Pandemic/Statistics/EudraVigilance

EudraVigilance

European database of suspected adverse drug reaction reports

EudraVigilance is a system designed for collecting reports of suspected side effects. These reports are used for evaluating the benefits and risks of medicines during their development and monitoring their safety following their authorisation in the European Economic Area (EEA). EudraVigilance has been in use since December 2001.

Source: EudraVigilance Background

About EudraVigilance

The European database of suspected adverse drug reaction reports, known as EudraVigilance, is managed by the European Medicines Agency (EMA).

The data can be searched by drug name, but for ease of access the Covid vaccines are grouped with the prefix COVID-19 followed by the product name. Note that product names in the EU may be different from those used in other countries.

How to access the data

To access the data for the Covid vaccines, follow these steps:-

1. It makes sense to start at the EudraVigilance Home Page which is here: https://www.adrreports.eu/en/index.html
2. The menus provide access to pages about the dataset, how to interpret the data, and specific warnings about interpretation of the data for Covid vaccines. If you browse around long enough you may find a link to a User Manual. If not, follow this link User Manual for online access via the adrreports.eu portal which was current in mid July 2021.
3. On the Home Page is an instruction which is repeated here without the hyperlink:-
   

   NEW! To consult the reports for COVID-19 vaccines, follow this link, then click on the letter 'C' and scroll down until “COVID-19”.

   The link leads to a Disclaimer at https://www.adrreports.eu/en/disclaimer.html which you have to Accept before moving on.
4. If you clicked on Accept on the Disclaimer page you will arrive at a page where you can Search A to Z by drug name. As per the instructions on the Home Page, select C and scroll down to the group of products named COVID-19...
5. After making a selection for a specific vaccine you can then view the available data. The tabbed menu at the top of the results page links to more detailed information.

Safety Reports

The European Medicines Agency regularly publishes Safety Reports for each COVID-19 vaccine. The page has a long URL so just access it from here: Authorised COVID-19 Vaccines.

The Safety Reports provide the essential information about adverse events for each vaccine; the number of doses, the number of cases of suspected side effects, and the number of those which reported a fatal outcome. Data for 4 July 2021 has been extracted and presented below:-

Comirnaty

As of 4 July 2021, a total of 206,668 cases of suspected side effects with Comirnaty were spontaneously reported to EudraVigilance from EU/EEA countries; 3,848 of these reported a fatal outcome. Around that time about 276 million doses of Comirnaty had been given to people in the EU/EEA.

Spikevax (Moderna)

As of 4 July 2021, a total of 36,294 cases of suspected side effects with Spikevax were spontaneously reported to EudraVigilance from EU/EEA countries; 347 of these reported a fatal outcome. Around that time, about 35 million doses of Spikevax had been given to people in the EU/EEA.

Vaxzevria (Astrazeneca)

As of 4 July 2021, a total of 152,250 cases of suspected side effects with Vaxzevria were spontaneously reported to EudraVigilance from EU/EEA countries; 938 of these reported a fatal outcome. Around that time, about 58.4 million of doses of Vaxzevria had been given to people in the EU/EEA.

Janssen

As of 4 July 2021, a total of 12,036 cases of suspected side effects with COVID-19 Vaccine Janssen were spontaneously reported to EudraVigilance from EU/EEA countries; 68 of these reported a fatal outcome. Around that time, about 8.5 million of doses of COVID-19 Vaccine Janssen had been given to people in the EU/EEA.

Notes

1. Although the case numbers and fatalities may be alarming it is important to note the extremely high numbers of vaccine doses administered. Most of us can visualise a crowd of a thousand people, but have no realistic vision of what 50 million would look like.
2. Each of the extracts had notes which were not included here. Please refer to the original documents, as linked.
3. Each of the Safety Reports includes an important paragraph which is repeated here:-
   

   These reports describe suspected side effects in individuals, i.e. medical events observed following the use of a vaccine. The fact that someone has had a medical issue or died after vaccination does not necessarily mean that this was caused by the vaccine. This may have been caused, for example, by health problems not related to the vaccination.

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References

A centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). Source: EMA Glossary of regulatory terms.

European database of suspected adverse reaction reports

European Economic Area (EEA)

European Medicines Agency. The EMA is responsible for authorizing vaccines in the European Union (EU)

CoronaVirus Disease 2019 (caused by SARS-CoV-2)

European Union