Italian Medicines Agency Agenzia Italiana del Farmaco

Pharmacovigilance on COVID-19 vaccines

Pharmacovigilance on COVID-19 vaccines

This page provides the most relevant information on pharmacovigilance activities on COVID-19 vaccines.

Reports on the results of pharmacovigilance activities are published on a monthly basis. Monthly reporting has been chosen in order to have sufficient data to ensure robustness in analysis, comparison and evaluation.

These reports focus on the results of the analysis of the association of the reported events with vaccination and, where possible, will include reference values and expected values to facilitate judgement on the safety of the different vaccines.

On this page are also available a series of interactive graphs, filterable by type of vaccine, relating to the reporting rate, i.e. the ratio between the number of reports of suspected adverse reactions submitted to the National Pharmacovigilance Network (RNF) for each vaccine and the number of administered doses, with distribution by gender and age group

There is also a link to a series of frequently asked questions and answers (FAQs) on pharmacovigilance to clarify doubts and uncertainties on the subject.

COVID-19 Vaccine Surveillance Report

Interactive graphs

Data source reports: National Pharmacovigilance Network (RNF)
Data source number of administered doses: Ministry of Health
Last update: 26/09/2021

Reporting rate

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Last update: 09/26/2021

Download file SegnalazionePerDose (1.8 kB)[csv]

Didascalia Tasso di segnalazione

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.

Distribution by sex

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Last update: 09/26/2021

Download file DistribuzionePerSesso (0.3 B)[csv]

Didascalia Distribuzione per sesso

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.

Distribution by age group

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Last update: 09/26/2021

Download file DistribuzioneFasciaEta (1.5 kB)[csv]

Didascalia Distribuzione per fascia di età

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.

 

Distribution by type of event

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
  • COVID-19 Vaccine Janssen

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).

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