Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
rapidly progressive upper MND from presumed PLS; rapidly progressive upper MND from presumed PLS; This literature-non-study case was reported in a literature article and describes the occurrence of MOTOR NEURONE DISEASE (rapidly progressive upper MND from presumed PLS) and UPPER MOTOR NEURONE LESION (rapidly progressive upper MND from presumed PLS) in a 67-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: Previously administered products included for COVID-19 vaccination: COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOTOR NEURONE DISEASE (rapidly progressive upper MND from presumed PLS) (seriousness criterion medically significant) and UPPER MOTOR NEURONE LESION (rapidly progressive upper MND from presumed PLS) (seriousness criterion medically significant). The patient was treated with Methylprednisolone (intravenous use) at a dose of 1 gram, (x5); Prednisone at a dose of 60 milligram once a day and Methotrexate sodium (Methotrexate) at a dose of 15 milligram once a week. At the time of the report, MOTOR NEURONE DISEASE (rapidly progressive upper MND from presumed PLS) and UPPER MOTOR NEURONE LESION (rapidly progressive upper MND from presumed PLS) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-GAD antibody: Negative. On an unknown date, Anti-neuronal antibody: (Negative) paraneoplastic including amphiphysin negative. On an unknown date, Antiacetylcholine receptor antibody: normal. On an unknown date, Antinuclear antibody: normal. On an unknown date, Blood copper: normal. On an unknown date, Blood folate: normal. On an unknown date, CSF cell count: 1 cells per high power field normal. On an unknown date, CSF glucose: 62 mg/dl. On an unknown date, CSF protein: 57 mg/dl. On an unknown date, Electromyogram: Three serial needle EMGs last performed 9 months from onset had no MND findings of fibrillations/fasciculations. On an unknown date, HIV test: normal. On an unknown date, HLA-B*27 assay: normal. On an unknown date, HTLV-1 test: human T lymphotropic virus type 1 was normal. On an unknown date, Lumbar puncture: normal. On an unknown date, Magnetic resonance imaging head: were serially repeated (x3) and at 9 months from onset imaging revealed T2 hyperintensity in corticospinal tracts, subcortical white matter, and precentral gyrus without enhancement. On an unknown date, Magnetic resonance imaging spinal: were serially repeated (x3) and at 9 months from onset imaging revealed T2 hyperintensity in corticospinal tracts, subcortical white matter, and precentral gyrus without enhancement. On an unknown date, Monoclonal immunoglobulin: Serum monoclonal proteins were normal. On an unknown date, Vitamin B12: normal. On an unknown date, Vitamin E: normal. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Patient developed progressive ascending stiffness 2 weeks after his second COVID-19 vaccination (Moderna mRNA-1273). He was without COVID 19 infection. At initial evaluation 4 months from onset, he had spastic dysarthria, dysphagia, and falls given whole limb quadriparesis. He could stand, but walking was unsafe. All reflexes were brisk including jaw jerk, Hoffman and Babinski signs, and ankle clonus. No fasciculations. Lyme was normal. Immunotherapy was attempted for possible COVID-19 vaccination immune mediated motor neuron disorders (MNDs). For MND methylprednisolone (x5), plasma exchange (x5), daily prednisone, methotrexate was given but was not beneficial and discontinued. At 10 months from onset with aspiration and oxygen desaturations, the patient chose hospice. Author concluded that this atypical case of rapidly progressive upper MND from presumed PLS expands knowledge of disease progression. The temporal association with COVID-19 vaccination was unclear.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Test Name: acetylcholine receptor antibodies; Result Unstructured Data: normal; Test Name: Glutamic acid decarboxylase 65; Test Result: Negative ; Test Name: amphiphysin; Test Result: Negative ; Test Name: antinuclear antibodies; Result Unstructured Data: normal; Test Name: copper; Result Unstructured Data: normal; Test Name: folate; Result Unstructured Data: normal; Test Name: total cells; Result Unstructured Data: Test Result:1 {cells}/[HPF];normal; Test Name: glucose; Test Result: 62 mg/dL; Test Name: protein; Test Result: 57 mg/dL; Test Name: EMGs; Result Unstructured Data: Three serial needle EMGs last performed 9 months from onset had no MND findings of fibrillations/fasciculations; Test Name: HIV; Result Unstructured Data: normal; Test Name: human leukocyte antigen B27; Result Unstructured Data: normal; Test Name: human T lymphotropic virus type 1; Result Unstructured Data: human T lymphotropic virus type 1 was normal; Test Name: Lumbar puncture; Result Unstructured Data: normal; Test Name: Brain MRI; Result Unstructured Data: were serially repeated (x3) and at 9 months from onset imaging revealed T2 hyperintensity in corticospinal tracts, subcortical white matter, and precentral gyrus without enhancement; Test Name: spine MRI; Result Unstructured Data: were serially repeated (x3) and at 9 months from onset imaging revealed T2 hyperintensity in corticospinal tracts, subcortical white matter, and precentral gyrus without enhancement; Test Name: Serum monoclonal proteins; Result Unstructured Data: Serum monoclonal proteins were normal; Test Name: B12; Result Unstructured Data: normal; Test Name: vitamin E; Result Unstructured Data: normal