{
 "_meta": {
  "title": "Controlled vaccine-safety study results (active surveillance, cohort, SCCS, case-control, RCT, meta-analysis)",
  "compiled": "2026-10-09",
  "method": "Every numeric value was transcribed from the PubMed abstract (NCBI E-utilities efetch), the FDA safety communication web page, or the IOM 2011 report summary tables, as named in location_in_source. No values were filled from memory. Where an abstract did not report a CI or estimate, the field is null.",
  "fields": {
   "estimate/ci_low/ci_high": "Value of 'measure' with 95% CI unless notes say otherwise (Lloyd 2026 uses 99% CIs; Gee 2017 upper bound is one-sided).",
   "attributable_per_million_doses": "Only filled when the source reports an excess/attributable risk (or a rate that converts directly). Conversions (e.g., per 100,000 -> per million, '1 in 40,000' -> 25) are stated in notes. Some are per person vaccinated rather than per dose; notes say which. null if not reported.",
   "conclusion": "'increased risk' = statistically significant elevation reported by the authors (or IOM 'convincingly supports'/'favors acceptance'); 'no increased risk detected' = null finding or protective; 'inconclusive' = authors flag uncertainty, few cases, or non-replicated signal."
  },
  "caveats": [
   "Rows with design containing 'PASSIVE' (yellow fever YEL-AND/AVD, Janssen TTS) are reporting rates derived from VAERS, included because no controlled-study rate exists; do not present them as active-surveillance results.",
   "Some rows are context comparators, not vaccines (SARS-CoV-2 infection and myocarditis; RSV disease and GBS).",
   "Pandemrix and GSK RSVPreF3-Mat are not US-licensed; Dengvaxia is filed under the yellow-fever key because no dengue key exists.",
   "Whole-schedule studies (antigen exposure vs autism / infections) are filed under the mmr key; the McNeil 2016 all-vaccine anaphylaxis rate is filed under hepatitis-b.",
   "Relative risks from different designs/windows are not directly comparable; attributable risk depends on background rates in each population.",
   "'notes' field added beyond the requested schema for secondary numbers and context."
  ],
  "row_count": 154,
  "main_sources": [
   "Vaccine Safety Datalink (CDC)",
   "FDA CBER / CMS Medicare analyses",
   "FDA Mini-Sentinel",
   "Nordic/Danish national registers",
   "Israel (Clalit, Ministry of Health)",
   "England SCCS (Patone 2022; Miller 2013)",
   "Maglione 2014 (RAND/AHRQ)",
   "IOM 2011 Adverse Effects of Vaccines"
  ]
 },
 "results": [
  {
   "vaccine": "mmr",
   "product": "MMRV (ProQuad) vs MMR+V same day",
   "outcome": "Febrile seizures",
   "design": "cohort (VSD, Poisson regression vs MMR+V)",
   "population": "Children 12-23 mo, first dose, US (VSD 2000-2008)",
   "risk_window": "7-10 days",
   "measure": "RR",
   "estimate": 1.98,
   "ci_low": 1.43,
   "ci_high": 2.73,
   "attributable_per_million_doses": 430,
   "conclusion": "increased risk",
   "source": "Klein NP et al., 2010, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2010-0665; PMID 20587679",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Excess risk 4.3 per 10,000 doses (95% CI 2.6-5.6) MMRV vs separate MMR+V; ~1 additional febrile seizure per 2,300 doses. Per-million value converted from 4.3/10,000."
  },
  {
   "vaccine": "mmr",
   "product": "MMRV or MMR+V, dose 2",
   "outcome": "Febrile seizures",
   "design": "cohort (VSD)",
   "population": "Children 4-6 y, US (VSD 2000-2008)",
   "risk_window": "7-10 days",
   "measure": "absolute risk",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Klein NP et al., 2012, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2011-3198; PMID 22473362",
   "location_in_source": "PubMed abstract, Results/Conclusions",
   "notes": "1 febrile seizure per 86,750 MMRV doses and 0 per 67,438 MMR+V doses; upper 95% bound rules out >1 per 15,500 MMRV doses and >1 per 18,000 MMR+V doses."
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Febrile seizures",
   "design": "cohort (VSD, 4 HMOs, chart review)",
   "population": "Children, US (679,942 children)",
   "risk_window": "8-14 days",
   "measure": "RR",
   "estimate": 2.83,
   "ci_low": 1.44,
   "ci_high": 5.55,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Barlow WE et al., 2001, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa003077; PMID 11547719",
   "location_in_source": "PubMed abstract, Results",
   "notes": "25-34 attributable febrile seizures per 100,000 children; no increased risk of non-febrile seizures or later neurodevelopmental disability."
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Febrile seizures",
   "design": "cohort (national registry)",
   "population": "Children born 1991-1998, Denmark (537,171)",
   "risk_window": "0-14 days",
   "measure": "RR (incidence rate ratio)",
   "estimate": 2.75,
   "ci_low": 2.55,
   "ci_high": 2.97,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Vestergaard M et al., 2004, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.292.3.351; PMID 15265850",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Risk difference at 15-17 mo: 1.56 per 1000 children (95% CI 1.44-1.68)."
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Epilepsy after post-vaccination febrile seizure (vs febrile seizure while unvaccinated)",
   "design": "cohort (national registry)",
   "population": "Children with febrile seizures, Denmark",
   "risk_window": "long-term follow-up",
   "measure": "RR",
   "estimate": 0.7,
   "ci_low": 0.33,
   "ci_high": 1.5,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Vestergaard M et al., 2004, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.292.3.351; PMID 15265850",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Immune thrombocytopenic purpura (ITP)",
   "design": "cohort, risk vs unexposed intervals (VSD)",
   "population": "Children 12-15 mo, US (1,036,689 vaccinated children)",
   "risk_window": "0-42 days",
   "measure": "IRR",
   "estimate": 7.1,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": 25,
   "conclusion": "increased risk",
   "source": "France EK et al., 2008, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2007-1578; PMID 18310189",
   "location_in_source": "PubMed abstract, Results",
   "notes": "1 ITP case per ~40,000 doses (= ~25 per million). IRR boys 12-15 mo 14.59, girls 3.22. CI not given in abstract."
  },
  {
   "vaccine": "mmr",
   "product": "MMR (and other early-childhood vaccines)",
   "outcome": "ITP",
   "design": "cohort, risk vs control intervals (VSD)",
   "population": "Children 6 wk-17 y, US (1.8 million)",
   "risk_window": "1-42 days",
   "measure": "IRR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "O'Leary ST et al., 2012, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2011-1111; PMID 22232308",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No elevated ITP risk after any early-childhood vaccine other than MMR at 12-19 mo. Estimates not in abstract."
  },
  {
   "vaccine": "hepatitis-a",
   "product": "Hepatitis A vaccine",
   "outcome": "ITP",
   "design": "cohort, risk vs control intervals (VSD)",
   "population": "Children 7-17 y, US",
   "risk_window": "1-42 days",
   "measure": "IRR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "inconclusive",
   "source": "O'Leary ST et al., 2012, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2011-1111; PMID 22232308",
   "location_in_source": "PubMed abstract, Results/Conclusions",
   "notes": "Statistically elevated but based on 1-2 exposed cases; authors cite possible confounding and call for further investigation."
  },
  {
   "vaccine": "varicella",
   "product": "Varicella vaccine",
   "outcome": "ITP",
   "design": "cohort, risk vs control intervals (VSD)",
   "population": "Adolescents 11-17 y, US",
   "risk_window": "1-42 days",
   "measure": "IRR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "inconclusive",
   "source": "O'Leary ST et al., 2012, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2011-1111; PMID 22232308",
   "location_in_source": "PubMed abstract, Results/Conclusions",
   "notes": "Statistically elevated but based on 1-2 exposed cases; requires further investigation."
  },
  {
   "vaccine": "dtap",
   "product": "Tdap",
   "outcome": "ITP",
   "design": "cohort, risk vs control intervals (VSD)",
   "population": "Adolescents 11-17 y, US",
   "risk_window": "1-42 days",
   "measure": "IRR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "inconclusive",
   "source": "O'Leary ST et al., 2012, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2011-1111; PMID 22232308",
   "location_in_source": "PubMed abstract, Results/Conclusions",
   "notes": "Statistically elevated but based on 1-2 exposed cases; requires further investigation."
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Autism",
   "design": "cohort (national registry, Cox)",
   "population": "Children born 1999-2010, Denmark (657,461)",
   "risk_window": "any time after vaccination",
   "measure": "HR",
   "estimate": 0.93,
   "ci_low": 0.85,
   "ci_high": 1.02,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Hviid A et al., 2019, Ann Intern Med",
   "doi_or_pmid": "doi:10.7326/M18-2101; PMID 30831578",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No increased risk in subgroups (sibling history, risk score) or in time periods after vaccination."
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Autistic disorder",
   "design": "cohort (national registry)",
   "population": "Children born 1991-1998, Denmark (537,303)",
   "risk_window": "any time",
   "measure": "RR",
   "estimate": 0.92,
   "ci_low": 0.68,
   "ci_high": 1.24,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Madsen KM et al., 2002, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa021134; PMID 12421889",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Other autism spectrum disorders",
   "design": "cohort (national registry)",
   "population": "Children born 1991-1998, Denmark",
   "risk_window": "any time",
   "measure": "RR",
   "estimate": 0.83,
   "ci_low": 0.65,
   "ci_high": 1.07,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Madsen KM et al., 2002, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa021134; PMID 12421889",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Autism (cohort studies pooled)",
   "design": "meta-analysis",
   "population": "Children, multiple countries (5 cohort studies, 1,256,407 children)",
   "risk_window": "any time",
   "measure": "OR",
   "estimate": 0.84,
   "ci_low": 0.7,
   "ci_high": 1.01,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Taylor LE, Swerdfeger AL, Eslick GD, 2014, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2014.04.085; PMID 24814559",
   "location_in_source": "PubMed abstract",
   "notes": "All vaccination vs autism OR 0.99 (0.92-1.06); thimerosal OR 1.00 (0.77-1.31)."
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "ASD in children with an older sibling with ASD (2 doses vs none, age 5)",
   "design": "cohort (commercial claims)",
   "population": "US children with older siblings (95,727)",
   "risk_window": "by age 5",
   "measure": "RR",
   "estimate": 0.56,
   "ci_low": 0.31,
   "ci_high": 1.01,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Jain A et al., 2015, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2015.3077; PMID 25898051",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "ASD in children whose older siblings did not have ASD (2 doses vs none, age 5)",
   "design": "cohort (commercial claims)",
   "population": "US children with older siblings",
   "risk_window": "by age 5",
   "measure": "RR",
   "estimate": 1.12,
   "ci_low": 0.78,
   "ci_high": 1.59,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Jain A et al., 2015, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2015.3077; PMID 25898051",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Autism (strength-of-evidence rating)",
   "design": "systematic review",
   "population": "US-licensed vaccines, children",
   "risk_window": "n/a",
   "measure": "evidence rating",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Maglione MA et al. (RAND/AHRQ), 2014, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2014-1079; PMID 25086160",
   "location_in_source": "PubMed abstract, Results",
   "notes": "'Strong evidence that MMR vaccine is not associated with autism.' Same review: high strength of evidence for MMR and febrile seizures; moderate evidence rotavirus vaccines associated with intussusception; varicella vaccine associated with complications in immunodeficient individuals."
  },
  {
   "vaccine": "rotavirus",
   "product": "Rotarix (RV1)",
   "outcome": "Intussusception",
   "design": "cohort, sequential vs historical and vs concurrent RV5 recipients (VSD)",
   "population": "Infants 4-34 wk, US (207,955 RV1 doses)",
   "risk_window": "0-7 days",
   "measure": "RR (vs RV5)",
   "estimate": 9.4,
   "ci_low": 1.4,
   "ci_high": 103.8,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Weintraub ES et al., 2014, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa1311738; PMID 24422678",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Attributable risk 5.3 per 100,000 infants vaccinated (2 doses). RR vs historical background 8.4."
  },
  {
   "vaccine": "rotavirus",
   "product": "RotaTeq (RV5)",
   "outcome": "Intussusception (dose 1)",
   "design": "self-controlled risk interval (FDA Mini-Sentinel)",
   "population": "Infants 5-37 wk, US (507,874 first doses)",
   "risk_window": "1-21 days",
   "measure": "attributable risk per 100,000 first-dose recipients",
   "estimate": 1.5,
   "ci_low": 0.2,
   "ci_high": 3.2,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Yih WK et al., 2014, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa1303164; PMID 24422676",
   "location_in_source": "PubMed abstract, Results",
   "notes": "7-day window: 1.1 (0.3-2.7) per 100,000. No significant increase after doses 2 or 3."
  },
  {
   "vaccine": "rotavirus",
   "product": "Rotarix (RV1)",
   "outcome": "Intussusception",
   "design": "self-controlled risk interval + cohort (FDA Mini-Sentinel)",
   "population": "Infants, US (53,638 first doses)",
   "risk_window": "1-21 days",
   "measure": "attributable risk",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "inconclusive",
   "source": "Yih WK et al., 2014, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa1303164; PMID 24422676",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Primary analysis not significant (underpowered); secondary cohort analysis showed significant risk after dose 2."
  },
  {
   "vaccine": "rotavirus",
   "product": "RotaTeq (RV5)",
   "outcome": "Intussusception (all doses)",
   "design": "cohort vs historical background (VSD)",
   "population": "Infants 4-34 wk, US (786,725 doses)",
   "risk_window": "1-30 days",
   "measure": "SIR",
   "estimate": 1.01,
   "ci_low": 0.62,
   "ci_high": 1.54,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Shui IM et al., 2012, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2012.97; PMID 22318281",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Dose 1, 1-7 days SIR 1.21 (0.03-6.75); upper bound ~1 case per 65,287 dose-1 recipients. Later larger study (Yih 2014) detected a small dose-1 risk."
  },
  {
   "vaccine": "rotavirus",
   "product": "Rotarix (RV1)",
   "outcome": "Intussusception (dose 1)",
   "design": "SCCS (active hospital surveillance)",
   "population": "Infants, Mexico",
   "risk_window": "1-7 days",
   "measure": "IRR (relative incidence)",
   "estimate": 5.3,
   "ci_low": 3.0,
   "ci_high": 9.3,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Patel MM et al., 2011, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa1012952; PMID 21675888",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Case-control OR 5.8 (2.6-13.0). Excess ~1 per 51,000 infants (Mexico)."
  },
  {
   "vaccine": "rotavirus",
   "product": "Rotarix (RV1)",
   "outcome": "Intussusception (dose 2)",
   "design": "SCCS + case-control (active hospital surveillance)",
   "population": "Infants, Brazil",
   "risk_window": "1-7 days",
   "measure": "IRR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Patel MM et al., 2011, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa1012952; PMID 21675888",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No significant dose-1 risk in Brazil; dose-2 risk increased by a factor of 1.9-2.6; ~1 per 68,000 infants. RV1 prevented ~80,000 hospitalizations and 1300 diarrhea deaths/yr in the two countries."
  },
  {
   "vaccine": "rotavirus",
   "product": "RV1, RV5 and others (RCTs)",
   "outcome": "Intussusception",
   "design": "meta-analysis of RCTs",
   "population": "Infants, 33 countries (25 trials, 200,594 participants)",
   "risk_window": "31 days",
   "measure": "RR",
   "estimate": 1.14,
   "ci_low": 0.49,
   "ci_high": 2.64,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Lu HL et al., 2019, JAMA Netw Open",
   "doi_or_pmid": "doi:10.1001/jamanetworkopen.2019.12458; PMID 31584679",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Trials are not powered to detect risks of ~1-5 per 100,000; post-licensure observational studies above do detect a small risk."
  },
  {
   "vaccine": "influenza",
   "product": "2009 H1N1 monovalent inactivated",
   "outcome": "Guillain-Barre syndrome",
   "design": "self-controlled risk interval, meta-analysis of 6 US systems",
   "population": "~23 million vaccinated, US",
   "risk_window": "1-42 days",
   "measure": "IRR",
   "estimate": 2.35,
   "ci_low": 1.42,
   "ci_high": 4.01,
   "attributable_per_million_doses": 1.6,
   "conclusion": "increased risk",
   "source": "Salmon DA et al., 2013, Lancet",
   "doi_or_pmid": "doi:10.1016/S0140-6736(12)62189-8; PMID 23498095",
   "location_in_source": "PubMed abstract, Findings",
   "notes": "About 1.6 excess GBS cases per million people vaccinated."
  },
  {
   "vaccine": "influenza",
   "product": "2009 H1N1 monovalent inactivated (MIV)",
   "outcome": "Guillain-Barre syndrome",
   "design": "self-controlled risk interval (VSD)",
   "population": "US, all ages (1.48 million MIV doses)",
   "risk_window": "1-42 vs 43-127 days",
   "measure": "risk difference per million doses",
   "estimate": 5.0,
   "ci_low": 0.5,
   "ci_high": 9.5,
   "attributable_per_million_doses": 5.0,
   "conclusion": "increased risk",
   "source": "Greene SK et al., 2012, Am J Epidemiol",
   "doi_or_pmid": "doi:10.1093/aje/kws195; PMID 22582210",
   "location_in_source": "PubMed abstract",
   "notes": "5 of 9 MIV cases had antecedent respiratory infection; MIV given during heightened influenza activity."
  },
  {
   "vaccine": "influenza",
   "product": "Seasonal TIV 2009-10 (without MIV)",
   "outcome": "Guillain-Barre syndrome",
   "design": "self-controlled risk interval (VSD)",
   "population": "US, all ages (1.72 million doses)",
   "risk_window": "1-42 vs 43-84 days",
   "measure": "risk difference per million doses",
   "estimate": 1.1,
   "ci_low": -3.1,
   "ci_high": 5.4,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Greene SK et al., 2012, Am J Epidemiol",
   "doi_or_pmid": "doi:10.1093/aje/kws195; PMID 22582210",
   "location_in_source": "PubMed abstract",
   "notes": null
  },
  {
   "vaccine": "influenza",
   "product": "Seasonal influenza (1995-2006)",
   "outcome": "Guillain-Barre syndrome",
   "design": "case-centered (KPNC)",
   "population": "All ages, Kaiser Northern California (415 confirmed cases)",
   "risk_window": "6 weeks",
   "measure": "OR",
   "estimate": 1.1,
   "ci_low": 0.4,
   "ci_high": 3.1,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Baxter R et al., 2013, Clin Infect Dis",
   "doi_or_pmid": "doi:10.1093/cid/cit222; PMID 23580737",
   "location_in_source": "PubMed abstract, Results",
   "notes": "All vaccines combined OR 1.3 (0.8-2.3)."
  },
  {
   "vaccine": "dtap",
   "product": "Td (tetanus-diphtheria)",
   "outcome": "Guillain-Barre syndrome",
   "design": "case-centered (KPNC)",
   "population": "Adolescents/adults, Kaiser Northern California",
   "risk_window": "6 weeks",
   "measure": "OR",
   "estimate": 1.4,
   "ci_low": 0.3,
   "ci_high": 4.5,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Baxter R et al., 2013, Clin Infect Dis",
   "doi_or_pmid": "doi:10.1093/cid/cit222; PMID 23580737",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Td rather than DTaP/Tdap."
  },
  {
   "vaccine": "pcv",
   "product": "PPSV23 (polysaccharide)",
   "outcome": "Guillain-Barre syndrome",
   "design": "case-centered (KPNC)",
   "population": "Adults, Kaiser Northern California",
   "risk_window": "6 weeks",
   "measure": "OR",
   "estimate": 0.7,
   "ci_low": 0.1,
   "ci_high": 2.9,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Baxter R et al., 2013, Clin Infect Dis",
   "doi_or_pmid": "doi:10.1093/cid/cit222; PMID 23580737",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Polysaccharide vaccine (PPSV23), not conjugate."
  },
  {
   "vaccine": "influenza",
   "product": "TIV 2010-11 + PCV13 same day",
   "outcome": "Febrile seizures",
   "design": "self-controlled risk interval (VSD)",
   "population": "Children 6-59 mo, US (206,174)",
   "risk_window": "0-1 days vs 14-20 days",
   "measure": "IRR",
   "estimate": 5.9,
   "ci_low": 3.1,
   "ci_high": 11.3,
   "attributable_per_million_doses": 449,
   "conclusion": "increased risk",
   "source": "Tse A et al., 2012, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2012.01.027; PMID 22361304",
   "location_in_source": "PubMed abstract",
   "notes": "Risk difference at 16 mo: 44.9 per 100,000 doses for concomitant TIV+PCV13 (per-million value = peak at 16 mo); 4.0 per 100,000 at 59 mo."
  },
  {
   "vaccine": "influenza",
   "product": "TIV 2010-11 (adjusted for PCV13)",
   "outcome": "Febrile seizures",
   "design": "self-controlled risk interval (VSD)",
   "population": "Children 6-59 mo, US",
   "risk_window": "0-1 days",
   "measure": "IRR",
   "estimate": 2.4,
   "ci_low": 1.2,
   "ci_high": 4.7,
   "attributable_per_million_doses": 125,
   "conclusion": "increased risk",
   "source": "Tse A et al., 2012, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2012.01.027; PMID 22361304",
   "location_in_source": "PubMed abstract",
   "notes": "Risk difference 12.5 per 100,000 doses at 16 mo (TIV without PCV13); 1.1 per 100,000 at 59 mo."
  },
  {
   "vaccine": "pcv",
   "product": "PCV13 (adjusted for TIV)",
   "outcome": "Febrile seizures",
   "design": "self-controlled risk interval (VSD)",
   "population": "Children 6-59 mo, US",
   "risk_window": "0-1 days",
   "measure": "IRR",
   "estimate": 2.5,
   "ci_low": 1.3,
   "ci_high": 4.7,
   "attributable_per_million_doses": 137,
   "conclusion": "increased risk",
   "source": "Tse A et al., 2012, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2012.01.027; PMID 22361304",
   "location_in_source": "PubMed abstract",
   "notes": "Risk difference 13.7 per 100,000 doses at 16 mo (PCV13 without TIV); 1.2 at 59 mo."
  },
  {
   "vaccine": "influenza",
   "product": "IIV4 simultaneous vs 2 wk after DTaP+PCV13",
   "outcome": "Fever days 1-2 (febrile seizure surrogate)",
   "design": "randomized controlled trial",
   "population": "Children 12-16 mo, US (221)",
   "risk_window": "days 1-2",
   "measure": "RR",
   "estimate": 0.87,
   "ci_low": 0.36,
   "ci_high": 2.1,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Walter EB et al., 2020, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2019-1909; PMID 32029684",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Delaying IIV did not reduce fever; outcome is fever, not seizure."
  },
  {
   "vaccine": "influenza",
   "product": "Pandemrix (AS03 H1N1; Europe, not US-licensed)",
   "outcome": "Narcolepsy",
   "design": "retrospective cohort",
   "population": "Children 4-19 y, Finland",
   "risk_window": "2009 to Aug 2010",
   "measure": "RR",
   "estimate": 12.7,
   "ci_low": 6.1,
   "ci_high": 30.8,
   "attributable_per_million_doses": 62,
   "conclusion": "increased risk",
   "source": "Nohynek H et al., 2012, PLoS One",
   "doi_or_pmid": "doi:10.1371/journal.pone.0033536; PMID 22470453",
   "location_in_source": "PubMed abstract, Findings",
   "notes": "Attributable risk 1 per 16,000 vaccinated 4-19 year olds (95% CI 1:13,000-1:21,000) = ~62 per million vaccinees (per person, not per dose)."
  },
  {
   "vaccine": "influenza",
   "product": "Pandemrix (AS03 H1N1; not US-licensed)",
   "outcome": "Narcolepsy",
   "design": "SCCS",
   "population": "Children/young people 4-18 y, England",
   "risk_window": "6 months",
   "measure": "relative incidence",
   "estimate": 9.9,
   "ci_low": 2.1,
   "ci_high": 47.9,
   "attributable_per_million_doses": 18,
   "conclusion": "increased risk",
   "source": "Miller E et al., 2013, BMJ",
   "doi_or_pmid": "doi:10.1136/bmj.f794; PMID 23444425",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Case-coverage OR 14.4 (4.3-48.5). Attributable risk 1 in 57,500 to 1 in 52,000 doses (~17-19 per million doses). Authors note possible ascertainment bias."
  },
  {
   "vaccine": "influenza",
   "product": "Pandemrix (AS03 H1N1; not US-licensed)",
   "outcome": "Narcolepsy",
   "design": "meta-analysis",
   "population": "Children/adolescents and adults, multiple European countries",
   "risk_window": "first year",
   "measure": "RR (range)",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": 54,
   "conclusion": "increased risk",
   "source": "Sarkanen TO et al., 2018, Sleep Med Rev",
   "doi_or_pmid": "doi:10.1016/j.smrv.2017.06.006; PMID 28847694",
   "location_in_source": "PubMed abstract",
   "notes": "RR 5-14 in children/adolescents and 2-7 in adults; risk limited to Pandemrix. Attributable ~1 per 18,400 doses in children (= ~54 per million)."
  },
  {
   "vaccine": "dtap",
   "product": "DTaP",
   "outcome": "Seizures (febrile or afebrile)",
   "design": "risk-interval cohort + SCCS (VSD)",
   "population": "Children 6 wk-23 mo, US (433,654)",
   "risk_window": "0-3 days",
   "measure": "IRR",
   "estimate": 0.91,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Huang WT et al., 2010, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2009-1496; PMID 20643726",
   "location_in_source": "PubMed abstract, Results",
   "notes": "SCCS IRR 0.91; cohort IRR 0.87. CIs not given in abstract."
