Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Colitis ulcerative, Pain in extremity
Clinical narrative: Pain in arm; CONTRACTED COVID WHICH FELT ULCERATIVE COLITIS SYMPTOMS; CONTRACTED COVID WHICH FELT ULCERATIVE COLITIS SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (CONTRACTED COVID WHICH FELT ULCERATIVE COLITIS SYMPTOMS) in a 29-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 Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Apr-2022, the patient experienced COLITIS ULCERATIVE (CONTRACTED COVID WHICH FELT ULCERATIVE COLITIS SYMPTOMS) (seriousness criterion medically significant) and COVID-19 (CONTRACTED COVID WHICH FELT ULCERATIVE COLITIS SYMPTOMS). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, COLITIS ULCERATIVE (CONTRACTED COVID WHICH FELT ULCERATIVE COLITIS SYMPTOMS), COVID-19 (CONTRACTED COVID WHICH FELT ULCERATIVE COLITIS SYMPTOMS) and PAIN IN EXTREMITY (Pain in arm) had resolved.            No concomitant and treatment medications were reported.  Patient experienced symptoms chills, body aches and fatigue. Patient received booster dose. Reporters causality for all events of Humira drug was not 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 a 29-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Colitis ulcerative and unexpected non-serious AESI COVID-19 after receiving a dose of mRNA-1273 vaccine on an unknown date. Patient reported that second vaccine caused her chills, body aches and fatigue, contracted COVID which felt ulcerative colitis symptoms. Patient had received 3 doses of mRNA-1273 vaccine on unknown dates.  Clinical course and treatment details were not reported. The outcome of events was reported as resolved. Co-suspect Adalimumab for moderate to severe ulcerative colitis could be considered as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 29-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Colitis ulcerative and unexpected non-serious AESI COVID-19 after receiving a dose of mRNA-1273 vaccine on an unknown date. Patient reported that second vaccine caused her chills, body aches and fatigue, contracted COVID which felt ulcerative colitis symptoms. Patient had received 3 doses of mRNA-1273 vaccine on unknown dates.  Clinical course and treatment details were not reported. The outcome of events was reported as resolved. Co-suspect Adalimumab for moderate to severe ulcerative colitis could be considered as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.