Evidence dossier · candidate cand-rotavirus-intussusception · VICP program · · DRAFT — not a determination
This is a draft research-tracking dossier, not a determination that Rotavirus vaccine causes Intussusception, 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
contested
C2
Consistent temporal window
contested
C3
Epidemiologic excess risk
contested
C4
Consistency / replication
contested
C5
Specificity (product / dose)
contested
C6
Biological mechanism
contested
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 reportssupports
Measure: New definite object in risk window T Comparator: Pre-vaccination baseline Hit rule: Definite object present, onset in window, competing causes considered
Finding: Two case reports describe intussusception in twin infants occurring about a week after rotavirus vaccination, with surgical intervention and consideration of genetic predisposition.
Case-certainty distribution (no established case definition): 2 Probable. Transparency layer — does not change this node's status or feed C1–C6.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
A2 · Series with objective confirmationmixed
Measure: Definite object plus objective test Comparator: Reference range / diagnostic criteria Hit rule: Objective confirmation in >=1 case per the working definition
Finding: Three case reports (PMID 27070956) and 10 spontaneous ICSRs (PMID 27641974) describe intussusception cases with causal attribution to rotavirus vaccine, but none explicitly confirm the case with objective testing as defined in the node; the African surveillance study (PMID 37596934) used standard case report forms and vaccination card review but does not report objective confirmation per case for this node.
Case-certainty distribution (no established case definition): 1 Probable, 1 Possible/unclassifiable. Transparency layer — does not change this node's status or feed C1–C6.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 33404379 · Journal of health communication (2020) — Undermining Credibility: The Limited Influence of Online Comments to Vaccine-related News Stories.
A3 · Onset histogrammixed
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: Two retrieved case reports describe intussusception onset within approximately one week after rotavirus vaccination (PMID 27641974; PMID 27070956), and a pooled analysis from five African countries (PMID 37596934) used self-controlled case-series methods to assess risk within a defined risk window, but the onset histogram data are not explicitly presented in the abstracts.
supporting: Rotavirus vaccine Intussusception case report OR case series Onset histogram pubmed · 19 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception alternative diagnosis OR not vaccine-related pubmed · 4052 hits · run 2026-09-07
21 retrieved record(s)
supports_node 27641974 · Indian journal of pediatrics (2017) — Risk of Intussusception with Rotavirus Vaccine.
supports_node 27070956 · Human vaccines & immunotherapeutics (2016) — Post-rotavirus vaccine intussusception in identical twins: A case report.
refutes_node 37596934 · Clinical infectious diseases : an offici (2024) — Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.
ambiguous 38813337 · Cureus (2024) — Intussusception With a Pathological Lead Point in a Two-Month-Old Infant.
does_not_resolve 19821204 · The Turkish journal of gastroenterology (2009) — Rotavirus-associated intussusception followed by spontaneous resolution.
does_not_resolve 34548901 · The Pan African medical journal (2021) — Intussusception in children under five years of age in Enugu, Nigeria.
does_not_resolve 30029630 · BMC public health (2018) — Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol.
does_not_resolve 28709556 · Vaccine (2018) — Intussusception among children less than 2years of age: Findings from pre-vaccine introduction surveillance in Pakistan.
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 case reports describe onset of intussusception approximately one week after rotavirus vaccination, consistent with a pre-specified risk window, and one case series report identifies three cases with causal relationship to the vaccine. Evidence is limited to individual case reports and small series, lacking formal temporal plausibility analysis from controlled studies.
supporting: Rotavirus vaccine Intussusception case report OR case series Temporal plausibility pubmed · 48 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception alternative diagnosis OR not vaccine-related pubmed · 4052 hits · run 2026-09-07
18 retrieved record(s)
supports_node 27070956 · Human vaccines & immunotherapeutics (2016) — Post-rotavirus vaccine intussusception in identical twins: A case report.
refutes_node 37596934 · Clinical infectious diseases : an offici (2024) — Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.
ambiguous 27641974 · Indian journal of pediatrics (2017) — Risk of Intussusception with Rotavirus Vaccine.
does_not_resolve 23754771 · Human psychopharmacology (2013) — Quality of case reports of adverse drug reactions with psychotropic drugs: a 25-year review.
ambiguous 38813337 · Cureus (2024) — Intussusception With a Pathological Lead Point in a Two-Month-Old Infant.
does_not_resolve 32294081 · PLoS neglected tropical diseases (2020) — Praziquantel and risk of visual disorders: Case series assessment.
supports_node 19821204 · The Turkish journal of gastroenterology (2009) — Rotavirus-associated intussusception followed by spontaneous resolution.
does_not_resolve 30000765 · (2006) — Human Papillomavirus Vaccines.
A5 · Onset-interval documentationmixed
Measure: Onset interval documented in source Comparator: Dose date Hit rule: Onset interval is recorded (not imputed) in a primary source
Finding: The retrieved evidence includes one publication (PMID 27641974) that reports adequate information to confirm a causal relationship in 3 of 10 individual case safety reports of intussusception after rotavirus vaccination, indicating that onset interval documentation is present in those cases. However, other retrieved studies (e.g., PMID 37596934, 27070956, 38813337) describe onset intervals (e.g., within a week) but do not explicitly state whether the interval was recorded in a primary source versus imputed.
supporting: Rotavirus vaccine Intussusception case report OR case series Onset-interval documentation pubmed · 17 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception alternative diagnosis OR not vaccine-related pubmed · 4052 hits · run 2026-09-07
21 retrieved record(s)
refutes_node 37596934 · Clinical infectious diseases : an offici (2024) — Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.
supports_node 27641974 · Indian journal of pediatrics (2017) — Risk of Intussusception with Rotavirus Vaccine.
supports_node 27070956 · Human vaccines & immunotherapeutics (2016) — Post-rotavirus vaccine intussusception in identical twins: A case report.
ambiguous 38813337 · Cureus (2024) — Intussusception With a Pathological Lead Point in a Two-Month-Old Infant.
ambiguous 19821204 · The Turkish journal of gastroenterology (2009) — Rotavirus-associated intussusception followed by spontaneous resolution.
does_not_resolve 34548901 · The Pan African medical journal (2021) — Intussusception in children under five years of age in Enugu, Nigeria.
does_not_resolve 30029630 · BMC public health (2018) — Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol.
does_not_resolve 28709556 · Vaccine (2018) — Intussusception among children less than 2years of age: Findings from pre-vaccine introduction surveillance in Pakistan.
A6 · Differential diagnosis excludedsupports
Measure: Competing causes assessed and excluded Comparator: Likely alternative diagnoses Hit rule: Pre-specified competing causes ruled out per the working definition
Finding: Three of ten intussusception case reports following rotavirus vaccination were assessed as having a causal relationship, indicating that competing causes were at least partially excluded in those cases.
Case-certainty distribution (no established case definition): 1 Probable, 1 Possible/unclassifiable. Transparency layer — does not change this node's status or feed C1–C6.
does_not_resolve 33404379 · Journal of health communication (2020) — Undermining Credibility: The Limited Influence of Online Comments to Vaccine-related News Stories.
ambiguous 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
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: No evidence of intussusception recurrence after a subsequent rotavirus vaccine dose was identified in the retrieved literature.
Cited: (none)
supporting: Rotavirus vaccine Intussusception case report OR case series Rechallenge / re-exposure pubmed · 19 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception alternative diagnosis OR not vaccine-related pubmed · 4052 hits · run 2026-09-07
22 retrieved record(s)
supports_node 27070956 · Human vaccines & immunotherapeutics (2016) — Post-rotavirus vaccine intussusception in identical twins: A case report.
supports_node 27641974 · Indian journal of pediatrics (2017) — Risk of Intussusception with Rotavirus Vaccine.
refutes_node 37596934 · Clinical infectious diseases : an offici (2024) — Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.
does_not_resolve 38813337 · Cureus (2024) — Intussusception With a Pathological Lead Point in a Two-Month-Old Infant.
does_not_resolve 19821204 · The Turkish journal of gastroenterology (2009) — Rotavirus-associated intussusception followed by spontaneous resolution.
does_not_resolve 34548901 · The Pan African medical journal (2021) — Intussusception in children under five years of age in Enugu, Nigeria.
does_not_resolve 30029630 · BMC public health (2018) — Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol.
does_not_resolve 28709556 · Vaccine (2018) — Intussusception among children less than 2years of age: Findings from pre-vaccine introduction surveillance in Pakistan.
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: Two case reports describe intussusception in infants after rotavirus vaccination, one involving identical twins with onset about one week post-vaccination and one reporting 3 out of 10 ICSRs with a causal relationship to rotavirus vaccine; a large African study examined but did not provide a definitive adjudication of cases as 'definite' by a published criterion set.
Case-certainty distribution (no established case definition): 2 Probable, 2 Possible/unclassifiable. Transparency layer — does not change this node's status or feed C1–C6.
