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Using Electronic Medical Records to Enhance Detection and Reporting of Vaccine Adverse Events

^a Department of Ambulatory Care and Prevention
^b Harvard Medical School
^c Harvard Pilgrim Health Care
^d Department of Pediatrics
^e Harvard Vanguard Medical Associates.

^_* Correspondence: Virginia L. Hinrichsen, Dept. of Ambulatory Care and Prevention, 133 Brookline Ave. Boston, MA 02215 (Email: Virginia_Hinrichsen{at}HarvardPilgrim.org).

Received for publication: 07/31/06; accepted for publication: 07/26/07.

We implemented an automated vaccine adverse event surveillance and reporting system based in an ambulatory electronic medical record to improve underreporting and incomplete reporting that prevails in spontaneous systems. This automated system flags potential vaccine adverse events for the clinician when a diagnosis is entered, prompts clinicians to consider the vaccine as a cause of the condition, and facilitates reporting of suspected adverse events to the Vaccine Adverse Event Reporting System (VAERS).

During five months, a total of 33,420 vaccinations were administered during 14,466 encounters. There were 5,914 follow-up contacts by vaccinees within 14 days of the vaccination visits; 686 (11.6%) generated an alert. Clinicians submitted VAERS reports for 23 of these (0.69 per 1,000 vaccine doses), which is almost 6 times the dose-based reporting rate to VAERS.¹ Clinician surveys indicated that it took a minimal amount of time to respond to the alerts. Of those who felt that an alert corresponded to an actual vaccine adverse event, the majority used the reporting feature to file a VAERS report.

We believe that elicited surveillance via real time prompts to clinicians holds substantial promise. By coupling simplified reporting with the initial prompt, clinicians can consider and report a vaccine adverse event electronically in a few moments during the office visit.