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USER GUIDE FOR COMPLETION AND SUBMISSION OF THE AEFI

1. 20 SECTION 12 Follow up information for a subsequent dose of same vaccine s 20 APPENDIX I Where to send a completed AEFI report TEE APPENDIX II List of current vaccines o oo o o sss 28 APPENDIX III National Case definition of AEFIs of Special Interest 26 NV A BACKGROUND When did National Vaccine Post Marketing Surveillance begin in Canada National monitoring of 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 uninten
2. 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 Parotitis Inflammation of the parotid gland s with pain and or tenderness Rash A skin or mucosal change temporary eruption Refer to Appendix III for the national case definition Choose the best descriptor from the list provided below that is most representative of the event Use this subsection to capture rash related to Varicella measles or other not allergic in nature For rash localized to the vaccination site capture in section 9a and for rash allergic in nature capture in section 9b When possible provide a written description of the rash using the terminology provided with the case definition of rash in appendix Ill 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 Refer to Appendix III for the national case definition Indicate the lowest platelet count on the AEFI form and provide any additional p
3. 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 is 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 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 i
4. 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 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 When co
5. CASE DEFINITION OF AEFIS OF SPECIAL INTEREST PREAMBLE KEY CAVEATS The Canadian AEFI case definitions are intended for purposes of AEFI classification and analysis not to govern management therapeutic decisions Having standard case definitions for AEFI facilitates vaccine safety monitoring on a global scale from pre licensure studies to post marketing surveillance Canada is a founding member of the WHO Programme for International Drug Monitoring since 1968 and shares AEFI report data in an effort to identify new adverse reaction signals Where possible AEFI case definitions have been based on published Brighton Collaboration case definitions see attached description of Brighton and process to develop case definitions AEFI reporters need not worry about classifying cases according to diagnostic level nor do they need to know the definition The 2008 AEFI form revision and accompanying user manual have been designed to incorporate as much as possible the case definition requirements Given the need for both clarity and simplicity in spontaneous AEFI reporting each case definition has been based on a single level of diagnostic certainty Inherent in choosing a single level is a goal for AEFI reports to include enough detail to meet the case definition as often as possible It is understood however that this is a long term goal and in the meantime AEFI reports will be accepted whether they meet the case definition or not Annual analy
6. Emergency Medicine A comprehensive study guide 6th edition 2004 McGraw Hill 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 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 Rhinorrhea Discharge of thin nasal mucus Hoarse voice An unnaturally rough deep or noisy quality of voice Sensation of throat closure Feeling or perception of throat obstruction or occlusion resulting in difficulty breathing Stridor A harsh high pitched breath sound heard on inhalation caused by air passing through a constricted passage 2 16 Dry cough Rapid expulsion of air from the lungs to clear the lung airways and not accompanied by expectoration a non productive cough Tachypnea Abnormally rapid and shallow breathing Wheezing A whistling squeaking musical or puffing sound made on exhalation by air passing through the fauces glottis or narrowed tracheobronchial airways bilateral both lungs Wheeze may be audible to the naked ear or may require the use of a stethoscope Indrawing retractions Inward movement of the muscles between the ribs The movements are usuall
7. 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 immunizing 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
