Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: Could not walk; Leg was swollen; Nurse told him his leg was hot; blood clot in both his lungs; Blood clot in both his legs; Fast heartbeat; Soreness in left calf; Ultrasonography NOS abnormal; CT abnormal; Ankle and foot still swollen; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness in left calf), GAIT DISTURBANCE (Could not walk), PERIPHERAL SWELLING (Leg was swollen), FEELING HOT (Nurse told him his leg was hot), PULMONARY EMBOLISM (blood clot in both his lungs), DEEP VEIN THROMBOSIS (Blood clot in both his legs), HEART RATE INCREASED (Fast heartbeat) and ULTRASOUND SCAN ABNORMAL (Ultrasonography NOS abnormal) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included IRBESARTAN and LEVOTHYROXINE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in left calf) (seriousness criterion hospitalization). On 17-Mar-2021, the patient experienced GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Leg was swollen) (seriousness criterion hospitalization), FEELING HOT (Nurse told him his leg was hot) (seriousness criterion hospitalization), PULMONARY EMBOLISM (blood clot in both his lungs) (seriousness criterion hospitalization), DEEP VEIN THROMBOSIS (Blood clot in both his legs) (seriousness criterion hospitalization) and HEART RATE INCREASED (Fast heartbeat) (seriousness criterion hospitalization). On 14-Apr-2021, the patient experienced JOINT SWELLING (Ankle and foot still swollen). On an unknown date, the patient experienced ULTRASOUND SCAN ABNORMAL (Ultrasonography NOS abnormal) (seriousness criterion hospitalization prolonged) and COMPUTERISED TOMOGRAM ABNORMAL (CT abnormal). The patient was hospitalized from 17-Mar-2021 to 20-Mar-2021 due to DEEP VEIN THROMBOSIS, PAIN IN EXTREMITY and PULMONARY EMBOLISM. At the time of the report, PAIN IN EXTREMITY (Soreness in left calf), GAIT DISTURBANCE (Could not walk), PERIPHERAL SWELLING (Leg was swollen), FEELING HOT (Nurse told him his leg was hot), PULMONARY EMBOLISM (blood clot in both his lungs), DEEP VEIN THROMBOSIS (Blood clot in both his legs), HEART RATE INCREASED (Fast heartbeat), ULTRASOUND SCAN ABNORMAL (Ultrasonography NOS abnormal), COMPUTERISED TOMOGRAM ABNORMAL (CT abnormal) and JOINT SWELLING (Ankle and foot still swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: abnormal (abnormal) Abnormal. In 2021, Ultrasound scan: abnormal (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.