Sex: M
Vaccine: COVID19
Symptoms: Creatinine renal clearance, Creatinine renal clearance decreased, Deep vein thrombosis, Investigation
Clinical narrative: pain in the lower leg and is diagnosed with an extensive lower extremity DVT.; Patient has a CrCl of 95; This is a spontaneous report received from a Pharmacist.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Lot number: HG4628) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "uveal melanoma" (unspecified if ongoing), notes: Patient was diagnosed 20 years ago; "eye removed" (unspecified if ongoing); "Atrial Fibrillation" (ongoing). Concomitant medication(s) included: APIXABAN taken for atrial fibrillation. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (booster); Unknown manufacturer), for COVID-19 immunization. The following information was reported: CREATININE RENAL CLEARANCE DECREASED (non-serious) with onset 2023, outcome "unknown", described as "Patient has a CrCl of 95"; DEEP VEIN THROMBOSIS (hospitalization, medically significant) with onset 20Dec2023, outcome "recovering", described as "pain in the lower leg and is diagnosed with an extensive lower extremity DVT.". The patient was hospitalized for deep vein thrombosis (start date: 20Dec2023). The events "pain in the lower leg and is diagnosed with an extensive lower extremity dvt." required emergency room visit. The patient underwent the following laboratory tests and procedures: Creatinine renal clearance: (unspecified date) 95; anti-Xa level: (20Dec2023) 152 ng/ml. Therapeutic measures were taken as a result of deep vein thrombosis.  Clinical course: Unknown if COVID prior vaccination and Unknown if COVID tested post vaccination. On 20Dec2023 patient presents to the emergency department for leg pain and was diagnosed with an extensive lower extremity DVT. HCP stated that the patient was receiving apixaban 5 mg bid and was very compliant with the medication. The patient was diagnosed with uveal melanoma 20 years ago (history of uveal melanoma 20 years ago) and had the affected eye removed at the time of diagnosis with no recurrences to date. An anti-Xa level was drawn and found to be 152 ng/ml. Apixaban was stopped, and patient was started on Lovenox which he'll be on for 1 month. The patient's Cr Cl was 95 and he weighed 103 kg. Adverse event treatment: Lovenox treatment for 1 month. Seriousness criteria reported as not resulted in death, no life threatening, no disabling/incapacitating and no congenital anomaly/birth defect.  The information on the batch/lot number for BNT162b2 omi xbb.1.5  will be requested and submitted if and when received.; Sender's Comments: Based on the given information and temporal association , the possible contributory role of the suspect for the event deep vein thrombosis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.