Early signal detection of adverse events following influenza vaccination using proportional reporting ratio, Victoria, Australia

Autoři: Hazel J. Clothier aff001;  Jock Lawrie aff001;  Melissa A. Russell aff003;  Heath Kelly aff004;  Jim P. Buttery aff001
Působiště autorů: Monash Centre for Health Research Implementation, Monash University, Clayton, Australia aff001;  SAEFVIC, Murdoch Children’s Research Institute, Parkville, Victoria, Australia aff002;  School of Population & Global Health, Melbourne University, Parkville, Victoria, Australia aff003;  School of Population Health, Australian National University, Canberra, Australia aff004;  Ritchie Centre, Hudson Institute, Monash Health, Clayton, Victoria, Australia aff005;  Monash Immunisation, Monash Health, Clayton, Victoria, Australia aff006
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: 10.1371/journal.pone.0224702



Timely adverse event following immunisation (AEFI) signal event detection is essential to minimise further vaccinees receiving unsafe vaccines. We explored the proportional reporting ratio (PRR) ability to detect two known signal events with influenza vaccines with the aim of providing a model for prospective routine signal detection and improving vaccine safety surveillance in Australia.


Passive AEFI surveillance reports from 2008–2017 relating to influenza vaccines were accessed from the Australian SAEFVIC (Victoria) database. Proportional reporting ratios were calculated for two vaccine-event categories; fever and allergic AEFI. Signal detection sensitivity for two known signal events were determined using weekly data; cumulative data by individual year and; cumulative for all previous years. Signal event thresholds of PRR ≥2 and Chi-square ≥4 were applied.


PRR provided sensitive signal detection when calculated cumulatively by individual year or by all previous years. Known signal events were detected 15 and 11 days earlier than traditional methods used at the time of the actual events.


Utilising a single jurisdiction’s data, PRR improved vaccine pharmacovigilance and showed the potential to detect important safety signals much earlier than previously. It has potential to maximise immunisation safety in Australia. This study progresses the necessary work to establish national cohesion for passive surveillance signal detection and strengthen routine Australian vaccine pharmacovigilance.

Klíčová slova:

Adverse events – Fevers – Immune receptor signaling – Infectious disease surveillance – Influenza – Statistical signal processing – Vaccination and immunization – Vaccines


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2019 Číslo 11