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Write-up: sudden Death unexplained; Feeling sick; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NY20210288 This is a report received from the Regulatory Authority. A 91-year-old male patient received bnt162b2 (COMIRNATY, lot EJ6795) intramuscular at single dose on 11Feb2021 08:45 for covid-19 immunisation. Medical history included living in home care, a long history including cardiovascular disease: arterial hypertension, heart failure due to hypokinetic heart disease, insulin-dependent diabetes, hiatus hernia, major vascular neurocognitive disorder, aortic valve incompetence, Permanent cardiac pacemaker insertion, gastric ulcer, large intestine polyp, atrial tachycardia, myocardial infarction, subdural hematoma in 2000, head trauma in 2004, osteoarthritis. Concomitant medication included insulin glargine (ABASAGLAR), subcutaneously 6 iU, daily for Dementia paracetamol (DAFALGAN) oral 4 DF, daily for Arthrosis, macrogol 4000 (FORLAX) oral 1 DF, 1x/day on demand for Constipation, furosemide (FUROSEMIDE ARROW) orla 1 DF, daily for Cardiac failure, omeprazole magnesium (MOPRAL) oral 1 DF, 1x/day (1 or 0.5 /day) for Ulcer gastric, paroxetine hydrochloride (PAROXETINE EVOLUGEN) oral 1 DF, 1x/day for Depression, fluindione (PREVISCAN) oral for Arrhythmia, risperidone (RISPERIDONE EG) oral 0.5 mg, 1x/day for Dementia, NUTRIVISC Eye drops, FIBRELINE as Food supplement. The patient received the 1st dose of bnt162b2 (COMIRNATY, lot # EJ6788) at single dose on 21Jan2021 for covid-19 immunisation, well tolerated with no side effects. The patient experienced feeling sick (fatal) sudden unexplained death on 11Feb2021 1.5 hours after receiving the 2nd dose of COMIRNATY, with heavy cardiovascular medical history and vascular dementia. Course of events: On 11Feb2021: measuring of constants: blood pressure 100/60 mm Hg, regular pulse at 92 bpm, temperature 36.6 Centigrade, no signs of infection, good reactivity and good conscience, INR (international normalized ratio) measured the day before (10Feb2021 at 1.2). At 8.45 am, he received the 2nd injection of COMIRNATY. Good tolerance during the 15 minutes of observation. He was transferred to the service around 9:30 am. At 9.50 am, he called for discomfort. The patient was placed in a lying position in his bed. Around 10 a.m., the nurse arrived and noticed the absence of vital parameters. Medical report of death performed at 10h20. He died approximately 1.5 hours after receiving the 2nd dose of COMIRNATY, with mention of illness before the death certificate. An autopsy was not performed. Imputability Method: C2S1=I1 (dubious).; Reported Cause(s) of Death: sudden Death unexplained
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