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Shoulder Injury Related to Vaccine Administration (SIRVA) is a preventable adverse event following incorrect vaccine administration, which can result in significant long-term morbidity. There has been a notable surge in reported cases of SIRVA as a rapid national population-based COVID-19 immunization program has been rolled out across Australia. Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) in Victoria identified 221 suspected cases of SIRVA following the commencement of the COVID-19 vaccination program, reported between February 2021 and February 2022. This review describes the clinical features and outcomes of SIRVA in this population. Additionally, a suggested diagnostic algorithm is proposed, in order to facilitate early recognition and management of SIRVA. 151 cases were confirmed as SIRVA, with 49.0% having received vaccines at state vaccination centers. 75.5% were suspected incorrect administration site, with most patients experiencing shoulder pain and restricted movement within 24 hours of vaccination, lasting on average 3 months. Improved awareness and education regarding SIRVA is imperative in a pandemic vaccine roll-out. The development of a structured framework for evaluating and managing suspected SIRVA will aid in timely diagnosis and treatment, essential to mitigate potential long-term complications. [ABSTRACT FROM AUTHOR]

Objectives: To examine the epidemiological and clinical characteristics of SARS-CoV-2-positive children in Australia during 2020.Design, Setting: Multicentre retrospective study in 16 hospitals of the Paediatric Research in Emergency Departments International Collaborative (PREDICT) network; eleven in Victoria, five in four other Australian states.Participants: Children aged 0-17 years who presented to hospital-based COVID-19 testing clinics, hospital wards, or emergency departments during 1 February - 30 September 2020 and who were positive for SARS-CoV-2.Main Outcome Measures: Epidemiological and clinical characteristics of children positive for SARS-CoV-2.Results: A total of 393 SARS-CoV-2-positive children (181 girls, 46%) presented to the participating hospitals (426 presentations, including 131 to emergency departments [31%]), the first on 3 February 2020. Thirty-three children presented more than once (8%), including two who were transferred to participating tertiary centres (0.5%). The median age of the children was 5.3 years (IQR, 1.9-12.0 years; range, 10 days to 17.9 years). Hospital admissions followed 51 of 426 presentations (12%; 44 children), including 17 patients who were managed remotely by hospital in the home. Only 16 of the 426 presentations led to hospital medical interventions (4%). Two children (0.5%) were diagnosed with the paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS).Conclusion: The clinical course for most SARS-CoV-2-positive children who presented to Australian hospitals was mild, and did not require medical intervention. [ABSTRACT FROM AUTHOR]

Objective: International studies describing COVID‐19 in children have shown low proportions of paediatric cases and generally a mild clinical course. We aimed to present early data on children tested for SARS‐CoV‐2 at a large Australian tertiary children's hospital according to the state health department guidelines, which varied over time. Methods: We conducted a retrospective cohort study at The Royal Children's Hospital, Melbourne, Australia. It included all paediatric patients (aged 0–18 years) who presented to the ED or the Respiratory Infection Clinic (RIC) and were tested for SARS‐CoV‐2. The 30‐day study period commenced after the first confirmed positive case was detected at the hospital on 21 March 2020, until 19 April 2020. We recorded epidemiological and clinical data. Results: There were 433 patients in whom SARS‐CoV‐2 testing was performed in ED (331 [76%]) or RIC (102 [24%]). There were four (0.9%) who had positive SARS‐CoV‐2 detected, none of whom were admitted to hospital or developed severe disease. Of these SARS‐CoV‐2 positive patients, 1/4 (25%) had a comorbidity, which was asthma. Of the SARS‐CoV‐2 negative patients, 196/429 (46%) had comorbidities. Risk factors for COVID‐19 were identified in 4/4 SARS‐CoV‐2 positive patients and 47/429 (11%) SARS‐CoV‐2 negative patients. Conclusion: Our study identified a very low rate of SARS‐CoV‐2 positive cases in children presenting to a tertiary ED or RIC, none of whom were admitted to hospital. A high proportion of patients who were SARS‐CoV‐2 negative had comorbidities. [ABSTRACT FROM AUTHOR]