8. by a physician as GBS that includes acute onset of bilateral flaccid weakness paralysis of the limbs with decreased or absent deep tendon reflexes and electrophysiologic findings consistent with GBS CSF test results if available must either be normal or have 50 wbc mm The evolution of illness is monophasic with a maximum degree of weakness reached from 12 hours to 28 days after onset followed by a clinical plateau and then either improvement or death Encephalitis based on Brighton level 3 Vaccine 2007 25 577 1 92 An illness diagnosed by a physician as encephalitis in which there is at least one listed indicator of central nervous system inflammation AND either gt 24 hours depressed or altered consciousness with one or more signs of reduced responsiveness or one OR more signs of focal or multi focal central nervous system abnormality Indicators of central nervous system inflammation Fever z 38 0C e CSF pleocytosis gt 15 wbc mm if lt 2 months old gt 5WBC mm if 22months EEG findings consistent with encephalitis Neuroimaging consistent with encephalitis N Signs of reduced responsiveness global cerebral dysfunction e Decreased or absent response to environment as defined by response to loud noise or painful stimuli e Decreased or absent eye contact e Inconsistent or absent response to external stimuli e Decreased arousability e Seizure associated with loss of consciousness 3 Signs of focal
9. deltoid etc gt Assessed by a health care provider means that a qualified health care professional has either examined the individual or has judged that the term is appropriate based on a verbal description of the reaction eg SECTION 9B ALLERGIC AND ALLERGIC LIKE EVENTS Choose one of the following events below Anaphylaxis is a clinical syndrome characterized by the sudden onset and rapid progression of signs and symptoms which affect more than one body system e g skin mucosal and or cardio vascular and or respiratory and or gastrointestinal The form has been designed to capture the major and minor manifestations of anaphylaxis each of which are defined below Accurate documentation of signs and symptoms contributes to the diagnostic certainty that an evolving event is indeed anaphylaxis Refer to Appendix III for the national case definition It is not necessary to know the definition prior to completing the AEFI report form nor should there be a delay in instituting appropriate management Oculo Respiratory Syndrome ORS is a set of signs symptoms of both the eyes and respiratory system following vaccination with influenza vaccine Refer to Appendix III for the national case definition Other allergic event encompasses all non anaphylactic allergic reactions 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 SKI
10. 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 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 Previous history of seizures Individuals who have had seizures at anytime prior to this vaccination Febrile With fever of gt 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 Hypotoni
11. or multifocal central nervous system abnormality e Focal cortical signs e g aphasia alexia agraphia cortical blindness e Cranial nerve abnormality abnormalities Visual field defect s Presence of primitive reflexes e g Babinski s sign sucking reflex Motor weakness diffuse of focal Sensory abnormalities positive or negative Altered deep tendon reflexes asymmetry hypo hyperreflexia Cerebellar dysfunction e g ataxia dysmetria cerebellar nystagmus 298 Myelitis based on Brighton level 3 Vaccine 2007 25 577 1 92 An illness diagnosed by a physician as myelitis in which there is clinical evidence of myelopathy accompanied by at least one indicator of spinal cord inflammation 1 Indicators of central nervous system inflammation Fever gt 38 0C e CSF pleocytosis gt 15 WBC mm if 2 months old 5WBC mm if 2months Neuroimaging demonstrates acute inflammation x meninges or spinal cord demyelination Acute disseminated encephalomyelitis ADEM based on Brighton level 3 Vaccine 2007 25 5771 92 An illness diagnosed by a physician as acute disseminated encephalomyelitis in which there are one or more focal or multifocal findings referable to the central nervous system 1 Signs of focal or multifocal central nervous system abnormality e Depressed or altered level of consciousness lethargy or personality change lasting gt 24 hours Focal cortical signs e g aphasia alexia agraphia corti
12. 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 Fever gt 38 0 C A temperature of gt 38 0 C in conjunction with neurologic symptoms CSF Cerebral Spinal Fluid abnormality Alteration in the normal CSF values EEG Electroencephalography abnormality Abnormal recording of changes in electric potentials in various areas of the brain EMG Electromyography abnormality Abnormal test results of the recording and study of the intrinsic electrical properties of skeletal muscle Neuroimaging abnormality Abnormal results in the tests e g CT scans MRIs Pet scans etc used to detect anomalies or trace pathways of nerve activity in the central nervous system Brain spinal cord histopathologic abnormality Microscopic changes of the diseased brain spinal cord tissues 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 i Generalized Bilateral with
13. 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 Patient 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 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 provinc
