Adverse Effects of Pfizer (BioNTech), Oxford-AstraZeneca (ChAdOx1 CoV-19), and Moderna COVID-19 Vaccines among the Adult Population in Saudi Arabia: A Cross-Sectional Study
Abstract
:1. Introduction
2. Subjects and Methods
2.1. Study Design and Settings
2.2. Study Participants
2.3. Inclusion and Exclusion Criteria
2.4. Sample Size Calculation
2.5. Study Questionnaire Development
2.6. Ethical Statement
2.7. Statistical Analysis
3. Results
3.1. Demographics
3.2. Adverse Effects of COVID-19 Vaccinations
3.3. Severity of Symptoms According to the Type of COVID-19 Vaccines
4. Discussion
5. Strength and Limitations
6. Conclusions
7. Study Implications
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
- Meo, S.A.; Al-Khlaiwi, T.; Usmani, A.M.; Meo, A.S.; Klonoff, D.C.; Hoang, T.D. Biological and epidemiological trends in the prevalence and mortality due to outbreaks of novel coronavirus COVID-19. J. King Saud. Univ. Sci. 2020, 32, 2495–2499. [Google Scholar] [CrossRef] [PubMed]
- World Health Organization. WHO Coronavirus (COVID-19) Dashboard. Available online: https://covid19.who.int/ (accessed on 26 December 2022).
- Da Rosa Mesquita, R.; Francelino Silva Junior, L.C.; Santos Santana, F.M.; Farias de Oliveira, T.; Campos Alcântara, R.; Monteiro Arnozo, G.; Rodrigues da Silva Filho, E.; Galdino Dos Santos, A.G.; Oliveira da Cunha, E.J.; Salgueiro de Aquino, S.H.; et al. Clinical manifestations of COVID-19 in the general population: Systematic review. Wien. Klin. Wochenschr. 2021, 133, 377–382. [Google Scholar] [CrossRef] [PubMed]
- Cazzolla, A.P.; Lovero, R.; Lo Muzio, L.; Testa, N.F.; Schirinzi, A.; Palmieri, G.; Pozzessere, P.; Procacci, V.; Di Comite, M.; Ciavarella, D.; et al. Taste and Smell Disorders in COVID-19 Patients: Role of Interleukin-6. ACS Chem Neurosci. 2020, 11, 2774–2781. [Google Scholar] [CrossRef]
- World Health Organization (WHO). Interim Recommendations for Use of the Inactivated COVID-19 Vaccine BIBP Developed by China National Biotec Group (CNBG), Sinopharm: Interim Guidance, First Issued the 7th of May 2021, Updated the 28th of October 2021, Updated the 15th of March 2022; World Health Organization: Geneva, Switzerland, 2022.
- Voysey, M.; Clemens, S.A.C.; Madhi, S.A.; Weckx, L.Y.; Folegatti, P.M.; Aley, P.K.; Angus, B.; Baillie, V.; Barnabas, S.; Bhorat, Q.; et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: An interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021, 397, 99–111. [Google Scholar] [CrossRef] [PubMed]
- Esba, L.C.A.; Al Jeraisy, M. Reported adverse effects following COVID-19 vaccination at a tertiary care hospital, focus on cerebral venous sinus thrombosis (CVST). Expert Rev. Vaccines 2021, 20, 1037–1042.9. [Google Scholar] [CrossRef] [PubMed]
- Saudi Food and Drug Authority. Available online: https://sfda.gov.sa/en/news/79059 (accessed on 12 November 2022).
- Al Bahrani, S.; Albarrak, A.; Alghamdi, O.A.; Alghamdi, M.A.; Hakami, F.H.; Al Abaadi, A.K.; Alkhrashi, S.; Alghamdi, M.; Almershad, M.; Alenazi, M.M.; et al. Safety and reactogenicity of the ChAdOx1 (AZD1222) COVID-19 vaccine in Saudi Arabia. Int. J. Infect. Dis. 2021, 110, 359–362. [Google Scholar] [CrossRef]
- Alghamdi, A.N.; Alotaibi, M.I.; Alqahtani, A.S.; Al Aboud, D.; Abdel-Moneim, A.S. BNT162b2 and ChAdOx1 SARS-CoV-2 post-vaccination side-effects among Saudi vaccinees. Front. Med. 2021, 2021, 1796. [Google Scholar] [CrossRef]
- Alghamdi, A.; Ibrahim, A.; Alraey, M.; Alkazemi, A.; Alghamdi, I.; Alwarafi, G. Side effects following COVID-19 vaccination: A cross-sectional survey with age-related outcomes in Saudi Arabia. J. Adv. Pharm. Educ. Res. 2021, 11, 119–125. [Google Scholar] [CrossRef]
- Meo, A.S.; Masood, A.; Shabbir, U.; Ali, H.; Nadeem, Z.; Meo, S.A.; Alshahrani, A.N.; AlAnazi, S.; Al-Masri, A.A.; Al-Khlaiwi, T. Adverse Effects of Sinopharm COVID-19 Vaccine among Vaccinated Medical Students and Health Care Workers. Vaccines 2023, 11, 105. [Google Scholar] [CrossRef]
- Centers for Disease Control and Prevention (CDC). Possible Side Effects After Getting a COVID-19 Vaccine. Available online: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html (accessed on 21 December 2022).
