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.
Note: Vault Safety automatically validates E2B files. Case and Submission Validation provides more information. In addition, Vault Safety enables you to configure custom Validation Criteria for Case data through the user-friendly Vault Expression Engine. For more information, see Configure Custom Validation Criteria.
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 |
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N.1.1 Types of Message in batch | This value is always 1 for ICH ICSR. |
N.1.2 Batch Number | The value entered in the E2B Message ID field on the Transmission (Submission or Distribution) record. |
N.1.3 Batch Sender Identifier | The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record. |
N.1.4 Batch Receiver Identifier | The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record. |
N.1.5 Date of Batch Transmission | The value entered in the Transmission Date field on the Transmission (Submission or Distribution) record. 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 |
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N.2.r.1 Message Identifier | The value entered in the UID field on the Case. |
N.2.r.2 Message Sender Identifier | The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record. |
N.2.r.3 Message Receiver Identifier | The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record. |
N.2.r.4 Date of Message Creation | If the Case is Approved or Closed, the date entered 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 | |||||||||||||||||||||||||||||||||
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C.1.1 Sender's (case) Safety Report Unique Identifier | The value from the UID field on the Case Number object. | |||||||||||||||||||||||||||||||||
C.1.2 Date of Creation | The date entered in the Approval Date field if the Case is Approved or Closed. 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. |
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C.1.3 Type of Report | The appropriate value is populated, based on the option selected in the Report Type field on the Case:
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C.1.4 Date Report Was First Received from Source |
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C.1.5 Date of Most Recent Information for This Report | The date entered in the New Info Date field on the Case. | |||||||||||||||||||||||||||||||||
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report? | If the Local Expedited Criteria ( If both fields are blank, nullFlavor ( |
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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:
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C.1.6 Additional Available Documents Held by Sender
E2B Data Element Name | Populated Value |
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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 entered 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 or blank, they are encoded. If the Retransmit field is set to No, documents are not encoded. |
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 |
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C.1.8.1 Worldwide Unique Case Identification Number | The value entered in the Worldwide UID field on the Case Number object. |
C.1.8.2 First Sender of This Case | The value entered 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 entered in the Source field on each Case Identifier object. This element is transmitted only when the Case Identifier Type ( |
C.1.9.1.r.2 Case Identifier(s) | The value entered in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type ( |
C.1.10.r Identification Number of the Report Which Is Linked to This Report | The value entered 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:
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C.1.11.2 Reason for Nullification/Amendment | The text entered 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
C.3 Information on Sender of Case Safety Report
E2B Data Element Name | Populated Value |
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C.3.1 Sender Type | The option selected in the Sender Type field in the Organization record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default Vault maps the Sender Type from the Organization on the Case. |
C.3.2 Sender's Organisation | The value entered in the Organization field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default 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 entered in the Department field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.3.2 Sender's Title | The value entered in the Title field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.3.3 Sender's Given Name | The value entered in the First Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.3.4 Sender's Middle Name | The value entered in the Middle Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.3.5 Sender's Family Name | The value entered in the Last Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.4.1 Sender's Street Address | The value entered in the Street field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.4.2 Sender's City | The value entered in the City field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.4.3 Sender's State or Province | The value entered in the State / Province field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.4.4 Sender's Postcode | The value entered in the Zip/Postal Code field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.4.5 Sender's Country Code | The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.4.6 Sender's Telephone | The value entered in the Telephone field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.4.7 Sender's Fax | The value entered in the Fax field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.3.4.8 Sender's E-mail Address | The value entered in the Email field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. |
C.4.r Literature Reference(s)
E2B Data Element Name | Populated Value |
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C.4.r.1 Literature Reference(s) | The value entered in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters. |
C.4.r.2 Included Documents | Any documents attached to the Case with the document type of Case > Source > Literature and the Retransmit field set to Yes are included with the transmission. |
C.5 Study Identification
E2B Data Element Name | Populated Value |
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C.5.1.r.1 Study Registration Number | The value entered in the Registration Number field on the Case Study Registration object. |
C.5.1.r.2 Study Registration Country | The 2-letter ISO code associated with the country selected in the Country field on the Case Study Registration object. For EMA E2B exports, country codes within the jurisdiction of EMA are replaced with EU in the resulting E2B file. |
C.5.2 Study Name | The values entered 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 value entered in the Study Number field on the associated Study. |
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed | The option populated in the Study Type field on the Case. |
D Patient Characteristics
E2B Data Element Name | Populated Value |
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D.1 Patient (name or initials) | The value entered in the Patient Initials / ID field on the Case. |
FDA.D.1a Patient Name Prefix | The value entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 |
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D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number) | The value entered 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 entered 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 entered 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 entered in the MRN - Investigation field on the Case. |
D.2 Age Information
E2B Data Element Name | Populated Value |
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D.2.1 Date of Birth | The date in the Date of Birth field on the Case. For this data element to be transmitted, 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 value in the Age field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted. |
D.2.2b Age at Time of Onset of Reaction / Event (unit) | The value in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted. |
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 option populated in the Age Group field on the Case. In accordance with ICH guidelines, this element is only transmitted when both the Patient Date of Birth (D.2.1) and Age at Onset (D.2.2) are not transmitted. |
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 option populated in the Gender 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 |
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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 object. |
D.7.1.r.2 Start Date | The date entered in the Start Date field on the Case Medical History object. |
D.7.1.r.3 Continuing | The appropriate value is populated, based on the Continuing field on the Case Medical History object. |
D.7.1.r.4 End Date | The date entered in the End Date field on the Case Medical History object. |
D.7.1.r.5 Comments | The text entered in the Comments field on the Case Medical History object, to a limit of 2,000 characters. |
D.7.1.r.6 Family History | The value selected in the Family History field on the Case Medical History object. |
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 entered 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 |
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D.8.r.1 Name of Drug as Reported | The value entered in the Drug (Reported) field on the Case Drug History record. |
D.8.r.2a MPID Version Date/Number | The value entered in the MPID Version field on the Case Drug History record. |
D.8.r.2b Medicinal Product Identifier (MPID) | The value entered in the MPID field on the Case Drug History record. |
D.8.r.3a PhPID Version Date/Number | The value entered in the PhPID Version field on the Case Drug History record. |
D.8.r.3b Pharmaceutical Product Identifier (PhPID) | The value entered in the PhPID field on the Case Drug History record. |
D.8.r.4 Start Date | The date entered in the Start Date field on the Case Drug History record. |
D.8.r.5 End Date | The value entered 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 entered in the Reaction MedDRA field on the Case Drug History record. |
FDA.D.8.r.8a Patient Age at Vaccination (number) | The number entered 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 |
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D.9.1 Date of Death | The date entered 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 entered in the Name (Reported) field on the Reported Case Cause of Death object. |
D.9.3 Was Autopsy Done? | The value selected 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 entered 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 |
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D.10.1 Parent Identification | The value entered in the Patient ID field on the associated Parental-type Case. |
D.10.2.1 Date of Birth of Parent | The date entered in the Date of Birth field on the associated Parental-type Case. For this data element to be transmitted, the full date is required with year, month, and day. |
D.10.2.2a Age of Parent (number) | The value entered in the Age field on the associated Parental-type Case. |
D.10.2.2b Age of Parent (unit) | The unit entered in the Age (unit) field on the associated Parental-type Case. |
FDA.D.10.2.2.1a Parent Age at Vaccination (number) | The number entered in the Age at Vaccination field on the associated Parental-type Case. |
FDA.D.10.2.2.1b Parent Age at Vaccination (unit) | The unit selected in the Age at Vaccination field on the associated Parental-type Case. |
D.10.3 Last Menstrual Period Date of Parent | The date entered in the Last Menstrual field on the associated Parental-type Case. |
D.10.4 Body Weight (kg) of Parent | The value entered in the Weight field on the associated Parental-type Case. |
D.10.5 Height (cm) of Parent | The value entered in the Height (normalized) field on the associated Parental-type Case. |
D.10.6 Sex of Parent | The value entered in the Gender field on the associated Parent-type Case. |
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 Parental-type Case. |
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code) | The MedDRA LLT coded on the Case Medical History object on the associated Parental-type Case. |
D.10.7.1.r.2 Start Date | The date entered in the Start Date field on the Case Medical History object on the associated Parental-type Case. |
