Diarrhea Home > Rotavirus Vaccine Risks

In March 2010, the United States Food and Drug Administration (FDA) recommended that Rotarix not be used, at least temporarily, since DNA from porcine circovirus type 1 (PCV1) has been found in the vaccine. This means that DNA from a virus found in pigs has been found in the vaccine. However, in May 2010, the FDA announced that it is safe to begin using Rotarix again, since PCV1 poses no known health risks to humans.
No similar problems have been found with RotaTeq.
Before your child receives the rotavirus vaccine (Rotarix®, RotaTeq®), risks associated with the vaccine should be reviewed. Although most children tolerate this vaccine well, side effects are possible.
Some of the rare but serious side effects that have been reported with the rotavirus vaccine include:
  • A high fever
  • Any unusual behavior changes (aside from the usual fussiness that typically occurs after vaccinations)
  • A seizure
  • Signs of an allergic reaction, such as:


    • An unexplained rash
    • Hives
    • Itching
    • Swelling of the mouth or throat
    • Wheezing
    • Difficulty breathing.


It is also important to know that the rotavirus vaccine has not been adequately studied in children with blood disorders (such as leukemia) or immune-suppressing conditions, or who are taking immune-suppressing medications (see Drug Interactions With the Rotavirus Vaccine). The risks associated with the use of the rotavirus vaccine in these children are not fully known.
(Click Side Effects of the Rotavirus Vaccine and Precautions and Warnings With the Rotavirus Vaccine for more information about the potential risks of the rotavirus vaccine, including other possible side effects and information on who should not get vaccinated.)
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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