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Vaccine Evidence Summary

MMR Vaccine Side Effects (Measles, Mumps & Rubella — What VAERS & Lareb Report)

This page answers “mmr vaccine side effects” with sourced pharmacovigilance data — live-scraped Lareb (Netherlands) and VigiAccess (WHO) PT data. Counts are database reports, not proven vaccine-caused injury rates.

Look up a vaccine lot or batch number in VAERS →

Last updated: July 2026  ·  Status: Current U.S. licensed products reviewed

ⓘ Methodology Note

This page summarizes published pre-licensure clinical trial data, post-licensure surveillance findings, and peer-reviewed epidemiological studies for the MMR vaccines currently licensed in the United States (M-M-R® II by Merck and PRIORIX by GSK). Safety and efficacy data are presented without interpretive language that implies the vaccine is "safe" or "unsafe." Each section notes the quality and strength of the underlying evidence. Data are drawn from FDA review documents, published clinical trials, Vaccine Safety Datalink (VSD) analyses, VAERS summaries, Cochrane systematic reviews, Institute of Medicine / National Academies consensus reports, and peer-reviewed literature. Where findings are inconsistent or limited, those limitations are explicitly stated.

1. Basic Information

Diseases Protected Against

CDC Recommended Schedule (United States, 2025)

Dose Recommended Age Notes
Dose 1 12–15 months MMR or MMRV (MMR + varicella) may be given
Dose 2 4–6 years Routinely given before school entry
Catch-up Any age ≥ 4 weeks after dose 1 For those lacking evidence of immunity
Early dose (travel) 6–11 months Does not replace routine 2-dose series; given before international travel to measles-endemic areas

Source: CDC Advisory Committee on Immunization Practices (ACIP), 2025 Child & Adolescent Immunization Schedule.

Licensed Products (U.S.)

Documented Adverse Events (HRSA VICP)

The following adverse events are documented by the HRSA Vaccine Injury Compensation Program (VICP) as having a temporal relationship to this vaccine. These are not necessarily confirmed causal relationships, but rather conditions for which claims have been compensated or are presumed caused by the vaccine.

WHO Causality Assessment Methodology

The World Health Organization's Global Advisory Committee on Vaccine Safety (GACVS) uses a 4-level causality classification:

  • Consistent: Epidemiological studies demonstrate a statistically significant association with temporal specificity and biological plausibility. Replicated across independent populations and study designs.
  • Indeterminate: Evidence exists but is insufficient to confirm or rule out causality. May be limited by sample size, confounding, or inconsistency across studies.
  • Inconsistent: Studies have not demonstrated a consistent or convincing association. Evidence against causality outweighs evidence for it.
  • Unclassifiable: Insufficient data to reach any conclusion. Requires further evidence.

Source: WHO Global Advisory Committee on Vaccine Safety (GACVS), 2021–2025 causality review cycles. See also Institute of Medicine (IOM) Adverse Effects of Vaccines: Evidence and Causality (2012) for pre-COVID vaccine assessments.

Condition Time Window Causality Level HRSA Description
Anaphylaxis 0-1 days Consistent
WHO Determination (2021, 2023): Consistent for all COVID-19 vaccines. Rate: ~2–5 per million doses. Temporal specificity (onset within minutes, consistent with IgE-mediated). Plausible biological mechanism: immediate hypersensitivity to vaccine excipients (PEG for mRNA, polysorbate for adenoviral). Verified via passive surveillance convergence across multiple national systems (VAERS, EudraVigilance, MHRA Yellow Card, TGA DAEN).
Biological Mechanism: Not thought to be spike protein mediated; likely polyethylene glycol (PEG) in mRNA vaccines triggers IgE-mediated mast cell degranulation
Clinical Evidence: (Kuder et al., 2021); Mechanism: (Risma et al., 2021)
Spike Protein Evidence: Not tested
Anaphylaxis occurring within 4 hours following vaccination
Measles Inclusion Body Encephalitis (MIBE) 0-365 days Indeterminate
WHO / IOM Causality Assessment: Evidence reviewed; causal association cannot be confirmed or excluded at current evidence level. Requires further epidemiological and mechanistic investigation. See HRSA VICP Table for program-specific determination.
Biological Mechanism: Neuroinflammation; Potential cross-reactivity with neuronal antigens
Clinical Evidence: (Abdelhady et al., 2023; Gao et al., 2022)
Spike Protein Evidence: Cell model and animal model (Fontes-Dantas et al., 2023)
MIBE (subacute sclerosing panencephalitis-like syndrome) in immunocompromised individuals, within 12 months
Vaccine Strain Measles Infection (Disseminated) 0-365 days Indeterminate
WHO / IOM Causality Assessment: Evidence reviewed; causal association cannot be confirmed or excluded at current evidence level. Requires further epidemiological and mechanistic investigation. See HRSA VICP Table for program-specific determination.
Biological Mechanism: Multiple plausible biological mechanisms under investigation. Brighton Collaboration AESI monitoring ongoing.
Clinical Evidence: See HRSA VICP/CICP program documentation for current determination.
Spike Protein Evidence: Evidence reviewed; consult Brighton Collaboration list for mechanistic assessment status.
Vaccine strain measles (disseminated) in immunocompromised vaccine recipients within 12 months
Intussusception (for MMR-V combination only) 0-30 days Indeterminate
WHO / IOM Causality Assessment: Evidence reviewed; causal association cannot be confirmed or excluded at current evidence level. Requires further epidemiological and mechanistic investigation. See HRSA VICP Table for program-specific determination.
Biological Mechanism: Vaccine-strain replication in intestinal lymphoid tissue leading to lead-point for intussusception (rotavirus-specific mechanism, not spike protein mediated)
Clinical Evidence: Post-licensure surveillance confirmed signal; ~1–5 excess cases per 100,000
Spike Protein Evidence: Not applicable (rotavirus vaccine, not COVID-19)
Intussusception within 30 days (MMRV vaccine only)
Syncope (Fainting) 0-1 days Indeterminate
WHO / IOM Causality Assessment: Evidence reviewed; causal association cannot be confirmed or excluded at current evidence level. Requires further epidemiological and mechanistic investigation. See HRSA VICP Table for program-specific determination.
Biological Mechanism: Multiple plausible biological mechanisms under investigation. Brighton Collaboration AESI monitoring ongoing.
Clinical Evidence: See HRSA VICP/CICP program documentation for current determination.
Spike Protein Evidence: Evidence reviewed; consult Brighton Collaboration list for mechanistic assessment status.
Syncope occurring within a few minutes to 2 hours after vaccination

