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Life Threatening? No
Write-up: died; pulmonary congestion; Oxygen saturation low; Cough; swelling of legs/slight leg edema; dyspnoea/shortness of breath; This is a spontaneous report downloaded from a non-contactable consumer via the Regulatory Authority-WEB. Regulatory Authority number DE-PEI-CADR2021087920, Safety Report Unique Identifier DE-PEI-202100080566. A 86-years-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 11May2021 (Lot Number: EX8680) as 0.3ml single dose for covid-19 immunisation. Medical history included Arterial hypertension, Hypertensive heart disease, Heart insufficiency (cardiac insufficiency), Type 1 diabetes mellitus, all ongoing. The patient''s concomitant medications were not reported. The patient experienced dyspnoea, cough, swelling of legs, oxygen saturation low since 22May2021. The patient''s outcome was fatal for death, not recovered/not resolved for other events. The patient died on 25May2021. An autopsy was not performed. Sender Comment: The patient had no known allergies. Information on risk factors or previous illnesses included arterial hypertension, hypertensive heart disease with cardiac insufficiency, diabetes mellitus type 1. Beginning with a clear cough from 22May2021 and subsequent increasing shortness of breath, for a home visit on 25May2021, rest dyspnoea, slight leg edema, pulmonary congestion, no fever, stable vital parameters (pulse, blood pressure, O2 saturation under room air). Event assessment for Comirnaty for all events per Regulatory Authority was Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: died
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