Background
Less than a year after the WHO announced a COVID-19 pandemic, the Pfizer-BioNTech was the first mRNA vaccine to be approved for mass use. However, vaccine hesitancy is still a major hinderance to its propagation, especially novel approaches. This study aimed to analyse reported side effects in a community setting as ongoing monitoring and analysis of vaccine acceptance, safety, and efficacy is essential for evaluation and reassurance.
Methods
This study is based on secondary analysis of data obtained from the Jordan Ministry of Health database for the National Vaccine Adverse Event Reporting System (NVAERS) from January to May 2021. Only those who received both doses of the vaccine were included in the study. Differences across categories were examined using Chi square testing.
Results
total of 1,874 individuals had received both doses of the vaccine. The mean age was 68 years with a 2:1 male to female ratio, and 73% of individuals had comorbidities. About one third (32%) of recipients reported adverse events after the first dose, 45.7% after the second, and 24.4% after both. Most common was pain at injection site (32%), fatigue (16%), and headache (8%), followed by fever, myalgia, and arthralgia. The 1.5 increase in reported adverse events was mostly for systemic side effects. Significantly more females than males reported adverse events, while those with comorbidities reported comparatively fewer side effects (52.2%) than the medically free (59%). Furthermore, 72.5% of recipients aged 55 years or younger reported side effects compared to 50% of older recipients. Severe side effects were rare and self-limiting, and no anaphylaxis or death was reported.
Conclusion
The Pfizer-BioNTech vaccine is well-tolerated among vulnerable recipients with comorbidities. Additionally, the NVAERS could be a valuable research and surveillance tool due to the similarity of these findings with results of international clinical trials.