Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Crohn's disease, SARS-CoV-2 test
Clinical narrative: Crohn's disease; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease) in a 19-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) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. In December 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (Crohn's disease) had not resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled syringe.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as a part of a retrospective clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation #QE-019993.  Company Comment: This spontaneous case concerns a 19-year-old, male patient with an underlying condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Crohn's disease with an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Exact latency of the events Crohn's disease and COVID-19 relative to vaccination cannot be established with unknown events' onset dates and vaccination date. A positive COVID-19 test was reportedly obtained on an unknown date. Vaccination history included only one dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying history of Crohn's disease and treatment with adalimumab could predispose the patient to various infectious disease. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Added dosage regimen for Humira.; Sender's Comments: This spontaneous case concerns a 19-year-old, male patient with an underlying condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Crohn's disease with an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Exact latency of the events Crohn's disease and COVID-19 relative to vaccination cannot be established with unknown events' onset dates and vaccination date. A positive COVID-19 test was reportedly obtained on an unknown date. Vaccination history included only one dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying history of Crohn's disease and treatment with adalimumab could predispose the patient to various infectious disease. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.