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Epidemiological evidence suggests a link between mercury (Hg) exposure from Thimerosal-containing vaccines and specific delays in development. A hypothesis-testing longitudinal cohort study (n=49,835) using medical records in the Vaccine Safety Datalink (VSD) was undertaken to evaluate the relationship between exposure to Hg from Thimerosal-containing hepatitis B vaccines (T-HBVs) administered at specific intervals in the first 6months of life and specific delays in development [International Classification of Disease, 9th revision (ICD-9): 315.xx] among children born between 1991 and 1994 and continuously enrolled from birth for at least 5.81years. Infants receiving increased Hg doses from T-HBVs administered within the first month, the first 2months, and the first 6months of life were significantly more likely to be diagnosed with specific delays in development than infants receiving no Hg doses from T-HBVs. During the decade in which T-HBVs were routinely recommended and administered to US infants (1991-2001), an estimated 0.5-1million additional US children were diagnosed with specific delays in development as a consequence of 25μg or 37.5μg organic Hg from T-HBVs administered within the first 6months of life. The resulting lifetime costs to the United States may exceed $1 trillion.

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OBJECTIVES: This analysis examined the incidence rate of chronic arthritis adverse reactions reported following adult rubella and hepatitis B vaccinations. In this analysis, etiologic mechanisms for chronic arthritis following adult rubella and hepatitis B vaccines were also explored. METHODS: The Vaccine Adverse Events Reporting System (VAERS) database was analyzed for the incidence rate of reported cases of chronic arthritis in comparison to Tetanus-diphtheria (Td) and tetanus toxoid adult vaccine control groups. RESULTS: Chronic arthritis adverse reactions following adult rubella vaccination were primarily reported in females (female/male ratio = 3.0), at about 45 years-old, and at a mean onset time of 10-11 days following vaccination. Chronic arthritis adverse reactions following adult hepatitis B vaccination were also primarily reported in females(female/male ratio = 3.5), at about 33 years-old, and with a mean onset time of 16 days following vaccination. The incidence rates of chronic arthritis following adult rubella and adult hepatitis B vaccinations were statistically significantly increased, by chi 2 analysis, in comparison to the adult vaccine control groups. The attributable risk of chronic arthritis following adult rubella vaccine ranged from 32 to 53 and from 5.1 to 9.0 following adult hepatitis B vaccine in comparison to the adult vaccine control groups. CONCLUSION: This study revealed that adult rubella and adult hepatitis B vaccines were statistically associated with chronic arthritis which persisted for at least one year. The etiology for these adverse reactions may involve autoimmune mechanisms. Furthermore, potential biases in the reporting rates of adverse reactions to VAERS were not observed.

We report one woman with acute cerebellar ataxia (ACA), a well-defined clinical syndrome, which occurred 10 days after the second vaccination with recombinant hepatitis B vaccine. The patient had no previous symptoms or signs of neurological disease and there was no evidence of neurologic disease in the family history. Within nine months the symptoms remitted completely according to other reports of ACA. As there was a close temporal connection and no noticeable other cause we assume a causal link between the vaccination and the disease. As far as we known this is the first case of ACA after hepatitis B vaccination.

Acute disseminated encephalomyelitis (ADEM) is an inflammatory demyelinating disease of the central nervous system, which has been associated with several vaccines such as rabies, diphtheria-tetanus-polio, smallpox, measles, mumps, rubella, Japanese B encephalitis, pertussis, influenza, and the Hog vaccine. Here, we presented a case of 12-year-old child who suffered from ADEM three weeks after hepatitis B vaccination. He was admitted to our hospital with symptoms of weakness of limbs, high fever, and alteration of consciousness. Some abnormalities were also found in CSF. Treatment with high-dose corticosteroids and intravenous immunoglobulin had significant effect, with marked improvement of the clinical symptoms and the results of CSF. The findings of MRI also detected some abnormal lesions located in both brain and spinal cord. The clinical features, the findings of CSF and MRI, and therapeutic effect may contribute to such diagnosis of ADEM.

OBJECTIVE: To report two cases of acute posterior multifocal placoid pigment epitheliopathy after immunization with a recombinant hepatitis B virus vaccine.

DESIGN: Case reports.

RESULTS: Two patients had development of visual loss 3 days to 2 weeks after the booster administration of 20 micrograms of recombinant hepatitis B virus surface antigen (Engerix-B). In both cases, fundus examination, fluorescein angiograms, and the course of the disease were typical of acute posterior multifocal placoid pigment epitheliopathy. In case 1, 1 week after immunization, the leukocyte count was 10.3 X 10(9)/L with 24% polynuclear eosinophils (2.47 X 10(9)/L); in case 2, blood cell counts were normal.

