SAEFVIC: Surveillance of adverse events following immunisation (AEFI) in Victoria, Australia, 2019–2020
DOI:
https://doi.org/10.33321/cdi.2026.50.012Keywords:
adverse events, vaccine safety, pharmacovigilance, surveillance, immunisation, post-licensureAbstract
Background
Adverse event following immunisation (AEFI) surveillance in Victoria is conducted through Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC), an enhanced surveillance system integrated with clinical services for vaccinees experiencing an AEFI. This report summarises SAEFVIC’s surveillance and vaccine pharmacovigilance activities in 2019 and 2020.
Methods
A retrospective cohort study approach was used to analyse AEFI reports submitted in 2019 and 2020, compared to those since 2015. Data were categorised by vaccinee demographics (age; sex; pregnancy; and Indigenous status), vaccines administered and reported AEFI. Age cohorts were defined as best fit to the National Immunisation Program age groups. Proportional reporting ratio was determined for perceived signals being investigated. Clinical services and educational activities were described.
Results
There were 3,828 AEFI reports received in 2019 and 2020 (28.8 per 100,000 population), with 7.6% defined as serious; 52% of all reports were female vaccinees; 56 of 464 reports among adult females (12.1%) were pregnant vaccinees; and 29 reports (0.9%) were Indigenous Australians. Reporting trends by age group were similar across all cohorts. No vaccine safety signals were confirmed. Telehealth consultations at Specialist Immunisation Clinics increased in 2020 in-line with Medicare eligibility criteria changes. Educational resources on various vaccine safety topics were published, particularly the anticipated coronavirus disease 2019 (COVID-19) vaccination program.
Conclusion
AEFI surveillance in Victoria continues to be robust through the SAEFVIC model and provides confidence in informing the safety profile of vaccines administered in Australia. These data provide a baseline for AEFI surveillance for comparison to the COVID-19 vaccination program commenced in 2021.
Downloads
References
Clothier HJ, Crawford NW, Kempe A, Buttery JP. Surveillance of adverse events following immunisation: the model of SAEFVIC, Victoria. Commun Dis Intell Q Rep. 2011;35(4):294–8. doi: https://doi.org/10.33321/cdi.2011.35.28.
Dey A, Wang H, Quinn H, Pillsbury A, Glover C, Hickie M et al. Surveillance of adverse events following immunisation in Australia annual report, 2019. Commun Dis Intell (2018). 2021;45. doi: https://doi.org/10.33321/cdi.2021.45.23.
Dey A, Wang H, Quinn H, Pillsbury A, Glover C, Hickie M et al. Surveillance of adverse events following immunisation in Australia: annual report, 2018. Commun Dis Intell (2018). 2020;44. doi: https://doi.org/10.33321/cdi.2020.44.12.
Melbourne Vaccine Education Centre (MVEC). Melbourne Vaccine Education Centre. [Webpage.] Melbourne: SAEFVIC, MVEC; 2021. [Accessed on 8 September 2021.] Available from: https://mvec.mcri.edu.au/.
Clothier HJ, Selvaraj G, McMinn A, Lewis G, Crawford NW, Buttery JP. SAEFVIC: surveillance of adverse events following immunisation (AEFI) in Victoria, 2012. Vic Infect Dis Bull. 2013;16(4):2–9.
Clothier HJ, Lawrie J, Lewis G, Russell M, Crawford NW, Buttery JP. SAEFVIC: surveillance of adverse events following immunisation (AEFI) in Victoria, Australia, 2018. Commun Dis Intell (2018). 2020;44. doi: https://doi.org/10.33321/cdi.2020.44.46.
National Centre for Immunisation Research & Surveillance (NCIRS). Vaccine Safety. [Internet.] Sydney: Sydney Children’s Hospitals Network, NCIRS; 2021. [Accessed on 9 September 2021.] Available from: https://www.ncirs.org.au/health-professionals/vaccine-safety.
NCIRS. Paediatric Active Enhanced Disease Surveillance (PAEDS). [Internet.] Sydney: Sydney Children’s Hospitals Network, NCIRS, PAEDS; 2024. [Accessed on 8 May 2024.] Available from: https://paeds.org.au/.
NCIRS. AusVaxSafety. [Internet.] Sydney: Sydney Children’s Hospitals Network, NCIRS, AusVaxSafety; 2022. [Accessed on 8 May 2024.] Available from: https://ausvaxsafety.org.au/.
Clothier HJ, Crawford NW, Russell M, Kelly H, Buttery JP. Evaluation of 'SAEFVIC', a pharmacovigilance surveillance scheme for the spontaneous reporting of adverse events following immunisation in Victoria, Australia. Drug Saf. 2017;40(6):483–95. doi: https://doi.org/10.1007/s40264-017-0520-7.
