Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis, Pain assessment, Pain in extremity, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Degenerative changes in both hips/degenerative in the right hip; Swelling in the hands; Pain in the feet and legs; Rheumatoid arthritis worsening/rheumatoid arthritis flare up with Rinvoq (upadacitinib); This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis worsening/rheumatoid arthritis flare up with Rinvoq (upadacitinib)) in a 58-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.   In May 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In September 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis worsening/rheumatoid arthritis flare up with Rinvoq (upadacitinib)) (seriousness criterion medically significant). On an unknown date, the patient experienced OSTEOARTHRITIS (Degenerative changes in both hips/degenerative in the right hip), PERIPHERAL SWELLING (Swelling in the hands) and PAIN IN EXTREMITY (Pain in the feet and legs). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis worsening/rheumatoid arthritis flare up with Rinvoq (upadacitinib)) had not resolved and OSTEOARTHRITIS (Degenerative changes in both hips/degenerative in the right hip), PERIPHERAL SWELLING (Swelling in the hands) and PAIN IN EXTREMITY (Pain in the feet and legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 6 on a scale of 0 to 10.         No concomitant medications were reported.   It was reported that, the patient had degenerative in the right hip where it was bone-on-bone. In Aug 2021 over the past month, she had an increase in bothersome symptoms such as new swollen joint or worsening joint pain. She had a pain of six on a scale of zero to 10. On 04-Aug-2021, she had a physician appointment to schedule hip replacement surgery in Oct-2021. She had been having RA flare-ups and swollen hands after taking the Covid booster. It was unknown if patient was enrolled in a COVID-19 vaccine Ttrial. On Sep-2021, patient received 2nd dose COVID-19.  The reporter's causality for the event(s) of degenerative changes in both hips/degenerative in the right hip where it was bone-on-bone, swelling in the hands, pain in the feet and legs and rheumatoid arthritis worsening/rheumatoid arthritis flare up with rinvoq (upadacitinib) was no reasonable possibility.  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.; Sender's Comments: This spontaneous case concerns a 58-years-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Rinvoq (upadacitinib), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to third dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. It was reported that, the patient had degenerative in the right hip where it was bone-on-bone. In Aug 2021 over the past month, she had an increase in symptoms such as new swollen joint or worsening joint pain. She had a pain of six on a scale of zero to 10. Patient had a physician appointment to schedule hip replacement surgery in Oct-2021. She had been having RA flare-ups and swollen hands after taking the Covid booster. The Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.