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Vaccine Evidence Summary

Hepatitis A vaccine side effects (Vaqta, Havrix): VAERS data, trials and schedule

This page answers “hep a vaccine side effects” with sourced pharmacovigilance data — VAERS and EudraVigilance case-linked data. Counts are database reports, not proven vaccine-caused injury rates.

Gold Standard EO (Aug 10, 2026) Federal recommendation status: High-risk groups & shared clinical decision-making

The August 10, 2026 Executive Order on Gold Standard Childhood Vaccine Recommendations places hepatitis A in both the Recommended for certain high-risk groups/populations and Based on shared clinical decision-making categories — not a universal recommendation for all children. The EO also expresses a preference, to the maximum extent feasible, for administering all childhood immunizations at separate medical visits. Section 2(a) of the order lists hepatitis A and hepatitis B in both clause (ii), certain high-risk groups or populations, and clause (iii), shared clinical decision-making. The overlap is the order’s own text.

Source: White House — Executive Order on Gold Standard Childhood Vaccine Recommendations (Aug 10, 2026) · Fact Sheet · EO 14407 (May 29, 2026) · Presidential Memorandum (Dec 5, 2025) · Federal Register, 91 FR 53173 (Aug. 14, 2026). These are federal recommendations; states set school-entry requirements. Always verify with current official sources.

Look up a vaccine lot or batch number in VAERS →

See the Hepatitis a vaccine schedule in 9 countries →

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

ⓘ Methodology Note

This page summarizes published data for inactivated hepatitis A vaccines on the U.S. childhood schedule (Havrix® and Vaqta®). Universal childhood HepA vaccination was recommended by ACIP in 2006. Data are presented without interpretive language that implies the vaccine is "safe" or "unsafe."

Evidence state

For each outcome: the specific question, what controlled studies found, and how certain that evidence is on the GRADE scale (high, moderate, low, very low). Ratings are editorial judgments by the site applying GRADE to the studies in the table below — observational evidence starts at low and is rated up for large, consistent effects or a dose/age gradient, and down for inconsistency or imprecision (Methods). Where an effect is confined to a subgroup (for example young males), the question says so. "Not searched" means no controlled study has been compiled here yet; it is not a finding that the outcome is rare or caused by the vaccine.

Outcome & questionFinding & certaintyWhy this rating
Immune thrombocytopenia
Hepatitis A vaccine, children 7–17
inconclusive
Very low certainty
Single study with too few events. Studies: O'Leary 2012. See table
AnaphylaxisNot searchedNo controlled-study result is compiled for this outcome yet.
Myocarditis or pericarditisNot searchedNo controlled-study result is compiled for this outcome yet.
Guillain-Barré syndromeNot searchedNo controlled-study result is compiled for this outcome yet.
Febrile seizureNot searchedNo controlled-study result is compiled for this outcome yet.

1. Basic Information

Disease Protected Against

Hepatitis A is an acute liver infection caused by hepatitis A virus (HAV), transmitted via the fecal-oral route. Illness ranges from asymptomatic (especially in children <6) to acute liver failure (rare; ~0.3–0.5% case-fatality overall; higher in older adults). Unlike hepatitis B and C, HAV does not cause chronic infection. Before vaccination, the U.S. experienced cyclical epidemics every 10–15 years. The last major epidemic was 1995–1996. Universal childhood vaccination was recommended in 2006.

CDC Schedule (U.S., 2025)

DoseAgeNotes
Dose 112–23 monthsFirst dose recommended at 1 year of age
Dose 2≥6 months after dose 12-dose series. Both Havrix and Vaqta are interchangeable.

Source: CDC ACIP, 2025 schedule. Catch-up vaccination recommended for children 2–18 years not previously vaccinated. Also recommended for adults at increased risk and anyone seeking protection.

Licensed Hepatitis A vaccine products

Each product has its own page with package-insert ingredients, side-effect data, lot lookup and comparisons with the other brands.

