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Write-up: COVID-19/ COVID-19 virus test, positive; COVID-19/ COVID-19 virus test, positive; Respiratory insufficiency. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient.; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is DK-DKMA-WBS-0032145. Safety Report Unique Identifier DK-DKMA-ADR 24693311. An 84-year-old male patient received first dose of bnt162b2 (COMIRNATY, Lot number: EJ6797, expiration date: 30Apr2021) intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included bypass surgery from 2008 and not ongoing, conditions included pain, vitamin b12 deficiency, esophageal acid reflux, insomnia, eye infection, constipation, mania, bronchospasm, ongoing general physical health deterioration, ongoing type 2 diabetes mellitus, ongoing chronic renal insufficiency, renal cysts from 2014 and ongoing, vascular dementia from 2015 and ongoing, atrial fibrillation from 2018 and ongoing, cerebral infarct from 2019 and ongoing, undiagnosed prostate cancer and unknown if ongoing, possibly prostate cancer, not diagnosed due to comorbidity, the patient was ongoing living in nursing home, there was a covid-19 outbreak among several residents and staff. Concomitant medication included hydroxyzine hydrochloride (ARAX) from 14Dec2020 for pain, cyanocobalamin-tannin complex (BETOLVEX) from 25Jan2016 for vitamin B12 deficiency, esomeprazole magnesium (ESOMEPRAZOL KRKA) from 23Dec2020 for esophageal acid reflux, zopiclone (IMOZOP) from 15Sep2020 for insomnia, chloramphenicol (KLORAMFENIKOL VISKOES DAK) from 08Dec2020 for eye infection, sodium picosulfate (LAXOBERAL) from 15Sep2020 for constipation, risperidone (RISPERDAL) from 17Sep2020 for mania, ipratropium bromide, salbutamol sulfate (SAPIMOL) from 13Sep2020 for bronchospasm and xarelto (rivaroxaban) from 12Apr2018 as thrombosis prophylaxis. The patient previously received Influvectra (Influenza Type A and Influenza Type B vaccine, 4-valent) on 22Dec2020 for immunisation, pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 19May2020 for immunisation. The patient experienced respiratory insufficiency, it is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient, in an 84 year old male patient vaccinated with bnt162b2. On 15Jan2021 the patient developed respiratory insufficiency, the patient was sweaty, did not react to voice or touch, the patient had apnoea, pain, increased fever and secretion and was treated palliatively with subcutaneous morphine. Spacer pressurised inhalation, prednisolone and furosemide (FURIX), but not with oxygen. On 18Jan2021 the patient was tested positive with COVID-19 and on 19Jan2021 the patient died. Respiratory insufficiency was reported by the physician as fatal. Reported causes of death: Death and of/with COVID-19. The patient underwent lab tests and procedures, which included test results COVID-19 virus test on 06Jan2021 as negative, COVID-19 virus test on 13Jan2021 as unknown result, test lost, COVID-19 virus test on 18Jan2021 as positive; Oxygen saturation on 15Jan2021 as 92%, Oxygen saturation on Jan2021, 88%, Pulse rate on Jan2021 as 76, unit not specified. Only ordinary inquest was performed post-mortem. No findings were reported. The patient died on 19Jan2021.An autopsy was not performed and the reported cause of death was Respiratory insufficiency and COVID-19. Causality from the reporter: it is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient.; Reported Cause(s) of Death: COVID-19/ COVID-19 virus test, positive; COVID-19/ COVID-19 virus test, positive; Respiratory insufficiency
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