14. FI 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 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 sen
15. N MUCOSAL Choose all that apply from the list provided below and indicate the site of reaction Urticaria hives Circumscribed intensely itchy weals with erythematous raised edges and pale blanched centres from the Australian immunisation handbook 9th edition Urticaria may be present at the vaccination site e g within a few centimetres of where immunization was given and or may be generalized involving body sites other than where the vaccine was injected Erythema Abnormal redness of the skin Pruritus An unpleasant cutaneous sensation that provokes a desire to rub and or scratch to obtain relief Prickle sensation Tingling or smarting stinging sensation Rash A skin or mucosal change temporary eruption Refer to Appendix III for the national case definition Use this check box when reporting rash which is allergic in nature For rash localized to the vaccination site capture in section 9a and for rash related to Varicella Measles or other not allergic in nature capture in section 9d Angioedema Localized edema of the deeper layers of the skin subcutaneous tissues or mucosa lining the throat airways and gut This most often affects the face near the eyes and mouth or hands and feet but may also involve the lip tongue uvula throat or larynx It is important that the swelling is confirmed by visual inspection by a qualified health care professional rather than rely on patient description alone my tongue f
16. RY 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 section 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 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
17. Reporting Adverse Events Following Immunization AEFI in Manitoba Ld Public Health A de t M peich d Canada NOTE Pursuant to section 59 of The Public Health Act C C S M c P10 within 7 days after becoming aware of a reportable event a health professional must report it in accordance with the regulations made under the Act 03 2013 TABLE OF CONTENTS A BACKBBOUND os 5 oes es 225 es IE eee PER WE EO mST SIUS PN MAS 1 B GUIDELINES ON HOW TO COMPLETE SECTIONS OF THE AEFI FORM REPORT OF ADVERSE EVENTS FOLLOWING IMMUNIZATION AEFI 000a 4 SECTION 1 Provincial and Regional Identifying Information 4 SECTION 2 IMPACT ENS Gir eaa E e a n E a pE E a aE 5 SECTION 3 Patient Identification 2 ooo o s 5 SECTION 4 Information at Time of Immunization and AEFI Onset 6 SECTION 5 Immunization Errors 8 SECTION 6 Previous AEFI yo o 5524 44 04 9G 2 SA GRAUE mehdi sub ege ha Edd RS Es 9 SECTION 7 Impact of AEFI Outcome and Level of Care Obtained 9 SECTION 8 Reporter Information 11 SECTION AEELDStailS lt ses pisia i RAD Le Gilet ed ic pep E ER ae toe P ate 12 SECTION 10 Supplementary Information 20 SECTION 11 Recommendations for future immunization s according to the Provincial best practices
18. c Hyporesponsive Episode age lt 2 years Sudden onset in a child aged less than two years of hypotonia limpness reduced responsiveness and either pallor or cyanosis Refer to the Appendix III for the national case definition If the patient is two 2 years of age or older please check Other severe or unusual events not listed above and describe the episode Choose all that apply to the reported AEFI from the list provided below Limpness Lacking 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 deficient oxygenation of the blood Decreased responsiveness unresponsiveness Change in usual responsiveness to sensory stimuli Refer to Appendix III for the national case definition on Hypotonic Hyporesponsive Episode Persistent crying Crying which is continuous unaltered and lasts for 3 or more hours Refer to Appendix III for the national case definition 49 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
19. cal blindness Cranial nerve abnormality abnormalities Visual field defect s Presence of primitive reflexes e g Babinski s sign sucking reflex Motor weakness diffuse of focal e Sensory abnormalities positive or negative Altered deep tendon reflexes asymmetry hypo hyperreflexia Cerebellar dysfunction e g ataxia dysmetria cerebellar nystagmus Hypotonic Hyporesponsive Episode HHE based on Brighton level 1 Vaccine 2007 25 5875 81 The sudden onset in a child aged less than 2 years of hypotonia AND either hyporesponsiveness or unresponsiveness AND either pallor or cyanosis Persistent crying based on Brighton level 1 Vaccine 2004 22 586 91 Crying of infants and children that is continuous unaltered and lasts for three or more hours Intussusception based on Brighton level 2 Vaccine 2004 22 569 74 An acute illness diagnosed by a physician as intussusception in which there is evidence of intestinal obstruction and or invagination and or vascular compromise If only one of these three is present at least 3 of the following must also be present 1 year old male abdominal pain lethargy pallor hypovolemic shock non bile stained vomiting non specific gas pattern on a plain abdominal radiograph 1 History of bile stained vomiting AND either examination findings of acute abdominal distension and abnormal OR absent bowel sounds or plain abdominal radiograph showing fluid levels and dilated bow
