J Korean Med Sci.  2025 Apr;40(16):e152. 10.3346/jkms.2025.40.e152.

Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea

• Hyun H
• Heo JY
• Choi YJ
• Nham E
• Yoon JG
• Noh JY
• Song JY
• Kim WJ
• Choi WS
• Choi MJ
• Seo YB
• Lee J
• Cheong HJ

• KMID: 2568083
• DOI: http://doi.org/10.3346/jkms.2025.40.e152

Abstract

South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI. We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.

Keyword

Adverse Events; Immunization; Safety; Vaccine; Surveillance

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