Evidence dossier · candidate cand-covid-myositis · CICP program · · DRAFT — not a determination
This is a draft research-tracking dossier, not a determination that COVID-19 vaccine causes Myositis, 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
supported
C2
Consistent temporal window
supported
C3
Epidemiologic excess risk
insufficient_data
missing: B2
C4
Consistency / replication
insufficient_data
missing: B5
C5
Specificity (product / dose)
contested
C6
Biological mechanism
supported
Two evidentiary bars apply to the epi nodes/claims (C3, C4): · VICP — preponderance of the evidence. · CICP (off-Table) — compelling, reliable, valid medical and scientific evidence (higher bar).
Bradford Hill assessment (computed)
Each viewpoint is derived from the node statuses below (see the framework crosswalk in compensation-tables-schema.md §8). Hill's viewpoints are aids to judgement, not a scoring checklist that proves causation; temporality is the only strictly necessary criterion.
Viewpoint
What it asks
Status (from evidence)
Temporality(necessary)
cause precedes effect in a plausible window (necessary)
NASEM (formerly IOM), "Adverse Effects of Vaccines: Evidence and Causality" (2011, updated 2024). Independent grading of epidemiologic and mechanistic evidence, synthesized into one of four causal-conclusion categories. This is a computed approximation of that framework, not a NASEM determination. See compensation-tables-schema.md §8bis.
Case-definition standard: no established case definition (needs_human_review — not in spec §1's named-standard list) — governs the case-certainty scale on A1/A2/A6/A8 below. See compensation-tables-schema.md §8ter.
Evidence matrix (68 nodes by workstream)
68 of 68 nodes evaluated · 136 PubMed queries logged (supporting + mirror, incl. zeros). Statuses are computed from retrieved citations; not hand-set.
Definition & attribution 24/24 evaluated
A1 · Case reportssupports
Measure: New definite object in risk window T Comparator: Pre-vaccination baseline Hit rule: Definite object present, onset in window, competing causes considered
Finding: Multiple case reports describe new-onset myositis occurring after COVID-19 vaccination, with onset within days to weeks and after excluding other causes, supporting a potential association.
supporting: COVID-19 vaccine Myositis case report OR case series Case reports pubmed · 66199 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
16 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
ambiguous 37800119 · Radiology case reports (2023) — Occurrence of proliferative myositis after COVID-19 vaccination: A case report.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 41306776 · Frontiers in pharmacology (2025) — HPV vaccine-related thyroid adverse events: temporal patterns and reporting trends.
supports_node 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
A2 · Series with objective confirmationsupports
Measure: Definite object plus objective test Comparator: Reference range / diagnostic criteria Hit rule: Objective confirmation in >=1 case per the working definition
Finding: Multiple case reports describe patients developing myositis after COVID-19 vaccination, with objective confirmation via elevated muscle enzymes, MRI, and/or electromyography. A comprehensive review also identifies additional published cases of vaccine-associated inflammatory myositis.
supporting: COVID-19 vaccine Myositis case report OR case series Series with objective confirmation pubmed · 5683 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
15 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
ambiguous 37800119 · Radiology case reports (2023) — Occurrence of proliferative myositis after COVID-19 vaccination: A case report.
supports_node 36110335 · Clinical case reports (2022) — COVID-19 vaccine-associated myositis - a case report.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
ambiguous 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
ambiguous 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
does_not_resolve 40902666 · Journal of the American Academy of Derma (2026) — Drug and vaccine-associated pemphigoid in patients aged 50 years and older: A pharmacovigilance study.
A3 · Onset histogramsupports
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: Multiple case reports describe myositis onset within days to weeks after COVID-19 vaccination, with onset times clustering in a pre-specified risk window (e.g., 5 days to 2 weeks post-dose).
supporting: COVID-19 vaccine Myositis case report OR case series Onset histogram pubmed · 44 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
21 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
ambiguous 37800119 · Radiology case reports (2023) — Occurrence of proliferative myositis after COVID-19 vaccination: A case report.
ambiguous 37088882 · Clinics in shoulder and elbow (2023) — Myositis unrelated to the inoculation site after COVID-19 vaccination: a case report.
supports_node 35132838 · Journal of Korean medical science (2022) — Dermatomyositis Following BNT162b2 mRNA COVID-19 Vaccination.
supports_node 35891299 · Vaccines (2022) — Clinical and Molecular Characterization of a Rare Case of BNT162b2 mRNA COVID-19 Vaccine-Associated Myositis.
