Vaccine Adverse Event Research Articles

Insight of a headache medicine provider in Indian Health Service: A personal and professional observation

Dr. Larry Charleston IV has received personal compensation for serving as a consultant for Allergan/AbbVie, Alder/Lundbeck, Amneal, Biohaven, Haleon, LinPharma, Satsuma, and Teva; was on the advisory panel for Ctrl M Health (stock); received grant support from the Disparities in Headache Advisory Council; served as an Expert Witness for Vaccine Injury Compensation Program. He is a non-compensated associate editor for Headache: The Journal of Head and Face Pain and serves as a non-compensated Board Member-at-Large for the Clinical Neurological Society of America. Mary Michelle Herne serves as a non-compensated member of the Advanced Practice Provider Committee for Association of Migraine Disorders.

Antidote to Vaccine Injuries: “Green Bioelectronics” Generating Antioxidants Broadcasting 528 Frequency Resonance: Homeo/Alchemically-Prepared “Structured Water” Vibrating OxySilverTM Nutraceuticals

Antidote to Vaccine Injuries: “Green Bioelectronics” Generating Antioxidants Broadcasting 528 Frequency Resonance: Homeo/Alchemically-Prepared “Structured Water” Vibrating OxySilverTM Nutraceuticals

백신 부작용과 국가책임

Vaccines remain an unstable and controversial technology in South Korean society, as evidenced by the adverse event debate during the COVID-19 vaccine rollout. The Korean government's primary policy response to this has been to implement a comprehensive immunization compensation system that provides state-level compensation to those who experience harm, even if a direct causal link to vaccination cannot be proven. Although South Korea's immunization compensation system was enacted in 1994 and fully implemented in 1995, government, medical, and public debates surrounding it have been ongoing since the mass vaccination campaigns of Korea. This study examines how attempts to manage vaccine adverse events in Korea have been shaped by conflicts between government, medical professionals, and the public over vaccination, particularly over adverse events. At the same time, the technical limitations of each vaccine led to questions of safety, and these limitations shaped the public's perceptions of effectiveness and trust in individual vaccines. This study focuses on three of the most widely recognized vaccine-related adverse reactions: the typhoid vaccine of the 1960s, the DPT vaccine of the 1970s, and the Japanese encephalitis vaccine of the 1990s. These cases reveal that state-oriented disease control initiatives were not always successful in mobilizing the public and medical personnel unilaterally, but rather that there were various resistances and backlash, requiring detailed policies such as “no-fault” compensation systems to manage them. Furthermore, these cases suggest that for future systematic vaccine policy formulation, it is necessary to build a historical understanding of the technical limitations of individual vaccines and the experiences and responses to their adverse effects, rather than analyzing vaccine policy as a single entity.

Some aspects of the safety of Russian vaccines against COVID-19 in employees of medical organizations

Medical staff and teachers are at high risk of infection. In this connection, it seems relevant to study the effectiveness of the safety of preventive measures aimed at reducing the incidence. A separate issue of which is the results of vaccination of risk groups for infection with SARS-CоV2. The purpose of the study is to evaluate the frequency of registration of post-vaccination reactions of various vaccines against COVID-19 approved for use in Russia among medical staff and faculty of medical higher educational institutions (HEI). A cross-sectional, retrospective, cross-sectional online study was conducted between January and March 2022. The survey involved the teaching staff and medical workers of medical higher educational institutions (HEI) and their subordinate clinics (n = 6032). The majority of vaccinated employees of medical institutions and medical schools had a good tolerability of immunization.Serious adverse events were not registered. A higher incidence of PE and NE was observed in respondents after the first vaccination (p < 0.05). Most often, respondents reported an increase in body temperature (6.9–21.7 %), myalgia (5.5–21.2 %), general weakness (8.4–23.6 %), arthralgia (1.7–9.7 %), local reactions (0.8–16.7 %). In more than 85 % of cases, the above complaints were detected in the first 3 days from the moment of vaccination. A history of COVID-19 infection increased the risk of local and systemic adverse reactions. Gender characteristics of the post-vaccination reaction were revealed, manifested by more frequent registration of NE and PE in men under 35. An inverse relationship between the frequency of NE and PE with age was determined. The presence of comorbid pathology in two or more systems, regardless of age, increased the risk (OR) of various PE and NE from 1.047 to 1.539. The results can be used as an additional tool when planning a personalized approach to vaccinating healthcare workers against COVID-19.

