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Company Merck & Co. Inc. / AE Rate AE / Merck Sharp & Dohme Corp. / / Country South Africa / France / United States / / Event FDA Phase / / Facility National Institute of Allergy / / IndustryTerm injection site / isotonic saline solution / sterile solution / injection-site / vaccine manufacturer / administration site / colorless solution / prevention of pneumococcal disease / drug products / / MedicalCondition sickle-cell anemia / skull fractures / chest pain / headache / Febrile convulsion Skin Rash Urticaria Cellulitis-like / pneumococcal pneumonia / cerebrovascular accident / Nausea / significantly less bacteremic pneumococcal disease / anaphylaxis / coronary vascular disease / headache/tremor / lumbar radiculopathy / Pruritus Systemic Complaints Solicited Events Asthenia/Fatigue Chills Unsolicited Events Back Pain / vaccine type pneumococcal pneumonia / Severe Acute Illness / injection-site erythema / angina pectoris / Diarrhea / chronic pulmonary disease / invasive infections / Neck Pain / infectious agents / edema/urinary retention/heart failure/diabetes / congestive heart failure / pneumonia / Hemolytic anemia / Severe allergic reaction / bacteremia / injected extremity Digestive System Nausea Vomiting Hematologic/Lymphatic Lymphadenitis Lymphadenopathy Thrombocytopenia / chronic cerebrospinal fluid / disease / immune thrombocytopenia / pneumococcal disease / pulmonary function / chronic illness / pneumococcal meningitis / Upper Respiratory Infection / erythema / Fever / ulcerative colitis / Leukocytosis Hypersensitivity / myocardial infarction / asthenia/fatigue / diabetes mellitus / heart failure / pancreatitis / sickle cell disease / pneumococcal infection / chronic medical conditions / depression / idiopathic thrombocytopenic purpura / type-specific pneumococcal bacteremia / Pharyngitis / disorders / / MedicalTreatment immunization / active immunization / vaccination / Antibiotic Prophylaxis / immunosuppressive therapy / / MusicGroup Nausea / / Organization U.S. Department of Health and Human Services / Concomitant Administration / Advisory Committee on Immunization Practices / National Institute of Allergy and Infectious Diseases / DOSAGE AND ADMINISTRATION / FDA / Veterans Administration / U.S. Centers for Disease Control and Prevention / / Person Sante Publique / Al-Ibrahim / / / Position investigator / Butler / Governor / / Product Safety N=1008 Injection / penicillin / Subcutaneous Injection / Revaccination* N=564 Placebo Injection / PNEUMOVAX / / Technology antibodies / Geriatrics / / URL http / SocialTag 
Proposed Prescribing Information PAS Jan 2011 PLR