Name: Meningococcal Vaccine
Brand: Menactra
SKU: meningococcal

1. Basic Information

Disease Protected Against

Meningococcal disease, caused by Neisseria meningitidis, presents as meningitis and/or septicemia. It is among the most rapidly progressive bacterial infections — a previously healthy person can die within 24 hours. Case-fatality is ~10–15% even with appropriate antibiotics; 11–19% of survivors have permanent sequelae (limb loss, neurological damage, hearing loss). Six serogroups (A, B, C, W, X, Y) cause most invasive disease. In the U.S., serogroups B and C predominate in adolescents; B predominates in infants. The U.S. incidence is low (~0.1–0.2 per 100,000; ~300–400 cases/year) but outbreaks occur in college settings.

CDC Schedule (U.S., 2025)

Vaccine	Age	Schedule
MenACWY (dose 1)	11–12 years	Routine adolescent dose
MenACWY (dose 2)	16 years	Booster; important for protection during highest-risk college years
MenACWY (high-risk)	As early as 2 months (Menveo/MenQuadfi) or 9 months (Menactra)	Complement deficiency, asplenia, HIV, outbreak settings, travel
MenB (shared clinical decision-making)	16–23 years (preferred 16–18)	Bexsero: 2-dose series; Trumenba: 2-dose or 3-dose depending on risk

Source: CDC ACIP, 2025 schedule. MenB is not universally recommended; shared clinical decision-making acknowledges the low absolute risk and high cost of the vaccine.

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

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.

Conjugate Subunit Intramuscular (IM) No preservative (typical single-dose) Adjuvant: Aluminum hydroxide Outer membrane vesicle (OMV) Aluminum hydroxide

Menveo GlaxoSmithKline Biologicals · Conjugate

Delivery

Route: Intramuscular (IM)

Form: Lyophilized powder (reconstitute)

Dose volume: 0.5 mL

Presentation: two-vial system (MenA lyophilized + MenCWY liquid) or ready-to-use presentations per current labeling

Encapsulation / delivery vehicle

None (no nanoparticle/VLP encapsulation system)

Antigens

Antigen	Type	Amount / dose
Neisseria meningitidis serogroup A polysaccharide-CRM197 conjugate Carrier: CRM197	Conjugate	10 mcg oligosaccharide
Serogroup C polysaccharide-CRM197 conjugate Carrier: CRM197	Conjugate	5 mcg
Serogroup W-135 polysaccharide-CRM197 conjugate Carrier: CRM197	Conjugate	5 mcg
Serogroup Y polysaccharide-CRM197 conjugate Carrier: CRM197	Conjugate	5 mcg

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

Ingredient	Category	Amount	Role
Potassium dihydrogen phosphate	Buffer	label quantity	buffer
Sucrose	Stabilizer	label quantity	stabilizer
Sodium chloride	Buffer	label quantity	tonicity
Sodium dihydrogen phosphate monohydrate / dibasic	Buffer	label quantity	buffer

Source: FDA package insert · Verified 2026-07-09

Bexsero GlaxoSmithKline Biologicals · Subunit

Delivery

Route: Intramuscular (IM)

Form: Suspension for injection

Dose volume: 0.5 mL

Presentation: single-dose prefilled syringe

Encapsulation / delivery vehicle

Outer membrane vesicle (OMV) — Includes Neisseria meningitidis group B outer membrane vesicles (OMV) as antigen component.

Antigens

Antigen	Type	Amount / dose
Neisseria meningitidis group B fHbp fusion protein	Recombinant protein	50 mcg
NadA protein	Recombinant protein	50 mcg
NHBA fusion protein	Recombinant protein	50 mcg
Outer membrane vesicles (OMV) from NZ98/254	OMV	25 mcg measured as amount of total protein containing PorA P1.4

Adjuvants

Aluminum hydroxide — ≈0.5 mg aluminum hydroxide (≈0.519 mg aluminum as hydroxide form per labeling conventions — verify current PI)

Preservatives

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

Excipients & residuals

Ingredient	Category	Amount	Role
Sodium chloride	Buffer	label quantity	tonicity
Histidine	Buffer	label quantity	buffer
Sucrose	Stabilizer	label quantity	stabilizer
Water for injection	Diluent	q.s.	vehicle

Source: FDA package insert · 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.
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.
SIRVA	0–2 days	Very likely / Probable Evidence: High	SIRVA — incorrect injection into shoulder structures (primary · procedural) Needle placement into the subdeltoid/subacromial bursa or joint rather than deltoid muscle causes prolonged local inflammation and restricted range of motion (procedural, not antigen-specific).
Local/systemic reactogenicity (MenB)	0–3 days	Very likely / Probable Evidence: High	Adjuvant-driven local and systemic reactogenicity (primary · innate_inflammation) Aluminum or other adjuvants (e.g., AS01B) amplify innate immune signaling, producing injection-site inflammation and transient systemic symptoms (fever, myalgia, fatigue).

