Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis aggravated; first dose 20-Jan-2021 and second dose 1-Oct-2021; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. 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.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2022, received third 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) UNK, Citrate free. On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 20-Jan-2021 and second dose 1-Oct-2021). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 20-Jan-2021 and second dose 1-Oct-2021) outcome was unknown.            No concomitant medications reported. No treatment medications reported. It was unknown if the patient was enrolled in the COVID-19 vaccine trial.  Company comment  This is a spontaneous case concerning a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (Medically significant) AESI of Rheumatoid Arthritis (Rheumatoid arthritis aggravated), unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 dose of Moderna vaccine about 8 months after receiving the 1 dose. Inappropriate schedule of Product administration was reported as an additional non serious event. The Patient went on to receive the 3 Moderna dose about 6 months after receiving the 2 dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) for Rheumatoid Arthritis. The event Rheumatoid Arthritis was resolving. No information was provided regarding the symptoms, clinical course, other labs, diagnostic procedures and treatment details. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (Medically significant) AESI of Rheumatoid Arthritis (Rheumatoid arthritis aggravated), unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 dose of Moderna vaccine about 8 months after receiving the 1 dose. Inappropriate schedule of Product administration was reported as an additional non serious event. The Patient went on to receive the 3 Moderna dose about 6 months after receiving the 2 dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) for Rheumatoid Arthritis. The event Rheumatoid Arthritis was resolving. No information was provided regarding the symptoms, clinical course, other labs, diagnostic procedures and treatment details. The benefit-risk relationship of mRNA-1273 is not affected by this report.