Evidence dossier · candidate cand-hepatitis-b-autoimmune-disorder · VICP program · · DRAFT — not a determination
This is a draft research-tracking dossier, not a determination that Hepatitis B vaccine causes Autoimmune disorder, and not an incidence or legal finding. All evidence is flagged needs_human_review and must be reviewed before any page is published or cited. Every value is grounded in retrieved citations (PMID + retrieval date); unsourced items read "no evidence found / not assessable". Symmetric search: every supporting query has a mirror/null query, and zeros are shown (negative dossiers report the absence of signal).
Claim matrix (C1–C6, computed)
Claim
Label
Status
Missing nodes
C1
Coherent clinical object exists
insufficient_data
missing: A1 A2
C2
Consistent temporal window
supported
C3
Epidemiologic excess risk
insufficient_data
missing: B1
C4
Consistency / replication
insufficient_data
missing: B6
C5
Specificity (product / dose)
insufficient_data
missing: C1n C2n
C6
Biological mechanism
insufficient_data
missing: E1
Two evidentiary bars apply to the epi nodes/claims (C3, C4): · VICP — preponderance of the evidence. · CICP (off-Table) — compelling, reliable, valid medical and scientific evidence (higher bar).
Bradford Hill assessment (computed)
Each viewpoint is derived from the node statuses below (see the framework crosswalk in compensation-tables-schema.md §8). Hill's viewpoints are aids to judgement, not a scoring checklist that proves causation; temporality is the only strictly necessary criterion.
Viewpoint
What it asks
Status (from evidence)
Temporality(necessary)
cause precedes effect in a plausible window (necessary)
NASEM (formerly IOM), "Adverse Effects of Vaccines: Evidence and Causality" (2011, updated 2024). Independent grading of epidemiologic and mechanistic evidence, synthesized into one of four causal-conclusion categories. This is a computed approximation of that framework, not a NASEM determination. See compensation-tables-schema.md §8bis.
Case-definition standard: no established case definition (needs_human_review — not in spec §1's named-standard list) — governs the case-certainty scale on A1/A2/A6/A8 below. See compensation-tables-schema.md §8ter.
Evidence matrix (68 nodes by workstream)
68 of 68 nodes evaluated · 136 PubMed queries logged (supporting + mirror, incl. zeros). Statuses are computed from retrieved citations; not hand-set.
Definition & attribution 24/24 evaluated
A1 · Case reportsno_data
Measure: New definite object in risk window T Comparator: Pre-vaccination baseline Hit rule: Definite object present, onset in window, competing causes considered
Finding: No retrieved evidence addresses Hepatitis B vaccine and autoimmune disorder; all retrieved PMIDs concern COVID-19, SARS-CoV-2, HPV, monkeypox, or other vaccine-related adverse events unrelated to Hepatitis B vaccine or autoimmune disorders.
Case-certainty distribution (no established case definition): 1 Possible/unclassifiable. Transparency layer — does not change this node's status or feed C1–C6.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series Case reports pubmed · 66238 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
9 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
ambiguous 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
does_not_resolve 40927603 · Journal of healthcare, science and the h (2024) — The Effects of Covid-19 Vaccination on Menstruation: Are women with underlying reproductive health conditions, particularly black women at a higher risk for vac
does_not_resolve 38500249 · Journal of movement disorders (2024) — COVID-19 Vaccine-Related Movement Disorders: A Systematic Review.
A2 · Series with objective confirmationno_data
Measure: Definite object plus objective test Comparator: Reference range / diagnostic criteria Hit rule: Objective confirmation in >=1 case per the working definition
Finding: No retrieved evidence addresses autoimmune disorder following Hepatitis B vaccination; all retrieved articles pertain to COVID-19, SARS-CoV-2, HPV, monkeypox, or other vaccines.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series Series with objective confirmation pubmed · 5711 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
9 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
does_not_resolve 40927603 · Journal of healthcare, science and the h (2024) — The Effects of Covid-19 Vaccination on Menstruation: Are women with underlying reproductive health conditions, particularly black women at a higher risk for vac
does_not_resolve 33661194 · Clinical nuclear medicine (2021) — COVID-19 Vaccine-Related Local FDG Uptake.
A3 · Onset histogramno_data
Measure: Distribution of onset times after dose Comparator: Pre-specified risk window Hit rule: Onset clusters inside the pre-specified window (not uniform/flat)
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series Onset histogram pubmed · 70 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
11 retrieved record(s)
supports_node 35850789 · BMJ case reports (2022) — Transient cryoglobulinaemic vasculitis following ChAdOx1 nCoV-19 vaccine.
supports_node 20630136 · Clinical nephrology (2010) — HLA haplotype in a patient with systemic lupus erythematosus triggered by hepatitis B vaccine.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
A4 · Temporal plausibilityno_data
Measure: Onset latency vs object pathophysiology Comparator: Object's known natural latency Hit rule: Onset latency consistent with the object's pathophysiology
Finding: No evidence found in the retrieved set that directly addresses onset latency of autoimmune disorders following Hepatitis B vaccination in relation to the object's pathophysiology.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series Temporal plausibility pubmed · 99 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
11 retrieved record(s)
supports_node 15638050 · Clinical and experimental rheumatology (2004) — A case-series of adverse events, positive re-challenge of symptoms, and events in identical twins following hepatitis B vaccination: analysis of the Vaccine Adv
supports_node 35850789 · BMJ case reports (2022) — Transient cryoglobulinaemic vasculitis following ChAdOx1 nCoV-19 vaccine.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
A5 · Onset-interval documentationno_data
Measure: Onset interval documented in source Comparator: Dose date Hit rule: Onset interval is recorded (not imputed) in a primary source
Finding: No retrieved evidence specifically addresses documentation of onset interval for autoimmune disorder following hepatitis B vaccine. One case report (PMID 20630136) describes lupus nephritis after hepatitis B vaccine but does not document onset interval in a manner relevant to this node's hit rule.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series Onset-interval documentation pubmed · 68 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
11 retrieved record(s)
supports_node 35850789 · BMJ case reports (2022) — Transient cryoglobulinaemic vasculitis following ChAdOx1 nCoV-19 vaccine.
