이상반응 보고
| VAERS ID | 1530361 |
|---|---|
| 성별 | 여성 |
| 나이 | 30세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EY7015 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-05-09 |
| 발병일 | 2021-05-24 |
| 상태 | 입원 사망 |
증상
- 두통(Headache)
- 호흡 정지(Respiratory arrest)
- 허혈성 뇌졸중(Ischaemic stroke)
- 뇌간 경색(Brain stem infarction)
이환 중 질병
지병
기타 의료
EFECTIN; ATYWIA
이전 예방접종
알레르기
임상 검사
증상 상세
Breathing arrested/respiratory arrest.
; Ischaemic stroke; Brain stem infarction/brainstem ischemic stroke; Headache, back part of the head; This is a spontaneous report from a contactable consumer (fiance of the patient) downloaded from the Regulatory authority.
Report number PL-URPL-DML-MLP.
4401.
2.
460.
2021.
A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09May2021 (at the age of 30-year-old)(Batch/Lot Number: EY7015) as dose 2, single for covid-19 immunisation.
The patient medical history was not reported.
Concomitant medications included venlafaxine hydrochloride (EFECTIN) taken as antidepressant therapy from Sep2019 to 05Jun2021; and dienogest, ethinylestradiol (ATYWIA) taken as contraception from Oct2015 to 05Jun2021.
The patient received first dose of bnt162b2 on an unspecified date for covid-19 immunisation.
The patient received two doses approximately 30 days.
On 24May2021, the patient experienced headache at back part of the head which was persisting for 12 days (24May2021 to 05Jun2021).
On 05Jun2021, the patient experienced brain stem infarction/brainstem ischemic stroke.
On 12Jun2021, the patient had another ischemic stroke.
The patient was hospitalized from 05Jun2021 to 21Jun2021.
The reporter marked the criterion for reporting a severe death and hospitalization.
The patient died on 21Jun2021.
The cause of death given by the reporter was respiratory arrest.
An autopsy was not performed.
Sender's comments: ischemic stroke, which can manifest as headache and result in respiratory arrest, is an unexpected effect of the Comirnaty vaccine.
There is currently no correlation between Comirnaty vaccine administration and thromboembolic events.
Although headache is included in the Comirnaty Summary of Product Characteristics, it should be associated with the occurrence of stroke in this case.
There is a temporal relationship between the administration of the vaccine and the onset of symptoms.
The submitter marked the criterion for severe notification death and hospitalization.
Regulatory authority classified the notification as severe.
Reaction(s) / Event(s) Assessed by Regulatory authority.
Method of assessment: WHO, Result of Assessment: unlikely.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Based on limited information in the case , the reported events and the suspect drug BNT162B2 cannot be totally excluded or assess.
Case reassess once additional information becomes available.
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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
; Reported Cause(s) of Death: Breathing arrested/respiratory arrest