Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: Orthopedic surgeon suggested to get an ultrasound to rule out VTE; left leg from ankle, shin, gluteus muscle intense pain; left leg from ankle intense pain; gluteus muscle with intense pain; can't stand on the feet; in a lot of pain / getting worse; This spontaneous case was reported by a patient and describes the occurrence of EMBOLISM VENOUS (Orthopedic surgeon suggested to get an ultrasound to rule out VTE) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (left leg from ankle, shin, gluteus muscle intense pain), ARTHRALGIA (left leg from ankle intense pain), MUSCULOSKELETAL PAIN (gluteus muscle with intense pain), DYSSTASIA (can't stand on the feet) and PAIN (in a lot of pain / getting worse). On an unknown date, the patient experienced EMBOLISM VENOUS (Orthopedic surgeon suggested to get an ultrasound to rule out VTE) (seriousness criterion medically significant). At the time of the report, EMBOLISM VENOUS (Orthopedic surgeon suggested to get an ultrasound to rule out VTE), PAIN IN EXTREMITY (left leg from ankle, shin, gluteus muscle intense pain), ARTHRALGIA (left leg from ankle intense pain), MUSCULOSKELETAL PAIN (gluteus muscle with intense pain), DYSSTASIA (can't stand on the feet) and PAIN (in a lot of pain / getting worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, X-ray: no breakage (normal) no breakage.         Patient had no side effects on first dose. Patient was not sure when patient experienced the left leg from ankle, shin, gluteus muscle with intense pain. Patient has been in a lot of pain. Patient can't stand on the feet and patient said that it is getting worse. Orthopedic surgeon suggested patient to get an ultrasound to rule out VTE. On 21 May 2021, X-ray result showed no breakage. Patient is currently not on any medications on daily basis.  Company Comment: This case concerns a 60-year-old female with a serious unexpected event of embolism venous, and nonserious events of pain in extremity, musculoskeletal pain, dysstasia, pain, and arthralgia. Event latency 29 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of embolism venous, and nonserious events of pain in extremity, musculoskeletal pain, dysstasia, pain, and arthralgia. Event latency 29 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.