Changes to Vaccines Adverse Event Reporting System Form
The Centers for Disease Control and Prevention and the Food and Drug Administration are hoping that a new form for their jointly administered Vaccines Adverse Event Reporting System (VAERS) will improve reporting efficiency and data quality.
The Centers for Disease Control and Prevention and the Food and Drug Administration are hoping that a new form for their jointly administered Vaccines Adverse Event Reporting System (VAERS) will improve reporting efficiency and data quality.
The proposed VAERS 2.0 form, intended to replace the current VAERS-1 form used since 1990, offers standardized responses, clearer instructions and guidance, and improved online reporting, according to a Nov. 24 Federal Register notice. Questions also have been updated and reorganized to decrease reporting burdens.
Healthcare providers and vaccine manufacturers are required to submit VAERS reports, which CDC says serve as an early warning system in the federal vaccine safety infrastructure. Patients, parents and others aware of adverse events also are able to file VAERS reports. In recent years, VAERS has received approximately 30,000 reports annually.
The CDC is seeking public comment on the new VAERS form either through mail or electronically. The draft VAERS 2.0 form can be found here.
The proposed VAERS 2.0 form, intended to replace the current VAERS-1 form used since 1990, offers standardized responses, clearer instructions and guidance, and improved online reporting, according to a Nov. 24 Federal Register notice. Questions also have been updated and reorganized to decrease reporting burdens.
Healthcare providers and vaccine manufacturers are required to submit VAERS reports, which CDC says serve as an early warning system in the federal vaccine safety infrastructure. Patients, parents and others aware of adverse events also are able to file VAERS reports. In recent years, VAERS has received approximately 30,000 reports annually.
The CDC is seeking public comment on the new VAERS form either through mail or electronically. The draft VAERS 2.0 form can be found here.
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