Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Stress
Clinical narrative: lot of stress; Rheumatoid arthritis flare up / Frequent Rheumatoid Arthritis flare-up; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up / Frequent Rheumatoid Arthritis flare-up) in a 34-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis since 2019.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up / Frequent Rheumatoid Arthritis flare-up) (seriousness criterion medically significant). On an unknown date, the patient experienced STRESS (lot of stress). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up / Frequent Rheumatoid Arthritis flare-up) and STRESS (lot of stress) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  On 2019, the patient experienced Rheumatoid Arthritis flare-up and On unknown date, Rheumatoid Arthritis flare-up recovered/resolved.  The reporter's causality for the events of Frequent Rheumatoid Arthritis flare-up, Rheumatoid Arthritis flare-up and lot of stress with Adalimumab solution for injection was not provided.  The other manufacturer opinion was that the causality for the events of Frequent Rheumatoid Arthritis flare-up, Rheumatoid Arthritis flare-up and lot of stress with Adalimumab solution for injection was not provided.  Assessment results for Humira 40MG/0.4ML with Rheumatoid arthritis flare up by non health care professional (Global Introspection) was reported as not reported.  Treatment information was not provided.  Company comment  This Spontaneous case concerns a 34 year old female patient with concurrent medical condition of Rheumatoid arthritis since 2019, who experienced the Serious (Medically significant), unexpected AESI of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up / Frequent Rheumatoid Arthritis flare-up) at an unknown date after receiving an unspecified dose of mRNA1273 vaccine in the covid 19 vaccination series, along with the non serious event of stress. Patient is on treatment with ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram, since 3 years for Rheumatoid Arthritis, which could be considered as a confounder. Details of symptoms, clinical course, lab investigations and treatment were not provided. Rheumatoid Arthritis flare-up was reported as recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report.; Sender's Comments: This Spontaneous case concerns a 34 year old female patient with concurrent medical condition of Rheumatoid arthritis since 2019, who experienced the Serious (Medically significant), unexpected AESI of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up / Frequent Rheumatoid Arthritis flare-up) at an unknown date after receiving an unspecified dose of mRNA1273 vaccine in the covid 19 vaccination series, along with the non serious event of stress. Patient is on treatment with ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram, since 3 years for Rheumatoid Arthritis, which could be considered as a confounder. Details of symptoms, clinical course, lab investigations and treatment were not provided. Rheumatoid Arthritis flare-up was reported as recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report.