CONCLUSION: Hepatitis B virus immunization may be a risk factor for acute posterior multifocal placoid pigment epitheliopathy. Molecular mimicry between a retinal pigment epithelium protein and hepatitis B surface antigen could play a role. These cases suggest an immune-mediated retinal pigment epithelium disruption or choroidal vascular occlusions triggered by hepatitis B surface antigen.

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INTRODUCTION:Acute transverse myelitis is an inflammatory disorder. The pathogenesis is unclear, but the probable mechanism involves an autoimmune phenomenon. Possible causes included multiple sclerosis and parainfectious and postvaccinal events. Myelitis has rarely been reported secondary to vaccinations including hepatitis B. We present a case of acute myelitis, which seems secondary to the administration of the hepatitis B vaccine.

CLINICAL CASE:A 15-years-old female presented with progressive numbness of the right arm and leg, with right leg weakness. Symptom began one week after receiving the first dose of the hepatitis B vaccine. Spinal cord magnetic resonance (MR) revealed a diffuse increased signal extending from C6 to D2. Cerebral MR and cerebrospinal fluid were normal. She was treated with high doses of methylprednisolone with a complete recovery of neurological functional. Repeat medullar cord MR was normal. There was no relapse during a four years follow up.

CONCLUSIONS:Potential causal relationship between vaccination against hepatitis B and multiple sclerosis was brought to the attention and to public debate. However, no conclusive association could be made between vaccination and demyelination. In the clinical setting, the distinction between a first episode of multiple sclerosis or postvaccinal myelitis depends upon subsequent course.

OBJECTIVE: To evaluate the safety of Hepatitis B vaccine by analyzing the 10 infants death after Hepatitis B vaccination.

METHODS: Collect the reporting data from the public health emergencies report system of China Disease Prevention and Control System. RESULTS: In the 10 death cases after hepatitis B vaccination, 2 cases would be acute anaphylactic shock caused by the vaccination, and the other 8 death cases were not related to vaccination.

CONCLUSIONS: The hepatitis B vaccine of China were safety, there were very few death cases of allergic reactions following hepatitis B vaccination. We should standardize the vaccination in order to reduce the adverse events following immunization.

Side effects of hepatitis vaccination are rare. Only a few cases of arthritis after hepatitis vaccination have been published. We report on three cases of vaccination-induced arthritis with different resulting disease. Two cases show the pattern of reactive arthritis. None of them was associated with HLA-B27. In the third case onset of rheumatoid arthritis was triggered by hepatitis vaccination. These three cases show that arthritis after hepatitis B vaccination probably is more common than reported so far, especially in a genetically predisposed subject (two of our patients expressed HLA-DR4).

OBJECTIVES:In this study we analyzed the clinical and demographic manifestations among patients diagnosed with immune/autoimmune-mediated diseases post-hepatitis B vaccination. We aimed to find common denominators for all patients, regardless of different diagnosed diseases, as well as the correlation to the criteria of Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants (ASIA).

PATIENTS AND METHODS:We have retrospectively analyzed the medical records of 114 patients, from different centers in the USA, diagnosed with immune-mediated diseases following immunization with hepatitis-B vaccine (HBVv). All patients in this cohort sought legal consultation. Of these, 93/114 patients diagnosed with disease before applying for legal consultation were included in the study. All medical records were evaluated for demographics, medical history, number of vaccine doses, peri-immunization adverse events and clinical manifestations of diseases. In addition, available blood tests, imaging results, treatments and outcomes were recorded. Signs and symptoms of the different immune-mediated diseases were grouped according to the organ or system involved. ASIA criteria were applied to all patients.

RESULTS:The mean age of 93 patients was 26.5± 15 years; 69.2% were female and 21% were considered autoimmune susceptible. The mean latency period from the last dose of HBVv and onset of symptoms was 43.2 days. Of note, 47% of patients continued with the immunization program despite experiencing adverse events. Manifestations that were commonly reported included neuro-psychiatric (70%), fatigue (42%) mucocutaneous (30%), musculoskeletal (59%) and gastrointestinal (50%) complaints. Elevated titers of autoantibodies were documented in 80% of sera tested. In this cohort 80/93 patients (86%), comprising 57/59 (96%) adults and 23/34 (68%) children, fulfilled the required criteria for ASIA.

CONCLUSIONS:Common clinical characteristics were observed among 93 patients diagnosed with immune-mediated conditions post-HBVv, suggesting a common denominator in these diseases. In addition, risk factors such as history of autoimmune diseases and the appearance of adverse event(s) during immunization may serve to predict the risk of post-immunization diseases. The ASIA criteria were found to be very useful among adults with post-vaccination events. The application of the ASIA criteria to pediatric populations requires further study.

Bell's Palsy is the sudden onset of unilateral temporary paralysis of facial muscles resulting from seventh cranial nerve dysfunction. Presented here is a two-year old female patient with right peripheral facial palsy following hepatitis B vaccination. Readers' attention is drawn to an uncommon cause of Bell's Palsy, as a rare complication of hepatitis B vaccination.

