Vaccine-associated Adverse Events Research Articles

Application Of Pharmacogenomics To Vaccines

The field of pharmacogenomics and pharmacogenetics provides a promising science base for vaccine research and development. A broad range of phenotype/genotype data combined with high-throughput genetic sequencing and bioinformatics are increasingly being integrated into this emerging field of vaccinomics. This paper discusses the hypothesis of the 'immune response gene network' and genetic (and bioinformatic) strategies to study associations between immune response gene polymorphisms and variations in humoral and cellular immune responses to prophylactic viral vaccines, such as measles-mumps-rubella, influenza, HIV, hepatitis B and smallpox. Immunogenetic studies reveal promising new vaccine targets by providing a better understanding of the mechanisms by which gene polymorphisms may influence innate and adaptive immune responses to vaccines, including vaccine failure and vaccine-associated adverse events. Additional benefits from vaccinomic studies include the development of personalized vaccines, the development of novel vaccines and the development of novel vaccine adjuvants.

New e-Prescribing Guide Unveiled

is less than $20 million. Greater investment in postmarket vaccinesafety studiesandsurveillancewould allow scientists to apply genetics research tools and other scientific advances to problems such as identifying the individuals at greatest risk for vaccine-associated adverse events. Efforts should also be made to ensure that such research is well coordinated, free of conflicts of interest, and transparent. “While we make the case for how overwhelming the benefits are of vaccines compared to the low risks that exist, we owe it to the public to assure them how rigorous our studies of vaccine safety are,” Cooper said. Tayloe agreed that greater investments in vaccine safety efforts should be made to bolster public support for vaccines. Additionally, he noted that because vaccines are very safe but not completely risk-free, the United States has a system to compensate individuals who experience vaccine-associated adverse events. A lawsuit against Tayloe’s father, David Tayloe Sr, MD, by parents who believed the diphtheria-pertussistetanus vaccine harmed their child, was among the factors that led to the passage of the National Childhood Vaccine Injury Act of 1986. The act established a special vaccine court and a fund to provide compensation when an individual has an injury linked to a vaccine. The court helped to shore up public confidence in vaccines and to ensure that physicians and vaccine manufacturers could continue to offer vaccinations. The alliance is encouraging individuals to discuss vaccine-related questions with their physicians and to rely on credible information about vaccines to make decisions about their child’s health. In addition, the group is urging journalists and others communicating about vaccines, such as bloggers, to learn about the evidence supporting vaccine use and to take care in providing scientifically accurate information about vaccine safety and effectiveness. Tayloe said the coordinated approach advocated by the alliance and an ongoing commitment to ensuring high rates of vaccine coverage are essential to the public’s health. “We can’t be complacent,” he said. “These diseases will come back with a fury if we drop these efforts.”

Herpes Zoster with Skin Lesions and Meningitis Caused by 2 Different Genotypes of the Oka Varicella‐Zoster Virus Vaccine

A previously healthy boy who had received varicella vaccine developed herpes zoster with meningitis. The vaccine strain recovered from scabs of 3 skin lesions had the wild-type allele at position 108111, a vaccine marker never previously associated with vaccine-associated adverse events. The vaccine strain from cerebrospinal fluid also contained mutations never previously observed at vaccine-associated single nucleotide polymorphisms that would alter amino acid sequences in ORF54 and ORF59. The presence of distinct strains in skin lesions and cerebrospinal fluid indicate that >1 variant strain may reactivate to cause herpes zoster.

The public perception of the value of vaccines - the case of Switzerland.

