PMID- 36908451 OWN - NLM STAT- MEDLINE DCOM- 20230314 LR - 20230327 IS - 2296-2565 (Electronic) IS - 2296-2565 (Linking) VI - 11 DP - 2023 TI - Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study. PG - 1043696 LID - 10.3389/fpubh.2023.1043696 [doi] LID - 1043696 AB - BACKGROUND: Vaccination against coronavirus disease 2019 (COVID-19) is the most effective way to end the pandemic. Any development of adverse events (AEs) from various vaccines should be reported. We therefore aimed to explore major and minor AEs among vaccinated individuals in Saudi Arabia. METHODS: This is a nationwide report based on the Saudi Arabian Ministry of Health (MOH) registry. It included those who received COVID-19 vaccines from 17th December 2020 to 31st December 2021. The study included spontaneous self-reported adverse effects to COVID-19 vaccines where the study participants used a governmental mobile app (Sehhaty) to report their AEs following vaccination using a checklist option that included a selection of side-effects. The primary outcome was to determine AEs reported within 14 days of vaccination which included injection site itching, pain, reaction, redness, swelling, anxiety, dizziness, fever, headache, hoarseness, itchiness, loss of consciousness, nausea, heartburn, sleep disruption, fatigue, seizures, anaphylaxis, shortness of breath, wheezing, swelling of lips, face, and throat, loss of consciousness, and admissions into the intensive care unit (ICU). RESULTS: The study included a total number of 28,031 individuals who reported 71,480 adverse events (AEs); which were further classified into minor and major adverse events including ICU admissions post vaccination. Of the reported AEs, 38,309 (53. 6%) side-effects were reported following Pfizer-BioNTech, 32,223 (45%) following Oxford-AstraZeneca, and 948 (1.3%) following Moderna. The following reported AEs were statistically significant between the different vaccine types: shortness of breath\difficulty of breathing, dizziness, fever above 39 degrees C, headache, hoarseness, injection site reactions, itchiness, nausea, sleep disruption, fatigue, wheezing, swelling of lips/face and\or throat, and loss of consciousness (p-value < 0.05). Fever and seizure were the only statistically significant AEs amongst the number of vaccine doses received (p-value < 0.05). Ten ICU admissions were reported in the 14 days observation period post-COVID-19 vaccination with the following diagnoses: acute myocardial infarction, pneumonia, atherosclerosis, acute respiratory failure, intracranial hemorrhage, grand mal seizure, Guillain-Barre syndrome, abnormal blood gas levels, and septic shock. CONCLUSION: This study demonstrated that the most prevalent SARS-CoV-2 vaccine side-effects among adults in Saudi Arabia were mild in nature. This information will help reduce vaccine hesitancy and encourage further mass vaccination to combat the COVID-19 pandemic, especially as booster doses are now available. Further studies are warranted to obtain a better understanding of the association between risk factors and the experiencing of side-effects post vaccination. CI - Copyright (c) 2023 Alkhalifah, Al Seraihi, Al-Tawfiq, Alshehri, Alhaluli, Alsulais, Alessa, Seddiq, Aljeri, Qahtani, Barry and Al-Otaiby. FAU - Alkhalifah, Joud Mohammed AU - Alkhalifah JM AD - College of Medicine, King Saud University, Riyadh, Saudi Arabia. FAU - Al Seraihi, Ahad AU - Al Seraihi A AD - The Saudi Ministry of Health, Riyadh, Saudi Arabia. FAU - Al-Tawfiq, Jaffar A AU - Al-Tawfiq JA AD - Infectious Disease Unit, Specialty Internal Medicine, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia. AD - Infectious Disease Division, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States. AD - Infectious Disease Division, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States. FAU - Alshehri, Badr Fadhel AU - Alshehri BF AD - College of Medicine, King Saud University, Riyadh, Saudi Arabia. FAU - Alhaluli, Alhanouf Hani AU - Alhaluli AH AD - College of Medicine, King Saud University, Riyadh, Saudi Arabia. FAU - Alsulais, Naif Mansour AU - Alsulais NM AD - College of Medicine, King Saud University, Riyadh, Saudi Arabia. FAU - Alessa, Mohammed Mesfer AU - Alessa MM AD - College of Medicine, King Saud University, Riyadh, Saudi Arabia. FAU - Seddiq, Waleed AU - Seddiq W AD - Center for Stem Cell and Translational Immunotherapy (CSTI), Harvard Medical School, Boston, MA, United States. AD - Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States. FAU - Aljeri, Thamer AU - Aljeri T AD - The Saudi Ministry of Health, Riyadh, Saudi Arabia. FAU - Qahtani, Mohammad Hassan AU - Qahtani MH AD - The Saudi Ministry of Health, Riyadh, Saudi Arabia. FAU - Barry, Mazin AU - Barry M AD - Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia. AD - Division of Infectious Diseases, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada. FAU - Al-Otaiby, Maram AU - Al-Otaiby M AD - The Saudi Ministry of Health, Riyadh, Saudi Arabia. AD - Department of Pathology, College of Medicine, King Saud University, Riyadh, Saudi Arabia. LA - eng PT - Journal Article DEP - 20230223 PL - Switzerland TA - Front Public Health JT - Frontiers in public health JID - 101616579 RN - 0 (COVID-19 Vaccines) SB - IM MH - Adult MH - Humans MH - *COVID-19 Vaccines MH - Saudi Arabia MH - Self Report MH - *COVID-19 MH - Dizziness MH - Hoarseness MH - Pandemics MH - Respiratory Sounds MH - SARS-CoV-2 MH - Dyspnea MH - Unconsciousness PMC - PMC9995884 OTO - NOTNLM OT - COVID-19 OT - Saudi Arabia OT - adverse events OT - cohort OT - registry OT - self-reported OT - side-effects OT - vaccines COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/03/14 06:00 MHDA- 2023/03/15 06:00 PMCR- 2023/02/23 CRDT- 2023/03/13 03:47 PHST- 2022/09/13 00:00 [received] PHST- 2023/02/07 00:00 [accepted] PHST- 2023/03/13 03:47 [entrez] PHST- 2023/03/14 06:00 [pubmed] PHST- 2023/03/15 06:00 [medline] PHST- 2023/02/23 00:00 [pmc-release] AID - 10.3389/fpubh.2023.1043696 [doi] PST - epublish SO - Front Public Health. 2023 Feb 23;11:1043696. doi: 10.3389/fpubh.2023.1043696. eCollection 2023.