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Life Threatening? Yes
Write-up: COVID-19 virus test positive; COVID-19 virus test positive; Breathing became progressively worse: fast, shallowand noisy.; Breathing became progressively worse: fast, shallowand noisy.; Breathing became progressively worse: fast, shallowand noisy.; Patient became very sick; Fever; lethargic; This is a spontaneous report from a contactable consumer (patient''s wife) received from the MHRA. The Agency Regulatory Authority report number is GB-MHRA-WEBCOVID-202102030931565490. Safety Report Unique Identifier GB-MHRA-ADR 24689483. A 53-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EJ1688), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunisation. Medical history included neoplasm (recently treated (radiotherapy or chemotherapy)), gastrointestinal carcinoma from 2017 and ongoing (in remission since 2018), surgery (not ongoing), atrial fibrillation from 2017 (unknown if ongoing). Patient has not had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Concomitant medications included amlodipine (unknown manufacturer) and bisoprolol (unknown manufacturer). The patient experienced COVID-19 virus test positive (death, hospitalization, medically significant, life threatening) on 30Dec2020, patient became very sick (hospitalization, life threatening) on 22Dec2020 evening with outcome of unknown, fever (hospitalization, life threatening) on 22Dec2020 with outcome of unknown, lethargic (hospitalization, life threatening) on 22Dec2020 with outcome of unknown, breathing became progressively worse: fast, shallow and noisy (hospitalization, life threatening) on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date, positive on 30Dec2020. The patient died on 19Jan2021 due to COVID-19 virus test positive. It was not reported if an autopsy was performed. Clinical course was as follow: from 22Dec2020 evening the patient became very sick. He had fever and was lethargic. Patient''s wife assumed it was the expected side effects. On 24Dec2020 the breathing became progressively worse: fast, shallow, and noisy. 4 or 5 days after vaccination, in Dec2020, in the middle of the night 999 was called, he was taken to hospital and was hospitalized due to the events. On 19Jan2021, about 3 weeks after, the patient died due to COVID-19 virus test positive (underwent on 30Dec2020). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 virus test positive; COVID-19 virus test positive
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