Vaccine Safety

Vaers1

Public and professional confidence in vaccination depends on accurate understanding of the risks as well as the benefits of vaccines so that patients, clinicians, and policy makers can make informed decisions regarding their use. Rigorous post-marketing surveillance systems are needed to identify rare adverse effects that might not have come to light during the initial studies that led to vaccine approval as well as to better quantify the risk of known adverse effects when vaccines are used in general practice. The goal of ESP:VAERS  is to leverage electronic health record (EHR) systems to improve the security of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS).

The EHR Support for Public Health (ESP) surveillance platform has been expanded to create a generalizable, EHR-based, VAERS detection and reporting system. In particular, we have developed algorithms to prospectively monitor vaccinated patients for novel diagnoses, changes in biochemical values, allergies, and suggestive medication prescriptions that might indicate a possible adverse reaction to vaccination.  When possible events are found, ESP classifies them as Category 1 (Reported automatically if clinician does not respond) or Category 2 (Requires clinican approval). ESP then sends the patient’s clinician a secure electronic message embedded in existing workflows that describes the purported event and invites the clinician to affirm or refute the event, add comments, and submit an automated, pre-populated electronic case report. . Adverse event reports are then securely transferred to the national VAERS repository as electronic messages in a secure, interoperable health data exchange format (HL7).