Risks of an Extra Dose of Pediarix

Key Safety Considerations

• Increased rates of local reactions, such as pain, redness, and swelling at the injection site, occur with additional doses of DTaP-containing vaccines, particularly after the 4th and 5th doses, according to the Centers for Disease Control and Prevention (CDC) 1, 2, 3
• The pertussis component is primarily responsible for these increased local reactions, as stated by the CDC 1

Management Recommendations

• If an extra dose of Pediarix is inadvertently given, count it as a valid dose in the vaccination series, as recommended by the Advisory Committee on Immunization Practices (ACIP) 4
• The ACIP guidelines state that if an extra dose of Tdap is given to someone who previously received Tdap, this dose should count as the next booster dose, without mention of safety concerns 4
• If the extra dose results in a 3rd dose being given before 24 weeks of age, an additional hepatitis B vaccine dose must be administered at age ≥24 weeks, as recommended by the ACIP 5, 6

Monitoring and Prevention of Adverse Events

• Observe the injection site for increased local reactions, which are the most likely adverse event, as reported by the CDC 1, 2
• The CDC recommends monitoring for local reactions, which are typically mild and self-limited 1