Sex: F
Vaccine: COVID19
Symptoms: Influenza, Myelopathy
Clinical narrative: Cervical disc disorder with myelopathy; Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of MYELOPATHY (Cervical disc disorder with myelopathy) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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.    Concurrent medical conditions included Crohn's disease (Moderate to Severe Adult Crohn's Disease).   In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen. On an unknown date, the patient experienced MYELOPATHY (Cervical disc disorder with myelopathy) (seriousness criterion medically significant) and INFLUENZA (Flu symptoms). The patient was treated with Surgery (Spinal surgery and plate put into lumbar four and five) for Myelopathy. At the time of the report, MYELOPATHY (Cervical disc disorder with myelopathy) and INFLUENZA (Flu symptoms) had resolved.            No medical history was reported. Concomitant product use was not provided by the reporter. The patient had cervical disc disorder with myelopathy and had spinal surgery and plate put into lumbar four and five. No pain afterwards. Patient got covid booster in Oct-2022 and felt like she was coming down with a cold or flu. Treatment medication was not provided. The reporter's causality for the events of Cervical disc disorder with myelopathy and Flu symptoms with Humira (Adalimumab) solution for injection was reported as not provided. The other manufacturer's causality with Humira (Adalimumab) solution for injection for the event of Cervical disc disorder with myelopathy was reported as no reasonable possibility and for the event Flu symptoms was reported as not assessable. The other manufacturer's alternative etiology for cervical disc disorder with myelopathy with Humira (Adalimumab) solution for injection was more likely related to musculoskeletal manifestation of underlying Crohn's disease.   Reporter did not allow further contact  Company Comment: This is a spontaneous case, reported by a consumer, concerning  an adult female patient with relevant medical condition of Moderate to Severe Crohn's Disease treated with Adalimumab, who experienced the unexpected serious (medically significant) event Myelopathy, reported as cervical disc disorder with myelopathy, in the context of a dose of mRNA-1273.222 as booster dose of COVID-19 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. It was reported that the patient had flu symptoms and cervical disc disorder with myelopathy. Patient underwent spinal surgery and placement of plate into the fourth and fifth lumbar area. It was reported that the alternative etiology for cervical disc disorder with myelopathy was more likely related to musculoskeletal manifestation of underlying Crohn's disease. No further details about the clinical course, diagnostic procedures and medical treatments were provided. It was reported that the events have resolved. The medical condition of Moderate to Severe Crohn's Disease treated with the co-suspect drug Adalimumab remain as confounders for the event. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning  an adult female patient with relevant medical condition of Moderate to Severe Crohn's Disease treated with Adalimumab, who experienced the unexpected serious (medically significant) event Myelopathy, reported as cervical disc disorder with myelopathy, in the context of a dose of mRNA-1273.222 as booster dose of COVID-19 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. It was reported that the patient had flu symptoms and cervical disc disorder with myelopathy. Patient underwent spinal surgery and placement of plate into the fourth and fifth lumbar area. It was reported that the alternative etiology for cervical disc disorder with myelopathy was more likely related to musculoskeletal manifestation of underlying Crohn's disease. No further details about the clinical course, diagnostic procedures and medical treatments were provided. It was reported that the events have resolved. The medical condition of Moderate to Severe Crohn's Disease treated with the co-suspect drug Adalimumab remain as confounders for the event. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.