# Uppsala Monitoring Centre product documentation Access product documentation for our products and services, including user guides, version verifications, and more to support your pharmacovigilance.

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VigiFlow	VigiFlow	VV Support.jpg
VigiLyze	VigiLyze product support	VV Support.jpg

### Other resources Contact us Online courses about our tools # VigiFlow product support Learn more about the functionality of VigiFlow with our how-to guides.


Getting started with VigiFlow	Getting started with VigiFlow
Organisation administration	Organisation administration
Import data	Import data
Export data	Export data
Entering and structuring data in reports	Entering dechallenge and rechallenge information
Delegate and assign reports	Delegate and assign reports
Manage reports	Manage reports
Find relevant reports using filters	Find relevant reports using filters

### Other resources Release notes Contact us # Getting started with VigiFlow Get started with VigiFlow.


Logging into VigiFlow for the first time	Set up your acocunt by resetting your password.	Logging into VigiFlow for the first time
Navigating in VigiFlow	Explore the different sections in the VigiFlow interface.	Navigating in VigiFlow

{% hint style="info" %} On the VigiFlow landing page, you will find links to VigiFlow with our online courses, such as **VigiFlow Introductory course**, which is a helpful starting point for first-time users. **Note:** VigiFlow online courses are only available to VigiFlow users. Check with your national regulatory authority for access. {% endhint %} # Logging into VigiFlow for the first time How to login to VigiFlow for the first time. #### Please follow the steps to activate your account and set your password: 1. Navigate to VigiFlow login page ([https://vigiflow.who-umc.org](https://vigiflow.who-umc.org/)) and click on **`Forgot your password`**. 2. Enter your email address and click **`Send verification code`**. 3. A field will appear requesting your verification code. Leave this window open, and open your email inbox in a new tab or app. 4. You will receive an email from Uppsala Monitoring Centre containing a verification code. Enter this code in the field Verification code. 5. Click **`Verify`**. 6. Click **`Continue`**. 7. Set your password. Next time you access VigiFlow, simply enter your email address and new password. {% hint style="success" %} For best performance, use the latest version of Google Chrome when accessing VigiFlow. {% endhint %} # Navigating in VigiFlow When you log into VigiFlow, you will see several buttons. However, not all functionality is available by default. {% hint style="warning" %} To activate buttons, please [contact UMC](mailto:support@who-umc.org). {% endhint %} ## Buttons ### “Report list” This section provides an overview of the reports submitt~~e~~d to VigiFlow. You can filter these reports by clicking on the Filter button. They can also be sorted based on criteria such as the Latest receive date, Initial receive date, and Worldwide Unique ID (WWUID). ### “Import” This section allows you to import reports, download the acknowledgment log, and view previously imported reports. ### “Export” This section handles the export of reports. By clicking on the Receiver button, you can add a receiver for a report and choose the types of reports they should receive based on various criteria. You can also edit the criteria for an existing receiver. Please note that this functionality is not available to all users. If you have any questions, contact UMC. ### “Manage Authority” This functionality allows the VigiFlow Administrator to manage suborganisations, decide on organisational structure, and handle decentralisation within the system. ### “VigiLyze” Provides direct access to VigiLyze for users of this tool.

{% hint style="info" %} Refer to the VigiFlow Introductory Course: **“What is VigiFlow?”** section → **“VigiFlow Overview”** **Note:** VigiFlow online courses are only available to VigiFlow users. Check with your national regulatory authority for access. {% endhint %} # Changing language in VigiFlow To change the language, click on the symbol next to your name. Here, you can change the interface language as well as the language for coding dictionaries.

# Organisation administration As a VigiFlow administrator, you can create, manage, and delete both users and suborganisations.


VigiFlow administrator capibilities	VigiFlow administors can create, manage, and delete user accounts and suborganisations.	VigiFlow administrator capibilities
Creating new user accounts	Create user accounts.	Creating new user accounts
Removing VigiFlow users	Delete user accounts.	Removing VigiFlow users
Listing all users in VigiFlow	Display all users in all your suborganisations.	Listing all users in VigiFlow
Creating suborganisations	Set up suborganisations.	Creating suborganisations
View and edit rights of suborganisations	Manage your suborganisations.	View and edit rights of suborganisations

# VigiFlow administrator capibilities VigiFlow Administrators have access to an additional tab called “Manage accounts” on the landing page of VigiFlow. It is possible to have multiple Administrators. ### Capabilities * [Create](/vigiflow/organisation-administration/creating-new-user-accounts), edit, and [delete](/vigiflow/organisation-administration/removing-vigiflow-users) VigiFlow user accounts at all levels (national centre level and suborganisations). * [Create suborganisations](/vigiflow/organisation-administration/creating-suborganisations) in VigiFlow. * [Edit the names](/vigiflow/organisation-administration/creating-suborganisations#name-the-new-suborganisation) of suborganisations. * Delete suborganisations. * Assign the Administrator role to other users. ### In case the organisation has no Administrator If no one is appointed as Administrator or they are unknown to the national PV centre staff, [contact UMC](mailto:support@who-umc.org) for necessary clarifications and action. # Creating new user accounts 1. Click the “**`Manage authority`**” tab. 2. Locate the organisation you want to add the new user to in the “Organisations” menu on the left. 3. Click **`Create new user`**. 4. Enter the name and email. Ensure the email is spelt correctly as it will become the new user ID and needs to be linked to an existing email. 5. Click **`Create`**. 6. Click **`Save`**. After adding a new user to VigiFlow, the user needs to activate their account by setting a personal password. Please provide[ these instructions](/vigiflow/getting-started-with-vigiflow/logging-into-vigiflow-for-the-first-time) for account activation to the new VigiFlow user. # Removing VigiFlow users {% hint style="warning" %} Before deleting the account, search for any *Open reports* assigned to the user. These reports will become unassigned when the user is deleted. {% endhint %} 1. Find the user in the list of “All users”. 2. Press the **`Delete`** icon next to the name of the user you want to remove. 3. Click **`Yes`** to confirm. 4. Click **`Save`** in the bottom right corner and wait for the green confirmation sign to appear at the bottom of the screen. # Listing all users in VigiFlow Display a list of all users in your suborganisations. In the top menu, click the “**`All users`**” tab. This will display the updated list of all users in VigiFlow for all suborganisations, sorted by names of users. It is not possible to generate an Excel file with all users, but you can easily copy and paste the list into an Excel file.

