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

How to cite: Gonella, L. A.; Moretti, F.; Capuano, A.; De Sarro, C.; Ferrara, L.; Geninatti, E.; Guarnieri, G.; Hysolakoj, X.; Lalli, M.; Leoni, O.; Mangano, A. M. P.; Marani Toro, P.; Mecchia, V.; Merlano, M. C.; Palleria, C.; Potenza, A. M.; Rossi, P.; Rossi, M.; Sanita, F.; Sapigni, E.; Scavone, C.; Sommaro, C.; Tuccori, M.; Zanoni, G.; Moretti, U. SMS-Based Active Surveillance of Adverse Events Following Immunization in Children: The VigiVax Study. Preprints 2024, 2024080588. https://doi.org/10.20944/preprints202408.0588.v1 Gonella, L. A.; Moretti, F.; Capuano, A.; De Sarro, C.; Ferrara, L.; Geninatti, E.; Guarnieri, G.; Hysolakoj, X.; Lalli, M.; Leoni, O.; Mangano, A. M. P.; Marani Toro, P.; Mecchia, V.; Merlano, M. C.; Palleria, C.; Potenza, A. M.; Rossi, P.; Rossi, M.; Sanita, F.; Sapigni, E.; Scavone, C.; Sommaro, C.; Tuccori, M.; Zanoni, G.; Moretti, U. SMS-Based Active Surveillance of Adverse Events Following Immunization in Children: The VigiVax Study. Preprints 2024, 2024080588. https://doi.org/10.20944/preprints202408.0588.v1

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MDPI and ACS Style

Gonella, L. A.; Moretti, F.; Capuano, A.; De Sarro, C.; Ferrara, L.; Geninatti, E.; Guarnieri, G.; Hysolakoj, X.; Lalli, M.; Leoni, O.; Mangano, A. M. P.; Marani Toro, P.; Mecchia, V.; Merlano, M. C.; Palleria, C.; Potenza, A. M.; Rossi, P.; Rossi, M.; Sanita, F.; Sapigni, E.; Scavone, C.; Sommaro, C.; Tuccori, M.; Zanoni, G.; Moretti, U. SMS-Based Active Surveillance of Adverse Events Following Immunization in Children: The VigiVax Study. Preprints 2024, 2024080588. https://doi.org/10.20944/preprints202408.0588.v1

APA Style

Gonella, L. A., Moretti, F., Capuano, A., De Sarro, C., Ferrara, L., Geninatti, E., Guarnieri, G., Hysolakoj, X., Lalli, M., Leoni, O., Mangano, A. M. P., Marani Toro, P., Mecchia, V., Merlano, M. C., Palleria, C., Potenza, A. M., Rossi, P., Rossi, M., Sanita, F., Sapigni, E., Scavone, C., Sommaro, C., Tuccori, M., Zanoni, G., & Moretti, U. (2024). SMS-Based Active Surveillance of Adverse Events Following Immunization in Children: The VigiVax Study. Preprints. https://doi.org/10.20944/preprints202408.0588.v1

Chicago/Turabian Style

Gonella, L. A., Giovanna Zanoni and Ugo Moretti. 2024 "SMS-Based Active Surveillance of Adverse Events Following Immunization in Children: The VigiVax Study" Preprints. https://doi.org/10.20944/preprints202408.0588.v1

Abstract

Underreporting is the main limitation of the spontaneous reporting systems. This study aims to reduce underreporting enhancing public participation in vaccinovigilance through an SMS-based reporting system integrated with electronic immunization registries (IRs). Using the VigiVax software, parents of vaccinated children aged 2 years or younger received a single SMS inquiry about adverse events following immunization (AEFI). Responses were collected, validated by health operators and integrated with the information on IRs. AEFI reports were automatically submitted to the Italian Pharmacovigilance system. Among 254,160 SMS messages sent, corre-sponding to 451,656 administered doses (AD), 71,643 responses were collected (28.2% response rate), 21,231of them (8.3%) reporting an AEFI. After seriousness assessment based on clinical criteria, 50 reports (0,24%) were classified as serious. Among these, causality assessment identi-fied 31 reports at least potentially related to the vaccination (RR: 6.86/100,000 AD). Febrile seizures following MMRV 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

Keywords

Active vaccine safety surveillance; Adverse event following immunization; Short Message Services; Pediatric vaccination; Patient reporting; Immunization Registries; Digital technologies; Digital innovation for vaccine safety surveillance; serious adverse events

Subject

Medicine and Pharmacology, Medicine and Pharmacology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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