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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started to bleed; Humongous scar on her nose; In her hand there''s a rash with different dots/red; She has petechiae/rash on the forearm; hit her face; knocked out, hit her nose; This is a spontaneous report from a contactable physician. This physician reported that a 30-year-old female patient (daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced blacked out, fainted, felt very unwell, nauseous, chills, fell, knocked out, hit her nose, started to bleed, humongous scar on her nose, in her hand there''s a rash with different dots/red, she has petechiae/rash on the forearm, all on an unspecified date in Jan2021. The Caller wanted information on side effects specifically looking at platelet or clotting or bleeding issues. Her daughter, (female, age 29 date of birth) received the 2nd dose of Pfizer vaccine, received it at the (State name), last night. She felt very unwell, nauseous, chills, and then blacked out, fell, knocked out, hit her nose, started to bleed; fainted and hit her face, didn''t stop bleeding for 2 hours. There''s a humongous scar on her nose. It took 2 hours to stop bleeding. She''s going to urgent care today. Her daughter was healthy, yesterday was 2nd dose. In her hand, there''s a rash with different dots/red. She has petechiae/rash on the forearm. Thankfully it (bleeding) did stop. The outcome of events for ''knocked out, hit her nose, started to bleed'' was resolved on an unspecified date, for other events was unknown. The case was reported as non-serious. Information on the Batch/Lot number has been requested.; Sender''s Comments: Based solely on a chronological association a causal relationship between events blacked out and fainted and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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