  },
  {
   "vaccine": "dtap",
   "product": "DTP (whole-cell; no longer used in US)",
   "outcome": "Febrile seizures",
   "design": "cohort (VSD)",
   "population": "Children, US",
   "risk_window": "day 0",
   "measure": "RR",
   "estimate": 5.7,
   "ci_low": 1.98,
   "ci_high": 16.42,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Barlow WE et al., 2001, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa003077; PMID 11547719",
   "location_in_source": "PubMed abstract, Results",
   "notes": "6-9 attributable febrile seizures per 100,000 children. Historical comparator for DTaP."
  },
  {
   "vaccine": "dtap",
   "product": "Tdap in pregnancy",
   "outcome": "Preterm birth",
   "design": "retrospective cohort (VSD, 2 California sites)",
   "population": "Pregnant women, singleton live births, US 2010-2012 (123,494)",
   "risk_window": "pregnancy",
   "measure": "RR (adjusted)",
   "estimate": 1.03,
   "ci_low": 0.97,
   "ci_high": 1.09,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Kharbanda EO et al., 2014, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2014.14825; PMID 25387187",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "dtap",
   "product": "Tdap in pregnancy",
   "outcome": "Small for gestational age",
   "design": "retrospective cohort (VSD)",
   "population": "Pregnant women, US 2010-2012",
   "risk_window": "pregnancy",
   "measure": "RR (adjusted)",
   "estimate": 1.0,
   "ci_low": 0.96,
   "ci_high": 1.06,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Kharbanda EO et al., 2014, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2014.14825; PMID 25387187",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "dtap",
   "product": "Tdap in pregnancy (before 20 wk)",
   "outcome": "Hypertensive disorders of pregnancy",
   "design": "retrospective cohort (VSD)",
   "population": "Pregnant women, US 2010-2012",
   "risk_window": "pregnancy",
   "measure": "RR (adjusted)",
   "estimate": 1.09,
   "ci_low": 0.99,
   "ci_high": 1.2,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Kharbanda EO et al., 2014, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2014.14825; PMID 25387187",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "dtap",
   "product": "Tdap in pregnancy",
   "outcome": "Chorioamnionitis (coded diagnosis)",
   "design": "retrospective cohort (VSD)",
   "population": "Pregnant women, US 2010-2012",
   "risk_window": "pregnancy",
   "measure": "RR (adjusted)",
   "estimate": 1.19,
   "ci_low": 1.13,
   "ci_high": 1.26,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Kharbanda EO et al., 2014, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2014.14825; PMID 25387187",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Small increase in coded chorioamnionitis; a later, larger VSD study (Greenberg 2023) found no association (HR 0.96)."
  },
  {
   "vaccine": "dtap",
   "product": "Tdap in pregnancy",
   "outcome": "Chorioamnionitis",
   "design": "retrospective cohort (VSD, 7 sites)",
   "population": "Pregnancies, US 2010-2013 (197,564)",
   "risk_window": "pregnancy",
   "measure": "RR (adjusted rate ratio)",
   "estimate": 1.23,
   "ci_low": 1.17,
   "ci_high": 1.28,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "DeSilva M et al., 2017, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2017.05.041; PMID 28552511",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No increase in related infant outcomes: TTN 1.04 (0.98-1.11), neonatal sepsis 1.06 (0.91-1.23), neonatal pneumonia 0.94 (0.72-1.22), RDS 0.91 (0.66-1.26), newborn convulsions 1.16 (0.87-1.53)."
  },
  {
   "vaccine": "dtap",
   "product": "Tdap in pregnancy",
   "outcome": "Neonatal sepsis",
   "design": "retrospective cohort (VSD)",
   "population": "Infants of vaccinated vs unvaccinated mothers, US 2010-2013",
   "risk_window": "first hospitalization",
   "measure": "RR (adjusted rate ratio)",
   "estimate": 1.06,
   "ci_low": 0.91,
   "ci_high": 1.23,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "DeSilva M et al., 2017, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2017.05.041; PMID 28552511",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "dtap",
   "product": "Tdap in pregnancy",
   "outcome": "Chorioamnionitis",
   "design": "retrospective cohort (VSD, 8 sites, IPW Cox)",
   "population": "Pregnant people 15-49 y, US 2016-2018 (118,211)",
   "risk_window": "pregnancy",
   "measure": "HR (adjusted)",
   "estimate": 0.96,
   "ci_low": 0.9,
   "ci_high": 1.03,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Greenberg V et al., 2023, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2023.04.043; PMID 37117057",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No association with preterm birth or chorioamnionitis-related infant outcomes either."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Syncope (day of vaccination)",
   "design": "self-controlled risk interval (Kaiser California)",
   "population": "Females 9-26 y, US (189,629)",
   "risk_window": "day 0",
   "measure": "OR",
   "estimate": 6.0,
   "ci_low": 3.9,
   "ci_high": 9.2,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Klein NP et al., 2012, Arch Pediatr Adolesc Med",
   "doi_or_pmid": "doi:10.1001/archpediatrics.2012.1451; PMID 23027469",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Skin infections",
   "design": "self-controlled risk interval (Kaiser California)",
   "population": "Females 9-26 y, US",
   "risk_window": "days 1-14",
   "measure": "OR",
   "estimate": 1.8,
   "ci_low": 1.3,
   "ci_high": 2.4,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Klein NP et al., 2012, Arch Pediatr Adolesc Med",
   "doi_or_pmid": "doi:10.1001/archpediatrics.2012.1451; PMID 23027469",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Judged likely association (injection-site related) by Safety Review Committee."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Pre-specified AEs (GBS, stroke, VTE, appendicitis, seizures, syncope, allergic reaction, anaphylaxis)",
   "design": "sequential surveillance vs historical/concurrent (VSD)",
   "population": "Females 9-26 y, US (600,558 doses)",
   "risk_window": "outcome-specific",
   "measure": "RR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Gee J et al., 2011, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2011.08.106; PMID 21907257",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No statistically significant increase for any outcome; non-significant VTE RR 1.98 in ages 9-17 (all 5 confirmed cases had VTE risk factors) prompted follow-up study (Naleway 2016)."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Venous thromboembolism",
   "design": "SCCS (VSD)",
   "population": "Ages 9-26 y, US 2008-2011",
   "risk_window": "1-60 days",
   "measure": "IRR",
   "estimate": 0.92,
   "ci_low": 0.54,
   "ci_high": 1.57,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Naleway AL et al., 2016, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2015.10.006; PMID 26549361",
   "location_in_source": "PubMed abstract, Results",
   "notes": "1-7 days IRR 1.47 (0.47-4.64). 97% of confirmed cases had a known VTE risk factor."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Multiple sclerosis",
   "design": "cohort (national registers)",
   "population": "Females 10-44 y, Denmark and Sweden (3,983,824; 1.93 million doses)",
   "risk_window": "2 years",
   "measure": "IRR (adjusted)",
   "estimate": 0.9,
   "ci_low": 0.7,
   "ci_high": 1.15,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Scheller NM et al., 2015, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2014.16946; PMID 25562266",
   "location_in_source": "PubMed abstract, Results",
   "notes": "SCCS: MS IR 1.05 (0.79-1.38)."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Other CNS demyelinating diseases",
   "design": "cohort (national registers)",
   "population": "Females 10-44 y, Denmark and Sweden",
   "risk_window": "2 years",
   "measure": "IRR (adjusted)",
   "estimate": 1.0,
   "ci_low": 0.8,
   "ci_high": 1.26,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Scheller NM et al., 2015, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2014.16946; PMID 25562266",
   "location_in_source": "PubMed abstract, Results",
   "notes": "SCCS IR 1.14 (0.88-1.47)."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Guillain-Barre syndrome",
   "design": "cohort, incidence vs background (VSD)",
   "population": "Ages 9-26 y, US 2006-2015 (2,773,185 doses)",
   "risk_window": "1-42 days",
   "measure": "incidence per million doses",
   "estimate": 0.36,
   "ci_low": null,
   "ci_high": 1.71,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Gee J et al., 2017, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2017.09.009; PMID 28935469",
   "location_in_source": "PubMed abstract, Results/Conclusion",
   "notes": "1 confirmed case; rate below background. Upper bound: at most 1.08 additional GBS cases per million vaccinated (upper bound, not a point estimate)."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil 9 (9vHPV)",
   "outcome": "Pre-specified AEs (anaphylaxis, allergic reaction, appendicitis, GBS, CIDP, pancreatitis, seizure, stroke, syncope, VTE)",
   "design": "near real-time sequential surveillance (VSD)",
   "population": "Ages 9-26 y, US 2015-2017 (838,991 doses)",
   "risk_window": "outcome-specific",
   "measure": "observed/expected",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Donahue JG et al., 2019, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2019-1808; PMID 31740498",
   "location_in_source": "PubMed abstract, Results",
   "notes": "4 statistical signals (appendicitis, pancreatitis, allergic reactions) were not confirmed after chart review and further analyses."
  },
  {
   "vaccine": "hpv",
   "product": "HPV vaccines (France)",
   "outcome": "Guillain-Barre syndrome",
   "design": "cohort (national insurance databases)",
   "population": "Girls 13-16 y, France 2008-2012 (2,252,716)",
   "risk_window": "mean follow-up 33 months",
   "measure": "HR (adjusted)",
   "estimate": 3.78,
   "ci_low": 1.79,
   "ci_high": 7.98,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Miranda S et al., 2017, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2017.06.030; PMID 28750853",
   "location_in_source": "PubMed abstract, Results",
   "notes": "1-2 attributable GBS cases per 100,000 girls vaccinated if causal (per girl, not per dose). Not replicated in US VSD (Gee 2017)."
  },
  {
   "vaccine": "hpv",
   "product": "HPV vaccines (France)",
   "outcome": "13 other autoimmune diseases (composite)",
   "design": "cohort (national insurance databases)",
   "population": "Girls 13-16 y, France",
   "risk_window": "mean follow-up 33 months",
   "measure": "HR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Miranda S et al., 2017, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2017.06.030; PMID 28750853",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Incidence of autoimmune diseases not increased except GBS."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Celiac disease (only association remaining among 45 chronic diseases)",
   "design": "cohort + SCCS (national registers)",
   "population": "Women 18-44 y, Denmark and Sweden (3,126,790)",
   "risk_window": "outcome-specific",
   "measure": "RR",
   "estimate": 1.56,
   "ci_low": 1.29,
   "ci_high": 1.89,
   "attributable_per_million_doses": null,
   "conclusion": "inconclusive",
   "source": "Hviid A et al., 2018, J Intern Med",
   "doi_or_pmid": "doi:10.1111/joim.12694; PMID 29044769",
   "location_in_source": "PubMed abstract, Results/Conclusion",
   "notes": "Authors consider unmasking of underdiagnosed celiac disease at vaccination visits a plausible explanation; study 'did not raise any safety issues of concern'."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Autoimmune disorders (any of 6 types)",
   "design": "case-control (PGRx, France)",
   "population": "Females 14-26 y, France (211 cases, 875 controls)",
   "risk_window": "24 months",
   "measure": "OR (adjusted)",
   "estimate": 0.9,
   "ci_low": 0.5,
   "ci_high": 1.5,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Grimaldi-Bensouda L et al., 2014, J Intern Med",
   "doi_or_pmid": "doi:10.1111/joim.12155; PMID 24206418",
   "location_in_source": "PubMed abstract, Results",
   "notes": "ITP OR 1.0 (0.4-2.6); MS 0.3 (0.1-0.9); type 1 diabetes 1.2 (0.4-3.6). Limited power for individual disorders."
  },
  {
   "vaccine": "hpv",
   "product": "HPV vaccines",
   "outcome": "Autoimmune diseases (all combined)",
   "design": "case-referent (PGRx, France 2008-2014)",
   "population": "Females 11-25 y, France (478 cases, 1869 referents)",
   "risk_window": "study time window",
   "measure": "OR (adjusted)",
   "estimate": 0.58,
   "ci_low": 0.41,
   "ci_high": 0.83,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Grimaldi-Bensouda L et al., 2017, J Autoimmun",
   "doi_or_pmid": "doi:10.1016/j.jaut.2017.01.005; PMID 28190705",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No association for ITP or GBS."
  },
  {
   "vaccine": "hepatitis-b",
   "product": "Childhood vaccines incl. hepatitis B, MMR, DTP/DT, Hib, OPV",
   "outcome": "Anaphylaxis",
   "design": "cohort with chart review (VSD, 1991-1997)",
   "population": "Children and adolescents, US (7,644,049 doses)",
   "risk_window": "day 0-2",
   "measure": "incidence per million doses",
   "estimate": 0.65,
   "ci_low": 0.21,
   "ci_high": 1.53,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Bohlke K et al., 2003, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.112.4.815; PMID 14523172",
   "location_in_source": "PubMed abstract, Results",
   "notes": "5 cases; no deaths. Vaccines generally given in combination, so per-vaccine rate not estimable. Rare but real (a rate, not a comparison)."
