Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Cerebral infarction, Computerised tomogram abnormal, Computerised tomogram head, Convulsion, Death
Clinical narrative: This report was received and described the occurrence of meningitis due to Escherichia coli (in a 7-month-old female subject who was vaccinated with PEDIARIX and PEDVAX HIB. Previous and or concurrent vaccination included ACTHIB;Sanofi Pasteur MSD; unknown given on 4 December 2007; PREVNAR; Wyeth Labs unknown given on 4 December 2007. There was no relevant previous medical history. On 4 December 2007 the subject received unspecified dose of PEDIARIX. On an unspecified date in December 2007, the subject received unspecified dose of PEDVAXHIB. On 7 Dec 2007, within days of vaccination with PEDVAXHIB, 3 days after vaccination with PEDIARIX, the subject experienced meningitis due to Escherichia coli, cerebral infarct, hydrocephalus, intra cranial pressure increased and seizures. Information was received from a nurse practitioner concerning an infant, who on an unknown date, was vaccinated with a dose of PEDVAXHIB and the day after vaccination, died in the hospital from meningitis. The nurse practitioner stated there were "rumors in the community" that the death was related to PEDVAXHIB. She felt it was possibly related to the vaccine recall and had received "no definitive information". No further details were provided. Additional information has been requested. On 28 December 2007, it was reported that no autopsy was done per the Decedant Affairs representative at the hospital. On 31 December 2007, the vaccination record and well Child Card of 04 December 2007 were received. It was reported that there were no concerns at this time. Temperature was reported as 99.1 degrees Fahrenheit, and physical examination was within normal limits. On 04 January 2008, the death certificate was received with cause of death was reported as mentioned. On 22 January 2008, the medical record was received from the hospital for "DOS" 11 December 2007 to 12 December 2007. The subject presented to the emergency room after transfer from local hospital with diagnosis of meningitis and altered mental status. The subject was initially seen by the primary care physician on 07 December 2007 for fever and vomiting. The subject presented again to the hospital on 09 December 2007 with increasing irritability and emesis with nuchal rigidity. The subject was admitted to the intensive care unit with eye rolling and was responsive only to painful stimuli. The subject had further seizures. The subject was transferred following head computed tomography which showed large bi-hemispheric strokes. The subject was incubated and sedated. An externalized ventricular shunt was placed for cerebrospinal fluid drainage. The neurological condition deteriorated progressively to brain death. The subject was extubated and care was withdrawn per parent request. The subject expired at 17:12. Assessment included poly bacterial meningitis and hydrocephalus. On 29 January 2008, the discharge summary was received for the above Hospitalization. The principal diagnosis was Escherichia Coli meningitis. Additional diagnoses were bilateral cerebral infarcts, hydrocephalus with increased intra cranial pressure and seizures.