Polyethylene Glycol and Polysorbate 80 Skin Tests in the Context of an Allergic Risk Assessment for Hypersensitivity Reactions to Anti-SARS-CoV-2 mRNA Vaccines.

Concern has arisen about hypersensitivity reactions in patients with allergic reactions to drugs containing polyethylene glycol (PEG) or polysorbate 80 (PS80), excipients of currently available anti-SARS-CoV-2 mRNA vaccines. However, the actual utility of PEG and PS80 skin allergy testing is currently still debated. We retrospectively analyzed all cases of patients on whom we performed allergometric skin tests for PEG and PS80 in the context of a pre-vaccination screening (for patients with multiple hypersensitivity reactions to drugs for which these excipients were among the suspected agents) or following suspected hypersensitivity reactions to anti-SARS-CoV-2 vaccines. A total of 134 tests were performed for PEG and PS80, eight of which produced uninterpretable results (due to dermographism or non-specific reactions). Of the remaining 126 cases (85 pre-vaccinal and 41 post-vaccine reactions), 16 (12.7%) were positive for PEG and/or PS80. Stratifying by clinical indication, there were no statistically significant differences in the proportion of positive tests between patients evaluated in the context of the pre-vaccination screening and those evaluated after a vaccine reaction (10.6% vs. 17.1%, respectively, p = 0.306). Allergometric skin tests for PEG and PS80 in our case series resulted positive in an unexpectedly high proportion of patients, suggesting that testing for allergy to these two excipients should not be ignored in case of reasonable clinical suspicion.

VACCINE INJURY COMPENSATION MECHANISM FOR ADVERSE EVENTS CAUSED BY COVID-19 VACCINES IN SOUTHEAST ASIAN COUNTRIES

Adverse events following immunization (AEFI) or vaccine injury is an issue of great concern in many nations, including Malaysia. This issue has long attracted the public's interest, but the emergence of COVID-19 disease has triggered greater interest as nations engaged in mass vaccination programs for their citizens. This is further exacerbated by the growing dissatisfaction with the traditional tort litigation system which necessitates exploring alternative ways to deal with vaccine injury cases. While the vaccine injury compensation program (VICP) has been implemented in several countries to compensate affected individuals following vaccination, not all VICP can cater to public health emergencies, especially regarding vaccine COVID-19. Malaysia, for example, has a similar program known as Special Financial Assistance Vaccine (SFA), which allows individuals to receive financial assistance if they suffer from AEFI COVID-19. Thus, this paper is intended to review and analyse the VICP in Southeast Asian countries and its implementation in Malaysia. This qualitative research was based on document review and comparative methodologies by exploring the VICP in Southeast Asia and similar mechanism in Malaysia to enrich the subject matter of the vaccine COVID-19 liability. The finding shows that the VICP program seems to be a great alternative in dealing with vaccine injury cases, especially in addressing the growing dissatisfaction with the traditional tort litigation system. Malaysia, Singapore and Thailand has its own VICP for affected individuals with COVID-19 vaccines while Myanmar, Cambodia, Timor-Leste, Indonesia, Vietnam, and the Philippines is under COVID-19 vaccine injury compensation scheme by COVID-19 Vaccines Global Access (COVAX) offered in 92 low- and middle-income nations.

Neurological Manifestations Post-COVID-19 Vaccination: A Review of Case Studies (P12-3.010)

