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Miles M Braun - One of the best experts on this subject based on the ideXlab platform.

  • Hypotonic Hyporesponsive Episode hhe as an adverse event following immunization case definition and guidelines for data collection analysis and presentation
    Vaccine, 2004
    Co-Authors: Jan Bonhoeffer, Miles M Braun, Dean A Blumberg, Harald Heijbel, Michael Gold, Patricia Vermeer, Glacus De Souzabrito, Robert L Davis, Scott A Halperin, Ulrich Heininger
    Abstract:

    Jan Bonhoeffer, Michael S Gold, Harald Heijbel, Patricia Vermeer, Dean Blumberg, Miles Braun, Glacus de Souza-Brito, Robert L Davis, Scott Halperin, Ulrich Heininger, Najwa Khuri-Bulos, John Menkes, Hanne Nokleby

  • Hypotonic Hyporesponsive Episodes reported to the vaccine adverse event reporting system vaers 1996 1998
    Pediatrics, 2000
    Co-Authors: Tracy S Duvernoy, Miles M Braun
    Abstract:

    Background. A Hypotonic–Hyporesponsive Episode (HHE) is the sudden onset of hypotonia, Hyporesponsiveness, and pallor or cyanosis that occurs within 48 hours after childhood immunizations. This syndrome has been primarily associated with pertussis-containing vaccines administered to children <2 years of age, and has been estimated to occur once every 1750 diphtheria-tetanus-pertussis (DTwP) vaccinations. Previous studies of HHE were limited by small numbers of cases and, sometimes, by limited details of the event. Objectives. To characterize a large number of HHE cases reported to the Vaccine Adverse Event Reporting System (VAERS), to assist clinicians in identifying HHE, and to assist researchers in investigating the risk factors, cause, and pathogenesis of this syndrome. Methods. More than 40 000 VAERS reports received between 1996 and 1998 were screened for HHE by a computer algorithm and reviewed, and a telephone follow-up questionnaire was administered to the witness of HHE. Results. There were 215 HHE cases, all nonfatal. The median age of onset of HHE was 4.0 months (range: 1.1–107 months). Over half of the reports (53%) concerned females. The median birth weight was 3.36 kg (range: 1.27–4.96 kg); 4.7% had a birth weight 24 months of age. There were no relevant findings regarding family medical history or the mothers' gestational history. Nearly all of the children (98.6%) returned to their prevaccination state according to the telephone questionnaire; median time to return was 6 hours (range: 1 minute– 4 months). The 3 children reported as not returning to their prevaccination state all had VAERS reports submitted after they developed conditions (autism, complex partial epilepsy, and developmental delays with infantile spasms) that are not known to be causally associated with immunization. The vast majority of children (93%) with HHE received a pertussis-containing vaccine, either diphtheria-tetanus-acellular pertussis (DTaP, 28%), DTwP (11%), or diphtheria-tetanus-pertussis- Haemophilus influenzae type b (DTwP-HIB, 61%). During the HHE Episode, 90.1% of the children had pallor and 49% had cyanosis. Because of the HHE event, 6.8% of children had had all vaccines withheld as of the date of the interview. Of the remainder, 66.5% of children have had 1 or more subsequent vaccinations or vaccine components withheld, and 26.7% have not had any subsequent vaccinations withheld. Only 1 child was reported to have had a repeat Episode of HHE, occurring after hepatitis B vaccination. From 1996 to 1998, the number of HHE reports decreased from 99 to 38, when the predominant pertussis vaccine administered to infants changed from whole-cell to acellular. Conclusion. This study represents the largest published case series of children with HHE and supports the generally benign, self-limited, nonrecurrent nature of this syndrome. Although HHE has been less frequently reported to VAERS after increased use of DTaP, HHE does occur after the administration of DTaP and other nonpertussis-containing vaccines. Although most parents and pediatricians withheld the pertussis component of subsequent vaccinations, many did not, with no reported adverse events occurring in the children after the subsequent immunizations. Restricting the definition of HHE to a more narrow age range (eg, <2 years of age) is also proposed because most of the older children probably experienced vasovagal syncope rather than HHE within 5 minutes of immunization.

