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An adverse event following immunization (AEFI) can have consequences for an individual's future decision making and may contribute to vaccine hesitancy. AEFIs vary in severity and can be experienced directly (by an individual themselves) or indirectly (through witnessed or recounted events). We sought to measure the prevalence of specific AEFIs and understand which AEFIs have the greatest associations with reduced willingness to receive a vaccine and how injection anxiety may moderate the relationship. We conducted a cross-sectional online survey with both qualitative and quantitative elements in a sample of adults aged 18 years and over in Australia. Nineteen percent of the 1050 respondents reported experiencing an AEFI that they found stressful. Those who experienced an AEFI reported significantly higher levels of injection anxiety than those who did not. Within the group who reported experiencing an AEFI, respondents were significantly less likely to be willing to receive a COVID-19 vaccine if they reported: indirect exposure to an uncommon/rare AEFI compared with other AEFIs (aOR:0.39; 95% CI: 0.18-0.87); indirect exposure to a scientifically unsupported AEFI compared with other AEFIs (aOR:0.18; 95% CI: 0.05-0.57). Direct exposure to an AEFI was not associated with willingness to receive a COVID-19 vaccine. For those who reported experiencing an AEFI, the odds of willingness to receive a COVID-19 vaccine decreased significantly with an increase in injection anxiety (aOR:0.94; 95% CI: 0.9-0.98). Our results suggest that more is needed to mitigate the consequences of AEFIs on vaccine willingness. Empathically acknowledging at a community level, the experience of both real and perceived AEFIs and incorporating accounts of positive vaccination experiences in vaccine hesitancy interventions may be useful.

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OBJECTIVE: To describe adverse events following COVID-19 immunisation (AEFI) and participation in AusVaxSafety surveillance in a Queensland regional community. METHODS: Participants presenting for second dose COVID-19 vaccine at the Hervey Bay Wide Bay Hospital and Health Service (WBHHS) vaccine clinic in July 2021 completed a survey pertaining to their first COVID-19 vaccine. Data collected included participation in AusVaxSafety surveillance, vaccine type (BNT162b2 (Pfizer/BioNTech) or ChAdOx1-S(Oxford/AstraZeneca), AEFI experienced and impact on work/routine activities. Multivariable logistic regression related demographic factors to odds of surveillance participation and AEFI occurrence. RESULTS: Of 1,148 participants, 37.6% participated in AusVaxSafety surveillance and 44.8% reported an AEFI. Participation in surveillance was higher in older (≥50 vs <50 years: OR 1.36, 95%CI:1.04-1.78) and less-educated participants (university vs. high school/below: OR 0.68, 95%CI:0.48-0.95). Reporting an AEFI was higher in younger (≥50 years vs. <50 years: BNT162b2: OR 0.69, 95%CI:0.51-0.93; ChAdOx1-S: OR 0.42, 95%CI:0.10-1.89), female (female vs. male: BNT162b2: OR 2.28, 95%CI:1.67-3.12; ChAdOx1-S: OR 1.85, 95%CI:1.17-2.94) and more educated participants (university vs. high school/below: BNT162b2:OR 1.63, 95%CI: 1.08-2.45; ChAdOx1-S: OR 3.98, 95%CI:2.03-7.79). Of participants with an AEFI, 15% reported missing work/routine activities. CONCLUSIONS: Participation in surveillance was modest in this regional population, despite AEFI being frequent, and impacts of absenteeism in this setting warrants further research. IMPLICATIONS FOR PUBLIC HEALTH: The findings can inform strategies to improve surveillance participation and inform workforce planning in regional areas.

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INTRODUCTION: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is an Australian hospital-based active surveillance system employing prospective case ascertainment for selected serious childhood conditions, particularly vaccine preventable diseases and potential adverse events following immunisation (AEFI). This report presents surveillance data for 2019. METHODS: Specialist nurses screened hospital admissions, emergency department records, laboratory and other data on a daily basis in seven paediatric tertiary referral hospitals across Australia, to identify children with the conditions under surveillance. Standardised protocols and case definitions were used across all sites. In 2019, the conditions under surveillance comprised: acute flaccid paralysis (AFP; a syndrome associated with poliovirus infection), acute childhood encephalitis (ACE), influenza, intussusception (IS; a potential AEFI with rotavirus vaccines), pertussis, varicella-zoster virus infection (varicella and herpes zoster), invasive meningococcal and invasive Group A streptococcus diseases and two new conditions, Kawasaki disease and gram-negative bloodstream infections. An additional social research component continued to evaluate parental attitudes to influenza vaccination. RESULTS: PAEDS captured 2,701 cases for 2019 across all conditions under surveillance. Key outcomes of PAEDS included: contribution to national AFP surveillance to reach the World Health Organization reporting targets for detection of poliomyelitis cases; demonstration of high influenza activity in 2019 and influenza-associated deaths in ACE cases; identification of key barriers to influenza vaccination of children hospitalised for acute respiratory illness; reporting of all IS cases associated with vaccine receipt to relevant state health department; and showing a further reduction nationally in varicella cases. Enhanced pertussis surveillance continued to capture controls to support vaccine efficacy estimation. Invasive meningococcal disease surveillance showed predominance of serotype B and a reduction in cases nationally. Surveillance for invasive group A streptococcus captured severe cases in children. Monitoring of Kawasaki disease incidence and gram-negative bloodstream infections commenced. CONCLUSIONS: PAEDS continues to provide unique policy-relevant data on serious paediatric conditions using sentinel hospital-based enhanced surveillance. Keywords: paediatric, surveillance, child, hospital, vaccine preventable diseases, adverse event following immunisation, acute flaccid paralysis, encephalitis, influenza, intussusception, pertussis, varicella zoster virus, meningococcal, group A streptococcus, Kawasaki, bloodstream infections.

