Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Immunodeficiency
Clinical narrative: IMMUNOCOMPROMISED; CROHN'S DISEASE FLARE; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHN'S DISEASE FLARE) and IMMUNODEFICIENCY (IMMUNOCOMPROMISED) in a 41-year-old male 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.   On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, received 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) at an unspecified dose. In November 2021, the patient experienced CROHN'S DISEASE (CROHN'S DISEASE FLARE) (seriousness criterion medically significant). On an unknown date, the patient experienced IMMUNODEFICIENCY (IMMUNOCOMPROMISED) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (CROHN'S DISEASE FLARE) was resolving and IMMUNODEFICIENCY (IMMUNOCOMPROMISED) outcome was unknown.            No Concomitant medication was reported. No treatment information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 a 41-year-old, male patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced the unexpected, medically significant events of Crohn's disease aggravated and Immunodeficiency in association with a dose of mRNA-1273 vaccine. Exact onset latency of all the events relative to vaccination cannot be determined with unknown events' onset dates. Outcome of the event Crohn's disease aggravated was reported as resolving. Patient received 3 consecutive doses of mRNA-1273 vaccine within the recommended schedule. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying Crohn's disease and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical.; Sender's Comments: This spontaneous case concerns a 41-year-old, male patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced the unexpected, medically significant events of Crohn's disease aggravated and Immunodeficiency in association with a dose of mRNA-1273 vaccine. Exact onset latency of all the events relative to vaccination cannot be determined with unknown events' onset dates. Outcome of the event Crohn's disease aggravated was reported as resolving. Patient received 3 consecutive doses of mRNA-1273 vaccine within the recommended schedule. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying Crohn's disease and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical.