PMID- 31740500
OWN - NLM
STAT- MEDLINE
DCOM- 20200218
LR  - 20231027
IS  - 1098-4275 (Electronic)
IS  - 0031-4005 (Print)
IS  - 0031-4005 (Linking)
VI  - 144
IP  - 6
DP  - 2019 Dec
TI  - Safety of the 9-Valent Human Papillomavirus Vaccine.
LID - 10.1542/peds.2019-1791 [doi]
LID - e20191791
AB  - BACKGROUND: The 9-valent human papillomavirus vaccine (9vHPV) was approved for 
      females and males aged 9 to 26 years in 2014. We analyzed postlicensure 
      surveillance reports to the Vaccine Adverse Event Reporting System (VAERS). 
      METHODS: We searched VAERS data for US reports of adverse events (AEs) after 
      9vHPV from December 2014 through December 2017. We calculated reporting rates and 
      conducted empirical Bayesian data mining to identify disproportional reporting. 
      Physicians reviewed reports for selected prespecified conditions. RESULTS: VAERS 
      received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and 
      for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. 
      Dizziness, syncope, headache, and injection site reactions were most commonly 
      reported; the most commonly reported AEs were similar between females and males. 
      Two reports of death after 9vHPV were verified; no information in autopsy reports 
      or death certificates suggested a causal relationship with vaccination. 
      Approximately 28 million 9vHPV doses were distributed during the study period; 
      crude AE reporting rates were 259 reports per million 9vHPV doses distributed for 
      all reports and 7 per million doses distributed for serious reports. Syncope (a 
      known AE associated with human papillomavirus vaccination) and several types of 
      vaccine administration errors (eg, administered at wrong age) exceeded the 
      statistical threshold for empirical Bayesian data mining findings. CONCLUSIONS: 
      No new or unexpected safety concerns or reporting patterns of 9vHPV with 
      clinically important AEs were detected. The safety profile of 9vHPV is consistent 
      with data from prelicensure trials and from postmarketing safety data of its 
      predecessor, the quadrivalent human papillomavirus vaccine.
CI  - Copyright (c) 2019 by the American Academy of Pediatrics.
FAU - Shimabukuro, Tom T
AU  - Shimabukuro TT
AD  - Division of Healthcare Quality Promotion, Immunization Safety Office, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia; and tshimabukuro@cdc.gov.
FAU - Su, John R
AU  - Su JR
AD  - Division of Healthcare Quality Promotion, Immunization Safety Office, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia; and.
FAU - Marquez, Paige L
AU  - Marquez PL
AD  - Division of Healthcare Quality Promotion, Immunization Safety Office, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia; and.
FAU - Mba-Jonas, Adamma
AU  - Mba-Jonas A
AD  - Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for 
      Biologics Evaluation and Research, US Food and Drug Administration, Silver 
      Spring, Maryland.
FAU - Arana, Jorge E
AU  - Arana JE
AD  - Division of Healthcare Quality Promotion, Immunization Safety Office, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia; and.
FAU - Cano, Maria V
AU  - Cano MV
AD  - Division of Healthcare Quality Promotion, Immunization Safety Office, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia; and.
LA  - eng
GR  - CC999999/ImCDC/Intramural CDC HHS/United States
PT  - Journal Article
DEP - 20191118
PL  - United States
TA  - Pediatrics
JT  - Pediatrics
JID - 0376422
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
CIN - Pediatrics. 2019 Dec;144(6):. PMID: 31740499
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*trends
MH  - Child
MH  - Databases, Factual/trends
MH  - Dizziness/chemically induced/epidemiology
MH  - Female
MH  - Headache/chemically induced/epidemiology
MH  - Humans
MH  - Male
MH  - Papillomavirus Infections/*epidemiology/*prevention & control
MH  - Papillomavirus Vaccines/*administration & dosage/*adverse effects
MH  - United States/epidemiology
MH  - Young Adult
PMC - PMC6935554
MID - NIHMS1061988
COIS- POTENTIAL CONFLICT OF INTEREST: Dr Arana currently works in Clinical Safety and 
      Risk Management, Merck Research Laboratories, Merck & Co, on matters unrelated to 
      the content of this article. During the time he worked on this article, he was 
      employed by the Centers for Disease Control and Prevention. His work on the 
      article ceased before his employment with Merck; the other authors have indicated 
      they have no potential conflicts of interest to disclose.
EDAT- 2019/11/20 06:00
MHDA- 2020/02/19 06:00
PMCR- 2020/12/01
CRDT- 2019/11/20 06:00
PHST- 2019/08/01 00:00 [accepted]
PHST- 2019/11/20 06:00 [pubmed]
PHST- 2020/02/19 06:00 [medline]
PHST- 2019/11/20 06:00 [entrez]
PHST- 2020/12/01 00:00 [pmc-release]
AID - peds.2019-1791 [pii]
AID - 10.1542/peds.2019-1791 [doi]
PST - ppublish
SO  - Pediatrics. 2019 Dec;144(6):e20191791. doi: 10.1542/peds.2019-1791. Epub 2019 Nov 
      18.