User guide: Report of Adverse Event Following
Contents
1. ew Z lt ZNouveau Brunswick C A N A DA User guide Report of Adverse Event Following Immunization AEFI Version 1 0 To be used as a guide for completion of The New Brunswick Adverse Event Following Immunization reporting form November 2010 User guide Report of Adverse Event Following Immunization AEFI Table of Contents Frequently Used ACronyi uu cece cccceceseeseseeseseeecseeeseecaeeaeseecseaeseeecseaesececseeaeeesaeetaeeeeaeeataeeeeaeeaea 3 1 GENERAL OVERVIEW i sarcstscastatesacusssnagntanscnnsianiustecmastahatantcaninieonascaneanaaanansactan 4 2 Sl i LM ga fas ene neon minced Creer a ete Poorer Mie eeneT ne etre Terre AT NCTE reer rere 4 3 JREPORTING REG UIREMEN TS ci isaincescsssasinsninnsapabdeadsssuiagassabesashessiiacrudcandadedasaetsdsaneasnietoatidveann 6 4 INSTRUCTIONS FOR NB AEFI REPORTING FORM COMPLETION ccseeseseseseeeseeeees 9 Gover pag Ereinen aea E ase one seen atin E ae 9 Section 1 Provincial identifying NAO aicsas cescatsaccrsedsavinwnced dcvoeesnudecntsudercobsgoasntediavensddaenndimecnasaeaeees 9 Section 2 Client identification lt cc cscescsassssessestnnsatnqanwersdnnienns aes denn meena meemaeten eee 9 Section 3 Vaccine WTC IION tags sscccsesusscestaesdeisiobnssduebasis aeiaai aeae aoaia EEE E Eaei 9 Section 4 Immunization errors 2s ssa cassaasnecssissaecnnnenscsa sveacmanizvaaass assent cncaaa dees tasaandonaiaeasiasicban aeaseeacstnes 10 Section 5 Previous AEFI js c2. cccccscsscescesesscseseecsessecsssseseeseececsessecaeseessesseeeeeaeeeseesereas 15 Section 10 Recommendations for future VACCINATION 0 0 ee eeeeeteeeeeeeceseeecetectseeeeeeeatseeeeseeatseeees 16 ISBN 978 1 55471 493 3 2 Page User guide Report of Adverse Event Following Immunization AEFI 5 APPENDIX I NB AEFI REPORTING FORM vssszscdcccsostesecaccadsssssncscescyesessesnpnactongendsbeansesnucndenrctecns 17 6 APPENDIX Il AEFI REPORTING FLOWCHART seesssessseisirsisrssrerrrisrssrsrrisrsresrsrrrisrssreens 21 7 APPENDIX Ill SUMMARY OF REPORTING CRITERIA essees 24 Frequently Used Acronyms AEFI Adverse Event Following Immunization AESI Adverse Event of Special Importance BGTD Biologic and Genetic Therapies Directorate CAEFISS Canadian Adverse Effects Following Immunization Surveillance System CDC Communicable disease control CIC Canadian Immunization Committee CIRID Centre for Immunization and Respiratory Infectious Disease CHN Community health nurse CSDS Client Service Delivery System GNB Government of New Brunswick GBS Guillain Barr syndrome GP General practitioner HCP Healthcare professional HPFB Health Products and Food Branch HPFBI Health Products and Food Branch Inspectorate IC Immunization coordinator MOH Medical Officer of Health MD Medical doctor NB New Brunswick NP Nurse practitioner OCMOH Office of the Chief Medical Officer of Health PH Public Health PHAC Public Health Agency of Canada PHO Public
3. Parotitis Parotid gland swelling with pain and or tenderness O Other serious or unusual unexpected event s not O Rash Non allergic Q Generalized O Localized site listed elsewhere on the form 19 Page User guide Report of Adverse Event Following Immunization AEFI New B Nouveau Brunswick 9 Supplementary information Please indicate the section when providing details please provide details of any investigation or treatment for the recorded AEFI For local Public Health Office use only 10 Recommendations for future immunizations check all that apply below and provide comments in section 9 if extra space is needed jo Other specify O No change to immunization schedule O Controlled setting for next immunization O Expert referral specify O No further immunizations with specify O Determine protective antibody level i O Active follow up for AEFI recurrence after next vaccine Professional status O MOH O PHN O Other specify Comments Date yvvy mm DD Signature 20 Page User guide Report of Adverse Event Following Immunization AEFI 6 APPENDIX II AEFI REPORTING FLOWCHART Service provider Local level AEFI is experienced Service provider and reported to advises vaccine recipient of the risk amp benefit immunization Feedback to Vaccine Recipient Reviews reported event and makes determination Reportable Event Service provider advises vaccine reci
4. the PHAC website e More than one form can be completed for the same client under these circumstances o If the client has had more than one AEFI following vaccination s administered at different dates then the separate AEFI details should be completed on separate forms o If the client has had more than one AEFI following the vaccination s administered at the same time then all AEFI details can be reported on the same form e Minimal criteria for AEFI reporting to the MOH 1 Client identification ID name date of birth and gender 2 Vaccine s received name date of administration route dose 3 Event description onset duration symptoms highest level of care 4 Reporter ID name contact information Lack of any of these four elements means that the report is incomplete e Following MOH s review of the AEFI form o Transcribe all relevant to AEFI information into the AEFI module in Client Service Delivery System CSDS NOTE enter ALL AEFIs o Prior to sending AEFl related documents to the CDC unit via fax remove all confidential information in Section in the form apart from First initial of client s first and last name Date of birth Gender City town Postal code 8 Page User guide Report of Adverse Event Following Immunization AEFI 4 INSTRUCTIONS FOR NB AEFI REPORTING FORM COMPLETION Cover page Please indicate what type of an AEFI is being reported on the form by ticking the app
