Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: Crohns disease aggravated/CROHNS DISEASE FLARE UP; Crohns disease aggravated/CROHNS DISEASE FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CROHN'S DISEASE (Crohns disease aggravated/CROHNS DISEASE FLARE UP) and the second episode of CROHN'S DISEASE (Crohns disease aggravated/CROHNS DISEASE FLARE UP) in a 71-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) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE).   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, received second 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) Solution for injection in pre-filled pen. In August 2021, the patient experienced the first episode of CROHN'S DISEASE (Crohns disease aggravated/CROHNS DISEASE FLARE UP) (seriousness criterion medically significant). In January 2022, the patient experienced the second episode of CROHN'S DISEASE (Crohns disease aggravated/CROHNS DISEASE FLARE UP) (seriousness criterion medically significant). In 2022, last episode of CROHN'S DISEASE (Crohns disease aggravated/CROHNS DISEASE FLARE UP) had resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of Crohns disease aggravated was  assessed as reasonable possibility for cosuspect humira. No treatment medications were reported.  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 is a spontaneous case, reported by a consumer concerning an a 71-year-old female patient with relevant medical condition of moderate to severe Crohn's disease, who experienced the unexpected serious (medically significant) events of two occurrence of Crohn's disease, reported as Crohns disease flare up. The first episode of Crohns disease flare up occurred on the same month of second mRNA-1273 vaccination, while the second episode of Crohns disease flare up occurred approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 31 days which falls within the recommended vaccine dosing schedule. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the events have resolved. The medical condition of moderate to severe Crohn's disease remains as a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case, reported by a consumer concerning an a 71-year-old female patient with relevant medical condition of moderate to severe Crohn's disease, who experienced the unexpected serious (medically significant) events of two occurrence of Crohn's disease, reported as Crohns disease flare up. The first episode of Crohns disease flare up occurred on the same month of second mRNA-1273 vaccination, while the second episode of Crohns disease flare up occurred approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 31 days which falls within the recommended vaccine dosing schedule. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the events have resolved. The medical condition of moderate to severe Crohn's disease remains as a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.