Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Colitis ulcerative, Dyspnoea, Headache
Clinical narrative: ULCERATIVE COLITIS FLARE UP; Vaccination failure; FEVER; JOINT PAIN; COVID-19; HEADACHE; DIFFICULTY BREATHING; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) in a 49-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 Colitis ulcerative (Moderate to severe).   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In February 2022, the patient experienced DYSPNOEA (DIFFICULTY BREATHING) and HEADACHE (HEADACHE). On 20-Feb-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) (seriousness criterion medically significant), VACCINATION FAILURE (Vaccination failure), PYREXIA (FEVER) and ARTHRALGIA (JOINT PAIN). At the time of the report, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) and ARTHRALGIA (JOINT PAIN) had not resolved and DYSPNOEA (DIFFICULTY BREATHING), VACCINATION FAILURE (Vaccination failure), COVID-19 (COVID-19), HEADACHE (HEADACHE) and PYREXIA (FEVER) outcome was unknown.            Concomitant Drugs Not Reported. treatment information was provided. 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 is a Spontaneous case reported by a consumer, concerning a 49-year-old male patient, with relevant medical condition of colitis ulcerative, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as ulcerative colitis flare up), and the unexpected and non-serious AESI of COVID-19. Colitis ulcerative occurred on an unknown date after the first dose of mRNA-1273 vaccine, and COVID-19 occurred approximately 9 months after the second dose of mRNA-1273 vaccine, administered in an appropriate schedule. Hence, Vaccination failure is noted. Co-suspect product included non-company product Adalimumab for colitis ulcerative. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, Colitis ulcerative had not resolved and COVID-19 outcome was unknown. Colitis ulcerative can present relapses as part of the natural history of disease, so that confounds the case.  The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 49-year-old male patient, with relevant medical condition of colitis ulcerative, who experienced the unexpected and serious (due to medically significant) event of Colitis ulcerative (reported as ulcerative colitis flare up), and the unexpected and non-serious AESI of COVID-19. Colitis ulcerative occurred on an unknown date after the first dose of mRNA-1273 vaccine, and COVID-19 occurred approximately 9 months after the second dose of mRNA-1273 vaccine, administered in an appropriate schedule. Hence, Vaccination failure is noted. Co-suspect product included non-company product Adalimumab for colitis ulcerative. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, Colitis ulcerative had not resolved and COVID-19 outcome was unknown. Colitis ulcerative can present relapses as part of the natural history of disease, so that confounds the case.  The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.