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EUDRAVIGILANCE : DATABASE SIDE EFFECTS COVID VACCINS

The figures for Europe ( excluding UK )


Pfizer : https://dap.ema.europa.eu/analytics/saw.dll?PortalPages&PortalPath=%2Fshared%2FPHV DAP%2F_portal%2FDAP&Action=Navigate&P0=1&P1=eq&P2="Line Listing Objects" Substance High Level Code"&P3=1+42325700


Moderna : https://dap.ema.europa.eu/analytics/saw.dll?PortalPages&PortalPath=%2Fshared%2FPHV DAP%2F_portal%2FDAP&Action=Navigate&P0=1&P1=eq&P2="Line Listing Objects". "Substance High Level Code"&P3=1+40983312


Astrazeneca : https://dap.ema.europa.eu/analytics/saw.dll?PortalPages&PortalPath=%2Fshared%2FPHV DAP%2F_portal%2FDAP&Action=Navigate&P0=1&P1=eq&P2="Line Listing Objects". "Substance High Level Code"&P3=1+40995439


Janssen : https://dap.ema.europa.eu/analytics/saw.dll?PortalPages&PortalPath=%2Fshared%2FPHV DAP%2F_portal%2FDAP&Action=Navigate&P0=1&P1=eq&P2="Line Listing Objects". "Substance High Level Code"&P3=1+42287887


Novavax : https://dap.ema.europa.eu/analytics/saw.dll?PortalPages&PortalPath=%2Fshared%2FPHV DAP%2F_portal%2FDAP&Action=Navigate&P0=1&P1=eq&P2="Line Listing Objects". "Substance High Level Code"&P3=1+42287887

https://www.adrreports.eu/


https://www.adrreports.eu/nl/index.html ( 21 languages )


COVID-19 important information

Important information you need to know before reading reports of possible side effects for COVID-19 vaccines

The information on this website refers to reports of possible side effects observed after administration of the COVID-19 vaccines, but which may not be related to or caused by the vaccine. These symptoms may have been caused by another disease or be a consequence of another medicine taken by the patient at the same time.

The EMA's scientific assessment takes into account a wide range of other factors, such as the patient's medical history, how common is the possible adverse reaction in the vaccinated population compared to the frequency in the general population and whether it is biologically plausible that the vaccine is the cause of the complaint.

Based on all available data, a careful assessment is made and a reliable conclusion is drawn about the benefits and risks of COVID-19 vaccines.

Each individual report usually relates to one patient; however, multiple adverse events may be reported in one report. Therefore, the number of adverse events will not be the same as the number of individual reports.

The data on this website reflect reports reported by national competent authorities and pharmaceutical companies. These reports may contain duplicate information. As part of the assessment, the EMA checks whether duplicates have been reported.

Warning of reports with fatal outcome

This website does not give the total number of reports with a fatal outcome. It shows the number of reports with a fatal outcome for specific target groups (e.g. heart disease) and for specific conditions (e.g. myocardial infarction). As one individual report can have more than one possible adverse reaction, the sum of the number of fatal cases per target group will always be higher than the total number of fatal cases.

The number of reports on the website, including those with a fatal outcome, which may have different causes, should be seen in the context of exposure to the different vaccines (the number of doses given may vary from one vaccine to another). Data on exposure are published by the European Centre for Disease Prevention and Control (https://www.ecdc.europa.eu/en).

What information does this website provide?

The information on this website relates to possible side effects reported through EudraVigilance, the EU pharmacovigilance database designed to collect reports of possible side effects.

The spontaneous reports reported through EudraVigilance come from patients and healthcare professionals and are submitted electronically by national medicines regulatory authorities and pharmaceutical companies.

These spontaneous reports are used to assess the benefits and risks of medicines during their development and monitor their safety after authorisation in the European Economic Area (EEA).

The information on this website may contain known side effects that already appear in the summary of product characteristics and package leaflet.

The EEA must comply with EU data protection legislation. Therefore, certain information (e.g. country where a specific side effect occurred) is not disclosed to protect the identity of individuals.







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