  },
  {
   "vaccine": "hepatitis-b",
   "product": "All vaccines combined",
   "outcome": "Anaphylaxis",
   "design": "cohort with chart review, Brighton definition (VSD, 2009-2011)",
   "population": "Children and adults, US (25,173,965 doses)",
   "risk_window": "vaccine-triggered",
   "measure": "incidence per million doses",
   "estimate": 1.31,
   "ci_low": 0.9,
   "ci_high": 1.84,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "McNeil MM et al., 2016, J Allergy Clin Immunol",
   "doi_or_pmid": "doi:10.1016/j.jaci.2015.07.048; PMID 26452420",
   "location_in_source": "PubMed abstract, Results",
   "notes": "33 confirmed cases. Row filed under hepatitis-b for the vaccine-anaphylaxis topic but applies to all vaccines; hep B-specific rate not in abstract."
  },
  {
   "vaccine": "influenza",
   "product": "Trivalent inactivated influenza (given alone)",
   "outcome": "Anaphylaxis",
   "design": "cohort with chart review (VSD)",
   "population": "Children and adults, US (7,434,628 doses)",
   "risk_window": "vaccine-triggered",
   "measure": "incidence per million doses",
   "estimate": 1.35,
   "ci_low": 0.65,
   "ci_high": 2.47,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "McNeil MM et al., 2016, J Allergy Clin Immunol",
   "doi_or_pmid": "doi:10.1016/j.jaci.2015.07.048; PMID 26452420",
   "location_in_source": "PubMed abstract, Results",
   "notes": "10 cases."
  },
  {
   "vaccine": "hepatitis-b",
   "product": "Hepatitis B vaccine",
   "outcome": "Multiple sclerosis",
   "design": "nested case-control (Nurses' Health Study I and II)",
   "population": "Women, US (192 MS cases, 645 controls)",
   "risk_window": "any time before onset",
   "measure": "RR (multivariate)",
   "estimate": 0.9,
   "ci_low": 0.5,
   "ci_high": 1.6,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Ascherio A et al., 2001, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJM200102013440502; PMID 11172163",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Within 2 years before onset: RR 0.7 (0.3-1.8). No dose-response."
  },
  {
   "vaccine": "hepatitis-b",
   "product": "Hepatitis B, tetanus, influenza vaccines",
   "outcome": "Relapse of multiple sclerosis",
   "design": "case-crossover",
   "population": "MS patients, Europe (643 relapses)",
   "risk_window": "2 months",
   "measure": "RR (any vaccination)",
   "estimate": 0.71,
   "ci_low": 0.4,
   "ci_high": 1.26,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Confavreux C et al., 2001, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJM200102013440501; PMID 11172162",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Vaccine-specific RRs for tetanus, hep B, influenza ranged 0.22-1.08, none increased."
  },
  {
   "vaccine": "hepatitis-b",
   "product": "Hepatitis B vaccine",
   "outcome": "MS / CNS acquired demyelinating syndromes",
   "design": "nested case-control (Kaiser Southern California)",
   "population": "All ages, US 2008-2011 (780 cases, 3885 controls)",
   "risk_window": "up to 3 years",
   "measure": "OR",
   "estimate": 1.12,
   "ci_low": 0.72,
   "ci_high": 1.73,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Langer-Gould A et al., 2014, JAMA Neurol",
   "doi_or_pmid": "doi:10.1001/jamaneurol.2014.2633; PMID 25329096",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Any vaccine within 30 days in <50 y: OR 2.32 (1.18-4.57), interpreted as possible acceleration of existing subclinical disease, no long-term association."
  },
  {
   "vaccine": "hpv",
   "product": "HPV vaccine",
   "outcome": "MS / CNS acquired demyelinating syndromes",
   "design": "nested case-control (Kaiser Southern California)",
   "population": "Females 9-26 y (and all ages), US",
   "risk_window": "up to 3 years",
   "measure": "OR",
   "estimate": 1.05,
   "ci_low": 0.62,
   "ci_high": 1.78,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Langer-Gould A et al., 2014, JAMA Neurol",
   "doi_or_pmid": "doi:10.1001/jamaneurol.2014.2633; PMID 25329096",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "shingles",
   "product": "Shingrix (RZV)",
   "outcome": "Guillain-Barre syndrome",
   "design": "SCCS, claims-based (FDA/CMS Medicare)",
   "population": "Medicare beneficiaries >=65 y, US 2017-2020",
   "risk_window": "1-42 vs 43-183 days",
   "measure": "IRR",
   "estimate": 2.84,
   "ci_low": 1.53,
   "ci_high": 5.27,
   "attributable_per_million_doses": 3,
   "conclusion": "increased risk",
   "source": "Goud R et al., 2021, JAMA Intern Med",
   "doi_or_pmid": "doi:10.1001/jamainternmed.2021.6227; PMID 34724025",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Attributable risk 3 per million RZV doses (95% CI 0.62-5.64). Medical-record-confirmed SCCS RR 4.96 (1.43-17.27). Cohort RZV vs Zostavax RR 2.34 (1.01-5.41)."
  },
  {
   "vaccine": "shingles",
   "product": "Shingrix (RZV) vs Zostavax (ZVL)",
   "outcome": "Guillain-Barre syndrome",
   "design": "cohort (Medicare)",
   "population": "Medicare beneficiaries >=65 y, US (849,397 RZV; 1,817,099 ZVL)",
   "risk_window": "42 days",
   "measure": "RR",
   "estimate": 2.34,
   "ci_low": 1.01,
   "ci_high": 5.41,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Goud R et al., 2021, JAMA Intern Med",
   "doi_or_pmid": "doi:10.1001/jamainternmed.2021.6227; PMID 34724025",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "rsv",
   "product": "Arexvy (RSVPreF3+AS01) and Abrysvo (RSVPreF)",
   "outcome": "11 prespecified outcomes (e.g., stroke, atrial fibrillation, anaphylaxis, encephalomyelitis; GBS reported separately)",
   "design": "SCCS (FDA/CMS Medicare)",
   "population": "Medicare beneficiaries >=65 y, US 2023-2024 (3.82 million vaccinated)",
   "risk_window": "outcome-specific",
   "measure": "IRR (99% CI)",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Lloyd PC et al., 2026, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2026.128459; PMID 41833132",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No statistically significant elevation; IRRs ranged 0.54 (encephalomyelitis, Abrysvo) to 5.99 (99% CI 0.34-106.47; anaphylaxis, Arexvy). Non-hemorrhagic stroke AR 0.77 per 100,000 doses (99% CI -1.77 to 3.32; Arexvy)."
  },
  {
   "vaccine": "rsv",
   "product": "Abrysvo (RSVpreF) in pregnancy",
   "outcome": "Preterm birth",
   "design": "retrospective cohort (2 NYC hospitals)",
   "population": "Pregnant individuals delivering >=32 wk, US 2023-2024 (2973)",
   "risk_window": "pregnancy",
   "measure": "HR (time-dependent)",
   "estimate": 0.93,
   "ci_low": 0.64,
   "ci_high": 1.34,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Son M et al., 2024, JAMA Netw Open",
   "doi_or_pmid": "doi:10.1001/jamanetworkopen.2024.19268; PMID 38976271",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Adjusted OR 0.87 (0.62-1.20). Hypertensive disorders of pregnancy HR 1.43 (1.16-1.77) in time-dependent model; authors say further investigation warranted."
  },
  {
   "vaccine": "rsv",
   "product": "Abrysvo (RSVpreF) in pregnancy",
   "outcome": "Hypertensive disorders of pregnancy",
   "design": "retrospective cohort (2 NYC hospitals)",
   "population": "Pregnant individuals, US 2023-2024",
   "risk_window": "pregnancy",
   "measure": "HR (time-dependent)",
   "estimate": 1.43,
   "ci_low": 1.16,
   "ci_high": 1.77,
   "attributable_per_million_doses": null,
   "conclusion": "inconclusive",
   "source": "Son M et al., 2024, JAMA Netw Open",
   "doi_or_pmid": "doi:10.1001/jamanetworkopen.2024.19268; PMID 38976271",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Not significant in logistic models; single health system."
  },
  {
   "vaccine": "rsv",
   "product": "Abrysvo (RSVpreF) in pregnancy (MATISSE trial)",
   "outcome": "Maternal and infant adverse events",
   "design": "randomized controlled trial (phase 3)",
   "population": "Pregnant women 24-36 wk, 18 countries (3682 vaccine, 3676 placebo)",
   "risk_window": "1 month after injection/birth; infants to 24 mo",
   "measure": "proportion with AE",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Kampmann B et al., 2023, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa2216480; PMID 37018474",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No safety signals; AEs within 1 month: 13.8% vs 13.1% (women), 37.1% vs 34.5% (infants). Preterm-birth figures are in the full text, not the abstract (not extracted)."
  },
  {
   "vaccine": "rsv",
   "product": "GSK RSVPreF3-Mat (candidate maternal vaccine; never licensed)",
   "outcome": "Preterm birth",
   "design": "randomized controlled trial (phase 3, stopped early)",
   "population": "Pregnant women 18-49 y, 24-34 wk (5328)",
   "risk_window": "birth",
   "measure": "RR",
   "estimate": 1.37,
   "ci_low": 1.08,
   "ci_high": 1.74,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Dieussaert I et al., 2024, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa2305478; PMID 38477988",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Preterm birth 6.8% vs 4.9%; neonatal death RR 2.16 (0.62-7.56). This candidate was NOT licensed; included as context for maternal RSV vaccine preterm-birth concerns."
  },
  {
   "vaccine": "covid",
   "product": "Pfizer-BioNTech BNT162b2",
   "outcome": "Myocarditis (any dose, all ages >=16)",
   "design": "cohort, Kaplan-Meier incidence (Clalit Health Services)",
   "population": "Vaccinated members >=16 y, Israel (>2.5 million)",
   "risk_window": "42 days after dose 1",
   "measure": "incidence per 100,000 vaccinated",
   "estimate": 2.13,
   "ci_low": 1.56,
   "ci_high": 2.7,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Witberg G et al., 2021, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa2110737; PMID 34614329",
   "location_in_source": "PubMed abstract, Results",
   "notes": "76% mild, 22% intermediate; 1 cardiogenic shock. Incidence (not excess) per person."
  },
  {
   "vaccine": "covid",
   "product": "Pfizer-BioNTech BNT162b2",
   "outcome": "Myocarditis, males 16-29 y",
   "design": "cohort (Clalit Health Services)",
   "population": "Males 16-29 y, Israel",
   "risk_window": "42 days after dose 1",
   "measure": "incidence per 100,000 vaccinated",
   "estimate": 10.69,
   "ci_low": 6.93,
   "ci_high": 14.46,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Witberg G et al., 2021, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa2110737; PMID 34614329",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "covid",
   "product": "Pfizer-BioNTech BNT162b2",
   "outcome": "Myocarditis after dose 2 vs unvaccinated (all ages)",
   "design": "national active surveillance, rate ratio vs unvaccinated",
   "population": "Israel, whole population (Dec 2020-May 2021)",
   "risk_window": "30 days after dose 2",
   "measure": "rate ratio",
   "estimate": 2.35,
   "ci_low": 1.1,
   "ci_high": 5.02,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Mevorach D et al., 2021, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa2109730; PMID 34614328",
   "location_in_source": "PubMed abstract, Results",
   "notes": "SIR vs historical 5.34 (4.48-6.40). 95% of cases mild; 1 fatal fulminant case."
  },
  {
   "vaccine": "covid",
   "product": "Pfizer-BioNTech BNT162b2",
   "outcome": "Myocarditis after dose 2, males 16-19 y",
   "design": "national active surveillance, rate ratio vs unvaccinated",
   "population": "Males 16-19 y, Israel",
   "risk_window": "30 days after dose 2",
   "measure": "rate ratio",
   "estimate": 8.96,
   "ci_low": 4.5,
   "ci_high": 17.83,
   "attributable_per_million_doses": 151,
   "conclusion": "increased risk",
   "source": "Mevorach D et al., 2021, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa2109730; PMID 34614328",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Risk 1 in 6637 (= ~151 per million second doses in this group; absolute risk not excess). Dose 2 vs dose 1 risk difference 13.73 per 100,000 (8.11-19.46); SIR 13.60 (9.30-19.20)."