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Introduction: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system employing prospective case ascertainment for selected serious childhood conditions, particularly vaccine-preventable diseases and potential adverse events following immunisation (AEFI). This report presents surveillance data for 2017 and 2018. Methods: Specialist nurses screened hospital admissions, emergency department (ED) records, laboratory and other data on a daily basis in seven paediatric tertiary referral hospitals across Australia to identify children with the conditions under surveillance. In 2017 and 2018 these included acute flaccid paralysis (AFP; a syndrome associated with poliovirus infection), acute childhood encephalitis (ACE), influenza, intussusception (IS; a potential AEFI with rotavirus vaccines), pertussis, varicella-zoster virus infection (varicella and herpes zoster), invasive meningococcal, and invasive Group A streptococcus diseases. An additional social research component was added to evaluate parental attitudes to vaccination. Results: PAEDS captured 1,580 and 925 cases for 2017 and 2018, respectively, across all conditions under surveillance. Key outcomes of PAEDS included: contribution to national AFP surveillance to reach the World Health Organization reporting targets; identification of a third human parechovirus outbreak among other infectious diseases linked to ACE; demonstration of variable influenza activity between 2017 and 2018, with vaccine effectiveness (VE) analysis demonstrating that the protection offered through vaccination is season-dependent. All IS cases associated with vaccine receipt were reported to the relevant state health department. Varicella and herpes zoster case numbers remained unchanged, with vaccine uptake found to be suboptimal among eligible children under the NIP. Enhanced pertussis surveillance continues to capture controls for VE estimation. Surveillance for invasive meningococcal disease showed predominance for serotype B at 57% over 2 years among 77 cases where serotyping was available, and surveillance for invasive group A streptococcus captured severe disease in children. Conclusion: PAEDS continues to provide unique policy-relevant data on serious paediatric conditions using hospital-based sentinel surveillance.

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Introduction: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system employing prospective case ascertainment for selected serious childhood conditions, particularly vaccine preventable diseases and potential adverse events following immunisation (AEFI). PAEDS data is used to better understand these conditions, inform policy and practice under the National Immunisation Program, and enable rapid public health responses for certain conditions of public health importance. PAEDS enhances data available from other Australian surveillance systems by providing prospective, detailed clinical and laboratory information on children with selected conditions. This is the third annual PAEDS report, and presents surveillance data for 2016. Methods: Specialist nurses screened hospital admissions, emergency department records, laboratory and other data, on a daily basis in 5 paediatric tertiary referral hospitals in New South Wales, Victoria, South Australia, Western Australia and Queensland to identify children with the conditions under surveillance. Retrospective data on some conditions was also captured by an additional hospital in the Northern Territory. Standardised protocols and case definitions were used across all sites. Conditions under surveillance in 2016 included acute flaccid paralysis (AFP) (a syndrome associated with poliovirus infection), acute childhood encephalitis (ACE), influenza, intussusception (IS; a potential AEFI with rotavirus vaccines), pertussis, varicella-zoster virus infection (varicella and herpes zoster), invasive meningococcal and invasive Group A streptococcus diseases. Most protocols restrict eligibility to hospitalisations; Emergency Department (ED) only presentations are also included for some conditions. Results: In 2016, there were 673 cases identified across all conditions under surveillance. Key outcomes of PAEDS included: contribution to national AFP surveillance to reach World Health Organization (WHO) reporting targets; identification of the leading infectious causes of acute encephalitis which included human parechovirus, influenza, enteroviruses, Mycoplasma pneumoniae, and bacterial meningo-encephalitis; demonstration of high influenza activity with vaccine effectiveness (VE) analysis demonstrating some protection offered through vaccination. All IS cases associated with vaccine receipt were reported to the relevant state health department. Varicella and herpes zoster case numbers increased from previous years associated with suboptimal vaccination in up to 40% of cases identified. Pertussis surveillance continued in 2016 with the addition of test negative controls captured for estimating vaccine effectiveness. Surveillance for invasive meningococcal disease showed predominance for serotype B in absence of immunisation, and new invasive group A streptococcus surveillance captured severe disease in children. Conclusions: PAEDS continues to provide unique policy-relevant data on serious paediatric conditions using hospital-based sentinel surveillance.

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INTRODUCTION: Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. METHODS: Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia's National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles. RESULTS: 7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p < .001). Meningococcal B vaccine was associated with the highest increase in AEFI rates among children receiving a specified concomitant vaccine: 30.3% reported an AEFI compared with 7.3% who received an influenza vaccine alone (p < .001). Reported fever was strongly associated with medical attendance (OR: 42.6; 95% Confidence Interval (CI): 25.6-71.0). TIV and QIV safety profiles included low and expected AEFI rates (fever: 4.3% for TIV compared with 3.2% for QIV (p = .015); injection site reaction: 1.9% for TIV compared with 3.0% for QIV (p < .001)). There was no difference in safety profile between brands. DISCUSSION: Active participant-reported data provided timely vaccine brand-specific safety information. Our surveillance system has particular utility in monitoring the safety of influenza vaccines, given that they may vary in composition annually.

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