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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: killed himself; tinnitus; contracted the virus; contracted the virus; This is a spontaneous report from a non-contactable nurse. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included COVID-19 on an unknown date. The patient''s concomitant medications were not reported. It was reported that the patient, contracted the virus and developed tinnitus after receiving the vaccine and killed himself. The outcome of the event tinnitus and contracted the virus was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow up attempts are possible; information about lot number/batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a causal association between the reported event tinnitus and BNT162B2 cannot be excluded. Drug ineffective depends on many fators including pharmacokinetics, patient general health condition and immunity system function. However on conservative basis, the possible causality cannot be excluded. The event "killed himself" is not related to BNT162B2. 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 RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: killed himself
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