Name: Rotavirus Vaccine
Brand: RotaTeq
SKU: rotavirus

1. Basic Information

Disease Protected Against

Rotavirus is the leading cause of severe acute gastroenteritis in infants and young children globally. Before vaccination, rotavirus caused ~2.7 million cases of gastroenteritis, ~400,000 physician visits, ~70,000 hospitalizations, and ~20–60 deaths annually in U.S. children <5. Globally, rotavirus caused ~215,000 deaths/year in children <5 (pre-vaccine), predominantly in low-income countries. Transmission is fecal-oral. Almost all children are infected by age 3–5, regardless of sanitation quality.

CDC Schedule (U.S., 2025)

Dose	Recommended Age	Notes
Dose 1	2 months	Minimum age 6 weeks; maximum age for dose 1 = 14 weeks 6 days
Dose 2	4 months	Minimum interval 4 weeks
Dose 3 (RotaTeq only)	6 months	RotaTeq (RV5) requires 3 doses; Rotarix (RV1) requires 2 doses. All doses must be completed by 8 months 0 days.

Source: CDC ACIP, 2025 schedule. The strict age window (must start by 14w6d, must finish by 8m0d) is due to a small background risk of intussusception in older infants unrelated to vaccination.

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
Intussusception	0-42 days	Consistent WHO / IOM Causality Assessment: Consistent for rotavirus vaccines (RR 1.6–5.3 depending on vaccine and dose). Peak risk 3–7 days post-first dose. Mechanism: Vaccine-strain replication in intestinal lymphoid tissue leading to lead-point for intussusception. Post-licensure surveillance confirmed signal from RotaShield era; current vaccines show ~1–5 excess cases per 100,000 in low-mortality settings. Biological Mechanism: Vaccine-strain replication in intestinal lymphoid tissue leading to lead-point for intussusception (rotavirus-specific mechanism, not spike protein mediated) Clinical Evidence: Post-licensure surveillance confirmed signal; ~1–5 excess cases per 100,000 Spike Protein Evidence: Not applicable (rotavirus vaccine, not COVID-19)	Intussusception within 42 days following first or subsequent rotavirus 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.

Live attenuated Oral No preservative (typical single-dose) Polysorbate 80

RotaTeq Merck Sharp & Dohme LLC · Live attenuated

Delivery

Route: Oral

Form: Oral solution

Dose volume: 2 mL

Presentation: single-dose ready-to-use oral tube

Encapsulation / delivery vehicle

None (no nanoparticle/VLP encapsulation system)

Antigens

Antigen	Type	Amount / dose
Live reassortant rotavirus G1	Live attenuated virus	≥2.2 × 10^6 infectious units
Live reassortant rotavirus G2	Live attenuated virus	≥2.8 × 10^6 infectious units
Live reassortant rotavirus G3	Live attenuated virus	≥2.2 × 10^6 infectious units
Live reassortant rotavirus G4	Live attenuated virus	≥2.0 × 10^6 infectious units
Live reassortant rotavirus P1A[8]	Live attenuated virus	≥2.3 × 10^6 infectious units

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
Sucrose	Stabilizer	label quantity	stabilizer/sweetener
Sodium citrate / phosphate buffers	Buffer	label quantity	buffer
Polysorbate 80	Surfactant	label quantity	surfactant
Fetal bovine serum	Residual (manufacturing)	trace residual	residual

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

Rotarix GlaxoSmithKline Biologicals · Live attenuated

Delivery

Route: Oral

Form: Oral solution

Dose volume: 1 mL

Presentation: oral applicator (liquid) or lyophilized + diluent (historical)

Encapsulation / delivery vehicle

None (no nanoparticle/VLP encapsulation system)

Antigens

Antigen	Type	Amount / dose
Live attenuated human rotavirus RIX4414 (G1P[8])	Live attenuated virus	≥10^6.0 CCID50

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
Sucrose	Stabilizer	label quantity	stabilizer
Dulbecco's Modified Eagle Medium components	Residual (culture)	residual/media	media
Amino acids / salts	Buffer	label quantity	buffer

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)
Intussusception HRSA table	1–21 days	Very likely / Probable Evidence: High	Intussusception after oral rotavirus vaccine (primary · innate_inflammation) Oral rotavirus vaccines can promote lymphoid hyperplasia and altered gut motility that rarely lead to telescoping of intestine (intussusception), especially after dose 1.

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
RV2	Rotarix	GSK	2 or 3	2M 4M 6M	Dextran, Sorbitol, Amino Acids, Dulbecco’s Modified Eagle Medium, and Xanthan	No	31 days + 1 year for intussusception
RV2	RotaTeq	Merck	2 or 3	2M 4M 6M	Polysorbate-80, Tissue Culture Medium, Fetal Bovine Serum, and Sodium Phosphate	No	42 days + 1 year for intussusception

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.

