Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from the father concerning his 15 year old daughter with acne and a history of Renoe syndrome (shaking of her hands) who in August 2007, was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml. On 15-OCT-2007, the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) 0.5 ml injection. Concomitant therapy included doxycycline (ADOXA). On 16-OCT-2007, the next day, the patient experienced tingling in her hand, and muscle pain in her legs. It only lasted less than one day, but the following week, she experienced weak legs and arms, and numbness and shaking muscles in her arms and legs. Unspecified medical attention was sought. Possible diagnosis was Guillain-Barre syndrome. At the time of reporting, the patient had not recovered. Upon internal review, Guillain-Barre syndrome was considered to be an Other Important Medical Event. Additional information has been requested.  1/25/08 Reviewed neurologist medical records which reveal patient initially seen 10/30/07 w/sensory complaints.  Neuro exam revealed slightly enhanced DTRs of all 4 extremities.  Labs were obtained.  Returned 11/27/07 & had no further episodes.  Neuro exam WNL except for mildly enhanced DTRs of all extremities unchanged from before.  Labs WNL.  No diagnosis provided except that GBS was ruled out.  3/20/08 Received via email from CDC: For VAERS 299810: CISA has reviewed this case and determined that it does NOT meet the case definition for GBS. This is in follow-up to report (s) previously submitted on 11/14/2007; 1/7/2008. Initial and follow-up information has been received from the father concerning his 15 year old daughter with acne, acne vulgaris, and a history of Renoe syndrome (shaking of her hands), and no drug allergies, who in August 2007, was vaccinated with a first dose of GARDASIL vaccine 0.5 ml. On 15-OCT-2007, the patient was vaccinated intramuscularly in the left arm with a second dose of GARDASIL vaccine (Lot# 659435/1265U) 0.5 ml injection. There were no illnesses at the time of vaccination. Concomitant therapy included ADOXA. The next day, on 16-OCT-2008 the patient experienced tingling in her hand, and muscle pain in her legs, the symptoms only lasted less than one day, but the following week she experienced weak legs and arms, and numbness and shaking muscles in her arms and legs. A possible diagnosis of Guillain-Barre syndrome was reported. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Follow-up information indicated that on 16-OCT-2007 the patient experienced faintness near syncope, diffuse numbness worsening at extremities, and pale hands and feet. An EKG was performed and was negative. A neurological examination was performed and was normal even with subjective symptoms. The patietn's blood pressure was within normal limits. No fever was reported and there were no other findings. The patient recovered on approximately 27-NOV-2007 (previously reported as not recovered). Follow-up was received from the physician's nurse via telephone who reported that other family memebers are his patients, but not this indivisual. The patient was not seen in the reporter's office and HPV was not given at their office. No additional information is expected. This report is corrected as amended.