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Write-up: DEATH; breath shortness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, report number SE-MPA-2021-000419, other case identifier SE-MPA-1610636715016. An 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot/batch number: EJ6796) solution for injection, intramuscular in Dec2020 at a single dose for Covid-19 vaccination. Medical history included somnolence in 2016 after Imovane intake, atrial fibrillation, Peripheral vascular disease, chronic renal failure, cardiac failure, type II diabetes mellitus, ischemic heart disease, Peripheral swelling and some fluid in lung; all unknown if ongoing; admitted to hospital after fall, unknown infection, and necrotic toes. Concomitant medications included furosemide sodium (FUROSEMID ACCORD) from 18Dec2020 as needed, 2-4 ml, sodium polystyrene sulfonate (RESONIUM) from 14Dec2020 at 0.5 DF, as needed, oxazepam (SOBRIL, 5mg) from 23Dec2020 as needed, 1-2 tablets, allopurinol (ALLOPURINOL NORDIC DRUGS, 100mg) from 22Aug2020 to Dec2020 at 100 mg, daily, darbepoetin alfa (ARANESP, 30ug) from 07Dec2020 at 1 DF, every 2 weeks, glycerol (MINIDERM [GLYCEROL], 20%) from 28Nov2020 to Dec2020 at 1 DF, as needed, glyceryl trinitrate (GLYCERYLNITRAT I ESSEX, 1%) from 28Nov2020 to Dec2020 at 1 DF, as needed, max 2 DF/daily, acetylcysteine 200mg from 28Nov2020 to Dec2020, midazolam hydrochloride (MIDAZOLAM HAMELN) from Dec2020 at as needed, 0.2-0.5 ml, latanoprost (LATANOPROST STADA, 50ug/ml) from 25May2018 to Dec2020 at 1 DF, daily, 1 drop at night, desloratadine (AERIUS [DESLORATADINE, 5mg]) from 20Dec2020 at 5 mg, daily, glycopyrronium bromide (ROBINUL) from 23Dec2020 at 1 mL, as needed, morphine hydrochloride (MORFIN MEDA) from Dec2020 at as needed, 0.25-1 ml, paracetamol (ALVEDON, 500mg) from 08Dec2020 at 3000 mg, daily, carbomer (VISCOTEARS, 2mg/g) from 25May2018 to Dec2020 at 1 DF, as needed, 1 dropp, finasteride (FINASTERID SANDOZ, 5mg) from 21Nov2017 to Dec2020 at 5 mg, daily, sodium picosulfate (CILAXORAL, 7.5mg/ml) from 18Dec2020 at daily, 10-20 drops per night, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) from 19Dec2020 at 1-2 sachets per day, omeprazole 10mg from 28Nov2020 to Dec2020 at 10 mg, daily, furosemide (FURIX [FUROSEMIDE, 500mg]) from Dec2020 at 250 mg, daily, haloperidol (HALDOL, 5mg/ml) from Dec2020 at as needed, 0.1-0.2 ml, morphine hydrochloride (MORFIN ABCUR, 10mg/ml) from 23Dec2020 at as needed, 0.25-0.5 ml, budesonide, formoterol fumarate (SYMBICORT FORTE TURBUHALER) from 09Dec2020 at 2 DF, daily, dalteparin sodium (FRAGMIN, 5000 IU) from 10Dec2020 at 1 DF, daily, hypromellose (HYPROSAN, 3.2mg/ml) from 15Jan2019 to Dec2020 at 1 DF, as needed, 1 dropp. The patient previously took zopiclone (IMOVANE) in 2016 and experienced somnolence. Patient was admitted to hospital after fall with unknown infection and necrotic toes due to vascular disease. Treated with antibiotics. During the hospital visit, patient had worsened renal and heart failure despite treatment. Transferred to palliative care. Awake, eating and drinking but bedridden. Peripheral swelling and some fluid in lung. Patient was then vaccinated with Comirnaty. After an hour, patient received palliative injection with morphine for breath shortness. Patient died the same evening. According to the reporter, since the patient was in the palliative care phase, it was not sure that death was caused by the vaccine. The patient died in Dec2020. The action taken in response to the event for bnt162b2 was not applicable. It was unknown if an autopsy was performed. No follow-up activities are needed. No further information is expected.; Reported Cause(s) of Death: Uknown cause of death
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