Field Import Data from External Data Sources

Veeva imports data from external sources, which Vault maps to Safety objects and fields for signal analysis. Vault can map data from: 

FAERS

Veeva ingests the following fields from FAERS to your Vault:

FAERS Field Description
age_in_years_derived The patient's age in years, determined based on the patient_age_number and patient_age_unit.
case_authority_number The regulatory authority's case report number.
case_company_number The unique identification number provided to the FDA by the manufacturer submitting the report.
case_deleted_date The date the Case version was deleted.
case_event_date The date on which the event occurred.
case_number The unique report identifier used by the FDA FAERS to link additional information.
case_prior_transmission Other case identifiers in previous Transmissions.
case_version The Safety report version number.
case_version_id The unique report identifier Veeva uses to identify a Case. This identifier is composed of the case_number, case_version, and receipt_date.
drug_action_taken_e2b_code

The action taken with the product and the corresponding E2B code values as a result of the adverse event:

  • 1: Drug Withdrawn
  • 2: Dose Reduced
  • 3: Dose Increased
  • 4:  Dose Not Changed
  • 0: Unknown
  • 9: Not Applicable
drug_authorization_number The New Drug Application (NDA) number.
drug_batch_number The batch or lot number.
drug_cumulative_dosage_number The cumulative dose to the first reaction.
drug_cumulative_dosage_unit

The unit of the cumulative dose to the first reaction:

  • 001: kg kilogram(s)
  • 002: G gram(s)
  • 003: Mg milligram(s)
  • 004: μg microgram(s)

For a list of additional units and codes, see the ICH ICSR Specification document.
drug_dechallenge_outcome_e2b_code

The dechallenge outcome information (event abated after stopping product use or reducing dose):

  • 1: Yes
  • 2: No
  • 3: Doesn’t Apply

Veeva extracts the first number from the reported text.
drug_dosage_form The pharmaceutical dose form.
drug_dosage_text The drug dosage and frequency in text.
drug_first_admin_date The date the patient started taking the drug.
drug_indication The MedDRA Preferred Term (PT).
drug_interval_dosage_unit_number The frequency of the drug dosage.
drug_interval_dosage_definition

The unit of frequency of the drug dosage:

  • 801: Year
  • 802: Month
  • 803: Week
  • 804: Day
  • 805: Hour
  • 806: Minute
  • 807: Second
  • 810: Trimester
  • 811: Cyclical
  • 812: As Necessary
  • 813: Total
drug_last_admin_date The date the patient stopped taking the drug.
drug_reaction_recurrence_e2b_code

Indicates whether a reaction recurred on readministration:

  • 1: Yes
  • 2: No
  • 3: Unknown
drug_role_e2b_code

The reported drug role in the adverse event:

  • 1: Suspect
  • 2: Concomitant
  • 3: Interacting
  • 4: Drug Not Administered

When the drug_dechallenge_outcome_e2b_code includes “Drug Not Administered” text and the drug_role_e2b_code is blank, Veeva populates this field as 4.
drug_route_of_admin

The route of administration:

  • 001: Auricular (otic)
  • 002: Buccal
  • 003: Cutaneous
  • 004: Dental
  • 005: Endocervical
  • 006: Endosinusial
  • 007: Endotracheal
  • 008: Epidural
  • 009: Extra-amniotic
  • 010: Hemodialysis
  • 011: Intra corpus cavernosum
  • 012: Intra-amniotic
  • 013: Intra-arterial
  • 014: Intra-articular

For a list of additional codes, see the ICH ICSR Specification document.
drug_separate_dosage_number The number of separate dosages.
drug_structured_dosage_number The dose number.
drug_structured_dosage_unit

The dose unit:

  • 001: kg kilogram(s)
  • 002: G gram(s)
  • 003: Mg milligram(s)
  • 004: µg microgram(s)
  • 005: ng nanogram(s)
  • 006: pg picogram(s)
  • 007: mg/kg milligram(s)/kilogram
  • 008: µg/kg microgram(s)/kilogram
  • 009: mg/m 2 milligram(s)/sq. meter 010=µg/ m 2 microgram(s)/ sq. Meter
  • 011: l litre(s)
  • 012: ml millilitre(s)
  • 013: µl microlitre(s)
  • 014: Bq becquerel(s)
  • 015: GBq gigabecquerel(s)
  • 016: MBq megabecquerel(s)
  • 017: Kbq kilobecquerel(s)
  • 018: Ci curie(s)
  • 019: MCi millicurie(s)
  • 020: µCi microcurie(s)
  • 021: NCi nanocurie(s)
  • 022: Mol mole(s)
  • 023: Mmol millimole(s)
  • 024: µmol micromole(s)
  • 025: Iu international unit(s)
  • 026: Kiu iu(1000s)
  • 027: Miu iu(1,000,000s)
  • 028: iu/kg iu/kilogram
  • 029: Meq milliequivalent(s)
  • 030: % percent
  • 031: Gtt drop(s)
  • 032: DF dosage form

For a list of additional units and codes, see the ICH ICSR document.
drug_treatment_duration_number The duration of drug administration.
drug_treatment_duration_unit

