Enable Vaccines and VAERS Submissions

Learn how to update your vault's configuration to enable vaccine case processing and VAERS submissions.

Last Updated

Note Beginning with 24R1 in April 2024 and for all subsequent releases, Vault Safety General Release Help content is moving to a new site. Test the new site using Limited Release content.

About the Feature

Vault Safety 20R3 introduced support for vaccine product types and data capture for VAERS submissions.

The following list outlines the configuration required to make this feature available for vaults, depending on the version the vault was originally deployed from:

  • 20R2 and Earlier: Follow all of the instructions on this page to enable vaccines in vaults originally deployed in 20R2 or an earlier release.
  • 20R3 and Later: The 20R3 Vault Safety template includes most of the configuration required to use this feature by default. However, your vault may require updates to the Transmission object lifecycle. Review the steps outlined under Update the Transmission Lifecycle.
  • All Versions: To display VAERS related dosage fields for external vaccines, the External Product Type field must be added to the External Case Product Page Layout.

Once this feature is enabled, Prepare Vaccine Submissions provides instructions for users.

Note For FDA VAERS electronic submissions, you must also configure the FDA Gateway.

New in 21R1: Add External Product Type Field to External Product Page Layout

To display VAERS related dosage fields for external vaccines, the External Product Type field must be added to the External Case Product Page Layout. This field is not displayed on page layouts by default.

Go to Configuration > Objects > Case Product > External Product Page Layout, and add the External Product Type field to the layout.

Ensure to update the appropriate Permission Sets to grant access to Edit this field.

Vaccine Combination Products

You must perform additional configuration to use combination products with a vaccine constituent. The combination product enablement instructions provide more information.

Activate Vaccine Object Type

Activate the Vaccine object type for the following objects:

  • Case Product
  • Product
  • Study Product

Activate VAERS Transmission Profile

In Business Admin > Transmission Profiles, move the CBER VAERS Transmission Profile to the Active state.

Note You may need to add a user action to Change State to Active on the Transmission Profile lifecycle to trigger the state change.

Activate Controlled Vocabularies

In Business Admin > Controlled Vocabularies, move the following Qualification-type Controlled Vocabularies to the Active state:

  • Patient
  • Parent

Update Navigation Tabs

In Configuration > Tabs, make the following changes to the navigation tabs:

  1. Under Business Admin (Quick Access), delete the Product Library tab.
  2. Add a new Product Library tab under Business Admin (Quick Access) with the following settings:
    • Type: Product
    • Object Type: Vaccines, Biologics, Drugs, Devices, Combination Products

Update the Transmission Lifecycle

Go to Configuration > Object Lifecycles > Transmission Lifecycle.

Pending State

Make the following changes to the Pending state:

  • Entry Criteria: Add CBER VAERS and GWTest to the FDA ESG Entry Criteria that validates the Transmission Profile when the Submission Method equals FDA ESG.
    New Pending State Entry Criteria
    New Pending State Entry Criteria
  • Entry Action: Add CBER VAERS to the CBER, CDER Entry Action to start the Submission: FDA ESG Workflow:
    New Pending State Entry Action
    New Pending State Entry Action

Ready for Submission State

Make the following changes to the Ready for Submission state:

Entry Criteria:

  1. Add FDA VAERS E2B (R3) to the FDA ESG Entry Criteria that validates the Transmission Document Type.
  2. Add CBER VAERS and GWTest to the FDA ESG Entry Criteria that validates the Transmission Profile.
New Ready for Submission State Entry Criteria
New Ready for Submission State Entry Criteria

Configure Page Layouts

Manage page layouts from the Page Layouts tab on the appropriate object from Configuration > Objects.

Case Page Layouts

Update page layouts for the following Case object types:

  • AER
  • Case
  • Imported Case
  • Parental Case

The following table outlines the sections that require updates and the relevant page layouts for each change:

Page Layouts Section Changes
  • Case Page Layout,
  • Imported Case Page Layout
 Products Edit the Products section to include the Vaccine object type.
  • Case Page Layout,
  • Imported Case Page Layout
 Reporters Make the following changes to the Reporters section:
  • Rename the section to Contacts.
  • Set Filter Related List option to includes:
    • Reporter
    • Facility
    • Health Care Professional
    • Patient Contact
  • Rearrange the columns to the following order:
    1. Case Contact Type
    2. Qualification
    3. Primary Source
    4. Rank
    5. First Name
    6. Last Name
    7. Facility Name
    8. Email Address
    9. Country
    10. Organization
  • Case Page Layout,
  • Imported Case Page Layout
 Patient Make the following changes to the Case Patient section:
  1. Add the following combined field controls:
    • Patient Name Prefix
    • Patient First Name
    • Patient Middle Name
    • Patient Last Name
    • Age at Vaccination
    • Pregnant at Exposure
  2. Add the Military Status field.
  3. Replace the following fields with the combined field and reason omitted controls:
    • Ethnicity
    • Race
  • AER Detail Page Layout
 Patient Add the following combined field controls to the Patient section:
  • Patient Name Prefix
  • Patient First Name
  • Patient Middle Name
  • Patient Last Name
  • Age at Vaccination
  • Parental Case Page Layout
 Parent Add the Age at Vaccination field.

