Table 1.
Sixty-four statistically significant AEs associated with BCG as TB vaccine.
Table 2.
Fourteen statistically significant AEs associated with BCG as bladder cancer vaccine.
Fig 1.
PRISMA flowchart of the selection of relevant papers.
Table 3.
BCG-associated AEs from literature meta-analysis.
Table 4.
Twelve most commonly reported BCG AEs from the literature.
Fig 2.
Venn diagram summary of the BCG-associated AEs from VAERS statistical analysis and literature meta-analysis.
TB-V: AEs associated with BCG TB vaccine from VAERS statistical analysis. TB-L: AEs associated with BCG TB vaccine from literature meta-analysis. BC-V: AEs associated with BCG bladder cancer vaccine from VAERS statistical analysis. BC-L: AEs associated with BCG bladder cancer vaccine from literature meta-analysis. Three AEs (i.e., chills, pneumonia, and CRP level increased) are shared by the BCG TB vaccine and bladder cancer vaccine.
Fig 3.
Hierarchical classification of 25 BCG-associated SAEs and their related top level classes using MedDRA and OAE.
(A) MedDRA-based classification. All oval circle highlighted terms are discussed in the main text. (B) Asserted OAE hierarchy of the 25 SAEs and related top level classes. (C) Inferred OAE hierarchy after reasoning with the ELK reasoner (version 0.4.10, downloaded from website: https://www.cs.ox.ac.uk/isg/tools/ELK/). The SAE labeled with “t” and “c” represents the SAE associated with BCG as a tuberculosis and bladder cancer vaccine, respectively. After reasoning, two classes of terms were inferred to under different parent terms as highlighted in dotted oval circles.
Table 5.
BCG-associated death AE case reports from VAERS.