{
  "schema_version": "2.0.0",
  "harmonisation_ruleset": "pais-harmony-v1",
  "id": "yale-listen-pvs",
  "name": "Yale LISTEN post-vaccination syndrome cohort (Krumholz)",
  "aliases": ["LISTEN Study post-vaccination syndrome", "Yale PVS registry"],
  "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": "self_referral",
  "time_zero_definition": "COVID-19 vaccination; self-reported chronic symptoms attributed to it",
  "time_zero_precision": "month",
  "control_group": "none",
  "control_matching_variables": [],
  "n_source_population": null,
  "n_enrolled": 241,
  "n_analysed": 241,
  "followups": [{ "months": 20, "n_assessed": 241, "n_lost": null }],
  "max_followup_months": 20,
  "instruments": ["sf-36"],
  "case_definition": "none",
  "pem_assessed": "yes_single_item",
  "objective_measures": ["lab_panel"],
  "specimens_collected": true,
  "specimen_types": ["serum", "plasma", "pbmc"],
  "acute_phase_specimens": "no",
  "storage": null,
  "biobank_status": "active",
  "consent_future_use": "unknown",
  "external_access": "collaboration_only",
  "contact": null,
  "registration_id": null,
  "funders": ["Yale University (LISTEN Study)"],
  "conflicts": null,
  "data_availability": null,
  "notes": "Self-selected online registry (Yale LISTEN) of 241 adults reporting post-vaccination syndrome after COVID-19 immunisation, surveyed a median of ~595 days (about 20 months) post-vaccination; no control group. A weak-design but broad symptom characterisation, with a linked immunological/antigen-signature analysis (Bhattacharjee 2025). Included to represent the self-report end of the vaccine-trigger spectrum; not denominator-defined for prevalence.",
  "symptom_inventory_scope": "comprehensive_inventory",
  "n_symptoms_queried": null,
  "symptom_instrument_note": null,
  "related_cohorts": [],
  "last_verified": "2026-07-20",
  "verified_by": "OSMF research-tracker (web-verified against source)",
  "publications": [
    {
      "id": "krumholz-2023",
      "title": "Post-Vaccination Syndrome: A Descriptive Analysis of Reported Symptoms and Patient Experiences After Covid-19 Immunization",
      "authors": "Krumholz HM, Wu Y, Sawano M, et al.",
      "year": 2023,
      "journal": "medRxiv (preprint)",
      "doi": "10.1101/2023.11.09.23298266",
      "pmid": "37986769",
      "url": "https://pubmed.ncbi.nlm.nih.gov/37986769/",
      "open_access": true,
      "is_primary_cohort_paper": true
    },
    {
      "id": "bhattacharjee-2025",
      "title": "Immunological and Antigenic Signatures Associated with Chronic Illnesses after COVID-19 Vaccination",
      "authors": "Bhattacharjee B, Lu P, Monteiro VS, et al. (incl. Krumholz HM, Iwasaki A)",
      "year": 2025,
      "journal": "medRxiv (preprint)",
      "doi": "10.1101/2025.02.18.25322379",
      "url": "https://www.medrxiv.org/content/10.1101/2025.02.18.25322379v1",
      "open_access": true,
      "is_primary_cohort_paper": false
    }
  ],
  "observations": [
    {
      "id": "listen-exercise-intolerance",
      "cohort_id": "yale-listen-pvs",
      "publication_id": "krumholz-2023",
      "schema_version": "2.0.0",
      "measure_id": "sym:exercise-intolerance",
      "measure_verbatim": "exercise intolerance",
      "population": { "scope": "whole_cohort", "stratum": null, "denominator_basis": "assessed_at_timepoint", "n_assessed": 241 },
      "timing": { "timepoint_months": 20, "timepoint_band": "12-24mo", "reference_period": "past_7d", "is_cumulative": false },
      "method": { "ascertainment": "structured_checklist", "instrument_id": null, "severity_threshold": null, "blinded_assessment": "not_reported" },
      "value": { "type": "proportion", "numerator": { "status": "measured_not_reported" }, "denominator": 241, "percent": 71, "ci": null, "precision": "exact" },
      "comparator": { "group": "none", "value": { "status": "not_applicable" }, "effect": null },
      "harmonised": null,
      "provenance": { "source_locator": "Results (exercise intolerance 71%)", "extracted_by": null, "extracted_on": null, "verified_by": "OSMF research-tracker (web-verified against source)", "verified_on": "2026-07-20", "extraction_method": "manual" }
    },
    {
      "id": "listen-fatigue",
      "cohort_id": "yale-listen-pvs",
      "publication_id": "krumholz-2023",
      "schema_version": "2.0.0",
      "measure_id": "sym:fatigue",
      "measure_verbatim": "excessive fatigue",
      "population": { "scope": "whole_cohort", "stratum": null, "denominator_basis": "assessed_at_timepoint", "n_assessed": 241 },
      "timing": { "timepoint_months": 20, "timepoint_band": "12-24mo", "reference_period": "past_7d", "is_cumulative": false },
      "method": { "ascertainment": "structured_checklist", "instrument_id": null, "severity_threshold": null, "blinded_assessment": "not_reported" },
      "value": { "type": "proportion", "numerator": { "status": "measured_not_reported" }, "denominator": 241, "percent": 69, "ci": null, "precision": "exact" },
      "comparator": { "group": "none", "value": { "status": "not_applicable" }, "effect": null },
      "harmonised": null,
      "provenance": { "source_locator": "Results (excessive fatigue 69%)", "extracted_by": null, "extracted_on": null, "verified_by": "OSMF research-tracker (web-verified against source)", "verified_on": "2026-07-20", "extraction_method": "manual" }
    },
    {
      "id": "listen-brainfog",
      "cohort_id": "yale-listen-pvs",
      "publication_id": "krumholz-2023",
      "schema_version": "2.0.0",
      "measure_id": "sym:cognitive-dysfunction",
      "measure_verbatim": "brain fog",
      "population": { "scope": "whole_cohort", "stratum": null, "denominator_basis": "assessed_at_timepoint", "n_assessed": 241 },
      "timing": { "timepoint_months": 20, "timepoint_band": "12-24mo", "reference_period": "past_7d", "is_cumulative": false },
      "method": { "ascertainment": "structured_checklist", "instrument_id": null, "severity_threshold": null, "blinded_assessment": "not_reported" },
      "value": { "type": "proportion", "numerator": { "status": "measured_not_reported" }, "denominator": 241, "percent": 63, "ci": null, "precision": "exact" },
      "comparator": { "group": "none", "value": { "status": "not_applicable" }, "effect": null },
      "harmonised": null,
      "provenance": { "source_locator": "Results (brain fog 63%)", "extracted_by": null, "extracted_on": null, "verified_by": "OSMF research-tracker (web-verified against source)", "verified_on": "2026-07-20", "extraction_method": "manual" }
    },
    {
      "id": "listen-numbness",
      "cohort_id": "yale-listen-pvs",
      "publication_id": "krumholz-2023",
      "schema_version": "2.0.0",
      "measure_id": "sym:paresthesia",
      "measure_verbatim": "numbness",
      "population": { "scope": "whole_cohort", "stratum": null, "denominator_basis": "assessed_at_timepoint", "n_assessed": 241 },
      "timing": { "timepoint_months": 20, "timepoint_band": "12-24mo", "reference_period": "past_7d", "is_cumulative": false },
      "method": { "ascertainment": "structured_checklist", "instrument_id": null, "severity_threshold": null, "blinded_assessment": "not_reported" },
      "value": { "type": "proportion", "numerator": { "status": "measured_not_reported" }, "denominator": 241, "percent": 63, "ci": null, "precision": "exact" },
      "comparator": { "group": "none", "value": { "status": "not_applicable" }, "effect": null },
      "harmonised": null,
      "provenance": { "source_locator": "Results (numbness 63%)", "extracted_by": null, "extracted_on": null, "verified_by": "OSMF research-tracker (web-verified against source)", "verified_on": "2026-07-20", "extraction_method": "manual" }
    }
  ]
}