(Optional) Case Page Layout Rules

The following page layout rules are optional but recommended for user experience.

Page Layouts Rule Label HIDE THE FOLLOWING PAGE LAYOUT ITEMS IF THIS LAYOUT RULE EXPRESSION IS TRUE
  • AER Detail Page Layout
 Reporter Fields
  • Type: Fields
  • Values: Reporter First Name, Reporter Last Name, Reporter Assessment Result
 reporter_qualification__vr.name__v = 'Patient'
  • Case Page Layout,
  • Imported Case Page Layout,
  • Parental Case Page Layout
 Not Female

Update the existing Not Female (not_female__c) layout rule to hide the following items:

  • Controls: Add Pregnant at Exposure
  • Fields: Add Pregnancy Conception Date and Pregnancy Due Date
 gender_value__vr.name__v != "Female" (unchanged)
  • Case Page Layout,
  • Imported Case Page Layout
 Hide if not Vaccine
  • Type: Controls
  • Values: Age at Vaccination
 product_type__vr.name__v != "Vaccine"

Case Contact Page Layouts

Update the Reporter-type Case Contact page layout and edit the page layouts for the Facility, Patient, and Health Care Professional object types.

Reporter Detail Page Layout

Make the following changes to the Reporter Detail Page Layout:

  • Replace the Email field with the Email combined field control
  • Add the Street Line 2 field.
  • Add the County combined field control.
  • Add the Best Doctor? field.

Facility Detail Page Layout

See the following table for the Facility Detail Page Layout setup:

Section Fields
Details
  • Facility Name
  • Facility Type
  • Telephone
  • Fax
  • Facility Military Flag
Address
  • Street
  • Street Line 2
  • City
  • State/Province
  • Country
  • Postal Code
Workflow Timeline Default Settings
System Information Default Settings

Patient Contact Detail Page Layout

See the following table for the Patient Contact Detail Page Layout setup:

Section Fields
Details
  • Title
  • First Name
  • Middle Name
  • Last Name
  • Telephone
  • Email
Address
  • Street
  • Street Line 2
  • City
  • State/Province
  • County
  • Country
  • Postal Code
Workflow Timeline Default Settings
System Information Default Settings

Health Care Professional Detail Page Layout

See the following table for the Health Care Professional Detail Page Layout setup:

Section Fields
Details
  • Title
  • First Name
  • Middle Name
  • Last Name
  • Telephone
  • Email Address
  • Best Doctor?
  • Additional Information
Workflow Timeline Default Settings
System Information Default Settings

Case Product Page Layout

Add the Vaccine Type field.

Product Page Layout

Add the Vaccine Type field.

Study Product Page Layout

Add the Vaccine object type to the Study Products section.

Case Adverse Event Page Layout

Add a Hospitalization/Treatment section with the following settings:

  • Label: Hospitalization/Treatment
  • Layout: Detail Form - One Column
  • Fields:
    • Hospitalization
    • Evaluated/Treated At
    • Days Hospitalized
    • Hospital Name
    • Hospital City
    • Hospital State
    • Hospital Admission Date
    • Hospital Discharge Date

Case Medical History Page Layout

Add the Illness at Vaccination field.

Case Drug History Page Layout

Add the Age at Vaccination Control

Study Page Layout

Add the Vaccine object type on the Study Product related object section.

Update Permissions

  • Administrator Actions > Tabs: Add View access to Product Library tab.
  • Permission Sets: Update permission sets according to the settings described in the following table.
Permission Set Object Object Type Object Permissions Field Field Permissions Action Action Permissions
Permission Set Object Object Type Permission Field Permission Action Permission
Administration Actions Case Contact Facility Read All Fields Read - -
Administration Actions Case Contact Patient Contact Read All Fields Read - -
Administration Actions Case Contact Health Care Professional Read All Fields Read - -
Administration Actions Case Product Vaccine Read All Fields Read - -
Administration Actions Controlled Vocabulary Anatomical Site Read All Fields Read - -
Administration Actions Controlled Vocabulary Facility Type Read All Fields Read - -
Administration Actions Controlled Vocabulary Military Status Type Read All Fields Read - -
Administration Actions Product Vaccine Create, Read, Update, Delete All Fields Read - -
Administration Actions Study Product Vaccine Create, Read, Update, Delete All Fields Read - -
Administration Actions Validation Criteria - Read All Fields Read - -
Administration Actions Validation Result - Read All Fields Read - -
Case Distribution Actions Case Contact Facility Read All Fields Read - -
Case Distribution Actions Case Contact Patient Contact Read All Fields Read - -
Case Distribution Actions Case Contact Health Care Professional Read All Fields Read - -
Case Distribution Actions Case Product Vaccine Read All Fields Read - -
Case Distribution Actions Controlled Vocabulary Anatomical Site Read All Fields Read - -
Case Distribution Actions Controlled Vocabulary Facility Type Read All Fields Read - -
Case Distribution Actions Controlled Vocabulary Military Status Type Read All Fields Read - -
Case Distribution Actions Product Vaccine Read All Fields Read - -
Case Distribution Actions Validation Criteria - Read All Fields Read - -
Case Distribution Actions Validation Result - Read All Fields Read - -
Case Entry Actions Case - - Reporter Language Edit - -
Case Entry Actions Case - - Reporter Email Address Edit - -
Case Entry Actions Case - - Reporter Email Consent Edit - -
Case Entry Actions Case - - Age at Vaccination (number) Edit - -
Case Entry Actions Case - - Age At Vaccination (unit) Edit - -
Case Entry Actions Case - - Age At Vaccination (normalized) Edit - -
Case Entry Actions Case - - Pregnant at Exposure Edit - -
Case Entry Actions Case - - Pregnant at Exposure (Reason Omitted) Edit - -
Case Entry Actions Case - - Patient Name Prefix Edit - -
Case Entry Actions Case - - Patient Name Prefix (Reason Omitted) Edit - -
Case Entry Actions Case - - Patient First Name Edit - -
Case Entry Actions Case - - Patient First Name (Reason Omitted) Edit - -
Case Entry Actions Case - - Patient Middle Name Edit - -
Case Entry Actions Case - - Patient Middle Name (Reason Omitted) Edit - -
Case Entry Actions Case - - Patient Last Name Edit - -
Case Entry Actions Case - - Patient Last Name (Reason Omitted) Edit - -
Case Entry Actions Case - - Race (Reason Omitted) Edit - -
Case Entry Actions Case - - Ethnicity (Reason Omitted) Edit - -
Case Entry Actions Case - - Military Status Edit - -
Case Entry Actions Case - - Pregnancy Conception Date Edit - -
Case Entry Actions Case - - Pregnancy Due Date Edit - -
Case Entry Actions Case - - Reason Received Late Edit - -
Case Entry Actions Case - - External System UID Edit - -
Case Entry Actions Case - - Suppress Submission Edit - -
Case Entry Actions Case Contact Facility Create, Read, Update, Delete - - - -
Case Entry Actions Case Contact Patient Contact Create, Read, Update, Delete - - - -
Case Entry Actions Case Contact Health Care Professional Create, Read, Update, Delete - - - -
Case Entry Actions Case Product Vaccine Create, Read, Update, Delete All Fields Edit - -
Case Entry Actions Controlled Vocabulary Anatomical Site Read All Fields Read - -
Case Entry Actions Controlled Vocabulary Facility Type Read All Fields Read - -
Case Entry Actions Controlled Vocabulary Military Status Type Read All Fields Read - -
Case Entry Actions Product Vaccine Read All Fields Read - -
Case Entry Actions Study Product Vaccine Read All Fields Read - -
Case Entry Actions Validation Criteria - Read All Fields Read - -
Case Entry Actions Validation Result - Read All Fields Read - -
Case Intake Actions Case - - Reporter Language Edit - -
Case Intake Actions Case - - Reporter Email Address Edit - -
Case Intake Actions Case - - Reporter Email Consent Edit - -
Case Intake Actions Case - - Age at Vaccination (number) Edit - -
Case Intake Actions Case - - Age At Vaccination (unit) Edit - -
Case Intake Actions Case - - Age At Vaccination (normalized) Edit - -
Case Intake Actions Case - - Pregnant at Exposure Edit - -
Case Intake Actions Case - - Pregnant at Exposure (Reason Omitted) Edit - -
Case Intake Actions Case - - Patient Name Prefix Edit - -
Case Intake Actions Case - - Patient Name Prefix (Reason Omitted) Edit - -
Case Intake Actions Case - - Patient First Name Edit - -
Case Intake Actions Case - - Patient First Name (Reason Omitted) Edit - -
Case Intake Actions Case - - Patient Middle Name Edit - -
