Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, COVID-19, Colitis ulcerative, Pain
Clinical narrative: COVID-19; Colitis ulcerative aggravated; Pain; Anal incontinence; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and COLITIS ULCERATIVE (Colitis ulcerative aggravated) in a 52-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) solution for injection for Ulcerative colitis.    The patient's past medical history included Sleep apnea. Concurrent medical conditions included Asthma and Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In September 2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). In January 2022, the patient experienced ANAL INCONTINENCE (Anal incontinence). On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant) and PAIN (Pain). At the time of the report, COVID-19 (COVID-19) and COLITIS ULCERATIVE (Colitis ulcerative aggravated) had resolved, ANAL INCONTINENCE (Anal incontinence) had not resolved and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had medical history of lung casting. Concomitant drugs not reported. The patient had covid in Sep-2021 and was in the hospital for five and half days. He had stopped Humira during this period. He had resumed injections. He still had fatigue, decreased taste senses, and residual breathing issues. He had a flare during the Fall. He had increased frequency and pain. The patient had Leaky anus this symptom since Jan-2022. No treatment information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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 concerning a 52-year-old male patient with medical history of ulcerative colitis, who experienced the unexpected, serious (hospitalization) adverse event of special interest of COVID-19 and the unexpected, serious (medically significant) event of Colitis ulcerative, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The events had resolved at the time of the report. Medical history of ulcerative colitis remains a risk factor for the event Colitis ulcerative. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Significant follow up received updated event information.; Sender's Comments: This is a spontaneous case concerning a 52-year-old male patient with medical history of ulcerative colitis, who experienced the unexpected, serious (hospitalization) adverse event of special interest of COVID-19 and the unexpected, serious (medically significant) event of Colitis ulcerative, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The events had resolved at the time of the report. Medical history of ulcerative colitis remains a risk factor for the event Colitis ulcerative. The benefit-risk relationship of mRNA-1273 is not affected by this report.