Key result
Pfizer-BioNTech mRNA vaccination is linked to any side effect in ~60% of adolescents.
Why the study?
While clinical studies showed excellent efficacy and safety, real-world monitoring of early Pfizer-BioNTech mRNA vaccine side effects in children aged 12–18 years remained important.
What are the early side effects of the Pfizer-BioNTech mRNA vaccine in children aged 12-18 years?
Cross-Sectional (n=965)
What are the early side effects of the Pfizer-BioNTech mRNA vaccine in children aged 12-18 years?
The Pfizer-BioNTech mRNA vaccine is associated with common, transient side effects in 60% of children aged 12-18 years, most frequently injection site pain, fatigue, and fever, which are more common after the second dose.
Supports counseling on expected transient effects in adolescents; extends observational safety data without altering practice.
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.
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Alamer et al. (2021) conducted a cross-sectional in COVID-19 vaccination side effects (n=965). Pfizer-BioNTech (BNT162b2) mRNA vaccine was evaluated on At least one side effect following vaccination. Pfizer-BioNTech mRNA vaccination was associated with at least one side effect in 60% of children aged 12-18 years, most frequently injection site pain (90%), fatigue (67%), and fever (59%).
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