20. ded 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 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 e 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 malforma
21. e diagnosed by a physician Choose all that apply to the reported AEFI from the list provided on the form and provide all pertinent details Guillain Barre Syndrome GBS Should be diagnosed by a physician Indicate if an Electromyograph EMG and or Lumbar Puncture LP were conducted and provide a summary of results in addition to any other relevant investigations including tests to look for possible causes especially Campylobacter a6 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 Episodes of hyperactivity in the brain resulting in sudden involuntary muscle contractions and abnormal behaviour loss or impairment of consciousness Refer to appendix III for the national case definition 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 responsiveness 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
22. e 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 of 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 HISTO
23. eels swollen Check all of the locations where angioedema is seen on the AEFI report form and if other is checked provide details Red eyes bilateral or unilateral Eye s showing dilatation of conjuctival episcleral or ciliary blood vessels Itchy eyes A sensation that provokes the desire to rub and or scratch to obtain relief ad CARDIO VASCULAR Choose all that apply from the list provided below Measured hypotension An abnormally low blood pressure systolic pressure 100mm hg documented by appropriate measurement Decreased central pulse volume Decreased pulse strength as a result of the decrease in volume of blood in the blood vessels 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 Tachycardia An extremely rapid heart rate above an established norm that varies by age The term is usually applied to a heart rate above 100 beats per minute for adults TABLE OF PULSE AND RESPIRATORY RATES Age Heart pulse rate per minute Upper Limit Respiratory rate per minute Upper Limit 0 1 mo 180 60 2 12 mo 160 50 12 24 mo 140 40 2 6 y 120 30 6 12 y 110 20 gt 12y adult 100 20 From
24. el loops 2 Presence of z 1 of abdominal mass rectal mass intestinal prolapse visible intussusceptum or soft tissue mass shown on plain abdominal radiograph OR abdominal ultrasound OR abdominal C 3 Presence of 21 of passage of blood per rectum passage of a stool containing red currant jelly material blood detected on rectal examination I Thrombocytopenia based on modified Brighton level 1 Vaccine 2007 25 5717 24 A platelet count of less than 150 x 10 Liter accompanied by clinical signs and or symptoms of spontaneous bleeding Rash based on Brighton level 3 Vaccine 2007 25 5697 5706 A skin or mucosal change that followed immunization and that is either new or an exacerbation of a previous condition NOTE while a morphologic description of the rash is not required it is preferred when possible using standard terms Mucocutaneous lesions pictures can be found at www dermatologylexicon org Bulla a fluid filled cavity or elevation 21 cm in diameter Fluid can be clear serous hemorrhagic or pus filled Cyst A closed cavity or sac containing fluid or semisolid material A cyst may have an epithelial endothelial or membranous lining Macule A flat generally 0 5 Cm area of skin or mucous membranes with different colour or texture from surrounding tissue Nodule A dermal or subcutaneous firm well defined lesion Papule A discrete solid elevated body usually 0 5 Cm in diameter Papules are fur
25. ertinent details 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 Fever gt 38 0 C A temperature of gt 38 0 C in conjunction with any other reportable event other than a neurological event Other serious or unexpected event s not listed in the form Specify and provide details in section 10 49 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 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 FUTURE IMMUNIZATION S ACCORDING TO THE PROVINCIAL BEST PRACTICES This section is to be completed by the regional Medical Officer of Health MOH 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 i
