Vaccine Adverse Event Research Articles

Non-glycosylated G protein with CpG ODN provides robust protection against respiratory syncytial virus without inducing eosinophilia.

Respiratory syncytial virus (RSV) vaccines targeting the fusion glycoprotein (F protein) are highly effective clinically in preventing RSV challenges. The attachment glycoprotein (G protein) is a potentially effective vaccine antigen candidate, as it is important for cell adhesion during infection. However, vaccine-associated enhanced diseases in mice, such as eosinophilic lung inflammation following RSV challenge, are a concern with G protein vaccines. This study aimed to design an effective G protein vaccine with enhanced safety and efficacy by evaluating the efficacy and adverse reactions of vaccines composed of different recombinant G proteins and adjuvants in mice. Mice were subcutaneously immunized with glycosylated G protein expressed in mammalian cells (mG), non-glycosylated G protein expressed in Escherichia coli (eG), or F protein with or without aluminum salts (alum), CpG oligodeoxynucleotide (CpG ODN), or AddaVax. After vaccination, the levels of G-specific antibody and T-cell responses were measured. The immunized mice were challenged with RSV and examined for the viral load in the lungs and nasal turbinates, lung-infiltrating cells, and lung pathology. mG with any adjuvant was ineffective at inducing G-specific antibodies and had difficulty achieving both protection against RSV challenge and eosinophilia suppression. In particular, mG+CpG ODN induced G-specific T helper 1 (Th1) cells but only a few G-specific antibodies and did not protect against RSV challenge. However, eG+CpG ODN induced high levels of G-specific antibodies and Th1 cells and protected against RSV challenge without inducing pulmonary inflammation. Moreover, the combination vaccine of eG+F+CpG ODN showed greater protection against upper respiratory tract RSV challenge than using each single antigen vaccine alone. These results indicate that the efficacy of recombinant G protein vaccines can be enhanced without inducing adverse reactions by using appropriate antigens and adjuvants, and their efficacy is further enhanced in the combination vaccine with F protein. These data provide valuable information for the clinical application of G protein vaccines.

Unpacking adverse events and associations post COVID-19 vaccination: a deep dive into vaccine adverse event reporting system data

ABSTRACT Introduction The rapid development of COVID-19 vaccines has provided crucial tools for pandemic control, but the occurrence of vaccine-related adverse events (AEs) underscores the need for comprehensive monitoring. Methods This study analyzed the Vaccine Adverse Event Reporting System (VAERS) data from 2020–2022 using statistical methods such as zero-truncated Poisson regression and logistic regression to assess associations with age, gender groups, and vaccine manufacturers. Results Logistic regression identified 26 System Organ Classes (SOCs) significantly associated with age and gender. Females displayed especially higher odds in SOC 19 (Pregnancy, puerperium and perinatal conditions), while males had higher odds in SOC 25 (Surgical and medical procedures). Older adults (>65) were more prone to symptoms like Cardiac disorders, whereas those aged 18–65 showed susceptibility to AEs like Skin and subcutaneous tissue disorders. Moderna and Pfizer vaccines induced fewer SOC symptoms compared to Janssen and Novavax. The zero-truncated Poisson regression model estimated an average of 4.243 symptoms per individual. Conclusion These findings offer vital insights into vaccine safety, guiding evidence-based vaccination strategies and monitoring programs for precise and effective outcomes.

