U.S. Department of 

Health and Human Services 

Centers for Disease 

Control and Prevention 

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 vaccine can prevent rotavirus disease.

Rotavirus commonly causes severe, watery diarrhea, 

mostly in babies and young children. Vomiting and 

fever are also common in babies with rotavirus. 

Children may become dehydrated and need to be 

hospitalized and can even die.

2. Rotavirus vaccine

Rotavirus vaccine is administered by putting drops 

in the child’s mouth. Babies should get 2 or 3 doses 

of rotavirus vaccine, depending on the brand of 

vaccine used.

 The first dose must be administered before 

15 weeks of age.

 The last dose must be administered by 8 months 

of age.

Almost all babies who get rotavirus vaccine will be 

protected from severe rotavirus diarrhea.

Another virus called “porcine circovirus” can be 

found in one brand of rotavirus vaccine (Rotarix). 

This virus does not infect people, and there is no 

known safety risk.

Rotavirus vaccine may be given at the same time as 

other vaccines.

3. Talk with your health 

care provider

Tell your vaccination provider if the person getting 

the vaccine:

 Has had an allergic reaction after a previous 

dose of rotavirus vaccine, or has any severe, lifethreatening allergies

 Has a weakened immune system

 Has severe combined immunodeficiency (SCID)

 Has had a type of bowel blockage called 

“intussusception”

In some cases, your child’s health care provider may 

decide to postpone rotavirus vaccination until a 

future visit.

Infants with minor illnesses, such as a cold, may be 

vaccinated. Infants who are moderately or severely ill 

should usually wait until they recover before getting 

rotavirus vaccine.

Your child’s health care provider can give you more 

information.

4. Risks of a vaccine reaction

 Irritability or mild, temporary diarrhea or vomiting 

can happen after rotavirus vaccine.

Intussusception is a type of bowel blockage that is 

treated in a hospital and could require surgery. It 

happens naturally in some infants 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 first or second 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 health care provider can give you more 

information.

As with any medicine, there is a very remote chance 

of a vaccine causing a severe allergic reaction, other 

serious injury, or death.
OFFICE 

USE 

ONLY

5. What if there is a serious 

problem?

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 first or second 

dose of rotavirus vaccine, but look for them any 

time after vaccination. If you think your baby has 

intussusception, contact a health care provider right 

away. If you can’t reach your health care provider, 

take your baby to a hospital. Tell them when your 

baby got rotavirus vaccine.

An allergic reaction could occur after the vaccinated 

person leaves the clinic. If you see signs of a 

severe allergic reaction (hives, swelling of the face 

and throat, difficulty breathing, a fast heartbeat, 

dizziness, or weakness), call 9-1-1 and get the person 

to the nearest hospital.

For other signs that concern you, call your health 

care provider.

Adverse reactions should be reported to the Vaccine 

Adverse Event Reporting System (VAERS). Your 

health care provider will usually file this report, or 

you can do it yourself. Visit the VAERS website at 

www.vaers.hhs.gov or call 1-800-822-7967. VAERS 

is only for reporting reactions, and VAERS staff 

members 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. Claims regarding alleged injury or 

death due to vaccination have a time limit for filing, 

which may be as short as two years. Visit the VICP 

website at www.hrsa.gov/vaccinecompensation or 

call 1-800-338-2382 to learn about the program and 

about filing a claim.

7. How can I learn more?

 Ask your health care provider.

 Call your local or state health department.

 Visit the website of the Food and Drug 

Administration (FDA) for vaccine package inserts 

and additional information at www.fda.gov/

vaccines-blood-biologics/vaccines.

 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

Rotavirus Vaccine

42 U.S.C. § 300aa-26

10/15/2021