Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Opisthotonus, Pyrexia, Unresponsive to stimuli, Vaccination complication, Viral infection
Clinical narrative: This case was forwarded to GSK by Pfizer. Information regarding Blinded Vaccine For Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding a 4-month-old female participant in a study who on 09-Feb-2007, received a second dose along with a second dose of ACT-HIB (Aventis) and PEDIARIX (GlaxoSmithKline). On 09 February 2007, the subject received a 2nd dose of 13-valent pneumococcal conjugate vaccine, a 2nd dose of PEDIARIX and a 2nd dose of ACT-HIB. This study was unblinded, due to end of study unblinding. The subject received a 2nd dose of 13-valent pneumococcal conjugate vaccine. The subject's past medical history included normal newborn. Medical conditions at the time of the event included gastroesophageal reflux disease. Concomitant medications were not reported. On 12 February 2007, three days after the 2nd dose of PEDIARIX, three days after the 2nd dose of Pneumococcal 7-valent conjugate vaccine (Non-GSK), three days after the 2nd dose of ACT-HIB, this four-month-old subject developed febrile convulsion and fever (viral vs due to vaccine). The subject was hospitalised. The subject was treated with paracetamol, ibuprofen, gentamicin sulphate and intravenous fluid(s). Febrile convulsion resolved on 12 February 2007 and viral fever resolved on 16 February 2007. The investigator considered that there was a reasonable possibility that the febrile convulsion and viral fever may have been caused by PEDIARIX, Pneumococcal 7-valent conjugate vaccine (Non-GSK) and ACT-HIB and that the event was possibly due to her medical condition of gastroesophageal reflux disease. EVENT DETAILS: On 12-Feb-2007, the patient was hospitalized with febrile seizure and a fever (viral vs due to vaccine) that began the day before along with a cough and a decrease in oral intake. The patient's temperature ranged from 102 degrees Fahrenheit to 104 degrees Fahrenheit (see laboratory section below). On admission to the hospital, the family also described the child as having had an episode at home where she was "arching her back and the eyes seem to roll into the back of her head. This lasted about 20 minutes following which she was somewhat limp and unresponsive for a few minutes". The emergency room physician noted possible seizure activity or febrile seizure. Treatment included TYLENOL, MOTRIN, Ampicillin/Gentamycin, intravenous fluids and the patient was to be placed on a CR (cardio-respiratory) monitor overnight. Other symptoms while hospitalized included several episodes of diarrhea. Several cultures were obtained. (See laboratory section). On 12-Feb-2007, the patient was considered recovered from the febrile seizure. On 16-Feb-2007, the patient recovered from the fever. The patient was withdrawn from the study. TEST RESULTS: Culture stool (results negative) was done in 2007. Body temperature (results: 103 deg. F.) was done on 11-Feb-2007. On 12-Feb-2007 test results were: heart rate (results: "170's"); respiratory rate (results: 16); CSF culture (results: negative): culture urine (results: negative); blood bicarbonate (results: "slightly low at 14"): chest X-ray (results: unremarkable): scan brain (results: no CT evidence of acute intracranial abnormality): body temperature (results: "up to 104 degrees Fahrenheit); body temperature (results: 39.2 deg. C.): body temperature (results: 102 deg. F.); and blood culture (results: pending). RELATEDNESS ASSESSMENT: The investigator(s) and medical monitor(s) considered pyrexia and febrile convulsion possibly related to the study product. The investigator also noted the event of fever could have been related to a "medical condition". No additional information was available at the time of this report. Follow-up (08Jun2014): Following the integration of the legacy safety adverse event reporting database, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I. VAERS or MedWatch report may indicate in the appropriate field that it is an initial report. New information reported includes: study drug data. Protocol was unblinded, due to end of study unblinding. End of study unblinding indicated the patient received pneumococcal 13-valent conjugate vaccine.