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Life Threatening? No
Write-up: loss of consciousness; confusion; difficult with elocution; heart palpitations; blurred vision; difficulty breathing; dizziness; headache; painful cramping in the calf; sweating; This is a spontaneous report from a contactable nurse (patient). This 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 04Jun2021 14:45 (at the age of 34-year-old) (Lot Number: EW0221) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient was not pregnant. On 04Jun2021 at 23:45, the patient experienced loss of consciousness, confusion, difficult with elocution, heart palpitations, blurred vision, difficulty breathing, dizziness, headache, painful cramping in the calf and sweating; the event loss of consciousness was considered serious as medically significant, all the other events were non-serious. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. No hospitalization was required; the patient received oxygen mask as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.; Sender''s Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is 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 RAs, Ethics Committees, and investigators, as appropriate.
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