  },
  {
   "vaccine": "covid",
   "product": "Pfizer-BioNTech BNT162b2",
   "outcome": "Myocarditis/pericarditis, dose 2",
   "design": "concurrent comparator risk interval (VSD)",
   "population": "Adults 18-39 y, US (2,891,498 doses)",
   "risk_window": "0-7 days",
   "measure": "RR",
   "estimate": 14.3,
   "ci_low": 6.5,
   "ci_high": 34.9,
   "attributable_per_million_doses": 22.4,
   "conclusion": "increased risk",
   "source": "Goddard K et al., 2022, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2022.07.007; PMID 35902278",
   "location_in_source": "PubMed abstract, Results",
   "notes": "22.4 excess cases per million doses. Most hospitalized <=1 day; none required intensive care."
  },
  {
   "vaccine": "covid",
   "product": "Moderna mRNA-1273",
   "outcome": "Myocarditis/pericarditis, dose 2",
   "design": "concurrent comparator risk interval (VSD)",
   "population": "Adults 18-39 y, US (1,803,267 doses)",
   "risk_window": "0-7 days",
   "measure": "RR",
   "estimate": 18.8,
   "ci_low": 6.7,
   "ci_high": 64.9,
   "attributable_per_million_doses": 31.2,
   "conclusion": "increased risk",
   "source": "Goddard K et al., 2022, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2022.07.007; PMID 35902278",
   "location_in_source": "PubMed abstract, Results",
   "notes": "31.2 excess cases per million doses. Head-to-head mRNA-1273 vs BNT162b2 (either dose): RR 1.61 (1.02-2.54)."
  },
  {
   "vaccine": "covid",
   "product": "BNT162b2 and mRNA-1273",
   "outcome": "23 serious outcomes incl. stroke, AMI, GBS, CVST, PE, Bell palsy (interim)",
   "design": "concurrent comparator risk interval (VSD)",
   "population": "Ages >=12, US (11,845,128 doses)",
   "risk_window": "1-21 vs 22-42 days",
   "measure": "RR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Klein NP et al., 2021, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2021.15072; PMID 34477808",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No outcome met signal threshold. Ischemic stroke RR 0.97 (0.87-1.08); AMI 1.02 (0.89-1.18); appendicitis 0.82 (0.73-0.93). Myocarditis was later confirmed in young males (see Goddard 2022)."
  },
  {
   "vaccine": "covid",
   "product": "Pfizer-BioNTech BNT162b2",
   "outcome": "Anaphylaxis",
   "design": "cohort with chart confirmation (VSD)",
   "population": "Ages >=12, US",
   "risk_window": "post-vaccination",
   "measure": "incidence per million doses",
   "estimate": 4.8,
   "ci_low": 3.2,
   "ci_high": 6.9,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Klein NP et al., 2021, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2021.15072; PMID 34477808",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Descriptive rate, no comparator."
  },
  {
   "vaccine": "covid",
   "product": "Moderna mRNA-1273",
   "outcome": "Anaphylaxis",
   "design": "cohort with chart confirmation (VSD)",
   "population": "Ages >=12, US",
   "risk_window": "post-vaccination",
   "measure": "incidence per million doses",
   "estimate": 5.1,
   "ci_low": 3.3,
   "ci_high": 7.6,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Klein NP et al., 2021, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2021.15072; PMID 34477808",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Descriptive rate, no comparator."
  },
  {
   "vaccine": "covid",
   "product": "BNT162b2 dose 2 (homologous)",
   "outcome": "Myocarditis, all ages >=12",
   "design": "4 cohort studies meta-analysed (Nordic registers)",
   "population": "23,122,522 residents, Denmark/Finland/Norway/Sweden",
   "risk_window": "28 days",
   "measure": "IRR (adjusted)",
   "estimate": 1.75,
   "ci_low": 1.43,
   "ci_high": 2.14,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Karlstad O et al., 2022, JAMA Cardiol",
   "doi_or_pmid": "doi:10.1001/jamacardio.2022.0583; PMID 35442390",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "covid",
   "product": "mRNA-1273 dose 2 (homologous)",
   "outcome": "Myocarditis, all ages >=12",
   "design": "4 cohort studies meta-analysed (Nordic registers)",
   "population": "23.1 million residents, Nordic countries",
   "risk_window": "28 days",
   "measure": "IRR (adjusted)",
   "estimate": 6.57,
   "ci_low": 4.64,
   "ci_high": 9.28,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Karlstad O et al., 2022, JAMA Cardiol",
   "doi_or_pmid": "doi:10.1001/jamacardio.2022.0583; PMID 35442390",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "covid",
   "product": "BNT162b2 dose 2",
   "outcome": "Myocarditis, males 16-24 y",
   "design": "cohort (Nordic registers)",
   "population": "Males 16-24 y, Nordic countries",
   "risk_window": "28 days",
   "measure": "IRR (adjusted)",
   "estimate": 5.31,
   "ci_low": 3.68,
   "ci_high": 7.68,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Karlstad O et al., 2022, JAMA Cardiol",
   "doi_or_pmid": "doi:10.1001/jamacardio.2022.0583; PMID 35442390",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Excess 5.55 (3.70-7.39) events per 100,000 vaccinees (per person, = ~56 per million)."
  },
  {
   "vaccine": "covid",
   "product": "mRNA-1273 dose 2",
   "outcome": "Myocarditis, males 16-24 y",
   "design": "cohort (Nordic registers)",
   "population": "Males 16-24 y, Nordic countries",
   "risk_window": "28 days",
   "measure": "IRR (adjusted)",
   "estimate": 13.83,
   "ci_low": 8.08,
   "ci_high": 23.68,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Karlstad O et al., 2022, JAMA Cardiol",
   "doi_or_pmid": "doi:10.1001/jamacardio.2022.0583; PMID 35442390",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Excess 18.39 (9.05-27.72) events per 100,000 vaccinees (= ~184 per million)."
  },
  {
   "vaccine": "covid",
   "product": "BNT162b2 dose 1",
   "outcome": "Myocarditis (hospital admission or death)",
   "design": "SCCS (England)",
   "population": "Ages >=16, England (16,993,389 vaccinated)",
   "risk_window": "1-28 days",
   "measure": "excess events per million vaccinated",
   "estimate": 1,
   "ci_low": 0,
   "ci_high": 2,
   "attributable_per_million_doses": 1,
   "conclusion": "increased risk",
   "source": "Patone M et al., 2022, Nat Med",
   "doi_or_pmid": "doi:10.1038/s41591-021-01630-0; PMID 34907393",
   "location_in_source": "PubMed abstract",
   "notes": "Comparator: +40 (38-41) myocarditis events per million in 28 days after a positive SARS-CoV-2 test. Increased risk with mRNA vaccines only in people <40."
  },
  {
   "vaccine": "covid",
   "product": "mRNA-1273 dose 2",
   "outcome": "Myocarditis (hospital admission or death)",
   "design": "SCCS (England)",
   "population": "Ages >=16, England (1,006,191 vaccinated)",
   "risk_window": "1-28 days",
   "measure": "excess events per million vaccinated",
   "estimate": 10,
   "ci_low": 7,
   "ci_high": 11,
   "attributable_per_million_doses": 10,
   "conclusion": "increased risk",
   "source": "Patone M et al., 2022, Nat Med",
   "doi_or_pmid": "doi:10.1038/s41591-021-01630-0; PMID 34907393",
   "location_in_source": "PubMed abstract",
   "notes": "Dose 1 mRNA-1273: +6 (2-8) per million."
  },
  {
   "vaccine": "covid",
   "product": "SARS-CoV-2 infection (comparator, not a vaccine)",
   "outcome": "Myocarditis",
   "design": "SCCS (England)",
   "population": "Ages >=16, England (3,028,867 positive tests)",
   "risk_window": "1-28 days after positive test",
   "measure": "excess events per million infected",
   "estimate": 40,
   "ci_low": 38,
   "ci_high": 41,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Patone M et al., 2022, Nat Med",
   "doi_or_pmid": "doi:10.1038/s41591-021-01630-0; PMID 34907393",
   "location_in_source": "PubMed abstract",
   "notes": "Infection comparator row for context."
  },
  {
   "vaccine": "covid",
   "product": "Pfizer-BioNTech BNT162b2",
   "outcome": "Myocarditis/myopericarditis (all ages >=12)",
   "design": "cohort (Danish registers, Cox)",
   "population": "Ages >=12, Denmark (3,482,295 vaccinated)",
   "risk_window": "0-28 days",
   "measure": "HR (adjusted)",
   "estimate": 1.34,
   "ci_low": 0.9,
   "ci_high": 2.0,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Husby A et al., 2021, BMJ",
   "doi_or_pmid": "doi:10.1136/bmj-2021-068665; PMID 34916207",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Absolute 1.4 (1.0-1.8) per 100,000 vaccinated. Females HR 3.73 (1.82-7.65), males 0.82 (0.50-1.34) in this study."
  },
  {
   "vaccine": "covid",
   "product": "Moderna mRNA-1273",
   "outcome": "Myocarditis/myopericarditis (all ages >=12)",
   "design": "cohort (Danish registers, Cox)",
   "population": "Ages >=12, Denmark (498,814 vaccinated)",
   "risk_window": "0-28 days",
   "measure": "HR (adjusted)",
   "estimate": 3.92,
   "ci_low": 2.3,
   "ci_high": 6.68,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Husby A et al., 2021, BMJ",
   "doi_or_pmid": "doi:10.1136/bmj-2021-068665; PMID 34916207",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Absolute 4.2 (2.6-6.4) per 100,000 vaccinated; ages 12-39 HR 5.24 (2.47-11.12), 5.7 per 100,000."
  },
  {
   "vaccine": "covid",
   "product": "Janssen Ad26.COV2.S",
   "outcome": "Guillain-Barre syndrome",
   "design": "cohort, risk vs comparison interval and vs mRNA (VSD)",
   "population": "Ages >=12, US (483,053 Janssen doses)",
   "risk_window": "1-21 days",
   "measure": "RR (vs mRNA vaccines, head-to-head)",
   "estimate": 20.56,
   "ci_low": 6.94,
   "ci_high": 64.66,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Hanson KE et al., 2022, JAMA Netw Open",
   "doi_or_pmid": "doi:10.1001/jamanetworkopen.2022.8879; PMID 35471572",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Incidence 32.4 (14.8-61.5) per 100,000 person-years in days 1-21, significantly above background; RR 1-21 vs 22-42 days 6.03 (0.79-147.79)."
  },
  {
   "vaccine": "covid",
   "product": "BNT162b2 and mRNA-1273",
   "outcome": "Guillain-Barre syndrome",
   "design": "cohort, risk vs comparison interval (VSD)",
   "population": "Ages >=12, US (14.6 million mRNA doses)",
   "risk_window": "1-21 vs 22-42 days",
   "measure": "RR (adjusted)",
   "estimate": 0.56,
   "ci_low": 0.21,
   "ci_high": 1.48,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Hanson KE et al., 2022, JAMA Netw Open",
   "doi_or_pmid": "doi:10.1001/jamanetworkopen.2022.8879; PMID 35471572",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Incidence 1.3 (0.7-2.4) per 100,000 person-years in days 1-21."
  },
  {
   "vaccine": "varicella",
   "product": "Varicella vaccine (Varivax)",
   "outcome": "Herpes zoster in vaccinated vs unvaccinated children",
   "design": "cohort (6 US integrated health care organizations)",
   "population": "Children 0-17 y, US 2003-2014 (6,372,067)",
   "risk_window": "12-year period",
   "measure": "incidence rate per 100,000 person-years",
   "estimate": 38,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Weinmann S et al., 2019, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2018-2917; PMID 31182552",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Vaccinated 38 vs unvaccinated 170 per 100,000 person-years (78% lower; P<.0001). Vaccine is protective: decreased, not increased, zoster."
  },
  {
   "vaccine": "varicella",
   "product": "Varicella vaccine (Varivax)",
   "outcome": "Herpes zoster in vaccinated cohort vs prevaccine-era unvaccinated children",
   "design": "prospective cohort (KPNC, 14 y)",
   "population": "Children vaccinated in 2nd year of life 1995, US (7585)",
   "risk_window": "14 years",
   "measure": "RR",
   "estimate": 0.61,
   "ci_low": 0.43,
   "ci_high": 0.89,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Baxter R et al., 2013, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2012-3303; PMID 23545380",
   "location_in_source": "PubMed abstract, Results",
   "notes": "HZ cases mild; vaccine associated with lower zoster risk."
  },
  {
   "vaccine": "varicella",
   "product": "Varicella vaccination program (population level)",
   "outcome": "Herpes zoster incidence, children <10 y",
   "design": "population-based active surveillance (Antelope Valley, CA)",
   "population": "Children <10 y, US 2000-2010",
   "risk_window": "2007-2010 vs 2000-2006",
   "measure": "incidence per 100,000 children",
   "estimate": 12.8,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Civen R et al., 2016, Pediatr Infect Dis J",
   "doi_or_pmid": "doi:10.1097/INF.0000000000001249; PMID 27622686",
   "location_in_source": "PubMed abstract, Results",
   "notes": "12.8 vs 41.6 per 100,000 (69% decline). Ages 10-19: 78.2 vs 68.0 (13% increase, P=0.123, not significant). Ecological, not individual-level."
