Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal infection, Sepsis
Clinical narrative: Sepsis; Gastrointestinal infection; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis) and GASTROINTESTINAL INFECTION (Gastrointestinal infection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 002B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Colostomy. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE and HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) for Rheumatoid arthritis.   In August 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant) and GASTROINTESTINAL INFECTION (Gastrointestinal infection) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Aug-2021 due to GASTROINTESTINAL INFECTION and SEPSIS. At the time of the report, SEPSIS (Sepsis) and GASTROINTESTINAL INFECTION (Gastrointestinal infection) had not resolved.            Patient was admitted for 7 days and 8 inches of her colon was removed. The symptom Severe pain in gut has been subsumed under the event of Gastrointestinal infection.  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.  No treatment medication reported by reporter.  Company Comment: This is a spontaneous case, reported by a consumer, concerning a 68-year-old female patient with current medications of Adalimumab and Methotrexate, who was hospitalized due to the unexpected serious (medically significant) events of Sepsis and Gastrointestinal infection, which occurred 121 days after receiving the second dose of mRNA-1273 vaccine. 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. After the first vaccination, patient had flu, joint pain, rheumatoid flare-up, body pain which were resolved. It was reported that the patient was hospitalized due to severe abdominal pain and infection was found in the colon. Patient underwent colostomy with removal of eight inches of colon. No further details about the diagnostic procedures and treatment medications were provided. It was reported that the events Sepsis and Gastrointestinal infection were not resolved. The medications Adalimumab and Methotrexate, which are immunosuppressants, increase the susceptibility of patient to acquire infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623208 (Patient Link).; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 68-year-old female patient with current medications of Adalimumab and Methotrexate, who was hospitalized due to the unexpected serious (medically significant) events of Sepsis and Gastrointestinal infection, which occurred 121 days after receiving the second dose of mRNA-1273 vaccine. 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. After the first vaccination, patient had flu, joint pain, rheumatoid flare-up, body pain which were resolved. It was reported that the patient was hospitalized due to severe abdominal pain and infection was found in the colon. Patient underwent colostomy with removal of eight inches of colon. No further details about the diagnostic procedures and treatment medications were provided. It was reported that the events Sepsis and Gastrointestinal infection were not resolved. The medications Adalimumab and Methotrexate, which are immunosuppressants, increase the susceptibility of patient to acquire infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.