Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram thorax, Echocardiogram, Fibrin D dimer, Positron emission tomogram
Clinical narrative: Occlusive thrombus; pulmonary emboli; This is a spontaneous report from a contactable pharmacist. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 01Mar2021 (Batch/Lot Number: EL9261), vaccinated at age of 64 years old, as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); and fluoxetine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL1284) on 08Feb2021 05:00 PM via intramuscular on arm right for covid-19 immunisation, at age of 64 years old. The patient experienced occlusive thrombus, and pulmonary emboli both on 26Oct2021 11:00 with outcome of recovering. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included CT scan: unknown results on 2021, Chest CT: Right upper lobe pulmonary nodule measuring 1 cm on unspecified date, Cariac Echo: unknown results on 2021, D Dimer: unknown results on 2021, PET/CT or tissue sampling: unknown results on 2021, POC COVID-19 Molecular, Abbott ID NOW: negative on 25Oct2021, Venous Doppler Ultrasound: unknown results on 2021. Occlusive thrombus seen along the right common femoral vein, femoral vein, popliteal vein, and posterior tibial vein. Short segment occlusive thrombus seen along the distal left femoral vein. No focal fluid collections. Result: Acute on subacute pulmonary emboli (mild to moderate burden) as described. No right heart strain. Right upper lobe pulmonary nodule measuring 1 cm. Consider a non contrast. Chest CT at 3 months, a PET/CT, or tissue sampling. Acute on subacute mild to moderate burden pulmonary emboli characterized by right upper, middle, and lower segmental as well as left lower lobe segmental pulmonary emboli. No right heart strain. RIGHT VENTRICLE: No right ventricular strain. Patient exercised 4-5 days per week and took only two medications. He was healthy, did not have high blood pressure, renal issues, etc. The vaccine was responsible for this event. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Treatment was received for events. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination covid test type post vaccination=Blood test, covid test name post vaccination=POC COVID-19 Molecular, Abbott ID NOW, covid test date=25Oct2021, covid test result=Negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Bell's palsy and Facial paralysis cannot be completely excluded.  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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.