Age: 1.66
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of febrile seizure in a 20-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent medical conditions included premature birth at 29 weeks gestation. Historic vaccination included Hib; manufacturer unspecified; unknown; unknown given in 2011; PEDIARIX; GlaxoSmithKline; unknown; unknown given on March 2011 and May 2011; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given in 2011. Concurrent vaccination included Hib; manufacturer unspecified; unknown; unknown given on 26 July 2012; Hep A; manufactured unspecified; unknown; unknown given on 26 July 2012. Concurrent medications included Multivitamin + fluoride. On 26 July 2012 at 10:00 the subject received 1st dose of INFANRIX (unknown, left thigh). On 26 July 2012, less than one day after vaccination with INFANRIX, the subject experienced a low grade fever. On 29 July 2012, three days after vaccination with INFANRIX the subject experienced febrile seizure, high fever, rash on trunk and neck, tonic clonic movements, not responsive, limp (nos), weakness, blue lips and foaming at mouth. The healthcare professional, who is also the mother of the subject, reported the subject experienced a febrile seizure three days after vaccination with INFANRIX. The seizure was described as full body tonic/clonic movements, foam and saliva from mouth, unresponsive, limp, weak and lips turned blue. Emergency services were called and the subject was taken to the emergency room (ER). His fever was recorded as 102.6 in the ER. The subject had blood work, computed tomography (CT) scan, and heart monitoring performed; intravenous fluids and Diazepam were administered. The subject was transferred to a hospital; a spinal tap, electroencephalography (EEG) and additional blood work were performed; antibiotics of Ceftriaxone and Vancomycin were administered for approximately 48 hours. The reporter stated "all test were negative/normal". The subject was discharged on 01 August 2012 with DIASTAT and children's TYLENOL was prescribed for the fever. On the night of 01 August 2012, the subject had a fever of 99.0 and has had no fever since 01 August 2012. The subject still had a rash on his trunk, location described as on the front, back and on the neck. The rash initially appeared on 29 July 2012 with the seizure event. The rash was faint initially with small red dots, but has increased in appearance. The subject's mother did not consider other vaccinations from that day  to be co-suspect. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the febrile seizure, fever, tonic clonic movements, not responsive, limp (nos), weakness, blue lips and foaming at mouth were resolved; rash on trunk and neck was unresolved. The mother also noted the subject had received PEDIARIX previously at 4 and 6 months of age and had experienced low-grade fever with those vaccinations. For this case please see A0988486B.