supports_node 20630136 · Clinical nephrology (2010) — HLA haplotype in a patient with systemic lupus erythematosus triggered by hepatitis B vaccine.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
A6 · Differential diagnosis excludedno_data
Measure: Competing causes assessed and excluded Comparator: Likely alternative diagnoses Hit rule: Pre-specified competing causes ruled out per the working definition
Finding: No retrieved evidence addresses autoimmune disorders following Hepatitis B vaccination; all retrieved papers focus on COVID-19, HPV, or monkeypox vaccine-related adverse events.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series Differential diagnosis excluded pubmed · 495 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
9 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
does_not_resolve 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
does_not_resolve 40927603 · Journal of healthcare, science and the h (2024) — The Effects of Covid-19 Vaccination on Menstruation: Are women with underlying reproductive health conditions, particularly black women at a higher risk for vac
does_not_resolve 33661194 · Clinical nuclear medicine (2021) — COVID-19 Vaccine-Related Local FDG Uptake.
A7 · Rechallenge / re-exposureno_data
Measure: Object recurs on a further dose Comparator: First-dose response Hit rule: Object recurs after a subsequent dose (re-exposure)
Finding: No evidence found for recurrence of autoimmune disorder after rechallenge with hepatitis B vaccine; retrieved evidence concerns other vaccines (COVID-19, HPV, monkeypox) or single primary-onset cases without re-exposure data.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series Rechallenge / re-exposure pubmed · 70 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
11 retrieved record(s)
supports_node 35850789 · BMJ case reports (2022) — Transient cryoglobulinaemic vasculitis following ChAdOx1 nCoV-19 vaccine.
supports_node 20630136 · Clinical nephrology (2010) — HLA haplotype in a patient with systemic lupus erythematosus triggered by hepatitis B vaccine.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
does_not_resolve 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
A8 · Adjudicated by criteria (no established case definition)no_data
Measure: Object adjudicated by published criteria Comparator: Published clinical / Brighton criteria Hit rule: Cases adjudicated to 'definite' by a published criterion set
Finding: No retrieved evidence addresses autoimmune disorder adjudicated as 'definite' by published criteria following Hepatitis B vaccination. All retrieved citations focus on COVID-19, SARS-CoV-2, HPV, monkeypox, or poliomyelitis vaccines, not Hepatitis B vaccine.
Case-certainty distribution (no established case definition): 1 Probable, 2 Possible/unclassifiable. Transparency layer — does not change this node's status or feed C1–C6.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series Adjudicated by criteria pubmed · 107 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
9 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
supports_node 36560483 · Vaccines (2022) — Vaccine-Related Autoimmune Hepatitis: Emerging Association with SARS-CoV-2 Vaccination or Coincidence?
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
ambiguous 40046048 · Frontiers in immunology (2025) — The protective role of vitamin D in BNT162b2 vaccine-related acute myocarditis.
ambiguous 7114977 · Archives of internal medicine (1982) — Vaccine-related poliomyelitis.
A9 · Natural-history consistencyno_data
Measure: Course matches the object's natural history Comparator: Known natural history of the object Hit rule: Clinical course (onset, peak, recovery) matches the object's natural history
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series Natural-history consistency pubmed · 171 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
9 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
ambiguous 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 30000765 · (2006) — Human Papillomavirus Vaccines.
ambiguous 36560483 · Vaccines (2022) — Vaccine-Related Autoimmune Hepatitis: Emerging Association with SARS-CoV-2 Vaccination or Coincidence?
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
does_not_resolve 7114977 · Archives of internal medicine (1982) — Vaccine-related poliomyelitis.
A10 · No confounding objectno_data
Measure: Not attributable to a co-occurring condition Comparator: Co-occurring illness that could produce the object Hit rule: Object not better explained by a co-occurring condition (infection, etc.)
Finding: The only retrieved evidence that mentions Hepatitis B vaccine is a case report of cryoglobulinaemic vasculitis following ChAdOx1 nCoV-19 vaccine, which lists Hepatitis B vaccine as a known associated cause in passing, but does not provide a specific case or analysis for Hepatitis B vaccine causing autoimmune disorder in the absence of confounding conditions.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder case report OR case series No confounding object pubmed · 87 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
10 retrieved record(s)
supports_node 35850789 · BMJ case reports (2022) — Transient cryoglobulinaemic vasculitis following ChAdOx1 nCoV-19 vaccine.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
ambiguous 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 30000765 · (2006) — Human Papillomavirus Vaccines.
supports_node 36560483 · Vaccines (2022) — Vaccine-Related Autoimmune Hepatitis: Emerging Association with SARS-CoV-2 Vaccination or Coincidence?
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
does_not_resolve 40046048 · Frontiers in immunology (2025) — The protective role of vitamin D in BNT162b2 vaccine-related acute myocarditis.
