Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Condition aggravated
Clinical narrative: Ulcerative colitis relapse; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis relapse) in an adult 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 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 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 (Ulcerative colitis relapse) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis relapse) and CONDITION AGGRAVATED (Condition aggravated) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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 female patient, with relevant medical condition of colitis ulcerative, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as ulcerative colitis relapse), which occurred on an unknown date related to an unspecified 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 female patient, with relevant medical condition of colitis ulcerative, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as ulcerative colitis relapse), which occurred on an unknown date related to an unspecified 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.