Abstract
BackgroundLicensed human vaccines can induce various adverse events (AE) in vaccinated patients. Due to the involvement of the whole immune system and complex immunological reactions after vaccination, it is difficult to identify the relations among vaccines, adverse events, and human populations in different age groups. Many known vaccine adverse events (VAEs) have been recorded in the package inserts of US-licensed commercial vaccine products. To better represent and analyze VAEs, we developed the Ontology of Vaccine Adverse Events (OVAE) as an extension of the Ontology of Adverse Events (OAE) and the Vaccine Ontology (VO).ResultsLike OAE and VO, OVAE is aligned with the Basic Formal Ontology (BFO). The commercial vaccines and adverse events in OVAE are imported from VO and OAE, respectively. A new population term ‘human vaccinee population’ is generated and used to define VAE occurrence. An OVAE design pattern is developed to link vaccine, adverse event, vaccinee population, age range, and VAE occurrence. OVAE has been used to represent and classify the adverse events recorded in package insert documents of commercial vaccines licensed by the USA Food and Drug Administration (FDA). OVAE currently includes over 1,300 terms, including 87 distinct types of VAEs associated with 63 human vaccines licensed in the USA. For each vaccine, occurrence rates for every VAE in different age groups have been logically represented in OVAE. SPARQL scripts were developed to query and analyze the OVAE knowledge base data. To demonstrate the usage of OVAE, the top 10 vaccines accompanying with the highest numbers of VAEs and the top 10 VAEs most frequently observed among vaccines were identified and analyzed. Asserted and inferred ontology hierarchies classify VAEs in different levels of AE groups. Different VAE occurrences in different age groups were also analyzed.ConclusionsThe ontology-based data representation and integration using the FDA-approved information from the vaccine package insert documents enables the identification of adverse events from vaccination in relation to predefined parts of the population (age groups) and certain groups of vaccines. The resulting ontology-based VAE knowledge base classifies vaccine-specific VAEs and supports better VAE understanding and future rational AE prevention and treatment.
Highlights
Licensed human vaccines can induce various adverse events (AE) in vaccinated patients
We introduce the basic framework of the OVAE and how OVAE is used to represent and analyze all adverse events reported in the product package inserts of 63 Food and Drug Administration (FDA) approved commercial vaccines currently used in the USA market
As the primary developer of the OAE and Vaccine Ontology (VO), we argue that OAE is not appropriate or responsible for representing various AEs specific for any particular medical intervention including vaccination due to the following reasons
Summary
Licensed human vaccines can induce various adverse events (AE) in vaccinated patients. Many known vaccine adverse events (VAEs) have been recorded in the package inserts of US-licensed commercial vaccine products. Many licensed vaccines exist to protect against a variety of diseases and infections. They are extremely useful in decreasing infection prevalence in human populations. There is a need to predict probabilities of different adverse events arising in different individuals, which can potentially lead to a decline in the risk of developing an adverse event. Many known vaccine adverse events (VAEs) at the population level have been recorded in the package inserts of commercial vaccine products. The VAE information in the package inserts may be used for systematic VAE analysis and comparison, providing a fundamental basis for further individual level VAE evaluation and prediction
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