Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Maternal exposure during pregnancy
Clinical narrative: COVID VACCINE CAUSED CROHN'S FLARE; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (COVID VACCINE CAUSED CROHN'S FLARE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    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) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced CROHN'S DISEASE (COVID VACCINE CAUSED CROHN'S FLARE) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, CROHN'S DISEASE (COVID VACCINE CAUSED CROHN'S FLARE) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            No concomitant and treatment medications were reported.  The fetus was exposed to maternal use of HUMIRA in utero. It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  Company comment: This is a spontaneous prospective pregnancy case concerning a adult female patient of unknown age with relevant concurrent medical condition of Crohn's disease. The patient has co-suspect medication of Adalimumab (Humira) for unspecified indication. The patient experienced the unexpected serious (medically significant) event of Crohn's disease (Covid vaccine caused Crohn's flare). Maternal exposure during pregnancy was also reported. The patient's age of gestation at the time of exposure to mRNA-1273 vaccine is unknown. The event's Crohn's disease (Covid vaccine caused Crohn's flare) occurrence unknown with respect to the booster dose of mRNA-1273 vaccine administration. No further clinical information was available for medical review. The outcome of the event Crohn's disease (Covid vaccine caused Crohn's flare) was reported as not resolved from the time of last observation. The natural course of the concurrent medical condition of Crohn's disease remain confounder for the event Crohn's disease (Covid vaccine caused Crohn's flare). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous prospective pregnancy case concerning a adult female patient of unknown age with relevant concurrent medical condition of Crohn's disease. The patient has co-suspect medication of Adalimumab (Humira) for unspecified indication. The patient experienced the unexpected serious (medically significant) event of Crohn's disease (Covid vaccine caused Crohn's flare). Maternal exposure during pregnancy was also reported. The patient's age of gestation at the time of exposure to mRNA-1273 vaccine is unknown. The event's Crohn's disease (Covid vaccine caused Crohn's flare) occurrence unknown with respect to the booster dose of mRNA-1273 vaccine administration. No further clinical information was available for medical review. The outcome of the event Crohn's disease (Covid vaccine caused Crohn's flare) was reported as not resolved from the time of last observation. The natural course of the concurrent medical condition of Crohn's disease remain confounder for the event Crohn's disease (Covid vaccine caused Crohn's flare). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.