Pharmacovigilance signal detection of central nervous system demyelinating diseases following human papillomavirus vaccination: data mining and signal analysis based on the VAERS database.
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The HPV vaccine, as a key tool for the prevention of cervical cancer and related diseases, has shown a rising trend in its vaccination rate year after year. Along with the increase in its vaccination rate, the related adverse events have also received widespread attention. This study employs real-world data to identify potential reporting signals between HPV vaccination and central nervous system demyelinating diseases using rigorous data analysis. This study is based on the HPV vaccination data of the US Vaccine Adverse Event Reporting System (VAERS) up to January 1, 2025. Four pharmacovigilance methodologies were integratively applied with Bonferroni-adjusted significance testing to detect disproportional reporting signals potentially related to HPV immunization and central nervous system demyelinating diseases. Meanwhile, differences in different population characteristics were assessed by subgroup analysis. In addition, the pattern of change in the incidence of adverse events over time after vaccination was explored using time-to-evocation analysis and Weber distribution analysis. This investigation systematically analyzed 60,840 human papillomavirus (HPV) immunization-associated adverse event reports within the Vaccine Adverse Event Reporting System (VAERS) database, and it was found that non-infectious myelitis and encephalomyelitis showed significant disproportional reporting signals (including transverse myelitis, optic nerve myelitis, acute disseminated encephalomyelitis, and white matter encephalomyelitis). Negative signals were observed for the remaining diseases within the central nervous system demyelinating disease spectrum. Subgroup analysis revealed positive signals for adverse events in female populations and in those within the FDA-recommended vaccination age range. Furthermore, the results of the Weibull distribution analysis exhibited an early-onset pattern, where the incidence of these diseases decreased significantly over time following vaccination. A positive disproportionality reporting signal of non-infectious myelitis and encephalomyelitis following HPV vaccination was observed in the VAERS database. The findings reflect potential reporting differences across populations and time intervals after vaccination. These results highlight the importance of sustained pharmacovigilance and the need for further epidemiological investigations to clarify whether this reporting signal corresponds to a true clinical association.