Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: Information has been received from a consumer concerning his 12 year old daughter with no pertinent medical history, drug reactions or allergies who in October 2010, was vaccinated with a first dose of GARDASIL (Lot# unknown). On 03-JAN-2011, the patient was vaccinated intramuscularly with the second dose of GARDASIL (Lot# unknown). There was no concomitant medication. The consumer reported that on 03-JAN-2011, the patient experienced "dizziness, almost fainted, pain in the thighs and especially severe pain in the knees." The patient also experienced "pain in the calves". The consumer reported that the patient "was in such pain she could not walk". The consumer had been talking with doctors and "was up all night talking with them". The consumer said that the patient had been given BENADRYL and ADVIL for the adverse events. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. Information was received from a health care provider who reported that on 03JAN2011 a 12 year old female student, 107 pounds, 62 inches, who received a dose of GARDASIL (lot # 663559/1178Y) intramuscularly in her left arm. The patient had received one previous dose in October 2010. On 03JAN2011 the patient experienced headaches, dizziness, nausea and shooting pains in arms and legs. The patient required an emergency room/doctor visit. Chemistry labs were performed on 14JAN2011. These labs indicated abnormal results of low red blood cells at 4.28 x10^6/mcl, neutrophils absolute (high) at 7.1 x10^3/mcl, alkaline phosphatase 143 units/liter (high) and serum C-reactive protein test normal at <0.300mg/dl. It was reported that the patient had not yet recovered. Information was received from a health care provider who reported that as of 31JAN2011 the patient has not yet recovered. Follow up information was received from a physician concerning a 12 year old female who received a second dose of GARDASIL (lot # 663559/1178Y) intramuscularly in the left arm on 03JAN2011. The patient had received a previous dose in October 2010 without incident. Following the second dose the patient developed headache, nausea, dizziness and shooting pains in both legs. The patient was seen by her physician and also in the Emergency Room and was treated with BENADRYL and ibuprofen. At the time of reporting the patient's symptoms did not improve and she was only able to attend school a couple of days per week. She was seeking alternative medicine providers but did not have a more traditional evaluation to date. The patient's symptoms include chronic low grade headache which worsened with episodes of facial flushing, nausea, dizziness, weakness and shooting leg pains. These episodes occurred several times per day and lasted for several minutes up to 35 minutes. On 28FEB2011 the patient "experienced one" while in the shower, fell and hit her head. The patient's parents stated they were now willing to seek medical attention at a hospital. It was reported that the patient's symptoms have not yet improved. Additional information has been requested.