Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Hypoaesthesia, Immobile, Injury
Clinical narrative: She kept feeling something in her leg; She kept feeling something in her leg, when she got to the hospital the doctors said there was her trauma to the leg; The blood clot turned into an edema; she had a blood clot in her left leg; she was immobile; She was hospitalized for 3 days to try to control her leg; Her legs became hot; it was sore/muscle butt like pain as if she pulled a hamstring/excruciating pain; all of a sudden she felt her left buttocks going numb; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (she had a blood clot in her left leg), IMMOBILE (she was immobile), LIMB DISCOMFORT (She was hospitalized for 3 days to try to control her leg), BURNING SENSATION (Her legs became hot), MYALGIA (it was sore/muscle butt like pain as if she pulled a hamstring/excruciating pain), OEDEMA PERIPHERAL (The blood clot turned into an edema), HYPOAESTHESIA (all of a sudden she felt her left buttocks going numb), INJURY (She kept feeling something in her leg, when she got to the hospital the doctors said there was her trauma to the leg) and FEELING ABNORMAL (She kept feeling something in her leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced THROMBOSIS (she had a blood clot in her left leg) (seriousness criteria hospitalization, disability and medically significant), IMMOBILE (she was immobile) (seriousness criteria hospitalization, disability and medically significant), LIMB DISCOMFORT (She was hospitalized for 3 days to try to control her leg) (seriousness criteria hospitalization and disability), BURNING SENSATION (Her legs became hot) (seriousness criterion hospitalization), MYALGIA (it was sore/muscle butt like pain as if she pulled a hamstring/excruciating pain) (seriousness criteria hospitalization and disability), OEDEMA PERIPHERAL (The blood clot turned into an edema) (seriousness criteria hospitalization and disability), HYPOAESTHESIA (all of a sudden she felt her left buttocks going numb) (seriousness criteria hospitalization and disability) and INJURY (She kept feeling something in her leg, when she got to the hospital the doctors said there was her trauma to the leg) (seriousness criteria hospitalization and disability). On an unknown date, the patient experienced FEELING ABNORMAL (She kept feeling something in her leg) (seriousness criteria hospitalization and disability). The patient was hospitalized for 3 days due to BURNING SENSATION, HYPOAESTHESIA, IMMOBILE, LIMB DISCOMFORT, MYALGIA and THROMBOSIS. At the time of the report, THROMBOSIS (she had a blood clot in her left leg), IMMOBILE (she was immobile), LIMB DISCOMFORT (She was hospitalized for 3 days to try to control her leg), BURNING SENSATION (Her legs became hot), MYALGIA (it was sore/muscle butt like pain as if she pulled a hamstring/excruciating pain), OEDEMA PERIPHERAL (The blood clot turned into an edema), HYPOAESTHESIA (all of a sudden she felt her left buttocks going numb), INJURY (She kept feeling something in her leg, when she got to the hospital the doctors said there was her trauma to the leg) and FEELING ABNORMAL (She kept feeling something in her leg) outcome was unknown.            Treatment medications were not reported.  Company Comment: 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.; 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.