Sex: M
Vaccine: COVID19
Symptoms: Anti factor VIII antibody test, Deep vein thrombosis, Factor V Leiden mutation, Fibrin D dimer, Pain in extremity
Clinical narrative: pain when he bent the leg but relief when he stood/felt as if he had a ligament injury; DVT below the left knee; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT below the left knee) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sports injury (in the 1980's that caused a clot) and Clot blood (in the 1980s; has not been on any medication for it until last year (2020)). Concurrent medical conditions included Pulmonary embolism (asymptomatic, in both lungs), Factor V Leiden mutation and Factor VIII deficiency. Concomitant products included APIXABAN (ELIQUIS) for Clot blood.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT below the left knee) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain when he bent the leg but relief when he stood/felt as if he had a ligament injury). The patient was treated with HEPARIN on 30-May-2021 for DVT, at an unspecified dose and frequency and ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) on 30-May-2021 for DVT, at a dose of 80 UNK, bid. At the time of the report, DEEP VEIN THROMBOSIS (DVT below the left knee) and PAIN IN EXTREMITY (pain when he bent the leg but relief when he stood/felt as if he had a ligament injury) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Anti factor VIII antibody test: low (Low) low factor VIII. On 30-May-2021, Factor V Leiden mutation: high (High) high factor V. On 30-May-2021, Fibrin D dimer: 0.56 (Inconclusive) 0.56.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to the hospital on 30 May 2021 and was diagnosed with a DVT below the left knee.  He stated he has only taken apixaban for 1 year, not other medications.  The patient stated that apixaban has been working without incident until he received the vaccine.  He also reported he was found to have Factor V "Liden" deficiency and Factor VIII.    Very limited information regarding the events have been provided at this time. Patient's history of prior DVT, asymptomatic PE, Factor V Liden deficiency an Factor VIII are confounding factors to the events. Further information has been requested.; Sender's Comments: Very limited information regarding the events have been provided at this time. Patient's history of prior DVT, asymptomatic PE, Factor V Liden deficiency an Factor VIII are confounding factors to the events. Further information has been requested.