PMID- 32600907
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20210427
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 38
IP  - 34
DP  - 2020 Jul 22
TI  - Signals and trends of Guillain-Barre syndrome after the introduction of 
      live-attenuated vaccines for influenza in the US and South Korean adverse event 
      reporting systems.
PG  - 5464-5473
LID - S0264-410X(20)30824-0 [pii]
LID - 10.1016/j.vaccine.2020.06.038 [doi]
AB  - BACKGROUND: With the advent of live-attenuated, quadrivalent, and cell-cultured 
      vaccines for influenza, there have been discussions on the safety of these 
      vaccines compared to conventional vaccines (such as inactivated, trivalent, and 
      egg-cultured vaccines) because of the development of neurological adverse events 
      (AEs). This study aimed to compare the trends and safety signals in the AE 
      reporting systems of the US and South Korea and, more particularly, to evaluate 
      the association between influenza vaccination and Guillain-Barre syndrome (GBS). 
      METHODS: In total, 400,535 AE reports from the US Vaccine Adverse Event Reporting 
      System (VAERS) and 28,766 AE reports from the Korea Adverse Event Reporting 
      System (KAERS) between 2005 and 2017 were assessed. Disproportionality analysis 
      was performed to detect the safety signals and examine the potential risk of GBS 
      with influenza vaccination using the case/non-case approach. RESULTS: In both 
      databases, GBS was the most frequently reported AE following influenza 
      immunization. Using the case/non-case approach, the adjusted reporting odds ratio 
      (ROR) of GBS was 3.57 (95% confidence interval [CI], 3.16-4.03) and 3.09 (95% CI, 
      0.83-11.45) in the VAERS and KAERS data, respectively. People vaccinated with 
      live-attenuated vaccines reported 2.30 times (95% CI, 1.74-3.05) more cases of 
      GBS than those vaccinated with other types of vaccines. CONCLUSIONS: Our analysis 
      of the VAERS and KAERS reports for AEs following immunization (AEFI) for 
      influenza shows the need for cautious monitoring regarding the development of GBS 
      after influenza vaccination, particularly, after live-attenuated vaccination. 
      However, owing to potential reporting bias caused by limited AEFI reports after 
      the introduction of new types of influenza vaccines, further prospective safety 
      studies are needed.
CI  - Copyright (c) 2020 Elsevier Ltd. All rights reserved.
FAU - Lee, Hankil
AU  - Lee H
AD  - CONNECT-AI Research Center, Yonsei University College of Medicine, 50-1 
      Yonsei-ro, Seodaemun-gu, Seoul 03722, South Korea. Electronic address: 
      hankil912@gmail.com.
FAU - Kim, Hyun Jeong
AU  - Kim HJ
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-to, Jangan-gu, Suwon, 
      Gyeong gi-do, South Korea. Electronic address: heavendays@g.skku.edu.
FAU - Choe, Young June
AU  - Choe YJ
AD  - Department of Social and Preventive Medicine, Hallym University College of 
      Medicine, 1, Hallymdaehak-gil, Chuncheon-si, Gangwon-do 24252, South Korea. 
      Electronic address: ychoe@hallym.ac.kr.
FAU - Shin, Ju-Young
AU  - Shin JY
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-to, Jangan-gu, Suwon, 
      Gyeong gi-do, South Korea. Electronic address: shin.jy@skku.edu.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200627
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Guillain-Barre Syndrome/chemically induced/epidemiology
MH  - Humans
MH  - *Influenza Vaccines/adverse effects
MH  - *Influenza, Human/prevention & control
MH  - Republic of Korea/epidemiology
MH  - Vaccines, Attenuated/adverse effects
OTO - NOTNLM
OT  - Disproportionality analysis
OT  - Guillain-Barre syndrome
OT  - Influenza vaccine
OT  - Korea Adverse Event Reporting System
OT  - Vaccine Adverse Event Reporting System
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2020/07/01 06:00
MHDA- 2021/04/28 06:00
CRDT- 2020/07/01 06:00
PHST- 2020/01/20 00:00 [received]
PHST- 2020/05/23 00:00 [revised]
PHST- 2020/06/14 00:00 [accepted]
PHST- 2020/07/01 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
PHST- 2020/07/01 06:00 [entrez]
AID - S0264-410X(20)30824-0 [pii]
AID - 10.1016/j.vaccine.2020.06.038 [doi]
PST - ppublish
SO  - Vaccine. 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. Epub 
      2020 Jun 27.