A4 · Temporal plausibilitysupports
Measure: Onset latency vs object pathophysiology Comparator: Object's known natural latency Hit rule: Onset latency consistent with the object's pathophysiology
Finding: Multiple case reports describe onset of myositis within days to weeks after COVID-19 vaccination, with reported latencies of approximately 5 days (PMID 37800119), 10 days (PMID 35132838), and 3 weeks (PMID 35004093), consistent with vaccine-triggered inflammatory myopathy pathophysiology.
supporting: COVID-19 vaccine Myositis case report OR case series Temporal plausibility pubmed · 73 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
18 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 35132838 · Journal of Korean medical science (2022) — Dermatomyositis Following BNT162b2 mRNA COVID-19 Vaccination.
supports_node 37088882 · Clinics in shoulder and elbow (2023) — Myositis unrelated to the inoculation site after COVID-19 vaccination: a case report.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
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: All retrieved case reports describe myositis onset after COVID-19 vaccination, but none explicitly state that the onset interval was documented (not imputed) in a primary source as required by the hit rule.
Cited: (none)
supporting: COVID-19 vaccine Myositis case report OR case series Onset-interval documentation pubmed · 42 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
21 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 37088882 · Clinics in shoulder and elbow (2023) — Myositis unrelated to the inoculation site after COVID-19 vaccination: a case report.
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: Three case reports and one systematic review of case reports describe inflammatory myositis occurring after COVID-19 vaccination, with diagnoses supported by elevated muscle enzymes, MRI, or electromyogram; however, none of the retrieved articles explicitly state that competing causes (e.g., infection, autoimmune disease, drug-induced myositis) were systematically assessed and excluded per a pre-specified working definition.
supporting: COVID-19 vaccine Myositis case report OR case series Differential diagnosis excluded pubmed · 469 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
14 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 36110335 · Clinical case reports (2022) — COVID-19 vaccine-associated myositis - a case report.
does_not_resolve 41306776 · Frontiers in pharmacology (2025) — HPV vaccine-related thyroid adverse events: temporal patterns and reporting trends.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
supports_node 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
supports_node 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
ambiguous 40902666 · Journal of the American Academy of Derma (2026) — Drug and vaccine-associated pemphigoid in patients aged 50 years and older: A pharmacovigilance study.
A7 · Rechallenge / re-exposuresupports
Measure: Object recurs on a further dose Comparator: First-dose response Hit rule: Object recurs after a subsequent dose (re-exposure)
Finding: Several case reports describe recurrence or new onset of myositis following a subsequent dose of COVID-19 vaccine, including a patient with myositis after the second dose of BNT162b2 (PMID 36928720, PMID 35315602) and a patient with pneumonitis, myositis, and myopericarditis after the second dose of AstraZeneca (PMID 35004093), consistent with a rechallenge pattern.
supporting: COVID-19 vaccine Myositis case report OR case series Rechallenge / re-exposure pubmed · 44 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
21 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
ambiguous 37088882 · Clinics in shoulder and elbow (2023) — Myositis unrelated to the inoculation site after COVID-19 vaccination: a case report.
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: Several case reports describe myositis, dermatomyositis, or proliferative myositis occurring after COVID-19 vaccination, with diagnoses supported by serology, MRI, EMG, or biopsy. However, none of the retrieved abstracts explicitly state that cases were adjudicated to 'definite' by a published criterion set.
Cited: (none)
supporting: COVID-19 vaccine Myositis case report OR case series Adjudicated by criteria pubmed · 81 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
21 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
ambiguous 37088882 · Clinics in shoulder and elbow (2023) — Myositis unrelated to the inoculation site after COVID-19 vaccination: a case report.
A9 · Natural-history consistencysupports
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: Case reports describe myositis onset days to weeks after COVID-19 vaccination, with clinical courses (e.g., peak weakness, elevated enzymes, response to immunosuppression) that are consistent with the natural history of inflammatory myositis.
supporting: COVID-19 vaccine Myositis case report OR case series Natural-history consistency pubmed · 145 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
15 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 36110335 · Clinical case reports (2022) — COVID-19 vaccine-associated myositis - a case report.
ambiguous 37800119 · Radiology case reports (2023) — Occurrence of proliferative myositis after COVID-19 vaccination: A case report.
ambiguous 33647971 · QJM : monthly journal of the Association (2021) — COVID-19 vaccine-related myositis.
does_not_resolve 36441403 · Current cardiology reports (2022) — COVID-19 Vaccine-Related Myocardial and Pericardial Inflammation.
does_not_resolve 37775180 · Clinical medicine (London, England) (2023) — SARS-CoV-2 vaccines and myocarditis.
ambiguous 30000765 · (2006) — Human Papillomavirus Vaccines.
A10 · No confounding objectsupports
Measure: Not attributable to a co-occurring condition Comparator: Co-occurring illness that could produce the object Hit rule: Object not better explained by a co-occurring condition (infection, etc.)
Finding: Multiple case reports describe new-onset inflammatory myositis, dermatomyositis, and proliferative myositis following various COVID-19 vaccines, with onset within days to weeks after vaccination and after excluding alternative causes such as infection or trauma.
supporting: COVID-19 vaccine Myositis case report OR case series No confounding object pubmed · 61 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis alternative diagnosis OR not vaccine-related pubmed · 4053 hits · run 2026-09-07
19 retrieved record(s)
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 37088882 · Clinics in shoulder and elbow (2023) — Myositis unrelated to the inoculation site after COVID-19 vaccination: a case report.
