Evidence dossier · candidate cand-hepatitis-b-anaphylaxis · VICP program · · DRAFT — not a determination
This is a draft research-tracking dossier, not a determination that Hepatitis B vaccine causes Anaphylaxis, 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
insufficient_data
missing: A5
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: Brighton Collaboration (named in spec §1: anaphylaxis) — 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 evidence found
Case-certainty distribution (Brighton Collaboration): 1 Level 3 (possible). Transparency layer — does not change this node's status or feed C1–C6.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis case report OR case series Case reports pubmed · 66172 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis alternative diagnosis OR not vaccine-related pubmed · 4054 hits · run 2026-09-07
11 retrieved record(s)
ambiguous 7739341 · Lancet (London, England) (1995) — Anaphylaxis after hepatitis B vaccination.
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.
does_not_resolve 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.
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 evidence found
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis case report OR case series Series with objective confirmation pubmed · 5644 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis alternative diagnosis OR not vaccine-related pubmed · 4054 hits · run 2026-09-07
10 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.
does_not_resolve 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.
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: The retrieved evidence includes a review (PMID 9607051) that lists anaphylaxis as an immediate reaction reported after hepatitis B vaccination, and a case report (PMID 7739341) of anaphylaxis after hepatitis B vaccination, but neither provide onset time distribution data or clustering analysis for this node.
does_not_resolve 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.
A4 · Temporal plausibilitysupports
Measure: Onset latency vs object pathophysiology Comparator: Object's known natural latency Hit rule: Onset latency consistent with the object's pathophysiology
Finding: Two retrieved PMIDs (7739341 and 9607051) report anaphylaxis following hepatitis B vaccination, with onset consistent with immediate-type hypersensitivity, but provide no detailed latency data or controlled comparison to expected pathophysiology.
supporting: Hepatitis B vaccine Anaphylaxis case report OR case series Temporal plausibility pubmed · 34 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis alternative diagnosis OR not vaccine-related pubmed · 4054 hits · run 2026-09-07
13 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
ambiguous 7739341 · Lancet (London, England) (1995) — Anaphylaxis after hepatitis B vaccination.
supports_node 9607051 · Vaccine (1998) — Major adverse reactions to yeast-derived hepatitis B vaccines--a review.
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.
does_not_resolve 36560483 · Vaccines (2022) — Vaccine-Related Autoimmune Hepatitis: Emerging Association with SARS-CoV-2 Vaccination or Coincidence?
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 documents whether the onset interval for anaphylaxis after hepatitis B vaccination was recorded (not imputed) in a primary source.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis case report OR case series Onset-interval documentation pubmed · 3 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis alternative diagnosis OR not vaccine-related pubmed · 4054 hits · run 2026-09-07
12 retrieved record(s)
ambiguous 7739341 · Lancet (London, England) (1995) — Anaphylaxis after hepatitis B vaccination.
ambiguous 9607051 · Vaccine (1998) — Major adverse reactions to yeast-derived hepatitis B vaccines--a review.
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.
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.
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 evidence found
Case-certainty distribution (Brighton Collaboration): 2 Level 3 (possible). Transparency layer — does not change this node's status or feed C1–C6.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis case report OR case series Differential diagnosis excluded pubmed · 430 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis alternative diagnosis OR not vaccine-related pubmed · 4054 hits · run 2026-09-07
10 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 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 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.
ambiguous 7114977 · Archives of internal medicine (1982) — Vaccine-related poliomyelitis.
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: Two case reports describe anaphylaxis after hepatitis B vaccination, but no evidence of recurrence upon rechallenge or re-exposure is reported.
does_not_resolve 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.
A8 · Adjudicated by criteria (Brighton Collaboration)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 evidence found
Case-certainty distribution (Brighton Collaboration): 1 Level 3 (possible). Transparency layer — does not change this node's status or feed C1–C6.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis case report OR case series Adjudicated by criteria pubmed · 42 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis alternative diagnosis OR not vaccine-related pubmed · 4054 hits · run 2026-09-07
11 retrieved record(s)
ambiguous 7739341 · Lancet (London, England) (1995) — Anaphylaxis after hepatitis B vaccination.
