Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Haemoglobin normal, Hallucination, Immunoglobulin therapy, Intensive care, International normalised ratio increased
Clinical narrative: meningitis aseptic; Activated Partial Thromboplastin Time Shortened; Alanine Aminotransferase Normal; Aspartate Aminotransferase Normal; Blood Albumin Normal; Blood Bilirubin Normal; Blood Calcium Normal; Blood Chloride Normal; Blood Creatinine Normal; Blood Glucose Normal; Blood Magnesium Increased; Blood Phosphorus Decreased; Blood Potassium Normal; Blood Sodium Decreased; Blood Urea Normal; CSF Glucose Decreased; CSF Lactate Increased; CSF Lymphocyte Count Increased; CSF Monocyte Count Decreased; CSF Neutrophil Count; CSF Protein Increased; CSF Red Blood Cell Count Positive; CSF White Blood Cell Count Increased; Carbon Dioxide Normal; Gram Stain; HIV Test Negative; Haematocrit Normal; Haemoglobin Normal; International Normalised Ratio Increased; Protein Total Increased; Red Blood Cell Count Normal; Red Blood Cell Sedimentation Rate Normal; White Blood Cell Count Increased; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  This spontaneous report as received from a regulatory authority refers to a 11 year old female patient with headache attributed to allergic rhinosinusitis the day of vaccination. The patient's medical history included Arthrogyposis with b/1 hand deformities. On 23-MAR-2018 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (route, anatomical location, lot # and expiration date were not reported). On 23-MAR-2018, 1 day after onset of therapy the patient experienced symptoms of aseptic meningitis (meningitis aseptic), white blood cell count increased, red blood cell sedimentation rate normal, red blood cell count normal, protein total increased, international normalised ratio increased, haemoglobin normal, haematocrit normal, hiv test negative, gram stain, carbon dioxide normal, csf white blood cell count increased, csf red blood cell count positive, csf protein increased, csf neutrophil count, csf monocyte count decreased, csf lymphocyte count increased, csf lactate increased, csf glucose decreased, blood urea normal, blood sodium decreased, blood potassium normal, blood phosphorus decreased, blood magnesium increased, blood glucose normal, blood creatinine normal, blood chloride normal, blood calcium normal, blood bilirubin normal, blood albumin normal, aspartate aminotransferase normal, alanine aminotransferase normal and activated partial thromboplastin time shortened the evening of vaccination.  Lab Data Results: Labs taken on 27-MAR-2018 at 13:07 Sodium: 132(units not provided) Potassium: 4.2(units not provided) Chloride: 91(units not provided) Carbon Dioxide (CO2): 23(units not provided) BUN: 16(units not provided) Creatine: 0.6(units not provided) Glucose: 134(units not provided) Calcium: 9.0(units not provided) Magnesium: 2.2(units not provided) Phosphorus: 4.1(units not provided) White Blood Cell Count (WBC): 10.3(units not provided) Red Blood Cell Count (RBC): 4.81(units not provided) Hemoglobin (HGB): 13.9(units not provided) Hematocrit (HCT): 40.3(units not provided) Total Protein (Total Pro): 8.8(units not provided) Aspartate Aminotransferase (ASTSGOT): 15(units not provided) Alanine Aminotransferase (ALTSGPT): 8(units not provided) Albumin: 4.5(units not provided) Total Bilirrubin (Bilirubin Tot): 0.6(units not provided) International Normalised Ratio (INR): 1.2 (units not provided) Activated Partial Thromboplastin Time (APTT): 25.6 (Low) (units not provided)  Labs taken on 27-MAR-2018 at 17:27 Cerebrospinal Fluid (CSF) Appearance: (reference range: none) (abnormal) Clear CSF Gram Stain: No Polys or No white blood cell counts Erythrocyte Sedimentation Rate (ESR): <1 (units not provided) Procl: 0.1 (units not provided) HIV: Negative result CSF Glucose: 49mg/dL (40-80mg/dL) CSF Protein: 147mg/dL (15-45mg/dL) High CSF Lactic Acid: 3.1mmol/L (0.0-2.2 mmol/L) High CSF Mono: 5% CSF RBC Count: 22/micro-l CSF WBC Count: 182 /micro-l CSF SEG Count: 4% CSF LYMPH count: 91%  The outcome of meningitis aseptic, white blood cell count increased, red blood cell sedimentation rate normal, red blood cell count normal, protein total increased, international normalised ratio increased, haemoglobin normal, haematocrit normal, hiv test negative, gram stain, carbon dioxide normal, csf white blood cell count increased, csf red blood cell count positive, csf protein increased, csf neutrophil count, csf monocyte count decreased, csf lymphocyte count increased, csf lactate increased, csf glucose decreased, blood urea normal, blood sodium decreased, blood potassium normal, blood phosphorus decreased, blood magnesium increased, blood glucose normal, blood creatinine normal, blood chloride normal, blood calcium normal, blood bilirubin normal, blood albumin normal, aspartate aminotransferase normal, alanine aminotransferase normal and activated partial thromboplastin time shortened was reported as not recovered/not resolved.  The causality assessement between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and aforementioned events was not reported.  Follow up received from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (707787) on 23-MAY-2019: The patient's was a African American or Black patient. The patient's concurrent conditions included congenital multiplex arthrogryposis and congenital hand malformation. The patient developed nasopharyngitis and malaise as the symptoms of headache and allergic rhinosinunsitis which the patient had at time of vaccination. The patient was 11 years at the time of vaccination. As per nurse follow-up on 19-APR-2019, the patient experienced neck stiffness, fever, fatigue, loss of appetite, vomiting and lethargy as the symptoms of post viral encephalomeningitis, due to enterovirus. The patient was admitted to PICU (Pediatric intensive care unit) and condition improved initially, but then complicated by hallucinations, confusion, salivary pooling, mental status deterioration and respiratory failure. The patient required intubation and received IVIG (intravenous immunoglobulin) with some improvement in consciousness, but developed dystonic posture, nystagmus and abnormal eye movement. Condition was still not back to baseline and patient was transferred to rehabilitation center. The patient underwent the following lab tests on 19-APR-2018: Sodium (blood sodium): 120 mmol/L (low), CSF WBC (Cerebrospinal fluid white blood cell count): 182/mm3 (high), CSF RBC (Cerebrospinal fluid red blood cell count positive): 22/mm3 (high), CSF protein (Cerebrospinal fluid protein): 147 mg/dL (high), CSF glucose (Cerebrospinal fluid glucose): 34 mg/dL (low), CSF LDH (CSF lactate dehydrogenase): 126 U/L (high), CSF Lactic Acid (Cerebrospinal fluid Lactic Acid): 3.1 mmol/L (high), VEEG (Video electroencephalogram) was abnormal, WBC (White blood cells) was 3.8-13.2 K/mm3, CXR (Chest X-ray) was abnormal, MRI brain (Magnetic resonance imaging) was abnormal. The patient was hospitalized for a total of 18 days.  Follow up information has been received on 18-JUL-2019. A phone call was placed to a nurse and was answered by unit clerk. The clerk was unfamiliar with the nurse and could not assist in obtaining any information. The case did not have a specific demographic for a patient. Additional information is not expected.