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Published on: February 23, 2014
Adverse events after pneumococcal vaccination
Maria Rita Donalisio1, Somnia Marlene Cadogan Piraggini Rodrigues, Elisa Teixeira Mendes
1State University at Campinas, School of Medical Sciences, Campinas, SP, Brazil. donalisi@fcm.unicamp.br
Objective:
To study the occurrence of adverse events after administration of a capsular polysaccharide vaccine against 23 pneumococcal serotypes in individuals for whom such vaccination is indicated.
Methods:
This was a prospective study, conducted in a general hospital in the city of Sumaré, in which 152 individuals were evaluated after intramuscular vaccination with 0.5 mL of the Pneumo 23 vaccine. The study variable was subject complaint of at least one symptom forming a temporal nexus with the vaccine (appearing within 48 h after its administration). The subjects were evaluated at five to seven days after vaccination. The covariables age, gender and clinical profile were tested using the chi-square test and multiple logistic regression, with the level of significance set at 5%.
Results:
The age of the population ranged from 5 to 86 years (mean, 61.8 years). For nearly all (99%) of the subjects, the vaccination evaluated was their first dose of the vaccine. Events occurring at the injection site were reported in 36 subjects (23.7%). Of those 36 events, 24 (68%) were mild and had no repercussions for the daily activities of the subjects. Pain at the site of the injection was the most common symptom, being reported by 97.2% of the subjects. Erythema and localized edema were found in 6.3% and 5.1% of the subjects, respectively. Of the subjects evaluated, 12.8% reported general symptoms (malaise, fever, sleepiness and generalized pain). In the bivariate analysis, none of the covariables were found to present a statistically significant correlation with adverse events (p > 0.20). The same held true in the multivariate analysis.
Conclusion:
Although, the 23-valent pneumococcal vaccine provokes few reactions in the first dose, it is still rarely recommended in the region, even for patients at risk.
Insights
The 23-valent pneumococcal polysaccharide vaccine caused few adverse events, primarily mild injection site pain, in individuals receiving their first dose. Vaccination is still underutilized in the region, even for at-risk populations.
Area of Science:
- Immunology and Vaccinology
- Public Health
- Clinical Research
Background:
- Pneumococcal infections pose a significant health risk, particularly to vulnerable populations.
- The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is indicated for individuals at increased risk of pneumococcal disease.
Purpose of the Study:
- To investigate the incidence and nature of adverse events following the administration of the 23-valent pneumococcal polysaccharide vaccine.
- To assess the safety profile of PPSV23 in individuals for whom vaccination is recommended.
Main Methods:
- A prospective study involving 152 individuals receiving intramuscular PPSV23 vaccination.
- Adverse events were monitored for symptoms appearing within 48 hours post-vaccination.
- Statistical analysis, including chi-square and logistic regression, examined the correlation of age, gender, and clinical profile with adverse events.
Main Results:
- The mean age of participants was 61.8 years, with 99% receiving their first dose.
- Local injection site reactions, predominantly mild pain (97.2%), occurred in 23.7% of subjects.
- General symptoms like malaise or fever were reported by 12.8%, with no significant correlation to demographic or clinical factors.
Conclusions:
- The 23-valent pneumococcal polysaccharide vaccine demonstrates a favorable safety profile with minimal adverse reactions upon first-time administration.
- Despite its safety, the vaccine's recommendation and uptake remain low in the studied region, even among high-risk groups.
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