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; 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), 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 solution for injection for Rheumatoid arthritis and PREDNISONE for an unknown indication.    Concurrent medical conditions included Drug allergy.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 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), 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), 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 increased Inflammatory marker increased.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. 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 no reported medical history , who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis (described as Rheumatoid arthritis flare up), which occurred on an unspecified date after the first dose of mRNA-1273. Drug tolerance decreased (pertaining to the non-steroidal anti-inflammatory drugs of the patient) and Therapeutic response shortened (wearing off effect of Humira/Adalimumab) were also reported as additional events in the case. On an unknown date the patient underwent inflammatory marker test which turned out to be elevated. The patient experienced rheumatoid arthritis flare up which presented as pain along with hands and joints locking up. The patient was then treated with methotrexate. Further details on the clinical course and other treatment modalities were not mentioned in the case.  Additionally, the patient's advanced age and the reported decreased therapeutic response to Adalimumab may be considered as a contributory factor to the Rheumatoid arthritis (RA flare up).  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-569635 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2022: no new information.; Sender's Comments: This spontaneous case concerns a 70-year-old, female patient with no reported medical history , who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis (described as Rheumatoid arthritis flare up), which occurred on an unspecified date after the first dose of mRNA-1273. Drug tolerance decreased (pertaining to the non-steroidal anti-inflammatory drugs of the patient) and Therapeutic response shortened (wearing off effect of Humira/Adalimumab) were also reported as additional events in the case. On an unknown date the patient underwent inflammatory marker test which turned out to be elevated. The patient experienced rheumatoid arthritis flare up which presented as pain along with hands and joints locking up. The patient was then treated with methotrexate. Further details on the clinical course and other treatment modalities were not mentioned in the case.  Additionally, the patient's advanced age and the reported decreased therapeutic response to Adalimumab may be considered as a contributory factor to the Rheumatoid arthritis (RA flare up).  The benefit-risk relationship of mRNA-1273 is not affected by this report.