Sex: M
Vaccine: COVID19
Symptoms: Muscle atrophy, Thrombosis
Clinical narrative: Vaccination site thrombosis / Blood clots after taking covid vaccines; Muscle atrophy / Lost muscle in legs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Vaccination site thrombosis / Blood clots after taking covid vaccines) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and Rheumatoid arthritis.    No Medical History information was reported.   In March 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced THROMBOSIS (Vaccination site thrombosis / Blood clots after taking covid vaccines) (seriousness criterion medically significant) and MUSCLE ATROPHY (Muscle atrophy / Lost muscle in legs). At the time of the report, THROMBOSIS (Vaccination site thrombosis / Blood clots after taking covid vaccines) and MUSCLE ATROPHY (Muscle atrophy / Lost muscle in legs) outcome was unknown.            No concomitant medications were reported. It was unknown if the patient was enrolled in a Covid-19 vaccine trial. No treatment medications were reported.  Company comment.  This spontaneous case concerns an adult male patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected, serious AESI of thrombosis. The patient received two doses of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The report stated that the patient experienced blood clots after taking COVID vaccines, and lost muscle in legs with Adalimumab. No further details were provided for medical review. Patient´s concomitant medication of Adalimumab (co  suspect product) and patient´s medical history of Rheumatoid arthritis could be confounders for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected, serious AESI of thrombosis. The patient received two doses of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The report stated that the patient experienced blood clots after taking COVID vaccines, and lost muscle in legs with Adalimumab. No further details were provided for medical review. Patient´s concomitant medication of Adalimumab (co  suspect product) and patient´s medical history of Rheumatoid arthritis could be confounders for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.