Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rheumatoid arthritis
Clinical narrative: INCREASED IN RHEUMATOID ARTHRITIS SYMPTOMS/Rheumatoid arthritis aggravated; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (INCREASED IN RHEUMATOID ARTHRITIS SYMPTOMS/Rheumatoid arthritis aggravated) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis, Plaque psoriasis and Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (INCREASED IN RHEUMATOID ARTHRITIS SYMPTOMS/Rheumatoid arthritis aggravated) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, RHEUMATOID ARTHRITIS (INCREASED IN RHEUMATOID ARTHRITIS SYMPTOMS/Rheumatoid arthritis aggravated) had not resolved and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The patient reported she noticed that increase in Rheumatoid Arthritis symptoms once Covid resolved. The reporter causality for the event of Rheumatoid arthritis aggravated was  assessed as reasonable possibility for cosuspect Rinvoq. The reporter causality for the event of COVID-19 was  not reported for cosuspect Rinvoq. No treatment medications were 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, with no reported medical history, who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis (reported as increased in rheumatoid arthritis symptoms) and unexpected non-serious AESI COVID-19 after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of rheumatoid arthritis was reported as not resolved and COVID-19 resolved. On unknown date, patient received co-suspect Upadacitinib for rheumatoid arthritis, psoriasis, and ulcerative colitis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an adult female patient, with no reported medical history, who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis (reported as increased in rheumatoid arthritis symptoms) and unexpected non-serious AESI COVID-19 after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of rheumatoid arthritis was reported as not resolved and COVID-19 resolved. On unknown date, patient received co-suspect Upadacitinib for rheumatoid arthritis, psoriasis, and ulcerative colitis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.