Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Scan
Clinical narrative: Severe lower leg swelling; Redness; Severe shortness of breath after showering; Near syncopal episodes; Large DVT in lower extremity; Massive saddle embolus; This is a spontaneous report received from contactable nurse. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 2, single (Lot number: EL9263) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild HTN" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing); "Multivitamin" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; VIT D [VITAMIN D NOS]; COQ10 [UBIDECARENONE]; GABAPENTIN. Past drug history included: Cymbalta, reaction(s): "Allergies". Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EK9231; in left arm), administration date: 18Jan2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, life threatening) with onset 18Feb2021, outcome "recovered with sequelae", described as "Large DVT in lower extremity"; EMBOLISM (hospitalization, life threatening) with onset 18Feb2021, outcome "recovered with sequelae", described as "Massive saddle embolus"; PRESYNCOPE (hospitalization, life threatening) with onset 18Feb2021, outcome "recovered with sequelae", described as "Near syncopal episodes"; ERYTHEMA (hospitalization, life threatening) with onset 18Feb2021, outcome "recovered with sequelae", described as "Redness"; PERIPHERAL SWELLING (hospitalization, life threatening) with onset 18Feb2021, outcome "recovered with sequelae", described as "Severe lower leg swelling"; DYSPNOEA EXERTIONAL (hospitalization, life threatening) with onset 18Feb2021, outcome "recovered with sequelae", described as "Severe shortness of breath after showering". The patient was hospitalized for peripheral swelling, erythema, dyspnoea exertional, presyncope, deep vein thrombosis, embolism (start date: 18Feb2021, discharge date: 22Feb2021, hospitalization duration: 4 day(s)). The events "severe lower leg swelling", "redness", "severe shortness of breath after showering", "near syncopal episodes", "large DVT in lower extremity" and "massive saddle embolus" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Scan: (18Feb2021) Large DVT in lower extremity, notes: And massive saddle embolus. Therapeutic measures were taken as a result of peripheral swelling, erythema, dyspnoea exertional, presyncope, deep vein thrombosis, embolism. Per clinical course, 10 days after second vaccine, the patient experienced severe lower leg swelling, redness, severe shortness of breath after showering, and near syncopal episodes started. Taken by ambulance to local medical center ED. Within an hour or so, the patient had scan showing large deep venous thrombosis (DVT) in lower extremity and massive saddle embolus. The patient was taken shortly to IR for catheter to remove clots. The patient is now on rivaroxaban (XARELTO) for the rest of his life. The adverse events resulted in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care, hospitalization, and life-threatening illness (immediate risk of death from the event). The patient recovered with lasting effects.; Sender's Comments: Based on the information in the case, an association between the reported events Swelling of legs, redness, dyspnoea, presyncope, dvt of legs and embolus and suspect product bnt162b2 cannot be ruled out.   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.