VACCINE INFORMATION STATEMENT

Rotavirus Vaccine

What You Need to Know

Many Vaccine Information Statements are 

available in Spanish and other languages. 

See www.immunize.org/vis

Hojas de información sobre vacunas están 

disponibles en español y en muchos otros 

idiomas. Visite www.immunize.org/vis

1 Why get vaccinated?

Rotavirus is a virus that causes diarrhea, mostly in babies 

and young children. The diarrhea can be severe, and lead 

to dehydration. Vomiting and fever are also common in 

babies with rotavirus.

Before rotavirus vaccine, rotavirus disease was a 

common and serious health problem for children in the 

United States. Almost all children in the U.S. had at least 

one rotavirus infection before their 5th birthday. 

Every year:

•	 more than 400,000 young children had to see a doctor 

for illness caused by rotavirus,

•	 more than 200,000 had to go to the emergency room,

•	 55,000 to 70,000 had to be hospitalized, and

•	 20 to 60 died. 

Rotavirus vaccine has been used since 2006 in the 

United States. Because children are protected by the 

vaccine, hospitalizations, and emergency visits for 

rotavirus have dropped dramatically.

2 Rotavirus vaccine

Two brands of rotavirus vaccine are available. Your baby 

will get either 2 or 3 doses, depending on which vaccine 

is used. 

Doses of rotavirus vaccine are recommended at these 

ages:

- First Dose: 2 months of age

- Second Dose: 4 months of age

- Third Dose: 6 months of age (if needed)

Rotavirus vaccine is a liquid that is swallowed, not a 

shot. 

Rotavirus vaccine may safely be given at the same time 

as other vaccines.

Rotavirus vaccine is very good at preventing diarrhea 

and vomiting caused by rotavirus. Almost all babies 

who get rotavirus vaccine will be protected from severe

rotavirus diarrhea. And most of these babies will not get 

rotavirus diarrhea at all. The vaccine will not prevent 

diarrhea or vomiting caused by other germs.

Another virus called porcine circovirus (or parts of 

it) can be found in both rotavirus vaccines. This is 

not a virus that infects people, and there is no known 

safety risk. For more information, see www.fda.gov/

BiologicsBloodVaccines/Vaccines/ApprovedProducts/

ucm205547.htm.

3 Some babies should not get 

this vaccine

•	 A baby who has had a severe (life-threatening) allergic 

reaction to a dose of rotavirus vaccine should not get 

another dose. 

A baby who has a severe (life threatening) allergy to 

any component of rotavirus vaccine should not get the 

vaccine.

Tell your doctor if your baby has any severe allergies 

that you know of, including a severe allergy to latex.

•	 Babies with “severe combined immunodeficiency”

(SCID) should not get rotavirus vaccine.

•	 Babies who have had a type of bowel blockage called 

“intussusception” should not get rotavirus vaccine.

•	 Babies who are mildly ill can probably get the vaccine 

today. Babies who are moderately or severely ill 

should probably wait until they recover. This includes 

babies with moderate or severe diarrhea or vomiting. 

•	 Check with your doctor if your baby’s immune system 

is weakened because of:

- HIV/AIDS, or any other disease that affects the 

immune system

- treatment with drugs such as long-term steroids

- cancer, or cancer treatment with x-rays or drugs
4 Risks of a vaccine reaction

With a vaccine, like any medicine, there is a chance of 

side effects. These are usually mild and go away on their 

own.

Serious side effects are also possible, but are very rare.

Most babies who get rotavirus vaccine do not have 

any problems with it. But some problems have been 

associated with rotavirus vaccine:

Mild problems

Babies might become irritable, or have mild, temporary 

diarrhea or vomiting after getting a dose of rotavirus 

vaccine.

Serious problems

Intussusception is a type of bowel blockage that 

is treated in a hospital, and could require surgery. It 

happens “naturally” in some babies every year in the

United States, and usually there is no known reason 

for it. 

There is also a small risk of intussusception from 

rotavirus vaccination, usually within a week after the 

1st or 2nd vaccine dose. This additional risk is estimated 

to range from about 1 in 20,000 U.S. infants to 1 in 

100,000 U.S. infants who get rotavirus vaccine. Your 

doctor can give you more information.

5 What if there is a 

serious reaction?

What should I look for?

•	 For intussusception, look for signs of stomach pain 

along with severe crying. Early on, these episodes 

could last just a few minutes and come and go several 

times in an hour. Babies might pull their legs up to 

their chest. 

Your baby might also vomit several times or have 

blood in the stool, or could appear weak or very 

irritable. These signs would usually happen during the 

first week after the 1st or 2nd dose of rotavirus vaccine, 

but look for them any time after vaccination.

•	 Look for anything else that concerns you, such as 

signs of a severe allergic reaction, very high fever, or 

behavior changes.

Signs of a severe allergic reaction can include hives, 

swelling of the face and throat, difficulty breathing,

a fast heartbeat, dizziness, and weakness. These 

would start a few minutes to a few hours after the 

vaccination.

What should I do?

•	 If you think it is intussusception, call a doctor right 

away. If you can’t reach your doctor, take your baby to 

a hospital. Tell them when your baby got the vaccine.

•	 If you think it is a severe allergic reaction or other 

emergency that can’t wait, call 9-1-1 or get your baby 

to the nearest hospital.

•	 Afterward, the reaction should be reported to 

the “Vaccine Adverse Event Reporting System”

(VAERS). Your doctor might file this report, or you

can do it yourself through the VAERS web site at 

www.vaers.hhs.gov, or by calling 1-800-822-7967.

VAERS is only for reporting reactions. They do not give 

medical advice.

6 The National Vaccine Injury 

Compensation Program

The National Vaccine Injury Compensation Program 

(VICP) is a federal program that was created to 

compensate people who may have been injured by 

certain vaccines.

Persons who believe they may have been injured by a 

vaccine can learn about the program and about filing a

claim by calling 1-800-338-2382 or visiting the VICP 

website at www.hrsa.gov/vaccinecompensation.

7 How can I learn more?

•	 Ask your doctor.

•	 Call your local or state health department.

•	 Contact the Centers for Disease Control and 

Prevention (CDC):

- Call 1-800-232-4636 (1-800-CDC-INFO) or

- Visit CDC’s website at www.cdc.gov/vaccines

 Vaccine Information Statement (Interim)

 Rotavirus Vaccine

 42 U.S.C. § 300aa-26

08/26/2013

Office Use Only