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.

Inactivated Intramuscular (IM) Adjuvant: Amorphous aluminum hydroxyphosphate sulfate No preservative (typical single-dose) AAHS aluminum Formaldehyde Neomycin Adjuvant: Aluminum hydroxide Aluminum hydroxide
Vaqta Merck Sharp & Dohme LLC · Inactivated

Delivery

Route: Intramuscular (IM)

Form: Suspension for injection

Dose volume: 0.5 mL pediatric / 1 mL adult

Presentation: single-dose vial or prefilled syringe

Encapsulation / delivery vehicle

None (no nanoparticle/VLP encapsulation system)

Antigens

AntigenTypeAmount / dose
Hepatitis A virus, inactivated
Strain: CR326F
Inactivated virus25 U pediatric / 50 U adult

Adjuvants

Preservatives

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

Excipients & residuals

IngredientCategoryAmountRole
Sodium borateBuffer35 mcg (pediatric 0.5 mL)pH stabilizer
Sodium chloride 0.9%Buffervehiclevehicle
FormaldehydeResidual (inactivating agent)<0.8 mcg residual (50 U dose scale)residual
Bovine albuminResidual (manufacturing)<10^-4 mcg residual (50 U scale)residual
NeomycinResidual (antibiotic)trace residualresidual

Latex: Vial stopper contains natural latex rubber (check presentation).

Source: DailyMed · Verified 2026-07-09

Havrix GlaxoSmithKline Biologicals · Inactivated

Delivery

Route: Intramuscular (IM)

Form: Suspension for injection

Dose volume: 0.5 mL pediatric / 1 mL adult

Presentation: single-dose vial or prefilled syringe

Encapsulation / delivery vehicle

None (no nanoparticle/VLP encapsulation system)

Antigens

AntigenTypeAmount / dose
Hepatitis A virus, inactivated
Strain: HM175
Inactivated virus720 EL.U. pediatric / 1440 EL.U. adult

Adjuvants

Preservatives

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

Excipients & residuals

IngredientCategoryAmountRole
Amino acid supplementStabilizerlabel quantitystabilizer
Phosphate-buffered saline componentsBufferlabel quantitybuffer
Polysorbate 20Surfactantlabel quantitysurfactant
FormaldehydeResidual (inactivating agent)≤0.1 mg residualresidual
Neomycin sulfateResidual (antibiotic)≤40 ng residualresidual

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.

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).

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
HepAHavrixGSK212M 18MEngerix-BNo6 months
HepAVaqtaMerck212M 18MAAHS and ThimerosalNo42 days

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.

Havrix (GSK) was licensed in 1995; Vaqta (Merck) in 1996. Both are inactivated whole-virus vaccines. The pivotal trial for Vaqta enrolled ~1,000 children in a community with high HAV incidence and demonstrated ~100% efficacy. Havrix efficacy was demonstrated in ~40,000 Thai children (~94–97% efficacy).

MetricData
Pre-licensure safety database (combined)~10,000+ across both products
Efficacy~94–100% in pivotal trials; seroprotection >97% after 2 doses
Most common reactionsInjection site pain (~20–50%), erythema (~10–20%), fever (~5–10%), headache (~5–15%)

Key Limitations

3. Post-Licensure Safety Data

Hepatitis A vaccines have >30 years of post-licensure safety data. VSD and VAERS surveillance have not identified unexpected safety signals. The vaccine is one of the least reactogenic on the pediatric schedule aside from injection site reactions. IOM (2012) did not identify safety concerns specific to hepatitis A vaccine. No confirmed post-licensure safety signals have been identified.

⚠ Critical Caveat

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

VAERS reports per million doses

U.S. VAERS reports for vaccinations given 2006–2024, divided by the 272 million doses distributed in the same years (HRSA, from CDC data).