Cited: (none)
supporting: Rotavirus vaccine Intussusception case report OR case series Adjudicated by criteria pubmed · 56 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception alternative diagnosis OR not vaccine-related pubmed · 4052 hits · run 2026-09-07
17 retrieved record(s)
supports_node 27070956 · Human vaccines & immunotherapeutics (2016) — Post-rotavirus vaccine intussusception in identical twins: A case report.
supports_node 27641974 · Indian journal of pediatrics (2017) — Risk of Intussusception with Rotavirus Vaccine.
refutes_node 37596934 · Clinical infectious diseases : an offici (2024) — Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.
ambiguous 38813337 · Cureus (2024) — Intussusception With a Pathological Lead Point in a Two-Month-Old Infant.
supports_node 19821204 · The Turkish journal of gastroenterology (2009) — Rotavirus-associated intussusception followed by spontaneous resolution.
does_not_resolve 34548901 · The Pan African medical journal (2021) — Intussusception in children under five years of age in Enugu, Nigeria.
does_not_resolve 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
A9 · Natural-history consistencymixed
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 retrieved evidence includes a large pooled analysis from 5 African countries (PMID 37596934) finding a low-level risk of intussusception after RotaTeq, with onset within a risk window, and three case reports (PMID 27641974, 27070956) describing intussusception cases following rotavirus vaccination, but the clinical course (onset, peak, recovery) matching natural history of intussusception is not explicitly detailed or validated against a natural history standard in these studies.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
A10 · No confounding objectmixed
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: One case report describes intussusception in twins following rotavirus vaccination, and a pharmacovigilance study found 3 of 10 reported cases had a causal relationship with the vaccine, but no controlled study directly rules out confounding by co-occurring infection or other conditions for this node.
supporting: Rotavirus vaccine Intussusception case report OR case series No confounding object pubmed · 36 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception alternative diagnosis OR not vaccine-related pubmed · 4052 hits · run 2026-09-07
18 retrieved record(s)
refutes_node 37596934 · Clinical infectious diseases : an offici (2024) — Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.
supports_node 27641974 · Indian journal of pediatrics (2017) — Risk of Intussusception with Rotavirus Vaccine.
supports_node 27070956 · Human vaccines & immunotherapeutics (2016) — Post-rotavirus vaccine intussusception in identical twins: A case report.
ambiguous 38813337 · Cureus (2024) — Intussusception With a Pathological Lead Point in a Two-Month-Old Infant.
does_not_resolve 19821204 · The Turkish journal of gastroenterology (2009) — Rotavirus-associated intussusception followed by spontaneous resolution.
does_not_resolve 34548901 · The Pan African medical journal (2021) — Intussusception in children under five years of age in Enugu, Nigeria.
ambiguous 30029630 · BMC public health (2018) — Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol.
does_not_resolve 28709556 · Vaccine (2018) — Intussusception among children less than 2years of age: Findings from pre-vaccine introduction surveillance in Pakistan.
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: Rotavirus vaccine Intussusception anatomic localization Predicted site of injury mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception anatomic localization Local vs systemic distribution mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception anatomic localization Kinetics class mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception anatomic localization Platform-mechanism match mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception Targeted treatment reverses intervention OR treatment OR reversal pubmed · 15141570 hits · run 2026-09-07
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: Rotavirus vaccine Intussusception No internal contradiction coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception Analogy to a known object coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception Latency coherence coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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 does not address Rotavirus vaccine, intussusception, or pre-specification of risk windows; it discusses immune-related adverse events from immune checkpoint inhibitors and drug-induced acute kidney injury risk prediction models.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Pre-specification pre-specified OR adjudicated pubmed · 13549 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Pre-specification post-hoc OR hypothesis-generating only pubmed · 1698 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: 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: Rotavirus vaccine Intussusception Contrary-evidence log pre-specified OR adjudicated pubmed · 13549 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Contrary-evidence log post-hoc OR hypothesis-generating only pubmed · 1698 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
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: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Intussusception No temporality-only claim pre-specified OR adjudicated pubmed · 13549 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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
does_not_resolve 40742144 · Journal of clinical sleep medicine : JCS (2025) — Association of weekend catch-up sleep with the atherosclerotic cardiovascular disease risk score: a hypothesis-generating study from US and Korean National Heal
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: Rotavirus vaccine Intussusception Passive-surveillance role pre-specified OR adjudicated pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Passive-surveillance role post-hoc OR hypothesis-generating only pubmed · 1698 hits · run 2026-09-07
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: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Intussusception Dose mapping pre-specified OR adjudicated pubmed · 13549 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Dose mapping post-hoc OR hypothesis-generating only pubmed · 1698 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
Epidemiologic chassis 13/13 evaluated
B1 · Excess vs baselinesupports
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 2017 meta-analysis of self-controlled case series studies reporting a mildly increased risk of intussusception after rotavirus vaccination, with relative risks summarized across doses, and a 2019 review noting previous associations of rotavirus vaccination with intussusception necessitating continued monitoring.
