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# Vaccine Electronic Safety Report Info
- URL: https://www.fdaweb.com/vaccine-electronic-safety-report-info/
- Published: 2020-11-19T12:00:00.000Z
- Updated: 2026-09-14T16:37:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148130

FDA has posted a page to give vaccine product manufacturers information about electronically submitting postmarket individual case safety reports to the Vaccine Adverse Events Reporting System (VAERS). The [notice](https://www.fda.gov/industry/about-esg/cber-vaccine-icsr-implementation?ref=fdaweb.com) says CBER has implemented the International Council on Harmonization’s Individual Case Study Report specification to support electronic reporting of vaccine postmarketing safety reports as specified in a 6/10/14 Electronic Safety Reporting Rule. Electronic submission of vaccine reports to FDA in this format has been operational since 2015, the notice says.

In 6/2020, CBER implemented a new version of VAERS reporting elements as described in the updated technical specifications document and business rules included with the notice.