이상반응 보고
| VAERS ID | 1533666 |
|---|---|
| 성별 | 남성 |
| 나이 | 86세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FA5765 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-06-25 |
| 발병일 | 2021-06-25 |
| 상태 | 사망 |
증상
- 가슴 통증(Chest pain)
- 산소포화도 감소(Oxygen saturation decreased)
- 청색증(Cyanosis)
- 변경된 의식 상태(Altered state of consciousness)
- 산소 포화도(Oxygen saturation)
- 심폐정지(Cardio-respiratory arrest)
- 급성 심부전(Cardiac failure acute)
이환 중 질병
지병
Medical History/Concurrent Conditions: Angina pectoris; Aortic stenosis; Aortic valve repair; Atrial fibrillation paroxysmal; Cardiac failure chronic.
기타 의료
CLOPIDOGREL; FUROSEMIDE; LIXIANA; BISOPROLOL FUMARATE; DIGOXIN
이전 예방접종
알레르기
임상 검사
Test Name: SpO2; Result Unstructured Data: Test Result: latter half of 80%; Comments: it was usually latter half of 80; Test Date: 20210625; Test Name: SpO2; Result Unstructured Data: Test Result: latter half of 70%.
증상 상세
cardiac failure acute; Cardio-respiratory arrest; consciousness disturbed; cyanosis; chest pain; the SpO2 was latter half of 70%; This is a spontaneous report from a contactable physician received from the Regulatory Authority.
Regulatory authority report number is v21121932.
An 86-year and 7-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration on 25Jun2021 at 15:00 at 86 years old as a single dose for COVID-19 immunization.
Body temperature before vaccination was not provided.
The patient had medical histories of aortic stenosis, cardiac failure chronic, angina pectoris, aortic valve surgery and atrial fibrillation paroxysmal.
The family history was not provided.
The concomitant medications included clopidogrel (tablet 75 mg) orally at 75 mg, furosemide (tablet 40mg) orally at 40 mg, edoxaban tosilate hydrate (LIXIANA, Orodispersible tablet 30 mg) orally at 30 mg, bisoprolol fumarate (tablet 2.
5 mg) orally at 2.
5 mg , and digoxin (tablet 0.
125 mg) orally at 0.
0625 mg (0.
5 tablet).
On 26May2021, the patient previously received the first dose of BNT162b2 (Lot number EX3617, Expiration date 31Aug2021) for COVID-19 immunization at 86 years old.
On 25Jun2021 (the day of the vaccination), the patient experienced chest pain.
On 26Jun2021 (one day after the vaccination), the patient experienced consciousness disturbed, cyanosis, and cardio-respiratory arrest.
The course of the event was as follows: On 25Jun2021 (the day of vaccination), at 15:00, the patient received the second dose of BNT162b2 vaccination.
After the patient went home, he experienced chest pain, and the SpO2 was latter half of 70% (it was usually latter half of 80%).
On 26Jun2021 (one day after vaccination), in the morning, the patient was found to have consciousness disturbed, and he had cyanosis.
While the patient was being transferred, he had cardio-respiratory arrest.
At 07:15 (one day after vaccination), the patient was confirmed to die.
The cause of death was considered as cardiac failure acute (as reported).
The patient originally had medical histories of aortic valve surgery and angina pectoris.
These symptoms were considered to be aggravated.
On 26Jun2021 at 7:15 (one day after the vaccination), the outcome of the events was fatal.
It was unknown if autopsy was performed.
The reporting physician classified the events as serious (death) and assessed that the events were unrelated to BNT162b2.
Other possible causes of the events such as any other diseases were cardiac valvulopathy and angina pectoris.
The reporting physician commented as follows: The patient originally had cardiac diseases and he was an elderly.
Thus, it was considered that the events was unrelated to BNT162b2 vaccination.
; Sender's Comments: There is no reasonable possibility of causal association between the event of Cardiac failure acute, Chest pain, Oxygen saturation decreased , Cardio-respiratory arrest, Altered state of consciousness , Cyanosis and the drug BNT162b2 .
The reported events are confounded by patient's history of aortic stenosis, cardiac failure chronic, angina pectoris, aortic valve surgery and atrial fibrillation paroxysmal.
; Reported Cause(s) of Death: chest pain; the SpO2 was latter half of 70%; Cardio-respiratory arrest; consciousness disturbed; cyanosis; cardiac failure acute