Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, Small intestinal obstruction
Clinical narrative: COVID-19 infection (confirmed); Partial small bowel obstruction; This spontaneous case was reported by a physician and describes the occurrence of SMALL INTESTINAL OBSTRUCTION (Partial small bowel obstruction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colon operation (ileum with cecum and/or ascending colon resection surgery) in 2002 and Cholecystectomy in 2019. Concurrent medical conditions included Disease Crohns since 1993, Depression, Allergy (Allergies), Hypothyroidism, Blood pressure high and Non-smoker. Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) from 01-Jan-2022 to an unknown date for Allergy, LOSARTAN from 01-Apr-2022 to an unknown date for Blood pressure high, BUPROPION from 01-Sep-2022 to an unknown date for Depression, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Jan-2022 to an unknown date for Hypothyroidism, PRAVASTATIN from 24-Jan-2022 to an unknown date and CITRIC ACID, MAGNESIUM OXIDE, SODIUM PICOSULFATE (CLENPIQ) from 10-Oct-2022 to 11-Oct-2022 for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced SMALL INTESTINAL OBSTRUCTION (Partial small bowel obstruction) (seriousness criterion medically significant). In January 2023, the patient experienced COVID-19 (COVID-19 infection (confirmed)). On 12-Jan-2023, COVID-19 (COVID-19 infection (confirmed)) had resolved. At the time of the report, SMALL INTESTINAL OBSTRUCTION (Partial small bowel obstruction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2023, Laboratory test: Pathogen was noted as SARS-CoV-2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (COVID-19 infection (confirmed)) to have an unknown relationship. No further causality assessment was provided for SMALL INTESTINAL OBSTRUCTION (Partial small bowel obstruction).    It was reported that there was no exposure noted prior to the event onset. Symptoms associated with the event included sore throat and cough. Patient was not hospitalized and received no treatment and developed no complications. Disease activity prior to the event onset was reported as low disease activity and there was no change at the time of event onset. The reporter did not attribute COVID-19 to concomitant or any other medications.  No treatment medications reported.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with concurrent Crohn's disease, who experienced the unexpected serious (medically significant) event of Small intestinal obstruction (reported as Partial small bowel obstruction), unknown days after receiving the second dose of mRNA-1273 vaccine. The patient also reported of COVID 19 on an unknown date in the context of receiving mRNA-1273 vaccine. The interval between the primary doses was as per the recommended schedule. No information on patient demographics, exact onset date of the events, detailed clinical course, treatment of the events was available in the report. The event COVID 19 had resolved. The outcome of Small intestinal obstruction was unknown. Concurrent Crohn's disease could be a risk factor for the event Small intestinal obstruction. The benefit-risk relationship of mRNA-1273 is not affected by this report.