D1 · Predicted site of injuryno_data
Measure: Object at the site the mechanism predicts Comparator: Predicted anatomic site from the mechanism Hit rule: Object localizes to the anatomic site the mechanism predicts
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder anatomic localization Predicted site of injury mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Predicted site of injury not consistent with mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
D2 · Spared structuresno_data
Measure: Structures the mechanism should spare are spared Comparator: Structures predicted unaffected Hit rule: Structures predicted spared by the mechanism are indeed spared
mirror: Hepatitis B vaccine Autoimmune disorder Spared structures not consistent with mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
D3 · Local vs systemic distributionno_data
Measure: Distribution matches mechanism scope Comparator: Local (injection site) vs systemic expectation Hit rule: Observed distribution (local vs systemic) matches the mechanism's predicted scope
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder anatomic localization Local vs systemic distribution mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Local vs systemic distribution not consistent with mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
D4 · Kinetics classno_data
Measure: Onset/offset kinetics match the mechanism Comparator: Expected kinetic class (acute vs chronic) Hit rule: Onset and offset kinetics are in the class the mechanism predicts
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder anatomic localization Kinetics class mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Kinetics class not consistent with mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
D5 · Platform-mechanism matchno_data
Measure: Mechanism is consistent with the platform Comparator: Mechanistic expectation for the platform Hit rule: The proposed mechanism is biologically consistent with the vaccine platform
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder anatomic localization Platform-mechanism match mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Platform-mechanism match not consistent with mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
H3 · Targeted treatment reversesno_data
Measure: A targeted treatment reverses the object in patients Comparator: Treatment-naive / placebo Hit rule: A mechanism-directed treatment reverses the object (vs control treatment)
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Targeted treatment reverses intervention OR treatment OR reversal pubmed · 15142392 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Targeted treatment reverses no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
1 retrieved record(s)
does_not_resolve 38189107 · Expert review of vaccines (2024) — Neoadjuvant personalized cancer vaccines: the final frontier?
I1 · No internal contradictionno_data
Measure: No node's finding contradicts another Comparator: Internal consistency across nodes Hit rule: No evaluated node directly contradicts another (coherence)
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder No internal contradiction coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder No internal contradiction inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 15578364 · Clinical infectious diseases : an offici (2004) — Varicella vaccine for susceptible adults: do it today.
does_not_resolve 19477561 · Vaccine (2009) — Genetic polymorphisms in host response to meningococcal infection: the role of susceptibility and severity genes.
I2 · Analogy to a known objectno_data
Measure: Object analogous to a well-established analog Comparator: Established analog's profile Hit rule: The object's profile matches a well-established analog on key features
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Analogy to a known object coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Analogy to a known object inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
I5 · Latency coherenceno_data
Measure: Observed latency matches the mechanism's latency Comparator: Mechanism-predicted latency Hit rule: Observed onset latency is coherent with the mechanism's predicted latency
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Latency coherence coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Latency coherence inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
2 retrieved record(s)
ambiguous 15578364 · Clinical infectious diseases : an offici (2004) — Varicella vaccine for susceptible adults: do it today.
does_not_resolve 19477561 · Vaccine (2009) — Genetic polymorphisms in host response to meningococcal infection: the role of susceptibility and severity genes.
J1 · Pre-specificationno_data
Measure: Window/hit-rule pre-specified before data Comparator: Pre-specified vs post-hoc Hit rule: The risk window, object, and hit rule were pre-specified before data were seen
Finding: The retrieved evidence describes the use of large language models (LLMs) to identify immune-related adverse events from immune checkpoint inhibitor therapy and the development of an AI-based system for adjudicating major adverse cardiovascular events, but does not address hepatitis B vaccine, autoimmune disorders, or any pre-specified risk window for that pair.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Pre-specification pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Pre-specification post-hoc OR hypothesis-generating only pubmed · 1700 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 39226489 · Journal of clinical oncology : official (2024) — Enhancing Precision in Detecting Severe Immune-Related Adverse Events: Comparative Analysis of Large Language Models and International Classification of Disease
does_not_resolve 41493293 · Journal of the American College of Cardi (2026) — Using Artificial Intelligence to Adjudicate Major Adverse Cardiovascular Events in Clinical Trials.
J2 · Contrary-evidence logno_data
Measure: Contrary evidence is logged, not omitted Comparator: Support-only dossier Hit rule: Contrary / null / refuting findings are logged and shown alongside support
Finding: No direct evidence retrieved regarding an autoimmune disorder attributed to Hepatitis B vaccine; the retrieved studies focus on using large language models or AI to identify immune-related adverse events in patients receiving immune checkpoint inhibitors or to adjudicate major adverse cardiovascular events, not on Hepatitis B vaccine or autoimmune disorders.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Contrary-evidence log pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Contrary-evidence log post-hoc OR hypothesis-generating only pubmed · 1700 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 39226489 · Journal of clinical oncology : official (2024) — Enhancing Precision in Detecting Severe Immune-Related Adverse Events: Comparative Analysis of Large Language Models and International Classification of Disease
does_not_resolve 41493293 · Journal of the American College of Cardi (2026) — Using Artificial Intelligence to Adjudicate Major Adverse Cardiovascular Events in Clinical Trials.
J3 · No temporality-only claimno_data
Measure: Claim not based on temporality alone Comparator: Sequence-only evidence Hit rule: The claim is not supported by temporal sequence alone (independent evidence exists)
Finding: The retrieved evidence discusses the use of large language models to identify immune-related adverse events (irAEs) from immune checkpoint inhibitors and the adjudication of drug-induced acute kidney injury, but does not address hepatitis B vaccine as a cause of autoimmune disorder or provide temporality-independent evidence for such a link.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder No temporality-only claim pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder No temporality-only claim post-hoc OR hypothesis-generating only pubmed · 1700 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 39226489 · Journal of clinical oncology : official (2024) — Enhancing Precision in Detecting Severe Immune-Related Adverse Events: Comparative Analysis of Large Language Models and International Classification of Disease
Measure: Passive-surveillance findings bounded correctly Comparator: Active-surveillance confirmation Hit rule: Passive-surveillance signals are framed as hypothesis-generating, not confirmatory
Finding: No evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Passive-surveillance role pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Passive-surveillance role post-hoc OR hypothesis-generating only pubmed · 1700 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 39226489 · Journal of clinical oncology : official (2024) — Enhancing Precision in Detecting Severe Immune-Related Adverse Events: Comparative Analysis of Large Language Models and International Classification of Disease
Measure: Dose/lot exposure mapped to the object Comparator: Unmapped exposure Hit rule: Dose / lot exposure is mapped to the object where the mechanism predicts it
Finding: The retrieved evidence describes the use of large language models to identify immune-related adverse events and an artificial intelligence system to adjudicate major adverse cardiovascular events, but neither study addresses dose/lot exposure mapping to autoimmune disorder outcomes for the Hepatitis B vaccine.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Dose mapping pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Dose mapping post-hoc OR hypothesis-generating only pubmed · 1700 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 39226489 · Journal of clinical oncology : official (2024) — Enhancing Precision in Detecting Severe Immune-Related Adverse Events: Comparative Analysis of Large Language Models and International Classification of Disease
does_not_resolve 41493293 · Journal of the American College of Cardi (2026) — Using Artificial Intelligence to Adjudicate Major Adverse Cardiovascular Events in Clinical Trials.
