State of implementation

La Information on suspected adverse drug reactions notified to the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H) have been made public on the AEMPS website. They are suspicious so it does not mean that the drug is the cause of the adverse reaction. This information should be evaluated along with additional information. If the evaluation concludes that the medicinal product is related, the information in the Summary of Product Characteristics and the package leaflet of the medicinal product is included. These assessments are carried out collaboratively by EU countries.

In the following link you can access the information published on the AEMPS website. This report includes adveso events reported with vaccines:

Suspected adverse reactions to medicinal products for human use

In addition, during the pandemic they are being elaborated periodic reports with suspected adverse reactions reported with treatments for COVID-19. You can access through the following link to the AEMPS website:

Suspected adverse reactions reported with treatments used in COVID-19

Pharmacovigilance bulletins have also been prepared with the information on reports of adverse events occurring temporarily following the administration of COVID-19 vaccines. You can access the information through the following link:

Periodic reports of pharmacovigilance of COVID-19 vaccines