  },
  {
   "vaccine": "meningococcal",
   "product": "Menactra (MCV4, MenACWY-D)",
   "outcome": "Guillain-Barre syndrome",
   "design": "retrospective cohort (5 US health plans)",
   "population": "Ages 11-21 y, US 2005-2008 (>1.4 million vaccinations)",
   "risk_window": "6 weeks",
   "measure": "attributable risk (upper 95% bound)",
   "estimate": 0,
   "ci_low": null,
   "ci_high": 1.5,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Velentgas P et al., 2012, Pharmacoepidemiol Drug Saf",
   "doi_or_pmid": "doi:10.1002/pds.3321; PMID 22807266",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No confirmed GBS cases within 6 weeks of vaccination; upper 95% bound 1.5 cases per million doses."
  },
  {
   "vaccine": "meningococcal",
   "product": "Menveo (MenACWY-CRM)",
   "outcome": "Bell's palsy",
   "design": "cohort with SCCS (Kaiser Southern California)",
   "population": "Ages 11-21 y, US 2011-2013 (48,899)",
   "risk_window": "predefined per event",
   "measure": "relative incidence (adjusted)",
   "estimate": 2.9,
   "ci_low": 1.1,
   "ci_high": 7.5,
   "attributable_per_million_doses": null,
   "conclusion": "inconclusive",
   "source": "Tseng HF et al., 2017, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2016-2084; PMID 28025240",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Only with concomitant vaccines RI 5.0 (1.4-17.8); without concomitant vaccines RI 1.1 (0.2-5.5). Authors: could be chance, concomitant vaccination, or medical history."
  },
  {
   "vaccine": "meningococcal",
   "product": "Menveo (MenACWY-CRM)",
   "outcome": "26 prespecified events of interest (other than Bell's palsy)",
   "design": "cohort with SCCS (Kaiser Southern California)",
   "population": "Ages 11-21 y, US",
   "risk_window": "predefined per event",
   "measure": "relative incidence",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Tseng HF et al., 2017, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2016-2084; PMID 28025240",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No cases in risk window for 14 of 26 events."
  },
  {
   "vaccine": "pcv",
   "product": "Prevnar 13 (PCV13) vs PCV7",
   "outcome": "Febrile seizures, urticaria/angioedema, asthma, thrombocytopenia, anaphylaxis",
   "design": "cohort vs historical PCV7 (VSD)",
   "population": "Children 1 mo-2 y, US 2010-2012 (599,229 doses)",
   "risk_window": "outcome-specific",
   "measure": "RR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Tseng HF et al., 2013, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2013.03.040; PMID 23579258",
   "location_in_source": "PubMed abstract",
   "notes": "No increased risk vs PCV7 for these outcomes; encephalopathy signal not confirmed on chart review. (Febrile seizure increase with same-day IIV is shown separately in Tse 2012.)"
  },
  {
   "vaccine": "pcv",
   "product": "Prevnar 13 (PCV13)",
   "outcome": "Kawasaki disease",
   "design": "self-controlled risk interval (VSD)",
   "population": "Children <2 y, US, born 2006-2017",
   "risk_window": "1-28 days",
   "measure": "RR (age-adjusted)",
   "estimate": 0.75,
   "ci_low": 0.47,
   "ci_high": 1.21,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Kamidani S et al., 2022, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2022-058789; PMID 36349537",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Earlier VSD study (Tseng 2013) had non-significant RR 1.94 (0.79-4.86) vs PCV7."
  },
  {
   "vaccine": "rotavirus",
   "product": "RotaTeq/Rotarix",
   "outcome": "Kawasaki disease",
   "design": "self-controlled risk interval (VSD)",
   "population": "Children <2 y, US, born 2006-2017",
   "risk_window": "1-28 days",
   "measure": "RR (age-adjusted)",
   "estimate": 0.66,
   "ci_low": 0.4,
   "ci_high": 1.09,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Kamidani S et al., 2022, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2022-058789; PMID 36349537",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "yellow-fever",
   "product": "Yellow fever vaccine (17D)",
   "outcome": "YEL-AND (neurologic disease)",
   "design": "PASSIVE reporting rate (VAERS) per doses distributed - not a controlled study",
   "population": "US travelers 2007-2013",
   "risk_window": "n/a",
   "measure": "reporting rate per 100,000 doses distributed",
   "estimate": 0.8,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": 8,
   "conclusion": "increased risk",
   "source": "Lindsey NP et al., 2016, J Travel Med",
   "doi_or_pmid": "doi:10.1093/jtm/taw045; PMID 27378369",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Included because YEL-AND/AVD rates come only from surveillance; caution: VAERS-based, not active surveillance. Rate increases with age. Per-million = per doses distributed."
  },
  {
   "vaccine": "yellow-fever",
   "product": "Yellow fever vaccine (17D)",
   "outcome": "YEL-AVD (viscerotropic disease)",
   "design": "PASSIVE reporting rate (VAERS) per doses distributed - not a controlled study",
   "population": "US travelers 2007-2013",
   "risk_window": "n/a",
   "measure": "reporting rate per 100,000 doses distributed",
   "estimate": 0.3,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": 3,
   "conclusion": "increased risk",
   "source": "Lindsey NP et al., 2016, J Travel Med",
   "doi_or_pmid": "doi:10.1093/jtm/taw045; PMID 27378369",
   "location_in_source": "PubMed abstract, Results",
   "notes": "VAERS-based. Rate increases with age. All serious AEs 3.8 per 100,000 (6.5 at 60-69 y, 10.3 at >=70 y); anaphylaxis 1.3 per 100,000."
  },
  {
   "vaccine": "yellow-fever",
   "product": "Dengvaxia (CYD-TDV; dengue, not yellow fever)",
   "outcome": "Hospitalization for virologically confirmed dengue in seronegative recipients",
   "design": "case-cohort reanalysis of 3 RCTs",
   "population": "Dengue-seronegative participants 2-16 y, Asia/Latin America",
   "risk_window": "5 years",
   "measure": "HR",
   "estimate": 1.75,
   "ci_low": 1.14,
   "ci_high": 2.7,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Sridhar S et al., 2018, N Engl J Med",
   "doi_or_pmid": "doi:10.1056/NEJMoa1800820; PMID 29897841",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Filed under yellow-fever key (flavivirus; no dengue key). Ages 9-16 seronegative HR 1.41 (0.74-2.68); seropositive 9-16 HR 0.21 (0.14-0.31)."
  },
  {
   "vaccine": "rsv",
   "product": "RSV disease (infection comparator, not a vaccine)",
   "outcome": "Guillain-Barre syndrome",
   "design": "SCCS (Medicare claims 2011-2024)",
   "population": "Adults >=65 y with medically attended RSV, US (452,471)",
   "risk_window": "1-42 days after RSV",
   "measure": "IRR (adjusted)",
   "estimate": 2.11,
   "ci_low": 1.01,
   "ci_high": 4.37,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Liang C et al., 2026, Clin Infect Dis",
   "doi_or_pmid": "doi:10.1093/cid/ciaf621; PMID 41234154",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Pfizer-authored. Context for vaccine-GBS risk: infection itself raises GBS risk; >=75 y IRR 3.98 (1.45-10.91)."
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Venous thromboembolism",
   "design": "register-based cohort",
   "population": "Girls 10-17 y, Denmark and Sweden (997,585; 696,420 doses)",
   "risk_window": "180 days",
   "measure": "RR (adjusted)",
   "estimate": 0.86,
   "ci_low": 0.55,
   "ci_high": 1.36,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Arnheim-Dahlstrom L et al., 2013, BMJ",
   "doi_or_pmid": "doi:10.1136/bmj.f5906; PMID 24108159",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "hpv",
   "product": "Gardasil (4vHPV)",
   "outcome": "Autoimmune events (23 analysed)",
   "design": "register-based cohort",
   "population": "Girls 10-17 y, Denmark and Sweden",
   "risk_window": "180 days",
   "measure": "RR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Arnheim-Dahlstrom L et al., 2013, BMJ",
   "doi_or_pmid": "doi:10.1136/bmj.f5906; PMID 24108159",
   "location_in_source": "PubMed abstract, Results/Conclusions",
   "notes": "20 of 23 not increased; Behcet's, Raynaud's, type 1 diabetes initially associated but weak, met only 1 of 3 signal criteria, not temporally related. Inverse associations with epilepsy (0.66, 0.54-0.80) and paralysis (0.56, 0.35-0.90)."
  },
  {
   "vaccine": "influenza",
   "product": "Trivalent inactivated influenza (TIV)",
   "outcome": "Any medically attended event (screen of all diagnoses)",
   "design": "self-controlled (VSD) with chart review",
   "population": "Children 6-23 mo, US 1991-2003 (45,356 children; 69,359 vaccinations)",
   "risk_window": "1-14 days (primary)",
   "measure": "matched OR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Hambidge SJ et al., 2006, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.296.16.1990; PMID 17062862",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Only gastritis/duodenitis elevated before chart review; after chart review OR 4.00 (0.85-18.84), not significant. No serious events associated."
  },
  {
   "vaccine": "hib",
   "product": "Hib conjugate",
   "outcome": "Type 1 diabetes",
   "design": "birth-cohort comparison (trial cohorts)",
   "population": "Children, Finland (128,936 + 116,352)",
   "risk_window": "10-year follow-up",
   "measure": "RR",
   "estimate": 1.01,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Karvonen M et al., 1999, BMJ",
   "doi_or_pmid": "doi:10.1136/bmj.318.7192.1169; PMID 10221937",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Vaccinated at 24 mo only vs pre-vaccine cohort RR 1.01; vaccinated from 3 mo vs 24 mo only RR 1.06; neither significant. CIs not given in abstract."
  },
  {
   "vaccine": "hib",
   "product": "Hib",
   "outcome": "Type 1 diabetes",
   "design": "case-control (VSD, 4 HMOs)",
   "population": "Children born 1988-1997, US (252 cases, 768 controls)",
   "risk_window": "any time before onset",
   "measure": "OR",
   "estimate": 1.14,
   "ci_low": 0.51,
   "ci_high": 2.57,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "DeStefano F et al., 2001, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.108.6.e112; PMID 11731639",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "hepatitis-b",
   "product": "Hepatitis B vaccine",
   "outcome": "Type 1 diabetes",
   "design": "case-control (VSD, 4 HMOs)",
   "population": "Children born 1988-1997, US",
   "risk_window": "any time before onset",
   "measure": "OR",
   "estimate": 0.81,
   "ci_low": 0.52,
   "ci_high": 1.27,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "DeStefano F et al., 2001, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.108.6.e112; PMID 11731639",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Birth dose vs unvaccinated OR 0.51 (0.23-1.15)."
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Type 1 diabetes",
   "design": "case-control (VSD, 4 HMOs)",
   "population": "Children born 1988-1997, US",
   "risk_window": "any time before onset",
   "measure": "OR",
   "estimate": 1.36,
   "ci_low": 0.7,
   "ci_high": 2.63,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "DeStefano F et al., 2001, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.108.6.e112; PMID 11731639",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "varicella",
   "product": "Varicella vaccine",
   "outcome": "Type 1 diabetes",
   "design": "case-control (VSD, 4 HMOs)",
   "population": "Children born 1988-1997, US",
   "risk_window": "any time before onset",
   "measure": "OR",
   "estimate": 1.16,
   "ci_low": 0.72,
   "ci_high": 1.89,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "DeStefano F et al., 2001, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.108.6.e112; PMID 11731639",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "dtap",
   "product": "Acellular pertussis-containing vaccines",
   "outcome": "Type 1 diabetes",
   "design": "case-control (VSD, 4 HMOs)",
   "population": "Children born 1988-1997, US",
   "risk_window": "any time before onset",
   "measure": "OR",
   "estimate": 0.92,
   "ci_low": 0.53,
   "ci_high": 1.57,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "DeStefano F et al., 2001, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.108.6.e112; PMID 11731639",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "mmr",
   "product": "Cumulative childhood schedule (antigen count)",
   "outcome": "Non-vaccine-targeted infections at 24-47 mo",
   "design": "nested case-control (VSD)",
   "population": "Children born 2003-2013, US (193 cases, 751 controls)",
   "risk_window": "birth to 23 mo exposure",
   "measure": "matched OR per 30-antigen increase",
   "estimate": 0.94,
   "ci_low": 0.84,
   "ci_high": 1.07,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Glanz JM et al., 2018, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2018.0708; PMID 29509866",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Addresses 'immune overload'; whole-schedule exposure, filed under mmr key for lack of a schedule key."