- Darraj, M.A.; Al-Mekhlafi, H.M. Prospective Evaluation of Side-Effects Following the First Dose of Oxford/AstraZeneca COVID-19 Vaccine among Healthcare Workers in Saudi Arabia. Vaccines 2022, 10, 223. [Google Scholar] [CrossRef]
- Raosoft Sample sie Calculator. Available online: http://www.raosoft.com/samplesize.html (accessed on 12 October 2022).
- Adam, M.; Gameraddin, M.; Alelyani, M.; Alshahrani, M.Y.; Gareeballah, A.; Ahmad, I.; Azzawi, A.; Komit, B.; Musa, A. Evaluation of Post-Vaccination Symptoms of Two Common COVID-19 Vaccines Used in Abha, Aseer Region, Kingdom of Saudi Arabia. Patient Prefer. Adherence 2021, 15, 1963–1970. [Google Scholar] [CrossRef]
- Kurdee, Z.; Al-Shouli, S.; AlAfaleq, N.; Meo, S.A.; Alshahrani, A.; Alshehri, A.; Alkathiri, N.; Bin Saiedan, S.; Alzahrani, Y. Public Perception towards the COVID-19 Vaccine in Riyadh, Saudi Arabia. Vaccines 2022, 10, 867. [Google Scholar] [CrossRef]
- El Zowalaty, M.E.; Järhult, J.D. From SARS to COVID-19: A previously unknown SARS-related coronavirus (SARS-CoV-2) of pandemic potential infecting humans–Call for a One Health approach. One Health 2020, 9, 100124. [Google Scholar] [CrossRef]
- Veiga, V.C.; Prats, J.A.G.G.; Farias, D.L.C.; Rosa, R.G.; Dourado, L.K.; Zampieri, F.G.; Machado, F.R.; Lopes, R.D.; Berwanger, O.; Azevedo, L.C.P.; et al. Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: Randomised controlled trial. BMJ 2021, 372, n84. [Google Scholar] [CrossRef]
- Alamer, E.; Alhazmi, A.; Qasir, N.A.; Alamer, R.; Areeshi, H.; Gohal, G.; Qadri, M.; Hashem, A.; Algaissi, A. Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia. Vaccines 2021, 9, 1297. [Google Scholar] [CrossRef]
- Andrzejczak-Grządko, S.; Czudy, Z.; Donderska, M. Side effects after COVID-19 vaccinations among residents of Poland. Eur. Rev. Med. Pharmacol. Sci. 2021, 25, 4418–4421. [Google Scholar]
- Beattie, M.; Murphy, D.J.; Atherton, I.; Lauder, W. Instruments to measure patient experience of healthcare quality in hospitals: A systematic review. Syst. Rev. 2015, 4, 1–21. [Google Scholar] [CrossRef] [Green Version]
- Zhu, F.-C.; Li, Y.-H.; Guan, X.-H.; Hou, L.-H.; Wang, W.-J.; Li, J.-X.; Wu, S.-P.; Wang, B.-S.; Wang, Z.; Wang, L.; et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: A dose-escalation, open-label, non-randomised, first-in-human trial. Lancet 2020, 395, 1845–1854. [Google Scholar] [CrossRef]
- Julianne, G.; Marquez, P.; Su, J.; Calvert, G.; Liu, R.; Myers, T.; Nair, N.; Martin, S.; Clark, T.; Markowitz, L.; et al. First month of COVID-19 vaccine safety monitoring-United States. US Dep. Health Hum. Serv. Dis. Control Prev. 2021, 70, 283–888. [Google Scholar]
- Alhazmi, A.; Alamer, E.; Daws, D.; Hakami, M.; Darraj, M.; Abdelwahab, S.; Maghfuri, A.; Algaissi, A. Evaluation of Side Effects Associated with COVID-19 Vaccines in Saudi Arabia. Vaccines 2021, 9, 674. [Google Scholar] [CrossRef]
- Swan, D.A.; Bracis, C.; Janes, H.; Moore, M.; Matrajt, L.; Reeves, D.B.; Burns, E.; Donnell, D.; Cohen, M.S.; Schiffer, J.T.; et al. COVID-19 vaccines that reduce symptoms but do not block infection need higher coverage and faster rollout to achieve population impact. Sci. Rep. 2021, 11, 1–9. [Google Scholar] [CrossRef]
