ESAVI FHIR Implementation Guide (IG)
0.1.45 - ci-build
ESAVI FHIR Implementation Guide (IG)
0.1.45 - ci-build
ESAVI FHIR Implementation Guide (IG), published by ESAVI -. This guide is not an authorized publication; it is the continuous build for version 0.1.45 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/PanAmericanHealthOrganization/ESAVI-IG-FHIR-EN/ and changes regularly. See the Directory of published versions
| Official URL: https://paho.org/fhir/esavi/Questionnaire/CuestionarioESAVI | Version: 0.1.45 | |||
| Draft as of 2022-03-17 | Computable Name: OPSCuestionarioESAVI | |||
Generated Narrative: Questionnaire CuestionarioESAVI
| LinkID | Text | Cardinality | Type | Description & Constraints |
|---|---|---|---|---|
  OPSCuestionarioESAVI | Questionnaire | https://paho.org/fhir/esavi/Questionnaire/CuestionarioESAVI#0.1.45 | ||
  datosNotificacionGeneral | Notification Administrative Data | 1..1 | group | |
 datosNotificacion | Data about who and where the notification is made | 1..1 | group | |
  paisOrigen-Reg | Country where the Record originated | 1..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/codPaises |
 nombreOrganizacionNotificador | Name of the local level institution that performs the primary notification. | 1..1 | string | |
| codigoDireccionOrganizacion | Subnational Geographic Level Code of the Location of the Notifying Institution | 0..1 | choice | Value Set: PAHO Codes for Addresses |
| nombreDireccionOrganizacion | Name of the Subnational Geographic Level of the Location of the Notifying Institution | 1..1 | string | |
 codigoProfesionNotificador | Profession code of the notifier | 0..1 | choice | Value Set: Type of Notifying Professional |
 Fechas | Administrative Dates (at least one date is necessary) | 1..1 | group | |
  fechaConsulta | Date of the first consultation with the health service due to ESAVI | 1..1 | date | |
| fechaNotificacion | Date on which the surveillance system officially becomes aware of the occurrence of the event. | 0..1 | date | |
| fechaLlenadoFicha | Date on which the notifier finishes filling out the notification form (if the form is electronic, it is the same as notificationdate) | 0..1 | date | |
| fechaRepoNacional | Recorded date of arrival of the notification to the national level database (if the record is electronic, it is the same as dateNotification) | 0..1 | date | |
| datosIdVacunado | Vaccinated Demographic Data generated by ESAVI | 1..1 | group | |
| dataPaciente | Vaccinated Person Data | 1..1 | group | |
| numeroCaso | UUID that identifies the case or notification. A person can have more than one notification. | 1..1 | string | |
| idPaciente | UUID identification of the person vaccinated/affected by ESAVI | 1..1 | string | |
| codigoResidenciaHabitual | Subnational Geographic Level Code of the Habitual Residence of the Person affected by ESAVI | 0..1 | choice | Value Set: PAHO Codes for Addresses |
| nombreResidenciaHabitual | Name Subnational Geographic Level of the Habitual Residence of the Person affected by ESAVI | 0..1 | string | |
| sexoPaciente | Sex of the vaccinated. | 1..1 | choice | Value Set: AdministrativeGender |
| fechaNacimiento | Date of birth of the vaccinated person | 1..1 | date | |
| etnia | Name of the ethnic group with which the vaccinated person identifies | 0..1 | string | |
| antecedentesMedicos | Medical history identified by the patient | 0..1 | group | |
| ensayoClinico | clinicaltrial | 0..1 | group | |
 ensayoClinicoCovid19 | See if you participated in any clinical trials for COVID-19 | 0..1 | boolean | |
| antecedentesEnfermedadesPrevias | History of previous illnesses | 0..* | group | |
| descripcionEnfPrevia | Description of previous health problems in the person affected by ESAVI with emphasis on comorbidities or diseases concomitant to the adverse event, similar previous events and medical events relevant to the current health event (if the disease is coded, it is the description corresponding to the code). | 1..1 | string | |