• Subcutaneous nodules are a rare adverse event following immunization. • Most nodules resolve within 12 months, but some may last for years. • We describe nodules associated with various vaccines, including without aluminum. • Nodules can recur. Deep intra-muscular injection may reduce recurrence. • Most children with nodules were fully immunized at follow-up. Subcutaneous nodules are a rare adverse event following immunization (AEFI). We aimed to describe nodules at the injection site reported to SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community) using the Brighton Collaboration Case Definition (BCCD), management and recurrence following subsequent immunizations. We assessed 58 cases (<18 years of age) of 'nodule at injection site' reported to SAEFVIC, Melbourne, Australia, between May 2007 and June 2016. Case details were analyzed from records and phone interview follow-up. The Australian Immunization Registry was reviewed for immunization status. 71% (41/58 reported cases) were consistent with the BCCD for subcutaneous nodule, 14% (8 cases) were 'possible subcutaneous nodules', 10% (6 cases) were nodules associated with BCG immunization and 5% (3 cases) were attributable to an alternative diagnosis. The median age at immunization was 12 months, (range 1 month–12 years); 54% male (22/41 cases). 17% (7 cases) had multiple nodules. Nodules were associated with immunizations containing aluminum (74%, 36/49 nodules), no aluminum (8%, 4 nodules) and unknown (18%, 9 nodules). Most cases developed symptoms within 3 days post-immunization (59%, 24 cases) and in the thigh (59%, 29 nodules). Pruritus was associated in 41% (17 cases). Around 1/3 (34%) of nodules resolved 6 months post immunization, 2/3 (68%) by 12 months, however 1/4 (24%) remained persistent for >24 months. 5 cases had prior nodules and 1 case had recurrence with subsequent immunization. 83% (34 cases) were fully immunized for age at follow-up. Subcutaneous nodules at the injection site may occur following a wide range of vaccines, including vaccines without aluminum. All cases require careful review and where possible, specialist management and to support subsequent immunizations. [ABSTRACT FROM AUTHOR]

Background  Invasive group A streptococcal disease (IGAS) carries significant morbidity and mortality in children. Fluctuations in disease incidence are well documented. However, the modulating factors that contribute to these changes remain unclear. Prospective monitoring of IGAS cases in Victoria, Australia, showed an increased number of cases in 2017, coinciding with a peak of influenza illness. Methods  Children identified to have IGAS are prospectively monitored in Melbourne through a disease surveillance network. Data on their presentation, investigations, and clinical course are collected. An increased number of cases identified between June 1, 2017, and October 31, 2017, have been retrospectively analyzed. Results  We identified 22 cases of pediatric IGAS during the study period. Increased case detection occurred during a period of increased influenza disease. Of 11 children in our cohort who underwent respiratory viral testing, 4 were confirmed to have concurrent respiratory tract illnesses, and 2 were confirmed to have influenza. [ABSTRACT FROM AUTHOR]

Introduction: Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community).Objective: The aim of this study was to evaluate Victoria's current AEFI surveillance system 'SAEFVIC' and inform ongoing quality improvement of vaccine pharmacovigilance in Victoria and Australia.Methods: We conducted a retrospective structured desktop evaluation of AEFI reporting received by SAEFVIC from 2007 to 2014, to evaluate the system according to its stated objectives, i.e. to improve AEFI reporting; provide AEFI signal detection; and to maintain consumer confidence in vaccination.Results: AEFI reporting has tripled since SAEFVIC commenced (incidence risk ratio [IRR] 3.04, 95% confidence interval [CI] 2.35-3.93), raising Victoria to be the lead jurisdiction by AEFI reporting volume and to rank third by population reporting rate nationally. The largest increase was observed in children. Data were utilised to investigate potential signal events and inform vaccine policy. Signal detection required clinical suspicion by surveillance nurses, or prior vaccine-specific concerns. Subsequent vaccination post-AEFI was documented for 56.2% (95% CI 54.1-58.4) of reports, and the proportion of children due or overdue for vaccination was 2.3% higher for those reporting AEFI compared with the general population.Conclusion: SAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly through data consistency and jurisdictional comparability in Australia. [ABSTRACT FROM AUTHOR]

A correction for the article "Changing Epidemiology of Respiratory Syncytial Virus in Australia—Delayed Re-Emergence in Victoria Compared to Western Australia/ New South Wales" is presented, which is published in the September–October 2020 issue of the periodical.

The article reports on a research aimed at exploring potential association between monovalent H1N1 vaccine and/or H1N1-containing trivalent influenza vaccine and occurrence of Guillain-Barré syndrome (GBS) in Victoria, Australia. The study conducted on September 30, 2009-September 30, 2010 established an active surveillance system for GBS in 10 hospitals in Victoria. The study found 66 cases of probable GBS in the 12-month study period. The article also discusses the study's conclusions.

