# E2B Generation: FDA VAERS E2B(R3) Mapping When you export a Case to an E2B file, either for an outbound Transmission or directly from the Case page, Vault Safety maps all case data and documents to the appropriate E2B data elements. This article describes how Vault maps information to generate FDA VAERS E2B(R3) files. See E2B Generation Data Mapping for details about all other E2B formats supported by Vault Safety.
## FDA VAERS E2B(R3) Mapping The following tables define how each E2B data element is mapped for an FDA VAERS E2B(R3) file. Use the section below to review only regional FDA mappings that are different from the ICH mappings.

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name Populated Value
N.1.1 Types of Message in batch This value is always 1 for ICH ICSR.
N.1.2 Batch Number The value in the E2B Message ID field on the ICSR Transmission.
N.1.3 Batch Sender Identifier The value in the Origin ID field on the Transmission Profile associated with the ICSR Transmission.
N.1.4 Batch Receiver Identifier The value in the Destination ID field on the Transmission Profile associated with the ICSR Transmission.
N.1.5 Date of Batch Transmission The value in the Transmission Date field on the ICSR Transmission. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

N.2.r ICH ICSR Message Header (message wrapper)

E2B Data Element Name Populated Value
N.2.r.1 Message Identifier The value in the UID field on the Case.
N.2.r.2 Message Sender Identifier The value in the Origin ID field on the Transmission Profile associated with the ICSR Transmission.
N.2.r.3 Message Receiver Identifier The value in the Destination ID field on the Transmission Profile associated with the ICSR Transmission.
N.2.r.4 Date of Message Creation If the Case is Approved, Closed, or Superseded, the date in the Approval Date field. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value
C.1.1 Sender's (case) Safety Report Unique Identifier The UID on the Case Version.
C.1.2 Date of Creation If the Case is Approved, Closed, or Superseded, the date in the Approval Date field. If Approval Date is unavailable, the date of report generation or transmission with a system warning. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.
C.1.3 Type of Report Vault populates a code based on the Report Type of the Case:
  • 1: Spontaneous
  • 2: Study
  • 3: Other
  • 4: Unknown
C.1.4 Date Report Was First Received from Source For initial and follow-up Cases, the Receipt Date on the Case. When the Receipt Date includes a time and time zone, Vault truncates the value to YYYYMMDD.
C.1.5 Date of Most Recent Information for This Report The New Info Date on the Case. When the New Info Date includes a time and time zone, Vault truncates the value to YYYYMMDD.
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report? If the Local Expedited Criteria (case_expedited__v) field on the ICSR Transmission has a value, Vault uses this value. If this field is not specified on the Transmission, Vault looks at the Expedited field on the Case. If the value is Yes, Vault populates this element with 1 (expedited). Otherwise, Vault populates this element with 2 (non-expedited).

If both fields are blank, nullFlavor (NI) is exported.
FDA.C.1.7.1 Local Criteria Report Type

If the primary product is set to Combination Product or if there are Vaccine Case Products, this field will auto-generate when the E2B file is created.

Vault uses the following logic to populate this field:

Populated E2B Code Conditions
FDA.C.1.12 Combination Product Report Flag C.1.7 Expedited Report Flag Device Report Type Field
1 No Yes N/A
1 Yes Yes Blank
2 No No N/A
2 Yes No Blank
4 Yes Yes Public Health Risk
5 Yes No Malfunction Only

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name Populated Value
C.1.6.1 Are Additional Documents Available? Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment.
C.1.6.1.r.1 Documents Held by Sender The text in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment. Text is populated to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank.
C.1.6.1.r.2 Included Documents

If any documents are attached to the Case with the document type of Case > Source > Attachment and the Retransmit field set to Yes, they are encoded. If the Retransmit field is set to No or is blank, documents are not encoded.

Depending on your Admin's configuration, Vault may exclude attachment contents on Transmissions for Cases or Localized Cases with previous Transmissions that included the attachment to the same reporting destination.
FDA.C.1.6.1.r.3 Attachment File Name The Case > Document > Filename for the attachment encoded in the transmission.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name Populated Value
C.1.8.1 Worldwide Unique Case Identification Number The Worldwide UID on the Case Version.
C.1.8.2 First Sender of This Case The value in the First Sender field on the original Inbound Transmission.

The transmission date is used to find the original Transmission.
C.1.9.1 Other Case Identifiers in Previous Transmissions Populated as True if there are any Case Identifier objects associated with the Case. If there are no Case Identifier objects associated with the Case, NI is exported.
C.1.9.1.r.1 Source(s) of the Case Identifier Repeated for the value in the Source field on each Case Identifier object.

This element is transmitted only when the Case Identifier Type (type__v) is set to Re-Transmittable or is blank.
C.1.9.1.r.2 Case Identifier(s) The value in the Case Identifier field on the Case Identifier object.

This element is transmitted only when the Case Identifier Type (type__v) is set to Re-Transmittable or is blank.
C.1.10.r Identification Number of the Report Which Is Linked to This Report The value in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
C.1.11.1 Report Nullification/Amendment The appropriate value is populated, based on the option selected in the Reason field on the Transmission:
  • 1: Nullification
  • 2: Amendment
C.1.11.2 Reason for Nullification/Amendment The text in the Reason Text field on the Transmission, to a limit of 2,000 characters.
FDA.C.1.12 Combination Product Report Flag Set as true when any Case Product is of the type Combination Product.

C.2.r Primary Source(s) of Information

E2B Data Element Name Populated Value
C.2.r.1.1 Reporter's Title The value in the Title field on a Reporter-type Case Contact.
C.2.r.1.2 Reporter's Given Name The value in the First Name field on a Reporter-type Case Contact.
C.2.r.1.3 Reporter's Middle Name The value in the Middle Name field on a Reporter-type Case Contact.
C.2.r.1.4 Reporter's Family Name The value in the Last Name field on a Reporter-type Case Contact.
C.2.r.2.1 Reporter's Organisation

The value in the Organization field on a Reporter-type Case Contact.

Any text that exceeds the 60-character limit for this data element is truncated.
C.2.r.2.2 Reporter's Department The value in the Department field on a Reporter-type Case Contact.
C.2.r.2.3 Reporter's Street The value in the Street Name field on a Reporter-type Case Contact.
FDA.C.2.r.2.3 Reporter's Street Address - LINE 2 The value in the Street Name - Line 2 field on a Reporter-type Case Contact.
C.2.r.2.4 Reporter's City The value in the City field on a Reporter-type Case Contact.
C.2.r.2.5 Reporter's State or Province The State/Province on the Case Contact record for the primary reporter.
FDA.C.2.r.2.5.1 Reporter's County The value in the County field on a Reporter-type Case Contact.
C.2.r.2.6 Reporter's Postcode The value in the Zip/Postal Code field on a Reporter-type Case Contact.
C.2.r.2.7 Reporter's Telephone The value in the Telephone field on a Reporter-type Case Contact.
FDA.C.2.r.2.8 Reporter's Email The value in the Reporter's Email Address field on a Reporter-type Case Contact.
C.2.r.3 Reporter's Country Code The ISO code in the Country field on a Reporter-type Case Contact.
C.2.r.4 Qualification The value in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the FDA Concept Code (NCI Concept Identifier) is mapped.
C.2.r.5 Primary Source for Regulatory Purposes Populated with 1 (true) if the Primary Source field is set to Yes on the associated Reporter-type Case Contact.

C.3 Information on Sender of Case Safety Report

E2B Data Element Name Populated Value
C.3.1 Sender Type The value in the Sender Type field in the Organization record associated with the Sender (User) on the ICSR Transmission.
If the Sender (User) is not specified on the Transmission, Vault maps the Sender Type from the Organization on the Case.
C.3.2 Sender Organization

The value in the Organization field in the User record associated with the Sender (User) on the ICSR Transmission.

If the Sender (User) is not specified on the Transmission, Vault maps the Organization on the Case.

Any text that exceeds the 100-character limit for this data element is truncated.
C.3.3.1 Sender's Department The value in the Department field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.2 Sender's Title The value in the Title field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.3 Sender's Given Name The value in the First Name field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.4 Sender's Middle Name The value in the Middle Name field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.5 Sender's Family Name The value in the Last Name field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.1 Sender's Street Address The value in the Street field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.2 Sender's City The value in the City field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.3 Sender's State or Province The value in the State / Province field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.4 Sender's Postcode The value in the Zip/Postal Code field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.5 Sender's Country Code The 2-letter ISO code associated with the country selected in the Country field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.6 Sender's Telephone The value in the Telephone field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.7 Sender's Fax The value in the Fax field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.8 Sender's E-mail Address The value in the Email field in the User record associated with the Sender (User) on the ICSR Transmission.

C.4.r Literature Reference(s)

E2B Data Element Name Populated Value
C.4.r.1 Literature Reference(s)

The value in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters.

When Vault generates a report for a Case linked to a Literature Article in your SafetyDocs Vault and if the document's Retransmit field value is Yes, Vault maps a value from the Literature Article using the following priority:

  1. Vancouver Citation (English)
  2. Vancouver Citation

For Localized Case Documents, Vault overrides the Vancouver Citation with the Reference field value, if populated.

Multiple literature source documents are encoded in separate C.4.r.1 blocks.
C.4.r.2 Included Documents

Case documents of the following classifications with the Retransmit field value of Yes are encoded in Transmissions:

  • Case > Source > Literature
  • Literature > Literature Article > Full-Text
  • Literature > Literature Article > Summary

Depending on your Admin's configuration, Vault may exclude the contents of literature articles on Transmissions for Cases or Localized Cases with previous Transmissions that included the literature article to the same reporting destination.

C.5 Study Identification

E2B Data Element Name Populated Value
C.5.1.r.1 Study Registration Number The Registration Number on the Case Study Registration.
C.5.1.r.2 Study Registration Country The 2-letter ISO code associated with the Country on the Case Study Registration.
C.5.2 Study Name The values in the Study Name and Study Name (Continued) fields on the associated Case, to a limit of 2,000 characters.
C.5.3 Sponsor Study Number The Study Number on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed Based on the Study Type on the Case, Vault populates an E2B code corresponding to the Study Type controlled vocabulary.

D Patient Characteristics

E2B Data Element Name Populated Value
D.1 Patient (name or initials) The value in the Patient Initials / ID field on the Case.
FDA.D.1a Patient Name Prefix The value in the Title field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1b Patient First Name The value in the First Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1c Patient Middle Name The value in the Middle Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1d Patient Last Name The value in the Last Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1e Patient Address Line 1 The value in the Street field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1f Patient Address Line 2 The value in the Street Line 2 field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1g Patient Address City The value in the City field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1h Patient Address State or Foreign Province Name The value in the State/Province field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1i Patient Address County The value in the County field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1i Patient Address Country The ISO country code for the country selected in the Country field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1k Patient Address Postal Code The value in the Zip/Postal Code field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1l Patient Telephone The value in the Telephone field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to tel:None.
FDA.D.1m Patient Email The value in the Email Address field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to mailto:None.

D.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number

E2B Data Element Name Populated Value
D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number) The value in the MRN - GP field on the Case.
D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number) The value in the MRN - Specialist field on the Case.
D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number) The value in the MRN - Hospital field on the Case.
D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number) The value in the MRN - Investigation field on the Case.

D.2 Age Information

E2B Data Element Name Populated Value
D.2.1 Date of Birth The Date of Birth on the Case. For Vault to transmit this value, the full date is required with year, month, and day.
FDA.D.2.1a Age at Time of Vaccination (number) The number value in the Age at Vaccination field on the Case.
FDA.D.2.1a Age at Time of Vaccination (unit) The unit in the Age at Vaccination field on the Case.
D.2.2a Age at Time of Onset of Reaction / Event (number) The Age on the Case. In accordance with ICH guidelines, Vault does not transmit this data element if the D.2.1 Date of Birth data element includes a value.
D.2.2b Age at Time of Onset of Reaction / Event (unit) The Age (unit) on the Case. In accordance with ICH guidelines, Vault does not transmit this data element if the D.2.1 Date of Birth data element includes a value.
D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number) The value in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit) The unit in the Gestation (unit) field on the Case.
D.2.3 Patient Age Group (as per reporter) The value in the Age Group field on the Case. In accordance with ICH guidelines, this element is transmitted only when both the Patient Date of Birth (D.2.1) and Age at Onset (D.2.2) are not transmitted. For Cases with blank Date of Birth, Age at Vaccination, Age, Gestation, and Age Group field values, Vault exports NI.
D.3 Body Weight (kg) The value in the Weight field on the Case, normalized to the accepted unit.
D.4 Height (cm) The value in the Height field on the Case, normalized to the accepted unit.
D.5 Sex The value in the Sex field on the Case.
D.6 Last Menstrual Period Date The date in the Last Menstrual field on the Case.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name Populated Value
D.7.1.r.1a MedDRA Version for Medical History Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code) The MedDRA LLT coded on the Case Medical History record.
D.7.1.r.2 Start Date The date in the Start Date field on the Case Medical History record.
D.7.1.r.3 Continuing The appropriate value is populated, based on the Continuing field on the Case Medical History record.
D.7.1.r.4 End Date The date in the End Date field on the Case Medical History record.
D.7.1.r.5 Comments The text in the Comments field on the Case Medical History record, to a limit of 2,000 characters.
D.7.1.r.6 Family History The value in the Family History field on the Case Medical History record.
FDA.D.7.4a Illness at Time of Vaccination MedDRA Version Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
FDA.D.7.4a Illness at Time of Vaccination MedDRA Code If a Case Medical History record has the Illness at Vaccination? field set to True, then this value is mapped from the MedDRA LLT coded on the Case Medical History. If the LLT term is not available, the PT term is populated.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event) The text in the Medical History Text field on the Case, to a limit of 10,000 characters. For a Case identified as Malfunction Only, if the Patient Initials (case_version__v.patient_id_value__v) field is populated with "NONE", then this data element is set to "None".
D.7.3 Concomitant Therapies Set to True when the Concomitant Therapies field is set to Yes on the Case.

