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Zostavax (live)	Withdrawn from U.S. market (2020)	Historical single dose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.

Recombinant protein Intramuscular (IM) Adjuvant: AS01B No preservative (typical single-dose) Liposome Polysorbate 80

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.

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 VigiAccess (WHO), Lareb (Netherlands), and DAEN (Australia) via SurVigilance. JADER: public CSV pmdacasereport202606. EudraVigilance: local EudraVigilance/ DAP exports. SurVigilance panels show MedDRA PT mention totals (not individual-case counts). Category assignment uses keyword matching — approximate, not official SOC coding. JADER reference (PDF)

VAERS (United States)

No VAERS category summary is mapped for this vaccine page.

Canada Vigilance (Canada)

JADER (PMDA, Japan)

EudraVigilance (EU)

No matching vaccine cases in the current EudraVigilance DAP export.

SurVigilance: VigiAccess, Lareb & DAEN

VigiAccess (WHO)

Lareb (Netherlands)

DAEN (Australia)

DAEN category breakdown not yet available for this vaccine.

Mapping note: Canada Vigilance and JADER on this page use the varicella pipeline bucket, which includes Shingrix/HERPES ZOSTER products alongside chickenpox vaccines — counts are not Shingrix-only. Canada Vigilance (CV Online extract): 11,067 reaction mentions in 3,417 unique reports (64.0% serious (2,186 of 3,417 reports)). Largest share: General / Systemic (non-local) (17%), Injection-site / Local reaction (17%), Neurological (10%). JADER (PMDA public CSV extract): 1,313 reaction mentions in 666 unique reports (8.1% serious (54 of 666 reports)). Largest share: Other / Unclassified (35%), Neurological (18%), General / Systemic (non-local) (13%). VigiAccess (WHO VigiBase): 1,395 reaction-term mentions · search: varicella. Largest share: Gastrointestinal (26%), Dermatological (non-injection-site) (18%), Other / Unclassified (12%). Lareb (Netherlands): 80 reaction-term mentions · search: Varicella vaccine. Largest share: General / Systemic (non-local) (22%), Other / Unclassified (16%), Injection-site / Local reaction (15%). 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 Canada Vigilance: General / Systemic (non-local); top JADER: Other / Unclassified. SurVigilance note: VigiAccess, Lareb, and DAEN counts are live-scraped MedDRA PT mention totals (not deduplicated individual cases). Data via SurVigilance (GPL-3.0). Category assignment uses keyword matching on reported reaction terms — approximate and exploratory. Neither database establishes causality.

Active Pharmacovigilance (Defined-Population Surveillance)

Curated findings for Recombinant zoster vaccine (Shingrix) 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; reactogenicity is expected and common

Tier 2 ○ No signal detected

Shingrix is known for high rates of transient local and systemic reactogenicity (expected pharmacologic effect of the AS01B-adjuvanted product). Active surveillance has not established unexpected rare serious risk signals that reverse the risk–benefit assessment used in ACIP recommendations; monitoring continues.

Population

Adults ≥50 (and other recommended groups) at VSD sites

Risk interval

Study-specific

Comparison

Control intervals

Evaluation period

2017–ongoing post-licensure

Method

Post-licensure observational studies and RCA as scheduled

Sources: CDC VSD · CDC Shingrix safety

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.

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.

Shingles Vaccine Side Effects (Shingrix — Trials, VAERS Lots & Pharmacovigilance Charts)