Evidence dossier · candidate cand-rotavirus-gastroenteritis-rotavirus · VICP program · · DRAFT — not a determination
This is a draft research-tracking dossier, not a determination that Rotavirus vaccine causes Gastroenteritis rotavirus, and not an incidence or legal finding. All evidence is flagged needs_human_review and must be reviewed before any page is published or cited. Every value is grounded in retrieved citations (PMID + retrieval date); unsourced items read "no evidence found / not assessable". Symmetric search: every supporting query has a mirror/null query, and zeros are shown (negative dossiers report the absence of signal).
Claim matrix (C1–C6, computed)
Claim
Label
Status
Missing nodes
C1
Coherent clinical object exists
insufficient_data
missing: A1 A2
C2
Consistent temporal window
supported
C3
Epidemiologic excess risk
supported
C4
Consistency / replication
contested
C5
Specificity (product / dose)
insufficient_data
missing: C1n
C6
Biological mechanism
insufficient_data
missing: E1
Two evidentiary bars apply to the epi nodes/claims (C3, C4): · VICP — preponderance of the evidence. · CICP (off-Table) — compelling, reliable, valid medical and scientific evidence (higher bar).
Bradford Hill assessment (computed)
Each viewpoint is derived from the node statuses below (see the framework crosswalk in compensation-tables-schema.md §8). Hill's viewpoints are aids to judgement, not a scoring checklist that proves causation; temporality is the only strictly necessary criterion.
Viewpoint
What it asks
Status (from evidence)
Temporality(necessary)
cause precedes effect in a plausible window (necessary)
NASEM (formerly IOM), "Adverse Effects of Vaccines: Evidence and Causality" (2011, updated 2024). Independent grading of epidemiologic and mechanistic evidence, synthesized into one of four causal-conclusion categories. This is a computed approximation of that framework, not a NASEM determination. See compensation-tables-schema.md §8bis.
Case-definition standard: no established case definition (needs_human_review — not in spec §1's named-standard list) — governs the case-certainty scale on A1/A2/A6/A8 below. See compensation-tables-schema.md §8ter.
Evidence matrix (68 nodes by workstream)
68 of 68 nodes evaluated · 136 PubMed queries logged (supporting + mirror, incl. zeros). Statuses are computed from retrieved citations; not hand-set.
Definition & attribution 24/24 evaluated
A1 · Case reportsno_data
Measure: New definite object in risk window T Comparator: Pre-vaccination baseline Hit rule: Definite object present, onset in window, competing causes considered
Finding: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series Case reports pubmed · 66192 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 hits · run 2026-09-07
10 retrieved record(s)
does_not_resolve 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.
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: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series Series with objective confirmation pubmed · 5669 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 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.
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: A case series and a case report document detection of vaccine-derived rotavirus strains in children with gastroenteritis after rotavirus vaccination, with onset timing consistent with a risk window, but the evidence is limited to case reports and does not provide a systematic distribution of onset times.
supporting: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series Onset histogram pubmed · 30 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 hits · run 2026-09-07
13 retrieved record(s)
ambiguous 22872730 · The Journal of infectious diseases (2012) — Symptomatic infection and detection of vaccine and vaccine-reassortant rotavirus strains in 5 children: a case series.
does_not_resolve 31693717 · The Pan African medical journal (2019) — Rotavirus prevalence and seasonal distribution post vaccine introduction in Nairobi county Kenya.
supports_node 20100758 · Pediatrics (2010) — Sibling transmission of vaccine-derived rotavirus (RotaTeq) associated with rotavirus gastroenteritis.
does_not_resolve 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 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
A4 · Temporal plausibilityno_data
Measure: Onset latency vs object pathophysiology Comparator: Object's known natural latency Hit rule: Onset latency consistent with the object's pathophysiology
Finding: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series Temporal plausibility pubmed · 59 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 hits · run 2026-09-07
11 retrieved record(s)
does_not_resolve 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
does_not_resolve 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.
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.
does_not_resolve 7114977 · Archives of internal medicine (1982) — Vaccine-related poliomyelitis.
