Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal dilation procedure, Postoperative adhesion, Somnolence
Clinical narrative: Postoperative adhesion; Gastrointestinal dilation procedure; Drowsiness; This spontaneous case was reported by a consumer and describes the occurrence of POSTOPERATIVE ADHESION (Postoperative adhesion), GASTROINTESTINAL DILATION PROCEDURE (Gastrointestinal dilation procedure) and SOMNOLENCE (Drowsiness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Bowel resection in 2020.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-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) CF. In 2021, the patient experienced POSTOPERATIVE ADHESION (Postoperative adhesion) (seriousness criterion medically significant), GASTROINTESTINAL DILATION PROCEDURE (Gastrointestinal dilation procedure) (seriousness criterion medically significant) and SOMNOLENCE (Drowsiness) (seriousness criterion medically significant). At the time of the report, POSTOPERATIVE ADHESION (Postoperative adhesion), GASTROINTESTINAL DILATION PROCEDURE (Gastrointestinal dilation procedure) and SOMNOLENCE (Drowsiness) outcome was unknown.            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.  In 2021, the patient underwent a dilation and had scar tissue which caused the reason for the bowel resection. He was put on an unknown antibiotic that made him drowsy. Unknown antibiotic was considered as co suspect. He did not agree to have physician contacted.It was unknown if patient was enrolled in a COVID-19 vaccine trial.the reporter's causality for the event(s) of had a dilation and the scar tissue caused the reason for the bowel resection onset in 2021, bowel resection, had a dilation and the scar tissue caused the reason for the bowel resection onset in october 2021 and unknown antibiotic made patient drowsy was not provided.No concomitant medication was provided by reporter.No treatment medication was provided by reporter.  Company comment: This spontaneous case concerns a 63 year old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) events of Postoperative adhesion, Gastrointestinal dilation and Somnolence, unknown days after receiving the first dose of mRNA-1273 vaccine. The patient underwent dilation of esophagus and colon. He had scar tissue which required bowel resection. He was put on an unknown antibiotic that made him drowsy.  No information on detailed clinical course, relevant investigations and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2022: Significant Live follow up appended  : Narrative part and event information updated; Sender's Comments: This spontaneous case concerns a 63 year old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) events of Postoperative adhesion, Gastrointestinal dilation and Somnolence, unknown days after receiving the first dose of mRNA-1273 vaccine. The patient underwent dilation of esophagus and colon. He had scar tissue which required bowel resection. He was put on an unknown antibiotic that made him drowsy.  No information on detailed clinical course, relevant investigations and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.