Clinical trials evaluate a vaccine's safety before approval, but some risks may escape detection or adequate characterization until larger population exposures occur after licensure.
To summarize reports of events occurring after vaccination with 7-valent pneumococcal conjugate vaccine (PCV), including those that may warrant further investigation to assess possible causation by PCV.
Descriptive epidemiology of reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance database.
United States during first 2 years after licensure of PCV (February 2000 through February 2002). Reports studied were for children younger than 18 years and vaccinated with PCV.
Numbers and proportional distributions of reports.
A total of 4154 reports of events following PCV were submitted to VAERS, for a rate of 13.2 reports per 100,000 doses distributed. Multiple vaccines were given in 74.3% of reports. The most frequently reported symptoms and signs included fever, injection site reactions, fussiness, rashes, and urticaria. Serious events were described in 14.6% of reports. There were 117 deaths, 23 reports of positive rechallenges, and 34 cases of invasive pneumococcal infections possibly representing vaccine failure. Immune-mediated events occurred in 31.3% of reports. All 14 patients with anaphylactic or anaphylactoid reactions survived. Thrombocytopenia developed in 14 patients and serum sickness in 6 others. Neurologic symptoms occurred in 38% of reports. Seizures described in 393 reports included 94 febrile seizures.
The majority of reports to VAERS in the first 2 years after licensure of PCV described generally minor adverse events previously identified in clinical trials. The proportion of reports portraying serious events was similar to that for other vaccines. Although there are important limitations in passive surveillance data, and caution in their interpretation is necessary, symptoms experienced by a few children more than once after successive PCV doses, including allergic reactions, prolonged or abnormal crying, fussiness, dyspnea, and gastrointestinal distress, warrant continued surveillance, as do reports of rare but potentially serious events, such as seizures, anaphylactic or anaphylactoid reactions, serum sickness, and thrombocytopenia.
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"The common components of PCV-7 and PPV-23 are pneumococcal polyosides. Reactions at the injection site of pneumococcal vaccines and fever are quite common, but anaphylactic reactions are exceedingly rare      . "
[Show abstract][Hide abstract] ABSTRACT: Anaphylaxis to pneumococcal vaccines is rare. In the only one child with anaphylaxis to a first injection of the 23-valent pneumococcal vaccine that has been explored, skin tests and specific IgE determination diagnosed immediate-type hypersensitivity to pneumococcal antigens. We report the case of a child who tolerated three injections of the 7-valent pneumococcal vaccine, but experienced anaphylaxis to a fourth injection of the 23-valent vaccine. Immediate responses in skin tests diagnosed immediate-type hypersensitivity to the two vaccines. Immunizations with the 7-valent pneumococcal vaccine may induce IgE-dependent sensitization to pneumococcal antigens, responsible for anaphylaxis to subsequent injections of pneumococcal vaccines.
"This vaccine is recommended for universal administration to children younger than 2 years old in a four-dose regimen (doses are given at 2, 4, 6, and 12 to 15 months), as well as to high-risk older children (eg, children who have sickle cell disease, HIV infection , cochlear implants, and other causes of immunocompromise) . This vaccine has been shown to be safe   and highly effective in preventing invasive pneumococcal disease. In a post licensure surveillance of the Northern California Kaiser Permanente study cohort, the incidence of invasive pneumococcal disease caused by vaccine and cross-reactive vaccine serotypes declined from 51.5 to 98.2 cases of invasive disease per 100,000 person-years in children less than 1 year old to zero cases per 100,000 person-years 4 years after licensure . "
[Show abstract][Hide abstract] ABSTRACT: Fever is a common complaint of young children who seek care in the emergency department. Recent advances, such as universal vaccination with the pneumococcal conjugate vaccine, require the review of traditional approaches to these patients. This article discusses newer strategies in the evaluation and management of the young child with fever, incorporating changes based on the shifting epidemiology of bacterial infection.
Emergency Medicine Clinics of North America 12/2007; 25(4):1087-115, vii. DOI:10.1016/j.emc.2007.07.012 · 0.78 Impact Factor
"This vaccine, licensed in 2000, is recommended for universal administration to children younger than 2 years old in a 4-dose regimen (doses are given at 2, 4, 6, and 12–15 months), as well as to high-risk older children (eg, children with sickle cell disease, chronic cardiac and pulmonary diseases, and other immunocompromising conditions) . This vaccine has been shown to be both safe  and highly effective in preventing invasive pneumococcal disease, with a prelicensure study demonstrating an efficacy of 97% . In a postlicensure surveillance of the Northern California Kaiser Permanente  study cohort, the cohort that served as the largest prelicensure study group of the PCV7 vaccine, the incidence of invasive pneumococcal disease caused by vaccine and cross-reactive vaccine serotypes declined from 51.5 to 98.2 cases of invasive disease per 100,000 person-years in children less than 1 year old to 0 cases per 100,000 person-years 4 years after licensure . "
[Show abstract][Hide abstract] ABSTRACT: Although fever in the young child (0-36 months) is a common clinical problem, the evaluation and treatment of febrile children remain controversial. Furthermore, universal vaccination with the heptavalent pneumococcal conjugate vaccine (PCV7) has changed the epidemiology of invasive bacterial disease in young children. This article addresses the approach to febrile neonates (0-28 days old), young infants (1-3 months old), and older infants and toddlers (3-36 months old) in the PCV7 era.
Pediatric Clinics of North America 05/2006; 53(2):167-94. DOI:10.1016/j.pcl.2005.09.012 · 2.12 Impact Factor