Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE FOR COVID; RHEUMATOID ARTHRITIS FLARES; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARES) in a 67-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 (Moderate to severe).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In February 2021, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARES) (seriousness criterion medically significant). On 09-Mar-2021, the patient experienced COVID-19 (TESTED POSITIVE FOR COVID). The patient was treated with PREDNISONE for Rheumatoid arthritis, at an unspecified dose and frequency. In 2021, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARES) and COVID-19 (TESTED POSITIVE FOR COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  It was reported that since Feb or Mar 2021 the patient had rheumatoid arthritis flares and was put on Prednisone for 25 days and had been able to taper off to five days in the last five months. She had done blood work to see if she got tapered down none at all. She had Covid 19 vaccine symptoms of body aches, nausea and fatigued on the second shot and only had fatigued on the third booster shot.  In 2021-bloodwork was performed.  The reporter's causality for the event(s) of BODY ACHES and NAUSEA with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of TESTED POSITIVE FOR COVID and RHEUMATOID ARTHRITIS FLARES was not provided.  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 67-year-old female patient, with concurrent medical history of rheumatoid arthritis treated with Upadacitinib (start date unknown), who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis and unexpected non-serious AESI COVID-19 after receiving the mRNA-1273 vaccine on an unknown date. Patient had rheumatoid arthritis flares and put on Prednisone for 25 days and tapered off to five days in the last five months. SARS-CoV-2 test was positive. Patient received 3 doses of mRNA-1273 vaccine on unknown dates. It was reported that patient experienced body aches and nausea on the second shot and fatigue on both second and third doses. Clinical course and treatment details were not reported. The outcome of events was reported as resolved. Concurrent rheumatoid arthritis and co-suspect Upadacitinib could be considered as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-632578 (Patient Link).; Sender's Comments: This spontaneous case concerns a 67-year-old female patient, with concurrent medical history of rheumatoid arthritis treated with Upadacitinib (start date unknown), who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis and unexpected non-serious AESI COVID-19 after receiving the mRNA-1273 vaccine on an unknown date. Patient had rheumatoid arthritis flares and put on Prednisone for 25 days and tapered off to five days in the last five months. SARS-CoV-2 test was positive. Patient received 3 doses of mRNA-1273 vaccine on unknown dates. It was reported that patient experienced body aches and nausea on the second shot and fatigue on both second and third doses. Clinical course and treatment details were not reported. The outcome of events was reported as resolved. Concurrent rheumatoid arthritis and co-suspect Upadacitinib could be considered as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.