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VigiAccess was launched by the World Health Organization (WHO) in 2015 to provide public access to information in VigiBase, the WHO global database of reported potential side effects of medicinal products. Side effects – known technically as adverse drug reactions (ADRs) and adverse events following immunization (AEFIs) – are reported by national pharmacovigilance centres or national drug regulatory authorities that are members of the WHO Programme for International Drug Monitoring (PIDM). WHO PIDM was created in 1968 to ensure the safer and more effective use of medicinal products. Read more about the background and purpose of the WHO PIDM here.

Data privacy

Due to data protection laws and agreements between WHO PIDM members and the WHO, individual case safety reports cannot be viewed in VigiAccess. For those same reasons, VigiAccess groups the search results both by active ingredient and by continental region, so you will not be able to retrieve data for specific brand names nor for individual WHO PIDM members. For more detailed questions about the data, please contact your national regulatory authority.

Special note regarding COVID-19 vaccine data

To see VigiBase data on COVID-19 vaccines, search for “covid-19 vaccine”. Please note that VigiAccess, as a result of the terminology used to structure the information, will group the data for vaccines by disease (for example, “Measles vaccine”, “Mumps vaccine”). This means that even searches for exact tradenames, such as “Comirnaty” or “Covishield”, will result in the total number of cases reported for all COVID-19 vaccines. It is not possible in VigiAccess to separate the numbers for specific vaccines.

Important points to consider

VigiAccess is intended as a useful starting point for people who wish to understand more about the types of potential side effects that have been reported in association with the use of medicinal products. However, VigiAccess cannot be used to infer any confirmed link between a suspected side effect and any specific medicine. See the VigiAccess FAQ for a more detailed explanation.

When using VigiAccess, it is important to consider the following:

  1. The information on this website relates to potential side effects; that is, symptoms and other circumstances that have been observed following the use of a medicinal product, but which may or may not be related to or caused by that product .
  2. Information in VigiAccess on potential side effects should not be interpreted as meaning that the medicinal product or its active substance either caused the observed effect or is unsafe to use. Confirming a causal link is a complex process that requires a thorough scientific assessment and detailed evaluation of all available data. The information on this website, therefore, does not reflect any confirmed link between a medicinal product and a side effect .
  3. VigiAccess cannot be used to determine the likelihood of a side effect occurring . A VigiAccess search on a medicinal product will return a basic list of reported potential side effects and the number of times each effect has been reported. However, the database does not include other factors needed to put that number into context, such as how many people have taken the product, how long they have taken it, how long it has been on the market, and the differing reporting practices that influence which observations are included in the reports.
  4. VigiAccess cannot be used to compare the safety profiles of different medicinal products . For the same reasons explained in point 3, VigiAccess cannot provide sufficient context to make such comparisons possible.
  5. The information on VigiAccess should not be used in isolation to make any decisions regarding a patient's treatment regimen . Patients and their healthcare providers should always consult other sources of information, including the product inserts and other recognised sources of prescribing information.

If you think that you may be experiencing a side effect from a medicinal product, please seek advice from a healthcare professional as soon as possible. Never stop or change the dose for any prescription medicines without consulting your physician .


http://vigiaccess.org/

For more information about the uses and limitations of VigiAccess, please

About the release of VigiAccess

As the maintenance organisation of VigiAccess and the VigiBase database, Uppsala Monitoring Centre (UMC) takes great care to ensure that the data displayed in VigiAccess is an accurate record of the publicly accessible data collected by the national regulatory authorities and transmitted to UMC.

UMC does not, however, guarantee, warrant, or make any representation whatsoever regarding the data contained herein including, but not limited to, guarantees, warranties, or representations of accuracy, reliability, completeness, currency, suitability, fitness, or usefulness for any particular purpose or with respect to non-infringement of any third-party rights.

In no event shall UMC be liable for any loss, damage, cost, or other expense whatsoever (whether direct, indirect, punitive, incidental, special, or consequential) arising out of or in any way connected with the use of or reference to any data contained herein. In no event shall UMC be liable other than i) under Swedish substantive law and ii) subject to the courts of Sweden with the District Court of Uppsala as first instance.

To access the search function, you must confirm that you have read and understood the above statements.

 

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