DTaP vaccine → Shoulder Injury Related to Vaccine Administration (SIRVA)
Evidence dossier · candidate cand-dtap-shoulder-injury-related-to-vaccine-administration · VICP program · · DRAFT — not a determination
This is a draft research-tracking dossier, not a determination that DTaP vaccine causes Shoulder Injury Related to Vaccine Administration (SIRVA), and not an incidence or legal finding. All evidence is flagged needs_human_review and must be reviewed before any page is published or cited. Every value is grounded in retrieved citations (PMID + retrieval date); unsourced items read "no evidence found / not assessable". Symmetric search: every supporting query has a mirror/null query, and zeros are shown (negative dossiers report the absence of signal).
Claim matrix (C1–C6, computed)
Claim
Label
Status
Missing nodes
C1
Coherent clinical object exists
insufficient_data
missing: A1 A2
C2
Consistent temporal window
supported
C3
Epidemiologic excess risk
insufficient_data
missing: B1 B2 B3
C4
Consistency / replication
insufficient_data
missing: B5 B6
C5
Specificity (product / dose)
insufficient_data
missing: C1n C2n
C6
Biological mechanism
insufficient_data
missing: E1
Two evidentiary bars apply to the epi nodes/claims (C3, C4): · VICP — preponderance of the evidence. · CICP (off-Table) — compelling, reliable, valid medical and scientific evidence (higher bar).
Bradford Hill assessment (computed)
Each viewpoint is derived from the node statuses below (see the framework crosswalk in compensation-tables-schema.md §8). Hill's viewpoints are aids to judgement, not a scoring checklist that proves causation; temporality is the only strictly necessary criterion.
Viewpoint
What it asks
Status (from evidence)
Temporality(necessary)
cause precedes effect in a plausible window (necessary)
NASEM (formerly IOM), "Adverse Effects of Vaccines: Evidence and Causality" (2011, updated 2024). Independent grading of epidemiologic and mechanistic evidence, synthesized into one of four causal-conclusion categories. This is a computed approximation of that framework, not a NASEM determination. See compensation-tables-schema.md §8bis.
Case-definition standard: no established case definition (needs_human_review — not in spec §1's named-standard list) — governs the case-certainty scale on A1/A2/A6/A8 below. See compensation-tables-schema.md §8ter.
Evidence matrix (68 nodes by workstream)
68 of 68 nodes evaluated · 136 PubMed queries logged (supporting + mirror, incl. zeros). Statuses are computed from retrieved citations; not hand-set.
Definition & attribution 24/24 evaluated
A1 · Case reportsno_data
Measure: New definite object in risk window T Comparator: Pre-vaccination baseline Hit rule: Definite object present, onset in window, competing causes considered
Finding: The retrieved evidence includes a review article on Shoulder Injury Related to Vaccine Administration (PMID 34185028) that describes SIRVA as a recognized complication of immunization, with typical onset within 48 hours of vaccination, but does not specifically mention DTaP vaccine or provide case reports of SIRVA following DTaP administration.
Case-certainty distribution (no established case definition): 1 Possible/unclassifiable. Transparency layer — does not change this node's status or feed C1–C6.
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series Case reports pubmed · 66169 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
10 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
ambiguous 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
ambiguous 34185028 · The Journal of the American Academy of O (2021) — Shoulder Injury Related to Vaccine Administration.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 32809680 · (2026) — Rubella Vaccine.
A2 · Series with objective confirmationno_data
Measure: Definite object plus objective test Comparator: Reference range / diagnostic criteria Hit rule: Objective confirmation in >=1 case per the working definition
Finding: The retrieved evidence includes a review article on shoulder injury related to vaccine administration (SIRVA) but does not provide any case-level data with objective confirmation for DTaP vaccine specifically.
Case-certainty distribution (no established case definition): 1 Possible/unclassifiable. Transparency layer — does not change this node's status or feed C1–C6.
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series Series with objective confirmation pubmed · 5641 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
11 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.
ambiguous 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
ambiguous 34185028 · The Journal of the American Academy of O (2021) — Shoulder Injury Related to Vaccine Administration.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 32809680 · (2026) — Rubella Vaccine.
