Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Interchange of vaccine products, Migraine, Rheumatoid arthritis, Vertigo
Clinical narrative: FELT LIKE BODY WAS IN FULL RHEUMATOID ARTHRITIS FLARE/INCREASED LEG PAIN/LEGS HURT REALLY BAD; COULD NOT WALK/SHUFFLE STEPS; MIGRAINE HEADACHE; VERTIGO; VISION ISSUES; VOMITING; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (FELT LIKE BODY WAS IN FULL RHEUMATOID ARTHRITIS FLARE/INCREASED LEG PAIN/LEGS HURT REALLY BAD) in an adult 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 products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and METHOTREXATE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free., dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (FELT LIKE BODY WAS IN FULL RHEUMATOID ARTHRITIS FLARE/INCREASED LEG PAIN/LEGS HURT REALLY BAD) (seriousness criterion medically significant), GAIT INABILITY (COULD NOT WALK/SHUFFLE STEPS), MIGRAINE (MIGRAINE HEADACHE), VERTIGO (VERTIGO), VISUAL IMPAIRMENT (VISION ISSUES), VOMITING (VOMITING) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, RHEUMATOID ARTHRITIS (FELT LIKE BODY WAS IN FULL RHEUMATOID ARTHRITIS FLARE/INCREASED LEG PAIN/LEGS HURT REALLY BAD), GAIT INABILITY (COULD NOT WALK/SHUFFLE STEPS), VISUAL IMPAIRMENT (VISION ISSUES), VOMITING (VOMITING) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown and MIGRAINE (MIGRAINE HEADACHE) and VERTIGO (VERTIGO) had resolved.            No concomitant medication was reported No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as a part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation #QE-020343.  Company comment: This spontaneous case concerns an adult female patient of an unknown age, with concurrent medical history of rheumatoid arthritis treated with co-suspect Adalimumab (start date unknown), with concomitant Methotrexate (indication not provided), who experienced the unexpected serous (medically significant) AESI Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) after receiving the mRNA-1273 vaccine as 3rd dose along with other non-serious events. Latency cannot be assessed as the onset date of the event and vaccination date were not provided. On unknown date, patient felt like her body as in full rheumatoid arthritis flare with increased leg pain and with shuffle step that could not walk. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received a dose of COVID-19 VACCINE NRVV AD26 on an unknown date. Concurrent rheumatoid arthritis and co-suspects Adalimumab and COVID-19 VACCINE NRVV AD26 remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of an unknown age, with concurrent medical history of rheumatoid arthritis treated with co-suspect Adalimumab (start date unknown), with concomitant Methotrexate (indication not provided), who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) after receiving the mRNA-1273 vaccine as 3rd dose along with other non-serious events. Latency cannot be assessed as the onset date of the event and vaccination date were not provided. On unknown date, patient felt like her body as in full rheumatoid arthritis flare with increased leg pain and with shuffle step that could not walk. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received a dose of COVID-19 VACCINE NRVV AD26 on an unknown date. Concurrent rheumatoid arthritis and co-suspects Adalimumab and COVID-19 VACCINE NRVV AD26 remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.