  },
  {
   "vaccine": "mmr",
   "product": "Cumulative childhood schedule (antigen exposure)",
   "outcome": "Autism spectrum disorder",
   "design": "case-control (3 MCOs)",
   "population": "Children, US (256 ASD cases, 752 controls)",
   "risk_window": "cumulative to age 2 y",
   "measure": "aOR per 25-unit antigen increase",
   "estimate": 0.999,
   "ci_low": 0.998,
   "ci_high": 1.001,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "DeStefano F et al., 2013, J Pediatr",
   "doi_or_pmid": "doi:10.1016/j.jpeds.2013.02.001; PMID 23545349",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Whole-schedule exposure (not MMR-specific); filed under mmr key."
  },
  {
   "vaccine": "polio",
   "product": "Kinrix (DTaP-IPV)",
   "outcome": "8 prespecified AEs (meningitis/encephalitis, seizures, stroke, GBS, SJS, anaphylaxis, serious allergic, serious local reactions)",
   "design": "sequential surveillance vs historical rates (VSD)",
   "population": "Children 4-6 y, US 2009-2012 (201,116)",
   "risk_window": "outcome-specific",
   "measure": "RR (sequential probability ratio test)",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Daley MF et al., 2014, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2014.03.063; PMID 24699471",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No statistically significant increase for any outcome; 97% received other vaccines same day."
  },
  {
   "vaccine": "polio",
   "product": "Pentacel (DTaP-IPV-Hib)",
   "outcome": "Fever, seizure, meningitis/encephalitis/myelitis, allergic reactions, anaphylaxis, GBS, invasive Hib",
   "design": "group sequential cohort vs historical DTaP recipients (VSD)",
   "population": "Children, US 2008-2011 (149,337)",
   "risk_window": "outcome-specific",
   "measure": "RR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Nelson JC et al., 2013, Am J Epidemiol",
   "doi_or_pmid": "doi:10.1093/aje/kws317; PMID 23292957",
   "location_in_source": "PubMed abstract",
   "notes": "No increased risk for any outcome; subgroup 1-2 y: medically attended fever RR 1.83 (1.34-2.50); infants <1 y RR 0.83 (0.73-0.94)."
  },
  {
   "vaccine": "hib",
   "product": "Pentacel (DTaP-IPV-Hib)",
   "outcome": "Medically attended fever, 1-2 year olds",
   "design": "group sequential cohort vs historical DTaP recipients (VSD)",
   "population": "Children 1-2 y, US",
   "risk_window": "outcome-specific",
   "measure": "RR",
   "estimate": 1.83,
   "ci_low": 1.34,
   "ci_high": 2.5,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Nelson JC et al., 2013, Am J Epidemiol",
   "doi_or_pmid": "doi:10.1093/aje/kws317; PMID 23292957",
   "location_in_source": "PubMed abstract",
   "notes": "End-of-study prespecified subgroup analysis; fever only (no increase in seizures)."
  },
  {
   "vaccine": "shingles",
   "product": "Shingrix (RZV)",
   "outcome": "10 prespecified outcomes incl. stroke, anaphylaxis, GBS",
   "design": "sequential surveillance vs historical Zostavax and concurrent comparators (VSD)",
   "population": "Adults >=50 y, US 2018-2019 (647,833 doses)",
   "risk_window": "outcome-specific",
   "measure": "RR",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "inconclusive",
   "source": "Nelson JC et al., 2023, Am J Epidemiol",
   "doi_or_pmid": "doi:10.1093/aje/kwac170; PMID 36193854",
   "location_in_source": "PubMed abstract",
   "notes": "No sustained increased risk for any outcome; confirmed increased systemic and local reactions; GBS 'uncertainty remains' due to few confirmed cases."
  },
  {
   "vaccine": "shingles",
   "product": "Shingrix (RZV)",
   "outcome": "Any diagnosis (tree-temporal data mining)",
   "design": "self-controlled tree-temporal scan (MarketScan)",
   "population": "Commercially insured adults >=50 y, US (1,014,329 doses)",
   "risk_window": "56 days",
   "measure": "scan statistic",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Yih WK et al., 2022, Am J Epidemiol",
   "doi_or_pmid": "doi:10.1093/aje/kwac030; PMID 35152283",
   "location_in_source": "PubMed abstract",
   "notes": "Clusters only for expected reactogenicity (fever, allergy, syncope, cellulitis, myalgia, dizziness). No GBS cluster detected (possibly insufficient sample)."
  },
  {
   "vaccine": "covid",
   "product": "Janssen Ad26.COV2.S",
   "outcome": "Thrombosis with thrombocytopenia syndrome (TTS)",
   "design": "case series with reporting rate (VAERS-based, confirmed cases) - not a controlled study",
   "population": "US, Dec 2020-Aug 2021",
   "risk_window": "n/a",
   "measure": "reporting rate per million doses",
   "estimate": 3.83,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": 3.83,
   "conclusion": "increased risk",
   "source": "See I et al., 2022, Ann Intern Med",
   "doi_or_pmid": "doi:10.7326/M21-4502; PMID 35038274",
   "location_in_source": "PubMed abstract, Results",
   "notes": "54 confirmed cases; 15% died. mRNA vaccines 0.00855 per million doses (consistent with background). Passive-surveillance derived; authors conclude TTS is a rare but serious adverse event associated with Ad26.COV2.S."
  },
  {
   "vaccine": "influenza",
   "product": "IIV3 + PCV (same day)",
   "outcome": "Febrile seizures",
   "design": "self-controlled risk interval (VSD)",
   "population": "Children 6-23 mo, US 2006-2011",
   "risk_window": "0-1 days vs 14-20 days",
   "measure": "IRR",
   "estimate": 3.5,
   "ci_low": 1.13,
   "ci_high": 10.85,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Duffy J et al., 2016, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2016-0320; PMID 27273711",
   "location_in_source": "PubMed abstract, Results",
   "notes": "IIV3 alone: IRR 0.46 (0.21-1.02), no independent risk. Maximum excess with IIV3+PCV+DTaP same day vs separate days: 30 FS per 100,000 vaccinated."
  },
  {
   "vaccine": "influenza",
   "product": "IIV3 + DTaP-containing vaccine (same day)",
   "outcome": "Febrile seizures",
   "design": "self-controlled risk interval (VSD)",
   "population": "Children 6-23 mo, US",
   "risk_window": "0-1 days",
   "measure": "IRR",
   "estimate": 3.5,
   "ci_low": 1.52,
   "ci_high": 8.07,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Duffy J et al., 2016, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2016-0320; PMID 27273711",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "influenza",
   "product": "IIV3 (alone, adjusted for concomitant vaccines)",
   "outcome": "Febrile seizures",
   "design": "self-controlled risk interval (VSD)",
   "population": "Children 6-23 mo, US",
   "risk_window": "0-1 days",
   "measure": "IRR",
   "estimate": 0.46,
   "ci_low": 0.21,
   "ci_high": 1.02,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Duffy J et al., 2016, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2016-0320; PMID 27273711",
   "location_in_source": "PubMed abstract, Results",
   "notes": null
  },
  {
   "vaccine": "pcv",
   "product": "PCV7",
   "outcome": "Febrile seizures (independent effect)",
   "design": "self-controlled risk interval (VSD)",
   "population": "Children 6-23 mo, US",
   "risk_window": "0-1 days",
   "measure": "IRR",
   "estimate": 1.98,
   "ci_low": 1.0,
   "ci_high": 3.91,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Duffy J et al., 2016, Pediatrics",
   "doi_or_pmid": "doi:10.1542/peds.2016-0320; PMID 27273711",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Borderline (lower CI 1.00)."
  },
  {
   "vaccine": "dtap",
   "product": "Infant vaccine visits (median 4 vaccines incl. DTaP, PCV, Hib, IPV, HepB, RV)",
   "outcome": "Febrile seizures",
   "design": "self-controlled risk interval (VSD)",
   "population": "Infants 1-5 mo, US 2006-2011 (585,342 vaccination visits)",
   "risk_window": "0-1 days vs 14-20 days",
   "measure": "IRR",
   "estimate": 23,
   "ci_low": 5.13,
   "ci_high": 100.8,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Duffy J et al., 2017, Pediatr Neurol",
   "doi_or_pmid": "doi:10.1016/j.pediatrneurol.2017.08.005; PMID 28958404",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Attributable risk 3.92 (1.68-6.17) per 100,000 persons vaccinated; 15 cases total. Visit-level, not vaccine-specific."
  },
  {
   "vaccine": "influenza",
   "product": "2009 H1N1 monovalent (Medicare)",
   "outcome": "Guillain-Barre syndrome",
   "design": "self-controlled risk interval (FDA/CMS Medicare, chart confirmed)",
   "population": "Medicare beneficiaries (mostly >=65 y), US 2009-2010",
   "risk_window": "6 weeks",
   "measure": "IRR",
   "estimate": 2.41,
   "ci_low": 1.14,
   "ci_high": 5.11,
   "attributable_per_million_doses": 2.84,
   "conclusion": "increased risk",
   "source": "Polakowski LL et al., 2013, Am J Epidemiol",
   "doi_or_pmid": "doi:10.1093/aje/kwt051; PMID 23652165",
   "location_in_source": "PubMed abstract",
   "notes": "Attributable 2.84 per million doses (0.21-5.48). Stricter Brighton level 1-2 not significant."
  },
  {
   "vaccine": "influenza",
   "product": "2009 H1N1 monovalent",
   "outcome": "Guillain-Barre syndrome",
   "design": "active population-based surveillance (CDC Emerging Infections Program)",
   "population": "45 million persons, 10 US sites 2009-2010",
   "risk_window": "42 days",
   "measure": "RR (adjusted)",
   "estimate": 1.57,
   "ci_low": 1.02,
   "ci_high": 2.21,
   "attributable_per_million_doses": 0.74,
   "conclusion": "increased risk",
   "source": "Wise ME et al., 2012, Am J Epidemiol",
   "doi_or_pmid": "doi:10.1093/aje/kws196; PMID 22582209",
   "location_in_source": "PubMed abstract",
   "notes": "0.74 excess GBS cases per million doses (0.04-1.56); much smaller than 1976."
  },
  {
   "vaccine": "influenza",
   "product": "US 2009 H1N1 and 2010-11 seasonal (non-adjuvanted; no Pandemrix)",
   "outcome": "Narcolepsy",
   "design": "cohort, observed vs expected (VSD)",
   "population": "Persons <30 y, US (650,995 pandemic; 870,530 seasonal)",
   "risk_window": "180 days",
   "measure": "observed vs expected",
   "estimate": 0,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Duffy J et al., 2014, Neurology",
   "doi_or_pmid": "doi:10.1212/WNL.0000000000000987; PMID 25320099",
   "location_in_source": "PubMed abstract, Results",
   "notes": "0 observed vs 6.52 expected after 2009 pandemic vaccine; 2 vs 8.83 expected after 2010-11 seasonal. Contrast with Pandemrix in Europe."
  },
  {
   "vaccine": "influenza",
   "product": "Trivalent inactivated influenza in pregnancy",
   "outcome": "Preterm birth (<37 wk)",
   "design": "matched cohort (VSD, 7 sites)",
   "population": "Pregnant women, US 2004-2009 (57,554)",
   "risk_window": "pregnancy",
   "measure": "OR",
   "estimate": 0.97,
   "ci_low": 0.93,
   "ci_high": 1.02,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Nordin JD et al., 2014, J Pediatr",
   "doi_or_pmid": "doi:10.1016/j.jpeds.2014.01.037; PMID 24582484",
   "location_in_source": "PubMed abstract, Results",
   "notes": "SGA <10th percentile OR 1.00 (0.96-1.04); first trimester vaccination also not associated."
  },
  {
   "vaccine": "influenza",
   "product": "Inactivated influenza in pregnancy (2012-15)",
   "outcome": "Spontaneous abortion",
   "design": "case-control (VSD)",
   "population": "Pregnant women, US (1236 cases); previously vaccinated stratum 627 pairs",
   "risk_window": "1-28 days",
   "measure": "aOR",
   "estimate": 0.9,
   "ci_low": 0.6,
   "ci_high": 1.5,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Donahue JG et al., 2019, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2019.09.035; PMID 31540812",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No association in any window or stratum; follow-up to the 2017 signal."
  },
  {
   "vaccine": "influenza",
   "product": "Inactivated influenza containing H1N1pdm09 (2010-12)",
   "outcome": "Spontaneous abortion",
   "design": "case-control (VSD)",
   "population": "Pregnant women, US (485 cases)",
   "risk_window": "1-28 days",
   "measure": "aOR",
   "estimate": 2.0,
   "ci_low": 1.1,
   "ci_high": 3.6,
   "attributable_per_million_doses": null,
   "conclusion": "inconclusive",
   "source": "Donahue JG et al., 2017, Vaccine",
   "doi_or_pmid": "doi:10.1016/j.vaccine.2017.06.069; PMID 28917295",
   "location_in_source": "PubMed abstract, Results",
   "notes": "Only among women also vaccinated with pH1N1 vaccine in prior season (aOR 7.7, 2.2-27.3); authors state causality not established. Not replicated in 2012-15 seasons (Donahue 2019)."
