Adverse events following immunization with DTP vaccine
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Abstract:
The Monitoring System for Adverse Events Following Immunization became fully operational in late 1978 in all 50 States, New York City and Washington, D.C. This system compiles information on adverse events temporally associated (within four weeks) to the administration of a vaccine. A total of 2,062 reports of adverse events following diphtheria and tetanus toxoids and pertussis vaccine (DTP) were received between 1979 and 1982. The number of reports received in 1979 was 387, increasing to 707 reports in 1982. The increase is predominantly in local reactions and fever. The number of persons with serious illnesses temporally associated with vaccine remained relatively constant over the four year period. The overall rate of reported adverse events following DTP (70.8 per million doses administered in the public sector) was about twice that of Td (33.5) or DT (38.4); however it was not substantially different from those following measles- or rubella-containing vaccines. Those who had convulsions (whether febrile or non-febrile) following receipt of DTP vaccine were substantially more likely to have had a personal history of convulsions than those who had a non-neurologic adverse event following DTP (p less than 0.0001). This information, along with data from the literature, has led to recent recommendations by advisory groups in the United States that any infant or child with a personal history of convulsions should be thoroughly evaluated before initiating or continuing immunization with pertussis vaccine.
Insights
The Monitoring System for Adverse Events Following Immunization tracked vaccine side effects. Diphtheria, tetanus, and pertussis vaccine (DTP) showed increased local reactions and fever, but serious illnesses remained stable.
Area of Science:
- Public Health
- Immunization Safety
- Vaccine Surveillance
Background:
- The Monitoring System for Adverse Events Following Immunization (MSAEFI) was established to track vaccine safety.
- Adverse events temporally associated with vaccination are compiled within four weeks of administration.
- Data collection spanned from 1979 to 1982 across the United States.
Purpose of the Study:
- To analyze adverse event reports following diphtheria, tetanus, and pertussis vaccine (DTP) administration.
- To compare adverse event rates between DTP and other vaccines.
- To investigate the association between personal history of convulsions and post-vaccination seizures.
Main Methods:
- Retrospective analysis of 2,062 adverse event reports submitted to MSAEFI between 1979 and 1982.
- Comparison of adverse event rates per million doses for DTP, Td, DT, and measles/rubella-containing vaccines.
- Statistical analysis to determine the correlation between prior convulsions and post-DTP vaccine convulsions.
Main Results:
- Adverse event reports for DTP increased from 387 in 1979 to 707 in 1982, primarily due to local reactions and fever.
- Serious illnesses temporally associated with DTP remained constant.
- The rate of reported adverse events for DTP (70.8/million doses) was higher than Td (33.5) or DT (38.4).
- Individuals with convulsions post-DTP were significantly more likely to have a personal history of convulsions (p < 0.0001).
Conclusions:
- While DTP vaccine showed an increase in non-serious adverse events, serious events were stable.
- A personal history of convulsions is a significant risk factor for convulsions following DTP vaccination.
- Recommendations were made for careful evaluation of children with a history of convulsions before pertussis vaccination.