National Vaccine Information Center

Serious Vaccine Reactions Follow RotaShield Vaccine Approval

Published: November 19, 2023

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On March 19, 1999, the CDC published its recommendation on the use of RotaShield vaccine and reported that five cases of intussusception, a serious bowel blockage requiring medical attention, had occurred in infants who had received a rotavirus vaccine in comparison to the one case among placebo recipients. The panel, however, reported this finding to be statistically insignificant. 

By the spring of 1999, several reports of intussusception following RotaShield vaccine administration had been made to the Vaccine Adverse Events Reporting System (VAERS). No mention of safety concerns regarding RotaShield were made at the June 1999 ACIP meeting; however, on July 16, 1999, the CDC announced that it was suspending its recommendation of RotaShield due to the increasing number of intussusception reports.    Later that year, at the CDC’s October ACIP meeting, the committee voted to withdraw its recommendation in light of evidence which found that intussusception occurred in one out of every 5,000 infants who received the vaccine.   

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