Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gastroenteritis bacterial
Clinical narrative: ENTERITIS CAUSED BY EATING SOMETHING WITH BACTERIA; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS BACTERIAL (ENTERITIS CAUSED BY EATING SOMETHING WITH BACTERIA) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced GASTROENTERITIS BACTERIAL (ENTERITIS CAUSED BY EATING SOMETHING WITH BACTERIA) (seriousness criterion hospitalization). The patient was hospitalized on sometime in September 2021 due to GASTROENTERITIS BACTERIAL. In 2021, GASTROENTERITIS BACTERIAL (ENTERITIS CAUSED BY EATING SOMETHING WITH BACTERIA) had resolved.            No concomitant medication was reported.   The patient experienced enteritis and was hospitalized for it in September 2021. She stated that the event was caused by eating something with bacteria. She was treated and released from hospital. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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 concerns a 62-year-old female patient, with no reported medical history, who experienced the unexpected serious (hospitalization) event of Gastroenteritis bacterial (reported as enteritis caused by eating something with bacteria) after receiving the 2nd dose of mRNA-1273 vaccine and co-suspect drug Risankizumab for moderate to severe chronic plaque psoriasis (start date not reported). Approximately 3 months post-vaccination, patient had enteritis, was hospitalized, treated, and was then discharged. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. Co-suspect drug Risankizumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 62-year-old female patient, with no reported medical history, who experienced the unexpected serious (hospitalization) event of Gastroenteritis bacterial (reported as enteritis caused by eating something with bacteria) after receiving the 2nd dose of mRNA-1273 vaccine and co-suspect drug Risankizumab for moderate to severe chronic plaque psoriasis (start date not reported). Approximately 3 months post-vaccination, patient had enteritis, was hospitalized, treated, and was then discharged. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. Co-suspect drug Risankizumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as serious based on medical judgement.