Complications of Bacillus Calmette-Guérin Vaccination at a University Hospital in Iranian Neonates

Abstract

Background: The most common complications of Bacillus Calmette-Guérin (BCG) vaccine are lymphadenopathy, lymphadenitis, abscess, and fistula. These occur in less than one percent of vaccinated individuals. The aim of this study was to determine the frequency of these side-effects in Iranian neonates at a university hospital. Objectives: The researchers decided to study the new results of BCG vaccine complications at the university center and compare them with previous results from Iran and other countries until the relative position of Iran was identified. Methods: In a prospective, descriptive-analytical study with the census method, 214 neonates at Golestan Hospital of Tehran, Iran from May 2015 to Jan 2018 were studied. Bacillus Calmette-Guérin vaccination was performed for all these neonates at the hospital. The neonates were examined on a monthly basis by a physician and the questionnaires were completed. Results: In this study, the rate of lymphadenopathy, lymphadenitis, and fistulization of the abscess after BCG vaccination were 2.5%, 0.5%, and 0%, respectively. No significant difference was observed between gender and age of the infants and the occurrence of the complications (P > 0.05). Conclusions: This study showed a higher rate of lymphadenopathy and lymphadenitis after BCG vaccination compared with other studied countries. Various factors are involved in making this difference, such as inaccuracy in the injection site and injection method, improper dilution and type of vaccine manufacturer, and a more immunogenic vaccine (Pasteur Company, Tehran). Therefore, health authorities should help reduce the incidence of complications of BCG vaccination with continuous education of the vaccination unit personnel, monitoring the preservation and method of vaccine preparation and change of the vaccine strain.