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Life Threatening? No
Write-up: malaise; This is a spontaneous report from a contactable physician The patient was a non-pregnant 22-years-old female (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. On 11May2021, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) intramuscular in the arm left for COVID-19 immunization. On 01Jun2021 at 11:30 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscular in the arm left for COVID-19 immunization. On 01Jun2021 at 14:00 (2.5 hours after the vaccination), the patient experienced malaise. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with treatment including Fluid replacement and Anti-inflammatory analgesic. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on temporal relationship and known safety profile, a causal association between suspect drug and the reported malaise cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
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