Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rheumatoid arthritis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 47-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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Skin rash from 2017 to 01-Jan-2022 and COVID-19 (7 days) from 25-Mar-2021 to 01-Apr-2021. Concurrent medical conditions included Rheumatoid arthritis and Allergy to chemicals (Sulfur allergy). On 01-Sep-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt tired). On 01-Mar-2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In 2022, FATIGUE (Felt tired) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events of rheumatoid arthritis flare ups and felt tired with Humira (adalimumab) was no reasonable possibility. No treatment medication was provided. Company comment: This is a spontaneous case concerning a 47-year-old female patient with a relevant history of rheumatoid arthritis, who had the unexpected serious (medically significant) adverse event of special interest of Rheumatoid arthritis flare up, which occurred 1 month, 5 days after receiving the third dose of mRNA-1273 vaccine. The outcome was reported as not resolved. No diagnostic workup to support the diagnosis and treatment medication were provided. Underlying history of rheumatoid arthritis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-642630 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 47-year-old female patient with a relevant history of rheumatoid arthritis, who had the unexpected serious (medically significant) adverse event of special interest of Rheumatoid arthritis flare up, which occurred 1 month, 5 days after receiving the third dose of mRNA-1273 vaccine. The outcome was reported as not resolved. No diagnostic workup to support the diagnosis and treatment medication were provided. Underlying history of rheumatoid arthritis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.