User GUide to completion and submission of the AeFi reports
Contents
1. Choose one of the responses as described below to describe the outcome following the administration of the subsequent dose of vaccine and provide all pertinent details in section 10 Vaccine administered without AEFI A subsequent dose of vaccine was administered without the occurrence of any AEFI Vaccine administered with recurrence of AEFI A subsequent dose of vaccine was administered and followed by the occurrence of the same adverse event that was previously experienced by the patient Please fill out a new AEFI form for the subsequent AEFI 24 USER GUIDE AEFI REPORT FORM Vaccine administered other AEFI observed A subsequent dose of vaccine was administered and followed by the occurrence of a different adverse event than was previously experienced by the patient Please fill out a new AEFI form for the subsequent AEFI Vaccine administered without information on AEFI A subsequent dose of vaccine was administered and it is unknown if it was followed by the occurrence of any AEFI Vaccine not administered A subsequent dose of the vaccine was not administered PUBLIC HEALTH AGENCY OF CANADA 25 ANNEX I WHERE TO SEND A COMPLETED AEFI REPORT Upon completing an AEFI report please send it to your federal provincial territorial F P T local health unit health services Contact information listed by F P T on where to send the completed report and for any other AEFI related questions can be accessed at http www phac aspc2. RESPIRATORY Choose all that apply from the list provided below Sneezing An involuntary reflex sudden violent and audible expulsion of air through the mouth and nose BCCD Vaccine 28 2010 4487 4498 Rhinorrhea Discharge of thin nasal mucus BCCD Vaccine 28 2010 4487 4498 Hoarse voice An unnaturally harsh cry of infant or vocalization in a child or adult BCCD Vaccine 28 2010 4487 4498 Sensation of throat closure Feeling or perception of throat closing with a sensation of difficulty breathing BCCD Vaccine 28 2010 4487 4498 Stridor A harsh and continuous sound made on breathing in BCCD Vaccine 28 2010 4487 4498 Dry cough Rapid expulsion of air from the lungs to clear the lung airways and not accompanied by expectoration a non productive cough BCCD Vaccine 28 2010 4487 4498 Tachypnea Rapid breathing which is abnormally high for age and circumstance rapid breathing whichis abnormally high for age and circumstance 1yr gt 60 1 2 yrs gt 40 2 5 yrs gt 35 5 12 yrs gt 30 gt 12 yrs gt 16 same source as tachycardia BCCD Vaccine 28 2010 4487 4498 Wheezing A whistling squeaking musical or puffing sound made by breathing out BCCD Vaccine 28 2010 4487 4498 Indrawing retractions Inward movement of the muscles between the ribs inter costal in the lower part of the neck supra clavicular or tracheal tug or below the chest sub costal The movements are usually a
3. USER GUIDE TC COMPLETION AND SUBMISSION OF THE AEFI REPORTS This guide was developed by the Vaccine Vigilance Working Group and the Public Health Agency of Canada CONTACT The Public Health Agency of Canada 130 Colonnade Road Ottawa Ontario K1A OK9 A L 6502A Telephone 613 954 5590 or 1 866 844 0018 Fax 613 954 9874 or 1 866 844 5331 E mail caefi 9 phac aspc gc ca PHAC 08 2011 TABLE OF CONTENTS ACKNOWLEDGEMENTS ACRONYMS AND ABBREVIATIONS A BACKGROUND B GUIDELINES ON HOW TO COMPLETE THE AEFI FORM SECTION 1 SECTION 2 SECTION 3 SECTION 4 SECTION 5 SECTION 6 SECTION 7 SECTION 8 SECTION 9 SECTION 10 SECTION 11 SECTION 12 ANNEX I ANNEX II Provincial and Regional Identifying Information IMPACT LIN Local Inventory Number Patient Identification Information at Time of Immunization and AEFI Onset Immunization Errors Previous AEFI Impact of AEFI Outcome and Level of Care Obtained Reporter Information AEFI Details Supplementary Information Recommendations for Further Immunization Follow up information for a subsequent dose of same vaccine s Where to send a completed AEFI report List of current vaccines N P m 12 12 14 15 24 24 24 26 27 ACKNOWLEDGEMENTS This adverse events following immunization AEFI user guide was developed by the Vaccine Vigilance Working group VVWG with the support of Vaccine Safety Section within the Centre for Im
4. Hib Infanrix IPV Quadracel Infanrix IPV Hib Pediacel Avaxim Avaxim Pediatric Havrix 1440 Havrix 720 Junior Vaqta Twinrix Twinrix Junior ViVAXIM Engerix B Engerix B Pediatric Recombivax HB ACT HIB Hiberix Liquid PedvaxHib Cervarix Gardasil MARKET AUTHORIZATION HOLDER PUBLIC HEALTH AGENCY OF CANADA 27 LIST OF CURRENT VACCINES con t VACCINE Influenza Inactivated Influenza Live attenuated Intranasal Influenza Thimerosal free Inactivated Poliomyelitis Japanese Encephalitis Meningococcal Conjugate Meningococcal Polysaccharide Measles Mumps and Rubella Measles Mumps Rubella and Varicella Pneumococcal Conjugate valent Pneumococcal Polysaccharide valent Rabies Rotavirus Tick borne Encephalitis Tetanus and diphtheria toxoids adsorbed Tetanus Toxoid reduced diphtheria toxoid and acellular pertussis Tetanus Toxoid reduced diphtheria toxoid and acellular pertussis combined with Inactivated poliomyelitis Tetanus and diphtheria toxoids adsorbed and Inactivated Poliomyelitis Typhoid Injection Typhoid Oral Varicella Yellow Fever Zoster 28 USER GUIDE AEFI REPORT FORM ABBREVIATION Men C ACYW 135 Men P ACYW 135 MMR MMRV Pneu C 7 Pneu C 10 Pneu C 13 Pneu P 23 Rab Rota Rota TBE Td Tdap Tdap IPV Td IPV Typh l Typh O Var YF TRADE NAME Fluviral
5. symptoms For each AEFI where a Brighton Collaboration Case Definition BCCD exists the most current published version of the case definition has been cited Time to onset interval and duration of signs and symptoms The time to onset interval and the duration of the signs and symptoms of the specified AEFI should be documented using the most appropriate time unit Days Hours or Minutes If the time to onset interval or the time to resolution is less than one 1 hour record in minutes f the time to onset interval or the time to resolution is greater than or equal to one 1 hour but less than one 1 day record in hours f the time to onset interval or the time to resolution is greater than or equal to one 1 day record in days SECTION 9A LOCAL REACTION AT OR NEAR VACCINATION SITE Any description of morphological or physiological change at or near the vaccination site BCCD Vaccine 26 2008 6800 6813 Indicate by choosing all that apply any local reactions at or near the vaccination site as described below Infected abscess A localized collection of pus in a cavity formed by the disintegration of tissue usually caused by microorganisms that invade the tissues Note presence of any of the following by ticking the appropriate box on the form erythema pain tenderness warmth spontaneous surgical drainage palpable fluctuance fluid collection shown by imaging technique lymphangitic streaking regional lympha
6. Vaxigrip Flumist Agriflu Fluad Influvac Intanza Imovax Polio IXIARO Meningitec Menjugate NeisVac C Menactra Menveo Menomune A C Y W 135 MMR II Priorix Priorix Tetra Prevnar Synflorix Prevnar 13 Pneumovax 23 Pneumo 23 Imovax Rabies RabAvert Rotarix RotaTeq FSME IMMUN Td Adsorbed Adacel Boostrix Adacel Polio Boostrix Polio Td Polio Adsorbed Typherix Typhim Vi Vivotif capsules Varilrix Varivax III YF Vax Zostavax MARKET AUTHORIZATION HOLDER ACRONYMS API Abbott Products Inc AZC AstraZeneca Canada Bax Baxter Corporation CV Crucell Vaccines Inc GSK Glaxo Kline Smith MF Merck Frosst NP Novartis Pharmaceuticals Canada Inc NVD Novartis Vaccines and Diagnostics Pfiz Pfizer Canada Inc Solv Solvay Pharma SP Sanofi Pasteur For additional information on each of the vaccines please refer to the Canadian National Immunization Guide at http www phac aspc gc ca publicat cig gci pdf cig gci 2006 e pdf PUBLIC HEALTH AGENCY OF CANADA 29
7. gc ca im ci rp eng php 26 USER GUIDE AEFI REPORT FORM ANNEX II LIST OF CURRENT VACCINES VACCINE Bacillus Calmette Gu rin Cholera E coli Oral Combined Diphtheria and Tetanus Toxoidc acellular Pertussis Combined Diphtheria and Tetanus Toxoids acellular Pertussis Hepatitis B recombinant Inactivated Poliomyelitis and adsorbed conjugated Haemophilus influenzae type b Combined Diphtheria and Tetanus Toxoids acellular Pertussis Hepatitis B recombinant Inactivated Poliomyelitis Haemophilus b conjugate vaccine reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine adsorbed Diphtheria and Tetanus Toxoids Acellular Pertussis vaccine adsorbed combined with Inactivated Poliomyelitis Diphtheria and Tetanus Toxoids and acellular Pertussis vaccine adsorbed combined with Inactivated Poliomyelitis vaccine and Haemophilus influenzae type b Hepatitis A Hepatitis A and B Hepatitis A Typhoid Hepatitis B Thimerosal free Haemophilus influenzae type b Human Papillomavirus Types 16 and 18 recombinant Quadrivalent Human Papillomavirus Types 6 11 16 18 recombinant ABBREVIATION BCG Chol Ecol O DTaP DTaP HB IPV Hib DTaP HB IPV DTaP Hib DTaP IPV DTaP IPV Hib HAHB HA Typh l HB TRADE NAME BCG Dukoral Infanrix Tripacel Tripacel Hybrid Infanrix hexa Pediarix Actacel ACTacel ACTacel Hybrid Infanrix
8. is always important to counsel vaccinees or their guardians regarding the possible occurrence of such reactions but there is no need to report such expected events unless they are more severe or more frequent than expected What type of AEFI should be reported AEFIs should be reported when the event Has a temporal association with a vaccine Has no other clear cause at the time of reporting A causal relationship between immunization and the event that follows does not need to be proven and submitting a report does not imply or establish causality Sometimes the vaccinee s medical history recent disease concurrent illness condition and or concomitant medication s can explain the event s Of particular interest are those AEFIs which Meet one or more of the seriousness criteria An adverse event that is life threatening or results in death requires hospitalization or prolongation of an existing hospitalization results in residual disability or causes congenital malformation Are unexpected regardless of seriousness An event that has either not been identified previously or one that has been identified previously but is at current being reported at an increased frequency For additional information regarding unexpected events please refer to the ICH Harmonised Tripartite Guideline E2D 2003 http www ich org fileadmin Public Web Site ICH Products Guidelines Efficacy E2D Step4 E2DGuideline pdf If there is any doubt as t
9. the Market Authorization Holder within 15 days of knowledge of their occurrence No other legal requirement for reporting AEFIs exists nationally Several provinces have enacted mandatory AEFI reporting requirements However overall reports are generally submitted on a voluntary basis by vaccine providers and other health care professionals The usual and preferred reporting flow is from local or regional health units to central provincial territorial immunization programs Reports are forwarded to PHAC electronically or in hard copy by the provinces and territories after all personal identifying information has been removed On occasion reports may be submitted directly to PHAC by travel health clinics pharmacists physicians or the general public To enhance timely detection and assessment of serious adverse events involving children PHAC funds an active pediatric hospital based surveillance system known as the Immunization Monitoring Program ACTive IMPACT AEFI reports completed by the IMPACT nurse monitors are sent to the appropriate provincial territorial jurisdiction as well as to PHAC directly Special numbering of the reports is done to avoid duplication What is done with AEFI reports at the provincial territorial level AEFI reports are received at the local regional level from multiple sources physicians nurses pharmacists public health IMPACT and the public Recommendations for future immunizations are usually made at the
10. AEFI Indicate the section of the AEFI report that the information applies to if applicable when recording information in section 10 SECTION 11 RECOMMENDATIONS FOR FURTHER IMMUNIZATION This section is to be completed by the health professional In some P Ts only the MOH or MD can provide recommendations for future immunizations In others RNs have been trained to provide the recommendations as well Indicate by choosing all that apply in section 11 your recommendations for the patient with regard to future vaccinations and specify additional information when requested A comments section has been added for your convenience however should you require additional space for your recommendation s please capture this information in section 10 Complete the reporter information section in full providing your full name and professional status MOH MHO Medical Officer of Health Medical Health Officer MD Medical Doctor RN Registered Nurse If your professional status is not listed describe under other In addition indicate a phone number where you can be reached and sign and date the AEFI form in the space provided SECTION 12 FOLLOW UP INFORMATION FOR A SUBSEQUENT DOSE OF SAME VACCINE S Note The information in this section is not collected by all provinces territories Complete section 12 when an individual who has previously experienced an AEFI following administration of a vaccine receives a subsequent dose of the same vaccine
11. EPORTER INFORMATION Complete the reporter information section in full including the reporter s first and last names a phone and fax contact number including extensions when applicable and the full mailing address of the institution setting centre Indicate the setting in which the reporter is located e g physician office public health clinic hospital or specify if other Sign and date the AEFI form in the space provided and specify your professional status e g MD Medical Doctor RN Registered Nurse or your affiliation e g IMPACT by choosing one of the options provided If your professional status or affiliation is not listed specify beside other 14 USER GUIDE AEFI REPORT FORM SECTION 9 AEFI DETAILS Indicate the details of the AEFI being reported by checking all that apply All additional pertinent details e g results of medical investigations laboratory test treatment etc should be provided in section 10 For convenience and consistency high level definitions have been provided for most events listed in section 9 However if an asterisk is present beside an AEFI term this specific event should be diagnosed by a physician If not sufficient information should be provided in section 10 to support the selection s For all AEFIs indicate the time to onset or interval time from immunization to onset of first symptom sign and the duration time from onset of first symptom sign to resolution of all of signs and
12. action Burning Sensation of stinging or heat not necessarily accompanied by redness or physical signs of skin irritation Indicate site of reaction Formication Sensation of insects crawling over or within the skin Indicate site of reaction Other Specify Specify in section 10 Fever gt 38 0 C Endogenous elevation of at least one body temperature regardless of measurement device anatomic site age or environmental conditions BCCD Vaccine 22 2004 551 556 Serious adverse event Is any untoward medical occurrence that at any dose that results in death is life threatening requires inpatient hospitalisation or results in prolongation of existing hospitalisation results in persistent or significant disability incapacity is a congenital anomaly birth defect or is a medically important event or reaction Unexpected adverse event s an event that has either not been identified previously or one that has been identified previously but is at current being reported at an increased frequency For additional information regarding unexpected events please refer to the CH Harmonised Tripartite Guideline E2D 2003 PUBLIC HEALTH AGENCY OF CANADA 23 SECTION 10 SUPPLEMENTARY INFORMATION Section 10 should be used to capture information that is pertinent to the AEFI but that has not been fully captured elsewhere or that needs further explanation Document all known details of any investigations or treatments for the recorded
