Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System

W. Katherine Yih*, Judith C. Maro, Michael Nguyen, Meghan A. Baker, Carolyn Balsbaugh, David V. Cole, Inna Dashevsky, Adamma Mba-Jonas, Martin Kulldorff

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

16 Citations (Scopus)

Abstract

The self-controlled tree-temporal scan statistic - a new signal-detection method - can evaluate whether any of a wide variety of health outcomes are temporally associated with receipt of a specific vaccine, while adjusting for multiple testing. Neither health outcomes nor postvaccination potential periods of increased risk need be prespecified. Using US medical claims data in the Food and Drug Administration's Sentinel system, we employed the method to evaluate adverse events occurring after receipt of quadrivalent human papillomavirus vaccine (4vHPV). Incident outcomes recorded in emergency department or inpatient settings within 56 days after first doses of 4vHPV received by 9- through 26.9-year-olds in 2006-2014 were identified using International Classification of Diseases, Ninth Revision, diagnosis codes and analyzed by pairing the new method with a standard hierarchical classification of diagnoses. On scanning diagnoses of 1.9 million 4vHPV recipients, 2 statistically significant categories of adverse events were found: cellulitis on days 2-3 after vaccination and "other complications of surgical and medical procedures" on days 1-3 after vaccination. Cellulitis is a known adverse event. Clinically informed investigation of electronic claims records of the patients with "other complications" did not suggest any previously unknown vaccine safety problem. Considering that thousands of potential short-term adverse events and hundreds of potential risk intervals were evaluated, these findings add significantly to the growing safety record of 4vHPV.

Original languageEnglish
Pages (from-to)1269-1276
Number of pages8
JournalAmerican Journal of Epidemiology
Volume187
Issue number6
DOIs
Publication statusPublished - 1 Jun 2018
Externally publishedYes

Bibliographical note

Funding Information:
W.K.Y. and J.C.M. contributed equally to this paper and are co–primary authors. This work was funded by the Food and Drug Administration through Department of Health and Human Services Mini-Sentinel contract HHSF223200910006I.

Funding Information:
This work was funded by the Food and Drug Administration through Department of Health and Human ServicesMini-Sentinel contract HHSF223200910006I.

Publisher Copyright:
© The Author(s) 2018. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.

Keywords

  • data mining
  • epidemiologic research design
  • human papillomavirus recombinant vaccine quadrivalent, types 6, 11, 16, 18
  • papillomavirus vaccines
  • vaccination

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