Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Venous thrombosis limb
Clinical narrative: covid 19; The patient states she was also diagnosed with a chronic minor blood clot in the left femoral vein during the time she got COVID.; This spontaneous case was reported by a patient and describes the occurrence of VENOUS THROMBOSIS LIMB (The patient states she was also diagnosed with a chronic minor blood clot in the left femoral vein during the time she got COVID.) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Batch number-031M20A, Dose 1) on 13-Feb-2021, Moderna COVID-19 Vaccine (Batch number-061A21A, Dose 2) on 13-Mar-2021, Moderna COVID-19 Vaccine (Batch number-026D21A, Dose 3) on 22-Oct-2021, Moderna COVID-19 Vaccine (Batch number-002M21A and Dose 4) on 08-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In May 2023, the patient experienced COVID-19 (covid 19). In 2023, the patient experienced VENOUS THROMBOSIS LIMB (The patient states she was also diagnosed with a chronic minor blood clot in the left femoral vein during the time she got COVID.) (seriousness criterion medically significant). The patient was treated with DABIGATRAN ETEXILATE MESILATE (PRADAXA) for Clot blood, at an unspecified dose and frequency. At the time of the report, VENOUS THROMBOSIS LIMB (The patient states she was also diagnosed with a chronic minor blood clot in the left femoral vein during the time she got COVID.) had not resolved and COVID-19 (covid 19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had COVID in May 2023. The patient stated that she was also diagnosed with a chronic minor blood clot in the left femoral vein during the time she got COVID. They told her she might have had it prior to developing COVID. They said it looked like it was not resulting from COVID. Patient was using the blood thinner at the time of reporting because it was stable but still there. Patient stated she confirmed from COVID within a week. She had some fatigue afterwards. She did not had any other treatment.  Company Comment: This is a Spontaneous case concerning a 74-year-old female patient with no medical history reported, who experienced the serious (per medically significant) unexpected AESI of thrombosis.  A non-serious event of COVID-19 was also reported. The events occurred approximately 8 months after the fifth dose of mRNA-1273 received for COVID-19 Vaccination. It was reported that the patient was diagnosed with a chronic minor blood clot in the left femoral vein during the time she got COVID. They told her she might have had it prior to developing COVID. She was treated with PRADAXA for thrombosis and did not receive any other treatment. Concurrent COVID-19 infection and patient's advanced age may remain as confounders for thrombosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.