Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Condition aggravated, Vaccination site pain
Clinical narrative: Colitis ulcerative aggravated; Condition aggravated; Vaccination site pain/Sore arm from Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated) in a male patient of an unknown age 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, CF. In 2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PAIN (Vaccination site pain/Sore arm from Moderna vaccination). On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated) and CONDITION AGGRAVATED (Condition aggravated) had not resolved and VACCINATION SITE PAIN (Vaccination site pain/Sore arm from Moderna vaccination) outcome was unknown.            It was reported that on an unknown date, the patient experienced ulcerative colitis flare up . In 2021, the patient experienced Sore arm from Moderna vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported. No treatment medications were reported.  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 a male patient of unknown age, 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 on an unknown date related to the first dose of mRNA-1273 vaccine. 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 a male patient of unknown age, 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 on an unknown date related to the first dose of mRNA-1273 vaccine. 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.