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Life Threatening? No
Write-up: Blacked Out; Syncope; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106011136336720-XFAXH, Safety Report Unique Identifier GB-MHRA-ADR 25397249. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 10:57 (Lot Number: EY5456) (at the age of 30-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, and unsure if patient was enrolled in clinical trial. On 01Jun2021, the patient experienced syncope and blacked out. The clinical course was reported as follows: Vaccine given at 10:57 ATRP (as reported) at 11:05 as syncopal episode. Blacked out and woke up on the floor. No preceding symptoms, no seizure activity reported, afterwards, alert and orientated, one inch superficial graze above right eye. The events were considered non serious by MHRA; Pfizer assessed the events as serious, medically significant. The outcome of the events was recovered on 01Jun2021. Report not related to possible blood clots or low platelet counts. No follow-up attempts are possible. No further information is Expected.
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