Association Between Pfizer COVID-19 Vaccine Adverse Effects and Diabetes Mellitus: A Prospective Multicenter Study

Abstract

Introduction The epidemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) triggered the contagion of coronavirus disease 2019 (COVID-19), which killed many individuals globally. The Pfizer BioNTech vaccine was the first messenger ribonucleic acid (mRNA)-based vaccine that boosted immunity against various adverse reactions. The objective of this study was to evaluate the frequency of Pfizer vaccine side effects among participants with and without diabetes mellitus (DM). Methods This multicenter study was cross-sectional and was performed using a non-probability consecutive sampling technique. The study duration was six months, from October 1, 2022, to March 31, 2023. A total of 750 participants who received both doses of the Pfizer vaccine were included in the study. Demographic details such as gender, age, comorbidities, preceding COVID-19 infection, and the occurrence of any local and systemic side effects of the first and second doses of vaccine were recorded. The association between local and general side effects and the presence of DM was assessed using the chi-square test. Results Of the 750 participants included in the study, 289 (77.1%) were males with diabetes mellitus (DM), and 217 (57.9%) were non-diabetic participants; however, 86 (22.9%) females had DM, and 158 (42.1%) were non-diabetic; their mean ages were 48.23 ± 16.22 and 37.56 ± 12.15 years, respectively. The most commonly occurring side effects after receiving the first dose of the Pfizer vaccine were: injection site burning in 251 (66.9%) diabetic and 254 (67.7%) non-diabetic participants. Likewise, the frequency of side effects of the second dose of the Pfizer vaccine showed that the most commonly reported side effects were: muscle pain, found in 240 (64.0%) diabetic patients and 194 (51.7%) non-diabetics, with a statistically significant association (p =0.001). Conclusion This study concluded that participants with DM had local and general adverse effects considerably more frequently than those without DM. The most frequently observed adverse effects in both diabetic and non-diabetic participants were injection site burning, rashes, muscle pain, and fever after receiving both doses of the Pfizer vaccine. Moreover, most of the side effects were minor.