Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cholestasis, Coagulopathy, Diarrhoea, Hyperbilirubinaemia, Investigation
Clinical narrative: microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; thrombotic microangiopathy; jaundice; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 29Mar2021 13:45 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient was not pregnant. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Metastatic breast cancer. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant Therapy included Clinical trial oral drug - ARV-471 on 22Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient presented to the hospital on 05Apr2021 complaint of (c/o) 1 week of jaundice, nausea, vomiting, and diarrhea, which started on an unknown date in Mar2021, and on 05Apr2021 found to have evidence of microangiopathic hemolytic anemia, thrombocytopenia, and severe hyperbilirubinemia/cholestasis with coagulopathy. Work-up revealed like thrombotic microangiopathy although etiology unclear. ADAMTS13 level 29 with no inhibitor not suggestive of Thrombotic thrombocytopenic purpura (TTP). Patient eventually died of this acute presentation. She also had a history of metastatic breast cancer and had also just started taking a phase 1/2 oral clinical trial drug ARV-471 on 22Mar2021. Unclear if the drug, COVID vaccine, or breast cancer may have contributed to current illness. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Patient died. Patient hospitalized for 5 days. Date of Death was on 09Apr2021. Death cause: Death certificate stated metastatic breast cancer. No autopsy performed. Therapeutic measures were taken as a result of events included plasmapheresis, steroids, antibiotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05Apr2021. The outcome of the events was fatal.; Sender's Comments: Based on temporal association and the limited information available, the causal association between BNT162B2 vaccine and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: severe hyperbilirubinemia/cholestasis with coagulopathy; jaundice; nausea; vomiting; diarrhea; microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with co