Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Faecaloma, Vaccination site pain
Clinical narrative: Fecal loading; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of FAECALOMA (Fecal loading) in a 69-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) 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 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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) Citrate Free, Solution for injection in pre-filled pen. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced FAECALOMA (Fecal loading) (seriousness criterion medically significant). At the time of the report, FAECALOMA (Fecal loading) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medication information was  provided. It was reported that on an unknown date, the patient experienced a lot of bowel build up in the colon and to do a colon cleanse/ was having diarrhea. In 2021, the patient experienced had sore arm and resolved.  It was reported that no known allergies.     It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication 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 is a spontaneous case, reported by a consumer, concerning a 69-year-old female patient with relevant medical condition of moderate to severe Crohn's disease, who experienced the unexpected serious (medically significant) event of Faecaloma, reported as fecal loading,  in the context of the three doses 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 28 days which falls within the recommended vaccine dosing schedule, prior to the third mRNA-1273 vaccination. It was reported that the patient experienced fecal build up in the colon and underwent colon cleansing procedure which resulted to post-procedural diarrhoea. Patient also experienced vaccination site pain post mRNA-1273 vaccination which resolved spontaneously. No further details about the diagnostic procedures were provided. It was reported that the event Faecaloma was resolving. The medical condition of moderate to severe Crohn's disease remains as a confounder for the event Faecaloma. 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 69-year-old female patient with relevant medical condition of moderate to severe Crohn's disease, who experienced the unexpected serious (medically significant) event of Faecaloma, reported as fecal loading,  in the context of the three doses 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 28 days which falls within the recommended vaccine dosing schedule, prior to the third mRNA-1273 vaccination. It was reported that the patient experienced fecal build up in the colon and underwent colon cleansing procedure which resulted to post-procedural diarrhoea. Patient also experienced vaccination site pain post mRNA-1273 vaccination which resolved spontaneously. No further details about the diagnostic procedures were provided. It was reported that the event Faecaloma was resolving. The medical condition of moderate to severe Crohn's disease remains as a confounder for the event Faecaloma. The benefit-risk relationship of mRNA-1273 is not affected by this report.