Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Headache, Micturition disorder, Muscle rigidity, Poor quality sleep
Clinical narrative: Confused; headache; poor sleep; Rigidity; tongue biting; tongue pain; Treatment noncompliance; Calcium blood decreased; Chloride increased; lymphocyte percentage decreased; neutrophil percentage increased; Osmolality decreased; urine drug screen positive; Computerised tomogram normal; Electroencephalogram normal; Nuclear magnetic resonance normal; Frequency of micturition; tension headache; Vitamin D deficiency; seizure; This report was identified from a line listing obtained on request by the Company from the FDA under the Act, referring a 25-year-old female patient. There was no information about the patient's concurrent conditions or medication, drug reactions/allergies, and pertinent medical history medication.Concomitant medications includes Vitamin D , tetracycline (Bio-x4) and dietary supplement.  On 01-DEC-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) (route of administration, lot number, and expiration date were not reported) for prophylaxis at private Doctor's Office/Hospital.   On 02-JAN-2018, after both vaccine doses, the patient had a seizure. Seizures were occurring exactly around a month time. On an unknown date, in January 2018, the patient was hospitalized. Between 03-JAN-2018 and 05-JAN-2018 the patient was tested for any epilepsy symptoms, with Computerised tomogram (CAT), Electroencephalogram (EEG) and Nuclear magnetic resonance imaging (MRI), and all gave normal/negative response (coded as adverse events by the agency). The patient was discharged for the first time after all tests. After the second time of seizure, patient was put on anti-seizure medication.  The outcome of the adverse events was reported as not recovered and the causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and aforementioned adverse events was not provided.   The agency considered the events to be serious for the following reason: hospitalization.  Follow-up information has been received from the FDA under the Act on 29-OCT-2019.   On 02-JAN-2019, the patient experienced frequency of micturition (pollakiuria), tension headache and vitamin D deficiency.   On 04-MAY-2018, the patient performed some laboratory tests that showed the following results: a blood calcium of 8.4 mg/dl, an osmolality of 276 m0sm/Kg,  a white blood cell count (WBC) of 8.1 K/uL, a lymphocyte percentage of 12.5 percent (%),  a neutrophil count of 83%, a blood calcium of 8.7 mg/dl, a blood chloride of 107 mmol/L, and an osmolality of 281 m0sm/Kg. Additionally, she underwent an urine drug screen and it result was positive.   On the same date, the patient was confused (confusional state), she experienced headache, poor sleep (poor quality sleep), rigidity (muscle rigidity), tongue biting, tongue pain (glossodynia), treatment noncompliance, calcium blood decreased, chloride increased (blood chloride increased), lymphocyte percentage decreased, neutrophil percentage increased, osmolality decreased (blood osmolality decreased), and urine drug screen positive.   It was also reported that all aforementioned events caused the patient's hospitalization.   At the time of reporting, the patient had not recovered from the events.   The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and aforementioned adverse events was not provided.  As of 17-JAN-2020, a phone call was placed to immunization coordinator and was answered by receptionist. The receptionist was unable to transfer any patient or contact information.