5. 8b one of the following Anaphylaxis Other allergic events or Oculo Respiratory Syndrome ORS For a chosen event indicate the affected body system skin mucosal cardio vascular respiratory gastrointestinal and the associated sign s and symptom s choosing all that apply 14 Page User guide Report of Adverse Event Following Immunization AEFI Provide all additional details in Section 9 including the measured pulse and blood pressure when available Also provide comment regarding whether there is visible swelling of the face e g lips tongue uvula etc and if a hoarse voice is audible to the reporter Please refer to Appendix III for the summary of reporting criteria Section 8c Neurologic events Please indicate the onset date and time of the first symptom or sign Choose from Section 8c all that apply neurologic events meningitis encephalopathy encephalitis Guillain Barr syndrome GBS Bell s palsy other paralysis seizure s other neurologic diagnosis For neurologic event chosen above indicate all that apply signs symptoms details and test results Provide all additional details in Section 9 Please refer to Appendix Ill for the summary of reporting criteria Section 8d Other defined events of interest Please indicate the onset date and time of the first symptom or sign Choose from Section 8d all defined events of interest that apply to reported AEFI hypotonic hyporesponsive episode pe
6. Adverse Event Following Immunization AEFI in Section 4 by checking the box next to the situation that most closely reflects the error as described below and provide all known details in Section 9 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 Vaxigrip expires within seven days of vial opening Dose exceeded that recommended for age A larger dose of vaccine was administered than is recommended for the client s age group Wrong dose Incorrect dose of vaccine was given Wrong vaccine given An unintended vaccine was administered Incorrect route The vaccine was administered via an incorrect route of administration e g subcutaneous vs intramuscular Other f an error has occurred that is not accurately reflected in the list of provided errors please choose other and provide all details in Section 9 Section 5 Previous AEFI Indicate whether the client had ever experienced an AEFI following a previous dose of any of the immunizing agents as listed Sectio
7. All HCPs in NB who administer vaccines and or care for clients who may have had an AEFI are required by law to report the event to their local Public Health office PHO within one week of event identification 6 Page User guide Report of Adverse Event Following Immunization AEFI 3 What to report Any reportable event should be forwarded to the local PHO NOTE Expected non serious AEFls are not required to be reported unless they are more severe or more frequent than expected e AEFI report should contain e Client unique identifier date of birth and gender e Immunization event s province where given date all vaccines given including name manufacturer lot number administration site and route as well as the number in series of vaccine doses if relevant e Adverse event s description including time of first onset following immunization duration health care utilization treatment and outcome e Relevant medical and treatment history underlying disease Known allergies prior AEFI concomitant medication e Associated event s acute illness injury exposure to environmental toxins e Reporter details 4 When to report e HCPs should notify their local PHO within one week of AEFI identification by telephone post or fax e lf an AEFI was assessed as serious requiring urgent medical attention unusual or unexpected an MOH should initially notify the Communicable disease control CDC unit within
8. Health office PHN Public Health nurse RN Registered nurse SAEFI Serious Adverse Event Following Immunization SOP Standard Operating Procedure WHO World Health Organization 3 Page User guide Report of Adverse Event Following Immunization AEFI 1 GENERAL OVERVIEW This guide is intended to be used when completing the report of Adverse Event Following Immunization AEFI for submission to New Brunswick NB Department of Health local Public Health Offices and Public Health Agency of Canada PHAC The purpose of this guide is to help healthcare professionals HCPs complete the form accurately It is not intended to guide the clinical assessment or management of the AEFI case What is AEFI surveillance AEFI surveillance also Known as vaccine safety surveillance is a system designed to collect adverse events temporally associated with receipt of vaccines This type of surveillance typically relies on health professionals associating an adverse event in an individual as a possible consequence of vaccination and reporting it to the appropriate authority Why AEFIs need to be reported e To ensure that the vaccines used in Canada are safe e To maintain public confidence in Canada s immunization programs e tis a health care professional responsibility e lItis alegal requirement in NB What is done with AEFI reports at the provincial level The AEFI data are analyzed and disseminated at the provincial level to provincial stakeholder
