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Life Threatening? No
Write-up: Died in the emergency room; Fever raised; Wheezing in lungs; This is a spontaneous report from a contactable healthcare professional. A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4242; Expiration date was not reported) as a single dose, with route of administration and therapy date unspecified for COVID-19 immunization. Medical history included hepatitis C, Alzheimer''s, hypertension, diabetes, hypoalbuminemia and anemia. The patient''s concomitant medications were not reported. On an unspecified date, days after the vaccination, the patient had fever raised and wheezing in the lungs. The events resulted into an emergency room visit, and the patient was treated with antibiotics. On an unspecified date, the patient had died in the emergency room. The outcome of the events, ''fever'' and ''wheezing in the lungs'', was unknown. It was unknown if an autopsy was performed, and the cause of death was not reported. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on current convention, the case of death is assessed as related to BNT162B2 until sufficient information is available to confirm an unrelated cause of death. The patient had multiple comorbidities that may have contributed to patient''s demise. Additional information is needed to better assess this report. 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.; Reported Cause(s) of Death: died in the emergency room
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