Important Notes

  • HRSA VICP: Conditions listed are documented by HRSA as having temporal relationship to vaccination. Compensation does not imply causation.
  • Temporal Association: These conditions occurred after vaccination within the specified time window, but other factors may have contributed.
  • Rarity: Most adverse events are extremely rare. Serious adverse events from vaccines occur in roughly 1-2 per million doses.
  • Biological Plausibility: Mechanistic evidence is under review and will be integrated in Q3 2026.
  • Benefit-Risk: This page documents documented injuries. See disease burden pages for context on prevented diseases.

Ingredients (Package Insert)

Structured composition for 2 branded products covered on this page, taken from FDA-approved package inserts (DailyMed / manufacturer prescribing information). Lists are per product — formulations differ by manufacturer and presentation. Click an ingredient name to open its safety-context page when available.

Live attenuated IM or SC Subcutaneous (SC) No preservative (typical single-dose) Gelatin Neomycin Egg protein
M-M-R II Merck Sharp & Dohme LLC · Live attenuated

Delivery

Route: IM or SC

Form: Lyophilized powder (reconstitute)

Dose volume: 0.5 mL

Presentation: single-dose vial + sterile diluent

Encapsulation / delivery vehicle

None (no nanoparticle/VLP encapsulation system) — No nanoparticle encapsulation; live attenuated virus suspension after reconstitution.

Antigens

AntigenTypeAmount / dose
Measles virus (live, attenuated)
Strain: Enders' attenuated Edmonston · System: chick embryo cell culture
Live attenuated virus≥3.0 log10 TCID50 per 0.5 mL
Mumps virus (live, attenuated)
Strain: Jeryl Lynn (B level) · System: chick embryo cell culture
Live attenuated virus≥4.1 log10 TCID50 per 0.5 mL
Rubella virus (live, attenuated)
Strain: Wistar RA 27/3 · System: WI-38 human diploid lung fibroblasts
Live attenuated virus≥3.0 log10 TCID50 per 0.5 mL

Adjuvants

None listed on the package insert for this product (common for live attenuated and some inactivated whole-virus vaccines).

Preservatives

  • None — Single-dose presentation; label states no preservative.

Excipients & residuals

IngredientCategoryAmountRole
SorbitolStabilizer14.5 mgstabilizer
SucroseStabilizer1.9 mgstabilizer
Hydrolyzed gelatinStabilizer14.5 mgstabilizer
Recombinant human albuminStabilizer≤0.3 mgstabilizer
Fetal bovine serumResidual (manufacturing)<1 ppmresidual from cell culture
NeomycinResidual (antibiotic)≈25 mcgresidual manufacturing antibiotic
Other buffer and media ingredientsBuffernot individually quantified on labelbuffer/media

Live attenuated; no adjuvant. Product contains no preservative.

Source: DailyMed · Verified 2026-07-09

PRIORIX GlaxoSmithKline Biologicals · Live attenuated

Delivery

Route: Subcutaneous (SC)

Form: Lyophilized powder (reconstitute)

Dose volume: 0.5 mL

Presentation: single-dose vial

Encapsulation / delivery vehicle

None (no nanoparticle/VLP encapsulation system)

Antigens

AntigenTypeAmount / dose
Measles virus (live, attenuated)
Strain: Schwarz · System: chick-embryo fibroblasts
Live attenuated virus≥3.4 log10 CCID50
Mumps virus (live, attenuated)
Strain: RIT 4385 (Jeryl Lynn-derived) · System: chick-embryo fibroblasts
Live attenuated virus≥4.2 log10 CCID50
Rubella virus (live, attenuated)
Strain: Wistar RA 27/3 · System: MRC-5 human diploid cells
Live attenuated virus≥3.3 log10 CCID50

Adjuvants

None listed on the package insert for this product (common for live attenuated and some inactivated whole-virus vaccines).

Preservatives

  • None — Single-dose presentation; label states no preservative.

Excipients & residuals

IngredientCategoryAmountRole
Anhydrous lactoseStabilizer32 mgstabilizer
SorbitolStabilizer9 mgstabilizer
Amino acidsStabilizer9 mgstabilizer
MannitolStabilizer8 mgstabilizer
Neomycin sulphateResidual (antibiotic)≤25 mcg residualresidual antibiotic
OvalbuminResidual (culture)≤60 ng residualresidual egg protein
Bovine serum albuminResidual (manufacturing)≤50 ng residualresidual BSA

Contains no gelatin — relevant for gelatin allergy. Residual ovalbumin possible from chick-embryo manufacture.

Source: DailyMed · Verified 2026-07-09

ⓘ How to read this section

Ingredient lists are sourced from official package inserts for the specific brands named above. Formulations can change between lots and over time — verify against the current label before any clinical decision. Presence of a substance does not by itself indicate harm; toxicology is dose-, route-, and context-dependent. Browse the full ingredient database: Vaccine Ingredients index.

Causality assessment & potential mechanisms

Conditions below combine WHO-style causality levels with potential biological mechanisms from the site mechanism catalog (ae_mechanisms_catalog.json). HRSA VICP table listing (where shown) indicates a compensable temporal association under U.S. program rules — not automatic proof of causation for every case. Mechanisms are hypothesis-level pathways with graded evidence.

Condition Time window Causality Potential mechanism(s)
Anaphylaxis HRSA table 0–1 days Very likely / Probable

Evidence: High

IgE-mediated hypersensitivity (anaphylaxis) (primary · hypersensitivity)

Pre-existing or newly formed IgE against vaccine antigens or excipients (e.g., gelatin, egg proteins, PEG, polysorbate) triggers mast-cell and basophil degranulation with systemic mediator release.