26. est 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 See abbreviations in section 4c Palpable fluctuance Wavelike motion on palpation due to presence of liquid content Refer to Appendix III for the national case definition of Abscess Fluid collection shown by imaging technique An imaging device is used in the detection of fluid collection e g MRI CT scan and ultrasound Spontaneous drainage Draining of fluid from a site without intervention When available 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 Refer to Appendix III for the national case definition Abscess When available provide all Gram stain culture results Microbial results Tests that are carried out to identify organisms that can cause disease or infection Lymphangitic streaking Painful and inflamed red streaks below the skin s surface 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
27. iality 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 personal 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 new form was first introduced in 2009 in Manitoba and other provinces and territories The form itself along with information regarding its implementation in Canada is posted on the Web at www phac aspc gc ca im aefi form eng php 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 Manitoba Health s adapted version of the form and user guide are posted at www gov mb ca health publichealth sri index html B GUIDELINES ON HOW TO COMPLETE SECTIONS OF 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 purp
28. ion 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 REPORTER 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 qi 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 inf
29. itis Tetanus and diphtheria toxoids adsorbed and Inactivated Poliomyelitis Typhoid Injection Typhoid Oral Varicella Yellow Fever Zoster ABBREVIATION Men C ACYW 135 Men P ACYW 135 MMR MMRV Pneu C 7 Pneu C 10 Pneu C 13 Pneu P 23 Rab Rot 1 Rot 5 TBE Tdap Tdap IPV Td IPV Typh l Typh O Var YF a es TRADE NAME Fluviral Vaxigrip Flumist Agriflu Fluad Influvac Intanza Imovax Polio IXIARO Meningitec Menjugate NeisVac C Menactra Menveo Menomune A C Y W 135 MMR9O II Priorix Priorix Tetra Prevnar Synflorix Prevnar 13 Pneumovax 23 Pneumo 23 Imovax Rabies RabAvert Rotarix RotaTeq FSME IMMUN 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 www phac aspc gc ca publicat cig gci index eng php 295 APPENDIX III NATIONAL
30. land s 290 Oculo Respiratory Syndrome ORS unchanged from previous Canadian definition there is no published Brighton Collaboration definition Level 1 Coding definition as of September 2004 PHAC case definition The presence of bilateral red eyes plus 21 of the seven respiratory symptoms cough wheeze chest tightness difficulty breathing difficulty swallowing hoarseness or sore throat that starts within 24 hrs of vaccination with or without facial oedema no restriction for duration Level 2 NACI case definition The onset of bilateral red eyes and or respiratory symptoms cough wheeze chest tightness difficulty breathing difficulty swallowing hoarseness or sore throat and or facial swelling occurring within 24 hours of influenza immunization A81
31. mpleting 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 II Lot number Document the complete lot number including all 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 Intranasal IN Oral PO Other please specify no abbreviations 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
32. n OR 23 signs of uncompensated shock tachycardia reduced central pulse volume capillary refill time gt 3 seconds decreased level of consciousness 4 Urticaria only at the injection site OR generalized prickle sensation OR generalized pruritus without skin rash OR red and itchy eyes O1 Persistent dry cough OR hoarse voice OR sensation of throat closure OR sneezing OR rhinorrhea OR difficulty breathing in the absence of wheeze OR strid OR 6 2 Signs of uncompensated shock tachycardia reduced central pulse volume capillary refill time gt 3 seconds decreased level of consciousness 7 Diarrhoea OR abdominal pain OR nausea OR vomiting 27 Generalized convulsive seizure based on Brighton level 2 Vaccine 2004 22 557 62 An episode of unconsciousness accompanied by generalized motor manifestations that may be tonic clonic tonic clonic or atonic Aseptic meningitis based on Brighton level 2 Vaccine 2007 25 5793 5802 An acute illness diagnosed by a physician as meningitis with cerebrospinal fluid test results showing pleocytosis negative gram stain and either no bacterial culture done or negative bacterial culture in the event that antibiotics were started prior to obtaining the CSF sample NOTE where available a negative PCR or other validated nucleic acid test may substitute for a negative gram stain Guillain Barr Syndrome GBS based on Brighton level 1B Vaccine 2011 29 599 612 An illness diagnosed
33. n section 10 Complete the reporter information section in full providing your full name and professional status MOH Medical Officer of Health 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 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 2090 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 subse
