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Pediarix Side Effects

Fussiness or irritability, drowsiness, and fever are the most common side effects that have been reported with Pediarix. Reactions to this vaccine appear to be mild in most cases and typically either do not require treatment or can be treated easily. Some of the rare but serious side effects that require immediate medical attention include a high fever, paralysis, and seizures.

An Introduction to Pediarix Side Effects

As with all vaccines, side effects are possible with Pediarix® (DTaP, hepatitis B vaccine, and inactivated polio vaccine). However, not everyone who receives the vaccine will experience side effects. In fact, most children tolerate it quite well. If side effects do occur, in most cases, they are minor and either require no treatment or can easily be treated by you or your healthcare provider.
(This article covers many, but not all, of the possible side effects with Pediarix. Your healthcare provider can discuss a more complete list of Pediarix side effects with you.)

Common Side Effects of Pediarix

Pediarix has been studied thoroughly in clinical trials. In these studies, the side effects that occurred in a group of children given Pediarix (a combination of multiple vaccines) were documented and compared to side effects that occurred in a similar group of children given the same vaccines separately (at the same time but not in the same injection).
This way, it is possible to see what side effects occurred, how often they appeared, and how they compare to the group receiving the vaccines separately. In some of these studies, other vaccines were also given at the same time.
In these studies, the most common Pediarix side effects included:
  • Fussiness or irritability -- in up to 64.9 percent of children
  • Drowsiness -- up to 57.2 percent
  • Fever -- up to 38.8 percent
  • Redness at the injection site -- up to 37.2 percent
  • Pain at the injection site -- up to 36.1 percent
  • Loss of appetite -- up to 30.6 percent
  • Swelling at the injection site -- up to 28.7 percent
Care must be taken when interpreting this data, since Pediarix was often given along with other vaccines. For instance, it is not accurate to say that Pediarix caused fussiness or irritability in 64.9 percent of children, since the vaccine was given along with other childhood vaccines at the same time. The other vaccines likely contributed somewhat to the side effects seen.
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Pediarix Vaccine Information

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