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Write-up: angioedema; This is a spontaneous report from a contactable physician (unspecified relationship with the patient), who is also a Pfizer colleague reporting through RA portal. A 13-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 10Sep2021 (Batch/Lot Number: Unknown) as dose 1, single at the age of 13-years-old for covid-19 immunisation. Medical history included urticaria and allergic reactions to environmental stimuli and after infectious conditions. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient was not taking any other medications/products within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced angioedema (medically significant) on 10Sep2021. The patient with a history of sporadic allergic conditions, including to infectious stimuli, having presented episodes of urticaria and hypersensitivity on some occasions, received the Pfizer vaccine on 10Sep2021 and evolved with edema of the lips and limbs around 6 hours after vaccination. She went to the health service, diagnosed with angioedema with complete reversal of the case after antihistamine and corticosteroids. The events result in doctor or other healthcare professional office/clinic visit; emergency room/department or urgent care. Outcome of the event was recovered. Information on the lot/batch number has been requested.; Sender''s Comments: A possibly contributory role of bnt162b2 (COMIRNATY) in triggering the onset of angioedema cannot be fully excluded, considering the close time association and known adverse event profile of the suspect vaccine. 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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