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Agenzia Italiana del Farmaco
Pharmacovigilance on COVID-19 vaccines
This page provides the most relevant information on pharmacovigilance activities on COVID-19 vaccines. You can read the periodic reports on the surveillance of COVID-19 vaccines already published by AIFA, which show the results of the association analyses with the vaccination carried out on reported events.
In view of the substantially stable trend of reports and in line with the approach of the various regulatory agencies at a European level, data on reports of suspected adverse reactions to COVID-19 vaccines will no longer be the subject of dedicated reports but will flow into the Report on post-marketing surveillance of all vaccines, published annually by AIFA.
A series of interactive graphs are also available on this page, updated monthly until 27/09/2022 and quarterly from that date, in view of the decrease in the number of reports.
These graphs can be filtered by type of vaccine, and show the reporting rate, i.e. the ratio between the number of reports of suspected adverse reactions included in the National Pharmacovigilance Network (RNF) for each vaccine and the number of doses administered, with distribution by sex and age group.
A link is also available to a series of frequently asked questions and answers (FAQs) on pharmacovigilance.
Data source reports: National Pharmacovigilance Network (RNF)
Data source number of administered doses: Ministry of Health
Last update: 12/27/2022
The graph shows the distribution of the reports submitted to the National Pharmacovigilance Network by date of onset of the suspected adverse reaction, depending on the vaccine administered doses, regardless of the dose number. The reporting rate is calculated as the number of reports that are observed every 100,000 doses administered, in order to obtain a standardised and comparable measure of the functioning of the system. Please note that rates are not calculated for doses <10,000.
The graph shows the reporting rate by sex, calculated from the ratio of the number of reports for each sex out of 100,000 administered doses.
For further information and details on data please refer to the COVID-19 Vaccine Surveillance Report published on this page.
Il grafico riporta il tasso di segnalazione per fascia di età (in anni), calcolato dal rapporto tra il numero di segnalazioni per ogni fascia di età su 100.000 dosi somministrate.
Per un maggior approfondimento e dettaglio dei dati si rimanda al Rapporto sulla Sorveglianza dei vaccini COVID-19 pubblicato in questa pagina.
The data on reports of suspected adverse reactions to COVID-19 vaccines submitted to the RNF are accessible from the RAM system (Database of Adverse Drug Reactions), which shows the data relating to the reports of any authorized drug organized by entry year in the National Pharmacovigilance Network (RNF).
Once accessed the system, the search must be performed by "medicine", by entering the brand name of the vaccine:
- COMIRNATY
- COVID-19 Vaccine Moderna
- VAXZEVRIA
- JCOVDEN
- NUVAXOVID
Once the medicine has been selected, it will then be possible to view the reactions described both by system or organ concerned (SOC - System Organ Classification) and in more detail by single term (PT - Preferred Term).