AimIn this original article, we seek to analyse the environment in which immunisation policies are adopted and, more specifically, the way the public perception of vaccines influences decision-making, by looking more closely at the case of Switzerland.Subjects and methodsHistorical and present-day examples of attitudes towards immunisation and specific vaccines, both on the part of the public and of health-care workers, are reviewed.ResultsDecision-making with regard to vaccine policy implementation has been and is still most often driven by fear: fear of disease (when perceived as rampant and/or dangerous), but also fear of vaccine-associated adverse events (when the disease is less or no longer “visible”). However, methodology for introducing evidence-based immunisation policies exists and can be used by public health authorities, while vaccination information systems (such as the Swiss InfoVac) have proven their usefulness in providing trustworthy, peer-based knowledge to health-care workers.ConclusionOnly information based on clear, evidence-based data gathered and analysed according to solid methodological criteria coupled with adequate information of health-care workers (and thus patients) can ensure in future the implementation of scientifically coherent, publicly acceptable, and equitable immunisation policies.

Vaccination against Smallpox in the Posteradication Era

The following introduction describes the context in which the national smallpox vaccination program was implemented and highlights the significance of the key policy, programmatic, or scientific challenges, observations, and lessons learned that are presented in the articles that follow within this supplement to Clinical Infectious Diseases. Although the execution of this national program posed multiple complex and varied challenges, the focus of this supplement is on vaccine-associated adverse events and vaccine safety.

A Process for Sentinel Case Review to Assess Causal Relationships between Smallpox Vaccination and Adverse Outcomes, 2003–2004

The US Department of Defense requested that the Advisory Committee on Immunization Practices-Armed Forces Epidemiological Board joint Smallpox Vaccine Safety Working Group define the likelihood that smallpox vaccination played a causal role in the fatal illness of an Army reservist. Reported serious adverse events for which there was no a priori reason to discount the existence of a causal association with smallpox vaccine were reviewed to assess whether they were signals of constellations of vaccine-associated adverse events. A causal relationship between the immunization experience and the index patient's death was favored, but the implication of an individual vaccine was precluded. No new smallpox vaccine-associated clinical syndromes were identified. The data supported neutrality regarding the hypothesis that dilated cardiomyopathy was causally associated with smallpox vaccine-induced myocarditis. This review of sentinel cases augmented the ongoing safety review process and was transparent, but it shares limitations with other case-based causality-assessment methods.

COMPILED BY THE VACCINATION GUIDELINES GROUP (VGG) OF THE WORLD SMALL ANIMAL VETERINARY ASSOCIATION (WSAVA)