13. all investigations conducted in section 10 PUBLIC HEALTH AGENCY OF CANADA 13 Emergency visit The patient was seen by a health care professional for an emergency visit for the assessment and or treatment of the reported AEFI Please note that emergency visits are not considered admission to hospital and therefore admission and discharge dates are not required Document all investigations conducted in section 10 Required hospitalization The patient was hospitalized for the assessment and or treatment of the reported AEFI Indicate the number of days the patient was hospitalized the date of admission and the date of discharge Document all investigations conducted in section 10 Resulted in prolongation of existing hospitalization If a patient was already in hospital at the time of immunization and the AEFI resulted in a longer hospital stay please check Resulted in prolongation of existing hospitalization and indicate the number of additional days stayed in hospital as a result of the AEFI Also indicate the date of hospital admission and discharge for the entire period of hospitalization if known Document all investigations conducted in section 10 SECTION 7D TREATMENT RECEIVED Indicate whether the patient received any treatment including self treatment for the reported AEFI by choosing yes no or unknown Provide details of all treatments received following the onset of the AEFI in section 10 when applicable SECTION 8 R
14. allowing hoarseness or sore throat that starts within 24 hrs of vaccination with or without facial oedema Other allergic event An event considered by reporter to be allergic in nature but not anaphylaxis or ORS Check all symptoms signs in section 9b that were present and use section 10 for any additional details For a chosen event describe the signs and symptoms by checking all that apply from the list below Provide all additional details in section 10 SKIN MUCOSAL Choose all that apply from the list provided below and indicate the site of reaction Urticaria hives Localized redness of superficial layers of skin that is itchy raised sharply demarcated and transient that is skin changes at any location are usually present for less than 12 hours Specify site of reaction BCCD Vaccine 28 2010 4487 4498 PUBLIC HEALTH AGENCY OF CANADA 17 Erythema Abnormal redness of the skin without any raised skin lesions Specify site of reaction BCCD Vaccine 28 2010 4487 4498 Pruritus An unpleasant skin sensation that provokes a desire to rub and or scratch to obtain relief Specify site of reaction Prickle sensation Tingling or smarting stinging sensation Specify site of reaction Rash A morphologically described change in the appearance of the skin or mucosa that occurs in the context of and in conjunction with an emerging allergic event that consists of one or more clearly identified primary lesion s
15. angemino 2 USER GUIDE AEFI REPORT FORM LIAISON MEMBERS IMPACT Heather Samson CSC Richard Johnson DND Fiann Crane James Anderson FNIHB Gina Dumaresq Vicki MacMurdo Marie Nikolaeva Jill Williams BGTD HC Joanne Xiong Farid Hindieh CANADIAN IMMUNIZATION REGISTRY NETWORK CIRN PHAC Lisa Belzak RCMP Thomas Turnbull ACRONYMS AND ABBREVIATIONS AEFI Adverse Events Following Immunization BGTD Biologics Genetics and Therapies Directorate BCCD Brighton Collaboration Case Definition CAEFISS Canadian Adverse Events Following Immunization Surveillance System CIC Canadian Immunization Committee CIRID Centre for Immunization and respiratory Infectious Diseases CIRN Canadian Immunization Registry Network csc Corrections Services Canada DND Department of National Defence F P T Federal Provincial Territorial FNIHB First Nations and Inuit Health Branch HC Health Canada ICH International Conference on harmonization IMPACT Immunization Monitoring Program ACTive IMPACT LIN IMPACT Local Inventory Number LCDC Laboratory Centre for Disease Control MHPD Marketed Health Products Directorate NIS National Immunization Strategy PHAC Public Health Agency of Canada RCMP Royal Canadian Mounted Police WHO World Health Organization VVWG Vaccine Vigilance Working Group PUBLIC HEALTH AGENCY OF CANADA 3 A BACKGROUND When did National Vaccine Post Marketing Surveillance begin in Canada National monitoring o
16. c and provide all Gram stain culture results BCCD Vaccine 25 2007 5821 5838 Microbial results Tests that are carried out to identify organisms that can cause disease or infection Lymphangitic streaking Red streaks below the skin s surface that follows the path of lymph draining from the site of infection via lymphatic vessels to regional lymph nodes Regional lymphadenopathy Abnormal enlargement of the lymph nodes closest to the vaccination site e g inguinal adenopathy when associated with an IM vaccination in the thigh axillary adenopathy associated with an IM vaccination in the deltoid etc SECTION 9B ALLERGIC AND ALLERGIC LIKE EVENTS Choose one of the following events below Anaphylaxis An acute hypersensitivity reaction with multi organ system involvement that can present as or rapidly progress to a severe life threatening reaction Check all applicable signs symptoms referable to skin mucosal cardio vascular respiratory and or gastrointestinal systems that were observed during the course of the event and use section 10 for additional details Provide specific measurements where available for pulse respiratory rate and blood pressure and indicate for each if before or after treatment with epinephrine if given BCCD Vaccine 25 2007 5675 5684 Oculo Respiratory Syndrome ORS The presence of bilateral red eyes plus 21 respiratory symptom cough wheeze chest tightness difficulty breathing difficulty sw
17. denopathy and microbial results if fever present check box in section 9d use section 10 for additional details If treated with antibiotics indicate if resolution improvement was temporally related to treatment BCCD Vaccine 25 2007 5821 5838 Sterile abscess An abscess whose contents are not caused by pyogenic bacteria Note presence of any of the following by ticking the appropriate box on the form erythema pain tenderness warmth spontaneous surgical drainage palpable fluctuance fluid collection shown by imaging technique lymphangitic streaking regional lymphadenopathy and microbial results if fever present check box in section 9d use section 10 for additional details If treated with antibiotics indicate if resolution improvement was temporally related to treatment BCCD Vaccine 25 2007 5821 5838 PUBLIC HEALTH AGENCY OF CANADA 15 Cellulitis A diffuse inflammatory process within solid tissues characterized by edema redness pain and interference with function usually caused by infection with streptococci staphylococci or similar organisms Note presence of any of the following by ticking the appropriate box on the form swelling pain tenderness erythema warmth induration lymphangitic streaking regional lymphadenopathy and microbial results if fever present check box in section 9d use section 10 for additional details BCCD Vaccine 25 2007 5803 5820 Nodule Discrete well demarcated soft tissue mas
18. ent Identification Information Provide the patient s first and last name health number if applicable address of usual residence including postal code with the understanding that this address might be in a different province territory than where the vaccine s was administered or where the AEFI is being reported and a telephone number either residential or business or both where the patient can be reached Information Source If the source of the information for the AEFI report is a parent or another care provider provide their name relation to the patient and contact information including their full mailing address and phone number where they can be reached if it is different from the patient s 8 USER GUIDE AEFI REPORT FORM SECTION 4 INFORMATION AT TIME OF IMMUNIZATION AND AEFI ONSET SECTION 4A AT TIME OF IMMUNIZATION Provide all information as described below in the space provided on the form Province Territory of immunization Indicate the province or territory where the immunization was received This may be different from the patient s province or territory of residence and or where the AEFI is being reported If the vaccine was administered outside of Canada indicate the country in which the vaccine s was were administered in the space to capture province territory and also comment if it was received at a Canadian operated clinic in that country Date and time vaccine administered Indicate the date and time o
