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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Main Authors: Silvia Bloise, Alessia Marcellino, Beatrice Frasacco, Pietro Gizzone, Claudia Proietti Ciolli, Vanessa Martucci, Mariateresa Sanseviero, Emanuela Del Giudice, Flavia Ventriglia, Riccardo Lubrano
Format: Article
Language:English
Published: MDPI AG 2022-07-01
Series:Vaccines
Subjects:
Online Access:https://www.mdpi.com/2076-393X/10/8/1224
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author Silvia Bloise
Alessia Marcellino
Beatrice Frasacco
Pietro Gizzone
Claudia Proietti Ciolli
Vanessa Martucci
Mariateresa Sanseviero
Emanuela Del Giudice
Flavia Ventriglia
Riccardo Lubrano
author_facet Silvia Bloise
Alessia Marcellino
Beatrice Frasacco
Pietro Gizzone
Claudia Proietti Ciolli
Vanessa Martucci
Mariateresa Sanseviero
Emanuela Del Giudice
Flavia Ventriglia
Riccardo Lubrano
author_sort Silvia Bloise
collection DOAJ
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 (<i>p</i> = 0.01), while systemic symptoms were more frequent after the second dose (<i>p</i> = 0.022). These symptoms were more frequent in patients with comorbidities (<i>p</i> = 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 doaj.art-0fb237e6e42146e7a25875b2585465a52023-12-03T14:36:46ZengMDPI AGVaccines2076-393X2022-07-01108122410.3390/vaccines10081224Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric ExperienceSilvia Bloise0Alessia Marcellino1Beatrice Frasacco2Pietro Gizzone3Claudia Proietti Ciolli4Vanessa Martucci5Mariateresa Sanseviero6Emanuela Del Giudice7Flavia Ventriglia8Riccardo Lubrano9Dipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyDipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyDipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyDipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyDipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyDipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyDipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyDipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyDipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyDipartimento Materno Infantile e di Scienze Urologiche, Sapienza Università di Roma, UOC di Pediatria e Neonatologia-Polo Pontino, 04100 Latina, ItalyObjective: 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 (<i>p</i> = 0.01), while systemic symptoms were more frequent after the second dose (<i>p</i> = 0.022). These symptoms were more frequent in patients with comorbidities (<i>p</i> = 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.https://www.mdpi.com/2076-393X/10/8/1224COVID-19vaccinechildrenadverse events
spellingShingle Silvia Bloise
Alessia Marcellino
Beatrice Frasacco
Pietro Gizzone
Claudia Proietti Ciolli
Vanessa Martucci
Mariateresa Sanseviero
Emanuela Del Giudice
Flavia Ventriglia
Riccardo Lubrano
Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience
Vaccines
COVID-19
vaccine
children
adverse events
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 COVID-19
vaccine
children
adverse events
url https://www.mdpi.com/2076-393X/10/8/1224
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