The WSAVA Vaccination Guidelines Group (VGG) was convened in order to develop guidelines for the vaccination of dogs and cats that have global application. The first version of these guidelines was published in 2007 and they were updated in 2010. The present document provides a further updated and expanded version of these international guidelines for the vaccination of small companion animals and indicates the scientific evidence base on which the recommendations are made. The VGG recognises that the keeping of pet small animals is subject to considerable variation in practice and associated economics throughout the world and that vaccination recommendations that might apply to a developed country may not be appropriate for a developing country. These guidelines are not a mandatory edict, but rather should be used by national associations and individual veterinary practices to develop vaccination schedules relevant locally. However, the VGG strongly recommends that wherever possible ALL dogs and cats receive the benefit of vaccination. This not only protects the individual animal, but provides optimum ‘herd immunity’ that minimises the likelihood of infectious disease outbreaks. With this background in mind, the VGG has defined core vaccines as those which ALL dogs and cats, regardless of circumstances or geographical location, should receive. Core vaccines protect animals from severe, life-threatening diseases that have global distribution. Core vaccines for dogs are those that protect against canine distemper virus (CDV), canine adenovirus (CAV) and the variants of canine parvovirus type 2 (CPV-2). Core vaccines for cats are those that protect against feline parvovirus (FPV), feline calicivirus (FCV) and feline herpesvirus-1 (FHV-1). In areas of the world where rabies virus infection is endemic, vaccination against this agent should be considered core for both species, even if there is no legal requirement for routine vaccination. The VGG recognizes that maternally-derived antibody (MDA) interferes with the efficacy of most current core vaccines administered to pups and kittens in early life. Because the level of MDA varies among litters, the VGG recommends administration of multiple core vaccine doses to pups and kittens, with the final dose given at 16 weeks or older and followed by a booster at 6- or 12-months of age. In cultural or financial situations where a pet animal may only be permitted the benefit of a single vaccination, that vaccination should be with core vaccines at 16 weeks of age or older. The VGG supports the use of simple in-practice tests for determination of seroconversion to the core vaccine components (CDV, CAV, CPV-2 and FPV) following vaccination, for determination of seroprotection in adult dogs and for management of infectious disease outbreaks in shelters. Vaccines should not be given needlessly. Core vaccines should not be given any more frequently than every three years after the 6- or 12-month booster injection following the puppy/kitten series, because the duration of immunity (DOI) is many years and may be up to the lifetime of the pet. The VGG has defined non-core vaccines as those that are required by only those animals whose geographical location, local environment or lifestyle places them at risk of contracting specific infections. The VGG has also classified some vaccines as not recommended (where there is insufficient scientific evidence to justify their use) and has not considered a number of minority products which have restricted geographical availability or application. The VGG strongly supports the concept of regular (usually annual) health checks which removes the emphasis from, and client expectation of, annual revaccination. The annual health check may still encompass administration of selected non-core vaccines which should be administered annually, as the DOI for these products is generally 1 year. The VGG has considered the use of vaccines in animal shelters, again recognising the particular circumstances of such establishments and the financial constraints under which they sometimes operate. The VGG minimum shelter guidelines are simple: that all dogs and cats entering such an establishment should be vaccinated before, or at the time of entry, with core vaccines. Where finances permit, repeated core vaccines should be administered as per the schedules defined in the guidelines and non-core vaccines against respiratory disease may be included. The VGG recognizes the importance of adverse reaction reporting schemes, but understands that these are variably developed in different countries. Wherever possible, veterinarians should be actively encouraged to report all possible adverse events to the manufacturer and/or regulatory authority to expand the knowledge base that drives development of improved vaccine safety. These fundamental concepts proposed by the VGG may be encapsulated in the following statement: We should aim to vaccinate every animal with core vaccines. Non-core vaccines should be given no more frequently than is deemed necessary.

Adverse events after vaccine administration in cats: 2,560 cases (2002–2005)

To determine the incidence of vaccine-associated adverse events (VAAEs) diagnosed within 30 days of vaccination in cats and characterize risk factors for their occurrence. Retrospective cohort study. 496,189 cats vaccinated at 329 hospitals. Electronic records were searched for VAAEs that occurred after vaccine administration classified by practitioners as nonspecific vaccine reaction, allergic reaction, urticaria, shock, or anaphylaxis. Clinical signs and treatments were reviewed. The association between potential risk factors and a VAAE occurrence was estimated via multivariate logistic regression. 2,560 VAAEs were associated with administration of 1,258,712 doses of vaccine to 496,189 cats (51.6 VAAEs/10,000 cats vaccinated). The risk of a VAAE significantly increased as the number of vaccines administered per office visit increased. Risk was greatest for cats approximately 1 year old; overall risk was greater for neutered versus sexually intact cats. Lethargy with or without fever was the most commonly diagnosed VAAE. No localized reactions recorded in the 30-day period were subsequently diagnosed as neoplasia when followed for 1 to 2 years. Although overall VAAE rates were low, young adult neutered cats that received multiple vaccines per office visit were at the greatest risk of a VAAE within 30 days after vaccination. Veterinarians should incorporate these findings into risk communications and limit the number of vaccinations administered concurrently to cats.

Yellow Fever: Epidemiology and Prevention

Yellow fever continues to occur in regions of Africa and South America, despite the availability of effective vaccines. Recently, some cases of severe neurologic disease and multiorgan system disease have been described in individuals who received yellow fever vaccine. These events have focused attention on the need to define criteria for judicious use of yellow fever vaccine and to describe the spectrum of adverse events that may be associated with yellow fever vaccine. Describing host factors that would increase risk of these events and identifying potential treatment modalities for yellow fever and yellow fever vaccine-associated adverse events are subjects of intense investigation.

