Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tinnitus, Vaccine positive rechallenge, Vaginal discharge, Vaginal infection, Vulvovaginitis
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. A 15 year old female patient with no known drug allergies, Attention deficit/hyperactivity disorder, anorexia, binge eating and who was reported to be sleep walker who after the second injection of GARDASIL experienced fatigue, polydipsia, cold extremities, chest discomfort, tinnitus, headache, muscle pain and weakness, severe abdominal pain, bloating, sleep trouble, impaired concentration, chills, hair falling out in clumps was vaccinated with the third dose of GARDASIL (Lot # 663573/0969Y) (route and site not reported). Concomitant therapy included CONCERTA. It was reported that the patient experienced the same symptoms with increase in intensity and discomfort. The information was obtained by the government on 19-JAN-2011. The pediatric rheumatology consult and diagnostics were received for DOS on 04-JAN-2011 to 07-JAN-2011. Impression: unlikely rheumatology disease. The patient was seen for evaluation of complained of fatigue, multiple aches/pains (no specific arthralgias), SOB and dizziness. The patient had multiple symptoms since spring. The parent reported the patient's symptoms started after receiving GARDASIL. After initial GARDASIL shot in March of 2010, the patient was reported to have experienced sore throat and stomach pain. After the second GARDASIL shot experienced blisters in throat, extreme tiredness, leg swelling, numb feet, stomach pain, nausea, enlarged notes on neck, forgetfulness, hot and cold intolerance and chest pain. After the third GARDASIL shot, the patient slept more, had mid day headache, food cravings, extreme thirstiness, had gained 40 pounds and had vaginal discharge. The patient was noted to be falling asleep in school and energy level had decreased significantly. Upon presentation, the patient was well appearing. Assessment exam: findings not consistent with rheumatology disease in that patient having weight gain and no joint pain, swelling or stiffness and no history of photosensitive rash. Plan: unlikely rheumatology disease but would obtain blood work. On 20-JAN-2011, PCP office records were received for DOS (11-MAR-2010 to 28-DEC-2010). Assessment: autoimmune disease. The patient presented on 11-MAR-2010 for scheduled adolescent well child visit. The patient had concern of acne on her back. The parent had no specific concern. Assessment was normal growth and development. The GARDASIL vaccine was administered. The patient was seen on 24-MAY-2010 for complained of sore throat. Assessment was pharyngitis acute; the plan was throat culture. The patient was seen on 29-SEP-2010 for complained of sore throat and left ear pain. The patient also reported bloated feeling in upper abdomen and pain associated with her period. Assessment: abdomen and pelvis symptoms other (likely lactic intolerance), pharyngitis acute. The patient presented on 19-OCT-2010 with   [Due to memory limitations, the remainder of this text could not be compared.]  0 with complained of vaginal discharge worse than usual for 2 weeks. The patient also reported belly pain and bloating, which she felt was due to her lactose intolerance. Assessment was vaginitis and vulvovaginitis unspecified. The patient was seen on follow up on 05-NOV-2010, for complained of continued bloating and vaginal discharge. The patient also received GARDASIL. The plan: cultures were sent. The patient was seen on 28-DEC-2010. The patient complained of stomach bloating, gassy and looser stools. The patient was tested for celiac and inflammation bowel disease in November and all was normal. The patient noted shin pain since September and the patient had nuclear med scan that showed shin splints. The patient complained of headaches and ringing in ear also the patient was being tired. The review labs revealed: ANA positive; needed rheumatologist evaluation. Assessment was autoimmune disease. On 20-JAN-2011, the PT evaluation was received for DOS for 08-DEC-2010. The diagnosis was shin pain and plan continued. The orthopedic consult and notes were received for DOS (05-OCT-2010 to 04-NOV-2010).The patient was seen for evaluation of bilateral leg severe pain. The patient run crossed-country and first experienced pain after activity in August. Assessment was possible chronic exertional compartment syndrome and plan was first step resolved shin splint component: orthotics, anti-inflammatory, scheduled non-invasive treadmill test. The patient was being tested for Pots Syndrome by neurologist. The ANA screen was positive and Diff manual bands high. Reactive lymphocytes 1 and positive crenated cells. ANA titer was 1:1280 and ANA pattern homogenous. This was originally reported by a consumer. The VAERS ID # is 414754. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 663573/0969Y 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.