19. eries BCCD Vaccine 28 2010 4487 4498 Capillary refill time gt 3 sec Capillary refill time is the time required for the normal skin colour to reappear after a blanching pressure is applied It is usually performed by pressing on the nail bed to cause blanching and then counting the time it takes for the blood to return to the tissue indicated by a pink colour returning to the nail Normally it is lt 3 seconds BCCD Vaccine 28 2010 4487 4498 Tachycardia A heart rate that is abnormally high for age and circumstance In beats per minute 1year old 2160 1 2 yrs 2150 2 5 yrs 2140 5 12 yrs 2120 gt 12 yrs 2100 BCCD Vaccine 28 2010 4487 4498 Citation for norms is Don amp Roberton Physical examination in Practical Pediatrics 2007 6th ed Decreased consciousness Reduced alertness or awareness of the outside world Indicate duration of the event 18 USER GUIDE AEFI REPORT FORM Loss of consciousness Total suspension of conscious relationship with the outside world demonstrated by the inability to perceive and to respond to verbal visual and painful stimulus Indicate duration of the event BCCD Vaccine 28 2010 4487 4498 Decreased consciousness Reduced alertness or awareness of the outside world Indicate duration of the event Loss of consciousness Total unresponsiveness suspension of conscious relationship with the outside world inability to perceive and to respond Indicate duration of the event
20. ersonal health information you may contact the privacy representatives at your local public health office Alternatively the Privacy Act can be accessed online at the following address http laws justice gc ca en P 21 index html Where and when can copies of the AEFI report form be obtained The form itself along with information regarding its implementation in Canada will be published on the Web at http www phac aspc gc ca im aefi form e html In addition the form can be viewed in the Compendium of Pharmaceuticals and Specialties and hard copies can be obtained from local public health units hospitals clinics including travel clinics etc 6 USER GUIDE AEFI REPORT FORM B GUIDELINES ON HOW TO COMPLETE THE AEFI FORM This guide is intended to be used when completing the Report of AEFI for submission to provincial and territorial authorities as well as to PHAC Its purpose is to provide assistance on how to accurately complete the form It is not intended to guide treatment Treatment of all AEFIs should proceed as appropriate prior to completing the AEFI form Following the immediate care of the vaccine recipient the AEFI form can be completed with all available information Given the variation in practice between each of the provinces and territories sections of the form may not be applicable to all settings If in doubt please contact your local public health unit REPORT OF ADVERSE EVENTS FOLLOWING IMMUNIZATION AEFI Com
21. f adverse events dates back to 1965 and was the responsibility of the Laboratory Centre for Disease Control LCDC for vaccines as well as for drugs LCDC s responsibility was limited to human preventive vaccines in 1987 That same year a computerized database was created to collate adverse event reports from all sources The Canadian Adverse Event Following Immunization Surveillance System CAEFISS is currently overseen by the Vaccine Safety Section in the Surveillance and Outbreak Response Division within the Centre for Immunization and Respiratory Infectious Diseases CIRID of the Public Health Agency of Canada PHAC What is an Adverse Event Following Immunization AEFI An AEFI is any untoward medical occurrence in a vaccinee which follows immunization and which does not necessarily have a causal relationship with the administration of the vaccine based on International Conference on Harmonisation ICH Topic E6 definition The adverse event may be any unfavourable and or unintended sign abnormal laboratory finding symptom or disease Should all AEFIs be reported No During their development vaccines undergo rigorous testing for safety and efficacy During these pre licensure trials efforts are made to capture every single adverse event that follows immunization By the time a vaccine is authorized for marketing the safety profile for common adverse events such as inflammation at the vaccination site or mild fever is well known It
22. f vaccine administration remembering to specify if the vaccine was administrated in the am or pm by circling the appropriate descriptor If complete information is unknown provide as much detail as is available e g month and or year Date of birth Indicate the patient s date of birth in the space provided If the complete date is unknown please provide as much information as is available e g month and or year Age Indicate the patient s age at the time of immunization Use days for infant s aged less than 1 week weeks for infants aged less than 1 month months for infants aged less than 1 year and years thereafter Fractions should be used as appropriate e g 6 weeks should be captured as 1 5 months 15 months should be captured as 1 25 years If the patient s exact age is unknown please estimate patient s age Sex Indicate the patient s gender e g male or female If the gender is unknown or ambiguous please choose other SECTION 4B MEDICAL HISTORY UP TO THE TIME OF AEFI ONSET Indicate the patient s medical history prior to the time of AEFI onset by choosing all that apply from the list provided below Provide all additional details when available in section 10 Concomitant medication s Provide the name of all medications including prescription over the counter and herbal supplements which the patient had been taking immediately prior to the time of AEFI onset including those taken only as needed in sectio
23. g the national reporting form And for the first time the working group also developed this user guide as a technical reference to provide assistance on how to accurately complete the new national AEFI reporting form The following members of the VVWG contributed to the development of this AEFI user guide ALBERTA Elaine Sartison Roxanne Hamm Cindy Dribnenki Pamela Miller Afsheen Remtulla BRITISH COLUMBIA Amy Schneeberg Samara David Cheryl McIntyre Maureen Anderson Monika Naus MANITOBA Michelle Long Alexandra Henteleff Kathleen Messner Janique Beaudette Jennifer McTaggart Eileen McQuade NEW BRUNSWICK Holy Akwar Lynn Cochrane Elena Buchatskaya NEWFOUNDLAND AND LABRADOR Cathy O Keefe Faith Stratton Gillian Butler NOVA SCOTIA Ann Coombs Gertrude Oliver Kim McGill NORTHWEST TERRITORIES Cheryl Case NUNAVUT Carolina Palacios Chiebere Ogbuneke Janet Brewster ONTARIO Sharon Dolman Joanne Rey PRINCE EDWARD ISLAND Anne Neatby QUEBEC Louise Ringuette Evelyn Toth Monique Landry SASKATCHEWAN Tania Diener Loretta van Haarlem Rosalie Tuchscherer YUKON Colleen Helmsley Joie McBryan Donna Marshall PUBLIC HEALTH AGENCY OF CANADA 1 VACCINE SAFETY SECTION PHAC Nooshin Ahmandipour Nadine Abboud Barbara Law Robert Pless Helen Anyoti Tracy Freeland Julie Lafleche Jean Nkanza Saundra Houle Christine Loiselle Christa Doherty Wikke Walop Chris Sangook Kim Wendy Patterson Nicole S
24. king firmness and strength no muscle tone Pallor Unnatural lack of colour in the skin abnormal loss of colour from normal skin Cyanosis A dark bluish or purplish discolouration of the skin and mucous membrane due to lack of oxygen of the blood BCCD Vaccine 28 2010 4487 4498 Decreased responsiveness Change in usual responsiveness to sensory stimuli Unresponsiveness Lack of responsiveness to sensory stimuli Persistent crying Crying which is continuous unaltered and lasts for 3 or more hours BCCD Vaccine 28 2010 4487 4498 Intussusception The prolapse of one part of the intestine into the lumen of an immediately adjacent part causing partial or complete intestinal obstruction and should be diagnosed by a physician Provide all pertinent details Arthritis Inflammation of the joint s Choose all that apply to the reported AEFI from the list provided and described below Joint redness Redness of the skin at the joint s Joint warm to touch Sensation of increase in temperature above body temperature at the joint s to touch Joint swelling An abnormal increase in the size of the joint s Inflammatory changes in synovial fluid Laboratory synovial or joint fluid analysis indicative of inflammatory response 22 USER GUIDE AEFI REPORT FORM Parotitis Swelling with pain and or tenderness of parotid gland s Previous Cdn def n CCDR 1995 21 13 page F 8 Rash A skin or mucosal change either ne
