Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Vaccination site pain
Clinical narrative: VACCINE CAUSED SORE ARM; ULCERATIVE COLITIS FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) in a 63-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.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM). At the time of the report, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) had not resolved and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) had resolved.            No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of VACCINATION SITE PAIN and COLITIS ULCERATIVE with Humira was not provided.  No 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 spontaneous case reported by a consumer, concerns a female patient of unknown age, with no relevant medical history, who experienced the unexpected, serious (medically significant) event of colitis ulcerative ((ULCERATIVE COLITIS FLARE UP) unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with the non serious event of vaccination site pain. Patient had previously received the 2 primary doses with Moderna vaccine with no adverse events reported. It was reported that the patient received  Adalimumab for Ulcerative colitis, which is a confounder for the event. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment were reported. The event had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a female patient of unknown age, with no relevant medical history, who experienced the unexpected, serious (medically significant) event of colitis ulcerative ((ULCERATIVE COLITIS FLARE UP) unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with the non serious event of vaccination site pain. Patient had previously received the 2 primary doses with Moderna vaccine with no adverse events reported. It was reported that the patient received  Adalimumab for Ulcerative colitis, which is a confounder for the event. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment were reported. The event had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.