  },
  {
   "vaccine": "rsv",
   "product": "Abrysvo (RSVpreF, Pfizer)",
   "outcome": "Guillain-Barre syndrome",
   "design": "SCCS (FDA/CMS Medicare claims, chart review when available)",
   "population": "Medicare beneficiaries >=65 y, US May 2023-Jul 2024",
   "risk_window": "1-42 vs 43-90 days",
   "measure": "attributable risk per million doses",
   "estimate": 9,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": 9,
   "conclusion": "increased risk",
   "source": "FDA Safety Communication, 'FDA Requires Guillain-Barre Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy', 2025-01-07",
   "doi_or_pmid": "https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and",
   "location_in_source": "FDA web page, study description",
   "notes": "FDA: overall evidence suggests increased risk but 'available evidence is insufficient to establish a causal relationship'; benefits outweigh risks; label warning added. No IRR/CI given on the page."
  },
  {
   "vaccine": "rsv",
   "product": "Arexvy (RSVPreF3+AS01, GSK)",
   "outcome": "Guillain-Barre syndrome",
   "design": "SCCS (FDA/CMS Medicare claims, chart review when available)",
   "population": "Medicare beneficiaries >=65 y, US May 2023-Jul 2024",
   "risk_window": "1-42 vs 43-90 days",
   "measure": "attributable risk per million doses",
   "estimate": 7,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": 7,
   "conclusion": "increased risk",
   "source": "FDA Safety Communication, 'FDA Requires Guillain-Barre Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy', 2025-01-07",
   "doi_or_pmid": "https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and",
   "location_in_source": "FDA web page, study description",
   "notes": "Same FDA communication; causality not established; label warning added."
  },
  {
   "vaccine": "rsv",
   "product": "Abrysvo (RSVpreF)",
   "outcome": "Guillain-Barre syndrome",
   "design": "SCCS (US EHR data platform, >270 million patients)",
   "population": "US adults >=60 y (4,746,518 RSV vaccine recipients, both products)",
   "risk_window": "6 weeks",
   "measure": "excess cases per million doses",
   "estimate": 18.2,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": 18.2,
   "conclusion": "increased risk",
   "source": "Fry SE et al., 2025, JAMA Netw Open",
   "doi_or_pmid": "doi:10.1001/jamanetworkopen.2025.8322; PMID 40343698",
   "location_in_source": "PubMed abstract, Results/Conclusions",
   "notes": "Statistically significant for RSVPreF."
  },
  {
   "vaccine": "rsv",
   "product": "Arexvy (RSVPreF3+AS01)",
   "outcome": "Guillain-Barre syndrome",
   "design": "SCCS (US EHR data platform)",
   "population": "US adults >=60 y",
   "risk_window": "6 weeks",
   "measure": "excess cases per million doses",
   "estimate": 5.2,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": 5.2,
   "conclusion": "inconclusive",
   "source": "Fry SE et al., 2025, JAMA Netw Open",
   "doi_or_pmid": "doi:10.1001/jamanetworkopen.2025.8322; PMID 40343698",
   "location_in_source": "PubMed abstract, Results/Conclusions",
   "notes": "Authors: elevation not statistically significant for RSVPreF3+AS01 in this study (FDA Medicare analysis did find ~7/million)."
  },
  {
   "vaccine": "rsv",
   "product": "Arexvy and Abrysvo",
   "outcome": "Immune thrombocytopenic purpura",
   "design": "SCCS (US EHR data platform)",
   "population": "US adults >=60 y (4,746,518 recipients)",
   "risk_window": "6 weeks",
   "measure": "excess risk",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Fry SE et al., 2025, JAMA Netw Open",
   "doi_or_pmid": "doi:10.1001/jamanetworkopen.2025.8322; PMID 40343698",
   "location_in_source": "PubMed abstract, Results",
   "notes": "No excess ITP risk detected."
  },
  {
   "vaccine": "rsv",
   "product": "Maternal RSV vaccination (Abrysvo, 32-36 wk)",
   "outcome": "Preterm birth and other adverse pregnancy outcomes",
   "design": "systematic review (RCTs + comparative observational studies)",
   "population": "Pregnant individuals, US-licensed products",
   "risk_window": "pregnancy",
   "measure": "narrative synthesis",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Senerth E et al., 2026, JAMA",
   "doi_or_pmid": "doi:10.1001/jama.2026.17871; PMID 42684247",
   "location_in_source": "PubMed abstract, Findings",
   "notes": "'None of the comparative studies ... found an association of RSV vaccination during pregnancy with preterm birth or other adverse pregnancy outcomes.' Older adults: 1 SCCS reported possible increased GBS risk; no GBS in 3 RCTs."
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Febrile seizures",
   "design": "expert causality review (IOM 2011)",
   "population": "General",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence convincingly supports a causal relationship.'"
  },
  {
   "vaccine": "mmr",
   "product": "MMR (measles component)",
   "outcome": "Measles inclusion body encephalitis",
   "design": "expert causality review (IOM 2011)",
   "population": "Individuals with demonstrated immunodeficiencies",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence convincingly supports a causal relationship' - restricted to immunodeficient individuals. No population rate per dose was located (see not_found)."
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Autism",
   "design": "expert causality review (IOM 2011)",
   "population": "General",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence favors rejection of a causal relationship.'"
  },
  {
   "vaccine": "mmr",
   "product": "MMR",
   "outcome": "Type 1 diabetes",
   "design": "expert causality review (IOM 2011)",
   "population": "General",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence favors rejection of a causal relationship.'"
  },
  {
   "vaccine": "mmr",
   "product": "MMR (rubella component)",
   "outcome": "Transient arthralgia in women; transient arthralgia in children",
   "design": "expert causality review (IOM 2011)",
   "population": "Women; children",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence favors acceptance of a causal relationship.'"
  },
  {
   "vaccine": "varicella",
   "product": "Varicella (Oka strain)",
   "outcome": "Disseminated Oka VZV; vaccine-strain reactivation (incl. with meningitis/encephalitis)",
   "design": "expert causality review (IOM 2011)",
   "population": "General (mostly immunodeficient)",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence convincingly supports a causal relationship.' Maglione 2014 likewise found complications in immunodeficient individuals."
  },
  {
   "vaccine": "dtap",
   "product": "DT, TT or aP-containing vaccines",
   "outcome": "Type 1 diabetes",
   "design": "expert causality review (IOM 2011)",
   "population": "General",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence favors rejection of a causal relationship.'"
  },
  {
   "vaccine": "influenza",
   "product": "Inactivated influenza",
   "outcome": "Asthma exacerbation / reactive airway disease",
   "design": "expert causality review (IOM 2011)",
   "population": "Children and adults",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence favors rejection of a causal relationship.'"
  },
  {
   "vaccine": "influenza",
   "product": "Inactivated influenza",
   "outcome": "Bell's palsy",
   "design": "expert causality review (IOM 2011)",
   "population": "General",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "no increased risk detected",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence favors rejection of a causal relationship.'"
  },
  {
   "vaccine": "influenza",
   "product": "Two particular trivalent inactivated vaccines (Canada, 3 seasons)",
   "outcome": "Oculorespiratory syndrome",
   "design": "expert causality review (IOM 2011)",
   "population": "Canada",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence favors acceptance of a causal relationship' - product/season specific."
  },
  {
   "vaccine": "hpv",
   "product": "HPV",
   "outcome": "Anaphylaxis",
   "design": "expert causality review (IOM 2011)",
   "population": "General",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence favors acceptance of a causal relationship.'"
  },
  {
   "vaccine": "hepatitis-b",
   "product": "Hepatitis B (also MMR, varicella, influenza, meningococcal, tetanus toxoid)",
   "outcome": "Anaphylaxis",
   "design": "expert causality review (IOM 2011)",
   "population": "Hep B: yeast-sensitive individuals",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence convincingly supports a causal relationship.' Absolute rates ~1 per million doses (see McNeil 2016, Bohlke 2003)."
  },
  {
   "vaccine": "meningococcal",
   "product": "Meningococcal",
   "outcome": "Anaphylaxis",
   "design": "expert causality review (IOM 2011)",
   "population": "General",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence convincingly supports a causal relationship.'"
  },
  {
   "vaccine": "hpv",
   "product": "Any injected vaccine (injection-related)",
   "outcome": "Syncope; deltoid bursitis",
   "design": "expert causality review (IOM 2011)",
   "population": "General",
   "risk_window": "n/a",
   "measure": "IOM causality category",
   "estimate": null,
   "ci_low": null,
   "ci_high": null,
   "attributable_per_million_doses": null,
   "conclusion": "increased risk",
   "source": "Institute of Medicine (Stratton K et al., eds.), 2011, Adverse Effects of Vaccines: Evidence and Causality, National Academies Press",
   "doi_or_pmid": "doi:10.17226/13164",
   "location_in_source": "Summary chapter, causality conclusion tables (nationalacademies.org/read/13164/chapter/2)",
   "notes": "'Evidence convincingly supports a causal relationship' for injection-related syncope and deltoid bursitis (filed under hpv because syncope is most studied with HPV; see Klein 2012)."
  }
 ],
 "not_found": [
  {
   "vaccine": "mmr",
   "topic": "Measles vaccine encephalitis/encephalopathy rate per dose in immunocompetent children",
   "status": "No controlled-study rate located. IOM 2011 supports causation only for measles inclusion body encephalitis in immunodeficient persons (row included). A VSD encephalitis/encephalopathy study was searched but not found in PubMed."
  },
  {
   "vaccine": "rsv",
   "topic": "Peer-reviewed FDA Medicare RSV-vaccine GBS paper with IRR/CI",
   "status": "Only the FDA Jan 2025 safety communication (9 and 7 excess per million) was read; IRRs/CIs not on that page. The companion Lloyd 2026 Vaccine paper explicitly says GBS was reported separately; that separate paper was not found in PubMed."
  },
  {
   "vaccine": "rsv",
   "topic": "Abrysvo MATISSE trial preterm-birth percentages",
   "status": "In the NEJM full text, not the abstract; not extracted."
  },
  {
   "vaccine": "influenza",
   "topic": "Seasonal influenza vaccine GBS attributable risk in Medicare (e.g., ~1-2 per million) from multi-season FDA/CMS analyses",
   "status": "Searched (Kawai/Medicare seasonal); not located. H1N1 2009 Medicare (Polakowski 2013) included instead."
  },
  {
   "vaccine": "dtap",
   "topic": "Tdap in pregnancy and autism",
   "status": "Searched; not located in this pass."
  },
  {
   "vaccine": "hepatitis-a",
   "topic": "Hepatitis A vaccine AESI (GBS, autoimmune) from controlled studies",
   "status": "Only O'Leary 2012 ITP signal (1-2 exposed cases) found; PubMed returned case reports only for GBS."
  },
  {
   "vaccine": "meningococcal",
   "topic": "MenB (Bexsero/Trumenba) post-licensure controlled safety studies",
   "status": "Searched; not found in this pass."
  },
  {
   "vaccine": "polio",
   "topic": "Standalone IPV controlled AESI studies",
   "status": "Only combination DTaP-IPV and DTaP-IPV-Hib VSD studies found (included)."
  },
  {
   "vaccine": "japanese-encephalitis",
   "topic": "IXIARO controlled AESI estimates",
   "status": "Schuller 2011 pooled 10 phase III trials (4043 subjects) and 12-month post-marketing data, but abstract reports no numeric estimates (qualitative 'good safety profile'); not entered as a row. Rabe 2015 is VAERS (passive)."
  },
  {
   "vaccine": "typhoid",
   "topic": "Any controlled AESI study for US-licensed typhoid vaccines",
   "status": "Not found."
  },
  {
   "vaccine": "rabies",
   "topic": "Any controlled AESI study for US-licensed rabies vaccines",
   "status": "Not found (only an Indian active-surveillance study of monoclonal antibody + vaccine, not reviewed)."
  },
  {
   "vaccine": "cholera",
   "topic": "Vaxchora controlled AESI study",
   "status": "Not found."
  },
  {
   "vaccine": "shingles",
   "topic": "Zostavax (ZVL) AESI controlled studies (e.g., stroke, GBS)",
   "status": "Not extracted; Zostavax appears only as comparator in Goud 2021."
  },
  {
   "vaccine": "covid",
   "topic": "COVID-19 vaccine myocarditis in children 5-11 and updated (2023-2025) formulations",
   "status": "Not extracted in this pass."
  },
  {
   "vaccine": "hpv",
   "topic": "Gardasil 9 syncope / POTS / CRPS controlled estimates",
   "status": "Donahue 2019 (included) reports no confirmed signals; POTS/CRPS-specific controlled studies not extracted."
  }
 ]
}