Initial U.S. Approval: 2002
DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis…
[S]eizures were reported in the DAPTACEL group… for overall rates of 2.3… per 1,000 vaccinees, respectively… infantile spasms…
Within 30 days… (3.9%) subjects reported at least one serious adverse event… bronchiolitis… pneumonia… meningitis… sepsis… pertussis… irritability and unresponsiveness.
Postmarketing Experience
– Lymphadenopathy
– Cyanosis
– Nausea, diarrhea
– Local reactions: injection site pain, injection site rash, injection site nodule, injection site mass, extensive swelling of injected limb (including swelling that involves adjacent joints).
– Injection site cellulitis, cellulitis, injection site abscess
– Hypersensitivity, allergic reaction, anaphylactic reaction (edema, face edema, swelling face, pruritus, rash generalized) and other types of rash (erythematous, macular, maculopapular)
– Convulsions [seizures]: febrile convulsion, grand mal convulsion, partial seizures, HHE, hypotonia, somnolence, syncope
– Screaming
[I]ngredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤5 mcg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative).
DAPTACEL has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.