Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Diarrhoea
Clinical narrative: COVID; stomach upset; liquid bowel movements; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID), ABDOMINAL DISCOMFORT (stomach upset) and DIARRHOEA (liquid bowel movements) in a 22-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.    Concurrent medical conditions included Crohn's disease (moderate to severe adult crohn's disease).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third 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) Citrate Free. In May 2022, the patient experienced ABDOMINAL DISCOMFORT (stomach upset) and DIARRHOEA (liquid bowel movements). In June 2022, the patient experienced COVID-19 (COVID). In May 2022, ABDOMINAL DISCOMFORT (stomach upset) and DIARRHOEA (liquid bowel movements) had resolved. At the time of the report, COVID-19 (COVID) was resolving.            Concomitant medication of the patient was not reported.   Formulation of Humira (adalimumab) was mentioned as solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided by the reporter.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of COVID, stomach upset/liquid bowel movements onset in May 2022 and stomach upset/liquid bowel movements onset in May 2022 were not provided.  Company comment:   This is a spontaneous case reported by a consumer, concerning a 22 year old female patient, with concurrent history of having chronic disease, who experienced the unexpected, non- serious AESI of COVID-19 on an unknown date, about 7 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received 2 primary doses with Moderna vaccines with the last dose given about 8 months prior to the 3 dose of Moderna, along with other non serious events. Patient was receiving Adalimumab as treatment for chron's disease from an unknown date, which could be considered as a confounder along with the ongoing Pandemia of covid 19.  The event was reported as resolving. No details on comorbidities, labs, diagnostic tests and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 22 year old female patient, with concurrent history of having chronic disease, who experienced the unexpected, non- serious AESI of COVID-19 on an unknown date, about 7 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received 2 primary doses with Moderna vaccines with the last dose given about 8 months prior to the 3 dose of Moderna, along with other non serious events. Patient was receiving Adalimumab as treatment for chron's disease from an unknown date, which could be considered as a confounder along with the ongoing Pandemia of covid 19.  The event was reported as resolving. No details on comorbidities, labs, diagnostic tests and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement.