Enable Vaccines and VAERS Submissions

Learn how to update your Vault’s configuration to enable vaccine case processing and VAERS submissions.

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 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 Product Page Layout. This field is not displayed on 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

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

Under Business Admin (Quick Access), delete the Product Library tab.
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.
Entry Action: Add CBER VAERS to the CBER, CDER Entry Action to start the Submission: FDA ESG Workflow:

Ready for Submission State

Make the following changes to the Ready for Submission state:

Entry Criteria:

Add FDA VAERS E2B (R3) to the FDA ESG Entry Criteria that validates the Transmission Document Type.
Add CBER VAERS and GWTest to the FDA ESG Entry Criteria that validates the Transmission Profile.

Configure Layouts

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

Case Layouts

Update layouts for the following Case object types:

Case
Imported Case
Parental Case

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

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 Related List option to `includes`: Reporter Facility Health Care Professional Patient Contact Rearrange the columns to the following order: Case Contact Type Qualification Primary Source Rank First Name Last Name Facility Name Email Address Country Organization
Case Page Layout, Imported Case Page Layout	Patient	Make the following changes to the Case Patient section: Add the following combined field controls: Patient Name Prefix Patient First Name Patient Middle Name Patient Last Name Age at Vaccination Pregnant at Exposure Add the Military Status field. Replace the following fields with the combined field and reason omitted controls: Ethnicity Race
Parental Case Page Layout	Parent	Add the Age at Vaccination field.

(Optional) Case Layout Rules

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

Layouts Rule Label HIDE THE FOLLOWING PAGE LAYOUT ITEMS IF THIS LAYOUT RULE EXPRESSION IS TRUE

Layouts	Rule Label	HIDE THE FOLLOWING PAGE LAYOUT ITEMS	IF THIS LAYOUT RULE EXPRESSION IS TRUE
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 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 Layouts

Update the Reporter-type Case Contact layout and edit the 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 Layout

Add the Vaccine Type field.

Product Layout

Add the Vaccine Type field.

Study Product Layout

Add the Vaccine object type to the Study Products section.

Case Adverse Event Layout

Insert 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 Layout

Add the Illness at Vaccination field.

Case Drug History Layout

Add the Age at Vaccination Control.

Study 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
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	-	-