PMID- 36424402
OWN - NLM
STAT- MEDLINE
DCOM- 20221129
LR  - 20230111
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 12
IP  - 1
DP  - 2022 Nov 24
TI  - Post-marketing surveillance study on influenza vaccine in South Korea using a 
      nationwide spontaneous reporting database with multiple data mining methods.
PG  - 20256
LID - 10.1038/s41598-022-21986-8 [doi]
LID - 20256
AB  - Safety profiles of the influenza vaccine and its subtypes are still limited. We 
      aimed to address this knowledge gap using multiple data mining methods and 
      calculated performance measurements to evaluate the precision of different 
      detection methods. We conducted a post-marketing surveillance study between 2005 
      and 2019 using the Korea Adverse Event Reporting System database. Three data 
      mining methods were applied: (a) proportional reporting ratio, (b) information 
      component, and (c) tree-based scan statistics. We evaluated the performance of 
      each method in comparison with the known adverse events (AEs) described in the 
      labeling information. Compared to other vaccines, we identified 36 safety signals 
      for the influenza vaccine, and 7 safety signals were unlabeled. In 
      subtype-stratified analyses, application site disorders were reported more 
      frequently with quadrivalent and cell-based vaccines, while a wide range of AEs 
      were noted for trivalent and egg-based vaccines. Tree-based scan statistics 
      showed well-balanced performance. Among the detected signals of influenza 
      vaccines, narcolepsy requires special attention. A wider range of AEs were 
      detected as signals for trivalent and egg-based vaccines. Although tree-based 
      scan statistics showed balanced performance, complementary use of other 
      techniques would be beneficial when large noise due to false positives is 
      expected.
CI  - (c) 2022. The Author(s).
FAU - Lee, Hyesung
AU  - Lee H
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, 
      Gyeonggi-do, 16419, South Korea.
AD  - Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South 
      Korea.
FAU - Hong, Bin
AU  - Hong B
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, 
      Gyeonggi-do, 16419, South Korea.
FAU - Kim, SangHee
AU  - Kim S
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, 
      Gyeonggi-do, 16419, South Korea.
FAU - Kim, Ju Hwan
AU  - Kim JH
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, 
      Gyeonggi-do, 16419, South Korea.
AD  - Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South 
      Korea.
FAU - Choi, Nam-Kyong
AU  - Choi NK
AD  - Department of Health Convergence, Ewha Womans University, Seoul, South Korea.
AD  - Graduate School of Industrial Pharmaceutical Science, Ewha Womans University, 
      Seoul, Korea.
FAU - Jung, Sun-Young
AU  - Jung SY
AUID- ORCID: 0000-0003-2032-112X
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea. 
      jsyoung@cau.ac.kr.
AD  - Department of Global Innovative Drugs, Graduate School of Chung-Ang University, 
      College of Pharmacy, Chung-Ang University, 84 Heukseok-ro, Dongjak-gu, Seoul, 
      06974, South Korea. jsyoung@cau.ac.kr.
FAU - Shin, Ju-Young
AU  - Shin JY
AUID- ORCID: 0000-0003-1010-7525
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, 
      Gyeonggi-do, 16419, South Korea. shin.jy@skku.edu.
AD  - Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South 
      Korea. shin.jy@skku.edu.
AD  - Department of Clinical Research Design & Evaluation, Samsung Advanced Institute 
      for Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, South 
      Korea. shin.jy@skku.edu.
LA  - eng
GR  - 20200509312-00/the Ministry of Food and Drug Safety of South Korea/
GR  - 21153MFDS607/the Ministry of Food and Drug Safety of South Korea/
GR  - 20015086/the Ministry of Trade, Industry & Energy (MOTIE, Korea)/
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221124
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Data Mining
MH  - Databases, Factual
MH  - *Influenza Vaccines/adverse effects
MH  - Republic of Korea/epidemiology
MH  - *Product Surveillance, Postmarketing
PMC - PMC9691710
COIS- J-YS received grants from the Ministry of Food and Drug Safety, the Ministry of 
      Health and Welfare, the National Research Foundation of Korea, and pharmaceutical 
      companies, including Daiichi Sankyo, GSK, and Pfizer, outside the submitted work. 
      S-YJ received grants from the Ministry of Food and Drug Safety, the Ministry of 
      Health and Welfare, the National Research Foundation of Korea. All other authors 
      have no conflicts of interest to report.
EDAT- 2022/11/25 06:00
MHDA- 2022/11/29 06:00
PMCR- 2022/11/24
CRDT- 2022/11/24 23:20
PHST- 2022/06/28 00:00 [received]
PHST- 2022/10/07 00:00 [accepted]
PHST- 2022/11/24 23:20 [entrez]
PHST- 2022/11/25 06:00 [pubmed]
PHST- 2022/11/29 06:00 [medline]
PHST- 2022/11/24 00:00 [pmc-release]
AID - 10.1038/s41598-022-21986-8 [pii]
AID - 21986 [pii]
AID - 10.1038/s41598-022-21986-8 [doi]
PST - epublish
SO  - Sci Rep. 2022 Nov 24;12(1):20256. doi: 10.1038/s41598-022-21986-8.