Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram QT prolonged, Electrocardiogram abnormal, Full blood count normal, Gait disturbance, Lethargy
Clinical narrative: shuffling feet and inability to walk independently; Experienced subsequent effects of lethargy; pallor; shuffling feet; dizziness; nausea; ekg (showed sinus rhythm, premature atrial complexes, borderline prolonged QT, possible left ventricular hyperthrophy); ekg (showed sinus rhythm, premature atrial complexes, borderline prolonged QT, possible left ventricular hyperthrophy); ekg (showed sinus rhythm, premature atrial complexes, borderline prolonged QT, possible left ventricular hyperthrophy); This spontaneous information has been received from a nurse prescriber via company representative, concerning a 12-years old non-pregnant female patient. The patient did not have any pertinent medical history, concurrent conditions, concomitant therapies or any known drug allergy.  On 21-AUG-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscularly (IM), for prophylaxis (reported as indicated age range for first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine) (lot number and expiration date reported as: U6321AA and 26-MAR-2022) (strength and anatomical location were not reported).  On the same date, the patient experienced effects of lethargy, pallor, dizziness, nausea, shuffling feet (gait disturbance) and inability to walk independently (gait inability). The patient went with her parent to the emergency department  and was treated with ondansetron (ZOFRAN), monitored and then released. On an unknown date in August 2020, the patient returned with her parent to the emergency department for a second time and was admitted to the hospital for 2 days where she received intravenous (IV) fluids, but still was unable to walk independently.  On an unknown date in August 2020, while she was hospitalized, the following test were performed: chest X-ray was normal, computerized tomography (CT) of head without contrast was normal, electrocardiogram showed sinus rhythm, premature atrial complexes (supraventricular extrasystoles), borderline prolonged QT and possible left ventricular hypertrophy, drug abuse panel and COVID-19 test were negative, C-reactive protein (CRP), complete blood count (CBC), erythrocyte sedimentation rate (ESR) and comprehensive metabolic panel (CMP) did not showed significant findings. It was reported that the cardiac test and electrocardiogram would be repeated because the patient had no prior history. At the time of this report the outcome of gait inability, nausea, dizziness, gait disturbance, pallor and lethargy was reported as not recovered. The outcome of electrocardiogram QT prolonged, supraventricular extrasystoles and left ventricular hypertrophy was not reported.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned adverse events was not provided.  Upon internal review, electrocardiogram QT prolonged was determined to be a medically significant event. Additionally, gait disturbance and gait inability were considered as disabling events.