Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare; a minor pain at the injection site following covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) in a 50-year-old 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (a minor pain at the injection site following covid vaccine). On 10-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) outcome was unknown and VACCINATION SITE PAIN (a minor pain at the injection site following covid vaccine) had not resolved.            No concomitant medications were reported.   The patient was experiencing pain, stiffness and swelling on 10-Oct-2021. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event(s) of injection site pain following COVID vaccine and rheumatoid arthritis flare was not provided.  The reporter's causality for injection site pain following COVID vaccine and rheumatoid arthritis flare with Moderna Covid-19 vaccine was reported as probable.  No treatment details 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 a 50-year-old female patient, with relevant medical history of rheumatoid arthritis treated with co suspect Upadacitinib, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis that occurred 7 months and 28 days after receiving the 2nd dose of mRNA-1273 vaccine. Patient experienced rheumatoid arthritis flare up with pain, stiffness and swelling. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Concurrent Rheumatoid arthritis and co-suspect Upadacitinib could be confounders as the disease flares. Patient received primary series of mRNA-1273 vaccine 28 days apart. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 50-year-old female patient, with relevant medical history of rheumatoid arthritis treated with co suspect Upadacitinib, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis that occurred 7 months and 28 days after receiving the 2nd dose of mRNA-1273 vaccine. Patient experienced rheumatoid arthritis flare up with pain, stiffness and swelling. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Concurrent Rheumatoid arthritis and co-suspect Upadacitinib could be confounders as the disease flares. Patient received primary series of mRNA-1273 vaccine 28 days apart. The benefit-risk relationship of mRNA-1273 is not affected by this report.