Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rheumatoid arthritis
Clinical narrative: Chills; after receiving the COVID-19 vaccine she came out of remission with her rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (after receiving the COVID-19 vaccine she came out of remission with her rheumatoid arthritis) in a 63-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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second 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 (after receiving the COVID-19 vaccine she came out of remission with her rheumatoid arthritis) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, RHEUMATOID ARTHRITIS (after receiving the COVID-19 vaccine she came out of remission with her rheumatoid arthritis) and CHILLS (Chills) had not resolved.            No concomitant medications were reported.  The patient reported that after receiving the COVID-19 vaccine she came out of remission with her rheumatoid arthritis and had tried several different medication, she was now on Rinvoq and still only getting relief for about eight hours a day. She had pain and swelling in hands and arms that went away about five hours after took her Rinvoq but came back about eight hours later. She had started getting the chills every morning. She did not had fever. It was reported that patient had wearing off effect.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.    The reporter's causality for the event(s) in aspect of Rinvoq of chills every morning, after receiving the covid-19 vaccine came out of remission with rheumatoid arthritis and only got relief for about eight hours a day with rinvoq/symptoms went away about five hours after taking rinvoq but came back about eight hours later with rinvoq (upadacitinib) was 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 63-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Rinvoq (upadacitinib), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up and an expected, non-serious event. The event rheumatoid arthritis flare-up occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The start date of the non-serious event chills was not provided, hence, the onset latency also could not be assessed. It was reported that after receiving the mRNA-1273 vaccine, the patient 'came out of remission with her rheumatoid arthritis' and had tried several different medications (unspecified). The patient took Rinvoq but only got relief for about 8 hours per day. She had pain and swelling in her hands and arms which resolved for about 5 hours after taking Rinvoq, however, the symptoms recurred after about 8 hours later. The patient also experienced chills every morning. The events had not resolved at the time of the report. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis flare-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Rinvoq (upadacitinib), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up and an expected, non-serious event. The event rheumatoid arthritis flare-up occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The start date of the non-serious event chills was not provided, hence, the onset latency also could not be assessed. It was reported that after receiving the mRNA-1273 vaccine, the patient 'came out of remission with her rheumatoid arthritis' and had tried several different medications (unspecified). The patient took Rinvoq but only got relief for about 8 hours per day. She had pain and swelling in her hands and arms which resolved for about 5 hours after taking Rinvoq, however, the symptoms recurred after about 8 hours later. The patient also experienced chills every morning. The events had not resolved at the time of the report. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis flare-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.