Shoulder injury directly related to vaccination (SIRVA) occurs when a vaccine is administered too high in the shoulder. The primary aim of this study was to accurately detail the occurrence, symptoms, diagnosis, management and long-term outcomes of SIRVA cases in Victoria, Australia. The study identified 102 SIRVA cases from 2007 to 2020 from the Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) database. The majority [73/85; (86 %)] of cases resolved completely with a median time to resolution of 8 weeks and no statistically significant difference in recovery by immunisation provider type or baseline imaging. This large case series includes long-term clinical progress in SIRVA, allowing accurate evaluation and analysis. Further evaluation is required to establish if other risk factors contribute to SIRVA, which may help with targeted, tailored education for providers on correct vaccine administration technique, including in large and rapid vaccine rollouts. [ABSTRACT FROM AUTHOR]

The article presents a study on the development of syncope and seizures after quadrivalent (4v) human papillomavirus (HPV) vaccination. Researchers examined retrospective case studies from the Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) in Victoria from May 2007 to April 2009. They found that the reporting rate of syncopal seizures following vaccine administration was 2.6 per 100,000 doses. They concluded that both syncope and syncopal seizures in Victoria happened after vaccination at rates similar across the world.

• There have been conflicting reports regarding a temporal association between COVID-19 vaccination and Guillain-Barré Syndrome (GBS). • This case series from Victoria, Australia, reports an excess of GBS cases following dose 1 of the adenovirus-vector COVID-19 vaccine Vaxzevria ChadOx1-S (AstraZeneca). • Global collaborative studies are required to provide precision and generalizability regarding risks of Adverse Events Following Immunization (AEFI) associated with different vaccine platforms. • To support further development of the adenovirus-vector vaccine platform, there is an urgent need for research exploring the mechanisms underlying Adverse Events of Special Interest (AESI) such as GBS, and whether predictive biomarkers may help to minimize risks. Guillain–Barré syndrome (GBS) is an adverse event of special interest (AESI) for surveillance systems monitoring adverse events following immunisation (AEFI) with COVID-19 vaccines. Emerging data support a temporal association between GBS and adenovirus-vector COVID-19 vaccines. We present a case series of GBS reports submitted between February and November 2021 to our enhanced spontaneous surveillance system (SAEFVIC) in Victoria, Australia, following vaccination with either the adenovirus-vector vaccine Vaxzevria ChadOx1-S (AstraZeneca) or an mRNA vaccine (Comirnaty BNT162b2 [Pfizer-BioNTech] or Spikevax mRNA-1273 [Moderna]). For each report, Brighton Collaboration case definitions were used to describe diagnostic certainty. Severity was graded using the GBS Disability Score. The observed incidence of GBS following immunisation against COVID-19 was compared to expected background ICD10-AM G61.0 coded hospitalisations. There were 41 total cases of GBS reported to SAEFVIC following Vaxzevria (n = 38), Comirnaty (n = 3), or Spikevax (n = 0) vaccines. The observed GBS incidence rate exceeded the expected background rate for Vaxzevria only, with 1.85 reports per 100,000 doses following dose 1, higher than the expected rate of 0.39 hospital admissions per 100,000 adults within 42 days of vaccination. Of 38 GBS reports following Vaxzevria, the median age at vaccination was 66 years and median onset of symptoms was 14 days following immunisation. There was one death. Four cases initially categorised as GBS were later reclassified as acute-onset chronic inflammatory demyelinating polyneuropathy. Fatigue was the predominant persisting symptom reported at follow up. Additional global studies are required to characterise risk factors, clinical variability, and to provide precision and generalizability regarding AEFI risks such as GBS associated with different vaccine platforms, which will help inform communication of the potential benefits and risks of COVID19 vaccination. [ABSTRACT FROM AUTHOR]

