Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of product administration; crohns; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (crohns) in a 52-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 an unknown indication.    No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. In 2020, the patient experienced CROHN'S DISEASE (crohns) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). The patient was treated with CEFIXIME (FLEXERIL [CEFIXIME]) at an unspecified dose and frequency. At the time of the report, CROHN'S DISEASE (crohns) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Action taken was reported as unknown for the co-suspect ADALIMUMAB (HUMIRA) with respect of the event.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.  Treatment information was not provided.  The reporter's causality for the event(s) of CROHNS was not providedwith HUMIRA(ADALIMUMAB).  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 52-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Crohn's disease in the context of receiving a dose of mRNA-1273 vaccine. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Patient received 1st and 2nd dose of mRNA-1273 vaccine 20 days apart, which is not in accordance with the recommended vaccine interval. On an unknown date, patient received co-suspect Adalimumab which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Live follow-up received additional event stomach pain was updated to crohns and reporter opinion of causality, suspect drug information and narrative description was updated.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Crohn's disease in the context of receiving a dose of mRNA-1273 vaccine. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Patient received 1st and 2nd dose of mRNA-1273 vaccine 20 days apart, which is not in accordance with the recommended vaccine interval. On an unknown date, patient received co-suspect Adalimumab which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.