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Cited by 46Pharmacovigilance and Adverse Drug ReactionsInfectious Encephalopathies and EncephalitisBacterial Infections and Vaccines

Risk of serious neurologic disease after immunization of young children in Britain and Ireland

Ward, Katherine N., Bryant, Naomi J., Andrews, Nick J., Bowley, Jennifer S., Ohrling, Anu, Verity, Christopher M., Ross, Euan M., Miller, Elizabeth·2007·PEDIATRICS
DOI 10.1542/peds.2006-3743
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Abstract

OBJECTIVE: We sought to investigate the risk of serious neurologic disease after immunization in early childhood. METHODS: The results of a 3-year prospective study of children (2-35 months old) in Britain and Ireland with encephalitis and/or severe illness with convulsions and fever were linked to each child's vaccine history. Cases were reported via the British Paediatric Surveillance Unit's network. The self-controlled case-series method was used to investigate associations between immunization and acute potential adverse events. The risk periods investigated were 0 to 3 and 0 to 7 days post-diphtheria, tetanus, whole cell pertussis, Haemophilus influenzae type b or meningococcal C conjugate vaccine and 6 to 11 and 15 to 35 days post-measles, mumps, rubella vaccine. RESULTS: A total of 157 disease episodes from 155 children met the analytical case definition. There were 11 cases of herpes simplex encephalitis and 23 cases of primary human herpesvirus 6 and/or 7 infection. There was no evidence of a raised relative incidence of serious neurologic disease in any of the specified risk periods with the exception of a raised relative incidence of 5.68 in the 6-11 days after measles, mumps, rubella vaccine. Based on this relative incidence, between 3 and 6 of the 6 cases in this period were estimated to be attributable to the vaccine with a best estimate of 5. The 6 cases all had fever with convulsions lasting >30 minutes; in all but 1, there was complete recovery by discharge from hospital. Of the 5 patients who recovered, 1 had a concurrent primary human herpesvirus 6 infection and one a primary human herpesvirus 7. CONCLUSIONS: Six to 11 days after measles, mumps, rubella vaccine there is an increased risk of fever and convulsions lasting >30 minutes. All 6 of the episodes temporally related to immunization met the criteria for complex febrile convulsions. The estimated attributable risk of serious neurological disease was similar to that previously found for measles vaccine.

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  • In Ward 2007, episodes of severe illness with fever and convulsion were more frequent within six to 11 days after MMR immunisation (relative incidence 5.68; 95% CI 2.31 to 13.97).

    “Episodes of severe illness with fever and convulsion were more frequent within six to 11 days after MMR immunisation (relative incidence (RI) 5.68; 95% CI 2.31 to 13.97).”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Ward 2007

  • In Ward 2007, the risk of bias was high for random sequence generation, allocation concealment, and blinding.

    “Ward 2007 Methods Self controlled case series study carried out to assess whether exposure to MMR and other vaccines (DTP/Hib, MenC) was associated with onset of serious neurological diseases Participants 155 children aged between 2 and 35 months from Republic of Ireland and Britain with serial neurological disease (see outcome definition) and documented vaccination history.”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Ward 2007

  • In Ward 2007, the incidence of encephalitis in the risk period (15 to 35 days) was not statistically different from that of the control period (relative incidence = 1.34; 95% CI 0.52 to 3.47).

    “The incidence of encephalitis in the risk period (15 to 35 days) was not statistically different from that of the control period (relative incidence = 1.34 ; 95% CI 0.52 to 3.47).”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Ward 2007

  • In Ward 2007, the estimate of relative incidence of encephalitis in the risk period (15 to 35 days) does not change in the presence or absence of primary HHV-6 or HHV-7 infections.

    “This estimate does not change in the presence or absence of primary HHV-6 or HHV-7 infections.”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Ward 2007

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Authors
Ward, K. N., Bryant, N. J., Andrews, N. J., Bowley, J. S., Ohrling, A., Verity, C. M., Ross, E. M., & Miller, E.
Affiliations
  • The Royal Free Hospital (GB)
  • Health Protection Agency (GB)
  • Addenbrooke's Hospital (GB)
  • King's College London (GB)
ORCID
Venue
PEDIATRICS
Publisher
American Academy of Pediatrics (AAP)
Published
2007-08-01
Volume
120
Issue
2
Pages
314-321
ISSN
  • 0031-4005 (ISSN-L)
  • 1098-4275
DOI
10.1542/peds.2006-3743
OpenAlex
W2082724377
Cited by
46
References
36
Citations by year
2025: 1 · 2024: 1 · 2021: 6 · 2020: 4 · 2018: 3 · 2017: 2 · 2016: 2 · 2015: 4 · 2014: 4 · 2013: 6 · 2012: 5
FWCI
3.23
Type
journal article
Language
en
Open access
closed
Locations
  • PEDIATRICS (publishedVersion)
  • PubMed (publishedVersion)
Funders
Wellcome Trust (051350)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Infectious Diseases › Infectious Encephalopathies and Encephalitis
  • Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
Keywords
vaccine adverse events, encephalitis, MMR vaccine, herpes simplex encephalitis, human herpesvirus 6, human herpesvirus 7, DTP vaccine, Haemophilus influenzae type b conjugate vaccine, meningococcal C vaccine, young children, vaccine safety
MeSH terms
Child, Preschool, England, Humans, Infant, Ireland, Measles Vaccine, Mumps Vaccine, Nervous System Diseases, Prospective Studies, Risk Factors, Rubella Vaccine, Vaccination, Meningococcal Vaccines

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