Post-authorization safety surveillance of Ad.26.COV2.S vaccine: Reports to the Vaccine Adverse Event Reporting System and v-safe, February 2021-February 2022.

BACKGROUND: On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system. METHODS: VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated. RESULTS: During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell's Palsy, and Guillain-Barré syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18-64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care. CONCLUSION: Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis.

Vaccine hesitancy in the post-vaccination COVID-19 era: a machine learning and statistical analysis driven study.

Background The COVID-19 pandemic has badly affected people of all ages globally. Therefore, its vaccine has been developed and made available for public use in unprecedented times. However, because of various levels of hesitancy, it did not have general acceptance. The main objective of this work is to identify the risk associated with the COVID-19 vaccines by developing a prognosis tool that will help in enhancing its acceptability and therefore, reducing the lethality of SARS-CoV-2. Methods: The obtained raw VAERS dataset has three files indicating medical history, vaccination status, and post vaccination symptoms respectively with more than 354 thousand samples. After pre-processing, this raw dataset has been merged into one with 85 different attributes however, the whole analysis has been subdivided into three scenarios ((i) medical history (ii) reaction of vaccination (iii) combination of both). Further, Machine Learning (ML) models which includes Linear Regression (LR), Random Forest (RF), Naive Bayes (NB), Light Gradient Boosting Algorithm (LGBM), and Multilayer feed-forward perceptron (MLP) have been employed to predict the most probable outcome and their performance has been evaluated based on various performance parameters. Also, the chi-square (statistical), LR, RF, and LGBM have been utilized to estimate the most probable attribute in the dataset that resulted in death, hospitalization, and COVID-19. Results: For the above mentioned scenarios, all the models estimates different attributes (such as cardiac arrest, Cancer, Hyperlipidemia, Kidney Disease, Diabetes, Atrial Fibrillation, Dementia, Thyroid, etc.) for death, hospitalization, and COVID-19 even after vaccination. Further, for prediction, LGBM outperforms all the other developed models in most of the scenarios whereas, LR, RF, NB, and MLP perform satisfactorily in patches. Conclusion: The male population in the age group of 50-70 has been found most susceptible to this virus. Also, people with existing serious illnesses have been found most vulnerable. Therefore, they must be vaccinated in close observations. Generally, no serious adverse effect of the vaccine has been observed therefore, people must vaccinate themselves without any hesitation at the earliest. Also, the model developed using LGBM establishes its supremacy over all the other prediction models. Therefore, it can be very helpful for the policymakers in administrating and prioritizing the population for the different vaccination programs.

Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis.

PURPOSE: To assess the risk of vaccine-associated uveitis (VAU) after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination and evaluate uveitis onset interval and clinical presentations in the patients. DESIGN: A retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention Vaccine Adverse Event Reporting System. PARTICIPANTS: Patients diagnosed with VAU after administration of BNT162b2 (Pfizer-BioNTech, Pfizer Inc/BioNTech SE), mRNA-1273 (Moderna, Moderna Therapeutics Inc), and Ad26.COV2.S (Janssen, Janssen Pharmaceuticals) vaccine worldwide. METHODS: A descriptive analysis of the demographics, clinical history, and presentation was performed. We evaluated the correlation among the 3 vaccines and continuous and categorical variables. A post hoc analysis was performed between uveitis onset interval after vaccination and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset postvaccination was performed. MAIN OUTCOME MEASURES: The estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration. RESULTS: A total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n = 853, 77.97%). The mean age of patients with VAU was 46.24 ± 16.93 years, and 68.65% (n = 751) were women. Most cases were reported after the first dose (n = 452, 41.32%) and within the first week (n = 591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22 ± 42.74 days) compared with BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (P < 0.0001). The post hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared with the mRNA 1273 vaccine (P < 0.0001). The 30-day risk analysis showed a significant difference among the 3 vaccines (P < 0.0001). CONCLUSIONS: The low crude reporting rate and observed to expected ratio suggest a low safety concern for VAU. This study provides insights into a possible temporal association between reported VAU events and SARS-CoV-2 vaccines; however, further investigations are required to delineate the associated immunological mechanisms.

