Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Skin mass
Clinical narrative: knot on nose, head inside ears and on torso; severe Ulcerative colitis after covid-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (severe Ulcerative colitis after covid-19 vaccination) in a 46-year-old male patient who received mRNA-1273 (Spikevax) 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 an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen. In 2022, the patient experienced COLITIS ULCERATIVE (severe Ulcerative colitis after covid-19 vaccination) (seriousness criterion medically significant). On an unknown date, the patient experienced SKIN MASS (knot on nose, head inside ears and on torso). At the time of the report, COLITIS ULCERATIVE (severe Ulcerative colitis after covid-19 vaccination) and SKIN MASS (knot on nose, head inside ears and on torso) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication information provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment information provided.  Company comment: This spontaneous case concerns a 46-years-old male patient, with concurrent medical condition of ulcerative colitis that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected, serious (medically significant) event of Colitis ulcerative (severe Ulcerative colitis after covid-19 vaccination) and a non-serious event of Skin mass (knot on nose, head inside ears and on torso). The event occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The concurrent medical condition of Ulcerative colitis remains a confounder to the event's Ulcerative colitis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 46-years-old male patient, with concurrent medical condition of ulcerative colitis that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected, serious (medically significant) event of Colitis ulcerative (severe Ulcerative colitis after covid-19 vaccination) and a non-serious event of Skin mass (knot on nose, head inside ears and on torso). The event occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The concurrent medical condition of Ulcerative colitis remains a confounder to the event's Ulcerative colitis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.