Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Paralysis, Pneumonia
Clinical narrative: Information has been received from a physician's assistant who received an e-mail from a family friend, concerning a 12 year old female patient who a "couple of weeks before" in approximately June 2009, was vaccinated with a dose of GARDASIL vaccine. On approximately 30-JUN-2009, the patient was diagnosed with Guillain Barre syndrome. The patient was admitted to the hospital the night of 30-JUN-2009. As of 01-JUL-2009, the Guillain Barre syndrome continued to move throughout the patient's body, affecting her lungs. The patient's parents consented to induce her into a coma. Per the patient's father, his daughter has been moved to a more restrictive area of the Pediatric Intensive Care Unit and was intubated in the morning of 02-JUL-2009. It was reported that with the "machine assisting the patient in breathing", she is getting more oxygen and resting more comfortably which is a "good thing", since before of the intubation she was expending all of her energy just trying to breath, and she could not get in a comfortable position with the constant pain. In the patient's current semi comatose state, she has opened her eyes and has moved her limbs a little bit. It was reported that the patient has run a fever so she has been started with antibiotics. The patient's father stated that the longer his daughter is assisted in breathing, the greater the chances are that she will need a tracheotomy and she might be hospitalized for an additional month. The reporting physician's assistant's friend stated that there is a good chance that the patient's Guillain Barre syndrome was an adverse reaction to the immunization with GARDASIL vaccine. At the time of reporting the patient had not recovered. The health care professional contacted during telephone follow-up could not supply the following information: date of birth, exact date (s) of vaccination, dose number, lot number, healthcare provider name and contact information. Guillain Barre syndrome and fever considered to be disabling, life threatening and required intervention to prevent serious criteria. Follow-up information has been identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female with a history of absence seizures and seizure who on 09-JUN-2009, was vaccinated IM with the first dose of GARDASIL vaccine (lot # 661046/0546X). Concomitant therapy included lamotrigine (LAMICTAL). On 27-JUN-2009 the patient developed progressive lower extremity weakness/numbness requiring endotracheal intubation on 30-JUN-2009 for respiratory failure. Electromyography (EMG) and magnetic resonance imaging (MRI) were performed which showed demyelinating process consistent with Guillain-Barre syndrome. The patient remained intubated in ICU with flaccid paralysis and paresthesias. The patient also had intensive care. Previous illness included sore throat and fever. The listing indicated that one or more of the events required hospitalization. No further information is available. Follow up information was received which reported that this patient with a history of seizure who on 09-JUN-2009, was vaccinated IM with the first dose of GARDASIL vaccine (lot # 661046/0546X) into her left arm. the patient experienced abasia, asthenia, back pain, blood product transfusion, chest x-ray, dysphagia, dyspnoea, dysstasia, eating disorder, endotracheal intubation, feeling abnormal, gastrointestinal tube insertion, Guillain-Barre syndrome, heart rate increased, hypoaestesia, hypokinesia, intensive care, mobility decreased, pain, pain in extremity, paralysis, pneumonia and posture abnormal. In the morning of 26-JUN-2009 (Friday), the patient complained that her legs felt funny. In the evening, she complained that her legs were not correctly and she could not run. In the morning of 27-JUN-2009 (Saturday), the patient was unable to walk without assistance, and felt if she tried to stand. In the morning, the patient was taken to the local emergency room (ER), and was sent home with crutches with a diagnosis of growing pains. In the evening, the patient was unable to walk and could not use arms. In the morning, she was taken to ER and hour and 20 minutes from home, preliminary diagnosis was Guillain-Barre syndrome and she was told she would be admitted to the hospital. In the afternoon of 28-JUN-2009 (Sunday), the patient was admitted to intermediate intensive care unit from the ER. In the evening, slowly things got worse. The numbness and paralysis continued progressing up her legs and arms. The patient complained of incredible back and leg pain. The first of 5 doses of Intravenous immunoglobulin (IVIG) began, and one dose per day for 5 consecutive days. On 29-JUN-2009 (Monday), the patient had continued progression of paralysis throughout the day. She struggled to breath. Oxygen through a nasal cannula was used to help with breathing. The patient continued to be in pain. She was placed on a feeding tube, was unable to eat and swallow correctly. On 30-JUN-2009 (Tuesday), the patient continued to struggle to breath. The patient was still in continual pain. She was very weak, her neck was "baby like" and unable to support head. The patient was transferred to the PICU very late for observation and was placed on a Bi-pap ventilator. On 01-JUL-2009 (Wednesday), the patient struggled with breathing, and heart rate increasing throughout the day. The patient was intubated between 11:30 and midnight. By this time paralysis was almost complete, no movement of legs and very little movement of arms, paralysis had obviously moved into the diaphragm causing the breathing problems. The patient was intubated for almost 4 weeks. During this time the patient had 2 bouts of pneumonia, numerous chest x-ray, respiratory treatments, MRI's, a PIC line was put in place, a central line was put in place for 8 plasmapheresis treatments, an EMG and Somatosensory Evoked Potential (SSEP) confirming diagnosis of Guillain-Barre Syndrome. The patient also had had a rapid heart rate for some time. It was not back down to normal. The patient also had lumbar puncture (no result provided). The listing indicated that one or more of the events required hospitalization, extended hospital stay and was considered to be immediately life-threatening. The patient required an emergency room visit. No further information is available. Guillain Barre syndrome and fever were considered to be other important medical events. The original reporting source was not provided. The VAERS ID# is 352364. Lot check has been requested. This is a consolidation of two reports. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center was released. Additional information has been requested. The patient was hospitalized. It has been determined that WAES# 0908USA03594 is a duplicate of WAES# 0907USA00954. Therefore, WAES# 0908USA03594 is being deleted from our files and the reports consolidated into WAES# 0907USA00954.