Safety of vaccines that have been kept outside of recommended temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008–2012

No 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.

Introdução: Os imunobiológicos são de grande importância para a prevenção e erradicação de doenças. Entretanto, a falta de manutenção da Rede de Frio gera diversos problemas relacionados a perdas dessas substâncias, onerando uma importante quantia de recursos públicos. Objetivo: Analisar as perdas vacinais da Região Ampliada de Saúde Oeste de Minas Gerais. Métodos: Trata-se de um estudo descritivo, com base em dados secundários obtidos através de formulários utilizados pela Superintendência Regional de Saúde (SRS), para avaliação de perdas de imunobiológicos por alteração de temperatura. Foram analisados os formulários de fevereiro de 2016 até janeiro de 2018. Os dados foram organizados e validados por dupla digitação, e a análise foi feita descritivamente. Resultados: Os resultados mostraram que dos motivos das ocorrências 40,83% foram por falta de energia elétrica, seguida de falha no equipamento (36,67%), e erro do profissional (10%). Foram inutilizados 17229 frascos de vacinas (65,78%), sendo 111.145 doses, com uma perda financeira de R$ 604.340,31. Conclusão: Identificou-se que as perdas físicas por alteração de temperatura de vacinas na região estudada foram relevantes, gerando prejuízos para o orçamento do SUS. Dessa forma sugere-se a adoção de condutas para minimizar estas perdas.