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

Adverse event following immunization (AEFI) is undesired medical events that occur post-vaccination without considering whether there is a cause-and-effect relationship with the use of the vaccine or not. COVID-19 vaccination is an ongoing vaccination but the AEFI research is still limited, especially in Bali. This study aimed to report the overview of COVID-19 vaccine AEFI in Bali during January 2021 – December 2022. This was a descriptive study with cross-sectional approach by using the recapitulation data of the COVID-19 vaccine AEFI reports from the Bali Provincial Health Service. Of 958 cases, AEFI cases of COVID-19 vaccine were dominated by females (61.38%), age group of 18 – 29 years (38.73%), and domiciled in Denpasar (38.62%). The majority of adverse reaction reports were obtained from the hospital (53.34%), post vaccination of Sinovac (41.34%), and after the first dose (68.72%). The most frequently reported COVID-19 vaccine AEFI cases were non-serious AEFI (94.57%) with the most common symptoms in the local reaction group was pain at the injection site (9.65%), in the systemic reaction group was fever (17.77%), and in the other reaction group was shortness of breath (1.79%). In conclusion, AEFI of COVID-19 vaccine in Bali was dominated by females, age 18 – 29 years, and domiciled in Denpasar with most reports obtained from hospitals, post-vaccination of Sinovac, and after the first dose. The most reported AEFI cases were non-serious AEFIs where the most common symptoms were pain at the injection site for local reactions, fever for systemic reactions, and breathing difficulty for other reactions. Keywords: COVID-19 vaccine, AEFI, side effect, adverse event

Gene-based COVID-19 vaccines: Australian perspectives in a corporate and global context

Pandemic management requires societal coordination, global orchestration, respect for human rights and defence of ethical principles. Yet some approaches to the COVID-19 pandemic, driven by socioeconomic, corporate, and political interests, have undermined key pillars of ethical medical science. We explore significant mistakes that may have occurred in recent pandemic control, in order to better navigate the future. Within corporate and geopolitical infrastructure, we review the COVID-19 pandemic and novel mRNA and viral-vector DNA COVID-19 vaccines, deployed by wealthy western countries. The pandemic, together with rollouts of unconventional, gene-based vaccine technology, has provided experimental opportunity to engineer social control of entire populations. The haste and scale of development, production, and distribution of these new pharmaceuticals is unprecedented in history. Key phase III clinical trials for these products are yet to be fully completed, despite administration to billions of people. Mass vaccination of workforces has been mandated, and vaccine mandates correlate with excess mortality. Many independent data sets concur - we have experienced a pandemic of viral illness, followed by a pandemic of vaccine injury. For Australia, matters have operated the other way around. Vaccination followed later by the main viral wave. Australian excess mortality data correlates with this. Neither risk nor cost can justify these products for the vast majority of people. Lack of efficacy against infection and transmission, and the equivalent benefits of natural immunity, obviate mandatory therapeutics. With the many gene-based pharmaceuticals planned, a new era of pathology lies ahead. We should pause, reflect, and reaffirm essential freedoms, welcome the end of the COVID-19 pandemic, embrace natural immunity, and lift all mandated medical therapy.

Fence off Black Swans: The Economics of Insurance for Vaccine Injury*

AbstractBeing injured during vaccination, although infrequent, can occur, and this necessitates understanding the consequences of vaccine injuries. In this study, we analyse the impact of the risk of vaccine injuries, particularly the economic importance of vaccine injury compensation insurance (VICI) programmes for the injured, which few studies have investigated. Specifically, we examine the role of VICI on individuals' vaccination decisions by integrating an imperfect vaccine into an epidemiological‐economic model in the presence and absence of such an insurance mechanism. Our findings show that the risk of being injured is a non‐negligible risk that lowers individuals' incentives to be vaccinated. The introduction of VICI largely alleviates decision‐makers' concern about vaccine injury. Furthermore, our extended discussion shows the effect of insurance in encouraging vaccination persists under some more sophisticated scenarios.

Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing.

