Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Small intestinal obstruction, Vaccination site pain, Vaccination site vesicles
Clinical narrative: Small bowel blockage; SORE ARM; blisters on arm due to covid 19 vaccinations; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SMALL INTESTINAL OBSTRUCTION (Small bowel blockage) in an elderly 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, Rheumatoid arthritis and Ulcerative colitis.    Concurrent medical conditions included Crohn's disease, Rheumatoid arthritis and Ulcerative colitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SMALL INTESTINAL OBSTRUCTION (Small bowel blockage) (seriousness criteria hospitalization and medically significant), VACCINATION SITE PAIN (SORE ARM), VACCINATION SITE VESICLES (blisters on arm due to covid 19 vaccinations) and FATIGUE (Fatigue). The patient was hospitalized from 26-Dec-2021 to 29-Dec-2021 due to SMALL INTESTINAL OBSTRUCTION. At the time of the report, SMALL INTESTINAL OBSTRUCTION (Small bowel blockage) outcome was unknown and VACCINATION SITE PAIN (SORE ARM), VACCINATION SITE VESICLES (blisters on arm due to covid 19 vaccinations) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was reported. No treatment drug was reported.  It was reported that after first shot patient had blisters on arm due to covid 19 vaccinations. Causality for humira(Solution for injection in pre-filled syringe) : the reporter's causality for the event(s) of small bowel blockage was not provided. the reporter's causality for the event(s) of fatigue sore arm/blisters on arm due to covid 19 vaccinations unknown onset, fatigue sore arm/blisters on arm due to covid 19 vaccinations unknown onset and fatigue sore arm/blisters on arm due to covid 19 vaccinations unknown onset with humira(adalimumab) was no reasonable possibility.   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 concerning an elderly female patient with Crohn's disease, Rheumatoid arthritis and Ulcerative colitis, who experienced the serious unexpected events small intestinal obstruction, after receiving, on an unknown date, the first dose of mRNA-1273. Patient was hospitalized for 3 days due to the event.  Clinical course, diagnostic tests and treatment details were not provided. Fatigue, vaccination site pain and vaccination site vesicles were also reported as non-serious events.  Patient´s medical condition of Chron´s disease and ulcerative colitis remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning an elderly female patient with Crohn's disease, Rheumatoid arthritis and Ulcerative colitis, who experienced the serious unexpected events small intestinal obstruction, after receiving, on an unknown date, the first dose of mRNA-1273. Patient was hospitalized for 3 days due to the event.  Clinical course, diagnostic tests and treatment details were not provided. Fatigue, vaccination site pain and vaccination site vesicles were also reported as non-serious events.  Patient´s medical condition of Chron´s disease and ulcerative colitis remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.