A comparative assessment of immunization records in the Defense Medical Surveillance System and the Vaccine Adverse Event Reporting System

We compared immunization data in the Defense Medical Surveillance System (DMSS) and immunization data for service members with an anthrax vaccine-associated adverse event reported to the Vaccine Adverse Event Reporting System (VAERS) during January 1998 through December 2004. Our main measure of agreement was sensitivity of the DMSS conditional on an immunization record(s) occurring in VAERS. The sensitivity of DMSS was 73% for all vaccines and 74% for the anthrax vaccine on the VAERS index immunization date. Our study is the first to quantify the agreement between immunization records in VAERS and DMSS. Our data suggest the immunization information in military VAERS reports and the DMSS is similar for anthrax and non-anthrax immunizations.

Vaccine adverse events reported in post-marketing study of the Kitasato Institute from 1994 to 2004

General physicians, pediatricians and parents realize that serious adverse events occur with an extremely rare incidence, but have no information on the incidences of vaccine-associated adverse events. A proper understanding of vaccine adverse events would be helpful in promoting an immunization strategy. Causal association can rarely be determined in adverse events through laboratory examinations. We examined the cases reported in the post-marketing surveillance of the Kitasato Institute, categorizing them into two groups: allergic reactions and severe systemic illnesses. Anaphylactic patients with gelatin allergy after immunization with live measles, rubella and mumps monovalent vaccines have been reported since 1993, but the number of reported cases with anaphylaxis dramatically decreased after 1999 when gelatin was removed from all brands of DPT. The incidence of anaphylactic reaction was estimated to be 0.63 per million for Japanese encephalitis virus (JEV) vaccine, 0.95 for DPT and 0.68 for Influenza vaccine, but the causative component has not yet been specified. Among 67.2 million immunization practices, 6 cases with encephalitis or encephalopathy, 7 with acute disseminated encephalomyelitis (ADEM), 10 with Guillain–Barré syndrome and 12 with idiopathic thrombocytopenic purpura (ITP) were reported. The wild-type measles virus genome was detected in a patient with encephalitis and in two of four bone marrow aspirates obtained from ITP after measles vaccination. Enterovirus infection was identified in two patients after mumps vaccination (one each with encephalitis and ADEM), one patient with encephalitis after immunization with JEV vaccine, and one with aseptic meningitis after immunization with influenza vaccine. The total estimated incidence of serious neurological illness after vaccination was 0.1–0.2 per million immunization practices. We found that enterovirus or wild-type measles virus infection was coincidentally associated with vaccination in several cases suspected of being vaccine adverse events.

A double-blind, randomized phase II trial of the safety and immunogenicity of 26-valent group A streptococcus vaccine in healthy adults

Background GrAS causes illness ranging from uncomplicated pharyngitis to life-threatening necrotizing fasciitis, toxic shock and rheumatic fever. Attempts to develop an M protein-based vaccine have been hindered by the fact that some M proteins elicit both protective antibodies and antibodies that cross-react with human tissues. New molecular techniques have allowed this obstacle to be largely overcome. Methods We performed a phase II trial of a 26-valent GrAS vaccine comprising four recombinant proteins containing N-terminal peptides from 26 M proteins (plus Spa = 27) of common pharyngitis, invasive, and/or rheumatogenic serotypes adsorbed to AlOH 3. Subjects were screened for good health and underwent baseline cardiac auscultation, echocardiography, ECG, and screening for human tissue-cross-reacting antibodies. Subjects (mean age = 33.6, range 18.9–50.9) were randomized in a 70:20 ratio to receive either GrAS or control vaccine, Havrix™, intramuscularly at 0, 1 and 6 months, with clinical and laboratory follow-up for safety and assay of type-specific M antibodies by quantitative ELISA. Results No vaccine-associated serious adverse events (SAE) occurred. Most adverse events (AEs) were at the injection site and were mild and self-limited. Systemic AEs were uncommon and did not differ between the 2 groups. No subject developed clinical or laboratory evidence of rheumatogenicity or nephritogenicity, and no induction of human tissue-reactive antibodies was demonstrated. The vaccine was highly immunogenic, eliciting an antibody response to the majority of group A streptococcus serotypes associated with pharyngitis, acute rheumatic fever, and invasive disease in North America Conclusions The 26-valent GrAS vaccine was well-tolerated and immunogenic in healthy adults; studies in adolescents and children are warranted.

Economic Evaluation of the 7-Vaccine Routine Childhood Immunization Schedule in the United States, 2001

To evaluate the economic impact of the routine US childhood immunization schedule: diphtheria and tetanus toxoids and acellular pertussis; tetanus and diphtheria toxoids; Haemophilus influenzae type b conjugate; inactivated poliovirus; measles, mumps, and rubella; hepatitis B; and varicella vaccines. Decision tree-based analysis was conducted using population-based vaccination coverage, published vaccine efficacies, historical data on disease incidence before vaccination, and disease incidence reported for 1995-2001. Costs were estimated using the direct cost and societal (direct and indirect costs) perspectives. Program costs included vaccine, administration, vaccine-associated adverse events, and parent travel and time lost. All costs were inflated to 2001 US dollars, and all costs and benefits in the future were discounted at a 3% annual rate. A hypothetical 2001 US birth cohort of 3,803,295 infants was followed up from birth through death. Net present value (net savings) and benefit-cost ratios of routine immunization. Routine childhood immunization with the 7 vaccines was cost saving from the direct cost and societal perspectives, with net savings of 9.9 billion dollars and 43.3 billion dollars, respectively. Without routine vaccination, direct and societal costs of diphtheria, tetanus, pertussis, H influenzae type b, poliomyelitis, measles, mumps, rubella, congenital rubella syndrome, hepatitis B, and varicella would be 12.3 billion dollars and 46.6 billion dollars, respectively. Direct and societal costs for the vaccination program were an estimated 2.3 billion dollars and 2.8 billion dollars, respectively. Direct and societal benefit-cost ratios for routine childhood vaccination were 5.3 and 16.5, respectively. Regardless of the perspective, the current routine childhood immunization schedule results in substantial cost savings.

HYPOTONIC-HYPORESPONSIVE EPISODE IN A 7-MONTH-OLD INFANT AFTER RECEIPT OF MULTIPLE VACCINATIONS

A 7-month-old boy became difficult to arouse, was limp and had blue extremities 8 hours after immunization with intravenous poliovirus, diphtheria-tetanus toxoids-acellular pertussis, Haemophilus influenzae type b-hepatitis B virus and pneumococcal vaccines. The hypotonic-hyporesponsive episode had resolved by the time the infant was seen in an emergency department 1 hour later. The report describes hypotonic-hyporesponsive episode, encourages reporting of vaccine-associated adverse events and discusses prognosis and implications for subsequent immunization.

Adverse events diagnosed within three days of vaccine administration in dogs

To determine incidence rates and potential risk factors for vaccine-associated adverse events (VAAEs) diagnosed within 3 days of administration in dogs. Retrospective cohort study. 1,226,159 dogs vaccinated at 360 veterinary hospitals. Electronic records from January 1, 2002, through December 31, 2003, were searched for possible VAAEs (nonspecific vaccine reaction, allergic reaction, urticaria, or anaphylaxis) diagnosed within 3 days of vaccine administration. Information included age, weight, sex, neuter status, and breed. Specific clinical signs and treatments were reviewed in a random sample of 400 affected dogs. The association between potential risk factors and a VAAE was estimated by use of multivariate logistic regression. 4,678 adverse events (38.2/10,000 dogs vaccinated) were associated with administration of 3,439,576 doses of vaccine to 1,226,159 dogs. The VAAE rate decreased significantly as body weight increased. Risk was 27% to 38% greater for neutered versus sexually intact dogs and 35% to 64% greater for dogs approximately 1 to 3 years old versus 2 to 9 months old. The risk of a VAAE significantly increased as the number of vaccine doses administered per office visit increased; each additional vaccine significantly increased risk of an adverse event by 27% in dogs < or = 10 kg (22 lb) and 12% in dogs > 10 kg. Young adult small-breed neutered dogs that received multiple vaccines per office visit were at greatest risk of a VAAE within 72 hours after vaccination. These factors should be considered in risk assessment and risk communication with clients regarding vaccination.