supporting: Rotavirus vaccine Intussusception Excess vs baseline incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no association OR null OR no increased risk Excess vs baseline pubmed · 88748 hits · run 2026-09-07
17 retrieved record(s)
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
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 42661284 · Expert review of vaccines (2026) — Stroke risk following BNT162b2 vaccination: a systematic review and meta-analysis of self-controlled case series studies.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
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.
refutes_node 34049735 · Vaccine (2021) — Safety of vaccines used for routine immunization in the United States: An updated systematic review and meta-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 provides a SCCS risk ratio > 1 with a CI excluding 1 for intussusception following rotavirus vaccination. The closest relevant study (PMID 38875047) reports that the risk of intussusception in the high-risk window (21 days post-vaccination) was comparable to background risk, not elevated.
does_not_resolve 38089855 · European heart journal open (2023) — Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
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 42661284 · Expert review of vaccines (2026) — Stroke risk following BNT162b2 vaccination: a systematic review and meta-analysis of self-controlled case series studies.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
ambiguous 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
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.
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 directly reports an incidence rate ratio (IRR) for intussusception following rotavirus vaccine in a pre-specified risk window, stratified by age and sex, with a confidence interval excluding 1. One review mentions that the risk of intussusception in the 21-day window after vaccination was comparable to background risk in an Indian SCCS study, but does not provide the IRR or confidence interval details required by the hit rule.
supporting: Rotavirus vaccine Intussusception Cohort / risk-interval incidence risk cohort OR self-controlled case series pubmed · 946 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no association OR null OR no increased risk Cohort / risk-interval pubmed · 88356 hits · run 2026-09-07
19 retrieved record(s)
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
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 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 38171315 · Neurospine (2023) — Limaprost and the Risk of Bleeding: A Self-Controlled Case Series Study.
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.
B4 · Meta-analysis / poolingsupports
Measure: Pooled effect across studies Comparator: Pooled estimate with heterogeneity Hit rule: Pooled estimate > 1 (or < 1) with quantified heterogeneity (I2)
Finding: Meta-analysis of 12 cohort and case-control studies found a pooled increased risk of intussusception after rotavirus vaccination, with quantified heterogeneity (I² reported), supporting a pooled estimate greater than 1.
supporting: Rotavirus vaccine Intussusception Meta-analysis / pooling incidence risk cohort OR self-controlled case series pubmed · 946 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no association OR null OR no increased risk Meta-analysis / pooling pubmed · 112188 hits · run 2026-09-07
16 retrieved record(s)
supports_node 28648544 · Vaccine (2017) — Risk of intussusception following rotavirus vaccination: An evidence based meta-analysis of cohort and case-control studies.
does_not_resolve 38089855 · European heart journal open (2023) — Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
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 42661284 · Expert review of vaccines (2026) — Stroke risk following BNT162b2 vaccination: a systematic review and meta-analysis of self-controlled case series studies.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
ambiguous 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
B5 · Negative-control outcomessupports
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: The self-controlled risk interval study of rotavirus vaccine safety (PMID 38875047) found that the risk of intussusception in the high-risk window (21 days after vaccination) was comparable to the background risk, indicating no excess. Other retrieved studies on rotavirus vaccine and intussusception (PMID 30570424, 16774301) discuss study designs and efficacy but do not provide a null finding for a negative-control outcome as defined here.
supporting: Rotavirus vaccine Intussusception Negative-control outcomes incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no association OR null OR no increased risk Negative-control outcomes pubmed · 88559 hits · run 2026-09-07
13 retrieved record(s)
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
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 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
does_not_resolve 38171315 · Neurospine (2023) — Limaprost and the Risk of Bleeding: A Self-Controlled Case Series Study.
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.
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: No retrieved evidence directly compares the risk of intussusception after rotavirus vaccination using a different-antigen comparator. The only relevant study (PMID 38875047) evaluates intussusception risk using self-controlled risk interval analysis but does not employ a different-antigen comparator.
supporting: Rotavirus vaccine Intussusception Other-antigen comparison incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no association OR null OR no increased risk Other-antigen comparison pubmed · 88321 hits · run 2026-09-07
does_not_resolve 38089855 · European heart journal open (2023) — Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
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 42661284 · Expert review of vaccines (2026) — Stroke risk following BNT162b2 vaccination: a systematic review and meta-analysis of self-controlled case series studies.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
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.
B7 · Absolute risksupports
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: A 2024 self-controlled risk interval study of an Indian rotavirus vaccine found that the risk of intussusception in the high-risk window (21 days after vaccination) was comparable to background risk, providing an absolute risk estimate per 100,000 that was stable and not an artifact of rarity.
supporting: Rotavirus vaccine Intussusception Absolute risk incidence risk cohort OR self-controlled case series pubmed · 946 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no association OR null OR no increased risk Absolute risk pubmed · 111582 hits · run 2026-09-07
19 retrieved record(s)
supports_node 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.
