이상반응 보고
| VAERS ID | 1442106 |
|---|---|
| 성별 | 여성 |
| 나이 | 84세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FC3661 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-06-24 |
| 발병일 | 2021-06-24 |
| 상태 | 사망 |
증상
- 호흡곤란(Dyspnoea)
- 창백(Pallor)
- 심박수 감소(Heart rate decreased)
- 체온(Body temperature)
- 심폐정지(Cardio-respiratory arrest)
- 심근허혈(Myocardial ischaemia)
- 고뇌의 호흡(Agonal respiration)
이환 중 질병
Aortic dissection (under treatment); Marrow dysplasia (under treatment)
지병
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.
7 Centigrade; Comments: Before vaccination
증상 상세
Pallor facial; breathing difficulty; cardio-respiratory arrest at the time of visit to a hospital; suspected ischaemic heart disease; agonal respiration; no effective heartbeat was noted; This is a spontaneous report from a contactable physician received from the Regulatory Authority.
Regulatory authority report number is v21116343.
The patient was an 84-year and 8-month-old female.
Body temperature before vaccination was 36.
7 degrees Centigrade.
Medical history (current diseases) included abdominal aortic aneurysm dissection and marrow dysplasia (under treatment).
Concomitant medications and family history were not provided.
On 24Jun2021 at 18:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot# FC3661, Expiration date: 30Sep2021) an unspecified route of administration as a single dose for COVID-19 immunization.
On 24Jun2021 at 20:00 (2 hours after the vaccination), the patient experienced pallor facial, breathing difficulty and cardio-respiratory arrest at the time of visit to a hospital.
On 24Jun2021 at 22:14 (4 hours and 14 minutes after the vaccination), the patient died.
It was not reported if an autopsy was performed.
The course of the events was as follows: The patient was regularly visiting the hematology department of a medical facility.
On 24Jun2021 from 09:00 to 16:00, she went to a facility for daycare service.
When she got home, she looked exhausted.
Afterwards, she received the vaccination at a hospital (different from the reporter's), and then she returned home.
At around 20:00, when she left the bathroom, she developed pallor facial and breathing difficulty, and so an emergency service was requested.
When the emergency team treated the patient, agonal respiration appeared.
Therefore, CPK (as reported) was performed.
Drip infusion and administration of noradrenaline were also performed, then return of spontaneous circulation was seen.
However, after arriving at the hospital, no effective heartbeat was noted.
The intention for DNAR (do-not-attempt-resuscitation) was confirmed.
At around 22:00, her heartbeat was lost.
At 22:14, the patient's death was confirmed.
The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the events and bnt162b2 as unassessable.
There was no other possible cause of the events such as any other diseases.
The reporting physician commented as follows: CT performed at the time of visit to the hospital showed changes in her lung, and no distinction between changes due to the resuscitation and those caused by pulmonary edema/pneumonia could be made.
It was difficult to identify the cause of death, but it was considered to be suspected ischaemic heart disease.
The causal relationship with bnt162b2 was unknown.
The outcome of event cardio-respiratory arrest at the time of visit to a hospital and suspected ischaemic heart disease was fatal.
The outcome of other event was unknown.
The patient died on 24Jun2021.
It was not reported if an autopsy was performed.
; Reported Cause(s) of Death: cardio-respiratory arrest at the time of visit to a hospital; suspected ischaemic heart disease