Febrile seizure 5–14 days Very likely / Probable

Evidence: High

Fever-triggered seizure (primary · innate_inflammation)

Vaccine-induced fever lowers seizure threshold in susceptible young children; measles-containing vaccines show a well-documented risk window roughly 7–14 days post-dose.

Idiopathic thrombocytopenic purpura (ITP) 0–42 days Possible

Evidence: Moderate

Immune-mediated thrombocytopenia (ITP) (primary · molecular_mimicry)

Cross-reactive antibodies against platelet antigens lead to accelerated platelet destruction, classically described after live measles-containing vaccines within weeks.

Measles inclusion body encephalitis (MIBE) HRSA table 0–365 days Very likely / Probable

Evidence: High

Uncontrolled live attenuated vaccine replication (primary · live_replication)

In immunocompromised or otherwise susceptible hosts, live attenuated vaccine strains can replicate beyond the intended limited infection, causing disseminated disease or organ-specific infection.

Vaccine-strain encephalitis / encephalomyelitis (contributing · live_replication)

Live viral vaccines can rarely cause CNS infection or demyelinating encephalomyelitis via direct viral invasion or post-infectious immune attack.

Disseminated vaccine-strain measles HRSA table 0–365 days Very likely / Probable

Evidence: High

Uncontrolled live attenuated vaccine replication (primary · live_replication)

In immunocompromised or otherwise susceptible hosts, live attenuated vaccine strains can replicate beyond the intended limited infection, causing disseminated disease or organ-specific infection.

Syncope HRSA table 0–1 days Possible

Evidence: Moderate

Vasovagal (needle) syncope (primary · vasovagal)

Pain, anxiety, or orthostatic stress from injection triggers parasympathetic surge with bradycardia and hypotension, producing transient loss of consciousness—common in adolescents.

Framework: WHO causality + HRSA VICP (where applicable) + AE mechanism catalog. Last updated: 2026-07-18. Schema: schemas/vaccine_injury_table.schema.json · Mechanisms: schemas/ae_mechanism.schema.json. Not medical or legal advice.

2. Pre-Licensure Clinical Trial Data

Licensure trial design (ICAN / OpenVAERS)

The table below reproduces ICAN’s No Placebo Table rows for U.S. childhood-schedule products relevant to this page — including the control/comparator used in FDA licensing trials (not always saline placebo). OSMF presents this for transparency; it is not an endorsement of ICAN interpretations.

Vaccine Brand Manufacturer Doses (schedule) Ages injected Control / comparator Placebo Safety review window
MMRM-M-R-IIMerck612M 4YNoneNo42 days
MMRPriorixGSK612M 4YM-M-R-IINo6 months

Source: OpenVAERS — No Placebo Table · ICAN original PDF · Attribution: Informed Consent Action Network (ICAN) via OpenVAERS · Last fetched: 2026-07-16. For many trials listing '6 months' safety review, ICAN notes review was typically ~30 days post-injection with a phone call at 6 months.

M-M-R® II (Merck) — Pivotal Trials

The original MMR vaccine (M-M-R) was licensed in 1971; M-M-R® II (with a more stabilised rubella component) was licensed in 1978. The pivotal pre-licensure trials for M-M-R® II enrolled approximately 1,964 children across multiple studies, principally evaluating immunogenicity (seroconversion rates).

Metric Data Evidence Strength
Total participants (combined trials) ~1,964 children Limited Small by modern standards
Age range Primarily 12 months – 6 years
Duration of safety follow-up 42 days post-vaccination (standard for the era) Limited
Seroconversion (measles) ~95–99% (hemagglutination inhibition titers) Moderate
Seroconversion (mumps) ~96–98% Moderate
Seroconversion (rubella) ~98–99% Moderate

PRIORIX (GSK) — Pivotal Trials for U.S. Licensure (2022)

PRIORIX was licensed in the U.S. based on six clinical trials that included a total of ~6,449 participants who received PRIORIX. The trials were conducted in multiple countries. Three studies compared PRIORIX to M-M-R® II. The primary immunogenicity endpoints were non-inferiority comparisons of seroresponse rates and geometric mean titers.

Most Common Adverse Reactions (Pre-Licensure Trials)

Reaction M-M-R® II (Approx.) PRIORIX (Approx.)
Injection site pain / tenderness ~15–25% ~20–30%
Injection site redness ~5–10% ~8–15%
Fever ≥ 38.0°C (100.4°F) ~5–15% ~8–18%
Fever ≥ 39.4°C (103°F) ~2–5% ~1–3%
Rash (measles-like, morbilliform) ~5% ~3–4%
Irritability / fussiness ~10–20% ~12–22%
Upper respiratory symptoms ~5–8% ~4–7%

Sources: M-M-R® II and PRIORIX prescribing information / FDA review documents. Frequencies vary by trial design, age group, and case definitions used.

Key Limitations of Pre-Licensure Trial Data

3. Post-Licensure Safety Data

Vaccine Safety Datalink (VSD)

The VSD is a collaboration between the CDC and integrated healthcare organizations that monitor the electronic health records of approximately 9–10 million people annually (~3% of the U.S. population). It enables near-real-time active surveillance ("rapid cycle analysis") as well as retrospective cohort and case-control studies.

Sources: DeStefano et al. (2004) Pediatrics; Klein et al. (2010) Pediatrics; VSD annual surveillance reports (CDC).

VAERS (Vaccine Adverse Event Reporting System)

VAERS is a passive (spontaneous) reporting system co-managed by the CDC and FDA. VAERS cannot establish causation. Reports may be submitted by anyone and reflect unverified temporal associations. Underreporting is common; conversely, stimulated reporting can occur after media attention.

VAERS Metric (MMR, cumulative data) Approximate Figures
Total U.S. doses distributed (estimated, all MMR products, through ~2024) >600 million doses
Total VAERS reports received for MMR ~85,000 – 100,000 (cumulative)
Reports classified as "serious" (per CFR 600.80 criteria: death, life-threatening illness, hospitalization, disability, congenital anomaly) ~8–10% of total MMR reports
Most commonly reported adverse events Fever, rash, injection site reactions, pyrexia, irritability (consistent with clinical trial data)

⚠ Critical Caveat

VAERS data represent unverified reports of events temporally associated with vaccination. A report to VAERS does not mean the vaccine caused the event. VAERS is designed to generate hypotheses and detect potential safety signals; it cannot be used to calculate incidence rates or establish causality. Any analysis that uses raw VAERS report counts as a measure of vaccine risk is scientifically invalid.