9. cription that best fits the AEFI being reported Make sure to record the onset date and time of the 1 symptom or sign Use section 9 to provide all additional details relevant to the event duration of all symptoms comments and other information as appropriate This section is to be completed by the MOH or their designate who provides public health recommendations MOH Medical Officer of Health MD Medical Doctor PHN Public Health Nurse Any item marked on the form with asterisk must be diagnosed by a physician For more complete instructions and definitions refer to the AEFI report form user guide at http www phac aspe ge ca im aefi_guide index eng php Return the completed form to your local Public Health Office Moncton Saint John Fredericton Edmundston Campbellton Tracadie Sheila Miramichi 81 Albert Street 55 Union Street 300 St Mary s 121 Church St 6 Arran Street 3520 Main Street 1780 Water St PO Box 5001 PO Box 93 Street Room 11 Suite 330 18 Floor Place Tracadie Suite 300 NB E1C 8R3 NB E2L 3X1 NB E3B 5H1 NB E3V 3L3 NB E3N 1K4 NB E1X 1C9 NB E1N 1B6 T 506 856 2401 T 506 658 5188 T 506 453 5200 T 506 735 2065 T 506 789 2266 T 506 394 3888 T 506 778 6104 F 506 856 2623 F 506 643 7894 F 506 444 4877 F 506 735 3142 F 506 789 2349 F 506 394 3858 F 506 778 6756 For local Public Health Office use only Please fax the completed form to 506 453 8702 to the attention of the CDC Unit Epidemiolo
10. dmission and the date of discharge If a client was already in hospital at the time of immunization and the AEFI resulted in a longer hospital stay please also indicate the date of hospital admission and discharge for the entire period of hospitalization if known Document all investigations conducted in Section 9 Section 6b 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 6b If the client is not yet recovered provide all available details in Section 9 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 9 When completing Section 6b provide the information as outlined below 12 Page User guide Report of Adverse Event Following Immunization AEFI Death Client died record the corresponding date of death in the space provided Unknown The outcome of the AEFI is unknown or unclear Not yet recovered Residual signs and or symptoms remain at the time of the report Permanent disability incapacity An injury that 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 Recovered All signs and symptoms have resolved at the time of reporting Please record the date in the space provided If the reaction la
11. drainage Q Microbial results O Lymphangitic streaking Regional lymphadenopathy O 8b ALLERGIC and ALLERGIC LIKE EVENTS Onset date and time of the 1st symptom orsign yrvy ma op hr am pm Chose one of the following UO Anaphylaxis O Other allergic events O Oculo Respiratory Syndrome ORS For a chosen event check all that apply below and provide details in section 9 O Urticaria O Erythema O Pruritus O Prickle sensation O Rash For these events specify site of reaction Skin mucosal ANGIOEDEMA O Tongue O Throat O Uvula O Larynx O Lip EYE S O Red bilateral Q Red unilateral O Eyelids OFace O Limbs O Other specify QO Itchy Cardio vaicilar O Measured hypotension Q veentral pulse volume OQ Capillary refill time gt 3 sec O Tachycardia O J or loss of consciousness Duration O Sneezing Q Rhinorrhea O Hoarse voice O Sensation of throat closure O Stridor Respiratory Q Drycough QO Tachypnea O Wheezing QO Indrawing retractions O Grunting O Cyanosis O Sore throat O Difficulty swallowing QO Difficulty breathing O Chest tightness Gastrointestinal O Diarrhoea O Abdominal pain OQ Nausea QO Vomiting O 8c NEUROLOGIC EVENTS Onset date and time of the 1 symptom or sign vyyyy mm boD hr O Meningitis O Encephalopathy Encephalitis O Guillain Barre Syndrome GBS O Bell s Palsy O Other Paralysis O Seizure O Other neurologic diagnosis specify For any neurologic event indicated above check all that apply below and provide details in
12. encephalopathy or encephalitis 25 Page User guide Report of Adverse Event Following Immunization AEFI Meningitis e Physician diagnosed meningitis for 0 15 days 2 42 days which no other cause was identified Anesthesia e Physician diagnosed anesthesia or 0 7 days 0 7 days paresthesia paresthesia lasting 24 hours or more Paralysis e Physician diagnosed paralysis 0 15 days 0 42 days lasting 24 hours or more GBS e Physician diagnosed GBS 0 8 weeks 0 3 months Bell s palsy e Physician diagnosed Bell s palsy 0 8 weeks 0 3 months SSPE e Physician diagnosed SSPE MISCELLANEOUS temporally linked to immunization where no other clear cause of death can be established Thrombocytopenia e Physician diagnosed occurring within 0 30 days 0 30 days 30 days post immunization Arthralgia Arthritis e Any arthralgia or arthritis that follows 0 42 days the receipt of rubella containing vaccine and lasting at least 24 hours Intussusception e Intussusception or Hematochezia 0 42 days following rotavirus vaccine receipt Syncope with e Any syncope with injury following 0 24 hours 0 24 hours injury immunization Death e Any death of a vaccine recipient Within 1 month Within 1 month Fetal death or abnormality Any fetal death or abnormality that follows immunization of a pregnant woman 26 Page
13. ent or prevention of a disease 4 Page User guide Report of Adverse Event Following Immunization AEFI e An Adverse Reaction in contrast to an Adverse Event is characterized by the fact that a causal relationship between the drug and the occurrence is suspected An AEFI can be classified as e Vaccine induced event Non specific inflammatory responses injection site reaction fever Immune mediated response anaphylaxis Consequence of replication of microbial agents in vaccine febrile rash Direct toxic effect of vaccine component or contaminant e Vaccine potentiated event Vasovagal response syncope Hyperventilation Stress related Immunization error Inappropriate transportation or storage Failure to adhere to recommended schedule Use of expired product or wrong diluents Incorrect dosage injecting equipment sterile technique route or site of injection e Other event Infection Reaction to concomitant medication Response to environmental allergen or toxin Manifestation of complication of birth injury or inherited condition Trauma Psychogenic illness Serious AEFI is an AEFI that e results in death is life threatening requires in patient hospitalization or prolongation of an existing hospitalization results in persistent or significant disability incapacity causes a congenital anomaly birth defect is medically important Life threatening e
14. erience can be captured in Section 6 please provide additional details in Section 9 Section 6 Level of care and outcome Section 6a 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 6a described in detail below Unknown It is unknown if the client received care for the reported AEFI None No care was received for the reported AEFI Telephone advice from a healthcare professional The client received a telephone advice from a health care professional e g nurse nurse practitioner physician etc regarding the reported AEFI This can also include a telephone advice from a provincial health information line such as Tele Care 811 Non urgent visit The client 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 9 Emergency visit The client 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 9 Required hospitalization Indicate if client was hospitalized for the assessment and or treatment of the reported AEFI If yes provide the date of a
15. gist November 2010 17 Page User guide Report of Adverse Event Following Immunization AEFI O Initial report Brunswick O Follow up report REPORT OF ADVERSE EVENTS FOLLOWING IMMUNIZATION AEFI Contact info if different Name of client s physician 3 Vaccine Information Date vaccine administered yyyy mm oo hr am pm 4 Immunization Errors 5 Previous AEFI Did this AEFI follow an incorrect immunization O Yes ONo O Unknown Did an AEFI follow a previous dose of any of the if Yes choose all that apply and provide detail in section 9 above immunizing agents Q Given outside the recommended age limits O Product expired O Wrong dose f O No O Yes Provide details in section 9 O Wrong vaccine given O Incorrectroute O Other specify O Unknown O Not applicable no prior doses 6 Level of care and outcome Provide details in section 9 6a Highest level of care obtained 6b Outcome at time of report O Unknown O None O Telephone advice from a health professional O Death Date wry wm DD O Unknown Q Non urgent visit Emergency visit O Notyetrecovered Permanent disability incapacity O Required hospitalization O Yes O No O Recovered Date vw wm oo hr am pm Date of hospital admission vyvy Date of hospital discharge yyvvy 6c Treatment received O Yes f yes provide details below ONO O Unknown 6d Medical history up to the time of AEFI onset Choose all that apply and provide details belo
16. h an applicable AEFI could occur Vaccines temporal criteria AEFI Reporting criteria inactivated Live attenuated LOCAL REACTION AT INJECTION SITE Minor reactions e Redness or swelling or pain extends 0 48 hours 0 48 hours past the nearest joint AND OR e Redness or swelling or pain persists for 10 days of more Major reactions e Onset within 48 hours of 0 48 hours 0 48 hours Arthus reaction immunization AND e Swelling extends past the nearest joint Infected abscess e Physician diagnosed AND 0 7 days 0 7 days e Material from the abscess is purulent positive gram stain or culture OR e Signs of localized inflammation erythema pain to touch warmth AND e Evidence of improvement with antimicrobial therapy Sterile abscess e Persists for gt 1 month is gt 2 5cm in 0 7 days 0 7 days diameter and or drainage is evident AND e Material from the mass is non purulent AND e Absence of localized inflammation OR e Failure to improve on antimicrobial therapy Nodule e Is gt 2 5cm in diameter 0 7 days 0 7 days e Persists for gt 1 month Cellulitis e Physician diagnosed AND 0 7 days 0 7 days e Characterized by at least 3 local signs or symptoms pain or tenderness to touch erythema induration or swelling warmth to touch 24 Page User guide Report of Adverse Event Following Immunization AEFI SYSTEMIC EVENTS Fever Fever that occurs in co
17. ively minor medical significance such as severe headache Seriousness not severity which is based on client event outcome or action criteria serves as guide for defining regulatory reporting obligations Medical Officer of Health MOH designate A designate is the healthcare professional who has the authority to complete the recommendations for further immunization such Public Health nurse PHN or immunization coordinator IC Reportable event is an event that meets the AEFI definition AND has a temporal association with a vaccine AND has no other clear cause at the time of reporting International Conference on Harmonization Post approval Safety Data Management Definitions and Standards for Expedited Reporting ICH E2D 2003 3 REPORTING REQUIREMENTS 1 Trigger for reporting Any adverse event that follows administration of an active immunizing agent vaccine should trigger the reporting Each institution is responsible for ensuring that a process is in place to notify the individual who will be reporting NOTE When an adverse event follows the administration of passive immunizing agent e g immune globulin and or diagnostic agent e g tuberculin skin test an AEFI form should not be completed Instead the event should be reported to Health Canada on Canada Vigilance Adverse Reaction Reporting Form http Awww hc sc gc ca dhp mps medeff report declaration ar ei_form eng php 2 Who can report
