이상반응 보고
| VAERS ID | 1477217 |
|---|---|
| 성별 | 여성 |
| 나이 | 91세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EY5420 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-06-25 |
| 발병일 | 2021-06-27 |
| 상태 | 입원 사망 |
증상
- 체온(Body temperature)
- 심장 마비(Cardiac arrest)
- 대 동맥류(Aortic aneurysm)
이환 중 질병
지병
Medical History/Concurrent Conditions: Pneumonia aspiration; Thoracic aortic aneurysm
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20210625; Test Name: body temperature; Result Unstructured Data: Test Result:36.
9 Centigrade; Comments: Before vaccination
증상 상세
Thoracic aortic aneurysm rupture; cardiac arrest; This is a spontaneous report from a contactable physician received from a regulatory authority.
Regulatory authority report number is v21117065.
The patient was a 91-year and 2-month-old female.
Body temperature before vaccination was 36.
9 degrees centigrade.
The patient had no particular family history.
On 20May2019, the patient was admitted to the reporting hospital for the treatment of aspiration pneumonia.
In 2020, the patient had thoracic aortic aneurysm, and the family understood the risk of sudden change due to the disease.
On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown).
On 25Jun2021 at 14:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as DOSE 2, SINGLE (received at the age of 91-years-old) for COVID-19 immunization.
On 27Jun2021 at 00:20 (one day/10 hours/5 minutes after the vaccination), the patient experienced thoracic aortic aneurysm rupture.
Since 20May2019 (before the vaccination), the patient was admitting to the hospital due to treatment for aspiration pneumonia.
On 27Jun2021 (2 days after the vaccination), the outcome of the event was fatal.
It was not reported if an autopsy was performed.
The course of the event was as follows: On 27Jun2021, at 00:20 (one day, 10 hours, and 5 minutes after vaccination), when a staff member visited the patient's room, she had haematemesis.
The blood was sucked, and a monitor was attached, and then, the patient was confirmed to have cardiac arrest.
The doctor on duty and the family were contacted.
After the family members arrived at the hospital, the patient was confirmed dead at 01:40 (one day, 11 hours, and 15 minutes after vaccination).
The reporting physician classified the event as serious (hospitalization and death) and assessed that the causality between the event and BNT162b2 as unassessable.
Other possible cause of the event such as any other diseases was the possibility of rupture of known thoracic aortic aneurysm.
The reporting physician commented as follows: Since it was at night, an imaging examination could not be performed.
However, it was considered that the patient died due to rupture of known thoracic aortic aneurysm (the disease was diagnosed in 2020, and at that time, the family was explained about the risk of sudden change due to the disease.
In addition, the family understood the necessity of BNT162b2 vaccination, and thus, the vaccination was performed this time).
; Reported Cause(s) of Death: Cardiac arrest; Thoracic aortic aneurysm rupture