Age: 19.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Confusional state, Disorientation, Head injury, Loss of consciousness
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 19 year old non pregnant female patient. No pertinent medical history, drug reactions or allergies were reported. On 19-JUL-2016 the patient was vaccinated with GARDASIL 9 intramuscularly (site of administration, lot #, expiry date and dose were not reported). Patient's concomitant therapies were reported as none. On 19-JUL-2016, after receiving GARDASIL 9 the patient passed out and hit her head on the floor. The patient was unable to recall the event of passing out. She woke up confused and not oriented. The patient was treated (unspecified treatment) in the doctor's office and then transferred to an unspecified emergency room. No lab diagnostic studies were performed. The reporter was unsure if the patient was admitted to the hospital and none lab diagnostics studies were performed. At reporting time the outcome regarding of the events was recovering. Follow up information has been received on 23-SEP-2016 and 26-SEP-2016 from a physician and other health care professional via a questionnaire and medical records. According to the questionnaire, the 19 year old female patient was vaccinated with GARDASIL 9 Lot # M007764 intramuscularly on 19-JUL-2016. On 19-JUL-2016 at 2:30 pm the patient experienced syncope, nausea, vomiting, confusion/disorientation, and a head injury suspected to be a concussion. The patient's head hit the ground. Her symptoms worsened with standing and it was unknown if her heart rate increased when moving from standing to supine position. The patient had no known allergies and no illness at the time of vaccination. The patient was taken to the emergency room by her mother. A CT scan was performed (results not reported). A Tilt table test was not performed. The outcome of the adverse events was reported as unknown and causality was not reported. According to medical records, the patient was seen on 19-JUL-2016 by her physician for a routine well medical exam. Her current conditions included constipation, nonsmoker and unspecified alcohol use. Her medical history included an acute upper respiratory infection which resolved on 20-NOV-2013. Concomitant medications included iron. Family history included heart disease (mother), stroke (maternal grandmother), and mental illness (mother, sister, maternal grandmother.) The patient reported that she felt well and was without medical concern. The patient's blood pressure was 120/80. The patient was vaccinated with GARDASIL 9 (Lot # M007764), 0.5 ml, intramuscularly in her right deltoid. Following administration of the vaccine the patient escorted herself out of the nursing area. The physician then heard a yell from the front office that the patient had passed out. The office staff witnessed the patient fall straight back and land directly on her head. The patient was diaphoretic, responsive but diminished and had a strong pulse. The patient lay on the ground for some time and her responsiveness increased. She was transferred to a wheelchair and brought to another exam room. At that time she was confused and disoriented. Her mother was called and arrived. The patient was monitored for 30 plus minutes. She continued to be disoriented to place and year. She had no recollection of her physician visit, receiving the injection or trying to leave the building. The patient had landed on her head sustaining a large contusion. Upon exam, her pupils were reactive to light; she was moving all extremities and had no dysarthria. Toward the end of the patient's observation period the patient had a new onset of nausea and vomiting. At that time the patient was transported to the emergency room for further observation. The patient presented to the emergency room with a head injury and syncopal episode. After receiving a human papillomavirus vaccination the patient fell backwards and struck her head with a brief loss of consciousness. The patient was confused with repetitive questioning. She had a mild headache, nausea and was significantly confused. The patient was noted to have passed out previously, although only one time with something similar when she was having something done to her eye. The patient denied ever having exertional syncope. Her neurological exam showed her to be disoriented to place and time with only recent memory affected. Her cranial nerves II through XII, sensation, motor function and cerebellar functions were intact. Labs included: white blood cells 15.7, neutrophil % 85.5, neutrophils absolute count 13.39 and lymphocytes % 10.3. Her labs showed leukocytosis which was likely an acute stress reaction as the patient did not have any infectious symptoms. The patient had vomited in the car and away from the physician's office. A head CT showed no acute intracranial process and a small posterior right scalp hematoma. Neurology was consulted who felt the case should be followed up with family medicine. The patient's final diagnoses were syncope and concussion with loss of consciousness of 30 minutes or less. The patient was discharged to home. She was to follow up with her family physician in a week or so and she was given a note for 2 days off of work. On 25-JUL-2016, the patient was seen by her physician in follow up of her concussion. Six days prior the patient was given the first dose of GARDASIL 9 and subsequently passed out with vasovagal in the waiting room. She was taken to the emergency room after disorientation and confusion after about 90 minutes of observation. Her head CT was negative. The patient stated that her headache had resolved the following morning. She did not have any significant fatigue. The patient reported that she feels back to her baseline and has been for the last 36 hours. Upon neurological exam, the patient was oriented to person, place and time. She had normal reflexes, coordination, muscle tone and had no nerve deficit. The physician assessed the patient with a resolved concussion and she was able to resume basic activities without restrictions. Upon internal review loss of consciousness was considered medically significant. All available medical records will be provided upon request. Additional information has been requested.