18. king 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 ndicate if the client had an acute illness and or injury immediately prior to the time of immunization and specify a corresponding date of onset 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 7 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 13 Page User guide Report of Adverse Event Following Immunization AEFI address of the institution setting centre Indicate the setting in which the reporter is located e g physician office public health clinic hospital pharmacy or specify if other Sign the AEFI form in the space provided and specify your professional status e g Medical doctor MD Registered nurse RN by choosing one of the options provided If your professional status or affiliation is not listed specify beside other Please also provide the dates when the event was reported to the service provider and when it was reported to the local PHO Section 8 AEFI details Indicate the details of the reported AEFI by checking all that app
19. ly All additional pertinent details e g associated fever medical investigation treatment etc should be provided in Section 9 For convenience and consistency high level definitions have been provided for most events listed in Section 8 However if an asterisk is present beside an AEFI term this specific event must be diagnosed by a physician and thus a corresponding definition has not been provided within the body of this document Please refer to Appendix III for the summary of reporting criteria Section 8a Local reaction around injection site Please indicate the onset date and time of the first symptom or sign Choose from Section 8a all local reactions at or near the injection site that best fit the AEFI being reported infected abscess sterile abscess cellulitis nodule reaction that crosses joint lymphadenitis or other For any injection site reaction indicated above describe the signs and symptoms by checking all that apply swelling pain tenderness erythema warmth induration rash largest diameter of injection site reaction site s of reaction palpable fluctuance fluid collection shown by imaging technique spontaneous surgical drainage microbial results lymphangitic streaking regional lymphadenopathy Please refer to Appendix III for the summary of reporting criteria Section 8b Allergic and allergic like events Please indicate the onset date and time of the first symptom or sign Choose from Section
20. n 3 Choose only one of the answers provided in Section 5 as described below No The client had previously received immunization with one or more of the immunizing agents listed in Section 3 and had not experienced a subsequent AEFI Yes The client had previously received immunization with at least one of the immunizing agents listed in Section 3 and had subsequently experienced an AEFI any AEFI including expected and non serious Unknown It is unknown if the client had previously received immunization with any of the immunizing agents listed in Section 3 and or if an AEFI followed Not applicable The client had never previously received immunization with any of the immunizing agents listed Section 3 If the answer is yes the client had previously experienced an AEFI following a previous dose of one or more of the immunizing agent s listed in Section 3 provide all details of the previous AEFI in Section 9 including the corresponding time to onset and duration when known Also 11 Page User guide Report of Adverse Event Following Immunization AEFI 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 client s past AEFI exp
21. njunction with 0 72 hours 0 42 days another reportable event Rash Generalized rash for which urgent 0 7 days 5 26 days medical attention is sought and believed to be related to vaccine Any rash requiring hospitalization or treatment in ER Adenopathy Enlargement of one or more lymph 0 6 days 1 6 months lymphadenopathy nodes 21 5cm in diameter AND OR Draining sinus over a lymph node HHE Physician diagnosed AND 0 48 hours 0 48 hours Reduced muscle tone AND Hyporesponsiveness AND Pallor or cyanosis AND Child lt 2 years of age Screaming Continuous unaltered crying lasting 0 72 hours 0 72 hours Persistent crying for 3 or more hours Parotitis Physician diagnosed following 5 30 days Orchitis immunization with mumps containing vaccine Vomiting 3 or more episodes in 24 hour period 0 72 hours 0 72 hours Diarrhea AND Severe i e projectile vomiting or explosive watery diarrhea ALLERGIC REACTIONS Allergic reactions Any allergic reaction hives 0 48 hours 0 48 hours bronchospasm edema occurring within 72 hours of immunization Anaphylaxis All adverse events managed as 0 24 hours 0 24 hours anaphylaxis at the time of occurrence ORS Bilateral red eyes and respiratory Influenza symptoms with onset within 24 hours 0 24 hours of Influenza vaccine receipt NEUROLOGIC EVENTS Convulsion Seizures febrile or afebrile if they 0 3 days 5 42 days seizure meet the temporal criteria Encephalopathy Physician diagnosed 0 15 days 2 42 days encephalitis