D.8.r Relevant Past Drug History

E2B Data Element Name Populated Value
D.8.r.1 Name of Drug as Reported The value in the Drug (Reported) field on the Case Drug History record.
D.8.r.3a PhPID Version Date/Number The PhPID Version on the Case Drug History record. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
D.8.r.3b Pharmaceutical Product Identifier (PhPID) The value in the PhPID field on the Case Drug History record.
D.8.r.4 Start Date The date in the Start Date field on the Case Drug History record.
D.8.r.5 End Date The date in the End Date field on the Case Drug History record.
D.8.r.6a MedDRA Version for Indication Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.6b Indication (MedDRA code) The MedDRA LLT coded for the indication on the Case Drug History record.
D.8.r.7a MedDRA Version for Reaction Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.7b Reaction (MedDRA code) The value in the Reaction MedDRA field on the Case Drug History record.
FDA.D.8.r.8a Patient Age at Vaccination (number) The number in the Age at Vaccination field on the Case Drug History record.
FDA.D.8.r.8b Patient Age at Vaccination (unit) The unit selected in the Age at Vaccination field on the Case Drug History record.

D.9 In case of Death

E2B Data Element Name Populated Value
D.9.1 Date of Death The date in the Date of Death field on the Case.
D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.2.r.1b Reported Cause(s) of Death (MedDRA code) The MedDRA LLT coded on the Reported Case Cause of Death object.
D.9.2.r.2 Reported Cause(s) of Death (free text) The text in the Name (Reported) field on the Case Cause of Death record.
D.9.3 Was Autopsy Done? The value in the Autopsy field on the Case.
D.9.4.r.1a MedDRA Version for Autopsy-determined Cause(s) of Death Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.4.r.1b Autopsy-determined Cause(s) of Death (MedDRA code) The MedDRA LLT coded on the Autopsy-Determined Case Cause of Death object.
D.9.4.r.2 Autopsy-determined Cause(s) of Death (free text) The information in the Name (Reported) field on the Autopsy-Determined Case Cause of Death object.

D.10 For a Parent-child / Foetus Report, Information Concerning the Parent

E2B Data Element Name Populated Value
D.10.1 Parent Identification The Patient ID on the associated Parent Information.
D.10.2.1 Date of Birth of Parent The Date of Birth on the associated Parent Information. For Vault to transmit this value, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number) The Age on the associated Parent Information. In accordance with ICH guidelines, Vault does not transmit this data element if the D.10.2.1 Date of Birth of Parent data element includes a value.
D.10.2.2b Age of Parent (unit) The Age (unit) on the associated Parent Information. In accordance with ICH guidelines, Vault does not transmit this data element if the D.10.2.1 Date of Birth of Parent data element includes a value.
FDA.D.10.2.2.1a Parent Age at Vaccination (number) The number in the Age at Vaccination field on the associated Parent Information.
FDA.D.10.2.2.1b Parent Age at Vaccination (unit) The unit in the Age at Vaccination field on the associated Parent Information.
D.10.3 Last Menstrual Period Date of Parent The date in the Last Menstrual field on the associated Parent Information.
D.10.4 Body Weight (kg) of Parent The value in the Weight field on the associated Parent Information.
D.10.5 Height (cm) of Parent The value in the Height (normalized) field on the associated Parent Information.
D.10.6 Sex of Parent The value in the Sex field on the associated Parent Information.
D.10.7.1.r.1a MedDRA Version for Medical History Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code) The MedDRA LLT coded on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.2 Start Date The date in the Start Date field on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.3 Continuing The value in the Continuing field on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.4 End Date The date in the End Date field on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.5 Comments The text in the Comments field on the Case Medical History record on the associated Parent Information, to a limit of 2,000 characters.
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent The text in the Medical History Text field on the associated Parent Information, to a limit of 10,000 characters.
FDA.D.11 Patient Race Code The appropriate NCI Concept Identifier is populated, based on the Race field on the Case.
FDA.D.12 Patient Ethnicity The appropriate NCI Concept Identifier is populated, based on the Ethnicity field on the Case.
FDA.D.13 Pregnant at Time of Vaccination The value from the Pregnant at Vaccination field on the Case.
FDA.D.14 Patient Military Status The appropriate NCI Concept Identifier is populated, based on the Military Status field on the Case.

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name Populated Value
D.10.8.r.1 Name of Drug as Reported The text in the Name Reported field on the Case Drug History record on the associated Parent Information.
D.10.8.r.3a PhPID Version Date/Number The PhPID Version on the Case Drug History record on the associated Parent Information. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID) The value in the PhPID field on the Case Drug History record on the associated Parent Information.
D.10.8.r.4 Start Date The date in the Start Date field on the Case Drug History record on the associated Parent Information.
D.10.8.r.5 End Date The date in the End Date field on the Case Drug History record on the associated Parent Information.
D.10.8.r.6a MedDRA Version for Indication Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information.
D.10.8.r.6b Indication (MedDRA code) The indication MedDRA LLT coded on the Case Drug History record on the associated Parent Information.
D.10.8.r.7a MedDRA Version for Reaction Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information.
D.10.8.r.7b Reactions (MedDRA code) Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information.