Covid-19 Vaccine safety and adverse event analysis from Pakistan

Covid immunization commenced on 2nd Feb 2021 in Pakistan and as of 7th Sep 2021, over 84 million vaccine doses were administered in Pakistan, of which 72% procured by the government, 22% received through Covax and 6% were donated. The vaccines rolled out nationally included: Sinopharm, Sinovac and CanSinoBIO (China), AstraZeneca (UK), Moderna and Pfizer (USA), Sputnik (Russia), and PakVac (China/Pakistan). About half of the eligible population in Pakistan (63 m) had received at least one dose of Covid vaccine as of Sep 2021. Pakistan National Pharmacovigilance Centre (PNPC) in coordination with WHO, MHRA and Uppsala Monitoring Centre (UMC) established pharmacovigilance centers across Pakistan. The Covid vaccine AEFIs in Pakistan were mainly reported via NIMS (National Immunization Management System), COVIM (Covid-19 Vaccine Inventory Management System), 1166 freephone helpline and MedSafety. There have been 39,291 ADRs reported as of 30th Sept 2021, where most reported after the first dose (n = 27,108) and within 24-72 h of immunization (n = 27,591). Fever or shivering accounted for most AEFI (35%) followed by injection-site pain or redness (28%), headache (26%), nausea/vomiting (4%), and diarrhoea (3%). 24 serious AEFIs were also reported and investigated in detail by the National AEFI review committee. The rate of AEFIs reports ranged from 0.27 to 0.79 per 1000 for various Covid vaccines in Pakistan that was significantly lower than the rates in UK (~4 per 1000), primarily atrributed to underreporting of cases in Pakistan. Finally, Covid vaccines were well tolerated and no significant cause for concern was flagged up in Pakistan's Covid vaccine surveillance system concluding overall benefits outweighed risks.Copyright © 2022

The conundrum of COVID-19 mRNA vaccine-induced anaphylaxis.

Novel messenger RNA (mRNA) vaccines have proven to be effective tools against coronavirus disease 2019, and they have changed the course of the pandemic. However, early reports of mRNA vaccine-induced anaphylaxis resulted in public alarm, contributing toward vaccine hesitancy. Although initial reports were concerning for an unusually high rate of anaphylaxis to the mRNA vaccines, the true incidence is likely comparable with other vaccines. These reactions occurred predominantly in young to middle-aged females, and many had a history of allergies. Although initially thought to be triggered by polyethylene glycol (PEG), lack of reproducibility of these reactions with subsequent dosing and absent PEG sensitization point away from an IgE-mediated PEG allergy in most. PEG skin testing has poor posttest probability and should be reserved for evaluating non-vaccine-related PEG allergy without influencing decisions for subsequent mRNA vaccination. Immunization stress-related response can closely mimic vaccine-induced anaphylaxis and warrants consideration as a potential etiology. Current evidence suggests that many individuals who developed anaphylaxis to the first dose of an mRNA vaccine can likely receive a subsequent dose after careful evaluation. The need to understand these reactions mechanistically remains critical because the mRNA platform is rapidly finding its way into other vaccinations and therapeutics.

Reporting rates for VAERS death reports following COVID-19 vaccination, December 14, 2020-November 17, 2021.

PURPOSE: Despite widely available safety information for the COVID-19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of reports of death to the Vaccine Adverse Event Reporting System (VAERS). We aimed to provide information and context about reports of death to VAERS following COVID-19 vaccination. METHODS: This is a descriptive study evaluating reporting rates for VAERS death reports for COVID-19 vaccine recipients in the United States between December 14, 2020, and November 17, 2021. Reporting rates were calculated as death events per million persons vaccinated and compared to expected all-cause (background) death rates. RESULTS: 9201 death events were reported for COVID-19 vaccine recipients aged 5 years and older (or age unknown). Reporting rates for death events increased with increasing age, and males generally had higher reporting rates than females. For death events within 7 days and 42 days of vaccination, respectively, observed reporting rates were lower than the expected all-cause death rates. Reporting rates for Ad26.COV2.S vaccine were generally higher than for mRNA COVID-19 vaccines, but still lower than the expected all-cause death rates. Limitations of VAERS data include potential reporting bias, missing or inaccurate information, lack of a control group, and reported diagnoses, including deaths, are not causally verified diagnoses. CONCLUSIONS: Reporting rates for death events were lower than the all-cause death rates expected in the general population. Trends in reporting rates reflected known trends in background death rates. These findings do not suggest an association between vaccination and overall increased mortality.

Reports of Guillain-Barre Syndrome Following COVID-19 Vaccination in the USA: An Analysis of the VAERS Database.

