search for




 

Signal Analysis of COVID-19 Vaccine compared to Influenza Vaccine using KAERS Database
Yakhak Hoeji 2024;68(6):471-478
Published online December 31, 2024
© 2024 The Pharmaceutical Society of Korea.

Hana Go*, Suvin Park**, Eunsun Lim**, Hui-Eon Lee*, Haerin Cho**, and Nam-Kyong Choi*,**,#

*Department of Industrial Pharmaceutical Science, College of Pharmacy, Ewha Womans University
**Department of Health Convergence, College of Science & Industry Convergence, Ewha Womans University
Correspondence to: #Nam-Kyong Choi, Graduate School of Industrial Pharmaceutical Science, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemungu, Seoul 03760, Republic of Korea
Tel: +82-2-3277-6585, Fax: +82-2-3277-2867
E-mail: nchoi@ewha.ac.kr
Received August 5, 2024; Revised October 7, 2024; Accepted November 1, 2024.
Abstract
Safety issues have arisen as vaccines have been rapidly vaccinated following a relatively short clinical trial period to prevent COVID-19 infection. In signal detection, based on disproportionality analysis, it is necessary to select an appropriate comparator because the results vary depending on the comparison group. To detect meaningful signals, we compared COVID-19 vaccines with Influenza vaccines, which targets respiratory diseases similarly and has well-known safety profile. We used adverse events of vaccines from Korea Adverse Event Reporting System Database between January 1, 2013, and December 31, 2022(2307A0006). We detected the signal that satisfied all three indices:　Proportional reporting ratio, Reporting odds ratio and Information component and detected signals were compared with the drug label in Korea, United States and Europe. A total of 15 signals of Headache, Dizziness, Nausea, Hypersensitivity, Chills, Chest pain, Injection site erythema, Urticaria, Vomiting, Rash, Abdominal pain, Diarrhoea, Lymphadenitis, Cellulitis and Generalized oedema were detected. Among these, Lymphadenitis, Cellulitis and Generalized oedema were not listed on drug label. The results in this study are expected to contribute to assess the safety of COVID-19 vaccines and well-controlled studies are required to determine the causal relationship between COVID-19 vaccines and the detected signal.
Keywords : COVID-19, Vaccine, Adverse event, Signal detection, KAERS Database

December 2024, 68 (6)
Full Text(PDF) Free

Social Network Service
Services

Cited By Articles
  • CrossRef (0)

Funding Information