Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Heart rate, Hypertension, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE; High blood pressure; Chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE) in a 57-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) modified-release tablet for Rheumatoid arthritis.    Previously administered products included for Drug use for unknown indication: Amoxicillin. Past adverse reactions to the above products included Rash with Amoxicillin. Concurrent medical conditions included Abstains from alcohol, Diabetes, Non-tobacco user and Rheumatoid arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In March 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2022, the patient experienced HYPERTENSION (High blood pressure) and CHEST DISCOMFORT (Chest tightness). In October 2022, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency. In January 2022, HYPERTENSION (High blood pressure) and CHEST DISCOMFORT (Chest tightness) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2022, Blood pressure measurement: High. On 10-Jan-2022, Heart rate: Rapid.         The reporters causality for the event(s) of rheumatoid arthritis flare with upadacitinib modified-release tablet was not provided and for the event(s) of chest tightness, high blood pressure and rapid heart rate was provided as no reasonable possibility.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Company comment: This spontaneous case concerns a 57-year-old female patient, with relevant medical history of Rheumatoid arthritis , who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) that occurred after receiving a dose (reported as booster) of mRNA-1273 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available. Patient also experienced high Blood pressure, rapid heart rate and chest tightness. Patient had received first and second dose of Pfizer vaccine . No further information regarding clinical course and investigations were provided. The outcome of the event was not recovered. Patients' medical history of Rheumatoid arthritis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 57-year-old female patient, with relevant medical history of Rheumatoid arthritis , who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) that occurred after receiving a dose (reported as booster) of mRNA-1273 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available. Patient also experienced high Blood pressure, rapid heart rate and chest tightness. Patient had received first and second dose of Pfizer vaccine. No further information regarding clinical course and investigations were provided. The outcome of the event was not recovered. Patients' medical history of Rheumatoid arthritis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.