Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction, Electrocardiogram, Fibrin D dimer, Fraction of inspired oxygen, Heart rate
Clinical narrative: Right ventricle thrombus; Covid PCR was positive; breakthrough covid infection; This is a literature report.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "hyperlipidemia" (unspecified if ongoing); "cardiac arrest" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIAC VENTRICULAR THROMBOSIS (death, hospitalization, medically significant), 3 weeks after the suspect product(s) administration, outcome "fatal", described as "Right ventricle thrombus"; DRUG INEFFECTIVE (death, hospitalization, medically significant), outcome "fatal", described as "Covid PCR was positive"; BREAKTHROUGH COVID-19 (death, hospitalization, medically significant), outcome "fatal", described as "breakthrough covid infection". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 685, notes: Units unknown; Angiogram: Small hypo densities associated with left upper, notes: lobe and right lower lobe pulmonary arteries which may reflect small nonocclusive emboli versus artifact, multifocal bilateral ground glass; Aspartate aminotransferase: 1149, notes: Units unknown; Blood bicarbonate: 16, notes: Units unknown; Blood bilirubin: 2.30, notes: Units unknown; Blood creatine: 2.4, notes: Units unknown; Blood lactic acid: 8.8, notes: Units unknown; Blood pressure measurement: 87/61, notes: Units unknown; Blood urea: 27, notes: Units unknown; Body temperature: 91.4, notes: Units unknown; Chest X-ray: showed multifocal pneumonia; Echocardiogram: showed EF of 60-65% without regional wall motion, notes: abnormalities, severely dilated and severely hypokinetic right ventricle with moderate sized mobile echo density within RV cavity consistent with thrombus; Ejection fraction: 60-65 %; Electrocardiogram: sinus tachycardia with frequent PVCs and PACs; Fibrin D dimer: Greater than 35.20; Fraction of inspired oxygen: 100 %; Heart rate: 101, notes: Units unknown; Oxygen saturation: 70 %; pH body fluid: 6.98, notes: Units unknown; 81.1, notes: Units unknown; 51, notes: Units unknown; 19, notes: Units unknown; Respiratory rate: 28, notes: Units unknown; SARS-CoV-2 test: Positive; Troponin: 0.605 ng/ml; White blood cell count: 34, notes: Units unknown. Therapeutic measures were taken as a result of cardiac ventricular thrombosis. The patient date of death was unknown. Reported cause of death: "breakthrough covid infection", "Covid PCR was positive", "Right ventricle thrombus". It was not reported if an autopsy was performed.  Clinical course: Patient with hypertension, hyperlipidemia, was transferred from another facility, post cardiac arrest. Patient had been complaining of shortness of breath from past few days, but when it suddenly got worse, EMS was called and his oxygen saturation was found to be 70%. He was already intubated upon admission. He had received his first dose of Pfizer vaccine 3 weeks prior. His temperature was 91.4, HR of 101, RR 28, BP of 87/61, pH was 6.98/81.1/51/19, 100% of FiO2 on Ventilator. Pertinent labs included WBC- 34, Bicarbonate - 16, BUN/Cr - 27/2.4, total bilirubin - 2.30, AST -1149. ALT 685, Troponin - 0.605 ng/ml, lactate - 8.8, d-dimer > 35.20 mg/L, Covid PCR was positive. EKG showed sinus tachycardia with frequent PVCs and PACs. CXR showed multifocal pneumonia. CTA showed small hypo densities associated with left upper lobe and right lower lobe pulmonary arteries which may reflect small nonocclusive emboli versus artifact, multifocal bilateral ground glass. He was managed with Iv fluid resuscitation, full dose anticoagulation, antibiotics, steroids and pressor support. Additionally, TTE was obtained which showed EF of 60-65% without regional wall motion abnormalities, severely dilated and severely hypokinetic right ventricle with moderate sized mobile echo density within RV cavity consistent with thrombus. Final Diagnosis and outcome: Patient was diagnosed with RV thrombus from covid vaccine/pneumonia and was given systemic tPA, but patient continued to deteriorate requiring maximal pressor support, worsening hypoxia and acidemia, despite all efforts to manipulate ventilator and placing on neuromuscular blockade and prone positioning. Family then opted for withdrawing care and unfortunately patient expired shortly after extubation.  No follow-up attempts are possible.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Breakthrough COVID-19 , Drug ineffective, Cardiac ventricular thrombosis 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: Right ventricle thrombus; breakthrough covid infection; Covid PCR was positive