In 1998, the Food and Drug Administration (FDA) approved the first rotavirus vaccine. RotaShield®
(Wyeth-Ayerst) is a live oral, tetravalent vaccine indicated for the prevention of rotavirus-associated
gastroenteritis in infants.

Prelicensures studies for rotavirus vaccine found only 5 cases of intussusception in 10,054 vaccinees compared with 1 case in 4633 controls, and this difference was thought not to be significant. However, an apparent increase in the number of cases reported to the VAERS reporting system, with subsequent results from a case-control study, prompted stopping administration of rotavirus vaccine. Postlicensure studies' data support the suspected increase in intussusception cases, but its association with rotavirus vaccine has not been proven.

See: Possible Association of Intussusception With Rotavirus Vaccination (RE9938)
Number of Rotavirus Vaccine-Associated Cases of Intussusception Escalates 

The rate of intussusception among never-vaccinated children was 45/100,000 infant-years, compared with
125/100,000 infant-years among vaccine recipients. Among children who had received the vaccine in the
previous week, the rate was 314/100,000 infant-years. With the appropriate person-time denominators, the
rates were elevated, although still not significantly.

See: Rotavirus Vaccine On Hold as CDC Investigates Risk

Information from Medscape