The Vaccine Adverse Event Reporting System (VAERS) has already been challenged by an extreme increase in the number of individual case safety reports (ICSRs) after the market introduction of coronavirus disease 2019 (COVID-19) vaccines. Evidence from scientific literature suggests that when there is an extreme increase in the number of ICSRs recorded in spontaneous reporting databases (such as the VAERS), an accompanying increase in the number of disproportionality signals (sometimes referred to as 'statistical alerts') generated is expected. The objective of this study was to develop a natural language processing (NLP)-based approach to optimize signal management by excluding disproportionality signals related to listed adverse events following immunization (AEFIs). COVID-19 vaccines were used as a proof-of-concept. The VAERS was used as a data source, and the Finding Associated Concepts with Text Analysis (FACTA+) was used to extract signs and symptoms of listed AEFIs from MEDLINE for COVID-19 vaccines. Disproportionality analyses were conducted according to guidelines and recommendations provided by the US Centers for Disease Control and Prevention. By using signs and symptoms of listed AEFIs, we computed the proportion of disproportionality signals dismissed for COVID-19 vaccines using this approach. Nine NLP techniques, including Generative Pre-Trained Transformer 3.5 (GPT-3.5), were used to automatically retrieve Medical Dictionary for Regulatory Activities Preferred Terms (MedDRA PTs) from signs and symptoms extracted from FACTA+. Overall, 17% of disproportionality signals for COVID-19 vaccines were dismissed as they reported signs and symptoms of listed AEFIs. Eight of nine NLP techniques used to automatically retrieve MedDRA PTs from signs and symptoms extracted from FACTA+ showed suboptimal performance. GPT-3.5 achieved an accuracy of 78% in correctly assigning MedDRA PTs. Our approach reduced the need for manual exclusion of disproportionality signals related to listed AEFIs and may lead to better optimization of time and resources in signal management.

Incidence of anaphylaxis to YF-VAX® yellow fever vaccination: a retrospective evaluation of vaccine adverse event reports 1999-2018.

The incidence of anaphylaxis after receipt of yellow fever (YF) vaccine is highly variable based upon previously published reports. Anaphylaxis after receiving the YF vaccine has been reported to range from 0 up to 22 per 1 000 000 doses. Our clinical experience suggested increased incidence, which prompted our investigation. We sought to evaluate the current incidence rate of anaphylaxis after receipt of the 17D-204 strain YF-VAX® brand reported in the US. We performed a retrospective review of the Vaccine Adverse Event Reporting System (VAERS) reports of anaphylaxis after receiving the YF-VAX vaccine occurring between 1 October 1999 and 30 September 2018. We utilized the Brighton Collaboration Case Definition and inclusion determination was made by a board-certified allergist. We also obtained the total number of YF-VAX doses distributed across the US during this same time-period and then calculated an updated incidence rate of YF-VAX vaccine-associated anaphylaxis. We identified 132 potential cases of possible or probable anaphylaxis. Of these, 111 met inclusion criteria: level 1 (n = 51), level 2 (n = 59) and level 3 (n = 1). The manufacturer reported a total distribution of 7 624 160 doses of YF-VAX from 1 October 1999 to 30 September 2018. The calculated incidence rate of YF-VAX vaccine-associated anaphylaxis is estimated at 14.6 events per 1 000 000 doses. We conclude the estimated rate of anaphylaxis per VAERS reports is 14.6 events per 1 000 000 doses after YF-VAX vaccination. This is consistent with some previous reports and substantially higher than rates of anaphylaxis after other vaccines.

BAYESIAN LEARNING OF COVID-19 VACCINE SAFETY WHILE INCORPORATING ADVERSE EVENTS ONTOLOGY.

While vaccines are crucial to end the COVID-19 pandemic, public confidence in vaccine safety has always been vulnerable. Many statistical methods have been applied to VAERS (Vaccine Adverse Event Reporting System) database to study the safety of COVID-19 vaccines. However, none of these methods considered the adverse event (AE) ontology. AEs are naturally related; for example, events of retching, dysphagia, and reflux are all related to an abnormal digestive system. Explicitly bringing AE relationships into the model can aid in the detection of true AE signals amid the noise while reducing false positives. We propose a Bayesian graph-assisted signal selection (BGrass) model to simultaneously estimate all AEs while incorporating the network of dependence between AEs. Under a fully Bayesian inference framework, we also propose a negative control approach to mitigate the reporting bias and an enrichment approach to detecting AE groups of concern. For posterior computation we construct an equivalent model representation and develop an efficient Gibbs sampler. We evaluate the performance of BGrass via extensive simulations. To study the safety of COVID-19 vaccines, we apply BGrass to analyze approximately one million VAERS reports (01/01/2016-12/24/2021) involving more than 800 AEs. In particular, we found that blood clots (including deep vein thrombosis, thrombosis, and pulmonary embolism) are more likely to be reported after COVID-19 vaccination, compared to influenza vaccines. They are also reported more often for Johnson & Johnson-Janssen vaccine, compared to mRNA-based COVID-19 vaccines. A user-friendly R package BGrass that implements the proposed methods to assess vaccine safety is included in the Supplementary Material and is publicly available at https://github.com/BangyaoZhao/BGrass.