<h3>Objective:</h3> To discern the central (CNS) and peripheral nervous system (PNS) manifestations associated with COVID-19 vaccines from individual case studies and describe their clinical and imaging findings, management, and outcomes. <h3>Background:</h3> With ten vaccines approved by the World Health Organization (WHO) and nearly 64% of people fully vaccinated worldwide, we have observed several neurological presentations post-COVID-19-vaccination, such as acute disseminated encephalomyelitis (ADEM), which have been reported in the Vaccine Adverse Event Reporting System (VAERS) and the Medicines and Healthcare products Regulatory Agency (MHRA). <h3>Design/Methods:</h3> A thorough literature search of Google Scholar and PubMed was conducted from December 2020 to October 2021, which included case reports of neurological complications with the following COVID-19 vaccines: Pfizer-BioNTech, Moderna, J&amp;J/Janssen, AstraZeneca, Sinovac-CoronaVac, Sputnik V, and COVAXIN. <h3>Results:</h3> Among the 51 cases, AstraZeneca was the most frequently administered vaccine (28, 55%), followed by Pfizer-BioNTech (8, 16%), Moderna (2,4%), Janssen (2,4%), Sputnik (1, 2%), and COVAXIN (1, 2%). The most common CNS manifestation was cerebral venous sinus thrombosis (CVST) (n=14) in females (64%) younger than 50 years (71%) after the first AstraZeneca dose (93%). Others included CNS demyelinating disorders [transverse myelitis, ADEM, multiple sclerosis, and neuromyelitis optica] (n=9), encephalopathy/encephalitis (n=3), seizures (n=3), and aseptic meningoencephalitis (n=1). The most common PNS manifestation was Guillain–Barré syndrome (GBS) (n=14) in males (71%) older than 50 years (79%), followed by Bell’s palsy (n=5), small fiber neuropathy (n=1), and phantosmia (n=1); most of these occurred with AstraZeneca (28.55%) and Pfizer-BioNTech (9.18%). IVIG and steroids were the treatment of choice. Nine out of the 14 patients with CVST (64%) died. However, most cases overall (42 out of 51) were non-fatal (82%). <h3>Conclusions:</h3> Several post-marketing CNS and PNS adverse events have occurred following the COVID-19 vaccination, including CVST, GBS, and TM. Further studies with non-vaccinated controls might help understand the pathophysiologic mechanisms of these neurological manifestations. <b>Disclosure:</b> Miss Beard has nothing to disclose. Kanika Sharma has nothing to disclose. Dr. Sharma has nothing to disclose. Dr. Basha has nothing to disclose. Mr. JHA has nothing to disclose. Dr. Sriwastava has nothing to disclose.

A Prospective Natural History Study of Patients with Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP) (S49.008)

A Prospective Natural History Study of Patients with Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP) (S49.008)

Association of Daily Physical Activity with Cervical Spinal Cord Areas in Multiple Sclerosis (S27.009)

Association of Daily Physical Activity with Cervical Spinal Cord Areas in Multiple Sclerosis (S27.009)

Interim Analysis of Subject Impression Data for STS101 From the Phase 3 Open-Label ASCEND Study (P13-12.003)

Interim Analysis of Subject Impression Data for STS101 From the Phase 3 Open-Label ASCEND Study (P13-12.003)

Application of Phosphorylated Alpha Synuclein (p-syn) Skin Biopsy in Clinical Practice: Audit at an Academic Medical Center (P8-9.004)

