Evaluation of vaccination error cases with fatal outcome reported to EudraVigilance

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Case review of spontaneous reporting data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07A) BACTERIAL VACCINES

  BACTERIAL VACCINES

  (J07B) VIRAL VACCINES

  VIRAL VACCINES

  (J07C) BACTERIAL AND VIRAL VACCINES, COMBINED

  BACTERIAL AND VIRAL VACCINES, COMBINED

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  This study aims to review cases in Eudravigilance between 1 January 2001 and 31 December 2016 reporting vaccination errors with fatal outcome.
• Outcomes:
  Death
• Data analysis plan:
  Cases are identified from EudraVigilance using the Standard MedDRA Query for medication errors in combination with a reported vaccine and a fatal outcome. All cases received between 1 January 2001 and 31 December 2016 are included for the analysis. A causality assessement for death will be performed by two independednt reviewers using the AEFI causality assessment form of the WHO and an estimation of the impact of the error will be performed.