| codigoMedDRAEnfPrevia | MedDRA code of the medical history | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/CodigoMedDRAEnfPreviaVS |
| otrosCodigosEnfPrevia | ICD-10/ICD-11/SNOMED code of the medical history | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/EnfermedadesPreviasCodificacionVS |
| antecedentesEventosAdversos | Declaration of existence of previous adverse events | 0..1 | group | |
| antecedentesAdvSimilar | History of adverse events similar to the current one | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/RespuestaSiNoNosabeVS |
| alergiaMedicamentos | History of allergic reactions to medications | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/RespuestaSiNoNosabeVS |
| alergiaVacunas | History of allergic reactions to other vaccines | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/RespuestaSiNoNosabeVS |
| antecedentesSarsCov2 | History of diagnosis of SARS-CoV-2 infection | 0..* | group | |
| diagnosticoprevioSarsCov2 | History of diagnosis of SARS-CoV-2 infection (Yes/No/Don't Know) | 1..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/RespuestaSiNoNosabeVS |
| asintomaticoSars | Diagnosis of Covid-19 without symptoms (Yes/No/Don't Know) | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/RespuestaSiNoNosabeVS |
 fechaSintomasCovid19 | Date the first sign and/or symptom of COVID-19 began. | 0..1 | dateTime | |
| tipoConfirmacionCovid19 | Type of COVID-19 diagnosis confirmation | 0..1 | choice | Value Set: COVID-19 Infection Confirmation Modes |
| fechaTomaMuestraCovid19 | Date on which the sample was taken for COVID-19 examination | 0..1 | date | |
| pacienteEmbarazada | Pregnancy status | 0..1 | group | Enable When: sexoPaciente = |
| embarazadaMomentoVacuna | Were you pregnant at the time of the vaccine? | 0..1 | boolean | |
| embarazadaMomentoESAVI | Was she pregnant at the time of the ESAVI? | 0..1 | boolean | |
| fechaUltimaMenstruacion | Date of the Patient's last menstruation | 0..1 | date | Enable When: |
| fechaProbableParto | Date of delivery, or probable date of delivery (calculated or indicated by the person affected by ESAVI) | 0..1 | date | Enable When: |
 edadGestacional | Current gestational age if pregnant or at the time of delivery of the most recent pregnancy | 0..1 | integer | Enable When: |
| monitoreoPosteriorVacuna | Response corresponding to the query about whether the patient was monitored once vaccinated | 1..1 | choice | Enable When: embarazadaMomentoVacuna = Value Set: https://paho.org/fhir/esavi/ValueSet/RespuestaSiNoNosabeVS |
| antecedentesFarmacosVacunas | Pharmacological History | 1..1 | group | |
| medicamento | History of medications that the patient took at the time of the ESAVI | 0..* | group | |
| nombreMedicamento | Name of the medication taken concomitantly with the vaccine or relevant to ESAVI, in free text (if coded, it is the code description) | 1..1 | string | |
| sistemaDeCodificacionParaNombreNormalizadoMedicamento | Encoding system | 0..1 | choice | Value Set: Coding Systems |
| nombreNormalizadoMedicamento | Name of the drug as reported by the notifier. May include standardized name if the country does not include a field in which the name of the drug is recorded in free text. medicine. | 0..1 | string | |
| codigoMedicamento | WHODrug/SCT/ICD-11/ATC code of the medication consumed by the patient | 0..1 | choice | Value Set: Medication Code |
| nombreFormaFarmaceutica | Name of the pharmaceutical form of the medication | 0..1 | string | |
| codigoFormaFarmaceutica | Code of the pharmaceutical form of the medication | 0..1 | choice | Value Set: Identification of Pharmaceutical Forms |
| nombreViaAdministracion | Name of administration route of the medication | 0..1 | string | |
| codigoViaAdministracion | Code Via medication administration | 0..1 | choice | Value Set: Medication Administration Routes |
| datosVacunas | Data on vaccines administered | 1..* | group | |
