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Life Threatening? No
Write-up: Severe sweating; fever; weakness; Worst headache of my life/daily headaches; searing eye pain; fatigue; This is a spontaneous report from a contactable physician (patient). A 50-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration in left arm on 05Jan2021 16:00 as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) in the right arm on 16Dec2020 12:00 PM. The patient had no other vaccine in four weeks. The patient had not been diagnosed with COVID prior vaccination. The patient experienced severe sweating, fever, weakness, "worst headache of my life," searing eye pain for the last 2 months, daily headaches and fatigue on 06Jan2021 12:00 AM (also reported as first 48 hours). The events resulted in disability or permanent damage. Treatment was administered for the reported events. Outcome of events was unknown. The patient underwent Covid nasal swab test post vaccination on 27Jan2021 with negative result.; Sender''s Comments: Based on temporal association and known drug profile a contributory role of BNT162B2 to the reported events cannot be excluded. Case will be reassessed if additional information is received. 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.
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