Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Spondylitis
Clinical narrative: Rheumatoid arthritis flare up/MODERNA COVID VACCINE ON UPPER ARM AND INJECTION CAUSED SEVERE RHEUMATOID ARTHRITIS INFLAMMATION LEFT SHOULDER with RINVOQ (UPADACITINIB); Back arthritis; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/MODERNA COVID VACCINE ON UPPER ARM AND INJECTION CAUSED SEVERE RHEUMATOID ARTHRITIS INFLAMMATION LEFT SHOULDER with RINVOQ (UPADACITINIB)) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose and UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/MODERNA COVID VACCINE ON UPPER ARM AND INJECTION CAUSED SEVERE RHEUMATOID ARTHRITIS INFLAMMATION LEFT SHOULDER with RINVOQ (UPADACITINIB)) (seriousness criterion medically significant) and SPONDYLITIS (Back arthritis). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/MODERNA COVID VACCINE ON UPPER ARM AND INJECTION CAUSED SEVERE RHEUMATOID ARTHRITIS INFLAMMATION LEFT SHOULDER with RINVOQ (UPADACITINIB)) and SPONDYLITIS (Back arthritis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.  It was reported as patient was still having flare ups five days a week and was taking additional medicine. She had covid vaccine on upper arm and injection caused severe Rheumatoid arthritis inflammation left shoulder. She still having occasional Rheumatoid arthritis flare ups. She had been diagnosed with arthritis in her back. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medication was reported by 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 concerns a female patient of unknown age, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up and Moderna COVID vaccine on upper arm and injection caused severe rheumatoid arthritis inflammation left shoulder with rinvoq (upadacitinib) and Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient also had back arthritis. The event had not resolved. No information on exact date of the event, detailed clinical course and relevant investigations was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up and Moderna COVID vaccine on upper arm and injection caused severe rheumatoid arthritis inflammation left shoulder with rinvoq (upadacitinib) and Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient also had back arthritis. The event had not resolved. No information on exact date of the event, detailed clinical course and relevant investigations was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.