(CAEFISS) Annual report for vaccines administered in 2012

Background: To describe the adverse event following immunization (AEFI) reporting profile for vaccines administered in Canada during 2012 and surveillance trends relative to reports for vaccines administered from 2005 through 2011.Methods: Analysis of data based on AEFI reports received by the Public Health Agency of Canada by April 30, 2013, for vaccines marketed in Canada and administered from January 1, 2005, through December 31, 2012.Results: The AEFI reporting rate was 10.1 per 100,000 population in Canada for vaccines administered in 2012 and was inversely proportional to age.There was a trend of declining rates from 2005 (14.8) to 2012 overall and by age group.The vast majority of reports (94%-95%) were non-serious involving reactions at or near the vaccination site, rash and febrile events.Conclusion: Canada has a strong pharmacovigilance system for vaccines with one of the highest AEFI reporting rates in developed countries.Vaccines marketed in Canada have a very good safety profile.This report enables comparisons across jurisdictions in Canada and globally. Rash onlyGeneralized, localized, or location not specified Other events specified on the CAEFISS report form Arthritis Hypotonic-hyporesponsive episode (HHE) Intussusception Paraesthesia/Anaesthesia Parotitis Persistent crying Thrombocytopenia Systemic events not specified on the CAEFISS report form Fever alone Infection Influenza-like illness Other general symptom(s) Rash with fever and/or other illness Syndrome Vaccination anxiety-related events (no subtype) Miscellaneous other events Gastrointestinal disorders Vaccine failure Other events Vaccination error without an associated AEFI (no subtype)Table 2: Severity classification for primary adverse event following immunization (AEFI) in the Medical Case Review Severity Criteria Serious  Fatal outcome  Results in hospitalization or prolongation of hospitalization for ≥24 hours  Results in persistent or significant disability/incapacity  Congenital anomaly or birth defect  Life-threatening High impact  Results in hospitalization for <24 hours  Requires medically supervised observation outside of hospital  Requires ≥3 separate physician assessments during acute AEFI episode  Requires outpatient intravenous therapy (e.g., for antibiotics or rehydration)  Prevents performance of daily activities for ≥4 days Moderate impact  Results in 1-2 unscheduled urgent or non-urgent physician assessments  Requires emergency medical services to come to immunization clinic  Results in a new drug prescription or increased dose of an existing drug  Prevents performance of daily activities for 1 to 3 days Low impact  Requires treatment limited to immunization clinic setting by on-site staff  Requires health professional advice/reassurance without a scheduled visit  Requires non-prescription medication for symptomatic relief  Prevents performance of daily activities for <24 hours  No discernible impact Key definitionsAn adverse event following immunization (AEFI) is "any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease" (22).In 1994 the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use defined seriousness criteria for expedited reporting of AEFIs (23).A serious AEFI (SAE) is one that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (23).Expedited reporting is defined as no later than 15 calendar days after initial recognition of the AEFI and preferably as soon as possible.At PHAC, all SAE reports are reviewed by a physician.

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