Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram heart, Fibrin D dimer, Polymyalgia rheumatica, Pulmonary embolism
Clinical narrative: Polymyalgia Rheumatica; Pulmonary embolism; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: tn6200) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden", start date: 11Jul2014 (unspecified if ongoing), notes: also found factor V leiden mutation; "Had a basket ball pole fall on his right foot in Aug. Clot found in Dec " (unspecified if ongoing), notes: Had a basket ball pole fall on his right foot in Aug. Clot found in Dec. Concomitant medication(s) included: AMLODIPINE (ongoing); LOSARTAN oral (ongoing); SIMVASTATIN oral (ongoing); VITAMIN D3 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, Lot Number /Expiry Date: GL3248, Route: Arm, Age at Immunization if date not available: 66), administration date: 05Feb2021, when the patient was 66-year-old, for COVID-19 IMMUNIZATION, reaction(s): "He has blood clots in his lungs", "Cough", "shortness of breath". The following information was reported: PULMONARY EMBOLISM (medically significant) with onset 05Mar2021, outcome "recovered"; POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown". The event "pulmonary embolism" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram heart: (05Mar2021) Clot in lungs, notes: CT Angiogram chest for pulmonary embolism; Fibrin D dimer: (05Mar2021) 7.17 mg, notes: Value 7.17 mg. Therapeutic measures were taken as a result of polymyalgia rheumatica, pulmonary embolism. Patient has had two adverse effects after getting his Pfizer vaccine. He has had blood clots in his lungs and the last vaccine he got he has Polymyalgia Rheumatica. He is afraid to get any more vaccines. He has blood clots in his lungs kept in sparrow for observation for 3 days. No admission to hospital due to the event. Treatment received and patient is fine now on blood thinner. Emergency room visit plus kept in hospital for observation for three days. Put on blood thinner for rest of life. Was diagnosed prior to this episode with factor V [illegible] mutation. Had first Pfizer vaccine on 05Feb2021, symptoms started about 2 wks prior to visit to primary care for physical on 05Mar2021 had a cough & experiencing shortness of breath. Blood clots in lungs began about two weeks before emergency room visit on 05Mar2021, physician office. Patient was not admitted, kept 3 days for observation. No known family medical history for blood clots. There are predisposing factors such as Factor V Leiden. Culture was not performed.; Sender's Comments: Based on the limited information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported events of Polymyalgia rheumatica and Pulmonary embolism cannot be excluded. There is very limited information provided in this report. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-PV202300136857 Same patient, reporter, same drug, different dose and event.;