Complications following Bacille Calmette-Guérin Vaccination in Children under the Age of 18 Months: A Multi-center Study

Background: The BCG vaccine, used since 1921 to prevent tuberculosis (TB), considered the world's most widely used vaccine. This study aimed to investigate the frequency and the type of complications associated with Bacillus Calmette-Guérin (BCG) vaccination in Iranian children. Materials and Methods This cross-sectional study conducted for 6months among children aged up to 18 months who presented to primary health care centers in Tehran (under supervision of all three Medical Universities of Tehran) for their routine vaccinations. All children had received BCG vaccination at birth. We investigated the occurrence of BCG complications through history taking from the parents and physical examination by the study physician. Complications categorized into four major groups: local, regional, remote, and generalized and the rate of occurrence compared between the two genders. Results: Finally, 14,095 children enrolled during the study period; 574 patients (4%) had experienced at least one complication following BCG vaccination. The most common complications were local side effects observed in 304 children (2.1%); followed by lymph node involvement detected in 270 children (1.9%). Lymph node involvement was more common in males (P<0.001) and axillary lymph nodes were the most common site of involvement. There was a significant increase in the frequency of lymph node involvement at age 18 months in comparison to 2 month old infants (odds ratio=7.76, P<0.001). Conclusion: We found local adverse reactions as the most common complication following BCG vaccination and age was an independent predictor for the time of presentation of post vaccination lymph node involvement. Disseminated BCG and Osteitis not observed among vaccinated children.