<h3>Objective:</h3> To assess how p-syn skin biopsy is being applied clinically by auditing its use in an academic medical center. <h3>Background:</h3> Cutaneous deposition of p-syn is found in synucleinopathies including Parkinson’s disease (PD), multiple system atrophy (MSA), dementia with Lewy body (DLB), and pure autonomic failure (PAF). Skin biopsy assessing for the presence of p-syn is an emerging diagnostic tool with reported good sensitivity and high specificity for detecting synucleinopathies. Commercial cutaneous testing for p-syn is now available in the US, though not yet in widespread clinical use despite its minimally invasive nature and relative accessibility in comparison to other testings such as DaTscan and MIBG myocardial scintigraphy. <h3>Design/Methods:</h3> All patients followed at our center who had undergone p-syn skin biopsy since its commercial availability were identified and their electronic medical records reviewed. <h3>Results:</h3> 10 patients underwent skin biopsies for p-sync from June 2021 to August 2022. 7 had isolated autonomic dysfunction; 2 had parkinsonism but potential alternative explanations (i.e. hydrocephalus, antidopaminergic medications), and 1 had speech apraxia with a question of Alzheimer or DLB. 5 of 7 patients with autonomic dysfunction had positive biopsies, obviating the search for other etiologies such as autoimmune disease or amyloidosis. The other 3 patients were also found to be p-sync positive. Affirming this diagnosis positively impacted subsequent monitoring and management and enabled accurate prognostication. <h3>Conclusions:</h3> Skin biopsy is a useful tool for diagnosing synucleinopathy in patients presenting with autonomic dysfunction. It can also add diagnostic value in patients with parkinsonism and other potential competing explanations. <b>Disclosure:</b> Dr. Wang has nothing to disclose. Dr. Robbins has received personal compensation in the range of $0-$499 for serving as a Consultant for Guidepoint Global Inc. The institution of Dr. Robbins has received research support from Diamond Endowment Fund. The institution of Dr. Robbins has received research support from Reeves Endowment Fund. The institution of Dr. Robbins has received research support from Institute for Ethnomedicine. The institution of Dr. Robbins has received research support from Dartmouth Hitchcock Swigart Ethics Fellowship. Dr. Robbins has received personal compensation in the range of $10,000-$49,999 for serving as a Neurohospitalist with Hayes Locums. Dr. Robbins has received personal compensation in the range of $10,000-$49,999 for serving as a Medical Expert with Vickery &amp; Shepherd. Dr. Robbins has received personal compensation in the range of $10,000-$49,999 for serving as a Medical Expert with Vaccine Injury Compensation Program. Dr. Robbins has received personal compensation in the range of $10,000-$49,999 for serving as a Medical Expert with Kraft Davies PLLC. Dr. Robbins has received personal compensation in the range of $500-$4,999 for serving as a Medical Expert with Northwestern University.

Real Life Approach to Outpatient Treatment of Status Migrainosus: A Survey Study (P3-12.012)

Real Life Approach to Outpatient Treatment of Status Migrainosus: A Survey Study (P3-12.012)

Real-world effectiveness of switching treatment after initial platform injectable disease-modifying therapies in pediatric multiple sclerosis in the US (P14-3.008)

Real-world effectiveness of switching treatment after initial platform injectable disease-modifying therapies in pediatric multiple sclerosis in the US (P14-3.008)

Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Black and African American Adults: Results From 3 Randomized, Placebo-Controlled Clinical Trials (P9-12.009)

Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Black and African American Adults: Results From 3 Randomized, Placebo-Controlled Clinical Trials (P9-12.009)

Longitudinal Cognitive Screening Findings in Pediatric MS vs. Pediatric Controls and Adult MS in a Multi-center Cohort (S31.008)

Longitudinal Cognitive Screening Findings in Pediatric MS vs. Pediatric Controls and Adult MS in a Multi-center Cohort (S31.008)

Nivolumab-induced Central Nervous System (CNS) Vasculitis Brought on by a Steroid Taper (P12-13.003)

