COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals

K Faksova; D Walsh; Y Jiang; J Griffin; A Phillips; A Gentile; JC Kwong; K Macartney; M Naus; Z Grange; S Escolano; G Sepulveda; A Shetty; A Pillsbury; C Sullivan; Z Naveed; NZ Janjua; N Giglio; J Perala; S Nasreen; H Gidding; P Hovi; T Vo; F Cui; L Deng; L Cullen; M Artama; H Lu; HJ Clothier; K Batty; J Paynter; H Petousis-Harris; J Buttery; S Black; A Hviid

Journal article

COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals

K Faksova, D Walsh, Y Jiang, J Griffin, A Phillips, A Gentile, JC Kwong, K Macartney, M Naus, Z Grange, S Escolano, G Sepulveda, A Shetty, A Pillsbury, C Sullivan, Z Naveed, NZ Janjua, N Giglio, J Perala, S Nasreen Show all

Vaccine | Elsevier | Published : 2024

DOI: 10.1016/j.vaccine.2024.01.100

Open access

Abstract

Background: The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries. Methods: Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the sa..

View full abstract