Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Somnolence, Staring, Tinnitus, Urticaria, Vomiting
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 13 year old female with hypothyroidism, depression, allergy to ADDERAL, LAMICTAL, rapid eye blinking and a history of bipolar, asthma, tics, anxiety, behavioral issued, allergy to AUGMENTIN, and a history of fibromyalgia. The patient had a previous vaccine illness of seizure and influenza H1N1, the patient was vaccinated with influenza H1N1 (manufacturer unknown). On 17-APR-2007 the patient was vaccinated with the first dose of GARDASIL (lot# 653937/0637F) IM. On 19-APR-2007 the patient experienced abdominal pain, activities of daily living impaired, adenotonsillectomy, anxiety, arthralgia, asthenia, candidiasis, change of bowel habit, chest pain, chills, conditions aggravated, confusional state, convulsion, cough depression, diarrhoea, dizziness, dysphagia, dysphonia, dyspnoea, ear pain, fatigue, feeling hot, fibromyalgia, gastroesophageal reflux disease, headache, heat exhaustion, hyperhidrosis, hypermobility syndrome, hypersensitivity, hypersomnia, hypophagia, irritable bowel syndrome, lethargy, malaise, memory impairment, muscle spasms, myalgia, myofascial pain syndrome, nasal congestion, nausea, neck pain, night sweats, odynophagia, oropharyngeal pain, pain, palpitations, paraesthesia, pharyngitis, pyrexia, rash, sleep disorder, somnolence, staring, tinnitus, urticaria, vomiting and weight increased. The patient was treated at hospital on 07-MAY-2007, 09-MAY-2007, 26-OCT-2007, 09-DEC-2007, 05-FEB-2008, 12-MAR-2008, 16-APR-2008, 17-APR-2008, 08-MAY-2008, 19-OCT-2008, 18-NOV-2008, 01-APR-2009, 18-MAY-2009, 27-MAY-2009, 28-MAY-2009 through 31-MAY-2009, on 03-SEP-2009, on 17-SEP-2009, on 20-SEP-2009, on 23-SEP-2009, on 19-OCT-2009, 23-OCT-2009, on 26-OCT-2009 through 28-OCT-2009, 17-NOV-2009, 23-NOV-2009, 24-NOV-2009, 14-DEC-2009 and 25-DEC-2009 for medical issues relating to adverse reaction to the GARDASIL. She was also treated at other hospital by multiple physicians on the following dates 17-APR-2007, 16-MAY-2007, 29-JUN-2007, 29-JUN-2007, 08-OCT-2008, 15-OCT-2008, 13-NOV-2008, 28-JAN-2009, 11-FEB-2009, 02-APR-2009, 12-MAY-2009, 28-MAY-2009. In Jun-2009, the patient had CT abdomen and pelvis within normal limits and a colonoscopy. On 02-JUN-2009, 10-JUN-2009, 02-JUL-2009, 28-JUL-2009, 12-AUG-2009, 14-SEP-2009, 21-SEP-2009, 25-SEP-2009 by two separate physicians, 09-OCT-2009, 12-OCT-2009, 19-OCT-2009, 09-NOV-2009, 16-NOV-2009, 17-NOV-2009, 23-NOV-2009, 30-NOV-2009, 02-DEC-2009, 11-DEC-2009, 14-DEC-2009 and on 01-JAN-2010 the patient continuing treated by multiple physicians. The patient was treated for the following ongoing medical issues: fibromyalgia allergic reactions, hoarseness, coughing, shortness of breath, difficulty/pain when swallowing, continued throat pain, dizziness, repeated severe headaches, light headed, chills, overheated, excessive night sweating, lethargic, sleeping for entire day without waking rested, confusion/short term memory issues, seizures, sharp chest pains, racing heart, muscle/joint aches, hives on trunk/arms/shoulders, ringing ears, severe depression, twisted/spastic colon, acid reflux, heartburn, weight gain. On 04-JAN-2010, gastroenterologist consulted records for 14-SEP-2009, patient with chronic but progressively worse abdominal pain of etiology, increased fatigue, non-specific chest pain, change in bowel movements, alternating constipation and diarrhea, cold sweats and shortness of breath with exertion, weakness with sensation of knees giving away. On 12-JAN-2010 received records from Primary Care Physician, multiple ED visits, Ear, nose and throat magnetic resonance, psych consult with dates ranging form MAY-2007 to 25-DEC-2009, Discharge summary and psych consult for 28-MAY-2009 multiple complaining of nausea, vomiting, fever, headaches, dizziness, nasal congestion, RL. On 26-JAN-2010 received medical records with past medical history. The listing indicated that one or more of the events required hospitalization, was considered to be disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, and 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 health regulatory agency and was released. The original reporting source was not provided. The VAERS ID# is 375681-1.