<h3>Objective:</h3> To illustrate a case of nivolumab-induced CNS vasculitis that developed while tapering steroids and was successfully treated expectantly without immunosuppression <h3>Background:</h3> Immune checkpoint inhibitors (ICIs) with anti-PD-1/PD-L1 and anti-CTLA4 activity are associated with CNS vasculitis. Generally, both intra- and extracranial vasculitides are treated with steroids <h3>Design/Methods:</h3> N/A <h3>Results:</h3> A 75 year-old male received two months of concurrent chemoradiation with weekly carboplatin/paclitaxel for esophageal adenocarcinoma. Esophagectomy was considered, but the patient opted for active surveillance. Three years later, enlarging lung nodules heralded recurrent, metastatic esophageal cancer. Treatment with FOLFOX and nivolumab was initiated. Six months later, due to worsening fatigue, he was transitioned to nivolumab monotherapy. Over the following two weeks, he developed progressive dyspnea. Work-up suggested ICI-associated pneumonitis, and he was started on 50 mg prednisone, with weekly taper. A month later, at 30 mg daily, he developed confusion and was hospitalized. A brain MRI revealed multifocal lesions, some with ring-enhancement, concerning for metastases or abscess. Cerebellar biopsy demonstrated small-vessel CNS vasculitis, but given clinical improvement without treatment the patient was managed expectantly and returned back to baseline over two weeks <h3>Conclusions:</h3> This case of biopsy-proven ICI-associated CNS vasculitis developed while tapering steroids, and was treated conservatively. Steroids are first-line treatment for vasculitis; the development of vasculitis while tapering steroids thus raises the possibility of a rebound effect facilitating the development of vasculitis. Cases of CNS vasculitis that started while tapering steroids have been infrequently reported in the literature, but to our knowledge this is the first description of this phenomenon with ICI-associated CNS vasculitis. Additionally, this patient underwent biopsy with concern for metastasis or abscess, but ultimately did not necessitate treatment for vasculitis. This raises the possibility that active surveillance is a reasonable management strategy in cases of self-resolving ICI-associated CNS vasculitis <b>Disclosure:</b> Dr. Karbhari has nothing to disclose. Dr. Galindo Mendez has nothing to disclose. Dr. Robbins has received personal compensation in the range of $0-$499 for serving as a Consultant for Guidepoint Global Inc. The institution of Dr. Robbins has received research support from Diamond Endowment Fund. The institution of Dr. Robbins has received research support from Reeves Endowment Fund. The institution of Dr. Robbins has received research support from Institute for Ethnomedicine. The institution of Dr. Robbins has received research support from Dartmouth Hitchcock Swigart Ethics Fellowship. Dr. Robbins has received personal compensation in the range of $10,000-$49,999 for serving as a Neurohospitalist with Hayes Locums. Dr. Robbins has received personal compensation in the range of $10,000-$49,999 for serving as a Medical Expert with Vickery &amp; Shepherd. Dr. Robbins has received personal compensation in the range of $10,000-$49,999 for serving as a Medical Expert with Vaccine Injury Compensation Program. Dr. Robbins has received personal compensation in the range of $10,000-$49,999 for serving as a Medical Expert with Kraft Davies PLLC. Dr. Robbins has received personal compensation in the range of $500-$4,999 for serving as a Medical Expert with Northwestern University.

Before and After: Attitude and Adverse Effects Induced by the First and Second Doses of mRNA BNT162b2 Vaccine among Healthcare Professionals in the First Weeks after Their Introduction in Poland.

In the last days of December 2020, the SARS-CoV-2 virus vaccine BNT162b2 (Comirnaty, Pfizer-BioNTech) was introduced, for the first time, for wide use in Poland. According to the vaccination schedule, healthcare workers were the first to receive the vaccine. The aim of this study was to analyse the attitudes of those who were determined to be vaccinated, with particular reference to their concerns, attitudes towards vaccination advocacy and sources of knowledge on vaccination, as well as the incidence of adverse reactions. The study had a three-stage design. Respondents completed a self-administered questionnaire before receiving the 1st and 2nd vaccine doses and 2 weeks after receiving the 2nd dose. A total of 2247 responses were obtained (1340 responses in the first stage, 769 in the second and 138 in the third). The main source of knowledge on vaccination was the Internet (32%; n = 428). Of the respondents, 6% (n = 86) reported anxiety before the 1st dose of the vaccine, which increased to 20% (n = 157) before the 2nd dose. A declaration of willingness to promote vaccination among their families was made by 87% (n = 1165). Among adverse reactions after the 1st dose of the vaccine, respondents most frequently observed pain at the injection site (n = 584; 71%), fatigue (n = 126; 16%) and malaise (n = 86; 11%). The mean duration of symptoms was 2.38 days (SD 1.88). After the 2nd dose of vaccine, similar adverse reactions-pain at the injection site (n = 103; 75%), fatigue (n = 28; 20%), malaise (n = 22; 16%)-predominated among respondents. Those who declared having had a SARS-CoV-2 virus infection (p = 0.00484) and with a history of adverse vaccination reactions (p = 0.00374) were statistically more likely to observe adverse symptoms after vaccination. Adverse postvaccinal reactions are relatively common after Comirnaty vaccination but are usually mild and transient in nature. It is in the interest of public health to increase the knowledge of vaccine safety.

COVID-19 Vaccine Safety First Year Findings in Adolescents.

