COVID-19 vaccine safety and side effects in children aged 5-11 years: a cross-sectional study

INTRODUCTION: The COVID-19 pandemic has prompted a global drive for vaccination, including children. Despite the urgency, understanding the safety and side effects remains crucial. Our study aimed to evaluate the safety of the Pfizer- BioNTech (BNT162b2) vaccine in children by determining the proportion of vaccinated children who experienced side effects and identifying factors associated with postvaccination side effects.

MATERIALS AND METHODS: A cross-sectional study was conducted among children who received the COVID-19 vaccine between 3 February and 8 May 2022. Data were collected using a self-administered questionnaire filled out by the parent or legal guardian.

RESULTS: The mean age of the study participants was 9 years old and 43.1% were males. Out of the 195 participants in the study, 62 (31.8%) reported side effects after vaccination. The most frequently reported side effects were pain at the injection site (29.7%, n=58), fever (15.9%, n=31), localised inflammation (10.8%, n=21) and arthralgia/myalgia (9.2%, n=18). There were no reported severe adverse events such as anaphylaxis or myocarditis. Most side effects occurred within the first two days post-vaccination. There was a higher proportion of side effects among children with underlying co-morbidities. No significant differences were observed based on age, weight, ethnicity and the presence of allergies, or the use of premedication.

CONCLUSION: The BNT162b2 vaccine was generally welltolerated in children, with most side effects being mild and self-limiting. These findings support the safety of the COVID-19 vaccine and would guide healthcare professionals, parents and policy-makers in making informed decisions about COVID-19 vaccination, especially among high-risk groups.