The Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), made up of the Autonomous Pharmacovigilance Centres and coordinated by the Spanish Agency for Medicines and Health Products (AEMPS), continuously assesses suspected adverse reactions reported in Spain with all authorised medicines, including vaccines.
Vaccines are special medicines and so is their regulation. Since millions of people are vaccinated, it is necessary to know about any adverse events that occur some time after vaccination and to analyse, among other factors, whether they occur more frequently than what is expected to occur in the general population. For this reason, any adverse event associated temporally after administration is recorded, without there being any suspicion that the vaccine may have caused it, since they may be medical problems that coincide in time or that are related to the act of vaccination itself.
In the event that the number of events recorded after vaccination is higher than what we expect to occur in the population, a broad and detailed evaluation is carried out with all the tunisia phone data information available in the EU; the notifications collected in Spain are part of the European evaluations. Thus, the AEMPS, a public and independent body, together with the rest of the EU agencies and the coordination of the European Medicines Agency (EMA), carries out a continuous evaluation of the data to detect adverse reactions not identified during the clinical trials of the vaccines.
Pharmacovigilance therefore ensures that all medicines authorised for human use, including vaccines, are safe and that the probability of an adverse effect occurring is minimal, with the benefit provided by the treatment always being much greater.
Thus, we can conclude that pharmacovigilance :
It is a public health activity whose objective is the identification, quantification, evaluation and prevention of the risks of using medicines once they have been marketed,
allows monitoring of possible adverse effects of drugs
Provides ongoing information on drug safety
enables the adoption of appropriate measures ,
ensures that the available medicines present a favorable benefit-risk ratio for people
guarantees the safety of the medicines we consume