Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Nausea, Oxygen supplementation, Petechiae, Pharyngolaryngeal pain, Pneumonia
Clinical narrative: Information has been received from the U.S. Centers for Disease Control and Prevention via a professional presentation at the Global Advisory Committee on Vaccine Safety, World Health Organization on 12-JUN-2007 and 13-Jun-2007 and a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 15 year old (also reported as a 14 year old) female with a history of migraines and a history of hernia repair. Family history: younger sister also with strep negative sore throat and a letter from school that group A strep infections were present. on 02-JAN-2007, the patient was vaccinated with a first dose of Gardasil DTaP (manufacturer unspecified). On 01-MAR-2007, the patient developed a fever, sore throat, cough, and myalgia. On 02-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # 654885/1424F) IM in her left arm. Concomitant therapy included topiramate (TOPAMAX). On 01-JUN-2007, the Death Certificate was received from the epidemiologist which revealed cause of death (COD) as multiorgan failure and influenza B viral sepsis with contributing cause of staphylococcal secondary infection. Medical records included with the death certificate indicated the patient was transferred to a higher level of care on 06-MAR-2007, was intubated and in pediatric intensive care unit (PICU) with pneumonia and acute respiratory distress syndrome (ARDS). Reportedly the patient had been in good health until 01-MAR-2007 when she developed sore throat, nasal congestion, rhinorrhea and a low grade fever. The patient continued to worsen and developed myalgias, chest pain and nonproductive cough with higher fever. She was seen by the primary care physician (PCP) on 05-MAR-2007 and rapid strep was negative. The diagnosis was probable influenza. She was sent home and developed nausea, vomiting, and diarrhea as well as petechial rash over her abdomen. She was taken to the outlying emergency room on 06-MAR-2007, and was found to be in respiratory failure. She was intubated and transferred to higher level of care. Her respiratory status declined further and she was placed on oscillator and extracorporeal circulation membrane oxygenation, oxygenator (ECMO). A peds infectious disease consult was done. The consult stated that Gardasil vaccination was given at the PCP on 02-MAR-2007 and no other recent vaccines. On 01-JUN-2007, received fax medical and vaccine records from the CDC who had contacted the provider. The records revealed that on 02-JAN-2007, the patient received TDaP and Gardasil. On 02-MAR-2007, the patient received second dose of Gardasil. VAERS database was updated with the same. On the day of vaccination, the patient also was diagnosed with right carpal tunnel syndrome (CTS), migraine headache, and scoliosis. She was referred to neurology and physical therapy (PT) for the CTS and headache. Laboratory tests that were performed revealed influenza B isolated by viral culture. The specimen was sent to the CDC for antigenic characterization. Throat and urine cultures and sensitivity (c/s) were negative. Blood and endotracheal c/s were positive for methicillin-resistant Staphylococcus aureus (MRSA). Nasal swat was positive for influenza B virus. Lymph node c/s was negative from the PCP office. Adverse events reported included: acute respiratory distress syndrome, chest pain, cough, mechanical ventilation, multi-organ failure, myalgia, nasal congestion, pharyngolaryngeal pain, Pneumonia staphylococcal, pyrexia, respiratory failure, rhinorrhea, influenza B viral sepsis, and Staphylococcal infection. The one or more of the events were reported as serious: the patient died, ER visit, hospitalization and life threatening. The VAERS ID number is 278865. No further information is available. This is a consolidation of two reports concerning the same patient.