The unit of duration of drug administration:

  • 801: Year
  • 802: Month
  • 803: Week
  • 804: Day
  • 805: Hour
  • 806: Minute
duplicate Populated by Veeva to identify the report is a duplicate of another Case version.
event_country_code The country where the reaction or event occurred. The FDA provides the list of country codes.
expedite_criteria_code

The expedited reporting options:

  • 3: Direct report
  • 4: 5-day report
  • 5: 30-day report
event_reaction_outcome_e2b_code

The outcome of the reaction or event at the time of the last observation:

  • 1: Recovered/resolved
  • 2: Recovering/resolving
  • 3: Not recovered/not resolved
  • 4: Recovered/resolved with sequelae
  • 5: Fatal
  • 6: Unknown
faers_quarter_end_date The quarterly period’s end date in which the Case version was ingested.
faers_quarter_start_date The quarterly period’s start date in which the Case version was ingested.
latest_version_reporter_country_code The reporter's country in the latest case version. The FDA provides the list of country codes.
literature_reference The literature reference information.
meddra_language_coded The MedDRA language (English), used by Veeva to code meddra_pt_as_reported to the latest MedDRA version.
meddra_manual_coded Indicates whether meddra_pt_coded and meddra_pt_code_coded were automatically coded to the latest MedDRA version (No), or manually coded (Yes).
meddra_pt_as_reported The reported MedDRA PT.
meddra_pt_coded The MedDRA PT, coded by Veeva to the latest MedDRA version.
meddra_pt_code_coded The MedDRA PT code, coded by Veeva to the latest MedDRA version.
meddra_version_as_reported The MedDRA version for the reaction or event PT.
meddra_version_coded The MedDRA version, used by Veeva to code meddra_pt_as_reported to the latest MedDRA version.
patient_age_number The patient's age at onset of the adverse event.
patient_age_unit

The unit of the patient’s age:

  • 800: Decade
  • 801: Year
  • 802: Month
  • 803: Week
  • 804: Day
  • 805: Hour
patient_age_group_e2b_code_derived The patient's age group code, determined based on the patient_age_group_e2b_code and age_in_years_derived.
patient_gender_e2b_code

The patient’s gender:

  • 0: Unknown
  • 1: Male
  • 2: Female
patient_weight_in_kg The patient's weight in kilograms.
primary_reporter_country_code The primary reporter's country. The FDA provides the list of country codes.
primary_reporter_qualification_e2b_code

The primary contact’s qualification:

  • 1: Physician
  • 2: Pharmacist
  • 3: Other Health Professional
  • 4: Lawyer
  • 5: Consumer or non-health professional
product_as_reported The product's trade name if available. Otherwise, the name as reported by the source.
product_id Unique Identifier for a product and substance combination.
receipt_date The date the most recent report was received by the FDA.
receive_date The date the report was initially received by the FDA.
report_type_e2b_code

The type of report:

  • 1: Spontaneous
  • 2: Report from Study
  • 3: Other
  • 4: Not available to sender (unknown)
sender_organization The sender’s organization, which populates as FDA-Public Use.
sender_type The sender’s type, which populates as 2 (Regulatory Authority).
serious Indicates whether the event is serious. If there are any seriousness criteria, this field populates as 1 (Yes). Otherwise, this field populates as 2 (No).
seriousness_congenital_anomaly Seriousness criterion: Congenital anomaly/birth defect
seriousness_death Seriousness criterion: Results in death
seriousness_disabling Seriousness criterion: Disabling/incapacitating
seriousness_hospitalization Seriousness criterion: Seriousness: Caused/prolonged hospitalisation
seriousness_life_threatening Seriousness criterion: Life threatening
seriousness_other Seriousness criterion: Other medically important condition
substance_as_reported The product's active ingredient.

VAERS

Veeva ingests the following fields from VAERS to your Vault:

