Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: RHEUMATOID ARTHRITIS FLARE; Vaccination site pain; Feeling hot; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE) in an adult female 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) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE) (seriousness criterion medically significant), VACCINATION SITE PAIN (Vaccination site pain) and FEELING HOT (Feeling hot). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE), VACCINATION SITE PAIN (Vaccination site pain) and FEELING HOT (Feeling hot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  On unknown dates, the patient experienced sore arm after covid vaccine, felt hot and rheumatoid arthritis flare. moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. the patient received covid-19 vaccine. The reporter's causality for the event(s) of sore arm after covid vaccine and rheumatoid arthritis flare with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt hot was not provided. No treatment information was reported by the reporter. 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 reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the Covid 19 vaccination series, along with other non serious events. On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the Covid 19 vaccination series, along with other non serious events. On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.