Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: . The patient received Spikevax, two weeks ago, 14Dcec2023, and has had severe arthritis lasting 4 days and couldn't walk. Now, it is moderately severe, with pain in hips, knees, hands, and shoulders, and cannot do much; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (. The patient received Spikevax, two weeks ago, 14Dcec2023, and has had severe arthritis lasting 4 days and couldn't walk. Now, it is moderately severe, with pain in hips, knees, hands, and shoulders, and cannot do much) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Rheumatoid arthritis (from untreated strep A infection 20 yrs ago that was well treated,in remission, under control, and no arthritic pain.) and Streptococcal infection (Step A infection) in 2003.    On 14-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced RHEUMATOID ARTHRITIS (. The patient received Spikevax, two weeks ago, 14Dcec2023, and has had severe arthritis lasting 4 days and couldn't walk. Now, it is moderately severe, with pain in hips, knees, hands, and shoulders, and cannot do much) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (. The patient received Spikevax, two weeks ago, 14Dcec2023, and has had severe arthritis lasting 4 days and couldn't walk. Now, it is moderately severe, with pain in hips, knees, hands, and shoulders, and cannot do much) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was unknown the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported. The suspect dosage text was reported as unknown. The patient had severe arthritis lasting 4 days and couldn't walk. Then it was moderately severe, with pain in hips, knees, hands, and shoulders, and cannot do much. She was fairly active and could take care of herself but now had started having a home health aide. The RA that was under control was back. The patient HCP states that the patient cannot take NSAIDS and had to be put on steroids. HCP did not have lot numbers nor name of pharmacy where the vaccine was administered.  No treatment medication was reported.  Company comment: This spontaneous case concerns an elderly female patient with medical history of rheumatoid arthritis (Rheumatic Arthritis from untreated strep A infection 20 yrs ago that was well treated, in remission, under control, and no arthritic pain), who experienced the unexpected serious (medically significant) AESI of rheumatoid arthritis. The event occurred approximately 2 weeks after a dose of SPIKEVAX 2023-2024. As reported, the patient had severe arthritis lasting 4 days and couldn't walk which was then moderately severe, with pain in hips, knees, hands, and shoulders, and cannot do much. Reportedly, patient was fairly active and could take care of herself but now had started having a home health aide. The RA that was under control was back. The patient had to be put on steroids. No further information about the event was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.