25. l and Territorial stakeholders as well as vaccine manufacturers key non governmental organizations and expert scientific advisors The purpose of the workshop was to develop a framework for a coordinated approach to optimize vaccine post marketing surveillance in Canada At the workshop post marketing surveillance for vaccines was defined as the coordinated structured systematic ongoing collection of data and their subsequent epidemiologic analysis and dissemination It was recommended that passive surveillance be centrally aggregated with input by public health and physicians and supplemented by active surveillance activities The first national vaccine adverse event report form was developed through a federal provincial territorial collaborative process during the year following the 1990 workshop It was agreed that the form would list several adverse events considered to be of public health importance Reporters could check off the specific event and add written detail There was also an other box so that any adverse event of concern to a reporter could be reported It was agreed that all Provincial Territorial AEFI forms would be based on the national form with nothing deleted but items could be added if they were of specific interest to a region Case definitions were also developed although many simply specified that a physician diagnosis would be required In 1996 the AEFI report form was revised and it is that version which has been in use un
26. l letters and numbers This information is essential for conducting future risk assessments Dose number Provide the number in series 1 2 3 4 or 5 or indicate if known For the Influenza vaccine unless a patient receives two doses in one season the dose should be recorded as one Dosage unit Indicate the dose e g 0 5 and unit e g ml for each vaccine Route Specify the route of administration for each vaccine received Abbreviations as described below are acceptable Intradermal ID Intramuscular IM Subcutaneous SC ntranasal IN Oral PO Other please specify no abbreviations 10 USER GUIDE AEFI REPORT FORM Site Indicate the site of injection for each vaccine administered Abbreviations as described below are acceptable Left arm LA Right arm RA Arm Arm Left leg LL Right leg RL Leg Leg Left gluteal LG Right gluteal RG Gluteal Glut Mouth Mo Nose Nose Multiple sites MS Other please specify no abbreviations SECTION 5 IMMUNIZATION ERRORS Indicate whether the AEFI has followed an incorrect immunization an immunization error program error etc by choosing no unknown or wes If yes please indicate all that apply in section 5 by checking the box next to the situation that most closely reflects the error as described below and provide all known details in section 10 Given outside the recommended age limits The vaccine was adminis
27. ld be left blank if it does not apply to your locale PUBLIC HEALTH AGENCY OF CANADA 7 SECTION 2 IMPACT LIN LOCAL INVENTORY NUMBER IMPACT is a paediatric hospital based national active surveillance network for adverse events following immunization vaccine failures and selected infectious diseases in children IMPACT is administered by the Canadian Paediatric Society with funding from the Public Health Agency of Canada IMPACT reports the more serious hospitalized cases and selected outpatient visits for adverse events and vaccine preventable diseases An IMPACT Local Inventory Number LIN is to be assigned by the IMPACT Nurse monitor when an AEFI report is generated from an IMPACT centre The IMPACT LIN should be marked on the top of the first three 3 pages of the AEFI form Please leave this section blank if it does not apply to you e g if you are not an IMPACT hospital centre The IMPACT LIN is used to link the initial provincial territorial AEFI report to the IMPACT report Once both reports have been received the data contained on the AEFI form and the IMPACT forms are merged in the CAEFISS database SECTION 3 PATIENT IDENTIFICATION This section is intended to capture patient information for use by regional and or provincial territorial health officials This information is kept confidential and should not be forwarded to PHAC This section should be completed in keeping with provincial territorial guidelines Pati
28. local regional level In provinces and territories with electronic systems the data are entered at the local health unit or regional health authority level and are then shared with the province territory The AEFI data are analyzed and disseminated at the provincial territorial level to provincial territorial stakeholders Data are then sent electronically to PHAC Those provinces and territories with paper based systems either fax this information directly to PHAC and or enter the information in a provincial database What is done with AEFI reports at the national level Personnel in the Vaccine Safety Section screen all submitted reports ensure they are entered into the CAEFI database and coded using standard international coding terminology Reports are monitored with special attention to serious or unusual events that could signal a concern regarding vaccine safety Canadian data are periodically forwarded on to the World Health Organization WHO International Drug Monitoring Program in Uppsala Sweden where global data are analyzed for any evidence of safety concerns PUBLIC HEALTH AGENCY OF CANADA 5 When why and how was a national AEFI report form first developed Critical groundwork for the current CAEFISS system was done at the Post Marketing Surveillance of Vaccine Associated Adverse Events workshop in 1990 sponsored by Health Canada s Bureau of Communicable Disease CDWR 1991 Vol 17 19 97 98 and attended by Federal Provincia
29. macule papule vesicle nodule bulla cyst plaque pustule and or secondary skin change s scaling atrophy ulcer fissure excoriation BCCD Vaccine 25 2007 5697 5706 Angioedema Areas of deeper swelling of the skin and or mucosal tissues in either single or multiple sites which may not be well circumscribed and is usually not itchy Reported symptoms of swelling of the lip or swelling of the tongue or throat should not be documented as angioedema unless there is visible skin or mucosal swelling Check all of the locations where angioedema is seen on the AEFI report form and if other is checked provide details BCCD Vaccine 28 2010 4487 4498 Red eyes bilateral or unilateral Redness of the white s of the eye s sclera BCCD Vaccine 28 2010 4487 4498 Itchy eyes A sensation that provokes the desire to rub and or scratch to obtain relief BCCD Vaccine 28 2010 4487 4498 CARDIO VASCULAR Choose all that apply from the list provided below Measured hypotension An abnormally low blood pressure and documented by appropriate measurement Infants and children age specific systolic BP of lt 3 5 percentile or greater than a 30 decrease from that person s baseline Adults systolic BP of 90mm Hg or greater than 30 decrease from that person s baseline BCCD Vaccine 28 2010 4487 4498 Decreased central pulse volume Absent or decreased pulse in one of the following vessels carotid brachial or femoral art
30. may not be remembered sometimes with light twitching fluttering eyelids etc Myoclonic Involuntary shock like contractions irregular in rhythm and amplitude followed by relaxation of a muscle or a group of muscles Partial Seizure that originates from a localized area of the cerebral cortex and involves neurologic symptoms specific to the affected area of the brain PUBLIC HEALTH AGENCY OF CANADA 21 Previous history of seizures Individuals who have had seizures at anytime prior to this vaccination Febrile With fever of 38 0 C Afebrile Without fever Unknown type It is unknown if the seizure was febrile or afebrile Provide all known details SECTION 9D OTHER EVENTS For a selected event describe the signs and symptoms by checking all that apply Provide all additional details in section 10 Hypotonic Hyporesponsive Episode age 2 years Sudden onset in a child aged less than two years of two to three of limpness change in skin colour pallor or cyanosis and or reduced responsiveness Check each appropriate box in section 9d and use section 10 to indicate if muscle tone responsiveness or skin colour is known to be normal Do not use the HHE checkbox if the patient is two 2 years of age or older instead please check Other severe or unusual events not listed above and describe the episode BCCD Vaccine 22 2004 563 568 Choose all that apply to the reported AEFI from the list provided below Limpness Lac
