Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Myalgia, Neurological examination normal, Pallor, Paraesthesia
Clinical narrative: near syncope; shaking muscles in her arms and legs; numbness of extremities/ could not feel her legs or arms; tingling in her hands; weakness in arms and legs; muscle pain in legs; hands and feet pale; Patient was not acting right; Patient had to lie down for 30 mins as for she "was not feeling good"/patient did not know how she got to school's nurse; Initial and follow-up information has been received from the father concerning his 15 year old white 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 quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) 0.5 ml. On 15-OCT-2007, the patient was vaccinated intramuscularly in the left arm with a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (Lot# 659435/1265U) 0.5 ml injection. There were no illnesses as the time of the vaccination. Concomitant therapy included doxycycline (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 then 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 no 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 patient'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 members are his patients, but not this individual. The patient was not seen in the reporter's office and HPV vaccine was not given at their office.  Follow-up information has been received from a consumer concerning her daughter on 04-OCT-2021.  The consumer reported that on 15-OCT-2007 after her daughter received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), she had to lie down for 30 minutes because she was not feeling well (malaise).  It was reported that the next day, on 16-OCT-2007,  the patient went to her school's nurse and mentioned to the nurse that "she did not know how she got there".  The reporter also mentioned that her daughter "was not acting right" (abnormal behavior) and that she could not feel her legs or arms (Hypoaesthesia). The outcome of not feeling well and was not acting right was not reported.  The causal relationship between the aforementioned events and of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not reported.