Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method

Pharmacoepidemiol Drug Saf. 2018 Apr;27(4):391-397. doi: 10.1002/pds.4397. Epub 2018 Feb 15.


Purpose: The objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY-D using the tree-temporal scan statistic in the Vaccine Safety Datalink population and demonstrate the feasibility of this method in a large distributed safety data setting.

Methods: Traditional pharmacovigilance techniques used in vaccine safety are generally geared to detecting AEs based on pre-defined sets of conditions or diagnoses. Using a newly developed tree-temporal scan statistic data mining method, we performed a pilot study to evaluate the safety profile of the meningococcal conjugate vaccine Menactra® (MenACWY-D), screening thousands of potential AE diagnoses and diagnosis groupings. The study cohort included enrolled participants in the Vaccine Safety Datalink aged 11 to 18 years who had received MenACWY-D vaccination(s) between 2005 and 2014. The tree-temporal scan statistic was employed to identify statistical associations (signals) of AEs following MENACWY-D at a 0.05 level of significance, adjusted for multiple testing.

Results: We detected signals for 2 groups of outcomes: diseases of the skin and subcutaneous tissue, fever, and urticaria. Both groups are known AEs following MENACWY-D vaccination. We also identified a statistical signal for pleurisy, but further examination suggested it was likely a false signal. No new MENACWY-D safety concerns were raised.

Conclusions: As a pilot study, we demonstrated that the tree-temporal scan statistic data mining method can be successfully applied to screen broadly for a wide range of vaccine-AE associations within a large health care data network.

Keywords: Bell's palsy; Menactra; adverse events; pharmacoepidemiology; post-licensure.

MeSH terms

  • Adolescent
  • Child
  • Cohort Studies
  • Data Mining / methods*
  • Databases, Factual / statistics & numerical data*
  • Electronic Health Records / statistics & numerical data
  • Female
  • Humans
  • Male
  • Meningococcal Vaccines / administration & dosage
  • Meningococcal Vaccines / adverse effects*
  • Pharmacovigilance*
  • Pilot Projects
  • Software
  • Vaccination / adverse effects*
  • Vaccination / methods


  • MenACWY-D vaccine
  • Meningococcal Vaccines