• ITP is known to occur after SARS-CoV-2 infection and measles-mumps-rubella vaccine. • Our data demonstrate an increased risk of ITP following AstraZeneca vaccine. • This has important implications for the patient as well as wider vaccination policy. Emerging evidence suggest a possible association between immune thrombocytopenia (ITP) and some formulations of COVID-19 vaccine. We conducted a retrospective case series of ITP following vaccination with Vaxzevria ChadOx1-S (AstraZeneca) and mRNA Comirnaty BNT162b2 COVID-19 (Pfizer-BioNTech) vaccines and compare the incidence to expected background rates for Victoria during the first six months of the Australian COVID-19 vaccination roll-out in 2021. Cases were identified by reports to the Victorian state vaccine safety service, SAEFVIC, of individuals aged 18 years or older presenting with thrombocytopenia following COVID-19 vaccination without evidence of thrombosis. Twenty-one confirmed or probable cases of ITP were identified following receipt of AstraZeneca (n = 17) or Pfizer-BioNTech (n = 4) vaccines. This translates to an observed incidence of 8 per million doses for AstraZeneca vaccine, twice the expected background rate of 4.1 per million. The observed rate for Pfizer-BioNTech was consistent with the expected background rate. The median time to onset for the cases post AstraZeneca vaccination was 10 days (range 1–78) and median platelet nadir 5 × 109/L (range 0–67 × 109/L). Hospital presentations or admissions for management of symptoms such as bleeding occurred in 18 (86%) of the cases. The majority of cases (n = 11) required intervention with at least 2 therapy modalities. In conclusion, we observed a substantially higher than expected rate of ITP following AstraZeneca vaccination. ITP is the second haematological adverse event, distinct from that of thrombosis with thrombocytopenia syndrome (TTS), observed following AstraZeneca vaccination. [ABSTRACT FROM AUTHOR]

Background Anaphylaxis is a rare life-threatening adverse event following immunization (AEFI). Variability in presentation can make differentiation between anaphylaxis and other AEFI difficult. This study summarizes pediatric anaphylaxis AEFI reported to an Australian state-based passive surveillance system. Methods All suspected and reported pediatric (<18 years) anaphylaxis AEFI notified to SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community) Melbourne, Australia, between May 2007 to May 2013 were analyzed. Clinical descriptions of the AEFI, using the internationally recognized Brighton Collaboration case definition (BCCD) and final outcome were documented. Results 93% (25/27) of AEFI classified as anaphylaxis met BCCD criteria, with 36% (9/25), assessed as the highest level of diagnostic certainty (Level 1). Median age was 4.7 years (range 0.3–16.2); 48% of cases were male. The vaccine antigens administered included: diphtheria, tetanus, acellular pertussis (DTaP) alone or in combination vaccines containing other antigens in 11 of 25 cases (44%); and live attenuated measles mumps rubella (MMR) vaccine for six (five also had other vaccines concomitantly administered). The estimated incidence rate of anaphylaxis for DTaP vaccines was 0.36 cases per 100,000 doses, and 1.25 per 100,000 doses for MMR vaccines. The majority of cases had rapid onset, but in 24% (6/25) of cases, first symptoms of anaphylaxis developed ≥30 min after immunization. In 60% (15/25) of cases, symptoms resolved ≤60 min of presentation. Intramuscular adrenaline was administered in 90% (18/25) of cases. All cases made a full recovery with no sequelae identified. Conclusion This comprehensive case series of pediatric anaphylaxis as an AEFI identified that diagnostic criteria are useful when applied to a passive vaccine surveillance system when adequate clinical information is available. Anaphylaxis as an AEFI is rare and usually begins within 30 min of vaccination. However, healthcare professionals and vaccinees/parents should be aware that onset of anaphylaxis can be delayed beyond 30 min following immunization and that medical attention should be sought promptly if anaphylaxis is suspected. [ABSTRACT FROM AUTHOR]

Background: Myocarditis and myopericarditis are well described adverse events of special interest (AESI) following COVID-19 vaccinations. Although reports are reassuring regarding initial clinical outcomes, information about longer term outcomes remains limited. We aimed to further this knowledge and report outcomes to 6 months post diagnosis from a single population cohort., Methods: Reports of myocarditis following COVID-19 vaccination were followed up by SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community), the state-wide vaccine safety service for Victoria, Australia. Confirmed myocarditis cases (Brighton Collaboration Criteria levels 1-3) were followed up via surveys at 1, 3 and 6 months post symptom onset. Responses received between 22 February 2021 and 30 September 2022 were analysed., Results: 87.5 % (N = 182) of eligible participants completed at least 1 survey report. 377 reports were analysed. 76.9 % of completed reports were from male patients. The median age of patients was 21 years [IQR: 16 to 32]. 54.8 % (n = 74) of survey reports at 6 months, reported ongoing symptoms. At all follow-up time points, females were significantly more likely to have ongoing symptoms. At 6 months, 51.9 % of male respondents reported symptom resolution compared to 22.6 % of female patients (p = 0.002). Females were also more likely to continue medication and have ongoing exercise restrictions. However, males were significantly more likely to have higher initial peak troponin results and abnormal initial cardiac imaging investigations., Conclusions: There appears to be a significant proportion of patients who experience ongoing symptoms to 6 months post onset amongst patients that experience these AESI. Male patients were more likely to report earlier and more complete symptom recovery, despite significantly higher average initial peak troponin. This difference in phenotypic presentation in females compared to males warrants further investigation and there is a need for longer term follow up data., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

