Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hyporeflexia, Immunology test normal, Injection site anaesthesia, Laboratory test normal, Liver function test normal
Clinical narrative: Initial and follow up information has been received from a physician concerning a 13 year old female patient with polycystic ovarian syndrome, diabetes Type II, and kyphoscoliosis with a history of tonsillectomy and adenoidectomy, and hormonal studies, who on 14-MAY-2007 was vaccinated IM in her left arm with her first dose, 0.5 ml, of GARDASIL (lot# 657736/0389U). Concomitant therapy included ZYRTEC, ZYRTEC-D, and metformin HCl (manufacturer not specified). A week to a week and a half later, the patient experienced numbness and tingling of the left hand, as well as numbness and tingling at the injection site. Her physician referred her to a rheumatologist, but the condition resolved so she did not follow through with the referral. Follow up information in the form of emergency department records, diagnostic tests, and physician notes were received. on 29-OCT-2007, the patient, when at the physician's office, reported numbness in her right lower extremity, that had been present for 5 days. At that time she was vaccinated with the second dose, 0.5 ml, IM In the left arm, of GARDASIL (lot# 658558/1061U). The physician again recommended consulting a rheumatologist, with consideration of evaluation for Raynaud's phenomenon or other rheumatological condition. On 03-NOV-2007, the patient visited the emergency department with complaints of lower left extremity (LLE) pain, right leg numbness and tingling. The numbness/tingling was described as "came on gradually 1.5 weeks ago, is constant and unchanging. Extends from toes to hip area." Three to 4 days prior, she also developed left leg pain that "came on gradually and is worse in her left calf, leading her to limp with ambulation." The patient was noted to have a left antalgic gait, mild. The emergency department (ED) noted the previous onset of numbness in her upper extremity as occurring in "April, 2007" and resolved after 2-3 weeks. Treatment prior to visiting the ED included ibuprofen (ADVIL) without improvement. A magnetic resonance imaging (MRI) of the cervical spine showed C7 to T1: increased signal, cord enlargement. An MRI of the spine showed multiple spinal cord lesions suggestive of demyelination vs. tumor. The patient could not tolerate additional time in the scanner, and was discharged to home, to return the next day for additional tests, including a lumbar puncture. The discharge diagnosis was acquired sensory neuropathy. she was instructed to return the following day, and was admitted to the hospital (hospitalization records not provided). Hospitalization was reported to last for 5 days. In November 2007, the neurologist, in a letter to the physician (dated 27-NOV-2007) stated that he saw the patient in follow up , after her hospitalization for transverse myelitis, with admission noted on 03-NOV-2007 to discharge on 08-NOV-2007. He stated that when she presented to the hospital, she reported a 10-day history of right leg paresthesias, as well as, "some stomach upset, without fever, rash, nausea, or vomiting." Over 24 hours, she then developed paresthesias, described as "pins and needles, " of the right foot, evolving to her right leg and into the right lower abdomen and right chest. The patient added that 2 or 3 days prior to hospitalization, she noticed her ankle seemed "weak." The neurologist noted that at the time of hospitalization, the patient's exam revealed "a slight left hemiparesis on toe and heel walking with 4 +/- 5 strength in the left leg and reflexes 2/4 in the right side and left arm, 2+/4 in the left leg with a positive Babinski sign in the left foot. In addition, she had diminished cold sensation on the right leg and right thigh to midline up to a sensory level of T7." The remainder of her sensations were normal. The neurologist reported during hospitalization, the patient received IV SOLU-MEDROL, 1 gm daily for 5 days ,with a tapering dose of oral prednisone over an additional 7 days. The prednisone was discontinued (reason and duration not specified). During the hospitalization, "she had some improvement in this sensory disturbance of her right side. No clear weakness upon discharge home. Now, she has been home approximately 2 weeks to 3 weeks, and she has been symptom free and is now back to 'normal.'" The neurologist reported that "after the hospitalization" the patient underwent brain imaging and spinal cord imaging, which revealed a "high T2 signal lesion with enhancement at the C8 - T1 level of the spinal cord on the left. The brain MRI was completely normal and no lesions were seen on the spinal cord region below. The lumbar puncture documented cerebral spinal fluid (CSF) red cells, 11, white cells, 1; negative culture; subsequent IgG index negative, cytology negative. However a positive oligoclonal bands were obtained. Varicella antibodies negative. Serum studies for Epstein-Barr viral panel documented remote infection. Anticardiolipin and antiphospholipid antibodies were negative. A Lyme-Western blot negative. ANA negative. Anti-DNA negative. Liver profile and serum chemistries otherwise negative or normal. She also underwent neuromyelitis optica antibody testing, which was negative." He also noted the previous exam for hospitalization was "consistent with a partial Brown-Seguard syndrome, and MRI of cervical spine documented a high intensity lesion, consistent with a demyelinating isolated syndrome." The patient's exam at this follow up visit was entirely normal, with "no residual symptomatology." The neurologist discussed the potential use of immunomodulators, "in an effort to reduce the risk or subsequent development of multiple sclerosis." A brain and spinal MRI would be repeated in 2 months. On07-DEC-2007, the patient was seen in her physician's office by an advanced practiced registered nurse (APRN), with complaints of "when she puts head down has a feeling of vibration in hip area and feels then nauseated. No vomiting." The sensation radiates across her abdomen and lower back, described "as if her electric toothbrush was vibrating her hip area." The sensation stops when she put her head upright. The physician's exam showed no other abnormalities, with the exception of decreased range of motion not related to the symptoms. The APRN did not see "any type of illness that could be causing these unusual sensation." She referred the patient for additional follow up. On 18-FEB-2008, the referred physician ordered an MRI of the brain and total spine. The MRI results showed normal brain, and "limited examination of the cervical spine. Signal abnormalities in the lower cervical spine without change except no longer enhancing. Focal signal abnormality in the cervical spine at C2 without change. The remainder of the spine is normal." The outcome of transverse myelitis was unknown. The outcome of feeling of vibration in hip area, nauseated and some stomach upset was not specified. No further details were provided. Additional information has been requested. All available records will be provided upon request.