{
  "schema_version": "2.0.0",
  "harmonisation_ruleset": "pais-harmony-v1",
  "id": "vitae-survey",
  "name": "VITAE vaccine-injury survey (Halma & Varon)",
  "aliases": ["Vaccination Injury Treatment and Access to Essential Care survey"],
  "outbreak_event": "COVID-19 vaccination campaign (2021-)",
  "pathogen_id": "covid-19-vaccine",
  "pathogen_class": "vaccine",
  "exposure_ascertainment": "self_report",
  "design": "survey",
  "denominator_defined": "no",
  "denominator_method": null,
  "recruitment_source": "patient_organisation",
  "time_zero_definition": "COVID-19 vaccination; self-reported vaccine injury / post-vaccination syndrome",
  "time_zero_precision": "year",
  "control_group": "none",
  "control_matching_variables": [],
  "n_source_population": null,
  "n_enrolled": 706,
  "n_analysed": 706,
  "followups": [{ "months": 24, "n_assessed": 706, "n_lost": null }],
  "max_followup_months": 24,
  "instruments": [],
  "case_definition": "none",
  "pem_assessed": "no",
  "objective_measures": ["none"],
  "specimens_collected": false,
  "specimen_types": [],
  "acute_phase_specimens": "not_applicable",
  "storage": null,
  "biobank_status": "not_applicable",
  "consent_future_use": "not_applicable",
  "external_access": "unknown",
  "contact": null,
  "registration_id": null,
  "funders": ["not reported"],
  "conflicts": "Lead author is affiliated with the Open Source Medicine Foundation, which maintains this database, and with the FLCCC; the survey was distributed through vaccine-injury patient-advocacy networks (self-selected sample).",
  "data_availability": "Aggregate results in the preprint.",
  "notes": "Self-selected online survey (n=706) of people self-identifying as COVID-19 vaccine-injured, focused on disease burden and barriers to care rather than clinical symptom prevalence: chronic symptoms >=6 months in 91%, symptoms >2 years in ~80%, and large economic impact (about 70% of those employed dropped an income category; 26% became unemployed due to their condition). Flagged as a non-peer-reviewed preprint, patient-reported, self-selected, uncontrolled, with an author conflict. Included to represent the patient-advocacy end of the vaccine-trigger spectrum, explicitly labelled as such.",
  "symptom_inventory_scope": "incidental",
  "n_symptoms_queried": null,
  "symptom_instrument_note": "Primarily a barriers-to-care / disease-burden instrument, not a symptom-prevalence survey.",
  "related_cohorts": [
    { "id": "yale-listen-pvs", "relation": "sibling_analysis" },
    { "id": "postvac-germany-survey", "relation": "sibling_analysis" }
  ],
  "flags": ["preprint", "not_peer_reviewed", "patient_reported", "self_selected", "no_control", "author_conflict"],
  "last_verified": "2026-07-20",
  "verified_by": "OSMF research-tracker (verified against source PDF)",
  "publications": [
    {
      "id": "halma-2025-vitae",
      "title": "Assessing Barriers to Care for the Vaccine Injured: The Vaccination Injury Treatment and Access to Essential Care (VITAE) Survey",
      "authors": "Halma M, Varon J.",
      "year": 2025,
      "journal": "Preprints.org",
      "type": "preprint",
      "doi": "10.20944/preprints202501.0567.v1",
      "url": "https://www.preprints.org/manuscript/202501.0567/v1",
      "open_access": true,
      "is_primary_cohort_paper": true
    }
  ],
  "observations": [
    {
      "id": "vitae-chronic-6mo",
      "cohort_id": "vitae-survey",
      "publication_id": "halma-2025-vitae",
      "schema_version": "2.0.0",
      "measure_id": "func:any-persistent-symptom",
      "measure_verbatim": "chronic symptoms lasting six months or more post-treatment",
      "population": { "scope": "whole_cohort", "stratum": null, "denominator_basis": "responders", "n_assessed": 706 },
      "timing": { "timepoint_months": 24, "timepoint_band": "24mo+", "reference_period": "since_infection", "is_cumulative": true },
      "method": { "ascertainment": "open_ended_report", "instrument_id": null, "severity_threshold": null, "blinded_assessment": "not_applicable" },
      "value": { "type": "proportion", "numerator": { "status": "measured_not_reported" }, "denominator": 706, "percent": 91.35, "ci": null, "precision": "exact" },
      "comparator": { "group": "none", "value": { "status": "not_applicable" }, "effect": null },
      "harmonised": null,
      "provenance": { "source_locator": "Results, Table 3 (chronic symptoms >=6 months in 91.35%)", "extracted_by": "mh", "extracted_on": "2026-07-20", "verified_by": "OSMF research-tracker", "verified_on": "2026-07-20", "extraction_method": "manual" }
    },
    {
      "id": "vitae-unemployed",
      "cohort_id": "vitae-survey",
      "publication_id": "halma-2025-vitae",
      "schema_version": "2.0.0",
      "measure_id": "func:unable-to-work",
      "measure_verbatim": "became unemployed due to their condition",
      "population": { "scope": "whole_cohort", "stratum": null, "denominator_basis": "responders", "n_assessed": 706 },
      "timing": { "timepoint_months": 24, "timepoint_band": "24mo+", "reference_period": "since_infection", "is_cumulative": true },
      "method": { "ascertainment": "open_ended_report", "instrument_id": null, "severity_threshold": null, "blinded_assessment": "not_applicable" },
      "value": { "type": "proportion", "numerator": { "status": "measured_not_reported" }, "denominator": 706, "percent": 26.36, "ci": null, "precision": "exact" },
      "comparator": { "group": "none", "value": { "status": "not_applicable" }, "effect": null },
      "harmonised": null,
      "provenance": { "source_locator": "Results (26.36% became unemployed due to their condition)", "extracted_by": "mh", "extracted_on": "2026-07-20", "verified_by": "OSMF research-tracker", "verified_on": "2026-07-20", "extraction_method": "manual" }
    }
  ]
}