Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Lymphocyte count decreased, Nausea, Neutrophil count decreased
Clinical narrative: Patient received Gardasil vaccine in addition to hepatitis A and tetanus vaccines in August 2007.  5 minutes later became pale and diaphoretic, complained of ears ringing and tunnel vision and was presyncopal.  Laid down for 15 minutes and felt better.  Returned on October 17, 2007 for second dose of Gardasil.  Immediately after the vaccine was uneventful.  The next day became pale and diaphoretic and was presyncopal.  Symptoms persisted for 5 hours and she was taken to the Emergency Room where she was found to have orthostatic hypotension.  An electrocardiogram was performed which showed prolonged QT interval.  Repeat electrocardiogram the next day and subsequently have shown normal QT intervals.  The patient has not had prior or subsequent syncope or presyncope. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow-up information has been received from a physician concerning a 11 year old female who on 07-AUG-2007 was vaccinated with her first dose of GARDASIL (lot# 658094/0524U), 0.5mL injection. On 07-AUG-2007 the patient experienced syncope right after receiving the first dose of GARDASIL. The patient also received hepatitis A vaccine (inactive) the same day. On-Oct-2007 the patient received her second dose of GARDASIL (lot# 658560/1062U) and again experienced syncope. The patient also received influenza virus vaccine (unspecified) (lot# 02505AA) the same day. Subsequently, the patient recovered. Unspecified medical attention was sought. Information was received from a cardiologist and medical records. The patient was seen on 13-NOV-2007 in consultation at a request for the evaluation of recurrent presyncope and an abnormal electrocardiogram. The patient also had a tetanus vaccine. Approximately 5 minutes after administration the patient became pale and diaphoretic. The patient's ears were ringing and the patient had tunnel vision. The patient was presyncope and laid down. The patient was symptomatically improved within 15 to 20 minutes. In October 2007, the patient was presented for a second dose of GARDASIL. The next day she had similar symptoms and had to lay down. With this episode however, the patient was symptomatic for more than 5 hours. The patient was admitted for overnight observation on 18-OCT-2007 following repeated episodes of lightheadedness, tunnel vision and nausea. The patient was taken to emergency room where she was shown to have orthostatic blood pressure changes and received IV fluid resuscitation and improvement in her symptomatology. The patient was hospitalized overnight on telemetry monitoring with no abnormalities identified. The patient's initial ECG was on 18-OCT-2007 and demonstrated sinus arrhythmia with a QTc interval = 450ms. An electrocardiogram was performed on 18-OCT-2007 at 20:23:41 which showed sinus rhythm with sinus arrhythmia and significant QT interval prolongation with a corrected QT interval of 471 ms. On 18-OCT-2007 the patient had several tests performed. The serum blood urea nitrogen test was 8 mg/dL (low), serum glucose test was 102 mg/dL (high), the blood band neutrophil count was 2 % (low), blood segmented neutrophil count was 79% (high), blood lymphocyte count was 17% (low) and the serum potassium test was 3.4 mmol/L (low). The patient's symptoms gradually improved, and she was discharged from the emergency room. The patient returned the next day for an electrocardiogram (19-OCT-2007 09:44:03) which showed sinus rhythm with sinus arrhythmia and normal corrected QT interval of 416ms. An echocardiogram was performed which was interpreted as being normal. The patient returned on 26-OCT-2007 for performance of an electrocardiogram at 14:21:14 which showed sinus rhythm with sinus arrhythmia and borderline corrected QT interval of 445ms. A graded exercise test was performed on 26-OCT-2007 and showed a normal treadmill time, normal systolic blood pressure response, normal maximal oxygen consumption and normal heart rate and rhythm response. Of note her QT interval was normal before, during and after exercise. The patient was not frankly syncopal during either episode. The patient has never had syncope or presyncope prior to the first episode or subsequent to the second. The patient's past medical history was remarkable for the diagnosis of VON WILLEBRAND syndrome. The diagnosis was made when she had recurrent bloody noses and a significant bleed tonsillectomy. Her family history is remarkable for her mother carrying the diagnosis of neurocardiogenic syncope. There is no family history of anyone else with syncope or unexplained sudden death. On 13-NOV-2007 a physical examination was performed the patient was a healthy appearing young lady. Her blood pressure was 96/62 taken in the right arm in the sitting position with a small adult cuff. The patient's chest is clear to auscultation and her heart rhythm is regular. The patient's first and second heart sounds are both normal and there are no murmurs, rubs, clicks or gallops. The patient's precordial activity was normal to palpation and her abdomen is soft with the liver being palpable at the right costal margin. The patient's extremities show normal symmetric pulses without brahiofemoral delay. The patient's electrocardiogram demonstrates sinus rhythm with sinus arrhythmia and is within normal limits for her age. The physician's impression had two episodes of presyncope following administration of HPV vaccine. The first episode was shortly following administration of the vaccine and resolved quickly and certainly would not have raised any suspicion as being anything but neurally mediated hypotension secondary to medical intervention. The second episode is more concerning. This episode occurred the day following administration of the vaccine and the symptoms were quite prolonged. Certainly her symptoms at that time would seem to be consistent with hypotension rather than arrhythmia, but her electrocardiogram did demonstrate QT interval prolongation at that time as well. The patient's subsequent  electrocardiograms and her graded exercise test were normal. The physician does not think the patient has a congenital prolonged QT syndrome. The patient is due for a third dose of the HPV vaccine in February 2008. The physician feels he would be concerned about administering a third dose and think that the risk/benefit of this would be seriously considered. If administered the physician recommends that an electrocardiogram be performed prior to, immediately following the administration of the vaccine and the next day as well. Consideration might even be given cardiac monitoring around the time of administration. If given, the physician suggests that the next dose of the vaccine be administered on a day when she does not have to go to school that day or the next. The physician is not certain as to whether the QT interval prolongation was related to the vaccine or not and cannot definitely tie the vaccine to the hypotensive episodes either. Based on the patient's evaluation to date from another physician, the physician does not believe that the patient has congenital long QT syndrome. No further testing is indicated at this time and is allowed to resume full activity without limitations. The mother and patient understand the importance of regular fluid and salt in her diet as well as appropriate intake at meals to prevent recurrent pre-syncope symptoms. At this point, no routine cardiology follow-up has been recommended. Additional information is not expected. Medical records are available upon request.