BACKGROUND AND PURPOSE: An association between Guillain-Barre syndrome and its variants (GBS/V) and vaccines has led to hesitancy toward vaccination. COVID-19 vaccines could theoretically provoke GBS/V via immune activation. We analyzed reports of GBS/V after COVID-19 vaccination in the vaccine adverse event reporting system (VAERS). METHODS: The VAERS database is a surveillance system used to report vaccination events in the USA, and is open for consumers and physicians to access. It was queried for reports of GBS/V following COVID-19 vaccination. Reports were reviewed by four neurologists. Modified diagnostic criteria were used to classify reports into definite, possible, and not GBS/V or insufficient data. Descriptive statistics were used to describe the sample, chi-square tests and one-way ANOVAs were used to compare intergroup differences, and t-test were used to compare group means. RESULTS: In 2021, 815 reports of GBS/V were filed. The completion rate for the variables in VAERS was 93.5%. The median age was 55 years (interquartile range [IQR]=5-86 years) and 50% of the subjects were male. The median time of onset was 10 days (IQR=0-298 days), 11% reported onset on the day of vaccination, and 13% reported onset after 6 weeks. Hospitalization was reported by 77%, with a median stay of 7 days (IQR=1-150 days). Lack of recovery, permanent disability, and death constituted 57%, 46%, and 2% of the reports, respectively. Based on GBS/V criteria, 47% of the cases were definite, 16% were possible, and 37% were not GBS/V or insufficient data. An alternate diagnosis was provided in 9% of cases. CONCLUSIONS: GBS/V reports following COVID-19 vaccination were common, but many occurred outside of the expected timelines for GBS/V. Only 47% of cases represented definite GBS/V.

Mining adverse events in large frequency tables with ontology, with an application to the vaccine adverse event reporting system.

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. The AE ontology contains important information about biological similarities between AEs. In this paper, we develop a model to estimate vaccine-AE associations while incorporating the AE ontology. We model a group of AEs using the zero-inflated negative binomial model and then estimate the vaccine-AE association using the empirical Bayes approach. This model handles the AE count data with excess zeros and allows borrowing information from related AEs. The proposed approach was evaluated by simulation studies and was further illustrated by an application to the Vaccine Adverse Event Reporting System (VAERS) dataset. The proposed method is implemented in an R package available at https://github.com/umich-biostatistics/zGPS.AO.

Vaccine confidence among those living with allergy during the COVID pandemic (ACCORD): A scoping review.

Background: Reports of allergic reactions to coronavirus disease 2019 (COVID-19) vaccines, coupled with an "infodemic" of misinformation, carry the potential to undermine confidence in the COVID-19 vaccines. However, no attempts have been made to comprehensively synthesize the literature on how allergic disease and fear of allergic reactions to the vaccines contribute to hesitancy. Objectives: Our aim was to review the academic and gray literature on COVID-19 vaccine hesitancy and allergic reactions. Methods: We searched 4 databases (CINAHL, PsycINFO, MEDLINE, and Embase) using a search strategy developed by content and methodologic experts. No restrictions were applied regarding COVID-19 vaccine type, country of study, or patient age. Eligible articles were restricted to 10 languages. Results: Of the 1385 unique records retrieved from our search, 60 articles (4.3%) were included. Allergic reactions to the COVID-19 vaccine were rare but slightly more common in individuals with a history of allergic disease. A fifth of the studies (13 of 60 [22%]) discussed vaccine hesitancy due to possibility of an allergic reaction. Additionally, the present review identified research on details of vaccine-related anaphylaxis (eg, a mean and median [excluding clinical trial data] of 12.4 and 5 cases per million doses, respectively) and allergic reactions (eg, a mean and median [excluding clinical trial data] of 489 and 528 cases per million doses, respectively). Conclusion: COVID-19 vaccine acceptance among individuals living with allergy and among those with no history of allergic disease may be affected by fear of an allergic reaction. Despite the low incidence of allergic reactions to the COVID-19 vaccine, fear of such reactions is one of the most commonly cited concerns reported in the literature.

Facial nerve palsy following the administration of COVID-19 mRNA vaccines: analysis of a self-reporting database.

OBJECTIVES: Facial nerve palsy (or Bell's palsy) has occasionally been reported following the administration of coronavirus disease 2019 (COVID-19) mRNA vaccines (BNT162b2 and mRNA-1273). Our study investigated such cases using a large self-reporting database from the USA (Vaccine Adverse Event Reporting System [VAERS]). METHODS: A disproportionality analysis, adjusted for age and sex, was conducted for VAERS reports from individuals who were vaccinated at the age of 18 years or over, between January 2010 and April 2021. RESULTS: The analysis revealed that the adverse events following immunization (AEFI) of facial nerve palsy, after administration of COVID-19 mRNA vaccines, was significantly highly reported, both for BNT162b2 (reporting odds ratio [ROR] 1.84; 95% confidence interval [CI] 1.65-2.06) and mRNA-1273 (ROR 1.54; 95% CI 1.39-1.70). These levels were comparable to that following influenza vaccination reported before the COVID-19 pandemic (ROR 2.04; 95% CI 1.76-2.36). CONCLUSIONS: Our pharmacovigilance study results suggest that the incidence of facial nerve palsy as a non-serious AEFI may be lower than, or equivalent to, that for influenza vaccines. This information might be of value in the context of promoting worldwide vaccination, but needs to be validated in future observational studies.

Glaucoma Cases Following SARS-CoV-2 Vaccination: A VAERS Database Analysis.

Background: To counter the rapidly spreading severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), global vaccination efforts were initiated in December 2020. We assess the risk of glaucoma following SARS-CoV-2 vaccination and evaluate its onset interval and clinical presentations in patients. Methods: We performed a retrospective analysis of the glaucoma cases reported to the Vaccine Adverse Event Reporting System (VAERS) database between 16 December 2020, and 30 April 2022. We assessed the crude reporting rate of glaucoma, clinical presentations, onset duration, and associated risk factors. Results: During this period, 161 glaucoma cases were reported, with crude reporting rates (per million doses) of 0.09, 0.06, and 0.07 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The mean age of the patients was 60.41 ± 17.56 years, and 67.7% were women. More than half (56.6%) of the cases were reported within the first week of vaccination. The cumulative-incidence analysis showed a higher risk of glaucoma in patients who received the BNT162b2 vaccines compared with mRNA-1273 (p = 0.05). Conclusions: The incidence of glaucoma following vaccination with BNT162b2, mRNA-1273, or Ad26.COV2.S is extremely rare. Amongst the patients diagnosed with glaucoma, the onset interval of adverse events was shorter among those who received the BNT162b2 and rAd26.COV2.S vaccines compared with mRNA-1273. Most glaucoma cases were reported within the first week following vaccination in female patients and from the fifth to seventh decade. This study provides insights into the possible temporal association between reported glaucoma events and SARS-CoV-2 vaccines; however, further investigations are required to identify the potential causality link and pathological mechanisms.

Vaccine adverse event reporting system (VAERS): Evaluation of 31 years of reports and pandemics' impact.

Background: Vaccine adverse event reporting system (VAERS) was established in the United States (U.S.) as an early warning system with a main purpose of collecting post-marketing Adverse events following immunizations (AEFIs) reports to monitor the vaccine safety and to mitigate the risks from vaccines. During the coronavirus diseases 2019 (COVID-19) pandemic, VAERS got more attention as its important role in monitoring the safety of the vaccines. The aim of this study was to investigate VAERS patterns, reported AEFI, vaccines, and impact of different pandemics since its inception. Methods: This was an observational study using VARES data from 2/7/1990 to 12/11/2021. Patterns of reports over years were first described, followed by a comparison of reports statistics per year. Furthermore, a comparison of incidents (death, ER visits, etc.) statistics over years, in addition to statistics of each vaccine were calculated. Moreover, each incident's statistics for each vaccine were calculated and top vaccines were reported. All analyses were conducted using R (Version 1.4.1717) and Excel for Microsoft 365. Results: There were 1,396,280 domestic and 346,210 non-domestic reports during 1990-2021, including 228 vaccines. For both domestic and non-domestic reports, year of 2021 had the highest reporting rate (48.52 % and 70.33 %), in addition a notable change in AEFIs patterns were recorded during 1991, 1998, 2000, 2006, 2009, 2011, and 2017. AEFIs were as follow: deaths (1.00 % and 4.08 %), ER or doctor visits (13.37 % and 2.27 %), hospitalizations (5.84 % and 27.78 %), lethal threat (1.42 % and 4.38 %), and disabilities (1.4 % and 7.96 %). Pyrexia was the top reported symptom during the past 31 years, except for 2021 where headache was the top one. COVID-19 vaccines namely Moderna, Pfizer-Biontech, and Janssen were the top 3 reported vaccines with headache, pyrexia, and fatigue as the top associated AEFIs. Followed by Zoster, Seasonal Influenza, Pneumococcal, and Human papillomavirus vaccines. Conclusions: The large data available in VARES make it a useful tool for detecting and monitoring vaccine AEFIs. However, its usability relies on understating the limitations of this surveillance system, the impact of governmental regulations, availability of vaccines, and public health recommendations on the reporting rate.

