Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Gastrointestinal disorder
Clinical narrative: COVID-19; affected gastrointestinal tract; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and GASTROINTESTINAL DISORDER (affected gastrointestinal tract) in an adult female 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 Ulcerative colitis.    The patient had no known allergies.  Concurrent medical conditions included Ulcerative colitis.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19) and GASTROINTESTINAL DISORDER (affected gastrointestinal tract). At the time of the report, COVID-19 (COVID-19) had resolved and GASTROINTESTINAL DISORDER (affected gastrointestinal tract) outcome was unknown.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event of affected gastrointestinal tract was not provided. The reporter's causality for the event of COVID-19 with Humira (adalimumab) was no reasonable possibility. The reporter assessed events of affected gastrointestinal tract and COVID-19 as possibly related to Moderna COVID-19 vaccine.  No treatment details were reported.  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 spontaneous case concerns an adult female patient of unknown age with concurrent condition of Ulcerative colitis, who experienced the unexpected non serious AESI of COVID 19 , unknown days after receiving the booster dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, investigation and treatment was available in the report. The event resolved. Co suspect Adalimumab and the COVID 19 pandemic could be confounders for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with concurrent condition of Ulcerative colitis, who experienced the unexpected non serious AESI of COVID 19 , unknown days after receiving the booster dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, investigation and treatment was available in the report. The event resolved. Co suspect Adalimumab and the COVID 19 pandemic could be confounders for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.