The Food and Drug Administration expanded Emergency Use Authorization for use of Pfizer-BioNTech (BNT-162b2) coronavirus disease 2019 vaccine to include people ages 12 years and older on May 10, 2021. We describe adverse events observed during the first full year of the US coronavirus disease 2019 vaccination program for adolescents ages 12 to 17 years. We conducted descriptive analyses using data from 2 complementary US vaccine safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health impacts, and the Vaccine Adverse Event Reporting System (VAERS), the national spontaneous reporting system. We reviewed reports and calculated adverse event reporting rates using vaccine administration data. Among 172 032 adolescents ages 12 to 17 years enrolled in v-safe, most reported reactions following BNT-162b2 were mild to moderate, most frequently reported on the day after vaccination, and more common after dose 2. VAERS received 20 240 adverse event reports; 91.5% were nonserious. Among adverse events of interest, we verified 40 cases of multisystem inflammation syndrome in children (1.2 cases per million vaccinations), 34 (85%) of which had evidence of prior severe acute respiratory syndrome coronavirus 2 infection; and 570 cases of myocarditis (17.7 cases per million vaccinations), most of whom (77%) reported symptom resolution at the time of report. During the first year BNT-162b2 was administered to adolescents ages 12 to 17 years, most reported adverse events were mild and appeared self-limited. Rates of myocarditis were lower than earlier reports. No new serious safety concerns were identified.

Threat of resurgence or hope for global eradication of poliovirus?

Recent outbreaks of poliomyelitis in countries that have been free of cases for decades highlight the challenges of eradicating polio in a globalized interconnected world beset with a novel viral pandemic. We provide an epidemiological update, advancements in vaccines, and amendments in public health strategy of poliomyelitis in this review. Last year, new cases of wild poliovirus type 1 (WPV1) were documented in regions previously documented to have eradicated WPV1 and reports of circulating vaccine-derived poliovirus type 2 (cVDPV2) and 3 (cVDPV3) in New York and Jerusalem made international headlines. Sequencing of wastewater samples from environmental surveillance revealed that the WPV1 strains were related to WPV1 lineages from endemic countries and the cVDPV2 strains from New York and Jerusalem were not only related to each other but also to environmental isolates found in London. The evidence of importation of WPV1 cases from endemic countries, and global transmission of cVDPVs justifies renewed efforts in routine vaccination programs and outbreak control measures that were interrupted by the COVID-19 pandemic. After the novel oral poliovirus vaccine type 2 (nOPV2) received emergency authorization for containment of cVDPV2 outbreaks in 2021, subsequent reduced incidence, transmission rates, and vaccine adverse events, alongside increased genetic stability of viral isolates substantiates the safety and efficacy of nOPV2. The nOPV1 and nOPV3 vaccines, against type 1 and 3 cVDPVs, and measures to increase accessibility and efficacy of inactivated poliovirus vaccine (IPV) are in development. A revised strategy utilizing more genetically stable vaccine formulations, with uninterrupted vaccination programs and continued active surveillance optimizes the prospect of global poliomyelitis eradication.

Signal detection of COVID-19 vaccines adverse events using spontaneous reports from South Korea.

Studies on the detection of COVID-19 vaccine signals in South Korea are insufficient. Therefore, to investigate adverse events (AEs) that might be associated with COVID-19 vaccines, signals were detected using spontaneous reports from South Korea. We compared the signals with the vaccine insert lists of the regulators in the four countries. Spontaneous reports from 62 sites were collected by the National Medical Center between January 2013 and May 2022. A descriptive analysis of AEs associated with COVID-19 vaccines (Pfizer, Moderna, AstraZeneca, and Janssen) was performed, and the proportional reporting ratio, reporting odds ratio, and information component were calculated. We performed five analyses, with five cases and one control group. During the study period, 68,355 cases were reported, of which 12,485 were COVID-19 vaccine AEs. Injection site pain (2,198 cases, 17.6%), myalgia (1,552 cases, 12.4%), headache (1,145 cases, 9.2%), pyrexia (1,003 cases, 8.0%), and fatigue (735 cases, 5.9%) were frequently reported. When comparing all COVID-19 vaccines with other viral vaccines, 20 signals were detected, of which cachexia, dyspepsia, abdominal discomfort, and mood swings were not listed on the vaccine inserts in all four countries. Overall, 20, 17, 29, and 9 signals were detected in vaccines developed by Pfizer, Moderna, AstraZeneca, and Janssen, respectively. Based on a disproportionate analysis of COVID-19 vaccine AEs using spontaneous reports from South Korea, different signals were detected for each vaccine manufacturer.