Evidence map›Paper›PMID 32839511›Full record

ArticleScientific reports2020

Ten years of vaccinovigilance in Italy: an overview of the pharmacovigilance data from 2008 to 2017.

F Moretti, L Gonella, S Gironi, A R Marra, C Santuccio, P Felicetti, F Petronzelli, P Marchione, S A Barnaba, A Poli and 2 more

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 49% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

F MorettiSection of Hygiene and Environmental Occupational Preventive Medicine, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
L GonellaSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
S GironiSection of Hygiene and Environmental Occupational Preventive Medicine, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
A R MarraItalian Medicines Agency, Rome, Italy.
C SantuccioItalian Medicines Agency, Rome, Italy.
P FelicettiItalian Medicines Agency, Rome, Italy.
F PetronzelliItalian Medicines Agency, Rome, Italy.
P MarchioneItalian Medicines Agency, Rome, Italy.
S A BarnabaLocal Health Unit (ASL), Rieti, Italy.
A PoliSection of Hygiene and Environmental Occupational Preventive Medicine, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
G ZanoniImmunology Unit, University Hospital, Verona, Italy.
U MorettiSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, Italy. ugo.moretti@univr.it.ORCID http://orcid.org/0000-0001-5108-5807
University of Verona · ITItalian Medicines Agency · ITAzienda Sanitaria Locale Roma 3 · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Reporting and analysis of Adverse Events Following Immunization (AEFIs) are the cornerstones of vaccine safety surveillance prompting causality assessment and signal detection. This paper describes the impact of the Italian Pharmacovigilance System of vaccines over a 10-year period (2008-2017). The reporting rate (RR) per all distributed dose was calculated. Serious AEFIs and causality assessments for fatal cases were described. The main results from signal detection were reported. During the study period, 46,430 AEFIs were reported with an overall RR of 17.2 per 100,000 distributed doses. Italy showed the highest number of reports among European countries. Only 4.4% of the reports came from citizens. Of the total, 12.7% were classified as serious with a RR over the study period of 2.20 per 100,000 distributed doses. They were mainly related to hyperpyrexia and usually had a positive outcome. Fatal outcomes were reported in 0.3% of the cases and were primarily associated with the influenza vaccine in elderly patients. None of these outcomes had a consistent causal association with the vaccination. Febrile convulsions by the measles, mumps, rubella and varicella vaccines and intussusception by the rotavirus vaccine were among the highlighted signals. The reporting rate and the analysis of serious events from 10 years support the good risk/benefit profiles of vaccines.

Indexed as

PharmacovigilanceAdolescentAdultAgedChickenpox VaccineChildChild, PreschoolDrug and Narcotic ControlHumansInfantItalyMeasles-Mumps-Rubella VaccineMiddle AgedRotavirus VaccinesVaccinationVaccinesChickenpox VaccineMeasles-Mumps-Rubella Vaccinemeasles, mumps, rubella, varicella vaccineRotavirus VaccinesVaccinesVaccines, Combined

Identifiers

PMID32839511
PMCPMC7445254
OpenAlexW3081152755

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.