Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

• Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series [ Time Frame: 6 months post 4th dose vaccination ] [ Designated as safety issue: Yes ]

  Positive response is a 'Yes' to any of the following questions:

  1. Has your child been admitted to a hospital?
  2. Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician's office?
  3. Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?
  4. Has your child been diagnosed by a physician as having:

  Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?

  
  
• Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. [ Time Frame: 6 Months post 4th dose vaccination ] [ Designated as safety issue: Yes ]

  SAE: any untoward medical occurrence with the following outcomes:

  • death,
  • a life-threatening adverse drug experience (as confirmed by the investigators),
  • inpatient hospitalization or prolongation of existing hospitalization,
  • a persistent or significant disability/incapacity, or
  • a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)
  
  

This is a retrospective survey to collect selected safety data at 6 months following the 4th dose of Pentacel® in children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.