Current rotavirus vaccines were developed with intussusception safety specifically in mind, following the RotaShield experience. Both RotaTeq and Rotarix conducted very large pivotal trials.

Metric	RotaTeq (RV5, Merck)	Rotarix (RV1, GSK)
Pivotal trial size	~70,000 infants (REST trial); ~35,000 received RotaTeq	~63,000 infants; ~31,500 received Rotarix
Efficacy against severe rotavirus gastroenteritis	~98% (U.S./Europe); lower in low-income settings (~50–65%)	~85–96% (high-income); lower in low-income settings (~50–65%)
Efficacy against any rotavirus hospitalization	~96%	~85–96%
Intussusception (pre-licensure)	No signal observed vs. placebo within 42 days (6 cases vs. 5 cases in placebo)	No signal observed vs. placebo within 31 days

The REST (RotaTeq) and Rotarix pivotal trials are the largest pre-licensure vaccine trials ever conducted, with ~130,000+ infants combined. Both were specifically powered to evaluate intussusception risk.

Most Common Adverse Reactions

Reaction	RotaTeq / Rotarix (Approx.)
Diarrhea	~10–20% (mild, self-limited)
Vomiting	~8–15%
Irritability	~15–25%
Fever	~10–20%

Adverse reactions are generally mild and self-limited (1–3 days). Rates are comparable to placebo in the large trials, reflecting the high background rate of these symptoms in infants.

Key Limitations

Intussusception at very low rates: Even the very large pivotal trials (N=130,000+) were not adequately powered to detect intussusception at rates of ~1–5 per 100,000 doses. This risk was identified and quantified post-licensure.
Lower efficacy in low-income countries: Rotavirus vaccine efficacy is substantially lower in low-income settings, a phenomenon also observed with oral polio vaccine but not fully understood. Possible contributing factors include maternal antibody interference, gut microbiome differences, and malnutrition.
Contraindication in SCID: Infants with severe combined immunodeficiency (SCID) can develop severe, prolonged vaccine-strain rotavirus gastroenteritis. SCID is now screened at birth in the U.S., allowing identification before the 2-month vaccination visit.

3. Post-Licensure Safety Data

Intussusception — Confirmed Post-Licensure Signal

Post-licensure VSD and international studies identified a small but statistically significant increased risk of intussusception following rotavirus vaccination, primarily in the 3–7 day window after the first dose.

RotaTeq (RV5): Estimated ~1–1.5 excess cases of intussusception per 100,000 first doses (VSD data). Attributable fraction small relative to background risk of intussusception (~35 per 100,000 infant-years).
Rotarix (RV1): Estimated ~1–5 excess cases per 100,000 first doses (international studies; higher estimates from some datasets).
Risk-benefit: Studies estimate that rotavirus vaccination prevents ~50,000–70,000 U.S. hospitalizations annually while causing ~40–120 excess intussusception cases. The benefit-risk ratio is estimated at approximately 500–1,000 hospitalizations prevented per excess intussusception case.

The intussusception risk is acknowledged by ACIP, CDC, and WHO, and is included in product labeling. IOM (2012) concluded evidence favors acceptance of a causal relationship for rotavirus vaccine and intussusception.

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 (Rotavirus (RotaTeq + Rotarix combined)):

Metric	Value
U.S. doses administered (2006–2022)	150,866,652
Total VAERS AE reports	19,899
AE reporting rate (per 100,000 doses)	13.2
Total death reports	476
Death reporting rate (per 100,000 doses)	0.316
AE-to-Death ratio	42:1

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): 25,405 symptom mentions (5.61/100k doses). Largest share: Other / Unclassified (74%), Gastrointestinal (11%), General / Systemic (non-local) (4%). Canada Vigilance (CV Online extract): 187 reaction mentions in 65 unique reports (84.6% serious (55 of 65 reports)). Largest share: Gastrointestinal (28%), Thrombotic / Hematological (9%), General / Systemic (non-local) (8%). JADER (PMDA public CSV extract): 2,763 reaction mentions in 1,217 unique reports (0.7% serious (8 of 1,217 reports)). Largest share: Gastrointestinal (46%), Other / Unclassified (37%), General / Systemic (non-local) (7%). VigiAccess (WHO): 250,075 reaction-term mentions · search: rotavirus. Largest share: Other / Unclassified (26%), Gastrointestinal (20%), General / Systemic (non-local) (15%). Lareb (Netherlands): 3,974 reaction-term mentions · search: Rotavirus vaccine. Largest share: Gastrointestinal (34%), General / Systemic (non-local) (26%), Other / Unclassified (18%). Medsafe (New Zealand): 1,120 reaction-term mentions · search: rotavirus. Largest share: Gastrointestinal (48%), Other / Unclassified (14%), Psychiatric / Neuropsychiatric (12%). 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: Gastrointestinal; top JADER: Gastrointestinal. 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

