DTaP

Not contraindications or precautions — Conditions that are NOT considered contraindications or precautions to diphtheria-, tetanus-, and/or pertussis-containing immunization and should NOT be used to defer immunization include :

---Mild acute illness with or without fever

---Family history of seizure or sudden infant death syndrome

---Stable or resolved neurologic condition (e.g., controlled idiopathic epilepsy, cerebral palsy, developmental delay)

---Immunosuppression (see "Medical management of immune deficiency", section on 'Vaccination')

---Extensive local reaction after the fourth dose of DTaP

ADVERSE REACTIONS — Acellular pertussis-containing vaccines produce fewer local reactions, fever, and systemic symptoms than whole-cell pertussis-containing vaccines (table 4).

Adverse reactions to diphtheria-tetanus-pertussis vaccines may include, (from most to least frequent):

---Mild local and systemic reactions

---Entire limb swelling

---Persistent, inconsolable crying (≥3 hours)

---Hypotonic-hyporesponsive episode (collapse or shock-like state)

---Seizures

---Fever ≥105ºF (40.5ºC)

---Anaphylaxis

Mild local and systemic reactions are the most common adverse reactions to DTaP. These reactions include fever (1 in 4 children); redness and tenderness at the injection site (1 in 4 children); drowsiness or poor appetite (1 in 10 children); fussiness (1 in 3 children); and vomiting (1 in 50 children). These reactions occur within several hours of vaccination and resolve spontaneously without sequelae. Higher rates of low-grade fever have been reported among infants who receive the DTaP-HepB-IPV combination vaccine than among children who receive the vaccines separately.

Extensive local reactions (>46 mm) of erythema or swelling are more common among children who receive four or five consecutive doses of DTaP than those who receive a mixture of DTaP and DTwP. Extensive local reaction after the fourth DTaP is not predictive of a similar reaction after the fifth dose. In a retrospective review, local reactions to the fifth dose of DTaP serious enough to require medical attention were uncommon (43.5 per 10,000 injections). However, they occurred more frequently after administration in the arm than in the thigh (47.4 versus 32.1 per 10,000 injections). Administration of acetaminophen or ibuprofen before and 6 to 12 hours after the fifth dose does not appear to prevent extensive local reactions. 

Swelling of the entire limb has been reported in 2 to 3 percent of children after receipt of the fourth or fifth dose of DTaP.  Limb swelling may be accompanied by erythema, pain, and fever. It may interfere with walking, but most children have no limitation of activity.

Prolonged crying and hypotonic-hyporesponsive episodes have been associated with other vaccines. Neither of these reactions is known to be associated with long-term sequelae.

Seizures following pertussis-containing vaccines are usually febrile seizures. (See "Febrile seizures" and "Patient information: Febrile seizures".) In a cohort of almost 680,000 children who received DTwP, the risk of febrile seizures was increased on the day of vaccination (adjusted RR 5.7). Vaccine-associated febrile seizures were not associated with an increased risk of afebrile seizures or neurodevelopmental disability. The risk of seizures does not appear to be increased after DTaP vaccine. In a cohort of more than 430,000 children who received DTaP at ages 6 through 23 months, the risk of seizures was not increased within zero to three days after vaccination (incidence rate ratio 0.87, 95% CI 0.72-1.05).

Vaccine associated seizures may be the initial presentation of severe myoclonic epilepsy of infancy (Dravet syndrome), which should be considered before attributing the seizures to DTaP.