이상반응 보고
| VAERS ID | 2003098 |
|---|---|
| 성별 | 남성 |
| 나이 | 77세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 3 |
| 접종일 | 2021-11-23 |
| 발병일 | 2021-11-23 |
| 상태 | 사망 |
증상
- 출혈(Haemorrhage)
- 면제(Immunisation)
- 국제 표준화 비율(International normalised ratio)
이환 중 질병
지병
Medical History/Concurrent Conditions: Fibrillation atrial (anticoagulated with Sintrom, last INR 3.9 on 17Nov2021); Hypertension; Living in residential institution
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20211117; Test Name: INR; Result Unstructured Data: Test Result:3.
9; Comments: i.
e.
, 7 days before death
증상 상세
Haemorrhage; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority.
Regulatory number: CH-SM-2021-29497.
A 77 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation; acenocoumarol (SINTROM), oral (Batch/Lot number: unknown) for anticoagulant therapy.
Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: anticoagulated with Sintrom, last INR 3.
9 on 17Nov2021; "Hypertension" (unspecified if ongoing); "The patient has been institutionalized since 2011", start date: 2011 (unspecified if ongoing).
The patient's concomitant medications were not reported.
Vaccination history included: Comirnaty (Dose 1, single, intramuscular, Lot number unknown), administration date: 01May2021, when the patient was 77 years old, for Covid-19 immunisation; Comirnaty (Dose 2, single, intramuscular, Lot number unknown), administration date: 05Jun2021, when the patient was 77 years old, for Covid-19 immunisation.
The following information was reported: IMMUNISATION (death, medically significant) with onset 23Nov2021, outcome "fatal", described as "Booster"; HAEMORRHAGE (death, medically significant) with onset 24Nov2021, outcome "fatal", described as "Haemorrhage".
The patient underwent the following laboratory tests and procedures: international normalised ratio: (17Nov2021) 3.
9, notes: i.
e.
, 7 days before death.
The patient date of death was 24Nov2021.
The reported cause of death was "The doctor who witnessed the death reported that the patient died in the toilet with the release of fresh blood, without specifying the source of the bleeding (high versus low).
", haemorrhage.
No autopsy was performed.
Additional information: "On 24Nov2021, less than 24 hours after vaccination, the patient died in his institution in circumstances for which we have only fragmentary data.
The doctor who witnessed the death reported that the patient died in the toilet with the release of fresh blood, without specifying the source of the bleeding (high versus low).
The staff of the institution reported no specific complaints in the days preceding the death.
The patient's chronic treatment included anticoagulation with Acenocoumarol (Sintrom).
The INR was measured at 3.
9 on 17Nov2021, i.
e.
, 7 days before death.
The posologies mentioned corresponded to the usual posologies administered to this patient.
An autopsy was not performed in agreement with the forensic pathologist and the judicial authority.
The exact cause of death is therefore not known to us.
" A causal relationship between Comirnaty and hemorrage was assessed by Swissmedic according to WHO as Unassessable/Unclassifiable.
A causal relationship between Sintrom and hemorrage was assessed by Regulatory Authority according to Regulatory Authority as possible.
Regulatory Authority assessed this case as serious with fatal outcome.
Discrepant information: Comirnaty was reported in structured fields as Concomitant medication, neverthless the fields were populated as for a suspect drug and also causality was provided (unassessable (unclassifiable)).
The lot number for bnt162b2 was not provided and will be requested during follow up.
; Reported Cause(s) of Death: The doctor who witnessed the death reported that the patient died in the toilet with the release of fresh blood, without specifying the source of the bleeding (high versus low).
; The doctor who witnessed the death reported that the patient died in th