Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Pyrexia, Vaccination site pain
Clinical narrative: CROHN'S DISEASE FLARE UP/ ACTIVE CROHNS SYMPTOMS; Vaccination site pain; COVID VACCINE ISSUE SLIGHT FEVER; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHN'S DISEASE FLARE UP/ ACTIVE CROHNS SYMPTOMS) in a 31-year-old male 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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 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) UNK, Citrate Free, 1 in 1 wk. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (COVID VACCINE ISSUE SLIGHT FEVER). In 2022, the patient experienced CROHN'S DISEASE (CROHN'S DISEASE FLARE UP/ ACTIVE CROHNS SYMPTOMS) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (CROHN'S DISEASE FLARE UP/ ACTIVE CROHNS SYMPTOMS), VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (COVID VACCINE ISSUE SLIGHT FEVER) outcome was unknown.            There was no reported medical history.   Concomitant drugs not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter contact for lot number information was unsuccessful.   Action taken for Humira was reported as dose increased for the event Crohn's disease aggravated.  The reporter's causality for the events of vaccination site pain, loose bowels, ineffective drug dosing regimen was not provided for Humira.  Patient still experienced loose bowel moments.  No treatment medication were provided.  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.  Company comment: This spontaneous case concerns a 31-year-old male patient, treated with co-suspect drug Adalimumab for moderate to severe Crohn's disease (start date not provided and with no reported medical history), who experienced the unexpected serious (medically significant) event of Crohn's disease after receiving the 3rd dose of mRNA-1273 vaccine. Patient reported Crohn's disease flare up/ active Crohn's symptoms of loose bowel movements. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Adalimumab for Crohn's disease could be considered as a confounder for the event since the disease was aggravated. Patient received 2 doses of mRNA-1273 vaccine as primary series approximately one month apart, and approximately 5 months later the 3rd dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2022: Live-significant follow up received: Suspect product information, new event Crohn's disease added, seriousness criteria added and narrative updated.Event Drug ineffective and Diarrhoea removed.; Sender's Comments: This spontaneous case concerns a 31-year-old male patient, treated with co-suspect drug Adalimumab for moderate to severe Crohn's disease (start date not provided and with no reported medical history), who experienced the unexpected serious (medically significant) event of Crohn's disease after receiving the 3rd dose of mRNA-1273 vaccine. Patient reported Crohn's disease flare up/ active Crohn's symptoms of loose bowel movements. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Adalimumab for Crohn's disease could be considered as a confounder for the event since the disease was aggravated. Patient received 2 doses of mRNA-1273 vaccine as primary series approximately one month apart, and approximately 5 months later the 3rd dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.