22. one working day by telephone e mail or fax which should follow by a complete report within one week e The CDC unit will notify PHAC within one week of AEFI receipt NOTE It is important to remember that timeliness of AEFI reporting is very important as it facilitates effective risk management and allows addressing any safety concerns quickly and efficiently In the event of a matter that requires immediate attention e g anaphylaxis reaction to a vaccine the MOH should be informed as soon as possible by telephone after the client had received an appropriate treatment This form should then be completed to document the event and sent to the CDC unit 5 When an AEFI form needs to be completed In NB an AEFI form should only be completed for reportable events that are o serious in nature OR o required an urgent medical attention not resulting in hospitalization OR o unusual unexpected regardless of severity NOTE A casual relationship between immunization and the event that follows does not need to be proven and submitting a report does not imply or establish causality 6 How to report e Obtain the NB AEFI form Both the form and user guide are available on the Government of New Brunswick GNB website www gnb ca Orcontact your local PHO for a copy 7 Page User guide Report of Adverse Event Following Immunization AEFI NOTE the NB AEFI form supersedes that of the PHAC AEFI form and user guide available on
23. pient No further action Consultation with local PHO as needed CETTITETTTTTTTTITTTTTTITITTTT Report within 1 week of AEFI identification verbal paper or electronic Local PHO 21 Page User guide Report of Adverse Event Following Immunization AEFI Regional level Local PHO AEFI report review to ensure minimal Feedback to Service Provider data is provided and triage MOH or designate Serious AEFI Require an urgent medical attention Recommendations for future immunizations 22 Page User guide Report of Adverse Event Following Immunization AEFI Provincial level All data received is entered and or updated in AEFI database paper format or checked in CSDS electronic format Forward data to Case Surveillance PHAC review data analysis reports guidelines policies national updates Federal level PHAC receives required data elements paper or electronic format Data entered into National AEFI Database Data analysis Notification of BGTD Vaccine companies ACCA Review of selected AEFIs 23 Page User guide Report of Adverse Event Following Immunization AEFI 7 APPENDIX Ill SUMMARY OF REPORTING CRITERIA The length of time between vaccine administration and onset of symptoms is an important consideration in causality assessment Temporal criteria listed below are approximate timelines of whic
24. rds should be included in the report and their availability should be mentioned in the narrative and supplied on request Section 10 Recommendations for future vaccination This section is to be completed by the MOH or his or her designate that provides recommendation s for further immunization s Indicate by choosing all that apply in Section 10 your recommendations for the client 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 9 Complete the MOH s or his or her designate information section in full providing your full name and professional status Medical Officer of Health MOH Public Health Nurse PHN In addition indicate a telephone number where you can be reached and sign and date the AEFI form in the space provided 16 Page User guide Report of Adverse Event Following Immunization AEFI 5 APPENDIX I NB AEFI REPORTING FORM wee Brunswick ADVERSE EVENTS FOLLOWING IMMUNIZATION AEFI REPORT FORM INSTRUCTIONS Please complete this form to report events that are serious OR require an urgent medical attention OR unusual unexpected AND have a temporal association with a vaccine and that cannot be clearly attributed to other causes A causal relationship does not need to be proven and submitting a report doe
25. ropriate category e Serious e Required urgent medical attention e Unusual or unexpected Section 1 Provincial identifying info Unique episode number A unique case number is to be assigned to each AEFI report This number will be assigned automatically if the AEFI form is completed electronically or will be assigned manually by the CDC unit for paper forms The format of this number year NB Region N case number The unique case number should be marked on the top of the 2 3 and 4 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 2 Client identification Client Identification Information First and last name Provincial medicare number Date of birth Indicate the client s date of birth in the space provided If the complete date is unknown please provide as much information as is available yyyy mm dd format Gender Indicate client s gender e g male or female Address of usual residence including postal code with the understanding that this address might be in a different province than where the vaccine s was administered or where the AEFI is being reported Telephone number either residential or business or both where the client can be reached Information Source f the source of the information for the AEFI report is a parent or another care provider provide the name relation to
26. rsistent crying intussusception arthritis parotitis rash thrombocytopenia aneasthesia paresthesia fever other serious or unusual unexpected events not listed elsewhere on the form For events chosen above indicate all that apply signs symptoms details and test results Provide all additional details in Section 9 Please refer to Appendix Ill for the summary of reporting criteria Section 9 Supplementary information Section 9 should be used to capture information pertinent to the AEFI but that has not been fully captured elsewhere on the form or that needs further explanation Document all known details of investigations that support or refute the event s treatments course of the event s and diagnosis for the recorded AEFI The narrative should serve as a comprehensive stand alone medical story The information should be presented in a logical time sequence ideally this should be presented in the chronology of the client s experience rather than in the chronology in which the information was received In follow up reports new information should be clearly identified Also indicate the section of the AEFI report that the information applies to if applicable when recording information in Section 9 15 Page User guide Report of Adverse Event Following Immunization AEFI Abbreviations and acronyms should be avoided with the possible exception of laboratory parameters and units Key information from supplementary reco
