**Source URL:** https://safety.veevavault.help/en/lr/1205285/

# 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: 
* [FDA Adverse Event Reporting System][1] (FAERS)
* [Vaccine Adverse Event Reporting System][2] (VAERS)

**Note**: The FDA has relabeled the FAERS database to the Adverse Event Monitoring System (AEMS). Vaults will reflect this change in a future release.

## FAERS {#faers}

Veeva ingests the following fields from FAERS to your Vault:

<table>
<thead>
<tr>
<th>FAERS Field
<th>Description

<tbody>
<tr>
<td>age_in_years_derived
<td>The patient's age in years, determined based on the patient_age_number and patient_age_unit.

<tr>
<td>case_authority_number
<td>The regulatory authority's case report number.

<tr>
<td>case_company_number
<td>The unique identification number provided to the FDA by the manufacturer submitting the report.

<tr>
<td>case_deleted_date
<td markdown="span">The date the _Case_ version was deleted.

<tr>
<td>case_event_date
<td>The date on which the event occurred.

<tr>
<td>case_number
<td>The unique report identifier used by the FDA FAERS to link additional information.

<tr>
<td>case_prior_transmission
<td markdown="span">Other case identifiers in previous _Transmissions_.

<tr>
<td>case_version
<td>The Safety report version number.

<tr>
<td>case_version_id
<td markdown="span">The unique report identifier Veeva uses to identify a _Case_. This identifier is composed of the case_number, case_version, and receipt_date.

<tr>
<td>drug_action_taken_e2b_code
<td markdown="block">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* `1`: Drug Withdrawn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

<tr>
<td>drug_authorization_number
<td>The New Drug Application (NDA) number.

<tr>
<td>drug_batch_number
<td>The batch or lot number.

<tr>
<td>drug_cumulative_dosage_number
<td>The cumulative dose to the first reaction.

<tr>
<td>drug_cumulative_dosage_unit
<td markdown="block">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.

<tr>
<td>drug_dechallenge_outcome_e2b_code
<td markdown="block">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.

<tr>
<td>drug_dosage_form
<td>The pharmaceutical dose form.

<tr>
<td>drug_dosage_text
<td>The drug dosage and frequency in text.

<tr>
<td>drug_first_admin_date
<td>The date the patient started taking the drug.

<tr>
<td>drug_indication
<td>The MedDRA Preferred Term (PT).

<tr>
<td>drug_interval_dosage_unit_number
<td>The frequency of the drug dosage.

<tr>
<td>drug_interval_dosage_definition
<td markdown="block">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

<tr>
<td>drug_last_admin_date
<td>The date the patient stopped taking the drug.

<tr>
<td>drug_reaction_recurrence_e2b_code
<td markdown="block">Indicates whether a reaction recurred on readministration:

* `1`: Yes
* `2`: No
* `3`: Unknown

<tr>
<td>drug_role_e2b_code
<td markdown="block">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`.

<tr>
<td>drug_route_of_admin
<td markdown="block">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.

<tr>
<td>drug_separate_dosage_number
<td>The number of separate dosages.

<tr>
<td>drug_structured_dosage_number
<td>The dose number.

<tr>
<td>drug_structured_dosage_unit
<td markdown="block">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.

<tr>
<td>drug_treatment_duration_number
<td>The duration of drug administration.

<tr>
<td>drug_treatment_duration_unit
<td markdown="block">The unit of duration of drug administration:

* `801`: Year
* `802`: Month
* `803`: Week
* `804`: Day
* `805`: Hour
* `806`: Minute

<tr>
<td>duplicate
<td markdown="span">Populated by Veeva to identify the report is a duplicate of another _Case_ version.

<tr>
<td>event_country_code
<td>The country where the reaction or event occurred. The FDA provides the list of country codes.

<tr>
<td>expedite_criteria_code
<td markdown="block">The expedited reporting options:

* `3`: Direct report
* `4`: 5-day report
* `5`: 30-day report

<tr>
<td>event_reaction_outcome_e2b_code
<td markdown="block">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

<tr>
<td>faers_quarter_end_date
<td markdown="span">The quarterly period's end date in which the _Case_ version was ingested.

<tr>
<td>faers_quarter_start_date
<td markdown="span">The quarterly period's start date in which the _Case_ version was ingested.

<tr>
<td>latest_version_reporter_country_code
<td>The reporter's country in the latest case version. The FDA provides the list of country codes.

<tr>
<td>literature_reference
<td>The literature reference information.

<tr>
<td>meddra_language_coded
<td>The MedDRA language (English), used by Veeva to code meddra_pt_as_reported to the latest MedDRA version.

<tr>
<td>meddra_manual_coded
<td>Indicates whether meddra_pt_coded and meddra_pt_code_coded were automatically coded to the latest MedDRA version (No), or manually coded (Yes).

<tr>
<td>meddra_pt_as_reported
<td>The reported MedDRA PT.

