| Definitions |
SMQ for generalized convulsive seizure (GCS) developed to address the occurrence of this form of seizure as an adverse event following immunization (AEFI). "Seizure" = abnormal paroxysmal discharge of cerebral neurons because of cortical hyperexcitability. Categories include: partial seizures (i.e., focal or localization related seizures); generalized. Generalized seizures are classified as: atonic; tonic; clonic; tonic-clonic; myoclonic; absence. Seizures are characterized by: sudden, involuntary muscular contractions; sensory disturbances; autonomic dysfunction; behavioral abnormalities; impairment or loss of consciousness. With GCS, patient becomes unconscious and has convulsions over whole body. Brighton Collaboration case definition of generalized convulsive seizure as AEFI describes the following levels of diagnostic certainty: Level 1 of diagnostic certainty - witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 2 of diagnostic certainty - history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 3 of diagnostic certainty - history of unconsciousness AND other generalized motor manifestations.
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| definition |
SMQ for generalized convulsive seizure (GCS) developed to address the occurrence of this form of seizure as an adverse event following immunization (AEFI). "Seizure" = abnormal paroxysmal discharge of cerebral neurons because of cortical hyperexcitability. Categories include: partial seizures (i.e., focal or localization related seizures); generalized. Generalized seizures are classified as: atonic; tonic; clonic; tonic-clonic; myoclonic; absence. Seizures are characterized by: sudden, involuntary muscular contractions; sensory disturbances; autonomic dysfunction; behavioral abnormalities; impairment or loss of consciousness. With GCS, patient becomes unconscious and has convulsions over whole body. Brighton Collaboration case definition of generalized convulsive seizure as AEFI describes the following levels of diagnostic certainty: Level 1 of diagnostic certainty - witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 2 of diagnostic certainty - history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 3 of diagnostic certainty - history of unconsciousness AND other generalized motor manifestations.
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| Scope Statement |
To apply the algorithm for this SMQ, a report is considered a relevant case for further review if: It includes a term from Category A OR it includes a term from Category B (terms related to level of consciousness and other neurological events) and a term from Category C (terms for motor manifestations and observed effects of generalized convulsions). Based on testing of SMQ Generalised convulsive seizures following immunisation, this SMQ is deemed not suitable for pharmaceutical products as several previously "narrow" PTs that are relevant for those products are not present in this algorithmic SMQ.
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| SMQ SOURCE |
Ko, DY. Generalized tonic-clonic seizures. http://emedicine.medscape.com/article/1184608-overview; Bonhoeffer, J et al. Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 22 (2004) 557-562
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