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: COVID-19 vaccine Myositis anatomic localization Predicted site of injury mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis anatomic localization Local vs systemic distribution mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis anatomic localization Kinetics class mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis anatomic localization Platform-mechanism match mechanism pubmed · 0 hits (0 hits — negative) · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Targeted treatment reverses intervention OR treatment OR reversal pubmed · 15141378 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: COVID-19 vaccine Myositis No internal contradiction coherence OR latency OR susceptibility pubmed · 870020 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Analogy to a known object coherence OR latency OR susceptibility pubmed · 870020 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Latency coherence coherence OR latency OR susceptibility pubmed · 870020 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis Latency coherence 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.
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: COVID-19 vaccine Myositis Pre-specification pre-specified OR adjudicated pubmed · 13548 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis Pre-specification post-hoc OR hypothesis-generating only pubmed · 1698 hits · run 2026-09-07
4 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 42474879 · Biological trace element research (2026) — Cadmium Exposure and Osteoporosis: A Spatially Contextualized Adverse Outcome Pathway Integrating Epidemiology, Toxicogenomics and Transcriptomics.
does_not_resolve 42569385 · Frontiers in medicine (2026) — Antibiotic-associated adverse events in bone and joint infections: a FAERS pharmacovigilance study.
Measure: Contrary evidence is logged, not omitted Comparator: Support-only dossier Hit rule: Contrary / null / refuting findings are logged and shown alongside support
Finding: The retrieved evidence does not address myositis attributed to COVID-19 vaccine; PMID 39226489 focuses on immune-related adverse events from immune checkpoint inhibitors, and PMID 42569385 covers antibiotic-associated adverse events in bone and joint infections.
Cited: (none)
supporting: COVID-19 vaccine Myositis Contrary-evidence log pre-specified OR adjudicated pubmed · 13548 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis Contrary-evidence log 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 42569385 · Frontiers in medicine (2026) — Antibiotic-associated adverse events in bone and joint infections: a FAERS pharmacovigilance study.
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: COVID-19 vaccine Myositis No temporality-only claim pre-specified OR adjudicated pubmed · 13548 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis No temporality-only claim post-hoc OR hypothesis-generating only pubmed · 1698 hits · run 2026-09-07
4 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 42474879 · Biological trace element research (2026) — Cadmium Exposure and Osteoporosis: A Spatially Contextualized Adverse Outcome Pathway Integrating Epidemiology, Toxicogenomics and Transcriptomics.
does_not_resolve 42569385 · Frontiers in medicine (2026) — Antibiotic-associated adverse events in bone and joint infections: a FAERS pharmacovigilance study.
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: COVID-19 vaccine Myositis Passive-surveillance role pre-specified OR adjudicated pubmed · 13548 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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 42569385 · Frontiers in medicine (2026) — Antibiotic-associated adverse events in bone and joint infections: a FAERS pharmacovigilance study.
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: COVID-19 vaccine Myositis Dose mapping pre-specified OR adjudicated pubmed · 13548 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis Dose mapping post-hoc OR hypothesis-generating only pubmed · 1698 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 39226489 · Journal of clinical oncology : official (2024) — Enhancing Precision in Detecting Severe Immune-Related Adverse Events: Comparative Analysis of Large Language Models and International Classification of Disease
Measure: 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 myositis following COVID-19 vaccination, with no studies reporting RR/IRR estimates for this specific adverse event.
Cited: (none)
supporting: COVID-19 vaccine Myositis Excess vs baseline incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk Excess vs baseline pubmed · 88529 hits · run 2026-09-07
7 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.
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 40440921 · Vaccine (2025) — Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study.
refutes_node 40808308 · Human vaccines & immunotherapeutics (2025) — Effects of COVID-19 vaccination on irAEs and prognosis in lung cancer patients receive PD-(L)1 inhibitors.
does_not_resolve 34489307 · Gut (2022) — Non-alcoholic fatty liver disease and incident major adverse cardiovascular events: results from a nationwide histology cohort.
does_not_resolve 40794640 · European heart journal (2026) — Cardiovascular benefit of continuous positive airway pressure according to high-risk obstructive sleep apnoea: a multi-trial analysis.
B2 · SCCSno_data
Measure: Self-controlled case series risk ratio Comparator: Individuals' own risk intervals (no-event) Hit rule: SCCS risk ratio > 1 in the post-vaccination window, CI excluding 1
Finding: No retrieved study directly examines the risk of myositis after COVID-19 vaccination using an SCCS design with a risk ratio > 1 and CI excluding 1.
Cited: (none)
supporting: COVID-19 vaccine Myositis SCCS incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk SCCS pubmed · 88637 hits · run 2026-09-07
13 retrieved record(s)
does_not_resolve 30172612 · American journal of infection control (2019) — Antibiotic exposure and risk of community-associated Clostridium difficile infection: A self-controlled case series analysis.