- Rosenblum, H.G.; Gee, J.; Liu, R.; Marquez, P.L.; Zhang, B.; Strid, P.; Abara, W.E.; McNeil, M.M.; Myers, T.R.; Hause, A.M.; et al. Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: An observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. Lancet Infect. Dis. 2022, 22, 802–812. [Google Scholar] [CrossRef]
- Barda, N.; Dagan, N.; Ben-Shlomo, Y.; Kepten, E.; Waxman, J.; Ohana, R.; Hernán, M.A.; Lipsitch, M.; Kohane, I.; Netzer, D.; et al. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N. Engl. J. Med. 2021, 385, 1078–1090. [Google Scholar] [CrossRef]
- Thomas, S.J.; Moreira, E.D., Jr.; Kitchin, N.; Absalon, J.; Gurtman, A.; Lockhart, S.; Perez, J.L.; Pérez Marc, G.; Polack, F.P.; Zerbini, C.; et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N. Engl. J. Med. 2021, 385, 1761–1773. [Google Scholar] [CrossRef]
Variables | Frequency | Percent (%) |
---|---|---|
Gender Male Female | 149 277 | 35 65 |
Age groups (years) 18–25 26–30 31–40 41–60 >60 | 113 43 93 149 28 | 26.5 10.1 21.8 35.0 6.6 |
Nationality Saudi Non-Saudi | 401 25 | 94.1 5.9 |
Education Student higher secondary, undergraduate, and graduate Self employed Employed (government, private etc.) | 226 91 109 | 53.1 21.4 25.6 |
Smoking History Smokers Non-smokers | 64 362 | 15 85 |
Health status History of any chronic disease No history of any chronic disease | 95 331 | 22.3 77.7 |
Parameters | First Doses Frequency (%) | Second Doses Frequency (%) | Third Doses Frequency (%) |
---|---|---|---|
Type of vaccine: Pfizer-BioNTech AstraZeneca (ChAdOx1) Moderna | 333 (78.2%) 86 (20.2%) 7 (1.1%) | 341 (80%) 68 (16%) 17 (4%) | 339(79.6%) 19 (4.5%) 68 (16%) |
Common adverse effects after vaccine: Feeling tired and headache Pain at the injection site Muscle and joint pain and feeling unwell Temperature and body shivering Dizziness Menstrual disorder No sides effect | 187 (43.9%) 258 (60.6%) 138 (32.4%) 103 (24.2%) 54 (12.7%) 51 (12%) 82 (19.2%) | 180 (42.3%) 238 (55.9%) 125 (29.3%) 101 (23.7%) 45 (10.6%) 41 (9.6%) 121 (28.4%) | 155 (36.4%) 209 (49.1%) 106 (24.9%) 85 (20%) 44 (10.3%) 36 (8.5%) 152 (35.7%) |
Feeling side effects after the vaccination First day Second day Third day No symptoms | 147 (34.5%) 167 (39.2%) 11 (2.6%) 101 (23.7%) | 143 (33.6%) 138 (32.4%) 11 (2.6%) 134 (31.5%) | 136 (31.9%) 107 (25.1%) 8 (1.9%) 175 (41.1%) |
The severity of the side effects Mild Moderate Sever No symptoms | 102 (23.9%) 172 (40.4%) 55 (12.9%) 97 (22.8%) | 88 (20.7%) 157 (36.9%) 55 (12.9%) 126 (29.6%) | 82 (19.2%) 125 (29.3%) 59 (13.8%) 160 (37.6%) |
How long adverse effect last after vaccination One-two days Three days Four or more No symptoms | 210 (49.3%) 78 (20.4%) 36 (8.5%) 93 (21.8%) | 195 (45.8%) 64 (15%) 38 (8.9%) 129 (30.3%) | 158 (37.1%) 65 (15.3%) 37 (8.7%) 166 (39%) |
Take medications Got any medication to reduce the severity of the side effects No taking medicine to reduce the severity of the side effects | 40 (9.4%) 386 (90.6%) | 222 (52.1%) 204 (47.9%) | 139 (45.3%) 233 (54.7%) |
Low Side Effect | First Doses Frequency (%) | Second Doses Frequency (%) | Third Doses Frequency (%) |
---|---|---|---|
Vomiting | 11 (2.6%) | 5 (1.2%) | 3 (0.7%) |
Breathing congestion | 7 (1.6%) | 5 (1.2%) | 11 (2.6%) |
Skin itching or rash | 18 (4.2%) | 15 (3.5%) | 10 (2.3%) |
Drop-sugar level | 4 (0.9%) | 2 (0.5%) | 2 (0.5%) |
Independent Samples t-Test | ||||||
---|---|---|---|---|---|---|