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 onset interval recording for rotavirus vaccine-associated gastroenteritis rotavirus; PMID 22872730 and PMID 20100758 describe cases but do not report explicit onset interval documentation in the source.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series Onset-interval documentation pubmed · 28 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 hits · run 2026-09-07
13 retrieved record(s)
ambiguous 22872730 · The Journal of infectious diseases (2012) — Symptomatic infection and detection of vaccine and vaccine-reassortant rotavirus strains in 5 children: a case series.
does_not_resolve 31693717 · The Pan African medical journal (2019) — Rotavirus prevalence and seasonal distribution post vaccine introduction in Nairobi county Kenya.
supports_node 20100758 · Pediatrics (2010) — Sibling transmission of vaccine-derived rotavirus (RotaTeq) associated with rotavirus gastroenteritis.
does_not_resolve 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.
ambiguous 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
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series Differential diagnosis excluded pubmed · 455 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 hits · run 2026-09-07
10 retrieved record(s)
does_not_resolve 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.
Measure: Object recurs on a further dose Comparator: First-dose response Hit rule: Object recurs after a subsequent dose (re-exposure)
Finding: No evidence retrieved directly addresses rotavirus vaccine causing new onset of rotavirus gastroenteritis upon re-exposure via a subsequent dose (rechallenge). The available case reports describe detection of vaccine-strain rotavirus in children with gastroenteritis after initial vaccination, but do not document recurrence after a further dose.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series Rechallenge / re-exposure pubmed · 30 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 hits · run 2026-09-07
13 retrieved record(s)
ambiguous 31693717 · The Pan African medical journal (2019) — Rotavirus prevalence and seasonal distribution post vaccine introduction in Nairobi county Kenya.
ambiguous 22872730 · The Journal of infectious diseases (2012) — Symptomatic infection and detection of vaccine and vaccine-reassortant rotavirus strains in 5 children: a case series.
supports_node 20100758 · Pediatrics (2010) — Sibling transmission of vaccine-derived rotavirus (RotaTeq) associated with rotavirus gastroenteritis.
does_not_resolve 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.
ambiguous 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
A8 · Adjudicated by criteria (no established case definition)no_data
Measure: Object adjudicated by published criteria Comparator: Published clinical / Brighton criteria Hit rule: Cases adjudicated to 'definite' by a published criterion set
Finding: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series Adjudicated by criteria pubmed · 67 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 hits · run 2026-09-07
10 retrieved record(s)
does_not_resolve 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.
Measure: Course matches the object's natural history Comparator: Known natural history of the object Hit rule: Clinical course (onset, peak, recovery) matches the object's natural history
Finding: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series Natural-history consistency pubmed · 131 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 hits · run 2026-09-07
10 retrieved record(s)
does_not_resolve 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.
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: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus case report OR case series No confounding object pubmed · 47 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus alternative diagnosis OR not vaccine-related pubmed · 4062 hits · run 2026-09-07
11 retrieved record(s)
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 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.
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.
does_not_resolve 7114977 · Archives of internal medicine (1982) — Vaccine-related poliomyelitis.
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 Gastroenteritis rotavirus anatomic localization Predicted site of injury mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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 Gastroenteritis rotavirus 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 Gastroenteritis rotavirus anatomic localization Local vs systemic distribution mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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 Gastroenteritis rotavirus Targeted treatment reverses intervention OR treatment OR reversal pubmed · 15141576 hits · run 2026-09-07
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 Gastroenteritis rotavirus No internal contradiction coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus No internal contradiction 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.
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 Gastroenteritis rotavirus Analogy to a known object coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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: Rotavirus vaccine Gastroenteritis rotavirus Latency coherence coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Pre-specification pre-specified OR adjudicated pubmed · 13549 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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
does_not_resolve 28105738 · Diabetes, obesity & metabolism (2017) — Glucagon-like peptide-1 receptor agonists and risk of acute pancreatitis in patients with type 2 diabetes.
