Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Nausea, Nervous system disorder, Neurological examination abnormal, Nuclear magnetic resonance imaging 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. A 14 year old female with conversion disorder and had an allergy of rash to red food dyes and a history of central auditory processing defect who on 31-DEC-2008 was vaccinated in right arm with a dose of GARDASIL (lot # 660616/0570X). Secondary suspected vaccination included a dose of MENACTRA. A 14 year old female experienced activities of daily living impaired, alopecia, amnesia, ataxia, burning sensation, conversion disorder, deafness, dizziness, dyspnoea, eating disorder, erythema, fatigue, feeling cold, gait disturbance, headache, hyperhidrosis, hypersomnia, hypoaesthesia, menstruation irregular, migraine, muscle spasms, muscular weakness, nausea, nervous system disorder, neurological examination abnormal, pain, pallor, palpitations, paraesthesia, phonophobia, pyrexia, rash, rhinorrhoea, screaming, skin warm, stress, swelling, tremor, upper respiratory tract infection, vision blurred and wrong drug administered. On 26-DEC-2008, the patient was given a wrong shot (another meningitis shot given, instead of the third dose of GARDASIL). On 06-JAN-2009, the patient experienced upper respiratory infection, headache. On 14-JAN-2009 headaches worsen. Respiratory cleared up with antibiotics/looked like pneumonia. On 15-JAN-2009, the patient experienced dizziness. On 28-JAN-2009, headaches spike to levels 5-7 out of 10, 100% of the time. Ibuprofen did not work (800 mg). In the middle of February: the patient saw doctor. AUGMENTIN was given for possible sinus infection. Headaches worsen, nasal fluid leakage continued. AUGMENTIN did nothing. CAT scan MRI to be ordered within 5 days of AUGMENTIN. Headaches spike to 7-8 100% of the time. Dizzy, no focus, loss of memory. The patient then removed from school. Saw chiropractor - no one could touch the back of her head (meninga area) without her screaming. Said her head felt swollen and numb. Spine started to burn. On 15-FEB-2009 at 8:00 pm, headaches go to 10/10, patient screaming. Considered possibility of brain tumor and taken her to ER. She had trouble walking in straight line. CAT scan ordered by ER. Doctor sent her home and told her to take 2 TYLENOL and 3 ibuprofens. CAT scan was normal. On 17-FEB-2009 saw pediatrician again. Full blood work ordered: tests vitamin D, thyroid function, regular blood-work, and was referred to neurologist. 19-FEB-2009 doctor agreed problem could have been caused by cross reactions of GARDASIL and MENACTRA; given her TOPAMAX at 50 mg/day and ordered MRI. On 20-FEB-2009: MRI looks normal. There was spine still burning, back of head untouchable, having more trouble walking in a straight line. On 23-FEB-2009 second day of TOPAMAX, can only walk in 45 degree angles....cannot walk to bathroom.. Went to ER, where she was seen by a team on neurologists and admitted to hospital for next 3 days. Ibuprofen administered via IV. No response. Second day: dihydroergotamine mesylate administered, which took effect and after third day she was released. March and April 2009: patient can get through 2-4 hours of school each day and in the midst of that, needed a 1 hour rest on couch in office at school. Most days the parent picked her up at lunch. She was pale and very dizzy, with headaches reoccurring daily. Typically levels 4-5, with 7-8 spikes. She lose. The labs included CAT scan, MRI, thyroid testing, blood-work, heart monitoring...26-APR-2010 and 05-MAY-2010 PCP records December 2008, MR, for 23-FEB-2009 to 25-FEB-2009, neurologist consulted 03-APR-2009, diagnosed as migraines. Labs: BHCG negative Dx studies: Echo, CT head and MRI. 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. The original reporting source was not provided. A priority check has been initiated. 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 Biologic Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS ID number is 385808-1.