Severity of Adverse Effects | Gender | N | Mean | Std. Deviation | T | p Value |
Severity of the side effects after the first dose | Male | 149 | 1.18 | 0.966 | −3.974 | 0.000 |
Female | 277 | 1.57 | 0.963 | |||
Severity of the side effects after the second dose | Male | 149 | 1.08 | 1.017 | −3.713 | 0.000 |
Female | 277 | 1.47 | 1.023 | |||
Severity of the side effects after the third dose | Male | 149 | 0.96 | 1.006 | −3.406 | 0.000 |
Female | 277 | 1.32 | 1.114 |
Tests of Normality | |||||||
---|---|---|---|---|---|---|---|
Severity of Adverse Effects | Type of the Vaccine | Kolmogorov-Smirnov | Shapiro-Wilk | ||||
Statistic | df | Sig. | Statistic | df | Sig. | ||
Severity of the side effects after the first dose | Pfizer | 0.246 | 333 | 0.000 | 0.858 | 333 | 0.000 |
AstraZeneca Oxford (ChAdOx1) | 0.272 | 86 | 0.000 | 0.835 | 86 | 0.000 | |
Moderna | 0.357 | 7 | 0.007 | 0.787 | 7 | 0.030 | |
Severity of the side effects after the second dose | Pfizer | 0.239 | 341 | 0.000 | 0.852 | 341 | 0.000 |
AstraZeneca Oxford (ChAdOx1) | 0.267 | 68 | 0.000 | 0.822 | 68 | 0.000 | |
Moderna | 0.229 | 17 | 0.018 | 0.858 | 17 | 0.014 | |
Severity of the side effects after the third dose | Pfizer | 0.232 | 339 | 0.000 | 0.838 | 339 | 0.000 |
AstraZeneca Oxford (ChAdOx1) | 0.304 | 19 | 0.000 | 0.783 | 19 | 0.001 | |
Moderna | 0.270 | 68 | 0.000 | 0.799 | 68 | 0.000 |
Severity of Adverse Effects | Type of the Vaccine | N | Mean Rank | Z | p-Value |
---|---|---|---|---|---|
Severity of the side effects after the first dose | Pfizer-BioNTech | 333 | 198.36 | 25.597 | 0.001 |
AstraZeneca Oxford (ChAdOx1) | 86 | 266.38 | |||
Moderna | 7 | 284.14 | |||
Total | 426 | ||||
Severity of the side effects after the second dose | Pfizer-BioNTech | 341 | 213.87 | 1.257 | 0.533 |
AstraZeneca Oxford (ChAdOx1) | 68 | 204.91 | |||
Moderna | 17 | 240.44 | |||
Total | 426 | ||||
Severity of the side effects after the third dose | Pfizer-BioNTech | 339 | 213.15 | 0.018 | 0.991 |
AstraZeneca Oxford (ChAdOx1) | 19 | 216.24 | |||
Moderna | 68 | 214.50 | |||
Total | 426 |
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Aldali, J.; Meo, S.A.; Al-Khlaiwi, T. Adverse Effects of Pfizer (BioNTech), Oxford-AstraZeneca (ChAdOx1 CoV-19), and Moderna COVID-19 Vaccines among the Adult Population in Saudi Arabia: A Cross-Sectional Study. Vaccines 2023, 11, 231. https://doi.org/10.3390/vaccines11020231
Aldali J, Meo SA, Al-Khlaiwi T. Adverse Effects of Pfizer (BioNTech), Oxford-AstraZeneca (ChAdOx1 CoV-19), and Moderna COVID-19 Vaccines among the Adult Population in Saudi Arabia: A Cross-Sectional Study. Vaccines. 2023; 11(2):231. https://doi.org/10.3390/vaccines11020231
Chicago/Turabian StyleAldali, Jehad, Sultan Ayoub Meo, and Thamir Al-Khlaiwi. 2023. "Adverse Effects of Pfizer (BioNTech), Oxford-AstraZeneca (ChAdOx1 CoV-19), and Moderna COVID-19 Vaccines among the Adult Population in Saudi Arabia: A Cross-Sectional Study" Vaccines 11, no. 2: 231. https://doi.org/10.3390/vaccines11020231
APA StyleAldali, J., Meo, S. A., & Al-Khlaiwi, T. (2023). Adverse Effects of Pfizer (BioNTech), Oxford-AstraZeneca (ChAdOx1 CoV-19), and Moderna COVID-19 Vaccines among the Adult Population in Saudi Arabia: A Cross-Sectional Study. Vaccines, 11(2), 231. https://doi.org/10.3390/vaccines11020231