  • report of a us public health service workshop on Hypotonic Hyporesponsive Episode hhe after pertussis immunization
    Pediatrics, 1998
    Co-Authors: Miles M Braun, Gina Terracciano, Marcel E Salive, Dean A Blumberg, Patricia Vermeerde E Bondt, Harald Heijbel, Geoffrey Evans, Peter A Patriarca, Susan S Ellenberg
    Abstract:

    Hypotonic–Hyporesponsive Episode (HHE) is a term used to describe a somewhat heterogenous group of clinical disorders that have been reported primarily in association with whole-cell pertussis vaccination. A 1991 review by the Institute of Medicine determined that the evidence available was indeed consistent with a causal relation between whole-cell pertussis-diphtheria-tetanus immunization and HHE, but that the evidence was insufficient to indicate a causal relationship between HHE and the subsequent development of permanent neurologic damage. More recent data from clinical trials conducted in Europe suggest that HHE also occurs after vaccination with acellular pertussis vaccines. The US Food and Drug Administration, in collaboration with the US Public Health Service, sponsored a workshop on HHE in Rockville, Maryland, on June 19, 1997. The primary goals of the workshop were to develop a case definition of HHE and to evaluate the general design and feasibility of possible studies of HHE using the federal Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system. The goals of such studies would be to understand better the acute HHE event and to evaluate the possibility of long-term sequelae. Case Definition . There has been no generally accepted definition of HHE, and a standard definition would be useful for vaccine safety work and would potentially facilitate interstudy comparisons of the growing number of licensed vaccines containing acellular pertussis components. The workshop defined HHE as an event of sudden onset occurring within 48 hours of immunization, with duration of the Episode ranging from 1 minute to 48 hours, in children younger than 10 years of age. All of the following must be present: 1) limpness or hypotonia, 2) reduced responsiveness or Hyporesponsiveness, and 3) pallor or cyanosis or failure to observe or to recall skin coloration. HHE is not considered to have occurred if there is a known cause for these signs (eg, postictal), if urticaria is present during the event, if normal skin coloration is observed throughout the Episode, or if the child is simply sleeping. This inclusive (sensitive) case definition will allow investigators, through the technique of stratification according to certain characteristics (eg, time from vaccination to onset of HHE), to attempt to hone the definition and make it more specific. Refinement of the definition of HHE has been hindered by the lack of information on its pathophysiology and by the lack of pathognomonic signs, symptoms, and diagnostic tests. Another hindrance is that by the time the child presents for medical evaluation, the signs of HHE often have normalized. Moreover, different mechanisms may be involved in different individuals whose events meet this workshop9s HHE definition. Further Study of HHE.  Probably the most important question about HHE is whether it has any permanent sequelae. The workshop assessed the possible contribution VAERS-based studies could make to answering this question and found substantial methodologic problems; however, ongoing studies in Sweden and The Netherlands have the potential to provide useful information on this question. The most useful contribution of VAERS data would be in a descriptive study of HHE, with a possible case–control study of factors that may affect the risk of HHE after vaccination, rather than a study of possible permanent sequelae. The workshop participants felt that a detailed descriptive study of ∼100 HHE events reported during a 1- to 2-year period could provide a more in-depth description of HHE cases in greater numbers than has been published previously, but the study would not address the issue of long-term sequelae of HHE. Better descriptive data may lead to new hypotheses concerning risk factors, etiology, and pathophysiology of HHE that might be evaluated further by studying subsequent cases and controls from VAERS or from other sources, depending on the hypotheses being tested. Workshop participants agreed that the question of possible long-term sequelae of HHE may currently be best answered in studies being conducted outside of the United States. A cohort of 82 892 infants was enrolled in the Stockholm II randomized, double-blind, controlled trial of one whole-cell and three acellular pertussis vaccines in Sweden in 1993–1994. In this trial, 101 infants developed HHE after vaccination. Of these children, 100 (1 had left Sweden) were evaluated subsequently at 18 months of age, using routine screening tests of motor and cognitive development intended to detect moderate to serious developmental problems. All 100 were found to be developing normally. At older ages, when more subtle developmental problems are detectable, comparison of the physical development and neurodevelopment of these children with a sample of trial participants without a history of HHE should be feasible. A protocol for a study to make such a comparison at ages 5½ and 8½ years is being prepared. In The Netherlands, a case–control study of infants who had HHE reported in 1995 is ongoing. The HHE events were detected through national surveillance linked to the health care delivery system. Growth, health, and neurodevelopment are being assessed. Data presented at the workshop concerning children with HHE reported in 1994 indicate that all 101 children followed during the second year of life (mean age, 1.5 years) were in good health and developing normally. An interesting finding of this follow-up study was the low rate of recurrent collapse (subsequent HHE occurrences) after repeat doses of pertussis vaccine. Summary.  Despite increasingly widespread use of acellular pertussis vaccine in infants, HHE will continue to occur. The HHE definition proposed by this workshop should facilitate interstudy comparisons of HHE incidence among in the growing number of vaccines containing acellular pertussis components and perhaps of other vaccines as well. This definition also may aid study in VAERS and elsewhere of the etiology, pathophysiology, and descriptive epidemiology of HHE. Ongoing investigations in Sweden and The Netherlands have the potential to expand substantially knowledge of the possibility of long-term sequelae of HHE.

