Pediarix vaccine contraindications and precautions (Please see GlaxoSmithKline product insert for complete list):
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- Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
- Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
- Persistent crying lasting three hours or more within 48 hours of a previous pertussis vaccination;
- Convulsions with or without fever, occurring within three days of a previous pertussis vaccination;
- Serious allergic reaction to a previous dose of diphtheria toxoid-, tetanus toxoid-, pertussis-, poliovirus, or hepatitis B-, containing vaccine or any ingredient of Pediarix;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
- Sensitivity to any component of Pediarix, including yeast or neomycin and polymyxin B (antibiotics);
- Apnea following intramuscular vaccination has been observed in some infants born prematurely. Pediarix vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination.
- The tip caps of prefilled Pediarix syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, assessment of the possible risks and potential benefits of receiving Pediarix should be carefully considered prior to vaccination.
Pediarix is FDA approved for use in infants and children between six weeks through six years of age. Pediarix should not be administered to infants younger than six weeks or children older than six years of age.
