What are the side effects of the pneumococcal vaccine (PCV - Pneumococcal Conjugate Vaccine, PPSV - Pneumococcal Polysaccharide Vaccine)?

Pneumococcal Vaccine Side Effects

Pneumococcal vaccines generally have mild side effects, with approximately half of recipients experiencing local reactions such as pain, redness, and swelling at the injection site that typically resolve within 48 hours. 1

Common Side Effects

Local Reactions

• Pain at the injection site, erythema (redness), and swelling are the most common side effects, occurring in approximately one-third to half of vaccine recipients 1
• These local reactions usually persist for less than 48 hours 1
• Injection site erythema (28-30%), injection site pain (24%), and injection site swelling (18%) are the most frequently reported adverse events 1

Systemic Reactions

• Fever (22%) is among the most common systemic side effects, particularly in adults aged 19-64 years 1
• Moderate systemic reactions such as myalgias (muscle pain) are rare 1
• More severe local reactions like induration (hardening at the injection site) are also rare 1

Safety Profile by Vaccine Type

Pneumococcal Conjugate Vaccine (PCV)

• A postlicensure review of PCV13 using VAERS data showed that 94.1% of reported adverse events were nonserious 1
• The most common adverse events in persons aged ≥65 years receiving PCV13 were injection site erythema (30%), general erythema (20%), and injection site swelling (18%) 1
• No increased rate of adverse events was observed after PCV13 administration in persons aged ≥65 years compared with PPSV23 in a large cohort study 1
• Data mining analysis did not reveal disproportionate reporting of any new or unexpected adverse events with PCV13 1

Pneumococcal Polysaccharide Vaccine (PPSV23)

• PPSV23 is generally considered safe based on clinical experience since 1977 1
• In a meta-analysis of nine randomized controlled trials, local reactions were observed among approximately one-third or fewer of 7,531 patients receiving PPSV23 1

Serious Adverse Events

• Severe systemic adverse effects such as anaphylactic reactions are rare 1
• No reports of severe febrile or anaphylactic reactions were found in a meta-analysis of nine randomized controlled trials 1
• No neurologic disorders (e.g., Guillain-Barré syndrome) have been associated with pneumococcal vaccination 1
• Pneumococcal vaccination has not been causally associated with death among vaccine recipients 1

Special Considerations

Pregnancy

• The safety of pneumococcal polysaccharide vaccine during the first trimester of pregnancy has not been fully evaluated 1
• No adverse consequences have been reported among newborns whose mothers were inadvertently vaccinated during pregnancy 1

Administration Warnings

• Intradermal administration may cause severe local reactions and is inappropriate 1
• Before administering any pneumococcal vaccine, healthcare providers should consult the relevant package inserts regarding precautions, warnings, and contraindications 1

Contraindications

• Vaccination with PCV or PPSV23 is contraindicated in persons known to have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine 1
• PCVs are also contraindicated in persons known to have had a severe allergic reaction to any diphtheria toxoid–containing vaccine 1

Reporting Adverse Events

• Healthcare providers should report suspected adverse events after administration of pneumococcal vaccines to the Vaccine Adverse Event Reporting System (VAERS) 1
• Reports can be submitted to VAERS online, by facsimile, or by mail 1