Prevenar 13 Adverse Reactions

Infants and Children Aged 6 Weeks to 5 Years: In a clinical study (0887X-100811) with pneumococcal 7-valent conjugate vaccine in infants vaccinated at 2, 3, and 4 months of age, fever ≥38°C was reported at higher rates among infants who received pneumococcal 7-valent conjugate vaccine concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%). After a booster dose at 12-15 months of age, the rate of fever ≥38°C was 50.0% in infants who received pneumococcal 7-valent conjugate vaccine and Infanrix hexa at the same time as compared to 33.6% in infants receiving Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39°C) and transient.
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 Aged 18 Years and Older: 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 in adults 18-49 years of age compared to adults >50 years of age, 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 adults >50 years of age.
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 from Clinical Trials with Pneumococcal Conjugate Vaccine, 13-Valent (adsorbed) (Prevenar 13): Infants and Children Aged 6 Weeks to 5 Years: These data are from clinical trials in which Pneumococcal Conjugate Vaccine, 13-Valent (adsorbed) (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 reactions 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 Aged 18 Years and Older: (See Table 26.)

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Overall, no significant differences in frequencies of adverse reactions were noted if Pneumococcal Conjugate Vaccine, 13-Valent (adsorbed) (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 Pneumococcal Conjugate Vaccine 13-Valent (adsorbed) (Prevenar 13) and TIV: Frequencies of local reactions in adults aged 50-59 years and in adults aged ≥65 years were similar after Pneumococcal Conjugate Vaccine, 13-Valent (adsorbed) (Prevenar 13) was administered with TIV compared to Pneumococcal Conjugate Vaccine, 13-Valent (adsorbed) (Prevenar 13) administered alone.
Higher frequency of some solicited systemic reactions was observed when Pneumococcal Conjugate Vaccine, 13-Valent (adsorbed) (Prevenar 13) was administered concomitantly with TIV compared to TIV given alone (headache, chills, rash, decreased appetite, muscle and joint pain) or Pneumococcal Conjugate Vaccine, 13-Valent (adsorbed) (Prevenar 13) given alone (headache, fatigue, chills, decreased appetite, and joint pain).
Adverse Reactions from Pneumococcal Conjugate Vaccine 13-Valent (adsorbed) (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 Pneumococcal Conjugate Vaccine, 13-Valent (adsorbed) (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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