Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis symptom relief began to end towards end of Humira injection cycle and rheumatoid arthritis symptoms resume/symptoms of rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis symptom relief began to end towards end of Humira injection cycle and rheumatoid arthritis symptoms resume/symptoms of rheumatoid arthritis) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROXYCHLOROQUINE SULFATE for Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis symptom relief began to end towards end of Humira injection cycle and rheumatoid arthritis symptoms resume/symptoms of rheumatoid arthritis) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis symptom relief began to end towards end of Humira injection cycle and rheumatoid arthritis symptoms resume/symptoms of rheumatoid arthritis) outcome was unknown.            No treatment medications were provided  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Company comment: This spontaneous case concerns an adult male patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of rheumatoid arthritis flare up. The event occurred on an unknown date. Temporal relationship to mRNA-1273  bivalent BA.4/BA.5 is unclear. As reported, rheumatoid arthritis symptom relief began to end towards end of Humira injection cycle and rheumatoid arthritis symptoms resume. Although no medical history was reported and limited information about treatment of RA was provided, it is likely that patient had concurrent RA which can provide etiology for flare up along with time relation to treatment with adalimumab.  No further information was provided. The benefit-risk relationship of mRNA-1273  bivalent BA.4/BA.5 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of rheumatoid arthritis flare up. The event occurred on an unknown date. Temporal relationship to mRNA-1273  bivalent BA.4/BA.5 is unclear. As reported, rheumatoid arthritis symptom relief began to end towards end of Humira injection cycle and rheumatoid arthritis symptoms resume. Although no medical history was reported and limited information about treatment of RA was provided, it is likely that patient had concurrent RA which can provide etiology for flare up along with time relation to treatment with adalimumab.  No further information was provided. The benefit-risk relationship of mRNA-1273  bivalent BA.4/BA.5 is not affected by this report.