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,
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
Affiliations
Laura Augusta Gonella
Section of Pharmacology, Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy
Francesca Moretti
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
Annalisa Capuano
Department of Experimental Medicine, University of Campania “Luigi Vanvitelli”, Via Costantinopoli 16, 80138 Napoli, Italy
Caterina De Sarro
Unit of Clinical Pharmacology and Pharmacovigilance, “Renato Dulbecco” University Hospital, Research Center FAS@UMG, Department of Health Science, Magna Graecia University, 88100 Catanzaro, Italy
Lorenza Ferrara
Local Unit Health of Asti, Via Conte Verde 125, 14100 Asti, Italy
Elisabetta Geninatti
Regional Center of Pharmacovigilance, Piemonte Region, Via Silvio Pellico 19, 10125 Torino, Italy
Greta Guarnieri
Unit of Pharmacovigilance & Clinical Research, ASST Fatebenefratelli-Sacco, Department of Biomedical and Clinical Sciences, Università degli Studi di Milano, 20157 Milan, Italy
Xhikjana Hysolakoj
Regional Center of Pharmacovigilance—Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy
Lombardy Regional Centre of Pharmacovigilance and Regional Epidemiologic Observatory, Welfare General Directorate, Lombardy Region, Piazza Città di Lombardia 1, 20124 Milan, Italy
Antea Maria Pia Mangano
Regional Center of Pharmacovigilance, Marche Region, Via Gentile da Fabriano, 60125 Ancona, Italy
Patrizia Marani Toro
Health Office, Epidemiology and Public Health, ASL Pescara, Regional Department of Prevention Abruzzo, Via R. Paolini, 47, 65100 Pescara, Italy
Viviana Mecchia
Regional 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 Merlano
ALISA/Liguria Region, Via Gabriele D Annunzio 64, 16121 Genova, Italy
Caterina Palleria
Unit 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 Potenza
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
Paola Rossi
Regional Center of Pharmacovigilance—Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy
Marco Rossi
Department of Medical, Surgical and Neuroscience Sciences, University of Siena, Viale Mario Bracci 16, 53100 Siena, Italy
Francesca Sanità
Territorial Assistance Service, ASL Pescara, Regional Center of Pharmacovigilance, Abruzzo, Via R. Paolini 47, 65100 Pescara, Italy
Ester Sapigni
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
Cristina Scavone
Department of Experimental Medicine, University of Campania “Luigi Vanvitelli”, Via Costantinopoli 16, 80138 Napoli, Italy
Claudia Sommaro
Regional Center of Pharmacovigilance—Friuli Venezia Giulia Region, Department of Central Health, Social and Disability Policies, Via Cassa di Risparmio 10, 34100 Trieste, Italy
Marco Tuccori
Unit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Via Roma 55, 56126 Pisa, Italy
Giovanna Zanoni
Immunology Unit, Pathology and Diagnostics Department, University Hospital of Verona, 37134 Verona, Italy
Ugo Moretti
Section of Pharmacology, Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy
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.
