Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Influenza like illness
Clinical narrative: Colitis ulcerative aggravated; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated) in an adult 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. Treatment medication was not provided by the reporter.  On 19 Nov 2021, Colonoscopy was done.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of feeling generally ill with flu like symptoms after first covid vaccine and ulcerative colitis symptoms flared up with humira (adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult male patient, with relevant medical condition of ulcerative colitis, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as colitis ulcerative aggravated), which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for ulcerative colitis. Colonoscopy was performed with unknown result. No information disclosed about treatments received. At the time of the report, the event had resolved. Colitis ulcerative can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult male patient, with relevant medical condition of ulcerative colitis, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as colitis ulcerative aggravated), which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for ulcerative colitis. Colonoscopy was performed with unknown result. No information disclosed about treatments received. At the time of the report, the event had resolved. Colitis ulcerative can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.