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.
does_not_resolve 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.
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: The only retrieved evidence potentially relevant to anaphylaxis after hepatitis B vaccination is a single case report (PMID 7739341) with no abstract; all other retrieved evidence concerns COVID-19, HPV, monkeypox, or other vaccines and is not applicable to the Hepatitis B vaccine–anaphylaxis pair.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis case report OR case series Natural-history consistency pubmed · 106 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis alternative diagnosis OR not vaccine-related pubmed · 4054 hits · run 2026-09-07
11 retrieved record(s)
ambiguous 7739341 · Lancet (London, England) (1995) — Anaphylaxis after hepatitis B vaccination.
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 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 36560483 · Vaccines (2022) — Vaccine-Related Autoimmune Hepatitis: Emerging Association with SARS-CoV-2 Vaccination or Coincidence?
ambiguous 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.
A10 · No confounding objectsupports
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: Two retrieved PMIDs (7739341 and 9607051) report anaphylaxis after hepatitis B vaccination, with 9607051 explicitly listing anaphylaxis as an immediate reaction to yeast-derived hepatitis B vaccines.
supporting: Hepatitis B vaccine Anaphylaxis case report OR case series No confounding object pubmed · 22 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis alternative diagnosis OR not vaccine-related pubmed · 4054 hits · run 2026-09-07
13 retrieved record(s)
ambiguous 7739341 · Lancet (London, England) (1995) — Anaphylaxis after hepatitis B vaccination.
does_not_resolve 34312836 · Clinical pharmacology and therapeutics (2022) — Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin Secretagogues and the Risk of Serious Hypoglycemia.
ambiguous 9607051 · Vaccine (1998) — Major adverse reactions to yeast-derived hepatitis B vaccines--a review.
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 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 36560483 · Vaccines (2022) — Vaccine-Related Autoimmune Hepatitis: Emerging Association with SARS-CoV-2 Vaccination or Coincidence?
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") anatomic localization Predicted site of injury mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") anatomic localization Spared structures mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") anatomic localization Local vs systemic distribution mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") anatomic localization Kinetics class mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") anatomic localization Platform-mechanism match mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Targeted treatment reverses intervention OR treatment OR reversal pubmed · 15142392 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Targeted treatment reverses no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") No internal contradiction coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") No internal contradiction inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Analogy to a known object coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Analogy to a known object inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
1 retrieved record(s)
does_not_resolve 25187623 · Reproduction (Cambridge, England) (2014) — Epigenetics and life-long consequences of an adverse nutritional and diabetic intrauterine environment.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Latency coherence coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Latency coherence inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
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 and artificial intelligence to identify immune-related adverse events from immune checkpoint inhibitor therapy and to adjudicate major adverse cardiovascular events in clinical trials, but it does not address anaphylaxis following Hepatitis B vaccination.
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Pre-specification pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 evidence found
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Contrary-evidence log pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 focuses on identifying immune-related adverse events (irAEs) in patients receiving immune checkpoint inhibitors, with no mention of hepatitis B vaccine or anaphylaxis.
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") No temporality-only claim pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") No temporality-only claim post-hoc OR hypothesis-generating only pubmed · 1700 hits · run 2026-09-07
1 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
J4 · Passive-surveillance roleno_data
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Passive-surveillance role pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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
does_not_resolve 41493293 · Journal of the American College of Cardi (2026) — Using Artificial Intelligence to Adjudicate Major Adverse Cardiovascular Events in Clinical Trials.
J5 · Dose mappingno_data
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 discusses using large language models and AI to identify immune-related adverse events and adjudicate cardiovascular outcomes, but does not address dose/lot exposure mapping for Hepatitis B vaccine and anaphylaxis.
