Human papillomavirus vaccine in boys: background rates of potential adverse events

Hazel J Clothier, Katherine J Lee, Vijaya Sundararajan, Jim P Buttery and Nigel W Crawford
Med J Aust 2013; 198 (10): 554-558. || doi: 10.5694/mja12.11751


Objectives: To determine background rates of potential adverse events following immunisation (AEFI) before expansion of the quadrivalent human papillomavirus (4vHPV) vaccination program to adolescent boys.

Design, patients and setting: Retrospective analysis of hospital discharge data obtained from the Victorian Admitted Episodes Dataset and emergency department visit data obtained from the Victorian Emergency Minimum Dataset for boys aged 12 to < 16 years during the period 1 July 2004 to 30 June 2009.

Main outcome measures: Numbers of and incidence rates for Guillain-Barré syndrome, anaphylaxis, seizures, syncope and other potential AEFI from 1 July 2004 to 30 June 2009, and estimated numbers of events after 4vHPV vaccination assuming no association (other than temporal) with the vaccine.

Results: We estimated background rates of neurological and allergic events in adolescent boys to be 252.9 and 175.2 per 100 000 person-years, respectively. Assuming an 80% vaccination rate with three doses per person — which equates to 1 440 000 doses administered nationally per year in the first 2 years of the program — about 2.4 episodes of Guillain-Barré syndrome would be expected to occur in the 6 weeks following vaccination. Within 1 day of vaccination, about 3.9 seizures, 0.3 episodes of anaphylaxis and 6.5 acute allergy presentations would be expected.

Conclusions: Routinely collected health outcome administration data can inform postlicensure safety surveillance of target conditions that might be perceived as AEFI.

  • Hazel J Clothier1,2
  • Katherine J Lee3
  • Vijaya Sundararajan4
  • Jim P Buttery1,5
  • Nigel W Crawford1,6

  • 1 Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC), Murdoch Childrens Research Institute, Melbourne, VIC.
  • 2 School of Population and Global Health, University of Melbourne, Melbourne, VIC.
  • 3 Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, VIC.
  • 4 Department of Medicine, Monash University, Melbourne, VIC.
  • 5 Department of Infectious Diseases and Department of Paediatrics, Monash University, Melbourne, VIC.
  • 6 Department of General Medicine, Royal Children’s Hospital, Melbourne, VIC.


We thank Lalitha Sundaresan of the Victorian Department of Health for initial data extractions.

Competing interests:

Hazel Clothier and Jim Buttery are members of the Advisory Committee on the Safety of Vaccines.

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