Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia

<b>Background</b>: Massive vaccination campaigns have been undertaken globally to combat the spread of the Coronavirus Disease 2019 (COVID-19). While most COVID-19 vaccines have shown excellent efficacy and safety profiles in clinical studies, real-world monitoring of vaccine safety is s...

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Autores principales:	Edrous Alamer, Abdulaziz Alhazmi, Naaif A. Qasir, Rahaf Alamer, Halima Areeshi, Gassem Gohal, Marwa Qadri, Anwar M. Hashem, Abdullah Algaissi
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	SARS-CoV-2 COVID-19 pandemic COVID-19 vaccine Pfizer-BioNTech Medicine R
Acceso en línea:	https://doaj.org/article/eafb5d7b32764e66a2335129c0940820
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spelling	oai:doaj.org-article:eafb5d7b32764e66a2335129c09408202021-11-25T19:11:04ZSide Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia10.3390/vaccines91112972076-393Xhttps://doaj.org/article/eafb5d7b32764e66a2335129c09408202021-11-01T00:00:00Zhttps://www.mdpi.com/2076-393X/9/11/1297https://doaj.org/toc/2076-393X<b>Background</b>: Massive vaccination campaigns have been undertaken globally to combat the spread of the Coronavirus Disease 2019 (COVID-19). While most COVID-19 vaccines have shown excellent efficacy and safety profiles in clinical studies, real-world monitoring of vaccine safety is still important. In this study, we aimed to investigate the early side effects of Pfizer-BioNTech (BNT162b2) mRNA vaccine in children between 12–18 years old in Saudi Arabia. <b>Method</b>: To investigate the side effects in children in this age range following the administration of either one or two doses of Pfizer-BioNTech (BNT162b2) mRNA vaccine, we conducted a retrospective, cross-sectional study using a self-administered online survey. General and demographic data were collected, and vaccine-associated side effects following vaccination were evaluated. <b>Results</b>: The study recruited a total of 965 eligible participants. Overall, 571 (60%) of the study participants reported at least one side effect following Pfizer-BioNTech (BNT162b2) mRNA vaccination. The most frequently reported side effects were pain or redness at the site of injection (90%), fatigue (67%), fever (59%), headache (55%), nausea or vomiting (21%), and chest pain and shortness of breath (20%). Joint or bone pain were reported less frequently among our participants (2%). Our data showed that more female participants reported side effects compared to male participants, with 52% and 48%, respectively. Side effects were more common after the second dose compared to the first dose in our study cohort. <b>Conclusions</b>: While 60% of the children (12–18 years old) who received Pfizer-BioNTech (BNT162b2) mRNA vaccine reported side effects, our data showed that these side effects were not different from those that were reported in the clinical trials which lasted only for a few days. Side effects were more common after the second dose. Larger epidemiological and molecular studies are needed to evaluate the safety and the effectiveness of COVID-19 vaccine in protection of children against SARS-CoV-2 reinfections.Edrous AlamerAbdulaziz AlhazmiNaaif A. QasirRahaf AlamerHalima AreeshiGassem GohalMarwa QadriAnwar M. HashemAbdullah AlgaissiMDPI AGarticleSARS-CoV-2COVID-19 pandemicCOVID-19SARS-CoV-2vaccinePfizer-BioNTechMedicineRENVaccines, Vol 9, Iss 1297, p 1297 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	SARS-CoV-2 COVID-19 pandemic COVID-19 SARS-CoV-2 vaccine Pfizer-BioNTech Medicine R
spellingShingle	SARS-CoV-2 COVID-19 pandemic COVID-19 SARS-CoV-2 vaccine Pfizer-BioNTech Medicine R Edrous Alamer Abdulaziz Alhazmi Naaif A. Qasir Rahaf Alamer Halima Areeshi Gassem Gohal Marwa Qadri Anwar M. Hashem Abdullah Algaissi Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia
description	<b>Background</b>: Massive vaccination campaigns have been undertaken globally to combat the spread of the Coronavirus Disease 2019 (COVID-19). While most COVID-19 vaccines have shown excellent efficacy and safety profiles in clinical studies, real-world monitoring of vaccine safety is still important. In this study, we aimed to investigate the early side effects of Pfizer-BioNTech (BNT162b2) mRNA vaccine in children between 12–18 years old in Saudi Arabia. <b>Method</b>: To investigate the side effects in children in this age range following the administration of either one or two doses of Pfizer-BioNTech (BNT162b2) mRNA vaccine, we conducted a retrospective, cross-sectional study using a self-administered online survey. General and demographic data were collected, and vaccine-associated side effects following vaccination were evaluated. <b>Results</b>: The study recruited a total of 965 eligible participants. Overall, 571 (60%) of the study participants reported at least one side effect following Pfizer-BioNTech (BNT162b2) mRNA vaccination. The most frequently reported side effects were pain or redness at the site of injection (90%), fatigue (67%), fever (59%), headache (55%), nausea or vomiting (21%), and chest pain and shortness of breath (20%). Joint or bone pain were reported less frequently among our participants (2%). Our data showed that more female participants reported side effects compared to male participants, with 52% and 48%, respectively. Side effects were more common after the second dose compared to the first dose in our study cohort. <b>Conclusions</b>: While 60% of the children (12–18 years old) who received Pfizer-BioNTech (BNT162b2) mRNA vaccine reported side effects, our data showed that these side effects were not different from those that were reported in the clinical trials which lasted only for a few days. Side effects were more common after the second dose. Larger epidemiological and molecular studies are needed to evaluate the safety and the effectiveness of COVID-19 vaccine in protection of children against SARS-CoV-2 reinfections.
format	article
author	Edrous Alamer Abdulaziz Alhazmi Naaif A. Qasir Rahaf Alamer Halima Areeshi Gassem Gohal Marwa Qadri Anwar M. Hashem Abdullah Algaissi
author_facet	Edrous Alamer Abdulaziz Alhazmi Naaif A. Qasir Rahaf Alamer Halima Areeshi Gassem Gohal Marwa Qadri Anwar M. Hashem Abdullah Algaissi
author_sort	Edrous Alamer
title	Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia
title_short	Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia
title_full	Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia
title_fullStr	Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia
title_full_unstemmed	Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia
title_sort	side effects of covid-19 pfizer-biontech mrna vaccine in children aged 12–18 years in saudi arabia
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/eafb5d7b32764e66a2335129c0940820
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Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia

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