Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Discomfort, Pyrexia, Unevaluable event
Clinical narrative: Unevaluable event; Fever; Flare up of Crohn's disease; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Flare up of Crohn's disease) in a 21-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.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Solution for injection in pre-filled pen. In 2022, the patient experienced CROHN'S DISEASE (Flare up of Crohn's disease) (seriousness criterion medically significant), DISCOMFORT (Discomfort) and PYREXIA (Fever). On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, CROHN'S DISEASE (Flare up of Crohn's disease) had not resolved and DISCOMFORT (Discomfort), UNEVALUABLE EVENT (Unevaluable event) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was provided by reporter. Causality for HUMIRA: The reporter's causality for the event(s) of FLARE UP OF CROHN'S DISEASE with HUMIRA(ADALIMUMAB) was a  reasonable possibility. The reporter's causality for the event(s) of MODERNA VACCINES CAUSED FEVER with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of DISCOMFORT and FREQUENCY was not provided. Primary reporter contact for lot number information was unsuccessful. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment drug was provided by reporter. Company Comment: This spontaneous case was reported by a consumer concerning a 21 year old female patent , with no medical history reported ,  with reported  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease, who experienced , Serious ( Medically significant ) , unexpected event of Crohn's disease ( flare up of Crohn's disease) and non-serious unexpected event of discomfort , non-serious, expected event of fever. These events occurred on an unknown date in 2022 post vaccination with the three doses of mRNA-1273 vaccine. On an unknown date  post vaccination with the dose 1 , 2 and 3 of mRNA-1273 vaccine this patient experienced non-serious , unexpected event of unevaluable event . The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event Crohn's disease ( flare up of Crohn's disease ) was not resolved while for the other events is was unknown . Event fever was reported as related by the reporter. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case was reported by a consumer concerning a 21 year old female patent , with no medical history reported ,  with reported  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease, who experienced , Serious ( Medically significant ) , unexpected event of Crohn's disease ( flare up of Crohn's disease) and non-serious unexpected event of discomfort , non-serious, expected event of fever. These events occurred on an unknown date in 2022 post vaccination with the three doses of mRNA-1273 vaccine. On an unknown date  post vaccination with the dose 1 , 2 and 3 of mRNA-1273 vaccine this patient experienced non-serious , unexpected event of unevaluable event . The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event Crohn's disease ( flare up of Crohn's disease ) was not resolved while for the other events is was unknown . Event fever was reported as related by the reporter. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.