Pneumococcal Vaccine (PPSV23/Pneumovax 23) Side Effects
The 23-valent pneumococcal polysaccharide vaccine (PPSV23/Pneumovax 23) is a safe vaccine with predominantly mild, self-limited local reactions; serious adverse events are exceedingly rare, and no causal association with death has been established. 1
Common Local Reactions (Most Frequent)
The most commonly reported side effects are injection site reactions that typically resolve within 48 hours: 1
- Injection site pain (19.3-24% of recipients) 1, 2
- Injection site erythema/redness (21.1-30% of recipients) 1, 2
- Injection site swelling (18-19.3% of recipients) 1, 2
These local reactions occur in approximately one-third to half of vaccine recipients and are self-limited. 2
Systemic Reactions
- Fever occurs in approximately 22% of adults aged 19-64 years 2
- General erythema (not at injection site) occurs in about 20% of recipients aged ≥65 years 2
Serious Adverse Events (Rare)
Severe adverse events are exceptionally uncommon: 2
- Anaphylaxis: 1 case per million PPSV23 doses distributed (similar to the 0.8 per million rate across all vaccines) 1
- No neurologic disorders (including Guillain-Barré syndrome) have been causally associated with PPSV23 2
- No deaths have been causally linked to PPSV23 vaccination based on clinical review of death reports 1
Long-Term Safety Data
A comprehensive postlicensure review of VAERS data from 1990-2013 (25,168 reports) and updated data from 2014-2022 (24,926 reports) found: 1
- 95.3% of reported adverse events were nonserious 1
- No safety signals or new/unexpected adverse events were identified through data mining analysis 1
- Clinical experience since 1983 has not raised safety concerns 1
Special Populations
Pregnancy considerations: 2
- Safety during first trimester has not been fully evaluated
- No adverse consequences reported among newborns whose mothers were inadvertently vaccinated during pregnancy
Children: The safety profile in children appears similar to adults, with mild local reactions being most common 1
Contraindications
Absolute contraindications include: 2
- Severe allergic reaction (anaphylaxis) to any vaccine component
- Severe allergic reaction to any diphtheria toxoid-containing vaccine (for conjugate vaccines)
Important Clinical Caveat
Hyporesponsiveness concern: Repeat vaccination with PPSV23 at intervals <5 years may result in lower antibody responses (hyporesponsiveness) to certain serotypes, though the clinical relevance remains unclear. 1 When multiple doses are indicated, maintain ≥5 year intervals between PPSV23 doses. 1
Adverse Event Reporting
Healthcare providers should report any suspected adverse events to VAERS, even if causality is uncertain, through online reporting at https://vaers.hhs.gov or by calling 1-800-822-7967. 1, 2