COVID-19 vaccine and menstrual conditions in female: data analysis of the Vaccine Adverse Event Reporting System (VAERS).

BACKGROUND: In reports of adverse reactions following vaccination with the coronavirus disease 2019(COVID-19) vaccines, there have been fewer reports of concern for menstrual disorders in female. OBJECTIVE: Our study employed Vaccine Adverse Event Reporting System (VAERS) to investigate and analyze the relationship between COVID-19 Vaccines and menstrual disorders in female. METHODS: We collected reports of menstrual disorders in VAERS from July 2, 1990 to November 12, 2021, and performed a stratified analysis. The potential relationship between COVID-19 vaccine and reports of menstrual disorders was evaluated using the Reporting Odds Ratio (ROR) method. RESULTS: A total of 14,431 reports of menstrual disorders were included in the study, and 13,118 were associated with COVID-19 vaccine. The ROR was 7.83 (95% confidence interval [95%CI]: 7.39-8.28). The most commonly reported event was Menstruation irregular (4998 reports), and a higher percentage of female aged 30-49 years reported menstrual disorders (42.55%) after exposure to COVID-19 Vaccines. Both for all reports of menstrual disorders (ROR = 5.82; 95%CI: 4.93-6.95) and excluding reports of unknown age (ROR = 13.02; 95%CI: 10.89-15.56),suggest that female age may be associated with menstrual disorders after vaccination with the COVID-19 Vaccines. CONCLUSION: There is a potential safety signal when the COVID-19 vaccine is administered to young adult female (30-49 years old), resulting in menstrual disorders in. However, due to the well-known limitations of spontaneous reporting data, it is challenging to explicity classify menstrual disorders as an adverse event of the COVID-19 Vaccines, and reports of adverse reactions to COVID-19 Vaccines in this age group should continue to be tracked.

Venous Thromboembolism following Two Doses of COVID-19 mRNA Vaccines in the US Population, 2020-2022.

The COVID-19 mRNA vaccine is one of the most effective strategies used to fight against COVID-19. Recently, venous thromboembolism (VTE) events after COVID-19 mRNA vaccination have been reported in various research. Such a concern may hamper the ongoing COVID-19 vaccination campaign. Based on the US Vaccine Adverse Event Reporting System data, this modified self-controlled case series study investigated the association of COVID-19 mRNA vaccination with VTE events among US adults. We found the VTE incidence rate in the recommended dose interval does not change significantly after receiving COVID-19 mRNA vaccines. This conclusion still holds if the analysis is stratified by age and gender. The VTE onset may not be significantly associated with COVID-19 mRNA vaccination.

Possible Side Effects after Getting COVID-19 Vaccine Based on Pre-Existing Disease: Asthma

Vaccination could be a critical preventative strategy against coronavirus disease 2019 (COVID-19), and it is essential to understand the vaccine's usability in the general population. A safe and effective vaccination is the most effective way to terminate this epidemic. Many communities throughout the globe have expressed concerns regarding the efficacy and side effects of coronavirus SARS CoV2 vaccinations. Vaccines are now being rushed to market. Many papers have been published on COVID-19 vaccine, hesitancy, acceptance rate, local survey, vaccine distribution, vaccine information, etc. However, none of them mentioned any potential side effects from the COVID-19 vaccination for those with pre-existing disease like Asthma. The study aimed to describe the possible side effects after getting COVID-19 vaccines (Moderna, Pfizer and Janssen) for those who have a pre-existing disease like Asthma. © 2022 ACM.

Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System.

