Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Histology
Clinical narrative: Ulcerative Colitis; This literature-study case was reported in a literature article and describes the occurrence of COLITIS ULCERATIVE (Ulcerative Colitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Sigmoid hemicolectomy. Concurrent medical conditions included Diverticulitis (Patient had a history of diverticulitis requiring sigmoid colectomy).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COLITIS ULCERATIVE (Ulcerative Colitis) (seriousness criterion medically significant). The patient was treated with BUDESONIDE at an unspecified dose and frequency and MESALAMINE at an unspecified dose and frequency. At the time of the report, COLITIS ULCERATIVE (Ulcerative Colitis) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: abnormal (abnormal) Colonoscopy showed friable mucosa and a loss of vascular markings. On an unknown date, Histology: abnormal (abnormal) histology was consistent with ulcerative colitis (UC).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COLITIS ULCERATIVE (Ulcerative Colitis) to be related.    Concomitant product use was not provided by the reporter.    Company comment:  This literature case concerns a 66-year-old female patient, with history of diverticulitis and sigmoid colectomy, who experienced the serious (medically significant) unexpected event of COLITIS ULCERATIVE. The event occurred approximately 1 week after receiving the first dose of mRNA-1273. The rechallenge is positive since the event reoccur after the second dose. Diagnosis was confirmed with colonoscopy and histology. Patient was treated with budesonide and mesalamine and symptoms resolved. Patient's history of diverticulitis and sigmoid colectomy remains as a confounder. The benefit-risk relation of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-399731 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Followup received by safety on 03-Dec-2021 included an Email, contains new information: Author added; Sender's Comments: This literature case concerns a 66-year-old female patient, with history of diverticulitis and sigmoid colectomy, who experienced the serious (medically significant) unexpected event of COLITIS ULCERATIVE. The event occurred approximately 1 week after receiving the first dose of mRNA-1273. The rechallenge is positive since the event reoccur after the second dose. Diagnosis was confirmed with colonoscopy and histology. Patient was treated with budesonide and mesalamine and symptoms resolved. Patient's history of diverticulitis and sigmoid colectomy remains as a confounder. The benefit-risk relation of mRNA-1273 is not affected by this report.