A3 · Onset histogramno_data
Measure: Distribution of onset times after dose Comparator: Pre-specified risk window Hit rule: Onset clusters inside the pre-specified window (not uniform/flat)
Finding: The retrieved evidence includes a review on SIRVA (PMID 34185028) that states onset of severe pain and limited range of motion typically occurs within 48 hours of vaccination, which could support an onset window for DTaP-associated SIRVA; however, no evidence specifically addresses DTaP vaccine or provides a distribution of onset times after dose for this vaccine.
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series Onset histogram pubmed · 2 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
11 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
Measure: Onset latency vs object pathophysiology Comparator: Object's known natural latency Hit rule: Onset latency consistent with the object's pathophysiology
Finding: The retrieved evidence includes one review article on SIRVA that describes onset of severe pain and limited range of motion within 48 hours of vaccination, which is temporally consistent with the pathophysiology of shoulder injury from injection into the bursa or joint space. No evidence specifically addresses DTaP vaccine or provides onset latency data for DTaP-associated SIRVA.
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series Temporal plausibility pubmed · 31 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
12 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 32294081 · PLoS neglected tropical diseases (2020) — Praziquantel and risk of visual disorders: Case series assessment.
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.
ambiguous 34185028 · The Journal of the American Academy of O (2021) — Shoulder Injury Related to Vaccine Administration.
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 evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series Onset-interval documentation pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
11 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: Competing causes assessed and excluded Comparator: Likely alternative diagnoses Hit rule: Pre-specified competing causes ruled out per the working definition
Finding: No retrieved evidence directly addresses DTaP vaccine-related SIRVA or the exclusion of competing causes for SIRVA. The only relevant article (PMID 34185028) discusses SIRVA in general but does not address DTaP specifically or the systematic exclusion of differential diagnoses.
Case-certainty distribution (no established case definition): 1 Possible/unclassifiable. Transparency layer — does not change this node's status or feed C1–C6.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series Differential diagnosis excluded pubmed · 427 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 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: Object recurs on a further dose Comparator: First-dose response Hit rule: Object recurs after a subsequent dose (re-exposure)
Finding: No retrieved evidence specifically describes recurrence of Shoulder Injury Related to Vaccine Administration (SIRVA) following a subsequent dose of DTaP vaccine or any vaccine.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series Rechallenge / re-exposure pubmed · 2 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
10 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
ambiguous 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
does_not_resolve 34185028 · The Journal of the American Academy of O (2021) — Shoulder Injury Related to Vaccine Administration.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 32809680 · (2026) — Rubella Vaccine.
A8 · Adjudicated by criteria (no established case definition)no_data
Measure: Object adjudicated by published criteria Comparator: Published clinical / Brighton criteria Hit rule: Cases adjudicated to 'definite' by a published criterion set
Finding: No retrieved evidence directly addresses DTaP vaccine-related Shoulder Injury Related to Vaccine Administration (SIRVA) adjudicated as 'definite' by published criteria. One non-systematic review (PMID 34185028) discusses SIRVA generally but does not mention DTaP or adjudication criteria.
Case-certainty distribution (no established case definition): 1 Possible/unclassifiable. Transparency layer — does not change this node's status or feed C1–C6.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series Adjudicated by criteria pubmed · 39 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
10 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
ambiguous 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
ambiguous 34185028 · The Journal of the American Academy of O (2021) — Shoulder Injury Related to Vaccine Administration.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 32809680 · (2026) — Rubella Vaccine.
A9 · Natural-history consistencyno_data
Measure: Course matches the object's natural history Comparator: Known natural history of the object Hit rule: Clinical course (onset, peak, recovery) matches the object's natural history
Finding: The retrieved evidence includes a review article (PMID 34185028) that describes the clinical course of SIRVA, with onset within 48 hours of vaccination, which matches the natural history of the condition for DTaP vaccine-related SIRVA, but no specific evidence for DTaP vaccine is provided.
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series Natural-history consistency pubmed · 103 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
11 retrieved record(s)
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
supports_node 34185028 · The Journal of the American Academy of O (2021) — Shoulder Injury Related to Vaccine Administration.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 32809680 · (2026) — Rubella Vaccine.
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: PMID 34185028 describes SIRVA as a rare complication of immunization presenting with severe pain and limited range of motion within 48 hours of vaccination, but does not specifically attribute cases to DTaP vaccine or assess competing causes.
