Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Crohn's disease, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Crohns disease aggravated/Crohns disease flare up; Aching (l) knee/left knee hurting/knees had some pain; second dose of Moderna on 15-Feb-2022 and booster is given on 01-Mar-2022; Vaccination site pain/COVID vaccine booster caused sore arm at injection location; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease aggravated/Crohns disease flare up) in a 71-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 01-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2022, 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) Unknown. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown. On 01-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna on 15-Feb-2022 and booster is given on 01-Mar-2022). In March 2022, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/COVID vaccine booster caused sore arm at injection location). On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease aggravated/Crohns disease flare up) (seriousness criterion medically significant) and ARTHRALGIA (Aching (l) knee/left knee hurting/knees had some pain). In 2022, VACCINATION SITE PAIN (Vaccination site pain/COVID vaccine booster caused sore arm at injection location) had resolved. At the time of the report, CROHN'S DISEASE (Crohns disease aggravated/Crohns disease flare up) had resolved, ARTHRALGIA (Aching (l) knee/left knee hurting/knees had some pain) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna on 15-Feb-2022 and booster is given on 01-Mar-2022) outcome was unknown.            Concomitant product use was not provided by the reporter. The reporter's causality of Humira for the event(s) of COVID  vaccine booster caused sore arm at injection location, left knee hurting/knees had some pain and crohns disease flare up was not provided Treatment information was not 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 71-years-old female patient with concurrent medical condition of Crohn's disease that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected serious (medically significant) event of Crohn's disease (Crohn's aggravated) that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event was resolved. The co-suspect Adalimumab (Humira) could be the contributory factor for the event Chron's aggravated. the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to MOD-2022-624079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Live-Significant Follow up-Event added, case upgraded to serious and  Narrative updated.; Sender's Comments: This spontaneous case concerns a 71-years-old female patient with concurrent medical condition of Crohn's disease that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected serious (medically significant) event of Crohn's disease (Crohn's aggravated) that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event was resolved. The co-suspect Adalimumab (Humira) could be the contributory factor for the event Chron's aggravated. the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.