Observational studyThe Medical journal of Australia2022
The short term safety of COVID-19 vaccines in Australia: AusVaxSafety active surveillance, February - August 2021.
Observational study in The Medical journal of Australia, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Minimum Data Set and Metadata for Active Vaccine Safety Surveillance: Systematic Review.JMIR public health and surveillance · 2025Pooled it
- Short-Term Safety and Adverse Event Risk Profiles for SARS-CoV-2 Booster Vaccine Doses in Australian Adults: A Survey Study.The Medical journal of Australia · 2026Article
- Statistical Methods for Multi-jurisdictional Australian Vaccine Safety Investigations of Rare Adverse Events.Drug safety · 2026Article
- Electronic, self-reported active vaccine safety surveillance: A three-country comparison of AusVaxSafety (Australia), CANVAS (Canada) and V-safe (United States).Human vaccines & immunotherapeutics · 2025Article
- Article
- Short term safety profile of respiratory syncytial virus vaccine in adults aged ≥ 60 years in Australia.The Lancet regional health. Western Pacific · 2025Article
- COVID-19 vaccination pharmacovigilance in Khojaly district, Uzbekistan: an epidemiological evaluation.Frontiers in public health · 2025Article
- A scoping review of active, participant centred, digital adverse events following immunization (AEFI) surveillance of WHO approved COVID-19 vaccines: A Canadian immunization Research Network study.Human vaccines & immunotherapeutics · 2024Article
- Non-linear effects of age in reporting of adverse events following influenza immunization in Zhejiang, China.BMC infectious diseases · 2024Article
- Applying causal inference and Bayesian statistics to understanding vaccine safety signals using a simulation study.NPJ vaccines · 2024Article
- Short-Term Active Safety Surveillance of the Spikevax and Nuvaxovid Priming Doses in Australia.Vaccines · 2024Article
- COVID-19 vaccine short-term adverse events in the real-life family practice in Krakow, Poland.The European journal of general practice · 2023Article
- Side Effects of COVID-19 Vaccines in Pregnant and Lactating Mexican Women and Breastfed Infants: A Survey-Based Study.Vaccines · 2023Article
- Article
- Comparison of Adverse Effects of Two SARS-CoV-2 Vaccines Administered in Workers of the University of Padova.Vaccines · 2023Article
- Short term adverse event profile of COVID-19 mRNA vaccines in children aged 5-15 years in Australia.The Lancet regional health. Western Pacific · 2023Article
- Article
- Vaccine safety: what systems are required to ensure public confidence in vaccines?The Medical journal of Australia · 2022Article
Corrections and comments
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Authors and funding
11 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the short term safety of the COVID-19 vaccines Comirnaty (Pfizer-BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia.
designProspective observational cohort study; online surveys by AusVaxSafety, a national active vaccine safety surveillance system, three and eight days after vaccination. SETTING,
participantsPeople aged 16 years or more who received COVID-19 vaccines at sentinel vaccination hubs, general practices, or Aboriginal Community Controlled Health Organisation clinics, 22 February - 30 August 2021.
main outcome measuresPrimary outcome: proportion of respondents who reported any adverse event following immunisation (AEFI) 0-3 days after vaccination. SECONDARY OUTCOMES: proportions of respondents who reported specific adverse events or medical review for AEFI within seven days of vaccination; impact on usual daily activities; recovery.
results4 851 480 people received COVID-19 vaccines at participating sentinel sites during the study period (25% of all COVID-19 vaccine doses administered in Australia to 30 August 2021). 3 035 983 people responded to both surveys (response rate, 62.6%); 35.9% of respondents reported one or more AEFI 0-3 days after Comirnaty dose 1, 54.7% after Comirnaty dose 2, 52.8% after Vaxzevria dose 1, and 22.0% after Vaxzevria dose 2. Local pain, fatigue, headache, and myalgia were the most frequently reported symptoms. After adjusting for demographic characteristics, vaccination site type, jurisdiction, and self-reported medical conditions, the odds of reporting any AEFI were higher for women than men (range of adjusted odd ratios [aORs], by vaccine and dose, 1.53-1.84), for people with a history of anaphylaxis (aOR range, 1.28-1.45), and for people reporting certain underlying conditions, including obesity (aOR range, 1.15-1.75), immunodeficiency (aOR range, 1.04-2.24), or chronic inflammatory disease (aOR range, 1.05-1.75). 0.9% of respondents sought medical advice in the three days following vaccination, most frequently after Comirnaty dose 2 (1.4%) and Vaxzevria dose 1 (1.2%).
conclusionAusVaxSafety active surveillance affirms the short term safety profile of Comirnaty and Vaxzevria vaccines in a large population sample during the first six months of the Australian COVID-19 vaccination program.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.