The analysis of the effect of the COVID-19 pandemic on patients with hereditary angioedema type I and type II

Due to the similarity between the pathomechanism of SARS-CoV-2 infections and hereditary angioedema due to C1-inhibitor deficiency (C1-INH-HAE), a possibility emerged that C1-INH-HAE may worsen the course of the infection, or that the infection may influence the severity of angioedema (HAE) attacks in C1-INH-HAE patients. Our study aimed to evaluate the effects of the COVID-19 pandemic on the quality of life (QoL) of Hungarian C1-INH-HAE patients, and to survey the acute course of the infection, post COVID symptoms (PCS), vaccination coverage and the side effects of vaccines in this patient population. 93 patients completed our questionnaire between 1st July 2021 and 31st October 2021. In this same period and between March 2019 and March 2020, 63 patients completed the angioedema quality of life questionnaire (AE-QoL). Out of those patients infected with SARS-CoV-2 in the examined period (18/93 patients; 19%), 5% required hospitalization, 28% experienced HAE attacks in the acute phase of the infection, and 44% experienced PCS. A total number of 142 doses of vaccines were administered to the patients. Serious vaccine reactions did not occur in any case, 4 (5%) out of the 73 vaccinated patients experienced HAE attacks. No significant difference (p = 0.59) was found in the median of the AE-QoL total score, or in the number of HAE attacks prior and during the pandemic. Based on our study, HAE patients did not experience more serious SARS-CoV-2 infection, and it did not aggravate the course of HAE either. Changes in the QoL were not significant, and vaccines were safe in HAE patients.

Acceptance for coronavirus disease 19 vaccines among pregnant women seeking antenatal care in tertiary care hospital

: Corona virus disease 2019 (COVID -19) is caused by the Severe acute respiratory syndrome corona virus (SARS-COV-2). In the absence of an effective treatment, vaccination becomes the main modality to control the incidence of infectious diseases. Hence, there is a need to estimate the attitudes and willingness among pregnant women for COVID 19 Vaccine.To estimate the frequency of COVID 19 Vaccine acceptance and non acceptance in pregnant women attending antenatal OPD. To describe the factors associated with non acceptance of COVID 19 Vaccine in pregnant women attending antenatal OPDThis is an observational cross-sectional study where 500 pregnant women attending antenatal care were counseled about the COVID-19 vaccine. Women who refused the vaccine were asked about the reasons for refusal and the same was noted. 95.6% accepted the vaccine and 4.4% did not accept. Majority belonged to 21 to 25 years(45% acceptors and 72% non acceptors), were second gravidas (38.7% acceptors and 54.5% non acceptors) and were between 25 to 36 weeks gestation(52.7% acceptors and 50% non acceptors). 13.8% of acceptors and 4.5% of non acceptors had previous history of abortions. Commonest concern was fear of vaccine related complications and fear of harming the fetus. Vaccine reactions followed by fear of harming the baby were the commonest reasons for non acceptance. Vaccine acceptance was high in this study (95.6%). Vaccine induced reactions followed by fear of harming the baby were the commonest reasons for non acceptance.

Analyzing an immunization resource website: User browsing trends

PurposeAccess to internet-based resources may help to improve population health awareness and literacy surrounding immunization related topics. The primary aim of this study was to evaluate and analyze trends for a single immunization resource website, the Melbourne Vaccine Education Centre (MVEC). Principal resultsOver a four-year period from 2019 to 2022, the website had over 2 million visitors from 236 countries. Users were predominantly female, in the 25 to 44 year age bracket and accessed resources using a mobile device.There was significant interest in specific vaccine related topics, particularly during the COVID-19 pandemic, that corresponded with key vaccine related recommendations and updates from a national level. Usage patterns saw spikes in interest around topics including COVID-19 vaccine administration techniques and adverse events following immunization. Major conclusionsUse of online platforms including websites such as MVEC may reflect trends and behaviors towards immunization related information. Analysis of usage patterns have provided user insights into key domains of interest including areas such as vaccine administration, policies and programs, vaccine safety and barriers to vaccine uptake.

