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          CBER Vaccine ICSR ImplementationAbout ESG CBER Vaccine ICSR Implementation
  
  	
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    PrintThis 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 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:**

ICH E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files
	Electronic Vaccine Adverse Event Reporting System (eVAERS) Guidance
	Postmarketing Safety Reporting for Combination Products siteFDA ICH E2B(R3) Regional Technical Specifications Document for Vaccine Reporting Version 2.3: Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRs) for VaccinesAppendix I to the FDA ICH E2B(R3) Technical Specifications Document for Vaccine Reporting Version 2.3  eVAERS Business Rules DocumentAppendix II to the FDA ICH E2B(R3) Technical Specifications Document for Vaccine Reporting Version 2.3:   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.xmlInformation 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: ICSR reports in the original (i.e., Version 1.0) format are no longer accepted. Contact CBERICSRsubmissions@fda.hhs.gov to begin reporting in Version 2 format, which has been in place since June 2020 and is described above.

                                                                                  Content current as of:
      01/04/2024
              
              
Regulated Product(s)
		 BiologicsAbout ESG

          
                        User Guide
          Account Management Portal User Guide
          Submission Statistics
          Impact of the Gateway
          Center Submission Types
          Submission Acknowledgements
          ESG Submission Process
          Planned Maintenance and Status History
          Submission Times
 
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