Alzarea Abdulaziz Ibrahim, Khan Yusra Habib, Alatawi Ahmed D, Alanazi Abdullah Salah, Alzarea Sami I, Butt Muhammad Hammad, Almalki Ziyad Saeed, Alahmari Abdullah K, Mallhi Tauqeer Hussain
Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi Arabia.
Health Sciences Research Unit, Jouf University, Sakaka 72388, Saudi Arabia.
Vaccines (Basel). 2022 Jun 10;10(6):924. doi: 10.3390/vaccines10060924.
Vaccines are considered to be the most beneficial means for combating the COVID-19 pandemic. Although vaccines against SARS-CoV-2 have demonstrated excellent safety profiles in clinical trials, real-world surveillance of post-vaccination side effects is an impetus. The study investigates the short-term side effects following the administration of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines in Saudi Arabia. A cross-sectional quantitative study was conducted among the general population with age ≥ 18 years, from five regions (Central, Northern, Eastern, Southern, and Western Regions) of Saudi Arabia for a period of 6 months (July to December 2021). A self-administered study instrument was used to record the side effects among the COVID-19 vaccine recipients. Of the total 398 participants (males: 59%), 56.3% received Pfizer and 43.7% were vaccinated with AstraZeneca. Only 22.6% of respondents received the second dose of the COVID-19 vaccines. The most commonly reported side effects were pain at the injection site (85.2%), fatigue (61.8%), bone or joint pain (54.0%), and fever (42.5%). The average side effects score was 3.4 ± 2.2. Females, young people, and Oxford-AstraZeneca recipients had a higher proportion of side effects. The Oxford-AstraZeneca vaccine recipients complained more about fever (p < 0.001), bone and joint pain (p < 0.001), fatigue (p < 0.001), loss of appetite (p = 0.001), headache (p = 0.008), and drowsiness (p = 0.003). The Pfizer-BioNTech vaccinees had more pain and swelling at the injection site (p = 0.001), and sexual disturbance (p = 0.019). The study participants also reported some rare symptoms (<10%) including heaviness, sleep disturbance, fainting, blurred vision, palpitations, osteomalacia, and inability to concentrate. This study revealed that both Pfizer-BioNTech and Oxford-AstraZeneca administration was associated with mild to moderate, transient, short-lived side effects. These symptoms corroborate the results of phase 3 clinical trials of these vaccines. The results could be used to inform people about the likelihood of side effects based on their demographics and the type of vaccine administered. The study reported some rare symptoms that require further validation through more pharmacovigilance or qualitative studies.
疫苗被认为是抗击新冠疫情最有益的手段。尽管针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的疫苗在临床试验中已显示出优异的安全性，但对疫苗接种后副作用进行现实世界监测很有必要。本研究调查了在沙特阿拉伯接种辉瑞-生物新技术公司（Pfizer-BioNTech）和牛津-阿斯利康（Oxford-AstraZeneca）疫苗后的短期副作用。对沙特阿拉伯五个地区（中部、北部、东部、南部和西部地区）年龄≥18岁的普通人群进行了一项为期6个月（2021年7月至12月）的横断面定量研究。使用自行填写的研究工具记录新冠疫苗接种者的副作用情况。在总共398名参与者中（男性占59%），56.3%接种了辉瑞疫苗，43.7%接种了阿斯利康疫苗。只有22.6%的受访者接种了第二剂新冠疫苗。最常报告的副作用是注射部位疼痛（85.2%）、疲劳（61.8%）、骨骼或关节疼痛（54.0%）以及发热（42.5%）。平均副作用评分为3.4±2.2。女性、年轻人以及接种牛津-阿斯利康疫苗的人副作用比例更高。接种牛津-阿斯利康疫苗的人更多抱怨发热（p<0.001）、骨骼和关节疼痛（p<0.001）、疲劳（p<0.001）、食欲不振（p = 0.001）、头痛（p = 0.008）和嗜睡（p = 0.003）。接种辉瑞-生物新技术公司疫苗的人注射部位疼痛和肿胀更多（p = 0.001），以及有性功能障碍（p = 0.019）。研究参与者还报告了一些罕见症状（<10%），包括身体沉重、睡眠障碍、昏厥、视力模糊、心悸、骨软化症和注意力不集中。本研究表明，接种辉瑞-生物新技术公司和牛津-阿斯利康疫苗均会出现轻至中度、短暂、短期的副作用。这些症状证实了这些疫苗3期临床试验的结果。研究结果可用于让人们了解基于其人口统计学特征和所接种疫苗类型出现副作用的可能性。该研究报告了一些罕见症状，需要通过更多的药物警戒或定性研究进行进一步验证。
