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Systematic review and meta-analysis on BCG lymphadenitis incidence in healthy childrenA review of one point eight million children shows BCG vaccine side effects vary greatly depending on how doctors watch for them

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Key Takeaway
Consider the pooled 2.5% incidence of BCG lymphadenitis in children, noting significant variability across studies.

This is a systematic review and meta-analysis of the incidence proportion of BCG lymphadenitis in healthy children. The authors synthesized data from studies involving about 1.8 million children. The pooled incidence proportion was 2.5% (95% CI, 1.6-3.6), with individual study results ranging from 0.0% to 25.6%.

The review found that incidence proportions were significantly higher with active surveillance compared to passive surveillance. Incidence was also significantly higher in randomized controlled trials versus prospective and retrospective cohort studies. Incidence significantly differed by study quality, publication period, and BCG strain.

The authors note substantial variability in the incidence of BCG lymphadenitis among diverse studies. They acknowledge the influence of surveillance methods, study design, and vaccine strain on reported outcomes as key limitations.

Practice relevance is not specified. The evidence is observational and does not establish causality. Clinicians should interpret these pooled estimates with caution due to the noted heterogeneity.

Doctors looked at data from many different studies involving about one point eight million children. They wanted to know how often the BCG vaccine caused swelling in the lymph nodes. The rate of this side effect was not the same in every single study. It went from zero percent all the way up to twenty five point six percent. This big difference makes it hard to give one simple number for how common the problem is.

The way doctors looked for the swelling made a huge difference in the results. When studies used active checking, they found more cases than when they just waited for parents to call. Also, the type of study design mattered. Some studies that compared groups directly found higher rates than others that just watched over time. The specific brand of vaccine used also played a role in the numbers reported.

Because of these many differences, it is difficult to say exactly how often this happens. The review shows that the answer depends on many factors like the vaccine strain and how the study was done. This means doctors and parents need to understand that the risk is not the same everywhere. It is important to look at the specific situation when talking about vaccine safety.

What this means for you:
The chance of BCG lymphadenitis varies widely based on how the study was done and how carefully doctors checked for it.

Study Details

Study typeMeta analysis
EvidenceLevel 1
PublishedDec 2026
View Original Abstract ↓
Few systematic reviews or meta-analyses have addressed on the incidence of Bacille Calmette-Guérin (BCG) lymphadenitis in healthy children. A systematic literature search was independently conducted by two researchers using four English and Korean databases (PubMed, Scopus, KMbase, RISS). The risk of bias was assessed. A total of 52 peer-reviewed journal articles (about 1.8 million children) were included in meta-analyses. The incidence proportion of BCG lymphadenitis ranged from 0.0% to 25.6%. The pooled incidence proportion was 2.5% (95% CI, 1.6-3.6; I = 99%). Studies employing active (vs. passive) surveillance reported a significantly higher incidence proportion of lymphadenitis, as did randomized controlled trials (vs. prospective and retrospective cohort studies). Also, the incidence significantly differed according to study quality, publication period, and BCG strain. This study highlights substantial variability in the incidence of BCG lymphadenitis among diverse studies and underscores the influence of surveillance methods, study design, and vaccine strain on reported outcomes.
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