# Creating suborganisations Suborganisations can be set up by administrators. {% hint style="info" %} Before starting to set up suborganisations, please refer to the **VigiFlow Intermediate Course**: “**Different ways of receiving ICSRs**” section → “**Suborganisations**” and/or [reach out to UMC](mailto:support@who-umc.org) for dedicated support. {% endhint %} When you have considered the practical implications of setting up new sub-accounts you need to create them in the “**`Manage account`**” tab. ### Add the new suborganisation in the right place Suborganisations can be set up hierarchically.

VigiFlow organisation hierarchy with plus signs under the national PV centre and Region A.

Consider the example above. If you click the sign marked "1", you will create a new suborganisation under Copper District. Such organisation would be able to delegate their reports to *Copperbelt Province*, *National EPI* or *UMC PV centre*. If the new organisation is created using the plus sign next to “2”, the centre will be placed beneath Steel District. If it is created using the plus sign next to “3”, it will be placed directly beneath *Copperbelt Province*. \ To create a new sub-organisation beneath *National EPI* or the *UMC PV Centre*, scroll down to locate the appropriate plus sign. Once an organisation has been created, it cannot be moved within the hierarchy. If an organisation is added in the wrong location, it must be removed and then created again in the correct place. **Once created, an organisation cannot be moved within the hierarchy.** If added to the wrong place, simply remove it and add it to the correct location. ### Name the new suborganisation The new organisation is now created. You need to name it with its proper name. This name can be in the local language and should be understandable to any VigiFlow user in your country. For example, “Regional centre” is not a good name; instead, it should be called by the specific name of the regional centre. Click **`Save`**. ### Add users Now that the new suborganisation is created, it will automatically appear in “Administrative statistics”, and it is possible to delegate reports to it. However, you must add users to the suborganisation. See: Creating new user accounts # View and edit rights of suborganisations Manage the viewing and editing rights of suborganisations. By default, the new suborganisation will only be able to view and edit the ICSRs that it has created itself or that have been delegated to it. Organisations at higher levels of the hierarchy have access to reports from all suborganisations beneath them. The Administrator can change this setting so that a suborganisation can access all reports of another level by adjusting the setting in “**`View/Edit`**”. # Import data How importing data works. {% hint style="warning" %} Import functionality might need to be enabled by UMC. For assistance, [contact UMC](mailto:support@who-umc.org). {% endhint %}


Importing E2B XML files	E2B XML files can be imported in the "Import" section.	Importing E2B XML files
The differences between validated and non-validated import	The requirements differ for validated and non-validated import.	The differences between validated and non-validated import
Interpreting the import status	The import status can be "ok", "partial", or "fail".	Broken link
How to tell why an import has failed	Learn why an import failed under "Import details".	How to tell why an import has failed
Downloading E2B acklogs	E2B acklogs can be downloaded in the E2B acklog column.	Downloading E2B acknowledgement messages
Follow-up reports are automatically merged	Follow-up reports are always merged with the original report.	Follow-up reports are automatically merged
How to find a previously uploaded report	Find uploaded reports by using the search filters.	How to find a previously uploaded report

# Importing E2B XML files {% hint style="warning" %} Import functionality might need to be enabled by UMC. For assistance, [contact UMC](mailto:support@who-umc.org). {% endhint %} ### How to import E2B XML files 1. In VigiFlow, go to “Import”. 2. For Type of import, the default option **`validated`** is selected and should always be used for ICSRs from marketing authorisation holders (MAHs). 3. Click on **`Choose File`** and select the XML files you want to upload. 4. Once the import is complete, it will immediately appear in the list of imports with a summary of the status and the number of ICSRs successfully imported into VigiFlow. ### Maximum number of ICSRs that can be imported per XML file To guarantee system performance, include a maximum of 100 ICSRs in one XML file. # The differences between validated and non-validated import {% hint style="warning" %} Import functionality might need to be enabled by UMC. For assistance, [contact UMC](mailto:support@who-umc.org) {% endhint %} ### Validated import Requires that the ICSRs in the file capture some administrative and basic information, such as: * Report type * Reporter identifier * Designation/Qualification of the reporter * Patient identifier * At least one reaction/event – MedDRA coded * At least one suspect drug ### Non-validated import This option has no requirements for administrative and basic information to be captured in the ICSR. # How to tell why an import has failed {% hint style="warning" %} Import functionality might need to be enabled by UMC. For assistance, [contact UMC](mailto:support@who-umc.org) {% endhint %} There are three different import statuses in VigiFlow. * **`Ok`**: All ICSRs contained in the file were successfully imported. * **`Partial`**: Some ICSRs were successfully imported but others did not meet the minimum requirements of the validation rules. In the “Number of ICSRs” column, you can view the total number of ICSRs in the report, with the successfully imported ones indicated in parentheses. * **`Fail`**: None of the ICSRs were imported. If the import of XML files has failed or partially failed, you can tell why by following these steps: 1. Go to the “**`List of imports`**” in VigiFlow. 2. Click on the specific row of an imported file. 3. In “**`Import details`**”, you can see which ICSRs failed to import and why.

The messages under “**`ICSRs not imported`**” explain the specific error. If you do not understand a particular error message, please [contact UMC](mailto:support@who-umc.org) for assistance. # Downloading E2B acknowledgement messages {% hint style="warning" %} Import functionality might need to be enabled by UMC. For assistance, [contact UMC](mailto:support@who-umc.org) {% endhint %} In accordance with the ICH E2B standard, a receipt confirmation must be available for each imported file. This is known as the *acknowledgement message*. In VigiFlow, you can easily download the acknowledgement message by clicking on **`Download`** in the **E2B acklog** column. # Follow-up reports are automatically merged {% hint style="warning" %} Import functionality might need to be enabled by UMC. For assistance, [contact UMC](mailto:support@who-umc.org) {% endhint %} Follow-up reports are automatically merged with their original report if the Worldwide Unique ID (WWUID) is the same. When a follow-up report is uploaded, VigiFlow will automatically show the latest version. To see previous versions, click on the **`WWUID`** in the audit trail. # How to find a previously uploaded report {% hint style="warning" %} Import functionality might need to be enabled by UMC. For assistance, [contact UMC](mailto:support@who-umc.org) {% endhint %} It is possible to search for imported files based on the date and the name of the sender organisation. 1. Navigate to the VigiFlow homepage and select **`Import`**. 2. Click on **`Filter`**. 3. Enter the desired search criteria and click **`Search`**. You can input data in multiple fields to refine your search. # Export data Export data, AEFI line lists, and PDFs from VigiFlow.