A Finnish Survey of Adverse Effects of COVID-19 Injectables and the Functionality of the Medical System

The declaration of the COVID-19 pandemic brought unprecedented containment measures across multiple countries, with the announced intent of saving lives. Among them was the rapid development of prophylactic vaccines, with the promise of no corners cut, but warning signals from safety monitoring systems around the world raised concerns. The current survey was undertaken to evaluate the Finnish medical system in light of adverse effects from COVID-19 vaccination. An online survey consisting of 96 questions (see the Appendix) was promoted through social media. Persons believing they had been injured by any COVID-19 injectable contacted the second author who first verified the identity of the respondent and then gave that person the key to complete the questionnaire. The open period lasted from 5 March 2023 to 25 July 2023.: Out of 67 respondents 63 completed the survey and the collected data was analyzed. Of 63 respondents, 55 (87%) were females and 8 (13%) males. The majority, 56 (89%) of them, were fully employed, and 29 (46%) were social sector or medical professionals. None were previously “vaccine hesitant”. All received from 1 to 4 doses of COVID-19 injectable(s), and 19 (30%) reported doing so under duress. Despite having complied with mandatory vaccination, 13 of the individuals (21%) lost their jobs, and 13 (21%) changed their profession because of the shots. Of the vaccine recipients, 40 (63%) reported that they were only partially able to continue their daily routines, and 17 (27%) reported not being able to maintain daily routines at all. Upon noticing adverse effects, 58 (92%) of the respondents opted to refuse any further doses, but 29 (46%) of them were compelled to take further shots despite their symptoms of prior vaccine injury. A broad range of system disorders was reported, including, notably, neurological and cardiovascular problems. Respondents were asked to describe their experience with the medical system and the healthcare workers they called on for help. Results show that COVID-19 injectables elicited a broad range of severe symptoms, raising grave concerns about the dangers of the products and casting doubt on whether promised benefits outweigh the risks that are increasingly well-known. Dozens of vaccinees in this data set were gravely impacted and these cases can only represent a small fraction of the larger number of injuries that have already occurred and continue to occur in Finland alone. Further use of these and future products based on this gene therapy technology should be suspended or discontinued altogether and medical doctors must educate and prepare themselves to face the consequences of this worldwide public health disaster. Open and sincere debates on the implications for medical ethics and the risk-benefit ratio of this novel technology are warranted.

A Finnish Survey of Adverse Effects of COVID-19 Injectables and the Functionality of the Medical System

The declaration of the COVID-19 pandemic brought unprecedented containment measures across multiple countries, with the announced intent of saving lives. Among them was the rapid development of prophylactic vaccines, with the promise of no corners cut, but warning signals from safety monitoring systems around the world raised concerns. The current survey was undertaken to evaluate the Finnish medical system in light of adverse effects from COVID-19 vaccination. An online survey consisting of 96 questions (see Appendix) was promoted through social media. Persons believing they had been injured by any COVID-19 injectable contacted the second author who first verified the identity of the respondent and then gave that person the key to complete the questionnaire. The open period lasted from 5 March 2023 to 25 July 2023.: Out of 67 respondents 63 completed the survey and the collected data was analyzed. Of 63 respondents, 55 (87%) were females and 8 (13%) males. The majority, 56 (89%) of them, were fully employed, and 29 (46%) were social sector or medical professionals. None were previously “vaccine hesitant”. All received from 1 to 4 doses of COVID-19 injectable(s), and 19 (30%) reported doing so under duress. Despite having complied with mandatory vaccination, 13 of the individuals (21%) lost their jobs, and 13 (21%) changed their profession because of the shots. Of the vaccine recipients, 40 (63%) reported that they were only partially able to continue their daily routines, and 17 (27%) reported not being able to maintain daily routines at all. Upon noticing adverse effects, 58 (92%) of the respondents opted to refuse any further doses, but 29 (46%) of them were compelled to take further shots despite their symptoms of prior vaccine injury. A broad range of system disorders was reported, including, notably, neurological and cardiovascular problems. Respondents were asked to describe their experience with the medical system and the healthcare workers they called on for help. Results show that COVID-19 injectables elicited a broad range of severe symptoms, raising grave concerns about the dangers of the products and casting doubt on whether promised benefits outweigh the risks that are increasingly well-known. Dozens of vaccinees in this data set were gravely impacted and these cases can only represent a small fraction of the larger number of injuries that have already occurred and continue to occur in Finland alone. Further use of these and future products based on this gene therapy technology should be suspended or discontinued altogether and medical doctors must educate and prepare themselves to face the consequences of this worldwide public health disaster. Open and sincere debates on the implications for medical ethics and the risk-benefit ratio of this novel technology are warranted.