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 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
does_not_resolve 38171315 · Neurospine (2023) — Limaprost and the Risk of Bleeding: A Self-Controlled Case Series Study.
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 does not provide any data on intussusception risk attributable to a specific rotavirus vaccine platform. One study (PMID 38875047) re-analyzes SCCS data for an Indian rotavirus vaccine but does not report platform-specific risk for intussusception; another (PMID 30570424) reviews intussusception monitoring approaches but does not isolate platform-attributable risk.
supporting: Rotavirus vaccine Intussusception Platform split incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no association OR null OR no increased risk Platform split pubmed · 88386 hits · run 2026-09-07
16 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.
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
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 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 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: 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: Retrieved evidence does not directly address host-structure stratification (e.g., age/sex subgroups) for the pair rotavirus vaccine and intussusception. Two reviews mention risk monitoring but provide no stratified risk data.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Host-structure stratification incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no association OR null OR no increased risk Host-structure stratification pubmed · 88319 hits · run 2026-09-07
18 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.
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
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 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
refutes_node 34049735 · Vaccine (2021) — Safety of vaccines used for routine immunization in the United States: An updated systematic review and meta-analysis.
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 whether the risk of intussusception after rotavirus vaccination tracks a documented formulation or component change over time.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Formulation / component change incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no association OR null OR no increased risk Formulation / component change pubmed · 88481 hits · run 2026-09-07
14 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.
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 30570424 · Expert opinion on drug safety (2019) — Approaches to monitoring intussusception following rotavirus vaccination.
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 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 34049735 · Vaccine (2021) — Safety of vaccines used for routine immunization in the United States: An updated systematic review and meta-analysis.
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: Rotavirus vaccine Intussusception Formulation natural experiment intervention OR treatment OR reversal pubmed · 15141570 hits · run 2026-09-07
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: Rotavirus vaccine Intussusception Policy / pause signal intervention OR treatment OR reversal pubmed · 15141570 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception Infection coherence coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Infection coherence inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
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 retrieved evidence examines a monotonic dose-response gradient in dose strength (size of dose) for intussusception risk after rotavirus vaccination. Available studies compare different vaccine brands or number of doses, not varying dose sizes within a single vaccine product.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Dose strength gradient dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no dose effect OR no dose-response Dose strength gradient pubmed · 241 hits · run 2026-09-07
11 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 28468712 · Deutsches Arzteblatt international (2017) — Risk of Intussusception After Rotavirus Vaccination.
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
refutes_node 37815175 · Emerging microbes & infections (2023) — No increased risk of intussusception after pentavalent rotavirus vaccination in China: a retrospective birth cohort using electronic health records of Ningbo ci
refutes_node 33176083 · The New England journal of medicine (2020) — Intussusception after Rotavirus Vaccine Introduction in India.
does_not_resolve 25145068 · The Journal of communicable diseases (2012) — Rotavirus vaccine: a review.
supports_node 24335963 · Current opinion in pediatrics (2014) — Safety of second-generation rotavirus vaccines, intussusception.
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: Rotavirus vaccine Intussusception Dose number gradient dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no dose effect OR no dose-response Dose number gradient pubmed · 685 hits · run 2026-09-07
14 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 38278806 · Scientific reports (2024) — Potential impact on using aspirin as the primary prevention of adverse pregnancy outcomes in twins conceived using ART.
supports_node 28468712 · Deutsches Arzteblatt international (2017) — Risk of Intussusception After Rotavirus Vaccination.
refutes_node 33176083 · The New England journal of medicine (2020) — Intussusception after Rotavirus Vaccine Introduction in India.
does_not_resolve 25145068 · The Journal of communicable diseases (2012) — Rotavirus vaccine: a review.
supports_node 24335963 · Current opinion in pediatrics (2014) — Safety of second-generation rotavirus vaccines, intussusception.
refutes_node 37596934 · Clinical infectious diseases : an offici (2024) — Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.
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 study reports risk of intussusception by measured-exposure tertile of rotavirus vaccine. Available studies assess risk by dose number or overall vaccination, not by tertile grouping of exposure.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Measured-exposure tertiles dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no dose effect OR no dose-response Measured-exposure tertiles pubmed · 130 hits · run 2026-09-07
14 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 38278806 · Scientific reports (2024) — Potential impact on using aspirin as the primary prevention of adverse pregnancy outcomes in twins conceived using ART.
supports_node 28468712 · Deutsches Arzteblatt international (2017) — Risk of Intussusception After Rotavirus Vaccination.
supports_node 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
refutes_node 37815175 · Emerging microbes & infections (2023) — No increased risk of intussusception after pentavalent rotavirus vaccination in China: a retrospective birth cohort using electronic health records of Ningbo ci
refutes_node 33176083 · The New England journal of medicine (2020) — Intussusception after Rotavirus Vaccine Introduction in India.
does_not_resolve 25145068 · The Journal of communicable diseases (2012) — Rotavirus vaccine: a review.
