Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Condition aggravated, Culture stool, Faecal calprotectin
Clinical narrative: Condition aggravated; Colitis ulcerative aggravated/Intestinal inflammation; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated/Intestinal inflammation) in a 52-year-old 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 ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    Concurrent medical conditions included Colitis ulcerative (Moderate to severe) and Crohn's disease (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) at an unspecified dose. On 12-Nov-2021, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated/Intestinal inflammation) (seriousness criterion medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated/Intestinal inflammation) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Culture stool: (Negative) Negative for E.Coli. On an unknown date, Faecal calprotectin: calprotectin results showed high.         Concomitant medications were not reported.  Patient reported non-serious events ulcerative colitis flare, calprotectin results showed high and gastro issues/inflammation in intestine with HUMIRA (ADALIMUMAB).   On unknown dates, the patient experienced gastro issues/inflammation in intestine.  On 12 Nov 2021, the patient experienced ulcerative colitis flare. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  In Nov-2021 patient reported Fecal test was performed but results was not provided.  Treatment information 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 a 52-year-old female patient, with relevant medical condition of colitis ulcerative and Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as colitis ulcerative aggravated), which occurred after 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 colitis ulcerative and Crohn´s disease. Faecal calprotectin showed high result, and fecal test was negative for Escherichia Coli. No information disclosed about clinical course or treatments received. Colitis ulcerative and Crohn´s disease can present relapses as part of the natural history of the diseases, 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 52-year-old female patient, with relevant medical condition of colitis ulcerative and Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as colitis ulcerative aggravated), which occurred after 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 colitis ulcerative and Crohn´s disease. Faecal calprotectin showed high result, and fecal test was negative for Escherichia Coli. No information disclosed about clinical course or treatments received. Colitis ulcerative and Crohn´s disease can present relapses as part of the natural history of the diseases, so that confounds the case.  The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.