Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Illness
Clinical narrative: Crohn's disease aggravated; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) formulation: Solution for injection in pre-filled pen. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criterion medically significant) and ILLNESS (Sickness). At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated) and ILLNESS (Sickness) outcome was unknown.            Formulation of Humira was reported as solution for injection in pre-filled pen.  It was reported that Humira not working, crohn's disease flare up and sick wit Humira. It was unknown if patient was enrolled in a covid-19 vaccine trail. Primary reporter did not have the lot number information, because the packaging was discarded.  No concomitant medication was reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 66-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease (Crohn's disease aggravated), on unknown date after receiving a dose of mRNA-1273 vaccine. The patient reported that Adalimumab is not working and reported Crohn's disease flare up and being sick. Dates of vaccination of the 3 doses of mRNA-1273, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 66-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease (Crohn's disease aggravated), on unknown date after receiving a dose of mRNA-1273 vaccine. The patient reported that Adalimumab is not working and reported Crohn's disease flare up and being sick. Dates of vaccination of the 3 doses of mRNA-1273, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.