Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Rash, Vaccination site pain
Clinical narrative: Crohn's disease; Soreness in arm after vaccination; Rash on face; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease) in an 80-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.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2020, the patient experienced RASH (Rash on face). On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Soreness in arm after vaccination). At the time of the report, CROHN'S DISEASE (Crohn's disease) had not resolved and VACCINATION SITE PAIN (Soreness in arm after vaccination) and RASH (Rash on face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  On an unknown date Colonoscopy was performed but the result was unknown.  Treatment information was not provided.  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.  CC: This spontaneous case concerns an 80-year-old, female patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Crohn's disease with an expected, non-serious event of Rash (Facial rash) in association with a dose of mRNA-1273 vaccine. Exact onset latency of all the events relative to vaccination cannot be determined with unknown events' onset dates and vaccination date. Outcome of the event Crohn's disease was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Cutaneous involvement is possible in patients with Crohn's disease. Patient's underlying Crohn's disease could be considered as a strong contributory factor in this case. Adalimumab remains a confounder to the event facial rash. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an 80-year-old, female patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Crohn's disease with an expected, non-serious event of Rash (Facial rash) in association with a dose of mRNA-1273 vaccine. Exact onset latency of all the events relative to vaccination cannot be determined with unknown events' onset dates and vaccination date. Outcome of the event Crohn's disease was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Cutaneous involvement is possible in patients with Crohn's disease. Patient's underlying Crohn's disease could be considered as a strong contributory factor in this case. Adalimumab remains a confounder to the event facial rash. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.