Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gangrene, Leg amputation, Product administration interrupted, Rehabilitation therapy, Thrombectomy
Clinical narrative: Blood clots; Gangrene; Missed her second dose as the hospital where the patient was admitted did not have Moderna vaccine; patient was sent to rehabilitation center; surgery (a leg was amputated); two clots were removed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots), THROMBECTOMY (two clots were removed), GANGRENE (Gangrene) and LEG AMPUTATION (surgery (a leg was amputated)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clot blood (blood clots in heart and lungs for last 15 years) and Thrombectomy (40 clots removed from heart and lungs from past 15 years). Concurrent medical conditions included Systemic lupus erythematosus (bad lupus).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria hospitalization and medically significant). On 01-Mar-2021, the patient experienced THROMBECTOMY (two clots were removed) (seriousness criterion hospitalization prolonged) and LEG AMPUTATION (surgery (a leg was amputated)) (seriousness criterion hospitalization prolonged). On 12-Mar-2021, the patient experienced REHABILITATION THERAPY (patient was sent to rehabilitation center). On an unknown date, the patient experienced GANGRENE (Gangrene) (seriousness criterion hospitalization prolonged) and PRODUCT ADMINISTRATION INTERRUPTED (Missed her second dose as the hospital where the patient was admitted did not have Moderna vaccine). The patient was hospitalized on 10-Feb-2021 due to THROMBOSIS, then on 27-Feb-2021 due to LEG AMPUTATION and THROMBECTOMY. The patient was treated with Surgery for Gangrene. On 01-Mar-2021, THROMBECTOMY (two clots were removed) and LEG AMPUTATION (surgery (a leg was amputated)) had resolved. At the time of the report, THROMBOSIS (Blood clots), PRODUCT ADMINISTRATION INTERRUPTED (Missed her second dose as the hospital where the patient was admitted did not have Moderna vaccine) and REHABILITATION THERAPY (patient was sent to rehabilitation center) outcome was unknown and GANGRENE (Gangrene) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As per the patient's doctor, it was too late and dangerous to remove clots from the patient's leg and eventually, the doctor had to amputate the patient's leg because of gangrene.  No concomitant medications were reported.  Company comment: Based on current available information and the temporal association between product use and het start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and het start date of the events a causal relationship cannot be excluded.