All reports
152
per million doses (150–153) · 41,289 reports
Serious reports
8.5
per million doses · 2,303 reports (death, life-threatening, hospitalised or disabled)
Reports with a death
0.58
per million doses · 158 reports

These are reporting rates: they mix real reactions, coincidental events and reports of conditions that would have happened anyway, and they depend on how actively each vaccine is watched. Doses are distributed, not administered. Combination vaccines count toward each component in both numerator and denominator. Compare with the observed-vs-expected analysis and the controlled studies above. Data: vaers_reporting_rates.json.

All vaccines, per million doses
VaccineAllSeriousDeath
pcv26628.13.23
rotavirus15727.94.08
hpv33525.32.00
hib12619.73.25
polio15217.62.77
mmr32015.30.94
varicella37214.10.84
hepatitis-b11012.72.15
meningococcal21411.80.70
dtap13211.21.31
hepatitis-a1528.50.58
influenza685.40.48

What controlled safety studies found

Unlike VAERS counts, these studies compare vaccinated people with a control group or control time window, so they can estimate whether a risk is raised and by how much. 1 results for hepatitis A vaccines: 0 found an increased risk of a specific outcome, 0 found no increased risk.

OutcomeDesign & populationEstimate (95% CI)Excess per million dosesFindingSource
ITP
Hepatitis A vaccine
cohort, risk vs control intervals (VSD)
Children 7-17 y, US
——inconclusiveO'Leary ST et al., 2012, Pediatrics
doi:10.1542/peds.2011-1111; PMID 22232308

Compiled from study abstracts and FDA/CDC pages, verified 2026-10-09; full table with every source on vaccine safety studies. Data: active_surveillance_results.json, disease_risks.json.

Trials, timing and other data sources

Randomized placebo-controlled trials: serious adverse events

Trials on ClinicalTrials.gov with posted results and a placebo, saline or no-vaccine control arm (4,469 vaccinated vs 1,487 controls), pooled with a random-effects model:

Trials included
TrialTitleVaccine: SAE/nControl: SAE/n
NCT00224484Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Betwee142/4,46937/1,487

Only blinded, placebo-controlled periods are used (open-label, crossover, booster and extension periods excluded) and vaccine and placebo arms are matched within the same trial part. Risk ratios use participant counts, not person-time: where placebo recipients crossed over to vaccine, the placebo arm is followed for less time, which pushes count-based ratios up. Serious adverse events are sponsor-coded and include events unrelated to vaccination; trials were powered for efficacy, not rare harms; most childhood-vaccine trials use active comparators and therefore do not appear here. Code: analysis/vaccine_trial_meta.py; data: vaccine_trial_meta.json.

When do reported events start? (time to onset)

Days from vaccination to onset in U.S. VAERS reports (0–180 days). A causal reaction usually starts inside a characteristic window; but people also report what happens soon after a shot, so each event is compared with all other reports for this vaccine. The Weibull shape measures bunching (below 1 = most onsets early).

EventReportsMedian daysIn risk windowShape (95% CI) vs othersReading
Syncope1,782096% (others 73%)0.75 (0.71–0.84) vs 0.66spread later than other reports
Seizure (any)1,596195% (others 96%)0.71 (0.68–0.75) vs 0.66spread later than other reports
Febrile seizure525295% (others 96%)0.86 (0.80–0.93) vs 0.66spread later than other reports
Guillain-Barré syndrome1411787% (others 47%)1.14 (1.01–1.35) vs 0.66spread later than other reports
Anaphylaxis112094% (others 73%)0.93 (0.82–1.22) vs 0.66spread later than other reports
Herpes zoster11014.557% (others 47%)0.54 (0.46–0.61) vs 0.66clusters earlier than other reports
ADEM / encephalitis721186% (others 47%)0.89 (0.78–1.01) vs 0.66spread later than other reports
Immune thrombocytopenia651788% (others 47%)1.14 (0.97–1.53) vs 0.66spread later than other reports
Bell's palsy / facial paralysis53481% (others 47%)0.76 (0.65–1.00) vs 0.66same timing as other reports
Myocarditis / pericarditis29369% (others 89%)0.85 (0.66–1.62) vs 0.66same timing as other reports
Transverse myelitis271489% (others 47%)1.13 (0.90–1.63) vs 0.66spread later than other reports
Stroke21371% (others 46%)0.62 (0.50–1.05) vs 0.66same timing as other reports