D.10.7.1.r.3 Continuing | The value selected in the Continuing field on the Case Medical History object on the associated Parental-type Case. |
D.10.7.1.r.4 End Date | The date entered in the End Date field on the Case Medical History object on the associated Parental-type Case. |
D.10.7.1.r.5 Comments | The text entered in the Comments field on the Case Medical History object on the associated Parental-type Case, to a limit of 2,000 characters. |
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent | The text entered in the Medical History Text field on the associated Parental-type Case, 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 |
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D.10.8.r.1 Name of Drug as Reported | The text entered in the Name Reported field on the Case Drug History object on the associated Parental-type Case. |
D.10.8.r.2a MPID Version Date/Number | The value entered in the MPID Version field on the Case Drug History object on the associated Parental-type Case. |
D.10.8.r.2b Medicinal Product Identifier (MPID) | The value entered in the MPID field on the Case Drug History object on the associated Parental-type Case. |
D.10.8.r.3a PhPID Version Date/Number | The value entered in the PhPID Version field on the Case Drug History object on the associated Parental-type Case. |
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID) | The value entered in the PhPID field on the Case Drug History object on the associated Parental-type Case. |
D.10.8.r.4 Start Date | The date entered in the Start Date field on the Case Drug History object on the associated Parental-type Case. |
D.10.8.r.5 End Date | The date entered in the End Date field on the Case Drug History object on the associated Parental-type Case. |
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 Parental-type Case. |
D.10.8.r.6b Indication (MedDRA code) | The indication MedDRA LLT coded on the Case Drug History object on the associated Parental-type Case. |
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 Parental-type Case. |
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 Parental-type Case. |
E.I Reaction/Event as Reported by the Primary Source
E2B Data Element Name | Populated Value |
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E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language | The text entered in the Event (Reported) field on the Case Adverse Event. |
E.i.1.1b Reaction / Event as Reported by the Primary Source Language | The text entered in the Event (Reported) - Language field on the Case Adverse Event. |
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation | The text entered 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 value entered in the Event (MedDRA) field on the Case Adverse Event. |
E.i.3.1 Term Highlighted by the Reporter | The value selected 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 | ||||||||||||||
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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 entered 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 entered 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 entered 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 entered 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 entered 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 entered in the Email field on the best doctor Health Care Professional Contact. | ||||||||||||||
E.i.4 Date of Start of Reaction / Event | The date entered in the Onset field on the Case Adverse Event. | ||||||||||||||
E.i.5 Date of End of Reaction / Event | The date entered in the Resolved field on the Case Adverse Event. | ||||||||||||||
E.i.6a Duration of Reaction / Event (number) | The value entered in the Duration field on the Case Adverse Event. | ||||||||||||||
E.i.6b Duration of Reaction / Event (unit) | The unit entered 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 selected 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.
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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 . |
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E.i.9 Identification of the Country Where the Reaction / Event Occurred | The value entered 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 entered in the Test Date field on the Case Test Result. |
F.r.2.1 Test Name (free text) | The information entered 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 selected in the Result (code) field on the Case Test Result. |
F.r.3.2 Test Result (value / qualifier) | The values entered 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 selected 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 information entered in the Result (Text) field on the Case Test Result. In accordance with ICH guidelines, Vault adheres to the following rules when mapping this field:
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F.r.4 Normal Low Value | The unit and value entered 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 entered 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 information entered in the Comments field on the Case Test Result. |
F.r.7 More Information Available | The value entered 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 value entered in the Drug Role field on the Case Product record. | ||||||||||||||
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. |
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G.k.2.4 Identification of the Country Where the Drug Was Obtained | The value entered in the Country Obtained field on the Case Product record. | ||||||||||||||
G.k.2.5 Investigational Product Blinded | The value entered in the Blinded field on the Case Product record. | ||||||||||||||
G.k.5a Cumulative Dose to First Reaction (number) | The value entered in the Cumulative Dose field on the Case Product record. | ||||||||||||||
G.k.5b Cumulative Dose to First Reaction (unit) | The unit selected in the Cumulative Dose (unit) field on the Case Product record. | ||||||||||||||
G.k.6a Gestation Period at Time of Exposure (number) | The value entered in the Gestation Exposure field on the Case Product record. | ||||||||||||||
G.k.6b Gestation Period at Time of Exposure (unit) | The unit selected in the Gestation Exposure (unit) field on the Case Product record. | ||||||||||||||
G.k.8 Action(s) Taken with Drug | The value selected 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.
