Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Renal impairment, Rheumatoid arthritis
Clinical narrative: Function kidney decreased; Generalized aching; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and RENAL IMPAIRMENT (Function kidney decreased) in a 65-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In September 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced RENAL IMPAIRMENT (Function kidney decreased) (seriousness criterion medically significant) and PAIN (Generalized aching). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and RENAL IMPAIRMENT (Function kidney decreased) was resolving and PAIN (Generalized aching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient reported reduced kidney function and body aches after COVID vaccine. In SEP2021, had rheumatoid arthritis flare up. On an unknown date, the body aches resolved.  The reporters causality for events reduced kidney function and body aches with RINVOQ were no reasonable possibility.  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 65-years-old female patient with medical history of Rheumatoid Arthritis that was treated with UPADACITINIB (RINVOQ ), who experienced the unexpected, serious (medically significant) AESI events of Rheumatoid arthritis (Rheumatoid arthritis flare up) and Renal impairment  among other non-serious events. The event occurred on an unknown date in context to first dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test was performed and result not reported. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. 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.; Sender's Comments: This spontaneous case concerns a 65-years-old female patient with medical history of Rheumatoid Arthritis that was treated with UPADACITINIB (RINVOQ ), who experienced the unexpected, serious (medically significant) AESI events of Rheumatoid arthritis (Rheumatoid arthritis flare up) and Renal impairment  among other non-serious events. The event occurred on an unknown date in context to first dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test was performed and result not reported. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. 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.