Major Independent Post-Licensure Reviews

Review / Institution Year(s) Design & Scope Key Finding
Institute of Medicine (IOM) — "Adverse Effects of Vaccines: Evidence and Causality" 2012 Systematic review of >12,000 peer-reviewed articles; consensus committee evaluated epidemiological and mechanistic evidence for 158 adverse event–vaccine pairs Favors acceptance of a causal relationship for MMR and: measles inclusion body encephalitis (in immunocompromised), febrile seizures, anaphylaxis, and transient arthralgia (rubella component). Rejects causal association for MMR and autism, type 1 diabetes, and asthma.
Cochrane Systematic Review — "MMR Vaccine" (Demicheli et al.) 2012 (updated 2020) Meta-analysis of 138 randomized and quasi-randomized controlled trials, plus observational studies; N > 23 million children in observational studies Effectiveness: 1-dose measles efficacy ~95%; 2-dose ~96%. Safety: No credible evidence of association with autism, asthma, leukemia, or multiple sclerosis. Identified febrile seizures and ITP as associated risks.
National Academies of Sciences, Engineering, and Medicine (NASEM) — "Vaccine Safety" 2020 (targeted updates ongoing) Review of safety data for the recommended childhood immunization schedule No evidence that the recommended schedule is associated with adverse neurodevelopmental outcomes.
Danish Nationwide Cohort Study (Hviid et al., Annals of Internal Medicine) 2019 Population-based cohort: 657,461 children born in Denmark 1999–2010; up to 14 years follow-up No increased risk of autism in MMR-vaccinated vs. unvaccinated children (HR 0.93; 95% CI 0.85–1.02). No increased risk in subgroups considered high-risk.

The Wakefield Paper (1998) and Subsequent Investigation

A 1998 case series (n=12) by Wakefield et al., published in The Lancet, hypothesised an association between MMR, gastrointestinal disease, and autism. The paper was fully retracted by The Lancet in 2010 following a General Medical Council (UK) investigation that found Wakefield guilty of serious professional misconduct, including ethical violations and undisclosed financial conflicts of interest. Multiple large-scale epidemiological studies (see Section 6 and References) have since found no evidence of an association. This is noted here because the Wakefield paper was the primary origin of the MMR–autism hypothesis and continues to influence public perception despite retraction.

Confirmed Safety Signals Identified in Post-Licensure Data

Note: Safety "signals" identified through post-licensure surveillance require further analytical epidemiological studies to confirm or refute causality. Signals may later be determined to be coincidental.

VAERS Reporting Data — Halma & Varon (2025), DARE-SAFE

The DARE-SAFE paper (Halma & Varon, Pharmacoepidemiology 2025, CC BY 4.0) analyzed VAERS reports for vaccines administered in the United States from 2006–2022. The following data are extracted from Table 1 of that paper for this vaccine (MMR combined (Measles, Mumps, Rubella; M-M-R II + PRIORIX)):

MetricValue
U.S. doses administered (2006–2022)134,424,338
Total VAERS AE reports35,743
AE reporting rate (per 100,000 doses)26.6
Total death reports88
Death reporting rate (per 100,000 doses)0.0655
AE-to-Death ratio406:1

Source: Halma, M.; Varon, J. DARE-SAFE. Pharmacoepidemiology. 2025. DOI: 10.3390/pharma4020007. CC BY 4.0. Data from Table 1.

📚 Important Interpretive Caveats (from the paper itself)

  • Reporting rate ≠ incidence rate. VAERS is a passive, unverified system. A report means someone submitted a claim of temporal association, not a confirmed causal event. The paper is explicit that causality cannot be inferred from these numbers alone.
  • Reporting behavior is not uniform. More serious, unusual, or media-salient events are reported at much higher rates than mild ones. Products receiving more public, media, legal, and clinical attention (particularly COVID-19 vaccines, which also benefited from V-safe active-surveillance prompts and CICP compensation pathways) generate more reports per dose regardless of true risk.
  • Age and comorbidity confounding is not adjusted. COVID-19 vaccines were disproportionately administered to elderly and comorbid populations (nursing homes, 65+, high-risk groups in early 2021) with much higher background all-cause mortality than the general child/working-age population. Some fraction of temporally-associated deaths would occur regardless of vaccination, and the paper does not perform a background-rate comparison.
  • Stimulated reporting is a known, documented phenomenon. Media coverage, plaintiff attorney solicitation, and advocacy campaigns — all independently inflate VAERS reporting propensity. The paper cites this literature but does not correct for it.
  • Small-denominator rows are unreliable. Rates computed from small denominators (e.g., monovalent measles, DT, mumps, rubella) have enormous statistical uncertainty and should not be compared to vaccines with hundreds of millions of administered doses without noting the wide confidence intervals.

Source: Halma, M.; Varon, J. DARE-SAFE: Denominator-Adjusted Rate Estimates of Substance Adverse Events Frequency Evaluation in Pharmaceuticals and Vaccines. Pharmacoepidemiology. 2025, 4, 7. DOI: 10.3390/pharma4020007. CC BY 4.0.

Passive Surveillance: AE Type Breakdown (Multi-System)

Side-by-side view of U.S. VAERS, Health Canada Canada Vigilance, Japan JADER (PMDA), EU EudraVigilance, and live-scraped international systems via SurVigilance (VigiAccess, Lareb, DAEN, DMA, Medsafe). SurVigilance panels show MedDRA PT mention totals (not individual-case counts). Category assignment uses keyword matching — approximate, not official SOC coding. VAERS ZIP CAPTCHA downloads use this site’s vaers_pipeline.py; FAERS is bulk quarterly ZIP via SurVigilance (not product search).

