Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Colonoscopy, Inappropriate schedule of product administration, Large intestine infection, Migraine
Clinical narrative: Infectious colitis; Rheumatoid arthritis flare up; COVID-19; Migraine; Nausea; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINE INFECTION (Infectious colitis), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and COVID-19 (COVID-19) in a 45-year-old female 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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and METHOTREXATE (unknown route) at an unspecified dose. On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In January 2022, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). In April 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced LARGE INTESTINE INFECTION (Infectious colitis) (seriousness criterion hospitalization), MIGRAINE (Migraine) and NAUSEA (Nausea). The patient was hospitalized on sometime in January 2022 due to COVID-19. At the time of the report, LARGE INTESTINE INFECTION (Infectious colitis) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) was resolving and COVID-19 (COVID-19), MIGRAINE (Migraine), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Hospitalized due to covid and received monoclonal antibodies  treatment.. On an unknown date, Colonoscopy: results not reported Results not reported.         No concomitant medication details were reported.  No treatment medication was reported.  Company Comment: This spontaneous case concerns a 45-year-old, female patient with relevant current condition of rheumatoid arthritis treated with methotrexate and adalimumab who experienced the unexpected, serious (hospitalization) adverse events of special interest of Rheumatoid arthritis flare up and COVID-19 (with a positive SARS-CoV-2 test) and unexpected, serious (hospitalization) event of Large intestine infection which occurred on unknown interval after receiving the booster dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was noted in the case as the third dose was received four months after completion of the primary series. Patient was admitted in a hospital due to large intestine infection. She underwent emergency colonoscopy, but findings were not reported. She also tested positive for COVID-19 requiring hospitalization. She was treated with unspecified monoclonal antibody but experienced an unspecified adverse drug reaction. Patient had another hospitalization due to rheumatoid arthritis flare up, but the clinical course, diagnostic evaluation and treatment details were not reported. Rheumatoid arthritis can flare up as part of the natural history of disease. Concomitant use of adalimumab and methotrexate remain as confounders for the event large intestine infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 45-year-old, female patient with relevant current condition of rheumatoid arthritis treated with methotrexate and adalimumab who experienced the unexpected, serious (hospitalization) adverse events of special interest of Rheumatoid arthritis flare up and COVID-19 (with a positive SARS-CoV-2 test) and unexpected, serious (hospitalization) event of Large intestine infection which occurred on unknown interval after receiving the booster dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was noted in the case as the third dose was received four months after completion of the primary series. Patient was admitted in a hospital due to large intestine infection. She underwent emergency colonoscopy, but findings were not reported. She also tested positive for COVID-19 requiring hospitalization. She was treated with unspecified monoclonal antibody but experienced an unspecified adverse drug reaction. Patient had another hospitalization due to rheumatoid arthritis flare up, but the clinical course, diagnostic evaluation and treatment details were not reported. Rheumatoid arthritis can flare up as part of the natural history of disease. Concomitant use of adalimumab and methotrexate remain as confounders for the event large intestine infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.