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Precautions and Warnings With the Rotavirus Vaccine

Specific Rotavirus Vaccine Warnings and Precautions

Warnings and precautions to be aware of prior to getting the vaccine include the following:
 
  • A previously marketed rotavirus vaccine (RotaShield®) was taken off the market due to the risk of a serious intestinal side effect known as intussusception (when one portion of the bowel slides over the other, creating a blockage).
Preliminary results from a study done in Mexico indicate there may be an increased risk of intussusceptions in the first 31 days after the first dose of Rotarix. Most of these cases occurred within the first 7 days of the 31-day period. RotaTeq was not evaluated in this study. Although initially it appeared that intussusception was not a problem with RotaTeq, a few cases possibly related to RotaTeq have been reported. As with Rotarix, most of these cases appeared within the first seven days.
It is important to seek immediate medical attention if your child develops symptoms of this problem, such as:
    • Intense abdominal pain (stomach pain)
    • Inconsolable shrieking
    • Bringing the knees to the chest
    • Bright-red "currant jelly" stool
    • Vomiting of green bile.

 

  • The rotavirus vaccine is a live virus vaccine and can potentially cause a rotavirus infection, particularly in children with weakened immune systems.
     
  • Occasionally, children who have been vaccinated may shed the virus in the stool and could potentially transmit it to others. If your child has close contacts (friends and relatives) with weakened immune systems, be sure to ask your child's healthcare provider if postponing (or not giving) the vaccine would be a good idea.
     
  • The rotavirus vaccine was not adequately studied in children with blood disorders (such as leukemia) or immune-suppressing conditions, nor has it been studied in children who take immune-suppressing medications (see Drug Interactions With the Rotavirus Vaccine). It is unknown if the rotavirus vaccine is safe and effective for such children.
     
  • Very rare cases of Kawasaki disease have been reported (too rare to know if there is any link to the vaccine). This disorder can be life-threatening if left untreated. Signs of Kawasaki disease include:

 

    • Fever
    • Rash
    • Red mouth and eyes
    • Swollen hands and feet
    • Swollen glands.

 

  • It is unknown if the rotavirus vaccine is safe or effective in children with current digestive illnesses, chronic diarrhea, poor weight gain (failure to thrive), or a history of abdominal surgery or intussusception.
     
  • Your child can receive the rotavirus vaccine if he or she has a mild illness (such as the common cold). However, it is usually best to postpone the vaccine in the case of a moderate or severe illness.

 

  • Parents who are concerned about exposing their children to thimerosal can be confident that the available rotavirus vaccines contain no thimerosal (a mercury-containing preservative), not even in trace amounts. Some parents are concerned about aluminum content of vaccines; these vaccines contain no aluminum.
     
  • These vaccines are not made from human fetal components, as some vaccines are. Rotarix is grown on a line of monkey kidney cells, and RotaTeq is made using bovine (cow) components. 

 

  • Make sure the healthcare provider knows if your child has ever had any serious reactions to any vaccines in the past. 

 

  • The rotavirus vaccine is considered a pregnancy Category C medication. This means it is unknown if it is safe for use during pregnancy. However, this is a childhood vaccine and should not be given to pregnant women.
     
  • At this time, it is unknown if the rotavirus vaccine passes through breast milk. However, this is a childhood vaccine and should not be given to breastfeeding women.
     
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Rotavirus Vaccine Information

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