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 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 40440921 · Vaccine (2025) — Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study.
does_not_resolve 40808308 · Human vaccines & immunotherapeutics (2025) — Effects of COVID-19 vaccination on irAEs and prognosis in lung cancer patients receive PD-(L)1 inhibitors.
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 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: 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: Three case reports describe new-onset dermatomyositis or inflammatory myositis after COVID-19 vaccination (PMIDs 36928720, 35661906, 38959927, 35132838), and one self-controlled case series in myasthenia gravis patients reports incidence rate ratios for disease exacerbation (PMID 37223097), but no retrieved study provides an IRR > 1 with CI excluding 1 for myositis specifically in a pre-specified risk window stratified by age/sex.
Cited: (none)
supporting: COVID-19 vaccine Myositis Cohort / risk-interval incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk Cohort / risk-interval pubmed · 88138 hits · run 2026-09-07
13 retrieved record(s)
does_not_resolve 33773635 · The Lancet. Public health (2021) — Periods of altered risk for non-fatal drug overdose: a self-controlled case series.
does_not_resolve 40818314 · Vaccine (2025) — COVID-19 vaccination and the risk of abnormal uterine bleeding: A nationwide self-controlled case series study.
does_not_resolve 38089855 · European heart journal open (2023) — Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.
does_not_resolve 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 37223097 · Frontiers in immunology (2023) — Safety of COVID-19 vaccine in patients with myasthenia gravis: 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.
refutes_node 40808308 · Human vaccines & immunotherapeutics (2025) — Effects of COVID-19 vaccination on irAEs and prognosis in lung cancer patients receive PD-(L)1 inhibitors.
does_not_resolve 41284649 · PloS one (2025) — Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States.
B4 · Meta-analysis / poolingno_data
Measure: Pooled effect across studies Comparator: Pooled estimate with heterogeneity Hit rule: Pooled estimate > 1 (or < 1) with quantified heterogeneity (I2)
Finding: The only retrieved evidence directly addressing COVID-19 vaccine-associated myositis is a single case report and narrative review (PMID 36928720), which does not provide a pooled meta-analytic estimate with quantified heterogeneity. No meta-analysis or pooled estimate for myositis after COVID-19 vaccination was retrieved.
supporting: COVID-19 vaccine Myositis Meta-analysis / pooling incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk Meta-analysis / pooling pubmed · 111969 hits · run 2026-09-07
9 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.
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 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 36226469 · Epilepsia (2022) — Association between the risk of seizure and COVID-19 vaccinations: 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 40808308 · Human vaccines & immunotherapeutics (2025) — Effects of COVID-19 vaccination on irAEs and prognosis in lung cancer patients receive PD-(L)1 inhibitors.
does_not_resolve 28230042 · Journal of cancer research and therapeut (2016) — Meta-analysis of association between mobile phone use and glioma risk.
B5 · Negative-control outcomesno_data
Measure: No excess for outcomes the vaccine should not cause Comparator: Negative-control outcomes (unaffected by mechanism) Hit rule: Null for negative-control outcomes while target outcome is positive (specificity)
Finding: No evidence found. None of the retrieved studies report on the association between COVID-19 vaccine and myositis as an adverse event; the closest study on irAEs in lung cancer patients (PMID 40808308) does not address vaccine-attributed myositis, and other studies focus on mortality, arrhythmias, Guillain-Barré syndrome, seizure, safety of XBB.1.5 vaccines, or unrelated pharmacological exposures.
Cited: (none)
supporting: COVID-19 vaccine Myositis Negative-control outcomes incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk Negative-control outcomes pubmed · 88340 hits · run 2026-09-07
9 retrieved record(s)
does_not_resolve 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 38089855 · European heart journal open (2023) — Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.
does_not_resolve 34937500 · Expert review of vaccines (2022) — Self-controlled case series design in vaccine safety: a systematic review.
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 36226469 · Epilepsia (2022) — Association between the risk of seizure and COVID-19 vaccinations: 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 42371637 · JAMA internal medicine (2026) — Prenatal Acetaminophen (Paracetamol) Use and the Risk of Autism and/or Attention-Deficit/Hyperactivity Disorder Among Sibling-Matched Cohorts.
does_not_resolve 40808308 · Human vaccines & immunotherapeutics (2025) — Effects of COVID-19 vaccination on irAEs and prognosis in lung cancer patients receive PD-(L)1 inhibitors.
B6 · Other-antigen comparisonno_data
Measure: Risk vs a different-antigen comparator Comparator: Comparator product with a different antigen Hit rule: Risk specific to the target antigen, not shared with the comparator antigen
Finding: The retrieved evidence includes case reports and narrative reviews describing myositis, dermatomyositis, and anti-MDA5 dermatomyositis following COVID-19 vaccination, but no controlled epidemiologic study (e.g., SCCS) comparing risk of myositis between a target COVID-19 vaccine antigen and a different-antigen comparator was found in the retrieved set.
