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Life Threatening? No
Write-up: Contamination spread to 34 residents and 13 deaths to be mourned; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the thirteenth of thirteen reports. A patient of unspecified age and gender started to received BNT162B2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Jan20211, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on 22Jan2021 with fatal outcome. 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/batch number cannot be obtained.; Sender''s Comments: Based on the current available information, the event COVID-19 is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reassessed if additional information becomes available. 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.,Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter/product/event, different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned; Contamination spread to 34 residents and 13 deaths to be mourned
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