COVID-19 vaccines - 8th report on adverse reactions reported in Luxembourg: interpreting correctly

The Division of Pharmacy and Medicines of the National Health Directorate in close collaboration with the "Centre Régional de Pharmacovigilance de Nancy" has published the 8th monthly report on adverse reactions reported in Luxembourg for COVID-19 vaccines. 

The report aims to provide transparency and increase trust in COVID-19 vaccines. It provides information on national pharmacovigilance data, i.e. adverse reactions reported in Luxembourg and suspected to be related to the vaccination. 

In order to correctly interpret the data published in this report, it is essential to consider the following points: 

  • The information presented in this report relates to suspected adverse events, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. 
  • The suspicion of an adverse reaction after vaccination does not necessarily imply a causal association.
  • These cases are therefore investigated and analysed by the health authorities individually as well as with cases from other countries registered in EudraVigilance (European pharmacovigilance database). 
  • These cases are therefore investigated and analysed by the health authorities individually as well as with cases from other countries registered within the EudraVigilance initiative (European pharmacovigilance database). 
  • The number of reported adverse reactions should be put into perspective with the number of vaccines administered.

The pharmacovigilance data collected by the health authorities alone cannot determine whether the vaccine caused the reported adverse reaction. This constraint regularly causes confusion about publicly available data, particularly with regard to the number of reported deaths.

Deaths do occur during mass vaccination campaigns, when millions of people are immunised. However, this does not necessarily imply a link to the administration of the vaccine: the temporal association between a vaccination and a death does not imply a causal association.

European data

In addition to monitoring at national level, the European Medicines Agency (EMA) is closely monitoring the safety of COVID-19 vaccines authorised in the European Union (EU). This allows for the detection of rare adverse reactions that may occur once several million people have been vaccinated.

Press release by the Ministry of Health

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