Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Back pain, Colitis ulcerative, Headache, Musculoskeletal stiffness, Stress
Clinical narrative: Colitis ulcerative aggravated/stress caused frequency on ulcerative colitis patient and ulcerative colitis flare up with HUMIRA.; Stress/Stress caused frequency on ulcerative colitis patient; Back stiffness; Back pain; Headache/Pain with headache; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated/stress caused frequency on ulcerative colitis patient and ulcerative colitis flare up with HUMIRA.) in a 54-year-old 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) for Ulcerative colitis.    There was no reported medical history.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Back stiffness), BACK PAIN (Back pain) and HEADACHE (Headache/Pain with headache). On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated/stress caused frequency on ulcerative colitis patient and ulcerative colitis flare up with HUMIRA.) (seriousness criterion medically significant) and STRESS (Stress/Stress caused frequency on ulcerative colitis patient). In 2021, MUSCULOSKELETAL STIFFNESS (Back stiffness), BACK PAIN (Back pain) and HEADACHE (Headache/Pain with headache) had resolved. At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated/stress caused frequency on ulcerative colitis patient and ulcerative colitis flare up with HUMIRA.) had not resolved and STRESS (Stress/Stress caused frequency on ulcerative colitis patient) outcome was unknown.            Concomitant drugs information not reported.  It was reported that second dose of Moderna vaccine caused back stiffness and pain with headache, stress caused frequency on ulcerative colitis patient and ulcerative colitis flare up with humira (adalimumab). On an unknown dates, the patient experienced stress caused frequency on ulcerative colitis patient and ulcerative colitis flare up.  In 2021, the second dose of Moderna vaccine caused back stiffness and pain with headache resolved. Moderna covid-19 vaccine (Elasomeran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment drugs information were provided.  Company comment: This spontaneous case concerns a 54-year-old male patient with no reported medical history who experienced the unexpected serious (medically significant) event of Colitis ulcerative (Colitis ulcerative aggravated) which occurred unknown days after the administration of second dose of mRNA-1273 vaccine in COVID 19 vaccination series. Co-suspected drug adalimumab remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 54-year-old male patient with no reported medical history who experienced the unexpected serious (medically significant) event of Colitis ulcerative (Colitis ulcerative aggravated) which occurred unknown days after the administration of second dose of mRNA-1273 vaccine in COVID 19 vaccination series. Co-suspected drug adalimumab remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.