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

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 potent...

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Bibliographic Details
Published in:	American journal of epidemiology 2018-06, Vol.187 (6), p.1269-1276
Main Authors:	Yih, W Katherine, Maro, Judith C, Nguyen, Michael, Baker, Meghan A, Balsbaugh, Carolyn, Cole, David V, Dashevsky, Inna, Mba-Jonas, Adamma, Kulldorff, Martin
Format:	Article
Language:	eng
Subjects:	Adolescent Adult Cellulitis Child Classification Complications Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - etiology Emergency medical services Emergency Service, Hospital - statistics & numerical data Evaluation Female Human papillomavirus Humans Immunization Incidence Inpatients - statistics & numerical data Male Papillomaviridae - immunology Papillomavirus Infections - prevention & control Papillomavirus Infections - virology Papillomavirus Vaccines - adverse effects Practice of Epidemiology Research design Risk Factors Safety Sentinel Surveillance Sentinel system Statistical analysis Time Factors United States - epidemiology Vaccination Vaccines Young Adult
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Summary:	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.
ISSN:	0002-9262 1476-6256