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Write-up: Oxygen saturation decreased; COVID-19 antigen test positive/positive COVID-19 test with symptoms; COVID-19 antigen test positive/positive COVID-19 test with symptoms; High fever; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, Regulatory Authority report number is PL-URPL-DML-MLP.4401.2.156.2021. A 71-year-old male patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), (Batch/Lot Number: EP9598) intramuscular on 19Feb2021 (at the age of 70 years-old) as single dose for covid-19 immunisation. The second dose was scheduled for 12Mar2021. Medical history included ongoing diabetes treated with oral hypoglycaemic drugs, ongoing hypertension. The patient''s concomitant medications were not reported. On 05Mar2021, SARS-COVID 2 test by ABBOTT was performed with a positive result. The patient also had a high fever for several days, the primary care physician did not start any treatment. On 05Mar2021, patient''s cardiovascular and respiratory were efficient, in full contact, sat. Without oxygen 93%. Patient was prescribed with Levoxa 500 mg, Pyralgina, Berodual N, Pabi-Dexamethason, Neoparin. Patient was then referred home. On 07Mar2021, in the morning, the patient''s condition worsened, and he was taken by ambulance to the hospital at the Emergency Room, and then placed in the Department of Infectious Disease. Oxygen was administered. On 09Mar2021, the patient''s condition worsened, and was connected to a ventilator. On 13Mar2021, at 18:20, patient was pronounced dead. Oxygen saturation decreased, COVID-19 antigen test positive and High fever all from 05Mar2021 were reported as the cause of death of the patient on 13Mar2021. An autopsy was not performed. Sender''s comment: Pyrexia is an expected adverse reaction as described in the SmPC following the administration of Comirnaty. Reduced saturation and a positive COVID-19 test result are unexpected symptoms. As of 19Mar2021, 197 cases of SARS-Cov-2 test positive and 231 cases of oxygen saturation decreased were reported in the database. The patient suffered from hypertension and diabetes. Due to the lack of medical information on the cause of death (no autopsy was also performed), the influence of other factors on the patient''s death cannot be ruled out. There is a time relationship between vaccination and the occurrence of adverse reactions. A regulatory authority due to the health result: death assessed the application as serious. No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: high fever; COVID-19 antigen test positive/positive COVID-19 test with symptoms; COVID-19 antigen test positive/positive COVID-19 test with symptoms; Oxygen saturation decreased
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