Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Vaccination failure; Flu; COVID-19; Diverticulitis; Scoliosis; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 43-year-old female 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 Crohn's disease.    The patient's past medical history included Colectomy in October 2020. Concurrent medical conditions included Crohn's disease (moderate to severe).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant) and SCOLIOSIS (Scoliosis). In September 2021, the patient experienced COVID-19 (COVID-19). In October 2021, the patient experienced INFLUENZA (Flu). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure). At the time of the report, DIVERTICULITIS (Diverticulitis), COVID-19 (COVID-19) and INFLUENZA (Flu) had resolved and SCOLIOSIS (Scoliosis) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of scoliosis, diverticulitis, covid-19 positive and flu with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medications were reported.  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 concerns a 43-year-old, female patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Diverticulitis and an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Vaccination failure was noted in this case. Exact onset latency of the event diverticulitis relative to vaccination cannot be determined with an unknown event's onset date. Patient was COVID-19 positive approximately 6 months after receiving a 2nd dose of mRNA-1273 vaccine. She had influenza the following month after being COVID-19 positive. Reportedly, patient had rods in the back from scoliosis on an unknown date. Outcome of the events diverticulitis and COVID-19 was reported as resolved. Additional medical history included removal of her colon in 2020 and vaccination with a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying Crohn's disease and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 43-year-old, female patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Diverticulitis and an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Vaccination failure was noted in this case. Exact onset latency of the event diverticulitis relative to vaccination cannot be determined with an unknown event's onset date. Patient was COVID-19 positive approximately 6 months after receiving a 2nd dose of mRNA-1273 vaccine. She had influenza the following month after being COVID-19 positive. Reportedly, patient had rods in the back from scoliosis on an unknown date. Outcome of the events diverticulitis and COVID-19 was reported as resolved. Additional medical history included removal of her colon in 2020 and vaccination with a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying Crohn's disease and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.