Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Chills, Diarrhoea, Fatigue, Guillain-Barre syndrome
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with polycystic ovarian syndrome, a history of thoracic sympathectomy for excessive sweating, and not known drug allergies, who on 27-JAN-2009 was vaccinated with a 0.5 mL first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 1423X), intramuscularly. Concomitant therapy included desogestrel/ethinyl estradiol (MIRCETTE) and prenatal vitamins (unspecified). That evening the patient had episodes of diarrhea, flu like feeling, fatigue, achiness and chills. The symptoms persisted and the patient stated that she started to develop tingling in her lower legs and feet on 29-JAN-2009. The registered nurse requested that the patient took her temperature and it was 98.4 degrees °F. The patient sought medical attention through a phone call. At the time of this report the patient had not recovered. Follow up information received on 19-FEB-2009 stated that the patient who was a corporate aircraft  dispatcher received a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 1423X), intramuscularly into the left deltoid on 27-JAN-2009 at approximately 12:00. The patient had a sympathectomy in 1999 for excessive sweating. It was also reported that the patient called to the physicians office on 29-JAN-2009 complaining of fatigue, diarrhea and flu like symptoms starting a few hours after administration of HPV rL1 6 11 16 18 VLP vaccine (yeast), The patient also complained of "tingling of feet". On 01-FEB-2009 the patient called for increasing numbness on legs, the patient went to E.R. on 02-FEB-2009 for numbness and saw the neurologist who prescribed gabapentin (NEURONTIN). Follow up information received on 27-FEB-2009 from the physician's secretary; she provided the patient's last name. It was also stated that the patient was in contact with the physician by phone on 24-FEB-2009 and she told the physician that she was go to a rehab center for physician therapy two  times a week for about a month, to "get resolution of symptoms". The secretary could not find the name of the neurologist in the chart, nor was there any mention of recovery for the other events. Follow up information received on 11-MAR-2009 from the physician stated that the patient was seen by a neurologist while at the E.R. on 02-FEB-2009. The neurologist diagnosed her symptoms as Guillain-Barre-unrelated to the prior sympathectomy- and placed the patient on gabapentin (NEURONTIN). The extent of the Guillain-Barre was from feet to mid thigh, causing a lower extremity deficit. For this reason, the patient was to go for physical therapy. According to the patient, the neurologist felt that the event was caused by the HPV rL1 6 11 16 18 VLP vaccine (yeast). The physician did not have the name of the neurologist in her records but could possibly get it from the patient if needed. The patient had recovered. Upon internal review Guillain-Barre syndrome was determined to be an other important medical event. Follow-up information has been received from the patient via an e-mail on 20-MAY-2019. The patient reported that she had suffered daily from immense pain and burning from small fiber neuropathy, as residual disease from her bout with Guillain Barre Syndrome. The patient reported that she intends to file a fraud lawsuit in regards to GARDASIL.