Abstract

Objectives: To describe clinical, socio-economic, and pathological characteristics of nine infants who died hours after receiving anti-polio and DPT vaccines, together with anti-Haemophilus influenzae b or in association to anti-hepatitis B vaccine or BCG. Materials and methods: Review of the clinical record, interview with the healthcare team in charge of immunization, and with parents of the deceased infant. Review the autopsy and pathology reports, as well as an interview with pathologists and forensic physicians. Quality control assessment of vaccines used immunohistochemistry examinations for virus diagnosis. Results: Between August and December 2001, nine cases of infant death were reported in Peru, between 8 hours and 3 days after receiving DPT and anti-polio vaccines. After immunization, symptoms appeared from thirty minutes to three hours, and death occurred between 8 to 78 hours. Most frequently reported symptoms were: irritability (8/9), persistent weeping (6/9), somnolence (5/9), nose and mouth bleeding (5/9). All cases occurred in poor or very poor families. Quality control assessments corroborated that vaccines complied with standards set by the World Health Organization. Causes of death reported in autopsies were pneumonia in 2 cases and pulmonary edema in 5 cases; pathology reports indicated the presence of interstitial pneumonitis and lymphocyte meningitis. No viral cytopathic effects in pulmonary tissues were found, and toxicological studies were reported as negative. Conclusions: There is no evidence of a causal relationship between fatal events and vaccine administration.

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