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) case report OR case series No confounding object pubmed · 19 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
12 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.
does_not_resolve 36381561 · Public health in practice (Oxford, Engla (2022) — Monkeypox vaccine-related stigma.
supports_node 34185028 · The Journal of the American Academy of O (2021) — Shoulder Injury Related to Vaccine Administration.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) anatomic localization Predicted site of injury mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Predicted site of injury not consistent with mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
D2 · Spared structuresno_data
Measure: Structures the mechanism should spare are spared Comparator: Structures predicted unaffected Hit rule: Structures predicted spared by the mechanism are indeed spared
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) anatomic localization Spared structures mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) anatomic localization Local vs systemic distribution mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) anatomic localization Kinetics class mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) anatomic localization Platform-mechanism match mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Targeted treatment reverses intervention OR treatment OR reversal pubmed · 15142089 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Targeted treatment reverses no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
I1 · No internal contradictionno_data
Measure: No node's finding contradicts another Comparator: Internal consistency across nodes Hit rule: No evaluated node directly contradicts another (coherence)
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) No internal contradiction coherence OR latency OR susceptibility pubmed · 870055 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Analogy to a known object coherence OR latency OR susceptibility pubmed · 870055 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Latency coherence coherence OR latency OR susceptibility pubmed · 870055 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Pre-specification pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Pre-specification 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
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. The retrieved abstract discusses the use of large language models to identify immune-related adverse events from immune checkpoint inhibitor therapy, with no mention of DTaP vaccine, Shoulder Injury Related to Vaccine Administration (SIRVA), or any vaccine adverse event evidence relevant to this node.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Contrary-evidence log pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Contrary-evidence log 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
J3 · No temporality-only claimno_data
Measure: Claim not based on temporality alone Comparator: Sequence-only evidence Hit rule: The claim is not supported by temporal sequence alone (independent evidence exists)
Finding: The retrieved evidence does not address DTaP vaccine, Shoulder Injury Related to Vaccine Administration (SIRVA), or temporality-only claims; one abstract discusses immune-related adverse events from immune checkpoint inhibitors, and the other discusses drug-induced acute kidney injury prediction models.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) No temporality-only claim pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) No temporality-only claim post-hoc OR hypothesis-generating only pubmed · 1699 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 39226489 · Journal of clinical oncology : official (2024) — Enhancing Precision in Detecting Severe Immune-Related Adverse Events: Comparative Analysis of Large Language Models and International Classification of Disease
Measure: Passive-surveillance findings bounded correctly Comparator: Active-surveillance confirmation Hit rule: Passive-surveillance signals are framed as hypothesis-generating, not confirmatory
Finding: The retrieved evidence describes a study using large language models to identify immune-related adverse events from immune checkpoint inhibitors, and does not address DTaP vaccine or shoulder injury related to vaccine administration (SIRVA).
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Passive-surveillance role pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Passive-surveillance role 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
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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Dose mapping pre-specified OR adjudicated pubmed · 13550 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Dose mapping 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
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 study directly addresses the risk of SIRVA following DTaP vaccination; the retrieved articles focus on other vaccines (rotavirus, shingles, COVID-19, etc.) or on general SCCS methodology, or are unrelated to vaccine safety (e.g., tirzepatide, NAFLD, radiotherapy).
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Excess vs baseline incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk Excess vs baseline pubmed · 88466 hits · run 2026-09-07
10 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 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 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 34672967 · Lancet (London, England) (2021) — Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, pha
does_not_resolve 40794640 · European heart journal (2026) — Cardiovascular benefit of continuous positive airway pressure according to high-risk obstructive sleep apnoea: a multi-trial analysis.
B2 · SCCSno_data
Measure: Self-controlled case series risk ratio Comparator: Individuals' own risk intervals (no-event) Hit rule: SCCS risk ratio > 1 in the post-vaccination window, CI excluding 1
Finding: No SCCS studies retrieved directly examine the association between DTaP vaccine and shoulder injury related to vaccine administration (SIRVA). The retrieved SCCS evidence addresses other vaccines and outcomes (e.g., rotavirus vaccine and intussusception, Shingrix and shingles, COVID-19 vaccines and various adverse events) and therefore provides no data on the specified pair.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) SCCS incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk SCCS pubmed · 88574 hits · run 2026-09-07
7 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
ambiguous 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 39795956 · International journal of molecular scien (2024) — The Potential Metalloestrogenic Effect of Aluminum on Breast Cancer Risk for Antiperspirant Users.
does_not_resolve 36696094 · JAMA cardiology (2023) — Association of Rurality With Risk of Heart Failure.