E.I Reaction/Event as Reported by the Primary Source

E2B Data Element Name Populated Value
E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language

Depending on your Vault's Deferred Domestic Processing: Localized Event Reported in Native Language setting, Vault exports the Event (Reported) field from either the global Case Adverse Event or the Localized Case Adverse Event.
E.i.1.1b Reaction / Event as Reported by the Primary Source Language

Depending on your Vault's Deferred Domestic Processing: Localized Event Reported in Native Language setting, Vault exports the Event (Reported) - Language field from either the global Case Adverse Event or the Localized Case Adverse Event.
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation The text in the Event (Reported) - English (event_reported_english__v) field on the Case Adverse Event.
FDA.E.i.1.3 Reaction Identifier When G.k.9.i (Causality Assessment) is populated, this field is populated with the UUID/GUID Identifier to associate the event from the Case Adverse Event with the Causality Assessment.
E.i.2.1a MedDRA Version for Reaction / Event Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
E.i.2.1b Reaction / Event (MedDRA code) The Event (LLT) on the Case Adverse Event.
E.i.3.1 Term Highlighted by the Reporter The value in the Highlighted Term field on the Case Adverse Event.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name Populated Value
E.i.3.2a Results in Death Set to True when Results in death is selected in the Seriousness field on the Case Adverse Event.
E.i.3.2b Life Threatening Set to True when Life threatening is selected in the Seriousness field on the Case Adverse Event.
E.i.3.2c Caused / Prolonged Hospitalisation Set to True when Caused / prolonged hospitalisation is selected in the Seriousness field on the Case Adverse Event.
FDA.E.i.3.2c.1 Hospitalization Required Populated from the Hospitalization field on the Case Adverse Event.
FDA.E.i.3.2c.1a Number of days hospitalized The value entered in the Days Hospitalized field on the Case Adverse Event.
FDA.E.i.3.2c.1b Hospital Name The value entered in the Hospital Name field on the Case Adverse Event.
FDA.E.i.3.2c.1c City The value entered in the Hospital City field on the Case Adverse Event.
FDA.E.i.3.2c.1d State The value entered in the Hospital State field on the Case Adverse Event.
FDA.E.i.3.2c.2 Resulted in Prolongation of Hospitalization Populated from the Hospitalization field on the Case Adverse Event.
E.i.3.2d Disabling / Incapacitating Set to True when Disabling / incapacitating is selected in the Seriousness field on the Case Adverse Event.
E.i.3.2e Congenital Anomaly / Birth Defect Set to True when Congenital anomaly / birth defect is selected in the Seriousness field on the Case Adverse Event.
E.i.3.2f Other Medically Important Condition Set to True when Other medically important condition or Required Intervention to Prevent Permanent Impairment/Damage (Devices) is selected in the Seriousness field on the Case Adverse Event.
FDA.E.i.3.3a Emergency room/department or urgent care Populated using the Evaluated/Treated At field on the Case Adverse Event.
FDA.E.i.3.3b Doctor or other HCP office/clinic visit Populated using the Evaluated/Treated At field on the Case Adverse Event.
FDA.E.i.3.2g AE Outcome None of the Above Populated as True when both the Seriousness and Evaluated/Treated At fields are blank on the Case Adverse Event.
FDA.E.i.3.4 Best doctor/healthcare professional title or prefix The value in the Title field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4a Best doctor/healthcare professional Last Name The value in the Last Name field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4b Best doctor/healthcare professional First Name The value in the First Name field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4c Best doctor/healthcare professional Middle Name The value in the Middle Name field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4d Best doctor/healthcare professional Telephone and extension The value in the Telephone and Extension field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4e Best doctor/healthcare professional Email The value in the Email field on the best doctor Health Care Professional Contact.
E.i.4 Date of Start of Reaction / Event The date in the Onset field on the Case Adverse Event.
E.i.5 Date of End of Reaction / Event The date in the Resolved field on the Case Adverse Event.
E.i.6a Duration of Reaction / Event (number) The value in the Duration field on the Case Adverse Event.
E.i.6b Duration of Reaction / Event (unit) The unit in the Duration (unit) field on the Case Adverse Event.
E.i.7 Outcome of Reaction / Event at the Time of Last Observation

The value in the Outcome field on the Case Adverse Event.

You must select a Vault E2B code value for this section.

See the following table for the E2B code values and their corresponding E2B(R3) Code values.

Vault E2B Code E2B(R3) Code
1 - Recovered/Resolved 1 - Recovered/Resolved
2 - Recovering/Resolving 2 - Recovering/Resolving
3 - Not Recovered/Not Resolved/Ongoing 3 - Not Recovered/Not Resolved.Ongoing
4 - Recovered/Resolved with Sequelae 4 - Recovered/Resolved with Sequelae
5 - Fatal 5 - Fatal
0 - Unknown 0 - Unknown
E.i.8 Medical Confirmation by Healthcare Professional Populated based on the value in the HCP Confirmed field on the Case Adverse Event. This field is only transmitted when the Qualification field on the primary (Rank 1) Reporter-type Case Contact does not designate a health professional. That is, the Qualification Controlled Vocabulary does not correspond to E2B codes 1, 2, or 3.
E.i.9 Identification of the Country Where the Reaction / Event Occurred The value in the Event Country field on the Case Adverse Event.

F.r Results of Tests and Procedures Relevant to the Investigation of the Patient

E2B Data Element Name Populated Value
F.r.1 Test Date The date or the Reason Omitted value in the Test Date field on the Case Test Result.
F.r.2.1 Test Name (free text) The value in the Test Name (Reported) field on the Case Test Result.
F.r.2.2a MedDRA Version for Test Name Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
F.r.2.2b Test Name (MedDRA code) The MedDRA LLT coded on the Case Test Result.
F.r.3.1 Test Result (code) The value in the Result (code) field on the Case Test Result.
F.r.3.2 Test Result (value / qualifier) The values in the Test Result (Qualifier) and (Number) fields on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided.
F.r.3.3 Test Result (unit) The unit in the Result (Unit) field on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided.
F.r.3.4 Result Unstructured Data (free text) The Result (Text) on the Case Test Result. In accordance with ICH guidelines, Vault:
  • Allows numeric values only and does not map values with non-numeric characters.
  • Does not populate this data element if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided.
F.r.4 Normal Low Value The unit and value in the Normal Low Value field on the Case Test Result.
If the result does not have a unit, Vault will map any text entered instead.
F.r.5 Normal High Value The unit and value in the Normal High Value field on the Case Test Result.
If the result does not have a unit, Vault will map any text entered instead.
F.r.6 Comments (free text) The value in the Comments field on the Case Test Result.
F.r.7 More Information Available The value in the More Information Available field on the Case Test Result.

