Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Crohn's disease, Fatigue, Pain
Clinical narrative: COVID-19; Crohn's disease; Fatigue; General body pain; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease) in a 49-year-old female 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to dose increased (1 in 1 wk). On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Increased to weekly. In 2021, the patient experienced FATIGUE (Fatigue) and PAIN (General body pain). In October 2021, the patient experienced CROHN'S DISEASE (Crohn's disease) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, CROHN'S DISEASE (Crohn's disease), COVID-19 (COVID-19), FATIGUE (Fatigue) and PAIN (General body pain) outcome was unknown.            No concomitant medication information was reported. No treatment medication information was reported. 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 where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 49-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease and the unexpected, non-serious adverse event of special interest of COVID-19. The patient had Crohn's disease breakthrough symptoms approximately 5 months after receiving the second dose of mRNA-1273 vaccine. The event COVID-19 occurred approximately 6 months after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. Medical history of Crohn's disease remains a risk factor for the event of Crohn's disease. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Significant Follow up- Event updated. On 28-Feb-2022: Significant follow up: Received updates to event information, suspect drug information and narrative description.; Sender's Comments: This is a spontaneous case concerning a 49-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease and the unexpected, non-serious adverse event of special interest of COVID-19. The patient had Crohn's disease breakthrough symptoms approximately 5 months after receiving the second dose of mRNA-1273 vaccine. The event COVID-19 occurred approximately 6 months after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. Medical history of Crohn's disease remains a risk factor for the event of Crohn's disease. The benefit-risk relationship of mRNA-1273 is not affected by this report.