Serious Adverse Events Associated with Bacille Calmette-Guérin Vaccine in Canada

Targeted Bacille Calmette-Guérin (BCG) vaccination is offered to neonates in some First Nations and Inuit (FNI) communities in Canada. Serious adverse events associated with BCG vaccine prompted a review to assess causality. The Immunization Monitoring Program Active (IMPACT), a pediatric hospital-based active surveillance network, reported admissions for BCG-related adverse events between 1993 and April 2002. The Canadian Advisory Committee on Causality Assessment (ACCA) reviewed the reports to assess causality. Data between 1987 and September 2002 from the Vaccine-Associated Adverse Event Surveillance (VAAES) Program, a passive national reporting system, were also reviewed. IMPACT identified 21 pediatric cases; 19 were Canadian-born, and 18 were FNI. Six disseminated BCG cases were identified; 5 were FNI infants who subsequently died. All had immunodeficiencies and concurrent infections. Other adverse events included 2 cases of osteomyelitis, BCG abscesses and lymphadenitis. ACCA reviewed the 21 cases and determined that 14 were very likely associated with the vaccine, including the 6 disseminated BCGs; 5 were probably associated and 1 was possibly associated with the vaccine; 1 was unclassifiable. The VAAES program identified 157 adverse events. No additional serious systemic adverse events (disseminated BCG or osteomyelitis) were identified. Serious BCG vaccine-associated complications continue to occur in Canada. The numbers of FNI children with disseminated disease was greater than expected from reported rates in the literature.

Incidence of and risk factors for adverse events associated with distemper and rabies vaccine administration in ferrets

To determine incidence of and risk factors for adverse events associated with distemper and rabies vaccine administration in ferrets. Retrospective cohort study. 3,587 ferrets that received a rabies or distemper vaccine between January 1, 2002, and December 31, 2003. Electronic medical records were searched for possible vaccine-associated adverse events. Adverse events were classified by attending veterinarians as nonspecific vaccine reactions, allergic reactions, or anaphylaxis. Patient information that was collected included age, weight, sex, cumulative number of distemper and rabies vaccinations received, clinical signs, and treatment. The association between potential risk factors and occurrence of an adverse event was estimated with logistic regression. 30 adverse events were recorded. The adverse event incidence rates for administration of rabies vaccine alone, distemper vaccine alone, and rabies and distemper vaccines together were 0.51%, 1.00%, and 0.85%, respectively. These rates were not significantly different. All adverse events occurred immediately following vaccine administration and most commonly consisted of vomiting and diarrhea (52%) or vomiting alone (31%). Age, sex, and body weight were not significantly associated with occurrence of adverse events, but adverse event incidence rate increased as the cumulative number of distemper or rabies vaccinations received increased. In multivariate logistic regression analysis, only the cumulative number of distemper vaccinations received was significantly associated with the occurrence of an adverse event. Results suggest that in ferrets, the risk of vaccine-associated adverse events was primarily associated with an increase in the number of distemper vaccinations.

Characteristics of Pediatric and Adolescent Patients Attending a Naturopathic College Clinic in Canada