Dean A Blumberg - One of the best experts on this subject based on the ideXlab platform.

  • Hypotonic Hyporesponsive Episode hhe as an adverse event following immunization case definition and guidelines for data collection analysis and presentation
    Vaccine, 2004
    Co-Authors: Jan Bonhoeffer, Miles M Braun, Dean A Blumberg, Harald Heijbel, Michael Gold, Patricia Vermeer, Glacus De Souzabrito, Robert L Davis, Scott A Halperin, Ulrich Heininger
    Abstract:

    Jan Bonhoeffer, Michael S Gold, Harald Heijbel, Patricia Vermeer, Dean Blumberg, Miles Braun, Glacus de Souza-Brito, Robert L Davis, Scott Halperin, Ulrich Heininger, Najwa Khuri-Bulos, John Menkes, Hanne Nokleby

  • report of a us public health service workshop on Hypotonic Hyporesponsive Episode hhe after pertussis immunization
    Pediatrics, 1998
    Co-Authors: Miles M Braun, Gina Terracciano, Marcel E Salive, Dean A Blumberg, Patricia Vermeerde E Bondt, Harald Heijbel, Geoffrey Evans, Peter A Patriarca, Susan S Ellenberg
    Abstract:

    Hypotonic–Hyporesponsive Episode (HHE) is a term used to describe a somewhat heterogenous group of clinical disorders that have been reported primarily in association with whole-cell pertussis vaccination. A 1991 review by the Institute of Medicine determined that the evidence available was indeed consistent with a causal relation between whole-cell pertussis-diphtheria-tetanus immunization and HHE, but that the evidence was insufficient to indicate a causal relationship between HHE and the subsequent development of permanent neurologic damage. More recent data from clinical trials conducted in Europe suggest that HHE also occurs after vaccination with acellular pertussis vaccines. The US Food and Drug Administration, in collaboration with the US Public Health Service, sponsored a workshop on HHE in Rockville, Maryland, on June 19, 1997. The primary goals of the workshop were to develop a case definition of HHE and to evaluate the general design and feasibility of possible studies of HHE using the federal Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system. The goals of such studies would be to understand better the acute HHE event and to evaluate the possibility of long-term sequelae. Case Definition . There has been no generally accepted definition of HHE, and a standard definition would be useful for vaccine safety work and would potentially facilitate interstudy comparisons of the growing number of licensed vaccines containing acellular pertussis components. The workshop defined HHE as an event of sudden onset occurring within 48 hours of immunization, with duration of the Episode ranging from 1 minute to 48 hours, in children younger than 10 years of age. All of the following must be present: 1) limpness or hypotonia, 2) reduced responsiveness or Hyporesponsiveness, and 3) pallor or cyanosis or failure to observe or to recall skin coloration. HHE is not considered to have occurred if there is a known cause for these signs (eg, postictal), if urticaria is present during the event, if normal skin coloration is observed throughout the Episode, or if the child is simply sleeping. This inclusive (sensitive) case definition will allow investigators, through the technique of stratification according to certain characteristics (eg, time from vaccination to onset of HHE), to attempt to hone the definition and make it more specific. Refinement of the definition of HHE has been hindered by the lack of information on its pathophysiology and by the lack of pathognomonic signs, symptoms, and diagnostic tests. Another hindrance is that by the time the child presents for medical evaluation, the signs of HHE often have normalized. Moreover, different mechanisms may be involved in different individuals whose events meet this workshop9s HHE definition. Further Study of HHE.  