Sex: U
Vaccine: COVID19
Symptoms: Crohn's disease, Large intestinal obstruction
Clinical narrative: Colon obstruction, blockage in colon; Crohn's disease aggravated/CROHN'S DISEASE FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINAL OBSTRUCTION (Colon obstruction, blockage in colon) and CROHN'S DISEASE (Crohn's disease aggravated/CROHN'S DISEASE FLARE UP) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen,Citrate free. On an unknown date, the patient experienced LARGE INTESTINAL OBSTRUCTION (Colon obstruction, blockage in colon) (seriousness criterion medically significant) and CROHN'S DISEASE (Crohn's disease aggravated/CROHN'S DISEASE FLARE UP) (seriousness criterion medically significant). At the time of the report, LARGE INTESTINAL OBSTRUCTION (Colon obstruction, blockage in colon) outcome was unknown and CROHN'S DISEASE (Crohn's disease aggravated/CROHN'S DISEASE FLARE UP) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication information was provided. Patient received surgery for blockage in colon. For Humira daily dose was reported as Citrate free. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Company comment-This spontaneous case concerns an adult patient (of unspecified age and gender) with relevant medical history of Crohn's disease reported, who experienced the unexpected serious (medically significant) events of Large intestinal obstruction and Crohn's disease (reported as Crohn's disease aggravated) on unknown dates after receiving first dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient underwent surgery for blockage in colon and had a flare up after receiving vaccination. No further clinical course, lab reports or treatment details were reported. Outcome of the event Large intestinal obstruction was unknown, Crohn's disease was resolved at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an adult patient (of unspecified age and gender) with relevant medical history of Crohn's disease reported, who experienced the unexpected serious (medically significant) events of Large intestinal obstruction and Crohn's disease (reported as Crohn's disease aggravated) on unknown dates after receiving first dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient underwent surgery for blockage in colon and had a flare up after receiving vaccination. No further clinical course, lab reports or treatment details were reported. Outcome of the event Large intestinal obstruction was unknown, Crohn's disease was resolved at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement