TESSy - The European
Surveillance System
Vaccine Preventable Diseases (VPD)
Reporting Protocol 2019
Diphtheria, Invasive H. influenzae Disease, Invasive Meningococcal disease, Invasive
Pneumococcal Disease, Pertussis, Measles, Mumps, Poliomyelitis, Rubella and Tetanus
Surveillance data for 2018 (2019 for measles and rubella)
March 2019
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Vaccine Preventable Diseases Reporting Protocol 2018
Introduction
Contents
Introduction ............................................................................................................... 5
How to use this document ..................................................................................................... 5
Finding further information .................................................................................................... 5
Copyright ............................................................................................................................. 6
Reporting to TESSy .................................................................................................... 7
Checking the data collection schedule .................................................................................... 7
Preparing data ...................................................................................................................... 7
Checking metadata ............................................................................................................... 7
Checking your data source profile .......................................................................................... 8
Submitting your data ............................................................................................................ 8
Finalising your submission ..................................................................................................... 8
TESSy HelpDesk ................................................................................................................... 8
Changes to current VPD metadata ............................................................................... 9
Annex 1 VPD metadata ............................................................................................. 10
VPD metadata set ............................................................................................................... 10
Current record type versions ........................................................................................... 10
Aggregated reporting ..................................................................................................... 11
VPD metadata change history .............................................................................................. 12
2018 VPD metadata changes .......................................................................................... 12
2017 VPD metadata changes .......................................................................................... 12
2016 VPD metadata changes .......................................................................................... 13
2015 VPD metadata changes .......................................................................................... 14
2014 VPD metadata changes .......................................................................................... 15
References .............................................................................................................. 17
Annex 2 VPD-specific material ................................................................................... 18
Case definitions .................................................................................................................. 18
https://ecdc.europa.eu/en/surveillance-and-disease-data/eu-case-definitions ......................... 18
VPD reporting frequency ..................................................................................................... 18
Annual reporting: deadline 15 October 2018 .................................................................... 18
Monthly reporting: deadline 25th of each month ............................................................... 19
Narrative information ..................................................................................................... 19
Changes in 2018 EU case definitions as compared to 2012 .................................................... 20
Rubella .......................................................................................................................... 20
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Vaccine Preventable Diseases Reporting Protocol 2018
Introduction
Pertussis ....................................................................................................................... 21
Streptococcus pneumonia infection, invasive disease ....................................................... 21
Changes in 2012 EU case definitions as compared to 2008 .................................................... 22
Diphtheria ..................................................................................................................... 22
Mumps .......................................................................................................................... 23
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Vaccine Preventable Diseases Reporting Protocol 2018
Introduction
Introduction
This reporting protocol is for the 2019 data call for vaccine preventable diseases (VPD) surveillance.
This data call covers cases diagnosed in 2018 for diphtheria, invasive H. influenzae disease, invasive
meningococcal disease, invasive pneumococcal disease, pertussis, mumps, poliomyelitis and tetanus
whereas for measles and rubella, the monthly data collection covers cases diagnosed in 2019. The
separate reporting protocol for invasive bacterial diseases was discontinued in 2016 and the
meningococcal, pneumococcal disease and Haemophilus influenzae invasive diseases are now
included in the VPD Reporting Protocol.
ECDC’s Reporting Protocols are data collection guidelines for reporting countries’ data managers, and
the design is intended to ensure user-friendliness by:
Introducing a uniform structure to make it easier for data managers to find data collection
information across different subjects.
Removing information not relevant to data managers.
Because reporting countries’ data managers sometimes play multiple roles, it is sometimes relevant to
distribute subject-specific material together with a Reporting Protocol. To maintain the uniform
structure, this sort of material is now included in
Annex 2.
How to use this document
This Reporting Protocol provides information for reporting countries’ data managers in three main
sections:
Reporting to TESSy – contains guidelines on how to prepare data for submission to TESSy,
deadlines, subject-specific information (e.g. new changes to metadata), and links to further
information.
Annex 1 – contains:
o A history of metadata changes for the subject(s) covered by this Reporting Protocol.
o The metadata set for the subject(s) covered by this Reporting Protocol.
Annex 2 – contains subject-specific material relevant for distribution with the Reporting
Protocol, for example:
o Guidelines for data collection in the field.
o Abbreviations.
Finding further information
Paragraphs denoted by the information icon tell where you can find further information.
Updated links to all the schedules, documentation and training materials mentioned in this Reporting
Protocol are included in the
TESSy document section, including:
Metadata sets and history.
Tutorials for data transformation using respectively Excel and Access.
TESSy user documentation.
CSV and XML transport protocols.
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Vaccine Preventable Diseases Reporting Protocol 2018
Introduction
Copyright
© European Centre for Disease Prevention and Control, 2019. Reproduction is authorised, provided
the source is acknowledged.
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Vaccine Preventable Diseases Reporting Protocol 2018
Reporting to TESSy
Reporting to TESSy
This section provides both an overview of the TESSy reporting process and tips on where you can find
useful information.
The overall process is:
1.
Familiarise yourself with the data collection deadlines.
2.
Prepare (export and transform) your data.
3.
Check that your data complies with the metadata.
4.
Check that your data source profile is up-to-date.
5.
Submit your file(s) to TESSy.
6.
Finalise and approve your submission.
Checking the data col ection schedule
The latest data collection schedule is available in the
TESSy website.
The deadline for the submission of all VPD data, with the exception of measles and rubella, is 15
October 2019. The deadline for the reporting of data on measles and rubella is the 25th of each
month (reporting data up to the end of the previous month). See a
lso VPD reporting frequency on
page
18.
Preparing data
After you have exported the data from your national database, you need to ensure that the data are
in a format that TESSy can accept. This applies both to the type of file submitted to TESSy (only CSV
and XML files can be submitted) and to the format of the data in certain fields.
Tutorials covering how you can transform your data to the correct TESSy format using Excel or
Access are available on the TESSy documents website. Information on the file formats is available in
the CSV Transport Protocol and XML Transport Protocol.
Checking metadata
The TESSy metadata define the fields and data formats that are valid as input to TESSy for a given
subject.
As requirements for the data to be shared among TESSy users change, the data changes needed to
support the new requirements are identified and agreed upon between the National Surveillance
Contact Points, the Network Coordination Groups and ECDC’s Disease Experts, and then implemented
as changes to the TESSy metadata.
In order to ensure that your data can be saved correctly in TESSy, you therefore need to check that
your data are correctly formatted according to the most recent metadata set.
Changes to the metadata for the subject of this Reporting Protocol are described in:
Changes to current metadata – changes since the last Reporting Protocol.
Annex 1 Metadata change history – all preceding changes.
It is especially important to focus on:
Field formats
Many fields require data to be formatted in a specific way. For example, dates must be in the
YYYY-MM-DD format; dates in the DD/MM/YYYY format will be rejected.
Coded values
Some fields only permit the use of specific values (coded values). For example,
M,
F,
UNK, or
Other are the
coded values for Gender and any other value in a Gender field will be rejected.
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Vaccine Preventable Diseases Reporting Protocol 2018
Reporting to TESSy
A single metadata set file contains all the definitions and rules you need to comply with to format
your data correctly for every subject (usually a disease). The file can be downloaded as an Excel file
from the TESSy documents website.
By filtering the fields in the file by subject, you can see the fields required for your subject and the
rules that apply to these fields.
Checking your data source profile
Before submitting your file(s), please review the profile for your data source(s) in TESSy (go to
Data
Sources), and update the information, if necessary.
Complete and up-to-date data source information for each subject is important for improving
interpretation of data - each surveillance system has different features that need to be taken into
account when comparing data at an international level.
If your data source information is out-of-date and you do not have access rights to update it, please
request your National Focal Point for Surveillance or National Coordinator to do so.
In-depth information on the data source variables is available in the TESSy user documentation.
Submitting your data
Data is submitted through the TESSy web interface (go to
Upload).
Finalising your submission
The compliance of your data with the validation rules in the metadata is checked automatically during
the data upload process.
The result of your upload – i.e. rejected or validated – is displayed immediately after the conclusion
of the check in the
Validation details webpage. Please review the result carefully:
If your file has been rejected, there will be a message explaining each instance of non-
compliance with the metadata that you need to correct.
If your file has been validated, there might be warnings and remarks relating to possible data
quality issues or to potential overwriting of existing records that you should consider.
When you file has been validated and you are satisfied that all corrections have been made, please
ensure prompt approval – unapproved uploads can block the approval of other uploads.
The TESSy user documentation provides information on reviewing validation results and adjusting
reporting periods to avoid overwriting existing records.
TESSy HelpDesk
Email:
xxxxx@xxxx.xxxxxx.xx
Telephone number:
+46-(0)8-5860 1601
Availability: 9:00 – 16:00 Stockholm time, Monday to Friday (except ECDC Holidays)
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Vaccine Preventable Diseases Reporting Protocol 2018
Changes to current VPD metadata
Changes to current VPD metadata
The previous metadata changes are described in
Annex 1.
Information on changes to the metadata for other subjects is available on the TESSy
documentation website.
Subject
Variables
Description
Validation rule
MENI
ResultFetVR, ResultPorA1,
Update coded value lists for the
ResultPorA2, ResultMLST
variables ResultFetVR, ResultPorA1,
ResultPorA2, ResultMLST – the new
codes added from the list:
http://neisseria.org/nm/typing/tessy/
MEAS.7
ClinicalCriteria
Add variable
(Error) if not completed when
Classification is 'CONF' and
VaccStatus’ is not 'NOTVACC'
and ‘VaccStatus’ is not 'UNK'
ClinicalCriteria; Classification;
Add validation rule
MEAS.7
(Error) if ClinicalCriteria is not
VaccStatus
‘Yes’, ‘No’ or ‘UNK’, if
Classification is 'CONF' and
VaccStatus’ is not 'NOTVACC'
and ‘VaccStatus’ is not 'UNK'
Classification; ResultIgG;
Add validation rule
(Error) If Classification is 'CONF'
MEAS.7
ResultIgM; ResultVirDetect
and (ResultVirDetect is not
'POS' or ResultIgM is not 'POS'
or ResultIgG is not 'POS')
Validation message: Confirmed
cases should have evidence of
laboratory confirmation, so
should be 'POS' for at least one
of ResultVirDetect, ResultIgM
or ResultIgG
MENIISO.1
New record type
Note: the above changes to measles were implemented following discussion at the Advisory Forum in
September 2018 about modified measles. Vaccinated, laboratory confirmed cases must have the
Clinicalcriteria field completed. The intention is to be able to identify modified measles cases, i.e. that
are vaccinated and laboratory confirmed but don’t meet the entire clinical criteria of the EU case
definition.
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Vaccine Preventable Diseases Reporting Protocol 2018
Annex 1 VPD metadata
Annex 1 VPD metadata
This section describes:
The VPD metadata set
Changes to the VPD metadata
VPD metadata set
Current record type versions
Table 1 shows the record type versions to be used when reporting 2018 VPD surveillance data to TESSy.
We strongly encourage
case-based reporting.
If case-based data are not available, aggregated data may be reported.
Table 1: VPD record type versions
Disease
Case-based
Aggregated
record type version
record type version
Diphtheria
DIPH.8
AGGR.1
Invasive Haemophilus influenzae disease
HAEINF.7
AGGR.1
Measles
MEAS.7
AGGRVPD.1
Invasive meningococcal disease
MENI.11
AGGR.1
Mumps
MUMP.5
AGGRVPD.1
Pertussis
PERT.5
AGGRVPD.1
Invasive pneumococcal disease
PNEU.5
AGGR.1
Polio
POLI.5
AGGR.1
Rubella
RUBE.6
AGGRVPD.1
Tetanus
TETA.5
AGGR.1
Neisseria Meningitidis Isolates (Molecular
MENIISO.1
surveillance)
Comment: An
aggregated format called
“
AGGRVPD” has been available for measles, mumps, pertussis and
rubella since 2013. This format is the same as the “AGGR” format, but with “Vaccination Status” as an additional
variable. This variable is not compulsory.
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Vaccine Preventable Diseases Reporting Protocol 2018
Annex 1 VPD metadata
Aggregated reporting
Please refer t
o Table 1 to see the format for aggregated reporting for each disease.
If only a few variables can be reported, it is recommended to give the following priority for reporting:
AgeClass, Classification, VaccStatus, Gender.
When reporting age the age classes liste
d in Table 2 (first preference) or Tables 3 and 4 (second
preference for measles, rubella, mumps and pertussis only) should be used.
Table 2: Categories compatible with VPD reports, ECDC Annual Epidemiological Report and the
Surveillance Atlas of Infectious Diseases for all VPDs
Narrative description
Variable
Coded value in TESSy of the variable
AgeClass
<1 year
AgeClass
0
1-4 years
AgeClass
01-04
5-9 years
AgeClass
05-09
10-14 years
AgeClass
10-14
15-19 years
AgeClass
15-19
20-24 years
AgeClass
20-24
25-29 years
AgeClass
25-29
30-34 years
AgeClass
30-34
35-39 years
AgeClass
35-39
40-44 years
AgeClass
40-44
45-49 years
AgeClass
45-49
50-54 years
AgeClass
50-54
55-59 years
AgeClass
55-59
60-64 years
AgeClass
60-64
65 and over
AgeClass
65+
Alternative categories (option 1) for measles, rubella, mumps and pertussis
Table 3: Alternative categories (option 1) compatible with VPD reports, the ECDC Annual
Epidemiological Report and the Surveillance Atlas of Infectious Diseases for measles, rubella, mumps
and pertussis only
Narrative description
Variable
Coded value in TESSy of the variable
AgeClass
<1 year
AgeClass
0
1-4 years
AgeClass
01-04
5-9 years
AgeClass
05-09
10-14 years
AgeClass
10-14
15-19 years
AgeClass
15-19
20-24 years
AgeClass
20-24
25-29 years
AgeClass
25-29
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Vaccine Preventable Diseases Reporting Protocol 2018
Annex 1 VPD metadata
30 and over
AgeClass
30+
Alternative categories 2 for measles, rubella, mumps and pertussis
Table 4: Alternative categories (option 2) compatible with VPD reports, the ECDC Annual
Epidemiological Report and the Surveillance Atlas of Infectious Diseases for measles, rubella, mumps
and pertussis only
Narrative description
Variable
Coded value in TESSy of the variable
AgeClass
<1 year
AgeClass
0
1-4 years
AgeClass
01-04
5-9 years
AgeClass
05-09
10-14 years
AgeClass
10-14
15-19 years
AgeClass
15-19
20-29 years
AgeClass
20-29
30 and over
AgeClass
30+
VPD metadata change history
Metadata changes prior to 2014 can be found on the TESSy documents website.
2018 VPD metadata changes
Subject
Description
MENI
Update coded value lists for the variables ResultFetVR, ResultPorA1, ResultPorA2,
ResultMLST – the new codes added from the list
: http://neisseria.org/nm/typing/tessy/
MEAS
The variable ‘ClinicalCriteria‘ was reactivated for use in the event of vaccinated
cases with classification ‘CONF’; whether these cases met the clinical criteria of the
EU case definition should be recorded here.
A new validation rule was added for ‘Classification’, ‘ResultIgG’, ‘ResultIgM’ and
‘ResultVirDetect’ so that cases with classification ‘CONF’ should also have at least
one positive laboratory marker.
2017 VPD metadata changes
Table 4: Summary of implemented changes in case-based record types for VPD in 2017
Subject
Description
All diseases
The description of the variable ‘DateLastVaccDose’ was updated to specify that the
date given should be the date of last dose before disease onset.
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Vaccine Preventable Diseases Reporting Protocol 2018
Annex 1 VPD metadata
Subject
Description
Diphtheria
The validation rules regarding the variables ‘Classification’ and ‘Pathogen’ were
changed to ‘error’ so that cases with Classification==CONF could not be reported with
unknown or missing data on Pathogen.
A validation rule (warning) was added for cases reported as Classification==CONF but
ClinicalPresentation==”UNK”.
A validation rule (warning) for cases of Pathogen==ULC with
ClinicalPresentation!=CUTA was removed.
For the variable ‘ClinicalPresentation’, the coded value ‘NUS’ (not under surveil ance)
was dropped.
For the variable ‘ClinicalPresentation’, the coded values ‘CONJ’ (conjunctival) and
“GEN” (genital) were added.
The variable ‘ClinicalPresentation’ was made a mandatory variable.
The variable ‘TestMethod’ was made a mandatory variable.
A validation rule (warning) was added where, for cases reported as
Classification==CONF, at least one of TestMethod1 or TestMethod2 must be reported
as 'PCR', 'RTPCR' , 'ELEK' or 'O'.
Measles
A validation rule was changed, so that cases reported with ResultVirDetect==POS,
must have Classification==CONF or DISCARDED. Previously, these cases could only be
reported as Classification==CONF.
Rubella
A validation rule was changed, so that cases reported with ResultVirDetect==POS,
must have Classification==CONF or DISCARDED. Previously, these cases could only be
reported as Classification==CONF.
Invasive
The available coded values for al fine typing variables (ResultFetVR, ResultPorA1,
meningococcal
ResultPorA2, ResultMLST) were updated fro
m http://neisseria.org/nm/typing/tessy/.
disease
Mumps
For the variable ‘Genotype’, the coded value ‘NA’ (not applicable) was added.
Pertussis
For the variable ‘TestMethod’, the coded value ‘ORALFLUIDIgG’ (IgG in oral fluid) was
added.
2016 VPD metadata changes
Table 5: Summary of implemented changes in case-based record types for VPD in 2016
Subject
Description
Diphtheria
The variables ‘TestMeth1’ and TestMeth2’ were renamed ‘TestMethod1’ and
‘TestMethod2’, in line with other VPDs.
The variable ‘AgeMonth’ was added.
The description of the variable ‘ClinicalPresentation’ was edited to match other VPDs.
Invasive H.
The variables ‘Specimen1’ and ‘Specimen2’ were dropped.
influenzae
The description of the variable ‘TestMethod1’ was edited to highlight that this is the
disease
laboratory method used on the primary laboratory specimen with a positive result for
case confirmation and further characterisation.
The description of the variable ‘TestMethod2’ was edited to highlight that this is the
laboratory method used on the second type laboratory specimen with a positive result
(if taken) for diagnosis or further characterisation.
The description of the variable ‘Age’ was edited to match other VPDs.
The coded value ‘PROB’ was removed from the variable ‘Classification’, as the EU case
definition for invasive H. influenzae disease does not include probable cases
The validation rule and message, warning if cases were reported as Classification is not
‘UNK’, and ClinicalPresentation is ‘EPIG’ were removed.
The variable ‘DateLastVaccDose’ was added.
The variable ‘Pathogen’ was dropped.
The description of the variable ‘ClinicalPresentation’ was edited to match other VPDs.
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Vaccine Preventable Diseases Reporting Protocol 2018
Annex 1 VPD metadata
Subject
Description
Invasive
The description of the variable ‘TestMethod1’ was edited to highlight that this is the
meningococcal
laboratory method used on the primary laboratory specimen with a positive result for
disease
case confirmation and further characterisation.
The description of the variable ‘TestMethod2’ was edited to highlight that this is the
laboratory method used on the second type laboratory specimen with a positive result
(if taken) for diagnosis or further characterisation.
The descriptions of the variables ‘ResultPorA1’, ‘ResultPorA2’ and ‘ResultMLST’ were
edited to improve clarity.
The available coded values for al fine typing variables (ResultFetVR, ResultPorA1,
ResultPorA2, ResultMLST) were updated fro
m http://neisseria.org/nm/typing/tessy/
The variable ‘DateLastVaccDose’ was added.
The variable ‘Pathogen’ was dropped.
Invasive
The variables ‘Specimen’ and ‘DateOfSpecimen’ were dropped.
pneumococcal
The description of the variable ‘TestMethod1’ was edited to highlight that this is the
disease
laboratory method used on the primary laboratory specimen with a positive result for
case confirmation and further characterisation.
The description of the variable ‘TestMethod2’ was edited to highlight that this is the
laboratory method used on the second type laboratory specimen with a positive result
(if taken) for diagnosis or further characterisation.
The coded values for the variable ‘ClinicalPresentation’ were edited. ‘Bacteraemia’ was
replaced with ‘Septicaemia’, and ‘Meningitis’ was split into ‘Meningitis’ and ‘Meningitis
and Septicaemia’.
The variable ‘DateLastVaccDose’ was added.
The description of the variable ‘VaccType’ was edited to improve clarity.
Mumps
The description of the variable ‘ClinicalPresentation’ was edited to match other VPDs.
Polio
The variable ‘DateLastVaccDose’ was added.
Tetanus
The variable ‘DateLastVaccDose’ was added.
2015 VPD metadata changes
General note:
Please be aware that since metadataset 27 (15.03.2013) additional coded values were added to the
variable ‘Specimen’ for
invasive pneumococcal disease. These additional coded values included;
JOINT = Joint fluid, O = Other (any other sterile site), PERIT = Peritoneal fluid and PLEURAL =
Pleural fluid. This change was not noted in the reporting protocol at the time.
Table 5: Summary of implemented changes in case-based record types for VPD in 2015
Subject
Description
All diseases
The variables EpiLink, ClinicalCriteria and Labresult were removed.
Diphtheria
The description of the variable ‘Classification’ was edited to ensure consistency with the
EU case definition.
The RecordType ‘HAGGR’ was removed.
The variable ‘DateLastVaccDose’ was added.
Two new coded values were added to the variable ‘Pathogen’. The coded value were
PSEU=Corynebacterium pseudotuberculosis and NUS = Not under surveil ance. This
change reflects the update of the case definition in 2012.
Invasive H.
The description of the variable ‘Clinical Presentation’ was edited to improve clarity.
influenzae
The description of the variable ‘Vaccination Status’ was edited to include the text
disease
‘against serotype b’.
The RecordType ‘HAGGR’ was removed.
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Vaccine Preventable Diseases Reporting Protocol 2018
Annex 1 VPD metadata
Subject
Description
Invasive
The description of the variable ‘Clinical Presentation’ was edited to improve clarity.
meningococcal
The variables ‘Specimen1’ and ‘Specimen2’ were dropped.
disease
The description of the variable ‘Vaccination Status’ was edited to include the text
‘against the serogroup of meningococcus that was the cause of his/her infection’.
In the variable ‘Serogroup’ the coded value W135 was replaced with W, due to a recent
reclassification.
The RecordType ‘HAGGR’ was removed.
The available coded values for al fine typing variables were updated from
http://neisseria.org/nm/typing/tessy/
Invasive
The description of the variable ‘Clinical Presentation’ was edited to improve clarity.
pneumococcal
The description of the variable ‘Classification’ was edited to ensure consistency with the
disease
EU case definition.
The description of the variable ‘Vaccination Status’ was edited to include the text ‘if
vaccine series was initiate with a vaccine different than the last one, indicate last
vaccine of the series’.
The RecordType ‘HAGGR’ was removed.
Measles
The description and coded values for the variable ‘Imported’ were edited to ensure
consistency with the Surveil ance Guidelines for measles, rubel a and congenital rubel a
syndrome in the WHO European Region1.
The description of the variable ‘Classification’ was edited to ensure consistency with the
EU case definition.
Mumps
The description of the variable ‘Classification’ was edited to ensure consistency with the
EU case definition.
The variable ‘Genotype’ was added.
Pertussis
The description of the variable ‘Classification’ was edited to ensure consistency with the
EU case definition.
Rubella
The description and coded values for the variable ‘Imported’ were edited to ensure
consistency with the Surveil ance Guidelines for measles, rubel a and congenital rubel a
syndrome in the WHO European Region1.
The description of the variable ‘Classification’ was edited to ensure consistency with the
EU case definition.
2014 VPD metadata changes
General note:
The description of the coding for DOSEUNK (VaccStatus variable) was changed in the 2014 metadata
for Measles, Mumps, Rubella, Pertussis, and Diphtheria. The name of the DOSEUNK coding was
changed from “Unknown number of doses” to “Vaccinated with unknown number of doses”. This
modification did not imply any operational change during data upload.
Table 6: Summary of implemented changes in case-based record types for VPD in 2014
Subject
Description
MENI
The fol owing variables were removed:
MIC_CIP
MIC_CTX
MIC_PEN
MIC_RIF
The fol owing variables should be used from now onwards:
ResultMICValueCIP
ResultMICValueCTX_CFX
ResultMICValuePEN
ResultMICValueRIF
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Vaccine Preventable Diseases Reporting Protocol 2018
Annex 1 VPD metadata
Subject
Description
MENI
The fol owing variables were added:
SIR_CIP
SIR_CTX_CFX
SIR_PEN
SIR_RIF
MENI,
The requirements for the fol owing variables were decreased:
HAEINF
Specimen1
Specimen2
LabMethod1
Labmethod2
MENI,
Validation rules were removed for the fol owing variables:
HAEINF
Specimen1
Specimen2
LabMethod1
Labmethod2
PNEUMO
A validation rule was updated:
(Warning) If ClinicalPresentation is 'MENI' and Specimen is not CSF and Specimen is not UNK
Message: If Clinical presentation is MENI, then Specimen should be CSF or UNK.
Change to:
(Warning) If ClinicalPresentation is 'MENI' and Specimen is not CSF and Specimen is not BLOOD
and Specimen is not UNK
Message: If Clinical presentation is MENI, then Specimen should be CSF or BLOOD or UNK.
All VPD
Improve description of vaccination status coded value list
All
Update NUTS codes according to the NUTS Codes 2010 classification from EUROSTAT
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Vaccine Preventable Diseases Reporting Protocol 2018
References
References
1. Surveillance guidelines for measles, rubella and congenital rubella syndrome in the WHO European
Region, update December 2012.
http://www.euro.who.int/en/health-topics/communicable-
diseases/measles-and-rubella/publications/2012/surveillance-guidelines-for-measles,-rubella-and-
congenital-rubella-syndrome-in-the-who-european-region,-update-december-2012
2. Renewed commitment to measles and rubella elimination and prevention of congenital rubella syndrome
in the WHO European Region by 2015. Regional Committee for Europe. Sixtieth session. Moscow, 13–16
September 2010.
http://www.euro.who.int/__data/assets/pdf_file/0008/119546/RC60_edoc15.pdf
3. Guidelines for measles and rubella outbreak investigation and response in the WHO European Region,
2013.
http://www.euro.who.int/__data/assets/pdf_file/0003/217164/OutbreakGuidelines-updated.pdf
4. European Centre for Disease Prevention and Control. Long-term surveillance strategy 2014–2020.
Stockholm: ECDC; 2013.
http://www.ecdc.europa.eu/en/publications/Publications/long-term-
surveillance-strategy-2014-2020.pdf
5. WHO Vaccine-Preventable Diseases Surveillance Standards, Measles, update 15 October 2018.
https://www.who.int/immunization/monitoring_surveillance/burden/vpd/WHO_SurveillanceVaccinePreve
ntable_11_Measles_R2.pdf
6. Manual for the Laboratory-based Surveillance of Measles, Rubella, and Congenital Rubella Syndrome.
https://www.who.int/immunization/monitoring_surveillance/burden/laboratory/manual_chapter8/en/
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Annex 2 VPD-specific material
Case definitions
Countries are encouraged to use the 2018 EU case definitions for the 2019 data collection. The case
definitions for measles, rubella, pertussis, poliomyelitis, tetanus remain the same as in the 2008
edition/version of the EU case definitions, while the case definitions for diphtheria and mumps have
been updated (see paragra
ph Changes in 2012 EU case definitions as compared to 2008 on page
20).
An updated case definition for pertussis has been proposed and is currently going through the
European Commission’s approval process. No major changes in the metadata in relation to this new
case definition are envisaged.
For a list of 2018 EU Case Definitions, see:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018D0945&from=EN
or https://ecdc.europa.eu/en/surveillance-and-disease-data/eu-case-definitions
VPD reporting frequency
For all diseases, any update of previously reported cases should be done before the reporting
deadline in order for data to be included in the annual epidemiological report and surveillance atlas.
In 2019, the surveillance data of the VPD that will be uploaded into TESSy will relate to cases with
date used for statistics in 2018, except for measles and rubella (see below).
(New) reporting of meningococcal disease isolates: deadline to be
updated
As of 14 March 2019, a new record type was created in order to capture information on the WGS
(whole genome sequence) typing of Neisseria meningitidis. However the specificities as well as the
timeframe of such data collection is still under finalization and will be included in a separate reporting
protocol and summarized here when these are available.
Annual reporting: deadline 15 October 2018
Invasive H. influenzae disease, invasive meningococcal disease and invasive
pneumococcal disease (enhanced surveillance)
Data should be uploaded annually. Possible, probable and confirmed cases should be reported for
invasive meningococcal disease. Confirmed cases only should be reported for invasive H. influenzae
disease and invasive pneumococcal disease.
Mumps and pertussis
Data should be uploaded annually. Possible, probable and confirmed cases should be reported.
Diphtheria
Cases should be reported on a monthly basis as they are identified. An annual data call will still be
carried out in order to finalise datasets for the previous year for use in the annual epidemiological
report. In the annual data call it will also be necessary to report “zero cases” if no cases have
occurred.
Once the data are checked by the disease experts at ECDC, they are made publically available on the
Surveillance Atlas of Infectious Diseases with a choice of weekly, monthly and annual temporal
resolution, and through annual surveillance reports on the ECDC website.
Polio and tetanus
Polio data should be uploaded annually. Confirmed cases should be reported, including “zero cases”.
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Tetanus data should be uploaded annually. Probable and confirmed cases should be reported.
Monthly reporting: deadline 25th of each month
Measles and Rubella (enhanced surveillance)
Measles and rubella surveillance data should be uploaded to TESSy on a monthly basis. The deadline
for upload is the 25th of each calendar month, and the data to be uploaded is up to the end of the
previous calendar month. On the morning of the 26th of each month, the dataset available in TESSy
is validated by disease experts at ECDC and forwarded to the WHO Regional Office for Europe.
Once the data are checked by the disease experts at ECDC, they are then made publically available
on the
Surveillance Atlas of Infectious Diseases, with a choice of monthly and annual temporal
resolution and through
monthly an
d annual surveillance reports on the ECDC website.
Collection of discarded cases
Possible, probable, confirmed and discarded cases of measles and rubella should be reported to
ECDC. The collection of discarded cases is important to monitor progress towards the measles and
rubella elimination goal1-3. The metadata variable “Classification” for measles and rubella includes five
different values (possible, probable, confirmed discarded and unknown).
Discarded cases are defined according t
o WHO guidelines1 as suspected cases which were
investigated and discarded either through negative results of adequate laboratory testing for
measles/rubella or by an epidemiological link to a laboratory-confirmed case of another disease.
Suspected cases are defined as cases with signs and symptoms consistent with the clinical criteria of
measles.
Collection of modified measles/cases that don’t fully meet the clinical criteria
Please see comments on page 9.
Narrative information
Changes over time in the number of cases reported in a surveillance system do not always reflect
true changes in the incidence of disease. New reporting practices, improved laboratory capacities and
changes in legislation are some of the factors that can influence the number of cases reported. It is
important to be aware of such “surveillance artefacts” when analysing surveillance data and countries
are encouraged to describe changes in the surveillance environment that may impact on the number
of cases reported. It is equally important to report if the surveillance environment has remained the
same from one year to the next. We encourage reporting countries to provide this information at the
same time as data submission to TESSy.
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Changes in 2018 EU case definitions as compared to 2012
Changes are indicated in red
Rubella
Clinical criteria
Any person with sudden onset of generalised maculo-papular rash
AND
At least one of the following five:
— Cervical adenopathy
— Sub-occipital adenopathy
— Post-auricular adenopathy
— Arthralgia
— Arthritis
Laboratory criteria
At least one of the following four:
— Isolation of rubella virus from a clinical specimen
— Detection of rubella virus nucleic acid in a clinical specimen
— Rubella IgM antibody detection (*)
— Rubella IgG seroconversion or significant rise in rubella IgG antibody titre in paired specimens
tested in parallel.
Laboratory results need to be interpreted according to the vaccination status (possible persistence of
IgM antibodies upon vaccination).
Epidemiological Criteria
An epidemiological link by human to human transmission
Case classification
A. Possible case
Any person meeting the clinical criteria
B. Probable case
Any person meeting the clinical criteria with an epidemiological link
C. Confirmed case
Any person meeting the clinical and the laboratory criteria who has not been recently vaccinated. In
case of recent vaccination, a person meeting the clinical criteria with detection of wild-type rubella
virus strain is considered as a confirmed case.
Note: When rubella in pregnancy is suspected, further confirmation of a positive rubella IgM results is
required for case management (for example, a rubella specific IgG avidity test, rubella IgM and
comparison of rubella IgG levels on paired sera conducted in a reference laboratory).
(*)In elimination settings, additional testing may be considered in certain situations to exclude false-positive IgM results (WHO
Manual for the Laboratory-based Surveil ance of Measles, Rubel a, and Congenital Rubel a Syndrome ).
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Pertussis
Laboratory Criteria
Any person with a cough lasting at least two weeks AND
— at least one of the following three:
— Paroxysms of coughing
— Inspiratory ‘whooping’
— Post-tussive vomiting
OR
Any person diagnosed as pertussis by a physician
OR
Apnoeic episodes in infants
Notes:
All individuals including adults, adolescents or vaccinated children can present with atypical
symptoms. Characteristics of cough should be investigate roxysmal in nature, increases during the
night and occurs in the absence of fever.
Laboratory Criteria
At least one of the following three:
— Isolation of Bordetella pertussis from a clinical specimen
— Detection of Bordetella pertussis nucleic acid in a clinical specimen
— Bordetella pertussis specific antibody response
Direct diagnosis (i)-(ii): Bordetella pertussis and its nucleic acid are best isolated/detected from
nasopharyngeal samples.
Indirect diagnosis (iii): if possible ELISA should be performed using highly purified Pertussis Toxin and
WHO reference sera as a standard. Results need to interpreted according to pertussis vaccination
status. If vaccinated within the last few years before specimen collection, the titre of specific antibodies
against Bordetella pertussis toxin may be a consequence of, or modified by, previous vaccination.
Epidemiological Criteria
An epidemiological link by human to human transmission
Case Classification
A. Possible case
Any person meeting the clinical criteria
B. Probable case
Any person meeting the clinical criteria with an epidemiological link
C. Confirmed case
Any person meeting the clinical and the laboratory criteria
Streptococcus pneumonia infection, invasive disease
Clinical Criteria
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Not relevant for surveillance purposes
Laboratory Criteria
At least one of the following three:
- Isolation of Streptococcus pneumoniae from a normally sterile site
- Detection of Streptococcus pneumoniae nucleic acid from a normally sterile site
- Detection of Streptococcus pneumoniae antigen from a normally sterile site
Epidemiological Criteria NA
Case Classification
A. Possible case NA
B. Probable case NA
C. Confirmed case
Any person meeting the laboratory criteria
Antimicrobial resistance:
The results of antimicrobial susceptibility tests must be reported according to the methods and
criteria agreed between ECDC European Antimicrobial Resistance Surveillance Network (EARS-Net)
Changes in 2012 EU case definitions as compared to 2008
Changes are indicated in red
Diphtheria
(Corynebacterium diphtheriae, Corynebacterium ulcerans and Corynebacterium pseudotuberculosis)
Clinical Criteria
Any person with at least one of the following clinical forms:
Classic Respiratory Diphtheria:
An upper respiratory tract illness with laryngitis or nasopharyngitis or tonsillitis
AND
an adherent membrane/pseudomembrane
Mild Respiratory Diphtheria:
An upper respiratory tract illness with laryngitis or nasopharyngitis or tonsillitis
WITHOUT
an adherent membrane/pseudomembrane.
Cutaneous Diphtheria:
Skin lesion
Diphtheria of other sites:
Lesion of conjunctiva or mucous membranes
Laboratory Criteria
Isolation of toxin-producing Corynebacterium diphtheriae, Corynebacterium ulcerans or
Corynebacterium pseudotuberculosis from a clinical specimen.
Epidemiological Criteria
At least one of the following epidemiological links:
— Human to human transmission
— Animal to human transmission
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Case Classification
A. Possible case
Any person meeting the clinical criteria for classical respiratory diphtheria
B. Probable case
Any person meeting the clinical criteria for diphtheria (Classic Respiratory Diphtheria, Mild
Respiratory Diphtheria, Cutaneous Diphtheria, Diphtheria of other sites) with an
epidemiological link to a human confirmed case or with an epidemiological link to animal to
human transmission
C. Confirmed case
Any person meeting the laboratory criteria AND at least one of the clinical forms
Mumps
(Mumps virus)
Clinical Criteria
Any person with
— Fever
AND
At least one of the following three:
— Sudden onset of unilateral or bilateral tender swelling of the parotid or other salivary
glands without other apparent cause
— Orchitis
— Meningitis
Laboratory Criteria
At least one of the following three:
— Isolation of mumps virus from a clinical specimen
— Detection of mumps virus nucleic acid
— Mumps virus specific antibody response characteristic for acute infection in serum or Saliva
Laboratory results need to be interpreted according to the vaccination status
Epidemiological Criteria
An epidemiological link by human to human transmission
Case Classification
A. Possible case
Any person meeting the clinical criteria
B. Probable case
Any person meeting the clinical criteria and with an epidemiological link
C. Confirmed case
Any person not recently vaccinated and meeting the laboratory criteria
In case of recent vaccination: any person with detection of wild-type mumps virus strain
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