COVID-19 vaccines – 8th report on adverse reactions reported in Luxembourg: interpret correctly
The Pharmacy and Medicines Division of the Health Directorate in close collaboration with the Regional Pharmacovigilance Center of Nancy has published the 8th monthly report on the adverse reactions declared in Luxembourg for COVID-19 vaccines.
The report aims to provide transparency and increase confidence in COVID-19 vaccines. It provides information on national pharmacovigilance data, namely adverse reactions collected in Luxembourg and suspected of having a possible link with vaccination.
In general, for a correct interpretation of the data published in this report, it is essential to consider the following points:
- The information presented in this report relates to suspected adverse reactions, that is, medical events which have been observed after vaccination, but which are not necessarily related or due to the vaccine.
- Suspicion of an adverse reaction after vaccination does not necessarily imply a causal association.
- These cases are therefore investigated and analyzed by the health authorities on an individual basis as well as with cases from other countries registered in EudraVigilance (European pharmacovigilance database).
- Only a detailed analysis and scientific evaluation of all available data can draw robust conclusions about the risks of the vaccine.
- The number of reported adverse reactions should be put into perspective with the number of vaccines administered.
The pharmacovigilance data defined by the health authorities can in no way determine whether the vaccine triggers the reported adverse event. This limitation regularly causes confusion over publicly available data, especially with regard to the number of reported deaths.
Deaths during mass vaccination campaigns, when millions of people are immunized, occur. However, this does not necessarily imply a link with the administration of the vaccine: the temporal association between vaccination and death does not imply a causal association.
European data
Beyond the monitoring carried out at national level, the European Medicines Agency (EMA) is monitoring very carefully the safety of COVID-19 vaccines authorized in the European Union (EU). This helps detect rare side effects that can occur after several million people are vaccinated.
Press release from the Ministry of Health