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RotaTeq Warnings and Precautions

Before your child gets vaccinated, warnings and precautions for RotaTeq should be thoroughly reviewed. It is important to know that RotaTeq may not be safe for children with a blood disorder or immune-suppressing condition; make sure your child's healthcare provider knows if your child has these conditions. You should postpone the vaccination if your child is moderately or severely ill.

What Should I Tell My Healthcare Provider Before My Child Gets RotaTeq?

You should talk to a healthcare provider before your child receives RotaTeq® (rotavirus vaccine) if your child is moderately to severely ill or has:
 
  • A history of intussusception (a problem where one part of the bowel moves into the next)
  • Diarrhea or vomiting
  • A blood disorder
  • A gastrointestinal (digestive) problem or condition
  • An immune-suppressing condition such as HIV or AIDS, diabetes, or cancer
  • Had any sort of a reaction to any vaccine in the past
  • Any relatives or other close contact with a weakened immune system
  • Any allergies, including allergies to foods, dyes, or preservatives.
     
Make sure to tell the healthcare provider about any medications your child is taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.
 

Specific Warnings and Precautions

Warnings and precautions to be aware of prior to taking RotaTeq include the following:
 
  • RotaTeq was not adequately studied in children with a blood disorder (such as leukemia) or immune-suppressing conditions, nor has it been studied in children who take immune-suppressing medications or immune globulins (see RotaTeq Drug Interactions). It is unknown if RotaTeq is safe and effective for such children.
     
  • RotaTeq 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.
     
  • 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). Although initially this did not appear to be a problem with RotaTeq, a few cases of intussusception possibly related to RotaTeq have been reported, mostly within the first seven days after the vaccination. It is important to seek immediate medical attention if your child develops symptoms of this problem, such as:

 

    • Intense abdominal pain
    • Inconsolable shrieking
    • Bringing the knees to the chest
    • Bright-red "currant jelly" stool
    • Vomiting of green bile.

 

  • Very rare cases of Kawasaki disease have also 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.

 

  • Parents who are concerned about exposing their children to thimerosal can be confident that this vaccine contains no thimerosal (a mercury-containing preservative), not even in trace amounts. Some parents are concerned about aluminum content of vaccines; this vaccine contains no aluminum.
     
  • This vaccine is not made from human fetal components, as some vaccines are. It is, however, made from bovine (cow) components.

 

  • It is unknown if RotaTeq is safe or effective in children who have current digestive illnesses, chronic diarrhea, failure to thrive (poor weight gain), or a history of abdominal surgery or intussusception.
     
  • Your child can receive RotaTeq 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.
     
  • Make sure the healthcare provider knows if your child has ever had any serious reactions to any vaccines in the past.
     
  • RotaTeq 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 RotaTeq passes through breast milk. However, this is a childhood vaccine and should not be given to breastfeeding women.
     
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RotaTeq Vaccine Information

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