Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injury, Joint range of motion decreased, Malaise, Pain in extremity
Clinical narrative: Rheumatoid arthritis flare up; Could not move shoulder; Injury; Redness; Felt ill; Sore arm; High fever; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) 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.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CITRATE FREE. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), JOINT RANGE OF MOTION DECREASED (Could not move shoulder), INJURY (Injury), ERYTHEMA (Redness), MALAISE (Felt ill), PAIN IN EXTREMITY (Sore arm) and PYREXIA (High fever). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), MALAISE (Felt ill), PAIN IN EXTREMITY (Sore arm) and PYREXIA (High fever) had resolved, JOINT RANGE OF MOTION DECREASED (Could not move shoulder) and INJURY (Injury) outcome was unknown and ERYTHEMA (Redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. Treatment medication was not provided by the reporter.  The reporter's causality for Humira for the event(s) of redness, sore arm, high fever, felt ill and rheumatoid arthritis flare with humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of could not move shoulder and injury was not provided.  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 is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis (reported as rheumatoid arthritis flare up), which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis (reported as rheumatoid arthritis flare up), which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.