Epidemiologic chassis 13/13 evaluated
B1 · Excess vs baselineno_data
Measure: RR/IRR vs unexposed or prior window Comparator: Unvaccinated person-time or pre-vaccination window Hit rule: RR/IRR > 1 with CI excluding 1 after pre-specified confounders
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Excess vs baseline incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk Excess vs baseline pubmed · 88568 hits · run 2026-09-07
6 retrieved record(s)
does_not_resolve 40716143 · Vaccine (2025) — Tinnitus risk after COVID-19 XBB.1.5 vaccination: A self-controlled case series study.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 34489307 · Gut (2022) — Non-alcoholic fatty liver disease and incident major adverse cardiovascular events: results from a nationwide histology cohort.
does_not_resolve 40794640 · European heart journal (2026) — Cardiovascular benefit of continuous positive airway pressure according to high-risk obstructive sleep apnoea: a multi-trial analysis.
does_not_resolve 42413069 · ESC heart failure (2026) — The HFpEF-ABA score predicts adverse cardiac remodelling and incident heart failure: a UK biobank study.
B2 · SCCSno_data
Measure: Self-controlled case series risk ratio Comparator: Individuals' own risk intervals (no-event) Hit rule: SCCS risk ratio > 1 in the post-vaccination window, CI excluding 1
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder SCCS incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk SCCS pubmed · 88676 hits · run 2026-09-07
6 retrieved record(s)
refutes_node 40716143 · Vaccine (2025) — Tinnitus risk after COVID-19 XBB.1.5 vaccination: A self-controlled case series study.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 39795956 · International journal of molecular scien (2024) — The Potential Metalloestrogenic Effect of Aluminum on Breast Cancer Risk for Antiperspirant Users.
refutes_node 12901584 · Expert review of vaccines (2002) — Hepatitis B vaccine and risk of multiple sclerosis.
B3 · Cohort / risk-intervalno_data
Measure: Incidence rate ratio in defined window Comparator: Pre-specified risk vs comparison interval Hit rule: IRR > 1 in the pre-specified window, CI excluding 1, stratified by age/sex
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Cohort / risk-interval incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk Cohort / risk-interval pubmed · 88177 hits · run 2026-09-07
5 retrieved record(s)
does_not_resolve 34751642 · Epidemiology and psychiatric sciences (2021) — Cardiovascular and metabolic risk of antipsychotics in children and young adults: a multinational self-controlled case series study.
does_not_resolve 37468475 · Nature communications (2023) — Herpes zoster vaccine safety in the Aotearoa New Zealand population: a self-controlled case series study.
refutes_node 40716143 · Vaccine (2025) — Tinnitus risk after COVID-19 XBB.1.5 vaccination: A self-controlled case series study.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
B4 · Meta-analysis / poolingno_data
Measure: Pooled effect across studies Comparator: Pooled estimate with heterogeneity Hit rule: Pooled estimate > 1 (or < 1) with quantified heterogeneity (I2)
Finding: No retrieved meta-analyses or pooled estimates with quantified heterogeneity (I2) directly assess the association between Hepatitis B vaccine and autoimmune disorder; one narrative review (PMID 12901584) discusses weak epidemiological evidence for multiple sclerosis but provides no pooled estimate with I2.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Meta-analysis / pooling incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk Meta-analysis / pooling pubmed · 112013 hits · run 2026-09-07
9 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 30851046 · Biostatistics (Oxford, England) (2020) — ConvSCCS: convolutional self-controlled case series model for lagged adverse event detection.
does_not_resolve 40664645 · Nature communications (2025) — Evaluating the safety of XBB.1.5-containing COVID-19 mRNA vaccines using a self-controlled case series study.
does_not_resolve 29402646 · Journal of the American Medical Director (2018) — Fall-Risk-Increasing Drugs: A Systematic Review and Meta-analysis: III. Others.
does_not_resolve 22622525 · Journal of assisted reproduction and gen (2012) — GSTM1 null genotype contributes to increased risk of male infertility: a meta-analysis.
does_not_resolve 23975364 · Tumour biology : the journal of the Inte (2014) — Meta-analysis: glutathione S-transferase T1 null allele is associated with gastric cancer risk.
does_not_resolve 32060073 · RMD open (2020) — Diabetes mellitus is not a risk factor for osteoarthritis.
refutes_node 12901584 · Expert review of vaccines (2002) — Hepatitis B vaccine and risk of multiple sclerosis.
B5 · Negative-control outcomesno_data
Measure: No excess for outcomes the vaccine should not cause Comparator: Negative-control outcomes (unaffected by mechanism) Hit rule: Null for negative-control outcomes while target outcome is positive (specificity)
Finding: No evidence found: The retrieved evidence does not address autoimmune disorders following Hepatitis B vaccination; it covers tinnitus after COVID-19 vaccination, SCCS design methodology, rotavirus vaccine safety, and valproate teratogenicity. None pertain to the specified pair (Hepatitis B vaccine → Autoimmune disorder) or the negative-control node B5.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Negative-control outcomes incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk Negative-control outcomes pubmed · 88379 hits · run 2026-09-07
4 retrieved record(s)
refutes_node 40716143 · Vaccine (2025) — Tinnitus risk after COVID-19 XBB.1.5 vaccination: A self-controlled case series study.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 38833248 · JAMA network open (2024) — Valproate Use During Spermatogenesis and Risk to Offspring.
