Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, HBHEPB
Symptoms: Haemorrhage, Laboratory test abnormal, Lethargy, Respiratory disorder
Clinical narrative: From telephone contact received on 10/31/02 concerning a 2 mth old female *w/no known allergies or past medical history* who on 9/27/02 was vaccinated with *a first dose of Haemophilus B conjugage vax (+) Hep B vax recombinant. Add'l therapies on 9/27/02 included Streptococcus penumoniae vax (Prevnar), diphphtheria toxoid (+) pertussis vax (+) tetanus toxoid,* IPOL. *The reporter indicated these were the PT's first vax's. It was also noted that the PT had been born after a normal course of labor and delivery, and she had been a well newborn.* The pt presented to the ER on 10/12/02 with brain swelling, yellowish discoloration around her neckline, lethargy, vomiting, and no seizure activity, *"not acting right, breathing not right", and had an "abnormal" cry.* *On 10/2/02 the parents reported the PT developed vomiting. On 10/12/02 the parents called the office and reported the PT was lethargic and had an abnormal cry. No fever was reported.* The outcome was not reported. From follow-up telephone correspondence received by manufacturer on 11/6/02: Personnel at physician's office reported that the pt remains hospitalized at this time. She had been on a ventilator, but is not breathing on her own. The infant is now permanently disabled and the parents are under investigation by child services for "yellowish discoloration" at neckline. The reporter's address field was also updated. *On 10/12/02 the PT was taken to ER had a respiratory arrest and was coded. The PT was placed on a ventilator, transferred and admitted to the pediatric intensive care unit at a hospital. It was noted the PT was Dx'd w/infarct stroke, encephalitis and retinal hemorrhage. On 10/18/02 the child was removed from the ventilator; she resumed respirations and has been maintaining respirations on her own; *however, an EEG showed "very little" brain activity. As of the date of this report, the infant has been transferred to a long term care facility as "no recovery is expected."* It was reported that her pupils were fixed and dilated, and she was nonresponsive. The reported noted an electroencephalography (EKG) showed little to no brain waves. The reporter indicated they are exploring every avenue and they do not think that the PT's episodes were related to the vax's. The reporter considered abnormal cry, infarct stroke, encephalitis and retinal hemorrhage to be immediately life-threatening. Add'l info has been requested. Seriousness criteria: other medically significant (OMIC).  A 15-day follow up report dated 01/28/2003 adds: This is in follow up to reports previously submitted on 11/15/2002 and 11/27/2002. Information has been received from a health professional concerning a 9 week-old female pt with no known allergies or past medical history who on 09/27/2002 was vaccinted with a first dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (Lot #641074/1393L). Additional therapies on 09/27/2002 included Streptococcus pneumoniae vaccine (Prevnar), diptheria toxoid (-) pertussis vaccine (-) tetanus toxoid and poliovirus vaccine (IPOL). The reporter indicated these were the pt's first vaccinations. It was also noted the pt had been born after a normal course of labor and delivery, and she had been a well newborn. On 10/02/2002 the parents reported the pt developed vomiting. On 10/12/2002 the parents called the office and reported the pt ws taken to the emergency room, had a respiratory arrest and was coded. The pt was placed on a ventilator, transferred and admitted to the pediatric intensive care unit at a hospital. It was noted the pt was diagnosed with infarct stroke, encephalitis and retinal hemorrhage. On 10/19/2002 the child was removed from the ventilator; she resumed respirations and has been maintaining respirations on her own. It was reported that her pupils were fixed and dilated, and she was nonresponsive. The reporter noted an electroencephalography (EEG) showed little to no brain waves. The reporter indicated they are exploring every avenue and they do not think that the pt's episodes were related to the vaccinations. The reporter considered abnormal cry, infarct stroke, encephalitis and retinal hemorrhage to be immediately life-threatening. Additional information has been received from Wyeth with an assigned manufacturer control number of HQ6138008NOV2002. The information was originally received from a physician who reported the pt also developed abnormal behavior and coma and was hospitalized. Additional information has been requested.  Follow up on 08/25/2003: "The reporter considered abnormal cry, infarct stroke, encephalitis and retinal hemorrhage to be immediately life-threatening.  The reporter considered infarct stroke, abnormal behavior, coma, abnormal crying, vomiting, brain swelling, retinal hemorrhage and skin discoloration to be disabling and upon internal review were also determined to be other important medical events (OMIC).  Other business partner numbers include U200200917 & F200202734.  No further information is available.  The case is closed."