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Life Threatening? Yes
Write-up: tiredness; breathlessness; Pancytopenia; This is a spontaneous report received from a contactable Healthcare Professional by Pfizer from the a regulatory authority(RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106090734582260-MXYUG. Safety Report Unique Identifier GB-MHRA-ADR 25442374. A 75-year-old male patient received his first dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration as a single dose on 31Jan2021 (lot number unknown) for COVID-19 immunisation. The patient''s medical history included diabetes mellitus, neoplasm malignant, non-tobacco user. The patient was completely fit and healthy, was playing tennis. He was only borderline diabetic and on very low dose metformin. There was no additional medical history, not already provided, that relates to previous venous or arterial thromboses. The patient did not have any previous reactions to medications, especially heparin or anticoagulants. The patient had no confirmed or suspected autoimmune or inflammatory disease, including vasculitis. Patient had no history of, or concurrent, intracranial malignancy and had no concurrent or recent intracranial infections. The patient did not have a recent surgical or medical interventions to the central nervous system (including lumbar puncture). Patient had no recent trauma/head injury. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Past drugs included heparin and metformin. The patient experienced pancytopenia on 01Apr2021, extremely tired and breathless on an unspecified date with fatal outcome. The events were reported as serious due to hospitalization, resulted in death, life-threatening, disability and medically significant. The patient had entirely normal blood results in Dec2020. After first Pfizer jab he started to feel breathless and extremely tired. Blood tests were performed after vaccine due to breathlessness and extreme tiredness and showed pancytopenia. Bone marrow biopsy result was unknown. Platelet count was measured on 01Apr2021 and then weekly afterwards. The lowest platelet count after vaccine (usual normal range 150-450) was 9 and the last platelet count before vaccine was 148. The patient was reviewed by a haematologist and was diagnosed with pancytopenia. Haemorrhage was not identified. No autopsy was performed. The reporter considered that this report related to possible blood clots or low platelet counts. COVID-19 virus test performed on an unspecified date was negative. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts possible; Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Pancytopenia; breathlessness; extremely tired
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