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Life Threatening? No
Write-up: epilepsy; intracranial process; concomitant medications included Anticoagulant, immunotherapy; concomitant medications included Anticoagulant, immunotherapy; Death unexplained; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, number FR-AFSSAPS-NT20210317. A 90-years-old male patient received second dose of BNT162b2 (COMIRNATY, lot#: EJ6789), intramuscular in right arm on 11Feb2021 09:45 at single dose for Covid-19 immunisation. Medical history included Right sylvian ischemic stroke, permanent anticoagulated AF, multimetastatic small cell bronchial carcinoma under immunotherapy. The patient''s concomitant medications included Anticoagulant, immunotherapy. Patient was death in unknown circumstances occurred 13 hours after the injection. Hypothesis put forward by the reporter: epilepsy complicating an intracranial process. It was unknown whether autopsy done. Patient had Covid 19 test on 14Jan2021 with negative result. No follow-up attempts possible. No further information expected.; Sender''s Comments: The limited information provided precludes a full clinical assessment of the case. As a cautionary measure and for reporting purposes, and assuming a drug-events temporal association, the company cannot completely exclude a causal association between the reported events and Comirnaty administration. The impacts 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: Death unexplained
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