Post-vaccination Adverse Events Research Articles

New Russian Trivalent Hepatitis B Vaccine (Bubo®­-Unigep): Reactogenicity, Safety and Immunological Efficacy

Relevance. In Russia, phase III of clinical trials of the domestic trivalent vaccine Bubo®-Unigep, containing protective antigens that provide protection against “wild” forms of the hepatitis B virus subtypes ay and ad, as well as the determinant of serotype ay with the G145R mutation, has been completed. Аim. Evaluation of the effect of the new recombinant polyvaccine against hepatitis B «Bubo-Unigep» on vital functions and laboratory parameters in previously unvaccinated individuals in an adult healthy population. Materials and methods. A randomized multicenter clinical study was conducted to assess the reactogenicity, safety and immunogenicity of Bubo®-Unigep (CJSC NPC «COMBIOTECH») in previously unvaccinated healthy adults (n = 166). The study performed according to the protocol developed by the contract research organization «R&D Pharma» at eight clinical centers located in Russian Federation. Results and discussion. Analysis of the studied parameters throughout the study (frequency and severity of adverse events, physical examination data of volunteers with assessment of vital signs, laboratory test results, etc.) made it possible to establish a high safety profile of Bubo®-Unigep vaccine, which turned out to be virtually areactogenic without causing development of targeted local and systemic post-vaccination adverse events. Conclusion. The wide range of specificity of the immune response, along with the high safety and reactogenicity of the Bubo®-Unigep vaccine, the production of which can be carried out through a full technological cycle without the use of imported substances, will increase the effectiveness of hepatitis B prevention.

Data quality and timeliness analysis for post-vaccination adverse event cases reported through healthcare data exchange to FDA BEST pilot platform.

This study is part of the U.S. Food and Drug Administration (FDA)'s Biologics Effectiveness and Safety (BEST) initiative, which aims to improve the FDA's postmarket surveillance capabilities by using real-world data (RWD). In the United States, using RWD for postmarket surveillance has been hindered by the inability to exchange clinical data between healthcare providers and public health organizations in an interoperable format. However, the Office of the National Coordinator for Health Information Technology (ONC) has recently enacted regulation requiring all healthcare providers to support seamless access, exchange, and use of electronic health information through the interoperable HL7 Fast Healthcare Interoperability Resources (FHIR) standard. To leverage the recent ONC changes, BEST designed a pilot platform to query and receive the clinical information necessary to analyze suspected AEs. This study assessed the feasibility of using the RWD received through the data exchange of FHIR resources to study post-vaccination AE cases by evaluating the data volume, query response time, and data quality. The study used RWD from 283 post-vaccination AE cases, which were received through the platform. We used descriptive statistics to report results and apply 322 data quality tests based on a data quality framework for EHR. The volume analysis indicated the average clinical resources for a post-vaccination AE case was 983.9 for the median partner. The query response time analysis indicated that cases could be received by the platform at a median of 3 min and 30 s. The quality analysis indicated that most of the data elements and conformance requirements useful for postmarket surveillance were met. This study describes the platform's data volume, data query response time, and data quality results from the queried postvaccination adverse event cases and identified updates to current standards to close data quality gaps.

Adverse reactions following COVID-19 immunization in children of elementary school age

Purpose: Due to the low rate of parent acceptance of vaccines, this study was conducted to evaluate post-vaccination adverse events among elementary school students.
 Methods: This survey took place in the Manggala Subdistrict of Makassar City. The study was conducted from September to October 2022 by distributing a paper-based questionnaire regarding the COVID-19 vaccines.
 Results: Of 129 respondents, the age range was 7-12 years. Sixty-five percent of respondents received the first vaccine shot in January or February, with a 4-week interval of the second dose among 46.5% of children. The vaccine administered was CoronaVac from Sinovac. The most common adverse events were injection pain (45-48%) and fever (15-17%). The other side effects were itching, swelling, fever, and shortness of breath. Around 17-18 % of respondents did not have any adverse reactions. There is no increase in the risk for younger children (years 1-3) compared with older children (years 4-6). 
 Conclusion: The children reported only mild adverse events such as injection pain, weakness, and fever. The CoronaVac has minimal side effects among elementary school children.