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
Men4	Menactra	Sanofi	2	11Y 16Y	Menomune	No	6 months
Men4	Menveo	GSK	2	11Y 16Y	Menactra or other vaccine	No	6 months
Men4	MenQuadfi	Sanofi	2	11Y 16Y	Menveo or other vaccine	No	6 months
MenB	Bexsero	GSK	0 or 2	10Y+ if indicated	See note	No	30 days
MenB	Trumenba	Pfizer	0 or 2	10Y+ if indicated	See note	No	30 days in 3 trials + 11M in 2 trials

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.

MenACWY vaccines were licensed based on immunogenicity (serum bactericidal antibody) rather than clinical efficacy, because meningococcal disease is too rare to power an efficacy trial. Menactra (Sanofi) was first licensed in 2005; Menveo (GSK) in 2010; MenQuadfi (Sanofi) in 2020. MenB vaccines (Bexsero/GSK 2015, Trumenba/Pfizer 2014) were licensed based on immunogenicity using a novel approach (hSBA assay against diverse MenB strains) — the first vaccines licensed under the FDA accelerated approval pathway using immunogenicity endpoints.

Metric	MenACWY Data	MenB Data
Pre-licensure safety database	~10,000+ per product	~8,000 (Bexsero), ~5,000 (Trumenba)
Efficacy basis	Immunobridging (SBA titers); effectiveness confirmed post-licensure	Immunogenicity (hSBA); effectiveness data limited but emerging
Seroresponse	>85–95% for all 4 serogroups	67–94% against diverse MenB test strains

Most Common Adverse Reactions

Reaction	MenACWY (Approx.)	MenB (Approx.)
Injection site pain	~40–60%	~85–95% (MenB is substantially more reactogenic)
Injection site swelling/erythema	~15–25%	~30–50%
Fever	~3–8%	~10–20% (higher when co-administered with other adolescent vaccines)
Headache	~20–30%	~30–45%
Fatigue/malaise	~15–25%	~30–50%
Myalgia/arthralgia	~10–20%	~30–50%

MenB vaccines are notably more reactogenic than MenACWY, with high rates of local and systemic reactions. This reactogenicity contributes to the shared clinical decision-making framework for MenB.

3. Post-Licensure Safety Data

VSD Findings

Guillain-Barré Syndrome (GBS) — Menactra: A VSD rapid cycle analysis in 2005–2006 identified a possible GBS signal following Menactra (MCV4-D). 17 GBS cases were reported to VAERS within 6 weeks of vaccination. Subsequent VSD and larger analyses estimated ~0.5–1.5 excess GBS cases per million doses, but results were not consistent across all studies. ACIP did not change the recommendation. Menveo and MenQuadfi have not shown a GBS signal.
Syncope: As with all adolescent vaccines, syncope is observed. 15-minute observation recommended.
No other consistent safety signals identified for MenACWY or MenB in VSD. MenB vaccines have been associated with higher rates of fever-related medical visits than MenACWY due to their higher reactogenicity profile.
Bell's palsy: A very small numerical imbalance was observed in Bexsero pre-licensure trials (4 cases vs. 0 placebo). No signal confirmed post-licensure.

⚠ Critical Caveat

VAERS data represent unverified reports. A report to VAERS does not mean the vaccine caused the event.

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 (Meningococcal (all MenACWY + MenB products combined)):

Metric	Value
U.S. doses administered (2006–2022)	152,565,553
Total VAERS AE reports	31,050
AE reporting rate (per 100,000 doses)	20.4
Total death reports	54
Death reporting rate (per 100,000 doses)	0.0354
AE-to-Death ratio	575:1

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)

No VAERS category summary is mapped for this vaccine page.

Canada Vigilance (Canada)

JADER (PMDA, Japan)

No matching vaccine reports in the current JADER public extract.

EudraVigilance (EU)

No matching vaccine cases in the current EudraVigilance DAP export.

SurVigilance: VigiAccess · Lareb · DAEN · DMA · Medsafe

VigiAccess (WHO)

Lareb (Netherlands)

DAEN (Australia)

No DAEN (Australia) data yet — run python scrape_survigilance_one.py daen <vaccine-id> or python survigilance_pipeline.py --system daen (SurVigilance + direct scrapers: GitHub).