The objectives of this study were to gather information regarding demographic and clinical characteristics of patients diagnosed with either fibromyalgia (FM) or chronic fatigue (CFS) following hepatitis B vaccination (HBVv) and furthermore to apply the recently suggested criteria of autoimmune (auto-inflammatory) syndromes induced by adjuvants (ASIA), in the aim of identifying common characteristics that may suggest an association between fibromyalgia, chronic fatigue and HBV vaccination. Medical records of 19 patients with CFS and/or fibromyalgia following HBVv immunization were analyzed. All of which were immunized during 1990-2008 in different centers in the USA. All medical records were evaluated for demographics, medical history, the number of vaccine doses, as well as immediate and long term post-immunization adverse events and clinical manifestations. In addition, available blood tests, imaging results, treatments and outcomes were analyzed. ASIA criteria were applied to all patients. The mean age of patients was 28.6± 11 years, of which 68.4 % were females. 21.05 % had either personal or familial background of autoimmune disease. The mean latency period from the last dose of HBVv to onset of symptoms was 38.6 ± 79.4 days, ranging from days to a year. Eight (42.1 %) patients continued with the immunization program despite experiencing adverse events. Manifestations that were commonly reported included neurological manifestations (84.2 %), musculoskeletal (78.9 %), psychiatric (63.1 %), fatigue (63.1 %), gastrointestinal complains (58 %) and mucocutaneous manifestations (36.8 %). Autoantibodies were detected in 71 % of patients tested. All patients fulfilled the ASIA criteria. This study suggests that in some cases CFS and FM can be temporally related to immunization, as part of ASIA syndrome. The appearance of adverse event during immunization, the presence of autoimmune susceptibility and higher titers of autoantibodies all can be suggested as risk factors. ASIA criteria were fulfilled in all patients eluding the plausible link between ASIA and CFS/FM.

INTRODUCTION: Although the hepatitis B vaccination tolerance is generally good, adverse effects, which are specially neurologic and cutaneous, have been observed and some cases of induced diseases with immunological disorders have been reported.

CASE REPORT: A 6 year-old boy presented a cutaneous lupus erythematosus and a severe buccal aphthosis following hepatitis B vaccination. There was no clinical or biological symptom of systemic lupus erythematosus nor of Behçet's disease. Under chloroquine therapy, the cutaneous manifestations of lupus erythematosus disappeared quickly and those of buccal aphthosis improved.

DISCUSSION: Hepatitis B vaccination side effects are probably in relation with a specific or non specific stimulation of the immune system. In our case, cellular immunity is perhaps involved through the HBs antigen. Considering the rarity of these side effects, an individual predisposition seems very likely.

The Hepatitis B vaccine is highly effective for the prevention of hepatitis B (HBV) infection. We report the development of chronic HBV infection (Genotype F) in a vaccinated immunocompetent individual with an anti-HBsAb of 35 mIU/mL post completion of vaccine series. HBV vaccine is based on recombinant proteins of genotype-A and D (predominant genotypes in Europe). It may not be as effective for the prevention of more genetically diverse viruses such as genotype F (predominant genotype in Central and South America). Healthcare providers and patients should be aware that the HB vaccine does not confer 100% protection against HBV infection, even in the setting of protective antibody levels. Partners of individuals infected with non-A or -D genotypes should be advised to consider additional precautions to prevent transmission even in the setting protective antibody levels. Surveillance of circulating HBV genotypes should be undertaken to inform public health policy in relation to prevention of HB in high-risk groups such as men who have sex with men.

OBJECTIVE:To describe clinical and MRI features of patients with a disease suggestive of CNS inflammation after hepatitis B vaccination.

METHODS:Eight patients with confirmed CNS inflammation occurring less than 10 weeks after hepatitis B vaccination are described. They received follow-up clinically and on MRI for a mean period of 18 months.

RESULTS:Clinical and MRI findings were compatible with acute disseminated encephalomyelitis. However, clinical follow-up, repeated MRI, or both showed the persistence of inflammatory activity, which makes this encephalitis more suggestive of MS than of acute disseminated encephalomyelitis.

CONCLUSION:The persistent inflammatory activity observed clinically and on MRI in these patients is comparable with that usually observed in MS. Epidemiologic studies are currently testing the hypothesis of a triggering role of hepatitis B vaccination in CNS demyelination.

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Erythema multiforme is a cutaneous reaction pattern precipitated by varied agents, notably herpes simplex and drugs. It predominantly occurs in adolescents and young adults but may be seen at other ages also. While vaccination is rarely a precipitating factor for erythema multiforme, it may occasionally be seen in infants and children. We report here a case of a two month-old infant with lesions of erythema multiforme minor appearing after two weeks following vaccination for DPT, Hepatitis B and influenza.