Is the US’s Vaccine Adverse Event Reporting System broken?

Is the US’s Vaccine Adverse Event Reporting System broken?

Abstract 13447: Political Orientation of Online Media Sources and Reporting of COVID-19 Vaccine Myocarditis

Background: Political orientation has played a role in patients' perceptions of risk associated with COVID-19 vaccination, including COVID-19 vaccine myocarditis (CVM). We examined the relationship between political orientation of popular online media outlets and reporting of CVM. Methods: Media sites were classified as “left” or “right" biased using the Allsides media bias rating report. For each site “COVID vaccine myocarditis” was searched in articles posted 5/21-12/22. Each search return was reviewed for the following: 1) Did it contain numerical data or reference the source of numerical data regarding CVM risk? 2) Did it report benefits of covid vaccination? 3) Did it mention covid infection -related myocarditis? Monthly reports of vaccine-related adverse events were obtained directly from the Vaccine Adverse Events Reporting System (VAERS). Correlations of reports of left- vs. right-leaning media were performed using Pearson Product Moment Correlation. Results: A total of 520 unique online reports regarding CVM were reviewed. Comparison of report volumes from left vs. right biased media sources by month during the assessment period demonstrated modest correlation (r=0.546, p=0.013), suggesting that monthly reporting volumes were driven by availability of information regarding CVM rather than media political alignment. Peak reporting across both left and right biased media was temporally proximate to peak volume of VAERS reporting. Left biased media sources were significantly more likely to include numerical data and/or links to source data vs. right biased sources (76.6% vs. 24.3%, p<0.001) and likewise were more likely to include data supporting benefits of covid vaccination (85.1% vs. 21.7%. p<0.001). In contrast, there was no difference regarding mention of COVID-19 infection-related myocarditis (24.5% vs. 24.3%, p=0.957). Conclusion: Political orientation of online news sites was not associated with frequency of CVM reports but was significantly related to report content, most notably whether reports included numerical vs verbal representations of CVM risk. These bias-related reporting characteristics may contribute to the relationship between political orientation and patient understanding of risk of CVM.

Tiza–Titre increase and enhanced immunity through an adjuvanted, recombinant herpes zoster subunit vaccine in patients with liver cirrhosis and post-liver transplantation: a study protocol for a prospective cohort study

IntroductionShingrix, an effective adjuvanted, recombinant herpes zoster vaccine (RZV), has been available since 2018. Immunocompromised patients are known to be predisposed to vaccine failure. In-vitro testing of immunological surrogates of...

