Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, Crohn's disease
Clinical narrative: Crohn's disease aggravated/several crohn's disease flare ups; This spontaneous case was reported by a patient and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated/several crohn's disease flare ups) in an elderly 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 (Adult Crohn's disease.).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated/several crohn's disease flare ups) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated/several crohn's disease flare ups) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Antibodies count was low..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported by reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported by reporter.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company Comment:  This spontaneous case concerns an elderly 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/several Crohn's disease flare ups) 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. An unspecified Antibody test was reported with a result of antibodies count low.  No information on any other doses of COVID-19 vaccination was provided. 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 an elderly 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/several Crohn's disease flare ups) 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. An unspecified Antibody test was reported with a result of antibodies count low.  No information on any other doses of COVID-19 vaccination was provided. 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.