World Health Organization (WHO). Global Vaccine Safety Blueprint 2.0 (GVBSB2.0) 2021–2023. Geneva: WHO; 2021. [Accessed on 8 May 2024.] Available from: https://iris.who.int/bitstream/handle/10665/348966/9789240036963-eng.pdf.
Brighton Collaboration. Case Definitions. [Webpage.] Decatur (GA): Task Force for Global Health, Brighton Collaboration; 2021. [Accessed on 8 September 2021.] Available from: https://brightoncollaboration.us/category/pubs-tools/case-definitions/.
Australian Government Department of Health, Disability and Ageing; Australian Technical Advisory Group on Immunisation (ATAGI). Australian Immunisation Handbook. [Online resource.] Canberra: Australian Government Department of Health, Disability and Ageing; 2021. [Accessed on 9 September 2021.] Available from: immunisationhandbook.health.gov.au.
WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre (UMC). Pharmacovigilance communications: glossary. [Webpage.] Uppsala: WHO UMC; 2021. [Accessed on 8 May 2024.] Available from: https://who-umc.org/pharmacovigilance-communications/glossary/.
Marshall T, Addison M, Crawford NW, Buttery JP, Cheng DR. Aiming too high: shoulder injury related to vaccine administration (SIRVA): a case series. Vaccine. 2022;40(52):7505–9. doi: https://doi.org/10.1016/j.vaccine.2022.10.086.
Australian Bureau of Statistics. Regional population by age and sex. Reference period: 2020. [Webpage.] Canberra: Australian Bureau of Statistics; 27 August 2021. [Accessed on 7 September 2021.] Available from: https://www.abs.gov.au/statistics/people/population/regional-population-age-and-sex/2020.
Australian Bureau of Statistics (ABS). Regional population. Reference period: 2019-20 financial year. [Webpage.] Canberra: Australian Bureau of Statistics; 30 March 2021. [Accessed on 9 September 2021.] Available from: https://www.abs.gov.au/statistics/people/population/regional-population/2019-20.
Australian Government Services Australia. Australian Immunisation Register. [Website.] Canberra: Australian Government; 2021. [Accessed on 8 May 2024.] Available from: https://www.servicesaustralia.gov.au/individuals/services/medicare/australian-immunisation-register.
Clothier HJ, Lawrie J, Russell MA, Kelly H, Buttery JP. Early signal detection of adverse events following influenza vaccination using proportional reporting ratio, Victoria, Australia. PLoS One. 2019;14(11):e0224702. doi: https://doi.org/10.1371/journal.pone.0224702.
Hauben M, Madigan D, Gerrits CM, Walsh L, Van Puijenbroek EP. The role of data mining in pharmacovigilance. Expert Opin Drug Saf. 2005;4(5):929–48. doi: https://doi.org/10.1517/14740338.4.5.929.
Victorian State Government Department of Health (Victoria Health). Vaccine history timeline. [Internet.] Melbourne: Victoria Health; 2024. [Accessed on 8 May 2024.] Available from: https://www.health.vic.gov.au/immunisation/vaccine-history-timeline.
Australian Government Department of Health, Disability and Ageing, ATAGI. Australian Immunisation Handbook: Bexsero [Internet]. Canberra: Australian Government Department of Health, Disability and Ageing; 4 June 2018. [Accessed on 8 May 2024.] Available from: https://immunisationhandbook.health.gov.au/vaccines/bexsero.
Victorian Department of Health COVID-19 writing group. Population-based analysis of the epidemiological features of COVID-19 epidemics in Victoria, Australia, January 2020 – March 2021, and their suppression through comprehensive control strategies. Lancet Reg Health West Pac. 2021;17:100297. doi: https://doi.org/10.1016/j.lanwpc.2021.100297.
Clothier HJ, Crawford N, Russell MA, Buttery JP. Allergic adverse events following 2015 seasonal influenza vaccine, Victoria, Australia. Euro Surveill. 2017;22(20):30535. doi: https://doi.org/10.2807/1560-7917.Es.2017.22.20.30535.
Gold MS, Effler P, Kelly H, Richmond PC, Buttery JP. Febrile convulsions after 2010 seasonal trivalent influenza vaccine: implications for vaccine safety surveillance in Australia. Med J Aust. 2010;193(9):492–3. doi: https://doi.org/10.5694/j.1326-5377.2010.tb04029.x
Therapeutic Goods Administration (TGA). Advisory Committee on Vaccines meeting statement, meeting 11, 5 December 2018. [Internet.] Canberra: Australian Government Department of Health, Disability and Ageing, TGA; 8 October 2019. [Accessed on 20 October 2021.] Available from: https://www.tga.gov.au/committee-meeting-info/acv-meeting-statement-meeting-11-5-december-2018.