G.k Drug(s) Information

E2B Data Element Name Populated Value
G.k.1 Characterisation of Drug Role The Drug Role on the Case Product. For Cases with Combination Products, if the Device Report Type includes Malfunction and the Drug Role of the Case Product is Similar Device, Vault populates 4 for Drug Not Administered.
G.k.1.a FDA Other Characterisation of Drug Role Set to 1 when the Drug Role field on the Case Product record is set to Similar Device.
G.k.2.4 Identification of the Country Where the Drug Was Obtained The value in the Country Obtained field on the Case Product record.
G.k.2.5 Investigational Product Blinded The value in the Blinded field on the Case Product record.
G.k.5a Cumulative Dose to First Reaction (number) The value in the Cumulative Dose field on the Case Product record.
G.k.5b Cumulative Dose to First Reaction (unit) The unit in the Cumulative Dose (unit) field on the Case Product record.
G.k.6a Gestation Period at Time of Exposure (number) The value in the Gestation Exposure field on the Case Product record.
G.k.6b Gestation Period at Time of Exposure (unit) The unit in the Gestation Exposure (unit) field on the Case Product record.
G.k.8 Action(s) Taken with Drug

The value in the Action Taken field on the Case Product record.

You must select a Vault E2B code value for this section.

See the following table for the E2B code values and their corresponding E2B(R3) Code values.

Vault E2B Code E2B(R3) Code
1 - Drug Withdrawn 1 - Drug Withdrawn
2 - Dose Reduced 2 - Dose Reduced
3 - Dose Increased 3 - Dose Increased
4 - Dose Not Changed 4 - Dose Not Changed
0 - Unknown 0 - Unknown
9 - Not Applicable 9 - Not Applicable
G.k.10.r Additional Information on Drug (coded) The value in the Additional Information field on the Case Product record.
FDA.G.k.10.r.1 FDA Specialized Product Category The value in the Combination Type field for the Combination Product record associated with the Case Product.
G.k.11 Additional Information on Drug (free text) The value in the Additional Information (text) field on the Case Product record.

G.k.4.r.14 Vaccination Facility

E2B Data Element Name Populated Value
FDA.G.k.4.r.14 Vaccination Facility Name Mapped from the Facility Name field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.1a Vaccination Facility Address Line 1 Mapped from the Street field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.1b Vaccination Facility Address Line 2 Mapped from the Street Line 2 field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.2 Vaccination Facility City Mapped from the City field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.3 Vaccination Facility State Mapped from the State/Province field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.4 Vaccination Facility Country Mapped from the Country field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.5 Vaccination Facility Postal Code Mapped from the Zip/Postal Code field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.6 Vaccination Facility Telephone Mapped from the Telephone field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.7 Vaccination Facility Fax Mapped from the Fax field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.8 Vaccination Facility Type The appropriate NCI Concept Identifier is populated, based on the Facility Type on the Facility Case Contact selected in the Administration Facility field on the Case Product Dosage.
FDA.G.k.4.r.14.9 Vaccination Facility Military Flag Mapped from the Facility Military Flag field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.

G.k.2 Drug Identification

E2B Data Element Name Populated Value
G.k.2.1.2a PhPID Version Date/Number The PhPID Version on the Case Product. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID) The value in the PhPID field on the Case Product record.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source The value in the Product (Reported) field on the Case Product record.
FDA.G.k.2.2.1 U.S. Generic Name The Generic Name field on the Product record associated with the Case Product record.

G.k.2.3.r Substance / Specified Substance Identifier and Strength

E2B Data Element Name Populated Value
G.k.2.3.r.1 Substance / Specified Substance Name The Name (Reported) on the Case Product Substance.
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number The TermID Version on the Case Product Substance. When the value corresponds to a date, Vault converts it to YYYYMMDD format. Vault exports this value only if there is no MPID Version on the Case Product.
G.k.2.3.r.2b Substance / Specified Substance TermID The TermID on the Case Product Substance. Vault exports this value only if there is no MPID on the Case Product.
G.k.2.3.r.3a Strength (number) The Strength (Number) on the Case Product Substance.
G.k.2.3.r.3b Strength (unit) The Strength (Unit) field on the Case Product Substance.

G.k.3 Holder and Authorisation / Application Number of Drug

E2B Data Element Name Populated Value
G.k.3.1 Authorisation / Application Number

If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Number field on the Case Product record.

If the Registration Country is not in the jurisdiction of the agency, this data element is blank.
G.k.3.2 Country of Authorisation / Application

If the Registration Country is within the jurisdiction of the agency, this is populated with the 2-letter country code for the country selected in the Registration Country field on the Case Product record.

If the Registration Country is not in the jurisdiction of the agency or is blank, this data element is blank.
G.k.3.3 Name of Holder / Applicant

If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Holder/Applicant field on the Case Product record.

If the Registration Country is not in the jurisdiction of the agency, this data element is blank.

G.k.4.r Dosage and Relevant Information

E2B Data Element Name Populated Value
G.k.4.r.1a Dose (number) The value in the Dose (number) field on the Case Product Dosage.
G.k.4.r.1b Dose (unit) The unit in the Dose (unit) field on the Case Product Dosage.
G.k.4.r.2 Number of Units in the Interval The value in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit The unit in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug The First Admin Date field on the Case Product Dosage.
G.k.4.r.5 Date and Time of Last Administration The Last Admin Date field on the Case Product Dosage.
G.k.4.r.6a Duration of Drug Administration (number) The Duration (number) on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit) The unit in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number The value in the Batch/Lot Number field on the Case Product Dosage.

