Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Crohn's disease, Pneumonia, Pyrexia
Clinical narrative: Crohn's Incident; Fever of 101 to 102 degrees; Pneumonia; Contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's Incident) and PNEUMONIA (Pneumonia) in a 53-year-old male 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.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In September 2021, the patient experienced COVID-19 (Contracted COVID-19). In November 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's Incident) (seriousness criteria hospitalization and medically significant) and PYREXIA (Fever of 101 to 102 degrees). The patient was hospitalized for 5 days due to CROHN'S DISEASE. At the time of the report, CROHN'S DISEASE (Crohn's Incident) outcome was unknown and PNEUMONIA (Pneumonia), COVID-19 (Contracted COVID-19) and PYREXIA (Fever of 101 to 102 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Fever of 101 to 102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was hospitalized for five days due to Crohn's incident. Patient was not absorbing Humira as much as hoped and his fever of 101 to 102 degrees after taking covid vaccination. Patient also contracted covid-19 in Sep 2021 and developed pneumonia in Nov 2021 and Dec 2021.  No concomitant medications were reported. 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 is a spontaneous case, reported by a consumer, concerning a 53-year-old male patient with relevant medical condition of moderate to severe adult Crohn's disease treated with Adalimumab, who experienced the unexpected serious (hospitalization and medically significant) event of Crohn's disease reported as Crohn's incident, unexpected serious (medically significant) event of Pneumonia, and unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor the exact event onset date were provided. It was reported that the patient was hospitalized for five days due to Crohn's incident and had a fever of 101 to 102 degrees after receiving COVID-19 vaccination. No further details about the diagnostic procedures and treatments were provided. Outcome of the event Crohn's disease was unknown, while the other events have resolved. The medical condition of moderate to severe adult Crohn's disease remains as a confounder for Crohn's incident. The co-suspect drug Adalimumab, which is an immunosuppressant, could increased the patient's susceptibility to have COVID-19 infection and Pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 53-year-old male patient with relevant medical condition of moderate to severe adult Crohn's disease treated with Adalimumab, who experienced the unexpected serious (hospitalization and medically significant) event of Crohn's disease reported as Crohn's incident, unexpected serious (medically significant) event of Pneumonia, and unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor the exact event onset date were provided. It was reported that the patient was hospitalized for five days due to Crohn's incident and had a fever of 101 to 102 degrees after receiving COVID-19 vaccination. No further details about the diagnostic procedures and treatments were provided. Outcome of the event Crohn's disease was unknown, while the other events have resolved. The medical condition of moderate to severe adult Crohn's disease remains as a confounder for Crohn's incident. The co-suspect drug Adalimumab, which is an immunosuppressant, could increased the patient's susceptibility to have COVID-19 infection and Pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report.