VAERS (United States)

Canada Vigilance (Canada)

JADER (PMDA, Japan)

EudraVigilance (EU)

47,233
individual cases · adrreports.eu DAP export (up to 28/06/2026)
Reaction SOC breakdown not included in this workbook export.

SurVigilance: VigiAccess · Lareb · DAEN · DMA · Medsafe

VigiAccess (WHO)

Lareb (Netherlands)

DAEN (Australia)

DMA (Denmark)

Denmark DMA interactive ADR search is currently offline (Danish Medicines Agency IT transition; public overviews frozen at 12 Mar 2024). Live product PT tables cannot be retrieved until DKMA restores the search. See DKMA notice. Denmark continues to report into EU EudraVigilance (panel above).

Medsafe (New Zealand)

VAERS (U.S., 2006–2024): 45,243 symptom mentions (33.66/100k doses). Largest share: Other / Unclassified (44%), General / Systemic (non-local) (11%), Dermatological (non-injection-site) (9%). Canada Vigilance (CV Online extract): 4,089 reaction mentions in 1,219 unique reports (51.4% serious (627 of 1,219 reports)). Largest share: General / Systemic (non-local) (21%), Dermatological (non-injection-site) (14%), Neurological (12%). JADER (PMDA public CSV extract): 1,603 reaction mentions in 1,132 unique reports (3.5% serious (40 of 1,132 reports)). Largest share: Neurological (52%), Other / Unclassified (18%), General / Systemic (non-local) (8%). EudraVigilance (EU DAP export): 47,233 individual cases (up to 28/06/2026). Reaction SOC categories were not exported in the local DAP workbooks — case count only. VigiAccess (WHO): 483,765 reaction-term mentions · search: MMR. Largest share: General / Systemic (non-local) (18%), Other / Unclassified (17%), Injection-site / Local reaction (16%). Lareb (Netherlands): 14,416 reaction-term mentions · search: MMR vaccine. Largest share: General / Systemic (non-local) (20%), Neurological (13%), Other / Unclassified (13%). DAEN (Australia): 3,958 reaction-term mentions · search: measles mumps rubella. Largest share: General / Systemic (non-local) (18%), Injection-site / Local reaction (17%), Other / Unclassified (14%). Medsafe (New Zealand): 2,841 reaction-term mentions · search: MMR. Largest share: Gastrointestinal (53%), Other / Unclassified (17%), Allergic / Anaphylactic (7%). Cross-database note: All systems are passive and unverified; reporting rates are not directly comparable across countries (different populations, reporting incentives, and lack of dose denominators for Canada/Japan/EU). top VAERS: Other / Unclassified; top Canada Vigilance: General / Systemic (non-local); top JADER: Neurological. SurVigilance note: VigiAccess, Lareb, DAEN, DMA, and Medsafe counts are live-scraped MedDRA PT mention totals (not deduplicated individual cases). Data via SurVigilance (GPL-3.0; pip install SurVigilance). Category assignment uses keyword matching on reported reaction terms — approximate and exploratory. Neither database establishes causality.

Compare AE patterns across all vaccines →

Pharmacovigilance Lot Signal Detection — Hypothesis-Generating Only

Multi-system context below. VAERS (U.S.) supports lot-level volume z-scores and seriousness flags by product and lot (2006–2024). Each lot links to a summary with report count, seriousness %, adverse-event pie chart, U.S. state map, and timeline. A signal flag means a statistical threshold was exceeded — not that a lot is unsafe. Full dashboard →

VAERS flags: VOL high report volume (z ≥ 3) · BURST clustered in <90 days · SER serious reports >50%. Lot numbers are voluntary/incomplete in VAERS. Location data is U.S. state only (no postal codes in the public extract).

VAERS (United States) — all lots by product

14,776 reports with usable lot across 2,001 lots · 232 flagged

Loading lot tables…

Other Pharmacovigilance Systems

Lot-level analysis is only possible where reporters supply batch/lot numbers in the public extract. Canada Vigilance, JADER (PMDA, Japan), and most other national systems publish product-level spontaneous reports without lot fields.

Canada Vigilance (Health Canada)

1,219 unique reports · 4,089 reaction mentions · 51.4% serious (627 of 1,219 reports). Top categories: General / Systemic (non-local) (21%), Dermatological (non-injection-site) (14%), Neurological (12%).

Canada Vigilance spontaneous reports are unverified temporal associations. The public CV Online data extract does not include lot or batch numbers, so lot-level signal detection is not possible for this system — only product-level reaction patterns are shown here. No Canadian dose denominators are available. Extract 2026-03-31.

Search Canada Vigilance →

JADER (PMDA, Japan)

1,132 unique reports · 1,603 reaction mentions · 3.5% serious (40 of 1,132 reports). Top categories: Neurological (52%), Other / Unclassified (18%), General / Systemic (non-local) (8%).

JADER (Japanese Adverse Drug Event Report database) spontaneous reports are unverified temporal associations; PMDA has not assessed causality per case. The public CSV extract does not include lot or batch numbers, so lot-level signal detection is not possible — only product-level reaction patterns are shown here. Reaction terms in source data use MedDRA/J Preferred Terms. JADER CSV extract pmdacasereport202606 (2026-06). JADER reference (PDF)

Search JADER / PMDA adverse reactions →

EudraVigilance (EU)

47,233 individual cases (up to 28/06/2026) · MEASLES, MUMPS AND RUBELLA VACCINE (LIVE). Reaction SOC breakdown not included in this DAP export.

EudraVigilance spontaneous reports are unverified temporal associations. The local EudraVigilance DAP workbooks provide individual-case counts from adrreports.eu; exported Reaction SOC filters were not set, so reaction-category charts are unavailable from this extract. Lot/batch numbers are not in public line listings.

Search EudraVigilance →

VigiAccess (WHO)

483,765 MedDRA PT mentions · search: MMR. Top categories: General / Systemic (non-local) (18%), Other / Unclassified (17%), Injection-site / Local reaction (16%).

Live-scraped public portal data via SurVigilance (GPL-3.0). Counts are reaction-term mentions, not deduplicated individual cases. No lot/batch field.

