Sex: F
Vaccine: COVID19
Symptoms: CSF test, Magnetic resonance imaging head, Multiple sclerosis
Clinical narrative: Multiple sclerosis; This literature-non-study case was reported in a literature article and describes the occurrence of MULTIPLE SCLEROSIS (Multiple sclerosis) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     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,  after starting mRNA-1273 (Spikevax), the patient experienced MULTIPLE SCLEROSIS (Multiple sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (Multiple sclerosis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CSF test: Oligoclonal bands was observed. and further analysis of her spinal fluid showed highly elevated IgG antibodies to the S1-RBD.. On an unknown date, Magnetic resonance imaging head: Two lesions on her brain and a C4 enhancing lesion on her spinal cord was observed..     For mRNA-1273 (Spikevax) (Unknown), the reporter considered MULTIPLE SCLEROSIS (Multiple sclerosis) to be related.    No concomitant medications were reported.  Patient began to hiccup and vomit, developed diplopia, and right-side weakness and numbness around two days post-second dose of the Moderna 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 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 an unknown age with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Multiple sclerosis on an unknown date after receiving mRNA-1273 vaccine given as second dose in the COVID-19 vaccination series.  Onset latency could not be established as date of vaccination and date of onset of event were not reported. Patient began to hiccup and vomit, and developed diplopia, right-side weakness, and numbness two days after vaccination for which a clinical neurological evaluation was carried out. Magnetic resonance imaging showed two lesions on her brain and a C4 enhancing lesion on her spinal cord. Cerebrospinal fluid CSF showed oligoclonal bands. However, further analysis of her spinal fluid showed highly elevated IgG antibodies to the spike protein subunit S1 receptor binding domain S1-RBD. Patient was then diagnosed with multiple sclerosis and was clinically improving.  Author stated that the presence of CSF antibodies to the S1- RBD protein suggests an immune response to the mRNA COVID-19 vaccinations crossing over to the central nervous system CNS as the likely cause of these neurological complications. No information on the first dose of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The event seriousness as assessed as per medical judgement.  This case was linked to MOD-2022-610681 (Linked Report).; Sender's Comments: This literature non-study case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Multiple sclerosis on an unknown date after receiving mRNA-1273 vaccine given as second dose in the COVID-19 vaccination series.  Onset latency could not be established as date of vaccination and date of onset of event were not reported. Patient began to hiccup and vomit, and developed diplopia, right-side weakness, and numbness two days after vaccination for which a clinical neurological evaluation was carried out. Magnetic resonance imaging showed two lesions on her brain and a C4 enhancing lesion on her spinal cord. Cerebrospinal fluid CSF showed oligoclonal bands. However, further analysis of her spinal fluid showed highly elevated IgG antibodies to the spike protein subunit S1 receptor binding domain S1-RBD. Patient was then diagnosed with multiple sclerosis and was clinically improving.  Author stated that the presence of CSF antibodies to the S1- RBD protein suggests an immune response to the mRNA COVID-19 vaccinations crossing over to the central nervous system CNS as the likely cause of these neurological complications. No information on the first dose of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The event seriousness as assessed as per medical judgement. MOD-2022-610681:Same Article, Patient 1