{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T23:37:09Z","timestamp":1790897829801,"version":"4.1.0"},"reference-count":40,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,9,23]],"date-time":"2022-09-23T00:00:00Z","timestamp":1663891200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Annals of Neurology"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Transverse myelitis (TM) has recently been associated by health authorities with Ad26.COV2.S (Janssen\/Johnson &amp; Johnson), one of the 5 US Food and Drug Administration (FDA) or European Medicines Agency (EMA) labeled severe acute respiratory syndrome\u2010coronavirus 2 (SARS\u2010CoV\u20102) vaccines. It is unknown whether a similar association exists for the other FDA or EMA labeled SARS\u2010CoV\u20102 vaccines (BNT162b2 [Pfizer\/BioNTech], mRNA\u20101273 [Moderna], ChAdOx1nCov\u201019 [Oxford\u2013AstraZeneca], and NVX\u2010CoV2373 [Novavax]). This study aimed to evaluate the association between SARS\u2010CoV\u20102 vaccine class and TM.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This observational, cross\u2010sectional, pharmacovigilance cohort study examined individual case safety reports from VigiBase, the World Health Organization's pharmacovigilance database. We first conducted a disproportionality analysis with the information component (IC) using the reports of TM that occurred within 28\u2009days following exposure to the FDA or EMA labeled SARS\u2010CoV\u20102 vaccines, from December 1, 2020 (first adverse event related to a SARS\u2010CoV\u20102 vaccine) to March 27, 2022. Second, we analyzed the clinical features of SARS\u2010CoV\u20102 vaccine\u2010associated TM cases reported in VigiBase.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>TM was significantly associated both with the messenger ribonucleic acid (mRNA)\u2010based (n\u00a0=\u00a0364; IC<jats:sub>025<\/jats:sub>\u00a0=\u00a00.62) and vector\u2010based (n\u00a0=\u00a0136; IC<jats:sub>025<\/jats:sub>\u00a0=\u00a00.52) SARS\u2010CoV\u20102 vaccines that are authorized by the FDA or the EMA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Findings from this observational, cross\u2010sectional pharmacovigilance study showed that mRNA\u2010based and vector\u2010based FDA\/EMA labeled SARS\u2010CoV\u20102 vaccines can be associated with TM. However, because TM remains a rare event, with a previously reported rate of 0.28 cases per 1 million vaccine doses, the risk\u2013benefit ratio in favor of vaccination against SARS\u2010CoV\u20102 virus remains unchallenged. Rather, this study suggests that clinicians should consider the diagnosis of TM in patients presenting with early signs of spinal cord dysfunction after SARS\u2010CoV\u20102 vaccination. 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