Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Large intestinal ulcer
Clinical narrative: Colon ulcer; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINAL ULCER (Colon ulcer) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (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 LARGE INTESTINAL ULCER (Colon ulcer) (seriousness criterion medically significant). At the time of the report, LARGE INTESTINAL ULCER (Colon ulcer) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: Ulcers in colon.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information was reported. The reporter's causality for the event of ULCERS IN COLON with respect to Humira was not provided.  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 Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Large intestinal ulcer, which occurred 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 Crohn´s disease. Colonoscopy was performed and revealed ulcers in colon. No information disclosed about treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease could be a confounding factor for Large intestinal ulcer. 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 Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Large intestinal ulcer, which occurred 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 Crohn´s disease. Colonoscopy was performed and revealed ulcers in colon. No information disclosed about treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease could be a confounding factor for Large intestinal ulcer. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.