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)

Canada Vigilance (CV Online extract): 2,096 reaction mentions in 455 unique reports (37.8% serious (172 of 455 reports)). Largest share: General / Systemic (non-local) (14%), Injection-site / Local reaction (12%), Cardiac / Cardiovascular (11%). VigiAccess (WHO): 393,905 reaction-term mentions · search: meningococcal. Largest share: General / Systemic (non-local) (21%), Injection-site / Local reaction (18%), Neurological (14%). Lareb (Netherlands): 7,095 reaction-term mentions · search: meningococcal vaccine. Largest share: General / Systemic (non-local) (21%), Injection-site / Local reaction (21%), Neurological (13%). Medsafe (New Zealand): 1,386 reaction-term mentions · search: meningococcal. Largest share: Injection-site / Local reaction (48%), General / Systemic (non-local) (25%), Gastrointestinal (14%). 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

9,190 reports with usable lot across 1,270 lots · 154 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)

455 unique reports · 2,096 reaction mentions · 37.8% serious (172 of 455 reports). Top categories: General / Systemic (non-local) (14%), Injection-site / Local reaction (12%), Cardiac / Cardiovascular (11%).

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 →

No JADER (PMDA, Japan) product-level summary is mapped for this page.

No EudraVigilance (EU) summary is mapped for this page.

VigiAccess (WHO)

393,905 MedDRA PT mentions · search: meningococcal. Top categories: General / Systemic (non-local) (21%), Injection-site / Local reaction (18%), Neurological (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 VigiAccess (WHO) →

Lareb (Netherlands)

7,095 MedDRA PT mentions · search: meningococcal vaccine. Top categories: General / Systemic (non-local) (21%), Injection-site / Local reaction (21%), Neurological (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) →

System	Region	Lot data
VAERS	United States	Lot data
Canada Vigilance	Canada	No public lot field
JADER (PMDA, Japan)	Japan	No public lot field
Lareb (Netherlands)	Netherlands	No public lot field
EudraVigilance	European Union	No public lot field
VigiAccess (WHO)	Global	No public lot field
Yellow Card (UK)	United Kingdom	No public lot field
DAEN (Australia)	Australia	No public lot field

All global data sources → · Data schemas →

Active Pharmacovigilance (Defined-Population Surveillance)

Curated findings for Meningococcal vaccines (MenACWY / MenB) 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: Pre-specified serious outcomes after MenACWY and MenB products

Tier 2 ○ No signal detected

Active post-licensure evaluations of meningococcal conjugate and MenB vaccines have supported continued recommended use. Product-specific findings (e.g., reactogenicity differences) appear in labels and ACIP materials without a confirmed rare risk that broadly suspended programs.

Population

Adolescents and other indicated groups

Risk interval

Study-specific

Comparison

Control intervals

Evaluation period

Conjugate and MenB post-licensure eras

Method

Post-licensure observational studies and RCA when scheduled

Sources: CDC VSD

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

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)
41	MENINGOCOCCAL CONJUGATE (MENVEO)	Product preparation error clinical-coded PT	134	GPS rank 30 (EBGM=29.33); PRR rank 84 (PRR=57.2877); ROR rank 84 (ROR=57.7609); BCPNN rank 25 (IC_LB=4.817)
171	MENINGOCOCCAL CONJUGATE (MENVEO)	Drug administration error clinical-coded PT	49	GPS rank 224 (EBGM=7.55); PRR rank 163 (PRR=25.4045); ROR rank 163 (ROR=25.4792); BCPNN rank 127 (IC_LB=3.5499)
7	MENINGOCOCCAL CONJUGATE (MENVEO)	Incorrect product formulation administered admin/quality term · published top-25	204	GPS rank 8 (EBGM=41.03); PRR rank 20 (PRR=190.5648); ROR rank 20 (ROR=193.0017); BCPNN rank 5 (IC_LB=5.8383)
12	MENINGOCOCCAL CONJUGATE (MENVEO)	Product reconstitution issue admin/quality term · published top-25	39	GPS rank 19 (EBGM=39.28); PRR rank 14 (PRR=330.798); ROR rank 15 (ROR=331.6002); BCPNN rank 48 (IC_LB=4.3591)
14	MENINGOCOCCAL CONJUGATE (MENVEO)	Incorrect drug dosage form administered admin/quality term	141	GPS rank 23 (EBGM=32.22); PRR rank 35 (PRR=146.564); ROR rank 35 (ROR=147.8522); BCPNN rank 8 (IC_LB=5.4719)
36	MENINGOCOCCAL CONJUGATE (MENVEO)	Wrong technique in drug usage process admin/quality term	114	GPS rank 34 (EBGM=28.19); PRR rank 75 (PRR=64.6356); ROR rank 75 (ROR=65.0901); BCPNN rank 24 (IC_LB=4.8259)
39	MENINGOCOCCAL CONJUGATE (MENVEO)	Wrong technique in product usage process admin/quality term	74	GPS rank 43 (EBGM=27.3); PRR rank 71 (PRR=71.6516); ROR rank 71 (ROR=71.9784); BCPNN rank 32 (IC_LB=4.6032)

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.