31. munization and Respiratory Infectious Diseases CIRID Public Health Agency of Canada PHAC The VVWG is a federal provincial territorial working group with representations from all provinces and territories including Immunization Monitoring Program ACTive IMPACT Health Canada s regulators including the Biologics and Genetic Therapies Directorate BGTD and the Marketed Health Products directorate MHPD First Nations and Inuit Health Branch FNIHB Correctional Services Canada CSC Department of National Defense DND the Royal Canadian Mounted police RCMP and PHAC The VVWG reports to the Canadian Immunization Committee The VVWG was created in keeping with the National Immunization Strategy NIS which highlighted the significance of strengthening and expanding vaccine safety surveillance activities and improving the system of public health response within Canada The VVWG focus is mainly on developing national guidelines and procedures for monitoring and management of AEFIs serving as a national forum to identify share and promote best practices regarding vaccine safety including training in AEFI reporting and management and providing a national network of safety sentinels that can rapidly share and disseminate information to appropriate stakeholders regarding emerging vaccine safety issues or signals In 2004 as part of the effort to further improve and harmonize the reporting of AEFIs in Canada VVWG took on the task of revisin
32. n 10 When available provide the dose frequency route of administration and reason for taking each concomitant medication Known medical conditions allergies Indicate all known medical conditions and or allergies that the patient experienced prior to the time of immunization with a corresponding date of onset in section 10 If an exact date of onset is unknown please provide the greatest amount of detail that is available e g year of onset Include any conditions for which the patient is taking a concomitant medication including chronic conditions with intermittent symptoms such as migraine headaches Also specify in this section if the subject was pregnant at the time of immunization PUBLIC HEALTH AGENCY OF CANADA 9 Acute illness injury Indicate if the patient had an acute illness and or injury immediately prior to the time of immunization and specify a corresponding date of onset in section 10 if known If an exact date of onset is unknown provide the greatest amount of detail that is available e g month and or year of onset SECTION 4 IMMUNIZING AGENT Provide all information pertaining to the immunizing agent s administered just prior to the onset of the reported AEFI s There is space to record five 5 immunizing agents in section 4c however if more than five 5 were administered simultaneously record the additional vaccines in section 10 Note that PHAC collects AEFI reports following the administration of acti
33. nsiveness to environmental stimuli Lethargy A general state of sluggishness listless or uninterested with being tired and having difficulty concentrating and doing simple tasks Personality changes lasting 24 hours Change in personal behaviour response patterns Focal or multifocal neurologic sign s Neurological impairment which is caused by a lesion in one particular focus or many foci of the central nervous system 20 USER GUIDE AEFI REPORT FORM Fever gt 38 0 C Endogenous elevation of at least one body temperature regardless of measurement device anatomic site age or environmental conditions BCCD Vaccine 22 2004 551 556 CSF Cerebral Spinal Fluid abnormality Alteration in normal CSF visual appearance measured hydrostatic pressure chemistry protein sugar and or cellular content white blood cells red blood cells as well as Gram stain routine bacterial culture results or other tests for presence of microbes EEG Electroencephalography abnormality Abnormal EEG as interpreted by a qualified health professional EMG Electromyography abnormality Abnormal skeletal EMG as interpreted by a qualified health professional Neuroimaging abnormality Abnormal results of any test used to detect anomalies or trace pathways of nerve activity in the central nervous system includes Computed Tomography CT scans Magnetic Resonance Imaging MRI Positron Emission Tomography PET scans Brain spinal cord hist
34. o whether or not an event should be reported a conservative approach should be taken and the event should be reported 4 USER GUIDE AEFI REPORT FORM Of Note PHAC collects AEFI reports following the administration of active immunizing agents vaccines In comparison Health Canada HC collects case reports of adverse events following the administration of therapeutic passive and diagnostic agents When an adverse event follows the administration of an active immunizing agent e g vaccine that is administered simultaneously with a passive immunizing agent e g immune globulin and or a diagnostic agent e g tuberculin skin test complete the AEFI Report form Provide the name of the active immunizing agent in addition to the passive immunizing agent and or diagnostic agent in section 4c and follow the established procedures for reporting an AEFI in your province This information will subsequently be forwarded to PHAC and to HC Alternatively if no active immunizing agent vaccine has been administered an AEFI Report form should not be completed Instead please follow the established procedures in your province for reporting an adverse drug reaction to HC e g completion of the Canada Vigilance Reporting Form Who reports AEFIs AEFI reports originate from multiple sources in Canada Vaccine manufacturers are required by law Food and Drugs Act and Regulations to report to PHAC all serious AEFIs with vaccines for which they are
35. ologic events Provide all additional details in section 10 Meningitis Should be diagnosed by a physician Check all applicable 9c boxes and use section 10 to record all additional pertinent clinical details and test results BCCD Vaccine 25 2007 5793 5802 Encephalopathy Encephalitis Should be diagnosed by a physician Check all applicable 9c boxes and use section 10 to record all additional pertinent clinical details and test results BCCD Vaccine 25 2007 5771 5792 Guillain Barre Syndrome Should be diagnosed by a physician Check all applicable 9c boxes and use section 10 to record all additional pertinent clinical details and test results especially Electromyograph EMG and or Lumbar Puncture LP BCCD Vaccine 29 2011 599 612 Bell s Palsy Should be diagnosed by a physician Provide any pertinent details Other paralysis Should be diagnosed by a physician Provide all pertinent details Seizure s Sudden loss of consciousness in conjunction with involuntary generalized motor manifestations BCCD Vaccine 22 2004 557 562 Other neurologic diagnosis Specify and provide all details Indicate all signs symptoms and test results relating to the reported neurologic event by choosing all that apply from the list below and provide a detailed description in section 10 Depressed altered level of consciousness Impairment of the ability to maintain awareness of self and environment combined with markedly reduced respo