WHAT IS KNOWN AND OBJECTIVE: Evidence on whether the coronavirus disease 2019 (COVID-19) vaccination could cause hearing-related adverse events is still conflicting. This study aims to access the association between COVID-19 vaccine and hearing disorder. METHODS: The Vaccine Adverse Event Reporting System (VAERS) was queried between January 2020 to November 2021. The disproportionality pattern for hearing impairment of COVID-19 vaccine was accessed by calculating the reporting odds ratio (ROR) and proportional reporting ratio (PRR). A further subgroup analysis based on the type of COVID-19 vaccine and the doses administered was performed. In addition, the disproportionalities for hearing dysfunction between COVID-19 and influenza vaccines were compared. RESULTS AND DISCUSSION: A total of 14,956 reports of hearing-related adverse events were identified with COVID-19 vaccination and 151 with influenza vaccine during the analytic period in VAERS. The incidence of hearing disorder following COVID-19 vaccination was 6.66 per 100,000. The results of disproportionality analysis revealed that the adverse events of hearing impairment, after administration of COVID-19 vaccine, was significantly highly reported (ROR 2.38, 95% confidence interval [CI] 2.20-2.56; PRR: 2.35, χ2 537.58), for both mRNA (ROR 2.37, 95% CI 2.20-2.55; PRR 2.34, χ2 529.75) and virus vector vaccines (ROR 2.50, 95% CI 2.28-2.73; PRR 2.56, χ2 418.57). While the disproportional level for hearing dysfunction was quite lower in influenza vaccine (ROR 0.36, 95% CI 0.30-0.42; PRR 0.36, χ2 172.24). WHAT IS NEW AND CONCLUSION: This study identified increased risk for hearing disorder following administration of both mRNA and virus vector COVID-19 vaccines compared to influenza vaccination in real-world settings.

Thromboembolic events after Ad.26.COV2.S COVID-19 vaccine: Reports to the Vaccine Adverse Event Reporting System.

PURPOSE: The Food and Drug Administration (FDA) has identified a potential safety concern for thromboembolic events (TEEs) after Ad.26.COV2.S COVID-19 Vaccine. We sought to characterize the frequency, severity, type, and anatomic location of TEEs reported to the Vaccine Adverse Event Reporting System (VAERS) following Ad.26.COV2.S. METHODS: Reports of TEEs after Ad.26.COV2.S were identified in VAERS, and demographics, clinical characteristics, and relevant medical history were summarized. For a subset of reports, physicians reviewed available medical records and evaluated clinical presentation, diagnostic evaluation, risk factors, and treatment. The crude reporting rate of TEEs was estimated based on case counts in VAERS and vaccine administration data. RESULTS: Through February 28, 2022, FDA identified 3790 reports of TEEs after Ad.26.COV2.S. Median age was 56 years, and 1938 individuals (51.1%) were female. Most reports, 2892 (76.3%), were serious, including 421 deaths. Median time to onset was 12 days post-vaccination. Obesity and ischemia were among the most commonly documented risk factors. Thrombocytopenia (platelet count less than 150 000/µl) was documented in 63 records (11.5%) and anti-platelet 4 antibodies in 25 (4.6%). Medical review identified cases of severe clot burden (e.g., bilateral, saddle, or other massive pulmonary embolism with or without cor pulmonale; lower extremity thrombus involving the external iliac, common femoral, popliteal, posterior tibial, peroneal, and gastrocnemius veins). The crude reporting rate was ~20.7 cases of TEE per 100 000 doses of Ad.26.COV2.S administered. CONCLUSIONS: Life-threatening or fatal TEEs have been reported after Ad.26.COV2.S, including bilateral massive pulmonary embolism or other severe clot burden.

Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for COVID-19 Vaccines.

Usefulness of Vaccine-Adverse Event-Reporting System (VAERS) data and protocols required for statistical analyses were pinpointed with a set of recommendations for the application of machine learning modeling or exploratory analyses on VAERS data with a case study of COVID-19 vaccines (Pfizer-BioNTech, Moderna, Janssen). A total of 262,454 duplicate reports (29%) from 905,976 reports were identified, which were merged into a total of 643,522 distinct reports. A customized online survey was also conducted providing 211 reports. A total of 20 highest reported adverse events were first identified. Differences in results after applying various machine learning algorithms (association rule mining, self-organizing maps, hierarchical clustering, bipartite graphs) on VAERS data were noticed. Moderna reports showed injection-site-related AEs of higher frequencies by 15.2%, consistent with the online survey (12% higher reporting rate for pain in the muscle for Moderna compared to Pfizer-BioNTech). AEs {headache, pyrexia, fatigue, chills, pain, dizziness} constituted >50% of the total reports. Chest pain in male children reports was 295% higher than in female children reports. Penicillin and sulfa were of the highest frequencies (22%, and 19%, respectively). Analysis of uncleaned VAERS data demonstrated major differences from the above (7% variations). Spelling/grammatical mistakes in allergies were discovered (e.g., ~14% reports with incorrect spellings for penicillin).