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 study provides an incidence rate ratio (IRR) for shoulder injury related to vaccine administration (SIRVA) after DTaP vaccination, or any cohort/risk-interval analysis of DTaP and SIRVA. The retrieved evidence covers self-controlled case series designs and findings for other vaccines (rotavirus, shingles, COVID-19) and unrelated outcomes (Guillain-Barré syndrome, mortality, genetic associations), but none address DTaP or SIRVA.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Cohort / risk-interval incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk Cohort / risk-interval pubmed · 88075 hits · run 2026-09-07
9 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 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 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 41284649 · PloS one (2025) — Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States.
does_not_resolve 23296494 · Molecular biology reports (2013) — Assessment of the association between GSTM1 null genotype and risk of type 2 diabetes.
B4 · Meta-analysis / poolingno_data
Measure: Pooled effect across studies Comparator: Pooled estimate with heterogeneity Hit rule: Pooled estimate > 1 (or < 1) with quantified heterogeneity (I2)
Finding: No retrieved evidence provides a pooled estimate for the association between DTaP vaccine and Shoulder Injury Related to Vaccine Administration (SIRVA). The retrieved studies focus on other vaccines (rotavirus, Shingrix, COVID-19, shingles) and other outcomes (intussusception, mortality, stroke, falls, cancer), without addressing SIRVA or DTaP.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Meta-analysis / pooling incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk Meta-analysis / pooling pubmed · 111911 hits · run 2026-09-07
11 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 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 29402646 · Journal of the American Medical Director (2018) — Fall-Risk-Increasing Drugs: A Systematic Review and Meta-analysis: III. Others.
does_not_resolve 28270112 · BMC infectious diseases (2017) — A meta-analysis of stroke risk following herpes zoster infection.
does_not_resolve 28230042 · Journal of cancer research and therapeut (2016) — Meta-analysis of association between mobile phone use and glioma risk.
B5 · Negative-control outcomesno_data
Measure: No excess for outcomes the vaccine should not cause Comparator: Negative-control outcomes (unaffected by mechanism) Hit rule: Null for negative-control outcomes while target outcome is positive (specificity)
Finding: The retrieved evidence does not include any studies evaluating the association between DTaP vaccine and Shoulder Injury Related to Vaccine Administration (SIRVA), nor any negative-control outcome analyses for DTaP vaccine.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Negative-control outcomes incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk Negative-control outcomes pubmed · 88277 hits · run 2026-09-07
7 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 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 38833248 · JAMA network open (2024) — Valproate Use During Spermatogenesis and Risk to Offspring.
does_not_resolve 42486607 · BMJ (Clinical research ed.) (2026) — Risk of hair loss associated with glucagon-like peptide-1 receptor agonists in adults with type 2 diabetes: target trial emulation.
B6 · Other-antigen comparisonno_data
Measure: Risk vs a different-antigen comparator Comparator: Comparator product with a different antigen Hit rule: Risk specific to the target antigen, not shared with the comparator antigen
Finding: No retrieved evidence evaluates the risk of SIRVA after DTaP vaccination using a different-antigen comparator, nor does any study address SIRVA or DTaP vaccine specifically.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Other-antigen comparison incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk Other-antigen comparison pubmed · 88039 hits · run 2026-09-07
8 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 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 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 23296494 · Molecular biology reports (2013) — Assessment of the association between GSTM1 null genotype and risk of type 2 diabetes.
does_not_resolve 23949879 · Tumour biology : the journal of the Inte (2014) — Meta-analysis of the association between GSTT1 null genotype and risk of nasopharyngeal carcinoma in Chinese.
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 retrieved evidence provides absolute risk per 100,000 for Shoulder Injury Related to Vaccine Administration (SIRVA) following DTaP vaccination, nor any stable window-based risk estimate for this specific vaccine-adverse event pair.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Absolute risk incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk Absolute risk pubmed · 111312 hits · run 2026-09-07
11 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 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 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 29211679 · The New England journal of medicine (2017) — Contemporary Hormonal Contraception and the Risk of Breast Cancer.
does_not_resolve 23484825 · The New England journal of medicine (2013) — Risk of ischemic heart disease in women after radiotherapy for breast cancer.
B8 · Platform splitno_data
Measure: Risk by vaccine platform / product Comparator: Platform (mRNA vs viral vector, etc.) Hit rule: Risk attributable to a specific platform, not to 'a vaccine' generally
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Platform split incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk Platform split pubmed · 88104 hits · run 2026-09-07
7 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 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 36370744 · The Lancet. Child & adolescent health (2023) — Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: a systematic review and meta-analysis.
