Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site pain, Nausea, Neurological examination, Peripheral vascular disorder
Clinical narrative: Information has been received from a medical writer concerning his 19 year old daughter with a history of chronic yeast infections, gets easily nervous and is allergic to BACTRIM who on 05-DEC-2007 was vaccinated with the first "standard dose" of Gardasil (lot # not reported).  Concomitant therapy included DEPO-PROVERA.  On 05-DEC-2007 after receiving the first dose of Gardasil, the patient experienced intense injection site pain.  Within an hour of administration the patient developed nausea and lot sensation of her arm.  Her hand turned purple as if her circulation had diminished.  The patient felt almost intoxicated and had slurred speech.  The patient had no hives and not itching but felt hot.  The patient went to the emergency room and her symptoms disappeared except for the injection site pain.  She was told to take ibuprofen and apply ice packs to the area and the patient was released.  Neurological tests (eye and head movements) were performed at the emergency room (results not provided).  The patient's outcome was reported as recovering.  Additional information has been requested. Follow-up information received on 23-JAN-2008. On 06-DEC-2007 the patient's father contacted the physician's office and reported that on 05-DEC-2007 his daughter could not feel her left arm, that she was confused and felt her speech was slurred. The patient reported that she was told by the nurse that the vaccine GARASIL causes discomfort once injected into site and that another nurse held her down. A nurse was asked to come in and assist by talking to the patient because patient was so anxious and acting somewhat inappropriate. At no time was the patient held down. Patient was asked several times if she wanted injection and she stated yes. Patient's father reported that his daughter's arm was purple when he picked her up and that her speech was slurred. Patient seen at the immediate care center. Patient's father stated he spoke with the manufacturer and that they recommended tha patient not have the second and third dose. The nurse attempted to call patient back the day following vaccination with no success. Physician's notes: The physician reported that the patient experienced localized discomfort after a vaccine injection. The 19 year old female seen at the physician's office was given a dose of GARDASIL at 11:45 hours in the region of the left deltoid. She waited 15 minutes and was discharged. At or about 12:45 she began noticing a discomfort in the area of the injection (she did notice some immediate and acute pain at the time of the injection) associated with eventual numbness of an odd degree in the left hand and forearm. She also noticed because of the intense pain, nausea and there was no dizziness, she did not feel itchy, rash or hives did not develop, and at no time did she vomit. At the time of evaluation, she felt like she had tenderness at the site of the injection. She felt her speech was abnormal although on exam evaluation, speech appeared normal and she was a little nauseated. She never vomited. During examination the patient had no acute distress. Her body temperature was 98.3, pulse of 79 and regular. Respiratory rate of 16 and regular. Blood pressure was 108/66. Oxygen saturation on room air was 98 to 99%. Ears were normal. Throat and mouth including mucus membranes were normal. Neck was supple trachea is midline. Lungs were clear. Skin was normal. Cardiac exam revealed regular rate without murmur, gallop, or rub. Abdomen and extremities were benign. Neurological exam revealed the patient was oriented x three. Grips and strength was normal. There was tenderness in the region of the deltoid injection on the left, but there was no redness and no fluctuance and no induration. The patient was observed for a period from 13:48 hours until time of discharge at 1500 hours. The patient evidenced no progressive nature of symtoms and in fact some of them improved. The patient was indicated to take ibuprofen as needed and ice off and on. She was instructed to follow up with the physician if not during better. No additional information is expected.