Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Colitis ulcerative, Colonoscopy
Clinical narrative: Ulcerative Colitis flare; This literature-study case was reported in a literature article and describes the occurrence of COLITIS ULCERATIVE (Ulcerative Colitis flare) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       Concurrent medical conditions included Diverticulitis (Patient has a history of diverticulitis requiring sigmoid colectomy).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative Colitis flare) (seriousness criteria hospitalization prolonged and medically significant). The patient was treated with INFLIXIMAB for Pancolitis, at a dose of UNK dosage form and Surgery (Total Colectomy) for Colitis ulcerative. At the time of the report, COLITIS ULCERATIVE (Ulcerative Colitis flare) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: 202 mg/l (abnormal) 202 mg/L. On an unknown date, Colonoscopy: severe pancolitis (abnormal) Repeat colonoscopy revealed severe pancolitis. Also demonstrating deep linear ulcerations and severe colitis in the sigmoid colon, minimal improvement a third colonoscopy showed minimal improvement and friable mucosa and a loss of vascular markings (abnormal) First colonoscopy showed friable mucosa and a loss of vascular markings and histology was consistent.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COLITIS ULCERATIVE (Ulcerative Colitis flare) to be related.    No relevant concomitant medications were reported.  The second dose was administered 4 weeks later, after which she immediately developed severe hematochezia and anorexia requiring hospital admission.   Symptoms persisted despite 2 weeks of intravenous and rectal corticosteroids.  Despite the addition of a biologic agent, a third colonoscopy showed minimal improvement.  Author concluded that patients without specific contraindications should continue to receive vaccination against COVID-19, however following an adverse event, clinicians should think carefully about administration of the second dose. While the importance of vaccination and herd immunity cannot be understated, cases such as this are important to report, especially with regard to advice on administration of the second dose of the vaccine when an adverse event was noted following the first dose. Company comment:  This case concerns a 66-year-old female patient with medical history of diverticulitis with requiring sigmoid colectomy and recent diagnosis of colitis ulcerative, who experienced the serious unexpected event of colitis ulcerative flare after second dose of mRNA-1273. The second dose was administered 4 weeks later after the first dose and the patient immediately developed severe hematochezia and anorexia requiring hospital admission. Colonoscopy revealed severe Pancolitis. The re-challenge is unknown since event outcome was unknown and occurred after second dose. Patient recent diagnosis of colitis ulcerative remains a contributing factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-399730 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Followup received by safety on 03-Dec-2021 included an Email containing new information: Author added; Sender's Comments: This case concerns a 66-year-old female patient with medical history of diverticulitis with requiring sigmoid colectomy and recent diagnosis of colitis ulcerative, who experienced the serious unexpected event of colitis ulcerative flare after second dose of mRNA-1273. The second dose was administered 4 weeks later after the first dose and the patient immediately developed severe hematochezia and anorexia requiring hospital admission. Colonoscopy revealed severe Pancolitis. The re-challenge is unknown since event outcome is unknown and occurred after second dose. Patient recent diagnosis of colitis ulcerative remains a contributing factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.