Prevenar 13 Adverse Reactions

Infants and children aged 6 weeks to 5 years: The safety of the vaccine was assessed in 13 controlled clinical trials where approximately 15,000 doses were given to 4,729 healthy infants in ages ranging from 6 weeks to 16 months of age. In all trials, Prevenar 13 was co-administered with routine paediatric vaccines (see Interactions).
In a catch-up study, 354 children (7 months to 5 years of age) receiving at least one dose of Prevenar 13 were also assessed for safety.
Children and adolescents 5 to 17 years of age: Safety was evaluated in 592 healthy children and adolescents, including those with asthma who may be predisposed to pneumococcal infection. Two hundred and ninety-four (294) children aged 5 to <10 years had previously been immunised with at least one dose of pneumococcal 7-valent conjugate vaccine and 298 children aged 10 to 17 had not previously been vaccinated with a pneumococcal vaccine.
Additional information in special populations: Children and adolescents with sickle cell disease, HIV infection or a hematopoietic stem cell transplant had similar frequencies of adverse reactions as children and adolescents 2-17 years of age, except that headaches, vomiting, diarrhea, pyrexia, fatigue, arthralgia and myalgia were very common.
Adults ≥18 years and the elderly: Safety was assessed in 7 clinical studies including 91,593 adults ranging in ages from 18 to 101 years. Prevenar 13 was administered to 48,806 adults; 2,616 (5.4%) aged 50 to 64 years and 45,291 (92.8%) aged 65 years and older. One of the 7 studies included a group of adults (n=899) ranging from 18 to 49 years who received Prevenar 13 and who were not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Of the Prevenar 13 recipients 1,916 adults were previously vaccinated with 23-valent pneumococcal polysaccharide vaccine at least 3 years prior to study vaccination, and 46,890 were 23-valent pneumococcal polysaccharide vaccine unvaccinated.
A trend to lower frequency of adverse reactions was associated with increasing age; adults >65 years of age (regardless of prior pneumococcal vaccination status) reported fewer adverse reactions than younger adults, with adverse reactions generally most common in adults, 18-29 years of age.
Overall, the frequency categories were similar for all age groups, with the exception of vomiting which was very common (≥1/10) in adults aged 18-49 years and common (≥1/100 to <1/10) in all other age groups, and pyrexia was very common in adults aged 18-29 years and common in all other age groups. Severe vaccination-site pain/tenderness and severe limitation of arm movement was very common in adults 18-39 years and common in all other age groups.
Additional information in special populations: Adults with HIV infection had similar frequencies of adverse reactions as adults 50 years of age and older, except that fever and vomiting were very common and nausea was common.
Adults with a hematopoietic stem cell transplant have similar frequencies of adverse reactions as adults 18 years and older, except that fever and vomiting were very common.
Adverse reactions reported in clinical trials or from the post-marketing experience are listed in the following table per body system and per frequency, and this is for all age groups. The frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (≤1/10,000).
Adverse reactions from clinical trials with Prevenar 13: Infants and children aged 6 weeks to 5 years: These data are from clinical trials in which Prevenar 13 was administered simultaneously with other routine childhood vaccines. (See Table 24.)

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Children and adolescents aged 5-17 years: The most common adverse reactions in children and adolescents 5-17 years of age were: see Table 25.

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Other adverse events observed in other age groups may also be applicable in this age group but due to the small sample size in this study (6096A1-3011) were not seen.
Adults ≥18 years and the elderly: see Table 26.

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Overall, no significant differences in frequencies of adverse reactions were noted if Prevenar 13 was given to adults pre-vaccinated with PPSV23 or adults PPSV23 unvaccinated. Frequency categories for all adverse reactions of adults aged 50-64 years and adults ≥65 years of age were similar.
Solicited adverse reactions in adult studies with Prevenar 13 and TIV: The safety of concomitant administration of Prevenar 13 with TIV was assessed in 2 studies in PPSV23 unvaccinated adults.
Frequencies of local reactions in adults aged 50-59 years and in adults aged ≥65 years were similar after Prevenar 13 was administered with TIV compared to Prevenar 13 administered alone.
Higher frequency in some solicited systemic reactions was observed when Prevenar 13 was administered concomitantly with TIV compared to TIV given alone (headache, chills, rash, decreased appetite, muscle and joint pain) or Prevenar 13 given alone (headache, fatigue, chills, decreased appetite, and joint pain).
Adverse reactions from Prevenar 13 post-marketing experience: Although the following adverse drug reactions were not observed in the clinical trials, they are considered adverse drug reactions for Prevenar 13 as they were reported in the post-marketing experience.
Because these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known. (See Table 27.)

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Apnea in very premature infants (≤30 weeks of gestation) (see Precautions).