SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study
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 yea...
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MDPI AG
2024-09-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/12/9/1076 |
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| author | Laura Augusta Gonella Francesca Moretti Annalisa Capuano Caterina De Sarro Lorenza Ferrara Elisabetta Geninatti Greta Guarnieri Xhikjana Hysolakoj Margherita Lalli Olivia Leoni Antea Maria Pia Mangano Patrizia Marani Toro Viviana Mecchia Maria Caterina Merlano Caterina Palleria Anna Maria Potenza Paola Rossi Marco Rossi Francesca Sanità Ester Sapigni Cristina Scavone Claudia Sommaro Marco Tuccori Giovanna Zanoni Ugo Moretti VigiVax Working Group |
| author_facet | Laura Augusta Gonella Francesca Moretti Annalisa Capuano Caterina De Sarro Lorenza Ferrara Elisabetta Geninatti Greta Guarnieri Xhikjana Hysolakoj Margherita Lalli Olivia Leoni Antea Maria Pia Mangano Patrizia Marani Toro Viviana Mecchia Maria Caterina Merlano Caterina Palleria Anna Maria Potenza Paola Rossi Marco Rossi Francesca Sanità Ester Sapigni Cristina Scavone Claudia Sommaro Marco Tuccori Giovanna Zanoni Ugo Moretti VigiVax Working Group |
| author_sort | Laura Augusta Gonella |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-ba962ffe5f2f4538ae851ef5478565bb |
| institution | OA Journals |
| issn | 2076-393X |
| language | English |
| publishDate | 2024-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj-art-ba962ffe5f2f4538ae851ef5478565bb2025-08-20T01:55:57ZengMDPI AGVaccines2076-393X2024-09-01129107610.3390/vaccines12091076SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax StudyLaura Augusta Gonella0Francesca Moretti1Annalisa Capuano2Caterina De Sarro3Lorenza Ferrara4Elisabetta Geninatti5Greta Guarnieri6Xhikjana Hysolakoj7Margherita Lalli8Olivia Leoni9Antea Maria Pia Mangano10Patrizia Marani Toro11Viviana Mecchia12Maria Caterina Merlano13Caterina Palleria14Anna Maria Potenza15Paola Rossi16Marco Rossi17Francesca Sanità18Ester Sapigni19Cristina Scavone20Claudia Sommaro21Marco Tuccori22Giovanna Zanoni23Ugo Moretti24VigiVax Working GroupSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, 37134 Verona, ItalySection of Hygiene and Environmental Occupational Preventive Medicine, Department of Diagnostics and Public Health, University of Verona, Piazzale L.A. Scuro 10, 37134 Verona, ItalyDepartment of Experimental Medicine, University of Campania “Luigi Vanvitelli”, Via Costantinopoli 16, 80138 Napoli, ItalyUnit of Clinical Pharmacology and Pharmacovigilance, “Renato Dulbecco” University Hospital, Research Center FAS@UMG, Department of Health Science, Magna Graecia University, 88100 Catanzaro, ItalyLocal Unit Health of Asti, Via Conte Verde 125, 14100 Asti, ItalyRegional Center of Pharmacovigilance, Piemonte Region, Via Silvio Pellico 19, 10125 Torino, ItalyUnit of Pharmacovigilance & Clinical Research, ASST Fatebenefratelli-Sacco, Department of Biomedical and Clinical Sciences, Università degli Studi di Milano, 20157 Milan, ItalyRegional Center of Pharmacovigilance—Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, ItalyU.O.C. Farmaceutica Territoriale, Azienda Sanitaria Territoriale di Macerata, Belvedere Raffaello Sanzio 1, 62100 Macerata, ItalyLombardy Regional Centre of Pharmacovigilance and Regional Epidemiologic Observatory, Welfare General Directorate, Lombardy Region, Piazza Città di Lombardia 1, 20124 Milan, ItalyRegional Center of Pharmacovigilance, Marche Region, Via Gentile da Fabriano, 60125 Ancona, ItalyHealth Office, Epidemiology and Public Health, ASL Pescara, Regional Department of Prevention Abruzzo, Via R. Paolini, 47, 65100 Pescara, ItalyRegional Center of Pharmacovigilance—Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, ItalyALISA/Liguria Region, Via Gabriele D Annunzio 64, 16121 Genova, ItalyUnit of Clinical Pharmacology and Pharmacovigilance, “Renato Dulbecco” University Hospital, Research Center FAS@UMG, Department of Health Science, Magna Graecia University, 88100 Catanzaro, ItalyRegional 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, ItalyRegional Center of Pharmacovigilance—Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, ItalyDepartment of Medical, Surgical and Neuroscience Sciences, University of Siena, Viale Mario Bracci 16, 53100 Siena, ItalyTerritorial Assistance Service, ASL Pescara, Regional Center of Pharmacovigilance, Abruzzo, Via R. Paolini 47, 65100 Pescara, ItalyRegional 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, ItalyDepartment of Experimental Medicine, University of Campania “Luigi Vanvitelli”, Via Costantinopoli 16, 80138 Napoli, ItalyRegional Center of Pharmacovigilance—Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, ItalyUnit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Via Roma 55, 56126 Pisa, ItalyImmunology Unit, Pathology and Diagnostics Department, University Hospital of Verona, 37134 Verona, ItalySection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, 37134 Verona, ItalyUnderreporting 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.https://www.mdpi.com/2076-393X/12/9/1076active vaccine safety surveillanceadverse event following immunizationshort message servicespediatric vaccinationpatient reportingimmunization registries |
| spellingShingle | Laura Augusta Gonella Francesca Moretti Annalisa Capuano Caterina De Sarro Lorenza Ferrara Elisabetta Geninatti Greta Guarnieri Xhikjana Hysolakoj Margherita Lalli Olivia Leoni Antea Maria Pia Mangano Patrizia Marani Toro Viviana Mecchia Maria Caterina Merlano Caterina Palleria Anna Maria Potenza Paola Rossi Marco Rossi Francesca Sanità Ester Sapigni Cristina Scavone Claudia Sommaro Marco Tuccori Giovanna Zanoni Ugo Moretti VigiVax Working Group SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study Vaccines active vaccine safety surveillance adverse event following immunization short message services pediatric vaccination patient reporting immunization registries |
| title | SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study |
| title_full | SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study |
| title_fullStr | SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study |
| title_full_unstemmed | SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study |
| title_short | SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study |
| title_sort | sms based active surveillance of adverse events following immunization in children the vigivax study |
| topic | active vaccine safety surveillance adverse event following immunization short message services pediatric vaccination patient reporting immunization registries |
| url | https://www.mdpi.com/2076-393X/12/9/1076 |
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