Timing alone cannot establish causation; it can make it more or less plausible. *Fitted on a random sample of 5,000 of these reports. Data: vaers_onset.json.

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 (Hepatitis A (Havrix + Vaqta combined)):

MetricValue
U.S. doses administered (2006–2022)231,034,565
Total VAERS AE reports30,930
AE reporting rate (per 100,000 doses)13.4
Total death reports85
Death reporting rate (per 100,000 doses)0.0368
AE-to-Death ratio364:1

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 files on this site are built from the public VAERS download. FAERS figures use the public quarterly FAERS files. Counts are mentions or reports, not incidence.

VAERS (United States)

Canada Vigilance (Canada)

JADER (PMDA, Japan)

EudraVigilance (EU)

No matching vaccine cases in the current EudraVigilance DAP 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): 74,945 symptom mentions (16.22/100k doses). Largest share: Other / Unclassified (49%), General / Systemic (non-local) (9%), Neurological (8%). Canada Vigilance (CV Online extract): 1,010 reaction mentions in 283 unique reports (70.7% serious (200 of 283 reports)). Largest share: Neurological (20%), General / Systemic (non-local) (11%), Gastrointestinal (8%). JADER (PMDA public CSV extract): 7 reaction mentions in 4 unique reports (0.0% serious (0 of 4 reports)). Largest share: Allergic / Anaphylactic (43%), Gastrointestinal (29%), General / Systemic (non-local) (29%). VigiAccess (WHO): 150,931 reaction-term mentions · search: hepatitis A. Largest share: Other / Unclassified (21%), Injection-site / Local reaction (17%), General / Systemic (non-local) (13%). Lareb (Netherlands): 1,539 reaction-term mentions · search: Hepatitis A vaccine. Largest share: General / Systemic (non-local) (24%), Injection-site / Local reaction (14%), Neurological (14%). DAEN (Australia): 3,877 reaction-term mentions · search: hepatitis A. Largest share: Other / Unclassified (16%), General / Systemic (non-local) (15%), Neurological (15%). Medsafe (New Zealand): 488 reaction-term mentions · search: hepatitis A. Largest share: Gastrointestinal (28%), General / Systemic (non-local) (25%), Injection-site / Local reaction (18%). 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: Neurological; top JADER: Allergic / Anaphylactic. 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

16,588 reports with usable lot across 1,604 lots · 163 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)

283 unique reports · 1,010 reaction mentions · 70.7% serious (200 of 283 reports). Top categories: Neurological (20%), General / Systemic (non-local) (11%), Gastrointestinal (8%).

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)

4 unique reports · 7 reaction mentions · 0.0% serious (0 of 4 reports). Top categories: Allergic / Anaphylactic (43%), Gastrointestinal (29%), General / Systemic (non-local) (29%).

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 →

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

VigiAccess (WHO)

150,931 MedDRA PT mentions · search: hepatitis A. Top categories: Other / Unclassified (21%), Injection-site / Local reaction (17%), General / Systemic (non-local) (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 VigiAccess (WHO) →

Lareb (Netherlands)

1,539 MedDRA PT mentions · search: Hepatitis A vaccine. Top categories: General / Systemic (non-local) (24%), Injection-site / Local reaction (14%), 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 Lareb (Netherlands) →

DAEN (Australia)

3,877 MedDRA PT mentions · search: hepatitis A. Top categories: Other / Unclassified (16%), General / Systemic (non-local) (15%), Neurological (15%).