VAERS Field Description
allergies_text Allergies to medications, food, or other products, including narrative text of any physician-diagnosed allergies that existed at the time of vaccination.
birth_defect Indicates whether the vaccine recipient had a congenital anomaly or birth defect associated with the vaccination.
case_number The unique report identifier used by the FDA VAERS to link vaers_case, vaers_case_product, and vaers_case_event.
case_prior_transmission_number The case identifier, for example, the manufacturer control number from the latest Case version.
case_prior_transmission_source The source of the case identifier, for example, the coded name of the manufacturer or the reported name of the organization sending the report.
case_version The Safety report version number.
case_version_id The unique report identifier Veeva uses to identify a Case. This identifier is composed of the case_number, case_version, and receipt_date.
company_number The reported manufacturer or immunization project report number.
date_of_death The date of death of the vaccine recipient, if applicable.
days_hospitalized The number of days the vaccine recipient was hospitalized.
domestic_case Indicates whether the report is domestic (the product was marketed and the event occurred in the United States).
er_ed_visit Indicates whether the vaccine recipient visited the emergency room/department or urgent care.
history_text Chronic or long-standing health conditions, including physician-diagnosed allergies, birth defects, or medical conditions that existed at the time of vaccination.
hospital_extended_stay Indicates whether the vaccine recipient's hospitalization is prolonged as a result of the adverse event associated with the vaccination.
illness_at_vaccination_text Illnesses at time of vaccination.
lab_data_text Reported diagnostic tests or laboratory results.
meddra_language_coded The MedDRA language (English), used by Veeva to code meddra_pt_as_reported to the latest MedDRA version.
meddra_manual_coded Indicates whether meddra_pt_coded and meddra_pt_code_coded were automatically coded to the latest MedDRA version (No), or manually coded (Yes).
meddra_pt_as_reported The reported MedDRA PT.
meddra_pt_coded The MedDRA PT, coded by Veeva to the latest MedDRA version.
meddra_pt_code_coded The MedDRA PT code, coded by Veeva to the latest MedDRA version.
meddra_version_as_reported The MedDRA version for the reaction or event PT.
meddra_version_coded The MedDRA version, used by Veeva to code meddra_pt_as_reported to the latest MedDRA version.
office_visit Indicates whether the vaccine recipient visited the doctor's or other healthcare provider's office or clinic.
onset_date The onset date of adverse event symptoms associated with the vaccination.
onset_days The calculated interval (in days) from the vaccination date to the onset date.
other_meds_text Prescription or non-prescription drugs the vaccine recipient was taking at the time of vaccination.
patient_age_group_e2b_code

The vaccine recipient’s age group code based on the patient_age_inyrs:

  • 0 (Fetus): Zero weeks/days/hours/minutes old
  • 1 (Neonate): More than zero to fewer than four weeks old
  • 2 (Infant): One month to fewer than 24 months old
  • 3 (Child): Two years to fewer than 12 years old
  • 4 (Adolescent): 12 years to fewer than 18 years old
  • 5 (Adult): 18 years to fewer than 65 years old
  • 6 (Elderly): 65 years and older
patient_age_inyrs The reported vaccine recipient's age in years.
patient_age_months The calculated vaccine recipient's age in months by the FDA.

The sum of patient_age_months and patient_age_value provide the calculated age of a person. For example, if patient_age_months is 0.5 and the patient_age_value is 1, then the individual's age is 1.5 years or 1 year 6 months.
patient_age_value The calculated vaccine recipient's age in years by the FDA.

The sum of patient_age_months and patient_age_value provide the calculated age of a person. For example, if patient_age_months is 0.5 and the patient_age_value is 1, then the individual's age is 1.5 years or 1 year 6 months.
patient_gender_e2b_code

The vaccine recipient’s gender:

  • U: Unknown
  • 1: Male
  • 2: Female
prior_vax_event_text Prior vaccination event information.
product_id Unique identifier for the vaccine.
product_name The FDA medicinal product.
receive_date The date the VAERS form information was initially received by the FDA.
recovered_e2b_code

Indicates whether the vaccine recipient recovered:

  • 0: Unknown (U) or blank (B)
  • 1: Yes (Y)
  • 3: No (N)
report_date The date the VAERS form information was reported.
serious Indicates whether the event is serious (seriousness criteria exists).
seriousness_congenital_anomaly Seriousness criterion: Indicates whether the vaccine recipient had a congenital anomaly or birth defect associated with the vaccination.
seriousness_death Seriousness criterion: Indicates whether the vaccine recipient died as a result of the vaccination.
seriousness_disabling Seriousness criterion: Indicates whether the vaccine recipient was disabled as a result of the vaccination.
seriousness_hospitalization

Seriousness criterion: Evaluates as true if any of the following criteria are met as a result of the vaccination:

  • The recipient was hospitalized
  • The number of days hospitalized is greater than zero
  • The recipient had a prolonged hospitalization
  • The recipient visited the emergency room or doctor
  • The recipient visited a doctor’s or other healthcare provider’s office or clinic
seriousness_life_threatening Seriousness criterion: Indicates whether the vaccine recipient had a life-threatening event associated with the vaccination.
state The two-letter US Postal Service abbreviation for the home state of the vaccine.
symptoms_text Reported symptoms associated with the vaccine.
vaccine_admin_facility_type

The type of facility where the vaccine was administered:

  • PUB: Public
  • PVT: Private
  • MIL: Military
  • PHM: Pharmacy or store
  • SCH: School or student health clinic
  • SEN: Nursing home or senior living facility
  • WRK: Workplace clinic
  • OTH: Other
  • UNK: Unknown
vaccine_date The date of vaccination.
vaccine_dose_series The number of vaccination doses administered.
vaccine_funded_by The type of funds used to purchase vaccines.
vaccine_lot_number The manufacturer's vaccine lot number.
vaccine_manufacturer The vaccine's manufacturer.
vaccine_name_as_reported The brand name of the administered vaccine.
vaccine_route_of_admin The vaccine's route of administration.
vaccine_route_of_admin_code The vaccine's route of administration (code).
vaccine_site_of_admin The vaccine's site of administration.
vaccine_site_of_admin_code The vaccine's site of administration (code).
vaccine_type The vaccine type.
vaccine_type_code The vaccine type (code).