The use of complementary and alternative medicine (CAM) has grown substantially in North America and has drawn the attention of conventional-medicine practitioners. Conventional-medicine practitioners have expressed concern about the potential for unregulated CAM therapies to cause harm, the sometimes-uncertain cost-benefit ratios associated with these therapies, and the possibility that some CAM providers might advise against established conventional therapies, such as vaccination. These concerns are heightened with respect to the pediatric use of CAM products. To address this issue, we conducted a systematic audit of pediatric and adolescent case files at a large, college-based, Canadian naturopathic teaching clinic. We specifically sought to describe the demographic characteristics, reasons for presentation, use of CAM products, and vaccinations status of children presenting for naturopathic assessment. We also determined factors associated with the use of CAM products and vaccination status. We identified all charts for children (<18 years of age) who presented to the Robert Schad Naturopathic Clinic, the teaching clinic of the Canadian College of Naturopathic Medicine, between February 1 and May 31, 2002. Data were abstracted directly from the standardized patient intake forms and from clinical notes recorded during the patient's initial visit to the clinic. The following data were obtained: age, gender, chief presenting complaints reported by parents, CAM product use at presentation, vaccination status, and reactions to vaccination. We conducted logistic regression analyses to identify factors associated with both CAM product use and vaccination status. A total of 482 charts were identified. The mean age of patients was 6.5 years (95% confidence interval [CI]: 1.6-11.4 years). The ratio of female subjects to male subjects was 1.09:1 (248:227). The most common reasons for presentation were skin disorders (23%), gastrointestinal complaints (17%), and psychiatric/behavioral disorders (15%). Thirty-five percent of children were using CAM products at presentation (21.2% when both vitamins and minerals were excluded). Vitamins were the most commonly used products (34.6%), followed by herbal remedies (14.9%), oil blends/fats (7.2%), minerals (5.6%), probiotics (4.5%), and homeopathic remedies (3.7%). Of charts with vaccination information, 8.9% indicated that children had not been vaccinated; possible vaccine-associated adverse events were reported for 27% of those who had been vaccinated. Partial or unvaccinated status was associated with younger age, attending the Canadian College of Naturopathic Medicine for advice regarding vaccination, and greater use of CAM products. CAM product use was associated with unvaccinated or partially vaccinated status (odds ratio [OR]: 2.86; 95% CI: 1.46-5.63), presenting with poor energy or fatigue (OR: 3.36; 95% CI: 1.00-11.26), or presenting with throat or sinus infections (OR: 4.06; 95% CI: 1.23-13.04). Children present for naturopathic assessment for diverse reasons, are high-level consumers of CAM products, and have lower rates of vaccination than population averages. The conventional-medicine community should work with naturopaths to address public health concerns in this population.

Oculo-respiratory syndrome after influenza vaccination: trends over four influenza seasons

Background: Oculo-respiratory syndrome (ORS) following influenza vaccination was identified in Canada in 2000. This report describes trends of ORS reported during four consecutive seasons 2000, 2001, 2002 and 2003 in the province of Quebec, Canada. Methods: Data come from the vaccine-associated adverse event (VAAE) passive reporting system of the Province of Quebec. Results: The rate of ORS reported per 100 000 doses distributed declined from 46.6 in 2000 to 34.2, 20.6 and 9 in 2001, 2002 and 2003, respectively. There was no significant difference in rates for ORS between the two vaccines in use in Canada (Fluviral and Vaxigrip) both in 2001 and 2002. During the 4 years, incidence was highest in people aged 40–59 years and declined in older age groups. The clinical profile of ORS has remained remarkably stable over years. Overall, ocular, respiratory symptoms or facial edema were reported by 58%, 84% and 31% of patients, respectively, and 15% had symptoms including all three symptom categories. ORS lasted more than a week in 8–13% of the cases. Conclusion: ORS is an adverse event that occurred with both influenza vaccines used in Canada. Its frequency has declined substantially but is still present after 4 years. It constitutes a clinical entity distinct from anaphylactic allergy. Unlike anaphylaxis, ORS does not constitute an absolute contraindication to further doses.

Update on side effects from common vaccines.

Vaccines have had a tremendous impact on public health by reducing morbidity and mortality from a variety of virulent pathogens. However, unintended side effects continue to pose a potential risk that may outweigh the vaccine's protective attributes. In this review, we discuss recent articles and controversies pertaining to vaccine-associated adverse events. Included in the discussion are influenza, hepatitis B, measles-mumps-rubella, diphtheria-tetanus-pertussis, polio, Haemophilus influenzae type b, and rotavirus vaccines. The importance and contribution of vaccine constituents (such as thimerosal) to side effects is also reviewed.