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Life Threatening? No
Write-up: Dizziness; Nausea; This is a spontaneous report from a contactable nurse received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 77-year-old female. 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. Other medical history included hypertension and cardiac failure. On 02Jun2021at 12:45 (the day of vaccination), the patient received the first single dose (also reported as 6th dose, pending clarification) of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 04Jun2021 at 5:00 (1 day 16 hours 15 minutes after the vaccination), the patient experienced dizziness and nausea. The outcome of the event was recovered with treatment by drip infusion. The reporter stated the events results in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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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