Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Diverticulum
Clinical narrative: Diverticulitis; Diverticulosis; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis (treated with Humira on ??-JUN-2021 ).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 22-Sep-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 experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant) and DIVERTICULUM (Diverticulosis). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AMOXICILLIN & CLAVULANIC ACID) at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis) and DIVERTICULUM (Diverticulosis) had not resolved.            No concomitant product was provided.  The reporter causality for all the events with Humira was not provided.  It was reported that on unknown dates patient experienced DEATHLY SICK, DIVERTICULITIS and DIVERTICULUM.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment: This spontaneous case concerns an elderly female patient on the 6th decade of life, with treatment of Adalimumab (Humira) but no reported relevant medical history, who experienced the non-serious Diverticulum (reported as Diverticulosis) with occurrence of the unexpected, serious (medically significant) event of Diverticulitis. The serious event was diagnosed on an unspecified date after completion of mRNA-1273 vaccination as primary series and as first booster dose. Presenting symptoms, disease course and diagnostic procedures conducted were not provided in the case. The patient was treated with AMOXICILLIN/CLAVULANIC ACID for an unspecified duration, although the reported outcome is still Not Resolved. The co-suspect Adalimumab remains a confounder for the diverticulitis and was discontinued on an unknown date, after events onset. Additionally, the elderly age of the patient could be considered a risk factor to developing the diverticular diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient on the 6th decade of life, with treatment of Adalimumab (Humira) but no reported relevant medical history, who experienced the non-serious Diverticulum (reported as Diverticulosis) with occurrence of the unexpected, serious (medically significant) event of Diverticulitis. The serious event was diagnosed on an unspecified date after completion of mRNA-1273 vaccination as primary series and as first booster dose. Presenting symptoms, disease course and diagnostic procedures conducted were not provided in the case. The patient was treated with AMOXICILLIN/CLAVULANIC ACID for an unspecified duration, although the reported outcome is still Not Resolved. The co-suspect Adalimumab remains a confounder for the diverticulitis and was discontinued on an unknown date, after events onset. Additionally, the elderly age of the patient could be considered a risk factor to developing the diverticular diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report.