| nombreVacuna | Name of vaccine administered | 1..1 | string | |
| sistemaDeCodificacionParaNombreNormalizadoVacuna | Encoding system | 0..1 | choice | Value Set: Coding Systems |
| nombreNormalizadoVacuna | Name of the vaccine as reported by the notifier. May include standardized name if the country does not include a field in which the name is recorded in free text of the vaccine | 0..1 | string | |
| identificadorVacuna | Correlative identifier of the vaccine useful to refer to the vaccine registered in other sections of the guide. | 1..1 | integer | |
| codigoVacunaWHODrug | Vaccine WHODrug code | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/CodigoWhoVacunaVS |
| codigoVacunaOtro | Vaccine non-WHODrug code | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/CodigoNoWhoVacunaVS |
| nombreFabricante | Name of the manufacturer or holder of the health registration as registered by the notifier | 0..1 | string | |
| codigoFabricanteWHODrug | Name of the manufacturer or holder of the health record registered in any pharmaceutical standard in the country. If there is more than one, WHO Drug is preferred. | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/CodigoWhoFabricanteVS |
| numeroDosisVacuna | Ordinal number of the administered dose | 1..1 | integer | |
| numeroLot | Lot Number of the Vaccine administered | 0..1 | string | |
| fechaVencimientoVacuna | Vaccine Expiration Date | 0..1 | date | |
| nombreDiluyenteVacuna | Name of Vaccine Diluent | 0..1 | string | |
| numeroLoteDiluyente | Vaccine diluent batch number | 0..1 | string | |
| fechaVencimientoDiluyente | Vaccine diluent expiration date | 0..1 | date | |
| nombreVacunatorio | Vaccination center name | 0..1 | string | |
| fechaVacunacion | Vaccination date | 0..1 | date | |
 horaVacunacion | Vaccination time | 0..1 | time | |
| codigoDireccionVacunatorio | Code for the subnational geographic level of the location of the health institution where the vaccine was administered | 0..1 | choice | Value Set: PAHO Codes for Addresses |
| nombreDireccionVacunatorio | Full address of the institution where the vaccine was administered | 0..1 | string | |
| codigoMecanismoVerificacion | Vaccine verification mechanism code | 0..1 | choice | Value Set: Previous Vaccine Verification Modes |
| nombreOtroMecanismoVerificacion | Description of another mechanism not considered in the codes | 0..1 | string | |
| fechaReconstitucionVacuna | Date on which the registered vaccine was reconstituted | 0..1 | date | |
| horaReconstitucionVacuna | Time at which the registered vaccine was reconstituted | 0..1 | time | |
| registroESAVI | ESAVI registry developed by the vaccinated person | 1..1 | group | |
| datosESAVI | ESAVI information and its classification according to severity | 1..* | group | |
| nombreESAVI | ESAVI name | 1..1 | string | |
| IdentificadorESAVI | ESAVI correlative identifier useful to refer to the event recorded in other sections of the guide | 1..1 | integer | |
| codigoESAVIMedDRA | MedDRA Code of the reported Adverse Event | 0..1 | choice | Value Set: MedDRA Code of the Reported Adverse Event |
| codigoESAVIOtro | Non-MedDRA code of the adverse event that occurred after vaccination | 0..1 | choice | Value Set: Other Adverse Event Codes |
| fechaESAVI | ESAVI start date referred by the patient or identified by the doctor | 1..1 | date | |
| horaESAVI | Start time of ESAVI referred by the patient or identified by the doctor | 0..1 | time | |
| descripcionESAVI | ESAVI narrative description | 1..1 | string | |
| ESAVIDuranteEmbarazo | Data related to medical conditions that occurred during pregnancy in which the vaccine was received and/or ESAVI occurred. | 0..* | group | Enable When: embarazadaMomentoESAVI = |
| codigoTipoComplicacionESAVI | Type code for pregnancy complications after vaccine administration | 1..1 | choice | Value Set: Pregnancy Complications |
| nombreComplicacionEmbarazoESAVI | Complication Description | 1..1 | string | |
