이상반응 보고
| VAERS ID | 2193111 |
|---|---|
| 성별 | 남성 |
| 나이 | 82세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EW8904 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-04-07 |
| 발병일 | 2021-04-08 |
| 상태 | 입원 사망 |
증상
- 혼란 상태(Confusional state)
- 선회(Vertigo)
- 졸도(Syncope)
- 혈당(Blood glucose)
- 컴퓨터 단층 촬영 헤드(Computerised tomogram head)
- 저혈당(Hypoglycaemia)
- 정신 장애(Mental impairment)
- 백치(Dementia)
- 뇌경색(Cerebral infarction)
이환 중 질병
Hypertension; Type I diabetes mellitus
지병
Medical History/Concurrent Conditions: Drug allergy; Ulcerative colitis
기타 의료
이전 예방접종
알레르기
임상 검사
Test Name: BG; Result Unstructured Data: Test Result:11.
2 mmol/L; Comments: hypoglycemia; Test Name: cCT; Result Unstructured Data: Test Result:without symptoms
증상 상세
Cerebral infarction; Delusional schizoid dementia; vertigo; syncopes; confusion; 2 days after the first vaccination inpatient admission due to repeated syncope and confusion interpreted as hypoglycemia (BG on intake 11.
2 mmol/L); rapid mental degeneration; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority.
Regulatory number: DE-PEI-CADR2022283766.
Other Case identifier(s): DE-CADRPEI-2022283766, DE-PEI-202200089204.
A 82 year-old male patient received bnt162b2 (COMIRNATY), administration date 07Apr2021 (Lot number: EW8904) at the age of 82 years as dose 1, single for covid-19 immunisation.
Relevant medical history included: "Type I diabetes" (ongoing); "ulcerative colitis" (unspecified if ongoing); "hypertension" (ongoing); "Salofalk allergy" (unspecified if ongoing).
The patient's concomitant medications were not reported.
The following information was reported: HYPOGLYCAEMIA (death, hospitalization) with onset 08Apr2021, outcome "fatal", described as "2 days after the first vaccination inpatient admission due to repeated syncope and confusion interpreted as hypoglycemia (BG on intake 11.
2 mmol/L)"; CEREBRAL INFARCTION (death, hospitalization) with onset Jan2022, outcome "fatal", described as "Cerebral infarction"; MENTAL IMPAIRMENT (hospitalization) with onset 2021, outcome "unknown", described as "rapid mental degeneration"; DEMENTIA (hospitalization) with onset 21Dec2021, outcome "unknown", described as "Delusional schizoid dementia"; VERTIGO (hospitalization) with onset 21Sep2021, outcome "unknown", described as "vertigo"; SYNCOPE (hospitalization) with onset 08Apr2021, outcome "unknown", described as "syncopes"; CONFUSIONAL STATE (hospitalization) with onset 08Apr2021, outcome "unknown", described as "confusion".
The patient was hospitalized for hypoglycaemia, syncope, confusional state (start date: 09Apr2021); for cerebral infarction (start date: Jan2022); for dementia (start date: Dec2021); for vertigo (start date: Sep2021).
The patient underwent the following laboratory tests and procedures: blood glucose: 11.
2 mmol/L, notes: hypoglycemia; computerised tomogram head: without symptoms.
The patient date of death was 09Feb2022.
The reported cause of death was cerebral infarction and Hypoglycemia.
It was not reported if an autopsy was performed.
Additional information: 2 days after the 1st vaccination hospital admission due to multiple syncopes and confusion interpreted as hypoglycemia (BG 11.
2 mmol/L), cCT without symptoms.
Since this initial event rapid mental degradation, Sep21 again at hospital because of vertigo, Dec21 again hospital because of Delusional schizoid dementia, Jan22 and Feb22 cerebral infarction, died on 09Feb2022.
Before the first event, the patient was mentally active, still drove a car, was the organizer in the family.
Relatedness of drug to Hypoglycemia and Cerebral infarction assessed by Regulatory Authority with result of assessment Unclassifiable.
No follow-up attempts are possible.
No further information is expected.
; Reported Cause(s) of Death: Cerebral infarction; Hypoglycemia