Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Large intestinal obstruction, Vaccination site pain, Weight decreased
Clinical narrative: Colon obstruction; Weight loss; Condition aggravated; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINAL OBSTRUCTION (Colon obstruction) and WEIGHT DECREASED (Weight loss) in a 70-year-old 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.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced LARGE INTESTINAL OBSTRUCTION (Colon obstruction) (seriousness criteria hospitalization and medically significant), WEIGHT DECREASED (Weight loss) (seriousness criterion hospitalization) and CONDITION AGGRAVATED (Condition aggravated). In 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, LARGE INTESTINAL OBSTRUCTION (Colon obstruction), WEIGHT DECREASED (Weight loss) and CONDITION AGGRAVATED (Condition aggravated) had not resolved. Not Provided          No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for Humira for the event(s) of flair up of colon obstruction, loss weight and vaccine site just hurt for a few days was not 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 a 70-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to hospitalization medically significant) event of Large intestinal obstruction, and the unexpected and serious (due to hospitalization) event of Weight decreased, which occurred related to primary vaccination with mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. Crohn´s disease can present relapses as part of the natural history of disease, so that confounds the case. 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 a 70-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to hospitalization medically significant) event of Large intestinal obstruction, and the unexpected and serious (due to hospitalization) event of Weight decreased, which occurred related to primary vaccination with mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. Crohn´s disease can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.