34. n 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 details 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 patie
35. nown to be non purulent OR absence of localized signs of inflammation OR failure to improve on antimicrobial therapy Cellulitis at the injection site based on Brighton level 2 Vaccine 2007 25 5803 20 An acute infectious expanding inflammatory condition of the skin located in subcutaneous tissue fat fascia or muscle at the vaccine injection site that has been diagnosed as cellulitis by a qualified healthcare provider and which is characterized by at least 3 of the following local signs or symptoms pain or tenderness to touch erythema induration or swelling warmth to touch Anaphylaxis based on Brighton level 2 Vaccine 2007 25 5675 84 A clinical syndrome characterized by sudden onset and rapid progression of signs and symptoms which include at least one major skin mucosal respiratory or cardiovascular manifestation and at least one more manifestation from a different organ system Evidence of involvement of a second organ system can be a major manifestation OR a minor skin mucosal respiratory cardiovascular or gastrointestinal manifestation OR laboratory confirmation of an elevated serum mast cell tryptase 1 Generalized urticaria OR generalized erythema OR generalized pruritus with rash OR angioedema N Stridor OR bronchospasm OR visible upper airway swelling OR z2 signs of respiratory distress tachypnea chest wall recession cyanosis grunting increased use of respiratory muscles 3 Measured hypotensio
36. nt 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 all investigations conducted in section 10 230 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 sect
37. o Appendix III for the national case definition 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 The national case definition of abscess can be found in Appendix III 49 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 site of vaccination of an vaccinated limb that is assessed by any person Refer to Appendix III for the national case definition 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 that is assessed by a health care provider Refer to Appendix III for the national case definition Rash A temporary eruption on the skin Larg
38. ormation 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 symptoms Refer to Appendix III for national case definitions of AEFIs of special interest 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 appropriate the most appropriate time unit day hour minute SECTION 9A LOCAL REACTION AT OR NEAR VACCINATION SITE 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 Sterile abscess An abscess whose contents are not caused by pyogenic bacteria Refer to Appendix III for the national case definition of Abscess 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 Nodule A firm small mass of tissue at the vaccination site with discrete or well demarcated borders in the absence of abscess formation erythema and warmth Refer t
39. osal 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 2599 TRADE NAME BCG Dukoral Infanrix Tripacel Tripacel Hybrid Infanrix hexa Pediarix Actacel ACTacel ACTacel Hybrid Infanrix Hib Infanrix IPV Quadracel Infanrix IPV Hib Pediacel Avaxim Avaxim Pediatric Havrix 1440 Havrix 720 Junior Vaqta Twinrix Twinrix amp Junior ViVAXIM Engerix B Engerix B Pediatric Recombivax HB ACT HIB Hiberix Liquid PedvaxHib Cervarix Gardasil MARKET AUTHORIZATION HOLDER 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 Toxoid reduced diphtheria toxoid and acellular pertussis Tetanus Toxoid reduced diphtheria toxoid and acellular pertussis combined with Inactivated poliomyel
40. ose 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 Complete 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 fir
41. quent 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 Of APPENDIX I WHERE TO SEND A COMPLETED AEFI REPORT Upon completion of an AEFI report please send to your regional Medical Officer of Health Nationally the contact information listed by federal provincial territorial F P T institution for any AEFI related questions can be accessed at www phac aspc gc ca im ci rp eng php 09 us APPENDIX 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 Thimer
42. 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 until 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 Confident
