Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12, Vitamin B12 decreased
Clinical narrative: COLONOSCOPY REVEALED STRICTURE GOT WORSENED; VITAMINS B12 LOW; IRON LOW; COVID VACCINES POTENTIALLY CAUSED A HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINAL STENOSIS (COLONOSCOPY REVEALED STRICTURE GOT WORSENED) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to Severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (COLONOSCOPY REVEALED STRICTURE GOT WORSENED) (seriousness criterion medically significant), VITAMIN B12 DECREASED (VITAMINS B12 LOW), BLOOD IRON DECREASED (IRON LOW) and HEADACHE (COVID VACCINES POTENTIALLY CAUSED A HEADACHE). At the time of the report, LARGE INTESTINAL STENOSIS (COLONOSCOPY REVEALED STRICTURE GOT WORSENED), VITAMIN B12 DECREASED (VITAMINS B12 LOW) and BLOOD IRON DECREASED (IRON LOW) had not resolved and HEADACHE (COVID VACCINES POTENTIALLY CAUSED A HEADACHE) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Colonoscopy: Stricture was getting worse. On an unknown date, Blood iron: Low. On an unknown date, Vitamin B12: Low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events LARGE INTESTINAL STENOSIS (COLONOSCOPY REVEALED STRICTURE GOT WORSENED) (seriousness criterion medically significant), VITAMIN B12 DECREASED (VITAMINS B12 LOW), BLOOD IRON DECREASED (IRON LOW) and HEADACHE (HEADACHE) with Humira (adalimumab) was no reasonable possibility.  In Aug-2021, Colonoscopy was performed: Results Not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Large intestinal stenosis, which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect products included non-company product Adalimumab for Crohn´s disease. Colonoscopy was performed and revealed that stricture got worsened. Blood iron and vitamin B12 were low. No information disclosed about treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease could be a confounding factor for Large intestinal stenosis. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Large intestinal stenosis, which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect products included non-company product Adalimumab for Crohn´s disease. Colonoscopy was performed and revealed that stricture got worsened. Blood iron and vitamin B12 were low. No information disclosed about treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease could be a confounding factor for Large intestinal stenosis. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.