Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Fatigue, Pain in extremity
Clinical narrative: CROHN'S DISEASE FLARE UP/STOMACH PRESSURE/ TROUBLE PASSING GAS/ SWELLING IN STOMACH CAUSING PAIN; ARM PAIN; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHN'S DISEASE FLARE UP/STOMACH PRESSURE/ TROUBLE PASSING GAS/ SWELLING IN STOMACH CAUSING PAIN) in an adult 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) solution for injection for Crohn's disease.    No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, received second 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. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate free. On an unknown date, the patient experienced CROHN'S DISEASE (CROHN'S DISEASE FLARE UP/STOMACH PRESSURE/ TROUBLE PASSING GAS/ SWELLING IN STOMACH CAUSING PAIN) (seriousness criterion medically significant), PAIN IN EXTREMITY (ARM PAIN) and FATIGUE (FATIGUE). At the time of the report, CROHN'S DISEASE (CROHN'S DISEASE FLARE UP/STOMACH PRESSURE/ TROUBLE PASSING GAS/ SWELLING IN STOMACH CAUSING PAIN) had not resolved and PAIN IN EXTREMITY (ARM PAIN) and FATIGUE (FATIGUE) outcome was unknown.            No concomitant product use was reported.  On unknown dates, the patient experienced STOMACH PRESSURE, TROUBLE PASSING GAS and SWELLING IN STOMACH CAUSING PAIN.  Formulation of Humira was reported as Solution for injection in pre-filled pen. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. Humira (Adalimumab) was citrate free.  No treatment information was provided.  The reporter's causality for the event of crohn's disease flare up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality with Humira (Adalimumab) for the events of stomach pressure, trouble passing gas and swelling in stomach causing pain was not provided. The reporter's causality for the events of arm pain and fatigue with Humira (Adalimumab) was no reasonable possibility.  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 an adult male patient of an unknown age, with no reported medical, who experienced the unexpected, serious (medically significant) event of Crohn's disease (reported as Crohn's disease flare up) on an unknown date after receiving a dose of mRNA-1273 vaccine and co-suspect Adalimumab.  Patient received 1st and 2nd dose of mRNA-1273 vaccine 29 days apart. The onset date of event was not provided. Patient experienced Crohn's flare up with stomach pressure sensation, trouble passing gas, and swelling abdomen. The outcome of the event was reported as not resolved. Adalimumab for Crohn's disease remains a confounder as the disease can have flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient of an unknown age, with no reported medical, who experienced the unexpected, serious (medically significant) event of Crohn's disease (reported as Crohn's disease flare up) on an unknown date after receiving a dose of mRNA-1273 vaccine and co-suspect Adalimumab.  Patient received 1st and 2nd dose of mRNA-1273 vaccine 29 days apart. The onset date of event was not provided. Patient experienced Crohn's flare up with stomach pressure sensation, trouble passing gas, and swelling abdomen. The outcome of the event was reported as not resolved. Adalimumab for Crohn's disease remains a confounder as the disease can have flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.