Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Diverticulitis, Vaccination site pain
Clinical narrative: Diverticulitis; COVID 19 vaccine caused arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 73-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) injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second 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) Solution for injection in pre-filled pen. In 2021, the patient experienced VACCINATION SITE PAIN (COVID 19 vaccine caused arm pain at injection site). On an unknown date, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant). At the time of the report, DIVERTICULITIS (Diverticulitis) had not resolved and VACCINATION SITE PAIN (COVID 19 vaccine caused arm pain at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: Diverticulitis was reported..         No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not 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 73-year-old male patient with relevant medical condition of moderate to severe adult Crohn's disease, who experienced the unexpected serious (medically significant) event of Diverticulitis, confirmed by a colonoscopy, in the context of a 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 30 days which falls within the recommended vaccine dosing schedule. No further details about the clinical course and treatments were provided. It was reported that the event Diverticulitis was not resolved. The medical condition of moderate to severe Crohn's disease could be a risk factor for Diverticulitis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 73-year-old male patient with relevant medical condition of moderate to severe adult Crohn's disease, who experienced the unexpected serious (medically significant) event of Diverticulitis, confirmed by a colonoscopy, in the context of a 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 30 days which falls within the recommended vaccine dosing schedule. No further details about the clinical course and treatments were provided. It was reported that the event Diverticulitis was not resolved. The medical condition of moderate to severe Crohn's disease could be a risk factor for Diverticulitis. The benefit-risk relationship of mRNA-1273 is not affected by this report.