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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: anaphylaxis; This is a spontaneous report from a contactable physician received via a Company sales representative. An elderly female patient of unspecified age received the first single dose of BNT162B2 (COMIRNATY) on an unspecified date in Mar2021, for COVID-19 immunisation. Medical history included ongoing hypertensive disease, she had pacemaker and was currently overweight. The patient''s concomitant medications were not reported. The patient experienced anaphylaxis on an unspecified date in Mar2021. This event had a fatal outcome. The patient in 5-10 minutes after the first dose of Comirnaty felt unwell, complained of lack of air and dyspnoea. She was provided with anti-anaphylactic treatment. As the condition was worsening, the patient was reanimated. After 15-20 minutes the death was declared. The patient died on an unspecified date in Mar2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on temporal association and known drug profile, a contributory role of the suspect drug cannot be excluded in the development of event fatal anaphylaxis. 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. This case will be reassessed upon receipt of additional information.; Reported Cause(s) of Death: anaphylaxis
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