Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Inappropriate schedule of product administration
Clinical narrative: ulcerative colitis flare; Received first dose on 14-APR-2021 and second dose on 21-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ulcerative colitis flare) in a 48-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) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-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 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 14-APR-2021 and second dose on 21-APR-2021). On an unknown date, the patient experienced COLITIS ULCERATIVE (ulcerative colitis flare) (seriousness criterion hospitalization). At the time of the report, COLITIS ULCERATIVE (ulcerative colitis flare) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 14-APR-2021 and second dose on 21-APR-2021) outcome was unknown.            Concomitant medications were not reported. 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 48-year-old male patient with relevant concurrent medical condition of ulcerative colitis. Patient has reported co-suspect medication of Adalimumab (Humira) for ulcerative colitis. The patient received first and second dose of mRNA-1273 vaccine with dosage interval of 7 days. On unknown date, patient experienced the unexpected serious (hospitalization) event of ulcerative colitis flare. Inappropriate schedule of product administration was also captured as non-serious. The occurrence of the event ulcerative colitis flare was unknown with respect to the first and second dose of mNA-1273 vaccine administration. No further clinical information was available for medical review. The outcome of the event ulcerative colitis flare was reported as resolved. The natural course of the concurrent medical condition of ulcerative colitis remain confounder for the event ulcerative colitis flare. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 48-year-old male patient with relevant concurrent medical condition of ulcerative colitis. Patient has reported co-suspect medication of Adalimumab (Humira) for ulcerative colitis. The patient received first and second dose of mRNA-1273 vaccine with dosage interval of 7 days. On unknown date, patient experienced the unexpected serious (hospitalization) event of ulcerative colitis flare. Inappropriate schedule of product administration was also captured as non-serious. The occurrence of the event ulcerative colitis flare was unknown with respect to the first and second dose of mNA-1273 vaccine administration. No further clinical information was available for medical review. The outcome of the event ulcerative colitis flare was reported as resolved. The natural course of the concurrent medical condition of ulcerative colitis remain confounder for the event ulcerative colitis flare. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.