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Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience

Objective: Our aim was to evaluate the safety of COVID-19 vaccine in children resident in the Latina Local Health Authority. Methods: We conducted a telephone survey among children aged 5–11 years receiving BNT162b2 mRNA COVID-19 vaccine between December 15 and 21. The main outcomes included the pre...

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Autores principales: Bloise, Silvia, Marcellino, Alessia, Frasacco, Beatrice, Gizzone, Pietro, Proietti Ciolli, Claudia, Martucci, Vanessa, Sanseviero, Mariateresa, Del Giudice, Emanuela, Ventriglia, Flavia, Lubrano, Riccardo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9416594/
https://www.ncbi.nlm.nih.gov/pubmed/36016112
http://dx.doi.org/10.3390/vaccines10081224
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author Bloise, Silvia
Marcellino, Alessia
Frasacco, Beatrice
Gizzone, Pietro
Proietti Ciolli, Claudia
Martucci, Vanessa
Sanseviero, Mariateresa
Del Giudice, Emanuela
Ventriglia, Flavia
Lubrano, Riccardo
author_facet Bloise, Silvia
Marcellino, Alessia
Frasacco, Beatrice
Gizzone, Pietro
Proietti Ciolli, Claudia
Martucci, Vanessa
Sanseviero, Mariateresa
Del Giudice, Emanuela
Ventriglia, Flavia
Lubrano, Riccardo
author_sort Bloise, Silvia
collection PubMed
description Objective: Our aim was to evaluate the safety of COVID-19 vaccine in children resident in the Latina Local Health Authority. Methods: We conducted a telephone survey among children aged 5–11 years receiving BNT162b2 mRNA COVID-19 vaccine between December 15 and 21. The main outcomes included the presence of allergic reactions or anaphylaxis, adverse events after 24–48 h, 7 and 20 days of taking the first and second doses of medications, and documented SARS-CoV-2 infection after vaccination. The information obtained was automatically linked to a spreadsheet and analyzed. Results: 569 children were enrolled. The mean age was 114 ± 4.24 months; there were 251 males in the study. The vaccine showed a favorable safety profile; no anaphylaxis or serious adverse events were reported. The most common symptoms both after the first and second dose were injection site reactions, asthenia, and headache. Injection site reactions were more frequent after the first dose (p = 0.01), while systemic symptoms were more frequent after the second dose (p = 0.022). These symptoms were more frequent in patients with comorbidities (p = 0.0159). Conclusion: Our findings confirm the safety of COVID-19 vaccine in children younger 11 years and could be useful to promote its diffusion in pediatric ages in order to achieve “herd immunity” and prevent the virus’s circulation.
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spelling pubmed-94165942022-08-27 Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience Bloise, Silvia Marcellino, Alessia Frasacco, Beatrice Gizzone, Pietro Proietti Ciolli, Claudia Martucci, Vanessa Sanseviero, Mariateresa Del Giudice, Emanuela Ventriglia, Flavia Lubrano, Riccardo Vaccines (Basel) Article Objective: Our aim was to evaluate the safety of COVID-19 vaccine in children resident in the Latina Local Health Authority. Methods: We conducted a telephone survey among children aged 5–11 years receiving BNT162b2 mRNA COVID-19 vaccine between December 15 and 21. The main outcomes included the presence of allergic reactions or anaphylaxis, adverse events after 24–48 h, 7 and 20 days of taking the first and second doses of medications, and documented SARS-CoV-2 infection after vaccination. The information obtained was automatically linked to a spreadsheet and analyzed. Results: 569 children were enrolled. The mean age was 114 ± 4.24 months; there were 251 males in the study. The vaccine showed a favorable safety profile; no anaphylaxis or serious adverse events were reported. The most common symptoms both after the first and second dose were injection site reactions, asthenia, and headache. Injection site reactions were more frequent after the first dose (p = 0.01), while systemic symptoms were more frequent after the second dose (p = 0.022). These symptoms were more frequent in patients with comorbidities (p = 0.0159). Conclusion: Our findings confirm the safety of COVID-19 vaccine in children younger 11 years and could be useful to promote its diffusion in pediatric ages in order to achieve “herd immunity” and prevent the virus’s circulation. MDPI 2022-07-30 /pmc/articles/PMC9416594/ /pubmed/36016112 http://dx.doi.org/10.3390/vaccines10081224 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Bloise, Silvia
Marcellino, Alessia
Frasacco, Beatrice
Gizzone, Pietro
Proietti Ciolli, Claudia
Martucci, Vanessa
Sanseviero, Mariateresa
Del Giudice, Emanuela
Ventriglia, Flavia
Lubrano, Riccardo
Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience
title Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience
title_full Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience
title_fullStr Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience
title_full_unstemmed Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience
title_short Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience
title_sort cross-sectional survey on bnt162b2 mrna covid-19 vaccine serious adverse events in children 5 to 11 years of age: a monocentric experience
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9416594/
https://www.ncbi.nlm.nih.gov/pubmed/36016112
http://dx.doi.org/10.3390/vaccines10081224
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