eVAERS updates

Summary

eVAERS Regulatory updates (Enhancements 33415880, 36173188, and 30838996)

Description

FDA CBER published revised guidelines in December 2023 for eVAERS report submission.

Console changes

• In the Flexible Codelist List Maintenance, a new NCI Code [C53528] labeled Urgent Care Center is added to Vaccinated_AT.
• In the Country flexible code list, a new GENC2 attribute is added and each country is assigned with a GENC2 code.

  You can modify the GENC2 code data for both factory-provided countries and custom countries.

Interchanging mapping changes

Mapping changes for Vaccine Facility section

The eVAERS Report mapping is enhanced, such that, when a report is generated, the VACCINE FACILITY[G.k.4.r.14] and ADMINISTRATION INFORMATION[FDA.E.i.3.4] elements are populated in the Drug(s) Information[G.k] section.

The Vaccine Administration section is transmitted for suspect and non-suspect vaccines, if data is present. If no vaccine facility information is available for vaccines other than the first suspect vaccine, then the Facility block under the Drug(s) Information[G.k] section is not populated for that vaccine in the XML.

Existing E2B generation validation for VACCAT[FDA.G.k.4.r.14.8] is revised to ensure the facility type information is checked for the scheduled suspect vaccine. If the facility type information is missing, then the validation messages are displayed. However, if the facility type information is missing for subsequent vaccines within the same case, then no validation message is displayed.

The following validations are removed as these validations are not triggered with the existing OOTB report mappings:

• VACCFACILITYNAME [FDA.G.k.4.r.14]
• VACCFACILITYADD [FDA.G.k.4.r.14.1a]
• VACCFACILITYCITY [ FDA.G.k.4.r.14.2]
• VACCFACILITYSTATE[FDA.G.k.4.r.14.3]
• VACCFACILITYCOUNTRY[FDA.G.k.4.r.14.4]
• VACCFACILITYPOSTCODE[FDA.G.k.4.r.14.5]
• VACCFACILITYTELEPHONE[FDA.G.k.4.r.14.6]
• VACCFACILITYFAX [FDA.G.k.4.r.14.7].

Populate GENC2 country codes in the country data element instead of ISO-3166-1 country codes

The mappings for the following country data elements are updated to send GENC2 codes instead of ISO A2 codes:

• REPORTERCOUNTRYR3[C.2.r.3]
• SENDERCOUNTRYCODE[C.3.4.5]
• STUDYREGCOUNTRY[C.5.1.r.2]
• PATIENTCOUNTRYCODE[FDA.D.1j]
• REACTIONOCCURCOUNTRY[E.i.9]
• OBTAINDRUGCOUNTRY[G.k.2.4]
• DRUGAUTHORIZATIONCOUNTRY[G.k.3.2]
• VACCFACILITYCOUNTRY[FDA.G.k.4.r.14.4]
• MANUFACTURERCOUNTRY[FDA.G.k.12.r.7.1e]

Other eVAERS profile updates

To accept additional characters, like underscore ("_"), space (" "), parentheses ("()"), and hash ("#"), mapping of the following data elements along with validation rule and validation message is updated:

• DOCFILENAME[FDA.C.1.6.1.r.3]
• LITFILENAME[FDA.C.1.6.1.r.3]

The updated list now includes Letters (a–z, A–Z), Digits (0-9), special characters plus ("+"), period ("."), and hyphen ("-").

The allowed value (CFG_M2) check on the DEVICEPROBLEMCODE[FDA.G.k.12.r.3.r] element is removed for the eVAERS profile.

Transmit FDA SPL Code or EDQM in Route of administration (ROA) and Dose formulation (DF)

The mapping for Patient Route of Administration, Parent Route of Administration, and Drug Formulation has been updated.

When the selected code list value does not have NCI Code in Patient Route of Administration, Parent Route of Administration, and Drug Formulation, then a valid EDQM Term ID is populated with version information in the following data elements:

• DRUGROUTEOFADMINTERMIDVER[G.k.4.r.10.2a]
• DRUGPHARMADOSEFORMTERMID[G.k.4.r.9.2b]
• DRUGPARROUTEOFADMINTERMIDVER[G.k.4.r.11.2a]
• DRUGPARROUTEOFADMINTERMID[G.k.4.r.11.2b]
• DRUGROUTEOFADMINTERMID[G.k.4.r.10.2b]
• DRUGPHARMADOSEFORMTERMIDVER[G.k.4.r.9.2a]

When the selected code list value does not have NCI Code or EDQM Term ID (deprecated, rejected, or unmapped EDQM Term ID) in Patient Route of Administration, Parent Route of Administration and Drug Formulation UI, then the selected code list value (free text) is populated in text format in the following data elements:

• DRUGADMINISTRATIONROUTETEXT[G.k.4.r.10.1]
• DRUGPARADMINISTRATIONTEXT[G.k.4.r.11.1]
• DRUGDOSAGEFORM[G.k.4.r.9.1]

For more information, refer to ArgusInterchange844_E2B (R3) Export Mappings.xlsx, E2BR3_Mappings Sheet.

Case form changes

When multiple vaccines are available in a case, you can now enter and save specific details for each individual vaccine in the Vaccine Administration section, Vaccine Facility section, and Best Doctor/Health Care Professional Information section.

Legacy cases having vaccines with facility or administration data are updated after upgrade as per the following logic :

• For cases with single suspect vaccine and one or more non-suspect vaccines, vaccine facility or administration detail is associated with the suspect vaccine present in the case. Vaccine facility or administration detail is not associated with the non-suspect vaccine present in the case.
• For cases with suspect and non-suspect vaccines:
  • If there is one suspect vaccine for which eVAERS or VAERS report is scheduled, generated, or submitted, then the vaccine facility or administration detail is associated with that vaccine, and left blank for other suspect and non-suspect vaccines.
  • If there is more than one vaccine for which eVAERS or VAERS report is scheduled, generated, or submitted, then the vaccine facility or administration detail is associated with the vaccines that has vaccine reports, and is left blank for other suspect and non-suspect vaccines.
  • If there are no eVAERS or VAERS report scheduled, generated, or submitted for the case, then the vaccine facility or administration detail is associated with the first suspect vaccine based on the sort order, and not with the non-suspect vaccine present in the case.
• For cases with non-suspect vaccines and no suspect vaccines, the vaccine facility or administration detail is associated with the first vaccine present in the case.