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: Rotavirus vaccine Gastroenteritis rotavirus Contrary-evidence log pre-specified OR adjudicated pubmed · 13549 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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 Gastroenteritis rotavirus No temporality-only claim pre-specified OR adjudicated pubmed · 13549 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus No temporality-only claim post-hoc OR hypothesis-generating only pubmed · 1699 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: Rotavirus vaccine Gastroenteritis rotavirus Passive-surveillance role pre-specified OR adjudicated pubmed · 13549 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Passive-surveillance role 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
does_not_resolve 28105738 · Diabetes, obesity & metabolism (2017) — Glucagon-like peptide-1 receptor agonists and risk of acute pancreatitis in patients with type 2 diabetes.
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 Gastroenteritis rotavirus Dose mapping pre-specified OR adjudicated pubmed · 13549 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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 baselineno_data
Measure: RR/IRR vs unexposed or prior window Comparator: Unvaccinated person-time or pre-vaccination window Hit rule: RR/IRR > 1 with CI excluding 1 after pre-specified confounders
Finding: No retrieved evidence directly addresses the risk of rotavirus vaccine causing new cases of rotavirus gastroenteritis as an adverse event; the available studies focus on rotavirus vaccine effectiveness against rotavirus gastroenteritis or on safety outcomes unrelated to this specific adverse event.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Excess vs baseline incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk Excess vs baseline pubmed · 89300 hits · run 2026-09-07
12 retrieved record(s)
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 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 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 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
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 study directly evaluates the risk of rotavirus gastroenteritis after rotavirus vaccination using a self-controlled case series (SCCS) design with a risk ratio >1 and a confidence interval excluding 1. The only potentially relevant SCCS study on rotavirus vaccine safety (PMID 38875047) examines intussusception, not rotavirus gastroenteritis, and reports risk comparable to background, not exceeding it.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus SCCS incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk SCCS pubmed · 89408 hits · run 2026-09-07
13 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 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 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 38171315 · Neurospine (2023) — Limaprost and the Risk of Bleeding: A 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 assesses the incidence rate ratio of rotavirus gastroenteritis following rotavirus vaccination using a cohort or risk-interval design with stratification by age/sex. One study (PMID 38875047) mentions self-controlled risk interval analysis for intussusception after rotavirus vaccine, but not for gastroenteritis rotavirus as the outcome.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Cohort / risk-interval incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk Cohort / risk-interval pubmed · 88909 hits · run 2026-09-07
13 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 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 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 38171315 · Neurospine (2023) — Limaprost and the Risk of Bleeding: A Self-Controlled Case Series Study.
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: The retrieved evidence includes a systematic review and meta-analysis of randomized clinical trials (PMID 33970192) showing rotavirus vaccines reduce rotavirus gastroenteritis in children, but no meta-analysis or pooled estimate was found that quantifies an increased risk of rotavirus gastroenteritis attributed to rotavirus vaccination (i.e., a pooled estimate >1 with quantified heterogeneity).
supporting: Rotavirus vaccine Gastroenteritis rotavirus Meta-analysis / pooling incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk Meta-analysis / pooling pubmed · 112742 hits · run 2026-09-07
12 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 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 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 38171315 · Neurospine (2023) — Limaprost and the Risk of Bleeding: A Self-Controlled Case Series Study.
does_not_resolve 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
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 retrieved evidence addresses the risk of new rotavirus gastroenteritis cases attributed to rotavirus vaccination specifically as a negative-control outcome or within a prespecified risk window after vaccination. The available studies focus on vaccine effectiveness or intussusception risk, not on an excess of rotavirus gastroenteritis caused by the vaccine itself.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Negative-control outcomes incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk Negative-control outcomes pubmed · 89111 hits · run 2026-09-07
12 retrieved record(s)
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 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 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 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
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 addresses the risk of rotavirus gastroenteritis attributed to rotavirus vaccination in a different-antigen comparator design; the available studies focus on COVID-19 vaccine safety, shingles vaccine safety, rotavirus vaccine effectiveness against gastroenteritis, and general SCCS methodology, not on antigen-comparison analyses for this specific outcome.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Other-antigen comparison incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk Other-antigen comparison pubmed · 88873 hits · run 2026-09-07
12 retrieved record(s)
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 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 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 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
refutes_node 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
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: Rotavirus vaccine Gastroenteritis rotavirus Absolute risk incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk Absolute risk pubmed · 112139 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.
