Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Cystitis
Clinical narrative: SYMPTOMS OF CROHN'S DISEASE/DIARRHEA/ FATIGUE; BLADDER INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (SYMPTOMS OF CROHN'S DISEASE/DIARRHEA/ FATIGUE) in an elderly 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 Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis (Moderate-to-severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate-free. On an unknown date, the patient experienced CROHN'S DISEASE (SYMPTOMS OF CROHN'S DISEASE/DIARRHEA/ FATIGUE) (seriousness criterion medically significant) and CYSTITIS (BLADDER INFECTION). At the time of the report, CROHN'S DISEASE (SYMPTOMS OF CROHN'S DISEASE/DIARRHEA/ FATIGUE) and CYSTITIS (BLADDER INFECTION) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  Formulation of Humira was reported as Solution for injection in pre-filled pen.  The reporter's causality for the events of SYMPTOMS OF CROHN'S DISEASE, FATIGUE AFTER BOOSTER COVID-19,DIARRHEA and BLADDER INFECTION was not provided.  No treatment medication were reported.  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 elderly, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of Crohn's disease and the unexpected, non-serious event of cystitis. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving the booster dose of the mRNA-1273 vaccine. Of note, the administration date of Humira, the vaccination date of the booster dose of the mRNA-1273 vaccine and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced symptoms of Crohn's disease (diarrhea, fatigue) and bladder infection. Treatment information was not provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of Crohn's disease and the unexpected, non-serious event of cystitis. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving the booster dose of the mRNA-1273 vaccine. Of note, the administration date of Humira, the vaccination date of the booster dose of the mRNA-1273 vaccine and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced symptoms of Crohn's disease (diarrhea, fatigue) and bladder infection. Treatment information was not provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.