1. Basic Information

Disease Protected Against

Streptococcus pneumoniae (Pneumococcus) is a bacterium causing invasive pneumococcal disease (IPD) including bacteremia and meningitis; pneumonia; and otitis media. Before vaccination, pneumococcus was the leading cause of bacterial meningitis and bacteremia in young children. There are >100 serotypes; PCV vaccines target the most clinically significant ones. IPD has a case-fatality rate of ~5–15% in children and can cause permanent neurological sequelae in meningitis survivors.

CDC Schedule (U.S., 2025)

Dose	Age	Product
Dose 1	2 months	PCV13 or PCV15 or PCV20
Dose 2	4 months	PCV13 or PCV15 or PCV20
Dose 3	6 months	PCV13 or PCV15 or PCV20
Dose 4 (booster)	12–15 months	PCV13 or PCV15 or PCV20

Source: CDC ACIP, 2025 schedule. PCV7 (7-valent) was introduced in 2000, replaced by PCV13 in 2010. PCV15 and PCV20 were licensed in 2021–2023. The schedule is transitioning to higher-valency products.

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 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.

Conjugate Intramuscular (IM) Adjuvant: Aluminum phosphate No preservative (typical single-dose) Aluminum phosphate Polysorbate 80 Yeast protein

Prevnar 20 Pfizer Inc. · Conjugate

Delivery

Route: Intramuscular (IM)

Form: Suspension for injection

Dose volume: 0.5 mL

Presentation: single-dose prefilled syringe

Encapsulation / delivery vehicle

None (no nanoparticle/VLP encapsulation system)

Antigens

Antigen	Type	Amount / dose
Pneumococcal capsular polysaccharides (20 serotypes) conjugated to CRM197 Carrier: CRM197 (diphtheria CRM197 protein ≈51 mcg)	Conjugate	2.2 mcg each of 19 serotypes + 4.4 mcg serotype 6B (typical PCV20 labeling)

Adjuvants

Aluminum phosphate — ≈0.125 mg aluminum per 0.5 mL

Preservatives

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

Excipients & residuals

Ingredient	Category	Amount	Role
Polysorbate 80	Surfactant	≈100 mcg	surfactant
Succinate buffer	Buffer	≈295 mcg	buffer
Sodium chloride	Buffer	label quantity	tonicity
Yeast / growth medium residuals	Residual (culture)	trace	residual

Source: Manufacturer prescribing information · 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).
Febrile seizure (with concurrent vaccines)	0–2 days	Possible Evidence: Moderate	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.

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
PCV	Prevnar 13, PCV-13	Pfizer	4	2M 4M 6M 12M	Prevnar 7	No	6 months
PCV	Vaxneuvance PCV-15	Merck	4	2M 4M 6M 12M	Prevnar 13	No	6 months
PCV	Prevnar 20, PCV-20	Pfizer	4	2M 4M 6M 12M	Prevnar 13	No	6 months
PPSV23	Pneumovax 23	Merck	0 or 2	2Y+ if indicated	See note	No	See note

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.

PCV7 (Prevnar, 2000) was licensed based on a pivotal efficacy trial in ~38,000 infants — one of the largest pediatric vaccine pre-licensure programs. PCV13 (2010) was licensed based on immunogenicity non-inferiority trials comparing to PCV7 plus safety data from ~6,000 infants. PCV15 and PCV20 were licensed based on immunogenicity bridging studies.

Metric	PCV7 Data	PCV13 Data
Pivotal trial size	~38,000 infants (NCKP trial)	~6,000 infants (safety); immunogenicity in ~3,200
Efficacy (IPD, vaccine types)	~97%	Immunobridged; real-world data confirm high effectiveness
Most common reactions	Injection site pain (10–20%), fever >38°C (15–25%), irritability (20–40%), decreased appetite (10–20%), drowsiness (15–30%)	Similar to PCV7; slightly higher rate of local reactions compared to PCV7 due to additional serotypes

The PCV7 pivotal trial was notable for its size and for using a saline placebo, providing one of the most robust pre-licensure safety databases for any pediatric vaccine. PCV13 and subsequent products used active comparators (PCV7) rather than placebo.

