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Rotavirus vaccination and short-term risk of adverse events in US infants
J Bradley Layton1,2, Anne M Butler3,4, Catherine A Panozzo5
1Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Research Triangle Park, North Carolina.
Insights
Rotavirus vaccination (RV) in infants showed no increased risk for intussusception or other serious adverse events. A slight increase in otitis media risk was observed, particularly with the RV1 formulation.
Area of Science:
- Pediatric Vaccinology
- Public Health
- Epidemiology
Background:
- Rotavirus vaccines (RV) are crucial for preventing severe rotavirus gastroenteritis in infants.
- Understanding the short-term safety profile of RV, including different formulations, is essential for public health recommendations.
Purpose of the Study:
- To evaluate the short-term risk of adverse events following rotavirus vaccination in infants.
- To compare adverse event risks between pentavalent (RV5) and monovalent (RV1) rotavirus vaccine formulations.
Main Methods:
- A cohort study of US newborns (2006-2014) receiving diphtheria-tetanus-pertussis vaccine (DTaP) was conducted.
- Infants were monitored for 30 days post-vaccination for intussusception, gastrointestinal events, seizures, Kawasaki disease, thrombocytopenia, otitis media, and hospitalizations.
- Cox proportional hazards models were used to compare risks between DTaP+RV and DTaP alone, and between RV5 and RV1.
Main Results:
- Over 1 million DTaP doses were analyzed, with 79.2% receiving concurrent RV (94.1% RV5).
- Absolute risks of serious outcomes were very low.
- No consistent increased risk of intussusception or other adverse events was found with RV+DTaP compared to DTaP alone, except for a small increase in otitis media after dose 2.
- The increased otitis media risk was less pronounced with RV5 compared to RV1.
Conclusions:
- Rotavirus vaccination is not associated with an increased risk of intussusception or other major adverse events.
- A potential small increase in otitis media risk may be associated with rotavirus vaccination, particularly the RV1 formulation.
- These findings support the overall safety of rotavirus vaccines in infants.
Background:
The aim of this study was to evaluate the short-term risk of adverse events associated with rotavirus vaccine (RV) in infants, overall and by vaccine formulation (three-dose pentavalent, RV5; two-dose monovalent, RV1).
Methods:
We identified US newborns with commercial insurance during 2006-2014 receiving a diphtheria-tetanus-pertussis vaccine (DTaP) dose and assessed if RV was administered concurrently. We followed infants for 30 days after each dose for diagnoses of intussusception, other gastrointestinal events, seizures, Kawasaki disease, thrombocytopenia, otitis media, all-cause emergency department visits, and all-cause hospitalisations. We estimated adjusted hazard ratios (HR) and 95% confidence intervals (CI) with multivariable Cox proportional hazards models comparing: (a) those receiving DTaP+RV vs those receiving DTaP alone; and (b) RV5 vs RV1. Analyses were performed separately within DTaP doses and then meta-analysed across doses.
Results:
We identified 1 031 431 first DTaP doses, 821 833 second doses, and 615 293 third doses; 79.2% had a concurrent RV, 94.1% of which were RV5. Absolute risks of serious outcomes were very low. Compared to infants who received DTaP alone, infants who received RV+DTaP did not experience consistently increased risk of intussusception (hazard ratio [HR] 1.13, 95% confidence interval [CI] 0.68, 1.88) or any other outcome except for otitis media after dose 2: HR 1.11, 95% CI 1.08, 1.15. This increased otitis media risk was not as pronounced in RV5 when comparing RV5 to RV1; HR 0.92, 95% CI 0.89, 0.95.
Conclusions:
These data were not consistent with an increased risk of intussusception or other adverse events following vaccination with RV, except potentially for a small increased risk of otitis media, particularly in RV1.
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