1. Basic Information
Shingles (herpes zoster) is reactivation of varicella-zoster virus, typically causing painful dermatomal rash. Shingrix (GSK, recombinant adjuvanted, 2-dose series) replaced live Zostavax in U.S. recommendations. Distinct from the childhood varicella (chickenpox) vaccine.
| Product | Status (U.S.) | Schedule |
|---|---|---|
| Shingrix | Preferred; ages ≥50 and immunocompromised indications | 2 doses, 2–6 months apart |
| Zostavax (live) | Withdrawn from U.S. market (2020) | Historical single dose |
Ingredients (Package Insert)
Structured composition for 1 branded product 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.
Shingrix GlaxoSmithKline Biologicals · Recombinant protein
Delivery
Route: Intramuscular (IM)
Form: Lyophilized powder (reconstitute)
Dose volume: 0.5 mL
Presentation: antigen vial + AS01B adjuvant suspension vial
Encapsulation / delivery vehicle
Liposome — AS01B adjuvant is a liposomal formulation containing MPL and QS-21.
| Component | Role | Amount |
|---|---|---|
| DOPC (dioleoyl phosphatidylcholine) | liposomal phospholipid | label quantity |
| Cholesterol | cholesterol | label quantity |
Antigens
| Antigen | Type | Amount / dose |
|---|---|---|
| Recombinant varicella-zoster virus glycoprotein E (gE) System: CHO cells | Recombinant protein | 50 mcg |
Adjuvants
- AS01B — MPL 50 mcg + QS-21 50 mcg per dose
- MPL (3-O-desacyl-4'-monophosphoryl lipid A) — 50 mcg
- QS-21 (Quillaja saponaria Molina, fraction 21) — 50 mcg
Preservatives
- None — Single-dose presentation; label states no preservative.
Excipients & residuals
| Ingredient | Category | Amount | Role |
|---|---|---|---|
| Sucrose | Stabilizer | label quantity | stabilizer |
| Polysorbate 80 | Surfactant | label quantity | surfactant |
| Sodium dihydrogen phosphate dihydrate / dipotassium phosphate | Buffer | label quantity | buffer |
| Sodium chloride | Buffer | label quantity | tonicity |
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 | 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. |
| Intense local/systemic reactogenicity | 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). |
| 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). |
| Guillain-Barré Syndrome | 0–42 days |
Unclassifiable
Evidence: Very Low |
Molecular mimicry → Guillain-Barré syndrome (hypothetical · molecular_mimicry) Vaccine- or infection-triggered immune responses cross-react with peripheral-nerve gangliosides or myelin components, producing demyelinating or axonal polyneuropathy. Temporal association — mechanism unknown (alternative · unknown) Reports show temporal clustering after vaccination but a specific pathogenic pathway is not established; alternative (coincidental) explanations remain plausible. |
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.
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) |
|---|---|---|---|---|
| 101 | ZOSTER LIVE (ZOSTAVAX) |
Post herpetic neuralgia
clinical-coded PT
|
139 | GPS rank 279 (EBGM=6.04); PRR rank 60 (PRR=100.1631); ROR rank 60 (ROR=100.324); BCPNN rank 52 (IC_LB=4.2626) |
| 139 | ZOSTER LIVE (ZOSTAVAX) |
Herpes zoster
clinical-coded PT
|
3994 | GPS rank 243 (EBGM=5.88); PRR rank 133 (PRR=26.1159); ROR rank 132 (ROR=27.3422); BCPNN rank 71 (IC_LB=3.9432) |
| 247 | ZOSTER (SHINGRIX) |
Incomplete course of vaccination
clinical-coded PT
|
112 | GPS rank 288 (EBGM=6.05); PRR rank 199 (PRR=17.7653); ROR rank 201 (ROR=17.7821); BCPNN rank 209 (IC_LB=3.0726) |
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.
2. Pre-Licensure Clinical Trial Data (Shingrix)
Licensure trial design (ICAN / OpenVAERS)
This vaccine is not listed in ICAN’s childhood-schedule No Placebo Table (which covers CDC routine pediatric injectable products). Pre-licensure trial comparators for travel, adult, or specialty vaccines should be taken from FDA review documents and product labels in the sections below.
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.
Pivotal trials ZOE-50 (≥50 years) and ZOE-70 (≥70 years) demonstrated high efficacy against shingles and post-herpetic neuralgia vs. placebo.
| Endpoint | ZOE-50 (~15,400 per arm) | ZOE-70 |
|---|---|---|
| Shingles incidence reduction | ~97% (overall; sustained in follow-up) | ~90% in ≥70 |
| Post-herpetic neuralgia | ~89% reduction vs. placebo | Significant reduction vs. placebo |
Most common solicited reactions (pooled trials)
| Reaction | Dose 1 (approx.) | Dose 2 (approx.) |
|---|---|---|
| Injection-site pain | ~78% | ~72% |
| Myalgia | ~45% | ~38% |
| Fatigue | ~45% | ~38% |
| Headache | ~38% | ~32% |
| Shivering / fever | ~15–27% | Lower than dose 1 |
Source: Shingrix prescribing information (FDA); ZOE trial publications. Grade 3 systemic symptoms were uncommon (<3%).
3. Post-Licensure Safety Data
Shingrix has one of the highest VAERS report volumes among non-COVID adult vaccines — consistent with intense reactogenicity in trials and broad age ≥50 rollout. What databases report below is not the same as trial reactogenicity rates.
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)
No matching vaccine reports in the current Canada Vigilance extract.
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)
No VigiAccess (WHO) data yet — run python scrape_survigilance_one.py vigiaccess <vaccine-id> or python survigilance_pipeline.py --system vigiaccess (SurVigilance + direct scrapers: GitHub).
Lareb (Netherlands)
No Lareb (Netherlands) data yet — run python scrape_survigilance_one.py lareb <vaccine-id> or python survigilance_pipeline.py --system lareb (SurVigilance + direct scrapers: GitHub).
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)
Compare AE patterns across all vaccines →
VAERS Lot-Level Reports
42,821 VAERS reports with usable lot data (U.S.). Signal flags are hypothesis-generating only — not proof of an unsafe lot. Full dashboard →
4. Disease Prevention Context
Lifetime shingles risk is ~30%; incidence rises sharply after 50. Shingrix substantially reduces shingles and PHN in trial and observational data. VAERS counts do not measure vaccine effectiveness.
Zoster-related case literature · Varicella / VZV family page