Headache as the most prevalent post-vaccination adverse event after Covid-19 vaccination

Context: In 2020, the first vaccines were approved, according to the WHO. However, speculations have arisen regarding its efficacy and post-vaccination adverse events (AEFI). Objective: To evaluate the prevalence of headache as AEFI from the SARSCoV-2 vaccine in Piauí, Brazil.Methods: This is a quantitative, observational, cross-sectional and prevalence study. The data were provided by the Post-Vaccination Adverse Events Information System (SI-AEFV), of cases reported in the period from January to September 2021. The data were analyzed and the research was approved by the Research Ethics Committee of the UFPI. Results: 2,008 cases were analyzed. Headache was reported in 752 cases (27.99%) as AEFI after vaccination against SARS-CoV-2. In most cases, the patients were from Teresina (67.62%), of mixed race/ethnicity (52.67%), female (79.00%) and the majority were not healthcare professionals (54. 27%). The most common age of patients, with the original data, was 33 years old. After correcting the data, the most common age was 28 years old. The majority of these cases were not serious (96.44%) and the majority of cases were associated with the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine (43.18%). Conclusion: Thus, it is concluded from the partial analysis of the results that headache is the most common adverse event after vaccination against SARS-CoV-2. The profile of patients with the most notifications was mixed-race women aged between 30 and 40 years who received the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine. Regarding the severity of the events, the vast majority were considered non-serious and no deaths were mentioned, demonstrating the safety of immunobiologicals.

Comparative analysis of efficacy and safety of ChAdOx1 nCov-19 and AD26.COV2.S

Vaccine technology has been going through some radical and incremental advancement over the years for its importance as the most crucial tool in the prevention and elimination of transmissive diseases. Since the outbreak of COVID-19, several vaccine platforms were being studied, developed, and entered the market. Among the platforms, vector viral vaccines attracted particular attention for the cooperation of viral vectors to deliver genetic material of the pathogens. While the mechanism has improved the flexibility of vaccine design and efficacy, the adverse events after vaccination were worth attention at the same time. Taking ChAdOx12 nCov-19 and AD26.COV2.S. as the subjects, the efficacy and safety of the two vaccine platforms were compared and analyzed. In this paper, the initial vaccine efficacy, the resistances against virus variants, and various post vaccination adverse events were looked in more detail to identify the different factors that could affect the performance of viral vector vaccines.

A retrospective cohort study: vaccination status and safety analysis of SARS-CoV-2 vaccine in patients with Wilson’s disease

ABSTRACT Background Wilson’s disease (WD) is a rare hepatic and neurological disorder, which can dramatically worsen by traumatic injuries, surgeries, and infections. No studies have reported safety data of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in WD patients. We aimed to investigate the SARS-CoV-2 vaccination status and post-vaccination adverse events in WD patients. Methods This is a multicenter, retrospective, observational study. We investigated the vaccination rates, the type of vaccine, subjective reasons for non-vaccination, and the adverse events following vaccination. Logistic regression analysis was used to assess the correlation between vaccination status and increased Unified Wilson’s Disease Rating Scale (UWDRS) scores. Results A total of 554 WD patients with a mean (SD) age of 25.3 (10.85) years were included in this study, of whom 336 (60.6%) were males and 218 (39.4%) were females. 368 (66.4%) patients received at least one dose of the SARS-CoV-2 vaccine.186 (33.6%) patients were unvaccinated. Logistic regression analysis showed that vaccination against SARS-CoV-2 was not significantly associated with increased UWDRS scores. The safety analysis demonstrated that 21.2% had post-vaccination adverse events. Conclusions In this study, vaccination against SARS-CoV-2 was safe in WD patients, providing evidence for the safety of vaccination in WD patients.

Effect of Secukinumab and Tumor Necrosis Factor Inhibitors on Humoral Response to BNT162b2 mRNA Vaccine in Patients With Spondyloarthritis Compared to Immunocompetent Controls.

