Yonsei Med J.  2020 Mar;61(3):243-250. 10.3349/ymj.2020.61.3.243.

Signal Detection of Adverse Events Following Pneumococcal Vaccines from the Korea Adverse Event Reporting System Database, 2005–2016

Affiliations
  • 1Department of Pharmaceutical Medicine and Regulatory Sciences, Yonsei University Graduate School, Seoul, Korea. minspark@yuhs.ac
  • 2School of Pharmacy, Sungkyunkwan University, Suwon, Korea. shin.jy@skku.edu
  • 3College of Nursing and Health, Kongju National University, Gongju, Korea.
  • 4Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.

Abstract

PURPOSE
We aimed to analyze the surveillance reports of adverse events (AEs) due to different types of pneumococcal vaccines, in addition to detecting and validating signals of pneumococcal vaccines by comparing AEs with labels.
MATERIALS AND METHODS
We analyzed the percentages of AEs according to vaccine type [pneumococcal polysaccharide vaccines (PPSVs) and pneumococcal conjugate vaccines (PCVs)] in children and adults using data from the Korea Adverse Event Reporting System (KAERS) database from 2005 to 2016. A signal was defined as an AE that met all three indices of data mining: proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). We validated the detected signals by calculating sensitivity, specificity, as well as positive and negative predictive values of the signals against label information.
RESULTS
Of the 39933 AE reports on vaccination, 5718 (7.0%) were related to pneumococcal vaccine. The most frequent AE after vaccination with PPSV was fever (23.9%) in children and injection-site reaction in adults. The most frequent AE after vaccination with PCV in children was pharyngitis (26.2%). In total, 13 AEs met all three indices for signal detection. Among these, hypotension, apathy, sepsis, and increased serum glutamic oxaloacetic transaminase level were not listed on vaccine labels. In validation analysis, PRR and ROR performed slightly better than IC for adults who were vaccinated with PPSVs.
CONCLUSION
Overall, 13 new signals of PPSVs, including four signals not listed on the labels, were detected. Further research based on additional AE reports is required to confirm the validity of these signals for children.

Keyword

Signal detection; pneumococcal vaccines; data-mining; KAERS database

MeSH Terms

Adult
Apathy
Aspartate Aminotransferases
Child
Data Mining
Fever
Humans
Hypotension
Korea*
Odds Ratio
Pharyngitis
Pneumococcal Vaccines*
Sensitivity and Specificity
Sepsis
Vaccination
Vaccines
Vaccines, Conjugate
Aspartate Aminotransferases
Pneumococcal Vaccines
Vaccines
Vaccines, Conjugate
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