5,733 reports with usable lot across 702 lots · 118 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)

65 unique reports · 187 reaction mentions · 84.6% serious (55 of 65 reports). Top categories: Gastrointestinal (28%), Thrombotic / Hematological (9%), General / Systemic (non-local) (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)

1,217 unique reports · 2,763 reaction mentions · 0.7% serious (8 of 1,217 reports). Top categories: Gastrointestinal (46%), Other / Unclassified (37%), General / Systemic (non-local) (7%).

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)

250,075 MedDRA PT mentions · search: rotavirus. Top categories: Other / Unclassified (26%), Gastrointestinal (20%), General / Systemic (non-local) (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 VigiAccess (WHO) →

Lareb (Netherlands)

3,974 MedDRA PT mentions · search: Rotavirus vaccine. Top categories: Gastrointestinal (34%), General / Systemic (non-local) (26%), Other / Unclassified (18%).

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 Rotavirus vaccines (RotaTeq / Rotarix) 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: Intussusception

Tier 2 ● Signal confirmed (true association)

Active surveillance confirmed a small increased risk of intussusception after current rotavirus vaccines (on the order of ~1–5 excess cases per 100,000 vaccinated infants in published estimates, product- and window-dependent). Risk is much lower than with the withdrawn RotaShield product; benefits against severe gastroenteritis remain the policy rationale for continued use.

Population

Infants receiving monovalent and pentavalent rotavirus vaccines

Risk interval

Typically 1–7 and 1–21 days after dose 1 (and additional dose windows in some analyses)

Comparison

Control intervals / unexposed person-time

Evaluation period

Post-licensure U.S. monitoring (key NEJM report 2014 for monovalent product)

Method

Active surveillance / cohort and self-controlled designs with chart validation

Related passive AE category on this page: Gastrointestinal (see multi-system charts above — not additive with active rates).

Sources: Weintraub ES et al. NEJM 2014 — intussusception after monovalent rotavirus vaccine · 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)
2	ROTAVIRUS (ROTASHIELD)	Gastrointestinal haemorrhage clinical-coded PT · published top-25	94	GPS rank 2 (EBGM=112.59); PRR rank 8 (PRR=343.7149); ROR rank 8 (ROR=361.035); BCPNN rank 6 (IC_LB=5.8346)
31	ROTAVIRUS (ROTASHIELD)	Intestinal obstruction clinical-coded PT	23	GPS rank 14 (EBGM=46.73); PRR rank 40 (PRR=150.3139); ROR rank 40 (ROR=152.0924); BCPNN rank 99 (IC_LB=3.7254)
77	ROTAVIRUS (ROTASHIELD)	Gastroenteritis clinical-coded PT	30	GPS rank 78 (EBGM=22.47); PRR rank 95 (PRR=58.4477); ROR rank 93 (ROR=59.3435); BCPNN rank 89 (IC_LB=3.7933)
91	ROTAVIRUS (ROTATEQ)	Rotavirus test positive clinical-coded PT	246	GPS rank 175 (EBGM=7.59); PRR rank 100 (PRR=45.2311); ROR rank 100 (ROR=45.5059); BCPNN rank 36 (IC_LB=4.5275)
95	ROTAVIRUS (ROTASHIELD)	Constipation clinical-coded PT	37	GPS rank 105 (EBGM=18.0); PRR rank 125 (PRR=40.0525); ROR rank 122 (ROR=40.8062); BCPNN rank 87 (IC_LB=3.7983)
97	ROTAVIRUS (ROTATEQ)	Rotavirus infection clinical-coded PT	129	GPS rank 233 (EBGM=6.72); PRR rank 86 (PRR=57.0732); ROR rank 86 (ROR=57.2553); BCPNN rank 40 (IC_LB=4.4775)
102	ROTAVIRUS (ROTATEQ)	Oral administration complication clinical-coded PT	70	GPS rank 255 (EBGM=6.74); PRR rank 79 (PRR=67.5708); ROR rank 79 (ROR=67.688); BCPNN rank 53 (IC_LB=4.2281)
113	ROTAVIRUS (ROTATEQ)	Haematochezia clinical-coded PT	769	GPS rank 160 (EBGM=7.53); PRR rank 144 (PRR=23.4892); ROR rank 142 (ROR=23.9319); BCPNN rank 61 (IC_LB=4.0715)
114	ROTAVIRUS (ROTASHIELD)	Melaena clinical-coded PT	12	GPS rank 117 (EBGM=28.21); PRR rank 66 (PRR=108.9005); ROR rank 66 (ROR=109.5673); BCPNN rank 259 (IC_LB=2.6617)
118	ROTAVIRUS (ROTATEQ)	Intussusception clinical-coded PT	867	GPS rank 153 (EBGM=7.87); PRR rank 154 (PRR=22.2368); ROR rank 152 (ROR=22.7092); BCPNN rank 66 (IC_LB=4.0212)
128	ROTAVIRUS (ROTATEQ)	Gastroenteritis rotavirus clinical-coded PT	73	GPS rank 308 (EBGM=6.09); PRR rank 89 (PRR=58.5007); ROR rank 90 (ROR=58.6062); BCPNN rank 55 (IC_LB=4.1822)
131	ROTAVIRUS (ROTATEQ)	Mucous stools clinical-coded PT	194	GPS rank 185 (EBGM=7.3); PRR rank 150 (PRR=24.9312); ROR rank 149 (ROR=25.0483); BCPNN rank 72 (IC_LB=3.9253)
133	ROTAVIRUS (ROTATEQ)	Enema administration clinical-coded PT	248	GPS rank 173 (EBGM=7.61); PRR rank 160 (PRR=22.5071); ROR rank 160 (ROR=22.6418); BCPNN rank 76 (IC_LB=3.8736)
134	ROTAVIRUS (ROTATEQ)	Occult blood positive clinical-coded PT	171	GPS rank 180 (EBGM=7.52); PRR rank 155 (PRR=24.0493); ROR rank 156 (ROR=24.1487); BCPNN rank 79 (IC_LB=3.8579)
140	ROTAVIRUS (ROTASHIELD)	Abnormal faeces clinical-coded PT	20	GPS rank 200 (EBGM=14.81); PRR rank 104 (PRR=57.52); ROR rank 104 (ROR=58.1045); BCPNN rank 171 (IC_LB=3.2782)

