Sex: F
Vaccine: HEPA, TDAP
Symptoms: Visual acuity reduced, White blood cell count decreased
Clinical narrative: This case was reported by a lawyer and described the occurrence of skin blistering and peeling in a female child who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect medications included SEPTRA and/or Sulpha (double strength). Co-suspect vaccine included ADACEL (Sanofi Pasteur). The following information was received via a legal complaint: On approximately 15 February 2007, the subject presented to her physician with a bump on the back of her left thigh, which was initially assessed to be due to Staphylococcus infection. A culture of the bump on thigh was taken at that time, and the subject was prescribed SEPTRA DS and/or Sulpha (double strength). On 21 February 2007, the subject returned for re-evaluation, at which time the thigh lesion was "healing nicely". Results of the culture revealed "lack of Staphylococcus infection" and instead Pseudomonas infection was diagnosed. The subject was instructed to continue SEPTRA and/or Sulpha. On 21 February 2007, the subject also received her second dose of HAVRIX (unknown), as well as an unspecified dose of ADACEL (Sanofi Pasteur). A "few days" later, in late February 2007 or early March 2007, the subject developed a fever, which was treated with TYLENOL. Fever persisted, and the subject returned to the physician on 02 March 2007. At that time, "a strip and flu test" were negative. The physician reportedly instructed the nurse to administer TYLENOL; however, the nurse instead administered ibuprofen. At that time, the physician instructed the subject's mother to take the subject to the hospital for further treatment. The subject presented to the emergency room, and was admitted to the hospital at 6:20 p.m. on 02 March 2007. The subject experienced increasing temperature, and at approximately 10:00 p.m. on 02 March 2007 developed burn blisters throughout her body, which were increased in size "as a function of time". The subject was moved to a "negative air flow room" later the same night. On 03 March 2007, the subject's skin was peeling off of her body, in addition to continued blisters. The physician indicated that intravenous (IV) therapy was "not sufficient and that minor child needs to be administered fluid and medications by 'central valve'". The "central valve" was not placed, and later the same day the physician reported indicated that there was "nothing that could be done" for the subject and instructed the parents to "begin making arrangements for funeral services". The subject's mother subsequently contacted a pharmacist who visited the subject and advised therapy with intravenous immunoglobulin. A low white blood cell count was noted, and on an unspecified date the subject was moved to the intensive care unit and therapy with intravenous immunoglobulin was initiated. During this time, the subject was described as "literally burning inside out and the skin melting of her body". The reporter further indicated that "in one instance the child was disconnected from the IV line and entire night". Attempts were made to administered intravenous immunoglobuin (IVIG) through a "regular IV line"; however, the subject had reportedly "lost all skin and an IV line would simply no longer attach" Intravenous access was subsequently administered via the subject's feet. On an unspecified date, the subject was transferred to a burn center for children, and received IVIG via a "central valve". She remained hospitalized for "a period of months", the was treated on an monthly and later quarterly basis. At the time of this report, she had reportedly "lost her bones" in her teeth and fingernail bases, and continued to experienced skin discoloration and blisters. There was "a question as to her ability to bear children", and additionally she experienced psychological suffering, diminished vision, and a "number of other injuries", and her "eyelashes are growing in and cause irritation among others". At the time of reporting, the subject "had yet to fully recover".