Background incidence rates of selected adverse events of special interest (AESI) to monitor the safety of COVID-19 vaccines.

Alexis Pillsbury, Anastasia Phillips, Lucy Deng, Helen Quinn, Kristine Macartney, Heather Gidding

Abstract read

In one paragraph

Article in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it

0cells of the map it votes in

3citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

Observed Versus Expected Analysis-How Does It Fit in the Pharmacovigilance Toolkit?Drug safety · 2025
Review
Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices.Frontiers in drug safety and regulation · 2025
Article
Incidence and Nature of Short-Term Adverse Events following COVID-19 Second Boosters: Insights from Taiwan's Universal Vaccination Strategy.Vaccines · 2024
Article

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Alexis PillsburyNational Centre for Immunisation Research and Surveillance, Children's Hospital at Westmead, Westmead, NSW, Australia; The University of Sydney Children's Hospital Westmead Clinical School, Westmead, NSW, Australia. Electronic address: alexis.pillsbury@health.nsw.gov.au.

Anastasia PhillipsNational Centre for Immunisation Research and Surveillance, Children's Hospital at Westmead, Westmead, NSW, Australia. Electronic address: anastasia.phillips@health.nsw.gov.au.

Lucy DengNational Centre for Immunisation Research and Surveillance, Children's Hospital at Westmead, Westmead, NSW, Australia; The University of Sydney Children's Hospital Westmead Clinical School, Westmead, NSW, Australia. Electronic address: lucy.deng@health.nsw.gov.au.

Helen QuinnNational Centre for Immunisation Research and Surveillance, Children's Hospital at Westmead, Westmead, NSW, Australia; The University of Sydney Children's Hospital Westmead Clinical School, Westmead, NSW, Australia. Electronic address: helen.quinn@health.nsw.gov.au.

Kristine MacartneyNational Centre for Immunisation Research and Surveillance, Children's Hospital at Westmead, Westmead, NSW, Australia; The University of Sydney Children's Hospital Westmead Clinical School, Westmead, NSW, Australia. Electronic address: kristine.macartney@health.nsw.gov.au.

Heather GiddingNational Centre for Immunisation Research and Surveillance, Children's Hospital at Westmead, Westmead, NSW, Australia; The University of Sydney Northern Clinical School, St Leonards, NSW, Australia; Women and Babies Research, Kolling Institute, Northern Sydney Local Health District, St Leonards, NSW, Australia; School of Population Health, UNSW Medicine, University of NSW, Sydney, NSW, Australia. Electronic address: heather.gidding@sydney.edu.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDetermining background rates of medical conditions identified as adverse events of special interest (AESI) that may occur following COVID-19 vaccination is important for contextualising and investigating potential vaccine safety signals.

methodsWe conducted a retrospective population-based cohort study using linked emergency department, hospitalisation and death data for 2017 and 2018 from Australia's most populous state, New South Wales. Incident cases of select neurological conditions, arterial or venous thromboembolic conditions, secondary thrombocytopenia, myocarditis/pericarditis, and unique events of anaphylaxis and generalised convulsions were identified using internationally agreed upon diagnostic (ICD-10) codes. State-specific rates per 100,000 person-years were calculated, with further stratification by age group and sex where clinically relevant to the condition, and the number of expected cases nationally in one and 6 weeks was estimated.

resultsBackground rates of selected neurological conditions were low with the exception of generalised convulsions for which 1,599-1,872 cases were estimated nationally in a 1-week period in the absence of vaccination. Using a narrow case definition, rates of Guillain-Barré Syndrome (3.9 per 100,000 person-years) were higher than international rates reported elsewhere. Thromboembolic and cerebral venous sinus thrombosis event rates increased with age. Myocarditis occurred more commonly in males, and was highest in males aged 18-24 years, with an estimated 1-4 cases expected nationally in a 1-week period.

conclusionsUsing routinely collected linked healthcare data provides localised estimates of background rates of new onset or periodic AESI which enables rapid estimation of observed-versus-expected rates of events reported following COVID-19 vaccination. This Australian-specific analysis contributes AESI background rates which can be compared with those from other countries to enhance understanding of geographic variability in the frequency of specific AESI in the absence of vaccination, and can be utilised for signal detection during program implementation.

Indexed as

COVID-19COVID-19 VaccinesMyocarditisAustraliaCohort StudiesHumansIncidenceMaleRetrospective StudiesVaccinationCOVID-19 VaccinesAdverse eventsBackground ratesCOVID-19 vaccinationVaccine safety

Identifiers

PMID37088604

DOI10.1016/j.vaccine.2023.04.041

PMCPMC10110935

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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.