A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. 1995

P Farrington, and S Pugh, and A Colville, and A Flower, and J Nash, and P Morgan-Capner, and M Rush, and E Miller
Public Health Laboratory Service Statistics Unit, Communicable Disease Surveillance Center, London, UK.

We describe a new method for active post-marketing surveillance of vaccine safety based on patient records. We studied the association between diphtheria/tetanus/pertussis (DTP) vaccination and febrile convulsion, and between measles/mumps/rubella (MMR) vaccination and febrile convulsion and idiopathic thrombocytopenic purpura (ITP) in five district health authorities in England by linking vaccination records with computerised hospital admission records. We found an increased relative incidence for convulsions 0-3 days after DTP vaccination. The effect was limited to the third dose of vaccine for which the attributable risk (all ages) was 1 in 12,500 doses. Completion of vaccination by 4 months instead of 10 months after the change in the UK to an accelerated immunisation schedule may have resulted in a 4-fold decrease in febrile convulsions attributable to DTP vaccine. 67% of admissions for a convulsion 6-11 days after MMR vaccination were attributable to the measles component of the vaccine (risk 1 in 3000 doses). An excess of admissions for a convulsion 15-35 days after MMR vaccination was found only for vaccines containing the Urabe mumps strain (1 in 2600 Urabe doses). There was a causal association between MMR vaccination and ITP resulting in admission 15-35 days subsequently; there was no evidence of a mumps strain-specific effect. The estimated absolute risk of 1 in 24,000 doses was 5 times that calculated from cases passively reported by clinicians. This finding emphasises the need for active surveillance of adverse events. The record linkage method that we used is an effective way to identify vaccine-attributable adverse events.

UI MeSH Term Description Entries
D007115 Immunization Schedule Schedule giving optimum times usually for primary and/or secondary immunization. Immunization Schedules,Schedule, Immunization,Schedules, Immunization
D007223 Infant A child between 1 and 23 months of age. Infants
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D008458 Measles Vaccine A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had measles or been immunized with live measles vaccine and have no serum antibodies against measles. Children are usually immunized with measles-mumps-rubella combination vaccine. (From Dorland, 28th ed) Vaccine, Measles
D008498 Medical Record Linkage The creation and maintenance of medical and vital records in multiple institutions in a manner that will facilitate the combined use of the records of identified individuals. Record Linkage, Medical,Linkage, Medical Record,Linkages, Medical Record,Medical Record Linkages,Record Linkages, Medical
D009108 Mumps Vaccine Vaccines used to prevent infection by MUMPS VIRUS. Best known is the live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine. Inactivated Mumps Vaccine,Inactivated Mumps Virus Vaccine,Live Attenuated Mumps Vaccine,Live Attenuated Mumps Virus Vaccine,Mumps Vaccine, Inactivated,Mumps Vaccine, Live Attenuated,Mumps Virus Vaccine, Inactivated,Mumps Virus Vaccine, Live Attenuated,Vaccine, Inactivated Mumps,Vaccine, Mumps
D011358 Product Surveillance, Postmarketing Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale. Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D003294 Seizures, Febrile Seizures that occur during a febrile episode. It is a common condition, affecting 2-5% of children aged 3 months to five years. An autosomal dominant pattern of inheritance has been identified in some families. The majority are simple febrile seizures (generally defined as generalized onset, single seizures with a duration of less than 30 minutes). Complex febrile seizures are characterized by focal onset, duration greater than 30 minutes, and/or more than one seizure in a 24 hour period. The likelihood of developing epilepsy (i.e., a nonfebrile seizure disorder) following simple febrile seizures is low. Complex febrile seizures are associated with a moderately increased incidence of epilepsy. (From Menkes, Textbook of Child Neurology, 5th ed, p784) Convulsions, Febrile,Febrile Seizures,Pyrexial Seizure,Febrile Convulsion Seizure,Febrile Fit,Fever Convulsion,Fever Seizure,Pyrexial Convulsion,Seizure, Febrile, Complex,Seizure, Febrile, Simple,Convulsion, Febrile,Convulsion, Fever,Convulsion, Pyrexial,Convulsions, Fever,Convulsions, Pyrexial,Febrile Convulsion,Febrile Convulsion Seizures,Febrile Convulsions,Febrile Fits,Febrile Seizure,Fever Convulsions,Fever Seizures,Fit, Febrile,Fits, Febrile,Pyrexial Convulsions,Pyrexial Seizures,Seizure, Febrile,Seizure, Febrile Convulsion,Seizure, Fever,Seizure, Pyrexial,Seizures, Febrile Convulsion,Seizures, Fever,Seizures, Pyrexial
D004338 Drug Combinations Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture. Drug Combination,Combination, Drug,Combinations, Drug
D006760 Hospitalization The confinement of a patient in a hospital. Hospitalizations

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