Sex: F
Vaccine: COVID19
Symptoms: Immunology test, Magnetic resonance imaging head, Multiple sclerosis, Myelitis transverse
Clinical narrative: transverse myelitis; Multiple sclerosis; This literature-non-study case was reported in a literature article and describes the occurrence of MYELITIS TRANSVERSE (transverse myelitis) and MULTIPLE SCLEROSIS (Multiple sclerosis) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (transverse myelitis) (seriousness criterion medically significant) and MULTIPLE SCLEROSIS (Multiple sclerosis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (transverse myelitis) and MULTIPLE SCLEROSIS (Multiple sclerosis) was resolving. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Immunology test: Highly elevated IgG levels against the spike protein receptor-binding domain  of COVID 19 was observed.. On an unknown date, Magnetic resonance imaging head: An enhancing thoracic cord lesion was observed..     For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYELITIS TRANSVERSE (transverse myelitis) and MULTIPLE SCLEROSIS (Multiple sclerosis) to be related.    No concomitant medications were reported.  Patient developed left-side numbness and difficulty walking six weeks post-second dose of the Moderna mRNA COVID-19 vaccine.  Clinical neurological evaluation, MRI imaging of brain and spine as well as serum and cerebrospinal fluid (CSF) analysis was performed.  Patient was diagnosed with transverse myelitis and possible multiple sclerosis   Author noted that the patient likely would have received long-term immunosuppressive therapy and had vaccine complications that had not been suspected. The presence of CSF antibodies to the S1- RBD protein suggests an immune response to the mRNA COVID-19 vaccinations crossing over to the CNS as the likely cause of these neurological complications.  Patient was clinically improving and would continue to be managed by a neurologist.  Company comment: This literature non study case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected, serious (medically significant) AESI of Transverse Myelitis and Multiple sclerosis, unknown days after receiving the 2 dose of mRNA-1273 vaccine. Patient developed left-side numbness and difficulty walking 6 weeks post-2 dose. Immunology test showed Highly elevated IgG levels against the spike protein receptor-binding domain (S1- RBD) of COVID 19, MRI head revealed an enhancing thoracic cord lesion. Patient was diagnosed with transverse myelitis and possible multiple sclerosis. Author noted that the patient likely would have received long-term immunosuppressive therapy and had the vaccine complications that had not been suspected.  The presence of CSF antibodies to the S1- RBD protein suggested an immune response to the mRNA COVID-19 vaccinations crossing over to the CNS. The events were resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-610730 (Linked Report).; Sender's Comments: This literature non study case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected, serious (medically significant) AESI of Transverse Myelitis and Multiple sclerosis, unknown days after receiving the 2 dose of mRNA-1273 vaccine. Patient developed left-side numbness and difficulty walking 6 weeks post-2 dose. Immunology test showed Highly elevated IgG levels against the spike protein receptor-binding domain (S1- RBD) of COVID 19, MRI head revealed an enhancing thoracic cord lesion. Patient was diagnosed with transverse myelitis and possible multiple sclerosis. Author noted that the patient likely would have received long-term immunosuppressive therapy and had the vaccine complications that had not been suspected.  The presence of CSF antibodies to the S1- RBD protein suggested an immune response to the mRNA COVID-19 vaccinations crossing over to the CNS. The events were resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-610730:Same Article, Patient 2