Abstract
Background: Death following vaccination has occasionally been described in the context of appropriate use, but also in the context of immunization errors. There is no thorough evaluation of spontaneously reported fatal vaccination errors available in the literature.
Objectives: The aim of this study is to systematically review reported Individual Case Safety Reports with a fatal outcome describing immunization errors as captured by EudraVigilance.
Methods: A case‐series analysis of Individual Case Reports on cases reporting vaccination errors and a fatal outcome. Causality was assessed by two independent reviewers using the WHO tool for “Causality assessment of an Adverse Event Following Immunization”. Causality was classified as consistent, indeterminate, inconsistent/coincidental, or unclassifiable. In addition, the impact of reported errors on the fatal outcomes was estimated. Error impact was classified as large, moderate, small, none, or unclassifiable.
Results: Preliminary data (based on one reviewer) show that there were 151 evaluable cases. Vaccines reported most frequently were pneumococcal (34), rabies (26) and influenza vaccines (24). Most frequently reported errors were incorrect schedule of vaccination (62), vaccination errors (23) and inappropriate age at vaccination (18). The most frequently reported vaccine‐error combinations were rabies vaccines with incorrect schedule of vaccination (22), pneumococcal vaccines with incorrect schedule of vaccination (13), and influenza vaccines with inappropriate age at vaccination (12). Ten cases were classified as consistent with large error impact. These cases concerned use of poor‐quality measles vaccines (6), administration of live varicella or rotavirus vaccines to immunocompromised patients (4). All but one of these cases was described in the literature. A third of the cases (35%) was also described in the literature, local newspapers or by regulatory authorities.
Conclusions: It is reassuring that very few cases were classified as consistent with large error impact. Continued publication of vaccination errors in the medical literature aids in transparency and detection of errors that need to be minimized. Delayed start of vaccination remains an issue in rabies post‐exposure prophylaxis. More education and availability of rabies vaccines is necessary to limit incorrect schedule of vaccination and unnecessary deaths.
Objectives: The aim of this study is to systematically review reported Individual Case Safety Reports with a fatal outcome describing immunization errors as captured by EudraVigilance.
Methods: A case‐series analysis of Individual Case Reports on cases reporting vaccination errors and a fatal outcome. Causality was assessed by two independent reviewers using the WHO tool for “Causality assessment of an Adverse Event Following Immunization”. Causality was classified as consistent, indeterminate, inconsistent/coincidental, or unclassifiable. In addition, the impact of reported errors on the fatal outcomes was estimated. Error impact was classified as large, moderate, small, none, or unclassifiable.
Results: Preliminary data (based on one reviewer) show that there were 151 evaluable cases. Vaccines reported most frequently were pneumococcal (34), rabies (26) and influenza vaccines (24). Most frequently reported errors were incorrect schedule of vaccination (62), vaccination errors (23) and inappropriate age at vaccination (18). The most frequently reported vaccine‐error combinations were rabies vaccines with incorrect schedule of vaccination (22), pneumococcal vaccines with incorrect schedule of vaccination (13), and influenza vaccines with inappropriate age at vaccination (12). Ten cases were classified as consistent with large error impact. These cases concerned use of poor‐quality measles vaccines (6), administration of live varicella or rotavirus vaccines to immunocompromised patients (4). All but one of these cases was described in the literature. A third of the cases (35%) was also described in the literature, local newspapers or by regulatory authorities.
Conclusions: It is reassuring that very few cases were classified as consistent with large error impact. Continued publication of vaccination errors in the medical literature aids in transparency and detection of errors that need to be minimized. Delayed start of vaccination remains an issue in rabies post‐exposure prophylaxis. More education and availability of rabies vaccines is necessary to limit incorrect schedule of vaccination and unnecessary deaths.
| Original language | English |
|---|---|
| Pages (from-to) | 389-390 |
| Journal | Pharmacoepidemiology and Drug Safety |
| Volume | 28 |
| Issue number | S2 |
| Publication status | Published - Aug 2019 |