Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Vaccine caused mild rheumatoid arthritis flare; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Vaccine caused mild rheumatoid arthritis flare) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Vaccine caused mild rheumatoid arthritis flare) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Vaccine caused mild rheumatoid arthritis flare) had resolved.            Concomitant medication was not reported. On unknown dates, the patient experienced vaccine caused mild rheumatoid arthritis flare and injection had some gray material in it. On an unknown date, vaccine caused mild rheumatoid arthritis flare resolved. Moderna COVID-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns an adult female patient of unspecified age with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (reported as Vaccine caused mild rheumatoid arthritis flare)) that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had received three doses of same vaccine on unknown dates. The Clinical course, Concomitant medication, investigations, treatment details were not available. Outcome of event Rheumatoid Arthritis was reported as resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (reported as Vaccine caused mild rheumatoid arthritis flare)) that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had received three doses of same vaccine on unknown dates. The Clinical course, Concomitant medication, investigations, treatment details were not available. Outcome of event Rheumatoid Arthritis was reported as resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.