Search VigiAccess (WHO) →

Lareb (Netherlands)

14,416 MedDRA PT mentions · search: MMR vaccine. Top categories: General / Systemic (non-local) (20%), Neurological (13%), Other / Unclassified (13%).

Live-scraped public portal data via SurVigilance (GPL-3.0). Counts are reaction-term mentions, not deduplicated individual cases. No lot/batch field.

Search Lareb (Netherlands) →

DAEN (Australia)

3,958 MedDRA PT mentions · search: measles mumps rubella. Top categories: General / Systemic (non-local) (18%), Injection-site / Local reaction (17%), Other / Unclassified (14%).

Live-scraped public portal data via SurVigilance (GPL-3.0). Counts are reaction-term mentions, not deduplicated individual cases. No lot/batch field.

Search DAEN (Australia) →

SystemRegionLot data
VAERSUnited StatesLot data
Canada VigilanceCanadaNo public lot field
JADER (PMDA, Japan)JapanNo public lot field
Lareb (Netherlands)NetherlandsNo public lot field
EudraVigilanceEuropean UnionNo public lot field
VigiAccess (WHO)GlobalNo public lot field
Yellow Card (UK)United KingdomNo public lot field
DAEN (Australia)AustraliaNo public lot field

All global data sources → · Data schemas →

Active Pharmacovigilance (Defined-Population Surveillance)

Curated findings for MMR / MMRV from active systems (not VAERS). Page inventory last reviewed: 2026-07-10.

ⓘ Active vs. passive — why this pane is separate

The VAERS / multi-system charts above are passive surveillance: spontaneous, unverified reports without a fixed denominator. Active surveillance starts from a defined, enumerated population (EHR/claims or structured post-vaccination surveys), applies pre-specified statistical tests, and asks whether an outcome occurs more often than expected in a risk window versus a comparison window or group. These are not two flavors of the same evidence — active findings are the harder tier that can confirm, refute, or leave under investigation a signal first hinted in passive data. Do not add VAERS report counts to active incidence rates.

○ No signal detected ◐ Signal under investigation ◑ Investigated — not confirmed ● Signal confirmed (true association) – Not currently under active surveillance

CDC Vaccine Safety Datalink (VSD)

Outcome: Febrile seizures (MMRV vs separate MMR + varicella)

Tier 2 ● Signal confirmed (true association)

VSD found approximately twice the febrile-seizure risk after first-dose MMRV versus separate MMR + varicella in toddlers. Finding confirmed and used in ACIP preference discussions (preference for separate vaccines for first dose in some periods). Background: febrile seizures are usually brief without long-term sequelae.

Population

Children 12–23 months receiving first dose

Risk interval

5–12 days post-vaccination (measles-component viremia window)

Comparison

Separate MMR + varicella same-day administration

Evaluation period

2000s–2010 (key RCA publication 2010; policy updates ongoing)

Method

Rapid Cycle Analysis and observational studies

Related passive AE category on this page: Neurological (see multi-system charts above — not additive with active rates).

Sources: Klein NP et al. Pediatrics 2010 — MMRV and febrile seizures · CDC VSD

Record last reviewed: 2026-07-10

CDC Vaccine Safety Datalink (VSD)

Outcome: Immune thrombocytopenic purpura (ITP)

Tier 2 ● Signal confirmed (true association)

Active observational studies support a small elevated risk of transient ITP after MMR, lower than ITP risk after natural measles/rubella infection. Typically self-limited.

Population

Children after MMR

Risk interval

Approximately 1–6 weeks post-vaccination

Comparison

Control intervals in self-controlled designs

Evaluation period

Multiple VSD eras (classic estimates ~1 per 30,000–40,000 doses)

Method

Self-controlled risk-interval / observational studies

Related passive AE category on this page: Hematologic (see multi-system charts above — not additive with active rates).

Sources: France EK et al. Pediatrics 2008 — ITP after MMR

Record last reviewed: 2026-07-10

CDC Vaccine Safety Datalink (VSD) / multi-country cohorts

Outcome: Autism spectrum disorder

Tier 2 ○ No signal detected

Multiple large active epidemiological studies (including VSD analyses and national cohorts) found no increased autism risk after MMR. IOM/NASEM favored rejection of a causal association.

Population

Pediatric cohorts with documented MMR exposure

Risk interval

Long-term follow-up (not a short post-dose RCA window)

Comparison

Unvaccinated or alternate timing comparators

Evaluation period

1990s–2010s landmark studies; ongoing surveillance context

Method

Large cohort and case-control active designs

Sources: Hviid et al. Ann Intern Med 2019 — Danish nationwide cohort · DeStefano et al. Pediatrics 2004 — VSD age-at-vaccination study

Record last reviewed: 2026-07-10

Update cadence: Tier 1: check AusVaxSafety monthly when public pages update. Tier 2/3: quarterly review around ACIP meetings and PubMed/MMWR; set lastReviewed per record. Source tiers: Tier 1 = public near-real-time dashboards (e.g. AusVaxSafety); Tier 2 = VSD / Sentinel / PRAC-type findings released via ACIP slides, MMWR, or papers (no public VSD raw dashboard); Tier 3 = regulator label/safety communications. Detecting a signal and later classifying it as not confirmed is normal system behavior — not an anomaly to hide or amplify.

4. Documented Adverse Events — Evidence of Association

Rank-aggregated VAERS signal detection (rankv)

The table below lists vaccine–event pairs that were detected as disproportionality signals by all four base methods used in rankv (GPS, PRR, ROR, BCPNN) on multi-decade VAERS data, then ordered by rank aggregation (Borda average rank; related to the Spearman/GA top-list approach in the rankv paper).

