Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Dry skin, Eye pruritus, Inflammation
Clinical narrative: Crohns disease flare up a lot; Dry feet/Dry patches on skin; Itchy eyes; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease flare up a lot) in a 63-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) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult crohn's disease).   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021, received third 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) Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease flare up a lot) (seriousness criterion medically significant), DRY SKIN (Dry feet/Dry patches on skin), EYE PRURITUS (Itchy eyes) and INFLAMMATION (Inflammation). At the time of the report, CROHN'S DISEASE (Crohns disease flare up a lot) and INFLAMMATION (Inflammation) was resolving and DRY SKIN (Dry feet/Dry patches on skin) and EYE PRURITUS (Itchy eyes) outcome was unknown.            The concomitant drugs were not reported.   experienced events dry feet/dry patches of skin, itchy eyes, inflammation on unknown dates and after Moderna COVID-19 vaccine Crohn's disease flare up a lot with Humira and Humira.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment medication were not provided.  Company Comment:  This is a spontaneous case concerning a 63-year-old female patient with relevant medical history of Crohn's disease, who experienced the unexpected serious (medically significant) event of Crohn's disease, described as Crohn's disease flare up/aggravated, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 30 days which falls within the recommended vaccine dosing schedule, approximately 7 months prior to third mRNA-1273 vaccination. Patient also experienced dry fee, dry patches of skin, itchy eyes, and non-specific inflammation. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event Crohn's disease was resolving. The medical history of Crohn's disease remains as a confounder for the event Crohn's disease aggravated. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 63-year-old female patient with relevant medical history of Crohn's disease, who experienced the unexpected serious (medically significant) event of Crohn's disease, described as Crohn's disease flare up/aggravated, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 30 days which falls within the recommended vaccine dosing schedule, approximately 7 months prior to third mRNA-1273 vaccination. Patient also experienced dry fee, dry patches of skin, itchy eyes, and non-specific inflammation. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event Crohn's disease was resolving. The medical history of Crohn's disease remains as a confounder for the event Crohn's disease aggravated. The benefit-risk relationship of mRNA-1273 is not affected by this report.