This element is not transmitted when nullFlavors are selected.
G.k.4.r.8 Dosage Text The Dosage Text on the Case Product Dosage. When the Dose (Unit) is a custom value, Vault maps the Dose and Dose (Unit) values to this element preceded by the label DOSAGE:.
G.k.4.r.9.1 Pharmaceutical Dose Form (free text) The Dose Form Text on the Case Product Dosage.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number The Dose Form TermID Version on the Case Product Dosage.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID The Dose Form TermID on the Case Product Dosage.
G.k.4.r.10.1 Route of Administration The Patient RoA on the Case Product Dosage. This field is included only if structured data is not provided in G.k.4.r.10.2a/b.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number The Patient RoA TermID Version on the Case Product Dosage.
G.k.4.r.10.2b Route of Administration TermID The Patient RoA TermID on the Case Product Dosage.
G.k.4.r.11.1 Parent Route of Administration (free text) The Parent RoA on the Case Product Dosage.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number The Parent RoA TermID Version on the Case Product Dosage.
G.k.4.r.11.2b Parent Route of Administration TermID The Parent RoA TermID on the Case Product Dosage.
FDA.G.k.4.r.12 Vaccine Anatomical Approach Site The appropriate NCI Concept Identifier is populated, based on the Anatomical Site field on the Case Product Dosage.
FDA.G.k.4.r.13 Dose Number in Series The value in the Dose Number in Series field on the Case Product Dosage.

G.k.7.r Indication for Use in Case

E2B Data Element Name Populated Value
G.k.7.r.1 Indication as Reported by the Primary Source The text from the Name (Reported) field on the Case Product Indication.
G.k.7.r.2a MedDRA Version for Indication Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
G.k.7.r.2b Indication (MedDRA code) The MedDRA LLT coded on the Case Product Indication.

G.k.9.i Drug-reaction(s) / Event(s) Matrix

Vault does not export this section for device constituent assessments.

E2B Data Element Name Populated Value
G.k.9.i.1 Reaction(s) / Event(s) Assessed The specific reaction or event being assessed, referenced in the Case Adverse Event field on the Case Assessment. This is not a user-entered element.
G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number) The First Dose Latency (number) on the Case Assessment.
G.k.9.i.3.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit) The unit in the First Dose Latency (unit) field on the Case Assessment.
G.k.9.i.3.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number) The Last Dose Latency (number) on the Case Assessment.
G.k.9.i.3.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit) The unit in the Last Dose Latency (unit) field on the Case Assessment.
G.k.9.i.4 Did Reaction Recur on Re-administration? The appropriate value is populated, based on the value in the Reaction Recurrence field on the Case Assessment:
  • 1: yes - yes (rechallenge was done, reaction recurred)
  • 2: yes - no (rechallenge was done, reaction did not recur)
  • 3: yes - unk (rechallenge was done, outcome unknown)
  • 4: no - n/a (no rechallenge was done, recurrence is not applicable)

G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) / Event(s)

Vault does not export this section for device constituent assessments.

E2B Data Element Name Populated Value
G.k.9.i.2.r.1 Source of Assessment Vault maps a value based on a Case Assessment Result field, using the following priority:
  1. The E2B code corresponding to the Source Type controlled vocabulary
  2. The Source (text)
G.k.9.i.2.r.2 Method of Assessment Vault maps a value based on a Case Assessment Result field, using the following priority:
  1. The value corresponding to the Method of Assessment controlled vocabulary
  2. The Method (text)
G.k.9.i.2.r.3 Result of Assessment Vault maps a value based on a Case Assessment Result field, using the following priority:
  1. If enabled, Assessment Result (Override)

  2. The Assessment Result value corresponding to the Case Assessment Result controlled Vocabulary
  3. The Result (text)

G.k.12 Device Information

E2B Data Element Name Populated Value
FDA.G.k.12.r.1 Malfunction

For each Combination Product Device Constituent, this element is populated with 1 (Yes) when the Malfunction field on the Case Product is set to Yes.

If the field is blank on the Case Product, Vault populates this element when the Device Report Type field on the Case contains Malfunction.
FDA.G.k.12.r.2.r If follow-up, what type? This element is populated with the value from the Device Follow-Up Type field on the Case.
FDA.G.k.12.r.3.r Device Problem Code

For each Combination Product Device Constituent, this element is populated with the level 1, 2, or 3 harmonized FDA/IMDRF code that was entered on the Case.

Otherwise, the value is mapped from the Device Problem field on the device-type Case Product.
FDA.G.k.12.r.4 Device Brand Name The value entered in the Product Name field on the Product record associated with the device-type Case Product.
FDA.G.k.12.r.5 Common Device Name The value entered in the Generic Name field on the Product record associated with the device-type Case Product.
FDA.G.k.12.r.6 Device Product Code Vault populates a value using the following priority order:
  1. The Product Code on the Case Product
  2. The Product Code on the Product Registration of the constituent of the Case Product
  3. The Product Code on the Product Registration of the associated Combination Product
FDA.G.k.12.r.7.1a Device Manufacturer Name The Name of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1b Device Manufacturer Address The Address of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1c Device Manufacturer City The City of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1d Device Manufacturer State The State of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1e Device Manufacturer Country The Country of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.8 Device Usage The value selected on the Device Usage Type field on the Case Product record.
FDA.G.k.12.r.9 Device Lot Number The value entered in the Lot Number field on the Case Product record.
FDA.G.k.12.r.10a Operator of the Device The value entered in the device Operator of the Device field on the Case Product record.
FDA.G.k.12.r.11.r Remedial Action Initiated

For each Combination Product Device Constituent, for each remedial action selected in the Remedial Action field on the Case Product, Vault populates the following values:

  • 1 (Recall)
  • 2 (Repair)
  • 3 (Replacement)
  • 4 (Relabeling)
  • 5 (Notification)
  • 6 (Inspection)
  • 7 (Patient Monitoring)
  • 8 (Modification/Adjustment)
  • 9 (Other)

If the field is blank on the Case Product, Vault populates this element based on the Remedial Action field on the Case, if available.

FDA.G2 Vaccines Given Within 4 Weeks Organizer

E2B Data Element Name Populated Value
FDA.G2.k.1 Vaccine Type The value from the Vaccine Type field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.3 Date Given The value for the First Admin Date field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.4a Route of Administration TermID Version Date / Number The FDA Concept Code Version from the Patient RoA Version field on the Case Product Dosage for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.4b Route of Administration TermID The FDA Concept Code for the value selected in the Patient RoA field on the Case Product Dosage for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.5 Vaccine Anatomical Approach Site The FDA Concept Code for the value selected in the Anatomical Site field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.6 Dose Number in Series The value from the Dose Number in Series field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.7 Lot Number The value from the Batch/Lot Number field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.8 Manufacturer Name The value from the Manufacturer field on the Product record for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.

H Narrative Case Summary and Further Information

E2B Data Element Name Populated Value
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information The text from the Narrative on the Case, to a limit of 100,000 characters.
H.2 Reporter's Comments The Reporter's Comments on the Case, to a limit of 20,000 characters.
H.4 Sender's Comments The value in the Company Comments field on the Case, to a limit of 20,000 characters.