Cited: (none)
supporting: COVID-19 vaccine Myositis Other-antigen comparison incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk Other-antigen comparison pubmed · 88102 hits · run 2026-09-07
14 retrieved record(s)
does_not_resolve 30172612 · American journal of infection control (2019) — Antibiotic exposure and risk of community-associated Clostridium difficile infection: A self-controlled case series analysis.
does_not_resolve 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 33773635 · The Lancet. Public health (2021) — Periods of altered risk for non-fatal drug overdose: a self-controlled case series.
does_not_resolve 40818314 · Vaccine (2025) — COVID-19 vaccination and the risk of abnormal uterine bleeding: A nationwide self-controlled case series study.
does_not_resolve 38089855 · European heart journal open (2023) — Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.
does_not_resolve 37223097 · Frontiers in immunology (2023) — Safety of COVID-19 vaccine in patients with myasthenia gravis: 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 40808308 · Human vaccines & immunotherapeutics (2025) — Effects of COVID-19 vaccination on irAEs and prognosis in lung cancer patients receive PD-(L)1 inhibitors.
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: A single case series reports new-onset and relapsed dermatomyositis following COVID-19 vaccination, but no controlled epidemiological study reports a per-100k absolute risk of new myositis attributed to COVID-19 vaccine in a defined risk window.
supporting: COVID-19 vaccine Myositis Absolute risk incidence risk cohort OR self-controlled case series pubmed · 946 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk Absolute risk pubmed · 111368 hits · run 2026-09-07
14 retrieved record(s)
does_not_resolve 33773635 · The Lancet. Public health (2021) — Periods of altered risk for non-fatal drug overdose: a self-controlled case series.
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 40818314 · Vaccine (2025) — COVID-19 vaccination and the risk of abnormal uterine bleeding: A nationwide self-controlled case series study.
does_not_resolve 38875047 · The International journal of risk & safe (2024) — Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.
does_not_resolve 37223097 · Frontiers in immunology (2023) — Safety of COVID-19 vaccine in patients with myasthenia gravis: a self-controlled case series study.
refutes_node 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 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: Retrieved evidence for COVID-19 vaccine platform-specific myositis risk is limited to case reports and a case-based review, with no large controlled epidemiological studies directly addressing a platform-specific attributable risk for myositis. One case report describes inflammatory myositis following the second dose of BTN162b2 (Pfizer-BioNTech), and other case-based reviews mention myositis/dermatomyositis after COVID-19 vaccination, but these do not provide comparative risk estimates by platform.
supporting: COVID-19 vaccine Myositis Platform split incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk Platform split pubmed · 88167 hits · run 2026-09-07
14 retrieved record(s)
does_not_resolve 38388239 · Vaccine (2024) — Mortality risk after COVID-19 vaccination: A self-controlled case series study.
does_not_resolve 33773635 · The Lancet. Public health (2021) — Periods of altered risk for non-fatal drug overdose: a self-controlled case series.
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 40818314 · Vaccine (2025) — COVID-19 vaccination and the risk of abnormal uterine bleeding: A nationwide self-controlled case series study.
does_not_resolve 37223097 · Frontiers in immunology (2023) — Safety of COVID-19 vaccine in patients with myasthenia gravis: 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 36226469 · Epilepsia (2022) — Association between the risk of seizure and COVID-19 vaccinations: A self-controlled case-series study.
does_not_resolve 35489031 · Journal of clinical psychopharmacology (2022) — Prescription Stimulants and the Risk of Psychosis: A Systematic Review of Observational Studies.
B9 · Host-structure stratificationno_data
Measure: Risk by age / sex / host structure Comparator: Unstratified estimate Hit rule: Risk concentrated in a defined host subgroup (e.g. young males), stable across sources
Finding: The retrieved evidence includes case reports and small case series describing new-onset myositis or dermatomyositis after COVID-19 vaccination, but no studies provide epidemiological risk estimates stratified by age or sex, and no data confirm a defined host subgroup with stable risk across sources.
Cited: (none)
supporting: COVID-19 vaccine Myositis Host-structure stratification incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk Host-structure stratification pubmed · 88100 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.
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 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 36226469 · Epilepsia (2022) — Association between the risk of seizure and COVID-19 vaccinations: A self-controlled case-series study.
does_not_resolve 40808308 · Human vaccines & immunotherapeutics (2025) — Effects of COVID-19 vaccination on irAEs and prognosis in lung cancer patients receive PD-(L)1 inhibitors.
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 35661906 · Rheumatology international (2022) — Anti-MDA5 dermatomyositis after COVID-19 vaccination: a case-based review.
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 documented formulation or component change in COVID-19 vaccines and its tracking of myositis risk; the studies focus on other outcomes (arrhythmias, Guillain-Barré syndrome, immune-related adverse events in lung cancer) or on methodologic aspects of self-controlled case series.
Cited: (none)
supporting: COVID-19 vaccine Myositis Formulation / component change incidence risk cohort OR self-controlled case series pubmed · 945 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no association OR null OR no increased risk Formulation / component change pubmed · 88262 hits · run 2026-09-07
7 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.
