Health Care Providers Health care providers are subject to the adverse event reporting provisions of the National Childhood Vaccine Injury Act (NCVIA). This act mandates the reporting of the following events: - Any event set forth in the Reportable Events Table that occurs within the time period specified.
- Any event listed in the manufacturer's package insert as a contraindication to subsequent doses of the vaccine.
There are no penalties specified in the law for health care providers who do not report adverse events. However, FDA takes active steps to educate physicians, nurses and other health care workers about the importance of reporting adverse vaccine events. Vaccine Manufacturers Under FDA regulations [21 CFR, Subpart D - Reporting of Adverse Experiences, Section 600.80] and the Vaccine Adverse Event Reporting System (VAERS), licensed vaccine manufacturers must report to FDA adverse experience information. FDA has a number of enforcement options at its disposal that can be used if a vaccine manufacturer fails to establish and maintain records, and report adverse events under VAERS. If a manufacturer were to fail to report an adverse event, FDA would warn the firm that it is out of compliance with the law. FDA also would examine the firm's total compliance situation and take further action according to the severity of the reporting violation. If necessary, FDA has the authority to revoke a manufacturer's biological product license for a vaccine. | 
