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In easy-to-understand language
Note: The terms "immunization," "vaccination," and "inoculation" are used to mean essentially the same thing throughout this site.

Rotavirus Disease

  • Rotavirus infection causes severe diarrheal illness in childhood that accounts for more than 500,000 physician visits and approximately 50,000 hospitalizations each year among children less than 5 years of age. Symptoms include fever, an upset stomach and vomiting followed by diarrhea, which may lead to severe dehydration in the U.S. Rotavirus illness has been estimated to result in $264 million in direct medical costs and $1 billion in total costs to society.
  • Rotavirus illness is a serious health concern for young children in the United States. Because there is currently no available vaccine, it is important that parents and health care providers quickly recognize and treat severe cases of childhood diarrhea.
  • Parents need to be sure to consult their health care provider for more information on the treatment of severe diarrhea in children.

Rotavirus Vaccine

  • The rotavirus vaccine (RotaShield�) was licensed by the Food and Drug Administration (FDA) on August 31, 1998. On October 22, 1999, the Advisory Committee on Immunization Practices (ACIP) voted to withdraw its recommendation for RotaShield�, due to an association between the vaccine and intussusception (a rare condition that can cause a blockage of the intestines). The decision was based primarily on the results of studies conducted by the Centers for Disease Control and Prevention (CDC), which suggested an association between the vaccine and intussusception. The RotaShield� vaccine was withdrawn from use by its manufacturer.
  • The series of events that led to ACIP�s decision to no longer recommend Rotavirus vaccine:
    • From September 1, 1998 to July 7, 1999, about 15 Vaccine Adverse Event Reporting System (VAERS) reports were filed for cases of intussusception occurring shortly after administration of RotaShield�.
    • VAERS showed an increase in the number of reports of intussusception following rotavirus vaccination. The number of reports was greater than would have been expected based on the rate of intussusception in infants in the U.S.
    • Scientific studies were launched by the CDC to study this "signal" from VAERS.
    • In July 1999, the CDC recommended suspension of immunization until it could be studied further.
    • On October 22, 1999, the ACIP voted to withdraw its recommendation of RotaShield� vaccine for infants in the U.S. based on a review of scientific data collected.
    • The CDC conducted a case-control study that linked vaccination with Rotashield� to increased risk of intussusception, particularly after the first dose. These results are published in the New England Journal of Medicine, 2001, Volume 344, pages 564 to 572. Additional studies are underway to further investigate.

Ensuring Vaccine Safety

  • The Federal government, including the CDC and FDA, plays a vital role in monitoring vaccine safety to identify and minimize vaccine-related injuries.
  • To report a health problem following vaccination, you or your health care provider can call VAERS at (800) 822-7967 to receive a reporting form. Forms can also be downloaded from the internet at:
CDC, National Immunization Program:

Last updated: August 2001

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