{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T15:53:32Z","timestamp":1783698812362,"version":"3.55.0"},"reference-count":47,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2024,9,20]],"date-time":"2024-09-20T00:00:00Z","timestamp":1726790400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Italian Medicines Agency (AIFA)"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>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\u2013May 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.<\/jats:p>","DOI":"10.3390\/vaccines12091076","type":"journal-article","created":{"date-parts":[[2024,9,20]],"date-time":"2024-09-20T04:31:23Z","timestamp":1726806683000},"page":"1076","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study"],"prefix":"10.3390","volume":"12","author":[{"given":"Laura Augusta","family":"Gonella","sequence":"first","affiliation":[{"name":"Section of Pharmacology, Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1235-1054","authenticated-orcid":false,"given":"Francesca","family":"Moretti","sequence":"additional","affiliation":[{"name":"Section of Hygiene and Environmental Occupational Preventive Medicine, Department of Diagnostics and Public Health, University of Verona, Piazzale L.A. Scuro 10, 37134 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annalisa","family":"Capuano","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, Via Costantinopoli 16, 80138 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3596-0090","authenticated-orcid":false,"given":"Caterina","family":"De Sarro","sequence":"additional","affiliation":[{"name":"Unit of Clinical Pharmacology and Pharmacovigilance, \u201cRenato Dulbecco\u201d University Hospital, Research Center FAS@UMG, Department of Health Science, Magna Graecia University, 88100 Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenza","family":"Ferrara","sequence":"additional","affiliation":[{"name":"Local Unit Health of Asti, Via Conte Verde 125, 14100 Asti, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Geninatti","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance, Piemonte Region, Via Silvio Pellico 19, 10125 Torino, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Greta","family":"Guarnieri","sequence":"additional","affiliation":[{"name":"Unit of Pharmacovigilance & Clinical Research, ASST Fatebenefratelli-Sacco, Department of Biomedical and Clinical Sciences, Universit\u00e0 degli Studi di Milano, 20157 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xhikjana","family":"Hysolakoj","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance\u2014Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margherita","family":"Lalli","sequence":"additional","affiliation":[{"name":"U.O.C. Farmaceutica Territoriale, Azienda Sanitaria Territoriale di Macerata, Belvedere Raffaello Sanzio 1, 62100 Macerata, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Leoni","sequence":"additional","affiliation":[{"name":"Lombardy Regional Centre of Pharmacovigilance and Regional Epidemiologic Observatory, Welfare General Directorate, Lombardy Region, Piazza Citt\u00e0 di Lombardia 1, 20124 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antea Maria Pia","family":"Mangano","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance, Marche Region, Via Gentile da Fabriano, 60125 Ancona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrizia","family":"Marani Toro","sequence":"additional","affiliation":[{"name":"Health Office, Epidemiology and Public Health, ASL Pescara, Regional Department of Prevention Abruzzo, Via R. Paolini, 47, 65100 Pescara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viviana","family":"Mecchia","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance\u2014Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Caterina","family":"Merlano","sequence":"additional","affiliation":[{"name":"ALISA\/Liguria Region, Via Gabriele D Annunzio 64, 16121 Genova, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caterina","family":"Palleria","sequence":"additional","affiliation":[{"name":"Unit of Clinical Pharmacology and Pharmacovigilance, \u201cRenato Dulbecco\u201d University Hospital, Research Center FAS@UMG, Department of Health Science, Magna Graecia University, 88100 Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Maria","family":"Potenza","sequence":"additional","affiliation":[{"name":"Regional 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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-7749-9711","authenticated-orcid":false,"given":"Paola","family":"Rossi","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance\u2014Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Rossi","sequence":"additional","affiliation":[{"name":"Department of Medical, Surgical and Neuroscience Sciences, University of Siena, Viale Mario Bracci 16, 53100 Siena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Sanit\u00e0","sequence":"additional","affiliation":[{"name":"Territorial Assistance Service, ASL Pescara,   Regional Center of Pharmacovigilance, Abruzzo, Via R. Paolini 47, 65100 Pescara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ester","family":"Sapigni","sequence":"additional","affiliation":[{"name":"Regional 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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9216-922X","authenticated-orcid":false,"given":"Cristina","family":"Scavone","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, Via Costantinopoli 16, 80138 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Sommaro","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance\u2014Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7979-8486","authenticated-orcid":false,"given":"Marco","family":"Tuccori","sequence":"additional","affiliation":[{"name":"Unit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Via Roma 55, 56126 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanna","family":"Zanoni","sequence":"additional","affiliation":[{"name":"Immunology Unit, Pathology and Diagnostics Department, University Hospital of Verona, 37134 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5108-5807","authenticated-orcid":false,"given":"Ugo","family":"Moretti","sequence":"additional","affiliation":[{"name":"Section of Pharmacology, Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"VigiVax Working Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,9,20]]},"reference":[{"key":"ref_1","unstructured":"EU Parliament (2010). 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