The following adverse experiences have been reported with PNEUMOVAX 23 in clinical trials and/or post-marketing experience: Injection site reactions, consisting of pain, soreness, erythema, warmth, swelling and local induration, decreased limb mobility and peripheral edema in the injected extremity. Rarely, cellulitis-like reactions were reported. These cellulitis-like reactions, reported in post-marketing experience, show short onset time from vaccine administration. Local reactions may be accompanied by systemic signs and symptoms including fever, leukocytosis and an increase in the laboratory value for serum C-reactive protein.
The most common adverse experiences reported in clinical trials were fever (≤38.8°C/102°F), injection site reactions including soreness, erythema, warmth, swelling and local induration.
In a clinical trial, an increased rate of self-limited local reactions has been observed with revaccination at 3-5 years following primary vaccination. It was reported that the overall injection-site adverse experiences rate for subjects ≥65 years of age was higher following revaccination (79.3%) than following primary vaccination (52.9%). The reported overall injection-site adverse experiences rate for re-vaccinees and primary vaccinees who were 50 to 64 years of age 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 most common systemic adverse experiences were as follows: asthenia/fatigue, myalgia and headache. The observed generally small increase (≤13%) in post-vaccination use of analgesics returned to baseline by day 5.
Other adverse experiences reported in clinical trials and/or in post-marketing experience include: Body as a whole: Cellulitis, Asthenia, Fever, Chills, Malaise.
Digestive System: Nausea, Vomiting.
Hematologic/Lymphatic System: Lymphadenitis, Lymphadenopathy, Thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura, 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-Barré Syndrome, Febrile convulsion.
Skin: Rash, Urticaria, Erythema multiforme.