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 retrieved evidence addresses dose-dependent effects of rotavirus vaccine antigen concentration on intussusception in organoid models. The available studies are epidemiological or clinical, not experimental organoid research.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Organoid concentration curve dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no dose effect OR no dose-response Organoid concentration curve pubmed · 141 hits · run 2026-09-07
12 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 28468712 · Deutsches Arzteblatt international (2017) — Risk of Intussusception After Rotavirus Vaccination.
refutes_node 33176083 · The New England journal of medicine (2020) — Intussusception after Rotavirus Vaccine Introduction in India.
does_not_resolve 25145068 · The Journal of communicable diseases (2012) — Rotavirus vaccine: a review.
supports_node 24335963 · Current opinion in pediatrics (2014) — Safety of second-generation rotavirus vaccines, intussusception.
refutes_node 37596934 · Clinical infectious diseases : an offici (2024) — Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.
does_not_resolve 11757786 · Current opinion in investigational drugs (2001) — Rotavirus vaccine AVANT/GlaxoSmithKline.
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 retrieved evidence reports pharmacokinetic or tissue exposure data (Cmax/EC50) relevant to rotavirus vaccine and intussusception; all studies are epidemiological assessments of risk.
Cited: (none)
supporting: Rotavirus vaccine Intussusception EC50 vs Cmax coherence dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception no dose effect OR no dose-response EC50 vs Cmax coherence pubmed · 130 hits · run 2026-09-07
13 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 28468712 · Deutsches Arzteblatt international (2017) — Risk of Intussusception After Rotavirus Vaccination.
refutes_node 33176083 · The New England journal of medicine (2020) — Intussusception after Rotavirus Vaccine Introduction in India.
does_not_resolve 25145068 · The Journal of communicable diseases (2012) — Rotavirus vaccine: a review.
supports_node 24335963 · Current opinion in pediatrics (2014) — Safety of second-generation rotavirus vaccines, intussusception.
refutes_node 37596934 · Clinical infectious diseases : an offici (2024) — Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.
does_not_resolve 11757786 · Current opinion in investigational drugs (2001) — Rotavirus vaccine AVANT/GlaxoSmithKline.
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: The systematic review reported that intussusception was one of the primary gastrointestinal outcomes examined following rotavirus vaccination, but the abstract does not provide data on mediator detection in affected tissue or any comparison between cases and controls.
supporting: Rotavirus vaccine Intussusception mechanism Mediator identified in cases in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Mediator identified in cases not associated mechanism pubmed · 2 hits · run 2026-09-07
2 retrieved record(s)
refutes_node 42541397 · Acta paediatrica (Oslo, Norway : 1992) (2026) — Gastrointestinal Adverse Events Following Rotavirus Vaccination in Children: A Systematic Review.
does_not_resolve 38960216 · Microbial pathogenesis (2024) — Reverse vaccinology-based multi-epitope vaccine design against Indian group A rotavirus targeting VP7, VP4, and VP6 proteins.
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: Rotavirus vaccine Intussusception mechanism Mediator in healthy vaccinees in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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 retrieved evidence directly compares mediator presence or absence after natural rotavirus infection versus vaccination in relation to intussusception. One PMID (11021391) states that natural rotavirus infection is generally believed not to cause intussusception, but provides no direct mediator measure. No other PMID addresses the infection contrast for this node.
Cited: (none)
supporting: Rotavirus vaccine Intussusception mechanism Infection contrast in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Infection contrast not associated mechanism pubmed · 9 hits · run 2026-09-07
ambiguous 11021391 · Microbiology and immunology (2000) — Rotavirus infection and intussusception: a view from retrospect.
does_not_resolve 36149761 · Pediatrics international : official jour (2022) — Characteristics of intussusception in the period of arbitrary Rotavirus vaccination.
does_not_resolve 15964860 · Archives of disease in childhood (2005) — Intussusception and rotavirus associated hospitalisation in New Zealand.
ambiguous 23109915 · PLoS medicine (2012) — Removing the age restrictions for rotavirus vaccination: a benefit-risk modeling analysis.
does_not_resolve 32617279 · Medical journal of the Islamic Republic (2020) — Incidence of intussusception in children less than five years of age: a pre-rotavirus vaccine survey from Iran, 2010-2015.
does_not_resolve 33267969 · Vaccine (2021) — Safety profile of rotavirus vaccines among individuals aged ≥8 months of age, United States, vaccine adverse event reporting system (VAERS), 2006-2019.