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 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 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
ambiguous 40808308 · Human vaccines & immunotherapeutics (2025) — Effects of COVID-19 vaccination on irAEs and prognosis in lung cancer patients receive PD-(L)1 inhibitors.
does_not_resolve 38890690 · BMC sports science, medicine & rehabilit (2024) — Efficacy of multicomponent interventions on injury risk among ice and snow sports participants-a systematic review and meta-analysis.
H2 · Formulation natural experimentno_data
Measure: Risk shifts with a formulation change in the field Comparator: Pre- vs post-change formulation Hit rule: Observed risk tracks a real-world formulation change (natural experiment)
Finding: no evidence found
Cited: (none)
supporting: COVID-19 vaccine Myositis Formulation natural experiment intervention OR treatment OR reversal pubmed · 15141378 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: COVID-19 vaccine Myositis Policy / pause signal intervention OR treatment OR reversal pubmed · 15141378 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Infection coherence coherence OR latency OR susceptibility pubmed · 870021 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis Infection coherence 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.
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: The retrieved evidence includes case reports and series of myositis/dermatomyositis after COVID-19 vaccination, but none of the cited studies report a monotonic dose-response gradient (larger dose → higher risk) for myositis following COVID-19 vaccines.
Cited: (none)
supporting: COVID-19 vaccine Myositis Dose strength gradient dose-response OR dose effect pubmed · 1299132 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no dose effect OR no dose-response Dose strength gradient pubmed · 131 hits · run 2026-09-07
7 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.
ambiguous 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 36586226 · Journal of clinical neuroscience : offic (2023) — Co-VAN study: COVID-19 vaccine associated neurological diseases- an experience from an apex neurosciences centre and review of the literature.
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: The evidence includes only case reports of myositis or dermatomyositis after the second dose of COVID-19 vaccine (e.g., PMID 36928720, PMID 37763807), and a population-based cohort study (PMID 41273774) that assessed risk after each dose but did not report a gradient or dose-number pattern for increased risk with successive doses. No retrieved study provides a direct comparison of risk between the 1st, 2nd, and 3rd doses to show an increasing or patterned trend.
Cited: (none)
supporting: COVID-19 vaccine Myositis Dose number gradient dose-response OR dose effect pubmed · 1299132 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no dose effect OR no dose-response Dose number gradient pubmed · 575 hits · run 2026-09-07
7 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 36586226 · Journal of clinical neuroscience : offic (2023) — Co-VAN study: COVID-19 vaccine associated neurological diseases- an experience from an apex neurosciences centre and review of the literature.
refutes_node 41273774 · Rheumatology (Oxford, England) (2026) — SARS-CoV-2 vaccination and myositis in Norway and Sweden.
C3n · Measured-exposure tertilesmixed
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 includes case reports and a population-based cohort study. The cohort study (PMID 41273774) provides the strongest evidence: it found no increased risk of myositis after SARS-CoV-2 vaccination in a large Norwegian and Swedish population, with incidence rate ratios comparing risk periods to reference periods. The other articles are case reports or small series describing instances of myositis following COVID-19 vaccination, but they do not provide exposure-tertile risk ordering or comparative effect estimates.
supporting: COVID-19 vaccine Myositis Measured-exposure tertiles dose-response OR dose effect pubmed · 1299132 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no dose effect OR no dose-response Measured-exposure tertiles pubmed · 20 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 34776011 · Infectious diseases of poverty (2021) — Effectiveness and safety of SARS-CoV-2 vaccine in real-world studies: a systematic review and meta-analysis.
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 36586226 · Journal of clinical neuroscience : offic (2023) — Co-VAN study: COVID-19 vaccine associated neurological diseases- an experience from an apex neurosciences centre and review of the literature.
Measure: Effect vs antigen concentration in organoid Comparator: Vehicle / zero antigen Hit rule: Dose-dependent effect across a graded concentration curve
Finding: Two case reports describe myositis following COVID-19 vaccination with serologic and MRI confirmation, and a population-based cohort study in Norway and Sweden reports an increased incidence rate of myositis within 180 days after mRNA or adenoviral vector vaccination. However, these studies do not provide organoid concentration-curve data evaluating dose-dependent effects versus antigen concentration.
supporting: COVID-19 vaccine Myositis Organoid concentration curve dose-response OR dose effect pubmed · 1299132 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no dose effect OR no dose-response Organoid concentration curve pubmed · 31 hits · run 2026-09-07
9 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 36586226 · Journal of clinical neuroscience : offic (2023) — Co-VAN study: COVID-19 vaccine associated neurological diseases- an experience from an apex neurosciences centre and review of the literature.
supports_node 35315602 · Journal of Korean medical science (2022) — Clinicopathological Characteristics of Inflammatory Myositis Induced by COVID-19 Vaccine (Pfizer-BioNTech BNT162b2): A Case Report.
refutes_node 41273774 · Rheumatology (Oxford, England) (2026) — SARS-CoV-2 vaccination and myositis in Norway and Sweden.
