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Life Threatening? No
Write-up: dyspnea; decrease of blood pressure; restlessness; death after second vaccination; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech, license party for Comirnaty (reference no.: 33877). An elderly female patient received bnt162b2 (COMIRNATY), first dose (Lot Number: EP2163) on 07Mar2021 and second dose (Lot Number: ER7812) on 28Mar2021; both were via an unspecified route of administration as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The physician wanted to report that a female patient died after second dose of bnt162b2. She was vaccinated on 07Mar2021 with first dose with lot EP2163 and on 28Mar2021 with second dose with lot ER7812. Since 29Mar2021, the patient experienced dyspnea, blood pressure decrease, restlessness; on 30Mar2021 admission to hospital via ambulance; on 01Apr2021 at 11:30 a.m. the patient died in hospital. the physician thinks the interval between first and second vaccination was too small. It is too strenuous for the organism, especially for elderly people. Cause of death was unknown. It was unknown if an autopsy was performed. The outcome of the events dyspnea, blood pressure decrease, restlessness was unknown.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. A causal association between the reported dyspnea, blood pressure decrease and restlessness cannot be completely excluded based on temporal association. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death
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