Basseal JM, Bennett CM, Collignon P, Currie BJ, Durrheim DN, Leask J et al. Key lessons from the COVID-19 public health response in Australia. Lancet Reg Health West Pac. 2023;30:100616. doi: https://doi.org/10.1016/j.lanwpc.2022.100616.
Laemmle-Ruff I, Lewis G, Clothier HJ, Dimaguila GL, Wolthuizen M, Buttery J et al. Vaccine safety in Australia during the COVID-19 pandemic: lessons learned on the frontline. Front Public Health. 2022;10:1053637. doi: https://doi.org/10.3389/fpubh.2022.1053637.
MVEC. Clinical Vaccinology Update (CVU) – December 2020. [Webpage.] Melbourne: SAEFVIC, MVEC; December 2020. [Accessed on 20 October 2021.] Available from: https://mvec.mcri.edu.au/events/clinical-vaccinology-update-cvu-monday-7th-december-2020/.
MVEC. VicVax (Victorian Immunisation Schedule) app- currently undergoing review. [Webpage.] Melbourne: SAEFVIC, MVEC; 28 July 2020. [Accessed on 20 October 2021.] Available from: https://mvec.mcri.edu.au/vicvax-victorian-immunisation-schedule-app-currently-undergoing-review/.
MVEC, Crawford N. COVID-19 Road to a vaccine. [Webpage; podcasts.] Melbourne: SAEFVIC, MVEC; 2020. [Accessed on 20 October 2021.] Available from: https://mvec.mcri.edu.au/podcasts/covid19-podcast-road-to-a-vaccine/.
Dey A, Wang H, Quinn H, Pillsbury A, Hickie M, Deng L et al. Surveillance of adverse events following immunisation in Australia annual report, 2020. Commun Dis Intell (2018). 2022;46. doi: https://doi.org/10.33321/cdi.2022.46.47.
Hull B, Hendry A, Dey A, Macartney K, Beard F. Immunisation Coverage Annual Report 2019. Commun Dis Intell (2018). 2021;45. doi: https://doi.org/10.33321/cdi.2020.45.18.
Hull B, Hendry A, Dey A, Macartney K, McIntyre P, Beard F. Exploratory analysis of the first 2 years of adult vaccination data recorded on AIR. Sydney: Sydney Children’s Hospital Network, NCIRS; November 2019. [Accessed on 27 October 2021.] Available from: https://ncirs.org.au/sites/default/files/2019-12/Analysis%20of%20adult%20vaccination%20data%20on%20AIR_Nov%202019.pdf.
Gibbons CL, Mangen MJ, Plass D, Havelaar AH, Brooke RJ, Kramarz P et al. Measuring underreporting and under-ascertainment in infectious disease datasets: a comparison of methods. BMC Public Health. 2014;14:147. doi: https://doi.org/10.1186/1471-2458-14-147.
Hazell L, Shakir SA. Under-reporting of adverse drug reactions : a systematic review. Drug Saf. 2006;29(5):385–96. doi: https://doi.org/10.2165/00002018-200629050-00003.
Australian Government Department of Health, Disability and Ageing. Vaccine safety in Australia: AusVaxSafety summary report 2019. Canberra: Australian Government Department of Health, Disability and Ageing; 2020. [Accessed on 8 May 2024.] Available from: https://www.health.gov.au/sites/default/files/documents/2020/11/vaccine-safety-in-australia-ausvaxsafety-summary-report-2019.pdf.
Westphal DW, Williams SA, Leeb A, Effler PV. Continuous active surveillance of adverse events following immunisation using SMS technology. Vaccine. 2016;34(29):3350–5. doi: https://doi.org/10.1016/j.vaccine.2016.05.015.
Australian Government Department of Health, Disability and Ageing. COVID-19 Temporary MBS Telehealth Services. [Internet.] Canberra: Australian Government Department of Health, Disability and Ageing; 19 December 2022. [Accessed on 8 May 2024.] Available from: http://www.mbsonline.gov.au/internet/mbsonline/publishing.nsf/Content/Factsheet-TempBB.
Australian Government Department of Health, Disability and Ageing. COVID-19 vaccination – Australia's COVID-19 vaccine national roll-out strategy. [Internet.] Canberra: Australian Government Department of Health, Disability and Ageing; 7 January 2021. [Accessed on 8 May 2024.] Available from: https://www.health.gov.au/resources/publications/covid-19-vaccination-australias-covid-19-vaccine-national-roll-out-strategy.
Published
How to Cite
Issue
Section
Categories
License
Copyright (c) 2026 Communicable Diseases Intelligence
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