Exporting data with Excel	Export data in several different Excel formats.	Downloading to Excel
Exporting an AEFI line list	Customise which reports to include in your export by using filters.	Exporting an AEFI line list
Exporting a PDF	Export one or multiple reports as a PDF.	Exporting a PDF

# Downloading to Excel Data can be exported to Excel in several different formats. Apply the necessary filters before initiating the Excel export. Excel exports include all reports visible in the list, regardless of whether some reports are marked as selected.

Select which Excel formats you wish to export before initating the export.

### Excel formats There are a few different Excel formats: #### **Excel** Contains data presented in the tabs “**`Reports`**”, “**`Drugs`**”, and “**`Reactions`**”. #### **AEFI excel** An AEFI line listing with data elements to support both analysis of AEFI data and surveillance performance. #### **Admin statistics** Provides a summary of data such as number of reports per reporter qualification, sender type, suborganisation, etc. #### Safety profile statistics Introduced during COVID-19 mass vaccinations, this Excel file contains detailed reports and distributions of adverse events, time frames, and demographics across products. {% hint style="warning" %} For assistance with specific searches or analyses you cannot resolve on your own, please [contact UMC](mailto:support@who-umc.org). {% endhint %} # Exporting an AEFI line list An AEFI line list can be extracted at any time by any VigiFlow user. In organisations with multi-level VigiFlow access (e.g. national, regional, district), extracted data includes all accessible reports. Before exporting, use the **`Filter`** to select which reports you want to include, such as a specific time period, vaccine, or whether to include all reports or only closed reports. Organisations handling both medicine and vaccine data can use the ATC code filter “**`J07`**” to include only vaccine reports. {% hint style="success" %} The AEFI line list is a single sheet with patient demographics, vaccine details, adverse event details, and administrative information. {% endhint %} # Exporting a PDF Export one or multiple reports as a PDF. ### Umasked and masked PDF exports The PDF export comes in two versions: * An unmasked version where all data that was put into the report is displayed. * A masked version where the certain Patient and Reporter information is masked, [read etails here](/vigiflow/export-data/data-masked-in-exports). ### Export a single report as PDF To export a single report, open the report and use the download button in the top menu. ![](https://844234868-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2FD7MbxF2Gm1Bf1uqE3mOA%2Fuploads%2FfhsbeNBD95P0I1g6n2IN%2FExport%20PDF_single.png?alt=media\&token=32604127-398f-420a-a3f3-04872a612e96) ### Export multiple reports as PDF To export multiple reports: 1. Select the reports in the **`Report list`**. 2. Got to **reports selected** at the bottom of the page, and choose either **`Masked PDF`** or **`Unmasked PDF`**.

# Data masked in exports When reports are shared with VigiLyze, or AfriVigilance, the data fields listed below are masked. The same applies when reports are exported from VigiFlow as XML or PDF files as Masked. #### Patient information that will be masked * Patient Identification Number * Patient Initials * Specialist Record Number, GP Medical Record Number, Hospital Record Number, Investigation * Number * Date of Death * Cause of Death (MedDRA) * Cause of Death as Reported by Initial Reporter * Cause of Death After Autopsy (MedDRA) * Cause of Death After Autopsy #### Reporter information that will be masked * Organisation * Department * Title * Given Name and Family Name * Country * Street Address, City, State or Province, Postcode * Telephone, Fax * Email Address # Sending reports to VigiLyze Level 1 organisations can share reports from VigiFlow to VigiBase. Once shared, the report will be accessible for analysis in VigiLyze alongside reports from other member organisations in the WHO Programme for International Drug Monitoring. VigiLyze is updated twice a week, on Sundays and Wednesdays. When you share reports with VigiLyze, [some patient and reporter data](/vigiflow/export-data/data-masked-in-exports) will be masked in the shared copy. ### Share individual reports When inside a report, you can share it using the **`Send copy`** button.

### Share multiple reports Multiple reports can also be shared in one go, from the "**Report list**". 1. Select the reports to be sent to VigiLyze by clicking the box to the left of the Worldwide Unique ID. 2. Go to **reports selected** menu and choose **`Send copy`**.

The next section describes how to [send batches of reports to VigiLyze](/vigiflow/export-data/sending-batches-of-reports-to-vigilyze). ### VigiLyze status in Report list The column VigiLyze in the “Report list” should be interpreted as this * **Empty**: The report has not been shared with VigiLyze * **Check mark** (✔): The report has been shared with VigiLyze * **Exclamation mark** ( **!** ) : The latest version of the report hasn’t been shared.

{% hint style="info" %} Explore training courses through our [Learning Management System](https://learning.who-umc.org/). Log in if you have a learner account or create a learner account by clicking **Enrol**. Refer to the VigiFlow Introductory Course: “**Receiving and sharing reports**” section → “**Receive and share ICSRs**” **Note**: VigiFlow online courses are only available to VigiFlow users. Check with your national regulatory authority for access. {% endhint %} # Sending batches of reports to VigiLyze To send large batches of reports to VigiLyze at once, click `Send copies to VigiLyze` from the VigiFlow landing page. This option is available to all users who have permission send reports to VigiLyze. You can include up to 10,000 reports in a batch. To create a new batch export, click **New batch**. Set the filters for the export. * Time span – last 7 or 30 days, or custom date range, referring to initial receive date of the reports. * **Status of report** – for example, if Closed is selected, only reports marked as Closed will be included in the batch. * **Only coded reports** – includes only reports with coded adverse events and medicines or vaccines. Click **Show reports** to apply the filters. This displays only reports that contain the minimum mandatory information, reports that haven’t been send, or reports that have been updated since they were last sent. You can click **Edit search** to change the search parameters. The option “**Close reports when sending**” will change the status of all reports successfully sent to VigiLyze to Closed. Reports that fail to send will retain their original status. The **Previously Sent** list shows details of past batch exports, including the number of copies sent and any that failed. To view more information about a specific batch, click anywhere in the row. If a report failed to send, its *WWUID* will be shown in the details. You can also hover over the report line to see the error message. Copy the *WWUID* and search for the report in the **Report list** to investigate and resolve the issue. # Exporting reports to AfriVigilance {% hint style="warning" icon="earth-africa" %} Sharing reports with AfriVigilance is only available to some African organisations. To request access, contact UMC . {% endhint %} In organisations where this feature is activated, users at the national level can send copies of reports to AfriVigilance. The following information is masked in the reports share with AfriVigilance: \ \- Patient information: Patient information: Initials, Parent initials, Additional record numbers. \ \- Reporter information: All data is masked, except for Reporter qualification and Country of reporter. #### To send copies of reports to AfriVigilance: 1. Go to “**Report list**” and apply the filter: **Advanced filter** → **Other** → **Show reports ready for copying to AfriVigilance**. 2. Apply any additional filters required by internal routines or other guidance. Examples include `Status of report`, `Initial receive date`, or specific medicines or vaccines. 3. Select the reports to be shared, either individually or by selecting all reports on the current page. 4. From the “**Reports selected**” menu, choose **Send copy to AfriVigilance**.

When search results span more than one page, increase **Items per page** to 100 and repeat steps 3 and 4 until all reports have been sent.

For recurring activities (for example, weekly, monthly, or quarterly sharing), it is recommended to save the search under “**My filters**”. #### Sending individual reports Reports can also be sent to AfriVigilance from within the report. using the **Send copy to AfriVigilance** button in the top menu.

#### Which reports are included when applying the filter Show reports ready for copying to AfriVigilance ? The filter identifies two types of reports: * New reports that have not been shared with AfriVigilance and meet the minimum data requirements, including: * Initial receive date * Report type * Initial reporter marked as primary * Patient information * Suspect/Interacting drug * Reaction/event * Follow-up reports to previously shared cases that also meet the minimum data requirements. # Entering and structuring data in reports How to code, link, record, enter, and document data in VigiFlow.


Creating parent-child reports	Parent-child reports include additional fileds for parent information.	Creating parent-child reports in VigiFlow
Linking related reports	It is possible to link two or more reports if they concern the same patient or a cluster of cases.	Linking related reports in VigiFlow
Recording information for reports from studies and clinical trials	Use the "Study information" tab.	Recording information for reports from studies and clinical trials
Attaching additional documents to a report	Addtional documents must be of one of the supported file types and less than 15 MB.	Attaching additional documents to a report
Using the reporter address book	If the same reporter sends multiple reports, use the “Reporter address book”.	Using the reporter address book
Recording patient information	Patient information is found primarily in the “Patient” section of reports.	Recording patient information in VigiFlow
Coding adverse event information	Coding adverse event information with MedDRA enables users to find reports in searches and queries and allows for computer processing of cases	Coding adverse event information
Entering dechallenge and rechallenge information	Where and how to enter dechallenge and rechallenge information.	Entering dechallenge and rechallenge information
Coding drug information with WHODrug	Coding drugs and vaccines with WHODrug enables users to find reports in searches and queries and allows for computer processing of cases.	Coding drug information with WHODrug
Documenting causality assessments	Casuality assessments can be documented in VigiFlow using several different methods.	Documenting causality assessments

# Creating parent-child reports in VigiFlow Parent-child reports include additional fileds for parent information. A parent-child report involves a foetus or breast-feeding infant exposed to medicine(s) or vaccine(s) through the parent and experiencing adverse effects. The child is considered the patient, and additional fields for parent information will be available. To designate a case as a parent-child case: {% hint style="success" %} Tick the box “Parent Child report” in the “Report information” section of the report. {% endhint %}

### Parent Child specific fields *Patient: Parent information, Parent medical history.* *Drug: Parent route of administration, Gestational age at exposure* (if foetus). # Linking related reports in VigiFlow You can link two or more reports if they concern the same patient or a cluster of cases. To link reports: 1. Paste the Worldwide Unique ID into the *Link report* field. 2. Add a reason for linking the cases and click **`Add`**. Both reports will now have a clickable link to each other. # Recording information for reports from studies and clinical trials For reports from studies, use the “**`Study information`**” tab in the “**`Report information`**” section. Enter the *Study type*, *Study name*, *Study sponsor number*, and registration details. The “Report type” is typically *Report from study*. When searching for reports, you can filter by *Study name* or *Study registration number*. # Attaching additional documents to a report In the “**`Report information`**” section, you can upload documents under the “**`Documents`**” tab. {% embed url="" %} 1. Name the document with an appropriate description. 2. Click the icon. 3. Select the file. Supported file types include: .pdf, .jpeg, .jpg, .txt, .rtf, .tiff, .tif, .html, .doc, .docx, .xls, .xlsx, .dicom, .png, .htm, .dcm. The total attachment size for **each report** is 15 MB. These documents are part of the report but are not searchable. You need to check the “Additional documents” section to see if there are any documents in a report. Some organisations add information about additional documents in the case narrative. # Using the reporter address book If the same reporter sends multiple reports, use the “Reporter address book”. ### Add a reporter To add a reporter: 1\. Click **`Select from address book`** and then the sign. 2\. Enter the reporter’s information and click **`Save`**. The address book is specific to your VigiFlow organisation. Other organisations cannot see it. If a suborganisation maintains an address book, other suborganisations cannot view it. ### Retrieve a reporter's contact information To retrieve a reporter’s contact information: 1\. Click **`Select from address book`**. 2\. Search for the reporter’s name or institution in the search bar. 3\. Click on their name in the search results. The system will automatically fill in their contact details in the report. # Recording patient information in VigiFlow Patient information is mainly in the “**`Patient`**” section but is spread over several sections of the report. To expand the “**`Patient`**” section: 1. Click on ![](https://844234868-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2FD7MbxF2Gm1Bf1uqE3mOA%2Fuploads%2FpEKAznNw2Z2TV4B1MpPF%2Fadditional%20fields.png?alt=media\&token=6d0c6b78-9821-47aa-83a4-013fa7c69bed)to access more record details and, if applicable, information about patient death. 2. You can also enable a *Patient identification number*, which must be enabled by UMC. # Coding adverse event information Coding adverse event information with MedDRA enables users to find reports in searches and queries and allows for computer processing of cases (such as calculations of disproportionality). ### Method 1 In the **`Reaction`** section, search for suitable terms in the field *Reaction/event (MedDRA)*. ### Method 2 If you don’t find the term when searching, click the list symbol on the right to browse the MedDRA hierarchy. Clicking the arrows expands levels of the dictionary, eventually leading to a list of LLTs. If you are unsure and cannot find an adequate MedDRA term, you can use the free text field *Reaction/event as reported by initial reporter*. However, free text reactions cannot be searched in neither VigiFlow nor VigiLyze. The two fields can also be used in combination to reflect both the original report and its corresponding MedDRA term. # Entering dechallenge and rechallenge information ### Enter dechallenge information Dechallenge information is entered as the combination of *Drug – Action taken* (Drug withdrawn) and Reaction - *Outcome*. ### Enter rechallenge information Rechallenge information is recorded for each drug. If the field *Was rechallenge performed?* is marked “Yes”, a new field called *Rechallenge information* appears, where you can enter the results of each rechallenge. # Coding drug information with WHODrug Coding drugs and vaccines with WHODrug enables users to find reports in searches and queries and allows for computer processing of cases (such as calculations of disproportionality). How to code drug information with WHODrug: 1. When coding to WHODrug in VigiFlow, you can search for both trade names and active substances in the field *Drug name*. A drop-down list appears with results matching the search. You can also click the icon on the right of the field to access the more detailed WHODrug search, where you can see additional information such as MAH and dose forms. 2. If you are unable to find the correct match for your search or if you have information to add, use the field *Drug name as reported by initial reporte*r. {% hint style="warning" %} If you can’t find a specific pharmaceutical product in WHODrug, [contact UMC](mailto:support@who-umc.org) to suggest its inclusion in the dictionary. {% endhint %} # Documenting causality assessments Casuality assessments can be documented using several different methods. VigiFlow allows you to record causality assessment results using four different methods: * WHO-UMC * Naranjo * French Method (Bégaud’s imputability method) * WHO AEFI (for adverse events following immunisation) {% hint style="success" %} If your organisation uses a different method, you can write it in the *Comments* field at the bottom of the section. {% endhint %} To register an assessment, go to the “Assessment” section of the report:

Multiple assessments can be added, if required, using the plus sign. This is useful if the reporter or sender made their own causality assessment, but the national centre uses a different method or disagrees with the initial assessment. {% hint style="info" %} Refer to the VigiFlow Intermediate Course: “**ICSR processing and content**” section → “Assessment” **Note**: VigiFlow online courses are only available to VigiFlow users. Check with your national regulatory authority for access. {% endhint %} # Delegate and assign reports Reports can be delegated to other organisations as well as assigned within your own organisation.


Delegating reports to other organisations	Use the Delegate to organisation feature to transfer a report outside your organisation.		Delegating reports to other organisations
Assigning reports within your organisation	Assigning reports helps distribute the workload and shows which user is handling a specific report.		Assigning reports within your organisation

# Delegating reports to other organisations You can use the Delegate to organisation feature to transfer a report outside your organisation. Local routines often describe when a report should be delegated. There are two methods to delegate reports: ### Delegate individual reports From within a report, go to the top menu and click on **`Delegate`**. Then search for the organisation you want to delegate the case to and choose it. ### Delegate multiple reports From the “**`Report list`**” you can also delegate multiple reports at once. 1. Mark the reports you want to delegate by clicking the box to the left of Worldwide Unique ID. 2. Click **`reports selected`** at the bottom-left of the screen. 3. Click **`Delegate to organisation`**. 4. Select the recipient for the report delegation. {% hint style="info" %} Refer to the VigiFlow Intermediate Course: “**Finding effective ways to work in VigiFlow**” section “**Report delegation**” **Note:** VigiFlow online courses are only available to VigiFlow users. Check with your national regulatory authority for access. {% endhint %} # Assigning reports within your organisation Assigning reports helps distribute the workload and shows which user is handling a specific report. However, other users can still access and edit the report. 1. Go to your VigiFlow homepage. 2. Select “**`Report list`**”. 3. Click on the circle next to the Worldwide Unique ID. 4. Select the colleague you want to assign the report to, or yourself. {% hint style="success" %} When a report is delegated to another organisation, it will automatically be unassigned. You can filter to view all reports assigned to you or any other user. {% endhint %} # Manage reports Update, share, delete, find, and compare reports.


Using the report status	The report status indicates the current stage of the report in the process.	Using the report status
Updating an existing report in VigiFlow	Level 1 organisations are also able to share the updates to VigiBase.	Updating an existing report in VigiFlow
Sharing reports with VigiBase	Level 1 organisations can share reports from VigiFlow to VigiBase.	Sending reports to VigiLyze
Ensuring an ICSR meets minimum requirements for VigiBase submission	ICSRs can be sent to VigiBase even if not assessed or complete.	Minimum requirements for VigiBase submission
Deleting an ICSR	ICSRs can be deleted from the "Report list".	Deleting an ICSR
Finding follow-up reports	Follow-up reports are only visible to level 1 organisations.	Finding follow-up reports
Comparing follow-up report content	Use the compare feature to see what has been changed in a follow-up report.	Comparing follow-up report content

# Using the report status The report status indicates the current stage of the report in the process. There are three available statuses, and each VigiFlow organisation determines how to use them. * **`Open`**: Active reports still being worked on. * **`Under assessment`**: Reports undergoing some form of assessment or investigation. * **`Closed`**: Reports that are finalised. The default filtering in VigiFlow is to show only reports with the status: **`Open`**. Report status is changed manually by users except for imported ICSRs. * If the previous ICSR version had the status **`Closed`**, the follow-up will get the status **`Open`**. * If the previous ICSR version had the status **`Open`** or **`Under assessment`**, the status of the follow-up will remain unchanged. # Updating an existing report in VigiFlow 1. Find the report you want to update. Use **`Filter`** to locate the specific report. 2. Click the Worldwide Unique ID of the report. 3. Make the necessary updates. 4. Click **`Save`**. For Level 1 organisations, you will be asked if you want to share updates to VigiBase if the report has been shared previously. # Minimum requirements for VigiBase submission ICSRs can be sent to VigiBase at any time, even if not assessed or complete. However, there is a minimum amount of information required. The exclamation mark symbol indicates insufficient information. Click the symbol to see what mandatory information is missing.

### Filter for eligible reports You can filter for eligible reports using Show only ICSRs that can be copied to VigiLyze.

# Deleting an ICSR 1. In VigiFlow, navigate to the “**`Report list`**”. 2. Click on the Worldwide unique ID of the report you want to delete. 3. Click on **`Delete`**. 4. State why the report is deleted in the box that appears. Deleted reports can still be found in the “**`Report list`**” using the filter *Include deleted reports*. Once deleted, a report cannot be restored. The Worldwide Unique ID will never be reused. # Finding follow-up reports {% hint style="info" %} Follow-ups are only visible to Level 1 organisations in VigiFlow. {% endhint %} A report in VigiFlow can be flagged as a follow-up if: * It is sent electronically as a follow up from an external sender such as company or * A report in VigiFlow has been updated by a suborganisation There is a quick filter in the top menu for follow-ups. There is also a column in the “Report list”, where follow-up reports are marked with a symbol. A report remains marked as a follow-up until its status is changed to **`Closed`**. To remove the follow-up flag, update the report status to **`Closed`**. # Comparing follow-up report content To see what has been changed in a follow-up report, go into the report by clicking the Worldwide Unique ID (WWUID). 1. Click the **`Compare`** button in the top menu. 2. This will open a new window where you have two versions of the report displayed with the newer version on the right. 3. Use the dropdown menus at the top to select which versions to compare. Follow-ups received from companies are marked “**`Imported`**”, whereas any other change to the report will be marked “**`Edited`**”. # Find relevant reports using filters Learn how to use the filters in VigiFlow.


Overview of filters	Make sure of quick filters, common filters, and advanced filters.	Overview of filters
Adding and removing filters	Filters can be added directly under the report list.	Adding and removing filters
Saving searches that you do repeatedly	If there are filters that you often use, you can save these for quicker access.	Saving searches that you do repeatedly
Searching for drugs/vaccines with WHODrug	Reports in VigiFlow can be filtered based on drugs or vaccines.	Searching for drugs/vaccines with WHODrug
Search for multiple drugs/vaccines	With advanced filters, you can include multiple drugs/vaccines in your search.	Search for multiple drugs/vaccines
Searching for reports delegated to specific organisations	Use advanced filters to search for delegated reports.	Searching for reports delegated to specific organisations
Finding a report that disappeared from the Report list	The report list only shows reports with the status set to "Open" by default. To view reports set to "Closed" or "Under assessment", use filters.	Finding a report that disappeared from the Report list

# Overview of filters There are three categories of filters available in VigiFlow: quick filters, common filters, and advanced filters. * **`Quick filters`**, marked as 1 in the image below, can be accessed directly from the report list in VigiFlow. These filters are available at the top of the page and can be used to view all reports, reports under assessment, and follow-ups. Please note that the follow-up option is visible exclusively to users at the national level. * **`Common filters`**, marked as 2 in the image below, appear when you click on Filter. These include frequently used filters such as Means of reporting, Report title, and Seriousness criteria. * **`Advanced filters`**, marked as 3 in the image below, are available under the “Advanced filter” tab, which appears after clicking on Filter. This section provides more precise filtering options, such as filters on drugs/vaccines and reaction/event.

# Adding and removing filters Filters can be added directly under the report list. The quick filters are available at the top of the screen. Here you can quickly filter follow-up reports, reports under assessment, and see all reports. ### Accessing additional filters To see additional filters, follow these steps: 1. Navigate to the report list and click on **Filter**. 2. Select your filter from either the “Filter” tab or “Advanced filter” tab. 3. Click on **Apply filter**. ### Removing applied filters To remove the applied filters, you can either: 1\. Click on Clear to remove all applied filters. 2\. Remove one or more filters without removing all by clicking on the next to the filter you wish to remove. # Saving searches that you do repeatedly If there are filters that you often use, you can save these for quicker access. To save filters, follow these steps: 1. Select the applicable filters by navigating to the “**`Report list`**” and clicking on **`Filter`**. 2. Click **`Apply filter`**. 3. Click **`Save`**. 4. A pop-up window will appear where you are asked to name the filter. Pick a suitable name and click **`Save`**. 5. You can now find your saved filter under **`My filters`**. # Searching for drugs/vaccines with WHODrug VigiFlow allows you to filter reports based on drugs or vaccines. Navigate to the “**`Drug/Vaccine`**” tab under the advanced filters to filter WHODrug. The following filtering options are available: * **`Drug name (WHODrug)`**: Type in the name of the drug to search for reports with that drug. Both trade name and active ingredient can be entered. * **`Active ingredient(s) (WHODrug)`**: A search on active ingredient will retrieve all reports with this active ingredient, regardless of whether coding was done on trade name or active ingredient. * **`Batch number`**: Enter the batch number of both medicines and diluents. * **`ATC code`**: For a broader search, enter the ATC code of interest. * **`Indication (MedDRA)`**: Reports can also be filtered by indication.

# Search for multiple drugs/vaccines When applying advanced filters in VigiFlow, you can adjust your search to include multiple reactions/events or drugs/vaccines. This can be done by selecting two or more drugs/vaccines in the **Drug name (WHODrug)** field and then selecting either “All names” or “Any names” in the adjacent field. ### "All names" To find all reports with *Paracetamol* AND *Perfalgan* as Drug name, enter the two substances in the **Drug name** field and select “**`All names`**”.

### **"Any names"** To find all reports with *Paracetamol* OR *Perfalgan* as Drug name, enter the two substances in the **Drug name** field and select “**`Any names`**”.

# Searching for reports delegated to specific organisations To search for delegated reports, navigate to the “**`Advanced filter`**” section and “**`Reports`**” tab. 1. Click on **`Delegated to organisation`** and tick the boxes next to the organisations you are interested in. 2. If you wish to select all units under a suborganisation, activate the **`Checkboxes select/deselect suborganisations`** button. When this is activated, all units under one suborganisation will automatically be selected when selecting the “higher” level organisation. 3. Click **`OK`** and then click **`Apply`**. # Finding a report that disappeared from the Report list There are several possible reasons for not finding reports, but one likely explanation is that the report status has been set to Closed or Under assessment, instead of Open. The default filter is set to only show reports with status = Open. To change this, follow these instructions: 1. Navigate to the ”**`Report list`**” in VigiFlow and select “**`Advanced filter`**”. 2. Click on **`Report`**. 3. Under “Status of report”, select **`Closed`** or **`Under assessment`** (or both) depending on what you wish to search for. 4. Click **`Apply filter`**. # Release notes (new) # eReporting for Industry VigiFlow eReporting for Industry is an addition to VigiFlow. # Overview # First‑time login # Selecting sender organisation # Navigating the Interface ### Selecting sender organisation If you are reporting on behalf of several MAHs or reporting to different NRAs, you will first come to a page where you select which organisation you represent. Further information is provided here.

### Main menu explained

From the Main menu you can access everything in eReporting for Industry. \ The page displays and explains the main functions such as Create a new report, Edit report, Follow up report, Nullfiy report, Upload E2B and Submission status. \ It is also possible to access these functions from the top menu (2). \ The User menu in the top-right corner, is where you can set language, Manage licenses and read terms and conditions. # Manual data entry # Page 2 # VigiUserAdmin product support **VigiUserAdmin** is used by national regulatory authorities (NRAs) to manage users in **VigiFlow eReporting for Industry**. It is accessed at: [https://vigiuseradmin.who-umc.org](https://vigiuseradmin.who-umc.org/)


First time login
Adding MAH users to Industry eReporting
Adding NRA users to VigiUserAdmin

# First-time login First your account must be set up by a colleague who has access to VigiUserAdmin, or in case you are the first user - by the Uppsala Monitoring Centre. 1. Access VigiUserAdmin: 2. Log in with your email and password. * If you have access to VigiFlow, use the same email and password in VigiUserAdmin. * If you do not have access to VigiFlow or VigiLyze and this is your first time logging in, you will need to set a new password by clicking “**Forgot your password?**” and following the instructions. If you have any problems logging in, please contact UMC. # User administraion in VigiUserAdmin There are two types of users in VigiUserAdmin * **NRA users** can add or remove MAH users and other NRA users. They can also create or delete MAH organisations. * **Marketing authorisation holder (MAH) users** do not have access to VigiUserAdmin, only to VigiFlow eReporting for Industry. # Adding MAH users to eReporting for Industry To add users to and MAH in VigiFlow eReporting for Industry: 1. Go to VigiUserAdmin: and log in. 2. In “**Marketing Authorisation Holders**”, scroll or search for the MAH and click on it. If the MAH is not yet added to VigiUserAdmin as an orgatinsation, it must be added before proceeding. 3. Click **Add MAH user**. 4. Enter given name, family name, and email. 5. Ensure the checkbox “Industry eReporting” is selected. If not, the user will not receive access. 6. Click **Save**. 7. Notify the user manually, as a welcome email is *not* sent automatically.

# Adding NRA users to VigiUserAdmin Adding an National Regulatory Authority (NRA) user: 1. Go to VigiUserAdmin: and log in. 2. Click **Add NRA user**. 3. Enter the person’s given name, family name, and email address. 4. Make sure to tick the checkbox “VigiUserAdmin” before clicking **Save**. 5. Notify the user manually, as a welcome email is not sent automatically. # Removing users in VigiFlow eReporting for Industry To remove users in VigiFlow eReporting for Industry 1. Open VigiUserAdmin. 2. Click either **MAH users** or **NRA users**, depending on the user type. 3. Search by name or email. 4. Click the **three dots** (**…**) next to the user’s name and select **Delete user**. 5. Confirm by clicking **Delete**. # Adding Marketing Authorisation Holders (MAH) 1. Access VigiUser: [https://vigiuseradmin.who-umc.org](https://vigiuseradmin.who-umc.org/) 2. To add a new MAH, click “**Add MAH organisation**”. 3. A window will appear where the required information should be entered based on details provided by the MAH. Click the arrow below to see full list of descriptions.

Click here to view field descriptions

a) **Short name** A concise identifier that forms part of the worldwide unique case ID (WWUID) and safety report unique identifier (SRUID). Usually an official abbreviation of the company name. b) **Long name** The legal name of the company. This name is displayed in the top left corner of the interface. c) **Sender organisation** The name included in the XML file to indicate which entity is sending the report. d) **Sender identifier** This corresponds to the issuer identifier and is the code used for electronic transmission between databases. For companies with E2B databases, the relevant fields are: * *E2B (R2): \ (ICH M.1.5: Message Sender Identifier)* * *E2B (R3): 2.16.840.1.113883.3.989.2.1.3.11 (ICH N.2.r.2: Message Sender Identifier)* The sender identifier may sometimes be the same as the short name, but not always. e) **Receiver identifier** An abbreviation or code to identify the receiving organisation (the NRA, in the case of VigiFlow eReporting for Industry). The receiver identifier may sometimes be the same as the short name for the receiver. For companies with E2B databases, the relevant fields are: * *E2B (R2): \ (ICH M.1.6: Message Receiver Identifier)* * *E2B (R3): 2.16.840.1.113883.3.989.2.1.3.12 (ICH N.2.r.3: Message Receiver Identifier)*\

4. Ensure all information is correct and click **Save**. The new MAH will now appear in the list of MAHs. #### Sending organisation representing multiple companies For companies reporting on behalf of multiple MAHs or CROs, the long name should be selected to clearly identify each MAH. Example: “*MAH B (PV Company A)*” when PV Company A reports for MAH B. # VigiLyze product support Learn more about the functionality of VigiLyze.


Algorithms used in VigiLyze	Algorithms used in VigiLyze

# Algorithms used in VigiLyze Learn about the algorithms used in VigiLyze.


Deduplication through vigiMatch	Deduplication through vigiMatch
Pregnancy algorithm	Pregnancy algorithm
Fatal algorithm	Fatal algorithm
Dechallenge computation	Dechallenge computation
Time computations	Time computations

# Deduplication through vigiMatch ### vigiMatch vigiMatch is a machine learning model that predicts duplicate case reports in pharmacovigilance databases such as VigiBase. It works by comparing pairs of reports and calculating a similarity score based on following * patient age * patient sex * onset date * summary of all dates present in the report (even those mentioned in case narratives) * adverse events and medicines/vaccines * externally indicated flag * Externally indicated flag is true when the case identifier (E2B R3 - C.1.9.1.r.2) in one report matches the sender’s report ID (E2B R3 - C.1.1) or the world wide unique case identifier (E2B R3 - C.1.8.1) in a different report. Please note that, vigiMatch predicts suspected duplicates, not confirmed duplicates and that there may be both false positives (i.e. suspected duplicates that are in fact not duplicates) and false negatives (i.e. true duplicates that have not been identified). {% hint style="info" %} **Read more here**: Barrett JW, Erlanson N, China JF, Norén GN. A Scalable Predictive Modelling Approach to Identifying Duplicate Adverse Event Reports for Drugs and Vaccines. arXiv preprint arXiv:2504.03729. 2025 Mar 31. {% endhint %} #### Clustering Once a pair of duplicate reports have been identified, complete-link clustering is applied to identify the master report. Within each cluster, the master report is selected based on the highest vigiGrade completeness score. Complete-link clustering is used, requiring all report pairs within a group to be marked as suspected duplicates. #### Using vigiMatch in VigiLyze To activate vigiMatch in VigiLyze go to **`Settings`** and **`Duplicate scope`** and set it to **De-duplicated**.