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 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
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: Retrieved evidence does not address risk of new rotavirus gastroenteritis attributable to rotavirus vaccine by platform or product; studies focus on intussusception, COVID-19, shingles, and vaccine effectiveness against severe disease, not on vaccine-attributed onset of rotavirus gastroenteritis.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Platform split incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk Platform split pubmed · 88938 hits · run 2026-09-07
12 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 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 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 38171315 · Neurospine (2023) — Limaprost and the Risk of Bleeding: A Self-Controlled Case Series Study.
does_not_resolve 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
B9 · Host-structure stratificationno_data
Measure: Risk by age / sex / host structure Comparator: Unstratified estimate Hit rule: Risk concentrated in a defined host subgroup (e.g. young males), stable across sources
Finding: No retrieved evidence directly addresses risk of rotavirus vaccine-attributed gastroenteritis stratified by host structure (age, sex, or other subgroups).
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Host-structure stratification incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk Host-structure stratification pubmed · 88871 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 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 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 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
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: No retrieved evidence addresses a formulation or component change of rotavirus vaccine and its association with risk of gastroenteritis rotavirus. The evidence includes studies on rotavirus vaccine effectiveness and safety, but none track risk changes following a documented formulation or component change over time.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Formulation / component change incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no association OR null OR no increased risk Formulation / component change pubmed · 89033 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 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 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 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
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 Gastroenteritis rotavirus Formulation natural experiment intervention OR treatment OR reversal pubmed · 15141576 hits · run 2026-09-07
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 Gastroenteritis rotavirus Policy / pause signal intervention OR treatment OR reversal pubmed · 15141576 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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: Rotavirus vaccine Gastroenteritis rotavirus Infection coherence coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Infection coherence inconsistent OR contradicts pubmed · 27612 hits · run 2026-09-07
Mediator & biological gradient 24/24 evaluated
C1n · Dose strength gradientno_data
Measure: Risk vs dose strength (dose size) Comparator: Lower dose strength Hit rule: Monotonic dose-response in dose strength (larger dose -> higher risk)
Finding: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Dose strength gradient dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no dose effect OR no dose-response Dose strength gradient pubmed · 380 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.
does_not_resolve 36090988 · Frontiers in immunology (2022) — A comprehensive analysis of the efficacy and effectiveness of COVID-19 vaccines.
does_not_resolve 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
does_not_resolve 31552856 · Indian journal of public health (2019) — Epidemiology of rotavirus gastroenteritis and need of high rotavirus vaccine coverage with early completion of vaccination schedule for protection against rotav
does_not_resolve 21504245 · PharmacoEconomics (2011) — Rotavirus vaccine RIX4414 (Rotarix™): a pharmacoeconomic review of its use in the prevention of rotavirus gastroenteritis in developed countries.
does_not_resolve 10466913 · The Annals of pharmacotherapy (1999) — Tetravalent rotavirus vaccine.
does_not_resolve 41088810 · Biomedical and environmental sciences : (2025) — Effectiveness of Pentavalent Rotavirus Vaccine - a Propensity Score Matched Test Negative Design Case-Control Study Using Medical Big Data in Three Provinces of
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 Gastroenteritis rotavirus Dose number gradient dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no dose effect OR no dose-response Dose number gradient pubmed · 824 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.
does_not_resolve 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
does_not_resolve 21504245 · PharmacoEconomics (2011) — Rotavirus vaccine RIX4414 (Rotarix™): a pharmacoeconomic review of its use in the prevention of rotavirus gastroenteritis in developed countries.
does_not_resolve 10466913 · The Annals of pharmacotherapy (1999) — Tetravalent rotavirus vaccine.
does_not_resolve 11757786 · Current opinion in investigational drugs (2001) — Rotavirus vaccine AVANT/GlaxoSmithKline.
does_not_resolve 17471034 · Current opinion in infectious diseases (2007) — Rotavirus vaccines in developed countries.
does_not_resolve 34814164 · Pediatrics (2021) — Rotavirus Vaccine Safety and Effectiveness in Infants With High-Risk Medical Conditions.
