Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blister, Blood product transfusion, Body temperature increased, Culture positive, Influenza serology negative
Clinical narrative: Initial report was received on 07 August 2009 from an attorney who is representing the patient's parents. A female patient had received an injection of ADACEL, and a second dose injection of HAVRIX manufactured by GlaxoSmithKline on (or about) 21 February 2007 (lot numbers, routes and sites of administration were not reported), and a few days later, she developed a persistent fever which required a doctor's visit on 02 March 2007. During this visit, the patient was administered Ibuprofen instead of TYLENOL and was immediately sent to the hospital for treatment and was admitted. Following admission, the patient developed burn blisters throughout her body, burns (burning off her entire skin), skin peeling off her body, loss of all skin, loss of bones, diminished vision and skin discoloration. Six days prior to vaccination, the patient had been evaluated by her pediatrician for a bump on the back of her left thigh which cultured positive for Pseudomonas. She had been prescribed SEPTRA and/or SULPHA DS (double strength) which she had been taking concomitantly at the time of vaccination. On 15 February 2007, the patient was seen by her pediatrician to discuss treatment for a bump on the back of her left thigh. A culture sample was obtained at that time, and the patient was prescribed SEPTRA and/or SULPHA DS (Double Strength) for two weeks duration. The patient returned to her pediatrician's on 21 February 2007 for re-evaluation as instructed. The lesion was healing nicely; however culture results had been positive for Pseudomonas and the patient was instructed to continue taking SEPTRA and/or SULPHA DS (Double Strength) as prescribed. During this visit, the patient was administered an injection of ADACEL, and a second dose injection of HAVRIX and her parent was instructed to administer TYLENOL if fever developed. After a few days, the patient developed a fever and was treated with TYLENOL. The fever persisted, so the patient returned to her pediatrician on (or about) 02 March 2007. During this visit, a "strip" and flu test were negative. The nurse was instructed by the physician to administer TYLENOL; however, the nurse administered Ibuprofen instead because it "works better in reducing fever". According to the reporter, the pediatrician became "physically enraged and upset" upon discovering that Ibuprofen was administered instead of TYLENOL. The pediatrician advised the mother to immediately take the patient to the hospital for treatment. The patient arrived at the hospital at 15:00 pm and was admitted at 18:20 pm. The patient was initially diagnosed with chickenpox and was isolated. Numerous tests were performed and her temperature continued to increase. By 22:00 pm she began to show burn blisters throughout her body which "were getting bigger in size as a function of time". That same evening, the patient was moved to a negative air flow room. The following day, on 03 March 2007, in addition to the blisters, the patient's skin was peeling off her body. The treating physician was unable to determine a diagnosis at that time. In addition to IV medications, the physician ordered that fluids and medications be administered through a "central valve". It was later discovered that a central valve had not been placed. Later that day, the physician informed the patient's parents that nothing could be done for the child and that they should begin making funeral arrangements. The patient's parent contacted a pharmacist and explained the sequence of events. The pharmacist evaluated the patient, then left, and returned with another physician; both of whom immediately diagnosed the illness (diagnosis not reported) and confirmed that IVIG should be prescribed immediately. It was later discovered that the patient had a low white blood cell count which the hospital physician initially treating the child had not been aware of. The child was moved to ICU the following day and IVIG was administered later that day. Her symptoms were described as "literally burning inside out and the skin melting off her body". Sometime after the patient had been moved to ICU, her parents were called and informed that the patient was suffering from burns and would need to be moved to another facility. The patient was transferred to a burn center and received treatment with IVIG through a central valve and began a long recovery process. She was hospitalized for a period of months, and then had to be treated at first on a monthly, then on a quarterly basis. The patient experiencing burning off her entire skin, loss of bone (teeth and finger nail bases) and diminished vision. The patient was reported to suffer psychologically, and it was unknown at the time of the report if the event would affect the patient's ability to bear children. At the time of the report, the patient had not yet fully recovered and it was noted that her skin was still discolored and blistered. Documents held by sender: Legal document.