Vaccine Adverse Events
The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
The purpose of VAERS is to detect possible signals of adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of US licensed vaccines.
Reports are welcome from all concerned individuals: patients, parents, health care providers, pharmacists and vaccine manufacturers.
FDA's VAERS overview page
Vaccine Adverse Event Reporting System Brochure(PDF - 376KB)
Published by HHS, FDA and CDC
Report a Vaccine Adverse Event
Department of Health and Human Services
Vaccine Adverse Event Reporting System (VAERS) Questions and Answers
FDA's Questions and Answers
Vaccine Adverse Event Reporting System (VAERS) Database Information
Basic information about data collection
Información en español acerca del Sistema para Reportar Reacciones Adversas a las Vacunas (VAERS)(PDF - 2.3MB)
VAERS information in Spanish
Understanding the Vaccine Adverse Event Reporting System (VAERS)(PDF - 868KB) Regulatory Submissions in Electronic Format for Biologic Products
Guidances & Rules
Vaccine Adverse Event Reporting; Revised Form VAERS-2; Withdrawal of Proposed Revised Form (Federal Register) - April 21, 2006 Vaccine Adverse Event Reporting System; Revised Form VAERS-2; Availability Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)(PDF - 63KB)
Dear Colleague Letter - Use of Haemophilus influenzae Conjugate Vaccines in Combination With DTaP in Infants
DTaP/Hib have not been licensed for combination use in the primary immunization series in infants