Age: 0.42
Sex: U
Vaccine: DTAPIPVHIB, FLU3, FLUX(H1N1), HEP, PPV, RVX
Symptoms: Body temperature increased, Drug administered to patient of inappropriate age, Febrile convulsion, Laboratory test
Clinical narrative: This case was reported in a literature article and described the occurrence of febrile seizure in a 5-month-old subject who received Hepatitis B vaccine. Co-suspect products included Pandemic Vaccine H1N1, Pneumococcal Conjugate Vaccine and DTAP-IPV-HIB. On an unknown date, less than a month after receiving Hepatitis B vaccine and Flu seasonal TIV Dresden, the subject developed febrile seizure. Serious criteria included GSK medically significant. The outcome of febrile seizure was unknown. The investigator considered that there was a reasonable possibility that the febrile seizure may have been caused by Hepatitis B vaccine and Flu seasonal TIV Dresden. Relevant Tests: Laboratory test performed on an unspecified date Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Body temperature result was equal to or more than 38 degree C. Additional information was provided. This case was reported in a literature article and described the occurrence of probable febrile seizure in an infant aged 5 month of unspecified gender who was vaccinated with unspecified Hepatitis B vaccine, unspecified inactivated trivalent influenza (IIV3) vaccine, unspecified monovalent pandemic 2009 H1N1 inactivated influenza vaccine, unspecified Pneumococcal conjugate vaccine, unspecified pentavalent rotavirus vaccine, unspecified DTaP-IPV-Hib vaccine (manufacturer unknown for all). The patient was part of study that aimed to determine the febrile seizure risk during the time from vaccination through the following day associated with vaccines administered to children aged one through five months. The study identified emergency department visits and inpatient admissions with International Classification of Diseases, Ninth Revision, febrile seizure codes among children enrolled in nine Vaccine Safety Datalink participating health care organizations from 2006 through 2011. Febrile seizures were confirmed by medical record abstraction. The self-controlled risk-interval method was used to compare the incidence of febrile seizure during post-vaccination days 0 to 1 (risk interval) versus days 14 to 20 (control interval). The study excluded visits that occurred equal to or less than 42 days after a previous visit with a convulsion ICD-9 code because those are unlikely to represent a new event. In this study, six case patients had a non-CNS infection documented at the time the seizure was evaluated (three with upper respiratory tract infection, one with upper respiratory tract infection and acute otitis media, one with sinusitis, and one with pyelonephritis. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date at the age of 5 months, the patient received unspecified Hepatitis B vaccine, unspecified inactivated trivalent influenza (IIV3) vaccine, unspecified monovalent pandemic 2009 H1N1 inactivated influenza vaccine, unspecified Pneumococcal conjugate vaccine, unspecified pentavalent rotavirus vaccine, unspecified DTaP-IPV-Hib vaccine (administration site and route unspecified; dosages unknown; batch number not provided for all). In the study, the day of vaccination was defined as "day 0", all vaccines received by the case patients were age appropriate. It was reported child received influenza vaccine at age five months, which is less than the minimum recommended age of six months. On an unspecified date between 1 July 2006 and 30 June 2011, within 20 days after the vaccinations, the patient had either emergency department visit or had inpatient admission. The reported seizure duration ranged from five seconds to five minutes. The patient was diagnosed with probable febrile seizure. [In this study, only convulsion visits that occurred on days zero to one or 14 to 20 following the administration of one or more vaccines of any type were included]. [In this study a "probable" seizure was defined as a clinical diagnosis of seizure by the treating physician. "Possible" seizure was defined as a paroxysmal event for which the treating physician did not make a definitive diagnosis but for which seizure was considered the more likely possibility in the differential diagnosis. Fever was defined a temperature of equal to or more than 38 deg. C. A febrile seizure was defined a seizure in a child who had a fever within the prior 24 hours, excluding patients with central nervous system (CNS) infection, criteria for other symptomatic seizures (e.g., brain structural abnormalities and metabolic disturbance), or a history of afebrile seizure. Seizures with fever that did not meet the febrile seizure definition were classified as "seizure with fever other than febrile seizure"]. Treatment was unknown. The outcome of the event was not reported. The authors commented "We cannot determine if the risk observed was due to PCV alone or if other individual vaccines or interactions between vaccines contributed to the observed risk because we did not have enough children who did not receive PCV for comparison. Our secondary analysis that included all seizures with fever also revealed a significantly increased risk, which could suggest an increased risk of epileptic seizure precipitated by fever following vaccination regardless of the underlying mechanism of seizure susceptibility. In as much as certain types of vaccine may elicit fever, and fever in turn may precipitate a seizure in susceptible individuals, this would not be surprising". The authors concluded "Vaccination in children aged three to five months was associated with a large relative risk of febrile seizure on the day of and the day after vaccination, but the risk was small in absolute terms. Post-vaccination febrile seizure should not be a concern for the vast majority of children receiving vaccines, but clinicians might take this risk into consideration when evaluating and treating children susceptible to seizures precipitated by fever". This is 1 of the 4 valid cases reported in the same literature article.