Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hand deformity, Inappropriate schedule of product administration, Inflammation, Rheumatoid arthritis
Clinical narrative: Right hand more inflamed and bent; Right hand more inflamed and bent; Worsened Rheumatoid arthritis flare up; Patient received first dose on 01-Mar-2021, second dose on 20-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Worsened Rheumatoid arthritis flare up) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-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 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Mar-2021, second dose on 20-Mar-2021). In July 2021, the patient experienced RHEUMATOID ARTHRITIS (Worsened Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLAMMATION (Right hand more inflamed and bent) and HAND DEFORMITY (Right hand more inflamed and bent). At the time of the report, RHEUMATOID ARTHRITIS (Worsened Rheumatoid arthritis flare up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Mar-2021, second dose on 20-Mar-2021) outcome was unknown and INFLAMMATION (Right hand more inflamed and bent) and HAND DEFORMITY (Right hand more inflamed and bent) had not resolved.            No concomitant medication reported.  Patient had Rheumatoid arthritis flare up with Humira.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Company Comment:  This is a spontaneous case concerning  a  59-year-old, male patient with use of Adalimumab for Rheumatoid arthritis, who experienced the unexpected serious AESI event of Rheumatoid arthritis and unexpected non-serious events of Inflammation, Hand deformity, Inappropriate schedule of product administration. The event Inappropriate schedule of product administration occurred same day after the second dose of mRNA-1273 COVID 19 Vaccine. The event Rheumatoid arthritis occurred on an unspecified date on July 2021, after the second dose of mRNA-1273 COVID 19 Vaccine. On an unknown date the events Unknown date Inflammation, Hand deformity occurred  The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The use of Adalimumab for Rheumatoid arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment:  This is a spontaneous case concerning  a  59-year-old, male patient with use of Adalimumab for Rheumatoid arthritis, who experienced the unexpected serious AESI event of Rheumatoid arthritis and unexpected non-serious events of Inflammation, Hand deformity, Inappropriate schedule of product administration. The event Inappropriate schedule of product administration occurred same day after the second dose of mRNA-1273 COVID 19 Vaccine. The event Rheumatoid arthritis occurred on an unspecified date on July 2021, after the second dose of mRNA-1273 COVID 19 Vaccine. On an unknown date the events Unknown date Inflammation, Hand deformity occurred  The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The use of Adalimumab for Rheumatoid arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.