Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Diarrhoea
Clinical narrative: Fluorescent yellow diarrhea; Crohn's disease aggravated/ Crohn's disease flare up; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated/ Crohn's disease flare up) in a 42-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 Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated/ Crohn's disease flare up) (seriousness criterion medically significant). On 28-Sep-2021, the patient experienced DIARRHOEA (Fluorescent yellow diarrhea). At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated/ Crohn's disease flare up) outcome was unknown and DIARRHOEA (Fluorescent yellow diarrhea) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had no known allergies. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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 a 42-year-old female patient with relevant medical history of Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's disease aggravated/ Crohn's disease flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and onset date of the event were not provided. Outcome of the event was reported as unknown. Patient received a total of 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series followed by a third dose, all reported with unspecified dates of administration.  The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old female patient with relevant medical history of Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's disease aggravated/ Crohn's disease flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and onset date of the event were not provided. Outcome of the event was reported as unknown. Patient received a total of 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series followed by a third dose, all reported with unspecified dates of administration.  The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.