Retrospective population-based assessment of medically attended injection site reactions, seizures, allergic responses and febrile episodes after acellular pertussis vaccine combined with diphtheria and tetanus toxoids

Background. Since 1997 diphtheria-tetanus toxoids-acellular pertussis (DTaP) vaccines have been recommended for the five dose pertussis vaccination series. To assess rates of medically attended injection site reactions (ISRs), seizures, allergic responses and febrile episodes after Tripedia DTaP vaccine administered in the context of routine care, we conducted a retrospective assessment among the population of Group Health Cooperative from 1997 through 2000. Methods. Administrative databases were used to identify medical visits linked with diagnostic codes potentially indicative of ISRs, seizures, allergic responses and febrile episodes after DTaP vaccine. Outcomes were confirmed by medical record review. Results. During the study period 76 133 doses of DTaP were administered. Of the 26 ISRs identified, 6 followed DTaP given as the fourth dose and 18 followed DTaP given as the fifth dose, for rates of 1 per 2779 and 1 per 900 vaccinations, respectively. During the study period nearly all children receiving DTaP as the fifth dose had received whole cell pertussis vaccine for their primary series, and all of the fifth dose ISRs were among that group. Four of those reactions involved the entire upper arm. The rate of febrile seizures within 2 days of DTaP among children <2 years of age was 1 per 19 496 vaccinations. Conclusions. The low rate of febrile seizures and other serious events confirms the safety of DTaP vaccine. The risk of medically attended ISRs was highest with DTaP given as the fifth dose, and whole arm reactions were reported, but medically attended ISRs were relatively uncommon and were self-limited.