Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Gait inability, Migraine, Pain in extremity, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP/FELT LIKE BODY WAS IN FULL RHEUMATOIS ARTHRITIS FLARE; VISUAL DISTURBANCE/VISION ISSUES; UNABLE TO WALK/COULD NOT WALK; GAIT SHUFFLING/SHUFFLE STEPS; MIGRAINE HEADACHE WHICH CAUSED VOMITING; VERTIGO; PAIN AGGRAVATED/INCREASED LEG PAIN/LEGS HURT REALLY BAD; This spontaneous report received from a patient via other manufacturer concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received non-company suspect drug adalimumab (solution for injection in pre-filled pen and solution for injection in pre-filled syringe, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency and therapy dates were not reported for moderate to severe rheumatoid arthritis.  The patient received methotrexate (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced visual disturbance/vision issues, rheumatoid arthritis flare up/felt like body was in full rheumatoid arthritis flare, unable to walk/could not walk, gait shuffling/shuffle steps, migraine headache which caused vomiting, vertigo and pain aggravated/increased leg pain/legs hurt really bad (dose number in series 1).  The patient additionally received booster dose of Moderna covid-19 vaccine (Spikevax) (elasomeran) (dose number in series 2) (form of admin unknown, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, administered on an unspecified date for covid-19 prophylaxis. It was unknown if the patient experienced any adverse events following administration of Moderna covid-19 vaccine (elasomeran) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and action taken with adalimumab, and methotrexate was not reported. The patient recovered from migraine headache which caused vomiting, vertigo, and pain aggravated/increased leg pain/legs hurt really bad, and the outcome of unable to walk/could not walk, gait shuffling/shuffle steps, visual disturbance/vision issues and rheumatoid arthritis flare up/felt like body was in full rheumatois arthritis flare was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220737374-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis flare up/felt like body was in full rheumatois arthritis flare. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.