B6 · Other-antigen comparisonno_data
Measure: Risk vs a different-antigen comparator Comparator: Comparator product with a different antigen Hit rule: Risk specific to the target antigen, not shared with the comparator antigen
Finding: The retrieved evidence describes self-controlled case series (SCCS) methodology and its application to vaccine safety studies (e.g., shingles vaccine and rotavirus vaccine), but none of the abstracts report a specific risk of autoimmune disorder after Hepatitis B vaccination compared with a different-antigen comparator.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Other-antigen comparison incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk Other-antigen comparison pubmed · 88141 hits · run 2026-09-07
4 retrieved record(s)
does_not_resolve 30851046 · Biostatistics (Oxford, England) (2020) — ConvSCCS: convolutional self-controlled case series model for lagged adverse event detection.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
B7 · Absolute riskno_data
Measure: Per-100k risk in window Comparator: Absolute incidence per 100k Hit rule: Absolute risk reported and stable across the window (not an artifact of rarity)
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Absolute risk incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk Absolute risk pubmed · 111415 hits · run 2026-09-07
9 retrieved record(s)
does_not_resolve 34751642 · Epidemiology and psychiatric sciences (2021) — Cardiovascular and metabolic risk of antipsychotics in children and young adults: a multinational self-controlled case series study.
does_not_resolve 37468475 · Nature communications (2023) — Herpes zoster vaccine safety in the Aotearoa New Zealand population: a self-controlled case series study.
does_not_resolve 30851046 · Biostatistics (Oxford, England) (2020) — ConvSCCS: convolutional self-controlled case series model for lagged adverse event detection.
does_not_resolve 29211679 · The New England journal of medicine (2017) — Contemporary Hormonal Contraception and the Risk of Breast Cancer.
does_not_resolve 23484825 · The New England journal of medicine (2013) — Risk of ischemic heart disease in women after radiotherapy for breast cancer.
does_not_resolve 26950145 · Nutrients (2016) — An Increase in the Omega-6/Omega-3 Fatty Acid Ratio Increases the Risk for Obesity.
does_not_resolve 40020995 · Chest (2025) — Changes in Lung Function and Mortality Risk in Patients With Idiopathic Pulmonary Fibrosis.
B8 · Platform splitno_data
Measure: Risk by vaccine platform / product Comparator: Platform (mRNA vs viral vector, etc.) Hit rule: Risk attributable to a specific platform, not to 'a vaccine' generally
Finding: The retrieved evidence describes self-controlled case series (SCCS) methodology and a study of COVID-19 mRNA vaccines, but does not address risk of autoimmune disorder following Hepatitis B vaccine by platform or product.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Platform split incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk Platform split pubmed · 88206 hits · run 2026-09-07
3 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 30851046 · Biostatistics (Oxford, England) (2020) — ConvSCCS: convolutional self-controlled case series model for lagged adverse event detection.
refutes_node 40664645 · Nature communications (2025) — Evaluating the safety of XBB.1.5-containing COVID-19 mRNA vaccines using a self-controlled case series study.
B9 · Host-structure stratificationno_data
Measure: Risk by age / sex / host structure Comparator: Unstratified estimate Hit rule: Risk concentrated in a defined host subgroup (e.g. young males), stable across sources
Finding: No evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Host-structure stratification incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk Host-structure stratification pubmed · 88139 hits · run 2026-09-07
3 retrieved record(s)
does_not_resolve 34751642 · Epidemiology and psychiatric sciences (2021) — Cardiovascular and metabolic risk of antipsychotics in children and young adults: a multinational self-controlled case series study.
does_not_resolve 37468475 · Nature communications (2023) — Herpes zoster vaccine safety in the Aotearoa New Zealand population: a self-controlled case series study.
Measure: Risk tracks a formulation change Comparator: Pre- vs post-change formulation Hit rule: Risk change tracks a documented formulation / component change over time
Finding: No retrieved evidence addresses formulation or component changes for the Hepatitis B vaccine or autoimmune disorders; the cited studies focus on COVID-19 XBB.1.5 vaccines and a systematic review of SCCS design methods.
supporting: Hepatitis B vaccine Autoimmune disorder Formulation / component change incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no association OR null OR no increased risk Formulation / component change pubmed · 88301 hits · run 2026-09-07
3 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 40664645 · Nature communications (2025) — Evaluating the safety of XBB.1.5-containing COVID-19 mRNA vaccines using a self-controlled case series study.
refutes_node 40716143 · Vaccine (2025) — Tinnitus risk after COVID-19 XBB.1.5 vaccination: A self-controlled case series study.
H2 · Formulation natural experimentno_data
Measure: Risk shifts with a formulation change in the field Comparator: Pre- vs post-change formulation Hit rule: Observed risk tracks a real-world formulation change (natural experiment)
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Formulation natural experiment intervention OR treatment OR reversal pubmed · 15142392 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Formulation natural experiment no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
1 retrieved record(s)
does_not_resolve 38189107 · Expert review of vaccines (2024) — Neoadjuvant personalized cancer vaccines: the final frontier?
H4 · Policy / pause signalno_data
Measure: Risk signal appears/disappears across a pause or policy change Comparator: Pre- vs post-pause period Hit rule: The signal appears or disappears coherently with a rollout / pause (H4)
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Policy / pause signal intervention OR treatment OR reversal pubmed · 15142392 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Policy / pause signal no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
1 retrieved record(s)
does_not_resolve 38189107 · Expert review of vaccines (2024) — Neoadjuvant personalized cancer vaccines: the final frontier?