C5n · EC50 vs Cmax coherencesupports
Measure: Measured exposure reaches effect threshold Comparator: Pharmacokinetic Cmax vs EC50 Hit rule: Achieved exposure (Cmax/tissue) plausibly reaches the in-vitro EC50
Finding: Case reports and a population-based cohort study indicate that COVID-19 vaccination can be temporally associated with new-onset myositis or dermatomyositis, with the cohort study providing risk estimates for myositis after mRNA and adenoviral vector vaccines.
supporting: COVID-19 vaccine Myositis EC50 vs Cmax coherence dose-response OR dose effect pubmed · 1299132 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis no dose effect OR no dose-response EC50 vs Cmax coherence pubmed · 20 hits · run 2026-09-07
9 retrieved record(s)
does_not_resolve 39082700 · The Journal of infectious diseases (2025) — Effectiveness of MenB-4C Vaccine Against Gonorrhea: A Systematic Review and Meta-analysis.
supports_node 36928720 · Immunologic research (2023) — COVID-19 vaccine-associated myositis: a comprehensive review of the literature driven by a case report.
supports_node 36586226 · Journal of clinical neuroscience : offic (2023) — Co-VAN study: COVID-19 vaccine associated neurological diseases- an experience from an apex neurosciences centre and review of the literature.
refutes_node 41273774 · Rheumatology (Oxford, England) (2026) — SARS-CoV-2 vaccination and myositis in Norway and Sweden.
supports_node 36110335 · Clinical case reports (2022) — COVID-19 vaccine-associated myositis - a case report.
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: A case-based review reports anti-MDA5 dermatomyositis after COVID-19 vaccination, noting that SARS-CoV-2 triggers MDA5 and downstream inflammatory mediators, but does not provide direct detection of a hypothesized mediator in affected tissue compared to control tissue.
Cited: (none)
supporting: COVID-19 vaccine Myositis mechanism Mediator identified in cases in vitro OR patient-derived pubmed · 29239 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis Mediator identified in cases not associated mechanism pubmed · 3 hits · run 2026-09-07
1 retrieved record(s)
supports_node 35661906 · Rheumatology international (2022) — Anti-MDA5 dermatomyositis after COVID-19 vaccination: a case-based review.
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: COVID-19 vaccine Myositis mechanism Mediator in healthy vaccinees in vitro OR patient-derived pubmed · 29239 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: Two case reports describe new-onset myositis after COVID-19 vaccination with onset within a short risk window, but neither provides a direct comparison of mediator levels (e.g., autoantibodies or inflammatory markers) after natural SARS-CoV-2 infection versus after vaccination.
Cited: (none)
supporting: COVID-19 vaccine Myositis mechanism Infection contrast in vitro OR patient-derived pubmed · 29239 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis Infection contrast not associated mechanism pubmed · 3 hits · run 2026-09-07
3 retrieved record(s)
supports_node 35315602 · Journal of Korean medical science (2022) — Clinicopathological Characteristics of Inflammatory Myositis Induced by COVID-19 Vaccine (Pfizer-BioNTech BNT162b2): A Case Report.
supports_node 35789569 · Journal of translational autoimmunity (2022) — Association of anti-SARS-COV-2 vaccine with increased incidence of myositis-related anti-RNA-synthetases auto-antibodies.
supports_node 36062603 · European journal of ophthalmology (2023) — Orbital myositis and scleritis after anti-SARS-CoV-2 mRNA vaccines: A report of three cases.
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: COVID-19 vaccine Myositis mechanism Transfer to recipient in vitro OR patient-derived pubmed · 29239 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis mechanism Transfer specificity in vitro OR patient-derived pubmed · 29239 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis mechanism Depletion / knockdown in vitro OR patient-derived pubmed · 29239 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: COVID-19 vaccine Myositis mechanism Add-back rescue in vitro OR patient-derived pubmed · 29239 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: The abstract describes a controlled trial of an inactivated SARS-CoV-2 vaccine in autoimmune myopathies that assessed neutralizing antibody positivity and median neutralizing activity, but it does not report any data on whether neutralization of a specific mediator blocks myositis phenotype.
supporting: COVID-19 vaccine Myositis mechanism Neutralization in vitro OR patient-derived pubmed · 29239 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis Neutralization not associated mechanism pubmed · 4 hits · run 2026-09-07
2 retrieved record(s)
does_not_resolve 34664616 · Rheumatology (Oxford, England) (2022) — Systemic autoimmune myopathies: a prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2.
does_not_resolve 41441654 · Vaccines (2025) — Antigen Format Determines Immunogenicity of AAV-Based SARS-CoV-2 Vaccines: Full-Length Spike Versus Truncated Subunits.
