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 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.

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Publication Details

Journal
Vaccines
Published
2024-09-20
DOI
https://doi.org/10.3390/vaccines12091076
Citations
1
Primary Topic
Vaccine Coverage and Hesitancy
Type
article
Field-Weighted Citation Impact
0.53
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article

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

Ester Sapigni, M Lalli, Annalisa Capuano, Francesca Moretti et al.
1 citations
Vaccines
Vaccine Coverage and Hesitancy
0.53
article

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

Ester Sapigni, M Lalli, Annalisa Capuano, Francesca Moretti, Caterina De Sarro, Lorenza Ferrara, Ugo Moretti, Caterina Palleria, Laura Augusta Gonella, Greta Guarnieri, Giovanna Zanoni, Anna Maria Potenza, Marco Tuccori, Maria Caterina Merlano, Olivia Leoni, Cristina Scavone, Marco Rossi, Paola Rossi, Xhikjana Hysolakoj, Viviana Mecchia, Claudia Sommaro, Elisabetta Geninatti, Francesca Sanità, Patrizia Marani Toro, Antea Maria Pia Mangano
article en
1 citations

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.

VaccinesVol. 12(9)
University of Siena (IT), University of Pisa (IT), University of Verona (IT), University of Milan (IT), University of Campania "Luigi Vanvitelli" (IT), Magna Graecia University (IT), CSI Piemonte (IT), Azienda Sanitaria Locale di Asti (IT), Agenzia Regionale per la Protezione dell'ambiente ligure (IT), ASST Fatebenefratelli Sacco (IT), Lombardia Informatica (Italy) (IT), Azienda Ospedaliera Universitaria Pisana (IT), Agenzia Sanitaria Regionale Abruzzo (IT), Regione Lombardia, Regione Emilia-Romagna, Regione Autonoma Friuli Venezia Giulia (IT), Regione Liguria, University of Macerata (IT)
Good health and well-being
Openalex Percentile: Top 30%
Vaccine Coverage and Hesitancy
0.53
DOIOpen Access PDFOpenAlex
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