The Victorian Specialist Immunization Services (VicSIS) was established in Victoria, Australia, in February 2021, aiming to enhance vaccine safety services for Coronavirus disease (COVID-19) vaccines. VicSIS supports practitioners and patients with complex vaccine safety questions, including those who experience adverse events following immunization (AEFI) after COVID-19 vaccines. VicSIS provides individual vaccination recommendations, allergy testing, vaccine challenges, and vaccination under supervision. VicSIS initially comprised of eight adult COVID-19 specialist vaccination clinics, subsequently, expanding to better support pediatric patients as the Australian vaccine roll-out extended to adolescents and children. Since their establishment to September 2021, the inaugural VicSIS clinics received a total of 26,401 referrals and reviewed 6,079 patients. Consults were initially predominantly for pre-vaccination reviews, later predominantly becoming post-vaccination AEFI reviews as the program progressed. Regardless of the type of consult, the most common consult outcome was a recommendation for routine vaccination (73% and 55% of consult outcomes respectively). VicSIS is an integral component of the COVID-19 vaccination program and supports confidence in COVID-19 vaccine safety by providing consistent advice across the state. VicSIS aims to strengthen the health system through the pandemic, bolstering specialist immunization services beyond COVID-19 vaccines, including training the next generation of vaccinology experts.

