Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Malaise, Metabolic function test, Paraesthesia, Sinus tachycardia, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient with CODEINE allergy who on 19-JUN-2008 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (Lot#660393/0067X) and with the second dose on 26-AUG-2008. Concomitant therapy included MENACTRA. The nurse reported that on 26-AUG-2008 the patient fainted twice after receiving the vaccine. The patient first fainted 4 hours after the vaccination. After the patient fainted for the second time, she was taken to an emergency room and discharged after receiving intravenous fluid. The patient had not yet received the third dose. The patient recovered on 26-AUG-2008. Additional information has been requested. Follow up information was received from the Registered Nurse and an KM physician and nurse via medical records concering the female student with gasterointestinal disease, and a history of bulimia and polyps status/post removal, appendectomand questionable irritable bowel syndrome who on 26-Aug-2008 was vaccinated intramuscularly with the second dose of GARDASIL (Lot # 660391/0067X) in her left arm. Concomitant therapy included REULAN, PROTONIX and CAKAFATE. At  9:45 on the same day after vaccination, the patient felt general tingling and not well all day, and then the patient had syncopal episodes at home. Enroute to ER, the patient had another episode lasting 4 or 5 seconds, shaking chills. THe triage nurse assessed viatl signs which were all normal. The patient reported general shakes, hot and cold spells. She ahd not chest pain, no shortness of breath, no nausea/vomiting or rash. The patient was observed to have intermittent general shivering. Patient's mother reported paresthesias. At 22:10, the blood pressure wa 134/54, cardiac monitor showing sinus tachycardia. A basic metabolic panel. CBC and urinalysis wer performed (all normal with exception of BUN at 7 mg/dL). She had a normal ECG. The patient was diagnosed with vasovagal syncope. She ahd an IV established and received 1000 ml normal saline. She also received ZOPHAN 4 mg. IV. At 23:37 routine re-evaluation indicated the patient had improved. She was slepping comfortably. On waking, she stated she still felt "warm" and not normal. Orthostatics were abnormal (see laboratory data section). The physician reported "will hydrate overnight and observe. If patient improved in the a.m. and not orthostatic, will discharge". Patient stated she was feelign better and wanted to go hom. The plan per physician was to hydrate and watch overnight, discuss ed with patient and mother as well as risks of leaving. They understood but wanted to leave. At 1:50 on 27-AUG-2008, the patietn was discharged to home in stable condition, ambulating without assistance, accompanied by parent, IV discontinued with verbalized understanding of discharge and follow up care. Final disposition was home self care, remove from ER. Rest, stay well hydrated. Follow up with PCP in 3-5 days for re-evaluation. Return to ER with worsening symptoms or any other concerns. Follow-up information received from the Registered Nurse concerning the patient who on 26-AUG-2008 received the first dose of MENACTRA (lot #U2606AA) IM in the right arm. The patietn fainted 4 hours after GARDASIL and MENACTRA given in the office, then again the same afternoon. She then went to the ER. At the time of reporting, the patient recovered from the events. No further information is available.