Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Ataxia, Back pain, Balance disorder, CSF cell count normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 08-AUG-2007, a 21 year old female patient with ampicillin and amoxicillin allergy was vaccinated intramuscularly with the first dose of GARDASIL (lot#0469U) into the right arm. Concomitant therapy included BACTRIM. 55 days later, on 02-OCT-2007 the patient awoke in the morning with severe neck and upper back pain. She developed numbness and tingling from shoulders down and then quickly turned into weakness then paralysis from shoulders down. She went to emergency room and was diagnosed clinically with T4 transverse myelitis. On 02-DEC-2009, DC summary and hospital records received for date of service from 02-OCT-2009 to 08-OCT-2007: patient awoke on morning of 02-OCT-2009 with stiff neck, shooting pain down both arms and progressive weakness of bilateral upper extremities. She was admitted to hospital and was treated with steroids with initial improvement of left upper extremity weakness. She developed gait ataxia during hospital stay which also improved by discharge. She was diagnosed with mycoplasma pneumoniae and infectious disease consult obtained, she was treated with antibiotic. Right upper extremity significant weakness remained. She discharged home to continue physical therapy as outpatient. Doctor diagnosis was: transverse myelitis, positive mycoplasma in serum with cerebrospinal fluid (CSF). On 02-DEC-2009, neurology records received for date of service: 12-OCT-2007, 20-NOV-2007, 10-AUG-2008, 01-JAN-2008, 15-FEB-2008, the patient presented with continued numbness of left leg with loss of pain and temperature sensation; persistent weakness of right arm. She was diagnosed with transverse myelitis, mild lateral gaze nystagmus. On 07-DEC-2009, neurology consult received for the date of service 02-DEC-2009, the patient was diagnosed with transverse myelitis, she had full movement of affected arm with continued weakness, and she had no pain. She had numbness of left leg to pain, trouble balancing on right leg at times, mild lateral gaze nystagmus. Magnetic resonance imaging (MRI) of C- T-spine and brain initially was negative. Repeat MRI 6 days later showed abnormal T2 signal at C2-3 through C5-6 level within cord that were gadolinium enhancing, involved white and grey matter. CSF exam was negative. At the time of this report, the patient's condition had improved. She continued with physical therapy. The listing indicated that one or more of the events required hospitalization, was considered to be disabling, was considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 370369. 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 for Biologics Evaluation and Research and was released. No further information is available.