Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Drug tolerance decreased, Inflammatory marker test, Rheumatoid arthritis, Therapeutic response shortened
Clinical narrative: Rheumatoid arthritis flare up/ pain in or rheumatoid arthritis flare up with both moderna vaccinations/Joint lock/ hands and joints started locking up; Drug tolerance decreased/ low tolerance to non steroidal anti inflammatory drugs; Wearing off effect/ tenth day humira dose was wearing off; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/ pain in or rheumatoid arthritis flare up with both moderna vaccinations/Joint lock/ hands and joints started locking up), DRUG TOLERANCE DECREASED (Drug tolerance decreased/ low tolerance to non steroidal anti inflammatory drugs) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect/ tenth day Humira dose was wearing off) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and PREDNISONE for an unknown indication.    Concurrent medical conditions included Drug allergy (Allergic to prednisone) and Rheumatoid arthritis (Moderate to sever Rheumatoid arthritis).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free and PREDNISONE (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/ pain in or rheumatoid arthritis flare up with both moderna vaccinations/Joint lock/ hands and joints started locking up), DRUG TOLERANCE DECREASED (Drug tolerance decreased/ low tolerance to non steroidal anti inflammatory drugs) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect/ tenth day humira dose was wearing off). The patient was treated with METHOTREXATE at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/ pain in or rheumatoid arthritis flare up with both moderna vaccinations/Joint lock/ hands and joints started locking up), DRUG TOLERANCE DECREASED (Drug tolerance decreased/ low tolerance to non steroidal anti inflammatory drugs) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect/ tenth day humira dose was wearing off) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Inflammatory marker test: inflammatory marker was elevated (High) Inflammatory marker was elevated(Increased).         Concomitant medication was not provided. It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  Company Comment: This spontaneous case concerns a 70-year-old, female patient with pre-existing rheumatoid arthritis (RA) and on treatment with Prednisone and Adalimumab (Humira), who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis described as exacerbation of the pre-existing condition, which occurred on an unspecified date after the second dose of mRNA-1273. Drug tolerance decreased and Therapeutic response shortened were reported as additional events pertaining to drug response to non-steroidal anti-inflammatory drugs and Adalimumab following vaccination, respectively. The RA flare-up presented as pain and joint locking of hands and with elevated inflammatory markers taken on an unspecified date. The patient reported the same occurrence on an unknown date after the first dose of mRNA-1273. Details of the prior RA treatment, including therapy dates and duration, were not provided in the case. The patient was then shifted to Methotrexate after the events. The pre-existing rheumatoid arthritis remains a confounder for the reported flare up, given its nature of remission and relapse. Additionally, the reported decreased therapeutic response to Adalimumab could be a contributor. Adalimumab and Prednisone were cited as co-suspect in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-569617 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2022: Live follow up document received on 18 may 2022 contained non significant information.; Sender's Comments: This spontaneous case concerns a 70-year-old, female patient with pre-existing rheumatoid arthritis (RA) and on treatment with Prednisone and Adalimumab (Humira), who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis described as exacerbation of the pre-existing condition, which occurred on an unspecified date after the second dose of mRNA-1273. Drug tolerance decreased and Therapeutic response shortened were reported as additional events pertaining to drug response to non-steroidal anti-inflammatory drugs and Adalimumab following vaccination, respectively. The RA flare-up presented as pain and joint locking of hands and with elevated inflammatory markers taken on an unspecified date. The patient reported the same occurrence on an unknown date after the first dose of mRNA-1273. Details of the prior RA treatment, including therapy dates and duration, were not provided in the case. The patient was then shifted to Methotrexate after the events. The pre-existing rheumatoid arthritis remains a confounder for the reported flare up, given its nature of remission and relapse. Additionally, the reported decreased therapeutic response to Adalimumab could be a contributor. Adalimumab and Prednisone were cited as co-suspect in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.