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CBER Vaccine ICSR Implementation

This page provides vaccine product manufacturers with information about electronically submitting postmarket individual case safety reports (ICSRs) for vaccines to the Vaccine Adverse Event Reporting System (VAERS).  CBER has implemented the International Council on Harmonisation’s (ICH) E2B(R3) Individual Case Safety Report (ICSR) specification to support electronic reporting of vaccine postmarketing safety reports as specified in the Electronic Safety Reporting Rule published June 10, 2014. See the rule at: https://www.federalregister.gov/documents/2014/06/10/2014-13480/postmarketing-safety-reports-for-human-drug-and-biological-products-electronic-submission

Electronic submission of vaccine reports in ICH E2B (R3) format has been in operation since 2015.  CBER  implemented (in June 2020) a new version of VAERS reporting elements, as described in the updated Technical Specifications document and Business Rules (Version 2.1 initially posted May 2019), provided below.  This new version supports adverse event reporting for combination product vaccines as required in the “Postmarketing Safety Reporting for Combination Products” rule, published in December 2016.  This version also incorporates various updates and clarifications of the Business Rules identified since electronic submissions to VAERS began in 2015. 

Instructions for manufacturers to begin reporting to VAERS, or to transition from the original reporting format to the updated version, are provided here: Getting Started with ICSR Submission to FDA's electronic Vaccine Adverse Event Reporting System (eVAERS)

VAERS Electronic Reporting Resources:

  • Appendix II to the FDA ICH E2B(R3) Technical Specifications Document for Vaccine Reporting Version 2.1:   XML Instance Examples
    • Scenario 1:  Manufacturer submits a vaccine report containing 3 vaccines that does not include any combination products.  There was an Adverse Event. VAERS2020Scenario1.xml
    • Scenario 2:  Manufacturer submits a vaccine report that includes 3 vaccines, one of which is a combination product.  There was an Adverse Event, but NO malfunction:  VAERS2020Scenario2.xml
    • Scenario 3:  Manufacturer submits a report that includes a vaccine that is a combination product.   There was a malfunction, but no Adverse Event.    Vaccine was administered to a patient.   VAERS2020Scenario3.xml
    • Scenario 4:  Manufacturer submits a report that includes a vaccine which is a combination product.  There was a malfunction, but no Adverse Event.  No patient was involved.   VAERS2020Scenario4.xml
    • Scenario 5:  Manufacturer submits a report that includes a vaccine which is a combination product.   There was an Adverse Event AND a malfunction. VAERS2020Scenario5.xml
    • Scenario 6:  A minimal example containing the basic elements for an Adverse Event report, no combination product.  VAERS2020Scenario6.xml
    • Scenario 7:  A minimal example containing the basic elements for an Adverse Event report, with a combination product, no malfunction. VAERS2020Scenario7.xml
    • Scenario 8:  A minimal example containing the basic elements for a Malfunction only report, no patient.  VAERS2020Scenario8.xml
    • Scenario 9:  A mega instance file, containing all elements. VAERS2020Scenario9.xml
    • Scenario 10:  An example containing a “similar device” malfunction scenario for a device component.  VAERS2020Scenario10.xml

Information about Postmarketing Safety Reporting for Combination Products, including the Rule, associated Guidance for Industry and Staff, and Compliance Policy, is available at: https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products

ATTENTION: In order to accommodate development timelines for stakeholders, FDA will continue to receive ICSR reports in the original (i.e., Version 1.0) format for the foreseeable future.  Previously published technical specifications and business rules for the original version are still available at CBER Vaccine ICSR (Legacy) Implementation

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