Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Rheumatoid arthritis
Clinical narrative: Concentration impaired; Rheumatoid arthritis flare up/Hands weakness/ Effusion of joint of shoulder region; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Hands weakness/ Effusion of joint of shoulder region) in a 59-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.    The patient's past medical history included Hip replacement. Concurrent medical conditions included Rheumatoid arthritis.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third 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 RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Hands weakness/ Effusion of joint of shoulder region) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (Concentration impaired). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Hands weakness/ Effusion of joint of shoulder region) outcome was unknown and DISTURBANCE IN ATTENTION (Concentration impaired) was resolving.            No concomitant and treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient experienced HIP replacement.  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 aged 59 years with reported concurrent condition of rheumatoid arthritis on RINVOQ, experienced unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) on unknown dates (in 2021) in the context of mRNA-1273 vaccination. patient was recovering from hip replacement surgery due to being off the RINVOQ during that time, she experienced rheumatoid arthritis flare ups with her wrist, knuckles and fluid in her shoulders, she had flare ups in her hands where her hands were not as strong as they could be. No further information on detailed clinical course, investigations and treatment  was available in the report.  Outcome of the event was unknown at the time of report. Patient had received initial two doses of same vaccine at an interval of 1 month and third dose 5 months later in 2021. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 59 years with reported concurrent condition of rheumatoid arthritis on RINVOQ, experienced unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) on unknown dates (in 2021) in the context of mRNA-1273 vaccination. patient was recovering from hip replacement surgery due to being off the RINVOQ during that time, she experienced rheumatoid arthritis flare ups with her wrist, knuckles and fluid in her shoulders, she had flare ups in her hands where her hands were not as strong as they could be. No further information on detailed clinical course, investigations and treatment  was available in the report.  Outcome of the event was unknown at the time of report. Patient had received initial two doses of same vaccine at an interval of 1 month and third dose 5 months later in 2021. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.