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VAERS ID	2583861
성별	남성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호	GJ1857
예방접종 횟수
접종일	2022-12-07
발병일	2023-01-30
상태	후유증

증상

이환 중 질병

지병

Medical History/Concurrent Conditions: Brain tumour operation; COVID-19

기타 의료

이전 예방접종

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임상 검사

Test Name: Investigation; Result Unstructured Data: Test Result:there was no meniere's disease; Test Name: MRI examination; Result Unstructured Data: Test Result:there was no abnormality

증상 상세

Light-headed feeling (unable to walk straight); This is a spontaneous report received from a contactable reporter(s) (Nurse).
A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.
4-5 (COMIRNATY RTU FOR BA.
4-5), on 07Dec2022 as dose number unknown (booster), 0.
3 ml single (Lot number: GJ1857, Expiration Date: 31Jul2023) intramuscular for covid-19 immunisation.
The patient's primary disease/complication was after brain tumour extraction operation.
The case was an employee of the same facility (PRIVACY), who was infected with COVID-19 in Aug2022.
The patient's concomitant medications were not reported.
Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 immunisation.
On 30Jan2023, the patient experienced light-headed feeling and unable to walk straight, so the patient went to the neurosurgery department of PRIVACY Hospital (a facility where the patient had previously had a brain tumor removed) and had an MRI examination, but there was no abnormality.
An examination was performed at an otolaryngology department (another facility other than PRIVACY Hospital, the name of the facility was unknown), but there was no meniere's disease.
In the future, the patient plans to undergo an examination at the otolaryngology department of PRIVACY hospital.
Even now, the patient was not recovered from his light-headed feeling and was absent from work.
The reporter classified the event as serious (Persistent or significant disability/ incapacity).
The reporter stated that the event was probably related to the BNT162B2, BNT162B2 OMI BA.
4-5.
; Sender's Comments: Based on the known the information available the Causal relation between the event Dizziness and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug 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.