Sex: F
Vaccine: COVID19
Symptoms: Chills, Colitis ulcerative, Condition aggravated, Fatigue, Headache
Clinical narrative: Colitis ulcerative aggravated; Generalized aching; Fatigue; Chills; Headache; Ulcerative colitis flare; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated) 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 (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Colitis ulcerative (Moderate to severe).   On an unknown date, the patient received first 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant), PAIN (Generalized aching), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and CONDITION AGGRAVATED (Ulcerative colitis flare). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated) and CONDITION AGGRAVATED (Ulcerative colitis flare) was resolving and PAIN (Generalized aching), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No concomitant medications was reported. No treatment medications 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 colitis ulcerative aggravated), which occurred after vaccination with the first 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 ulcerative colitis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. Colitis ulcerative can present relapses as part of the natural history of 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 colitis ulcerative aggravated), which occurred after vaccination with the first 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 ulcerative colitis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. Colitis ulcerative can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.