Prevnar 13

Prevnar 13 Adverse Reactions

vaccine, pneumococcal

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Infants and Children 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, fever ≥38°C was reported at higher rates among infants who received pneumococcal 7-valent conjugate vaccine concomitantly with Infanrix hexa (28.3-42.3%) than in infants receiving Infanrix hexa alone (15.6-23.1%). After a booster dose at 12-15 months, the rate of fever ≥38°C was 50% 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 (≤39°C) and transient.
Additional Information in Special Populations: Children and adolescents with sickle cell disease, HIV infection or an hematopoietic stem cell transplant had similar frequencies of adverse reactions as children and adolescents 2-17 years, except that headaches, vomiting, diarrhea, pyrexia, fatigue, arthralgia and myalgia were very common.
Adults ≥18 Years: A trend to lower frequency of adverse reactions was associated with increasing age; adults >65 years (regardless of prior pneumococcal vaccination status) reported fewer adverse reactions than younger adults, with adverse reactions generally most common in adults, 18-29 years.
Overall, the frequency categories were similar in adults 18-49 years compared to adults >50 years, with the exception of vomiting which was very common (≥1/10) in adults 18-49 years and common (≥1/100 to <1/10) in adults >50 years.
Additional Information in Special Populations: Adults with HIV infection had similar frequencies of adverse reactions as adults ≥50 years, except that fever and vomiting were very common and nausea was common.
Adults with an hematopoietic stem cell transplant have similar frequencies of adverse reactions as adults ≥18 years, except that fever and vomiting were very common.
Adverse Reactions from Clinical Trials with Prevnar 13: Infants and Children 6 Weeks to 5 Years: These data are from clinical trials in which Prevnar 13 was administered simultaneously with other routine childhood vaccines.
System Organ Class: Very Common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1000 to <1/100, rare ≥1/10000 to <1/1000.
Immune System Disorders: Rare: Hypersensitivity reaction including face edema, dyspnea, bronchospasm.
Metabolism and Nutrition Disorders: Very Common: Decreased appetite.
Psychiatric Disorders: Very Common: Irritability. Uncommon: Crying.
Nervous System Disorders: Very Common: Drowsiness/increased sleep; restless sleep/decreased sleep. Uncommon: Seizures (including febrile seizures). Rare: Hypotonic-hyporesponsive episode.
Gastrointestinal Disorders: Common: Diarrhea, vomiting.
Skin and Subcutaneous Tissue Disorders: Common: Rash. Uncommon: Urticaria or urticaria-like rash.
General Disorders and Administration Site Conditions: Very Common: Fever; any vaccination-site erythema, induration/swelling or pain/tenderness; vaccination-site erythema or induration/swelling 2.5-7 cm [after toddler dose and in older children (2-5 years)]. Common: Fever >39ºC; vaccination-site erythema or induration/swelling 2.5-7 cm (after infant series); vaccination-site pain/tenderness interfering with movement. Uncommon: Vaccination-site induration/swelling or erythema >7 cm.
Children and Adolescents 5-17 Years: The most common adverse reactions in children and adolescents 5-17 years were: Metabolism and Nutrition Disorders: Very Common: Decreased appetite.
Psychiatric Disorders: Very Common: Irritability.
Nervous System Disorders: Very Common: Drowsiness/increased sleep, restless sleep/decreased sleep. Common: Headache.
Gastrointestinal Disorders: Common: Diarrhea; vomiting.
Skin and Subcutaneous Tissue Disorders: Common: Rash; urticaria or urticaria-like rash.
General Disorders and Administration Site Conditions: Very Common: Any vaccination-site erythema, induration/swelling or pain/tenderness, vaccination-site tenderness (including impaired movement). Common: Fever.
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 ≥18 Years: Immune System Disorders: Uncommon: Hypersensitivity reaction including face edema, dyspnea, bronchospasm.
Metabolism and Nutrition Disorders: Very Common: Decreased appetite.
Nervous System Disorders: Very Common: Headache.
Gastrointestinal Disorders: Very Common: Diarrhea; vomiting (in adults 18-49 years). Common: Vomiting (in adults ≥50 years). Uncommon: Nausea.
Skin and Subcutaneous Tissue Disorders: Very Common: Rash.
Musculoskeletal, Connective Tissue and Bone Disorders: Very Common: Generalized new/aggravated joint and muscle pain.
General Disorders and Administration Site Conditions: Very Common: Chills; fatigue; vaccination-site erythema, induration/swelling and pain/tenderness; limitation of arm movement. Common: Fever. Uncommon: Lymphadenopathy localized to the region of the vaccination site.
Overall, no significant differences in frequencies of adverse reactions were noted if Prevnar 13 was given to adults pre-vaccinated with PPSV23 or adults PPSV23 unvaccinated. Frequency categories for all adverse reactions of adults 50-64 years and adults ≥65 years were similar.
Solicited Adverse Reactions in Adult Studies with Prevnar 13 and Trivalent Inactivated Influenza Vaccine: Frequencies of local reactions in adults 50-59 years and in adults ≥65 years were similar after Prevnar 13 was administered with TIV compared to Prevnar 13 administered alone.
Higher frequency in some solicited systemic reactions was observed when Prevnar 13 was administered concomitantly with TIV compared to TIV given alone (headache, chills, rash, decreased appetite, muscle and joint pain) or Prevnar 13 given alone (headache, fatigue, chills, decreased appetite and joint pain).
Adverse Reactions from Prevnar 13 Post-Marketing Experience: Although the following adverse drug reactions were not observed in the clinical trials, they are considered adverse drug reactions for Prevnar 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.
Blood and Lymphatic System Disorders: Frequency not known (cannot be estimated from available data)*: Lymphadenopathy localized to the region of the vaccination site.
Immune System Disorders: Frequency not known (cannot be estimated from available data)*: Anaphylactic/anaphylactoid reaction including shock.
Skin and Subcutaneous Tissue Disorders: Frequency not known (cannot be estimated from available data)*: Angioedema; erythema multiforme.
General Disorders and Administration Site Conditions: Frequency not known (cannot be estimated from available data)*: Vaccination-site dermatitis, urticaria and pruritus.
*Adverse drug reaction identified post-marketing.
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