ABSTRACT
BACKGROUND: Multiple vaccines have been tested in clinical trials for their efficacy and safety. In Saudi Arabia, Pfizer-BioNTech or Moderna were approved for children, however, previous studies to report their safety profile are limited. This research aims to understand the side effect of children's vaccination against SARS-CoV-2 infection in Saudi Arabia. METHODS: This was an observational retrospective cross-sectional study was conducted using an online survey in Saudi Arabia from March to May 2022. The inclusion criteria were parents aged 18 years and above who live in Saudi Arabia and have vaccinated their children. The self-reported questionnaire was adopted from published studies to investigate the study objectives Descriptive statistics were used to describe patients' demographic characteristics, continuous data were reported as mean ± S.D., categorical data were reported as percentages (frequencies), and logistic regression was used to identify predictors of persistent post-COVID-19 symptoms. RESULTS: This study had a total of 4,069 participants. Only 41.9% of the participants reported that their child(ren) had been infected with the coronavirus. 2.00 was the median number of children (IQR: 1.00-4.00). More than half of the study participants (64.2%) reported that a family member had been infected with the coronavirus. Both parents received COVID-19 vaccination, according to most participants (88.7%). Most participants (70.5%) stated that all children who met the vaccination criteria had received the vaccine. Most participants (83.5%) said their child or children had two doses of their vaccine, and about half (50.4%) of those who received the vaccine reported experiencing side effects. In addition, the majority (78.9%) reported that the side effects appeared within one day of receiving the vaccine, and nearly two-thirds (65.7%) reported that the side effects lasted between one and three. A total of 11,831 side effects cases were documented. Pain at the injection site, hyperthermia, and fatigue were the most reported side effects, accounting for 15.3%, 14.1%, and 13.2%, respectively. CONCLUSION: It appears that the side effects of the COVID-19 vaccine for children are minor, tolerable, and like those described previously in clinical trials. Our data should encourage the public about the safety of receiving the COVID-19 vaccine for children.