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Dose mapping pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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: The retrieved evidence includes a self-controlled case series study that examines anaphylaxis as an adverse event following XBB.1.5-containing COVID-19 mRNA vaccines, but no retrieved studies directly address the pair of Hepatitis B vaccine and anaphylaxis or provide evidence for an excess risk of anaphylaxis after Hepatitis B vaccination.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis Excess vs baseline incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis no association OR null OR no increased risk Excess vs baseline pubmed · 88471 hits · run 2026-09-07
8 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.
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 40440921 · Vaccine (2025) — Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study.
does_not_resolve 34672967 · Lancet (London, England) (2021) — Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, pha
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.
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 retrieved evidence addresses the risk of anaphylaxis following hepatitis B vaccination using a self-controlled case series design.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis SCCS incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis no association OR null OR no increased risk SCCS pubmed · 88579 hits · run 2026-09-07
10 retrieved record(s)
does_not_resolve 40440921 · Vaccine (2025) — Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational 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.
supports_node 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 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 38089855 · European heart journal open (2023) — Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.
refutes_node 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 39795956 · International journal of molecular scien (2024) — The Potential Metalloestrogenic Effect of Aluminum on Breast Cancer Risk for Antiperspirant Users.
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 retrieved evidence evaluates the incidence rate ratio (IRR) for anaphylaxis after Hepatitis B vaccination in a cohort or risk-interval design; the retrieved studies assess unrelated vaccines or outcomes (e.g., Guillain-Barré syndrome, shingles, arrhythmias) or non-vaccine genetic associations.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis Cohort / risk-interval incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis no association OR null OR no increased risk Cohort / risk-interval pubmed · 88080 hits · run 2026-09-07
11 retrieved record(s)
does_not_resolve 40440921 · Vaccine (2025) — Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational 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.
supports_node 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 38089855 · European heart journal open (2023) — Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.
does_not_resolve 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 41284649 · PloS one (2025) — Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States.
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 evidence provides a pooled meta-analysis estimate of the association between Hepatitis B vaccine and anaphylaxis, or reports quantified heterogeneity (I²) for such an estimate.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis Meta-analysis / pooling incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis no association OR null OR no increased risk Meta-analysis / pooling pubmed · 111916 hits · run 2026-09-07
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
supports_node 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 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 40440921 · Vaccine (2025) — Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational 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 1661751 · Journal of dairy science (1991) — Meta-analysis of nutritional risk factors for milk fever in dairy cattle.
does_not_resolve 28230042 · Journal of cancer research and therapeut (2016) — Meta-analysis of association between mobile phone use and glioma risk.
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 was retrieved that specifically evaluates anaphylaxis risk following Hepatitis B vaccination, or any negative-control outcome analysis for this vaccine-outcome pair.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis Negative-control outcomes incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis no association OR null OR no increased risk Negative-control outcomes pubmed · 88282 hits · run 2026-09-07
7 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
supports_node 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 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 40440921 · Vaccine (2025) — Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study.
does_not_resolve 38833248 · JAMA network open (2024) — Valproate Use During Spermatogenesis and Risk to Offspring.
does_not_resolve 42486607 · BMJ (Clinical research ed.) (2026) — Risk of hair loss associated with glucagon-like peptide-1 receptor agonists in adults with type 2 diabetes: target trial emulation.
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 includes studies on anaphylaxis after COVID-19 mRNA vaccines and other vaccines, but provides no data on anaphylaxis risk following Hepatitis B vaccine compared with a different-antigen comparator.
Cited: (none)
supporting: Hepatitis B vaccine Anaphylaxis Other-antigen comparison incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis no association OR null OR no increased risk Other-antigen comparison pubmed · 88044 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 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 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 40440921 · Vaccine (2025) — Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study.
does_not_resolve 23949879 · Tumour biology : the journal of the Inte (2014) — Meta-analysis of the association between GSTT1 null genotype and risk of nasopharyngeal carcinoma in Chinese.
does_not_resolve 23296494 · Molecular biology reports (2013) — Assessment of the association between GSTM1 null genotype and risk of type 2 diabetes.
does_not_resolve 24136740 · Tumour biology : the journal of the Inte (2014) — Association between glutathione S-transferase M1 null genotype and risk of gallbladder cancer: a meta-analysis.