For Domestic Cases with Localization Scope set to Company Comments or blank, the Localized Company Comments are populated to this element.

H.3.r Sender's Diagnosis

E2B Data Element Name Populated Value
H.3.r.1a MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
H.3.r.1b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code) The MedDRA LLT coded on the Case Diagnosis.

H.5.r Case Summary and Reporter's Comments in Native Language

E2B Data Element Name Populated Value
H.5.r.1a Case Summary and Reporter's Comments Text If there is a Case document classified as Case > Summary > Narrative, Vault populates the contents of that document in this element, to a limit of 100,000 characters.

For Localized Cases with Localization Scope set to Narrative or blank, Vault populates the localized narrative document to this element.

This information is separate from the data captured by H.2 Reporter's Comments.
H.5.r.1b Case Summary and Reporter's Comments Language The 3-letter ISO code from the Language (ISO) document field for the Case document classified as Case > Summary > Narrative.

For Localized Cases with Localization Scope set to Narrative or blank, Vault populates the language selected on the localized narrative document field (language_iso__v) to this element.

This information is separate from the data captured by H.2 Reporter's Comments.

FDA VAERS E2B(R3) Mapping - FDA VAERS Regional Mappings

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value
FDA.C.1.7.1 Local Criteria Report Type

If the primary product is set to Combination Product or if there are Vaccine Case Products, this field will auto-generate when the E2B file is created.

Vault uses the following logic to populate this field:

Populated E2B Code Conditions
FDA.C.1.12 Combination Product Report Flag C.1.7 Expedited Report Flag Device Report Type Field
1 No Yes N/A
1 Yes Yes Blank
2 No No N/A
2 Yes No Blank
4 Yes Yes Public Health Risk
5 Yes No Malfunction Only

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name Populated Value
FDA.C.1.6.1.r.3 Attachment File Name The Case > Document > Filename for the attachment encoded in the transmission.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name Populated Value
FDA.C.1.12 Combination Product Report Flag Set as true when any Case Product is of the type Combination Product.

C.2.r Primary Source(s) of Information

E2B Data Element Name Populated Value
FDA.C.2.r.2.3 Reporter's Street Address - LINE 2 The value in the Street Name - Line 2 field on a Reporter-type Case Contact.
FDA.C.2.r.2.5.1 Reporter's County The value in the County field on a Reporter-type Case Contact.
FDA.C.2.r.2.8 Reporter's Email The value in the Reporter's Email Address field on a Reporter-type Case Contact.
C.2.r.4 Qualification The value in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the FDA Concept Code (NCI Concept Identifier) is mapped.

D Patient Characteristics

E2B Data Element Name Populated Value
FDA.D.1a Patient Name Prefix The value in the Title field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1b Patient First Name The value in the First Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1c Patient Middle Name The value in the Middle Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1d Patient Last Name The value in the Last Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1e Patient Address Line 1 The value in the Street field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1f Patient Address Line 2 The value in the Street Line 2 field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1g Patient Address City The value in the City field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1h Patient Address State or Foreign Province Name The value in the State/Province field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1i Patient Address County The value in the County field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1i Patient Address Country The ISO country code for the country selected in the Country field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1k Patient Address Postal Code The value in the Zip/Postal Code field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to None.
FDA.D.1l Patient Telephone The value in the Telephone field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to tel:None.
FDA.D.1m Patient Email The value in the Email Address field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (patient_id_value__v) field is populated with "NONE", this element is set to mailto:None.

D.2 Age Information

E2B Data Element Name Populated Value
FDA.D.2.1a Age at Time of Vaccination (number) The number value in the Age at Vaccination field on the Case.
FDA.D.2.1a Age at Time of Vaccination (unit) The unit in the Age at Vaccination field on the Case.
D.2.3 Patient Age Group (as per reporter) The value in the Age Group field on the Case. In accordance with ICH guidelines, this element is transmitted only when both the Patient Date of Birth (D.2.1) and Age at Onset (D.2.2) are not transmitted. For Cases with blank Date of Birth, Age at Vaccination, Age, Gestation, and Age Group field values, Vault exports NI.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name Populated Value
FDA.D.7.4a Illness at Time of Vaccination MedDRA Version Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
FDA.D.7.4a Illness at Time of Vaccination MedDRA Code If a Case Medical History record has the Illness at Vaccination? field set to True, then this value is mapped from the MedDRA LLT coded on the Case Medical History. If the LLT term is not available, the PT term is populated.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event) The text in the Medical History Text field on the Case, to a limit of 10,000 characters. For a Case identified as Malfunction Only, if the Patient Initials (case_version__v.patient_id_value__v) field is populated with "NONE", then this data element is set to "None".

D.8.r Relevant Past Drug History

E2B Data Element Name Populated Value
FDA.D.8.r.8a Patient Age at Vaccination (number) The number in the Age at Vaccination field on the Case Drug History record.
FDA.D.8.r.8b Patient Age at Vaccination (unit) The unit selected in the Age at Vaccination field on the Case Drug History record.

D.10 For a Parent-child / Foetus Report, Information Concerning the Parent

E2B Data Element Name Populated Value
FDA.D.10.2.2.1a Parent Age at Vaccination (number) The number in the Age at Vaccination field on the associated Parent Information.
FDA.D.10.2.2.1b Parent Age at Vaccination (unit) The unit in the Age at Vaccination field on the associated Parent Information.
FDA.D.11 Patient Race Code The appropriate NCI Concept Identifier is populated, based on the Race field on the Case.
FDA.D.12 Patient Ethnicity The appropriate NCI Concept Identifier is populated, based on the Ethnicity field on the Case.
FDA.D.13 Pregnant at Time of Vaccination The value from the Pregnant at Vaccination field on the Case.
FDA.D.14 Patient Military Status The appropriate NCI Concept Identifier is populated, based on the Military Status field on the Case.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name Populated Value
FDA.E.i.3.2c.1 Hospitalization Required Populated from the Hospitalization field on the Case Adverse Event.
FDA.E.i.3.2c.1a Number of days hospitalized The value entered in the Days Hospitalized field on the Case Adverse Event.
FDA.E.i.3.2c.1b Hospital Name The value entered in the Hospital Name field on the Case Adverse Event.
FDA.E.i.3.2c.1c City The value entered in the Hospital City field on the Case Adverse Event.
FDA.E.i.3.2c.1d State The value entered in the Hospital State field on the Case Adverse Event.
FDA.E.i.3.2c.2 Resulted in Prolongation of Hospitalization Populated from the Hospitalization field on the Case Adverse Event.
FDA.E.i.3.3a Emergency room/department or urgent care Populated using the Evaluated/Treated At field on the Case Adverse Event.
FDA.E.i.3.3b Doctor or other HCP office/clinic visit Populated using the Evaluated/Treated At field on the Case Adverse Event.
FDA.E.i.3.2g AE Outcome None of the Above Populated as True when both the Seriousness and Evaluated/Treated At fields are blank on the Case Adverse Event.
FDA.E.i.3.4 Best doctor/healthcare professional title or prefix The value in the Title field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4a Best doctor/healthcare professional Last Name The value in the Last Name field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4b Best doctor/healthcare professional First Name The value in the First Name field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4c Best doctor/healthcare professional Middle Name The value in the Middle Name field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4d Best doctor/healthcare professional Telephone and extension The value in the Telephone and Extension field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4e Best doctor/healthcare professional Email The value in the Email field on the best doctor Health Care Professional Contact.

