Age: 12.0
Sex: U
Vaccine: FLUX
Symptoms: Urticaria, Wheezing
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 12-year-old subject of unspecified gender who was vaccinated with Influenza vaccine, manufacturer unspecified). The subject did not receive any concomitant vaccine. No egg allergy was reported in this patient. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). Less than one day after vaccination with Influenza vaccine, the subject experienced anaphylaxis with respiratory problem (chest tightness or wheezing) and skin reactions (erythema or hives). The patient was either hospitalised or treated at the emergency ward and further referred for allergy testing. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case is linked to cases B0695450A and B0695523A. It was not possible to attribute some of the information provided in the article to one or the other patient. Therefore this report contains only the genetic information all other details can be read in the article. Summary of the article: Influenza virus infection causes substantial morbidity in children with an attendant need for healthcare utilization, school absenteeism, and secondary illness in families. Also, influenza virus can rarely lead to death in children with underlying medical conditions and in children who are otherwise healthy. Vaccination against influenza virus is the primary method for preventing influenza and its complications. The Advisory Committee on Immunization Practices' recommendations for influenza vaccination of children have expanded from the long-stand recommendation to vaccinate high-risk children aged 6 months, to vaccinating all 6- to 23-month-olds (2004), 2- to 4-year-olds (2006), and 5- to 18-year-olds (2008). The objective of the authors was to identify new or unexpected adverse events (AEs) after trivalent inactivated vaccine (TIV) in children. Methods: analysis of reports after TIV to the Vaccine Adverse Event Reporting System from 1990-2006 in children aged 2 to 17 years, and from the 2008-2009 influenza season in children aged 5 to 17 years. Empiric Bayesian data mining techniques were used to identify new or unexpected AEs during 1990-2006. Results: During 1990-2006, the Vaccine Adverse Event Reporting System received 2054 reports of children aged 2 to 17 years with a peak in the 2003-2004 influenza season. In 2008-2009, 506 reports describing 5 to 17 year olds were received. The serious reports of tests performed after TIV were approximately 10% of all reports from 2001-2006, and 6% of the reports in the 2008-2009 season. Data mining showed an increased proportion of medication errors and GUILLAIN BARRE' Syndrome (GBS). The findings of GBS could not be interpreted as causality related to vaccination. Among 201 reports of medication error, 94% had no AE reported other than the medication error itself. Conclusion: In this analysis, we found no unexpected AEs. Our review of medication error and GBS reports suggests that ongoing monitoring in these areas is appropriate.