Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Pain assessment, Rheumatoid arthritis, Therapeutic response shortened
Clinical narrative: Activated Rheumatoid Arthritis; Could not walk; Pain; Humira did not last full 14 days; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Activated Rheumatoid Arthritis) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate free, every 14 days, Single Dose Pen. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Activated Rheumatoid Arthritis) (seriousness criterion medically significant), GAIT DISTURBANCE (Could not walk), PAIN (Pain) and THERAPEUTIC RESPONSE SHORTENED (Humira did not last full 14 days). The patient was treated with IBUPROFEN at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Activated Rheumatoid Arthritis), GAIT DISTURBANCE (Could not walk), PAIN (Pain) and THERAPEUTIC RESPONSE SHORTENED (Humira did not last full 14 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 80 percent pain free then dropped down to 20 percent.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.       No concomitant medications were reported. The reporter's causality for the events of activated rheumatoid arthritis, could not walk, Humira did not last full 14 days and pain with Adalimumab Solution for Injection was Not Provided. Manufacturer opinion was that the causality for the events of activated rheumatoid arthritis, could not walk, Humira did not last full 14 days and pain with Adalimumab Solution for Injection was Not Provided. Manufacturer opinion was that the causality for the events of activated rheumatoid arthritis, could not walk, Humira did not last full 14 days and pain with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.  Company Comment: This spontaneous case concerns an adult female patient, with relevant medical history of Rheumatoid arthritis and administration of Co-suspect drug ADALIMUMAB (HUMIRA), who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (flare-up), and the unexpected non-serious events of Gait disturbance, Pain and Therapeutic response shortened. The events occurred on an unknown date interval after receiving a dose of mRNA-1273 BIVALENT .222 Vaccine. It was reported that the patient's pain assessment was 80 percent pain free then dropped down to 20 percent. Treatment information was not provided. The outcome of the events was reported as unknown. The events Rheumatoid arthritis and Gait disturbance were considered related to the product as per reporter's assessment. The patient's medical history of Rheumatoid arthritis and administration of Co-suspect drug ADALIMUMAB (HUMIRA) remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient, with relevant medical history of Rheumatoid arthritis and administration of Co-suspect drug ADALIMUMAB (HUMIRA), who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (flare-up), and the unexpected non-serious events of Gait disturbance, Pain and Therapeutic response shortened. The events occurred on an unknown date interval after receiving a dose of mRNA-1273 BIVALENT .222 Vaccine. It was reported that the patient's pain assessment was 80 percent pain free then dropped down to 20 percent. Treatment information was not provided. The outcome of the events was reported as unknown. The events Rheumatoid arthritis and Gait disturbance were considered related to the product as per reporter's assessment. The patient's medical history of Rheumatoid arthritis and administration of Co-suspect drug ADALIMUMAB (HUMIRA) remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.