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G.k.10.r Additional Information on Drug (coded) | The value selected in the Additional Information field on the Case Product record. | ||||||||||||||
FDA.G.k.10.r.1 FDA Specialized Product Category | The value selected 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 information entered 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.2.1.1a MPID Version Date / Number | The value entered in the MPID Version field on the Case Product record. |
G.k.2.1.1b Medicinal Product Identifier (MPID) | The value entered in the MPID field on the Case Product record. |
G.k.2.1.2a PhPID Version Date/Number | The value entered in the PhPID Version field on the Case Product record. |
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID) | The value entered in the PhPID field on the Case Product record. |
G.k.2.2 Medicinal Product Name as Reported by the Primary Source | The information entered 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 information entered in the Name (Reported) field on the Case Product Substance. |
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number | The value entered in the TermID Version field on the Case Product Substance. |
G.k.2.3.r.2b Substance / Specified Substance TermID | The value entered in the TermID field on the Case Product Substance. |
G.k.2.3.r.3a Strength (number) | The value entered in the Strength (Number) field on the Case Product Substance. |
G.k.2.3.r.3b Strength (unit) | The unit selected in 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 entered in the Dose (number) field on the Case Product Dosage. |
G.k.4.r.1b Dose (unit) | The unit selected in the Dose (unit) field on the Case Product Dosage. |
G.k.4.r.2 Number of Units in the Interval | The value entered in the Frequency (number) field on the Case Product Dosage. |
G.k.4.r.3 Definition of the Time Interval Unit | The unit selected in the Frequency (unit) field on the Case Product Dosage. |
G.k.4.r.4 Date and Time of Start of Drug | The information entered in the First Administration field on the Case Product Dosage. |
G.k.4.r.5 Date and Time of Last Administration | The information entered in the Last Administration field on the Case Product Dosage. |
G.k.4.r.6a Duration of Drug Administration (number) | The value entered in the Duration (number) field on the Case Product Dosage. |
G.k.4.r.6b Duration of Drug Administration (unit) | The unit selected in the Duration (unit) field on the Case Product Dosage. |
G.k.4.r.7 Batch / Lot Number | The information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours are selected. |
G.k.4.r.8 Dosage Text | The information entered in the Dosage Text field on the Case Product Dosage. When a custom value is entered in the Dose (Unit) field, the Dose and Dose (Unit) values are mapped to this element, preceded by the label "DOSAGE:". |
G.k.4.r.9.1 Pharmaceutical Dose Form (free text) | The information entered in the Dose Form Text field on the Case Product Dosage. |
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number | The information entered in the Dose Form TermID Version field on the Case Product Dosage. |
G.k.4.r.9.2b Pharmaceutical Dose Form TermID | The information entered in the Dose Form TermID field on the Case Product Dosage. |
G.k.4.r.10.1 Route of Administration | The value in the Patient RoA field on the Case Product Dosage. This field is only included 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 information entered in the Patient RoA TermID Version field on the Case Product Dosage. |
G.k.4.r.10.2b Route of Administration TermID | The value entered in the Patient RoA TermID field on the Case Product Dosage. |
G.k.4.r.11.1 Parent Route of Administration (free text) | The value in the Parent RoA field on the Case Product Dosage. |
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number | The information entered in the Parent RoA TermID Version field on the Case Product Dosage. |
G.k.4.r.11.2b Parent Route of Administration TermID | The value entered in the Parent RoA TermID field 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 selected 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
E2B Data Element Name | Populated Value |
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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 value entered in the First Dose Latency (number) field 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 selected 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 value entered in the Last Dose Latency (number) field 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 selected 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 option selected in the Reaction Recurrence field on the Case Assessment:
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G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) / Event(s)
E2B Data Element Name | Populated Value |
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G.k.9.i.2.r.1 Source of Assessment | Vault maps this value from one of the following fields on the Case Assessment Result, ordered by priority:
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G.k.9.i.2.r.2 Method of Assessment | Vault maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:
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G.k.9.i.2.r.3 Result of Assessment | Vault maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:
Note: An Admin must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your Vault.
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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 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 | The value entered in the Product Code field on the Product Registration record associated with the device-type Case 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:
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 |
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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.2a MPID Version Date / Number | The value from the MPID Version field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product. |
FDA.G2.k.2b Medicinal Product Identifier (MPID) | The value from the MPID 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 text from the Reporter's Comments field on the Case, to a limit of 20,000 characters. |
H.4 Sender's Comments | The information entered 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 with the Case > Summary > Narrative, the contents of that document is populated in this element, to a limit of 100,000 characters. For Domestic Cases with Localization Scope set to "Narrative" or blank, the Localized Narrative document is populated 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 with the Case > Summary >Narrative. For Domestic Cases with Localization Scope set to "Narrative" or blank, the language selected on the Localized Narrative document (Document field ( 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 | |||||||||||||||||||||||||||||||||
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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:
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C.1.6 Additional Available Documents Held by Sender
E2B Data Element Name | Populated Value |
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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 |
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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 entered 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 populated in the County field on a Reporter-type Case Contact. |
FDA.C.2.r.2.8 Reporter's Email | The value populated in the Reporter's Email Address field on a Reporter-type Case Contact. |
C.2.r.4 Qualification | The option selected 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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.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 entered 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 entered 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 entered in the Age at Vaccination field on the associated Parental-type Case. |
FDA.D.10.2.2.1b Parent Age at Vaccination (unit) | The unit selected in the Age at Vaccination field on the associated Parental-type Case. |
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 entered 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 entered 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 entered 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 entered 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 entered 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 entered 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.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 selected 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 information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours 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 selected 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 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 | The value entered in the Product Code field on the Product Registration record associated with the device-type Case 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:
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.2a MPID Version Date / Number | The value from the MPID Version field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product. |
FDA.G2.k.2b Medicinal Product Identifier (MPID) | The value from the MPID 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. |