27. s Data are then sent to the PHAC via fax post or electronically What is done with AEFI reports at the national level Personnel at the PHAC screen all submitted reports ensure they are entered into the Canadian Adverse Event Following Immunization CAEFI database and coded using standard international coding systems 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 2 DEFINITIONS Adverse Event Following Immunization AEFI An AEFI is any untoward medical occurrence in a vaccinee that follows immunization and that does not necessarily have a causal relationship with the administration of the vaccine The adverse event may be any unfavorable and or unintended sign abnormal laboratory finding symptom or disease Vaccine pharmacovigilance Vaccine pharmacovigilance is defined as the science and activities relating to the detection assessment understanding prevention and communication of adverse events following immunization or of any other vaccine or immunization related issues Adverse Event versus Adverse Reaction e An Adverse Event is a noxious and unintended response to a vaccine that occurs at doses normally used or tested for the diagnosis treatm
28. 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 client 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 4 Immunization errors Indicate whether the AEFI has followed an incorrect immunization an immunization error program error etc by choosing yes no or unknown If yes please indicate all that apply 10 Page User guide Report of
29. s not imply causality Please indicate what type of event is reported with an v Q Serious death life threatening hospitalization disability congenital anomaly medically important Q Require an urgent medical attention not resulted in hospitalization Q Unusual or unexpected not consistent with product information labeling regardless of its severity An AEFI is a reportable event in New Brunswick and should be reported to a Medical Officer of Health in writing within one week of identification Public Health Act Charter P 22 4 New Brunswick regulation 2009 141 NOTE The numbers below correspond to the numbered sections of the form Please indicate if this report is initial or follow up top right corner of the 15t page of the form The Province case will be completed by the CDC Unit at the OCMOH The information provided in this section is confidential Only First Initial of the first and last names Date of Birth Gender Cityfown and Postal Code should be sent to the CDC Unit Please block all other personal information prior to sending the form to the CDC Unit Provide details of level of care obtained outcome and all investigations in section 9 If client had recovered at the time of reporting provide the date If the reaction lasted gt 1 hour but lt 1 day also provide the exact time of recovery For all hospitalizations indicate the date of admission and discharge Choose from section 8 AEFI details the des
30. section 9 O Depressed altered level of consciousness lethargy or personality change lasting gt 24hrs O Focal or multifocal neurologic sign s O Fever 2 38 0 C O CSF abnormality QO EEG abnormality Q EMG abnormality O Neuroimaging abnormality O Brain spinal cord histopathologic abnormality Seizure details O Witnessed by healthcare professional O Yes ONo O Unknown O Sudden loss of consciousness OYes ONo O Unknown O Focal OR O Generalized Specify O Tonic Clonic O Tonic Clonic O Atonic O Previous history of seizures Specify O Febrile O Afebrile Unknown type O 8d OTHER DEFINED EVENTS OF INTEREST Onset date and time of the 1 t symptom orsign yvvy mm o0 hr For all selected defined events of interest below provide details in section 9 O Hypotonic Hyporesponsive Episode age lt 2 years O Thrombocytopenia O Platelet count lt 150x10 L O Limpness O Pallor cyanosis O Jresponsiveness unresponsiveness O Petechial rash O Other clinical evidence of bleeding O Persistent crying Crying which is continuous and unaltered for 3h O Anaesthesia Paraesthesia Q Numbness O Tingling O Buming O Fomication O Other specify O Intussusception O Generalized OR O Localized Site O Arthritis O Joint redness O Joint warm to touch O Fever 238 0 C Note report ONLY if fever occurs in conjunction with O Joint swelling Inflammatory changes in synovial fluid a reportable event For fever in a neurological event use section 8c U
31. sted gt 1 hour but lt 1 day also provide the exact time of recovery Section 6c Treatment received Indicate whether the client received any treatment including self treatment for the reported AEFI by choosing yes no or unknown If yes was chosen provide all details of treatments received following the onset of the AEFI in the same section Use Section 9 if more space is needed Section 6d Medical history up to the time of AEFI onset Indicate the client 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 the same section or in Section 9 if more space is needed Enclose a print out if available Concomitant medication s Provide the name of all medications including prescription over the counter and herbal supplements that the client had been taking immediately prior to the time of AEFI onset including those taken only as needed 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 client experienced prior to the time of immunization with a corresponding date of onset 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 client is ta
