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    Mar 07, 2021
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    Fatal outcomes following immunization errors as reported to the EudraVigilance: A case series.

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    Hoeve et al 2020 Fatal outcomes ...
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    Authors
    Hoeve, CE
    Gadroen, K
    Kwa, MSG
    van Haren, A
    Sturkenboom, MCJM
    Straus, SMJM
    Issue Date
    2020-03-05
    Submitted date
    2021-02-22
    
    Metadata
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    Journal
    Vaccine
    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 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. 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.
    Publisher
    Elsevier
    URI
    http://hdl.handle.net/10144/619871
    DOI
    10.1016/j.vaccine.2020.02.074
    PubMed ID
    32147297
    Type
    Article
    Language
    en
    EISSN
    1873-2518
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.vaccine.2020.02.074
    Scopus Count
    Collections
    Vaccination

    entitlement

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