Prevenar 13 Adverse Reactions

Infants and children 6 weeks to 5 years of age: 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 to 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.
The most commonly reported adverse reactions were injection-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.
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 Prevenar 13.
Adverse reactions reported in clinical studies 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.
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 of age and older: The safety of Prevenar 13 was assessed in 6 clinical studies including 6,198 adults ranging in age from 50 to 95 years. Prevenar 13 was administered to 5,667 adults; 2,616 adults were aged 50 to 64 years and 3,051 adults were 65 years and older. Of the Prevenar 13 recipients 1,916 adults were previously vaccinated with PPSV23 at least 3 years prior, and 3,751 adults were PPSV23 unvaccinated. Frequencies shown below are for adults aged 50 to 64 years of age, and 65 and older. Subjects older than 65 years of age reported fewer events than younger adults, regardless of prior immunization status. Overall, the frequency categories were similar for both age groups.
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 previously vaccinated with the pneumococcal polysaccharide vaccine, have similar frequencies of adverse reactions as adults 50 years of age and older, except that vomiting was very 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.
The frequency is defined as follows: very common: ≥1/10, common: ≥1/100 and <1/10, uncommon: Adverse Reactions from Clinical Trials: ≥1/1,000 and <1/100, rare: ≥1/10,000 and <1/1,000, very rare: ≤1/10,000.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infants and children 6 weeks to 5 years of age: Children 6 weeks to 5 years of age: In clinical studies, the safety profile of Prevenar 13 was similar to pneumococcal 7-valent conjugate vaccine. The following frequencies are based on adverse reactions assessed as related to vaccination in Prevenar 13 clinical studies: Immune system disorders: Rare: Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm.
Nervous system disorders: Very common: Drowsiness/increased sleep; restless sleep/decreased sleep.
Uncommon: Seizure (including febrile convulsions).
Rare: Hypotonic-hyporesponsive episode.
Gastrointestinal disorders: Very common: Decreased appetite.
Common: Vomiting; diarrhoea.
Skin and subcutaneous tissue disorders: Common: Rash.
Uncommon: Urticaria or urticaria-like rash.
General disorders and administration site conditions: Very common: Pyrexia; irritability; any injection-site erythema, induration/swelling or pain/tenderness; somnolence; poor quality sleep; injection-site erythema or induration/swelling 2.5 cm - 7.0 cm (after the booster dose and in older children [age 2 to 5 years]).
Common: Pyrexia >39°C; injection-site pain/tenderness interfering with movement; injection-site erythema or induration/swelling 2.5 cm - 7.0 cm (after infant series).
Uncommon: Injection-site erythema, or induration/swelling >7.0 cm; Crying.
Children and adolescents aged 5-17 yearsThe most common adverse reactions in children and adolescents 5-17 years of age were: See Table 18.


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Adults 50 years of age and older: Metabolism and nutrition disorders: Very common: Decreased appetite.
Nervous system disorders: Very common: Headaches.
Gastrointestinal disorders: Very common: Diarrhea.
Common: Vomiting.
Uncommon: Nausea.
Immune system disorders: Uncommon: Hypersensitivity reaction including face edema, dyspnea, bronchospasm.
Skin and subcutaneous tissue disorders: Very common: Rash.
Musculoskeletal and connective tissue disorders: Very common: Generalized new/aggravated joint pain; generalized new/aggravated muscle pain.
General disorders and administration site conditions: Very common: Chills; fatigue; injection-site erythema; injection-site induration/swelling; injection-site pain/tenderness; limitation of arm movement.
Common: Fever.
Uncommon: Lymphadenopathy localized to the region of injection site.
Overall, no significant differences in frequencies of adverse reactions were noted if Prevenar 13 was given to adults pre-vaccinated with PPSV23 adults or PPSV23 unvaccinated. Frequency categories for all adverse reactions of adults aged 50 to 64 years and adults ≥65 years of age were similar.
Solicited Adverse Reactions in Adult Clinical Studies of Concomitant Administration of Prevenar 13 and TIV: 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 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 Pneumococcal 7-valent conjugate vaccine Post-marketing Experience: Children 6 weeks to 5 years of age: Although the following adverse drug reactions were not observed in the Prevenar 13 clinical studies, the following are considered adverse drug reactions for pneumococcal 7-valent conjugate vaccine and are considered adverse drug reactions for Prevenar 13 as well. These frequencies are based on spontaneous reporting rates for pneumococcal 7-valent conjugate vaccine.
Blood and lymphatic system disorders: Very rare: Lymphadenopathy (localised to the region of the injection site).
Immune system disorders: Rare: Anaphylactic/anaphylactoid reaction including shock; Angioedema.
Skin and subcutaneous tissue disorders: Very rare: Erythema multiforme.
General disorders and administration site conditions: Rare: Injection-site urticaria; injection-site dermatitis; injection-site pruritus; flushing.
Additional information in special populations: Apnoea in very premature infants (≤28 weeks of gestation) (see Precautions).