To assess the humoral response to the BNT162b2 mRNA vaccine among patients with spondyloarthritis (SpA) receiving secukinumab (SEC) compared to those receiving tumor necrosis factor inhibitors (TNFi) and immunocompetent controls. Consecutive patients with psoriatic arthritis or axial SpA receiving SEC (n = 37) or TNFi (monotherapy, n = 109; + methotrexate [MTX], n = 16), immunocompetent controls (n = 122), and patients with rheumatoid arthritis (RA) receiving TNFi therapy (controls, n = 50) were vaccinated with 2 or 3 doses of the BNT162b2 vaccine. We evaluated humoral response, adverse events, and disease activity, and monitored for breakthrough coronavirus disease 2019 (COVID-19) postvaccination. The 2-dose vaccine regimen induced a comparable seropositive response in all study groups. S1/S2 antibody titers (in binding antibody units/mL; mean [SD]) were higher in the SEC group vs the TNFi + MTX-SpA and TNFi-RA groups (192.5 [68.4] vs 104.6 [46.9], P < 0.001, and 143.1 [81.9], P = 0.004). After 6 months, 96.3%, 96.6%, and 80.9% of the SEC, immunocompetent, and TNFi monotherapy-SpA groups (P = 0.10), respectively; 66.7% of the TNFi + MTX-SpA group (P = 0.03); and 63% of the TNFi-RA group (P = 0.004) remained seropositive. S1/S2 antibody titer decline was steeper in the TNFi groups than the SEC group. After the third dose, 100% of the SpA and immunocompetent and 88.9% of the TNFi-RA (P = 0.25) groups were seropositive. Rate of breakthrough COVID-19 infection was higher in the TNFi groups than in the SEC group (36-37.5% vs 10.8%). No significant between-group differences were observed for postvaccination disease activity and adverse events. SEC did not interfere with the immunogenic response to BNT162b2 vaccine in patients with SpA; however, TNFi therapy was associated with lower S1/S2-antibody titers, faster decline, and higher rate of breakthrough infections.

Providing compensation for patients with diseases who cannot be given the COVID-19 Vaccine

This study aims to describe the procedures and barriers associated with compensating disease sufferers who are not eligible to receive the COVID-19 vaccine. The research method used is normative research, which focuses on analyzing legal aspects based on legal regulations, including Presidential Regulation Number 99 of 2020, concerning Procurement of Vaccines and Implementation of Vaccinations in the Context of Overcoming the 2019 Coronavirus Disease (COVID-19) Pandemic, as well as regulations other relevant matters. Research data was obtained through literature study and document analysis, including primary and secondary legal materials. Data analysis was carried out descriptively and qualitatively with a deductive approach, which refers to general legal principles. The research results identified various obstacles, including technical problems such as a lack of public discipline in undergoing health checks before receiving vaccination and a lack of compliance from medical personnel who manage vaccination procedures per established guidelines. As a result, some groups of people who should not receive the COVID-19 vaccine still receive vaccination, which can ultimately cause side effects. The research also highlights Presidential Regulation Number 14 of 2021 concerning Procurement of Vaccines and Implementation of Vaccinations in the Context of Overcoming the COVID-19 Pandemic, which provides compensation guarantees following applicable regulations if a Post-Vaccination Adverse Event (AEFI) occurs which has the potential to cause disability or death in sufferers of the disease who are not eligible to receive the COVID-19 vaccine. The results of this research provide a deeper understanding of the challenges and obstacles in implementing COVID-19 vaccination, especially in the context of disease sufferers who do not meet the requirements to receive the vaccine, as well as the importance of guaranteeing compensation in AEFI situations that have the potential to have profound impacts.

Adverse Events Following COVID-19 Vaccination in Anambra State, South East Nigeria

The use of safe and effective vaccination is critical to control of pandemics. Vaccines remain the bedrock in management of infectious diseases outbreaks. There has always been hesitancy to vaccination due to the fear of adverse events. It is therefore necessary that post vaccination adverse events be studied for effective enlightenment of the general populace.&#x0D; Objective: We aimed to investigate the adverse reactions following COVID-19 vaccination in Anambra state, South East Nigeria.&#x0D; Methods: Using a cross-sectional study design, 433 subjects aged 18years or older who had received any dose of the four COVID-19 vaccines (Moderna, Astra Zeneca, Pfizer and J&amp;J (Janssen) were selected using a multi-stage sampling technique. The subjects were interviewed about COVID-19 vaccine related adverse reactions using self-administered questionnaire. Descriptive statistics (mean, standard deviation) and analytical statistics were performed and level of significance set at &lt; 0.5 using SPSS V24.&#x0D; Results: Of the 433 subjects finally studied, 62.8% were females and 22.4% were married. About 69% of them had tertiary education. Those who received the second dose of their respective vaccines were 44.8% while 11.5% had received a booster dose. Approximately half (50.3%) of the COVID-19 vaccines had adverse events. The most common types of adverse events (AEs) were local pain at injection site (62.1%) followed by headache (54.3%) and then fatigue (50.1%). Majority of the adverse events were mild to moderate in severity. Those who had only local adverse events were 70.2% while 45% had systemic adverse events.&#x0D; Conclusion: In this study, severe adverse events were rare, even after the second dose. Most of the adverse events were mild to moderate in severity and therefore awareness campaign should be created to enlighten the community about the adverse effects of COVID-19 vaccines.

