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Write-up: Drug ineffective/COVID-19 respiratory infection; COVID-19 respiratory infection; polymyalgia rheumatica on chronic treatment with corticosteroids; polymyalgia rheumatica on chronic treatment with corticosteroids; This is a spontaneous from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-729768. A 98-year-old female patient received first dose of BNT162B2 (COMIRNATY) Solution for injection, intramuscular on 27Dec2020 as a single dose (lot number: EJ6796), second dose intramuscular on 17Jan2021 as a single dose (lot number/batch number: EM0477) for covid-19 vaccination. Medical history included chronic respiratory failure, parkinsonism, vascular dementia, polymyalgia rheumatica on chronic treatment with corticosteroids, nocturnal oxygen therapy for years for chronic respiratory failure, possible microaspirations due to dysphagia. Concomitant medications were not reported. As per verbatim: The patient''s (Institutionalized person) (AP) past antecedent included vascular dementia, parkinsonism, polymyalgia rheumatica on chronic treatment with corticosteroids, nocturnal oxygen therapy for years for chronic respiratory failure, possible microaspirations due to dysphagia. On 27Dec2020 she received the 1st dose of Comirnaty. On 17Jan2021 she received the 2nd dose (batch EM0477). Since 15Jan2021, she was confined by close contact in her module. Polymerase chain reaction (PCR) on 15Jan2021 and 20Jan2021 were negative. On 24Jan2021 he presented fever and desaturation. PCR was positive for COVID. Covid-19 infection. On 24Jan2021, the patient experienced COVID-19 respiratory infection (medically significant), drug ineffective (medically significant). The patient underwent laboratory tests and procedures which included SARS-CoV-2 PCR test: negative on 15Jan2021 and 20Jan2021, positive on 24Jan2021 and desaturation on 24Jan2021. It was further reported that the evolution was unfavorable and she died on 31Jan2021, no autopsy was performed. Follow-up (23Feb2021): New information from the same contactable physician, downloaded from the Regulatory Authority-WEB ES-AEMPS-729768 includes updated outcome for events vaccination failure and COVID-19 respiratory infection to fatal, death date provided, autopsy details reported, seriousness criterion (death) added for events vaccination failure and COVID-19 respiratory infection. Follow-up attempt are not possible. No expected further information.; Reported Cause(s) of Death: Vaccination failure; COVID-19 respiratory infection
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