdominal pain on 25Jun2021 12:00, fever, weakness of lower limbs, confusion, collapsed/falling, the patient was reported to have died on 25Jun2021 while at home.
Test COVID polymerase chain reaction (PCR) swab: positive on 25Jun2021.
Outcome of abdominal pain, fever, weakness of lower limbs, confusion, collapsed/falling, COVID polymerase chain reaction (PCR) swab: positive was unknown.
Autopsy was reported to have been performed, results were not made available.
No further details were provided at the time of this report.
; Sender's Comments: The causal relationship between BNT162b2 and the events death, abdominal pain, pyrexia, muscular weakness, confusional state, loss of consciousness, and COVID-19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment.
This case will be reassessed once additional information becomes available.
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: died