{% hint style="info" %} Note: There are other areas that require careful interpretation of analyses excluding suspected \ duplicates such as those based on reports coming from mass distribution campaigns involving \ other drugs e.g. in treatment programmes for tuberculosis or other public health initiatives. {% endhint %} # Pregnancy algorithm The VigiBase pregnancy algorithm is a rule-based method developed to identify pregnancy-related reports. More specifically, it uses structured data elements to identify reports of maternal exposure to a medicinal product before or during pregnancy, with or without adverse events in the pregnant person or the prenatally exposed. It does not flag patients over 50 years, paternal exposures, or lactation reports. The algorithm consists of two main steps, as shown in Figure 1. First, reports that are considered unlikely to be pregnancy-related are ruled out. Second, if none of the rule-out criteria are met, reports are flagged if they meet any of the rule-in criteria.

Figure 1. The VigiBase pregnancy algorithm According to UMC’s evaluation of the algorithm based on around 8,000 manually annotated reports, the algorithm is expected to identify 75% of all pregnancy cases in VigiBase (i.e. recall/sensitivity). When restricted to reports transmitted in the E2B format, this proportion increases to 91%. In addition, 92% of the reports identified by the algorithm as pregnancy cases are correctly classified (i.e. precision/positive predictive value. This proportion is unchanged when restricted to reports transmitted in the E2B format. #### Get to know more * [Comprehensive evaluation of algorithm - Research poster](https://who-umc.org/media/j2cpykuc/pregnancy_poster_digital.pdf) * [Uncovering pregnancy cases in VigiBase - Uppsala Reports](https://uppsalareports.org/articles/uncovering-pregnancy-cases-in-vigibase/) * Sandberg, L., Vidlin, S.H., K-Pápai, L. *et al.* Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm. *Drug Saf* (2025). # Fatal algorithm An algorithm has been developed to capture reports indicating that the patient died, regardless of whether the death was related to the reported adverse event. A case is considered fatal when any of the following is reported in the corresponding structured fields: * A death date * A cause of death * A cause of death after autopsy * An autopsy was performed * Seriousness classified as death * At least one reaction outcome of *fatal* * At least one reaction corresponding to a fatal term (e.g. Completed suicide, Death neonatal, Sudden infant death syndrome. For a complete list, contact Uppsala Monitoring Centre) Note that not all the above scenarios are available for every reporting format. # Dechallenge computation In the section “Time-to-onset, dechallenge, rechallenge and causality of suspect and \ interacting drugs”, the information about dechallenge is computed from different data \ elements to get a quick overview. The action taken with the drug together with the reaction \ outcome are translated into *Dechallenge performed (Yes/No/Unknown) and Reaction* \ *resolved/resolving* (Yes/No/Unknown) #### *Dechallenge performed is set to* * **yes**, if the action taken with the drug is “Drug withdrawn” or “Dose reduced” * **no**, if the action taken with the drug is “Dose increased” or “Dose not changed” * **unknown**, if the action taken with the drug is “Unknown” * blank, if the action taken with the drug is “Not applicable” #### *Reaction resolved/resolving is set to* * **yes**, if the outcome of the reaction is “recovered/resolved”, “recovering/resolving” or \ “recovered/resolved with sequelae” * **no**, if the outcome of the reaction is “not recovered/not resolved” or “fatal” * **unknown**, if the outcome of the reaction is “Unknown” Reaction resolved/resolving is only set if there is a reported value for action taken with the \ drug. If none of the above is true, then free text from the data element drug additional is used. This \ is mainly to capture dechallenge information from case reports where we know this is not \ reported within the structured fields but rather as specific text strings. * When drug additional is “DECHALL POS” then *Dechallenge performed* is set to **yes** and *Reaction resolved/resolving* is set to **yes** * When drug additional is “DECHALL NEG” then *Dechallenge performed* is set to **yes** and *Reaction resolved/resolving* is set to **no** * When drug additional is “DECHALL RESULT UNK” then *Dechallenge performed* is set to **yes** and *Reaction resolved/resolving* is set to **unknown** # Time computations Age, Reaction duration, Drug treatment duration and Time-To-Onset These values are considered durations and are all calculated according to the same principles. If the actual value is not reported, a calculated duration from reported dates are shown.’ | Duration | Start date | Stop date | | ----------------------- | ----------------- | ------------------- | | Patient age | PatientBirthDate | ReactionStartDate\* | | Reaction duration | ReactionStartDate | ReactionEndDate | | Drug treatment duration | DrugStartDate | DrugEndDate | | Time-To-Onset | DrugStartDate | ReactionStartDate | \*When several reactions with different start dates are reported within the same case, the \ earliest date is used. Each date is given a min and a max value (down to minute), see examples below: | Date (reported) | Date min | Date max | | --------------- | ---------------- | ---------------- | | 2000 | 2000-01-01 00:00 | 2000-12-31 23:59 | | 200001 | 2000-01-01 00:00 | 2000-01-31 23:59 | | 20000101 | 2000-01-01 00:00 | 2000-01-01 23:59 | | 2000010113 | 2000-01-01 13:00 | 2000-01-01 13:59 | | 200001011334 | 2000-01-01 13:34 | 2000-01-01 13:34 | Duration is calculated out of the min and the max dates and each duration is given a min, max \ and mean value. Duration min is set to the time span between the highest possible start date and the lowest \ possible stop date (e.g. for Patient age it is ReactionStartDate min – PatientBirthDate max) \ Duration max is set to the time span between the lowest possible start date and the highest possible stop date (e.g. for Patient age it is ReactionStartDate max – PatientBirthDate min) \ Duration mean is set to (Duration min + Duration max) /2. Durations are always rounded to nearest integer, except age which is rounded down. Duration \ mean is shown in VigiLyze, see examples below: | Start date - Stop date | Duration min | Duration max | | | ------------------------- | ------------ | ------------ | ----------- | | 200406-2006 | 1.5 years | 2.6 years | 2 years | | 20050506 – 2011 | 5.7 years | 6.7 years | 6 years | | 20130617-201309 | 2.5 months | 3.4 months |

3 months | |
2 months (if age)

| | | | | 19840108-19840111 | 2 days | 4 days | 3 days | | 19840108-19840108 | -1 day | 1 day | 0 days | | 20090511-20090530 | 18 days | 20 days | 19 days | | 201103-2011 | 3 months | 10 months | -\* | | 2005-2005 | -12 months | 12 months | -\* | | 200105-200105 | -31 days | 31 days | -\* | | 20040903-200409 | -3 days | 28 days | -\* | \*If the uncertainty is high, i.e. difference between max and mean duration is more than 1.5, \ no duration is shown. This happens with incomplete dates that are close in time. # Qualitative view # Adding drugs and vaccines to search criteria