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.
- VAERS Overview
FDA's VAERS overview page
- Vaccine Adverse Event Reporting System Brochure
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)
VAERS information in Spanish
- Understanding the Vaccine Adverse Event Reporting System (VAERS)
- 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)
- Dear Colleague Letter - Use of Haemophilus influenzae Conjugate Vaccines in Combination With DTaP in Infants - ARCHIVED
DTaP/Hib have not been licensed for combination use in the primary immunization series in infants
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