<tr>
<td>meddra_pt_coded
<td>The MedDRA PT, coded by Veeva to the latest MedDRA version.

<tr>
<td>meddra_pt_code_coded
<td>The MedDRA PT code, coded by Veeva to the latest MedDRA version.

<tr>
<td>meddra_version_as_reported
<td>The MedDRA version for the reaction or event PT.

<tr>
<td>meddra_version_coded
<td>The MedDRA version, used by Veeva to code meddra_pt_as_reported to the latest MedDRA version.

<tr>
<td>patient_age_number
<td>The patient's age at onset of the adverse event.

<tr>
<td>patient_age_unit
<td markdown="block">The unit of the patient's age: 

* `800`: Decade
* `801`: Year
* `802`: Month
* `803`: Week
* `804`: Day
* `805`: Hour

<tr>
<td>patient_age_group_e2b_code_derived
<td>The patient's age group code, determined based on the patient_age_group_e2b_code and age_in_years_derived.

<tr>
<td>patient_gender_e2b_code
<td markdown="block">The patient's gender:

* `0`: Unknown
* `1`: Male
* `2`: Female

<tr>
<td>patient_weight_in_kg
<td>The patient's weight in kilograms.

<tr>
<td>primary_reporter_country_code
<td>The primary reporter's country. The FDA provides the list of country codes.

<tr>
<td>primary_reporter_qualification_e2b_code
<td markdown="block">The primary contact's qualification:

* `1`: Physician
* `2`: Pharmacist
* `3`: Other Health Professional
* `4`: Lawyer
* `5`: Consumer or non-health professional

<tr>
<td>product_as_reported
<td>The product's trade name if available. Otherwise, the name as reported by the source.

<tr>
<td>product_id
<td>Unique Identifier for a product and substance combination.

<tr>
<td>receipt_date
<td>The date the most recent report was received by the FDA.

<tr>
<td>receive_date
<td>The date the report was initially received by the FDA.

<tr>
<td>report_type_e2b_code
<td markdown="block">The type of report:

* `1`: Spontaneous
* `2`: Report from Study
* `3`: Other
* `4`: Not available to sender (unknown)

<tr>
<td>sender_organization
<td markdown="span">The sender's organization, which populates as `FDA-Public Use`.

<tr>
<td>sender_type
<td markdown="span">The sender's type, which populates as `2` (Regulatory Authority).

<tr>
<td>serious
<td markdown="span">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).

<tr>
<td>seriousness_congenital_anomaly
<td>Seriousness criterion: Congenital anomaly/birth defect

<tr>
<td>seriousness_death
<td>Seriousness criterion: Results in death

<tr>
<td>seriousness_disabling
<td>Seriousness criterion: Disabling/incapacitating

<tr>
<td>seriousness_hospitalization
<td>Seriousness criterion: Seriousness: Caused/prolonged hospitalisation

<tr>
<td>seriousness_life_threatening
<td>Seriousness criterion: Life threatening

<tr>
<td>seriousness_other
<td>Seriousness criterion: Other medically important condition

<tr>
<td>substance_as_reported
<td>The product's active ingredient.

## VAERS {#vaers}

Veeva ingests the following fields from VAERS to your Vault:

<table>
<thead>
<tr>
<th>VAERS Field
<th>Description

<tbody>
<tr>
<td>allergies_text
<td>Allergies to medications, food, or other products, including narrative text of any physician-diagnosed allergies that existed at the time of vaccination.

<tr>
<td>birth_defect
<td>Indicates whether the vaccine recipient had a congenital anomaly or birth defect associated with the vaccination.

<tr>
<td>case_number
<td>The unique report identifier used by the FDA VAERS to link vaers_case, vaers_case_product, and vaers_case_event.

<tr>
<td>case_prior_transmission_number
<td markdown="span">The case identifier, for example, the manufacturer control number from the latest _Case_ version.

<tr>
<td>case_prior_transmission_source
<td>The source of the case identifier, for example, the coded name of the manufacturer or the reported name of the organization sending the report.

<tr>
<td>case_version
<td>The Safety report version number.

<tr>
<td>case_version_id
<td markdown="span">The unique report identifier Veeva uses to identify a _Case_. This identifier is composed of the case_number, case_version, and receipt_date.

<tr>
<td>company_number
<td>The reported manufacturer or immunization project report number.

<tr>
<td>date_of_death
<td>The date of death of the vaccine recipient, if applicable.

<tr>
<td>days_hospitalized
<td>The number of days the vaccine recipient was hospitalized.

<tr>
<td>domestic_case
<td>Indicates whether the report is domestic (the product was marketed and the event occurred in the United States).

<tr>
<td>er_ed_visit
<td>Indicates whether the vaccine recipient visited the emergency room/department or urgent care.

<tr>
<td>history_text
<td>Chronic or long-standing health conditions, including physician-diagnosed allergies, birth defects, or medical conditions that existed at the time of vaccination.

