PMID- 36411908
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221123
IS  - 2405-8440 (Print)
IS  - 2405-8440 (Electronic)
IS  - 2405-8440 (Linking)
VI  - 8
IP  - 11
DP  - 2022 Nov
TI  - OAE-based data mining and modeling analysis of adverse events associated with 
      three licensed HPV vaccines.
PG  - e11515
LID - 10.1016/j.heliyon.2022.e11515 [doi]
LID - e11515
AB  - PURPOSE: Three licensed human papillomavirus (HPV) vaccines (Cervarix, Gardasil, 
      and Gardasil 9) have been effectively used to prevent infection with oncogenic 
      HPV types; however, many adverse events (AEs) have also been reported following 
      their vaccinations. We assessed AE profiles after receiving the HPV vaccines 
      based on the reported data from Vaccine Adverse Event Reporting System (VAERS). 
      METHODS: The AE data associated with Cervarix, Gardasil, and Gardasil 9 were 
      retrieved from VAERS database respectively. The combinatorial biomedical 
      statistical methods were used to identify the statistically significant AEs. The 
      Gamma-Poisson Shrinker (GPS) model with gender/age stratification was applied to 
      ascertain the serious adverse events (SAEs) related to the three licensed HPV 
      vaccines. The AE profiles were classified and represented by the Ontology of 
      Adverse Events (OAE) for further analysis. RESULTS: As of July 31, 2020, VAERS 
      recorded 3,112, 31,606, and 6,872 AE case reports for Cervarix, Gardasil, and 
      Gardasil 9, respectively. Our Frequentist statistical methods identified 135 
      Cervarix-enriched AEs, 55 Gardasil-enriched AEs, and 17 Gardasil 9-enriched AEs. 
      Based on the OAE hierarchical classification, these AEs were clustered in the AEs 
      related to behavioral and neurological conditions, immune system, nervous system, 
      and reproductive system. Combined with GPS modeling, 46 unique statistically 
      significant SAEs were founded to be associated with at least one of the three 
      vaccines. CONCLUSIONS: Our study led to the better understanding of the AEs 
      associated with the licensed HPV vaccines. The hypotheses on the cause and effect 
      relationships between the HPV vaccination and specific AEs deserve further 
      epidemiological investigations as well as clinical trial studies.
CI  - (c) 2022 The Author(s).
FAU - Zi, Wenrui
AU  - Zi W
AD  - Chongqing Engineering Research Center of Medical Electronics and Information 
      Technology, School of Bioinformatics, Chongqing University of Posts and 
      Telecommunications, Chongqing, China.
FAU - Yang, Qiuyue
AU  - Yang Q
AD  - Chongqing Engineering Research Center of Medical Electronics and Information 
      Technology, School of Bioinformatics, Chongqing University of Posts and 
      Telecommunications, Chongqing, China.
FAU - Su, Jun
AU  - Su J
AD  - Chongqing Engineering Research Center of Medical Electronics and Information 
      Technology, School of Bioinformatics, Chongqing University of Posts and 
      Telecommunications, Chongqing, China.
FAU - He, Yongqun
AU  - He Y
AD  - Unit of Laboratory Animal Medicine, Development of Microbiology and Immunology, 
      Center of Computational Medicine and Bioinformatics, University of Michigan 
      Medical School, Ann Arbor, Michigan, United States.
FAU - Xie, Jiangan
AU  - Xie J
AD  - Chongqing Engineering Research Center of Medical Electronics and Information 
      Technology, School of Bioinformatics, Chongqing University of Posts and 
      Telecommunications, Chongqing, China.
LA  - eng
PT  - Journal Article
DEP - 20221111
PL  - England
TA  - Heliyon
JT  - Heliyon
JID - 101672560
PMC - PMC9674903
OTO - NOTNLM
OT  - Adverse event
OT  - Gamma-Poisson shrinker
OT  - Human papillomavirus
OT  - Ontology of adverse events
OT  - Vaccine
OT  - Vaccine adverse event reporting system (VAERS)
COIS- The authors declare no conflict of interest.
EDAT- 2022/11/23 06:00
MHDA- 2022/11/23 06:01
PMCR- 2022/11/11
CRDT- 2022/11/22 01:49
PHST- 2022/04/08 00:00 [received]
PHST- 2022/06/11 00:00 [revised]
PHST- 2022/11/03 00:00 [accepted]
PHST- 2022/11/22 01:49 [entrez]
PHST- 2022/11/23 06:00 [pubmed]
PHST- 2022/11/23 06:01 [medline]
PHST- 2022/11/11 00:00 [pmc-release]
AID - S2405-8440(22)02803-1 [pii]
AID - e11515 [pii]
AID - 10.1016/j.heliyon.2022.e11515 [doi]
PST - epublish
SO  - Heliyon. 2022 Nov 11;8(11):e11515. doi: 10.1016/j.heliyon.2022.e11515. 
      eCollection 2022 Nov.