Importance: COVID-19 mRNA vaccine-associated myocarditis has previously been described; however specific features in the adolescent population are currently not well understood., Objective: To describe myocarditis adverse events following immunisation reported following any COVID-19 mRNA vaccines in the adolescent population in Victoria, Australia., Design: Statewide, population-based study., Setting: Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) is the vaccine-safety service for Victoria, Australia., Participants: All SAEFVIC reports of myocarditis and myopericarditis in 12-17-year-old COVID-19 mRNA vaccinees submitted between 22 February 2021 and 22 February 2022, as well as accompanying diagnostic investigation results where available, were assessed using Brighton Collaboration criteria for diagnostic certainty., Exposures: Any mRNA COVID-19 vaccine., Main Outcomes/mmeasure: Confirmed myocarditis as per Brighton Collaboration criteria (levels 1-3)., Results: Clinical review demonstrated definitive (Brighton level 1) or probable (level 2) diagnoses in 75 cases. Confirmed myocarditis reporting rates were 8.3 per 100 000 doses in this age group. Cases were predominantly male (n=62, 82.7%) and post dose 2 (n=61, 81.3%). Rates peaked in the 16-17-year-old age group and were higher in males than females (17.7 vs 3.9 per 100 000, p=<0.001).The most common presenting symptoms were chest pain, dyspnoea and palpitations. A large majority of cases who had a cardiac MRI had abnormalities (n=33, 91.7%). Females were more likely to have ongoing clinical symptoms at 1-month follow-up (p=0.02)., Conclusion: Accurate evaluation and confirmation of episodes of COVID-19 mRNA vaccine-associated myocarditis enabled understanding of clinical phenotypes in the adolescent age group. Any potential vaccination and safety surveillance policies needs to consider age and gender differences., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: The immune response in children with SARS-CoV-2 infection is not well understood., Objective: To compare seroconversion in nonhospitalized children and adults with mild SARS-CoV-2 infection and identify factors that are associated with seroconversion., Design, Setting, and Participants: This household cohort study of SARS-CoV-2 infection collected weekly nasopharyngeal and throat swabs and blood samples during the acute (median, 7 days for children and 12 days for adults [IQR, 4-13] days) and convalescent (median, 41 [IQR, 31-49] days) periods after polymerase chain reaction (PCR) diagnosis for analysis. Participants were recruited at The Royal Children's Hospital, Melbourne, Australia, from May 10 to October 28, 2020. Participants included patients who had a SARS-CoV-2-positive nasopharyngeal or oropharyngeal swab specimen using PCR analysis., Main Outcomes and Measures: SARS-CoV-2 immunoglobulin G (IgG) and cellular (T cell and B cell) responses in children and adults. Seroconversion was defined by seropositivity in all 3 (an in-house enzyme-linked immunosorbent assay [ELISA] and 2 commercial assays: a SARS-CoV-2 S1/S2 IgG assay and a SARS-CoV-2 antibody ELISA) serological assays., Results: Among 108 participants with SARS-CoV-2-positive PCR findings, 57 were children (35 boys [61.4%]; median age, 4 [IQR, 2-10] years) and 51 were adults (28 women [54.9%]; median age, 37 [IQR, 34-45] years). Using the 3 established serological assays, a lower proportion of children had seroconversion to IgG compared with adults (20 of 54 [37.0%] vs 32 of 42 [76.2%]; P < .001). This result was not associated with viral load, which was similar in children and adults (mean [SD] cycle threshold [Ct] value, 28.58 [6.83] vs 24.14 [8.47]; P = .09). In addition, age and sex were not associated with seroconversion within children (median age, 4 [IQR, 2-14] years for both seropositive and seronegative groups; seroconversion by sex, 10 of 21 girls [47.6%] vs 10 of 33 boys [30.3%]) or adults (median ages, 37 years for seropositive and 40 years for seronegative adults [IQR, 34-39 years]; seroconversion by sex, 18 of 24 women [75.0%] vs 14 of 18 men [77.8%]) (P > .05 for all comparisons between seronegative and seropositive groups). Symptomatic adults had 3-fold higher SARS-CoV-2 IgG levels than asymptomatic adults (median, 227.5 [IQR, 133.7-521.6] vs 75.3 [IQR, 36.9-113.6] IU/mL), whereas no differences were observed in children regardless of symptoms. Moreover, differences in cellular immune responses were observed in adults compared with children with seroconversion., Conclusions and Relevance: The findings of this cohort study suggest that among patients with mild COVID-19, children may be less likely to have seroconversion than adults despite similar viral loads. This finding has implications for future protection after SARS-CoV-2 infection in children and for interpretation of serosurveys that involve children. Further research to understand why seroconversion and development of symptoms are potentially less likely in children after SARS-CoV-2 infection and to compare vaccine responses may be of clinical and scientific importance.

Background: SAEFVIC is the Victorian surveillance system for adverse events following immunisation (AEFI). It enhances passive surveillance by also providing clinical support and education to vaccinees and immunisation providers. This report summarises surveillance, clinical and vaccine pharmacovigilance activities of SAEFVIC in 2018., Methods: A retrospective observational cohort study of AEFI reports received by SAEFVIC in 2018, compared with previous years since 2008. Data were categorised by vaccinee demographics of age, sex, pregnancy and Indigenous status, vaccines administered and AEFI reactions reported. Age cohorts were defined as infant (0-12 months); young child (1-4 years); school-aged (5-17 years); adult (18-64 years); and older person (65+ years). Proportional reporting ratios were calculated for signal investigation of serious adverse neurological events with all vaccines and with influenza vaccines. Clinical support services and educational activities are described., Results: SAEFVIC received 1730 AEFI reports (26.8 per 100,000 population), with 9.3% considered serious. Nineteen percent (n = 329) attended clinical review. Annual AEFI reporting trends increased for infants, children and older persons, but were stable for school-aged and adult cohorts. Females comprised 55% of all reports and over 80% of reports among adults. There were 17 reports of AEFI in pregnant women and 12 (0.7%) in persons identifying as Indigenous Australians. A possible signal regarding serious adverse neurological events (SANE) was detected, but was not supported by signal validation testing. A clinical investigation is ongoing. Two deaths were reported coincident to immunisation with no evidence of causal association., Conclusion: SAEFVIC continues to provide robust AEFI surveillance supporting vaccine safety monitoring in Victoria and Australia, with new signal detection and validation methodologies strengthening capabilities., (© Commonwealth of Australia CC BY-NC-ND.)

