Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Colitis ulcerative, Dyspnoea, Headache
Clinical narrative: ULCERATIVE COLITIS FLARE; Shortness of breath; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE) in a 58-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.    Concurrent medical conditions included Ulcerative colitis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced DYSPNOEA (Shortness of breath), CHILLS (Chills) and HEADACHE (Headache). In August 2021, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE) (seriousness criterion medically significant). In 2021, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE), DYSPNOEA (Shortness of breath), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of CHILLS, HEADACHE and SHORTNESS OF BREATH was not provided. The reporter's causality for the events of ULCERATIVE COLITIS FLARE and HUMIRA TREATMENT NOT CONTROLING ULCERATIVE COLLITIS SYMPTOMS with HUMIRA(ADALIMUMAB) was a reasonable possibility.  In Aug 2021, it was reported that the HUMIRA TREATMENT NOT CONTROLING ULCERATIVE COLLITIS SYMPTOMS and was reported to be resolved in 2021.  No treatment medication was 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 58-year-old male patient with relevant medical history of Ulcerative colitis, who experienced the unexpected, serious  (medically significant) event of Colitis ulcerative (reported as Ulcerative colitis flare) approximately 4 months after receiving the  first dose of mRNA-1273 vaccine.  Patient was treated with Adalimumab which was reported as not controlling the symptoms.  Outcome of the event was reported as resolved. No information on any other doses of COVID-19 vaccination was provided. Ulcerative colitis could be considered a confounder as it is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 58-year-old male patient with relevant medical history of Ulcerative colitis, who experienced the unexpected, serious  (medically significant) event of Colitis ulcerative (reported as Ulcerative colitis flare) approximately 4 months after receiving the  first dose of mRNA-1273 vaccine.  Patient was treated with Adalimumab which was reported as not controlling the symptoms.  Outcome of the event was reported as resolved. No information on any other doses of COVID-19 vaccination was provided. Ulcerative colitis could be considered a confounder as it is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.