Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Rheumatoid factor negative, Sinus disorder, Ultrasound abdomen normal, Ultrasound bladder normal
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with no medical history or drug allergy who on 22-JAN-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, IM. On the same visit as GARDASIL, the patient administered MENACTRA, ADACEL, and her second dose of VARIVAX (Oka/Merck). Immediately after receiving GARDASIL, the patient experienced upper arm pain, dizziness and "did not feel right". The patient's symptoms progressed into chronic fatigue, chronic abdominal pain, allergy symptoms ("sinus issues") and roaming muscle pain. At one point the patient was unable to walk. The patient was treated with NEURONTIN, and her symptoms have since improved. However if the NEURONTIN dose was decreased or stopped the symptoms return. The patient sought medical attention by office visit. Follow-up information has been received from a registered nurse who confirmed that on 22-JAN-2008, the patient received GARDASIL (lot # 659435/1265U), VARIVAX (Oka/Merck) (lot # 658589/1274U), MENACTRA and ADACEL. Follow-up information was received on 26-JAN-2009 and 29-jan-2009 from a physician via medical records concerning a female student gymnast with "no chronic medical conditions and no known drug allergies". On 22-JAN-2008 the patient was vaccinated intramuscularly in the upper right arm with a first dose of GARDASIL (lot # 659435/1265U). On the same day, she also received a second dose of VARIVAX (Oka/Merck) (lot # 658589/1274U) subcutaneously in the upper right arm, a first dose of MENACTRA (Lot #U2418AA) intramuscularly in the upper left arm and a first dose of ADACEL (Lot #C2775AA) intramuscularly in the upper left arm. There was no illness at time of vaccination. On 13-JAN-2008 (previously reported as 22-JAN-2008) the patient experienced abdominal pain. On 22-JAN-2008 the patient experienced pain at injection site and intermittently pre-syncope. On 22-JAN-2008 the patient experienced weakness, myalgia and fatigue. On 15-MAR-2008 the patient developed intermittent difficulty breathing and trouble walking. It was reported that the patient also had cough and paresthesias. Abdominal radiology performed on 20-MAR-2008 revealed unremarkable ultrasound of the upper abdomen and the urinary bladder. On 10-APR-2008 the patient was seen by a neurologist. Nerve conduction studies were performed and were normal. There was no evidence of a demyelinating neuropathy to suggest GUILLAIN-BARRE syndrome. Chest radiology performed on 18-APR-2008 indicated that there was minimal peribronchial thickening, there was no evidence of air trapping. It was reported that the minimal peribronchial thickening could be related to reactive airway disease versus viral infection. On 18-APR-2008 the patient was seen by the neurologist again. A needle electromyogram was performed and was normal. There was no evidence of an inflammatory or chronic myopathy. At the time of the report, the patient had not recovered. The reporter considered the patient's events to be disabling. Additional information has been requested. All available medical records will be provided upon request.