36. opathologic abnormality Microscopic changes of the diseased brain spinal cord tissues Abnormalities seen on routine and or electron microscopy by qualified health professionals using appropriately prepared e g using special stains tissue samples from brain and or spinal cord SEIZURE DETAILS Check all that apply and record additional details in section 10 Indicate if the event was witnessed by a health care professional by choosing yes or no unknown Witnessed by healthcare professional A healthcare professional e g doctor nurse etc observed the seizure Sudden loss of consciousness Sudden total unresponsiveness suspension of conscious relationship with the outside world inability to perceive and respond If Yes indicate duration of the event Generalized Bilateral with more than minimal muscle involvement Tonic Sustained increase in muscle contraction lasting a few seconds to minutes Clonic Sudden brief 100 milliseconds involuntary contractions of the same muscle groups regularly repetitive at a frequency of about 2 to 3 contractions second Tonic clonic A sequence consisting of a tonic followed by a clonic phase Atonic Sudden loss of tone in postural muscles often pre ceded by a myoclonic jerk and precipitated by hyperventilation in the absence of Hypotonic Hyporesponsive Episode syncope or myoclonic jerks Absence The occurrence of an abrupt transient loss of impairment of consciousness which
37. phologically described change in the appearance of the skin or mucosa at or near vaccination site that consists of one or more clearly identified primary lesion s macule papule vesicle nodule bulla cyst plaque pustule and or secondary skin change s scaling atrophy ulcer fissure excoriation BCCD Vaccine 25 2007 5697 5706 Largest diameter of vaccination site reaction Indicate the diameter in centimetres of the largest vaccination site reaction that is present Site s of reaction Site s of the local reaction being reported if known Left arm LA Right arm RA Arm Arm Left leg LL Right leg RL Leg Leg Left gluteal LG Right gluteal RG Gluteal Glut Mouth Mo Nose Nose Multiple sites MS if Other please specify 16 USER GUIDE AEFI REPORT FORM Palpable fluctuance Wavelike motion on palpation due to presence of liquid content Fluid collection shown by imaging technique An imaging device is used in the detection of fluid collection e g ultrasound Magnetic Resonance Imaging MRI and or X ray Spontaneous drainage Draining of fluid from a site without intervention When available describe drainage material purulent or non purulent bloody etc and provide all Gram stain culture results Surgical drainage Withdrawal of fluids from the site through needle aspiration or incision which could be complete or partial When available describe drainage material purulent or non purulent bloody et
38. plete each section of the AEFI form as follows On the top right hand corner Indicate whether the AEFI report being submitted is an INITIAL or a FOLLOW UP report For all Follow up reports provide the UNIQUE EPISODE NUMBER and or REGION NUMBER of the initial report SECTION 1 PROVINCIAL AND REGIONAL IDENTIFYING INFORMATION SECTION 1A UNIQUE EPISODE NUMBER A unique episode number is to be assigned to each AEFI report In provinces territories that use electronic reporting systems this number may be automatically generated by the system In provinces territories that do no use electronic reporting systems this number should only be filled in by those persons who are authorized to assign the number at provincial territorial health authorities e g provincial territorial health professionals and or officials The unique episode number should be marked on the top of the first three 3 pages of the AEFI form as an identifier to link the pages together If you are not authorized to assign this number please leave this field blank SECTION 1B REGION NUMBER A region number that corresponds to a given health unit should be entered for those regions that have one The region number the number that corresponds to a given health unit should be marked on the top of the first three 3 pages of the AEFI form as an identifier to link the pages together This number should only be filled in by those persons who are authorized to assign it and shou
39. s or lump at the vaccination site that has a firm texture and is not accompanied by erythema warmth or abscess formation BCCD Vaccine 22 2004 575 585 Reaction crosses joint Reaction extending past at least one joint adjacent to the site of vaccine administration Lymphadenitis Inflammation of one or more lymph nodes usually caused by a primary focus of infection elsewhere in the body Other Specify all details of the vaccination site reaction in section 10 that are not already captured in section 9a above Examples of other local reactions that may be reported here include necrosis papule etc For all local reactions at or near the vaccination site describe the signs and symptoms by checking all that apply from the list below Provide any additional details in section 10 Swelling Visible enlargement of the vaccinated limb that is assessed by any person with or without objective measurement BCCD Vaccine 25 2007 5858 5874 Pain An unpleasant sensation occurring in varying degrees of severity that could be described as discomfort distress or agony Tenderness Abnormal sensitivity to touch or release of pressure Erythema Abnormal redness of the skin Warmth A sensation perception of an increase in temperature Induration Palpable thickening firmness or hardening of soft tissue subcutaneous tissue fat fascia or muscle that is assessed by a health care provider BCCD Vaccine 25 2007 5839 5857 Rash A mor
40. s reported by the patient in relation to their daily activities e g work exercise social commitments etc Interfered with but did not prevent daily activities Moderate change is reported by the patient in relation to their daily activities e g interfered with work exercise and or social commitments Prevented daily activities Significant change is reported by the patient in relation to their daily activities e g prevented work exercise and or social commitments 12 USER GUIDE AEFI REPORT FORM For young children e g infants and toddlers indicate the highest perceived impact of the AEFI on their daily activities as assessed by the child s parent caregiver according to the following Did not interfere with daily activities No change or only minimal change is observed in the child s daily patterns and or habits e g eating sleeping playing etc Interfered with but did not prevent daily activities Moderate change is observed in the child s daily patterns and or habits e g reduced appetite disrupted sleep disrupted play etc Prevented daily activities Significant change is observed in the child s daily patterns and or habits e g not eating not sleeping not playing etc SECTION 7B OUTCOME AT TIME OF REPORT Indicate the outcome of the AEFI at the time of completion of the report by choosing one of the provided responses in section 7b If the patient is not yet recovered provide all available de
41. sign of difficulty with breathing BCCD Vaccine 28 2010 4487 4498 Grunting A sudden and short noise with each breath when breathing out BCCD Vaccine 28 2010 4487 4498 Cyanosis A dark bluish or purplish discolouration of the skin and mucous membrane due to lack of oxygen in the blood BCCD Vaccine 28 2010 4487 4498 Sore throat Discomfort or pain in the throat Difficulty swallowing Sensation or feeling of difficulty in the passage of solids and liquids down to the stomach Difficulty breathing Sensation of difficult uncomfortable breathing or a feeling of not getting enough air Chest tightness Inability or perception of not being able to move air in or out of the lungs PUBLIC HEALTH AGENCY OF CANADA 19 GASTROINTESTINAL Choose all that apply from the list provided below Diarrhea Loose and or watery stool which may occur more frequently than usual Please provide details BCCD Vaccine 28 2010 4487 4498 Abdominal pain Sensation of discomfort or pain in the abdominal region BCCD Vaccine 28 2010 4487 4498 Nausea An unpleasant sensation vaguely referred to the upper abdominal region and the abdomen with a tendency to vomit BCCD Vaccine 28 2010 4487 4498 Vomiting The reflex act of ejecting the contents of the stomach through the mouth Provide details BCCD Vaccine 28 2010 4487 4498 SECTION 96 NEUROLOGIC EVENTS Indicate by choosing all that apply from the list provided all neur