Key Limitations

Serotype replacement: PCV vaccines reduce disease caused by vaccine serotypes, but non-vaccine serotypes can increase in prevalence (serotype replacement). This has been observed post-PCV7 and post-PCV13, necessitating development of higher-valency vaccines.
Febrile seizure risk with concomitant influenza vaccine: PCV13 given concomitantly with trivalent inactivated influenza vaccine (TIV) was associated with a small increased risk of febrile seizures in the 2010–2011 season (~1 additional seizure per 2,000–2,500 doses). This was not observed with PCV13 alone or with other concomitant vaccine combinations.

3. Post-Licensure Safety Data

PCV vaccines have extensive post-licensure safety data from VSD and VAERS, spanning >25 years for PCV7/PCV13. Key VSD findings:

Febrile seizures: PCV13 + TIV combination identified as a safety signal in VSD rapid cycle analysis (2010–2011). Signal resolved. PCV13 alone is not associated with increased febrile seizure risk.
No other consistent safety signals have been identified in VSD for PCV vaccines independently. IOM (2012) did not identify specific safety concerns for PCV.

⚠ 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 (Pneumococcal (all pneumococcal conjugate + polysaccharide vaccines combined)):

Metric	Value
U.S. doses administered (2006–2022)	517,159,908
Total VAERS AE reports	83,537
AE reporting rate (per 100,000 doses)	16.2
Total death reports	810
Death reporting rate (per 100,000 doses)	0.157
AE-to-Death ratio	103:1

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)

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)

VAERS (U.S., 2006–2024): 178,458 symptom mentions (8.63/100k doses). Largest share: Injection-site / Local reaction (30%), Other / Unclassified (16%), General / Systemic (non-local) (15%). Canada Vigilance (CV Online extract): 3,089 reaction mentions in 797 unique reports (59.5% serious (474 of 797 reports)). Largest share: Injection-site / Local reaction (18%), Respiratory (13%), General / Systemic (non-local) (11%). JADER (PMDA public CSV extract): 4,585 reaction mentions in 2,068 unique reports (5.8% serious (120 of 2,068 reports)). Largest share: General / Systemic (non-local) (27%), Other / Unclassified (20%), Respiratory (19%). VigiAccess (WHO): 884,927 reaction-term mentions · search: pneumococcal. Largest share: Injection-site / Local reaction (23%), General / Systemic (non-local) (18%), Other / Unclassified (14%). Lareb (Netherlands): 10,567 reaction-term mentions · search: pneumococcal conjugate vaccine. Largest share: Injection-site / Local reaction (33%), General / Systemic (non-local) (17%), Other / Unclassified (16%). Medsafe (New Zealand): 1,334 reaction-term mentions · search: pneumococcal. Largest share: Injection-site / Local reaction (64%), General / Systemic (non-local) (16%), Gastrointestinal (6%). 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: Injection-site / Local reaction; top Canada Vigilance: Injection-site / Local reaction; top JADER: General / Systemic (non-local). 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

29,802 reports with usable lot across 1,462 lots · 244 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)

797 unique reports · 3,089 reaction mentions · 59.5% serious (474 of 797 reports). Top categories: Injection-site / Local reaction (18%), Respiratory (13%), General / Systemic (non-local) (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 →

JADER (PMDA, Japan)

2,068 unique reports · 4,585 reaction mentions · 5.8% serious (120 of 2,068 reports). Top categories: General / Systemic (non-local) (27%), Other / Unclassified (20%), Respiratory (19%).

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)

884,927 MedDRA PT mentions · search: pneumococcal. Top categories: Injection-site / Local reaction (23%), General / Systemic (non-local) (18%), 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 VigiAccess (WHO) →

Lareb (Netherlands)

10,567 MedDRA PT mentions · search: pneumococcal conjugate vaccine. Top categories: Injection-site / Local reaction (33%), General / Systemic (non-local) (17%), Other / Unclassified (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 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 Pneumococcal conjugate 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 after conjugate pneumococcal vaccination

Tier 2 ○ No signal detected

Pneumococcal conjugates have extensive active post-licensure monitoring. Higher-valency products continue RCA-style monitoring as they enter schedules; no confirmed signal has reversed the overall pediatric IPD-prevention indication.

