tetano
Editor, Senior Moderator
Vaccines (Basel)
. 2021 Nov 9;9(11):1297.
doi: 10.3390/vaccines9111297.
Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12-18 Years in Saudi Arabia
Edrous Alamer[SUP] 1 2 [/SUP], Abdulaziz Alhazmi[SUP] 2 3 [/SUP], Naaif A Qasir[SUP] 1 2 [/SUP], Rahaf Alamer[SUP] 2 4 [/SUP], Halima Areeshi[SUP] 2 [/SUP], Gassem Gohal[SUP] 5 [/SUP], Marwa Qadri[SUP] 2 6 [/SUP], Anwar M Hashem[SUP] 7 8 [/SUP], Abdullah Algaissi[SUP] 1 2 [/SUP]
Affiliations
Abstract
Background: 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. Method: 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. Results: 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. Conclusions: 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.
Keywords: COVID-19; COVID-19 pandemic; Pfizer-BioNTech; SARS-CoV-2; children; side effects; vaccine.
. 2021 Nov 9;9(11):1297.
doi: 10.3390/vaccines9111297.
Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12-18 Years in Saudi Arabia
Edrous Alamer[SUP] 1 2 [/SUP], Abdulaziz Alhazmi[SUP] 2 3 [/SUP], Naaif A Qasir[SUP] 1 2 [/SUP], Rahaf Alamer[SUP] 2 4 [/SUP], Halima Areeshi[SUP] 2 [/SUP], Gassem Gohal[SUP] 5 [/SUP], Marwa Qadri[SUP] 2 6 [/SUP], Anwar M Hashem[SUP] 7 8 [/SUP], Abdullah Algaissi[SUP] 1 2 [/SUP]
Affiliations
- PMID: 34835228
- DOI: 10.3390/vaccines9111297
Abstract
Background: 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. Method: 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. Results: 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. Conclusions: 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.
Keywords: COVID-19; COVID-19 pandemic; Pfizer-BioNTech; SARS-CoV-2; children; side effects; vaccine.