<tr>
<td>hospital_extended_stay
<td>Indicates whether the vaccine recipient's hospitalization is prolonged as a result of the adverse event associated with the vaccination.

<tr>
<td>illness_at_vaccination_text
<td>Illnesses at time of vaccination.

<tr>
<td>lab_data_text
<td>Reported diagnostic tests or laboratory results.

<tr>
<td>meddra_language_coded
<td>The MedDRA language (English), used by Veeva to code meddra_pt_as_reported to the latest MedDRA version.

<tr>
<td>meddra_manual_coded
<td>Indicates whether meddra_pt_coded and meddra_pt_code_coded were automatically coded to the latest MedDRA version (No), or manually coded (Yes).

<tr>
<td>meddra_pt_as_reported
<td>The reported MedDRA PT.

<tr>
<td>meddra_pt_coded
<td>The MedDRA PT, coded by Veeva to the latest MedDRA version.

<tr>
<td>meddra_pt_code_coded
<td>The MedDRA PT code, coded by Veeva to the latest MedDRA version.

<tr>
<td>meddra_version_as_reported
<td>The MedDRA version for the reaction or event PT.

<tr>
<td>meddra_version_coded
<td>The MedDRA version, used by Veeva to code meddra_pt_as_reported to the latest MedDRA version.

<tr>
<td>office_visit
<td>Indicates whether the vaccine recipient visited the doctor's or other healthcare provider's office or clinic.

<tr>
<td>onset_date
<td>The onset date of adverse event symptoms associated with the vaccination.

<tr>
<td>onset_days
<td>The calculated interval (in days) from the vaccination date to the onset date.

<tr>
<td>other_meds_text
<td>Prescription or non-prescription drugs the vaccine recipient was taking at the time of vaccination.

<tr>
<td>patient_age_group_e2b_code
<td markdown="block">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

<tr>
<td>patient_age_inyrs
<td>The reported vaccine recipient's age in years.

<tr>
<td>patient_age_months
<td>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.

<tr>
<td>patient_age_value
<td>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.

<tr>
<td>patient_gender_e2b_code
<td markdown="block">The vaccine recipient's gender:

* `U`: Unknown
* `1`: Male
* `2`: Female

<tr>
<td>prior_vax_event_text
<td>Prior vaccination event information.

<tr>
<td>product_id
<td>Unique identifier for the vaccine.

<tr>
<td>product_name
<td>The FDA medicinal product.

<tr>
<td>receive_date
<td>The date the VAERS form information was initially received by the FDA.

<tr>
<td>recovered_e2b_code
<td markdown="block">Indicates whether the vaccine recipient recovered:

* `0`: Unknown (U) or blank (B)
* `1`: Yes (Y)
* `3`: No (N)

<tr>
<td>report_date
<td>The date the VAERS form information was reported.

<tr>
<td>serious
<td>Indicates whether the event is serious (seriousness criteria exists).

<tr>
<td>seriousness_congenital_anomaly
<td>Seriousness criterion: Indicates whether the vaccine recipient had a congenital anomaly or birth defect associated with the vaccination.

<tr>
<td>seriousness_death
<td>Seriousness criterion: Indicates whether the vaccine recipient died as a result of the vaccination.

<tr>
<td>seriousness_disabling
<td>Seriousness criterion: Indicates whether the vaccine recipient was disabled as a result of the vaccination.

<tr>
<td>seriousness_hospitalization
<td markdown="block">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

<tr>
<td>seriousness_life_threatening
<td>Seriousness criterion: Indicates whether the vaccine recipient had a life-threatening event associated with the vaccination.

<tr>
<td>state
<td>The two-letter US Postal Service abbreviation for the home state of the vaccine.

<tr>
<td>symptoms_text
<td>Reported symptoms associated with the vaccine.

<tr>
<td>vaccine_admin_facility_type
<td markdown="block">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

<tr>
<td>vaccine_date
<td>The date of vaccination.

<tr>
<td>vaccine_dose_series
<td>The number of vaccination doses administered.

<tr>
<td>vaccine_funded_by
<td>The type of funds used to purchase vaccines.

<tr>
<td>vaccine_lot_number
<td>The manufacturer's vaccine lot number.

<tr>
<td>vaccine_manufacturer
<td>The vaccine's manufacturer.

<tr>
<td>vaccine_name_as_reported
<td>The brand name of the administered vaccine.

<tr>
<td>vaccine_route_of_admin
<td>The vaccine's route of administration.

<tr>
<td>vaccine_route_of_admin_code
<td>The vaccine's route of administration (code).

<tr>
<td>vaccine_site_of_admin
<td>The vaccine's site of administration.

<tr>
<td>vaccine_site_of_admin_code
<td>The vaccine's site of administration (code).

<tr>
<td>vaccine_type
<td>The vaccine type.

<tr>
<td>vaccine_type_code
<td>The vaccine type (code).

[1]: #faers
[2]: #vaers