I3 · Infection coherenceno_data
Measure: Pattern is coherent with or distinct from infection Comparator: Infection-matched comparison Hit rule: The post-vaccine pattern is coherent with (or clearly distinct from) the infection pattern
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Infection coherence coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Infection coherence inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
Mediator & biological gradient 24/24 evaluated
C1n · Dose strength gradientno_data
Measure: Risk vs dose strength (dose size) Comparator: Lower dose strength Hit rule: Monotonic dose-response in dose strength (larger dose -> higher risk)
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Dose strength gradient dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no dose effect OR no dose-response Dose strength gradient pubmed · 133 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
does_not_resolve 34505706 · Journal of the American Geriatrics Socie (2021) — Association between vitamin D status and long-term falls-related hospitalization risk in older women.
C2n · Dose number gradientno_data
Measure: Risk vs dose number (1st vs 2nd vs 3rd) Comparator: First dose Hit rule: Risk increases (or shows a defined pattern) with dose number
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Dose number gradient dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no dose effect OR no dose-response Dose number gradient pubmed · 577 hits · run 2026-09-07
3 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
does_not_resolve 42488947 · Hypertension (Dallas, Tex. : 1979) (2026) — Clinical Modifiers of Salt Sensitivity: A Meta-Regression and Risk Translation Study.
does_not_resolve 30316563 · Radiotherapy and oncology : journal of t (2019) — Volume effects of radiotherapy on the risk of second primary cancers: A systematic review of clinical and epidemiological studies.
C3n · Measured-exposure tertilesno_data
Measure: Risk vs measured exposure tertile Comparator: Lowest-exposure tertile Hit rule: Risk ordered by measured-exposure tertile (high > mid > low)
Finding: No retrieved evidence directly addresses risk of autoimmune disorder ordered by measured-exposure tertile of hepatitis B vaccine; available studies include case series of autoimmune phenomena after hepatitis B vaccination (PMID 22235045, PMID 9730294) and studies on vaccine immunogenicity or safety in specific populations (PMID 17576737, PMID 39808236), but none provide comparative risk across measured-exposure tertiles.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Measured-exposure tertiles dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no dose effect OR no dose-response Measured-exposure tertiles pubmed · 22 hits · run 2026-09-07
8 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
does_not_resolve 39819099 · Neurology (2025) — Effect of the Number of Vaccine Doses Before Starting Anti-CD20 Therapy on Seroprotection Rates Against Hepatitis B Virus in People With MS.
refutes_node 17576737 · Lupus (2007) — Safety and efficacy of hepatitis B vaccine in systemic lupus erythematosus.
does_not_resolve 30676860 · Human vaccines & immunotherapeutics (2019) — High dose hepatitis B vaccine is not effective in patients using immunomodulatory drugs: a pilot study.
supports_node 22235045 · Lupus (2012) — Autoimmunity following hepatitis B vaccine as part of the spectrum of 'Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants' (ASIA): analysis of 93 case
supports_node 9730294 · Scandinavian journal of infectious disea (1998) — Immune thrombocytopenic purpura after recombinant hepatitis B vaccine: retrospective study of seven cases.
does_not_resolve 39808236 · Clinical rheumatology (2025) — Hepatitis B vaccine and juvenile idiopathic arthritis: comparison of the seropositivity rates with healthy children at the time of diagnosis and booster dose re
does_not_resolve 25205080 · Gastroenterologia y hepatologia (2015) — [Hepatitis B virus reactivation in rituximab-treated patients: incidence and risk factors].
C4n · Organoid concentration curveno_data
Measure: Effect vs antigen concentration in organoid Comparator: Vehicle / zero antigen Hit rule: Dose-dependent effect across a graded concentration curve
Finding: The retrieved evidence includes case reports and retrospective analyses of autoimmune disorders (e.g., immune thrombocytopenic purpura, systemic lupus erythematosus) following hepatitis B vaccination, but no study reports dose-dependent effects across a graded concentration curve in an organoid model.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Organoid concentration curve dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no dose effect OR no dose-response Organoid concentration curve pubmed · 33 hits · run 2026-09-07
8 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
does_not_resolve 39819099 · Neurology (2025) — Effect of the Number of Vaccine Doses Before Starting Anti-CD20 Therapy on Seroprotection Rates Against Hepatitis B Virus in People With MS.
does_not_resolve 17576737 · Lupus (2007) — Safety and efficacy of hepatitis B vaccine in systemic lupus erythematosus.
does_not_resolve 30676860 · Human vaccines & immunotherapeutics (2019) — High dose hepatitis B vaccine is not effective in patients using immunomodulatory drugs: a pilot study.
supports_node 22235045 · Lupus (2012) — Autoimmunity following hepatitis B vaccine as part of the spectrum of 'Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants' (ASIA): analysis of 93 case
supports_node 9730294 · Scandinavian journal of infectious disea (1998) — Immune thrombocytopenic purpura after recombinant hepatitis B vaccine: retrospective study of seven cases.
does_not_resolve 39808236 · Clinical rheumatology (2025) — Hepatitis B vaccine and juvenile idiopathic arthritis: comparison of the seropositivity rates with healthy children at the time of diagnosis and booster dose re
does_not_resolve 25205080 · Gastroenterologia y hepatologia (2015) — [Hepatitis B virus reactivation in rituximab-treated patients: incidence and risk factors].
C5n · EC50 vs Cmax coherenceno_data
Measure: Measured exposure reaches effect threshold Comparator: Pharmacokinetic Cmax vs EC50 Hit rule: Achieved exposure (Cmax/tissue) plausibly reaches the in-vitro EC50
Finding: The retrieved evidence includes case reports and retrospective analyses of autoimmune phenomena following hepatitis B vaccination, but no study reports in-vitro EC50 or Cmax/tissue exposure data for hepatitis B vaccine that could be compared to an EC50 threshold relevant to autoimmune disorders.
