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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: Sudden death; This is a spontaneous report from a contactable physician and consumer. A 41-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on 30Dec2020 at 0.3 mL single dose for COVID-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. On 01Jan2021, the patient experienced sudden death. The clinical course was as follows: The patient didn''t experience any adverse event at the moment of inoculation with COVID-19 vaccine or the following days. On 01Jan2021, at lunch time, two days after receiving the vaccine, the patient was found unresponsive in her bed by her partner. The cause of death was unknown. It was reported that an autopsy would be performed in the next days; the results were not yet available. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The reported information is limited and does not allow a meaningful assessment of the case. It will be reassessed upon receipt of follow up information. 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.; Reported Cause(s) of Death: Sudden death
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