Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study

Abstract

BackgroundVaccination 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.MethodsThis 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).ResultsThe 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°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-Barré syndrome, abnormal blood gas levels, and septic shock.ConclusionThis 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.

Overview of COVID-19 Vaccine Adverse Events Following Immunization in Bali

“…Research by Abu-Hammad et al(2021) in Jordan also got results that the most common reaction was breathing difficulty which was experienced by 19 people (4,6%). [46] Similar results were also obtained in a research byAlkhalifah et al (2023) in Saudi Arabia where from a total sample of 28.031 people, there were 1.736 people (6,19%…”

“…who experienced breathing difficulty. [47] Breathing difficulty can occur as an immune response. Another source states that breathing difficulty could be related to immunization stress-related responses (ISRRs), which is one of the AEFIs that is not caused by the components contained in the vaccine, but rather by the vaccination process itself.…”

Neurological Disorders following COVID-19 Vaccination

“…Guillain–Barre syndrome (GBS) is an acute immune-mediated polyradiculoneuropathy that affects myelinated nerves. GBS is a severe complication after COVID-19 vaccination and a common cause of intensive care unit admission [ 2 , 52 ]. Most GBS cases were reported after the first dose of the vaccine [ 53 , 54 , 55 , 56 ].…”

Connecting the dots: the role of fatigue in female infertility

“…Studies from 2011 highlighted that 7-45% of the U.S. population experiences persistent fatigue [34]. A cross-sectional study involving 2063 individuals showed that over 50% of patients were troubled by fatigue in Saudi Arabia [35]. Importantly, women appear to be more susceptible to fatigue than men, with a pooled odds ratio [33].…”