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 addresses DTaP vaccine, Shoulder Injury Related to Vaccine Administration (SIRVA), or host-structure stratification by age/sex. The studies focus on self-controlled case series designs for other vaccines and outcomes, with no discussion of SIRVA or host-subgroup risk concentration for DTaP.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Host-structure stratification incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk Host-structure stratification pubmed · 88037 hits · run 2026-09-07
6 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 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 23296494 · Molecular biology reports (2013) — Assessment of the association between GSTM1 null genotype and risk of type 2 diabetes.
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 the relationship between a formulation/component change in DTaP vaccine and risk of Shoulder Injury Related to Vaccine Administration (SIRVA). The studies focus on self-controlled case series methods for other vaccines and outcomes, not on formulation changes for DTaP or SIRVA.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Formulation / component change incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no association OR null OR no increased risk Formulation / component change pubmed · 88199 hits · run 2026-09-07
6 retrieved record(s)
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
does_not_resolve 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 41092926 · Lancet (London, England) (2025) — Burden of 375 diseases and injuries, risk-attributable burden of 88 risk factors, and healthy life expectancy in 204 countries and territories, including 660 su
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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Formulation natural experiment intervention OR treatment OR reversal pubmed · 15142089 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Formulation natural experiment no effect intervention pubmed · 0 hits (0 hits — negative) · run 2026-09-07
H4 · Policy / pause signalno_data
Measure: Risk signal appears/disappears across a pause or policy change Comparator: Pre- vs post-pause period Hit rule: The signal appears or disappears coherently with a rollout / pause (H4)
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Policy / pause signal intervention OR treatment OR reversal pubmed · 15142089 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Infection coherence coherence OR latency OR susceptibility pubmed · 870055 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Dose strength gradient dose-response OR dose effect pubmed · 1299174 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no dose effect OR no dose-response Dose strength gradient pubmed · 111 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
does_not_resolve 33373368 · PLoS medicine (2020) — Assessing the risk of ketoacidosis due to sodium-glucose cotransporter (SGLT)-2 inhibitors in patients with type 1 diabetes: A meta-analysis and meta-regression
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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Dose number gradient dose-response OR dose effect pubmed · 1299174 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no dose effect OR no dose-response Dose number gradient pubmed · 555 hits · run 2026-09-07
1 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
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 evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Measured-exposure tertiles dose-response OR dose effect pubmed · 1299174 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no dose effect OR no dose-response Measured-exposure tertiles pubmed · 0 hits (0 hits — negative) · run 2026-09-07
1 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
C4n · Organoid concentration curveno_data
Measure: Effect vs antigen concentration in organoid Comparator: Vehicle / zero antigen Hit rule: Dose-dependent effect across a graded concentration curve
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Organoid concentration curve dose-response OR dose effect pubmed · 1299174 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no dose effect OR no dose-response Organoid concentration curve pubmed · 11 hits · run 2026-09-07
1 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) EC50 vs Cmax coherence dose-response OR dose effect pubmed · 1299174 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) no dose effect OR no dose-response EC50 vs Cmax coherence pubmed · 0 hits (0 hits — negative) · run 2026-09-07
1 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
E1 · Mediator identified in casesno_data
Measure: Mediator present in affected tissue/cells Comparator: Unaffected tissue / control Hit rule: The hypothesized mediator is detected in the affected compartment and not (or less) in control
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Mediator identified in cases in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Mediator identified in cases not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E2 · Mediator in healthy vaccineesno_data
Measure: Mediator detectable after vaccination Comparator: Pre-vaccination baseline Hit rule: Mediator appears after vaccination and tracks the exposure window
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Mediator in healthy vaccinees in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Mediator in healthy vaccinees not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E3 · Infection contrastno_data
Measure: Mediator absent/low after natural infection Comparator: Recovered natural infection Hit rule: Mediator signal is specific to vaccination vs a comparable natural-infection control
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Infection contrast in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Infection contrast not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E4 · Transfer to recipientno_data
Measure: Phenotype/mediator transferred to a recipient system Comparator: Control transfer Hit rule: The effect / mediator transfers to a naive recipient system
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Transfer to recipient in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Transfer specificity in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Depletion / knockdown in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Depletion / knockdown not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E7 · Add-back rescueno_data
Measure: Adding the mediator restores the effect Comparator: Add-back of a control protein Hit rule: Adding back the mediator (not a control) restores the phenotype
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Add-back rescue in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Add-back rescue not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E8 · Neutralizationno_data
Measure: Neutralizing the mediator blocks the effect Comparator: Isotype control Hit rule: Neutralization of the mediator (not an isotype control) blocks the phenotype
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Neutralization in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Neutralization not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
E9 · Isotype controlno_data
Measure: Isotype control does not reproduce the effect Comparator: Active antibody Hit rule: An isotype control fails to reproduce the block/activation
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Isotype control in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Isotype control not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
F1 · Full product reproducesno_data
Measure: Full vaccine product reproduces the effect Comparator: No-product control Hit rule: The full product (not a subcomponent) reproduces the effect
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Full product reproduces component OR antigen OR vector pubmed · 2045284 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Full product reproduces no effect component isolation pubmed · 0 hits (0 hits — negative) · 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.
