Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Condition aggravated, Fatigue, Feeling abnormal
Clinical narrative: Colitis ulcerative aggravated; Foggy feeling in head; Condition aggravated; Fatigue; 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 Colitis ulcerative (Moderate to Severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant), FEELING ABNORMAL (Foggy feeling in head), CONDITION AGGRAVATED (Condition aggravated) and FATIGUE (Fatigue). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated) and CONDITION AGGRAVATED (Condition aggravated) had not resolved and FEELING ABNORMAL (Foggy feeling in head) and FATIGUE (Fatigue) had resolved.            Concomitant Medication use information was not provided by reporter.  On unknown dates, the patient experienced fatigue, foggy and ulcerative colitis flare up. on unknown dates, fatigue and foggy resolved.   It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality of humira for the events of fatigue and foggy was no reasonable possibility and for the event of ulcerative colitis flare up with humira(adalimumab) was a reasonable possibility.  Treatment Medication use information was not provided by reporter.  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 colitis ulcerative, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as colitis ulcerative aggravated), which occurred after the first dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for colitis ulcerative. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Colitis ulcerative can present relapses as part of the natural history of the 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 colitis ulcerative, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as colitis ulcerative aggravated), which occurred after the first dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for colitis ulcerative. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Colitis ulcerative can present relapses as part of the natural history of the disease, so that confounds the case.  The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.