Agg. rank VAERS product Preferred term (event) N Method ranks (GPS / PRR / ROR / BCPNN)
32 RUBELLA (MERUVAX II) Osteoarthritis
clinical-coded PT
61 GPS rank 35 (EBGM=29.83); PRR rank 70 (PRR=74.0237); ROR rank 69 (ROR=75.9249); BCPNN rank 27 (IC_LB=4.6685)
119 RUBELLA (MERUVAX II) Arthritis
clinical-coded PT
41 GPS rank 146 (EBGM=12.15); PRR rank 139 (PRR=30.8789); ROR rank 139 (ROR=31.3973); BCPNN rank 104 (IC_LB=3.6915)
137 MEASLES + MUMPS + RUBELLA (MMR II) Rubella antibody negative
clinical-coded PT
148 GPS rank 126 (EBGM=10.75); PRR rank 130 (PRR=37.1621); ROR rank 131 (ROR=37.1885); BCPNN rank 189 (IC_LB=3.1489)
142 MEASLES + MUMPS + RUBELLA (MMR II) Mumps antibody test negative
clinical-coded PT
182 GPS rank 159 (EBGM=8.06); PRR rank 122 (PRR=38.3875); ROR rank 123 (ROR=38.4209); BCPNN rank 182 (IC_LB=3.2106)
153 MEASLES + MUMPS + RUBELLA (MMR II) Measles antibody negative
clinical-coded PT
193 GPS rank 143 (EBGM=8.72); PRR rank 136 (PRR=29.9321); ROR rank 136 (ROR=29.9595); BCPNN rank 193 (IC_LB=3.1199)
181 MEASLES + MUMPS + RUBELLA (NO BRAND NAME) Morbillivirus test positive
clinical-coded PT
14 GPS rank 218 (EBGM=20.4); PRR rank 111 (PRR=59.2833); ROR rank 111 (ROR=59.3401); BCPNN rank 256 (IC_LB=2.6764)
193 RUBELLA (MERUVAX II) Arthralgia
clinical-coded PT
226 GPS rank 226 (EBGM=6.57); PRR rank 202 (PRR=15.4938); ROR rank 195 (ROR=16.9977); BCPNN rank 114 (IC_LB=3.6497)
210 RUBELLA (MERUVAX II) Lymphadenopathy
clinical-coded PT
111 GPS rank 217 (EBGM=7.0); PRR rank 213 (PRR=14.9241); ROR rank 212 (ROR=15.5982); BCPNN rank 149 (IC_LB=3.4361)
263 RUBELLA (MERUVAX II) Pharyngitis
clinical-coded PT
49 GPS rank 211 (EBGM=7.76); PRR rank 259 (PRR=11.0466); ROR rank 260 (ROR=11.2557); BCPNN rank 246 (IC_LB=2.7708)
283 MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) Rash generalised
clinical-coded PT
42 GPS rank 264 (EBGM=7.03); PRR rank 269 (PRR=9.5087); ROR rank 269 (ROR=9.7591); BCPNN rank 271 (IC_LB=2.5265)
288 MEASLES + MUMPS + RUBELLA (VIRIVAC) Oedema
clinical-coded PT
135 GPS rank 287 (EBGM=5.99); PRR rank 279 (PRR=7.5848); ROR rank 277 (ROR=7.7894); BCPNN rank 265 (IC_LB=2.59)
289 RUBELLA (MERUVAX II) Rash maculo-papular
clinical-coded PT
58 GPS rank 220 (EBGM=7.45); PRR rank 298 (PRR=6.2555); ROR rank 298 (ROR=6.3854); BCPNN rank 295 (IC_LB=2.1297)
294 MEASLES + MUMPS + RUBELLA (VIRIVAC) Feeling hot
clinical-coded PT
172 GPS rank 303 (EBGM=5.74); PRR rank 283 (PRR=7.0023); ROR rank 283 (ROR=7.242); BCPNN rank 272 (IC_LB=2.5231)
199 MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) Extra dose administered
admin/quality term
372 GPS rank 208 (EBGM=6.59); PRR rank 205 (PRR=14.6101); ROR rank 207 (ROR=14.7867); BCPNN rank 137 (IC_LB=3.5078)

Showing up to 15 pairs for this page (clinical-coded terms listed first). Full processed tables: rankv_signals.json.

  • Methods combined: BCPNN (IC), GPS/EBGM, PRR, ROR — then rank aggregation.
  • Data: ~30 years of public VAERS (rankv processed tables).
  • Origin: precisionFDA “Gaining New Insights by Detecting Adverse Event Anomalies” challenge solution.
  • Caveat: Disproportionality signals are statistical associations in spontaneous reports. They do not establish causality, incidence, or product defect. Many top pairs reflect administration/product-use coding rather than clinical injury.

Source: nanx.me/rankv · Code: github.com/nanxstats/rankv (MIT) · Built: 2026-07-30.

▶ Adverse Events with Strong Evidence of Causal Association

Criteria: Consistent epidemiological data from multiple independent studies, supported by mechanistic plausibility, and reviewed by IOM / NASEM or equivalent authoritative body.

▶ Adverse Events with Moderate or Preliminary Evidence

Criteria: Some epidemiological evidence consistent with a signal, but data are limited by sample size, inconsistent findings across studies, or insufficient mechanistic evidence.

▶ Published Evidence Does Not Support a Causal Association

Criteria: Multiple large, well-controlled epidemiological studies have consistently failed to find an association; IOM / NASEM has rejected a causal relationship; or the preponderance of high-quality evidence is against an association.

5. Disease Prevention Benefits

5a. Measles — Pre-Vaccine vs. Post-Vaccine Era (United States)

Metric Pre-Vaccine Era (Annual Average, ~1958–1962) Post-Vaccine Era (Annual, 2010–2024)
Estimated cases ~3–4 million (500,000 reported annually) <1,300 (range: 13 cases in 2020 to 1,274 in 2019); majority importation-linked
Hospitalizations ~48,000 Fewer than 100 most years; 128 in the 2019 outbreak
Deaths ~400–500 0–2 most years; 0 deaths in the 2019 outbreak
Encephalitis cases ~1,000 <5 most years
SSPE cases ~40–100 per year (estimated) Extremely rare (<5 per year)
U.S. elimination status Declared eliminated in 2000. Elimination status has been threatened by outbreaks in 2014, 2019, and 2024–2025.

Source: CDC MMWR surveillance summaries; CDC Pink Book (Measles chapter). Reported cases underestimate true incidence; pre-vaccine era case estimates are ~10x higher than reported cases because measles was ubiquitous.

