Global safety studies on vaccine reactogenicity have shown that the mRNA COVID-19 vaccine recipients have reported injection site or local reactions more frequently than systemic reactions and serious adverse events were rare ( 11, 12). Similarly, AstraZeneca and Sputnik vaccine trials have also reported only mild/moderate side effects ( 9, 10).
COVID VACCINE SIDE EFFECT TIME TRIAL
The Pfizer-BioNTech mRNA vaccine trial has reported that the most common adverse effect was mild to moderate fatigue and headache ( 8). In the Sinopharm inactivated vaccine trial, the most common adverse reaction observed was injection site pain followed by fever and all the adverse reactions reported were mild and self-limiting and did not require any treatment ( 7). Data published from the vaccine trials have demonstrated that the adverse effects of the COVID-19 vaccine most commonly include fever, fatigue, muscle pain, joint pain, and headache and serious adverse events were rarely reported ( 7– 10). The worldwide vaccination coverage for COVID-19 vaccination is still low and as of 24 November 2021, only 42% of the world population have received initial two doses of COVID-19 vaccination ( 6). Apart from Sinopharm, the UAE government has also approved mRNA Pfizer-BioNTech, adenovirus-based AstraZeneca, and Sputnik V and other vaccines and made them accessible for all people in the UAE. Since then, vigorous vaccination of the population was undertaken and the UAE tops the world in the vaccine distribution rate per 100 people ( 4)and has effectively vaccinated more than 90% of the population so far ( 5). The United Arab Emirates (UAE) government had successfully completed the vaccination trial for the BBIBP-CorV or Sinopharm vaccine which was approved for general public in December 2020 ( 3).
Many of these vaccines obtained emergency approval and governments around the world started vaccination campaigns against COVID-19 ( 1, 2). In the world's fight against the COVID-19 pandemic, vaccines emerged as the greatest savior for humankind and many vaccine candidates were developed and entered clinical trials in early 2020. The study found that individuals less than 55 years of age, female gender, with history of one or more comorbid conditions, who had received mRNA Pfizer- BioNTech vaccine, and with history of COVID-19 infections are at higher odds of developing an adverse effect post COVID-19 vaccination compared to the others. Severe adverse effects after COVID-19 vaccinations were rare and 95% of the adverse effects reported after either an inactivated or mRNA vaccine were mild requiring no or home-based treatment. The average number of adverse effects reported between individuals who had received Sinopharm and Pfizer-BioNTech vaccines was 1.61 ± 2.08 and 2.20 ± 2.58, respectively, and the difference was statistically significant ( p <0.001). The adverse effects were more common among recipients of mRNA Pfizer-BioNTech vaccine than among recipients of inactive Sinopharm vaccine with the odds ratio of 1.39 (95% CI 1.14–1.68).
The major adverse effects reported by the COVID-19 vaccine recipients were pain at the site of injection, fatigue and drowsiness, and headache followed by joint/muscle pain. Differences in adverse events and the severity were compared between inactivated and mRNA vaccine recipients. The factors potentially associated with the reported side effects like age, gender, ethnicity, comorbidities, and previous COVID-19 infection were analyzed based on the type of vaccine received. A survey was conducted among 1,878 adult (≥18 years) COVID-19 vaccine recipients through online survey platforms and telephonic interviews during March to September 2021. Therefore, we aim to investigate the nature and severity of the adverse effects reported and the differences based on the type of vaccine received. 6College of Medicine and Health Sciences, UAE University, Abu Dhabi, United Arab EmiratesĬOVID-19 vaccines have proven to be very safe in the clinical trials, however, there is less evidence comparing the safety of these vaccines in real-world settings.5Ambulatory Healthcare Services, SEHA, Abu Dhabi, United Arab Emirates.4College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates.3Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates.2Insights Research Organization and Solutions, Abu Dhabi, United Arab Emirates.1G42 Healthcare, Abu Dhabi, United Arab Emirates.Subhashini Ganesan 1,2 * † Latifa Mohammad Baynouna Al Ketbi 3 † Nawal Al Kaabi 3,4 Mohammed Al Mansoori 5 Noura Nasser Al Maskari 5 Mariam Saif Al Shamsi 5 Aysha Saeed Alderei 5 Hamada Nasser El Eissaee 5 Rudina Mubarak Al Ketbi 5 Noura Saeed Al Shamsi 5 Khuloud Mohammed Saleh 5 Aysha Fahad Al Blooshi 5 Flavia Martinez Cantarutti 1 Katherine Warren 1 Faheem Ahamed 1 Walid Zaher 1,2,4,6
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