Probably the most important question about HHE is whether it has any permanent sequelae. The workshop assessed the possible contribution VAERS-based studies could make to answering this question and found substantial methodologic problems; however, ongoing studies in Sweden and The Netherlands have the potential to provide useful information on this question. The most useful contribution of VAERS data would be in a descriptive study of HHE, with a possible case–control study of factors that may affect the risk of HHE after vaccination, rather than a study of possible permanent sequelae. The workshop participants felt that a detailed descriptive study of ∼100 HHE events reported during a 1- to 2-year period could provide a more in-depth description of HHE cases in greater numbers than has been published previously, but the study would not address the issue of long-term sequelae of HHE. Better descriptive data may lead to new hypotheses concerning risk factors, etiology, and pathophysiology of HHE that might be evaluated further by studying subsequent cases and controls from VAERS or from other sources, depending on the hypotheses being tested. Workshop participants agreed that the question of possible long-term sequelae of HHE may currently be best answered in studies being conducted outside of the United States. A cohort of 82 892 infants was enrolled in the Stockholm II randomized, double-blind, controlled trial of one whole-cell and three acellular pertussis vaccines in Sweden in 1993–1994. In this trial, 101 infants developed HHE after vaccination. Of these children, 100 (1 had left Sweden) were evaluated subsequently at 18 months of age, using routine screening tests of motor and cognitive development intended to detect moderate to serious developmental problems. All 100 were found to be developing normally. At older ages, when more subtle developmental problems are detectable, comparison of the physical development and neurodevelopment of these children with a sample of trial participants without a history of HHE should be feasible. A protocol for a study to make such a comparison at ages 5½ and 8½ years is being prepared. In The Netherlands, a case–control study of infants who had HHE reported in 1995 is ongoing. The HHE events were detected through national surveillance linked to the health care delivery system. Growth, health, and neurodevelopment are being assessed. Data presented at the workshop concerning children with HHE reported in 1994 indicate that all 101 children followed during the second year of life (mean age, 1.5 years) were in good health and developing normally. An interesting finding of this follow-up study was the low rate of recurrent collapse (subsequent HHE occurrences) after repeat doses of pertussis vaccine. Summary.  Despite increasingly widespread use of acellular pertussis vaccine in infants, HHE will continue to occur. The HHE definition proposed by this workshop should facilitate interstudy comparisons of HHE incidence among in the growing number of vaccines containing acellular pertussis components and perhaps of other vaccines as well. This definition also may aid study in VAERS and elsewhere of the etiology, pathophysiology, and descriptive epidemiology of HHE. Ongoing investigations in Sweden and The Netherlands have the potential to expand substantially knowledge of the possibility of long-term sequelae of HHE.

Harald Heijbel - One of the best experts on this subject based on the ideXlab platform.

