What Are the Side Effects of the Rotavirus Vaccine for Babies?

Most potential side effects of the rotavirus vaccine are mild, but there’s a very small chance of severe complications. For most babies, the benefits of vaccination outweigh the risks.

Rotavirus is a highly contagious type of virus that causes vomiting and diarrhea. It most often affects babies and small children.

Before the introduction of the rotavirus vaccine in 2006 , the virus was the leading cause of severe diarrhea among infants and young children in the United States.

Rotavirus is estimated to cause more than 129,000 deaths annually, the majority occurring in countries without access to the vaccine.

Each year, the rotavirus vaccine prevents an estimated 40,000 to 50,000 hospitalizations in the United States. And the rotavirus vaccine is estimated to be more than 90% effective at preventing severe disease in higher income countries.

Babies should receive their first vaccine dose before the age of 15 weeks .

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Read on to learn about common and rare side effects of the rotavirus vaccine.

There are two rotavirus vaccines approved for babies in the United States:

  • RotaTeq: administered in three doses, at 2 months, 4 months, and 6 months
  • Rotarix: administered in two doses, at 2 months and 4 months

Most babies don’t have any side effects from these vaccines. For those who do, the most common side effects are mild and usually go away on their own.

The most common side effects include:

  • irritability
  • diarrhea
  • vomiting

Other reported symptoms after rotavirus vaccination include :

  • fever
  • crying
  • blood in stool
  • paleness
  • decreased appetite
  • dehydration
  • discolored feces
  • abdominal pain
  • mucus in stools
  • blue tint to skin

All vaccinations come with some risks, but the benefits of preventing severe disease usually outweigh these risks. Serious side effects of the rotavirus vaccine are rare.

Intussusception

There’s a very small risk of developing intussusception, usually a week after receiving the vaccine. The risk ranges from about 1 in 20,000 to 1 in 100,000 U.S. babies . Intussusception is a potentially life threatening type of bowel obstruction where a part of the intestines folds up like a telescope.

Large clinical trials of the RotaTeq and Rotarix vaccines didn’t find an increased risk of intussusception in babies who were vaccinated. However, safety monitoring since the vaccines received Food and Drug Administration (FDA) approval has identified a slightly increased risk in the 7 days after vaccination.

Children who received an older vaccine called RotaShield, which was removed from the market in 1999, had about a 10 times higher risk of intussusception compared with children who were unvaccinated.

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Kawasaki’s disease

In a 2020 study , researchers also suggested a potential association between rotavirus vaccination and Kawasaki’s disease. However, newer research hasn’t found a link.

In a 2022 study, researchers didn’t find an increased risk of Kawasaki’s disease in U.S. children under 2 who received the rotavirus or pneumococcal conjugate vaccines between 2006 and 2017.

Severe allergic reaction

A severe allergic reaction can occur from any vaccine, though it’s very rare. It’s estimated to occur in less than 1 in 1 million doses .