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The most common adverse experiences reported with PNEUMOVAX (pneumococcal vaccine polyvalent) 23 in clinical trials were: Local reaction at injection site including soreness, erythema, warmth, swelling and induration Fever ≤ 102°F

Other adverse experiences reported in clinical trials and/or in post-marketing experience with PNEUMOVAX (pneumococcal vaccine polyvalent) 23 include:

General disorders and administration site conditions

Cellulitis
Asthenia
Malaise
Fever ( > 102°F)
Chills
Pain
Decreased limb mobility
Peripheral edema in the injected extremity

Digestive System

Nausea
Vomiting

Hematologic/Lymphatic

Lymphadenitis
Lymphadenopathy
Thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura³⁸
Hemolytic anemia in patients who have had other hematologic disorders
Leukocytosis

Hypersensitivity reactions including

Anaphylactoid reactions
Serum Sickness
Angioneurotic edema

Musculoskeletal System

Arthralgia
Arthritis
Myalgia

Nervous System

Headache
Paresthesia
Radiculoneuropathy
Guillain-Barre syndrome
Febrile convulsion

Skin

Rash
Urticaria

Investigations

Increased serum C-reactive protein

In post-marketing experience, injection site cellulitis-like reactions were reported rarely; between 1989 and 2002, when approximately 43 million doses were distributed, the annual reporting rate was < 2/100,000 doses. These cellulitis-like reactions occurred with initial and repeat vaccination at a median onset time of 2 days after vaccine administration.

Systemic signs and symptoms including fever, leukocytosis and an increase in the laboratory value for serum C-reactive protein may be associated with local reactions.

In a clinical trial, an increased rate of local reactions has been observed with revaccination at 3-5 years following primary vaccination.

For subjects aged ≥ 65 years, it was reported that the overall injection-site adverse experiences rate was higher following revaccination (79.3%) than following primary vaccination (52.9%). For subjects aged 50-64 years, the reported overall injection-site adverse experiences rate for re-vaccinees and primary vaccinees were similar (79.6% and 72.8% respectively).

In both age groups, re-vaccinees reported a higher rate of a composite endpoint (any of the following: moderate pain, severe pain, and/or large induration at the injection site) than primary vaccinees. Among subjects ≥ 65 years of age, the composite endpoint was reported by 30.6% and 10.4% of revaccination and primary vaccination subjects, respectively, while among subjects 50-64 years of age, the endpoint was reported by 35.5% and 18.9% respectively. The injection site reactions occurred within the 3 day monitoring period and typically resolved by day 5.

The rate of overall systemic adverse experiences was similar among both primary vaccinees and re-vaccinees within each age group. The rate of vaccine-related systemic adverse experiences was higher following revaccination (33.1%) than following primary vaccination (21.7%) in subjects ≥ 65 years of age, and was similar following revaccination (37.5%) and primary vaccination (35.5%) in subjects 50-64 years of age. The most common systemic adverse experiences reported after PNEUMOVAX (pneumococcal vaccine polyvalent) 23 were as follows: asthenia/fatigue, myalgia and headache.

Regardless of age, the observed increase in post vaccination use of analgesics ( ≤ 13% in the re-vaccinees and ≤ 4% in the primary vaccinees) returned to baseline by day 5.

No information provided.

REFERENCES

38. Kelton, J.G.: Vaccination-associated relapse of immune thrombocytopenia, J.A.M.A. 245(4): 369-371,1981.

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.