43. ses will include a description of the proportion of reports that meet each level of diagnostic certainty and those that fail to meet any level of diagnostic certainty These analyses will inform efforts to either improve the quality of AEFI report data and or to revise national case definitions as appropriate Many of the defined AEFI include those that have previously required a physician diagnosis for reporting purposes e g encephalitis Guillain barre syndrome This concept remains and has been incorporated into the case definition terminology 26 Abscess at the injection site based on Brighton level 2 Vaccine 2007 25 5821 38 A confirmed localized collection of material in subcutaneous tissue fat fascia or muscle at the site of immunization Depending on the availability of case details the abscess may be further classified as due to infectious etiology a sterile abscess or indeterminant 1 The localized collection must be confirmed in one of three ways Spontaneous or surgical drainage of material from the mass Demonstration of material by an imaging technique such as ultrasound CT or MRI Presence of palpable fluctuance defined as a wavelike motion on palpation due to liquid content 2 Material from abscess known to be purulent OR one or more signs of localized inflammation erythema pain to light tough warmth to touch with evidence of improvement related to antimicrobial therapy 3 Material from abscess k
44. st 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 should be left blank if it does not apply to your locale SECTION 2 IMPACT LIN 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
45. t 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 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 da
46. ta are analyzed for any evidence of safety concerns 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 Provincial 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
47. the AEFI has followed an incorrect immunization an immunization error program error etc by choosing no unknown or yes 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 administered 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 SECTION 6 PREVIOUS AEFI Indicate whether the patient had ever experienced an AEFI following a previous dose of any of the immunizing
48. ther classified by shape size color and surface change Plaque A discrete solid elevated body usually broader than it is thick measuring gt 0 5 Cm in diameter Plaques may be further classified by shape size color and surface change Pustule A superficial vesicle containing a cloudy or purulent fluid Pustules are usually 0 5 Cm in diameter Vesicle Fluid filled cavity or elevation 1 cm diameter Fluid may be clear serous or hemorrhagic Wheal hive An edematous transitory papule or plaque Secondary mucocutaneous changes Erosion A localized loss of the epidermal or mucosal epithelium Crusting Dried exudates of plasma Scaling Whitish scales or flakes are present on the skin Atrophy Thinning or absence of the dermis or subcutaneous fat Excoriations Oval or linear depressions in the skin with complete removal of the epidermis exposing a broad section of red dermis Fissures Linear wedge shaped cracks in the epidermis which may extend down to the dermis Ulcer A circumscribed loss of the epidermis or mucosa extending to dermis Arthritis modified from previous Canadian definition ccdr 2002 28 S6 p 22 Evidence of joint inflammation lasting at least 24 hours and or requiring hospitalization 1 By joint swelling pain redness and or sensation of warmth Parotitis unchanged from previous Canadian definition CCDR 1995 21 13 page f 8 Swelling with pain and or tenderness of parotid g
49. tion 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 to whether or not an event should be reported a conservative approach should be taken and the event should be reported 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 AE
50. y a sign of difficulty with breathing Grunting A laboured breathing of expiratory effort due to obstruction of the airway Cyanosis A dark bluish or purplish discolouration of the skin and mucous membrane due to deficient oxygenation of the blood Sore throat Discomfort or pain in the throat Difficulty swallowing Sensation of food stuck in the throat or upper chest Difficulty breathing Sensation of difficult uncomfortable breathing or a feeling of not getting enough air Chest tightness Chest discomfort or pain anywhere along the front of the body between the neck and upper abdomen GASTROINTESTINAL Choose all that apply from the list provided below Diarrhea Abnormally frequent discharge of loose and or watery fecal matter from the bowel Please provide details Abdominal pain Sensation of discomfort distress or agony in the abdominal region Nausea An unpleasant sensation vaguely referred to the epigastric region upper region of the abdomen and the abdomen with a tendency to vomit Vomiting The reflex act of ejecting the contents of the stomach through the mouth Provide details SECTION 90 NEUROLOGIC EVENTS Indicate by choosing all that apply from the list provided all neurologic events Provide all additional details in section 10 Meningitis Should be diagnosed by a physician Document the results of any cerebrospinal fluid investigations and pertinent details Encephalopathy Encephalitis Should b

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