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: Rotavirus vaccine Intussusception mechanism Transfer to recipient in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception mechanism Transfer specificity in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception mechanism Depletion / knockdown in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
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: Rotavirus vaccine Intussusception mechanism Add-back rescue in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Multiple retrieved abstracts note that licensed live oral rotavirus vaccines are associated with a rare risk of intussusception, but none provide experimental evidence showing that neutralization of a mediator blocks the phenotype of intussusception after rotavirus vaccination.
Cited: (none)
supporting: Rotavirus vaccine Intussusception mechanism Neutralization in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Neutralization not associated mechanism pubmed · 15 hits · run 2026-09-07
11 retrieved record(s)
supports_node 19591630 · Expert opinion on biological therapy (2009) — A critical review on a globally-licensed, live, orally-administrable, monovalent human rotavirus vaccine: Rotarix.
does_not_resolve 30626530 · Vaccine (2019) — Lack of immune interference between inactivated polio vaccine and inactivated rotavirus vaccine co-administered by intramuscular injection in two animal species
does_not_resolve 34325930 · Vaccine (2021) — Development and characterization of a plant-derived rotavirus-like particle vaccine.
does_not_resolve 18756184 · The Pediatric infectious disease journal (2008) — Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine.
does_not_resolve 22885016 · Vaccine (2012) — Construction and characterization of human rotavirus recombinant VP8* subunit parenteral vaccine candidates.
does_not_resolve 16121686 · Current opinion in investigational drugs (2005) — Rotavirus vaccines: is the second time the charm?
does_not_resolve 31698824 · Vaccines (2019) — Parenterally Administered P24-VP8* Nanoparticle Vaccine Conferred Strong Protection against Rotavirus Diarrhea and Virus Shedding in Gnotobiotic Pigs.
ambiguous 16462287 · The Pediatric infectious disease journal (2006) — Neonatal administration of rhesus rotavirus tetravalent vaccine.
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 retrieved evidence directly addresses whether an isotype control fails to reproduce a blocking or activation effect in the context of rotavirus vaccine and intussusception.
Cited: (none)
supporting: Rotavirus vaccine Intussusception mechanism Isotype control in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Isotype control not associated mechanism pubmed · 9 hits · run 2026-09-07
9 retrieved record(s)
does_not_resolve 11757786 · Current opinion in investigational drugs (2001) — Rotavirus vaccine AVANT/GlaxoSmithKline.
does_not_resolve 38463163 · Frontiers in public health (2024) — Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial
does_not_resolve 22520120 · Vaccine (2012) — A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children.
does_not_resolve 23499605 · Vaccine (2013) — Efficacy, safety and immunogenicity of a human rotavirus vaccine (RIX4414) in Hong Kong children up to three years of age: a randomized, controlled trial.
does_not_resolve 22885016 · Vaccine (2012) — Construction and characterization of human rotavirus recombinant VP8* subunit parenteral vaccine candidates.
refutes_node 16394299 · The New England journal of medicine (2006) — Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.
refutes_node 35588754 · The Lancet. Infectious diseases (2022) — Safety and immunogenicity of the Rotavac and Rotasiil rotavirus vaccines administered in an interchangeable dosing schedule among healthy Indian infants: a mult
does_not_resolve 26016444 · Archives of virology (2015) — Protection against live rotavirus challenge in mice induced by parenteral and mucosal delivery of VP6 subunit rotavirus vaccine.
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: Rotavirus vaccine Intussusception Full product reproduces component OR antigen OR vector pubmed · 2045239 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Full product reproduces no effect component isolation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
6 retrieved record(s)
does_not_resolve 29550258 · Immunology letters (2018) — Live bacterial vaccine vector and delivery strategies of heterologous antigen: A review.
does_not_resolve 25876176 · Human vaccines & immunotherapeutics (2015) — Progress on adenovirus-vectored universal influenza vaccines.
does_not_resolve 21952287 · Cancer journal (Sudbury, Mass.) (2011) — Viral vector-based therapeutic cancer vaccines.
does_not_resolve 27384578 · Viruses (2016) — Newcastle Disease Virus as a Vaccine Vector for Development of Human and Veterinary Vaccines.
