Abstract
BackgroundSince 2020, over 250 million doses of mRNA-based SARS-CoV-2 vaccines have been administered in the United States and hundreds of millions worldwide between the Pfizer-BioNTech and Moderna SARS-CoV-2 vaccines. To date, there have been rare reports associating mRNA-based SARS-CoV-2 vaccines with episodes of inflammatory and autoimmune CNS disorders. We report a case series of five patients with new-onset neurological disorders of inflammatory or immunological origin temporally associated with these vaccines.MethodsA case-series of five patients within a single 23-hospital health system who developed new-onset CNS inflammatory disease within 2 weeks of receiving a dose of an mRNA-based SARS-CoV-2 vaccine.ResultsFive cases of post-vaccination CNS disorders of immune origin (fatal ADEM; n = 1, new-onset NMOSD; n = 2, new-clinical onset MS-like syndrome but with preexisting clinically silent mild demyelination; n = 1, meningoencephalitis; n = 1) observed within 2 weeks of inoculation with either the first or second dose of mRNA-based SARS-CoV-2 vaccines (Moderna = 3, Pfizer = 2).DiscussionTo our knowledge, these are among the emerging cases of CNS adverse events of immunological or inflammatory origin. These findings should be interpreted with great caution as they neither prove a mechanistic link nor imply a potential long-term increased risk in post-vaccination CNS autoimmunity. Larger prospective studies assessing the potential association between mRNA-based vaccination and the development of neurological adverse events of suspected immune origin, particularly among those with underlying CNS or systemic autoimmune disorders, are needed. The use of mRNA-based SARS-CoV-2 vaccines should continue to be strongly encouraged given their high efficacy in overcoming this pandemic.
Highlights
Several vaccines have been temporally associated with central nervous system (CNS) inflammatory events, including monophasic disorders like acute disseminated encephalomyelitis (ADEM) [1], or exacerbations of chronic conditions like neuromyelitis optica spectrum disorder (NMOSD) [2, 3], and multiple sclerosis (MS) [4, 5], there have not been any reports mechanistically linking mRNA-based SAR-CoV-2 vaccines to a higher rate of inflammatory or autoimmune CNS disease.ADEM is a rare, typically monophasic, CNS inflammatory disease that commonly occurs after a viral infection, including instances associated with SARS-CoV-2 infection [6, 7]
We report five cases of clinically new-onset CNS events of suspected immune origin (ADEM; n = 1, NMOSD; n = 2, MS-like syndome; n = 1, meningoencephalitis; n = 1) that were temporally associated with mRNA-based SARS-CoV-2
Vaccines have been available, data limited to a single hospital system, as well as the retrospective nature of the study. These are among the emerging cases of CNS adverse events of suggested immunological or inflammatory origin that occurred within 2 weeks of inoculation with an mRNA-based SARS-CoV-2 vaccine
Summary
Several vaccines have been temporally associated with central nervous system (CNS) inflammatory events, including monophasic disorders like acute disseminated encephalomyelitis (ADEM) [1], or exacerbations of chronic conditions like neuromyelitis optica spectrum disorder (NMOSD) [2, 3], and multiple sclerosis (MS) [4, 5], there have not been any reports mechanistically linking mRNA-based SAR-CoV-2 vaccines to a higher rate of inflammatory or autoimmune CNS disease.ADEM is a rare, typically monophasic, CNS inflammatory disease that commonly occurs after a viral infection, including instances associated with SARS-CoV-2 infection [6, 7]. NMOSD relapses have been associated with multiple infections, including SARS-CoV-2 infections [8, 9], and several case reports have suggested a temporal association between NMOSD relapses and various vaccines such as the influenza, tetanus diphtheria and pertussis, human papilloma virus, pneumococcal, hepatitis A, hepatitis B, typhoid, yellow fever, and Japanese encephalitis vaccines [2, 3]. Since post-marketing vaccination against SARS-CoV-2 began in 2020, there have been isolated reports of CNS autoimmunity, including one case of ADEM following the inactivated BBIBPCorV SARS-CoV-2 vaccine in China [10]. We report five separate cases of CNS autoimmunity and inflammatory pathologies that occurred in previously healthy individuals shortly following the administration of mRNA-based SARS-CoV-2 vaccines at a single health system in the greater New York City area. There have been rare reports associating mRNA-based SARS-CoV-2 vaccines with episodes of inflammatory and autoimmune CNS disorders. We report a case series of five patients with new-onset neurological disorders of inflammatory or immunological origin temporally associated with these vaccines
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