Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Colitis ulcerative, Condition aggravated
Clinical narrative: Colitis ulcerative aggravated; Condition aggravated; COVID-19; Condition aggravated; Colitis ulcerative aggravated; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of COLITIS ULCERATIVE (Colitis ulcerative aggravated) and the second episode of COLITIS ULCERATIVE (Colitis ulcerative aggravated) in a 26-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 22-Mar-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) 1 in 1 wk. In March 2021, the patient experienced the first episode of COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant) and the first episode of CONDITION AGGRAVATED (Condition aggravated). In September 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced the second episode of COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant) and the second episode of CONDITION AGGRAVATED (Condition aggravated). The last dose administered for ADALIMUMAB (HUMIRA) was on 22-Mar-2021. In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, last episode of COLITIS ULCERATIVE (Colitis ulcerative aggravated) and the last episode of CONDITION AGGRAVATED (Condition aggravated) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. No concomitant medications were reported. No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 26-year-old male patient, with relevant medical condition of colitis ulcerative, who experienced the unexpected and serious (due to medically significant) events of Colitis ulcerative (2 episodes reported as colitis ulcerative aggravated), and the unexpected and non-serious AESI of COVID-19. One episode occurred on an unknown date related to the first dose of mRNA-1273 vaccine, and the other episode occurred the same month after the first dose of mRNA-1273 vaccine. COVID-19 occurred approximately 6 months after the same dose of mRNA.1273 vaccine. 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, one episode of colitis ulcerative had resolved, and the other one was resolving. Colitis ulcerative can present relapses as part of the natural history of the disease, so that confounds the case.  The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Live Significant follow-up appended(Dose date updated). adding current condition. New event added.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 26-year-old male patient, with relevant medical condition of colitis ulcerative, who experienced the unexpected and serious (due to medically significant) events of Colitis ulcerative (2 episodes reported as colitis ulcerative aggravated), and the unexpected and non-serious AESI of COVID-19. One episode occurred on an unknown date related to the first dose of mRNA-1273 vaccine, and the other episode occurred the same month after the first dose of mRNA-1273 vaccine. COVID-19 occurred approximately 6 months after the same dose of mRNA.1273 vaccine. 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, one episode of colitis ulcerative had resolved, and the other one was resolving. Colitis ulcerative can present relapses as part of the natural history of the disease, so that confounds the case.  The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.