Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Haemoglobin, Intestinal sepsis, Large intestine perforation
Clinical narrative: Intestinal sepsis; Perforated colon; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL SEPSIS (Intestinal sepsis) and LARGE INTESTINE PERFORATION (Perforated colon) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In December 2020, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced INTESTINAL SEPSIS (Intestinal sepsis) (seriousness criteria hospitalization, medically significant and life threatening) and LARGE INTESTINE PERFORATION (Perforated colon) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on sometime in December 2021 due to INTESTINAL SEPSIS and LARGE INTESTINE PERFORATION. At the time of the report, INTESTINAL SEPSIS (Intestinal sepsis) and LARGE INTESTINE PERFORATION (Perforated colon) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Haemoglobin: dropped to 4, decreased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. On Dec-2021 the patient had terrible gut pain and went to the hospital. They diagnosed her with sepsis and her colon perforated. They had to do emergency surgery and she had to go back since her Hemoglobin dropped to 4. Patient was 40 days in hospital from hole in colon with sepsis and loss of Blood. Patient agreed to have physician contacted. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.  CC: This spontaneous case concerns a 64-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with upadacitinib, who experienced the unexpected, medically significant, and life-threatening events of Large intestine perforation and Intestinal sepsis in association with a 3rd dose of mRNA-1273 vaccine. All the events led to the patient's hospitalization. Exact onset latency of the events perforated colon and intestinal sepsis relative to vaccination cannot be determined with unspecified events' onset dates and vaccination dates. Approximately 4 months after vaccination, patient had a terrible gut pain that prompted hospitalization. She was diagnosed with colon perforated and sepsis. Hemoglobin level dropped to 4 (unspecified unit). An emergency surgery was done. Patient stayed in the hospital for 40 days. Outcome of all the events was reported as not resolved. Vaccination history included a 2-dose primary series and a 3rd dose of mRNA-1273 vaccine. Treatment with upadacitinib remains a confounder in this case. 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 64-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with upadacitinib, who experienced the unexpected, medically significant, and life-threatening events of Large intestine perforation and Intestinal sepsis in association with a 3rd dose of mRNA-1273 vaccine. All the events led to the patient's hospitalization. Exact onset latency of the events perforated colon and intestinal sepsis relative to vaccination cannot be determined with unspecified events' onset dates and vaccination dates. Approximately 4 months after vaccination, patient had a terrible gut pain that prompted hospitalization. She was diagnosed with colon perforated and sepsis. Hemoglobin level dropped to 4 (unspecified unit). An emergency surgery was done. Patient stayed in the hospital for 40 days. Outcome of all the events was reported as not resolved. Vaccination history included a 2-dose primary series and a 3rd dose of mRNA-1273 vaccine. Treatment with upadacitinib remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.