Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Lower limb fracture, Pelvic fracture
Clinical narrative: crushed pelvis; patient fell from a garage roof; fractured right leg as a result of the fall; light-headed before stumbling and falling; had felt similar light-headedness a couple of limes in the past; This is a spontaneous report received from a contactable reporter(s) (Physician). Other Case identifier(s): 2022SA467056 (Sanofi).  A 79-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular, in right deltoid for covid-19 immunisation; hydroxyzine pamoate (HYDROXYZINE PAMOATE), in Mar2022 as 10 mg, 1x/day (10 mg qd oral) oral for insomnia; amiodarone HCl (AMIODARONE HCL), in 2021 for atrial fibrillation; diltiazem HCl (DILTIAZEM HCL), in 2016 as 120 mg, 1x/day (120 mg qd oral) oral for atrial fibrillation; tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), in 2012 as 0.4 mg, 1x/day (0.4 mg qd oral) (Batch/Lot number: unknown) oral for benign prostatic hyperplasia; losartan (LOSARTAN), in 2016 as 25 mg, 1x/day (25mg qd oral) (Batch/Lot number: unknown) oral for atrial fibrillation. The patient's relevant medical history included: "Insomnia", start date: 1994 (ongoing); "Chronic pulmonary disease", start date: 2002 (ongoing); "Prostate cancer", start date: 2015, stop date: 2015; "Atrial fibrillation", start date: 2016 (ongoing); "Seasonal allergy", start date: 2017 (ongoing); "Non-alcoholic fatty liver" (unspecified if ongoing); "Benign prostatic hyperplasia" (unspecified if ongoing); "supplementation therapy" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE taken for seasonal allergy; BETAINE; FOLIC ACID; MECOBALAMIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN taken for supplementation therapy; APIXABAN taken for atrial fibrillation; UBIDECARENONE taken for supplementation therapy; BUDESONIDE taken for chronic obstructive pulmonary disease. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Time of administration: 14:32, Route of administration: Intramuscular; Anatomical location: left deltoid), administration date: 09Dec2020, for COVID-19 IMMUNIZATION; BNT162b2 (DOSE 2, SINGLE; Time of administration: 13:29, Route of administration: Intramuscular; Anatomical location: left deltoid), administration date: 10Mar2021, for COVID-19 IMMUNIZATION. The following information was reported: PELVIC FRACTURE (hospitalization, medically significant) with onset 11Apr2022, outcome "unknown", described as "crushed pelvis"; LOWER LIMB FRACTURE (hospitalization) with onset 11Apr2022, outcome "recovered", described as "fractured right leg as a result of the fall"; FALL (hospitalization) with onset 11Apr2022, outcome "unknown", described as "patient fell from a garage roof"; DIZZINESS (medically significant), outcome "unknown", described as "light-headed before stumbling and falling; had felt similar light-headedness a couple of limes in the past". The action taken for hydroxyzine pamoate, amiodarone HCl, diltiazem HCl and tamsulosin hydrochloride was unknown. Therapeutic measures were taken as a result of lower limb fracture.  Clinical course: The patient fell from a garage roof, fractured right leg as a result of the fall, crushed pelvis and light-headed before stumbling and falling; had felt similar light-headedness a couple of times in the past while receiving vaccine BNT162B2 and while treated with Tamsulosin hydrochloride [Flomax], hydroxyzine, losartan, diltiazem and amiodarone. Received operation to place 3 plates and 9 screws in the right leg was received as corrective treatment was received for the event (fractured right leg as a result of the fall).  Company Comment: Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited  information causal association between  the events dizziness, fall, pelvic fracture, lower lib fracture, and suspect drug Comirnaty 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 RAs, Ethics Committees, and Investigators, as appropriate.