A framework for nationwide COVID-19 vaccine safety research in the Republic of Korea: the COVID-19 Vaccine Safety Research Committee.

With the introduction of coronavirus disease 2019 (COVID-19) vaccines, the Korea Disease Control and Prevention Agency (KDCA) commissioned the National Academy of Medicine of Korea to gather experts to independently assess post-vaccination adverse events. Accordingly, the COVID-19 Vaccine Safety Research Committee (CoVaSC) was launched in November 2021 to perform safety studies and establish evidence for policy guidance. The CoVaSC established 3 committees for epidemiology, clinical research, and communication. The CoVaSC mainly utilizes pseudonymized data linking KDCA's COVID-19 vaccination data and the National Health Insurance Service's claims data. The CoVaSC's 5-step research process involves defining the target diseases and organizing ad-hoc committees, developing research protocols, performing analyses, assessing causal relationships, and announcing research findings and utilizing them to guide compensation policies. As of 2022, the CoVaSC completed this research process for 15 adverse events. The CoVaSC launched the COVID-19 Vaccine Safety Research Center in September 2022 and has been reorganized into 4 divisions to promote research including international collaborative studies, long-/short-term follow-up studies, and education programs. Through these enhancements, the CoVaSC will continue to swiftly provide scientific evidence for COVID-19 vaccine research and compensation and may serve as a model for preparing for future epidemics of new diseases.

Adverse events following immunization with COVID-19 vaccines

Objective: The purpose of this study was to identify Post-Vaccination Adverse Events (PVAE) with Moderna vaccine, locally systemically, and other reactions. Methods: A quantitative descriptive research method with a retrospective approach was used in this study. The study was carried out at RSUD Cicalengka Bandung with a population of employees who had received the Moderna vaccine after two complete doses of Sinovac from August to September 2021. Purposive sampling was used, with a total of 162 respondents calculated using the Yamane formula.

Recommended Adult Immunization Schedule, United States, 2023.

Recommended Adult Immunization Schedule, United States, 2023.

Adverse events following the first, second and third doses of a COVID-19 vaccine in hemodialysis patients

Background This study aimed to identify adverse events following the first three doses of COVID-19 vaccines in hemodialysis (HD) patients. Risk factors associated with postvaccination adverse events were explored. Methods Postvaccination adverse events in 438 HD patients who received 3 doses of COVID-19 vaccines were prospectively assessed. The adverse events among three doses were compared using generalized linear mixed models. Factors associated with adverse events were assessed with multivariate analyses. Results The vast majority of participants received Oxford/AstraZeneca ChAdOx1 as their first two doses and Moderna mRNA-1273 as their third dose. Overall, 79%, 50% and 84% of the participants experienced at least one adverse event after their first, second, and third doses, respectively. These adverse events were mostly minor, short-lived and less than 5% reported daily activities being affected. Compared with the first dose, the second dose caused a lower rate of adverse events. Compared with the first dose, the third dose elicited a higher rate of injection site reactions and a lower rate of systemic reactions. Multivariate analyses showed that every 10-year increase of age (odds ratio 0.67, 95% confidence intervals 0.57-0.79) was associated with decreased risk of adverse events, while female sex (2.82, 1.90-4.18) and arteriovenous fistula (1.73, 1.05–2.84) were associated with increased risk of adverse events. Compared with Oxford/AstraZeneca ChAdOx1, Moderna mRNA-1273 was associated with an increased risk of injection site reactions. Conclusions COVID-19 vaccination was well tolerated in HD patients. Age, sex, dialysis vascular access and vaccine types were associated with postvaccination adverse events.

