이상반응 보고
| VAERS ID | 1489877 |
|---|---|
| 성별 | 남성 |
| 나이 | 76세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | F00927 |
| 예방접종 횟수 | |
| 접종일 | 2021-06-25 |
| 발병일 | 2021-06-26 |
| 상태 | 사망 |
증상
- 떨어지다(Fall)
- 피부 열상(Skin laceration)
- 머리 부상(Head injury)
- 심장 장애(Cardiac disorder)
- 폐부종(Pulmonary oedema)
- 뇌혈관 장애(Cerebrovascular disorder)
이환 중 질병
지병
Medical History/Concurrent Conditions: Carotid endarterectomy; Diabetes mellitus; Heart disease, unspecified; Hypercholesterolaemia; Hypertension; Penicillin allergy; Transient ischaemic attacks (3 previous)
기타 의료
PREDNISONE; AUSTELL-LISINOPRIL [LISINOPRIL DIHYDRATE]; VERAHEXAL; CIPLA SIMVASTATIN; RIDAQ; ECOTRIN; TREPILINE [AMITRIPTYLINE HYDROCHLORIDE]; DIAPHAGE; GLYGARD
이전 예방접종
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임상 검사
증상 상세
Lungs oedematous; possible head injury from a fall; possible head injury from a fall; laceration on his nasal bridge; Cerebrovascular disease; Cardiac disease; This is a spontaneous report from a contactable physician.
A 76-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: F00927; Expiration Date: 30Sep2021), via an unspecified route of administration on 25Jun2021 14:35 (at the age of 76 years old) as dose number unknown, single for COVID-19 immunization.
Medical history included hypercholesterolaemia, heart disease, diabetes mellitus, hypertension, and he also had three previous transient ischaemic attacks, penicillin allergy, and a right carotid endarterectomy.
Concomitant medications included prednisone, lisinopril dihydrate (AUSTELL-LISINOPRIL), verapamil hydrochloride (VERAHEXAL), simvastatin (CIPLA SIMVASTATIN), hydrochlorothiazide (RIDAQ), acetylsalicylic acid (ECOTRIN), amitriptyline hydrochloride (TREPILINE), metformin hydrochloride (DIAPHAGE) and gliclazide (GLYGARD).
The patient's cause of death is reported to be cerebrovascular disease and cardiac disease on 26Jun2021.
The patient was also found to have oedematous lungs on an unspecified date.
The patient was found deceased on 26Jun2021 with rigor mortis partially set in.
It is reported that the patient soon attempted to perform CPR, possible head injury from a fall, found in a pool of blood.
As per the doctors communication mail, this deceased was a 76 year old man with a history of diabetes, hypertension, hypercholesterolaemia, and heart disease.
He had also had three previous transient ischaemic attacks and a right carotid endarterectomy.
The vaccine site was noted.
There was no rash or oedema externally.
He had a laceration on his nasal bridge (likely occurred when he collapsed).
There was no intracranial injury.
He had severe multifocal atherosclerosis in his Circle of Willis, with evidence of remote infarction.
There was an ulcerated plaque at the bifurcation of the right carotid artery, with no fresh thrombus.
The heart was dilated and very heavy (610g) with significant coronary artery disease and an old infarct in the posterior left ventricle.
The lungs were oedematous.
COD is natural: cerebrovascular and cardiac disease.
This is not a Sudden/Unexpected death at all.
It would have been best dealt with by conducting a 'verbal autopsy', and signed out by his physician.
The outcome of the events Cerebrovascular disease and Cardiac disease were fatal while the outcome of the rest of the events was unknown.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association.
However, underlying medical conditions may provide the alternate explanations.
The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
; Reported Cause(s) of Death: Cardiac disease; Cerebrovascular disease