Background Transverse myelitis (TM) has recently been associated by health authorities with Ad26.COV2.S (Janssen/Johnson & Johnson), one of the 5 US Food and Drug Administration (FDA) or European Medicines Agency (EMA) labeled severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2) vaccines. It is unknown whether a similar association exists for the other FDA or EMA labeled SARS‐CoV‐2 vaccines (BNT162b2 [Pfizer/BioNTech], mRNA‐1273 [Moderna], ChAdOx1nCov‐19 [Oxford–AstraZeneca], and NVX‐CoV2373 [Novavax]). This study aimed to evaluate the association between SARS‐CoV‐2 vaccine class and TM. Methods This observational, cross‐sectional, 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 days following exposure to the FDA or EMA labeled SARS‐CoV‐2 vaccines, from December 1, 2020 (first adverse event related to a SARS‐CoV‐2 vaccine) to March 27, 2022. Second, we analyzed the clinical features of SARS‐CoV‐2 vaccine‐associated TM cases reported in VigiBase. Results TM was significantly associated both with the messenger ribonucleic acid (mRNA)‐based (n = 364; IC 025 = 0.62) and vector‐based (n = 136; IC 025 = 0.52) SARS‐CoV‐2 vaccines that are authorized by the FDA or the EMA. Conclusions Findings from this observational, cross‐sectional pharmacovigilance study showed that mRNA‐based and vector‐based FDA/EMA labeled SARS‐CoV‐2 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–benefit ratio in favor of vaccination against SARS‐CoV‐2 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‐CoV‐2 vaccination. ANN NEUROL 2022

Aims Due to their central mechanism of action, antiseizure medications (ASMs) could lead to adverse effects likely to impair driving skills. Their extended use to neuropsychiatric disorders makes it a class of drugs to monitor for their road traffic accidental (RTA) potential. We aimed to assess the reporting association between ASMs and RTAs using the World Health Organization pharmacovigilance database (VigiBase). Methods We performed a disproportionality analysis to compute adjusted reporting odds ratios to evaluate the strength of reporting association between ASMs and RTAs. A univariate analysis using the reporting odds‐ratio was used to assess drug–drug interactions between ASMs and RTAs. Results There were 1 341 509 reports associated with at least 1 ASM in VigiBase of whom 2.91‰ were RTAs reports. Eight ASMs were associated with higher reporting of RTAs compared to others (ranging from 1.35 [95% confidence interval 1.11–1.64] for lamotrigine to 4.36 [95% confidence interval 3.56–5.32] for cannabis). Eight significant drug–drug interactions were found between ASMs and the onset of RTA, mainly involving CYP450 induction. Conclusion A significant safety signal between RTAs and some ASMs was identified. Association of several ASMs might further increase the occurrence of RTA. ASMs prescription in patients with identified risk factors of RTA should be considered with caution. Study number: http://ClinicalTrials.gov, NCT04480996.