Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammatory marker test, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE) in a 49-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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced FATIGUE (TIRED). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE) and FATIGUE (TIRED) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Inflammatory marker test: Inflammatory marker increased.         No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient did have Chron's and it flared with the weather change. When the weather changed, she did notice that she would start to flare. Her inflammation markers were up some the last time she went to the physician so she was curious because she was not in any pain. Her legs were uncomfortable on 17 Oct 2021, when the weather dramatically changed. She did get her Covid third shot and was a little tired. The physician had her not take Rinvoq for a week after vaccine.  On an unknown date, INFLAMMATION MARKERS test performed.  The reporter's causality for the events of INFLAMMATION NUMBERS/MARKERS UP A LITTLE, CROHN'S FLARE, TIRED and RHEUMATOID ARTHRITIS FLARE with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of LEGS WERE UNCOMFORTABLE was not provided No treatment medication was 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.  CC: This spontaneous case concerns a 49-year-old, female patient with a concurrent condition of rheumatoid arthritis (RA) treated with upadacitinib, who experienced an unexpected, medically significant AESI Rheumatoid arthritis flare up in association with a dose of mRNA-1273 vaccine. Reportedly, inflammation markers were up, and her legs were uncomfortable. Outcome of the event was reported as resolving. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart, and a 3rd COVID-19 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying history of RA remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 49-year-old, female patient with a concurrent condition of rheumatoid arthritis (RA) treated with upadacitinib, who experienced an unexpected, medically significant AESI Rheumatoid arthritis flare up in association with a dose of mRNA-1273 vaccine. Reportedly, inflammation markers were up, and her legs were uncomfortable. Outcome of the event was reported as resolving. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart, and a 3rd COVID-19 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying history of RA remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.