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 Hepatitis A vaccines 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 in pediatric/adult cohorts

Tier 2 ○ No signal detected

Inactivated hepatitis A vaccines are among the least reactogenic routine products. Active post-licensure work has not identified a confirmed rare serious risk that changed routine childhood recommendations.

Population

VSD HepA vaccinees

Risk interval

Study-specific

Comparison

Control intervals

Evaluation period

Post-1990s licensure era

Method

Post-licensure observational monitoring

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)
228 HEP A (VAQTA) Hepatitis A
clinical-coded PT
17 GPS rank 253 (EBGM=14.89); PRR rank 159 (PRR=34.3359); ROR rank 159 (ROR=34.3532); BCPNN rank 261 (IC_LB=2.6484)

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

5. Disease Prevention Benefits

MetricPre-Vaccine EraPost-Vaccine Era
Annual HAV cases (U.S.)~30,000–60,000 (1980s–1990s); ~57,000 in the 1995 peak~3,000–6,000 reported cases (2015–2020); >95% reduction from peak
HAV incidence (children)Highest incidence in children 5–14 years>98% reduction in vaccinated age cohorts
HAV-related mortality~100–150 deaths/year<50 deaths/year

Source: CDC Pink Book; MMWR. However, the U.S. has experienced large person-to-person outbreaks since 2016 among unvaccinated adults (homeless populations, persons who inject drugs, MSM), reminding that population immunity depends on maintaining high vaccination coverage.

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

Hepatitis A vaccine has a well-established safety profile with >30 years of post-licensure data. It is among the least reactogenic vaccines on the pediatric schedule. No significant safety signals have been identified. Effectiveness is high (>94%). The main evidence gap is the duration of protection beyond 25 years, though immunologic memory is expected to provide long-term protection even after antibody levels wane.

8. International Surveillance & Global Data

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

9. Curated Adverse Event Literature

Curated peer-reviewed literature linking specific adverse events to Hepatitis A 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.

Common questions

How long do Hepatitis a vaccine side effects last?

Most reported Hepatitis a vaccine reactions are short-lived: injection-site soreness, tiredness, and low-grade fever that typically begin within a day or two and resolve within a few days. Longer-lasting or more serious events are rarer and are the ones tracked in the post-licensure surveillance and documented adverse-event sections of this page, with report counts that are not incidence rates. Anything severe or persisting beyond a week warrants medical review.

Is the Hepatitis a vaccine given to adults, and are side effects different in adults?

Whether the Hepatitis a vaccine is recommended for adults depends on the vaccine and the person's risk factors; the schedule and product sections above describe the licensed indications and age groups. Reporting patterns in adults can differ from children, so this page's VAERS and international database breakdowns should be read with the reporting population in mind. Check the current CDC/ACIP adult schedule and the product's prescribing information for adult dosing.

10. Key References

  1. IOM. Adverse Effects of Vaccines: Evidence and Causality. National Academies Press; 2012.
  2. CDC. Pink Book — Hepatitis A chapter. cdc.gov/pinkbook
  3. Innis BL, et al. Protection against hepatitis A by an inactivated vaccine. JAMA. 1994;271(17):1328–1334. (Havrix pivotal trial)
  4. CDC. VSD. cdc.gov/vaccine-safety/about/vsd.html
  5. CDC/FDA. VAERS. vaers.hhs.gov
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Next-Gen Pipeline & Clinical Candidates

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Phase 3 Primary completion (most advanced trial): 2028-03-17 (registry estimate)

Healive (hepatitis A vacine(human diploid cell), inactivated)

Sinovac Biotech Co., Ltd

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Discontinued Primary completion (most advanced trial): 2019-01-28 (registry estimate)

Havrix®

GlaxoSmithKline

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7. Compensation

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8. Risk-benefit and gaps

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