Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rheumatoid arthritis
Clinical narrative: had flare up / Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (had flare up / Rheumatoid arthritis flare up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    Concurrent medical conditions included Hypothyroidism and Rheumatoid arthritis. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   In November 2020, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 11 milligram once a day. On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced RHEUMATOID ARTHRITIS (had flare up / Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (had flare up / Rheumatoid arthritis flare up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: all of that has been good.         Patient reported regrading xe janz xr 11mg. that she got off the medication for a week and it was hard to walk again and had a flare up at the end of the week. It was when she had her booster, was within the past year, before her 68th birthday, she was 67. It just happened to come up in the fact that she did not want to be without the medication for any period of time. Off medication for a week, had flare up: it was sometime last year when she had the booster. had a flare up when she was not on her medication for a week. It was in 2021. when she had her booster, her doctor gave her an antibody shot in the appropriate time frame. 17nov2021 was when she had the booster. It had been a week later that she had the flare up. Was off the medication for a week. had to be off it for a day, to get the booster and had to be off it a week, to allow the booster to work. it was the end of that week, that she had the flare up. clarified booster, calling referring to as, Moderna covid booster. Suspect product: xe janz xr 11mg: has several bottles, provides details from one of the bottles she has. Start date: about 2 and a half years ago, probably nov2020, might have been a little after that. No treatment information was provided.  Company Comment: This Spontaneous case concerns 67 years old female patient with concurrent medical condition of Rheumatoid arthritis on medication TOFACITINIB CITRATE, who experienced unexpected serious (medically significant) event of Rheumatoid arthritis (reported as had flare up / Rheumatoid arthritis flare up), which occurred a week later after a booster dose of mRNA-1273 vaccine. It is reported that patient started on xe janz xr 11mg. that she got off the medication for a week and it was hard to walk again and had a flare up at the end of the week and then patient had booster within the past year. It was in 2021. when Patient had her booster, her doctor gave her an antibody shot in the appropriate time frame. 17nov2021 was when she had the booster. It had been a week later that patient had the flare up. At the time of reporting outcome of the event is unknown. Concurrent medical condition of Rheumatoid arthritis is confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This Spontaneous case concerns 67 years old female patient with concurrent medical condition of Rheumatoid arthritis on medication TOFACITINIB CITRATE, who experienced unexpected serious (medically significant) event of Rheumatoid arthritis (reported as had flare up / Rheumatoid arthritis flare up), which occurred a week later after a booster dose of mRNA-1273 vaccine. It is reported that patient started on xe janz xr 11mg. that she got off the medication for a week and it was hard to walk again and had a flare up at the end of the week and then patient had booster within the past year. It was in 2021. when Patient had her booster, her doctor gave her an antibody shot in the appropriate time frame. 17nov2021 was when she had the booster. It had been a week later that patient had the flare up. At the time of reporting outcome of the event is unknown. Concurrent medical condition of Rheumatoid arthritis is confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.