ulcerative colitis; this case was received via agency (reference number: gr-greof-202200705) on 28-feb-2022 and was forwarded to moderna on 28-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of colitis ulcerative (ulcerative colitis) in a 70-year-old male patient who received mrna-1273 (moderna covid-19 vaccine) for covid-19 vaccination. the patient's past medical history included diverticulitis (diverticulitis twice in 2015, treatment with rifacol.) in 2015. on 07-apr-2021, the patient received first dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 22-may-2021, received second dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) dosage was changed to 1 dosage form. on 25-nov-2021, received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) dosage was changed to 1 dosage form. on 13-apr-2021, after starting mrna-1273 (moderna covid-19 vaccine), the patient experienced colitis ulcerative (ulcerative colitis) (seriousness criteria hospitalization and medically significant). at the time of the report, colitis ulcerative (ulcerative colitis) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on 29-jun-2020, colonoscopy: normal (normal) normal. on 29-jun-2020, endoscopy upper gastrointestinal tract: normal (normal) normal. on 06-sep-2021, faecal calprotectin increased: 262 262. on 04-nov-2021, colonoscopy: abnormal (abnormal) mild to moderate lesions of chronic active inflammation in the large intestine. on 13-dec-2021, faecal calprotectin increased: 3000 3000. on 21-dec-2021, faecal calprotectin increased: 2880 2880. this regulatory authority case was reported by a consumer and describes the occurrence of colitis ulcerative (ulcerative colitis) in a 70-year-old male patient who received mrna-1273 (moderna covid-19 vaccine) for covid-19 vaccination. the patient's past medical history included diverticulitis (diverticulitis twice in 2015, treatment with rifacol.) in 2015. on 07-apr-2021, the patient received first dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 22-may-2021, received second dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) dosage was changed to 1 dosage form. on 25-nov-2021, received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) dosage was changed to 1 dosage form. on 13-apr-2021, after starting mrna-1273 (moderna covid-19 vaccine), the patient experienced colitis ulcerative (ulcerative colitis) (seriousness criteria hospitalization and medically significant). at the time of the report, colitis ulcerative (ulcerative colitis) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on 29-jun-2020, colonoscopy: normal (normal) normal. on 29-jun-2020, endoscopy upper gastrointestinal tract: normal (normal) normal. on 06-sep-2021, faecal calprotectin increased: 262 262. on 04-nov-2021, colonoscopy: abnormal (abnormal) mild to moderate lesions of chronic active inflammation in the large intestine. on 13-dec-2021, faecal calprotectin increased: 3000 3000. on 21-dec-2021, faecal calprotectin increased: 2880 2880. company comment: this is a regulatory case concerning a 70-year-old male patient with past medical history of diverticulitis in 2015 (twice), who experienced the serious (hospitalization and medically significant) unexpected event colitis ulcerative, 5 days after the first dose of mrna-1273. more relevant diagnostic test included colonoscopy with mild to moderate lesions of chronic active inflammation in the large intestine and faecal calprot; sender's comments: company comment: this is a regulatory case concerning a 70-year-old male patient with past medical history of diverticulitis in 2015 (twice), who experienced the serious (hospitalization and medically significant) unexpected event colitis ulcerative, 5 days after the first dose of mrna-1273. more relevant diagnostic test included colonoscopy with mild to moderate lesions of chronic active inflammation in the large intestine and faecal calprotectin increased: 3000. the benefit-risk relationship of mrna-1273 is not affected by this report

test date: 20200629; test name: colonoscopy; result unstructured data: normal; test date: 20211104; test name: colonoscopy; result unstructured data: mild to moderate lesions of chronic active inflammation in the large intestine; test date: 20200629; test name: gastroscopy; result unstructured data: normal; test date: 20210906; test name: faecal calprotectin increased; result unstructured data: 262; test date: 20211213; test name: faecal calprotectin increased; result unstructured data: 3000; test date: 20211221; test name: faecal calprotectin increased; result unstructured data: 2880

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