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 Anaphylaxis Absolute risk incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine Anaphylaxis no association OR null OR no increased risk Absolute risk pubmed · 111317 hits · run 2026-09-07
12 retrieved record(s)
does_not_resolve 40440921 · Vaccine (2025) — Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational 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.
supports_node 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 38089855 · European heart journal open (2023) — Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.
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 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.
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: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Platform split incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") no association OR null OR no increased risk Platform split pubmed · 88113 hits · run 2026-09-07
4 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 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 37468475 · Nature communications (2023) — Herpes zoster vaccine safety in the Aotearoa New Zealand population: 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: The retrieved evidence includes studies on antipsychotic cardiovascular risk, SCCS methodology, rotavirus vaccine safety, and herpes zoster vaccine safety, but none address Hepatitis B vaccine and anaphylaxis, or any host-structure stratification of risk by age/sex for that outcome.
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Host-structure stratification incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") no association OR null OR no increased risk Host-structure stratification pubmed · 88046 hits · run 2026-09-07
4 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 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 37468475 · Nature communications (2023) — Herpes zoster vaccine safety in the Aotearoa New Zealand population: a self-controlled case series study.
B10 · Formulation / component changeno_data
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: The retrieved evidence does not address any formulation or component change in the Hepatitis B vaccine or anaphylaxis risk; all studies focus on antipsychotics or other vaccines (rotavirus, herpes zoster) using self-controlled designs.
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Formulation / component change incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") no association OR null OR no increased risk Formulation / component change pubmed · 88208 hits · run 2026-09-07
4 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 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
ambiguous 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 37468475 · Nature communications (2023) — Herpes zoster vaccine safety in the Aotearoa New Zealand population: 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Formulation natural experiment intervention OR treatment OR reversal pubmed · 15142392 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Formulation natural experiment no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Policy / pause signal intervention OR treatment OR reversal pubmed · 15142392 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Policy / pause signal no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Infection coherence coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Infection coherence inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
1 retrieved record(s)
does_not_resolve 15578364 · Clinical infectious diseases : an offici (2004) — Varicella vaccine for susceptible adults: do it today.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Dose strength gradient dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") no dose effect OR no dose-response Dose strength gradient pubmed · 113 hits · run 2026-09-07
1 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.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Dose number gradient dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") no dose effect OR no dose-response Dose number gradient pubmed · 557 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 34703927 · Heliyon (2021) — Development of a protective inactivated vaccine against Crimean-Congo hemorrhagic fever infection.
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: The retrieved evidence does not address the relationship between Hepatitis B vaccine and anaphylaxis. PMID 39082700 discusses MenB-4C vaccine and gonorrhea, PMID 35108152 covers pentavalent vaccine AEFI surveillance, and PMID 27174834 mentions anaphylactic shock after hepatitis B vaccination but only as a background event in a media-trust survey, with no measured-exposure tertile analysis or risk ordering by exposure level.
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Measured-exposure tertiles dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") no dose effect OR no dose-response Measured-exposure tertiles pubmed · 2 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.
supports_node 35108152 · Human vaccines & immunotherapeutics (2022) — Surveillance on the adverse events following immunization with the pentavalent vaccine in Zhejiang, China.
ambiguous 27174834 · International journal of epidemiology (2016) — Loss of confidence in vaccines following media reports of infant deaths after hepatitis B vaccination in China.
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: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Organoid concentration curve dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") no dose effect OR no dose-response Organoid concentration curve pubmed · 13 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.
supports_node 35108152 · Human vaccines & immunotherapeutics (2022) — Surveillance on the adverse events following immunization with the pentavalent vaccine in Zhejiang, China.
does_not_resolve 27174834 · International journal of epidemiology (2016) — Loss of confidence in vaccines following media reports of infant deaths after hepatitis B vaccination in China.
