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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: DVT; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse asked if there is any DVT cases reported following the administration of Pfizer-BioNTech COVID-19 Vaccine. E-transmitting duplicate AE caller already reported a DVT case post vaccination. Caller also asked "Why is there''s a statement indicating that individuals with a history of bleeding disorder or taking anti-coagulant should contact their vaccination provider? How did they prove 95 % efficacy? Why aren''t antibodies produced after the 1st dose of Covid-19 vaccine?" The outcome of the event DVT was unknown. Information on Lot/batch number has been requested.; Sender''s Comments: Very limited information was provided for this individual patient, such as pre-existing medical history, suspect administration details, clinical course and relevant supportive lab data for the reported Deep vein thrombosis (DVT). Pending further details, the Company would handle this reported DVT related to the administration of BNT162B2, COVID-19 immunization, for reporting purpose. 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 RA, IEC, as appropriate.
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