Case Intake Actions Case - - Patient Middle Name (Reason Omitted) Edit - -
Case Intake Actions Case - - Patient Last Name Edit - -
Case Intake Actions Case - - Patient Last Name (Reason Omitted) Edit - -
Case Intake Actions Case - - Race (Reason Omitted) Edit - -
Case Intake Actions Case - - Ethnicity (Reason Omitted) Edit - -
Case Intake Actions Case - - Military Status Edit - -
Case Intake Actions Case - - Pregnancy Conception Date Edit - -
Case Intake Actions Case - - Pregnancy Due Date Edit - -
Case Intake Actions Case - - Reason Received Late Edit - -
Case Intake Actions Case - - External System UID Edit - -
Case Intake Actions Case - - Suppress Submission Edit - -
Case Intake Actions Case Contact Facility Read All Fields Read - -
Case Intake Actions Case Contact Patient Contact Read All Fields Read - -
Case Intake Actions Case Contact Health Care Professional Read All Fields Read - -
Case Intake Actions Case Product Vaccine Read All Fields Read - -
Case Intake Actions Controlled Vocabulary Anatomical Site Read All Fields Read - -
Case Intake Actions Controlled Vocabulary Facility Type Read All Fields Read - -
Case Intake Actions Controlled Vocabulary Military Status Type Read All Fields Read - -
Case Intake Actions Product Vaccine Read All Fields Read - -
Case Intake Actions Study Product Vaccine Read All Fields Read - -
Case Intake Actions Validation Criteria - Read All Fields Read - -
Case Intake Actions Validation Result - Read All Fields Read - -
Case Review Actions Case Contact Facility Read All Fields Read - -
Case Review Actions Case Contact Patient Contact Read All Fields Read - -
Case Review Actions Case Contact Health Care Professional Read All Fields Read - -
Case Review Actions Case Product Vaccine Read All Fields Read - -
Case Review Actions Controlled Vocabulary Anatomical Site Read All Fields Read - -
Case Review Actions Controlled Vocabulary Facility Type Read All Fields Read - -
Case Review Actions Controlled Vocabulary Military Status Type Read All Fields Read - -
Case Review Actions Product Vaccine Read All Fields Read - -
Case Review Actions Study Product Vaccine Read All Fields Read - -
Case Review Actions Validation Criteria - Read All Fields Read - -
Case Review Actions Validation Result - Read All Fields Read - -
Case Translation Actions Case - - - - Evaluate Regulatory Conformance No Access
Lock Manager Actions Case - - - - Evaluate Regulatory Conformance No Access
Safety Operations Actions Case Contact Facility Read All Fields Read - -
Safety Operations Actions Case Contact Patient Contact Read All Fields Read - -
Safety Operations Actions Case Contact Health Care Professional Read All Fields Read - -
Safety Operations Actions Case Product Vaccines Read All Fields Read - -
Safety Operations Actions Controlled Vocabulary Anatomical Site Read All Fields Read - -
Safety Operations Actions Controlled Vocabulary Facility Type Read All Fields Read - -
Safety Operations Actions Controlled Vocabulary Military Status Type Read All Fields Read - -
Safety Operations Actions Product Vaccine Read All Fields Read - -
Safety Operations Actions Study Product Vaccine Read All Fields Read - -
Safety Operations Actions Validation Criteria - Read All Fields Read - -
Safety Operations Actions Validation Result - Read All Fields Read - -
Safety Operations Actions - - - - - All Actions No Access
Safety Writer Case Contact Facility Read All Fields Read - -
Safety Writer Case Contact Patient Contact Read All Fields Read - -
Safety Writer Case Contact Health Care Professional Read All Fields Read - -
Safety Writer Case Product Vaccine Read All Fields Read - -
Safety Writer Controlled Vocabulary Anatomical Site Read All Fields Read - -
Safety Writer Controlled Vocabulary Facility Type Read All Fields Read - -
Safety Writer Controlled Vocabulary Military Status Type Read All Fields Read - -
Safety Writer Product Vaccine Read All Fields Read - -
Safety Writer Study Product Vaccine Read All Fields Read - -
Safety Writer Validation Criteria - Read All Fields Read - -
Safety Writer Validation Result - Read All Fields Read - -
Safety Writer - - - - - Lock Case No Access
Safety Writer - - - - - Unlock Case No Access
Safety Writer - - - - - Evaluate Regulatory Conformance No Access
Safety Writer - - - - - - -
Submission Actions Case Contact Facility Read All Fields Read - -
Submission Actions Case Contact Patient Contact Read All Fields Read - -
Submission Actions Case Contact Health Care Professional Read All Fields Read - -
Submission Actions Case Product Vaccine Read All Fields Read - -
Submission Actions Controlled Vocabulary Anatomical Site Read All Fields Read - -
Submission Actions Controlled Vocabulary Facility Type Read All Fields Read - -
Submission Actions Controlled Vocabulary Military Status Type Read All Fields Read - -
Submission Actions Controlled Vocabulary Ethnicity Read - - - -
Submission Actions Product Vaccine Read All Fields Read - -
Submission Actions Study Product Vaccine Read All Fields Read - -
Submission Actions Validation Criteria - Read All Fields Read - -
Submission Actions Validation Result - Read All Fields Read - -
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