이상반응 보고
| VAERS ID | 1462750 |
|---|---|
| 성별 | 남성 |
| 나이 | 66세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FC3661 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-06-24 |
| 발병일 | 2021-06-25 |
| 상태 | 사망 |
증상
- 순환기 허탈(Circulatory collapse)
- 대장염 허혈성(Colitis ischaemic)
이환 중 질병
지병
기타 의료
RISPERDAL; DEPAS [ETIZOLAM]; LENDORMIN; AMLODIPINE
이전 예방접종
알레르기
임상 검사
증상 상세
Acute circulatory failure; suspected ischaemic enterocolitis; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution.
The patient was a 66-year-old male.
The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
The patient received risperidone (RISPERDAL), etizolam (DEPAS), brotizolam (LENDORMIN), and amlodipine (AMLODIPINE) within 2 weeks of vaccination.
On 24Jun2021 at 13:30 (the day of vaccination), the patient received the dose 1, single (at the age of 66 years old) of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization at a nursing home.
On 25Jun2021 at 00:30 (1 day after the vaccination), the patient experienced acute circulatory failure and suspected ischaemic enterocolitis.
The events resulted in death.
The outcome of the events was fatal without treatment.
An autopsy was not performed.
The course of the events was as follows: About eleven (hours) after the vaccination, the patient defecated a large amount accompanied by bloody stools.
Thirteen hours after the vaccination, cardio-respiratory arrest was confirmed.
The assessment of causality between the events and BNT162b2 was not provided.
; Sender's Comments: A possible contributory role of the suspect drug to the reported events "Acute circulatory failure" and "suspected ischaemic enterocolitis" cannot be completely excluded based on temporal association.
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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
; Reported Cause(s) of Death: suspected ischaemic enterocolitis; Acute circulatory failure