15 Pneumococcal disease

15.7 Expected responses and adverse events following immunisation (AEFI)

Always check the manufacturers’ data sheets if further information is required.

15.7.1 Expected responses


The most commonly reported adverse reactions are injection-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.56 An increase in injection site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with PCV13.56


Local discomfort, erythema and induration lasting a couple of days are expected responses.57 Revaccination is not associated with an increase in systemic events.58, 59 A large study compared hospitalisation rates after first or repeat vaccination and found no significant difference.60 Therefore, it appears that revaccination may be safely given, with a small increased risk of self-limiting, large local reactions.

15.7.2 Adverse events following immunisationTop


Rare events (≥0.01 percent and <0.1 percent) include hypersensitivity reactions, including face oedema, dyspnoea, bronchospasm, febrile seizures and hypotonic-hyporesponsive episode. Very rare events (<0.01 percent) include urticaria or urticaria-like rash, erythema multiforme, and hypersensitivity, including anaphylaxis.

During the 2010/11 influenza season in the US, PCV13 co-administered with inactivated influenza vaccine was associated with increased risk of fever over 39oC and febrile convulsions in children aged 6 to 59 months.61 Concomitant administration of PCV13 with inactivated influenza vaccine doubled the incidence risk ratio from 2.4 and 2.5, respectively, to 5.9 when given together in this age group. The bioCSL-manufactured influenza vaccines that were associated with febrile events in the southern hemisphere in 2010 (see section 10.7) were not recommended for this age group in the US (note that bioCSL is now known as Seqirus). The study does not note which brands of influenza vaccines were used.

PCV13 has been evaluated when co-administered with trivalent influenza vaccine in adults aged 65 years and older. Systemic reactions were more common (chills, rash and myalgia) after administration of both vaccines, but were low in severity. No serious events were vaccine related.62

The safety profile of PCV13 is similar to that of PCV7 when co-administered with other routine childhood vaccines, including DTaP-IPV-HepB/Hib (Infanrix-hexa).48–51 When PCV7 or PCV13 was co-administered with another routine childhood vaccine, most of the local reactions and systemic adverse events, including fever, were mild in severity. However, following an analysis of post-marketing reporting rates, there is a potential increased risk of convulsions (with or without fever) and hypotonic-hyporesponsive episodes when co-administering DTaP-IPV-HepB/Hib (Infanrix-hexa) and PCV13 compared to the use of DTaP-IPV-HepB/Hib alone.47 


Adverse events requiring a GP consultation occur in approximately 8 per 1000 vaccinations, and more severe adverse events in 1 per 100,000.63