Evidence map›Paper›PMID 39340106›Full record

ArticleVaccines2024

SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study.

Laura Augusta Gonella, Francesca Moretti, Annalisa Capuano, Caterina De Sarro, Lorenza Ferrara, Elisabetta Geninatti, Greta Guarnieri, Xhikjana Hysolakoj, Margherita Lalli, Olivia Leoni and 16 more

Abstract read
In one paragraph

Article in Vaccines, 2024. 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
–field-weighted citation impact
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.

  1. Trial
  2. Review
  3. Article
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

26 authors.

Laura Augusta GonellaSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy.
Francesca MorettiSection of Hygiene and Environmental Occupational Preventive Medicine, Department of Diagnostics and Public Health, University of Verona, Piazzale L.A. Scuro 10, 37134 Verona, Italy.ORCID 0000-0003-1235-1054
Annalisa CapuanoDepartment of Experimental Medicine, University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138 Napoli, Italy.
Caterina De SarroUnit of Clinical Pharmacology and Pharmacovigilance, "Renato Dulbecco" University Hospital, Research Center FAS@UMG, Department of Health Science, Magna Graecia University, 88100 Catanzaro, Italy.ORCID 0000-0002-3596-0090
Lorenza FerraraLocal Unit Health of Asti, Via Conte Verde 125, 14100 Asti, Italy.
Elisabetta GeninattiRegional Center of Pharmacovigilance, Piemonte Region, Via Silvio Pellico 19, 10125 Torino, Italy.
Greta GuarnieriUnit of Pharmacovigilance & Clinical Research, ASST Fatebenefratelli-Sacco, Department of Biomedical and Clinical Sciences, Università degli Studi di Milano, 20157 Milan, Italy.
Xhikjana HysolakojRegional Center of Pharmacovigilance-Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy.
Margherita LalliU.O.C. Farmaceutica Territoriale, Azienda Sanitaria Territoriale di Macerata, Belvedere Raffaello Sanzio 1, 62100 Macerata, Italy.
Olivia LeoniLombardy Regional Centre of Pharmacovigilance and Regional Epidemiologic Observatory, Welfare General Directorate, Lombardy Region, Piazza Città di Lombardia 1, 20124 Milan, Italy.
Antea Maria Pia ManganoRegional Center of Pharmacovigilance, Marche Region, Via Gentile da Fabriano, 60125 Ancona, Italy.
Patrizia Marani ToroHealth Office, Epidemiology and Public Health, ASL Pescara, Regional Department of Prevention Abruzzo, Via R. Paolini, 47, 65100 Pescara, Italy.
Viviana MecchiaRegional Center of Pharmacovigilance-Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy.
Maria Caterina MerlanoALISA/Liguria Region, Via Gabriele D Annunzio 64, 16121 Genova, Italy.
Caterina PalleriaUnit of Clinical Pharmacology and Pharmacovigilance, "Renato Dulbecco" University Hospital, Research Center FAS@UMG, Department of Health Science, Magna Graecia University, 88100 Catanzaro, Italy.
Anna Maria PotenzaRegional Center for Pharmacovigilance, Emilia-Romagna Region, Medicines and Medical Devices Governance Area, Hospital Care Sector, General Directorate for Personal Care, Health and Welfare, Viale Aldo Moro 21, 40127 Bologna, Italy.
Paola RossiRegional Center of Pharmacovigilance-Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy.ORCID 0009-0002-7749-9711
Marco RossiDepartment of Medical, Surgical and Neuroscience Sciences, University of Siena, Viale Mario Bracci 16, 53100 Siena, Italy.
Francesca SanitàTerritorial Assistance Service, ASL Pescara, Regional Center of Pharmacovigilance, Abruzzo, Via R. Paolini 47, 65100 Pescara, Italy.
Ester SapigniRegional Center for Pharmacovigilance, Emilia-Romagna Region, Medicines and Medical Devices Governance Area, Hospital Care Sector, General Directorate for Personal Care, Health and Welfare, Viale Aldo Moro 21, 40127 Bologna, Italy.
Cristina ScavoneDepartment of Experimental Medicine, University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138 Napoli, Italy.ORCID 0000-0002-9216-922X
Claudia SommaroRegional Center of Pharmacovigilance-Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy.
Marco TuccoriUnit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Via Roma 55, 56126 Pisa, Italy.ORCID 0000-0002-7979-8486
Giovanna ZanoniImmunology Unit, Pathology and Diagnostics Department, University Hospital of Verona, 37134 Verona, Italy.
Ugo MorettiSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy.ORCID 0000-0001-5108-5807
VigiVax Working Group

Funding

the Italian Medicines Agency (AIFA) in the context of the multiregional pharmacovigilance project VigiFarmacoVax: Surveillance of adverse events following immunization. na
6 · The paper itself

Abstract

Underreporting is the main limitation of spontaneous reporting systems. This cohort-event monitoring study aims to examine the potential of short message service (SMS)-based surveillance compared to traditional surveillance systems. Using VigiVax software, parents of vaccinated children aged two years or younger, in the period March 2021-May 2022, received a single SMS inquiry about adverse events following immunization (AEFI). Responses were collected, validated by health operators and integrated with the information on electronic immunization registries. AEFI reports were automatically submitted to the Italian Pharmacovigilance system. Among 254,160 SMS messages sent, corresponding to 451,656 administered doses (AD), 71,643 responses were collected (28.2% response rate), and 21,231 of them (8.3%) reported AEFI. After a seriousness assessment based on clinical criteria, 50 reports (0.24%) were classified as serious. Among these, a causality assessment identified 31 reports at least potentially related to the vaccination (RR: 6.86/100,000 AD). Febrile seizures following MMRV (measles, mumps, rubella, varicella) vaccination accounted for 11 of these 31 cases, with an incidence of 32 per 100,000 AD. No fatal outcomes were reported. Our findings support the highly favorable risk profile of pediatric vaccinations and the possibility to improve spontaneous reporting through the integration of digital technologies.

Indexed as

active vaccine safety surveillanceadverse event following immunizationdigital innovation for vaccine safety surveillancedigital technologiesimmunization registriespatient reportingpediatric vaccinationserious adverse eventsshort message services

Identifiers

PMID39340106
PMCPMC11435886

What OpenQuestion holds

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LicenceCC BY
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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.