32. the client and contact information including the full mailing address and telephone number where he or she can be reached if it is different from the client s Name of client s physician Provide the name mailing address and telephone number of client s family physician Section 3 Vaccine information 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 three immunizing agents in this section 9 Page User guide Report of Adverse Event Following Immunization AEFI however if more than three were administered simultaneously record the additional vaccines in Section 9 Province of immunization Record the province where the vaccine was administered it could be different from the province of residency Date and time vaccine administered ndicate the date and exact time of vaccine administration remembering to specify if the vaccine was administrated in the a m or p m by circling the appropriate descriptor If complete information is unknown provide as much detail as is available e g month and or year Immunizing agent s Please record the proper name or accepted abbreviation for all active immunizing agent s e NOTE if an active immunizing agent cannot be found in CSDS please send an urgent request to the CDC unit and the agent will be added to the database Trade name Indicate the trade name of all vaccine
33. ucsacss ices scuncinctssisteet ans tteralatncuscsuasscedestvse tae ansenclecapaicecnnndesaanie is aeaee ir eea 11 Section 6 Level Of care and OUICOME es ccasssencesazsarsssacsesdensiessnssedeoseonsvasbessocvonrenatsnssavouecrenaveezsnieiense 12 Section 6a Highest level of care obtained ec eccceseescsseeecseesecsesseeeceaeeecseesecaeseesseeaesaeeaeeeseesereas 12 Section 6b Outcome at time of report aissacssssssecosarscesssasaneentavascssscsenteosaiasaesssssceeonacadesassbangeosavesensnestond 12 Section 6c Treatment received occas sacri cescinasisd cosets ousinnssdswsatess ete anueiarcedaacscodeddseaenraeb daaslarsebedementennd 13 Section 6d Medical history up to the time Of AEFI ONSet cece eceeeseeecneeeteeeeceeeeeeeteeetaeseeeees 13 Section 7 Reporter information gcsiscscceticae tease enradeeasicacintntaGcasicnvenmdntatinsewheadscaincungementadae 13 Section 8 AEF detailS rre eee er E e EE E EES EEE 14 Section 8a Local reaction around injection Site oo ee eeeeeceeceseeeceeeeeseeeceseetseeeeseeatseeeeseeatseaees 14 Section 8b Allergic and allergic like CVONtS cc eesessscecesecseeceeseeceesseanseeeceeaeeeseceeseeaesseanseeeees 14 Section 8c Neurologic SV CES cscsccescnssacaiccsctaccean canta cciceasbeanenimerapaeinanettouacaecepaer enon teensaantenecsaiens 15 Section 8d Other defined events of interest ese eesseeeeeeeeceseeeceeeeseeceeeetseeeeseeatseeeeseeansesaees 15 Section 9 Supplementary information
34. vent is an event a reaction in which the client was at risk of death at the time of the event reaction it does not refer to an event a reaction that hypothetically might have caused death if it were more severe Example anaphylaxis Medically important events Medical and scientific judgment should be exercised in deciding whether other situations should be considered as serious such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the client or may require intervention to prevent one of the other outcomes listed in the definition above These should also be considered serious Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm or convulsions that do not result in hospitalization 5 Page User guide Report of Adverse Event Following Immunization AEFI Unusual or unexpected AEFI An event that is not identified in nature severity or frequency among the currently known adverse effects associated with the administration of the product For example first reports of intussusception following rotavirus immunization Please refer to the current product information or labelling Serious AEFI versus Severe The term severe is not synonymous with serious and it is used to describe the intensity severity of a specific event as in mild moderate or severe The event itself however may be of relat
35. w or enclose a print out O Concomitant medication s O Known medical conditions allergies O Acute illness injury 7 Reporter Information Setting Physician office Public Health Hospital Pharmacy Other specify Name Phone ext Fax Address Date reported to Service Provider City Province Postal code Date reported to Public Health 9 ww Signature OMD O RN O Other specify Canada Note Discuss with client or his her parenv caregiver reason for reporting and confidentiality of information 2 18 Page User guide Report of Adverse Event Following Immunization AEFI Province case 8 AEFI Details for each section check all signs symptoms that apply Use section 9 to provide clinical details and test results Any item marked with asterisk must be diagnosed by a physician O 8a LOCAL REACTION around injection site Onset date and time of the 1st symptom or sign yvvy mm DD hr am pm O Infected abscess O Sterile abscess O Cellulitis O Nodule O Reaction crosses joint O Lymphadenitis O Other specify For any injection site reaction indicated above check all that apply below and provide details in section 9 O Swelling OPain OTendemess Q Erythema OQ Warmth QO Induration O Rash O Largest diameter of injection site reaction ___ cm Site s of reaction e g LA RA 2 Palpable fluctuance O Fluid collection shown by imaging technique e g MRI CT ultrasound a Spontaneous surgical
Download Pdf Manuals
Related Search