Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fistula, Gastric disorder, Pyrexia, Surgery
Clinical narrative: Another fistula; Gastric disorder/Stomach issues; Diarrhea; patient had surgery; Fever/ran a fever after second covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (patient had surgery) in a 65-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 Rectovaginal fistula, Anal fistula and Drain placement (Drain tube was done as part of fistula treatment for vaginal rectal and colon). Concurrent medical conditions included Crohn's disease (moderate to severe adult crohn's disease).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-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 ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrte free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrte free and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrte free. In May 2021, the patient experienced PYREXIA (Fever/ran a fever after second covid-19 vaccine). In September 2021, the patient experienced SURGERY (patient had surgery). On an unknown date, the patient experienced FISTULA (Another fistula), GASTRIC DISORDER (Gastric disorder/Stomach issues) and DIARRHOEA (Diarrhea). The patient was treated with Surgery for Surgery. In May 2021, PYREXIA (Fever/ran a fever after second covid-19 vaccine) had resolved. At the time of the report, SURGERY (patient had surgery), FISTULA (Another fistula), GASTRIC DISORDER (Gastric disorder/Stomach issues) and DIARRHOEA (Diarrhea) had not resolved.            No concomitant medications were repoted. No treatment details were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality causality for humira(adalimumab) for the event(s) of ran a fever after second covid-19 vaccine, stomach issues and diarrhea was not provided.  The other mft opinion is that there is no reasonable possibility that the events of ran a fever after second covid-19 vaccine, stomach issues and diarrhea are related to humira(adalimumab).  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 65-year-old female patient with medical history of Crohn's disease and rectovaginal and anal fistulas, who experienced the unexpected, serious (medically significant) event of surgery. Further details regarding type of surgery have not been provided. The medical history of Crohn's disease and rectovaginal and anal fistulas are risk factors for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow up received on 28-Dec-2021 and included event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of Stomach issues" and diarrhea were added. On 28-Jan-2022: Follow up received on 28-Jan-2022 and incldued updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with medical history of Crohn's disease and rectovaginal and anal fistulas, who experienced the unexpected, serious (medically significant) event of surgery. Further details regarding type of surgery have not been provided. The medical history of Crohn's disease and rectovaginal and anal fistulas are risk factors for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.