Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Maternal exposure during pregnancy; Crohn's aggravated; Nausea; Vaccination site pain/sore arm following each covid vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's aggravated) in a 39-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.    The patient's past medical history included Miscarriage, Tiredness, Tenderness, Medical marijuana therapy in 1994, Ganglion removal in 2007, Gallbladder removal in 2017, Nerve operation in 2019 and Abortion. Concurrent medical conditions included Tobacco user (Two packs of cigarette per week), Carpal tunnel syndrome in March 2008, Latex allergy (manifested by scratchy throat, swelling and hives) and Alcohol use (Eight glass) since 1994. Concomitant products included MESALAZINE (APRISO) for Crohn's disease, INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.   In May 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced CROHN'S DISEASE (Crohn's aggravated) (seriousness criterion medically significant), NAUSEA (Nausea) and VACCINATION SITE PAIN (Vaccination site pain/sore arm following each covid vaccine). On 09-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, CROHN'S DISEASE (Crohn's aggravated), NAUSEA (Nausea), VACCINATION SITE PAIN (Vaccination site pain/sore arm following each covid vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2022, Pregnancy test: positive Positive. On 22-Feb-2022, Ultrasound scan vagina: positive Positive.         No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Company comment: This spontaneous case concerns a 39-years-old female patient with relevant medical history of Crohn's disease (with concomitant medication MESALAZINE), who experienced the unexpected serious (medically significant) Crohn's diseases which occurred on unspecified day after the third dose of mRNA-1273 vaccine. Maternal exposure during pregnancy was reported as Pregnancy test and Ultrasound scan vagina was positive approximately 5 months after the current vaccination. However, last menstrual period and estimated date of delivery were not provided. It was reported that patient started  with co-suspect ADALIMUMAB (HUMIRA ) for Crohn's disease on unspecified day and Patient's relevant medical history of Crohn's disease (with concomitant medication MESALAZINE) remains confounder for the event Crohn's disease. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-589107, MOD-2022-589108 (Patient Link).; Sender's Comments: This spontaneous case concerns a 39-years-old female patient with relevant medical history of Crohn's disease (with concomitant medication MESALAZINE), who experienced the unexpected serious (medically significant) Crohn's diseases which occurred on unspecified day after the third dose of mRNA-1273 vaccine. Maternal exposure during pregnancy was reported as Pregnancy test and Ultrasound scan vagina was positive approximately 5 months after the current vaccination. However, last menstrual period and estimated date of delivery were not provided. It was reported that patient started  with co-suspect ADALIMUMAB (HUMIRA ) for Crohn's disease on unspecified day and Patient's relevant medical history of Crohn's disease (with concomitant medication MESALAZINE) remains confounder for the event Crohn's disease. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.