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Life Threatening? No
Write-up: anaphylactic reaction upon receipt of the vaccine; This is a spontaneous report from contactable pharmacist via a Pfizer Sales Representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in Dec2020 at a single dose for COVID-19 immunization. The patient was reported as a healthcare worker. Medical history included latex allergy. The patient''s concomitant medications were not reported. The patient experienced an anaphylactic reaction upon receipt of the vaccine in Dec2020. The reporter called to confirm to confirm the lack of latex in the vaccine and also to inquire about the latex content of the 0.9% sodium chloride (NaCl) used to dilute the vaccine. The clinical outcome of anaphylactic reaction upon receipt of the vaccine was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender''s Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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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