Fatal outcomes following immunization errors as reported to the EudraVigilance: A case series

Abstract

Background: Serious adverse reactions after immunization are rare but do occur. In very rare instances, cases with fatal outcome have been reported. These reports can have a huge impact and even more so when due to an immunization error. The aim of this study is to systematically review immunization errors with fatal outcomes in EudraVigilance. Methods: This was a case-series analysis of Individual Case Safety Reports (ICSRs) reporting immunization errors and a fatal outcome. To determine the level of certainty of a causal association between the immunization errors and fatal outcomes two independent reviewers assessed all ICSRs using the WHO tool ''Causality assessment of an Adverse Event Following Immunization (AEFI)". In accordance with the tool, the ICSRs were classified as consistent, indeterminate, inconsistent/coincidental, or unclassifiable. In addition, we estimated the contribution of reported errors to the fatal outcomes as large, moderate, small, none, or unclassifiable using a classification developed for this study. Results: A total of 154 ICSRs met the inclusion criteria. Vaccines reported most frequently were pneumococcal (33), rabies (27) and influenza vaccines (24). Most frequently reported errors were noncompliance with recommended schedules of immunization (63). The most frequently reported vaccine-error combination was rabies vaccines and non-compliance with a recommended schedule of immunization (23). Twelve cases were classified as consistent with causal association and had a large error contribution. These cases concerned a cluster of six cases reporting incorrect handling of multidose vials containing measles vaccine and six cases reporting administration of live-attenuated vaccines to immunocompromised patients. Discussion: In this study, we showed that fatal outcomes following immunization errors are very rare. Four key issues were the importance of: (1) quality control of multi-dose vaccines, (2) screening patients for immunocompromising factors, (3) education on the importance of adherence, and (4) measures to improve distinction between vaccines and medicines.

Lessons learned from a cluster of immunization errors in newborns

“…This study highlights the importance of measures to improve visually distinguishing features of vaccines and medicines. 16 In the European Union, clear guidelines are in place to limit similarity in packaging. 17 The WHO has released recommendations to limit confusion between vaccines and medicines by, for example, separate storage places for these products.…”

COVID-19 Vaccine Hesitancy: The Perils of Peddling Science by Social Media and the Lay Press

“…Many countries neither have well-defined surveillance and reporting systems nor trained professionals to detect AEFIs, assess causality, manage AEFIs, and eliminate confounders [ 36 , 37 ]. Hoeve et al identified 154 potentially biased individual case reports on AEFIs that cannot be directly attributed to vaccines but could have occurred from non-compliance to recommended immunization schedules [ 38 ]. Healthcare professionals specialized in this discipline have a significant role in separating and resolving confounders from genuine AEFIs.…”

Erro de imunização na administração de vacina: perspectiva da gestão

“…Desde que os erros de medicação foram identificados como os mais comuns na prestação de cuidados à saúde (KOHN; CORRIGAN; DONALDSON, 2000), outros estudos específicos para EI decorrentes de vacinação têm contribuído para sua compreensão (ARSHI et al, 2003;AZAR et al, 2021;BARBOZA et al, 2020;BISETTO, 2017;BRASIL, 2018a;BRITO, 2014;CABELLO;ORTIZ, 2020;CAPPONI;PAZ, 2020;CONDON;HAYNEY, 2016;HAMPTON, 2020;HIBBS et al, 2015;HOEVE et al, 2018;HOEVE et al, 2020;LANG et al, 2014;LEE et al, 2021;LIU et al, 2022;MORO et al, 2019;PACHECO et al, 2018;REED;TARINI;ANDREA, 2019;REES et al, 2015;PASCHOALOTTO;BRUNIERA, 2012;SILVA, T. et al, 2021;WALLIS;DOVEY, 2011).…”