Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Crohn's disease, Gingival bleeding, SARS-CoV-2 test
Clinical narrative: inflammation related to crohns; bleeding gums; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (inflammation related to crohns) in an adult 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) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   In December 2021, the patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced COVID-19 (COVID-19 virus test positive). On an unknown date, the patient experienced CROHN'S DISEASE (inflammation related to crohns) (seriousness criterion medically significant) and GINGIVAL BLEEDING (bleeding gums). In 2022, COVID-19 (COVID-19 virus test positive) had resolved. At the time of the report, CROHN'S DISEASE (inflammation related to crohns) outcome was unknown and GINGIVAL BLEEDING (bleeding gums) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of tested positive for covid and inflammation related to crohns was not provided. the reporter's causality for the event(s) of bleeding gums with humira(adalimumab) was reasonable possibility.  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. An adult male patient in treatment with ADALIMUMAB (HUMIRA) for Crohn's disease, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of inflammation related to Crohn's disease and non serious event of gingival bleeding. Onset date of the events was not provided, latency cannot be assessed. In addition, the month following third vaccination, patient experienced non serious event of COVID-19 (AESI). No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Adalimumab is a confounding factor for inflammation related to Crohn's disease and gingival bleeding. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. An adult male patient in treatment with ADALIMUMAB (HUMIRA) for Crohn's disease, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of inflammation related to Crohn's disease and non serious event of gingival bleeding. Onset date of the events was not provided, latency cannot be assessed. In addition, the month following third vaccination, patient experienced non serious event of COVID-19 (AESI). No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Adalimumab is a confounding factor for inflammation related to Crohn's disease and gingival bleeding. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.