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Life Threatening? No
Write-up: resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food, or other products: none. Concomitant medications included unspecified products (List of any other medications the patient received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender''s Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all these pre-existing medical conditions contribute to the patient death. More information including complete medical history, concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of the case. 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: resident coded on 09Jan at 8am and expired
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