Background: Bacillus Calmette-Guérin (BCG) vaccine is used worldwide, with high efficacy against childhood Mycobacterium tuberculosis (TB) meningitis and miliary TB. BCG vaccine is considered safe, with serious systematic adverse events following immunization (AEFI) of immunocompetent recipients being rare, although adverse event rates vary between differing BCG strains. In Victoria, Australia, AEFI are reported to SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community), an enhanced passive surveillance system operational since 2007., Objective: To describe the epidemiology of reported BCG AEFI in Victoria, Australia, particularly following the 2012 recall of Connaught BCG vaccine, substitution with Denmark-SSI vaccine and subsequent programme delivery adjustments., Methods: Retrospective analysis of reported BCG AEFI in Victoria, Australia, for the 6-year period 2008-2013. Incidence rates were calculated using available doses-distributed, doses-administered and population data denominators with 95 % confidence intervals., Results: The predominant BCG AEFI reported were abscess and lymphadenopathy, with higher reports for males than for females (p = 0.039).The rates of AEFI per 10,000 doses distributed were similar for the Connaught and Denmark-SSI strains, at 11.6 and 15.4, respectively (p = 0.414). When doses administered rather than doses distributed were considered, the rate of reported Denmark-SSI AEFI was much higher, at 62.8 per 10,000 doses administered. Meaningful result interpretation was hampered by a lack of a BCG vaccination register, multiple disparate providers and absent doses-administered data prior to the recall., Conclusion: Effective AEFI surveillance is of paramount importance as countries are faced with unplanned vaccine strain changes following the 2012 BCG recall and subsequent global vaccine supply shortages. The Australian experience and lessons learned serve as a timely reminder to BCG vaccination programmes worldwide to review AEFI surveillance systems.

Objectives: To determine background rates of potential adverse events following immunisation (AEFI) before expansion of the quadrivalent human papillomavirus (4vHPV) vaccination program to adolescent boys., Design, Patients and Setting: Retrospective analysis of hospital discharge data obtained from the Victorian Admitted Episodes Dataset and emergency department visit data obtained from the Victorian Emergency Minimum Dataset for boys aged 12 to < 16 2013s during the period 1 July 2004 to 30 June 2009., Main Outcome Measures: Numbers of and incidence rates for Guillain-Barré syndrome, anaphylaxis, seizures, syncope and other potential AEFI from 1 July 2004 to 30 June 2009, and estimated numbers of events after 4vHPV vaccination assuming no association (other than temporal) with the vaccine., Results: We estimated background rates of neurological and allergic events in adolescent boys to be 252.9 and 175.2 per 100 000 person-2013s, respectively. Assuming an 80% vaccination rate with three doses per person - which equates to 1 440 000 doses administered nationally per 2013 in the first 2 2013s of the program - about 2.4 episodes of Guillain-Barré syndrome would be expected to occur in the 6 weeks following vaccination. Within 1 day of vaccination, about 3.9 seizures, 0.3 episodes of anaphylaxis and 6.5 acute allergy presentations would be expected., Conclusions: Routinely collected health outcome administration data can inform postlicensure safety surveillance of target conditions that might be perceived as AEFI.

State-based adverse events following immunisation (AEFI) reporting systems in Australia demonstrate marked regional differences in surveillance methodologies and reporting rates. To improve AEFI services in Victoria, Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) was established in 2007. SAEFVIC comprises a central reporting enhanced passive surveillance system integrated with clinical services. AEFI may be reported by phone, fax or on-line. Immunisation nurse specialists follow up all reports, coupled with physician review as required. Supervised re-vaccination in a hospital environment, when appropriate, helps ensure clinical support for vaccinees, families and health-care providers. The Brighton Collaboration, the Australian Immunisation Handbook and in-house case definitions are used to categorise AEFI reports. In the first 3 years (2007-2010) of operation 3,265 reports were received, describing 4,293 AEFI. The number of reports received increased annually over the 3-year period. Seventy-six per cent of AEFI met one of 52 established case definitions and the remainder were recorded verbatim: 22% of reported AEFI were considered severe. Of 1,086 persons reporting an AEFI in 2009, 356 (36%) attended for a clinical consultation and 325 (83%) were revaccinated, of which 114 were day stay or overnight patients. Enhanced passive AEFI surveillance using integrated clinical services has been shown to improve adverse event reporting with reporting rates in Victoria increasing from 2.6 per 100,000 in 2003 to 13.5 per 100,000 per annum in 2009. This report describes the SAEFVIC service model and summarises outcomes and lessons learnt in the first 3 years of operation.