Age: 77.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Pruritus
Clinical narrative: Itching; Crohn's aggravated; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's aggravated) in a 77-year-old male 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) injection for Crohn's disease and Rheumatoid arthritis.    The patient's past medical history included Crohn's disease. Concurrent medical conditions included Rheumatoid arthritis.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-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) CF. In 2021, the patient experienced CROHN'S DISEASE (Crohn's aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, CROHN'S DISEASE (Crohn's aggravated) and PRURITUS (Itching) had resolved.            Concomitant products were not provided. Treatment medication were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported adverse event information provided related to COVID vaccine.  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 77-year-old male patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's aggravated) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and onset date of event were not provided. Outcome of the event was reported as resolved. Patient received a 2-dose primary series of mRNA-1273 vaccine given 29 days apart which falls within the recommended dosing schedule. 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 77-year-old male patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's aggravated) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and onset date of event were not provided. Outcome of the event was reported as resolved. Patient received a 2-dose primary series of mRNA-1273 vaccine given 29 days apart which falls within the recommended dosing schedule. 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.