▶ Strong Evidence

Injection site reactions: Common; MenB (85–95% pain) >> MenACWY (40–60%). Strong
Systemic reactions: Fever, headache, fatigue, myalgia. More common with MenB. Strong
Syncope: Adolescent vasovagal response. Strong
Anaphylaxis: ~1 per million doses. Strong

▶ Moderate or Preliminary Evidence

GBS (Menactra-specific): Possible small increased risk (~0.5–1.5 per million doses). Signal not consistently replicated; not observed with Menveo or MenQuadfi. Moderate

5. Disease Prevention Benefits

Metric	Pre-Vaccine Era	Post-Vaccine Era
Meningococcal incidence (U.S., all ages)	~1.0–1.5 per 100,000 (1990s)	~0.1–0.2 per 100,000; >90% reduction in vaccine serogroups (C, W, Y); serogroup B now predominates
Adolescent meningococcal disease	~15% of cases age 11–24; highest CFR	>80% reduction in ACWY disease in vaccinated age groups
College outbreaks	Multiple outbreaks in the 1990s–2000s	Rare (primarily MenB); MenACWY college entry requirements have been effective

Source: CDC MMWR; CDC Pink Book. MenB disease has not declined as dramatically because MenB vaccine uptake is low (shared clinical decision-making) and serogroup B vaccine coverage is not yet population-level.

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. Evidence Summary

MenACWY vaccines have a well-established safety record and demonstrated real-world effectiveness. The Menactra GBS signal remains an area of ongoing monitoring but has not changed vaccine policy. MenB vaccines are distinguished by their high reactogenicity profile, limited clinical efficacy data (licensed on immunogenicity), and the shared clinical decision-making framework — reflecting a different risk-benefit calculus from universally recommended vaccines. The low absolute incidence of meningococcal disease in the U.S. limits the statistical power of post-licensure safety studies for very rare adverse events.

8. International Surveillance & Global Data

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

Note: Spontaneous reports are unverified observations. Compare with epidemiological studies in Sections 3–6 before drawing conclusions.

9. Curated Adverse Event Literature

Curated peer-reviewed literature linking specific adverse events to Meningococcal 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.

Disclaimer: Published reports describe observations and associations; they do not establish population incidence or causality.

10. Key References

IOM. Adverse Effects of Vaccines: Evidence and Causality. National Academies Press; 2012.
CDC. Pink Book — Meningococcal chapter. cdc.gov/pinkbook
Velentgas P, et al. Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination. Pharmacoepidemiol Drug Saf. 2012;21(12):1350–1358.
CDC. VSD. cdc.gov/vaccine-safety/about/vsd.html
CDC/FDA. VAERS. vaers.hhs.gov

1. Basic Information

Disease Protected Against

CDC Schedule (U.S., 2025)

Documented Adverse Events (HRSA VICP)

WHO Causality Assessment Methodology

Important Notes

Ingredients (Package Insert)

Antigens

Adjuvants

Preservatives

Excipients & residuals

Antigens

Adjuvants

Preservatives

Excipients & residuals

Causality assessment & potential mechanisms

2. Pre-Licensure Clinical Trial Data

Licensure trial design (ICAN / OpenVAERS)

Most Common Adverse Reactions

3. Post-Licensure Safety Data

VSD Findings

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

Passive Surveillance: AE Type Breakdown (Multi-System)

VAERS (United States)

Canada Vigilance (Canada)

JADER (PMDA, Japan)

EudraVigilance (EU)

SurVigilance: VigiAccess · Lareb · DAEN · DMA · Medsafe

VigiAccess (WHO)

Lareb (Netherlands)

DAEN (Australia)

DMA (Denmark)

Medsafe (New Zealand)

Pharmacovigilance Lot Signal Detection — Hypothesis-Generating Only

Other Pharmacovigilance Systems

Canada Vigilance (Health Canada)

VigiAccess (WHO)

Lareb (Netherlands)

Active Pharmacovigilance (Defined-Population Surveillance)

CDC Vaccine Safety Datalink (VSD)

4. Documented Adverse Events

Rank-aggregated VAERS signal detection (rankv)

▶ Strong Evidence

▶ Moderate or Preliminary Evidence

5. Disease Prevention Benefits

Disease Burden Over Time

7. Evidence Summary

8. International Surveillance & Global Data

9. Curated Adverse Event Literature

10. Key References

Part of the Open Source Medicine Foundation Network