Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rheumatoid arthritis
Clinical narrative: Inappropriate schedule of vaccine administered; Rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant medication was not reported.  On an unknown date, patient experienced HUMIRA not working (lack of drug effect with HUMIRA). In 2021, patient experienced rheumatoid arthritis.The reporter's causality for HUMIRA for events rheumatoid arthritis and HUMIRA not working was not provided.  It was unknown if patient was enrolled in COVID-19 Vaccine trial.  No treatment information was provided.  Company comment: This spontaneous case reported by a consumer, concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected,non  serious AESI of Rheumatoid Arthritis on an unknown date in 2021, after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 primary doses of Moderna vaccines at an interval of about 46 days. Inappropriate schedule of product administration was noted. On an unknown date, the patient started Adalimumab (humira) (Subcutaneous) at an unspecified dose. It was also reported that on an unknown date, patient experienced HUMIRA not working (lack of drug effect with HUMIRA). No concomitant and treatment medications were reported. The event Rheumatoid Arthritis was not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per Medical judgement.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected,non  serious AESI of Rheumatoid Arthritis on an unknown date in 2021, after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 primary doses of Moderna vaccines at an interval of about 46 days. Inappropriate schedule of product administration was noted. On an unknown date, the patient started Adalimumab (humira) (Subcutaneous) at an unspecified dose. It was also reported that on an unknown date, patient experienced HUMIRA not working (lack of drug effect with HUMIRA). No concomitant and treatment medications were reported. The event Rheumatoid Arthritis was not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per Medical judgement.