Sex: U
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: FLARE UP OF ULCERATIVE COLITIS; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (FLARE UP OF ULCERATIVE COLITIS) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    There was no reported medical history.  Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received third 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 first 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 (FLARE UP OF ULCERATIVE COLITIS) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (FLARE UP OF ULCERATIVE COLITIS) outcome was unknown.            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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  Company comment-This is a spontaneous case concerning a patient of an unknown age and gender with relevant medical history of ULCERATIVE COLITIS on Humira reported, who experienced unexpected serious (medically significant) event of Colitis ulcerative (Colitis ulcerative aggravated) in the context of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date nor event onset date were provided. Patient had received 3 doses of mRNA-1273 on unknown dates. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was unknown at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement. Treatment medications were not reported.  The reporter's causality for the event(s) of flare up of ulcerative colitis was not provided.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with relevant medical history of ULCERATIVE COLITIS on Humira reported, who experienced unexpected serious (medically significant) event of Colitis ulcerative (Colitis ulcerative aggravated) in the context of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date nor event onset date were provided. Patient had received 3 doses of mRNA-1273 on unknown dates. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was unknown at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.