What is rotavirus?

What is rotavirus?

Rotavirus is a common virus that is easy to catch. It infects the stomach and intestines, causing symptoms like diarrhea and vomiting. In the pre-vaccine era, nearly all children were affected by rotavirus by age 5.

Rotavirus Is a Common Virus That Spreads Easily From Person to Person

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Babies Are at Particular RIsk for Rotavirus

Babies are at higher risk for rotavirus infection. The most severe cases happen to babies between 6 months and 2 years old.

Rotavirus can cause your baby to throw up and/or have diarrhea as many as 10-20 times a day, which can quickly lead to a life-threatening loss of fluids (dehydration).

Rotavirus Spreads Easily

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Rotavirus spreads easily

  • Rotavirus usually spreads through contaminated hands or objects that have the virus on them. Rotavirus can live on surfaces for a long time.
  • Only certain disinfectants can kill rotavirus. Many common soaps don't work.

Rotavirus symptoms can be mild, moderate, or severe.

  • Rotavirus infection may cause fever, upset stomach, throwing up, and watery diarrhea. Symptoms can last from 3 to 7 days. Because your baby is so small, symptoms can lead to a loss of fluids, called dehydration.
  • A severe case of rotavirus could send your baby to the emergency room, or lead to a hospital stay.
  • If you think your baby has rotavirus or you want to learn more, talk with your baby’s doctor.
Rotavirus Symptoms Can Be Mild, Moderate, or Severe

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Help protect your baby from rotavirus.

RotaTeq is an oral vaccine that can help prevent rotavirus infection in children.

Get the facts about RotaTeq

What is RotaTeq?

RotaTeq is an oral vaccine used to help prevent rotavirus infection in children. Rotavirus infection can cause fever, vomiting, and diarrhea that can be severe and can lead to loss of body fluids (dehydration), hospitalization, and even death in some children. RotaTeq may not fully protect all children that get the vaccine, and if your child already has the virus it will not help them.

RotaTeq is not a shot; the vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later, and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age.

Important Safety Information

RotaTeq may not fully protect all children who get the vaccine.

RotaTeq should not be given to infants who are allergic to any part of the vaccine.

Your child should not get RotaTeq if he or she has Severe Combined Immunodeficiency Disease (SCID).

Your child should not get RotaTeq if he or she has ever had intussusception, a form of blockage in the intestines.

The most common side effects reported after taking RotaTeq were diarrhea, vomiting, fever, runny nose and sore throat, wheezing or coughing, and ear infection.

Other reported side effects include: hives; Kawasaki disease (a serious condition that can affect the heart, symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet, and if untreated, can be life threatening).

Call your child’s doctor or go to the emergency department right away if your child has any of the following problems after getting RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent), even if it has been several weeks since the last dose, because these may be signs of a serious problem called intussusception:

  • bad vomiting
  • bad diarrhea
  • severe stomach pain
  • blood in the stool.

Intussusception happens when a part of the intestine gets blocked or twisted. Since FDA approval, reports of infants with intussusception following RotaTeq have been received by the Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred days and sometimes weeks after vaccination. Some infants needed hospitalization, surgery on their intestines, or a special enema to treat this problem. Death due to intussusception has occurred. A study conducted after approval of RotaTeq showed an increased risk of intussusception in the 21 days after the first dose of RotaTeq, but especially in the first 7 days.

There are some important things your doctor needs to know about your baby. Tell your doctor if your baby:

  • Is sick with fever, diarrhea, or vomiting
  • Is not growing or gaining weight as expected
  • Has a weakened immune system from a disease (such as cancer, HIV/AIDS, or a blood disorder) or from medicine (such as steroids)
  • Has received a blood transfusion or blood products recently
  • Was born with gastrointestinal problems, had a blockage, or had abdominal surgery

The spread of vaccine virus to non-vaccinated contacts has been reported. Tell your doctor if you have someone in your household who has a weak immune system, cancer, or is taking medications that can weaken the immune system so that your doctor can provide further advice.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to the Merck National Service Center at 1-800-444-2080.

Please read the accompanying Patient Information for RotaTeq and discuss it with your doctor. The physician Prescribing Information also is available.