| codigoMedDRAComplicacionEmbarazoESAVI | MedDRA pregnancy complication code | 0..1 | choice | Value Set: MEDDRA Codes Complications in Pregnancy ESAVI |
| otrosCodigosComplicacionEmbarazoESAVI | SNOMED-CT/ICD-10/ICD-11 code of pregnancy complication | 0..1 | choice | Value Set: https://paho.org/fhir/esavi/ValueSet/ComplicacionEmbarazoOtroVS |
| gravedadESAVI | Determination of ESAVI severity status | 1..1 | group | |
| tipoGravedad | Serious ESAVI? | 1..1 | boolean | |
| gravMuerte | Death | 0..1 | boolean | Enable When: tipoGravedad = |
| gravRiesgoVida | Life threatening at the time of ESAVI detection | 0..1 | boolean | Enable When: tipoGravedad = |
| gravDiscapacity | Generates severe or permanent disability at the time of detection | 0..1 | boolean | Enable When: tipoGravedad = |
| gravHospitalizacion | Hospitalization or extension thereof | 0..1 | boolean | Enable When: tipoGravedad = |
| gravAnomaliaCongenita | Congenital anomaly | 0..1 | boolean | Enable When: tipoGravedad = |
| gravAborto | Abortion | 0..1 | boolean | Enable When: |
| gravMuerteFetal | Fetal death | 0..1 | boolean | Enable When: |
| otrosEventosImportantes | Otros Eventos considerados Médicamente Importantes | 0..1 | boolean | Enable When: tipoGravedad = |
| otrosEventosImportantesTx | Descripción de Otros Eventos medicamente importantes | 0..* | string | Enable When: otrosEventosImportantes = |
| desenlaceESAVI | Desenlace ESAVI | 1..1 | group | |
| codDesenlaceESAVI | Código Desenlace ESAVI | 1..1 | choice | Value Set: Outcomes After ESAVI |
| fechaMuerte | Fecha de muerte producida por posible ESAVI | 0..1 | date | Enable When: gravMuerte = |
| autopsia | Determinación si hubo o no Autopsia | 0..1 | choice | Enable When: gravMuerte = Value Set: https://paho.org/fhir/esavi/ValueSet/RespuestaSiNoNosabeVS |
| fechaNotificaMuerte | Fecha en la cual se notifico la muerte del paciente al registro nacional | 0..1 | date | Enable When: gravMuerte = |
| fechaNotificaMuerteFetal | Fecha en la cual se notifico la muerte del feto de paciente al registro nacional | 0..1 | date | Enable When: gravMuerteFetal = |
| autopsiaFetal | Determinación si hubo o no Autopsia Fetal | 0..1 | choice | Enable When: gravMuerteFetal = Value Set: https://paho.org/fhir/esavi/ValueSet/RespuestaSiNoNosabeVS |
| comentarios | Comentarios adicionales en cuanto al cuadro ESAVI | 0..1 | string | |
| fechaInicioInvestigacion | Fecha en la cual se inicia investigación | 0..1 | date | |
| causalidadESAVI | Información sobre la clasificación de causalidad | 0..* | group | |
| fechaCausalidadESAVI | Final case clasification date | 0..1 | date | |
| sistemaClasfCausalidad | Causality classification method | 1..1 | choice | Value Set: Type of Causality Classification Method |
| otroSistemaClasfCausalidad | Another causality classification system | 0..1 | string | Enable When: sistemaClasfCausalidad = |
| clasificacioncausaESAVI | Description of the ESAVI causality classification | 0..1 | string | |
| clasificacionDeCausalidadWHOAEFI | Causality classification according to the WHO AEFI methodology | 1..1 | choice | Enable When: sistemaClasfCausalidad = Value Set: WHO-AEFI causality classification |
| clasificacionDeCausalidadWHOUMC | Causality classification according to the WHO UMC methodology | 1..1 | choice | Enable When: sistemaClasfCausalidad = Value Set: https://paho.org/fhir/esavi/ValueSet/ClasificacionDesenlaceWHOUMCVS |
| clasificacionDeCausalidadNaranjo | Causality classification according to the Naranjo methodology | 1..1 | choice | Enable When: sistemaClasfCausalidad = Value Set: Naranjo Causality Classification |
| referenciaIdentificadorVacuna | Correlative identifier of the vaccine | 1..1 | integer | |
| referenciaIdentificadorESAVI | ESAVI correlative identifier | 1..1 | integer | |
| embarazoDuranteESAVI | Indicator if maternal or fetal complications are those reported as ESAVI. | 0..1 | boolean | |
| Documentation for this format | ||||