  • Hypotonic Hyporesponsive Episode hhe as an adverse event following immunization case definition and guidelines for data collection analysis and presentation
    Vaccine, 2004
    Co-Authors: Jan Bonhoeffer, Miles M Braun, Dean A Blumberg, Harald Heijbel, Michael Gold, Patricia Vermeer, Glacus De Souzabrito, Robert L Davis, Scott A Halperin, Ulrich Heininger
    Abstract:

    Jan Bonhoeffer, Michael S Gold, Harald Heijbel, Patricia Vermeer, Dean Blumberg, Miles Braun, Glacus de Souza-Brito, Robert L Davis, Scott Halperin, Ulrich Heininger, Najwa Khuri-Bulos, John Menkes, Hanne Nokleby

  • report of a us public health service workshop on Hypotonic Hyporesponsive Episode hhe after pertussis immunization
    Pediatrics, 1998
    Co-Authors: Miles M Braun, Gina Terracciano, Marcel E Salive, Dean A Blumberg, Patricia Vermeerde E Bondt, Harald Heijbel, Geoffrey Evans, Peter A Patriarca, Susan S Ellenberg
    Abstract:

    Hypotonic–Hyporesponsive Episode (HHE) is a term used to describe a somewhat heterogenous group of clinical disorders that have been reported primarily in association with whole-cell pertussis vaccination. A 1991 review by the Institute of Medicine determined that the evidence available was indeed consistent with a causal relation between whole-cell pertussis-diphtheria-tetanus immunization and HHE, but that the evidence was insufficient to indicate a causal relationship between HHE and the subsequent development of permanent neurologic damage. More recent data from clinical trials conducted in Europe suggest that HHE also occurs after vaccination with acellular pertussis vaccines. The US Food and Drug Administration, in collaboration with the US Public Health Service, sponsored a workshop on HHE in Rockville, Maryland, on June 19, 1997. The primary goals of the workshop were to develop a case definition of HHE and to evaluate the general design and feasibility of possible studies of HHE using the federal Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system. The goals of such studies would be to understand better the acute HHE event and to evaluate the possibility of long-term sequelae. Case Definition . There has been no generally accepted definition of HHE, and a standard definition would be useful for vaccine safety work and would potentially facilitate interstudy comparisons of the growing number of licensed vaccines containing acellular pertussis components. The workshop defined HHE as an event of sudden onset occurring within 48 hours of immunization, with duration of the Episode ranging from 1 minute to 48 hours, in children younger than 10 years of age. All of the following must be present: 1) limpness or hypotonia, 2) reduced responsiveness or Hyporesponsiveness, and 3) pallor or cyanosis or failure to observe or to recall skin coloration. HHE is not considered to have occurred if there is a known cause for these signs (eg, postictal), if urticaria is present during the event, if normal skin coloration is observed throughout the Episode, or if the child is simply sleeping. This inclusive (sensitive) case definition will allow investigators, through the technique of stratification according to certain characteristics (eg, time from vaccination to onset of HHE), to attempt to hone the definition and make it more specific. Refinement of the definition of HHE has been hindered by the lack of information on its pathophysiology and by the lack of pathognomonic signs, symptoms, and diagnostic tests. Another hindrance is that by the time the child presents for medical evaluation, the signs of HHE often have normalized. Moreover, different mechanisms may be involved in different individuals whose events meet this workshop9s HHE definition. Further Study of HHE.  Probably the most important question about HHE is whether it has any permanent sequelae. The workshop assessed the possible contribution VAERS-based studies could make to answering this question and found substantial methodologic problems; however, ongoing studies in Sweden and The Netherlands have the potential to provide useful information on this question. The most useful contribution of VAERS data would be in a descriptive study of HHE, with a possible case–control study of factors that may affect the risk of HHE after vaccination, rather than a study of possible permanent sequelae. The workshop participants felt that a detailed descriptive study of ∼100 HHE events reported during a 1- to 2-year period could provide a more in-depth description of HHE cases in greater numbers than has been published previously, but the study would not address the issue of long-term sequelae of HHE. Better descriptive data may lead to new hypotheses concerning risk factors, etiology, and pathophysiology of HHE that might be evaluated further by studying subsequent cases and controls from VAERS or from other sources, depending on the hypotheses being tested. Workshop participants agreed that the question of possible long-term sequelae of HHE may currently be best answered in studies being conducted outside of the United States. A cohort of 82 892 infants was enrolled in the Stockholm II randomized, double-blind, controlled trial of one whole-cell and three acellular pertussis vaccines in Sweden in 1993–1994. In this trial, 101 infants developed HHE after vaccination. Of these children, 100 (1 had left Sweden) were evaluated subsequently at 18 months of age, using routine screening tests of motor and cognitive development intended to detect moderate to serious developmental problems. All 100 were found to be developing normally. At older ages, when more subtle developmental problems are detectable, comparison of the physical development and neurodevelopment of these children with a sample of trial participants without a history of HHE should be feasible. A protocol for a study to make such a comparison at ages 5½ and 8½ years is being prepared. In The Netherlands, a case–control study of infants who had HHE reported in 1995 is ongoing. The HHE events were detected through national surveillance linked to the health care delivery system. Growth, health, and neurodevelopment are being assessed. Data presented at the workshop concerning children with HHE reported in 1994 indicate that all 101 children followed during the second year of life (mean age, 1.5 years) were in good health and developing normally. An interesting finding of this follow-up study was the low rate of recurrent collapse (subsequent HHE occurrences) after repeat doses of pertussis vaccine. Summary.  Despite increasingly widespread use of acellular pertussis vaccine in infants, HHE will continue to occur. The HHE definition proposed by this workshop should facilitate interstudy comparisons of HHE incidence among in the growing number of vaccines containing acellular pertussis components and perhaps of other vaccines as well. This definition also may aid study in VAERS and elsewhere of the etiology, pathophysiology, and descriptive epidemiology of HHE. Ongoing investigations in Sweden and The Netherlands have the potential to expand substantially knowledge of the possibility of long-term sequelae of HHE.