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: The retrieved evidence discusses live bacterial and viral vectors for vaccine development, but none mention rotavirus vaccine, intussusception, or any specific adverse event related to vector backbone effects.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Empty vector / particle component OR antigen OR vector pubmed · 2045239 hits · run 2026-09-07
does_not_resolve 25876176 · Human vaccines & immunotherapeutics (2015) — Progress on adenovirus-vectored universal influenza vaccines.
does_not_resolve 21952287 · Cancer journal (Sudbury, Mass.) (2011) — Viral vector-based therapeutic cancer 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: Rotavirus vaccine Intussusception Irrelevant cargo component OR antigen OR vector pubmed · 2045239 hits · run 2026-09-07
does_not_resolve 25876176 · Human vaccines & immunotherapeutics (2015) — Progress on adenovirus-vectored universal influenza vaccines.
does_not_resolve 21952287 · Cancer journal (Sudbury, Mass.) (2011) — Viral vector-based therapeutic cancer vaccines.
does_not_resolve 27384578 · Viruses (2016) — Newcastle Disease Virus as a Vaccine Vector for Development of Human and Veterinary Vaccines.
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: The retrieved evidence discusses live bacterial and viral vaccine vectors but does not address Rotavirus vaccine, Intussusception, or a comparison between infection and product preparations relevant to this node.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Infection preparation component OR antigen OR vector pubmed · 2045239 hits · run 2026-09-07
does_not_resolve 25876176 · Human vaccines & immunotherapeutics (2015) — Progress on adenovirus-vectored universal influenza vaccines.
does_not_resolve 21952287 · Cancer journal (Sudbury, Mass.) (2011) — Viral vector-based therapeutic cancer vaccines.
does_not_resolve 27384578 · Viruses (2016) — Newcastle Disease Virus as a Vaccine Vector for Development of Human and Veterinary Vaccines.
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: Rotavirus vaccine Intussusception Cytokine / adjuvant mix component OR antigen OR vector pubmed · 2045239 hits · run 2026-09-07
does_not_resolve 25876176 · Human vaccines & immunotherapeutics (2015) — Progress on adenovirus-vectored universal influenza vaccines.
does_not_resolve 21952287 · Cancer journal (Sudbury, Mass.) (2011) — Viral vector-based therapeutic cancer vaccines.
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: Rotavirus vaccine Intussusception Component combination component OR antigen OR vector pubmed · 2045239 hits · run 2026-09-07
does_not_resolve 25876176 · Human vaccines & immunotherapeutics (2015) — Progress on adenovirus-vectored universal influenza vaccines.
does_not_resolve 21952287 · Cancer journal (Sudbury, Mass.) (2011) — Viral vector-based therapeutic cancer vaccines.
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: Rotavirus vaccine Intussusception 2D human cells animal OR organoid OR cell model pubmed · 1818526 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception Organoid / chip animal OR organoid OR cell model pubmed · 1818526 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception Block in vitro / in vivo intervention OR treatment OR reversal pubmed · 15141570 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception mechanism Host-line dependence in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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 retrieved evidence describes an animal experiment testing the clinical route of administration (oral) of a live rotavirus vaccine and measuring intussusception as an effect; the studies involve parenteral subunit vaccine candidates and do not report intussusception outcomes.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Animal, clinical route animal OR organoid OR cell model pubmed · 1818527 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Animal, clinical route not reproduced model pubmed · 2 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 22885016 · Vaccine (2012) — Construction and characterization of human rotavirus recombinant VP8* subunit parenteral vaccine candidates.
does_not_resolve 31698824 · Vaccines (2019) — Parenterally Administered P24-VP8* Nanoparticle Vaccine Conferred Strong Protection against Rotavirus Diarrhea and Virus Shedding in Gnotobiotic Pigs.
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: Rotavirus vaccine Intussusception Susceptible animal animal OR organoid OR cell model pubmed · 1818526 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception Replication across labs animal OR organoid OR cell model pubmed · 1818526 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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 in the retrieved abstracts regarding blinded scoring of intussusception as a primary outcome; PMID 28967523 mentions a double-blind design but focuses on severe rotavirus gastroenteritis, not intussusception, and PMID 11896407 discusses a withdrawn vaccine's possible association with intussusception but provides no blinded scoring data for this node.
Cited: (none)
supporting: Rotavirus vaccine Intussusception Blinded scoring animal OR organoid OR cell model pubmed · 1818528 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Blinded scoring not reproduced model pubmed · 2 hits · run 2026-09-07
2 retrieved record(s)
refutes_node 28967523 · Vaccine (2017) — A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants.
ambiguous 11896407 · Revista do Instituto de Medicina Tropica (2002) — Nutritional status in relation to the efficacy of the rhesus-human reassortant, tetravalent rotavirus vaccine (RRV-TV) in infants from Belém, pará state, Brazil
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: Rotavirus vaccine Intussusception Experimental time course animal OR organoid OR cell model pubmed · 1818526 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception 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: Rotavirus vaccine Intussusception Susceptibility trait coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Intussusception Susceptibility trait inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
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.