Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Throat tightness
Clinical narrative: Information has been received from a mother concerning her 17 year old daughter with no pertinent medical history and no history of drug reactions/allergies who on 09-AUG-2007 was vaccinated with the first dose of Gardasil IM.  Concomitant therapy included YASMIN.  On 09-AUG-2007, the patient experienced dizziness, nausea and throat tightening after being vaccinated.  Medical attention was sought.  The patient was evaluated in the emergency room.  She was treated with famotidine (MSD), intravenous BENADRYL, an unspecified steroid, and discharged to home.  On 10-AUG-2007, the patient recovered from the dizziness, nausea and throat tightening.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007; 1/7/2008. Information has been received from a mother concerning her 17 year old daughter taking birth control pills with no pertinent medical history, no alcohol, tobacco or drug use, and no history of drug reactions/allergies. There was a family history of allergic reaction. The patient had no illness at the time of being vaccinated. On 09-AUG-2007, the patient was vaccinated with the first dose of GARDASIL vaccine (lot# 658222/0927U) IM in the left deltoid at 1 PM. Concomitant therapy included YASMIN and ORTHO TRI-CYCLEN LO). On 09-AUG-2007, at 3 PM, the patient experienced dizziness, nausea and throat thightening after being vaccinated. Medical attention was sought. The patient was evaluated in the emergency room. She was treated with MSD, intravenous BENADRYL, an unspecified steroid, and was discharged to home. On 10-AUG-2007, the patient recovered from dizziness, nausea, and throat thightening. Follow-up information was received from the physician and emergency room medical record. At 5:50 PM, the patient presented to the emergency room with complaint of thightness in her throat. She reported that she was still feeling minimal tightness in her throat but it did not seem to be as tight as it was before. Examination revealed: temperature 98.7, pulse 94, respirations 14 and blood pressure (BP) 114/58. The patient was talkative, alert, comfortable and in no acute distress. Moist mucous membranes, pharynx open and clear without any evidence of edema or obstruction. No rashes, tongue, lip or throat swelling. Lungs clear, motor sensory intact. No rash, pallor, or cyanosis. No shortness of breath, no headache, and no chest pain. Electrocardiogram revealed normal sinus rhythm on the monitor; pulse oximetry 96 to 98 % on room air, hypoxia. She was treated with SOLU-MEDROL 125 mgG IV, MSD 20 mg IV, BENADRYL 25 mg IV, REGLAN 5 mg IV. The patient reported that she felt significantly better after receiving the medicatios, although she was nauseated so she was given metoclopramide.Clinical impression was allergic reaction, throat thightness which was resolved. The patient potentially could have had an allergic reaction to GARDASIL vaccine. At 8:30 PM she was discharged to home in stable improved condition. Discharge plan included; follow-up with primary care doctor in 1 to 7 days, take prednisone, diphenthyramine, ZANTAC for 4 days, and return if there are any problems. Follow-up information was received from the patient's mother who reported that her daugther's pediatrician felt that the events her daugther experienced after her initial dose of GARDASIL vaccine were not related to the GARDASIL vaccine. Her daugther received her second dose on 24-OCT-2007 without incident and plans to receive the final dose. No additional information is expected.