Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Fibrin D dimer, Inappropriate schedule of product administration, Off label use
Clinical narrative: DVT left lower extremity; Bilateral Pulmonary Emboli; first dose: 23Feb2021; second dose: 16Mar2021; first dose: 23Feb2021; second dose: 16Mar2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199 and expiration date not provided) intramuscular, administered in the left arm on 16Mar2021 13:30 as a single dose for COVID-19 immunization. The patient has no relevant medical history. Family history included diabetes (mother). The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200 and expiration date not provided) Injected intramuscularly in left upper arm on 23Feb2021, 13:30 for COVID-19 immunization and experienced DVT symptoms, soft tissue injury, muscle pull and ankle strain. The patient experienced DVT left lower extremity and bilateral pulmonary emboli on 23Apr2021. The patient called regarding the Pfizer COVID vaccine. He had adverse events to report. He has a DVT on his left calf, which he later clarified was left lower extremity. He is currently on double dose of apixaban (ELIQUIS) since Friday. He finally went and got it looked at. He is still being treated and will be seeing a hematologist. He stated that DVT symptoms occurred after first dose and was undiagnosed. He treated it as soft tissue injury and thought it was a muscle pull and ankle strain. Eliquis was started on 23Apr2021 and dose is 5 mg. He is taking two tablets twice daily for 7 days and then 1, 5mg tablet bid (twice a day) as well. No emergency room or physician's office required but Urgent care facility was visited on 23Apr2021. During this visit, they did Lab work, D Dimer results 1590 on 23Apr2021; Venous Doppler resulted in positive DVT in Left Lower Extremity. Chest CT resulted in positive peripheral defects in small branches of the lower lobes bilaterally, left greater than right, consistent with Pulmonary Emboli. Left sided pleural effusion and left basillary infiltrate, possibly atelectasis or developing infarct. Few pleural based nodular densities at right lung base, again atelectasis versus developing infarcts. The rest just states what was normal. Eliquis was prescribed on 23Apr2021, 5 mg two tablets twice daily for 7 days, then regular dose times 7 days. He is to report to hematologist on 29Apr2021. The outcome of the events deep vein thrombosis and pulmonary embolism was unknown. The reporter assessed the events as serious (life-threatening).; 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 DVT of legs and Pulmonary embolism cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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.