Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea exertional, Joint swelling, Peripheral swelling, Pulmonary embolism
Clinical narrative: dizzy spells/lightheaded; shortness of breath on exertion; swelling of ankles; swelling of legs/swelling of calves; Unprovoked Pulmonary Emboli; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2022 as dose 4 (booster), single (Lot number: PJ4991) at the age of 82 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BETIMOL [TIMOLOL MALEATE]; BIOTIN; ROCKLATAN; ROSUVASTATIN; SERTRALINE; TELMISARTAN; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 32030BD, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 21Oct2021, when the patient was 82-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: 9261, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 19Feb2021, when the patient was 81-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: 5318, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 29Jan2021, when the patient was 81-year-old, for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, disability) with onset 01Oct2022 at 21:00, outcome "not recovered", described as "Unprovoked Pulmonary Emboli"; DIZZINESS (hospitalization, disability) with onset 01Oct2022 at 21:00, outcome "not recovered", described as "dizzy spells/lightheaded"; DYSPNOEA EXERTIONAL (hospitalization, disability) with onset 01Oct2022 at 21:00, outcome "not recovered", described as "shortness of breath on exertion"; JOINT SWELLING (hospitalization, disability) with onset 01Oct2022 at 21:00, outcome "not recovered", described as "swelling of ankles"; PERIPHERAL SWELLING (hospitalization, disability) with onset 01Oct2022 at 21:00, outcome "not recovered", described as "swelling of legs/swelling of calves". The patient was hospitalized for dizziness, dyspnoea exertional, joint swelling, peripheral swelling, pulmonary embolism (hospitalization duration: 3 day(s)). The events "dizzy spells/lightheaded", "shortness of breath on exertion", "swelling of ankles", "swelling of legs/swelling of calves" and "unprovoked pulmonary emboli" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of dizziness, dyspnoea exertional, joint swelling, peripheral swelling, pulmonary embolism.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination. It was Unknown if covid tested post vaccination. The facility type vaccine was Nursing Home/Senior Living Facility. The patient was hospitalized for 3 days. The patient was received Heparin and Eliquis as a treatment.; 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 the reported event dizziness, dyspnea exertional, joint swelling, peripheral swelling, pulmonary embolism 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.