Jose G Dorea - One of the best experts on this subject based on the ideXlab platform.

  • adverse events following immunization in brazil age of child and vaccine associated risk analysis using logistic regression
    International Journal of Environmental Research and Public Health, 2018
    Co-Authors: Silvia R C Lopes, Joao Lucas Da Rosa Perin, Taiane Schaedler Prass, Sandra Maria Deotti Carvalho, Sergio De Castro Lessa, Jose G Dorea
    Abstract:

    Objective: Vaccines are effective in controlling and eradicating infectious diseases. However, adverse events following immunization (AEFI) can occur in susceptible individuals. The objective of this study was to analyze the Brazilian AEFI database and compare eight vaccines in order to profile risks of AEFIs related to the mandated pediatric schedule of immunization, considering the age and sex of the child, type of vaccine, and reported adverse events. Methods: We analyzed the Brazilian AEFI database integrating reports between 2005 and 2010 for children less than 10-years old immunized with eight mandated vaccines: diphtheria, pertussis, tetanus, Haemophilus influenzae type b (TETRA); diphtheria, tetanus, and pertussis (DTP); Bacillus Calmette–Guerin (BCG); oral poliovirus vaccine (OPV); measles, mumps, and rubella (MMR); oral rotavirus vaccine (ORV); hepatitis B (HB); and yellow fever (YF). We compared the children’s age regarding types of AEFI, evaluated AEFI factors associated with the chance of hospitalization of the child, and estimated the chance of notification of an AEFI as a function of the type of vaccine. In total, 47,105 AEFIs were observed for the mandated vaccines. Results: The highest AEFI rate was for the TETRA vaccine and the lowest was for the OPV vaccine, with 60.1 and 2.3 events per 100,000 inoculations, respectively. The TETRA vaccine showed the highest rate of Hypotonic Hyporesponsive Episode, followed by convulsion and fever. The MMR and YF vaccines were associated with generalized rash. BCG was associated with enlarged lymph glands but showed the largest negative (protective) association with Hyporesponsive events and seizures. Compared with children aged 5–9-years old, young children (<1 year) showed significantly higher odds of hospitalization. Conclusions: The Brazilian AEFI registry is useful to compare the magnitude and certain characteristics of adverse events associated with mandated pediatric vaccines.

Ulrich Heininger - One of the best experts on this subject based on the ideXlab platform.