G.k Drug(s) Information

E2B Data Element Name Populated Value
G.k.1 Characterisation of Drug Role The Drug Role on the Case Product. For Cases with Combination Products, if the Device Report Type includes Malfunction and the Drug Role of the Case Product is Similar Device, Vault populates 4 for Drug Not Administered.
G.k.1.a FDA Other Characterisation of Drug Role Set to 1 when the Drug Role field on the Case Product record is set to Similar Device.
FDA.G.k.10.r.1 FDA Specialized Product Category The value in the Combination Type field for the Combination Product record associated with the Case Product.

G.k.4.r.14 Vaccination Facility

E2B Data Element Name Populated Value
FDA.G.k.4.r.14 Vaccination Facility Name Mapped from the Facility Name field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.1a Vaccination Facility Address Line 1 Mapped from the Street field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.1b Vaccination Facility Address Line 2 Mapped from the Street Line 2 field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.2 Vaccination Facility City Mapped from the City field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.3 Vaccination Facility State Mapped from the State/Province field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.4 Vaccination Facility Country Mapped from the Country field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.5 Vaccination Facility Postal Code Mapped from the Zip/Postal Code field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.6 Vaccination Facility Telephone Mapped from the Telephone field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.7 Vaccination Facility Fax Mapped from the Fax field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.8 Vaccination Facility Type The appropriate NCI Concept Identifier is populated, based on the Facility Type on the Facility Case Contact selected in the Administration Facility field on the Case Product Dosage.
FDA.G.k.4.r.14.9 Vaccination Facility Military Flag Mapped from the Facility Military Flag field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.

G.k.2 Drug Identification

E2B Data Element Name Populated Value
FDA.G.k.2.2.1 U.S. Generic Name The Generic Name field on the Product record associated with the Case Product record.

G.k.4.r Dosage and Relevant Information

E2B Data Element Name Populated Value
G.k.4.r.7 Batch / Lot Number The value in the Batch/Lot Number field on the Case Product Dosage.

This element is not transmitted when nullFlavors are selected.
FDA.G.k.4.r.12 Vaccine Anatomical Approach Site The appropriate NCI Concept Identifier is populated, based on the Anatomical Site field on the Case Product Dosage.
FDA.G.k.4.r.13 Dose Number in Series The value in the Dose Number in Series field on the Case Product Dosage.

G.k.12 Device Information

E2B Data Element Name Populated Value
FDA.G.k.12.r.1 Malfunction

For each Combination Product Device Constituent, this element is populated with 1 (Yes) when the Malfunction field on the Case Product is set to Yes.

If the field is blank on the Case Product, Vault populates this element when the Device Report Type field on the Case contains Malfunction.
FDA.G.k.12.r.2.r If follow-up, what type? This element is populated with the value from the Device Follow-Up Type field on the Case.
FDA.G.k.12.r.3.r Device Problem Code

For each Combination Product Device Constituent, this element is populated with the level 1, 2, or 3 harmonized FDA/IMDRF code that was entered on the Case.

Otherwise, the value is mapped from the Device Problem field on the device-type Case Product.
FDA.G.k.12.r.5 Common Device Name The value entered in the Generic Name field on the Product record associated with the device-type Case Product.
FDA.G.k.12.r.6 Device Product Code Vault populates a value using the following priority order:
  1. The Product Code on the Case Product
  2. The Product Code on the Product Registration of the constituent of the Case Product
  3. The Product Code on the Product Registration of the associated Combination Product
FDA.G.k.12.r.7.1a Device Manufacturer Name The Name of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1b Device Manufacturer Address The Address of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1d Device Manufacturer State The State of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1e Device Manufacturer Country The Country of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.8 Device Usage The value selected on the Device Usage Type field on the Case Product record.
FDA.G.k.12.r.9 Device Lot Number The value entered in the Lot Number field on the Case Product record.
FDA.G.k.12.r.10a Operator of the Device The value entered in the device Operator of the Device field on the Case Product record.
FDA.G.k.12.r.11.r Remedial Action Initiated

For each Combination Product Device Constituent, for each remedial action selected in the Remedial Action field on the Case Product, Vault populates the following values:

  • 1 (Recall)
  • 2 (Repair)
  • 3 (Replacement)
  • 4 (Relabeling)
  • 5 (Notification)
  • 6 (Inspection)
  • 7 (Patient Monitoring)
  • 8 (Modification/Adjustment)
  • 9 (Other)

If the field is blank on the Case Product, Vault populates this element based on the Remedial Action field on the Case, if available.

FDA.G2 Vaccines Given Within 4 Weeks Organizer

E2B Data Element Name Populated Value
FDA.G2.k.1 Vaccine Type The value from the Vaccine Type field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.3 Date Given The value for the First Admin Date field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.4a Route of Administration TermID Version Date / Number The FDA Concept Code Version from the Patient RoA Version field on the Case Product Dosage for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.4b Route of Administration TermID The FDA Concept Code for the value selected in the Patient RoA field on the Case Product Dosage for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.5 Vaccine Anatomical Approach Site The FDA Concept Code for the value selected in the Anatomical Site field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.6 Dose Number in Series The value from the Dose Number in Series field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.7 Lot Number The value from the Batch/Lot Number field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.8 Manufacturer Name The value from the Manufacturer field on the Product record for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.