Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Throat irritation, Unresponsive to stimuli, Vision blurred
Clinical narrative: Sneezing; some scratchiness in her throat; cloudy vision; Dizziness/slightly dizzy; upper arm very red; does not react to having the arm pinched; Neurology consult; "stabbing" pain in center of chest and radiating through to the back.; Chest pain; chest very red; squeeze my finger with both hands. Did so with right hand but states she is trying with left hand and cannot.; left arm numbness/she cannot feel anything; Raises left shoulder but cannot bend left arm at wrist or elbow.; left arm pain; left arm pale; This report was identified from a line listing obtained on request by the Company from the FDA (Agency# 708369) under the Freedom of Information Act, referring to a 15 years old female patient. The patient's concurrent condition included rhinitis allergic, chronic rhinitis and vasomotor rhinitis. Other medications included ipratropium bromide (ATROVENT) as needed and polyethylene glycol 3350 (GLYCOLAX) as needed.  On 15-AUG-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose and strength were unknown; lot # N009801, expiration date 20-NOV-2019) intramuscularly in the left deltoid for prophylaxis.   Lot No. N009801 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 20-NOV-2019.  After the injection, the patient was asked to remain in room for 15 minutes. When the nurse returned to check the patient response to vaccine, the patient complained of "cloudy vision and dizziness". The nurse asked the patient to lie down and then asked physician to assess the patient. The physician noted regarding the assessment: Upon entering the room, she was sneezing numerous times and also complained of some scratchiness in her throat. This was similar to the reaction she had when she used hand sanitizer and other perfumed items in the past. The physician felt that perhaps the patient was actually having a reaction to hand sanitizer used in the office, so the physician gave the patient with diphenhydramine hydrochloride (BENADRYL) 25 mg (oral, 1 dose). Approximately 5 minutes later, the physician went to reassess the patient and the patient began complaining of chest pain. The patient complained of "stabbing" pain in center of chest and radiating through to the back. The chest pain was reproducible with palpation of the costochondral junction. The lungs were clear. The cardiovascular (CV) examination (regular rate and rhythm (RRR)) was without murmur. Oxygen saturation (Ox Sat was 99-100%) and the heart rate (HR) was 72 (unit unspecified).   The patient was provided reassurance, and left in a quiet room. The patient was put the cool washcloth on chest and reassessed shortly after, and the patient stated that she was feeling better. At the reporting time, the patient was still slightly dizzy but vision better (could identify number of fingers being held up. etc). The patient felt comfortable and was ready to go home. The physician decided to have a nurse escort her out of office in wheelchair to ensure she continued to do well with standing and the patient got into car. The patient did well getting from bed to wheelchair and seemed more comfortable upon leaving office. The nurse returned to office to retrieve O2 saturation monitor and stated that the patient got into car and began complaining again of chest pain and left arm pain and numbness. The physician went to reassess in parking lot and the patient complained that she could not move her left arm. The patient's pulse was good but her left arm was pale and upper arm and chest were very red. There was no labored breathing. The lungs were clear to auscultation bilaterally (CTAB) and cardiovascular (CV) examination (regular rate and rhythm (RRR)) was without murmur. The patient's saturation (Sat) was 98%. The physician asked the patient to squeeze his finger with both hands. The patient did so with right hand but stated that she was trying with left hand and could not do it. The patient could raise her left shoulder but could not bend left arm at wrist or elbow. When the physician raised the arm at elbow and let go, the patient allowed it to simply "flop" into the car seat, and stated that she could not feel anything and did not react to having the arm pinched, etc. The physician decided to have the patient admitted for observation, and informed the nurse that the patient directed to go straight to peds floor and with doctor regarding observations in office and desire to admit overnight (hospitalized). The patient had neurology consult while inpatient on16-AUG-2017. The outcome of the events was reported as not resolved. The reporter did not give the causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Follow up information has been received from a health care professional on 15-APR-2019. The patient had no known allergies and other illness at the time of vaccination. The patient was not pregnant at the time of vaccination. The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at 15:16. The events occur ring after 15 minutes was reported as started at 15:31. The patient had physician office visit due to all events.  As of 02-JUL-2019, all telephone attempts to obtain follow-up information have been unsuccessful.