Adverse Events Following Immunization Data Submission and Response Guidelines

Alberta Health Version 7.2 March, 2021

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Table of Contents A. DATA SUBMISSION GUIDELINE ...... 1

1. INTRODUCTION ...... 1 2. SUBMISSION FILE NAMING CONVENTION ...... 2 3. SUBMISSION FILE STRUCTURE ...... 3 Overview ...... 3 Record Descriptions ...... 4 Version Record ...... 4 Header Record ...... 4 Patient Record ...... 5 Adverse Event Record ...... 5 Immunization Record ...... 7 Adverse Event Detail Record ...... 8 Footer Record ...... 9 4. SUBMISSION TYPE USAGE ...... 10 Rules for Adding Data ...... 10 Rules for Deleting Data ...... 10 Rules for Changing Data ...... 10 5. DATA ELEMENTS ...... 11 Version Record ...... 12 Record Type ...... 12 DSG Version Number...... 12 Record Type ...... 13 Submitter Prefix ...... 14 Batch Number ...... 16 Patient Record ...... 17 Record Type ...... 17 Record Number ...... 17 Unique Lifetime Identifier (ULI) ...... 17 Provincial Health Number Type ...... 18 Provincial Health Number ...... 18 Alternate Person Identifier Type ...... 19 Alternate Person Identifier ...... 19 Last Name ...... 19 Given Name ...... 20 Middle Name ...... 20 Address Type ...... 20 Street Address 1 ...... 20 Street Address 2 ...... 21 Street Address 3 ...... 21 Street Address 4 ...... 21 City Name ...... 21 Province Code ...... 22 Country Code ...... 22 Postal Code ...... 28 Quarter Section Code...... 28 Section ...... 29 Township ...... 29 Range...... 29 Meridian ...... 30 Birth Date ...... 30 Gender Code ...... 30 Homeless/Indigent Flag...... 31 Adverse Event Record ...... 32 Record Type ...... 32 Record Number ...... 32 Unique Lifetime Identifier (ULI) ...... 32 AEFI Number ...... 33 Submission Type ...... 33 ______© 2021 Government of Alberta

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Required Hospitalization ...... 34 Admission Date ...... 34 Discharge Date ...... 34 Emergency Room ...... 35 Advice from a Health Professional ...... 35 Treatment for Adverse Events ...... 36 Treatment by Analgesic/Antipyretic ...... 36 Treatment by Epinephrine ...... 36 Treatment by Antihistamine ...... 37 Treatment by Other ...... 37 Treatment by Other Specify ...... 37 Previous Adverse Events to Immunization ...... 38 Previous Adverse Event to Immunization Specify ...... 38 History of Allergies ...... 38 Allergy List Specify ...... 39 History of Convulsions...... 39 Known Medical Conditions ...... 39 Known Medical Condition Specify ...... 40 Report Date ...... 40 Reporter ...... 40 Reporter Designation ...... 41 Outcome of Events ...... 41 Description of Event ...... 41 Regional Recommendations Comments ...... 42 Regional Recommendations Comments Date ...... 42 Associated Submitter Prefix ...... 42 Associated AEFI Number ...... 42 CMOH Advice Requested Indicator ...... 43 Delivery Management Site ...... 43 LIN Number ...... 51 Change to Immunization Schedule ...... 51 No Further Immunization ...... 51 No Further Immunization Specify ...... 52 Expert Referral Type ...... 52 Regional Recommendation Other ...... 53 Regional Recommendation Other Specify ...... 53 Immunization Record ...... 54 Record Type ...... 54 Record Number ...... 54 Unique Lifetime Identifier (ULI) ...... 54 AEFI Number ...... 54 Immunization Type ...... 55 Immunization Date ...... 55 Vaccine Code ...... 56 Vaccine Site Code ...... 61 Dosage ...... 63 Dosage Type Code ...... 63 Manufacturer ...... 64 Lot Number ...... 65 Number in Series ...... 66 Adverse Event Detail Record ...... 67 Record Type ...... 67 Record Number ...... 67 Unique Lifetime Identifier (ULI) ...... 67 AEFI Number ...... 67 Event Detail Code ...... 68 Adverse Event Interval ...... 69 Adverse Event Interval Type ...... 70 Temperature ...... 70 Adenopathy Location ...... 71 Allergic Events Location ...... 71 Arthralgia/Arthritis Location ...... 71

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Adverse Event Duration ...... 72 Adverse Event Duration Type ...... 72 Footer Record ...... 73 Record Type ...... 73 Total Record Count ...... 73 Checksum ...... 73 6. DATA SUBMISSION SAMPLE ...... 74 B. DATA SUBMISSION RESPONSE GUIDELINE ...... 76

7. INTRODUCTION ...... 76 8. DSG RESPONSE FILE NAMING CONVENTION ...... 77 9. OVERVIEW...... 78 Record Descriptions ...... 79 AEFI Response Version Record ...... 79 AEFI Response Header Record ...... 79 AEFI Response Summary Record ...... 80 AEFI Response DSG File Failure Record ...... 80 AEFI Response Business Rule Failure Record ...... 81 AEFI Response Program Validation Rule Failure Record ...... 81 AEFI Response Footer Record ...... 82 C. AEFI REGION OF RESIDENCE REPORT FILE GUIDELINE ...... 83

10. INTRODUCTION...... 83 11. AEFI REGION OF RESIDENCE REPORT FILE NAMING CONVENTION ...... 84 12. AEFI REGION OF RESIDENCE REPORT FILE STRUCTURE ...... 85 Overview ...... 85 Record Descriptions ...... 86 Version Record ...... 86 Header Record ...... 86 Patient Record ...... 87 Adverse Event Record ...... 88 RHA of Service Record ...... 90 Immunization Record ...... 90 Adverse Event Detail Record ...... 91 Footer Record ...... 91 D. APPENDICES ...... 92 Appendix I - General Reporting Guidelines ...... 92 Appendix II - Process Overview ...... 93 Appendix III – Glossary ...... 94 Appendix IV – Contact Information ...... 96 Appendix V – DSG File Format for Submission of Multiple Lot Numbers ...... 97 Appendix VI - Document Revisions ...... 101

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Data Element Tables

TABLE 1 - RECORD TYPE CODES ...... 12

TABLE 2 - SUBMITTER PREFIX CODES...... 14

TABLE 3 - PROVINCIAL HEALTH NUMBER TYPE CODES ...... 18

TABLE 4 - ALTERNATE PERSON IDENTIFIER TYPE CODES...... 19

TABLE 5 - ADDRESS TYPE CODES ...... 20

TABLE 6 - PROVINCE CODES ...... 22

TABLE 7 - COUNTRY CODES ...... 22

TABLE 8 - QUARTER SECTION CODES ...... 28

TABLE 9 - GENDER CODES ...... 30

TABLE 10 - HOMELESS/INDIGENT FLAG CODES ...... 31

TABLE 11 - SUBMISSION TYPE CODES ...... 33

TABLE 12 - REQUIRED HOSPITALIZATION CODES ...... 34

TABLE 13 - EMERGENCY ROOM CODES ...... 35

TABLE 14 - ADVICE FROM HEALTH PROFESSIONAL CODES ...... 35

TABLE 15 - TREATMENT FOR ADVERSE EVENTS CODES ...... 36

TABLE 16 - TREATMENT BY ANALGESIC/ANTIPYRETIC CODES ...... 36

TABLE 17 - TREATMENT BY EPINEPHRINE CODES ...... 36

TABLE 18 - TREATMENT BY ANTIHISTAMINE CODES ...... 37

TABLE 19 - TREATMENT BY OTHER CODES ...... 37

TABLE 20 - PREVIOUS ADVERSE EVENTS TO IMMUNIZATION CODES ...... 38

TABLE 21 - HISTORY OF ALLERGIES CODES ...... 38

TABLE 22 - HISTORY OF CONVULSIONS CODES ...... 39

TABLE 23 - KNOWN MEDICAL CONDITIONS CODES ...... 39

TABLE 24 - REPORTER DESIGNATION CODES ...... 41

TABLE 25 - OUTCOME OF EVENTS CODES ...... 41

TABLE 26 – CMOH ADVICE REQUESTED INDICATORS CODES ...... 43

TABLE 27 – DELIVERY MANAGEMENT SITE CODES ...... 43

TABLE 28 – CHANGE TO IMMUNIZATION SCHEDULE CODES ...... 51

TABLE 29 – NO FURTHER IMMUNIZATION CODES...... 51

TABLE 30 –EXPERT REFERRAL CODES ...... 52

TABLE 31 – REGIONAL RECOMMENDATION OTHER CODES ...... 53

TABLE 32 - IMMUNIZATION TYPE CODE ...... 55

TABLE 33 - VACCINE CODES ...... 56

TABLE 34 - VACCINE SITE CODES ...... 61

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

TABLE 35 - ADMINISTERING METHOD CODES ...... 62

TABLE 36 - DOSAGE TYPE CODES ...... 63

TABLE 37 - MANUFACTURER CODES ...... 64

TABLE 38 - EVENT DETAIL CODES ...... 68

TABLE 39 - ADVERSE EVENT INTERVAL TYPE CODES ...... 70

TABLE 40 – ADVERSE EVENT DURATION TYPE CODES ...... 72

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

A. DATA SUBMISSION GUIDELINE

1. INTRODUCTION

The Adverse Events following immunization (AEFI) Data Submission Guideline is a technical reference that defines the requirements for the electronic submission of AEFI data from Alberta Health Services, to Alberta Health. The guideline identifies the submission file naming convention, the submission file structure and the specific data elements that comprise each record. Adherence to this document will ensure minimal data rejection due to incorrect or improper data structure and format.

In addition to the business rules identified in the AEF Data Submission Guideline, there are program validation rules specific to the reporting of Adverse Events Following immunization data. A comprehensive listing of all program validation rules are included in this document.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

2. SUBMISSION FILE NAMING CONVENTION

Submission files may be compressed or uncompressed. The naming convention for the submitted file must take one of the following forms:

 ARIXXXXBBBBBBBBBB.TXT – This is an uncompressed submission file. The ‘XXXX’ corresponds to the Submitter Prefix for the Regional Health Authority or the First Nations & Inuit Health Branch. The ‘BBBBBB’ corresponds to the Batch Number for the batch submission. Please refer to Table 2 – Submitter Prefix Codes in the Patient record for a list of acceptable values. The delivery organization that submitted the file to the Department defines the batch number for each submission file.

 ARIXXXXBBBBBBBBBB.ZIP – This is a compressed submission file. The ‘XXXX’ corresponds to the Submitter Prefix for the Regional Health Authority or the First Nations & Inuit Health Branch. The ‘BBBBBBBBBB’ corresponds to the Batch Number for the batch submission. The file must be compressed using PKZip or WinZip.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

3. SUBMISSION FILE STRUCTURE

OVERVIEW

The submission file structure consists of seven record types. These are:  AV – Version record type  AH – Header record type  AP – Patient record type  AA – Adverse Events record type  AI – Immunization record type  AE – Adverse Event Detail record type  AF – Footer record type

The record structure of the submission file should follow these business rules:

 Each submission file must have one Version record. The Version record must be the first record in the submission file.  Each submission file must have one Header record. The Header record must be the second record in the submission file.  Each submission file must have one Footer record. The Footer record must be the last record in the submission file.  For each Patient record there must be one or more Adverse Events records submitted.  For each Adverse Events record there must be one or more Immunization records submitted.  For each Adverse Events record there must be one or more Adverse Event Detail records submitted.  All Patient, Adverse Events, Immunization and Adverse Event Detail records must be reported between the Header and Footer records.  Report all Adverse Events and associated Immunization and Adverse Event Detail records for a Patient record before a different Patient record is submitted. See Section 6 Data Submission Sample for an example of the required layout.  Report all associated Immunization and Adverse Event Detail records for an Adverse Events record before another Adverse Events record for the same patient is submitted. See Section 6 Data Submission Sample for an example of the required layout.

Each field within each record type is to be delimited. The only delimiter accepted is the pipe symbol (|).The first pipe delimiter signals the beginning of the field. The second pipe delimiter signals the end of the field. The Last Name and Given Name fields in the Patient record would be represented in the submission file as |Smith|John|.

The exception to the delimiter rule is the first field in each submission record. The first field of a record should not include a delimiter at the beginning of the field. For example, a Header record should be submitted as AH|10|000001|. This example does not include a delimiter at the beginning of the record. The last field of a record should always include a delimiter at the end of the field.

Fields that do not always have values (called NULL) must still be included in the record. NULL fields are represented as one delimiter followed by another. For example, using the pipe symbol it is ||.

An uncompressed submission file must not exceed 5 Mbytes. Uncompressed submission files that are larger than this must be split up into multiple files prior to submission. If file compression is used, the limit of 5 Mbytes applies to the submission file before compression is applied.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

RECORD DESCRIPTIONS

VERSION RECORD

The Version record contains the Data Submission Guideline (DSG) version number that identifies which version of the Data Submission Guideline the reported file adheres to. This field will accommodate any changes to the Data Submission Guideline record layouts in the future. Listed below is the layout of the record.

Field Format Mandatory Rule Record Type Alpha only (2) Mandatory DSG Version Number Numeric (2) Mandatory

Example: AV|01|

HEADER RECORD

The Header record must be the second record in the submitted file. It contains information that is used to identify the submitter and batch number of the submitted data. The Header record is used in conjunction with the Footer record to ensure that Alberta Health has received a complete submission. Consequently, it helps in the follow up and tracking of invalid or rejected data.

The combination of the Submitter Prefix and the Batch Number must be unique for each AEFI batch submission. Duplicate batch submissions will be rejected if found. Listed below is the layout of the record.

Field Format Mandatory Rule Record Type Alpha only (2) Mandatory Submitter Prefix Numeric (4) Mandatory Batch Number Numeric (10) Mandatory

Example: AH|10|000001|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

PATIENT RECORD

The Patient record contains all the required patient demographic data. Listed below is the layout of the record.

Field Format Mandatory Rule Record Type Alpha only (2) Mandatory Record Number Numeric (5) Mandatory Unique Lifetime Identifier (ULI) Numeric (9) Conditional Provincial Health Number Type Alpha only (2) Conditional Provincial Health Number Alphanumeric (15) Conditional Alternate Person Identifier Type Alpha only (4) Conditional Alternate Person Identifier Alphanumeric (15) Conditional Last Name Alpha only (50) Mandatory Given Name Alpha only (50) Mandatory Middle Name Alpha only (50) Non-mandatory Address Type Alpha only (4) Mandatory Street Address 1 Alphanumeric (35) Conditional Street Address 2 Alphanumeric (35) Conditional Street Address 3 Alphanumeric (35) Conditional Street Address 4 Alphanumeric (35) Conditional City Name Alphanumeric (60) Conditional Province Code Alpha only (3) Conditional Country Code Alpha only (2) Mandatory Postal Code Alphanumeric (12) Conditional Quarter Section Code Alpha only (2) Conditional Section Numeric (2) Conditional Township Numeric (3) Conditional Range Numeric (2) Conditional Meridian Numeric (1) Conditional Birth Date Numeric (8) Mandatory Gender Code Alpha only (1) Mandatory Homeless/Indigent Alpha Only (1) Conditional

Example: AP|1|890980089|AB|890980089|||Reed|Steve|Allan|MAIL|5334 103 Avenue||||Edmonton|AB|CA|T5J3G2||||||19831028|M| Y|

Note: The  symbol indicates that the line will be continued. This symbol has been used for formatting of this document and should not be present in the actual data submission.

ADVERSE EVENT RECORD

The Adverse Event record contains information related to the Adverse Events to immunization event. Listed below is the layout of the record.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Field Format Mandatory Rule Admission Date Numeric (8) Conditional Discharge Date Numeric (8) Conditional Emergency Room Alpha only (1) Mandatory Advice From a Health Professional Alpha only (1) Mandatory Treatment for Adverse Events Alpha only (1) Mandatory Treatment by Analgesic/Antipyretic Alpha only (1) Mandatory Treatment by Epinephrine Alpha only (1) Mandatory Treatment by Antihistamine Alpha only (1) Mandatory Treatment by Other Alpha only (1) Mandatory Treatment by Other Specify Alphanumeric (40) Conditional Previous Adverse Event to Immunization Alpha only (1) Mandatory Previous Adverse Event to Immunization Alphanumeric (40) Conditional Specify History of Allergies Alpha only (1) Mandatory Allergy List Specify Alphanumeric (1600) Conditional History of Convulsions Alpha Only (1) Mandatory Known Medical Conditions Alpha Only (1) Mandatory Known Medical Conditions Specify Alphanumeric (1600) Conditional Report Date Numeric (8) Mandatory Reporter Alphanumeric (40) Mandatory Reporter Designation Alpha only (10) Mandatory Outcome of Events Numeric (2) Mandatory Description of Event Alphanumeric (4000) Mandatory Regional Recommendations Comments Alphanumeric (1600) Mandatory Regional Recommendations Comments Date Numeric (8) Mandatory Associated Submitter Prefix Numeric (4) Non-Mandatory Associated AEFI Number Numeric (9) Conditional CMOH Advice Requested indicator Alpha only (1) Non-mandatory Delivery Management Site Alphanumeric (5) Non-mandatory LIN Number Alphanumeric (11) Non-mandatory Change to Immunization Schedule Alpha Only (1) Mandatory No Further Immunization Alpha Only (1) Mandatory No Further Immunization Specify Alphanumeric (40) Conditional Expert Referral Alpha Only (1) Mandatory Expert Referral Type Alphanumeric (40) Conditional Regional Recommendations Other Alpha Only (1) Non-Mandatory Regional Recommendations Other Specify Alphanumeric (40) Conditional

Example:

AA|2|180469009|12345|A|Y|20130527|20130528|Y|N|Y|Y|Y|Y|Y|Treatment OtherSpecify|Y|Previous Adverse Event to Immunization Specify|Y|Peanut Allergies|N|Y|Known Medical Conditions Specify|20130514|L Smith|RN|01|Description of Event(4000)|Regional Comments|20130514|25|12346|Y|105|LINNumber|Y|Y|No Further ImmunizationSpecify|Y|Expert Type|Y|RegionalRecommendationOtherSpecify|

Note: The  symbol indicates that the line will be continued. This symbol has been used for formatting of this document and should not be present in the actual data submission.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

IMMUNIZATION RECORD

The Immunization record displays given events (current immunization events) and historical events (historical immunization events) All vaccines given on the day that the AEFI is either temporally or causally linked needs to be included in the AEFI record. Historical immunization will not require the reason, route, dose, units, injection site, lot number, manufacturer, delivery management site. A minimum of one immunization event record will appear in the report file for each Adverse Events record. Listed below is the layout of the record.

Field Format Mandatory Rule Record Type Alpha only (2) Mandatory Record Number Numeric (5) Mandatory Unique Lifetime Identifier (ULI) Numeric (9) Conditional AEFI Number Numeric (9) Mandatory Immunization Type Alpha only (1) Mandatory Immunization Date Numeric (8) Mandatory Vaccine Code Alphanumeric (15) Mandatory Vaccine Site Code ** Alpha only (4) Conditional Administering Method Code ** Alpha only (3) Conditional Dosage ** Numeric (8,2) Conditional Dosage Type Code Alpha only (4) Conditional Manufacturer Alpha only (3) Conditional Lot Number ** Alphanumeric (20) Conditional Number in Series Numeric (2) Conditional

** Immunizations with multiple Lot numbers can be submitted. The noted elements can be different for each Lot Number. For details see Data Submission Sample Page 68 and Appendix V – DSG File Format for Submission of Multiple Lot Numbers.

Example:

AI|3|890980089|12345|R|19990513|HBV|LA|IM|0.5|ML|CON|11110|1| AI|4|890980089|12345|H|19990503|Td|||2|ML|||4|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

ADVERSE EVENT DETAIL RECORD

Adverse Event Detail records are used to provide the required information about the Adverse Events to support the Chief Medical Officer of Health (CMOH) when consulting with a Medical Officer of Health (MOH) on a specific patient. An Adverse Event Detail record must be reported for each adverse event or events thought to be associated with the immunization given on the specified Immunization Date. A minimum of one Adverse Event Detail record must be submitted for each Adverse Events record. Listed below is the layout of the record.

Field Format Mandatory Rule Record Type Alpha only (2) Mandatory Record Number Numeric (5) Mandatory Unique Lifetime Identifier (ULI) Numeric (9) Conditional AEFI Number Numeric (9) Mandatory Event Detail Code Numeric (2) Mandatory Adverse Event Interval Numeric (4,1) Mandatory Adverse Event Interval Type Alpha only (1) Mandatory Temperature Numeric (4,1) Conditional Adenopathy Location Alphanumeric (50) Conditional Allergic Events Location Alphanumeric (50) Conditional Arthralgia/Arthritis Location Alphanumeric (50) Conditional Adverse Event Duration Numeric (4,1) Mandatory Adverse Event Duration Type Alpha only (1) Mandatory

Example: AE|4|180469009|12312|1|1.0|D|38.9||||1.0|D|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

FOOTER RECORD

The Footer record provides summary information on the submitted data. The Footer record in conjunction with the Header record completes the submission of AEFI data. The Footer record must also provide a total count of the Patient, Adverse Events, Immunization and Adverse Event Detail records submitted (Total Record Count). Listed below is the layout of the record.

Field Format Mandatory Rule Record Type Alpha only (2) Mandatory Total Record Count Numeric (5) Mandatory Checksum Numeric (6) Mandatory

Example: AF|5|999999|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

4. SUBMISSION TYPE USAGE

A Submission Type classifies data transactions as Add, Change or Delete transactions. Delivery organizations must correctly use the three submission types to submit Adverse Events to immunization data to Alberta Health.

An Adverse Events to immunization event is an instance of an immunization service recipient having an Adverse Events to the immunization they were administered. An Adverse Events to immunization event is made up of: one Patient record, one Adverse Events record, one or more Immunization records and one or more Adverse Event Detail records.

Submission Types are only reported for Adverse Events records. Immunization records and Adverse Event Detail records inherit the Submission Type of the Adverse Events record to which they pertain.

RULES FOR ADDING DATA

When adding Adverse Events to immunization events, a strict hierarchy must be followed:

 When a Patient record is added, the Adverse Events records that follow must refer to that Patient.  When an Adverse Events record is added, the Immunization and Adverse Event Detail records that follow must refer to that Adverse Events to immunization event.

If more than one Adverse Events to immunization event is being reported for a Patient, and the patient has a different address at the time of each event, a new Patient record containing the new address should be reported before the events to which the new address applies.

RULES FOR DELETING DATA

When deleting Adverse Events to immunization events, the following rule applies:

 When an Adverse Events record is deleted, the provincial Immunization/AEFI Application will delete all Immunization and Adverse Event Detail records that refer to it.

RULES FOR CHANGING DATA

If changing any of the data within a previously submitted and accepted Adverse Events to immunization event, all records associated with the event must be resubmitted. This includes the Patient record, the Adverse Events record, all Immunization records and all Adverse Event Detail records. The Adverse Events record must have a Submission type of ‘C’ – Change Record/Transaction.

All business rules must be adhered to regardless if the record is an original submission or is an amendment.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

5. DATA ELEMENTS

For each data element, the following information is identified:

 A narrative description of the field.

 Format (Length)  Identifies if the field is:  alpha only – alphabetic characters only, plus any special characters as specified in the Business Rule component of the field definition,  alphanumeric – alphabetic and numeric characters, plus any special characters as specified in the Business Rule component of the field definition,  numeric – numeric value, either:  an integer if the format has a single value in parenthesis, e.g. Numeric (2) or  a decimal value if the format has two values, separated by a comma, in parenthesis, e.g. Numeric (8,2)  Identifies the maximum length of the field, and in the case of a numeric decimal value field, how many digits are to the right of the decimal point (e.g. The Dosage field, defined as Numeric (8,2), may have a maximum of 6 digits to the left of the decimal point, and two to the right of the decimal point, for a total of 8 digits. An example of such a value is 123456.78).

 Mandatory  Identifies ‘Yes’ if the field must always be submitted.  Identifies ‘No’ if the field does have to be submitted.  Identifies ‘Conditional’ if the field may have to be submitted under some circumstances.

 Business Rules  Identifies rules applicable to the field.  Identifies rules applicable to both the field and other related fields.

 Program Validation Rules  Identifies rules applicable to the event.

 Reformatting  Identifies if the submitted field will be reformatted upon processing of the file.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

VERSION RECORD

RECORD TYPE

The Record Type field identifies the type of record within a data submission.

Format (Length): Alpha only (2) Mandatory: Yes Business Rule: For the Version record, the Record Type must be ‘AV’ – Version record type Reformatting: None

Table 1 - Record Type Codes Code Description AV Version record type AH Header record type AP Patient record type AA Adverse Events record type AI Immunization record type AE Adverse Event Detail record type AF Footer record type

DSG VERSION NUMBER

The DSG Version Number field identifies which version of the Data Submission Guideline (DSG) the reported file adheres to. This field will allow for changes to the Data Submission Guideline record layouts in the future by ensuring files are validated against the correct version of the Data Submission Guidelines.

Format (Length): Numeric (2) Mandatory: Yes Business Rule: The DSG Version Number must be a valid version number as defined by Alberta Health Reformatting: None

Value Description 01 Data Submission Guideline Version 1

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

HEADER RECORD

RECORD TYPE

The Record Type field identifies the type of record within a data submission.

Format (Length): Alpha only (2) Mandatory: Yes Business Rule: For the Header record, the Record Type must be ‘AH’ – Header record type Reformatting: None

Please refer to Table 1 – Record Type Codes in the Version record for a list of acceptable values.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

SUBMITTER PREFIX

The Submitter Prefix field identifies the delivery organization that submitted the file to the Department.

Format (Length): Numeric (4) Mandatory: Yes Business Rule: Must be a valid Submitter Prefix Code Reformatting: Incoming value will be right justified and any leading blanks will be replaced with zeros

Table 2 - Submitter Prefix Codes Value Description 01 Chinook Regional Health Authority 02 Palliser Health Authority 03 Headwaters Health Authority 04 Calgary Health Region 05 Health Authority 5 06 David Thompson Regional Health Authority 07 East Central Regional Health Authority 08 Westview Regional Health Authority 09 Crossroads Regional Health Authority 10 Capital Health Authority 11 Aspen Regional Health Authority 12 Lakeland Regional Health Authority 13 Mistahia Regional Health Authority 14 Peace Health Region 15 Keeweetinok Lakes Regional Health Authority 16 Northern Lights Regional Health Authority 17 Northwestern Health Services Region 20 First Nations & Inuit Health Branch 21 Chinook Regional Health Authority 22 Palliser Health Region 23 Calgary Health Region 24 David Thompson Regional Health Authority 25 East Central Health 26 Capital Health 27 Aspen Regional Health Authority 28 Peace Country Health 29 Northern Lights Health Region 30 Pharmacies 31 University of Alberta 32 Atlas Immunization Services 33 Workplace Health and Safety – AHS 34 Workplace Health and Safety – Covenant Health 35 University of Calgary 36 Southern Alberta Institute of Technology 37 International Paper Grande Prairie Health Department 45 Fort McKay First Nation 46 Alexis First Nation 47 Beaver First Nation 48 Lubicon Lake Nation 49 Swan River First Nation 50 Nunee Health Board Society

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Value Description 51 Paul First Nation 52 Dene Tha' - Chateh 53 Driftpile First Nation 56 Saddle Lake Cree Nation 57 Sunchild First Nation 58 Alexander First Nation 59 Enoch Cree Nation 60 Beaver Lake Cree Nation 61 Little Red River Cree Nation - John D’or Prairie 62 Little Red River Cree Nation - Fox Lake 63 Little Red River Cree Nation - Garden River 64 Duncan’s First Nation 65 Wesley First Nation-Bighorn 66 Maskwacis Health Services 67 Whitefish Lake First Nation - Atikameg 68 Woodland Cree First Nation 69 Loon River First Nation 70 Tallcree First Nation 71 Heart Lake First Nation 72 Blood Tribe Department of Health 73 Sturgeon Lake Cree Nation 74 Sucker Creek First Nation 75 Kapawe’no First Nation 76 Dene Tha’ - Bushe River 77 Dene Tha’ - Meander River 78 O’Chiese First Nation 79 Tsuu Tina Nation 80 Whitefish Lake First Nation - Goodfish 81 Aakom Kiyii Health Services - Piikani 82 Bigstone Health Commission - Calling Lake 83 Bigstone Health Commission - Bigstone 84 Cold Lake First Nations 85 Stoney Trail Wellness Centre - Eden Valley 86 Morning Sky Health & Wellness Society - Frog Lake 87 Kehewin Cree Nation 88 Stoney Health Services - Morley 89 Siksika Health Services 90 OKAKI Community Clinic 99 Unknown 100 Direct Form Submitter 413 Calgary Zone (end dated) 416 Connect Care 417 North Zone (end dated) 418 South Zone (end dated) 419 Central Zone (end dated)

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

BATCH NUMBER

The Batch Number field is used with the Submitter Prefix to uniquely identify each batch submission. The delivery organization that submitted the file to the Department defines the Batch Number for each submission file.

Format (Length): Numeric (10) Mandatory: Yes Business Rule:  The combination of the Submitter Prefix and the Batch Number must be unique for each Adverse Events to immunization batch submission  The Batch Number must increase sequentially by one within the delivery organization  The first submission file sent by a delivery organization should have a Batch Number of ‘1’ Reformatting: None

Value Description 1– 9999999999

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

PATIENT RECORD

RECORD TYPE

The Record Type field identifies the type of record within a data submission.

Format (Length): Alpha only (2) Mandatory: Yes Business Rule: For the Patient record, the Record Type must be ‘AP’ – Patient record type Reformatting: None

Please refer to Table 1 – Record Type Codes in the Version record for a list of acceptable values.

RECORD NUMBER

The Record Number field is used to sequentially number each Patient, Adverse Events, Immunization and Adverse Event Detail record submitted.

Format (Length): Numeric (5) Mandatory: Yes Business Rule: None Reformatting: None

Value Description 1 – 99999

UNIQUE LIFETIME IDENTIFIER (ULI)

The Unique Lifetime Identifier (ULI) field identifies a unique and permanent number assigned to all persons with a vested interest in the health system of Alberta. This includes all Alberta residents and any non- Alberta residents who receive health services in Alberta. The ULI identifies the Adverse Event patient.

Format (Length): Numeric (9) Mandatory: Conditional – must be reported, otherwise the Adverse Events to immunization event will be flagged for investigation Business Rule: Must be a valid ULI on the Provincial Client Registry

Must be a Primary ULI on the Alberta Health Central Stakeholder Registry Program Validation Rules: Must submit the ULI to complete the event Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

PROVINCIAL HEALTH NUMBER TYPE

The Provincial Health Number Type field identifies the province that assigned the Provincial Health Identifier to the Adverse Event patient.

Format (Length): Alpha only (2) Mandatory: Conditional – must be reported if a Provincial Health Number is submitted Business Rule: Must be a valid Provincial Health Number Type Code Program Validation Rules: None Reformatting: None

Table 3 - Provincial Health Number Type Codes Code Description AB Alberta BC British Columbia Health Number MB Manitoba Health Number NB New Brunswick Health Number NL Newfoundland and Labrador Health Number NT Northwest Territories Health Number NS Nova Scotia Health Number NU Nunavut Health Number ON Ontario Health Number PE Prince Edward Island Health Number QC Quebec Health Number SK Saskatchewan Health Number YT Yukon Territory Health Number

PROVINCIAL HEALTH NUMBER

The Provincial Health Number field is the identifier assigned to the Adverse Event patient by a province. It presumes eligibility for basic health services for the Adverse Event patient from the designated province.

Format (Length): Alphanumeric (15) Mandatory: Conditional – must be reported if a Provincial Health Number Type is submitted Business Rule: If the Provincial Health Number Type equals ‘AB’ – Alberta, the Provincial Health Number must equal the ULI Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

ALTERNATE PERSON IDENTIFIER TYPE

The Alternate Person Identifier Type field identifies the purpose or jurisdiction of the Alternate Person Identifier.

Format (Length): Alpha only (4) Mandatory: Conditional – must be reported if an Alternate Person Identifier is submitted Business Rule: Must be a valid Alternate Person Identifier Type Code Program Validation Rules: None Reformatting: None

Table 4 - Alternate Person Identifier Type Codes Code Description ABC Alberta Blue Cross CF Canadian Armed Forces FP Federal Penitentiary RCMP RCMP Collator Regional Number TRTY Treaty Number VAC Veteran Affairs Canada WCB Workers Compensation Board

ALTERNATE PERSON IDENTIFIER

The Alternate Person Identifier field identifies personal identification codes assigned by jurisdictions other than the provincial health ministries. The Alternate Person Identifier is another identifier for the Adverse Event patient.

Format (Length): Alphanumeric (15) Mandatory: Conditional – must be reported if an Alternate Person Identifier Type is reported Business Rule: None Program Validation Rules: None Reformatting: None

LAST NAME

The Last Name field identifies the full surname or family name of the Adverse Event patient.

Format (Length): Alpha only (50) Mandatory: Yes Business Rule: None Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

GIVEN NAME

The Given Name field identifies the first name of the Adverse Event patient.

Format (Length): Alpha only (50) Mandatory: Yes Business Rule: None Program Validation Rules: None Reformatting: None

MIDDLE NAME

The Middle Name field identifies the other given name of the Adverse Event patient.

Format (Length): Alpha only (50) Mandatory: No Business Rule: None Program Validation Rules: None Reformatting: None

ADDRESS TYPE

The Address Type field identifies the type of address or location reported for the Adverse Event patient.

Format (Length): Alpha only (4) Mandatory: Yes Business Rule:  Must be a valid Address Type code  If the Quarter Section Code, Section, Township, Range and Meridian are reported, Address type must be ‘PHYS’ – Physical Address Program Validation Rules: None Reformatting: None

Table 5 - Address Type Codes Code Description MAIL Mailing Address PHYS Physical Address

STREET ADDRESS 1

The Street Address 1 field identifies line 1 of the street or mailing address of the Adverse Event patient at the time of the Adverse Events.

Format (Length): Alphanumeric (35) Mandatory: Conditional – either Street Address or Quarter Section Code, Section, Township, Range and Meridian must be reported Business Rule: None Reformatting: None Program Validation Rules: None Example: Suite 2101

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

STREET ADDRESS 2

The Street Address 2 field identifies line 2 of the street or mailing address of the Adverse Event patient at the time of the Adverse Events.

STREET ADDRESS 3

The Street Address 3 field identifies line 3 of the street or mailing address of the Adverse Event patient at the time of the Adverse Events.

STREET ADDRESS 4

The Street Address 4 field identifies line 4 of the street or mailing address of the Adverse Event patient at the time of the Adverse Events.

CITY NAME

The City Name field identifies the city, town or village where the Adverse Event patient resided at the time of the Adverse Events.

Format (Length): Alphanumeric (60) Mandatory: Conditional – must be reported if Province Code equals ‘AB’ – Alberta Business Rule: None Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

PROVINCE CODE

The Province Code field is a standard abbreviation for a Canadian province or territory. It identifies the province or territory where the Adverse Event patient resided at the time of the Adverse Events.

Format (Length): Alpha only (3) Mandatory: Conditional – must be reported if Country Code equals ‘CA’ – Canada Business Rule: Must be a valid Province Code Program Validation Rules: None Reformatting: None

Table 6 - Province Codes Code Description AB Alberta BC British Columbia MB Manitoba NB New Brunswick NL Newfoundland and Labrador NT Northwest Territories NS Nova Scotia NU Nunavut ON Ontario PE Prince Edward Island QC Quebec SK Saskatchewan YT Yukon

COUNTRY CODE

The Country Code field identifies the country where the Adverse Event patient resided at the time of the Adverse Events.

Format (Length): Alpha only (2) Mandatory: Yes Business Rule: Must be a valid Country Code – A detailed listing of valid values for 2 character alpha codes can be found in the International Country Codes table complied by the International Organization for Standardization (ISO) at the web site:

http://www.nationsonline.org/oneworld/country_code_list.htm

Program Validation Rules: None Reformatting: None

Table 7 - Country Codes Code Description AF Afghanistan AX Aland Islands AL Albania DZ Algeria

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description AS American Samoa AD Andorra AO Angola AI Anguilla AQ Antarctica AG Antigua and Barbuda AR Argentina AM Armenia AW Aruba AU Australia AT Austria AZ Azerbaijan BS Bahamas BH Bahrain BD Bangladesh BB Barbados BY Belarus BE Belgium BZ Belize BJ Benin BM Bermuda BT Bhutan BO Bolivia BA Bosnia and Herzegovina BW Botswana BV Bouvet Island BR Brazil IO British Indian Ocean Territory BN Brunei Darussalam BG Bulgaria BF Burkina Faso BI Burundi KH Cambodia CM Cameroon CA Canada CV Cape Verde KY Cayman Islands CF Central African Republic TD Chad CL Chile CN China CX Christmas Island CC Cocos (Keeling) Islands CO Colombia KM Comoros CG Congo (Brazzaville) CD Congo, Democratic Republic of the CK Cook Islands CR Costa Rica CI Cote D'Ivoire HR Croatia

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description CU Cuba CY Cyprus CZ Czech Republic DK Denmark DJ Djibouti DM Dominica DO Dominican Republic TP East Timor EC Ecuador EG Egypt SV El Salvador GQ Equatorial Guinea ER Eritrea EE Estonia ET Ethiopia FK Falkland Islands (Malvinas) FO Faroe Islands FJ Fiji FI Finland FR France FX France, Metropolitan (No longer on ISO site) GF French Guiana PF French Polynesia TF French Southern Territories(the) GA Gabon GM Gambia GE Georgia DE Germany GH Ghana GI Gibraltar GR Greece GL Greenland GD Grenada GP Guadeloupe GU Guam GT Guatemala GG Guernsey GN Guinea GW Guinea-Bissau GY Guyana HT Haiti HM Heard and Mc Donald Islands VA Holy See (Vatican City State) HN Honduras HK Hong Kong HU Hungary IS Iceland IN India ID Indonesia IR Iran (Islamic Republic of) IQ Iraq

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description IE Ireland IM Isle of Man IL Israel IT Italy JE Jersey JM Jamaica JP Japan JO Jordan KZ Kazakhstan KE Kenya KI Kiribati KP Korea, Democratic People’s Republic of KR Korea, Republic of KW Kuwait KG Kyrgyzstan LA Lao People’s Democratic Republic LV Latvia LB Lebanon LS Lesotho LR Liberia LY Libyan Arab Jamahiriya LI Liechtenstein LT Lithuania LU Luxembourg MO Macau MK Macedonia, The Former Yugoslav Republic of MG Madagascar MW Malawi MY Malaysia MV Maldives ML Mali MT Malta MH Marshall Islands MQ Martinique MR Mauritania MU Mauritius YT Mayotte MX Mexico FM Micronesia, Federated States of MD Moldova, Republic of MC Monaco MN Mongolia MS Montserrat ME Montenegro MA Morocco MZ Mozambique MM Myanmar NA Namibia NR Nauru NP Nepal NL Netherlands

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description AN Netherlands Antilles NC New Caledonia NZ New Zealand NI Nicaragua NE Niger NG Nigeria NU Niue NF Norfolk Island MP Northern Mariana Islands NO Norway OM Oman PK Pakistan PW Palau PS Palestinian Territory, Occupied PA Panama PG Papua New Guinea PY Paraguay PE Peru PH Philippines PN Pitcairn PL Poland PT Portugal PR Puerto Rico QA Qatar RE Reunion RO Romania RU Russian Federation RW Rwanda KN Saint Kitts and Nevis LC Saint Lucia BL Saint Barthelemy SH Saint Helena MF Saint Martin (French part) PM Saint Pierre and Miquelon VC Saint Vincent and the Grenadines WS Samoa SM San Marino ST Sao Tome and Principe SA Saudi Arabia SN Senegal RS Serbia SC Seychelles SL Sierra Leone SG Singapore SK Slovakia (Slovak Republic) SI Slovenia SB Solomon Islands SO Somalia ZA South Africa GS South Georgia and the South Sandwich Islands SS South Sudan

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description ES Spain LK Sri Lanka SD Sudan SR Suriname SJ Svalbard and Jan Mayen Islands SZ Swaziland SE Sweden CH Switzerland SY Syrian Arab Republic TW Taiwan, Province of China TJ Tajikistan TZ Tanzania, United Republic of TH Thailand TL Timor-Leste TG Togo TK Tokelau TO Tonga TT Trinidad and Tobago TN Tunisia TR Turkey TM Turkmenistan TC Turks and Caicos Islands TV Tuvalu UG Uganda UA Ukraine AE United Arab Emirates GB United Kingdom US United States UM United States Minor Outlying Islands UY Uruguay UZ Uzbekistan VU Vanuatu VE Venezuela VN Viet Nam VG Virgin Islands (British) VI Virgin Islands (U.S.) WF Wallis and Futuna Islands EH Western Sahara YE Yemen YU Yugoslavia (Now Macedonia, the former Yugoslav Republic of) ZR Zaire (now Congo, the Democratic Republic of the) ZM Zambia ZW Zimbabwe

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

POSTAL CODE

The Postal Code field identifies the postal code where the Adverse Event patient resided at the time of the Adverse Events.

Format (Length): Alphanumeric (12) Mandatory: Conditional – must be reported if Province Code equals ‘AB’ – Alberta Business Rule: If Country equals ‘CA’ – Canada, the postal code will be validated as ANANAN Reformatting: Blank spaces will be removed Program Validation Rules: If Province Code equals ‘AB’ – Alberta, the Postal Code will be verified against information provided by Canada Post to ensure it is a valid Alberta Postal Code. If Postal Code is reported, must match Postal Code for the reported ULI on the Provincial Client Registry. If Homeless/Indigent flag is set to “Y” the Postal Code must be blank. Example: T6L5R9

QUARTER SECTION CODE

The Quarter Section Code field describes one quarter of a Section. The Quarter Section Code is one component of the legal land description where the rural Adverse Event patient physically resided at the time of the Adverse Events. Reporting the legal land description provides more information about an Adverse Event patient’s physical location than a mailing address.

Format (Length): Alpha only (2) Mandatory: Conditional – either Street Address or Quarter Section Code, Section, Township, Range and Meridian must be reported Business Rule: Must be a valid Quarter Section Code Program Validation Rules: None Reformatting: None

Table 8 - Quarter Section Codes Code Description SE South East SW South West NE North East NW North West

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

SECTION

The Section field identifies one thirty-sixth of a Township. The Section is one component of the legal land description where the rural Adverse Event patient physically resided at the time of the Adverse Events. Reporting the legal land description provides more information about an Adverse Event patient’s physical location than a mailing address.

Format (Length): Numeric (2) Mandatory: Conditional – either Street Address or Quarter Section Code, Section, Township, Range and Meridian must be reported Business Rule: Must be greater than or equal to 1 and less than or equal to 36 Program Validation Rules: None Reformatting: None

TOWNSHIP

The Township field identifies a row which crosses both Meridians and Ranges. The Township is one component of the legal land description where the rural physically resided at the time of the Adverse Events. Reporting the legal land description provides more information about an Adverse Event patient’s physical location than a mailing address.

Format (Length): Numeric (3) Mandatory: Conditional – either Street Address or Quarter Section Code, Section, Township, Range and Meridian must be reported Business Rule: Must be greater than or equal to 1 and less than or equal to 126 Program Validation Rules: None Reformatting: None

RANGE

The Range field identifies a numbered column which falls between an identified Meridian. The Range is one component of the legal land description where the rural physically resided at the time of the Adverse Events. Reporting the legal land description provides more information about an Adverse Event patient’s physical location than a mailing address.

Format (Length): Numeric (2) Mandatory: Conditional – either Street Address or Quarter Section Code, Section, Township, Range and Meridian must be reported Business Rule: Must be greater than or equal to 1 and less than or equal to 30 Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

MERIDIAN

The Meridian field identifies a north-south line used for longitudinal orientation. The Meridian is one component of the legal land description where the rural Adverse Event patient physically resided at the time of the Adverse Events. Reporting the legal land description provides more information about an Adverse Event patient’s physical location than a mailing address.

Format (Length): Numeric (1) Mandatory: Conditional – either Street Address or Quarter Section Code, Section, Township, Range and Meridian must be reported Business Rule: Must be either 4, 5 or 6 Program Validation Rules: None Reformatting: None

BIRTH DATE

The Birth Date field identifies the calendar date on which the Adverse Event patient was born as reported upon registration.

Format (Length): YYYYMMDD - Numeric (8) Mandatory: Yes Business Rule:  Must be less than or equal to today’s date  Must be greater than or equal to 18700101 Reformatting: None Program Validation Rules: Must match the Birth Date for the reported ULI on the Provincial Client Registry Example: A person born December 1, 1965 should have a reported Birth Date of 19651201

GENDER CODE

The Gender Code field identifies the biological sex of the Adverse Event patient as reported upon registration.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid Gender Code Program Validation Rules: If ‘F’ – Female or ‘M’ – Male is reported, must match the gender for the reported ULI on the Provincial Client Registry If the Event Detail is ‘30’ – Orchitis, Gender Code must be “M” – Male Reformatting: None

Table 9 - Gender Codes Code Description F Female M Male O Other U Unknown

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

HOMELESS/INDIGENT FLAG

The Homeless/Indigent Flag identifies clients with no fixed address.

Format (Length): Alpha only (1) Mandatory: Conditional Business Rule: If Client has a fixed address default the Homeless/Indigent Flag to “N” If client has no fixed address set Homeless/Indigent Flag to “Y” Program Validation None Rules: Reformatting: None

Table 10 - Homeless/Indigent Flag Codes Code Description Y Yes N No

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

ADVERSE EVENT RECORD

RECORD TYPE

The Record Type field identifies the type of record within a data submission.

Format (Length): Alpha only (2) Mandatory: Yes Business Rule: For the Adverse Events record, the Record Type must be ‘AA’ – Adverse Events record type Reformatting: None

Please refer to Table 1 – Record Type Codes in the Version record for a list of acceptable values.

RECORD NUMBER

The Record Number field is used to sequentially number each Patient, Adverse Events, Immunization and Adverse Event Detail record submitted.

Format (Length): Numeric (5) Mandatory: Yes Business Rule: None Reformatting: None

Value Description 1 – 99999

UNIQUE LIFETIME IDENTIFIER (ULI)

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

AEFI NUMBER

The AEFI Number field identifies a unique number assigned to each Adverse Events case by a delivery organization (Regional Health Authority or First Nations & Inuit Health Branch). When combined with the Submitter Prefix, the AEFI Number identifies a unique adverse Event(s) to immunization event within the province.

Format (Length): Numeric (9) Mandatory: Yes Business Rule:  Within each delivery organization, must be unique for each Adverse Events to immunization event submitted to Alberta Health.  Valid range of numbers available for RHA use is 1 - 899999999. Program Validation Rules: The AEFI Number is generated manually or by the RHA system. Reformatting: None

SUBMISSION TYPE

The Submission Type field identifies the type of data transaction.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule:  Must be a valid Submission Type Code  Cannot be ‘C’ – Change Record/Transaction if not previously submitted and accepted as ‘A’ – Add Record/Transaction  Cannot be ‘D’ – Delete Record/Transaction if not previously submitted and accepted as ‘A’ – Add Record/Transaction  Cannot be ‘A’ – Add Record/Transaction if already previously submitted and accepted as ‘A’ – Add Record/Transaction or ‘C’ – Change Record/Transaction Reformatting: None

Table 11 - Submission Type Codes Value Description A Add Record/Transaction C Change Record/Transaction D Delete Record/Transaction

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

REQUIRED HOSPITALIZATION

The Required by Hospitalization field identifies if the Adverse Event patient was hospitalized as a result of the Adverse Event(s).

Format (Length): Alpha only (1) Mandatory: Yes Business Rule:  Must be a valid Required Hospitalization Code  Must be ‘Y’ – Yes if Admission Date is reported  Must be ‘Y’ – Yes if Discharge Date is reported Program Validation Rules: None Reformatting: None

Table 12 - Required Hospitalization Codes Code Description Y Yes N No U Unknown

ADMISSION DATE

The Admission Date field identifies the date when the Adverse Event(s) patient was admitted to the hospital as a result of the Adverse Events.

Format (Length): YYYYMMDD – Numeric (8) Mandatory: Conditional – must be reported if Required Hospitalized Indicator is reported Business Rule:  Must be greater than or equal to the Immunization Date (of the related vaccine)  Must be less than or equal to the Discharge Date  Must be less than or equal to today’s date  Must be less than or equal to the Adverse Event patient’s Date of Death in the Provincial Client Registry Program Validation Rules: None Reformatting: None

DISCHARGE DATE

The Discharge Date field identifies the date the Adverse Event patient was discharged from the hospital after being hospitalized as a result of the Adverse Events.

Format (Length): YYYYMMDD – Numeric (8) Mandatory: Conditional – Must be reported if Admission Date is reported Business Rule:  Must be greater than or equal to the Admission Date  Must be less than or equal to today’s date  Must be less than or equal to the Adverse Event patient’s Date of Death in the Provincial Client Registry Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

EMERGENCY ROOM

The Emergency Room field identifies if the Adverse Event patient visited and was seen in an emergency department as a result of the Adverse Events.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid Emergency Room Code Program Validation Rules: None Reformatting: None

Table 13 - Emergency Room Codes Code Description Y Yes N No U Unknown

ADVICE FROM A HEALTH PROFESSIONAL

The Advice from a Health Professional field identifies if the Adverse Event patient was given advice by a health professional in regards to the patient’s Adverse Events.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule:  Must be a valid Advice From a Health Professional Code Program Validation Rules: None Reformatting: None

Table 14 - Advice from Health Professional Codes Code Description Y Yes N No U Unknown

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

TREATMENT FOR ADVERSE EVENTS

The Treatment for Adverse Events field identifies whether treatments are causally related to the patient’s Adverse Events.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid Treatment for Adverse Events Code Program Validation Rules: None Reformatting: None

Table 15 - Treatment for Adverse Events Codes Code Description Y Yes N No U Unknown

TREATMENT BY ANALGESIC/ANTIPYRETIC

The Treatment by Analgesic/Antipyretic field identifies whether or not the Adverse Event patient was treated with an analgesic or antipyretic.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid Treatment by Analgesic/Antipyretic Code Program Validation Rules: None Reformatting: None

Table 16 - Treatment by Analgesic/Antipyretic Codes Code Description Y Yes N No U Unknown

TREATMENT BY EPINEPHRINE

The Treatment by Epinephrine field identifies whether or not the Adverse Event patient was treated with Epinephrine.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid Treatment by Epinephrine Code Program Validation Rules: None Reformatting: None

Table 17 - Treatment by Epinephrine Codes Code Description Y Yes N No U Unknown

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

TREATMENT BY ANTIHISTAMINE

The Treatment by Antihistamine field identifies whether or not the Adverse Event patient was treated with an antihistamine.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid Treatment by Antihistamine Code Program Validation Rules: None Reformatting: None

Table 18 - Treatment by Antihistamine Codes Code Description Y Yes N No U Unknown

TREATMENT BY OTHER

The Treatment by Other field identifies whether or not the Adverse Event patient was treated with another method.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule:  Must be a valid Treatment by Other Code  Must be ‘Y’ – Yes if Treatment by Other Specify is reported Program Validation Rules: None Reformatting: None

Table 19 - Treatment by Other Codes Code Description Y Yes N No U Unknown

TREATMENT BY OTHER SPECIFY

The Treatment by Other Specify field describes the other method of treatment given to the Adverse Event patient.

Format (Length): Alphanumeric (40) Mandatory: Conditional – must be reported if Treatment by Other equals ‘Y’ – Yes Business Rule: Spaces, periods, parentheses, dashes, comas, colons, slashes and pound signs are allowed Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

PREVIOUS ADVERSE EVENTS TO IMMUNIZATION

The Previous Adverse Events to Immunization field identifies whether or not the Adverse Event patient suffered Adverse Events to previous immunization(s)

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid Previous Adverse Events to Immunization Code Program Validation Rules: None Reformatting: None

Table 20 - Previous Adverse Events to Immunization Codes Code Description Y Yes N No U Unknown

PREVIOUS ADVERSE EVENT TO IMMUNIZATION SPECIFY

The Previous Adverse Event to Immunization Specify field lists all previous Adverse Events of the Adverse Event patient.

Format (Length): Alphanumeric (40) Mandatory: Conditional – must be reported if Previous Adverse Event to Immunization equals "Y" – Yes. Business Rule: Spaces, periods, parentheses, dashes, comas, colons, slashes and pound signs are allowed. Program Validation Rules: None Reformatting: None

HISTORY OF ALLERGIES

The History of Allergies field identifies whether or not the adverse event patient has a personal history of allergies.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule:  Must be a valid History of Allergies Code  Must be ‘Y’ – Yes if Allergy List Specify is reported Program Validation Rules: None Reformatting: None

Table 21 - History of Allergies Codes Code Description Y Yes N No U Unknown

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

ALLERGY LIST SPECIFY

The Allergy List Specify field lists all of the known allergies of the Adverse Event patient.

Format (Length): Alphanumeric (1600) Mandatory: Conditional – must be reported if History of Allergies equals ‘Y’ – Yes Business Rule: Spaces and the following special characters are allowed: ~ ` ! @ # $ % ^ & * ( ) _ - + = \ { } [ ] : ; " ' ? / > . < , Program Validation Rules: None Reformatting: None

HISTORY OF CONVULSIONS

The History of Convulsions field identifies whether or not the Adverse Event patient has a history of convulsions.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid History of Convulsions Code Program Validation Rules: None Reformatting: None

Table 22 - History of Convulsions Codes Code Description Y Yes N No U Unknown

KNOWN MEDICAL CONDITIONS

The Known Medical Conditions field identifies whether or not the adverse event patient has known medical conditions.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule:  Must be a valid Known Medical Conditions Code  Must be ‘Y’ – Yes if Medical Condition Specify is reported Program Validation Rules: None Reformatting: None

Table 23 - Known Medical Conditions Codes Code Description Y Yes N No U Unknown

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

KNOWN MEDICAL CONDITION SPECIFY

The Known Medical Condition Specify field lists all of the known medical conditions of the Adverse Event patient.

Format (Length): Alphanumeric (1600) Mandatory: Conditional – must be reported if Known Medical Conditions equals ‘Y’ – Yes Business Rule: Spaces and the following special characters are allowed: ~ ` ! @ # $ % ^ & * ( ) _ - + = \ { } [ ] : ; " ' ? / > . < , Program Validation Rules: None Reformatting: None

REPORT DATE

The Report Date field identifies the date when the primary recipient of the Adverse Events incident receives notification (verbal, written or electronic) from a parent, guardian, physician, hospital, lab, clinic, or other source. The primary recipient is the Medical Officer of Health or their designate of a Regional Health Authority or the First Nations & Inuit Health Branch.

Format (Length): YYYYMMDD – Numeric (8) Mandatory: Yes Business Rule:  Must be greater than or equal to the Immunization Date (of the related immunization)  Must be less than or equal to the MOH Comments Date  Must be less than or equal to today’s date Program Validation Rules: None Reformatting: None

REPORTER

The Reporter field identifies the name of the person who collects the data from an external source and reports the Adverse Events to the Medical Officer of Health of a Regional Health Authority or the First Nations & Inuit Health Branch.

Format (Length): Alphanumeric (40) Mandatory: Yes Business Rule: Spaces, periods, parentheses, dashes, comas, colons, slashes and pound signs are allowed Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

REPORTER DESIGNATION

The Reporter Designation field identifies a person’s education and/or profession designation.

Format (Length): Alpha only (10) Mandatory: Yes Business Rule: Must be a valid Reporter Designation Code. Program Validation Rules: None Reformatting: None

Table 24 - Reporter Designation Codes Code Description LPN Licensed Practical Nurse MD Medical Doctor OTH Other Vaccine Providers RN Registered Nurse

OUTCOME OF EVENTS

The Outcome of Events field identifies the outcome of the Adverse Events on the patient.

Format (Length): Numeric (2) Mandatory: Yes Business Rule: Must be a valid Outcome of Events Code Program Validation Rules: None Reformatting: Incoming value will be right justified and any leading blanks will be replaced with zeros

Table 25 - Outcome of Events Codes Code Description 01 Patient Recovered 04 Death 05 Unknown 06 Not yet Recovered 07 Permanent Disability/Incapacity 08 Lost to Follow-up

DESCRIPTION OF EVENT

The Description of Events field identifies details and supplementary information relating to the Adverse Events.

Format (Length): Alphanumeric ( 4000) Mandatory: Yes Business Rule: Spaces and the following special characters are allowed: ~ ` ! @ # $ % ^ & * ( ) _ - + = \ { } [ ] : ; " ' ? / > . < , Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

REGIONAL RECOMMENDATIONS COMMENTS

The Regional Recommendations Comments field identifies input and recommendations from the Medical Officer of Health (MOH) or their designate of a Regional Health Authority or the First Nations & Inuit Health Branch regarding the Adverse Events.

Format (Length): Alphanumeric (1600) Mandatory: Yes Business Rule: Spaces and the following special characters are allowed: ~ ` ! @ # $ % ^ & * ( ) _ - + = \ { } [ ] : ; " ' ? / > . < , Program Validation Rules: None Reformatting: None

REGIONAL RECOMMENDATIONS COMMENTS DATE

The Regional Recommendations Comments Date field identifies the date when the Medical Officer of Health (MOH) or their designate of a Regional Health Authority or the First Nations & Inuit Health Branch provided input and recommendations specific to the Adverse Events. Format (Length): YYYYMMDD – Numeric (8) Mandatory: Yes Business Rule:  Must be greater than or equal to the Report Date  Must be less than or equal to today’s date Program Validation Rules: None Reformatting: None

ASSOCIATED SUBMITTER PREFIX

The Associated Submitter Prefix field identifies the delivery organization who reported an associated Adverse Event to the Department.

Format (Length): Numeric (4) Mandatory: Non-mandatory Business Rule: None Program Validation Rules: None Reformatting: Incoming value will be right justified and any leading blanks will be replaced with zeros

Please refer to Table 2 – Submitter Prefix Codes in the Header record for a list of acceptable values.

ASSOCIATED AEFI NUMBER

The Associated AEFI Number field identifies the unique number assigned to an associated Adverse Events reported by a delivery organization (Regional Health Authority or the First Nations & Inuit Health Branch). When combined with the Associated Submitter Prefix, the Associated AEFI Number identifies a unique associated adverse Event within the province.

Format (Length): Numeric (9) Mandatory: Conditional – must be reported if Associated Submitter Prefix is reported Business Rule: None Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

CMOH ADVICE REQUESTED INDICATOR

The CMOH (Chief Medical Officer of Health) Advice Requested Indicator field identifies whether or not the Medical Officer of Health (MOH) or their designate of a Regional Health Authority or the First Nations & Inuit Health Branch is requesting advice from the Chief Medical Officer of Health (CMOH) regarding the Adverse Events.

Format (Length): Alpha only (1) Mandatory: No Business Rule: Must be a valid CMOH Advice Requested Indicator Code. Program Validation Rules: None Reformatting: None

Table 26 – CMOH Advice Requested Indicators Codes Code Description Y Yes N No

DELIVERY MANAGEMENT SITE

The Delivery Management Site field identifies the clinic location where the immunization service was administered, or the clinic location where the adverse event following immunization was reported.

Format (Length): Alphanumeric (5) Mandatory: No Business Rule: Must be a valid Delivery Management Site Code Program Validation Rules: None Reformatting: Incoming value will be right justified and any leading blanks will be replaced with zeros

Table 27 – Delivery Management Site Codes

Code Description End <= 001 Fort McLeod 002 Pincher Creek 003 Crowsnest Pass 004 Cardston 005 Magrath 006 Coaldale 007 Taber 008 Vauxhall 009 Picture Butte 010 Milk River 011 Raymond 012 Lethbridge 013 Brooks 014 Bow Island 015 Medicine Hat 016 Oyen/Empress 017 High River 018 Black Diamond

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description End <= 019 Okotoks 020 Vulcan 021 Nanton 022 Claresholm 023 Canmore 024 Banff 025 North Hill CHC 026 Thornhill CHC 027 Northwest CHC 028 8th & 8th Health Centre 029 Communicable Disease 030 East Edmonton CHC 031 Forest Lawn CHC 2010/05/22 032 Acadia CHC 033 South CHC 034 Scarboro CHC 035 Shaganappi CHC 036 Village Square CHC 037 Airdrie Regional CHC 038 Cochrane CHC 039 Millican Ogden Sub Office 2007/12/01 040 Drumheller 041 Three Hills 042 Strathmore 043 Hanna 044 Didsbury 045 Red Deer Bremner CHC 046 Innisfail 047 Rocky Mountain House 048 Lacombe 049 Olds 050 Eckville 051 Ponoka 052 Sylvan Lake 053 Rimbey 054 Elnora/Delburne 055 Sundre 056 Camrose HLTH 057 Sedgewick HLTH 058 Tofield HLTH 059 Holden/Viking HLTH 060 Vermilion HLTH 061 Wainwright HLTH 062 Kitscoty HLTH 063 Provost HLTH 064 Stettler HLTH 065 Castor HLTH 066 Coronation HLTH 067 Consort HLTH 068 Stony Plain 069 Hinton

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description End <= 070 Edson 071 Jasper Public Health 072 Evansburg 073 Devon 074 Spruce Grove 075 Wetaskiwin 076 Winfield 077 Drayton Valley 078 Travellers 079 Woodcroft 080 Eastwood 2010/01/28 081 Bonnie Doon 082 West Jasper Place 083 Twinbrooks 084 Millwoods 085 Castledowns 2009/04/23 086 Northeast Community 087 St. Albert 088 North Central 2009/04/23 089 Strathcona County 090 Beaumont 091 Thorsby 092 Leduc 093 Athabasca 094 Calling Lake 095 Whitecourt 096 Fox Creek 097 Swan Hills 098 Morinville 099 Smith 100 Boyle 101 Flatbush 102 Barrhead 103 Westlock 104 Mayerthorpe 105 Onoway 106 Redwater 107 Fort Saskatchewan 108 Lac La Biche 109 St. Paul 110 Smoky Lake 111 Bonnyville 112 Elk Point 113 Cold Lake 114 Lamont 115 Two Hills 116 Vegreville 117 Grande Prairie 118 Beaverlodge 119 Spirit River 120 Valleyview

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description End <= 121 Fairview 122 Worsley 123 Grande Cache 124 Grimshaw 125 Peace River 126 McLennan 127 Manning 128 Cadotte Lake 129 High Prairie 130 Kinuso 131 Slave Lake 132 Wabasca 133 Gift Lake 134 Northern Communities 135 Fort McMurray 136 Anzac 137 Conklin 138 Ft. McKay 139 High Level Public Health 140 LaCrete 141 Fort Vermilion 142 Rainbow Lake 143 Paddle Prairie 144 Gibbons 145 Thorhild 146 Mannville 147 Elizabeth 148 Fishing Lake 149 Kikino 150 Buffalo Lake 151 Red Deer 49 Street Community Health Centre 152 Occupational Health and Safety 153 Lloydminster 154 Boyle McCauley 155 STD Clinic Edmonton 156 Birth Control Clinic Edmonton 157 IBU (Immunization Business Unit) Edmonton 158 TB Clinic Edmonton 159 McLennan Public Health (Sacred Heart CHC) 160 Traveler’s - St Albert 161 Traveler’s - Strathcona 162 New Canadian’s Clinic 163 Red Deer Johnstone Crossing CHC 164 South Urgent Care Health Centre 165 Sheldon M Chumir Urgent Care Health Centre 166 Community Outreach 167 Clinical Trial 168 Northgate Health Centre 169 Rutherford Health Centre 170 East Calgary CHC 171 Westend Seniors Activity Centre

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description End <= 172 Jewish Community Centre 173 CDI College South Campus 174 Grandin Park Plaza - St Albert 175 Westmount Shopping Centre 176 Millborne Market Mall 177 Avenida Village 178 Brentwood Village Mall 179 EMS Whitehorn, North Side Entrance 180 Richmond Road Diagnostic Treatment Centre 181 Stampede Park 182 Bonnie Doon Shopping Centre 183 Airdrie Urgent Care 184 Cochrane Urgent Care 185 Okotoks Urgent Care 186 Calgary International Travel Clinic 187 Vaccine Depot Edmonton 188 Chinook Regional Hospital 189 University of Alberta Clinic 190 Chestermere CHC 191 SMCHC 192 Red Earth Creek 193 Peerless/Trout Lake 194 Atlas Travel Clinic 195 Workplace Health and Safety – AHS 196 Workplace Health and Safety – Covenant Health 197 Calgary Southport 198 Telus Convention Centre 300 Shoppers 2413 Evergreen Village (Calgary) 301 Winters Pharmacy (Drayton Valley) 302 Safeway 8844 Dalhousie Station (Calgary) 303 Safeway 8906 Windermere (Edmonton) 304 Safeway 2243 Thorncliffe (Calgary) 305 Shoppers 2335 Sunpark (Calgary) 306 Winters Pharmacy North (Drayton Valley) 307 University of Alberta Pharmacy 308 Safeway 8898 Bonnie Doon (Edmonton) 309 Pharmasave 367 Heritage Pointe (De Winton) 310 Sobeys 1129 Royal Oak (Calgary) 311 Sobeys 5191 Nolan Hill - Calgary 312 Safeway 8903 Aspen - (Calgary) 313 Sobeys 3194 Lewis Estates (Edmonton) 314 Sobeys 3143 Millwoods (Edmonton) 315 Sobeys 1110 Tuscany (Calgary) 316 Rita’s Apothecary and Home Healthcare Ltd. (Barrhead) 317 Polaris Travel Clinic and Pharmacy (Airdrie) 318 Safeway 8857 (Leduc) 319 Sobeys 5190 (Walker) 320 Safeway Safeway 8863 (St. Albert) 321 Safeway 8830 (Airdrie) 322 Safeway 8897 (Spruce Grove) 323 Safeway 8886 Callingwood (Edmonton)

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description End <= 324 Safeway 8912 Garrison Woods (Calgary) 325 Safeway 8877 (Red Deer) 326 Safeway 8894 (Fort Saskatchewan) 327 Safeway 8885 (Stoney Plain) 328 Safeway 8842 (Glenmore Landing) 329 Discovery Ridge Compounding Pharmacy & Travel Clinic 330 Safeway 8833 Crowfoot (Calgary) 331 Two Pharmacy (Cochrane) 332 University of Calgary Staff Wellness 333 Medicine Shoppe 365 Sherwood Park 334 EDM Royal Alexandra Hospital - Pharmacy 2020/11/30 335 EDM WMC Kaye Edmonton Clinic – 3A Medicine Clinic 2020/11/30 336 EDM Edmonton General Continuing Care Centre - NARP 2020/11/30 337 EDM RAH Community Services Centre - HIV 2020/11/30 338 EDM WMC Stollery Children's Hospital 2020/11/30 339 EDM RAH Community Services Centre - NARP 2020/11/30 340 EDM WMC Health Sciences Centre - NARP Unit 5C2 2020/11/30 341 EDM WMC Health Sciences Centre - NARP Unit 5B1 2020/11/30 342 STO Westview Health Centre - Pharmacy 2020/11/30 343 EDM Alberta Hospital Edmonton - Pharmacy 2020/11/30 444 STA Sturgeon Community Hospital - Pharmacy 2020/11/30 345 EDM WMC Health Sciences Centre - Pharmacy 2020/11/30 346 EDM Lynnwood Family Medicine Clinic 2020/11/30 347 EDM RAH Anderson Hall- Indigenous Wellness Clinic 2020/11/30 348 EDM WMC Stollery Childrens Hospital - Pediatric Clinical 2020/11/30 Investigation Unit - Pharmacy 349 EDM WMC Kaye Edmonton Clinic - Research Pharmacy 2020/11/30 350 Safeway 8841 South Centre 351 University of Calgary Staff Wellness Health Sciences 352 Safeway 8924 Sherwood Park Mall 353 SAIT Health Services 354 International Paper Grande Prairie 355 AHS Calgary Zone 356 AHS Edmonton Zone 357 AHS North Zone 358 AHS South Zone 359 AHS Central Zone 360 South Calgary Health Centre 361 South Park Center (Leased 362 Brooks Health Centre Hospital 363 Cardston Health Centre Hospita 364 Fort McMurray Wolverine Community Health Centre 365 Medicine Hat Regional Hospital 366 North Gate Village Mall 367 Oyen Big Country Hospital 368 Pincher Creek Health Centre Hospital 369 Skyview Power Centre 370 Taber Health Centre Hospital 371 Wainwright COVID Testing Site 372 Medicine Place 373 Bow Trail

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description End <= 374 Macleod South 375 Safeway 8803 Northgate 376 Safeway 8816 Market Mall 377 Safeway 8879 Manning Crossing 378 Safeway 8891 Westmount Centre 379 Safeway 8892 Northgate Centre 380 Safeway 8904 Southgate 381 Safeway 8905 Jasper Gates 382 Safeway 8913 North Hill Centre 383 Safeway 8916 Montgomery 384 Safeway 8928 Abbotsfield Mall 385 Edmonton West Centre 386 Genesis Centre 387 Guardian Drugs Medicine Chest 388 Safeway 8989 South Trail 389 Carebridge RemedyRx 390 Wabamun Pharmacy 391 Health Net Pharmacy 392 Medicine Shoppe 170 393 Medicine Shoppe 225 394 Londondale Guardian Pharmacy 856 Fort McKay Health Centre 857 Alexis Health Services 858 Beaver First Nations Health Centre 859 Lubicon Lake Health Centre 860 Swan River Health Centre 862 Chateh Health Centre 863 Maggie Willier Wellness - Driftpile 864 Fort Chipewyan Health & Wellness Centre 865 Paul Band Health Centre 866 Saddle Lake Health Care Centre 867 Sunchild Health Centre 868 Alexander Health Services 869 Enoch Health Services 870 Beaver Lake Health Services 871 John D’or Prairie Health Centre 872 Fox Lake Nursing Station 873 Garden River Health Centre 874 Duncan’s FN Health Centre 875 Kiska Waptin Health Centre - Bighorn 876 Maskwacis Health Services 877 Atikameg Health Centre 878 Woodland Cree Health Centre 879 Loon River Health Centre 880 Tallcree Health Services 881 Heart Lake Health Centre 882 Blood Tribe Department of Health 883 Sturgeon Lake Heath Centre 884 Sucker Creek Health Centre 885 Kapawe’no First Nation Health Centre 886 Four Chiefs Complex - Bushe River

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description End <= 887 Meander River Health Centre 888 O’Chiese Health Centre 889 Tsuu Tina Health and Wellness Centre 890 Goodfish Lake Health Centre 891 Aakom Kiyii Health Services - Piikani 892 Calling Lake Health Centre 893 Bigstone Health Centre 894 Cold Lake First Nations Health Centre 895 Stoney Trail Wellness Centre - Eden Valley 896 Morning Sky Health & Wellness Centre - Frog Lake 897 Kehewin Health Services 898 Stoney Health Services - Morley 899 Siksika Health & Wellness Centre 901 OKAKI Community Clinic 902 AFCC 995 Administered outside of AHS Public Health 996 Rapid Response 997 Other (Non AHS Immunizers) 998 Unknown 99009 Direct Form Immunizers

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

LIN NUMBER

The LIN number field identifies the case number assigned by the IMPACT centers for the Adverse Event reported to IMPACT

Format (Length): Alphanumeric (11) Mandatory: No Business Rule: Dashes accepted. Program Validation Rules: None Reformatting: None

CHANGE TO IMMUNIZATION SCHEDULE

The Change to Immunization Schedule field identifies if there is no Regional Recommendation to change the immunization schedule.

Format (Length): Alpha (1) Mandatory: Yes Business Rule: Must be a valid Change to immunization Schedule Code Program Validation Rules: None Reformatting: None

Table 28 – Change to Immunization Schedule Codes Code Description Y Yes N No U Unknown

NO FURTHER IMMUNIZATION

The No Further Immunization field identifies if there is a Regional Recommendation to no longer immunize with a particular vaccine or antigen.

Format (Length): Alpha (1) Mandatory: Yes Business Rule: Must be a valid No Further Immunization Codes Program Validation Rules: None Reformatting: None

Table 29 – No Further Immunization Codes Code Description Y Yes N No U Unknown

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

NO FURTHER IMMUNIZATION SPECIFY

The No Further Immunization Specify field identifies what vaccines or antigens the Medical Officer of Health (MOH) or their designate of a Regional Health Authority or the First Nations & Inuit Health Branch is recommending that the Adverse Event Patient should no longer receive. Format (Length): Alphanumeric (40) Mandatory: Conditional – must be reported if No Further Immunization equals "Y” Yes Business Rule: Spaces, periods, parentheses, dashes, comas, colons, slashes and pound signs are allowed. Program Validation Rules: None Reformatting: None

Expert Referral

The Expert Referral field identifies if there is a Regional Recommendation for the Adverse Event Patient to be referred to a Specialist. Format (Length): Alpha (1) Mandatory: Yes Business Rule: Must be a valid Expert Referral Code Program Validation Rules: None Reformatting: None

Table 30 –Expert Referral Codes Code Description Y Yes N No U Unknown

EXPERT REFERRAL TYPE

The Expert Referral Type Field identifies the type of specialist the Medical Officer of Health (MOH) or their designate of a Regional Health Authority or the First Nations & Inuit Health Branch is recommending to the Adverse Event Patient.

Format (Length): Alphanumeric (40) Mandatory: Conditional – must be reported if Expert Referral equals "Y" Yes. Business Rule: Spaces, periods, parentheses, dashes, comas, colons, slashes and pound signs are allowed. Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

REGIONAL RECOMMENDATION OTHER

The Regional Recommendation Other field identifies if there is a Regional Recommendation not otherwise specified for the Adverse Event patient.

Format (Length): Alpha (1) Mandatory: No Business Rule: None Program Validation Rules: None Reformatting: None

Table 31 – Regional Recommendation Other Codes Code Description Y Yes N No U Unknown

REGIONAL RECOMMENDATION OTHER SPECIFY

The Regional Recommendation Other Specify field identifies if there is a Regional Recommendation not otherwise specified for the Adverse Event patient.

Format (Length): Alphanumeric (40) Mandatory: Conditional – must be reported if Regional Recommendation Other equals "Y" Yes. Business Rule: Spaces, periods, parentheses, dashes, comas, colons, slashes and pound signs are allowed. Program Validation Rules: None Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

IMMUNIZATION RECORD

RECORD TYPE

The Record Type field identifies the type of record within a data submission.

Format (Length): Alpha only (2) Mandatory: Yes Business Rule: For the Immunization record, the Record Type must be ‘AI’ – Immunization record type Reformatting: None

Please refer to Table 1 – Record Type Codes in the Version record for a list of acceptable values.

RECORD NUMBER

The Record Number field is used to sequentially number each Patient, Adverse Events, Immunization and Adverse Event Detail record submitted.

Format (Length): Numeric (5) Mandatory: Yes Business Rule: None Reformatting: None

Value Description 1 – 99999

UNIQUE LIFETIME IDENTIFIER (ULI)

AEFI NUMBER

The AEFI Number field identifies a unique number assigned to each Adverse Events case by the delivery organization.

Format (Length): Numeric (9) Mandatory: Yes Business Rule: Must match the AEFI Number submitted in the preceding Adverse Events record Program Validation Rules: The AEFI Number is generated manually or by the RHA system. Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

IMMUNIZATION TYPE

The Immunization Type field identifies if the reported immunization is a given event or a historical event. If entering an Adverse Event on a given event, enter ‘related’ for type. If entering an Adverse Event on a historical event, enter ‘historical’ for the type. All vaccines given on the day that the AEFI is either temporally or causally linked needs to be included in the AEFI record. All immunization records within a single Adverse Event record must have the same immunization date. Listed below is the layout of the record.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid Immunization Type Code Program Validation Rules: None Reformatting: None

Table 32 - Immunization Type Code Code Description R Related Immunization H Associated Historical Immunization

IMMUNIZATION DATE

The Immunization Date field identifies the date when a related immunization or an associated historical immunization was administered to the Adverse Event patient.

Format (Length): YYYYMMDD – Numeric (8) Mandatory: Yes Business Rule:  Must be greater than or equal to the Adverse Event patient’s Birth Date  Must be less than or equal to the Report Date  Must be less than or equal to today’s date  Must be less than or equal to patient’s Date of Death in the Provincial Client Registry Program Validation Rules:  If the Event Detail Code is ‘22’ – Hypotonic-Hyporesponsive Episode, the client’s age at the Immunization Date must be less than 2 years

 Within a specific Adverse Events event, all Immunization records with Immunization Type = ‘R’ – Related Immunization, must have the same Immunization Date. Reformatting: None

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

VACCINE CODE

The Vaccine Code field identifies the vaccine administered to the Adverse Event patient for a related immunization or an associated historical immunization.

Format (Length) Alphanumeric (15) Mandatory Yes Business Rule  Must be a valid Vaccine Code  Must be an active Vaccine Code for the reported Immunization Date Program Validation Rule  If Event Detail Code is 30 – Orchitis and the Immunization Type is ‘R’ Related Immunization, the Vaccine Code must be MMR, MU or MMR-Var  If Event Detail Code is 29 – Parotitis and the Immunization Type is ‘R’ Related Immunization, the Vaccine Code must be MMR, MU or MMR-Var

Reformatting None

Table 33 - Vaccine Codes Vaccine Code 1 Type 2 Vaccine Name/Description Active 3 Start >= End <= aP A Acellular Pertussis N 1997/07/01 2001/10/31 Anth A Anthrax Y 1996/01/01 BA P Botulism Antitoxin Y 1962/06/12 BA-7 P Botulism Antitoxin Heptavalent Y 2016/12/15 BCG A Bacillus Calmette Guerin (TB) Y 1956/01/01 BAIg P Botulism Antitoxin Immune Y 2013/05/27 Globulin COVNVASub A COVID-19 Sub Unit/Nano part Y 2020/12/01 COVSGSub A COVID-19 Recomb - Sub Y 2020/12/01 Unit/Protein Nano COVAUVec A AZ-COVID-19 ChAdOx1 - NR Y 2020/12/01 viral Vector COVJANVec A COVID-19 Ad26 SARS - NR Y 2020/12/01 viral Vector COVMODmRNA A COVID-19 mRNA 1273 - Y 2020/12/01 mRNA COVPBmRNA A COVID-19 BNT162b2 - mRNA Y 2020/12/01 COVMGOVLP A COVID-19 Virus Like Partical Y 2020/12/01 COVSIIVec A SII - COVID-19 ChAdOx1 - NR Y 2020/12/01 viral Vector CH A Cholera (unspecified) H 1900/01/01 ONLY used when documenting historical records where the type of vaccine is unknown CHI A Cholera (injectable) N 1970/01/01 1999/01/01 CHO A Cholera (oral) N 1997/01/01 2010/09/23 Chol-Ecol-O A Cholera - E.coli (oral) Y 2003/02/21 D A Diphtheria Toxoid (fluid) N 1954/04/01 1994/08/01 DA P Diphtheria Antitoxin Y 1895/01/01 DD A Diphtheria Toxoid (fluid-diluted) U 1954/04/01 1994/08/01

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Vaccine Code 1 Type 2 Vaccine Name/Description Active 3 Start >= End <= No longer available for historical documentation as of 2011/05/01 DPT A Diphtheria/whole cell Pertussis/ N 1948/01/01 1997/06/30 Tetanus DPTP A Diphtheria/whole cell Pertussis/ N 1994/08/02 1997/06/30 Tetanus/ IPV DPTPHib A Diphtheria/whole cell Pertussis/ N 1994/08/02 1997/06/30 Tetanus/ IPV/Hib DRT CP Diphtheria Reaction Test N 1923/01/01 1996/01/01 DT A Diphtheria/Tetanus toxoids N 1948/01/01 1998/12/31 (pediatric) DTaP A Diphtheria/Tetanus/Acellular U 1997/07/01 1999/01/01 When documenting Pertussis historical trivalent acellular pertussis events and the vaccine type is UNKNOWN use this code if the age of the client at immunization is <12 years dTap A Diphtheria/Tetanus/Acellular U 2004/02/01 2004/02/01 Pertussis When documenting historical trivalent acellular pertussis events and the vaccine type is UNKNOWN use this code if the age of the client at immunization is = or >12 years dTap-IPV A Diphtheria/Tetanus/Acellular Y 2008/06/12 Pertussis/IPV DTaP-HB-IPV A Diphtheria/Tetanus/Acellular Y 2008/08/13 Pertussis/Hepatitis B/IPV DTaP-IPV A Diphtheria/Tetanus/Acellular Y 1997/07/01 Pertussis/IPV DTaP-IPV-Hib A Diphtheria/Tetanus/Acellular Y 1997/07/01 Pertussis/IPV/Hib DTaP-IPV-Hib-HB A Diphtheria/Tetanus/Acellular Y 2004/05/28 Pertussis/IPV/Hib/Hepatitis B DT-IPV A Diphtheria/Tetanus/IPV N 1996/07/01 2005/10/31 (pediatric) DTwP-Hib-HB A Diphtheria/Tetanus/Whole Cell H 1900/01/01 Pertussis/Hib/Hepatitis B EZM A E/Z Measles U 1969/01/01 1971/01/01 No longer available for historical

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Vaccine Code 1 Type 2 Vaccine Name/Description Active 3 Start >= End <= documentation as of 2011/05/01 FLU A Influenza Y 1939/01/01 HABV A Hepatitis A and B Y 1997/01/01 HA-Typh-I A Hepatitis A and Typhoid Y 2003/10/29 HAV A Hepatitis A Y 1994/01/01 HBIG P Hepatitis B Immune Globulin Y 1971/01/01 HbOC A Haemophilus Influenza b U 1992/05/19 1993/02/01 No longer available for historical documentation as of 2011/05/01 HBTmf A Hepatitis B Thimerosal Free U 2003/04/16 2011/05/01 No longer available for historical documentation as of 2011/05/01 HBV A Hepatitis B Y 1983/01/01 HBVD A Hepatitis B for Dialysis Y 1983/01/01 Hib A Haemophilus Influenza b Y 1993/02/01 Hib-MenC A Haemophilus Influenza H 2010/08/01 2015/02/05 b/Meningococcal Conjugate HPV A Human Papillomavirus Y 2006/07/11 2019/06/30 (Quadravalent) HPV-2 A Human Papillomavirus Y 2010/02/09 2019/06/30 (Bivalent) HPV-9 A Human Papillomavirus Y 2015/02/05 (Nonavalent) HPV-U A Human Papillomavirus H 1900/01/01 ONLY used when (unspecified) documenting historical records where the type of vaccine is unknown H1N1-09-AD A Adjuvanted Pandemic 2009 N 2009/10/19 2010/10/01 Influenza H1N1-09 A Non-Adjuvanted Pandemic N 2009/10/19 2010/10/01 2009 Influenza IG P Immune Globulin (human Y 1987/02/18 intramuscular) IPV A Inactivated Polio Y 1956/01/01 JEV A Japanese Encephalitis Y 1990/01/01 KMEA A Killed Red Measles N 1963/01/01 1970/12/31 Lym A Lymerix N 1998/12/02 2002/07/30 MEA A Measles (red) N 1970/07/01 1998/12/31 MenACs A Meningococcal Polysaccharide U 2001/01/01 2002/03/01 No longer available Bivalent (A, C) for historical documentation as of 2011/05/01 MenC-ACYW A Meningococcal Conjugate (A, Y 2006/05/03 C, Y, W-135)

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Vaccine Code 1 Type 2 Vaccine Name/Description Active 3 Start >= End <= MenconC A Meningococcal Conjugate Y 2001/06/15 Monovalent (C) MeninAC A Meningococcal Polysaccharide N 2001/01/01 2002/03/01 Bivalent (A, C) MENING A Meningococcal Polysaccharide Y 1983/05/04 2012/01/18 Quadravalent (A, C, Y, W-135) Men-B A Meningococcal B (4C, OMV Y 2013/12/09 recombinant absorbed) MenB-FHbp A Meningococcal B FHbp Y 2017/10/05 (recombinant) MenB-U A Meningococcal B (unspecified) H 1900/01/01 MENING-C A Meningococcal Conjugate H 1900/01/01 ONLY used when (unspecified) documenting historical records where the type of vaccine is conjugate but unknown serotype MENING-P A Meningococcal Polysaccharide H 1900/01/01 ONLY used when (unspecified) documenting historical records where the type of vaccine is polysaccharide but unknown serotype MENOTET A Meningococcal Polysaccharide U 1983/05/04 2000/11/01 No longer available Quadravalent (A, C, Y, W-135) for historical documentation as of 2011/05/01 MMR A Measles/Mumps/Rubella Y 1982/01/01 MMR-Var A MMR and Varicella Y 2007/07/30 MONM A Measles (Red) U 1997/04/01 1998/06/30 No longer available for historical documentation as of 2011/05/01 MR A Measles/Rubella N 1997/01/01 1999/12/31 MU A Mumps N 1982/01/01 2004/02/08 OMP A Haemophilus Influenza b U 1990/01/01 1994/08/02 No longer available for historical documentation as of 2011/05/01 OPV A Oral Polio N 1962/01/01 1994/07/31 P A Whole Cell Pertussis N 1939/01/01 1997/06/30 POL A Polio (unspecified) Y 1994/08/02 1998/12/31 PPD CP Purified Protein Derivative 5TU Y 1960/01/05 (Mantoux - TB Test) PNEU-C A Pneumococcal (7 conjugate) N 2001/01/16 2010/07/01 PNEU-C10 A Pneumococcal (10 conjugate) Y 2008/12/11 2008/12/11

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Vaccine Code 1 Type 2 Vaccine Name/Description Active 3 Start >= End <= PNEU-C13 A Pneumococcal (13 conjugate) Y 2009/12/21 PNEU-CON A Pneumococcal Conjugate H 1900/01/01 ONLY used when (unspecified) documenting historical records where the type is conjugate but the serotype is unknown PNEUMO-P A Pneumococcal (23 Y 1983/01/01 polysaccharide) PRPD A Haemophilus Influenza b U 1988/03/16 1992/05/18 No longer available for historical documentation as of 2011/05/01 RAB A Rabies Y 1980/01/01 RIG P Rabies Immune Globulin Y 1983/09/16 Rot A Rotavirus Y 2006/08/16 Rot-5 A Rotavirus (pentavalent) Y 2006/08/01 Rot-U A Rotavirus (unspecified) H 1900/01/01 RSVIg P Respiratory Syncytial Virus Y 2002/06/01 RUB A Rubella N 1971/01/01 1998/10/01 Sma A Smallpox N 1870/01/01 2015/06/01 SNAKE P Snakebite Antivenom N 1980/01/01 2002/02/03 TBEV A Tick-Borne Encephalitis Virus N 1995/06/01 2014/03/03 Td A Tetanus/Diphtheria Toxoids Y 1980/07/09 (adult) TdP A Tetanus/Diphtheria/IPV (adult) N 1984/01/10 2015/03/01 Td-IPV A Tetanus/Diphtheria/IPV Y 1984/01/10 TIG P Tetanus Immune Globulin Y 1963/12/09 TP A Tetanus Polio N 1959/01/01 1994/08/01 TT A Tetanus Toxoid N 1947/01/01 2000/12/31 TY A Typhoid (unspecified) H 1900/01/01 ONLY used when documenting historical records where the type of vaccine is unknown TYO A Typhoid Ty21a (oral) Y 1992/01/01 TYVI A Typhoid (injectable) Y 1993/11/01 Var-S A Shingles Live Y 2008/08/22 Var-SI A Shingles Inactivated Y 2016/09/01 Var-SU A Shingles (unspecified) H 1900/01/01 VZ A Varicella Zoster Y 1998/12/01 VZIG P Varicella Zoster Immune Y 1985/01/01 Globulin VZU A Varicella Zoster (unspecified) H 1900/01/01 ONLY used when documenting historical records where the type of vaccine is unknown

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Vaccine Code 1 Type 2 Vaccine Name/Description Active 3 Start >= End <= YF A Yellow Fever Y 1935/01/01  Vaccine Code 1

VACCINE SITE CODE

The Vaccine Site Code field identifies the anatomical site into which the vaccine was administered to the Adverse Event patient during a related immunization or an associated historical immunization.

Format (Length): Alpha only (4) Mandatory: Conditional  must be reported if Immunization Type equals ‘R’ – Related Immunization (non-mandatory if Immunization Type equals ‘H’ – Associated Historical Immunization)  must be reported if Administering Method Code is reported Business Rule:  Must be a valid Vaccine Site Code  If Administering Method Code equals ‘PO’ – Oral, Vaccine Site Code must be ‘MO’ – Mouth  If Administering Method Code equals ‘IN’ – Intranasal, Vaccine Site Code must be ‘NO’ – Nose Program Validation Rules: None Reformatting: None

Table 34 - Vaccine Site Codes Code Description LA Left Arm LAF Left Arm - Forearm LAL Left Arm – Lower (the lower site of two injections given in the left deltoid) LAU Left Arm – Upper (the upper site of two injections given in the left deltoid) LDG Left Dorsogluteal LL Left Leg (left vastus lateralus) LLL Left Leg – Lower (the lower site of two injections given in the left vastus lateralus) LLU Left Leg – Upper (the upper site of two injections given in the left vastus lateralus) LVG Left Ventrogluteal RA Right Arm RAF Right Arm – Forearm RAL Right Arm – Lower (the lower site of two injections given in the right deltoid) RAU Right Arm – Upper (the upper site of two injections given in the right deltoid) RDG Right Dorsogluteal RL Right Leg (right vastus lateralus) RLL Right Leg – Lower (the lower site of two injections given in the right vastus lateralus) RLU Right Leg – Upper (the upper site of two injections given in the right vastus lateralus) RVG Right Ventrogluteal LG Left Gluteal RG Right Gluteal MO Mouth MS Multiple Sites (for IG products) NO Nose WO Wound VE Vein OTH Other

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Code Description UNK Unknown

ADMINISTERING METHOD CODE

The Administering Method Code identifies the route of administration of the vaccine administered to the Adverse Event patient during a related immunization or an associated historical immunization.

Format (Length): Alpha only (3) Mandatory: Conditional  must be reported if Immunization Type equals ‘R’ – Related Immunization (non-mandatory if Immunization Type equals ‘H’ – Associated Historical Immunization)  must be reported if Vaccine Site Code is reported Business Rule:  Must be a valid Administering Method Code  If Vaccine Site Code equals ‘MO’ – Mouth, Administering Method Code must be ‘PO’ – Oral  If Vaccine Site Code equals ‘NO’ – Nose, Administering Method Code must be ‘IN’ – Intranasal  Program Validation Rules: None Reformatting: None

Table 35 - Administering Method Codes Code Description ID Intradermal IM Intramuscular IN Intranasal IV Intravenous Infusion PO Oral SC Subcutaneous INF Infiltrate UNK Unknown OTH Other

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

DOSAGE

The Dosage field identifies the amount of vaccine administered to the Adverse Event patient during a related immunization or an associated historical immunization.

Format (Length): Numeric (8,2) Mandatory: Conditional  must be reported if Immunization Type equals ‘R’ – Related Immunization (non-mandatory if Immunization Type equals ‘H’ – Associated Historical Immunization)  must be reported if Dosage Type Code is reported Business Rule: None Program Validation Rules: None Reformatting: None

Value Description 0 – 999999.99

DOSAGE TYPE CODE

The Dosage Type Code field identifies the units in which the dosage of the vaccine was administered to the Adverse Event patient during a related immunization or an associated historical immunization.

Table 36 - Dosage Type Codes Code Description End<= CAP Capsules DROP Drops 2015/12/01 GTTS Drops 2015/12/01 IU International Units 2015/12/01 MCG Micrograms 2015/12/01 MG Milligrams 2015/12/01 ML Milliliters PKG Package UNIT Units UNK Unknown

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

MANUFACTURER

The Manufacturer field identifies the company that made the vaccine administered to the Adverse Event patient during a related immunization or an associated historical immunization.

Format (Length): Alpha only (3) Mandatory: Conditional – must be reported if Immunization Type equals ‘R’ – Related Immunization (non-mandatory if Immunization Type equals ‘H’ – Associated Historical Immunization) Business Rule: Must be a valid Manufacturer Code Program Validation Rules: None Reformatting: None

Table 37 - Manufacturer Codes Code Description End<= ABV AbbVie Corporation AL Abbott Laboratories AP Aventis Pasteur (historical) 2008/01/01 AU AstraZeneca/University of Oxford AZC AstraZeneca BA Bayer (historical) 2008/01/01 BAX Baxter BC Biochem Pharma Inc (historical) 2008/01/01 BGP BGP Pharma ULC BP Berna Biotech CBS Canadian Blood ServicesF CGC Cangene Corporation CHI Chiron CON Connaught (historical) 2008/01/01 CRU Crucell CSL CSL Limited EME Emergent Biosolutions GRF Grifols GSK Glaxo-SmithKline IDB ID Biomedical IIC Institute of Immunology Inc. Croatia INB Instituto Butantan JAN Janssen/Johnson and Johnson KAM Kamada Limited MGO Medicago MF Merck Frosst MYL Mylan NB Nuron Biotech MOD Moderna NOV Novartis NVA Nonavax PFZ Pfizer PB Pfizer/BioNTech SG Sanofi/GSK SEQ Seqirus SAO SAOL Therapeutics Research Limited SF Sanofi Pasteur

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Code Description End<= SH Shire Biologies (historical) 2008/01/01 SII Serum Institute of India SKB SmithKline Beecham (historical) 2008/01/01 SP Solvay Pharma TAL Talecris VAL Valneva VIN ViNS Bioproducts Limited WA Wyeth-Ayerst UNK Unknown

LOT NUMBER

The Lot Number field identifies the manufacturer’s lot number for the vaccine administered into the Adverse Event patient during a related immunization or an associated historical immunization. It represents a code assigned to a package of several individual doses of a particular vaccine comprising a manufacturer’s unit of production.

** Immunizations with multiple Lot numbers can be submitted. See Data Submission Sample Page 67 and Appendix V – DSG File Format for Submission of Multiple Lot Numbers

Format (Length): Alphanumeric (20) Mandatory: Conditional – must be reported if Immunization Type equals ‘R’ – Related Immunization (non-mandatory if Immunization Type equals ‘H’ – Associated Historical Immunization) Business Rule: Include dashes (-) in the Lot Number where appropriate Program Validation Rules: None Reformatting: None Additional Rules for Paper Report only the key lot number for Pentacel vaccine (do not report only Forms: the DTaP-IPV portion or both the DTaP-IPV and the Hib number). Ensure the lot number is transferred to the paper form correctly. Examples:  PO-454  N-120025-1

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

NUMBER IN SERIES

The Number in Series field identifies the dose number in a vaccine series administered to the Adverse Event patient to date for the specified vaccine or in a series of related vaccines (which contain similar vaccine components or antigens). The Number in Series applies to a related immunization or an associated historical immunization.

Format (Length): Numeric (2) Mandatory: Conditional – must be reported if Immunization Type equals ‘R’ – Related Immunization (non-mandatory if Immunization Type equals ‘H’ – Associated Historical Immunization) Business Rule: If antigen code = Flu and age is greater than or equal to 9 years then antigen count = 1 None Program Validation Rules: None Reformatting: None Example:  If a child received two ‘MMR’ – Measles/Mumps/Rubella vaccines and one ‘MEA’ – Measles vaccine, the number in series at the time of submission would be three.

Value Description 0 – 99

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

ADVERSE EVENT DETAIL RECORD

RECORD TYPE

The Record Type field identifies the type of record within a data submission.

Format (Length): Alpha only (2) Mandatory: Yes Business Rule: For the Adverse Events record, the Record Type must be ‘AE’ – Adverse Event Detail record type Reformatting: None

Please refer to Table 1 – Record Type Codes in the Version record for a list of acceptable values.

RECORD NUMBER

The Record Number field is used to sequentially number each Patient, Adverse Events, Immunization and Adverse Event Detail record submitted.

Format (Length): Numeric (5) Mandatory: Yes Business Rule: None Reformatting: None

Value Description 1 – 99999

UNIQUE LIFETIME IDENTIFIER (ULI)

AEFI NUMBER

The AEFI Number field identifies a unique number assigned to each Adverse Events case by the delivery organization.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

EVENT DETAIL CODE

The Event Detail Code field identifies the adverse condition or symptom thought to be associated with the vaccine(s) administered on the Immunization Date (of the related immunization) to the Adverse Event patient.

Format (Length): Numeric (2) Mandatory: Yes Business Rule: Must be a valid Event Detail Code Program Validation Rules: None Reformatting: Incoming value will be right justified and any leading blanks will be replaced with zeros

Table 38 - Event Detail Codes Code Description Active 01 Fever Y 02 Infective Abscess Y 03 ^ Sterile Abscess or Nodule N 04 ^ Pain and/or Swelling Y 05 * Local Inflammation, Swelling, and/or Pain (Moderate Severity) N 06 Screaming Episode/Persistent Crying Y 07 ^ High Pitched Unusual Crying N 08 * Consolable Cry N 09 Convulsion/Seizure Y 10 ^ Encephalopathy N 11 ^ Meningitis and/or Encephalitis N 12 Anesthesia/Paraesthesia Lasting Over 24 Hours Y 13 Paralysis Y 14 Guillain-Barre Syndrome Y 15 Subacute Sclerosing Panencephalitis (SSPE) Y 16 Adenopathy Y 17 Anaphylaxis Y 18 Allergic Reaction Y 19 * Allergic Reaction (Mild) N 20 Erythema Multiforme Y 21 Rash Y 22 Hypotonic Hyporesponsive Episode Y 23 * Excessive Somnolence N 24 * Irritability N 25 * Coma – reported as 32 N 26 * Apnoea – reported as 32 N 27 Arthralgia/Arthritis Y 28 Severe Diarrhea and/or Vomiting Y 29 Parotitis Y 30 Orchitis Y 31 Thrombocytopenia Y 32 Other Unusual Events Y 33 Cellulitis Y 34 Sterile Abscess Y 35 Nodule Y 36 Encephalitis, ADEM, Myelitis Y 37 Meningitis Y

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Code Description Active 38 Oculo Respiratory Syndrome (ORS) Y 39 Bell's Palsy Y 40 Intussusception Y 41 AESI (Adverse Event of Special Interest) Y

* No longer reportable as of January 1, 2004 ^ No longer reportable as of January 1, 2014 ^ Removed “Severe” from description.

ADVERSE EVENT INTERVAL

The Adverse Event Interval field identifies the time interval between the time the vaccine(s) was administered (related immunization) to the Adverse Event patient and the onset of the adverse event.

Format (Length): Numeric (4,1) Mandatory: Yes Business Rule: If Adverse Event Interval type is “U” - Unknown, Adverse Event Interval must be ‘999.9’ Program Validation Rules: If the Event Detail Code is ‘17’ – Anaphylaxis, Adverse Event Interval must be less than or equal to 24 or less than or equal to 1440 If the Event Detail Code is ‘18’ – Allergic Events (Severe; Other), Adverse Event Interval must be less than or equal to 72 or less than or equal to 4320 If the Event Detail Code is ‘29’ - Parotitis, Adverse Event Interval must be greater than or equal to 5 and less than or equal to 30 If the Event Detail Code is ‘30’ - Orchitis, Adverse Event Interval must be greater than or equal to 5 and less than or equal to 30 If the Event Detail Code is ‘31’ – Thrombocytopenia, Adverse Event Interval must be less than or equal to 30 Reformatting: None Additional Rules for Paper Note the Adverse Event Interval Type for each event in minutes, hours Forms: or days.

Value Description 0 – 4599.9

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ADVERSE EVENT INTERVAL TYPE

The Adverse Event Interval Type field identifies the unit of time of the adverse event interval.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: If Adverse Event Interval type is “U”-Unknown. Adverse Event Interval must be 999.9 see page 66 Program Validation Rules: If the Event Detail Code is ‘17’ – Anaphylaxis, Adverse Event Interval Type must be ‘H’ – Hours or ‘M’ - Minutes If the Event Detail Code is ‘18’ – Allergic Events (Severe; Other), Adverse Event Interval Type must be ‘H’ – Hours or ‘M’ - Minutes If the Event Detail Code is ‘29’ – Parotitis, Adverse Event Interval Type must be ‘D’ – Days If the Event Detail Code is ‘30’ – Orchitis, Adverse Event Interval Type must be ‘D’ – Days If the Event Detail Code is ‘31’ – Thrombocytopenia, Adverse Event Interval Type must be ‘D’ – Days Additional Rules for Paper Note the Adverse Event Interval Type for each event in minutes, hours Forms: or days. Reformatting: None

Table 39 - Adverse Event Interval Type Codes Code Description M Minutes H Hours D Days Y Years U Unknown

TEMPERATURE

The Temperature field identifies the temperature of the Adverse Event patient in degrees Celsius at the time of the Adverse Events.

Format (Length): Numeric (4,1) Mandatory: Conditional  Must be reported if the Event Detail Code equals:  “01” Fever  Business Rule: Must be reported in degrees Celsius Program Validation Rules: None Reformatting: None

Please refer to Table 38 – Event Detail Codes in the Adverse Event Detail record for a list of systemic events.

Value Description 0 – 999.9

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ADENOPATHY LOCATION

The Adenopathy Location field identifies the anatomical location of the Adenopathy on the Adverse Event patient. Format (Length): Alphanumeric (50) Mandatory: Conditional – must be reported if the Event Detail Code equals:  ‘16’ – Adenopathy Business Rule: Spaces, periods, parentheses, dashes, comas, colons, slashes and pound signs are allowed Program Validation Rules: None Reformatting: None

ALLERGIC EVENTS LOCATION

The Allergic Events Location identifies the site on the Adverse Event patient’s body of the allergic Events.

Format (Length): Alphanumeric (50) Mandatory: Conditional – must be reported if the Event Detail Code equals:  ‘18’ – Allergic Events (Severe; Other)  ‘21’ – Other Rash Business Rule: Spaces, periods, parentheses, dashes, comas, colons, slashes and pound signs are allowed Program Validation Rules: None Reformatting: None

ARTHRALGIA/ARTHRITIS LOCATION

The Arthralgia/Arthritis Location field identifies the Adverse Event patient’s area(s) of the body affected by Arthralgia or the joints of the body affected by arthritis.

Format (Length): Alphanumeric (50) Mandatory: Conditional – must be reported if Event Detail Code equals:  ‘27’ – Arthralgia/Arthritis Business Rule: Spaces, periods, parentheses, dashes, comas, colons, slashes and pound signs are allowed Program Validation Rules: None Reformatting: None

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ADVERSE EVENT DURATION

The Adverse Event Duration indicates the onset of the event until it is resolved. Format (Length): Numeric (4, 1) Mandatory: Yes Business Rule: If the Adverse Event Duration Type is ‘P’ – Pending, Adverse Event Duration must be ‘888.8’.

If Adverse Event Duration Type is ‘U’ – Unknown, Adverse Event Duration must be ‘999.9’ Program Validation Rules: None Reformatting: None

Value Description 0 – 999.9

ADVERSE EVENT DURATION TYPE

The Adverse Event Duration Type identifies the unit of time of the Adverse Event Duration.

Format (Length): Alpha only (1) Mandatory: Yes Business Rule: Must be a valid Adverse Event Duration Type Code. Program Validation Rules: None Reformatting: None

Table 40 – Adverse Event Duration Type Codes Code Description M Minutes H Hours D Days Y Years P Pending U Unknown

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FOOTER RECORD

RECORD TYPE

The Record Type field identifies the type of record within a data submission.

Format (Length): Alpha only (2) Mandatory: Yes Business Rule: For the Footer record, the Record Type must be ‘AF’ – Footer record type Reformatting: None

Please refer to Table 1 – Record Type Codes in the Version record for a list of acceptable values.

TOTAL RECORD COUNT

The Total Record Count Field identifies the total number of Patient, Adverse Events, Immunization and Adverse Event Detail records included in the submission file.

Format (Length): Numeric (5) Mandatory: Yes Business Rule: None Reformatting: None

Value Description 1 – 99999

CHECKSUM

The Checksum field is the remainder that results from adding up the ASCII value of every character in all records between the Header and Footer records, and then dividing by 1,000,000. The Version record, Header record and Footer records are excluded from this calculation. For all other records, every character, including the pipe delimiters "|", is included in the calculation. Any carriage return (CR) or line feed (LF) characters are not included in the calculation.

When Alberta Health receives a submission file, the Checksum will be recalculated and compared to the one submitted in the Footer record. If the submitted Checksum does not match the Alberta Health calculated Checksum, the submission file will be rejected.

Format (Length): Numeric (6) Mandatory: Yes Business Rule: Must match the Alberta Health calculated Checksum Reformatting: None

The addition of the ASCII value of all characters between the Header and Example: Footer records is 2,935,171. This sum is then divided by 1,000,000, which leaves a remainder of 935,171. The remainder of 935,171 is the resulting Checksum for the submission file.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

6. DATA SUBMISSION SAMPLE

SAMPLE 1

AV|01| AH|25|5| AP|1|180469009|AB|180469009|||Mcpherson|Zulfioar|Acullador|MAIL|Apt 201-9717 111 St NW||||Edmonton||AM|T5K2M6||||||19620705|M|N| AA|2|180469009|12345|A|Y|20130527|20130528|Y|N|Y|Y|Y|Y|Y|Treatment Other Specify|Y|Previous Adverse Event to Immunization Specify|Y|Peanut Allergies|N|Y|Known Medical Conditions Specify|20130514|L Smith|RN|01|Description of Event(4000)|Regional Comments|20130514|25|2|Y|105|LIN Number|Y|Y|No Further Immunization With Specify|Y|ExpertType A|Y|Regional Recommendation Other Specify| AI|3|180469009|3|R|20130514|Anth|LA|ID|1.0|UNIT|AL|1|1| AI|4|180469009|3|H|20130514|Anth|LA|ID|1.5|UNIT|AL|1|1| AE|5|180469009|3|1|1.0|D|38.9||||1.0|D| AP|6|246130009|AB|246130009|||Mcpherson|Zulfioar|Acullador|MAIL|Apt 201-9717 111 St NW||||Edmonton||AM|T5K2M6||||||19620705|M|N| AA|7|246130009|4|A|Y|20130527|20130528|Y|N|Y|Y|Y|Y|Y|Treatment Other Specify|Y|Previous Adverse Event to Immunization Specify|Y|Peanut Allergies|N|Y|Known Medical Conditions Specify|20130514|Wei|MD|01|Description of Event(4000)|Regional Comments|20130514|25|2|Y|105|linNumber|Y|Y|No Further Immunization With Specify|Y|Expert A|Y|Regional Recommendation Other Specify| AI|8|246130009|4|R|20130514|Anth|LA|ID|1.0|UNIT|AL|1|1| AI|9|246130009|4|H|20130514|Anth|LA|ID|1.5|UNIT|AL|1|1| AI|10|246130009|4|H|20130515|Anth|LA|ID|2.0|UNIT|AL|1|1| AE|11|246130009|4|1|1.0|D|38.9||||1.0|D| AE|12|246130009|4|16|1.0|D||Adenopathy Location|||1.0|D| AF|12|104870|

Notes: 1) The  symbol indicates that the line will be continued. This symbol has been used for formatting of this document and should not be present in the actual data submission. 2) Null or empty values are represented as ||. 3) The above submission sample file contains:  1 Version record  1 Header record  2 Patient records  2 Adverse Events records  5 Immunization records  3 Adverse Event Detail records  1 Footer record

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

SAMPLE 2

AV|01| AH|25|6| AP|1|180469009|AB|180469009|||Mcpherson|Zulfioar|Acullador|MAIL|Apt 201-9717 111 St NW||||Edmonton||AM|T5K2M6||||||19620705|M|N| AA|2|180469009|5|A|Y|20130527|20130528|Y|N|Y|Y|Y|Y|Y|Treatment Other Specify|Y|Previous Adverse Event to Immunization Specify|Y|Peanut Allergies|N|Y|Known Medical Conditions Specify|20130514|Wei|MD|01|Description of Event (4000) |Regional Comments|20130514|25|2|Y|105|linNumber|Y|Y|No Further Immunization With Specify|Y|Expert A|Y|Regional Recommendation Other Specify| AI|3|180469009|5|R|20130514|Anth|LA|ID|1.0|UNIT|AL|1|1| AI|4|180469009|5|R|20130514|Anth|LA|ID|2.0|UNIT|AL|1|1| AI|5|180469009|5|H|20130514|Anth|LA|ID|1.5|UNIT|AL|1|1| AE|6|180469009|5|1|1.0|D|38.9||||1.0|D| AF|6|53076|

Notes: 1) The  symbol indicates that the line will be continued. This symbol has been used for formatting of this document and should not be present in the actual data submission. 2) Null or empty values are represented as ||. 3) The above submission sample file contains:  1 Version record  1 Header record  1 Patient record  1 Adverse Events records  2 Immunization records  1 Additional Immunization record  1 Adverse Event Detail records  1 Footer record

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

B. DATA SUBMISSION RESPONSE GUIDELINE

7. INTRODUCTION

The purpose of the Data Submission Response section of this document is to define the machine-readable Adverse Events to Immunization (AEFI) Data Submission Guideline (DSG) Response File layout, which identifies validation errors for submitted AEFI data.

The AEFI validation reports are generated in two formats: a human readable format and a machine- readable file, the DSG Response File. The DSG Response File combines the human readable File Rejection and File Validation reports into a machine-readable file. This document only describes the machine-readable DSG Response File.

After a submission of an AEFI DSG file, it is validated by the provincial Immunization/AEFI Application and a machine-readable DSG Response File is generated. The purpose of the DSG Response File is to provide the submitter with feedback regarding their DSG file. In particular, the DSG Response File identifies any errors found with the file or the data elements (fields) within it.

During validation, both the file and the individual fields within it are verified. If there are serious errors in the structure of the DSG file submitted, the entire file could fail, in which case no fields are processed. If the file structure passes validation, then as many individual fields are processed as possible. If a field does not comply with the AEFI Data Submission Guideline business rules, the entire event will be rejected. If an event does not comply with the AEFI program validation rules, the event will be flagged for investigation. Neither case will prevent other fields and events in the submitted file from being validated.

If an AEFI event is rejected or flagged for investigation, it will be fully validated to provide the submitter with as much information about the problems identified. This will allow the submitter to fix all known errors, increasing the likelihood that the event will be error free when it is resubmitted. As a result, an event may contain one or more error records.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

8. DSG RESPONSE FILE NAMING CONVENTION

The naming convention for DSG Response Files is ARIXXXXBBBBBBBBBB-RSP.ZIP. The ‘XXXX’ corresponds to the Submitter Prefix for the Regional Health Authority or the First Nations & Inuit Health Branch. The ’BBBBBBBBBB’ corresponds to the Batch Number for the batch submission. The ‘-RSP’ appended to the file name distinguishes the file as a DSG Response FileDSG Response File Structure

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

9. OVERVIEW

The structure of the DSG Response File is very similar to that of the DSG files submitted. It is a text file that contains a number of different record types, and each record consists of a number of pipe-delimited (|) fields. The AEFI DSG Response File consists of the following record types:

 ARV – AEFI Response Version record type  ARH – AEFI Response Header record type  ARS – AEFI Response Summary record type  ARD – AEFI Response DSG File Failure record type  ARB – AEFI Response Business Rule Failure record type  ARP – AEFI Response Program Validation Rule Failure record type  ARF – AEFI Response Footer record type

The AEFI Response Summary, AEFI Response DSG File Failure, AEFI Response Business Rule Failure and AEFI Response Program Validation Rule Failure records in the DSG Response File all have a counter field called Record Number that enumerates these records in the batch, beginning at 1. This Record Number does not occur in AEFI Response Version, AEFI Response Header or AEFI Response Footer records.

The record structure of the submission file should follow these business rules:

 Each response file must have one AEFI Response Version record. This must be the first record in the response file.  Each response file must have one AEFI Response Header record. This must be the second record in the response file.  Each response file must have one AEFI Response Footer record. This must be the last record in the response file.  The record following the AEFI Response Header record must be an AEFI Response Summary record. This provides summary information about the DSG file processed.  If the file structure of the incoming DSG file was invalid, so that the validation engine was unable to process any AEFI events, the AEFI Response Summary record will be followed by one or more AEFI Response DSG File Failure records. These specify the error(s) that prevented the DSG file from being processed.  If the file structure of the incoming file was valid, the AEFI Response Summary record will be followed by:  zero or more AEFI Response Business Rule Failure records, and  zero or more AEFI Response Program Validation Rule Failure records.

Note: Listings of error codes and descriptions (for the field ‘Error Code’) and field codes and descriptions (for the field ‘Field with Error’) are available as separate documents.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

RECORD DESCRIPTIONS

AEFI RESPONSE VERSION RECORD

The AEFI Response Version record must be the first record in the response file, and there should only be one such record. It identifies the version of the response file to follow.

Field Format Description of Contents Record Type Alpha only (3) This field must contain ‘ARV’ Response File Version Number Numeric (2) Version number of the response file; must be ‘01’

Example: ARV|01|

AEFI RESPONSE HEADER RECORD

The AEFI Response Header record must be the second record in the response file, and there should only be one such record. It contains details of the file submitted, and is used in conjunction with the Footer record to ensure that the submitter has sent a complete submission.

Field Format Description of Contents Record Type Alpha only (3) This field must contain ‘ARH’ Submitter Prefix Numeric (4) Identifies the delivery organization that submitted the DSG file Batch Number Numeric (10) Batch number, from the DSG file submission

Example: ARH|03|555555|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

AEFI RESPONSE SUMMARY RECORD

The AEFI Response Summary record will be the third record in the response file. It details when the DSG file was submitted and processed, and provides aggregate results from that file.

Field Format Description of Contents Record Type Alpha only (3) This field must contain ‘ARS’ Record Number Numeric (5) Record number, must be 1 for this record Date Submitted Numeric (8) Submission date of the DSG file, in format YYYYMMDD Time Submitted Numeric (6) Submission time of the DSG file, in format HHMMSS Date Processed Numeric (8) Processing date of the DSG file, in format YYYYMMDD Number of File Errors Numeric (6) Number of ARD type records to follow, if DSG validation failed to process the file; either this field or the DSG Records Processed should be 0 DSG Records Processed Numeric (9) Number of records in the DSG file submitted that were processed; either this field or the Number of File Errors should be 0 Number of Business Rule Numeric (6) Number of IRB records to follow; if DSG Errors validation failed to process the file, this field should be 0 Number of Program Validation Numeric (6) Number of IRP records to follow; if DSG Rule Errors validation failed to process the file, this field should be 0

Example: ARS|1|20001217|151539|20001217|0|14|3|1|

AEFI RESPONSE DSG FILE FAILURE RECORD

If the DSG file has serious errors in its structure and cannot be processed, then a minimum of one ARD records will follow the ARS record. Each one identifies a problem with the incoming DSG file. These should be followed immediately by the AEFI Response Footer (ARF) record.

Field Format Description of Contents Record Type Alpha only (3) This field must contain ‘ARD’ Record Number Numeric (5) Record number, in sequence DSG Record Number Numeric (5) DSG file record number which caused the fatal error Error Code Numeric (6) The error code that identifies the file failure condition

Example: ARD|2|345|1005|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

AEFI RESPONSE BUSINESS RULE FAILURE RECORD

One or more Business Rule Failure records appear for each field with an error. This record identifies the patient, the event and additional details, including the error that caused the event to be rejected. Rejected events are not written to the provincial Immunization/AEFI Application Event Registry.

Field Format Description of Contents Record Type Alpha only (3) This field must contain ‘ARB’ Record Number Numeric (5) Record number, in sequence Unique Lifetime Identifier Numeric (9) ULI for the patient to which the event pertains AEFI Number from DSG Numeric (9) This is the AEFI number created on the RHA system DSG Record Number Numeric (5) The DSG record number where the error occurred DSG Record Type Alpha only (2) The DSG record type where the error occurred Field with Error Alpha only (6) The field code that identifies the name of the field in the DSG record where the error occurred Reported Field Value Alphanumeric (40) The contents of the field in the DSG record where the error occurred, truncated if necessary Error Code Numeric (6) The error code that identifies why the event was rejected

Example: ARB|4|123456789|37|AP|30|Jonathan|20052|

AEFI RESPONSE PROGRAM VALIDATION RULE FAILURE RECORD

One or more Program Validation Rule Failure records appear for each event that is flagged for RHA or First Nations & Inuit Health Branch investigation. These events are written to the provincial Immunization/ AEFI Application Event Registry.

Field Format Description of Contents Record Type Alpha only (3) This field must contain ‘ARP’ Record Number Numeric (5) Record number, in sequence Unique Lifetime Identifier Numeric (9) ULI for the patient to which the event pertains Error Code Numeric (6) The error code that identifies why the event was flagged for RHA or First Nations & Inuit Health Branch investigation

Example: ARP|7|123123123|20044|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

AEFI RESPONSE FOOTER RECORD

The Response Footer record must be the last record in the response file, and there should only be one such record. It marks the end of the DSG Response File.

Field Format Description of Contents Record Type Alpha only (3) This field must contain ‘ARF’ Time Processed Numeric (6) Processing time of the DSG file, in format HHMMSS Total Record Count Numeric (5) The total number of ARS, ARD, ARE and ARP records in the batch CheckSum Numeric (6) A checksum for the response file. It is calculated by adding the ASCII value of all characters in all ARS, ARD, ARB and ARP records, then taking the remainder when the total is divided by 1,000,000

Example: ARF|235859|7|999999|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

C. AEFI REGION OF RESIDENCE REPORT FILE GUIDELINE

10. INTRODUCTION

The AEFI Region of Residence Reports are generated in two formats: a human readable format and a machine-readable file, the AEFI Region of Residence Report file. The purpose of this section is to define the machine-readable AEFI Region of Residence Report file layout. The report contains AEFI events reported to Alberta Health where the RHA of Service is not the same as the client’s RHA of Residence. The Immunization/ AEFI application, via the AEFI Region of Residence Report, will make the information regarding these events, available to the RHA of Residence.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

11. AEFI REGION OF RESIDENCE REPORT FILE NAMING CONVENTION

The naming convention for the AEFI Region of Residence Report filename is RORXXARI_YYYYMMDD_YYYYMMDD.TXT.

The “ROR” is the abbreviation for ‘Region of Residence’. The “XXXX” corresponds to the number of the RHA requesting the AEFI Region of Residence report. “ARI” indicates this is an AEFI report. The first “YYYYMMDD” corresponds to the “From” date report criterion, and the second “YYYYMMDD” corresponds to the “To” date report criterion. The “TXT” indicates that this is a text file.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

12. AEFI REGION OF RESIDENCE REPORT FILE STRUCTURE

OVERVIEW

The structure of the AEFI Region of Residence Report file is very similar to that of the DSG files originally submitted by the RHA of Service. It is a text file that contains a number of different record types, and each record consists of a number of pipe-delimited (|) fields. The AEFI Region of Residence Report file consists of the following record types:

 AV - Version record type  AH - Header record type  AP - Patient record type  AA - Adverse Events record type  AR - RHA of Service record type  AI - Immunization record type  AE - Adverse Event Detail record type  AF - Footer record type

The record structure of the AEFI Region of Residence Report file will follow these rules:

 Each report file must have one Version record. The Version record will be the first record in the report file.  Each report file will have one Header record. The Header record will be the second record in the report file.  Each report file will have one Footer record. The Footer record will be the last record in the report file.  For each Patient record there will be one Adverse Events record.  For each Patient record there will be one RHA of Service record.  For each Adverse Events record there will be one or more Immunization records.  For each Adverse Events record there will be one or more Adverse Event Detail records.  All Patient, Adverse Events, RHA of Service, Immunization and Adverse Event Detail records will be reported between the Header and Footer records.

Each field within each record type will be delimited. The only delimiter will be the pipe symbol (|).The first pipe delimiter signals the beginning of the field. The second pipe delimiter signals the end of the field. The Last Name and Given Name fields in the Patient record would be represented in the submission file as |Smith|John|.

The exception to the delimiter rule is the first field in each report record. The first field of a record will not include a delimiter at the beginning of the field. For example, a Header record will appear as AH|10|20030101|20030131|20020203|. This example does not include a delimiter at the beginning of the record. The last field of a record will always include a delimiter at the end of the field.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

RECORD DESCRIPTIONS

VERSION RECORD

Field Format Description of Contents Record Type Alpha only (2) This field will contain ‘AV’ DSG Version Number Numeric (2) Identifies which version of the Data Submission Guideline the report file adheres to

Example: AV|01|

HEADER RECORD

The Header record will be the second record in the report file. It contains information that is used to identify the requestor, reporting period and the date and time of the request. The Header record is used in conjunction with the Footer record to ensure that Alberta Health has created a complete report file. Consequently, it assists in the follow up and tracking of requested report data.

Field Format Description of Contents Record Type Alpha only (2) This field will contain ‘AH’ Requestor RHA Prefix Numeric (4) This is the number of the RHA requesting the report Reporting Period From Date Numeric (8) Start date of the time period for which the report was requested in YYYYMMDD format Reporting Period To Date Numeric (8) End date of the time period for which the report was requested in YYYYMMDD format Report Request Date Numeric (14) Date and time when the report was requested in YYYYMMDDHHMMSS format

Example: AH|10|20030101|20030131|20030203143025|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

PATIENT RECORD

The Patient record contains all the required patient demographic data. Listed below is the layout of the record. NOTE: The description of the fields may be found in the Data Elements sub-section of the Section A. Data Submission Guideline section of this document.

Field Format Description of Contents Record Type Alpha only (2) This field will contain ‘AP’ Record Number Numeric (5) See the Data Elements sub-section. Unique Lifetime Identifier (ULI) Numeric (9) See the Data Elements sub-section. Provincial Health Number Type Alpha only (2) See the Data Elements sub-section. Provincial Health Number Alphanumeric (15) See the Data Elements sub-section. Alternate Person Identifier Type Alpha only (4) See the Data Elements sub-section. Alternate Person Identifier Alphanumeric (15) See the Data Elements sub-section. Last Name Alpha only (50) See the Data Elements sub-section. Given Name Alpha only (50) See the Data Elements sub-section. Middle Name Alpha only (50) See the Data Elements sub-section. Address Type Alpha only (4) See the Data Elements sub-section. Street Address 1 Alphanumeric (35) See the Data Elements sub-section. Street Address 2 Alphanumeric (35) See the Data Elements sub-section. Street Address 3 Alphanumeric (35) See the Data Elements sub-section. Street Address 4 Alphanumeric (35) See the Data Elements sub-section. City Name Alphanumeric (60) See the Data Elements sub-section. Province Code Alpha only (3) See the Data Elements sub-section. Country Code Alpha only (2) See the Data Elements sub-section. Postal Code Alphanumeric (12) See the Data Elements sub-section. Quarter Section Code Alpha only (2) See the Data Elements sub-section. Section Numeric (2) See the Data Elements sub-section. Township Numeric (3) See the Data Elements sub-section. Range Numeric (2) See the Data Elements sub-section. Meridian Numeric (1) See the Data Elements sub-section. Birth Date Numeric (8) See the Data Elements sub-section. Gender Code (1) Alpha only (1) See the Data Elements sub-section. Homeless/Indigent Alpha only (1) See the Data Elements sub-section.

Example: AP|1|890980089|AB|890980089|||Reed|Steve|Allan|MAIL|5334 103 Avenue||||Edmonton|AB|CA|T5J3G2||||||19831028|M|Y|

Note: The  symbol indicates that the line will be continued. This symbol has been used for formatting of this document and will not be present in the actual report file.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

ADVERSE EVENT RECORD

The Adverse Event record contains information related to the Adverse Events to immunization event. Listed below is the layout of the record.

NOTE: The description of the fields may be found in the Data Elements sub-section of the Section A. Data Submission Guideline section of this document.

Field Format Description of Contents Record Type Alpha only (2) This field will contain ‘AA’ Record Number Numeric (5) See the Data Elements sub-section. Unique Lifetime Identifier (ULI) Numeric (9) See the Data Elements sub-section. AEFI Number Numeric (9) See the Data Elements sub-section. Submission Type Not Used Will be null in the report record. Required Hospitalization Alpha only (1) See the Data Elements sub-section. Admission Date Numeric (8) See the Data Elements sub-section. Discharge Date Numeric (8) See the Data Elements sub-section. Emergency Room Alpha only (1) See the Data Elements sub-section. Advice From a Health Professional Alpha only (1) See the Data Elements sub-section. Treatment for Adverse Events Alpha only (1) See the Data Elements sub-section. Treatment by Analgesic/Antipyretic Alpha only (1) See the Data Elements sub-section. Treatment by Epinephrine Alpha only (1) See the Data Elements sub-section. Treatment by Antihistamine Alpha only (1) See the Data Elements sub-section. Treatment by Other Alpha only (1) See the Data Elements sub-section. Treatment by Other Specify Alphanumeric (40) See the Data Elements sub-section. Previous Adverse Event to Alpha only (1) See the Data Elements sub-section. Immunization Previous Adverse Event to Alphanumeric (40) See the Data Elements sub-section. Immunization Specify History of Allergies Alpha only (1) See the Data Elements sub-section.

Allergy List Specify Alphanumeric See the Data Elements sub-section. (1600) History of Convulsions Alpha only (1) See the Data Elements sub-section. Known Medical Conditions Alpha only (1) See the Data Elements sub-section. Known Medical Conditions Specify Alphanumeric See the Data Elements sub-section. (1600) Report Date Numeric (8) See the Data Elements sub-section. Reporter Alphanumeric (40) See the Data Elements sub-section. Reporter Designation Alpha only (10) See the Data Elements sub-section. Outcome of Events Numeric (2) See the Data Elements sub-section. Description of Event Alphanumeric See the Data Elements sub-section. (4000) Regional Recommendations Alphanumeric See the Data Elements sub-section. Comments (1600) Regional Recommendations Numeric (8) See the Data Elements sub-section. Comments Date Associated Submitter Prefix Numeric (4) See the Data Elements sub-section. Associated AEFI Number Numeric (9) See the Data Elements sub-section. CMOH Advise Requested Indicator Alpha only (1) See the Data Elements sub-section. Delivery Management Site Alphanumeric (5) See the Data Elements sub-section. LIN Number Alphanumeric (11) See the Data Elements sub-section. Change to Immunization Schedule Alpha Only (1) See the Data Elements sub-section

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Field Format Description of Contents No Further Immunization Alpha Only (1) See the Data Elements sub-section No Further Immunization Specify Alphanumeric (40) See the Data Elements sub-section Expert Referral Alpha Only (1) See the Data Elements sub-section Expert Referral Type Alphanumeric (40) See the Data Elements sub-section Regional Recommendations Other Alpha Only (1) See the Data Elements sub-section Regional Recommendations Other Alphanumeric (40) See the Data Elements sub-section Specify

Example: AA|2|890980089|12345|A|Y|19990514|19990515|Y|N|Y|Y|Y|Y|Y|Treatment Other  Specify|Y|PreviousAEFISpec ify|Y|Peanut Allergies|N|Y|Known Medical Conditions Specify  |20130514|L Smithi|RN|01|Description of Event (4000)|Regional Comments  |20130514|25|2|Y|105|LINNumber|Y|Y|NoFurtherImmSpecify|Y|ExpertA|Y|RegionalRecomOtherSpecify|

Note: The  symbol indicates that the line will be continued. This symbol has been used for formatting of this document and will not be present in the actual report file.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

RHA OF SERVICE RECORD

The RHA of Service record contains information regarding the region that originally submitted the ARI event information to AH&W. Listed below is the layout of the record.

Field Format Description of Contents Record Type Alpha only (2) This field will contain ‘AR’ RHA of Service Numeric (2) Identifies which RHA originally submitted the AEFI event information to AH&W Example: AR|07|

IMMUNIZATION RECORD

The Immunization record describes related immunizations and associated historical immunizations. A related immunization is an immunization that is either temporally or causally related to the Adverse Events to immunization event being reported. An associated historical immunization is a previous immunization containing the same vaccine or related antigens as those contained in the related immunization; or any immunization administered within one month (30 days) prior to the Immunization Date of the related immunization. A minimum of one Immunization record will appear in the report file for each Adverse Events record. An Immunization record will be reported for each vaccine given on the Immunization Date thought to be related to the Adverse Events to immunization event being reported by the RHA of Service. Listed below is the layout of the record.

Field Format Description of Contents Record Type Alpha only (2) This field will contain ‘AI’ Record Number Numeric (5) See the Data Elements sub-section. Unique Lifetime Identifier (ULI) Numeric (9) See the Data Elements sub-section. AEFI Number Numeric (9) See the Data Elements sub-section. Immunization Type Alpha only (1) See the Data Elements sub-section. Immunization Date Numeric (8) See the Data Elements sub-section. Vaccine Code Alphanumeric (15) See the Data Elements sub-section. Vaccine Site Code Alpha only (4) See the Data Elements sub-section. Administering Method Code Alpha only (3) See the Data Elements sub-section. Dosage Numeric (8,2) See the Data Elements sub-section. Dosage Type Code Alpha only (4) See the Data Elements sub-section. Manufacturer Alpha only (3) See the Data Elements sub-section. Lot Number Alphanumeric (20) See the Data Elements sub-section. Number in Series Numeric (2) See the Data Elements sub-section.

Example: AI|3|890980089|12345|R|19990513|HBV|LA|IM|0.5|ML|CON|11110|1| AI|4|890980089|12345|H|19990503|Td|||2|ML|||4|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

ADVERSE EVENT DETAIL RECORD

Adverse Event Detail records are used to provide the required information about the Adverse Events to support the Provincial Health Officer (PHO) when consulting with a Medical Officer of Health (MOH) on a specific patient. An Adverse Event Detail record will be reported for each adverse event or Events thought to be associated with the immunization given on the specified Immunization Date. A minimum of one Adverse Event Detail record will be reported for each Adverse Events record. Listed below is the layout of the record.

Field Format Description of Contents Record Type Alpha only (2) This field will contain ‘AE’ Record Number Numeric (5) See the Data Elements sub-section. Unique Lifetime Identifier (ULI) Numeric (9) See the Data Elements sub-section. AEFI Number Numeric (9) See the Data Elements sub-section. Event Detail Code Numeric (2) See the Data Elements sub-section. Adverse Event Interval (Onset) Numeric (4,1) See the Data Elements sub-section. Adverse Event Interval Type Alpha only (1) See the Data Elements sub-section. (Onset) Temperature Numeric (4,1) See the Data Elements sub-section. Adenopathy Location Alphanumeric (50) See the Data Elements sub-section. Allergic Events Location Alphanumeric (50) See the Data Elements sub-section. Arthralgia/Arthritis Location Alphanumeric (50) See the Data Elements sub-section. Adverse Event Duration Numeric (4,1) See the Data Elements sub-section. Adverse Event Duration Type Alpha only (1) See the Data Elements sub-section.

Example: AE|6|111111111|12345|1|1.0|D|38.9||||1.0|D|

FOOTER RECORD

The Footer record provides summary information on the reported data. The Footer record in conjunction with the Header record completes the reporting of AEFI data. The Footer record also provides a total count of the Patient, Adverse Events, RHA of Service, Immunization and Adverse Event Detail records reported (Total Record Count). Listed below is the layout of the record.

Field Format Description of Contents Record Type Alpha only (2) This field will contain ‘AF’ Total Record Count Numeric (5) The total number of AP, AA, AR, AI and AE records in the report file. Checksum Numeric (6) A checksum for the report file. It is calculated by adding the ASCII value of all characters in all AP, AA, AR, AI and AE records, then taking the remainder when the total is divided by 1,000,000

Example: AF|43|243580|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

D. APPENDICES APPENDIX I - GENERAL REPORTING GUIDELINES

Adverse Events to Immunizing Agents – Alberta

Introduction

An Adverse Event following immunization event is defined as an untoward event temporally associated with immunization that may or may not have been caused by the vaccine or the immunization process. Reporting and monitoring Adverse Events is an important part in the post-marketing surveillance of vaccines, confirming results of pre-licensure clinical trials, and providing a process to identify any previously unknown concerns for each product. To provide the best analysis of reactogenicity of each vaccine, Health Canada and the vaccine manufacturers depend on accurate, ongoing reporting of AEFI events from the health care workers who administer the vaccines.

Another benefit of local reporting is to provide up to date data on the current safety of the specific vaccines used in Alberta. This provides health care workers with the best information to use in discussion with clients and parents about vaccine safety.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

APPENDIX II - PROCESS OVERVIEW

All Adverse Events following immunization events involving the administration of provincially funded vaccines and privately purchased must be submitted to Alberta Health through the Alberta Health Services Centralized AEFI team. See Adverse Event Following Immunization (AEFI) Reporting for All Health Care Practitioners in Alberta. The AHS Centralized AEFI team will submit the AEFI by electronic means to Alberta Health.

Consultation with the Provincial Health Officer (PHO) or designate is available to the MOH/designate upon request. The requests should be specific, requesting causality assessment, or individual case management advice, including recommendations for future immunization for the client.

Provincial reporting requirements apply regardless of where the client resides (within Alberta or outside of the province) or who administered the vaccine (Alberta public health, physician, occupational health, etc.).

Non identifiable reports are forwarded to the Public Health Agency of Canada (PHAC) to become part of national summary data and for individual case causality assessment as requested.

Parents/guardians, adolescents and other adults should be counseled to report Adverse Events to immunization events following immunization to a health practitioner. Information should be collected and reported with or without clear evidence of causality. All information about AEFI events that meet the criteria for reporting, as well as other severe or unusual Events, should be collected from the client or parent/guardian and any health practitioner who assessed the event. At any subsequent immunization visit, health practitioners should inquire about previous Adverse Events and gather information from the client or parent/guardian.

See Adverse Events Following Immunization Policy for Alberta Immunization Providers for additional information and definitions of reportable AEFIs to Alberta Health.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Summary – General Reporting Guidelines

Report all events following an immunization with provincially and non-provincially funded vaccine, regardless who administered the vaccine, that meet the criteria for each adverse event as well as any other severe, unusual event temporally related to the immunization.

 Do not report minor events that do not meet the minimum reporting criteria listed for each category (such as one 15 minute episode of crying, vomiting once, followed by pallor).  Ensure complete information is available for each category that requires definition of the location of the Events (site), measurement (temperature or size) or duration of the event (hours).  Report only specific information in the Further Details field that is not captured elsewhere for the event. If more space is required, send extra nurses notes or paper sheets (typed) to submit further information (do not submit additional paper forms for this purpose).  For both electronic submission and manual paper submission, when submitting extra information on paper, ensure the AEFI Number is clearly marked on each extra sheet of paper. Note in the Further Details field that extra information is being submitted by paper.

Amendment/New Event Submission Deadlines

The provincial Immunization/Adverse Events to Immunization Application will apply program validation rules to Adverse Events following immunization events submitted by AHS.. If an event does not meet the criteria of the program validation rules, it will be flagged and appear on the File Validation Report for AHS to investigate and resubmit. Point Service systems must have the ability to update and resubmit records to Alberta Health.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

APPENDIX III – GLOSSARY

Adverse Event Identifies the Adverse Events, condition or symptom thought to be associated with the vaccine(s) administered on the immunization date to the Adverse Events client.

Adverse Events to A case report that includes the details of an adverse event (Events, Immunization Event condition or symptom) thought to be associated to a vaccine, details of the immunization event, and subsequent interventions and case management details. The case report may or may not include causality assessment. An Adverse Events to immunization case may have more than one adverse event associated with it.

Associated AEFI An associated Adverse Events is one previously reported and temporally related to a previous immunization received by the client. An Associated AEFI may or may not be related to an immunization with the same vaccine or with related vaccines. An Associated AEFI Number and Associated Submitter Prefix should be reported when the reporter believes these previous Adverse Events provide significant information relating to the current AEFI.

Data Submission Guideline Defines the required file layout, the record structure and the field lengths and business rules for the submission of immunization or AEFI data.

Effective Antigen A valid antigen of a vaccine administered to a client that counts towards their complete immunization for a particular disease. Only effective antigens are included in the calculation of immunization coverage rates.

Flagged Event An immunization, not immunized or Adverse Events to immunization that has been flagged for regional health authority investigation and review. All flagged events are communicated back to the submitting RHA for their action.

Immunization Event The provision of an immunization service to a recipient by a provider at a given time when an assessment with the intention of immunizing, or the administration of a vaccine, or a past unreported immunization

Not Immunized Event The provision of an immunization service to a recipient by a provider at a given time where a vaccine is not administered.

Program Reporting Guide Defines the program validation rules applicable to immunization, not immunized and Adverse Events to immunization events.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

APPENDIX IV – CONTACT INFORMATION

Role (IMM team) Name Phone Fax E-mail Business & Information Analyst Jill Svenson 780-422-4770 780-415-9609 [email protected] Director, CD/Immunization Céline O’Brien 780-415-1101 780-415-9609 [email protected] Manager, Immunization Business Kari Bergstrom 780-644-0004 780-422-6663 [email protected] Manager, Immunization Policy Susan Smith 780-643-1726 780-422-6663 [email protected]

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

APPENDIX V – DSG FILE FORMAT FOR SUBMISSION OF MULTIPLE LOT NUMBERS

ARI DSG File Format for Submission of Multiple Lot Numbers

There is a requirement to facilitate submission of multiple lot #s for an ARI event. This enhancement is optional and does not impact the existing format of submissions. The following method of submissions should be followed for the new enhancement. The sample submissions shown are simulated and are used for illustration purposes.

Previous Format

AP|1|111111111|AB|111111111|||Adams|Jennifer|Lynn|PHYS|1234 River St.||||Edmonton|AB|CA|T5N4A3||||||19991218|F|Y| AA|2|111111111|12345|A|Y|20000629|20000630|Y|N||Y|20000701|Y|Y|N|N|N||N|N|N||N||20000702|Dr. Smith|01|Admitted to Royal Alexander hospital. The patient maintained a high fever for several hours. Tylenol was given every 6 hours.|No long-term effects were experienced by the patient.|20000704|||N|N|MR| AI|3|111111111|12345|R|20000627|DTaP-IPV-Hib|LA|IM|0.5|ML|CON|1-N04586|3| AI|4|111111111|12345|H|20000422|DTaP-IPV-Hib|||||||2| AE|5|111111111|12345|01|4.5|H|40.1|O|||||||50|M|

In the above record there are two immunization events for

ULI = 111111111 ARI = 12345

Currently ImmARI cannot accept events repeating for an immunization date and vaccine.

If it has additional information on Vaccine Site Code, Dosage, Administration Method, and Lot Number it can be submitted in the new format

Current Format

AP|1|111111111|AB|111111111|||Adams|Jennifer|Lynn|PHYS|1234 River St.||||Edmonton|AB|CA|T5N4A3||||||19991218|F|Y| AA|2|111111111|12345|A|Y|20000629|20000630|Y|N||Y|20000701|Y|Y|N|N|N||N|N|N||N||20000702|Dr. Smith|01|Admitted to Royal Alexander hospital. The patient maintained a high fever for several hours. Tylenol was given every 6 hours.|No long-term effects were experienced by the patient.|20000704|||N|N|MR| AI|3|111111111|12345|R|20000627|DTaP-IPV-Hib|LA|IM|0.5|ML|CON|1-N04586|3| AI|4|111111111|12345|R|20000627|DTaP-IPV-Hib|RA|SC|0.75|ML|CON|1-N04600|3| AI|5|111111111|12345|H|20000422|DTaP-IPV-Hib|||||||2| AE|6|111111111|12345|01|4.5|H|40.1|O|||||||50|M|

 The additional events can differ in dosage, administration method, vaccine site, and lot number.  Manufacturer code, dosage type, and number in series must be the same for the additional events. Otherwise it will be flagged.  Any record not following above rules will be rejected. All other normal rules for rejections apply.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

AEFI:

Field Whether it need to be the same for all the records for the same event (Y/N) Record Type Y – All are AI types Record Number N – Different sequence number Unique Lifetime Identifier (ULI) Y – Must be same ARI Number Y – Must be same Immunization Type Y – Must be same Immunization Date Y – Must be same Vaccine Code Y – Must be same Vaccine Site Code N – Can be different Administering Method Code N – Can be different Dosage N – Can be different Dosage Type Code Y – Must be same Manufacturer Y – Must be same Lot Number N – Can be different Number in Series Y – Must be same

Currently the blue highlighted fields are used to identify a unique ARI event. If the same combination is submitted again it will be rejected. This business rule still applies to all the events. But within a block of events occurring on the same day + vaccine, highlighted fields are considered. If they are all repeated in any event the whole block will be rejected.

If the dosage type, manufacturer or number-in-series are not the same, it will be flagged.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Examples of Rejected Formats

1) AP|1|111111111|AB|111111111|||Adams|Jennifer|Lynn|PHYS|1234 River St.||||Edmonton|AB|CA|T5N4A3||||||19991218|F|Y| AA|2|111111111|12345|A|Y|20000629|20000630|Y|N||Y|20000701|Y|Y|N|N|N||N|N|N||N||20000702|Dr. Smith|01|Admitted to Royal Alexander hospital. The patient maintained a high fever for several hours. Tylenol was given every 6 hours.|No long-term effects were experienced by the patient.|20000704|||N|N|MR| AI|3|111111111|12345|R|20000627|DTaP-IPV-Hib|LA|IM|0.5|ML|CON|1-N04586|3| AI|4|111111111|12346|R|20000627|DTaP-IPV-Hib|RA|SC|0.75|ML|CON|1-N04600|3| AI|5|111111111|12345|H|20000422|DTaP-IPV-Hib|||||||2| AE|6|111111111|12345|01|4.5|H|40.1|O|||||||50|M|

Here the whole block is rejected because ARI number is different in the additional immunization record.

Examples of Flags

1) AP|1|111111111|AB|111111111|||Adams|Jennifer|Lynn|PHYS|1234 River St.||||Edmonton|AB|CA|T5N4A3||||||19991218|F|Y| AA|2|111111111|12345|A|Y|20000629|20000630|Y|N||Y|20000701|Y|Y|N|N|N||N|N|N||N||20000702|Dr. Smith|01|Admitted to Royal Alexander hospital. The patient maintained a high fever for several hours. Tylenol was given every 6 hours.|No long-term effects were experienced by the patient.|20000704|||N|N|MR| AI|3|111111111|12345|R|20000627|DTaP-IPV-Hib|LA|IM|0.5|ML|CON|1-N04586|3| AI|4|111111111|12346|R|20000627|DTaP-IPV-Hib|RA|SC|0.75|ML|CON|1-N04600|4| AI|5|111111111|12345|H|20000422|DTaP-IPV-Hib|||||||2| AE|6|111111111|12345|01|4.5|H|40.1|O|||||||50|M|

The whole block is flagged because the number in series is not the same in the additional immunization event.

2) AP|1|111111111|AB|111111111|||Adams|Jennifer|Lynn|PHYS|1234 River St.||||Edmonton|AB|CA|T5N4A3||||||19991218|F|Y| AA|2|111111111|12345|A|Y|20000629|20000630|Y|N||Y|20000701|Y|Y|N|N|N||N|N|N||N||20000702|Dr. Smith|01|Admitted to Royal Alexander hospital. The patient maintained a high fever for several hours. Tylenol was given every 6 hours.|No long-term effects were experienced by the patient.|20000704|||N|N|MR| AI|3|111111111|12345|R|20000627|DTaP-IPV-Hib|LA|IM|0.5|ML|CON|1-N04586|3| AI|4|111111111|12345|R|20000627|DTaP-IPV-Hib|RA|SC|0.75|ML|AP|1-N04600|3| AI|5|111111111|12345|H|20000422|DTaP-IPV-Hib|||||||2| AE|6|111111111|12345|01|4.5|H|40.1|O|||||||50|M|

The whole block is flagged because the manufacturer is not the same in the additional immunization event.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Change

Example

AP|1|111111111|AB|111111111|||Adams|Jennifer|Lynn|PHYS|1234 River St.||||Edmonton|AB|CA|T5N4A3||||||19991218|F|Y| AA|2|111111111|12345|C|Y|20000629|20000630|Y|N||Y|20000701|Y|Y|N|N|N||N|N|N||N||20000702|Dr. Smith|01|Admitted to Royal Alexander hospital. The patient maintained a high fever for several hours. Tylenol was given every 6 hours.|No long-term effects were experienced by the patient.|20000704|||N|N|MR| AI|3|111111111|12345|R|20000627|DTaP-IPV-Hib|LA|IM|0.5|ML|CON|1-N04586|3| AI|4|111111111|12345|R|20000627|DTaP-IPV-Hib|RA|SC|0.75|ML|CON|1-N04600|3| AI|5|111111111|12345|H|20000422|DTaP-IPV-Hib|||||||2| AE|6|111111111|12345|01|4.5|H|40.1|O|||||||50|M|

Delete

It is encouraged to submit whole block for deletion.

Example

AP|1|111111111|AB|111111111|||Adams|Jennifer|Lynn|PHYS|1234 River St.||||Edmonton|AB|CA|T5N4A3||||||19991218|F|Y| AA|2|111111111|12345|D|Y|20000629|20000630|Y|N||Y|20000701|Y|Y|N|N|N||N|N|N||N||20000702|Dr. Smith|01|Admitted to Royal Alexander hospital. The patient maintained a high fever for several hours. Tylenol was given every 6 hours.|No long-term effects were experienced by the patient.|20000704|||N|N|MR| AI|3|111111111|12345|R|20000627|DTaP-IPV-Hib|LA|IM|0.5|ML|CON|1-N04586|3| AI|4|111111111|12345|R|20000627|DTaP-IPV-Hib|RA|SC|0.75|ML|CON|1-N04600|3| AI|5|111111111|12345|H|20000422|DTaP-IPV-Hib|||||||2| AE|6|111111111|12345|01|4.5|H|40.1|O|||||||50|M|

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

APPENDIX VI - DOCUMENT REVISIONS

Version Date Revision Description 7.2 March 2021 Submitter Codes (Table 2) End dated Submitter Codes:  413 Calgary Zone  417 North Zone  418 South Zone  419 Central Zone

Added Submitter Code:  90 OKAKI Community Clinic

Changed Description for Submitter Code 416 Edmonton Zone to Connect Care

Delivery Management Sites (Table 27) Added Delivery Management Sites:  198 Telus Convention Centre  372 Medicine Place  373 Bow Trail  374 Macleod South  375 Safeway 8803 Northgate  376 Safeway 8816 Market Mall  377 Safeway 8879 Manning Crossing  378 Safeway 8891 Westmount Centre  379 Safeway 8892 Northgate Centre  380 Safeway 8904 Southgate  381 Safeway 8905 Jasper Gates  382 Safeway 8913 North Hill Centre  383 Safeway 8916 Montgomery  384 Safeway 8928 Abbotsfield Mall  385 Edmonton West Centre  386 Genesis Centre  387 Guardian Drugs Medicine Chest  388 Safeway 8989 South Trail  389 Carebridge RemedyRx  390 Wabamun Pharmacy  391 Health Net Pharmacy  392 Medicine Shoppe 170  393 Medicine Shoppe 225  394 Londondale Guardian Pharmacy  901 OKAKI Community Clinic  902 AFCC

Vaccine Codes (Table 33) Added Vaccine Code:  COVSIIVec SII - COVID-19 ChAdOx1 - NR viral Vector

Manufacturer Codes (Table 37) Added Manufacturer Code:  SII Serum Institute of India

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Event Detail Codes (Table 38) Added Event Detail Code:  AESI (Adverse Event of Special Interest) 7.1 December 2020 Delivery Management Sites (Table 27) Added Delivery Management Sites:  355 AHS Calgary Zone  356 AHS Edmonton Zone  357 AHS North Zone  358 AHS South Zone  359 AHS Central Zone  360 South Calgary Health Centre  361 South Park Center (Leased)  362 Brooks Health Centre Hospital  363 Cardston Health Centre Hospital  364 Fort McMurray Wolverine Community Health Centre  365 Medicine Hat Regional Hospital  366 NorthGate Village Mall  367 Oyen Big Country Hospital  368 Pincher Creek Health Centre Hospital  369 Skyview Power Centre  370 Taber Health Centre Hospital  371 Wainwright COVID Testing Site

End Dated Delivery Management Sites:  334 EDM Royal Alexandra Hospital - Pharmacy  335 EDM WMC Kaye Edmonton Clinic – 3A  336 EDM Edmonton General Continuing Care Centre - NARP  337 EDM RAH Community Services Centre – HIV  338 EDM WMC Stollery Children's Hospital  339 EDM RAH Community Services Centre - NARP  340 EDM WMC Health Sciences Centre - NARP Unit 5C2  341 EDM WMC Health Sciences Centre - NARP Unit 5B1  342 STO Westview Health Centre - Pharmacy  343 EDM Alberta Hospital Edmonton - Pharmacy  344 STA Sturgeon Community Hospital - Pharmacy  345 EDM WMC Health Sciences Centre - Pharmacy  346 EDM Lynnwood Family Medicine Clinic  347 EDM RAH Anderson Hall - Indigenous Wellness Clinic  348 EDM WMC Stollery Children’s Hospital - Pediatric Clinical Investigation Unit

Vaccine Codes (Table 33) Added Vaccine Codes:  COVNVASub COVID-19 Sub Unit/Nano part  COVSGSub COVID-19 Recomb - Sub Unit/Protein Nano  COVAUVec COVID-19 ChAdOx1 - NR viral Vector

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description  COVJANVec COVID-19 Ad26 SARS - NR viral Vector  COVMODmRNA COVID-19 mRNA 1273 – mRNA  COVPBmRNA COVID-19 BNT162b2 – mRNA  COVMGOVLP COVID-19 Virus Like Partical

Manufacturer Codes (Table 37) Added Manufacturer Codes:  AU AstraZeneca/University of Oxford  JAN Janssen/Johnson and Johnson  MGO Medicago  MOD Moderna  NVA Novavax  PB Pfizer/BioNTech  SG Sanofi/GSK

7.0 June 2020 Submitter Prefix Codes (Table 2) Added Submitter Prefix Code:  36 Southern Alberta Institute of Technology  37 International Paper Grande Prairie Health Department  413 Calgary Zone  417 North Zone  418 South Zone  419 Central Zone  100 Direct Form Submitter

Delivery Management Site Codes (Table 27) Added Delivery Management Site Code:  353 SAIT Health Services  354 International Paper Grande Prairie  99009 Direct form Immunizers

Removed End date of Delivery Management Site:  151 Red Deer 49 Street Community Health Centre

Vaccine Codes (Table 33) Added Historical Vaccine Code:  Var-SU Shingles (unspecified)

Manufacturer Code (Table 37) Added Manufacturer codes:  BGP BGP Pharma ULC  KAM Kamada Limited

Removed Business rules for First Name, Middle Name and Last Name Updated Batch Number Reformatting

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Updated: Data Submission Guideline  Introduction  Submission File Naming Convention

Appendix B Data Submission Response Guideline  Introduction  DSG Response File Naming Convention

Appendix II - Process Overview 6.9 January 2020 Format Changes:  Submitter Prefix Numeric (4)  Batch Number Numeric (10)  Delivery Management Site Alphanumeric 5

Submitter Prefix Codes (Table 2) Added Submitter Prefix Code:  416 Edmonton Zone

Delivery Management Site Codes (Table 27) Added Delivery Management Site Code:  333 Medicine Shoppe 365 Sherwood Park  334 EDM Royal Alexandra Hospital - Pharmacy  335 EDM WMC Kaye Edmonton Clinic – 3A Medicine Clinic  336 EDM Edmonton General Continuing Care Centre - NARP  337 EDM RAH Community Services Centre - HIV  339 EDM RAH Community Services Centre - NARP  340 EDM WMC Health Sciences Centre - NARP Unit 5C2  341 EDM WMC Health Sciences Centre - NARP Unit 5B1  342 STO Westview Health Centre - Pharmacy  343 EDM Alberta Hospital Edmonton - Pharmacy  344 STA Sturgeon Community Hospital - Pharmacy  345 EDM WMC Health Sciences Centre - Pharmacy  346 EDM Lynnwood Family Medicine Clinic  347 EDM RAH Anderson Hall - Indigenous Wellness Clinic  348 EDM WMC Stollery Children’s Hospital - Pediatric Clinical Investigation Unit  350 Safeway 8841 South Centre  351 University of Calgary Staff Wellness Health Sciences  352 Safeway 8924 Sherwood Park Mall

Vaccine Codes (Table 33) Added Historical Vaccine Code:  DTwP-Hib-HB - Diphtheria/Tetanus/Whole Cell Pertussis/Hib/Hepatitis B

Manufacturer Code (Table 37) Added Manufacturer codes:  SAO SAOL Therapeutics Research Limited 6.8 August 2019 Changed the description of Immunization Record on page 6 (associated and related immunization)

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Submitter Prefix Codes(Table 2) Added Submitter Code :  35 - University of Calgary

Delivery Management Site Codes (Table 27) Added Delivery Management Site Code:  197 - Calgary Southport  330 - Safeway 8833 Crowfoot (Calgary)  331 – Two Pharmacy (Cochrane)  332 – University of Calgary Staff Wellness  995 - Administered outside of AHS Public Health

End Dated Delivery Management Site Code:  151- Red Deer 49 Street Community Health Centre

Changed Description of Delivery Management Codes :  071 - Jasper to Jasper Public Health  139 - High Level to High Level Public Health  159 - Sacred Heart CHC to McLennan Public Health

Vaccine Codes (Table 33) Added Vaccine Codes:  MenB-U - Meningococcal B (unspecified)

End dated Vaccine Codes:  Hib-Menc  HPV  HPV-2  MENING  PNEU-C10

Vaccine Site Codes: (Table 34) Added Vaccine Site Codes:  LVG - Left Ventrogluteal  RVG - Right Ventrogluteal  LDG – Left Dorsogluteal  RDG – Right Dorsogluteal

Manufacturer Code (Table 37) Added Manufacture codes:  EME Emergent Biosolutions 6.7 September 2018 Submitter Prefix Codes(Table 2)  33 - Workplace Health and Safety – AHS  34 - Workplace Health and Safety – Covenant Health  45 - Fort McKay First Nation  46 – Alexis First Nation

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description  47 – Beaver First Nation  48 – Lubicon Lake Nation

Vaccine Codes (Table 33) Added Vaccine Codes:  Var-SI Shingles Inactivated  MenB-FHbp Meningococcal B FHbp (recombinant)

Changed description of Vaccine Codes  Var-S Shingles Live  RSVIg Respiratory Syncytial Virus  Meningococcal B (4C, OMV recombinant, absorbed)

Delivery Management Site Codes (Table 27)  195 - Workplace Health and Safety – AHS  196 - Workplace Health and Safety – Covenant Health  320 - Safeway 8863 (St. Albert)  321 - Safeway 8830 (Airdrie)  322 - Safeway 8897 (Spruce Grove)  323 - Safeway 8886 Callingwood (Edmonton)  324 – Safeway 8912 Garrison Woods (Calgary)  325 - Safeway 8877 Red Deer  326 – Safeway 8894 (Fort Saskatchewan)  327 – Safeway 8885 (Stoney Plain)  328 - Safeway 8842 (Glenmore Landing)  329 - Discovery Ridge Compounding Pharmacy & Travel Clinic  856 - Fort McKay Health Centre  857 – Alexis Health Services  858 – Beaver First Nation Health Centre  859 - Lubicon Lake Health Centre 6.6 July 2017 Submitter Codes (Table 2) Added Submitter Codes:  32 Atlas Immunization Services  49 Swan River First Nation

Delivery Management Site Codes (Table 27) Added Delivery Management Site Codes:  194 Atlas Travel Clinic  313 Sobeys 3194 Lewis Estates (Edmonton)  314 Sobeys 3143 Millwoods (Edmonton)  315 Sobeys 1110 Tuscany (Calgary)  316 Rita’s Apothecary and Home Healthcare Ltd. (Barrhead)  317 Polaris Travel Clinic and Pharmacy (Airdrie)  318 Safeway 8857 (Leduc)  319 Sobeys 5190 (Walker)  860 Swan River Health Centre

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Vaccine Codes (Table 33) Added Vaccine Codes:  BA-7 Botulism Antitoxin Heptavalent  Hib-MenC Haemophilus Influenza b/Meningococcal Conjugate

Vaccine Site Codes (Table 34) Added Vaccine Site Codes:  WO Wound  VE Vein

Administering Method Codes (Table 35) Added Administering Method Codes:  INF Infiltrate  UNK Unknown 6.5 September 2016 Country Codes (Table 7) Updated County Code List

Delivery Management Site Codes (Table 27) Added Delivery Management Sites:  192 Red Earth Creek  193 Peerless/Trout Lake  311 Sobeys 5191 Nolan Hill - (Calgary)  312 Safeway 8903 - (Calgary) 6.4 February 2016 Changed descriptions of First Nations Submitter and Delivery Management Site Codes. See tables 2 and 27.

Submitter Codes (Table 2) Added Submitter Codes:  31 University of Alberta  50 Nunee Health Board Society

Delivery Management Site Codes (Table 27) Added Delivery Management Sites:  190 Chestermere CHC  191 SMCHC  307 University of Alberta Pharmacy  308 Safeway 8898 Bonnie Doon (Edmonton)  309 Pharmasave 367 Heritage Pointe (De Winton)  310 Sobeys 1129 Royal Oak (Calgary)  861 Nunee Health & Wellness Centre  996 Rapid Response

Changed Description of Delivery Management Site: The Delivery Management Site field identifies the clinic location where the immunization service was administered, or the clinic location where the adverse event following immunization was reported.

Dosage Type Codes (Table 36) End Dated Dosage Type Codes:  Drop  GTTS  IU  MCG

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description  MG

Manufacturer Code (Table 37) Added Manufacture codes:  MYL Mylan  SEQ Seqirus  VAL Valneva 6.3 July 2015 Submitter Codes (Table 2) Added Submitter Codes:  51 Paul First Nation  52 Dene Tha' First Nation- Chateh  53 Driftpile First Nation  54 Athabasca Chipewyan First Nation  56 Saddle Lake Cree Nation  57 Sunchild First Nation

Delivery Management Site Codes (Table 27) Added Delivery Management Sites:  862 Chateh Health Center  863 Maggie Willier Wellness Centre-Driftpile  864 Fort Chipewyan Health & Wellness Centre  865 Paul Band Health Centre  866 Saddle Lake Health Care Centre  867 Sunchild Health Centre

Country Codes (Table 7) Added Country Code:  RS Serbia

Vaccine Codes (Table 33) Added Vaccine Codes:  HPV- 9 Human Papillomavirus- Nonavalent  Td-IPV Tetanus/Diphtheria/Polio

End Dated Vaccine Code:  TdP Tetanus/Diphtheria/Polio  Sma Smallpox Changed start Date for MEA vaccine to 1970/07/01

Manufacturer Codes (Table 37) Added Manufacturer Code:  NB Nuron Biotech 6.2 September 2014 Delivery Management Site Codes (Table 27) Added Delivery Management Site Codes:  188 Chinook Regional Hospital  189 University of Alberta  302 Safeway 8844 Dalhousie Station (Calgary)  303 Safeway 8906 (Windermere)  304 Safeway 2243 (Thorncliffe)  305 Shoppers 2335 (Sunpark)  306 Winters Pharmacy North (Drayton Valley)  997 Non AHS Immunizers

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Vaccine Codes (Table 33) Added Vaccine Codes:  Rot-5 Rotavirus – Pentavalent  Rot-U Rotavirus – Unspecified

End Dated Vaccine Codes:  TBEV Tick-borne Encephalitis  CHO Cholera

Changed Description of HPV and HPV-2 Vaccine descriptions (descriptions were reversed in previous DSG):  HPV Human Papillomavirus - Quadravalent  HPV- 2 Human Papillomavirus - Bivalent 6.1 May 2014 Submitter Prefix Codes (Table 2) Added Submitter Prefix Codes:  58 Alexander First Nation  59 Enoch Cree Nation  60 Beaver Lake Cree Nation  61 Little Red River Cree Nation - John D’or Prairie  62 Little Red River Cree Nation - Fox Lake  63 Little Red River Cree Nation - Garden River  64 Duncan’s First Nation  65 Wesley First Nation - Bighorn  66 Maskwacis Health Services  67 Whitefish Lake First Nation #459 - Atikameg  68 Woodland Cree First Nation  69 Loon River First Nation  70 Tallcree First Nation  71 Heart Lake First Nation  72 Blood Tribe Department of Health  73 Sturgeon Lake Cree Nation  74 Sucker Creek First Nation  75 Kapawe’no First Nation

Changed Description of Submitter Prefix Codes:  76 Dene Tha’ First Nation to Dene Tha’ - Bushe River  77 North Peace Tribal Council to Dene Tha’ - Meander River  80 Goodfish Lake Health Centre to Whitefish Lake First Nation #128 - Goodfish  81 Aakom Kiyii Health Services to Aakom Kiyii Health Services - Piikani  83 Bigstone Health Commission – Bigstone 1 to Bigstone Health Commission - Bigstone  84 Cold Lake First Nations Health Services to Cold Lake First Nations  85 Stoney Trail Wellness Centre to Stoney Trail Wellness Centre - Eden Valley  86 Morning Sky Health & Wellness Society to Morning Sky Health & Wellness Society - Frog Lake  87 Kehewin Health Services to Kehewin Cree Nation  88 Stoney Health Services to Stoney Health Services - Morley

Delivery Management Site Codes (Table 27) Added Delivery Management Codes:  868 Alexander Health Services

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description  869 Enoch Health Services  870 Beaver Lake Health Services  871 John D’or Prairie Health Centre  872 Fox Lake Nursing Station  873 Garden River Health Centre  874 Duncan’s FN Health Centre  875 Kiska Waptin Health Centre - Bighorn  876 Maskwacis Health Services  877 Atikameg Health Centre  878 Woodland Cree Health Centre  879 Loon River Health Centre  880 Tallcree Health Services  881 Heart Lake Health Centre  882 Blood Tribe Department of Health  883 Sturgeon Lake Heath Centre  884 Sucker Creek Health Centre  885 Kapawe’no Health Centre

Changed Description of Delivery Management Sites Codes:  886 Four Chiefs Complex to Four Chiefs Complex - Bushe River  891 Aakom Kiyii Health Centre to Aakom Kiyii Health Services - Piikani  895 Stoney Trail Wellness Centre to Stoney Trail Wellness Centre - Eden Valley  897 Kehewin Health Centre to Kehewin Health Services  898 Stoney Health Centre to Stoney Health Services - Morley

Vaccine Codes (Table 33) Added Vaccine Code:  Men-B Meningococcal B

Changed description of HPV and HPV-2 vaccines:  Human Papillomavirus – Bivalent  Human Papillomavirus – Quadravalent

Dosage Type Codes (Table 36) Added Dosage Type Code:  UNK Unknown

Manufacturer Codes (Table 37) Added Manufacturer Code:  VIN ViNS Bioproducts Limited 6.0 Jan 2014 Updated to Reflect changes to the new AEFI Form (Last revised Event Detail Codes no longer reportable: December 2013  3 “Sterile Abscess or Nodule” with minor  7 “High Pitched Unusual Crying” changes to code  10 “Encephalopathy” table additions)  11 “Meningitis and/or Encephalitis”

Changed Event Detail Codes:  4 “Severe Pain and/or Swelling” to “Pain and/or Swelling”  21 “Other Rash” to “Rash”

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Added the following event details:  33 – Cellulitis  34 – Sterile Abscess  35 – Nodule  36 – Encephalitis, ADEM, Myelitis  37 – Meningitis  38 – Oculo-Respiratory Syndrome (ORS)  39 – Bell’s Palsy  40 – Intussusception

Adverse Event Record Removed the following data elements:  Consulted by HCW Date  Consulted by Parent/Patient  Consulted by Parent/Patient Date  History of Allergies in Family  Grade Code  MOH Defer Immunization Indicator

Added the following data elements:  Previous Adverse Event to Immunization Specify  Known Medical Conditions  Known Medical Conditions Specify  LIN Number  Change to Immunization Schedule  No Further Immunization  No Further Immunization Specify  Expert Referral  Expert Referral Type  Regional Recommendations Other  Regional Recommendations Other Specify

Changed data element names:  Hospital Indicator - Required Hospitalization  Seen in Emergency - Emergency Room  Consulted by HCW - Advice from a Health Professional  Treatment by Adrenaline - Treatment by Epinephrine  Previous Illness or Reaction - Previous Adverse Event to Immunization  History of Allergies in Patient - History of Allergies  History of Convulsions in Patient - History of Convulsions  Outcome Code - Outcome of Events  Further Events Details - Description of Event  MOH Comments - Regional Recommendations Comments  MOH Comments Date - Regional Recommendations Comments Date  PHO Advice Requested Indicator - CMOH Advice Requested Indicator

Outcome of Events Codes Added:  07 – Permanent Disability/Incapacity  08 – Lost to Follow-up

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Changed:  04 – Fatal – Death  06 Pending – Not Yet Recovered

Adverse Event Detail Record Removed the following data elements:  Temperature Site Code  Temperature not Measured Indicator  Local Events Measurement  Screaming/Crying Duration

Submitter Prefix Codes (Table 2) Added Submitter Prefix Code:  30 Pharmacies  76 Dene Tha’ First Nation  77 North Peace Tribal Council  78 O’chiese First Nation  79 Tsuu Tina Nation

Delivery Management Site Codes (Table 27) Added Submitter Prefix Code:  300 Shoppers 2413 Evergreen Village (Calgary)  301 Winters Pharmacy (Drayton Valley)  886 Four Chiefs Complex  887 Meander River Health Centre  888 O’Chiese Health Centre  889 Tsuu Tina Health and Wellness Centre

Vaccine Code Table (Table 33) Added Vaccine Code:  BAIg Botulism Antitoxin Immune Globulin

Administering Method Code (Table 35) Added Administering Method Code:  IV Intravenous Infusion

Manufacturer Codes (Table 37) Added Manufacturer Code:  IIC Institute of Immunology Inc., Croatia  ABV AbbVie Corporation 5.4 April 2013 Delivery Management Site Codes (Table 30) Added Delivery Management Codes  187 Vaccine Depot Edmonton

Manufacture Codes (Table 36) Added manufacture code  GRF Grifols

Adverse Event Interval  Corrected interval for Thrombocytopenia from 24 hours to 72 hours 5.3 Oct 2012 Submitter Prefix Codes (Table 2) Added Submitter Prefix Codes  80 Goodfish Lake Health Centre

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description  81 Aakom Kiyii Health Services  82 Bigstone Health Commission - Calling Lake  83 Bigstone Health Commission - Bigstone

Grade Codes (Table 25) Added grade Code PK Pre-Kindergarten Delivery Management Site Codes (Table 30) Added Delivery Management Codes  890 Goodfish Lake Health Centre  891 Aakom Kyii Health Centre  892 Calling Lake Health Centre  893 Bigstone Health Centre

Changed Delivery Management Sites  894 Cold Lake First Nations Health Centre  895 Stoney Trail Wellness Centre  898 Stoney Health Centre

Vaccine Codes (Table 32) Added Vaccine Code:  dTap-IPV Diphtheria/Tetanus/Acellular Pertussis/IPV

Adverse Event Interval Reformatting Value 0 -999.9 changed to 0-4599.9

Screaming/Crying Duration Changed to non-mandatory

Updated to new logo

Changed all references to Alberta Health to Alberta Health

Changed all references to Provincial Client Registry to Provincial Client Registry

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description 5.2 Jan 2012 Submitter Prefix Codes (Table 2) Added Submitter Prefix Codes  84 Cold Lake First Nations Health Services  85 Stoney Trail Wellness Centre  86 Morning Sky Health & Wellness Centre  87 Kehewin Health Services  88 Stoney Health Services  89 Siksika Health Services

Grade Codes (Table 25) Added Grade Code EC Early Childhood

Reporter Designation Codes (Table 26)  LPN Licensed Practical Nurse  OTH Other Vaccine Providers

Delivery Management Site Codes (Table 30) Added Delivery Management Codes  894 Stoney Trail Wellness Centre  895 Cold Lake First Nations Health Centre  896 Morning Sky Health & Wellness Centre - Frog Lake  897 Kehewin Health Centre  898 Stoney Trail Wellness Centre  899 Siksika Health & Wellness Centre

Vaccine Codes (Table 32) Changed end date of TT to 2000/12/31 to match end date in the AIM

Manufacturer Codes (Table 36) Added Manufacturer Code  CRU Crucell

Removed end date for Manufacturer CGC Cangene Corporation

Data Submission Sample Added example of Submissions of immunization record with multiple lot# s

Added Appendix V – DSG File Format for Submission of Multiple Lot Numbers

5.1 Sept 2011 Delivery Management Code(Table 30) Added Delivery Management Codes:  183 Airdrie Urgent Care  184 Cochrane Urgent Care  185 Okotoks Urgent Care  186 Calgary International Travel Clinic  998 Unknown

End Dated Delivery Management Site:  080 Eastwood

Removed Product Names from descriptions in the Vaccine and Antigen Code Tables

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Vaccine Code (Table 32) End dated Vaccine Code:  HBTmf 2011/05/01  Lym 2007/07/30

Added Vaccine Codes:  DTaP-HB-IPV Diphtheria/Tetanus/Acellular Pertussis/Hepatitis B/IPV  CH Cholera (unspecified)  HPV-2 Human Papillomavirus  HPV-U Human Papillomavirus (unspecified)  MENING-C Menigococcal Conjugate (Unspecified)  MENING-P Menigococcal Polysaccharide (unspecified)  PNEU-CON Pneumococcal – Conjugate (unspecified)  TY Typhoid (unspecified)  VZU Varicella Zoster (unspecified)

Some of these codes were added for documenting of historical immunizations. See Vaccine Code Table for details.

Dosage Type Codes (Table 35) Added Dosage Type Codes  DROP Drops  UNIT Units

Manufacturer Code (Table 36) Added Manufacturer Codes  PFZ Pfizer  UNK Unknown 5.0 Dec 2010 Vaccine Code (Table 32) Changed description of vaccine code TYVI to Typhoid – Injectable

End dated Vaccine Codes: H1N1-09-AD 2010/10/01 H1N1-09 2010/10/01 PNEU-C 2010/07/01

Manufacturer Code (Table 36) Added Manufacturer Code AZC - AstraZeneca

Added Delivery Management Sites (Table 30) 171 Westend Seniors Activity Centre 172 Jewish Community Centre 173 CDI College South Campus 174 Grandin Park Plaza - St Albert 175 Westmount Shopping Centre 176 Millborne Market Mall 177 Avenida Village 178 Brentwood Village Mall 179 EMS Whitehorn, North Side Entrance 180 Richmond Road Diagnostic Treatment Centre 181 Stampede Park 182 Bonnie Doone Shopping Centre

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description 4.9 June 2010 Delivery Management Site Codes (Table 30) Added Delivery Management Site:  170 East CHC

End Dated Delivery Management Site :  031 Forest Lawn 2010/05/22 4.8 March 2010 Vaccine Code (Table 32) Added Vaccine Codes:  PNEU-C10 - Pneumococcal (10-Conjugate)  PNEU-C13 - Pneumococcal (13-Conjugate)  DTaP-IPV-Hib-HB – Diphtheria/Tetanus/Acellular  Pertussis/IPV/Hib/Hepatitis B

Dosage Type Codes (Table 35) Added Dosage Type Code:  PKG Package 4.7 Oct 2009 Vaccine Code (Table 32) Added H1H1 Vaccine Codes:  H1N1-09-AD - Adjuvanted Pandemic 2009 Influenza  H1N1-09 - Non-Adjuvanted Pandemic 2009 Influenza

Addition of Manufacturer Code (Table 36)  CSL CSL Limited 4.6 Sept 2009 Removed Business Rule for Last Name and Given Name (rule was removed from Imm/ARI but not the DSG)  Must match the last name of the reported ULI on the Alberta Health & Wellness Central Stakeholder Registry 4.5 June 2009 Added Business Rule for Unique Lifetime Identifier (ULI)  Must be a Primary ULI on the Alberta Health Central Stakeholder Registry

Removed new Program Validation rules for Birth Date and Gender:  Must match the previously submitted birth date for the reported ULI  Must match the previously submitted gender for the reported ULI

Addition of Manufacturer Code (Table36)  NOV Novartis

Addition of Delivery Management Sites (Table 30)  168 Northgate Health Centre  169 Rutherford Health Centre

End Dated Delivery Management Site (Table 30)  085 Castledowns  088 North Central

Vaccine Codes (Table 32) Correction to Active column from Y to N for some vaccines that were end dated

Modified Adverse Event Interval If the Event Detail Code is ‘31’ – Thrombocytopenia, Adverse Event Interval must be less than or equal to 30 or 24

Modified Adverse Event Interval Type

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description If the Event Detail Code is ‘31’ – Thrombocytopenia, Adverse Event Interval Type must be ‘D’ – Days or ‘H’ - Hours 4.4 Jan 2009 Vaccine Codes (Table 32) Added New Vaccine Code for Shingles vaccine:  Var-S Varicella Zoster – Shingles

Added new Program Validation rules for Birth Date and Gender:  Must match the previously submitted birth date for the reported ULI  Must match the previously submitted gender for the reported ULI

Delivery Management Sites (Table 30) Added the following Delivery Management Sites:  164 South Urgent Care Health Centre  165 Sheldon M Chumir Urgent Care Health Centre  166 Community Outreach  167 Clinical Trial 4.3 Oct 2008 Added the following Business rule for Influenza: If antigen code = Flu and age is greater than or equal to 9 years then antigen count = 1

Delivery Management Site Codes – (Table 30) Removed end date for Delivery Management Site 126 - Smoky River and changed description to McLennan

Vaccine Codes – (Table 32) Added end dates to the following Vaccine Codes:  MU – 2004/02/08  Snake – 2002/02/03

Manufacturer Codes – (Table 36) Added end date to the following Manufacturer Codes: AP Aventis Pasteur 2008/01/01 BA Bayer 2008/01/01 BC Biochem Pharma Inc 2008/01/01 CGC Cangene Corporation 2008/01/01 CON Connaught 2008/01/01 SH Shire Biologies 2008/01/01 SKB SmithKline Beecham 2008/01/01

Added Manufacturer INB Instituto Butantan 4.2 March 2008 Delivery Management Site Codes – (Table 30) Added end date to Delivery Management Site 126 - Smoky River

Changed Description of Delivery Management Sites:  45 Red Deer to Red Deer Bremner CHC  151 49th Street CHC to Red Deer 49th Street CHC

Added Delivery Site 163 – Red Deer Johnstone Crossing CHC 4.1 Jan 2008 Delivery Management Site Codes – (Table 30) Changed Description of Delivery Management Site:  032 Haysboro CHC to Acadia CHC

Added end date to Delivery Management Site 039 – Millican Ogden Sub Office

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Addition of Delivery Management Sites:  159 Sacred Heart Community Health Centre  160 Traveller’s - St Albert  161 Travellers’ - Strathcona  162 New Canadian’s Clinic

Addition of Vaccine Code for MMR Varicella ( Table 32)  MMR-Var MMR and Varicella Start Date 2007-07/30

Addition of Manufacturer Code (Table 36) CGC Cangene Corporation 4.0 Feb 2007 Changed Description of Vaccine Code for Menactra (Table 32)  MenC-ACYW to Match Product Name

Change Smallpox Vaccine Start Date to 1870/01/01

Addition of Vaccine Code for Dukoral (Table 32)  Chol-Ecol-O start date 2003/02/02

Change Description of Delivery Sites (Table 30)  083 Twinbrooks/Duggan to Twinbrooks  089 Sherwood Park to Strathcona County

Addition of Delivery Management Sites (Table 30)  Boyle McCauley  STD Clinic Edmonton  Birth Control Clinic Edmonton  IBU (Immunization Business Unit) Edmonton  TB Clinic Edmonton

Addition of Manufacturer Code (Table 36)  AL Abbott Laboratories

Addition of Homeless/Indigent Flag (Patient Record)

Addition of Table 10 Homeless/Indigent Flags

Addition of Business Rule for Postal Code If Homeless/Indigent flag is set to “Y” the Postal Code must be blank. 3.9 Nov 2006 The following codes were added:

Table 31 - Vaccine Code Table Anth Anthrax HA-Typh-I Hepatitis A and Typhoid HBTmf Hepatitis B Thimerosal Free HPV Human Papillomavirus Lym Lymerix MenC- ACWY Meningococcal - Conjugate (Menactra) Rot Rotavirus (RotaTeq) RSVIg Respiratory Syncytial Virus Immunie Globulin Sma Smallpox 3.8 July 2006 Manufacturer Codes (Table 17)

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description  Added Manufacturer Codes: TAL - Talecris and SP - Solvay Pharma 3.7 March 2006 Vaccine Codes (Table 11):  Added end date for DT-IPV - 2005/10/31  Changed start date for Vaccine Code PHEUMO-P (Pneumococcal (23 Polysaccharide) to 1983/01/01

Dosage Type Codes (Table 16):  Added new Dosage Type Code: CAP-Capsules

Delivery Management Site Codes (Table 19):  Changed Delivery Management Site 113 Description to Cold Lake

Event Detail Codes (Table 19):  Added code for U-Unknown Changed all references of Adverse Reaction to Adverse Events 3.6 July 2005 Consulted by HCW Date and Consulted by Parent/Patient Codes were changed from mandatory to non-mandatory Changed description of Delivery Management Site 083 to Twinbrooks/Duggan (Table 29). Added definitions for Vaccine site Codes (Table 32). Added New Manufacturer code : SF Sanofi Pasteur (Table 35) Added Program Validation Rule to Adverse Event Interval  “If Adverse Event interval type is “U” - Unknown, Adverse Event Interval must be ‘999.9’ 3.5 Oct 2004 Added new manufacturer code – Table 17 – Manufacturer Codes  IDB – ID Biomedical

Changed Program Validation rules to allow recording of minutes for Allergic Events (Severe; Other): Adverse Event Interval If the Event Detail Code is ‘18’ - Allergic Events (Severe; Other), Adverse Event Interval must be less than or equal to 72 or Less than or equal to 4320

Adverse Event Interval Type If the Event Detail Code is ‘18’ - Allergic Events (Severe; Other), Adverse Event Interval Type must be ‘H’ Hours or ‘M’ – Minutes 3.4 May 2004 Added New RHA Codes to Table 2 – Submitter Prefix Codes

Added Delivery Management Site 153 – Lloydminster (Table 29 – Delivery Management Site Codes)

Added new Vaccine Code (Table 31 – Vaccine Codes):  dTap – Diphtheria/Tetanus/Acellular Pertussis (Adacel)

Removed end date for HABV Vaccine (Table 31 – Vaccine Codes)

Added additional Vaccine Site Codes (Table 32 – Vaccine Site Codes):  LAF – Left Arm Forearm  LAL – Left Arm Lower

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description  LAU – Left Arm Upper  LLL – Left Leg Lower  LLU – Left Leg Upper  RAF – Right Arm Forearm  RAL – Right Arm Lower  RAU – Right Arm Upper  RLL – Right Leg Lower  RLU – Right Leg Upper  UNK – Unknown

Identified ARI Event Detail Codes no longer reportable as of January 2004 (Table 36 – Event Detail Codes)  05 – Local inflammation, swelling, and/or pain (moderate severity)  08 – Consolable Cry  19 – Allergic Events (mild)  23 – Excessive Somnolence  24 – Irritability  25 – Coma - to be reported under 32 – Severe or Unusual Events  26 – Apnea – to be reported under 32 – Severe or Unusual Events

Adverse Event Interval for Anaphylaxis rule modified to read as follows:  If the Event Detail Code is ‘17’ – Anaphylaxis, Adverse Event Interval must be less than or equal to 24 or less than or equal to 1440 Adverse Event Interval Type for Anaphylaxis rule modified to read as follows:  If the Event Detail Code is ‘17’ – Anaphylaxis, Adverse Event Interval Type must be ‘H’ – Hours or ‘M’ - Minutes 3.3 Aug 2003 Added Program Validation Rule for Postal Code:  If Postal Code Is reported, must match Postal Code for the reported ULI on the Provincial Client Registry.

Added Delivery Management Site to Adverse Event Record

Added Delivery Management Site to ARI Region of Residence Report

Added end dates for the following Historical Vaccines: MenACs, MeninAC, MENOTET, MEA and MR

Removed Reason codes associated with the following Historical Vaccines: MenACs, MeninAC and MENOTET (Reason Code 05 – Outbreak Control) Removed select Program Validation Rules (for details refer to Enhancement E018 and proposed additional Changes Document on ISS Website) Changed Number in Series to non-mandatory for “H” Associated Historical Immunization

Local Events Measurement  Removed Conditional Rule for Event Detail Code ‘05” – Local Inflammation, Swelling, and or Pain (Moderate Severity).

Screaming Crying Duration  Removed Conditional Rule for Event Detail ‘08’ - Consolable Cry

Allergic Events Location

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description  Removed Conditional Rule Event Detail ‘19’ – Allergic Events (mild) 3.2 April 2003 Correction to reference of Event Detail Codes Table number to Table 35.

Adverse Event Duration Business rule added for “Unknown”:  If the Adverse Event Duration Type is ‘U’ – Unknown, Adverse Event Duration must be ‘999.9’

Table 39 – Adverse Event Duration Type Codes:  Added missing value of U – Unknown 3.1 March 2003 AM012R02/AS028 IMMARI Enhancement Project: Add Program Validation to Postal Code in the Patient record. If the patient is identified as a resident of Alberta, the Postal Code will be verified against information provided by Canada Post to ensure it is a valid Alberta Postal Code.

Update the Region of Residence report naming convention. 3.0 Jan 2003 AM012R02/AS028 IMMARI Enhancement Project:

Updated document with the five new fields.

Adverse Events Record  MOH Defer Immunization Indicator  PHO Advice Requested Indicator  Reporter Designation

Adverse Event Detail Record Adverse Event Duration Adverse Event Duration Type

Add Program Validation rule to Immunization Date in Immunization record stating all Related Immunization records within a single Adverse Events Event, must have the same Immunization Date.

Add Business Rule to ARI Number in Adverse Events Record stating that the number range available for RHA use is 1 – 899999999.

Incorporate ARI DSG Response File document into this document and rename entire document from ARI Data Submission Guideline to ARI Data Submission and Response Guidelines.

Add Section C – ARI Region of Residence Report File Guideline. SR03193: Change the allowed characters in the Further Event Details field from: spaces, periods, parentheses, dashes, commas, colons slashes and pound signs, to: Spaces and the following special characters, ~ ` ! @ # $ % ^ & * ( ) _ - + = \ { } [ ] : ; " ' ? / > . < ,

SR03203: Change the Provincial Health Number Type Code for Newfoundland from “NF” to “NL” for Newfoundland and Labrador.

Alberta Health Adverse Events to Immunization Data Submission and Response Guidelines March 2021

Version Date Revision Description Change the Province Code for Newfoundland from “NF” to “NL” for Newfoundland and Labrador.

SR03213: Change the allowed characters in the Allergy List Specify field from: spaces, periods, parentheses, dashes, commas, colons slashes and pound signs to: Spaces and the following special characters, ~ `! @ # $ % ^ & * ( ) _ - + = \ { } [ ] : ; " ' ? / > . < , 2.0 Sep 2002 Consolidated Adverse Events to Immunization Program Reporting Guide with Adverse Events to Immunization Data Submission Guide by incorporating:  Program Validation Rules  Appendixes: o A – General Reporting Guidelines o B – Process Overview o C – Glossary o D – Contact Information

Revised Business Rule for MOH Comments Field to include additional special characters. The following special characters are allowed : ~ ` ! @ # $ % ^ & * ( ) _ - + = \ { } [ ] : ; " ' ? / > . < , 1.1 Nov 2001 Final version published based on production release dated January 3, 2002.