이상반응 보고
| VAERS ID | 2568856 |
|---|---|
| 성별 | 남성 |
| 나이 | 66세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | GJ2674 |
| 예방접종 횟수 | 5 |
| 접종일 | 2023-01-18 |
| 발병일 | 2023-01-20 |
| 상태 | 사망 |
증상
- 체온(Body temperature)
- 심폐정지(Cardio-respiratory arrest)
이환 중 질병
지병
Medical History/Concurrent Conditions: Hospitalization NOS (The patient was under hospitalization for nearly 10 years from Nov2012 at that time.); Schizophrenia
기타 의료
HALOPERIDOL; LEMBOREXANT; NITRAZEPAM
이전 예방접종
알레르기
임상 검사
Test Date: 20230118; Test Name: Body temperature; Result Unstructured Data: Test Result:36.
7 Centigrade; Comments: before vaccination
증상 상세
Cardio-respiratory arrest; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority.
Regulatory number: v2210003671 (RA).
A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.
4-5 (COMIRNATY RTU FOR BA.
4-5), on 18Jan2023 at 13:00 as dose 5 (booster), single (Lot number: GJ2674, Expiration Date: 31Jan2024) at the age of 66 years for covid-19 immunisation.
The patient's relevant medical history included: "schizophrenia" (unspecified if ongoing); "hospitalization", start date: Nov2012 (unspecified if ongoing), notes: The patient was under hospitalization for nearly 10 years from Nov2012 at that time.
Concomitant medication(s) included: HALOPERIDOL taken for schizophrenia (ongoing); LEMBOREXANT taken for schizophrenia (ongoing); NITRAZEPAM taken for schizophrenia (ongoing).
Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunisation.
The following information was reported: CARDIO-RESPIRATORY ARREST (death) with onset 20Jan2023, outcome "fatal".
The patient underwent the following laboratory tests and procedures: Body temperature: (18Jan2023) 36.
7 Centigrade, notes: before vaccination.
The patient date of death was 20Jan2023.
Reported cause of death: "Cardio-respiratory arrest".
It was not reported if an autopsy was performed.
The course of the event was as follows: On 20Jan2023 at around 11:00 (2 days after the vaccination), the patient experienced the unspecified event.
On 20Jan2023 (2 days after the vaccination), the outcome of the event was fatal.
The patient was under hospitalization for nearly 10 years from Nov2012 at that time.
The patient received the ongoing treatment with haloperidol 4 mg/day, lemborexant 2.
5 mg/day, and nitrazepam 5 mg/day for schizophrenia.
Since no other diseases were noted, the patient received the 5th dose of COVID-19 vaccine on 18Jan2023.
On 20Jan2023, the patient was found in a state of cardio-respiratory arrest while taking a bath.
The reporting physician classified the event as serious (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 schizophrenia.
; Reported Cause(s) of Death: Cardio-respiratory arrest