Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Colitis ulcerative
Clinical narrative: ULCERATIVE COLITIS FLARE; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2022, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 102 degree Celsius.         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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All doses of vaccine including booster taken one in once.   No treatment information was provided.  The reporter's causality for the event of ulcerative colitis flare with Humira (Adalimumab) was a reasonable possibility.  Company comment  This spontaneous case reported by a consumer, concerns a 23 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) event of Colitis Ulcerative (Ulcerative Colitis Flare) unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 primary doses with Moderna vaccine with no adverse events reported. Concurrent medical conditions included Ulcerative colitis. On an unknown date, the patient had received ADALIMUMAB for Ulcerative colitis, which could be considered as a confounder.  On an unknown date, Body temperature was 102 degree Celsius.  No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 23 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) event of Colitis Ulcerative (Ulcerative Colitis Flare) unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 primary doses with Moderna vaccine with no adverse events reported. Concurrent medical conditions included Ulcerative colitis. On an unknown date, the patient had received ADALIMUMAB for Ulcerative colitis, which could be considered as a confounder.  On an unknown date, Body temperature was 102 degree Celsius.  No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.