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 of Causal Association

Intussusception: ~1–5 excess cases per 100,000 first doses within 3–7 days post-dose 1. IOM (2012) favored acceptance of causal relationship. Background risk (~35 per 100,000 infant-years) is higher than vaccine-attributable risk. Strong
Diarrhea / vomiting: Mild, self-limited (10–20%). Strong
Irritability: 15–25%; self-limited. Strong
Vaccine-strain gastroenteritis in SCID infants: Severe, prolonged diarrhea in immunocompromised infants. Strong

▶ No Causal Association

Kawasaki disease: An initial VAERS signal was investigated in VSD and found not to be associated. No Association

5. Disease Prevention Benefits

Metric	Pre-Vaccine Era	Post-Vaccine Era (U.S.)
Rotavirus hospitalizations (annual, children <5)	~55,000–70,000	>90% reduction; ~4,000–6,000 hospitalizations/year
Rotavirus ER visits (annual, <5)	~200,000	~80–85% reduction
Rotavirus deaths (annual, U.S., <5)	~20–60	<5/year
Global rotavirus deaths (2000 vs. 2022)	~528,000 (2000)	~128,000 (2022) — ~76% reduction

Source: CDC Pink Book; WHO. Substantial herd protection has been observed, with declines in rotavirus disease in unvaccinated older children and adults.

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

Rotavirus vaccines have been studied in the largest pre-licensure trials in vaccine history (N=130,000+ combined), specifically designed to evaluate intussusception risk. The post-licensure identification of a small intussusception risk (~1–5 per 100,000 first doses) is an example of the surveillance system functioning as designed—detecting a risk too small to be identified even in the very large pre-licensure trials. The benefit-risk ratio strongly favors vaccination. The primary evidence gap is the lower efficacy in low-income countries, an active area of research.

Domain	Evidence Grade
Efficacy (severe rotavirus disease, high-income)	Strong
Intussusception risk	Strong
Efficacy (low-income settings)	Moderate

8. International Surveillance & Global Data

Quick links to public pharmacovigilance databases and trial registries relevant to Rotavirus 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 Rotavirus 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

Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(1):23–33. (REST trial; N=68,038)
Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354(1):11–22. (Rotarix pivotal trial; N=63,225)
IOM. Adverse Effects of Vaccines: Evidence and Causality. National Academies Press; 2012.
Weintraub ES, et al. Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med. 2014;370(6):513–519.
Yih WK, et al. Intussusception risk after rotavirus vaccination in U.S. infants. N Engl J Med. 2014;370(6):503–512. (VSD study)
CDC. Pink Book — Rotavirus chapter. cdc.gov/pinkbook
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

Key Limitations

3. Post-Licensure Safety Data

Intussusception — Confirmed Post-Licensure Signal

Other Post-Licensure 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)

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 of Causal Association

▶ 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

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