Age: 11.0
Sex: M
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Electrocardiogram QT prolonged, Electrocardiogram abnormal, Eye movement disorder, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a health professional refers to a 11 year old male patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 21-JUL-2014, the patient was vaccinated with a first dose of GARDASIL (lot # J009243, expiration date 23-APR-2016), 0.5 ml, intramuscular along with MENVEO, Tdap and hepatitis A vaccine, inactivated (manufacturer unknown). On 21-JUL-2014, immediately after the GARDASIL was administered, the patient's head rolled back and his eyes rolled back in his head. It was reported that the patient experienced a "vasovagal event". The patient was sitting during the injection and did not have any injury. The patient "came back to" shortly after and reported feeling lethargic. No treatment was given. No lab diagnostic studies were performed. On 21-JUL-2014, the patient recovered from the events. Follow up information has been received from a physician on 11-SEP-2014 via medical record, concerning the 11 year old male patient with no known allergies or birth defects. Surgical history included tonsillectomy and adenoidectomy on unspecified dates (also reported as there was no pertinent past medical history). The patient was single, did not smoke, did not use smokeless tobacco, alcohol or drugs, and was not sexually active. On 21-JUL-2014 at 11:30 in the morning, the patient was vaccinated with his first dose of GARDASIL (lot # J009243, expiration date 23-APR-2016, Vaccine Information Statements (VIS) revision date on 17-MAY-2013), 0.5 ml, intramuscular in the right thigh. On 21-JUL-2014 at 11:30 in the morning, the patient was also vaccinated with the first doses of HAVRIX (lot # 4H9R4; VIS revision date on 25-OCT-2011), intramuscular in the left thigh, MENVEO (lot # A13054; VIS revision date on 14-OCT-2011), intramuscular in the left thigh, and BOOSTRIX (lot # 7734Y; VIS revision date on 09-MAY-2013), intramuscular in the right thigh. On 21-JUL-2014, the patient became very lethargic, lightheaded, and then fainted. It was reported that the patient was very anxious prior to receiving the vaccines. The patient was transported to emergency room for further monitoring. The following additional information was received from medical record on 21-JUL-2014: The Chief Complaint was that the patient presented with Loss of Consciousness, syncopal episode after receiving vaccines at doctor's office on 21-JUL-2014. History of Present Illness (HPI): The patient presented after a passing out spell. The patient received a vaccine at his pediatrician's office and then passed out. The patient was sent to the Emergency Room for further evaluation. Patient denied any pain complaints. The patient had reportedly been doing well that morning according to mother. There were no discharge medications for this patient. Review of Systems (21-JUL-2014): Constitutional: No reported mental status changes. Gastrointestinal (GI): No noted abdominal tenderness. Lymphatic: No reported swollen glands. Physical exam (21-JUL-2014): Vital Signs: Blood pressure (BP) 80/46; Pulse 62; Temperature ("Src") 98 degrees F (36.7 degrees C) (Oral); Resp 32; Weight (wt) 32 kg (70 lb 8.8 oz); Oxygen saturation (SpO2) 99%. Constitutional: Alert, good eye contact, non-ill appearing. Head, Eyes, Ears, Nose and Throat (HEENT): Normocephalic, atraumatic, bilateral external ears normal, tympanic membranes clear bilaterally; moist mucous membranes. Eyes: Conjunctiva normal. Neck: Normal range of motion, no tenderness, supple, no nuchal rigidity, no meningeal signs, no stridor. Lymphatic: No cervical lymphadenopathy noted. Cardiovascular: normal rhythm. Thorax and Lungs: Normal breath sounds, no respiratory distress, no wheezing, no retractions. Skin: Warm, no petechiae. Gastrointestinal: Bowel sounds normal, soft, no tenderness, no masses. Extremities: Intact distal pulses, no edema, no cyanosis. Musculoskeletal: Good range of motion in all major joints. No tenderness to palpation or major deformities noted. Neurologic: Alert and interactive, normal motor function, no focal deficits noted. Electrocardiogram (EKG) (21-JUL-2014): Ventilation rate: 55 BPM; PR interval: 146 ms; QRS duration 90 ms; QT/QTc duration 493/470 ms; P-R-T axes 64-70-40. Sinus bradycardia. Borderline prolonged QT routine pediatric cardiology follow up suggested. No previous ECGs available. EKG Interpretation: Rhythm: sinus; Rate: 55; Axis: Normal; Ectopy: none; ST Segments: no significant elevation. Clinical Impression: sinus rhythm without an ST segment elevation to suggest an acute myocardial infarction. Emergency Department (ED) course and Medical decision making: Pertinent and Imaging studies reviewed. The nursing records and vitals were reviewed. The patient presented with syncope. Many causes of the patient's syncope were considered, including, but not limited to, (1) dehydration (2) cardiac arrythmia (3) anemia and (4) vasovagal reaction. The physician suspected that the patient had a vasovagal reaction. On repeat exam, the patient was ambulating and smiling and was not ill-appearing. The patient's family was instructed to return immediately to the Emergency Department with any worsening symptoms or any other concerns. The family was told to follow-up with a Pediatrician, the patient had been instructed to follow up physician in 1 week. The following vitals were reviewed on 21-JUL-2014: 09:39. Blood pressure: 105/63 mmHg; Pulse 59; Respiration 20; SpO2 100%; Temperature 98 degrees F (36.7 degrees C); Weight 32 Kg (70 lb 8.8 oz). 10:15. Blood pressure: 109/58 mmHg; Pulse 60; Respiration 15; SpO2 100%. 11:10. Blood pressure: 90/52 mmHg; Pulse 62; Respiration 25; SpO2 99%. 12:09. Blood pressure: 80/46 mmHg; Pulse 62; Respiration 32; SpO2 99%. The final impression was syncope. The diagnosis also included vasovagal syncope. On 21-JUL-2014, the patient recovered from the reported adverse events. The causality between the above mentioned events and GARDASIL was not provided. Upon internal review, the event "Chief complaint was loss of consciousness / passing out spell" was considered as medically significant. All available medical records will be provided upon request. Additional information is not expected since all follow ups requested to complete the case were received.