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. The retrieved evidence discusses viral and bacterial vaccine vectors in the context of influenza, measles, and cancer vaccines, but does not address shoulder injury related to vaccine administration (SIRVA) or the DTaP vaccine vector/particle backbone.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Empty vector / particle component OR antigen OR vector pubmed · 2045284 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Empty vector / particle no effect component isolation pubmed · 0 hits (0 hits — negative) · 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.
F3 · Antigen alone reproducesno_data
Measure: Isolated antigen reproduces the effect Comparator: Vehicle Hit rule: The isolated antigen (not the full product) reproduces the effect
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Antigen alone reproduces component OR antigen OR vector pubmed · 2045284 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Antigen alone reproduces no effect component isolation pubmed · 0 hits (0 hits — negative) · 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Irrelevant cargo component OR antigen OR vector pubmed · 2045284 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Irrelevant cargo no effect component isolation pubmed · 0 hits (0 hits — negative) · 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: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Infection preparation component OR antigen OR vector pubmed · 2045284 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Infection preparation no effect component isolation pubmed · 0 hits (0 hits — negative) · 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.
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 regarding the reproducibility of shoulder injury related to vaccine administration (SIRVA) by a cytokine/adjuvant mix alone.
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Cytokine / adjuvant mix component OR antigen OR vector pubmed · 2045284 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Cytokine / adjuvant mix no effect component isolation pubmed · 0 hits (0 hits — negative) · 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Component combination component OR antigen OR vector pubmed · 2045284 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Component combination no effect component isolation pubmed · 0 hits (0 hits — negative) · 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.
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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 2D human cells animal OR organoid OR cell model pubmed · 1818620 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Organoid / chip animal OR organoid OR cell model pubmed · 1818620 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Block in vitro / in vivo intervention OR treatment OR reversal pubmed · 15142089 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) mechanism Host-line dependence in vitro OR patient-derived pubmed · 29243 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Host-line dependence not associated mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G3 · Animal, clinical routeno_data
Measure: Effect in animal via the clinical route of administration Comparator: Vehicle, same route Hit rule: Effect reproduced in an animal using the clinical route of administration
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Animal, clinical route animal OR organoid OR cell model pubmed · 1818620 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Animal, clinical route not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G4 · Susceptible animalno_data
Measure: Effect in a susceptible animal model Comparator: Non-susceptible model Hit rule: Effect in a defined susceptible animal model
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Susceptible animal animal OR organoid OR cell model pubmed · 1818620 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Replication across labs animal OR organoid OR cell model pubmed · 1818620 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Replication across labs not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G6 · Blinded scoringno_data
Measure: Outcomes scored blinded Comparator: Unblinded reference Hit rule: Primary outcomes scored by a blinded assessor
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Blinded scoring animal OR organoid OR cell model pubmed · 1818620 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Blinded scoring not reproduced model pubmed · 0 hits (0 hits — negative) · run 2026-09-07
G7 · Experimental time courseno_data
Measure: Effect follows a defined experimental time course Comparator: No-exposure time course Hit rule: The effect's onset/offset follows a defined experimental time course
Finding: no evidence found
Cited: (none)
supporting: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Experimental time course animal OR organoid OR cell model pubmed · 1818620 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) Susceptibility trait coherence OR latency OR susceptibility pubmed · 870055 hits · run 2026-09-07
mirror: DTaP vaccine Shoulder Injury Related to Vaccine Administration (SIRVA) 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.