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 provide any data on risk of gastroenteritis rotavirus ordered by measured-exposure tertile of rotavirus vaccine; it focuses on vaccine effectiveness against rotavirus gastroenteritis, not on exposure-response gradients.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Measured-exposure tertiles dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no dose effect OR no dose-response Measured-exposure tertiles pubmed · 269 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 36090988 · Frontiers in immunology (2022) — A comprehensive analysis of the efficacy and effectiveness of COVID-19 vaccines.
does_not_resolve 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
does_not_resolve 31552856 · Indian journal of public health (2019) — Epidemiology of rotavirus gastroenteritis and need of high rotavirus vaccine coverage with early completion of vaccination schedule for protection against rotav
does_not_resolve 21504245 · PharmacoEconomics (2011) — Rotavirus vaccine RIX4414 (Rotarix™): a pharmacoeconomic review of its use in the prevention of rotavirus gastroenteritis in developed countries.
does_not_resolve 10466913 · The Annals of pharmacotherapy (1999) — Tetravalent rotavirus vaccine.
does_not_resolve 41088810 · Biomedical and environmental sciences : (2025) — Effectiveness of Pentavalent Rotavirus Vaccine - a Propensity Score Matched Test Negative Design Case-Control Study Using Medical Big Data in Three Provinces of
C4n · Organoid concentration curveno_data
Measure: Effect vs antigen concentration in organoid Comparator: Vehicle / zero antigen Hit rule: Dose-dependent effect across a graded concentration curve
Finding: The retrieved evidence does not contain any in vitro organoid concentration-response experiments testing rotavirus vaccine against rotavirus gastroenteritis; all retrieved studies are epidemiological vaccine effectiveness or safety trials.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Organoid concentration curve dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no dose effect OR no dose-response Organoid concentration curve pubmed · 280 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.
does_not_resolve 36090988 · Frontiers in immunology (2022) — A comprehensive analysis of the efficacy and effectiveness of COVID-19 vaccines.
refutes_node 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
does_not_resolve 31552856 · Indian journal of public health (2019) — Epidemiology of rotavirus gastroenteritis and need of high rotavirus vaccine coverage with early completion of vaccination schedule for protection against rotav
does_not_resolve 10466913 · The Annals of pharmacotherapy (1999) — Tetravalent rotavirus vaccine.
does_not_resolve 41088810 · Biomedical and environmental sciences : (2025) — Effectiveness of Pentavalent Rotavirus Vaccine - a Propensity Score Matched Test Negative Design Case-Control Study Using Medical Big Data in Three Provinces of
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 evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus EC50 vs Cmax coherence dose-response OR dose effect pubmed · 1299145 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus no dose effect OR no dose-response EC50 vs Cmax coherence pubmed · 269 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 36090988 · Frontiers in immunology (2022) — A comprehensive analysis of the efficacy and effectiveness of COVID-19 vaccines.
does_not_resolve 39252660 · Pediatrics (2024) — Rotavirus Vaccine Effectiveness Against Severe Acute Gastroenteritis: 2009-2022.
does_not_resolve 31083495 · Pharmaceutics (2019) — Rotavirus VP6 as an Adjuvant for Bivalent Norovirus Vaccine Produced in Nicotiana benthamiana.
does_not_resolve 31552856 · Indian journal of public health (2019) — Epidemiology of rotavirus gastroenteritis and need of high rotavirus vaccine coverage with early completion of vaccination schedule for protection against rotav
does_not_resolve 10466913 · The Annals of pharmacotherapy (1999) — Tetravalent rotavirus vaccine.
