Abstract
BackgroundSerious 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. MethodsThis 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. ResultsA 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 non-compliance 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 multi-dose vials containing measles vaccine and six cases reporting administration of live-attenuated vaccines to immunocompromised patients. DiscussionIn 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.
Highlights
The introduction of vaccines has had a major impact on public health worldwide and is one of the most cost-effective medical interventions [1,2]
In this follow-up paper, we report on an in-depth analysis of the 187 Individual Case Safety Reports (ICSRs) with a fatal outcome following immunization errors as captured in EudraVigilance using the World Health Organisation (WHO) tool ‘‘Causality assessment of an Adverse Event Following Immunization (AEFI)”
Case reports published in the medical literature may qualify for submission to EudraVigilance if they fulfil the criteria for a valid case report and the product involved is licensed in the Economic Area (EEA) [6]
Summary
The introduction of vaccines has had a major impact on public health worldwide and is one of the most cost-effective medical interventions [1,2]. Cases with fatal outcome have been reported These reports can have a huge impact and even more so when due to an immunization error. 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)”. 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. 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. 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
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