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Life Threatening? Yes
Write-up: Sudden cardiac death; Sudden death; sudden cardiac death/fatal failure of one of the organs; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority number is CZ-CZSUKL-21005455. A 78-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, on 29Apr2021 (batch/lot number: EY3014), as 2nd dose, single dose, for COVID-19 immunisation. Medical history included vertebrogenic pain syndrome, cerebral atherosclerosis with occasional dizziness/head spinning, chronic ischemic heart disease, unspecified, essential hypertension, and constipation. Concomitant medications included lactulose lactulose (DUPHALAC) taken for constipation; diclofenac (DICLOFENAC) taken for an unspecified indication; and unspecified dietary supplements, immune-boosting and over-the-counter medications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY Solution for injection) on 08Apr2021 (batch/lot number: EW2246), for COVID-19 immunisation. The patient experience sudden cardiac death and sudden death on 09May2021. It was reported that the patient died suddenly on 09May2021 without any previous symptoms. According to the reporter, due to the very good condition of the patient, it is believed that the death was caused by the administration of a vaccine against SARS-CoV-2. Record of the coroner''s departure on 09May2021: Examination of the body by a coroner stated that "No traces of external injuries were found during the examination. A mobile, self-sufficient senior living alone in an apartment, found by her grandson on a bed lying dressed in pyjamas. On the right side in a rest position. A non-compliance patient who had only Diclofenac of the drugs per scriptum, otherwise many dietary supplements, immune-boosting and over-the-counter medications (Duphalac for constipation). Most likely hypertension, chronic ischemic heart disease, cerebral atherosclerosis with occasional dizziness, but she had never had a myocardial infarction, stroke, pulmonary embolism. She did not complain about anything but verterobrogenic algic syndrome. Postmortem stiffness almost fully formed and postmortem stains marginally extrudable by the edge. Cause of death was set as a sudden cardiac death." The outcome of the events was fatal. Causes of death were "Sudden cardiac death. An autopsy was not ordered. The second dose of Comirnaty is most likely the cause death. This drug probably caused fatal failure of one of the organs" (as reported), sudden death, and "sudden cardiac death/fatal failure of one of the organs". No autopsy was performed. The health authority assessed the event sudden cardiac death as serious (death) and the event sudden death as serious (death, life-threatening, medically significant). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac deathAn autopsy was not ordered. The second dose of Comirnaty is most likely the cause death. This drug probably caused fatal failure of one of the organs.; Sudden death; sudden cardiac death/fatal failure of one of the organs
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