does_not_resolve 41088810 · Biomedical and environmental sciences : (2025) — Effectiveness of Pentavalent Rotavirus Vaccine - a Propensity Score Matched Test Negative Design Case-Control Study Using Medical Big Data in Three Provinces of
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 retrieved evidence describes a reverse vaccinology approach for designing a multi-epitope vaccine against rotavirus and discusses low efficacy and increased intussusception risk with live-attenuated vaccines, but does not report detection of a mediator in affected tissue or any case-level evidence of vaccine-attributed gastroenteritis rotavirus.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus mechanism Mediator identified in cases in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Mediator identified in cases not associated mechanism pubmed · 1 hits · run 2026-09-07
1 retrieved record(s)
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 Gastroenteritis rotavirus mechanism Mediator in healthy vaccinees in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Mediator in healthy vaccinees not associated mechanism pubmed · 1 hits · run 2026-09-07
1 retrieved record(s)
does_not_resolve 34017343 · Frontiers in immunology (2021) — Antibodies Elicited by the Shigella sonnei GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalatio
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: The retrieved evidence includes studies on rotavirus vaccine effectiveness and safety but does not provide data comparing a mediator signal specific to vaccination versus a comparable natural-infection control, nor does it assess mediator absence or low levels after natural infection for this node.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus mechanism Infection contrast in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Infection contrast not associated mechanism pubmed · 36 hits · run 2026-09-07
ambiguous 34814164 · Pediatrics (2021) — Rotavirus Vaccine Safety and Effectiveness in Infants With High-Risk Medical Conditions.
does_not_resolve 29149283 · Clinical infectious diseases : an offici (2018) — Multivalent Rotavirus Vaccine and Wild-type Rotavirus Strain Shedding in Australian Infants: A Birth Cohort Study.
does_not_resolve 27835052 · Human vaccines & immunotherapeutics (2017) — Options for improving effectiveness of rotavirus vaccines in developing countries.
does_not_resolve 31384727 · Vaccine: X (2019) — Effectiveness of oral rotavirus vaccination in England against rotavirus-confirmed and all-cause acute gastroenteritis.
does_not_resolve 20593908 · Paediatric drugs (2010) — Rotavirus infections and vaccines: burden of illness and potential impact of vaccination.
does_not_resolve 35641360 · Vaccine (2022) — Long-term surveillance of rotavirus vaccination after implementation of a national immunization program in Finland (2008-2018).
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 Gastroenteritis rotavirus mechanism Transfer to recipient in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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: The retrieved evidence does not address transfer specificity for rotavirus vaccine-attributed gastroenteritis rotavirus; it describes maternal antibody transfer in humans and pigs, but no experiment removing a specific mediator to test loss of transfer effect.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus mechanism Transfer specificity in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Transfer specificity not associated mechanism pubmed · 7 hits · run 2026-09-07
3 retrieved record(s)
does_not_resolve 39089515 · Clinical gastroenterology and hepatology (2025) — Live Rotavirus Vaccination Appears Low-risk in Infants Born to Mothers With Inflammatory Bowel Disease on Biologics.
does_not_resolve 33211872 · The Journal of infectious diseases (2021) — Persistence of Maternal Anti-Rotavirus Immunoglobulin G in the Post-Rotavirus Vaccine Era.
does_not_resolve 38140269 · Vaccines (2023) — Role of Pre-Farrow Natural Planned Exposure of Gilts in Shaping the Passive Antibody Response to Rotavirus A in Piglets.
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 Gastroenteritis rotavirus 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 Gastroenteritis rotavirus mechanism Add-back rescue in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
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: Rotavirus vaccine Gastroenteritis rotavirus mechanism Neutralization in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Neutralization not associated mechanism pubmed · 122 hits · run 2026-09-07
5 retrieved record(s)
does_not_resolve 41885419 · Journal of virology (2026) — An oral rotavirus-vectored vaccine confers protection against Clostridium perfringens and rotavirus.
does_not_resolve 38543803 · Viruses (2024) — Novel Universal Recombinant Rotavirus A Vaccine Candidate: Evaluation of Immunological Properties.
does_not_resolve 2548276 · Reviews of infectious diseases (1989) — Prospects for development of a rotavirus vaccine against rotavirus diarrhea in infants and young children.
does_not_resolve 30808567 · Vaccine (2019) — Immunogenicity of pentavalent rotavirus vaccine in Chinese infants.
does_not_resolve 38823689 · Virus research (2024) — Circulating rotavirus strains in children with acute gastroenteritis in Iran, 1986 to 2023 and their genetic/antigenic divergence compared to approved vaccines
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 describes isotype control experiments relevant to rotavirus vaccine and gastroenteritis rotavirus; the abstracts focus on vaccine immunogenicity, efficacy, and correlates of protection, not on isotype controls failing to reproduce block/activation.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus mechanism Isotype control in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Isotype control not associated mechanism pubmed · 85 hits · run 2026-09-07
11 retrieved record(s)
does_not_resolve 41671339 · Science translational medicine (2026) — Parenteral vaccination with an adjuvanted mRNA vaccine induces protective mucosal immunity against rotavirus in neonatal mice.
