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Write-up: Unexpected and sudden death 30-36 hours after vaccination with Pfizer-BioNTech 1st dose.; Vaccination with Comirnaty on 11Feb2021, subcutaneously (not known why),; This is a spontaneous report received from a contactable physician, the regulatory authority. Regulatory authority report number CH-SM-2021-11636. A non-pregnant 35-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot/batch number not provided), subcutaneous on 11Feb2021 (at age of 35-year-old) at 0.3 mL, single for COVID-19 immunisation. Medical history included eosophageal reflux, hypertension, Schizophrenia, chronic bonchitis, Nicotine abuse (Smoking: 14-18 cig/day for years), obesity, folliculitis in the cheek area on the right from 05Feb2021, Seizures from 07Sep2020, infected atheroma, Alcohol use (Occasional). Allergies was None. Kidney disease and Liver disease were Not known. Concomitant medications included: pantoprazole sodium sesquihydrate (PANTOPRAZOL SPIRIG HC) from May2018 for reflux, candesartan cilexetil (CANSARTAN) from 14Mar2017 for hypertension, clozapine (CLOPIN ECO) from 11Jan2011 for Schizophrenia, zuclopenthixol decanoate (CLOPIXOL) from 11Jan2011 for schizophrenia, formoterol fumarate (OXIS TURBOHALER), from 28May2018 for chronic bronchitis in nicotine abuse, clonazepam (RIVOTRIL) from 04Jul2017 for Seizures, medroxyprogesterone acetate (SAYANA) from 29Aug2017 for Contraception, amoxicillin, clavulanate potassium (AZICLAV) from 05Feb2021 to 12Feb2021 for infected atheroma/folliculitis in the cheek area on the right. Vaccination with COMIRNATY on 11Feb2021, subcutaneously (not known why), In the evening (13Feb2021), the patient was found dead in institution. Unexpected sudden death 30-36 hours after vaccination. Forensic medical examination at (privacy) ordered by prosecution. The outcome of the event was fatal. On 09Mar2021 the results of the autopsy were not yet available. As soon as we receive them we will evaluate the case and adjust the causality assessment. An autopsy was performed and results were not provided. A causal relationship between Comirnaty and Death is at the moment conditional/unclassified. This case was reported as serious (fatal outcome). Sender''s comment: Unexpected sudden death 30-36 hours after vaccine in a young patient known for several pathologies (schizophrenic, eosophageal reflux, hypertensive, chronic bonchitis, nictotin abuse, obese and recent folliculitis treated with antibiotic), and in chronic therapy with several drugs. From the first data of the autopsy a clear cause of death did not emerge but they are investigating further and will give us the details of the final report. At the moment (09Mar2021) we have therefore judged the causal correlation between the vaccine and the death of the patient as conditional/unclassified. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unexpected and sudden death 30-36 hours after vaccination with Pfizer-BioNTech 1st dose.
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