Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test, Sinus disorder, Stoma creation, Stomatitis
Clinical narrative: STOMAS; SUSCEPTIBLE TO HEAT; SINUS ISSUES; NOT FEELING GOOD; BAD PROBLEMS WITH TEETH; HIGH INFLAMMATION IN ORAL CAVITY; DENTAL PAIN; the patient experienced FELT LIKE MINI COVID EPISODE; This spontaneous case was reported by a consumer and describes the occurrence of STOMA CREATION (STOMAS) in a 47-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) for Crohn's disease.    The patient's past medical history included COVID-19. Concurrent medical conditions included Crohn's disease.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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) Solution for injection in pre-filled pen. In 2021, the patient experienced SUSPECTED COVID-19 (the patient experienced FELT LIKE MINI COVID EPISODE). On an unknown date, the patient experienced STOMA CREATION (STOMAS) (seriousness criterion medically significant), TEMPERATURE INTOLERANCE (SUSCEPTIBLE TO HEAT), SINUS DISORDER (SINUS ISSUES), MALAISE (NOT FEELING GOOD), TOOTH DISORDER (BAD PROBLEMS WITH TEETH), STOMATITIS (HIGH INFLAMMATION IN ORAL CAVITY) and TOOTHACHE (DENTAL PAIN). At the time of the report, STOMA CREATION (STOMAS), TEMPERATURE INTOLERANCE (SUSCEPTIBLE TO HEAT), STOMATITIS (HIGH INFLAMMATION IN ORAL CAVITY) and SUSPECTED COVID-19 (the patient experienced FELT LIKE MINI COVID EPISODE) outcome was unknown and SINUS DISORDER (SINUS ISSUES), MALAISE (NOT FEELING GOOD), TOOTH DISORDER (BAD PROBLEMS WITH TEETH) and TOOTHACHE (DENTAL PAIN) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive. On an unknown date, SARS-CoV-2 test: (Negative) Negative.         No concomitant medications were reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  In December 2020, The patient was positive covid. Patient thought that she had covid took a test and it was negative. Patient did not took Humira because she thought she had covid. After received covid vaccine patient felt like she had a mini covid episode, 2nd covid vaccine the reaction was not as bad.  The reporter causality for the events of stomas, susceptible to heat, high inflammation in oral cavity, covid positive and felt like mini covid episode was not provided. the reporter's causality for the events of sinus issues, not feeling good, bad problems with teeth and dental pain with Humira(adalimumab) was a reasonable possibility.  No treatment medications were reported.  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 47-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of stoma creation, and non-serious event of suspected COVID-19 (AESI). The events occurred an unknown time after the first dose of mRNA-1273. Medical history of Crohn's disease could be a plausible alternative explanation for stoma creation. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 47-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of stoma creation, and non-serious event of suspected COVID-19 (AESI). The events occurred an unknown time after the first dose of mRNA-1273. Medical history of Crohn's disease could be a plausible alternative explanation for stoma creation. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.