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder EC50 vs Cmax coherence dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder no dose effect OR no dose-response EC50 vs Cmax coherence pubmed · 22 hits · run 2026-09-07
8 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
does_not_resolve 39819099 · Neurology (2025) — Effect of the Number of Vaccine Doses Before Starting Anti-CD20 Therapy on Seroprotection Rates Against Hepatitis B Virus in People With MS.
does_not_resolve 17576737 · Lupus (2007) — Safety and efficacy of hepatitis B vaccine in systemic lupus erythematosus.
does_not_resolve 30676860 · Human vaccines & immunotherapeutics (2019) — High dose hepatitis B vaccine is not effective in patients using immunomodulatory drugs: a pilot study.
supports_node 22235045 · Lupus (2012) — Autoimmunity following hepatitis B vaccine as part of the spectrum of 'Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants' (ASIA): analysis of 93 case
supports_node 9730294 · Scandinavian journal of infectious disea (1998) — Immune thrombocytopenic purpura after recombinant hepatitis B vaccine: retrospective study of seven cases.
does_not_resolve 25205080 · Gastroenterologia y hepatologia (2015) — [Hepatitis B virus reactivation in rituximab-treated patients: incidence and risk factors].
does_not_resolve 39808236 · Clinical rheumatology (2025) — Hepatitis B vaccine and juvenile idiopathic arthritis: comparison of the seropositivity rates with healthy children at the time of diagnosis and booster dose re
E1 · Mediator identified in casesno_data
Measure: Mediator present in affected tissue/cells Comparator: Unaffected tissue / control Hit rule: The hypothesized mediator is detected in the affected compartment and not (or less) in control
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Mediator identified in cases in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Mediator identified in cases not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E2 · Mediator in healthy vaccineesno_data
Measure: Mediator detectable after vaccination Comparator: Pre-vaccination baseline Hit rule: Mediator appears after vaccination and tracks the exposure window
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Mediator in healthy vaccinees in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Mediator in healthy vaccinees not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E3 · Infection contrastno_data
Measure: Mediator absent/low after natural infection Comparator: Recovered natural infection Hit rule: Mediator signal is specific to vaccination vs a comparable natural-infection control
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Infection contrast in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Infection contrast not associated mechanism pubmed · 2 hits · run 2026-09-07
E4 · Transfer to recipientno_data
Measure: Phenotype/mediator transferred to a recipient system Comparator: Control transfer Hit rule: The effect / mediator transfers to a naive recipient system
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Transfer to recipient in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Transfer to recipient not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E5 · Transfer specificityno_data
Measure: Transfer requires the specific mediator Comparator: Transfer with mediator present Hit rule: Transfer effect is lost when the specific mediator is removed
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Transfer specificity in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Transfer specificity not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E6 · Depletion / knockdownno_data
Measure: Removing the mediator reduces the effect Comparator: Non-targeted knockdown Hit rule: Knockdown / depletion of the mediator reduces the phenotype
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Depletion / knockdown in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Depletion / knockdown not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E7 · Add-back rescueno_data
Measure: Adding the mediator restores the effect Comparator: Add-back of a control protein Hit rule: Adding back the mediator (not a control) restores the phenotype
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Add-back rescue in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Add-back rescue not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E8 · Neutralizationno_data
Measure: Neutralizing the mediator blocks the effect Comparator: Isotype control Hit rule: Neutralization of the mediator (not an isotype control) blocks the phenotype
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Neutralization in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Neutralization not associated mechanism pubmed · 1 hits · run 2026-09-07
1 retrieved record(s)
does_not_resolve 28673589 · Medical hypotheses (2017) — Hepatitis B vaccine non response: A predictor of latent autoimmunity?
E9 · Isotype controlno_data
Measure: Isotype control does not reproduce the effect Comparator: Active antibody Hit rule: An isotype control fails to reproduce the block/activation
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Isotype control in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Isotype control not associated mechanism pubmed · 3 hits · run 2026-09-07
F1 · Full product reproducesno_data
Measure: Full vaccine product reproduces the effect Comparator: No-product control Hit rule: The full product (not a subcomponent) reproduces the effect
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Full product reproduces component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Full product reproduces no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
7 retrieved record(s)
does_not_resolve 34816398 · Methods in molecular biology (Clifton, N (2022) — Avian Paramyxoviruses as Vectors for Vaccine Development.
does_not_resolve 31300111 · Comparative immunology, microbiology and (2019) — Construction of recombinant capripoxviruses as vaccine vectors for delivering foreign antigens: Methodology and application.
does_not_resolve 42172979 · Virology (2026) — Towards the development of a mucosal vectored vaccine against enterovirus D68.
does_not_resolve 21952287 · Cancer journal (Sudbury, Mass.) (2011) — Viral vector-based therapeutic cancer vaccines.
does_not_resolve 15853721 · Current HIV research (2005) — Non-replicating viral vector-based AIDS vaccines: interplay between viral vectors and the immune system.
does_not_resolve 22683663 · Vaccine (2012) — Malaria vaccines: focus on adenovirus based vectors.
F2 · Empty vector / particleno_data
Measure: Vector/particle without antigen reproduces (or not) Comparator: Full product Hit rule: Effect attributed to (or excluded from) the vector/particle backbone alone
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Empty vector / particle component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Empty vector / particle no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
5 retrieved record(s)
does_not_resolve 34816398 · Methods in molecular biology (Clifton, N (2022) — Avian Paramyxoviruses as Vectors for Vaccine Development.
does_not_resolve 25876176 · Human vaccines & immunotherapeutics (2015) — Progress on adenovirus-vectored universal influenza vaccines.
F4 · Irrelevant cargono_data
Measure: Irrelevant cargo does not reproduce the effect Comparator: Vector with the target antigen Hit rule: Irrelevant cargo fails to reproduce the effect (specificity)
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Irrelevant cargo component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Irrelevant cargo no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 34816398 · Methods in molecular biology (Clifton, N (2022) — Avian Paramyxoviruses as Vectors for Vaccine Development.
does_not_resolve 15174971 · Expert opinion on biological therapy (2004) — Particle-mediated DNA vaccine delivery to the skin.
does_not_resolve 29550258 · Immunology letters (2018) — Live bacterial vaccine vector and delivery strategies of heterologous antigen: A review.