42. tails in section 10 and provide updates as they become available Similarly should the event result in permanent disability and or incapacity or death provide all available details in section 10 When completing section 7b provide the information as outlined below Death Patient died record the corresponding date of death in the space provided Permanent disability incapacity An injury which impairs the physical and or mental ability of a person to perform his her normal work or non occupational activities supposedly for the remainder of his her life Not yet recovered Residual signs and or symptoms remain at the time of the report Fully recovered All signs and symptoms have resolved Unknown The outcome of the AEFI is unknown or unclear SECTION 76 HIGHEST LEVEL OF CARE OBTAINED Indicate the highest level of care obtained for the reported AEFI by choosing one of the provided options in section 7c described in detail below Unknown It is unknown if the patient received care for the reported AEFI None No care was received for the reported AEFI Telephone advice from a health professional The patient received telephone advice from a health care professional e g nurse nurse practitioner physician etc regarding the reported AEFI Non urgent visit The patient was seen by a health care professional e g at a physician s office or walk in clinic for the assessment and or treatment of the reported AEFI Document
43. tered to an individual who was not within the recommended age limits for a specific vaccine Product expired The vaccine was administered after the expiry date as indicated on the vaccine label by the manufacturer and or after the recommended amount of time elapsed between the first use of a multi dose vial and the last use e g as indicated in the product monograph for Fluviral once entered the multi dose vial should be discarded after 28 days Incorrect route The vaccine was administered via a route not recommended for its administration e g subcutaneous vs intramuscular Wrong vaccine given An unintended vaccine was administered Dose exceeded that recommended for age A larger dose of vaccine was administered than is recommended for the patient s age group Other If an error has occurred that is not accurately reflected in the list of provided errors please choose other and provide all details PUBLIC HEALTH AGENCY OF CANADA 11 SECTION 6 PREVIOUS AEFI Indicate whether the patient had ever experienced an AEFI following a previous dose of any of the immunizing agents as listed in response to question 4c Choose only one of the answers provided in section 6 as described below No The patient had previously received immunization with one or more of the immunizing agents listed in section 4c and had not experienced a subsequent AEFI Yes The patient had previously received immunization with at least one of the imm
44. til now A series of federal provincial territorial workshops held from 2000 2002 led to the development of published functional standards a minimum core data set and updated data definitions for AEFI reporting CCDR 2002 28 Why has the form been revised Priorities to improve vaccine safety surveillance in Canada were established during the development of the National Immunization Strategy NIS As a part of the efforts to improve voluntary AEFI reporting it was decided to revise the AEFI report form This has been done over the last two years by members of the Vaccine Vigilance Working Group VVWG which is a federal provincial territorial group that reports to the Canadian Immunization Committee CIC Another reason to revise the form was to facilitate application of standardized AEFI case definitions developed by the Brighton Collaboration which is an international voluntary group whose goal is to facilitate the development evaluation and dissemination of high quality information about the safety of human vaccines How is Privacy and Confidentiality of information ensured Personal health information is confidential All provinces territories and PHAC take great care to protect personal health information Health care workers are encouraged to discuss with clients or the clients caregiver the reason for reporting the AEFI and the confidentiality of all collected information For further information regarding the protection of p
45. unizing agents listed in section 4c and had subsequently experienced an AEFI Unknown It is unknown if the patient had previously received immunization with any of the immunizing agents listed in section 4c and or if an AEFI followed Not applicable The patient had never previously received immunization with any of the immunizing agents listed section 4c If the answer is yes the patient had previously experienced an AEFI following a previous dose of one or more of the immunizing agent s listed in section 4c provide all details of the previous AEFI in section 10 including the corresponding time to onset and duration when known Also when possible provide information regarding the severity of the AEFI and if the previous AEFI was less or more severe than the currently reported AEFI If there is uncertainty regarding which option to choose or if there is additional information to provide e g multiple vaccines were administered and not all of the information regarding the patient s past AEFI experience can be captured in section 6 please provide additional details in section 10 SECTION 7 IMPACT OF AEFI OUTCOME AND LEVEL OF CARE OBTAINED SECTION 7A HIGHEST IMPACT OF AEFI Indicate the highest perceived impact of the AEFI by choosing one of the provided responses in section 7a based on the patient s assessment of the impact on their daily activities Did not interfere with daily activities No change or only minimal change i
46. ve immunizing agents vaccines In comparison Health Canada HC collects case reports of adverse events following the administration of therapeutic passive and diagnostic agents When an adverse event follows the administration of an active immunizing agent e g vaccine that is administered simultaneously with a passive immunizing agent e g immune globulin and or a diagnostic agent e g tuberculin skin test complete the AEFI Report form Provide the name of the active immunizing agent in addition to the passive immunizing agent and or diagnostic agent in section 4c and follow the established procedures for reporting an AEFI in your province This information will subsequently be forwarded to PHAC and to HC Alternatively if no active immunizing agent vaccine has been administered an AEFI Report form should not be completed Instead please follow the established procedures in your province for reporting an adverse drug reaction to HC e g completion of the Canada Vigilance Reporting Form When completing section 4c provide all information as outlined below Immunizing agent s Please record the proper name or accepted abbreviation as outlined in Appendix II for all immunizing agent s Trade name Indicate the trade name of all vaccine s received Manufacturer Specify the name of the manufacturer as indicated on the product label and as referenced in Appendix Il Lot number Document the complete lot number including al
47. w or an exacerbation of a previous condition following immunization that consists of clearly identified primary lesion s bulla cyst macule nodule papuple plaque pustule vesicle wheal and or secondary skin change s scaling atrophy excoriation fissure ulcer When possible provide a written description of the rash using the terminology provided BCCD Vaccine 25 2007 5697 5706 Generalized rash Systemic eruption in 2 or more parts of the body Localized at non vaccination site Eruption localized at another part of the body away from the vaccination site Thrombocytopenia Should be diagnosed by a physician Platelets count of less than 150 X 10 liter accompanied by petechial rash or other clinical signs and or symptoms of spontaneous bleeding epistaxis hematoma hematemasis hematochezia hematuria hemoptysis petechia purpura ecchymiosis Indicate the lowest platelet count on the AEFI form and provide any additional pertinent details including the clinical evidence for spontaneous bleeding Anaesthesia The loss of normal feeling or sensation Paraesthesia Abnormal physical sensation such as tingling burning prickling formication etc For Anaesthesia Paraesthesia describe the symptoms by checking all that apply indicate the site of reaction Numbness Loss of sensation often accompanies by tingling Indicate site of reaction Tingling Sensation commonly described as pins and needles Indicate site of re
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