Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema, Pharyngitis, Pruritus, Somnolence, Swelling face
Clinical narrative: Information has been received from an advanced registered nurse concerning a 23 year old female patient without any allergies or pertinent medical history who on 07-OCT-2010 was vaccinated with a first dose of GARDASIL (lot # 0644z, expiry date 11-MAR-2011), and on 03-DEC-2010 was vaccinated with a second dose of GARDASIL (dose, route and lot # not reported). The nurse stated that "two weeks" after the first GARDASIL dose, on approximately 21-OCT-2010, the patient had itching and swelling on her face. The nurse also stated that "very soon" "2 days" after the second GARDASIL dose was given on 05-DEC-2010 the patient experienced tongue swelling, facial swelling, low blood pressure and difficulty breathing. The nurse claimed that the patient went to emergency room after the second GARDASIL dose and was given IV fluids (not specified) and was not admitted. There were no laboratories performed. At the time of the report the patient had recovered. Follow-up information has been received from an adult nurse practitioner and medical records concerning a 23 year old female (159 pounds, 62.5 inches) with multiple allergies (unspecified). Concomitant medication included AVIANE as an oral contraceptive pill. On 07-OCT-2010 she was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 0644Z, expiry date 11-MAR-2011) at 10:30 am. On 03-DEC-2010 at 09:30 am, she was vaccinated intramuscularly in the left deltoid with a second dose of GARDASIL (lot # 0644Z) at 0930 am. On 05-DEC-2010, at 7:00 PM, the patient presented to an urgent care center with the complaint of itching and swelling of the throat an lips after she had eaten (she was not sure what she ate). The patient reported her mom gave her BENADRYL (amount unknown) and she felt better. The following active problems were listed on the urgent care record (onset dates not reported): acute upper respiratory infection (treated with Z-pak (azithromycin)) and pharyngitis (treated with xylocaine (LIDOCAINE VISCOUS 2%) solution). Physical exam revealed decreased blood pressure of 79/52, pulse 105, oxygen saturation 94% on room air, slightly sleepy due to BENADRYL and slight edema and erythema around her eyelids bilaterally and on her lips. Her tongue was non-edematous (initially reported that the patient had tongue swelling). Initial assessment: "allergic reaction, probably to food products". The patient was treated with a liter of normal saline bolus along with SOLU-MEDROL 125 milligrams (mg) intravenously (IV), ZANTAC 50 mg IV and BENADRYL 12.5 mg IV. Following treatment, blood pressure was 116/74 and pulse was 89. There was no dizziness. The patient felt a lot better and the swelling had subsided greatly. The physician's assessment was an allergic reaction. The patient was discharged to home with instructions to follow-up with the Primary Care Physician in the next three to six days for re-evaluation and a referral to see an allergy doctor. She was told to hold off on her Z-pak (azithromycin) and go to the Emergency Room if worse. Discharge orders were prednisone, ZANTAC and BENADRYL as needed. The outcomes of the upper respiratory infection and pharyngitis were not specified. According to the nurse practitioner, the patient had no illnesses at the time of vaccination and had no known pre-existing allergies, birth defects or medical conditions. The nurse practitioner indicated the events required emergency room/doctor visit and required medical/surgical intervention to prevent one of the outcomes listed. She noted that the patient had recovered. Additional information has been requested.