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Write-up: suspected severe infection; increased creatinine value; deterioration in general condition; increased liver value; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-023979. A 94 years old female patient received second dose of BNT162B2 (Comirnaty, solution for injection) on Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Hypertension, Cholesterol high, myocardial infarct on Feb2021. The patient received first dose of vaccine on Feb2021. It was also informed that patient had for a few days before second dose of vaccine felt unwell with a little headache, body pain and stomachache, nausea and reduced appetite. Concomitant medications included losartan, ticagrelor (BRILIQUE), paracetamol (ALVEDON) and atorvastatin calcium trihydrate (ATORVASTATIN ACCORD). On Mar2021 the same day after second dose general health condition was reduced and at the evening the woman went to the hospital. Laboratory values showed creatinine increased and elevated liver enzymes. She also had a suspected severe infection. Reported suspect adverse events from the physician were creatinine increased, elevated liver enzymes, infection, reduced general condition. The patient died the day after vaccination. All reported events were assessed as fatal. It was unknown if an autopsy was perfofmed. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: creatinine increased; Hepatic enzyme increased; General physical health deterioration; suspected severe infection
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