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Published on: January 28, 2019
Intussusception among recipients of rotavirus vaccine: reports to the vaccine adverse event reporting system
L R Zanardi1, P Haber, G T Mootrey
1Epidemic Intelligence Service Program, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. lzanardi@cdc.gov
Insights
Rotavirus vaccine use was linked to a fourfold increase in infant intussusception cases. This finding led to the vaccine
Area of Science:
- Pediatric Vaccinology
- Gastroenterology
- Public Health Surveillance
Background:
- Rotavirus vaccine was licensed in 1998 and recommended for infant immunization.
- Postlicensure surveillance was implemented to detect rare adverse events.
Purpose of the Study:
- To investigate intussusception cases in infants who received rotavirus vaccine.
- To analyze data reported to the Vaccine Adverse Event Reporting System (VAERS).
Main Methods:
- Surveillance of infants vaccinated with rotavirus vaccine in the United States.
- Confirmed intussusception cases through radiological, surgical, or autopsy reports.
- Utilized vaccine distribution data and incidence rates for comparison.
Main Results:
- 98 confirmed intussusception cases were reported post-vaccination.
- 60 cases occurred within one week of receiving the rotavirus vaccine.
- An estimated 7-16 cases were expected by chance alone in the same period.
Conclusions:
- A significant increase in intussusception cases was observed within a week of rotavirus vaccination.
- Further studies were initiated to clarify the vaccine-intussusception relationship.
- The rotavirus vaccine was voluntarily withdrawn from the market, and its recommendation rescinded.
Background:
Rotavirus vaccine was licensed on August 31, 1998, and subsequently recommended for routine use among infants. To assess rare adverse events, postlicensure surveillance was conducted.
Objective:
To describe the cases of intussusception among rotavirus vaccine recipients reported to the Vaccine Adverse Event Reporting System from October 1998 through December 1999.
Setting And Participants:
Infants vaccinated with rotavirus vaccine in the United States.
Outcome Measures:
Intussusception confirmed by radiology, surgery, or autopsy report with medical record documentation or confirmed by a primary health care provider.
Results:
There were 98 confirmed cases of intussusception after vaccination with rotavirus vaccine reported to the Vaccine Adverse Event Reporting System; 60 of these developed intussusception within 1 week after vaccination. Based on calculations using vaccine distribution data and intussusception incidence rates from 2 separate databases, an estimated 7 to 16 cases would have been expected to occur in the week after vaccination by chance alone.
Conclusion:
Using a passive surveillance system for vaccine adverse events, we observed at least a fourfold increase over the expected number of intussusception cases occurring within 1 week of receipt of rotavirus vaccine. Other studies were initiated to further define the relationship between rotavirus vaccine and intussusception. In light of these and other data, the rotavirus vaccine manufacturer voluntarily removed its product from the market, and the recommendation for routine use of rotavirus vaccine among US infants has been withdrawn.
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