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Life Threatening? No
Write-up: Autoimmune disease; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A male patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced autoimmune disease on an unspecified date. The patient died on an unspecified date due to autoimmune disease. It was unknown if an autopsy was performed. The information on the lot/batch number has been requested.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the fatal autoimmune disease and suspect vaccine BNT162B2. Additional information regarding therapy duration, relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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: Autoimmune disease
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