Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Muscle spasms, Pain, Sjogren's syndrome, Systemic lupus erythematosus, Urinary tract infection
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, concerning a 12 year old female patient. The patient's past medical history included: colic as infant (3 weeks old to 8 months old), ear infections, Upper Respiratory Tract Infection (URI), atopic dermatitis, eczema, Attention Deficit/Hyperactivity Disorder (ADHD), questionable Attention Deficit Disorder (ADD). On 12-MAY-2010 the patient received the first dose of GARDASIL (lot # 663573/0969Y) IM in left arm and the second dose of VARIVAX (lot # reported as "1048S") SC in left arm. Concomitant vaccinations on the same included the first dose of MENACTRA (lot # U3068AA) IM in right arm, the first dose of HAVRIX (lot # AHAVB365CA) IM in right arm, and the fifth dose of ADACEL (lot # U3052AA) IM in left arm. On 23-SEP-2010 (134 days after vaccination) the patient experienced memory and cognitive deficit. In "May" to present - hair loss, nose bleeds, fatigue, lethargy, dry eyes, positive ANA (reported as antiphospholipid antibodies test) for an autoimmune diagnosis for either lupus, multiple sclerosis (MS), arthritis and Sjogren's. Patient went to neurology of hospital. Continued treatment. The following information was obtained through follow-up and/or provided by the government. On 19-NOV-2010, primary care physician (PCP) records was received for date of service (DOS) on 17-NOV-1997 - 18-NOV-2010 with assessment: multiple arthralgias of uncertain etiology. On 15-OCT-2010 patient complained of poor concentration, poor memory, body aches, falling grades. Past Medical History included (vitamin) B12 deficiency (per mom, no documentation), poor sleep, fatigue, and questionable Attention Deficit Disorder (ADD). The patient was provided flu vaccine and sent for labs. She was referred to rheumatologist. On 12-NOV-2010 the patient returned for labs results, complained of not feeling well. She was diagnosed with urinary tract infection (UTI). The patient returned on 18-NOV-2010 complained of feeling "like crap". She was scheduled for magnetic resonance imaging (MRI) and electroencephalography (EEG). She had poor eye contact during visit. Provided copy of lab results for rheumatology appointment. On 18-OCT-2010 more lupus 1:320, positive ANA testing TBD (to be determined). On 19-NOV-2010 lab/diagnostic reports received for DOS 10-NOV-2010 "IgG & IgM negative Anti-". Outcome of the events was not reported. The report indicated one or more of the reported AEs were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 406578. 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   [Due to memory limitations, the remainder of this text could not be compared.]  the requirements of the Research Center and was released. No further information is available.