Rotavirus Vaccine Safety

Key points

You can protect against rotavirus disease with vaccination.

Overview

Rotavirus is a contagious virus that can cause gastroenteritis (inflammation of the stomach and intestines).

The rotavirus vaccine is effective at preventing rotavirus disease.

Available vaccines & manufacturer package inserts

  • The FDA approved in 2008 for use in infants 6 to 24 weeks of age.
  • The FDA approved in 2006 for use in infants 6 to 32 weeks of age
Keep Reading: Rotavirus Vaccine Information Statement (VIS)

Who should & should not get the vaccine

Most babies who get rotavirus vaccine do not have any problems with it.

Keep Reading: Who should & should not get the rotavirus vaccine?

Common side effects

  • Irritability.
  • Mild, temporary diarrhea or vomiting.

Some studies suggest that rotavirus vaccination possibly causes a small increase in the risk of intussusception, a type of bowel blockage. This side effect is very rare.

Vaccines, like any medicine, can have side effects. Most babies who get rotavirus vaccine do not have any problems with it.

Report possible adverse events to VAERS‎

The Vaccine Adverse Event Reporting System (VAERS) is an early warning system, co-managed by ÐÇ¿ÕÓéÀÖ¹ÙÍø and FDA, that monitors for potential vaccine safety problems. Healthcare providers and vaccine manufacturers are required by law to report certain adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) following vaccination to VAERS; patients and caregivers can also submit reports.

Submitting a Vaccine Adverse Event Reporting System (VAERS) Report and Using VAERS Data

A closer look at the safety data

Studies from the United States and other countries show a small increased risk of intussusception following rotavirus vaccination. About 1 in 20,000 US infants to 1 in 100,000 US infants who get rotavirus vaccine might develop intussusception within a week of getting the vaccine. This means that between 40 and 120 U.S. infants might develop intussusception related to rotavirus vaccine each year.

Keep Reading: Questions & Answers about Intussusception and Rotavirus Vaccine

How ÐÇ¿ÕÓéÀÖ¹ÙÍø monitors vaccine safety

ÐÇ¿ÕÓéÀÖ¹ÙÍø and FDA are committed to monitoring the safety of vaccines. Once vaccines are licensed or authorized by FDA for use in the United States, ÐÇ¿ÕÓéÀÖ¹ÙÍø, FDA, and other federal agencies work together to monitor them using several safety systems.

Keep Reading: About Vaccine Safety Programs

Resources

Contraindications and Precautions
Contraindications and Precautions: General Best Practice Guidelines for Immunization. Advisory Commi...
Immunization Schedules
Stay up-to-date on getting recommended vaccines. Here are immunization schedules for people of all a...
Vaccine & Immunization Information for Health Care Providers
ÐÇ¿ÕÓéÀÖ¹ÙÍø vaccine and vaccination information for U.S. health care providers.
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Content Source:
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
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