Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tendon rupture
Clinical narrative: High level of rheumatoid in blood work/diagnosed with Rheumatoid Arthritis; Pressure in their shoulder that caused their bicep tendon tore; Crazy amount of ligament and hamstring is constantly hurting; They have been cramping at night primarily in left leg. They feel like their groin is being pulled off or torn from cramps.; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (High level of rheumatoid in blood work/diagnosed with Rheumatoid Arthritis) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced RHEUMATOID ARTHRITIS (High level of rheumatoid in blood work/diagnosed with Rheumatoid Arthritis) (seriousness criterion medically significant), TENDON RUPTURE (Pressure in their shoulder that caused their bicep tendon tore), LIGAMENT PAIN (Crazy amount of ligament and hamstring is constantly hurting) and MUSCLE SPASMS (They have been cramping at night primarily in left leg. They feel like their groin is being pulled off or torn from cramps.). The patient was treated with METHOTREXATE for Rheumatoid arthritis, at a dose of 1 dosage form and ETANERCEPT (ENBREL) for Rheumatoid arthritis, at a dose of 1 dosage form. At the time of the report, RHEUMATOID ARTHRITIS (High level of rheumatoid in blood work/diagnosed with Rheumatoid Arthritis), TENDON RUPTURE (Pressure in their shoulder that caused their bicep tendon tore), LIGAMENT PAIN (Crazy amount of ligament and hamstring is constantly hurting) and MUSCLE SPASMS (They have been cramping at night primarily in left leg. They feel like their groin is being pulled off or torn from cramps.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high level of rheumatoid (abnormal) Diagnosed with Rheumatoid Arthritis.. On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) Results pending..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did  MRI. MRI results were pending at the time of the report but the Orthopedic doctor indicated that patient's bicep tendon has been tore. Patient was initially treated with Methotrexate, however, as the patient could not handle the medicine he was switched to Enbrel. No concomitant information was reported.  Company comment: This case concerns a 59-year-old male patient with no medical history provided who experienced serious unexpected event of Rheumatoid arthritis and non-serious unexpected events of Tendon rupture, Ligament pain and Muscle spasms. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported events was not provided. Very limited information regarding clinical course of the events has been provided at this time. It was reported that the patient was treated with Methotrexate and Enbrel, however, at the time of the report outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 59-year-old male patient with no medical history provided who experienced serious unexpected event of Rheumatoid arthritis and non-serious unexpected events of Tendon rupture, Ligament pain and Muscle spasms. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported events was not provided. Very limited information regarding clinical course of the events has been provided at this time. It was reported that the patient was treated with Methotrexate and Enbrel, however, at the time of the report outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.