Age: 44.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Condition aggravated, Influenza like illness
Clinical narrative: Colitis ulcerative aggravated; Condition aggravated; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated) in a 44-year-old 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).   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 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, Citrate Free. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.            No concomitant medications were reported. Patient experienced non-serious events flu like symptoms and ulcerative colitis flares with HUMIRA(ADALIMUMAB).   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of flu like symptoms and ulcerative colitis flares was not provided. No treatment medications information were 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 a 44-year-old 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 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, clinical course or treatments received. 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 44-year-old 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 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, clinical course or treatments received. 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.