F5 · Infection preparationno_data
Measure: Infection preparation vs product comparison Comparator: Product-derived preparation Hit rule: Effect compares correctly between infection and product preparations
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Infection preparation component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Infection preparation no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 34816398 · Methods in molecular biology (Clifton, N (2022) — Avian Paramyxoviruses as Vectors for Vaccine Development.
does_not_resolve 15174971 · Expert opinion on biological therapy (2004) — Particle-mediated DNA vaccine delivery to the skin.
does_not_resolve 29550258 · Immunology letters (2018) — Live bacterial vaccine vector and delivery strategies of heterologous antigen: A review.
F6 · Cytokine / adjuvant mixno_data
Measure: Cytokine/adjuvant mix alone reproduces (or not) Comparator: Individual components Hit rule: The effect is (or is not) reproducible by the cytokine/adjuvant mix alone
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Cytokine / adjuvant mix component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Cytokine / adjuvant mix no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 34816398 · Methods in molecular biology (Clifton, N (2022) — Avian Paramyxoviruses as Vectors for Vaccine Development.
does_not_resolve 15174971 · Expert opinion on biological therapy (2004) — Particle-mediated DNA vaccine delivery to the skin.
does_not_resolve 29550258 · Immunology letters (2018) — Live bacterial vaccine vector and delivery strategies of heterologous antigen: A review.
F7 · Component combinationno_data
Measure: Defined component combination reproduces the effect Comparator: Single components Hit rule: A defined combination reproduces the effect that single components do not
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Component combination component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Component combination no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
7 retrieved record(s)
does_not_resolve 34816398 · Methods in molecular biology (Clifton, N (2022) — Avian Paramyxoviruses as Vectors for Vaccine Development.
does_not_resolve 31300111 · Comparative immunology, microbiology and (2019) — Construction of recombinant capripoxviruses as vaccine vectors for delivering foreign antigens: Methodology and application.
does_not_resolve 42172979 · Virology (2026) — Towards the development of a mucosal vectored vaccine against enterovirus D68.
does_not_resolve 21952287 · Cancer journal (Sudbury, Mass.) (2011) — Viral vector-based therapeutic cancer vaccines.
does_not_resolve 15853721 · Current HIV research (2005) — Non-replicating viral vector-based AIDS vaccines: interplay between viral vectors and the immune system.
does_not_resolve 22683663 · Vaccine (2012) — Malaria vaccines: focus on adenovirus based vectors.
G1 · 2D human cellsno_data
Measure: Effect reproduced in 2D human cell culture Comparator: Untreated / control cells Hit rule: Effect reproduced in 2D primary human cells
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder 2D human cells animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder 2D human cells not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G2 · Organoid / chipno_data
Measure: Effect reproduced in organoid / organ-on-chip Comparator: Unexposed organoid Hit rule: Effect reproduced in a 3D organoid / organ-on-chip system
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Organoid / chip animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Organoid / chip not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
H1 · Block in vitro / in vivono_data
Measure: Blocking the mediator/mechanism prevents the effect Comparator: Control intervention Hit rule: Blocking the mechanism prevents or reverses the effect (not with a control intervention)
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Block in vitro / in vivo intervention OR treatment OR reversal pubmed · 15142392 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Block in vitro / in vivo no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
1 retrieved record(s)
does_not_resolve 38189107 · Expert review of vaccines (2024) — Neoadjuvant personalized cancer vaccines: the final frontier?
Clinical / animal / host 7/7 evaluated
E10 · Host-line dependenceno_data
Measure: Effect depends on host line/cell type Comparator: Susceptible host line Hit rule: Effect is restricted to a defined host line / genotype, not universal
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder mechanism Host-line dependence in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Host-line dependence not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G3 · Animal, clinical routeno_data
Measure: Effect in animal via the clinical route of administration Comparator: Vehicle, same route Hit rule: Effect reproduced in an animal using the clinical route of administration
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Animal, clinical route animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Animal, clinical route not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G4 · Susceptible animalno_data
Measure: Effect in a susceptible animal model Comparator: Non-susceptible model Hit rule: Effect in a defined susceptible animal model
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Susceptible animal animal OR organoid OR cell model pubmed · 1818667 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Susceptible animal not reproduced model pubmed · 5 hits · run 2026-09-07
1 retrieved record(s)
refutes_node 12093985 · Pediatrics (2002) — No evidence of autoimmunity in 6-year-old children immunized at birth with recombinant hepatitis B vaccine.
G5 · Replication across labsno_data
Measure: Effect replicated in an independent lab Comparator: Original result Hit rule: The key effect is replicated in an independent laboratory
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Replication across labs animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Replication across labs not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G6 · Blinded scoringno_data
Measure: Outcomes scored blinded Comparator: Unblinded reference Hit rule: Primary outcomes scored by a blinded assessor
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Blinded scoring animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Blinded scoring not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G7 · Experimental time courseno_data
Measure: Effect follows a defined experimental time course Comparator: No-exposure time course Hit rule: The effect's onset/offset follows a defined experimental time course
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Experimental time course animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Experimental time course not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
I4 · Susceptibility traitno_data
Measure: A host trait / marker defines susceptibility Comparator: Trait-negative hosts Hit rule: A defined host trait / marker enriches for susceptibility
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine Autoimmune disorder Susceptibility trait coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine Autoimmune disorder Susceptibility trait inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
How this was built
Per node: a supporting and a mirror PubMed query built from the node's measure / population / comparator / hit_rule; top hits fetched (title + abstract); each record classified (supports / refutes / ambiguous) by xAI with a heuristic fallback; a per-node synthesis is generated strictly from the retrieved PMIDs; the node status is then rolled up to C1–C6. Full query provenance is shown per node above. Reproduce the build: python -m evidence_run. Data: data/evidence_run/state.json.