Sex: U
Vaccine: FLUX
Symptoms: Chills, Loss of consciousness, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: This case was reported in a literature article and described the occurrence of convulsions generalized in a child subject who received Flu seasonal TIV Dresden. On an unknown date, less than a day after receiving Flu seasonal TIV Dresden, the subject developed convulsions generalized. Serious criteria included GSK medically significant. Additional event(s) included loss of consciousness with serious criteria of GSK medically significant and unresponsive to verbal stimuli with serious criteria of GSK medically significant. The outcome of convulsions generalized was unknown. The outcome(s) of the additional event(s) included loss of consciousness (unknown) and unresponsive to verbal stimuli (unknown). The investigator considered that there was a reasonable possibility that the convulsions generalized, loss of consciousness and unresponsive to verbal stimuli may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and described the occurrence of generalised seizures in a child patient of unspecified age and gender who was vaccinated with unspecified trivalent inactivated influenza vaccine (TIV) (manufacturer unknown). No information on patient medical or family history was provided. No information on patient's concomitant medication was provided. On an unspecified date between 1 August 2010 and 5 February 2011, the patient received one dose of unspecified TIV (administration route and site unspecified, dosages unknown; batch number not provided). The age at vaccination was unknown. On an unspecified date between 1 August 2010 and 6 February 2011, within 24 hours after vaccination with TIV, the patient experienced sudden loss of consciousness (unconsciousness includes unreactive to verbal and painful stimuli) and other generalised motor manifestations (including description such as shivering, trembling, shaking and quivering). The generalised seizures were diagnosed on the basis of VSD Level 4A criteria i.e. modified criteria for inclusion of seizures cases. Treatment was unknown. The outcome of event was not provided. The author did not comment on the causality relationship between generalised seizures and TIV. However authors stated that 'TIV and PCV13 were associated with an increased risk of febrile seizures independent of concomitant receipt of the other.' The authors stated that "In summary, an elevated risk of febrile seizures in the 0-1 days following first dose TIV was identified during the 2010-2011 influenza season in children ages 6-59 months in a large cohort. Among children 6-59 months of age, the IRRs of febrile seizures were elevated for both TIV adjusted for concomitant PCV13 and for PCV13 adjusted for concomitant TIV. The magnitude, in terms of risk difference, was dependent on age and receipt of concomitant PCV13 vaccine, with the highest estimates occurring at 16 months and the lowest estimates occurring at 59 months. As the same three strains in the 2010-2011 influenza vaccine have been included in the 2011-2012 influenza vaccine further monitoring in the VSD will be conducted for seizures as more doses are administered. Results should be placed in a benefit-risk framework to aid decision making by policymakers to maximize population health benefits."