Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Crohn's disease
Clinical narrative: Crohns disease aggravated/going to restroom eight times a day; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease aggravated/going to restroom eight times a day) in a male patient of an unknown age 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.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE).   In 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free (1 in 1 wk). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (1 in 2 wk). On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease aggravated/going to restroom eight times a day) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, CROHN'S DISEASE (Crohns disease aggravated/going to restroom eight times a day) outcome was unknown and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. On unknown dates experienced non-serious Crohn's disease flare up, COVID-19 and going to restroom eight times a day with HUMIRA (ADALIMUMAB).  The reporter's causality for the event(s) Crohn's disease flare up and  going to restroom eight times a day with HUMIRA (ADALIMUMAB) was not provided. The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications information 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 male patient of an unknown age with relevant medical history Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohns disease aggravated), and unexpected, non-serious adverse event of special interest COVID-19 on unknown dates in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset date of events  were not available.  Patient experienced Crohn's disease flare up that was further described as going to the restroom eight times a day. Dose of Adalimumab was increased to once weekly from once every 2 weeks. Treatment and SARS-CoV-2 test were not reported for the event of COVID-19. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares while Adalimumab as an immunosuppressant, may slow down the immune system and lower the immune response to mRNA-1273 vaccine predisposing  to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age with relevant medical history Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohns disease aggravated), and unexpected, non-serious adverse event of special interest COVID-19 on unknown dates in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset date of events  were not available.  Patient experienced Crohn's disease flare up that was further described as going to the restroom eight times a day. Dose of Adalimumab was increased to once weekly from once every 2 weeks. Treatment and SARS-CoV-2 test were not reported for the event of COVID-19. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares while Adalimumab as an immunosuppressant, may slow down the immune system and lower the immune response to mRNA-1273 vaccine predisposing  to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.