Important Selected 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 nonvaccinated 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.
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.
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.