이상반응 보고
| VAERS ID | 1320061 |
|---|---|
| 성별 | 남성 |
| 나이 | |
| 주 코드 | |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | |
| 접종일 | |
| 발병일 | 2021-04-13 |
| 상태 | 후유증 |
증상
- 난청 신경 감각(Deafness neurosensory)
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임상 검사
증상 상세
Sudden sensorineural hearing loss; This is a spontaneous report from a contactable physician.
An 84-year-old male patient received bnt162b2 (Pfizer COVID 19 vaccine) at the age of 84 years old, via an unspecified route of administration on an unspecified date (Lot Number: Unknown) at single dose for COVID-19 immunization.
The patient's medical history was not reported.
The patient was not diagnosed with COVID-19 prior to vaccination.
The patient's concomitant medications were not reported.
The patient experienced sudden sensorineural hearing loss on 13Apr2021.
Seriousness criterion was reported as disability.
The event resulted in doctor or other healthcare professional office/clinic visit.
The patient received high dose prednisone as treatment.
The patient has not been tested for COVID-19 since the vaccination.
The outcome of event was not resolved.
Information about lot/batch number has been requested.
; Sender's Comments: As there is limited information in the case provided, the causal association between the event sudden sensorineural hearing loss and the suspect vaccine BNT162B2 cannot be excluded.
The case will be reassessed once new information is 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.