Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3044210 | IM |
was diagnosed with Very Early Onset Ulcerative Colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (was diagnosed with Very Early Onset Ulcerative Colitis) in a 3-year-old male patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (batch no. 3044210) for COVID-19 prophylaxis. No Medical History information was reported. On 18-Oct-2024, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 19-Oct-2024, after starting mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS), the patient experienced COLITIS ULCERATIVE (was diagnosed with Very Early Onset Ulcerative Colitis) (seriousness criterion medically significant). The patient was treated with Mesalazine (Mesalamine) for Ulcerative colitis, at an unspecified dose and frequency and Prednisone for Ulcerative colitis, at an unspecified dose and frequency. At the time of the report, COLITIS ULCERATIVE (was diagnosed with Very Early Onset Ulcerative Colitis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Positive) very elevated levels of calprotectin indicating inflammation. On an unknown date, Colonoscopy: Test Result (Qualifier):- EQ, Colonoscopy showed ulcers throughout large intestine and was diagnosed with Very Early Onset Ulcerative Colitis. On an unknown date, Endoscopy: Endoscopy and colonoscopy showed ulcers throughout large instestine and was diagnosed with Very Early Onset Ulcerative Colitis. On an unknown date, Parasite stool test: Negative. The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported. Next day patient had loose stool, and within 3 days had mucous and blood with stool. It was resolved in 20 days but came back a few weeks later even worse. The patient did not experience any additional symptoms or events. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Test Name: blood tests; Test Result: Positive ; Test Name: Colonoscopy; Result Unstructured Data: Test Result (Qualifier):- EQ, Colonoscopy showed ulcers throughout large intestine and was diagnosed with Very Early Onset Ulcerative Colitis; Test Name: Endoscopy; Result Unstructured Data: Endoscopy and colonoscopy showed ulcers throughout large instestine and was diagnosed with Very Early Onset Ulcerative Colitis; Test Name: Parasite stool test; Test Result: Negative