Post-vaccination headache reporting: Trends according to the Vaccine Adverse Events Reporting System.

To assess the characteristics and associated disability of headache as an adverse event following vaccination. According to clinical trials and post-licensure surveillance, headache is a common symptom of vaccines, yet systematic investigations of post-licensure reports of this adverse event are lacking. This was a retrospective database analysis study. We searched the Vaccine Adverse Events Reporting System (VAERS) database completed from July 1990 to June 2020 (a 30-year period prior to the start of COVID-19 pandemic) to identify reports of headache. We evaluated epidemiological features, including event characteristics, patient demographics, and vaccine type. In those aged 3 years or older, headache was the fifth most reported adverse symptom, present in 8.1% (43,218/536,120) of all reports. Of headache reports, 96.3% (41,635/43,218) included the code "headache" not further specified. Migraine was coded in 1973 cases, although almost one-third (12,467/41,808; 29.8%) of headache reports without a migraine code mention nausea or vomiting. The onset of symptoms was within 1 day of vaccination in over two-thirds of cases. The majority of reports were classified as not serious; about one-third involved emergency room or office visits. Of the 43,218 total headache reports, only a minority involved hospitalizations (2624; 6.1%) or permanent disability (1091; 2.5%), females accounted for 68.9% (29,771) and males for 29.5% (12,725), patients aged 6 to 59 years represented 67.3% (29,112), and over one-third of cases were reported after herpes zoster (8665; 20.1%) and influenza (6748; 15.6%) vaccinations. In a national surveillance system, headache was a commonly reported post-vaccination adverse event; a small subset of reports was considered serious. The development of standardized vaccine-related case definitions could be useful for better evaluating headache as an adverse event during vaccine development, and may reduce vaccine hesitancy especially in headache-prone individuals.

Impact of educational interventions for the prevention and management of post-vaccination adverse events (CINAHL).

Abstract Educational interventions among health professionals about post-vaccination adverse events and/or immunization errors.

Impact of educational interventions for the prevention and management of post-vaccination adverse events (EMBASE).

Abstract Educational interventions among health professionals about post-vaccination adverse events and/or immunization errors.

Impact of educational interventions for the prevention and management of post-vaccination adverse events (MEDLINE).

Abstract Educational interventions among health professionals about post-vaccination adverse events and/or immunization errors.

Impact of educational interventions for the prevention and management of post-vaccination adverse events (SCOPUS).

Abstract Educational interventions among health professionals about post-vaccination adverse events and/or immunization errors.

Impact of educational interventions for the prevention and management of post-vaccination adverse events (LILACS).

Abstract Educational interventions among health professionals about post-vaccination adverse events and/or immunization errors.

COVID-19 vaccines-related adverse events and associated factors reported among adult Egyptians

COVID-19 vaccine recipients are more likely to experience post-vaccination adverse events, which are considered the source of concerns about vaccine safety. This study aims to describe the utilization of COVID-19 vaccines and the associated adverse events and their possible predictors among adult Egyptians. An online cross-sectional study was designed to collect data through a Google Form questionnaire in November 2021. Adults who received at least one dose of the COVID-19 vaccine were asked to report their experience with vaccination and associated adverse events. A total of 853 participants were included in the study after receiving Sinopharm/Sinovac (63%), AstraZeneca (27%), Pfizer-BioNTech (4.8%), and other vaccines (5.2%). Around 50% of participants thought that COVID-19 vaccines were safe, 30.8% advised others with vaccination, and 68.3% reported post-vaccination adverse events. The most commonly encountered adverse symptoms were injection site pain (82.5%), fatigue (67.4%), flu-like symptoms (59.6%), and bone and muscle pains (59.6%). Most adverse events were less likely reported by Sinopharm/Sinovac recipients than recipients of other vaccines. The significant predictors for reporting adverse events were female gender, the first dose of vaccination, and vaccine type (AstraZeneca versus Sinopharm/Sinovac) with multivariable-adjusted OR (95% CI) = 1.85 (1.34-2.54); 2.01 (1.24–3.25), and 3.86 (2.54–5.86). Findings revealed that adverse events of COVID-19 vaccines are common. Sinopharm/Sinovac recipients were reported to have lesser adverse events than other recipients. However, serious reactions were rare which ensures the safety of all vaccine types among the adult Egyptian population.