Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Joint noise, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Joint noise/Knees pop; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 36-year-old male 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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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 CHILLS (Chills). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and JOINT NOISE (Joint noise/Knees pop). In 2021, CHILLS (Chills) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and JOINT NOISE (Joint noise/Knees pop) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 is a spontaneous case reported by a consumer. A 36-year-old male patient in treatment with UPADACITINIB (RINVOQ) for Rheumatoid arthritis, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of Rheumatoid arthritis flare up (AESI). Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious events of chills and joint noise. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Rheumatoid arthritis can flare as part as its natural history. Rheumatoid arthritis flare up, chills and joint noise were considered not related to  mRNA-1273 per the reporter's assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 36-year-old male patient in treatment with UPADACITINIB (RINVOQ) for Rheumatoid arthritis, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of Rheumatoid arthritis flare up. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious events of chills and joint noise. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Rheumatoid arthritis can flare as part as its natural history. Rheumatoid arthritis flare up, chills and joint noise were considered not related to  mRNA-1273 per the reporter's assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.