Validating community concerns of menstrual changes associated with COVID-19 vaccination using a self-controlled case series analysis of real-world data.

Objectives: Stories of menstrual changes occurring post COVID-19 vaccination have abounded, with many affected persons expressing frustration their concerns were not being heard. In an era where misinformation is rampant and can fuel vaccine hesitancy it is imperative to address and validate community concerns. We aimed to investigate evidence of increased menstrual disturbances associated with COVID-19 vaccination.

Systematic review and meta-analysis of respiratory viral triggers for acute myocardial infarction and stroke.

Respiratory viral infections may trigger acute cardiovascular events. However, relative pathogen-specific associations are poorly understood, limiting optimal preventive recommendations. The aim of this study was to systematically review the association between respiratory viruses with two primary outcomes, acute myocardial infarction (AMI) and stroke.

Early-life gut microbiome associates with positive vaccine take and shedding in neonatal schedule of the human neonatal rotavirus vaccine RV3-BB.

Rotavirus vaccines are less effective in high mortality regions. A rotavirus vaccine administered at birth may overcome challenges to vaccine uptake posed by a complex gut microbiome. We investigated the association between the microbiome and vaccine responses following RV3-BB vaccine (G3P[6]) administered in a neonatal schedule (dose 1: 0-5 days), or infant schedule (dose 1: 6-8 weeks) in Indonesia (Phase 2b efficacy study) (n = 478 samples/193 infants) (ACTRN12612001282875) and in Malawi (Immunigenicity study) (n = 355 samples/186 infants) (NCT03483116).

Hepatitis B vaccination of preterm infants and risk of bronchopulmonary dysplasia: a cohort study, Australia.

Objective: To determine whether hepatitis B virus (HBV) vaccination of extremely preterm infants (defined in our study as < 29 weeks gestation) within 24 hours of birth (birth-dose) increases the risk of developing bronchopulmonary dysplasia.

Methods: Using data from Australia, we conducted a population data linkage study using the Victorian Vaccine Safety Health Link. This platform links state-wide immunization and health outcomes from the Victorian Perinatal Data Collection and the Victorian Admitted Episodes Dataset.

Nuvaxovid NVX-CoV2373 vaccine safety profile: real-world data evidence after 100,000 doses, Australia, 2022 to 2023.

IntroductionNuvaxovid became available in Australia from February 2022, a year after the first COVID-19 vaccines. This protein-based vaccine was an alternative for people who had had an adverse event to and/or were hesitant to receive an mRNA or adenovirus-based COVID-19 vaccine. Although safety from clinical trials was reassuring, small trial populations, low administration rates and limited post-licensure intelligence meant potential rare adverse events were underinformed.

Clinical phenotype of COVID-19 vaccine-associated myocarditis in Victoria, 2021-22: a cross-sectional study.

Objectives: To describe myocarditis as an adverse event after coronavirus disease 2019 (COVID-19) vaccination, including a detailed description of clinical phenotypes and diagnostic test results and differences by age, sex, and degree of troponin level elevation.

Study Design: Retrospective cross-sectional study.

Setting, Participants: Cases of suspected myocarditis following the administration of a COVID-19 vaccine in Victoria during 22 February 2021 - 30 September 2022 reported to Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), with symptom onset within 14 days of vaccination, and deemed to be confirmed myocarditis according to the Brighton Collaboration Criteria.

Establishing the Vaccine Safety Health Link: A large, linked data resource for the investigation of vaccine safety concerns.

Objective: Post-licensure vaccine safety surveillance of adverse events following immunisation is critical to ensure public safety and confidence in vaccines. This paper aims to describe the governance structure and data linkage methodology behind the establishment of the largest linked vaccine safety surveillance data resource in Australia - The Vaccine Safety Health Link (VSHL).

Methods: The Vaccine Safety Health Link contains linked records from the Australian Immunisation Register with records from hospital, perinatal, mortality, and notifiable disease datasets in near real-time.

Laboratory-confirmed respiratory viral infection triggers for acute myocardial infarction and stroke: Systematic review protocol.

Background: Cardiovascular disease contributes substantially to global mortality and morbidity. Respiratory tract infections, particularly influenza, may trigger an increase in the short-term risk of acute myocardial infarction (AMI) and stroke. Recent studies have also linked this risk to other respiratory viruses, including respiratory syncytial virus (RSV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Letter to the Editor: A comparison of post-COVID vaccine myocarditis classification using the Brighton Collaboration criteria versus (United States) Centers for Disease Control criteria: an update.

(No abstract provided).

Audiovestibular adverse events following COVID-19 vaccinations.

Introduction: Evidence regarding audiovestibular adverse events post COVID-19 vaccination to date has been inconclusive regarding a potential association. This study aimed to determine if there was an increase in audiovestibular events following COVID-19 vaccination in South-eastern Australia during January 2021-March 2023.

Methods: A multi-data source approach was applied.

Long term follow up and outcomes of Covid-19 vaccine associated myocarditis in Victoria, Australia: A clinical surveillance study.

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.

Shoulder injury following COVID-19 vaccine administration: a case series and proposed diagnostic algorithm.

Background: 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.

Methods: 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.

Guillain-Barré syndrome temporally associated with COVID-19 vaccines in Victoria, Australia.

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]).

Aiming too high: Shoulder injury related to vaccine administration (SIRVA): A case series.

Purpose: 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.

Principal Results: The study identified 102 SIRVA cases from 2007 to 2020 from the Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) database.

Information systems for vaccine safety surveillance.

Immunization implementation in the community relies upon post-licensure vaccine safety surveillance to maintain safe vaccination programs and to detect rare AEFI not observed in clinical trials. The increasing availability of electronic health-care related data and correspondence from both health-related providers and internet-based media has revolutionized health-care information. Many and varied forms of health information related to adverse event following immunization (AEFI) are potentially suitable for vaccine safety surveillance.

Myocarditis and myopericarditis cases following COVID-19 mRNA vaccines administered to 12-17-year olds in Victoria, Australia.

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.

Victorian Specialist Immunisation Services (VicSIS) - bolstering adult clinics for COVID-19 vaccines.

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.

Immune thrombocytopenia following immunisation with Vaxzevria ChadOx1-S (AstraZeneca) vaccine, Victoria, Australia.

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.

Applicability of the GAIA Maternal and Neonatal Outcome Case Definitions for the Evaluation of Adverse Events Following Vaccination in Pregnancy in High-income Countries.

Background: The Brighton Collaboration Global Alignment of Immunization Safety in Pregnancy (GAIA) project developed case definitions for the assessment of adverse events in mothers and infants following maternal immunization. This study evaluated the applicability of these definitions to data collected in routine clinical care and research trial records across 7 sites in high-resource settings.

Methods: Data collection forms were designed and used to retrospectively abstract the key elements of the GAIA definitions from records for 5 neonatal and 5 maternal outcomes, as well as gestational age.