Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration, Mean cell volume, Oxygen saturation, Platelet count, Protein total decreased
Clinical narrative: TTP; brain hemorrhage; This is a spontaneous report received from a contactable reporter (Physician).  A 72-year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "CAD" (unspecified if ongoing), notes: ICD CABG; "Vitamin D deficiency" (unspecified if ongoing), notes: Vitamin D deficiency; "BPH" (unspecified if ongoing), notes: BPH; "hyperlipidemia" (unspecified if ongoing), notes: hyperlipidemia; "Allergies" (unspecified if ongoing), notes: Allergies; "ICD", start date: 2013 (unspecified if ongoing), notes: ICD; "CABG", start date: 2013 (unspecified if ongoing), notes: CABG; "Former smoker" (unspecified if ongoing). Concomitant medications included: ASPIRIN [ACETYLSALICYLIC ACID] taken for coronary artery disease (ongoing); ATORVASTATIN taken for coronary artery disease, hyperlipidaemia (ongoing); METOPROLOL taken for coronary artery disease (ongoing); CHOLECALCIFEROL taken for vitamin D deficiency (ongoing). Vaccination history included: Tdap (Tdap> 7 years, 12:00:00 AM), administration date: 22Feb2021, for Immunization; Influenza (Influenza, seasonal, high dose, 12:00:00 AM), administration date: 26Nov2014, for Immunization; Fluzone high dose (Fluzone High Dose, 04:56:22 PM), administration date: 13Dec2018, for Immunization; Fluzone high dose (Fluzone High Dose, 04:31:22 PM), administration date: 08Nov2017, for Immunization; Pneumo (Pneumo (3 years older) 12:00:00 AM), administration date: 01Jan2015, for Immunization. The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (death, hospitalization, life threatening, medically significant) with onset 05Mar2021, outcome "fatal", described as "TTP"; CEREBRAL HAEMORRHAGE (death, hospitalization, life threatening, medically significant) with onset 05Mar2021, outcome "fatal", described as "brain hemorrhage". The events "TTP" and "brain hemorrhage" were evaluated at the physician office visit and emergency room visit.  Patient was a 72-year-old man with a history of a CABG and ICD who administered to the ICU for possible TTP. He presented to the ED because of dark stools. HC recently had back pain for which he took NSAIDS. He then noted bruising over his arms and legs and had an episode of dark stool. In the ED, he had a temperature of 38.2, hemoglobin of 9.0 and a platelet count of 11000. Hematology reviewed his smear and saw a few schistocytes, and is concerned about TTP. They have recommended plasmapheresis. Per patient, he had intermittent low back pain for which he took 1 dose of Motrin and 5 doses of Aleve over 1 week with some relief. Upon stopping pain medication, the patient had noted scattered bruises over his arms and legs. He also reportedly had one episode of black stools on 03May2021, He visited his PCP who performed focal occult and was reportedly positive. No prior history of endoscopy or peptic ulcer disease. Had a colonoscopy more than 10 years ago that was reportedly negative. He had cold-like symptoms with rhinorrhea 1 month ago but without cough, fever or chills, or diarrhea. No other new medications or changes to diet. No recent nosebleed, hematuria or mouth bleeding. On arrival in the ED, patient was noted to be febrile T-max 38.2, tachycardia, saturating at 97% on room air. Labs were significant for anemia hemoglobin 9.0, hematocrit 25.6 [baseline hemoglobin 14.3, HCT 43.9 in Nov2020] and thrombocytopenia PLT 11K [81K in Nov2020) Low fibrinogen 174 and low haptoglobin Hematology was consulted by ED, suggested further lab work-up, no acute indication for platelet transfusion. CT Gl bleed Was negative but did show moderate to large stool burden consistent with constipation. He was given 1 dose of ceftriaxone and 1 dose of IV pantoprazole. No passage of black stools in ED. Plan for CV: Continue beta-blocker. Hold aspirin. For GI: Continue PPI twice daily. Follow hemoglobin, LFTs. For ID: Fever likely from TTP, doubt acute infection-follow. Hemo: per hematology, will start plasmapheresis and prednisone. Check Adam 13 antibody. This patient is critical with a high probability of imminent or life threatening deterioration. Critical Care Time was 40 minutes. The patient underwent the following laboratory tests and procedures: activated partial thromboplastin time: (03May2021) 37.4 seconds, notes: HI; alanine aminotransferase: (03May2021) 36, notes: Unit/L; anion gap decreased: (03May2021) 6 mmol/L, notes: LOW; aspartate aminotransferase: (03May2021) 108, notes: Unit/L, HI; bilirubin conjugated: (03May2021) 0.40 mg/dl, notes: HI; blood albumin: (03May2021) 3.7 g/dl; blood alkaline phosphatase: (03May2021) 230, notes: unit/L, HI; blood bilirubin: (03May2021) 2.30 mg/dl, notes: HI; blood calcium: (03May2021) 8 .4 mg/dl, notes: LOW; blood chloride: (03May2021) 104 mmol/L; blood creatinine: (03May2021) 0.67 mg/dl; blood fibrinogen: (03May2021) 174 mg/dl, notes: LOW; blood glucose: (03May2021) 104 mg/dl, notes: HI; blood lactate dehydrogenase: (03May2021) 1062 uL, notes: HI; blood potassium: (03May2021) 3.8 mmol/L; blood pressure diastolic: (03May2021) 68 mmHg; blood pressure systolic: (03May2021) 134 mmHg; blood urea: (03May2021) 21 mg/dl, notes: HI; carbon dioxide: (03May2021) 25.4 mmol/L; chest x-ray: (03May2021) lungs clear; computerised tomogram: (03May2021) negative; fibrin d dimer: (03May2021) 20.00 mg/l, notes: FEU; haematocrit: (03May2021) 21.2 %, notes: low; haemoglobin: (03May2021) 7.5 g/dl, notes: LOW; haptoglobin: (03May2021) 20 mg/dl, notes: Low; heart rate: (03May2021) 98, notes: Bpm; investigation: (03May2021) 3.0/100 wbc, notes: HI; (03May2021) negative; mean cell haemoglobin: (03May2021) 30.9, notes: PG; mean cell haemoglobin concentration: (03May2021) 35.4 g/dl; mean cell volume: (03May2021) 87.2, notes: FL; oxygen saturation: (03May2021) unknown results; platelet count: (03May2021) 10, notes: K/MM3; protein total decreased: (03May2021) 5.8 g/dl, notes: LOW; prothrombin time: (03May2021) 18.1 seconds, notes: HI; red blood cell count: (03May2021) 2.43, notes: M/MM3, Low; (03May2021) 2.43, notes: M/MM3, LOW; red cell distribution width increased: (03May2021) 13.9 %; sars-cov-2 test: (03May2021) negative; (03May2021) negative; smear test: (03May2021) clumps absent; white blood cell count: (03May2021) 9.74; haemoglobin: (unspecified date) 9.0; (unspecified date) 11000; body temperature: (unspecified date) 38.2; (unspecified date) concerned about ttp, notes: saw a few schistocytes, and is concerned about TTP. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura, cerebral haemorrhage. The patient date of death was 05May2021. The reported cause of death was thrombotic thrombocytopenic purpura, cerebral haemorrhage. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events thrombotic thrombocytopenic purpura, cerebral haemorrhage cannot be 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: TTP; brain hemorrhage