Adverse events from HPV vaccination in Taiwan

The safety of human papillomavirus (HPV) vaccines has been evaluated continuously in pre-licensure clinical trials, post-marketing surveillance systems, and observational studies. Most studies have found no significant association between serious adverse events and HPV vaccination. However, these studies have focused on Western populations; similar studies focusing on Asian populations are insufficient. Our retrospective cohort study used the HPV-vaccination records of junior high-school adolescent girls aged 12–15 years between 2013 and 2018 in Taiwan’s National Immunization Information System and linked them to a registry for beneficiaries in Taiwan’s National Health Insurance Database (NHID) to establish the vaccinated group. We selected 19 serious diseases as serious adverse events. We compared the incidence rates of these serious adverse events between the vaccinated group and girls in the same age group population, and we calculated the standardized incidence ratio (SIR) to evaluate the risk of serious adverse events after HPV vaccination. Because of the onset of different types of diseases, we set three periods after the subjects received HPV vaccination: within 3 months, within 1 year, and during the study period (2013–2018). The results showed the incidence rates and the SIRs of 19 selected adverse events. Among the 19 selected serious adverse events, the disease with the highest incidence rate during the study period was fibromyalgia (73.23 cases per million population), and the disease with the lowest incidence rate during the study period was Crohn’s disease (0.15 cases per million population). The results showed no statistically significant increases in the risk of 19 selected serious adverse events and indicated no association between HPV vaccination and serious adverse events. Given the benefits and safety of HPV vaccination, our research can reduce concerns about vaccine side effects, inform health policies and improve public and clinician’s acceptance of HPV vaccine policy.

Citrobacter freundii-associated osteomyelitis and thromboembolic events following Moderna COVID-19 vaccination: a rare case report from Nepal.

Vaccination against coronavirus disease 2019 (COVID-19) is essential for controlling the ongoing cases of this disease. Citrobacter infections of the bones and joints are extremely uncommon. Thromboembolism and deep vein thrombosis (DVT) are very rare complications. The authors present a rare case of osteomyelitis, septic arthritis, deep venous thrombosis, and pulmonary embolism in a 15-year-old previously healthy boy occurring shortly after receiving the second dose of the Moderna COVID-19 vaccine. He experienced pain, swelling in the right leg, shortness of breath, and fever, followed by chest pain and leg edema. Treatment included anticoagulation, ketorolac for pain management, antipyretics, and intravenous antibiotics (Tazobactam/Piperacillin, Linezolid, Clindamycin) for osteomyelitis. The risk of COVID-19 vaccine-related thrombotic events is minimal. Thrombotic events reported among mRNA is very rare. Citrobacter freundii bone and joint infections are very rare, accounting for a small percentage of cases. Some documented cases include cefotaxime-resistant strains causing necrotizing fascitis and osteomyelitis, including postarthroplasty infections. Due to the diverse range of susceptibility patterns and the widespread occurrence of drug resistance, personalized treatment based on culture and sensitivity testing is recommended. However, in rare cases, severe complications like DVT and joint infections associated with Citrobacter infection may occur and should be reported to the vaccine adverse events reporting system. Administering the COVID-19 vaccine to enhance natural antibodies is crucial, despite the low risk of infection, thromboembolism, and DVT. Healthcare providers should stay vigilant about adverse effects postvaccination and promptly report those cases.

An Update in COVID-19 Vaccine Reactions in 2023: Progress and Understanding

An Update in COVID-19 Vaccine Reactions in 2023: Progress and Understanding

Breed, smaller weight, and multiple injections are associated with increased adverse event reports within three days following canine vaccine administration.

To evaluate patient and vaccine factors associated with adverse events (AEs) recorded within 3 days of vaccine administration in a large cohort of dogs. 4,654,187 dogs vaccinated in 16,087,455 office visits in a 5-year period at 1,119 hospitals of a corporate practice. Electronic medical records of dogs vaccinated between January 1, 2016, and December 31, 2020, were searched for diagnoses of possible AEs recorded within 3 days of administration of vaccines without concurrent injectable heartworm preventative. Patient risk factors (age, sex, breed, and weight) and number and type of vaccine were extracted from records. ORs (and 95% CIs) for risk factors were estimated via multivariable logistic regression mixed models with patient as a random effect. AEs were recorded following 31,197 vaccination visits (0.19%, or 19.4/10,000 visits). Reported AE rates increased from 1 to 4 vaccines administered and among individual vaccines were greatest for rabies vaccine. AE rate was generally inversely related to body weight, with largest rates in dogs ≤ 5 kg. The largest AE rates were noted in French Bulldogs and Dachshunds (ORs > 4 compared to mixed-breed dogs). Risk factor information can be used to update vaccination protocols and client communication. Breed differences may indicate genetics as the primary risk factor for adverse vaccine reactions following vaccinations.