Population

Infants and adults per product indications at VSD sites

Risk interval

Protocol-specific

Comparison

Control intervals / prior-valency comparators

Evaluation period

PCV7/13 historical; higher-valency products ongoing

Method

RCA and observational studies for new valencies (PCV13/15/20)

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)
182	PNEUMO (PNU-IMUNE)	Skin striae clinical-coded PT	32	GPS rank 101 (EBGM=18.66); PRR rank 197 (PRR=20.2955); ROR rank 198 (ROR=20.3596); BCPNN rank 201 (IC_LB=3.099)
229	PNEUMO (PNU-IMUNE)	Vasodilatation clinical-coded PT	479	GPS rank 119 (EBGM=11.43); PRR rank 256 (PRR=9.4544); ROR rank 253 (ROR=9.8952); BCPNN rank 214 (IC_LB=3.0469)
235	PNEUMO (PNU-IMUNE)	Injection site hypersensitivity clinical-coded PT	756	GPS rank 116 (EBGM=11.48); PRR rank 264 (PRR=8.5166); ROR rank 259 (ROR=9.1543); BCPNN rank 229 (IC_LB=2.9371)
267	PNEUMO (PNU-IMUNE)	Injection site oedema clinical-coded PT	674	GPS rank 138 (EBGM=8.73); PRR rank 294 (PRR=5.7224); ROR rank 293 (ROR=6.0763); BCPNN rank 287 (IC_LB=2.373)
308	PNEUMO (NO BRAND NAME)	Diet refusal clinical-coded PT	42	GPS rank 301 (EBGM=6.57); PRR rank 303 (PRR=5.5581); ROR rank 303 (ROR=5.568); BCPNN rank 304 (IC_LB=1.8385)

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: Pain (~10–20%), swelling (~5–15%). Strong
Fever: 15–25% (>38°C); 1–5% (>39°C). Strong
Irritability/decreased appetite/drowsiness: 15–40% in infants. Self-limited. Strong
Febrile seizures (PCV13 + TIV combination): Small increased risk when co-administered; ~1 per 2,000–2,500 doses. Strong
Anaphylaxis: ~1 per million doses. Strong

▶ No Causal Association

SIDS: No association. No Association
Autism: No association. No Association

5. Disease Prevention Benefits

Metric	Pre-Vaccine Era	Post-PCV Era
IPD in children <5 (annual, U.S.)	~16,000–17,000 cases (~190 per 100,000)	>90% reduction; vaccine-type IPD near-elimination in children
Pneumococcal meningitis (children <2)	~1,300 cases/year	<50 cases/year (vaccine types)
All-cause pneumonia hospitalizations (children <2)	Baseline pre-PCV7	~35–40% reduction; substantial herd protection in unvaccinated and older adults
Otitis media	Very high; most common reason for pediatric antibiotic prescriptions	~20–25% reduction in all-cause otitis media visits; larger reduction in vaccine-type OM

Source: CDC Pink Book; MMWR. PCV has produced substantial herd protection, reducing IPD in unvaccinated adults and the elderly.

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

PCV vaccines have a robust evidence base. The PCV7 pivotal trial (N=38,000) was among the largest pediatric vaccine pre-licensure studies ever conducted, with a true saline placebo. Post-licensure VSD data span >25 years. The primary evidence gaps relate to serotype replacement dynamics (ongoing), the safety of newer higher-valency products relative to established products (post-licensure data still limited for PCV15/PCV20), and the long-term population-level impact of PCV on non-vaccine serotypes.

8. International Surveillance & Global Data

Quick links to public pharmacovigilance databases and trial registries relevant to Pneumococcal Conjugate 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 Pneumococcal 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

Black S, Shinefield H, Fireman B, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000;19(3):187–195. (NCKP trial)
IOM. Adverse Effects of Vaccines: Evidence and Causality. National Academies Press; 2012.
CDC. Pink Book — Pneumococcal chapter. cdc.gov/pinkbook
Tse A, et al. Signal identification and evaluation for febrile seizures after PCV13 and TIV. Vaccine. 2012.
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

Causality assessment & potential mechanisms

2. Pre-Licensure Clinical Trial Data

Licensure trial design (ICAN / OpenVAERS)

Key Limitations

3. Post-Licensure Safety Data

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)

JADER (PMDA, Japan)

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

▶ No Causal Association

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