Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting

Clin Infect Dis. 2015 Sep 15;61(6):864-70. doi: 10.1093/cid/civ430. Epub 2015 Jun 9.


Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting.

Methods: ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values, and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the MetroHealth System, an integrated healthcare system in Ohio. We queried the VAERS database to determine MetroHealth's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS.

Results: In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2%) messages, responded to 209 (15.1%), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95% confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period.

Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS.

Keywords: adverse event; adverse reaction; immunization; reporting; vaccine.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems*
  • Aged
  • Aged, 80 and over
  • Child
  • Child, Preschool
  • Decision Support Systems, Clinical*
  • Drug-Related Side Effects and Adverse Reactions / diagnosis*
  • Female
  • Health Services Research
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Middle Aged
  • Ohio
  • Risk Management*
  • Vaccines / administration & dosage
  • Vaccines / adverse effects*
  • Young Adult


  • Vaccines