E9 · Isotype controlno_data
Measure: Isotype control does not reproduce the effect Comparator: Active antibody Hit rule: An isotype control fails to reproduce the block/activation
Finding: The retrieved evidence contains no direct mention of isotype control experiments for COVID-19 vaccine-induced myositis. The studies focus on vaccine safety, immunogenicity, and case reports, but none describe an isotype control failing to reproduce an effect.
Cited: (none)
supporting: COVID-19 vaccine Myositis mechanism Isotype control in vitro OR patient-derived pubmed · 29239 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis Isotype control not associated mechanism pubmed · 6 hits · run 2026-09-07
5 retrieved record(s)
does_not_resolve 35710908 · Nature communications (2022) — Single-cell profiling of the antigen-specific response to BNT162b2 SARS-CoV-2 RNA vaccine.
supports_node 40895572 · Frontiers in immunology (2025) — A possible role for immunogenetic factors in myositis developing after vaccination in the pre-covid-19 era.
does_not_resolve 34664616 · Rheumatology (Oxford, England) (2022) — Systemic autoimmune myopathies: a prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2.
does_not_resolve 37432024 · International journal of rheumatic disea (2024) — IgM nephropathy in a patient with dermatomyositis following COVID-19 vaccination: A case report.
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: COVID-19 vaccine Myositis Full product reproduces component OR antigen OR vector pubmed · 2045214 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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.
does_not_resolve 27384578 · Viruses (2016) — Newcastle Disease Virus as a Vaccine Vector for Development of Human and Veterinary Vaccines.
F2 · Empty vector / particleno_data
Measure: Vector/particle without antigen reproduces (or not) Comparator: Full product Hit rule: Effect attributed to (or excluded from) the vector/particle backbone alone
Finding: The retrieved evidence describes live bacterial and viral vaccine vectors (e.g., adenovirus, Newcastle disease virus) used to deliver heterologous antigens, but none of the abstracts report on myositis, any adverse event, or whether the vector/particle backbone alone (without antigen) reproduces myositis.
Cited: (none)
supporting: COVID-19 vaccine Myositis Empty vector / particle component OR antigen OR vector pubmed · 2045214 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 retrieved evidence addresses the specific question of whether an irrelevant cargo (e.g., a non-COVID-19 vaccine component) fails to reproduce myositis attributed to a COVID-19 vaccine; all retrieved studies discuss vaccine vector platforms (bacterial, measles, influenza, adenovirus, NDV) in general, without any mention of myositis or specificity testing.
Cited: (none)
supporting: COVID-19 vaccine Myositis Irrelevant cargo component OR antigen OR vector pubmed · 2045214 hits · run 2026-09-07
does_not_resolve 25876176 · Human vaccines & immunotherapeutics (2015) — Progress on adenovirus-vectored universal influenza vaccines.
does_not_resolve 21952287 · Cancer journal (Sudbury, Mass.) (2011) — Viral vector-based therapeutic cancer vaccines.
does_not_resolve 27384578 · Viruses (2016) — Newcastle Disease Virus as a Vaccine Vector for Development of Human and Veterinary Vaccines.
F5 · Infection preparationno_data
Measure: Infection preparation vs product comparison Comparator: Product-derived preparation Hit rule: Effect compares correctly between infection and product preparations
Finding: No retrieved evidence addresses myositis as an adverse event following COVID-19 vaccination or compares infection-related vs product-related myositis risk. The abstracts discuss vaccine vector technologies (viral, bacterial, live-attenuated) for influenza, measles, and cancer, but do not mention myositis or any adverse event outcomes.
Cited: (none)
supporting: COVID-19 vaccine Myositis Infection preparation component OR antigen OR vector pubmed · 2045214 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: The retrieved evidence discusses live bacterial and viral vaccine vectors as adjuvants, but does not address whether a cytokine/adjuvant mix alone can reproduce myositis following COVID-19 vaccination.
Cited: (none)
supporting: COVID-19 vaccine Myositis Cytokine / adjuvant mix component OR antigen OR vector pubmed · 2045214 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.
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: COVID-19 vaccine Myositis Component combination component OR antigen OR vector pubmed · 2045214 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.
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: COVID-19 vaccine Myositis 2D human cells animal OR organoid OR cell model pubmed · 1818474 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Organoid / chip animal OR organoid OR cell model pubmed · 1818474 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Block in vitro / in vivo intervention OR treatment OR reversal pubmed · 15141378 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis mechanism Host-line dependence in vitro OR patient-derived pubmed · 29239 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Animal, clinical route animal OR organoid OR cell model pubmed · 1818474 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Susceptible animal animal OR organoid OR cell model pubmed · 1818474 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Replication across labs animal OR organoid OR cell model pubmed · 1818474 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Blinded scoring animal OR organoid OR cell model pubmed · 1818474 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Experimental time course animal OR organoid OR cell model pubmed · 1818474 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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: COVID-19 vaccine Myositis Susceptibility trait coherence OR latency OR susceptibility pubmed · 870020 hits · run 2026-09-07
mirror: COVID-19 vaccine Myositis 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.