Article
Immunology
Emily Jane Woo, Pedro L. Moro
Summary: The study reviewed adverse event reports following vaccination with the quadrivalent recombinant influenza vaccine, finding that the majority were non-serious events. In some cases, allergic reactions were reported, including two individuals experiencing positive rechallenge. It is important to consider the potential underlying predisposition in individuals and continue postmarketing safety surveillance.
Article
Computer Science, Information Systems
Jingcheng Du, Yang Xiang, Madhuri Sankaranarayanapillai, Meng Zhang, Jingqi Wang, Yuqi Si, Huy Anh Pham, Hua Xu, Yong Chen, Cui Tao
Summary: This study implemented and evaluated state-of-the-art deep learning algorithms for named entity recognition to extract nervous system disorder-related events from vaccine safety reports. Results showed that deep learning-based methods outperformed conventional machine learning-based methods, with BioBERT and VAERS BERT models achieving the highest exact match F-1 scores for different entities. Additionally, an ensemble of these models achieved the highest exact match microaveraged F-1 score among peer models, demonstrating significant performance advantages.
JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION
(2021)
Article
Immunology
Yamin Shu, Jing Chen, Yiling Ding, Qilin Zhang
Summary: This study evaluated risankizumab-associated adverse events (AEs) and characterized the clinical priority through data mining of the FDA Adverse Event Reporting System (FAERS). The study found potential new AE signals and provided valuable evidence for clinicians to mitigate the risk of risankizumab-associated AEs.
FRONTIERS IN IMMUNOLOGY
(2023)
Article
Immunology
Silvia Perez-Vilar, Graca M. Dores, Paige L. Marquez, Carmen S. Ng, Maria Cano, Anuja Rastogi, Lucia Lee, John R. Su, Jonathan Duffy
Summary: Analysis of the Vaccine Adverse Event Reporting System data on the MenB-4C vaccine in the United States did not reveal any new safety concerns. The majority of reports were non-serious and the reported adverse events were consistent with the safety experience described in clinical studies and the product's package insert. Continued post-marketing surveillance is still warranted.
Review
Clinical Neurology
Marija Cauchi, Harriet Ball, Yoav Ben-Shlomo, Neil Robertson
Summary: Recent significant scientific investment has led to an expanding range of COVID-19 vaccines and increasing global uptake. However, concerns around potential risks and adverse events, such as vaccine-induced thrombosis and thrombocytopenia, pose challenges in interpreting data, communicating risks, and establishing causality. The 'infodemic' facilitated by the Internet and media further complicates understanding and communicating these risks to clinicians and the general population.
JOURNAL OF NEUROLOGY
(2022)
Article
Health Care Sciences & Services
Minh Tam H. Nguyen, Gerard Krause, Brigitte Keller-Stanislawski, Stephan Gloeckner, Dirk Mentzer, Joerdis J. Ott
Summary: The study utilized a novel digital application, SafeVac, for monitoring reports of adverse events post-influenza vaccination. Results indicated that adherence to app use was influenced by gender and age/education level, while AEFI occurrence was associated with gender and age. Commonly reported AEFIs included injection site pain, extremity pain, and fatigue/asthenia.
JMIR MHEALTH AND UHEALTH
(2021)
Article
Mathematical & Computational Biology
Shuoran Li, Lili Zhao
Summary: The study introduces meaningful structures to the Vaccine Adverse Event Reporting System (VAERS) database by connecting similar Adverse Events (AEs). Rigorous statistical methods were developed to identify interesting AE groups through AE enrichment analysis. The proposed methods extend gene enrichment tests to perform AE enrichment analysis while incorporating the special features of AE data.
STATISTICS IN MEDICINE
(2021)
Article
Immunology
Sz-An Tsai, Chun-Yi Lu, Tzu- Chen, Shih-Pei Huang, Yong-Chen Chen
Summary: This study examined the incidence of serious adverse events after HPV vaccination among Taiwanese girls and found no significant increased risk associated with the vaccine.
Article
Pediatrics
Pedro L. Moro, Bicheng Zhang, Paige Marquez, Jonathan Reich
Summary: The safety of hexavalent vaccine was assessed in this study using the Vaccine Adverse Event Reporting System. The reported adverse events were consistent with prelicensure studies, with fever and injection site erythema being the most frequently reported.
JOURNAL OF PEDIATRICS
(2023)
Article
Pharmacology & Pharmacy
Xingxing Li, Lin Zhang, Sang Hu, Dan Liu, Bin Hu, Jie Ran, Xiaofang Lin, Wei Mao, Jing Hu
Summary: This study explores the adverse events induced by sacituzumab govitecan by analyzing the FDA Adverse Event Reporting System (FAERS) database. It identifies 114 AE signals involving 20 systems, and finds that being male and experiencing colitis, pneumonitis, febrile neutropenia, pyrexia, sepsis, dehydration, and diarrhea are risk factors leading to hospitalization. This study highlights the need for close monitoring of specific adverse reactions when using sacituzumab govitecan.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Immunology
Penina Haber, Jacqueline Tate, Paige L. Marquez, Pedro L. Moro, Umesh Parashar
Summary: The introduction of two live, oral rotavirus vaccines in the US in 2006 and 2008 has led to routine immunization programs. No unexpected adverse events were identified among individuals aged >= 8 months receiving the vaccines. Healthcare providers should adhere to the recommended schedule, and older individuals should take necessary precautions to prevent potential secondary exposure.
Article
Immunology
Yu-Mi Wi, Si-Ho Kim, Kyong-Ran Peck
Summary: The study found that early adverse events of BNT162b2 and AZD1222 vaccines were mostly mild to moderate and generally transient. Providing sufficient explanation of the expected adverse events of the vaccine would be beneficial for wider vaccination efforts.
Article
Medicine, General & Internal
Chenyu Zou, Xiangzhong Xue, Jingjing Qian
Summary: This study assessed and compared the frequency and type of adverse events of Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines reported in VAERS. The majority of adverse events were mild, with mortality cases occurring in older adults with underlying conditions. Further assessment and validation through longitudinal, large healthcare data systems are needed.
FRONTIERS IN MEDICINE
(2022)
Review
Immunology
Naim Mahroum, Noy Lavine, Aviran Ohayon, Ravend Seida, Abdulkarim Alwani, Mahmoud Alrais, Magdi Zoubi, Nicola Luigi Bragazzi
Summary: Despite concerns, vaccines have proven efficacy and contribute greatly to global health. This review focuses on the immune and autoimmune adverse events following immunization (AEFIs) of COVID-19 vaccines, highlighting the rare but worrisome cases. By addressing the concerns and presenting the low occurrence rate of AEFIs, it aims to alleviate vaccine hesitancy.
FRONTIERS IN IMMUNOLOGY
(2022)
Article
Immunology
John R. Su, Michael M. McNeil, Kerry J. Welsh, Paige L. Marquez, Carmen Ng, Ming Yan, Maria Cano
Summary: A thorough analysis of myopericarditis reports to a national vaccine safety surveillance system in the United States revealed that most cases involved males with symptoms occurring within two weeks post-vaccination. Smallpox and anthrax vaccines were the most commonly reported vaccines associated with myopericarditis.
