Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 52-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.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) outcome was unknown.            On an unknown date, the patient experienced rheumatoid arthritis flare-up in right ankle and not much improvement in right ankle with Humira. In 2021, the patient experienced sore at injection site after COVID-19 vaccine and had tired.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No concomitant medications were reported. No treatment medications were reported.  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.   This case was linked to MOD-2021-622922 (Patient Link).  Company comment: This spontaneous case concerns a 52-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up, and the expected, non-serious events of vaccination site pain and fatigue. The event rheumatoid arthritis flare-up occurred unknown number of days after receiving Humira. Of note, the administration date of Humira and the event onset date were not provided, hence, the onset latency could not be assessed. 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 not provided, hence, the onset latency could not be assessed. The other non-serious events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided and the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. These events occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient experienced rheumatoid arthritis flare-up in the right ankle and not much improvement in the right ankle with Humira. No additional details were provided regarding the rheumatoid arthritis flare-up. The patient also experienced soreness at the injection site and tiredness. Treatment information was not provided. Of note, the reporter assessed the events vaccination site pain and fatigue as not related to the mRNA-1273 vaccine. 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 history of co-suspect administration of Humira also 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 52-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up, and the expected, non-serious events of vaccination site pain and fatigue. The event rheumatoid arthritis flare-up occurred unknown number of days after receiving Humira. Of note, the administration date of Humira and the event onset date were not provided, hence, the onset latency could not be assessed. 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 not provided, hence, the onset latency could not be assessed. The other non-serious events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided and the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. These events occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient experienced rheumatoid arthritis flare-up in the right ankle and not much improvement in the right ankle with Humira. No additional details were provided regarding the rheumatoid arthritis flare-up. The patient also experienced soreness at the injection site and tiredness. Treatment information was not provided. Of note, the reporter assessed the events vaccination site pain and fatigue as not related to the mRNA-1273 vaccine. 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 history of co-suspect administration of Humira also 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.