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

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°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. 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.

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

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°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. 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.

Demographic Characteristics, Comorbidities, and Length of Stay of COVID-19 Patients Admitted Into Intensive Care Units in Saudi Arabia: A Nationwide Retrospective Study.

Background: This study aimed to describe the demographic characteristics and determine the risk factors associated with disease severity and length of hospital and intensive care unit (ICU) stay in a cohort of COVID-19 patients admitted into ICU in Saudi Arabia. Methods: This was a national, multi-center, retrospective cross-sectional study of all COVID-19 cases admitted into different ICUs in Saudi Arabia between March 2020 and September 202l. Demographic, clinical features, comorbidities, and length of stay (LOS) data were retrieved from the national Health Electronic Surveillance Network (HESN) and Taqassi databases at the Saudi Ministry of Health (MOH) for subsequent analyses. We used multiple linear regression models to determine risk factors associated with critical outcomes (including LOS in ICU) among COVID-19 cases. Results: A total of 12,436 COVID-19 patients were included in this study, with a mean age of 59.57 ± 18.30 years and 7,679 (62%) were <65 years old. COVID-19 was more common in males (N = 7,686, 61.9%) and Saudi nationals (N = 8,516, 68.5%). The clinical characteristic findings showed that 36.3% of patients required invasive ventilation whilst 65.4% received tracheostomies for ventilation, and 4% were on dialysis. Our analysis revealed that 2,978 (23.9%) patients had one comorbidity, 4,977 (47.4%) had two or more comorbidities, and diabetes (48.2%) was the most prevalent comorbidity, followed by hypertension (44.2%), and chronic cardiovascular disease (10.5%). Thirteen variables emerged as significant predictors of LOS in ICU using multiple linear regression analyses, with invasive ventilation as the strongest predictor of LOS in the ICU (beta = -0.68, p = 0.001) and hospital admission (beta = -0.65, p = 0.001). Conclusions: COVID-19 continues to affect millions of people around the world, with a mortality rate of about 2-3% of all infected patients. Our analysis revealed that comorbidities such as chronic kidney disease, cardiovascular disease, diabetes, and older age were significant risk factors associated with a poorer prognosis and longer duration of stay in hospitals and ICU.

SARS-CoV-2 Reinfection Rate and Outcomes in Saudi Arabia: A National Retrospective Study.

BACKGROUND: The characterization of reinfection with SARS-CoV-2 has been a subject of concern and controversy, especially with the surge of infections with highly transmissible variants worldwide. METHODS: This retrospective national study used comorbidities, vaccination status, SARS-CoV-2 variants of concern, and demographics data to profile participants who were reinfected with SARS-CoV-2, defined as having two reverse transcriptase-polymerase chain reaction-positive SARS-CoV-2 tests within at least 90 days apart. A multivariate logistic regression model assessed the risk factors associated with reinfection . Two control groups were selected: nonreinfected participants reporting a positive test (control group one) and those reporting a negative test (control group two). RESULTS: Between March 2020 and December 2021, 4454 reinfected participants were identified in Saudi Arabia (0.8%, 95% confidence interval [CI] 0.7-0.8). The majority (67.3%) were unvaccinated (95% CI 65.9-68.7) and 0.8% (95% CI 0.6-1.1) had severe or fatal SARS-CoV-2 disease. COVID-19 vaccines were 100% effective against mortality in reinfected individuals who received at least one dose, whereas it conferred 61% (odds ratio [OR] 0.4, 95% CI 0.1-1.0) additional protection against severe disease after the first dose and 100% after the second dose. In the risk factor analysis, reinfection was highly associated with comorbidities, such as HIV (OR 2.5, 95% CI 1.3-5.2; P = 0.009), obesity (OR 2.3, 95% CI 1.3-3.9; P = 0.003), pregnancy (OR 3.2, 95% CI 1.4-7.4; P = 0.005), and working in health care facilities (OR 6.1, 95% CI 3.1-12.9; P <0.0001). The delta variant (B.1.617.2) was the most frequent variant of concern among the reinfected cohort. CONCLUSION: This in-depth study of the reinfection profile identified risk factors and highlighted the associated SARS-CoV-2 variants. Results showed that naturally acquired immunity to SARS-CoV-2 through multiple reinfections together with vaccine-induced immunity provided substantial protection against severe SARS-CoV-2 disease and mortality.

An Updated Literature Based Analysis on the Genetic Aspects of Coronavirus (COVID19) and its Connection with the Viral Genome

World Health Organization has declared in 2020 "coronavirus 2019" (COVID-2019 or 2019-nCoV or SARS-CoV-2 or CoV) as a global endemic. A recent respiratory disease produced by a novel coronavirus was born in Wuhan city of China in late December 2019. CoV is connected with a large family of viruses commonly found in cat, camel, cattle and bats. Severe acute respiratory syndrome (SARS) virus is genetically interrelated with COVID 19 strains which infect bats. MERS-CoV, SARS-CoV and SARS-CoV-2 are affected by humans from the animals. The COVID 19 is known to be the human-to-human transmission. Presently, there is no medication for COVID19, and this disease has been inherited to another global country. Pharma companies will have a major role when genomic medicine goes at the mainstream, and presently, there is no medication for COVID 19. However, genome sequencing analysis can help to design medication (Rx) by pharmacists. The genome sequencing can be identified by the next-generation sequencing (NGS) in the whole viral genome. The advantage of NGS is to identify the disease-causing or novel variants in the human genome. Limited global studies have sequenced the human genome and confirm similar to 88% of the human genome is similar to the Bats sequence in an effected person of COVID 19. This review will be connected to the pharma companies in designing the Rx for COVID 19. Thus, NGS analysis can be helpful for the pharma companies for scheming medications.