does_not_resolve 11757786 · Current opinion in investigational drugs (2001) — Rotavirus vaccine AVANT/GlaxoSmithKline.
supports_node 34788820 · Clinical infectious diseases : an offici (2022) — Plasma Rotavirus-specific IgA and Risk of Rotavirus Vaccine Failure in Infants in Malawi.
does_not_resolve 40938968 · PLoS medicine (2025) — Maternal-infant rotavirus-specific antibody kinetics to inform timing of vaccine boosting in Malawi: An observational study.
does_not_resolve 30808567 · Vaccine (2019) — Immunogenicity of pentavalent rotavirus vaccine in Chinese infants.
does_not_resolve 38330312 · The Journal of infectious diseases (2024) — Correlates of Rotavirus Vaccine Shedding and Seroconversion in a US Cohort of Healthy Infants.
does_not_resolve 37312718 · Archives of Razi Institute (2023) — Comparison of IgA Antibody Titer Induced by Human-Bovine Rotavirus Candidate Vaccine with Bovine Rotavirus and Rotarix.
does_not_resolve 32192193 · Viruses (2020) — The Impact of Human Genetic Polymorphisms on Rotavirus Susceptibility, Epidemiology, and Vaccine Take.
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 Gastroenteritis rotavirus Full product reproduces component OR antigen OR vector pubmed · 2045241 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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: No evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Empty vector / particle component OR antigen OR vector pubmed · 2045241 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.
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 Gastroenteritis rotavirus Irrelevant cargo component OR antigen OR vector pubmed · 2045241 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.
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, including attenuated strains, for delivering heterologous antigens, but none of the abstracts address Rotavirus vaccine causing Gastroenteritis rotavirus as an adverse event within a risk window after vaccination.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Infection preparation component OR antigen OR vector pubmed · 2045241 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 Gastroenteritis rotavirus Cytokine / adjuvant mix component OR antigen OR vector pubmed · 2045241 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 Gastroenteritis rotavirus Component combination component OR antigen OR vector pubmed · 2045244 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 38823689 · Virus research (2024) — Circulating rotavirus strains in children with acute gastroenteritis in Iran, 1986 to 2023 and their genetic/antigenic divergence compared to approved 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 Gastroenteritis rotavirus 2D human cells animal OR organoid OR cell model pubmed · 1818527 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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 Gastroenteritis rotavirus Organoid / chip animal OR organoid OR cell model pubmed · 1818527 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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 Gastroenteritis rotavirus Block in vitro / in vivo intervention OR treatment OR reversal pubmed · 15141576 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Block in vitro / in vivo no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
1 retrieved record(s)
does_not_resolve 38189107 · Expert review of vaccines (2024) — Neoadjuvant personalized cancer vaccines: the final frontier?
Clinical / animal / host 7/7 evaluated
E10 · Host-line dependenceno_data
Measure: Effect depends on host line/cell type Comparator: Susceptible host line Hit rule: Effect is restricted to a defined host line / genotype, not universal
Finding: no evidence found
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus mechanism Host-line dependence in vitro OR patient-derived pubmed · 29242 hits · run 2026-09-07
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 was retrieved that tests the effect of rotavirus vaccine via the clinical route of administration in animals for the outcome of gastroenteritis rotavirus; the cited studies describe vaccine development and strain differentiation but do not report vaccine-induced rotavirus gastroenteritis in animals via the clinical route.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Animal, clinical route animal OR organoid OR cell model pubmed · 1818530 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Animal, clinical route not reproduced model pubmed · 3 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 41161043 · Vaccine (2025) — A live-attenuated human-lamb rotavirus reassortant confers robust protective immunity in mice.
does_not_resolve 27590978 · Journal of virological methods (2016) — Differentiation of RotaTeq(®) vaccine strains from wild-type strains using NSP3 gene in reverse transcription polymerase chain reaction assay.
