Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Rheumatoid arthritis, Therapeutic response shortened
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis/Difficulty in walking) in a 68-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) solution for injection for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis/Difficulty in walking) (seriousness criterion medically significant) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis/Difficulty in walking), COVID-19 (COVID-19) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Therapy dates and duration for Moderna Covid-19 vaccine was reported as unknown and discontinued. The reporter's causality for the events of felt rheumatoid arthritis symptoms/could not walk good right before Humira injection on unknown onset and for Covid with Humira (Adalimumab) was reported as not provided. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. Treatment information was not provided. Company Comment: This spontaneous case concerns a 68-year-old, male patient with treatment of Humira (Adalimumab) indicated for rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest (AESI) Rheumatoid arthritis described as difficulty in walking before Adalimumab injection, and the unexpected, non-serious AESI COVID-19. Therapeutic response shortened was mentioned as an additional event, although the detailed description and associated drug were not specified. The events occurred on unspecified dates after receiving a booster dose of mRNA-1273, administered on an unknown date. Clinical course, diagnostic procedures conducted and treatment details were not provided in the case. The patient's elderly age remain as confounders for the adverse events of special interest. Adalimumab was cited as co-suspect in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with treatment of Humira (Adalimumab) indicated for rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest (AESI) Rheumatoid arthritis described as difficulty in walking before Adalimumab injection, and the unexpected, non-serious AESI COVID-19. Therapeutic response shortened was mentioned as an additional event, although the detailed description and associated drug were not specified. The events occurred on unspecified dates after receiving a booster dose of mRNA-1273, administered on an unknown date. Clinical course, diagnostic procedures conducted and treatment details were not provided in the case. The patient's elderly age remain as confounders for the adverse events of special interest. Adalimumab was cited as co-suspect in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.