Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Intestinal obstruction
Clinical narrative: BOWEL BLOCKAGE; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (BOWEL BLOCKAGE) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    NO KNOWN ALLERGIES No relevant medical history.  Concurrent medical conditions included Crohn's disease.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-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 INTESTINAL OBSTRUCTION (BOWEL BLOCKAGE) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in December 2021 due to INTESTINAL OBSTRUCTION. At the time of the report, INTESTINAL OBSTRUCTION (BOWEL BLOCKAGE) was resolving.            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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of bowel blockage was not provided. Abbvie's opinion is that there is no reasonable possibility that the event of bowel blockage is related to Humira(adalimumab).  CC: This spontaneous case concerns a 67-year-old, female patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Intestinal obstruction in association with a dose of mRNA-1273 vaccine. Event intestinal obstruction resulted to patient's hospitalization within the preceding month from her 2-dose primary series mRNA-1273 vaccination. Outcome of the event was reported as resolving. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying Crohn's disease and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on the available information.; Sender's Comments: This spontaneous case concerns a 67-year-old, female patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Intestinal obstruction in association with a dose of mRNA-1273 vaccine. Event intestinal obstruction resulted to patient's hospitalization within the preceding month from her 2-dose primary series mRNA-1273 vaccination. Outcome of the event was reported as resolving. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying Crohn's disease and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on the available information.