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 retrieved evidence directly describes an effect of Rotavirus vaccine causing Gastroenteritis rotavirus in a defined susceptible animal model. One study (PMID 33245014) evaluates reduced vaccine efficacy in a gnotobiotic pig model but does not report vaccine-attributed disease; another (PMID 25483333) uses a gnotobiotic pig model susceptible to HRV diarrhea but focuses on B cell responses, not adverse events.
Cited: (none)
supporting: Rotavirus vaccine Gastroenteritis rotavirus Susceptible animal animal OR organoid OR cell model pubmed · 1818535 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Susceptible animal not reproduced model pubmed · 13 hits · run 2026-09-07
5 retrieved record(s)
does_not_resolve 32192193 · Viruses (2020) — The Impact of Human Genetic Polymorphisms on Rotavirus Susceptibility, Epidemiology, and Vaccine Take.
does_not_resolve 33245014 · Beneficial microbes (2020) — Reduced rotavirus vaccine efficacy in protein malnourished human-faecal-microbiota-transplanted gnotobiotic pig model is in part attributed to the gut microbiot
does_not_resolve 27860553 · Viral immunology (2016) — Developing an Inactivated Rotavirus Vaccine and Evaluating the Immunogenicity Against a Commercially Available Attenuated Rotavirus Vaccine Using a Mice Animal
does_not_resolve 25483333 · Gut microbes (2014) — Lactobacilli and Bifidobacteria enhance mucosal B cell responses and differentially modulate systemic antibody responses to an oral human rotavirus vaccine in a
does_not_resolve 20546933 · Veterinary immunology and immunopatholog (2010) — Evaluation of a bovine rotavirus VP6 vaccine efficacy in the calf model of infection and disease.
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 Gastroenteritis rotavirus Replication across labs animal OR organoid OR cell model pubmed · 1818527 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Replication across labs not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G6 · Blinded scoringsupports
Measure: Outcomes scored blinded Comparator: Unblinded reference Hit rule: Primary outcomes scored by a blinded assessor
Finding: Multiple randomized double-blind placebo-controlled trials cited in the retrieved evidence used blinded assessment (double-blind design) and defined severe rotavirus gastroenteritis as the primary outcome, which was scored by a standardized system (e.g., Vesikari scoring score ≥11) by assessors unaware of treatment allocation, consistent with the node's requirement for blinded scoring of primary outcomes.
supporting: Rotavirus vaccine Gastroenteritis rotavirus Blinded scoring animal OR organoid OR cell model pubmed · 1818530 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus Blinded scoring not reproduced model pubmed · 22 hits · run 2026-09-07
12 retrieved record(s)
does_not_resolve 34214095 · PLoS medicine (2021) — Rotavirus vaccine efficacy up to 2 years of age and against diverse circulating rotavirus strains in Niger: Extended follow-up of a randomized controlled trial.
does_not_resolve 22252206 · The Pediatric infectious disease journal (2012) — Efficacy of a pentavalent human-bovine reassortant rotavirus vaccine against rotavirus gastroenteritis among American Indian children.
does_not_resolve 9652561 · Lancet (London, England) (1997) — Randomised placebo-controlled trial of rhesus-human reassortant rotavirus vaccine for prevention of severe rotavirus gastroenteritis.
does_not_resolve 22520141 · Vaccine (2012) — Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa.
does_not_resolve 20692030 · Lancet (London, England) (2010) — Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, doubl
refutes_node 20692031 · Lancet (London, England) (2010) — Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, place
does_not_resolve 18037080 · Lancet (London, England) (2007) — Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled
supports_node 22520135 · Vaccine (2012) — Efficacy of human rotavirus vaccine against severe gastroenteritis in Malawian children in the first two years of life: a randomized, double-blind, placebo cont
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 Gastroenteritis rotavirus Experimental time course animal OR organoid OR cell model pubmed · 1818527 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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 Gastroenteritis rotavirus Susceptibility trait coherence OR latency OR susceptibility pubmed · 870030 hits · run 2026-09-07
mirror: Rotavirus vaccine Gastroenteritis rotavirus 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.