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: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") EC50 vs Cmax coherence dose-response OR dose effect pubmed · 1299193 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") no dose effect OR no dose-response EC50 vs Cmax coherence pubmed · 2 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.
supports_node 35108152 · Human vaccines & immunotherapeutics (2022) — Surveillance on the adverse events following immunization with the pentavalent vaccine in Zhejiang, China.
ambiguous 27174834 · International journal of epidemiology (2016) — Loss of confidence in vaccines following media reports of infant deaths after hepatitis B vaccination in China.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Mediator identified in cases in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Mediator in healthy vaccinees in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Infection contrast in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Infection contrast not associated mechanism pubmed · 1 hits · run 2026-09-07
1 retrieved record(s)
does_not_resolve 3409544 · Clinical and experimental immunology (1988) — Selectivity in IgG subclass response to hepatitis B vaccine in infants born to HBsAg-positive mothers.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Transfer to recipient in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Transfer specificity in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Depletion / knockdown in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Add-back rescue in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Neutralization in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Neutralization not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
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: The retrieved evidence describes IgG subclass responses to hepatitis B vaccine in infants but does not mention anaphylaxis, isotype controls, or any block/activation assay.
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Isotype control in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Isotype control not associated mechanism pubmed · 1 hits · run 2026-09-07
1 retrieved record(s)
ambiguous 3409544 · Clinical and experimental immunology (1988) — Selectivity in IgG subclass response to hepatitis B vaccine in infants born to HBsAg-positive mothers.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Full product reproduces component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Full product reproduces no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 28420073 · International journal of molecular scien (2017) — Future Prospects for the Development of Cost-Effective Adenovirus Vaccines.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Empty vector / particle component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Empty vector / particle no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 28420073 · International journal of molecular scien (2017) — Future Prospects for the Development of Cost-Effective Adenovirus Vaccines.
Measure: Isolated antigen reproduces the effect Comparator: Vehicle Hit rule: The isolated antigen (not the full product) reproduces the effect
Finding: no evidence found
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Antigen alone reproduces component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Antigen alone reproduces no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 28420073 · International journal of molecular scien (2017) — Future Prospects for the Development of Cost-Effective Adenovirus Vaccines.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Irrelevant cargo component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Irrelevant cargo no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 28420073 · International journal of molecular scien (2017) — Future Prospects for the Development of Cost-Effective Adenovirus Vaccines.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Infection preparation component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Infection preparation no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 28420073 · International journal of molecular scien (2017) — Future Prospects for the Development of Cost-Effective Adenovirus Vaccines.
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 retrieved evidence addresses whether a cytokine/adjuvant mix alone reproduces anaphylaxis attributed to Hepatitis B vaccine. The retrieved articles discuss measles, influenza, Newcastle disease, rabies, malaria, adenovirus, and COVID-19 vaccine platform technologies, but none mention cytokine/adjuvant mixes, Hepatitis B vaccine, or anaphylaxis.
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Cytokine / adjuvant mix component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Cytokine / adjuvant mix no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 28420073 · International journal of molecular scien (2017) — Future Prospects for the Development of Cost-Effective Adenovirus Vaccines.
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 retrieved evidence addresses the combination of Hepatitis B vaccine components producing anaphylaxis, nor any defined component combination reproducing an effect that single components do not.
Cited: (none)
supporting: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Component combination component OR antigen OR vector pubmed · 2045311 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Component combination no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
does_not_resolve 28420073 · International journal of molecular scien (2017) — Future Prospects for the Development of Cost-Effective Adenovirus Vaccines.
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 2D human cells animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Organoid / chip animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Block in vitro / in vivo intervention OR treatment OR reversal pubmed · 15142392 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Block in vitro / in vivo no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") mechanism Host-line dependence in vitro OR patient-derived pubmed · 29244 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Animal, clinical route animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Susceptible animal animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Susceptible animal not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Replication across labs animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Blinded scoring animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Experimental time course animal OR organoid OR cell model pubmed · 1818663 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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 (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") Susceptibility trait coherence OR latency OR susceptibility pubmed · 870068 hits · run 2026-09-07
mirror: Hepatitis B vaccine (anaphylaxis OR "anaphylactic" OR "severe allergic reaction") 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.