5b. Mumps — Pre-Vaccine vs. Post-Vaccine Era (United States)

Metric Pre-Vaccine Era (Annual Average, ~1967) Post-Vaccine Era (Annual, 2010–2024)
Reported cases ~186,000 <6,200 (range: 229 in 2012 to 6,109 in 2016)
Deaths ~20–30 <5 per year
Encephalitis ~200–400 cases Very rare (<10 per year)

Source: CDC MMWR; CDC Pink Book (Mumps chapter). Note: Mumps outbreaks continue to occur in highly vaccinated populations, particularly in close-contact settings (colleges, sports teams), likely due to waning immunity and less-than-perfect 2-dose effectiveness (~88%, range 79–95%).

5c. Rubella and Congenital Rubella Syndrome — Pre-Vaccine vs. Post-Vaccine Era (United States)

Metric Pre-Vaccine Era (1964–1965 Epidemic as Reference) Post-Vaccine Era
Rubella cases (epidemic year) ~12.5 million (1964–1965) <10 reported cases annually since 2010; rubella declared eliminated in the Americas in 2015
CRS cases (epidemic) ~20,000 infants with CRS (1964–1965) 0–1 per year; last known U.S.-acquired CRS case reported in 2012
Deaths (rubella/CRS) ~2,100 neonatal deaths; ~11,000 fetal losses (1964–1965) <5 per year

Source: CDC Pink Book (Rubella chapter); PAHO rubella elimination declaration (2015).

Current Disease Burden & Outbreak Context

Disease Burden Over Time

Reported U.S. disease burden by year. The dashed vertical line marks vaccine introduction. Hover or tap data points for values; use arrow keys when a chart has focus.

ⓘ About these charts: These are accessible SVG line charts with keyboard navigation, hover tooltips, and an underlying data table (expand below). The dashed vertical line marks the year of vaccine introduction. Reported cases undercount true incidence; case definitions, reporting practices, and diagnostic methods have changed over time. See Section 5 for additional context and pre-vs-post era comparisons.

7. International Surveillance & Global Data

Quick links to public pharmacovigilance databases and trial registries relevant to MMR Vaccine. Reporting counts do not establish causality.

8. Curated Adverse Event Literature

Curated peer-reviewed literature linking specific adverse events to MMR Vaccine. Each entry is a case report, case series, or related safety publication identified via PubMed. Expand Search PubMed for additional literature below to run custom queries.

9. Key References

References are organised by category. Links are provided to the original source where available.

Pre-Licensure Trials / FDA Review Documents

  1. Merck & Co., Inc. M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live) — Prescribing Information. merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf
  2. GlaxoSmithKline. PRIORIX (Measles, Mumps, and Rubella Vaccine, Live) — Prescribing Information. gskpro.com
  3. FDA. Clinical Review — PRIORIX (BLA 125759), 2022. fda.gov/vaccines-blood-biologics/vaccines/priorix

Systematic Reviews & Meta-Analyses

  1. Demicheli V, Rivetti A, Debalini MG, Di Pietrantonj C. Vaccines for measles, mumps and rubella in children. Cochrane Database of Systematic Reviews. 2012 (updated 2020). DOI: 10.1002/14651858.CD004407.pub3
  2. Taylor LE, Swerdfeger AL, Eslick GD. Vaccines are not associated with autism: an evidence-based meta-analysis of case-control and cohort studies. Vaccine. 2014;32(29):3623–3629. DOI: 10.1016/j.vaccine.2014.04.085
  3. Pietrantonj CD, Rivetti A, Marchione P, Debalini MG, Demicheli V. Vaccines for measles, mumps, rubella, and varicella in children. Cochrane Database Syst Rev. 2020. DOI: 10.1002/14651858.CD004407.pub4

Institute of Medicine / National Academies Reports

  1. Institute of Medicine. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press; 2012. nationalacademies.org
  2. Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. National Academies Press; 2013.

Major Post-Licensure Observational Studies

  1. Hviid A, Hansen JV, Frisch M, Melbye M. Measles, Mumps, Rubella Vaccination and Autism — A Nationwide Cohort Study. Annals of Internal Medicine. 2019;170(8):513–520. DOI: 10.7326/M18-2101
  2. DeStefano F, Bhasin TK, Thompson WW, et al. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects. Pediatrics. 2004;113(2):259–266. DOI: 10.1542/peds.113.2.259
  3. Klein NP, Fireman B, Yih WK, et al. Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics. 2010;126(1):e1–e8. DOI: 10.1542/peds.2010-0665
  4. Fombonne E, Zakarian R, Bennett A, et al. Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations. Pediatrics. 2006;118(1):e139–e150. DOI: 10.1542/peds.2005-2993
  5. Smeeth L, Cook C, Fombonne E, et al. MMR vaccination and pervasive developmental disorders: a case-control study. The Lancet. 2004;364(9438):963–969. DOI: 10.1016/S0140-6736(04)17020-7
  6. France EK, Smith-Raymond L, Xu S, et al. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children. Pediatrics. 2008;121(3):e687–e692. DOI: 10.1542/peds.2007-1578

Official Surveillance and Public Health References

  1. CDC. Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book) — Measles, Mumps, Rubella chapters. cdc.gov/pinkbook
  2. CDC. Vaccine Safety Datalink (VSD). cdc.gov/vaccine-safety/about/vsd.html
  3. CDC/FDA. Vaccine Adverse Event Reporting System (VAERS). vaers.hhs.gov
  4. CDC. 2025 Child & Adolescent Immunization Schedule. cdc.gov/vaccines/hcp/imz-schedules
  5. CDC. Measles Cases and Outbreaks (current surveillance). cdc.gov/measles/data-research
  6. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. The Lancet. 1998;351(9103):637–641. RETRACTED (2010). DOI: 10.1016/S0140-6736(97)11096-0 (retracted)
  7. Halma, M.; Varon, J. DARE-SAFE: Denominator-Adjusted Rate Estimates of Substance Adverse Events Frequency Evaluation in Pharmaceuticals and Vaccines. Pharmacoepidemiology. 2025, 4, 7. DOI: 10.3390/pharma4020007. CC BY 4.0.

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