Adverse drug reactions from two COVID-19 vaccines reported in Saudi Arabia

Abstract

Background Several reports have been published about the impact of coronavirus disease 2019 (COVID-19) vaccines on human health, and each vaccine has a different safety and efficacy profile. The aim of this study was to reveal the nature and classification of reported adverse drug reactions (ADRs) of the two COVID-19 vaccines (tozinameran and ChAdOx1) among citizens and residents living in Saudi Arabia, and show possible differences between the two vaccines and the differences between each batch on the health of populations. Methods A cross-sectional study was conducted in Saudi Arabia between December 2020 and March 2021. Saudi citizens and residents aged ≥ 16 years who had at least one dose of any batch of either of the two approved COVID-19 vaccines (tozinameran and ChAdOx1) and who reported at least one ADR from the vaccines were included. The study excluded people who reported ADRs after receiving tozinameran or ChAdOx1 vaccines but no information was provided about the vaccine’s batch number. Results During the study period, 12,868 vaccinated people, including a high-risk group (i.e., those with chronic illness or pregnant women), reported COVID-19 vaccine ADRs that had been documented in the General Directorate of Medical Consultations, Saudi Ministry of Health. The study reported several ADRs associated with COVID-19 vaccines, with the most common (> 25%) being fever/chills, general pain/weakness, headache, and injection site reactions. Among healthy and high-risk people, the median onset of all reported ADRs for tozinameran and ChAdOx1 vaccine batches were 1.96 and 1.64 days, respectively ( p < 0.01). Furthermore, significant differences ( p < 0.05) were recorded between the two studied vaccines in regard to fever/chills, gastrointestinal symptoms, headache, general pain/weakness, and neurological symptoms, with higher incidence rates of these ADRs observed with the ChAdOx1 vaccine than the tozinameran vaccine. However, the tozinameran vaccine was found to cause significantly ( p < 0.05) more palpitation, blood pressure variations, upper respiratory tract symptoms, lymph node swelling, and other unspecified ADRs than the ChAdOx1 vaccine. Among patients vaccinated with seven different batches of the tozinameran vaccine, people vaccinated with the T4 and T5 batches reported the most ADRs. Conclusion There were significant differences regarding most of the reported ADRs and their onset among tozinameran and ChAdOx1 vaccines on both healthy people and high-risk individuals living in Saudi Arabia. Moreover, the study found that the frequencies of most listed ADRs were statistically different when seven batches of tozinameran vaccine were compared.

Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile

“…The fatigue and fever symptoms were found to be associated with Oxford-AstraZeneca administration and these results are aligned with other studies [12,14,15,17]. Our analysis revealed a high proportion of side effects among AstraZeneca recipients, and these findings are consistent with previous investigations [12,14].…”

“…In this context, surveillance of vaccine safety is of paramount importance to mitigate the fear of vaccinations among the masses. On the other hand, the real-world data (RWD) on pharmacovigilance of the COVID-19 vaccine in Saudi Arabia are primarily based on the reporting from healthcare professionals [12], adolescents [13], the general population [14][15][16], and recipients of one type of vaccine [17,18]. This study aimed to investigate the short-term side effects of the administration of the COVID-19 vaccine doses among the general population in Saudi Arabia.…”

Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management

“…A study conducted in Saudi Arabia which included 7768 Vaxzevria vaccinees and 5100 receiving Comirnaty, no case of anaphylaxis was reported. However, authors reported that mild/ moderate allergic reactions occurred at a frequency of 4.5% for the Vaxzevria vaccine and 7.2% for Comirnaty [22].…”

Evaluation of health care professionals’ knowledge, attitudes, practices and barriers to pharmacovigilance and adverse drug reaction reporting: A cross-sectional multicentral study

“…must be reported. ADRs related to herbal and traditional medications [ 66 , 67 ], cosmetics [ 34 , 68 ], vaccines [ 69 , 70 ], newly approved drugs [ 71 ], and unknown ADRs to old drugs [ 72 , 73 ] are well recognized. However, only 51% of HCPs considered the mandatory reporting of all ADRs.…”