Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Smear site unspecified normal, Specific gravity urine normal, Streptococcus test negative, Syncope, Urine ketone body present
Clinical narrative: This is a spontaneous report from a contactable nurse manager communicated to a Pfizer sales representative. Additional information received from a contactable physician. A 16-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA (Batch/lot M77282 and expiration date: 30Jun2017) intramuscular in left arm at 0.5 ml, single on 26Aug2016 at 12:50 as routine vaccination, third dose of GARDASIL 9 (Manufacturer: Merck; Lot#: M013636) intramuscular in left arm at 1 DF single on 26Aug2016  as preventative childhood diseases and second dose of MENACTRA (Manufacturer: Sanofi Pasteur; Lot#: U5392AA) intramuscular in right arm at 1 DF single on 26Aug2016, as preventative childhood diseases. The patient medical history included anemia from 2012 to 2014, ongoing dizzy spells, and fever (unspecified cause). Concomitant medications were not reported.  Illness at time of vaccination included diarrhea for 2 weeks, which  resolved few days prior to visit. Previously, on an unknown date, she took the first dose of MENACTRA and two doses of GARDASIL 9. The patient experienced syncope (was fainting), seizure, headache and weakness on 27Aug2016, due to which she was hospitalized for 2 days. The did not feel well after she fainted in Aug2016. Blood culture and CSF culture were negative on an unknown date. X-ray chest done on 27Aug2016 showed heart normal in size, no pneumonia, no pleural fluid. CT brain without contrast on 27Aug2016 was normal, no hemorrhage, no infarct and ventricular system, sulci and visualized sinuses are unremarkable. Lab tests done on 27Aug2016 at 16:12 showed: CSF was Colorless and clear; Glucose CSF 60 mg/dL (Ref range: 40-70); Protein CSF, 21.0 mg/dl (Ref range: 15.0-45.0); RBC CSF, 1/mm3; WBC CSF, 0/mm3.Lab tests done on 27Aug2016 at 16:16 showed: Lyme IgG in CSF and Lyme IgM In CSF Negative; P93 Ab IgG CSF, P66Ab IgG CSF, P58 Ab IgG CSF, P45 Ab IgG CSF, P41 Ab IgG CSF, P39 Ab IgG CSF, P30 Ab IgG CSF, P18 Ab IgG CSF, P28 Ab IgG CSF, P23 Ab IgG CSF, P41 Ab IgM CSF, P39 Ab IgM CSF, P23 Ab IgM CSF were absent. Cerebrospinal fluid culture showed no growth on 01Sep2016 (day 4), on31Aug2016 (day 3), on30Aug2016 (day2) and on 29Aug2016 (day 1). Blood cultures showed no growth on 02Sep2016 (at 5 days), No growth on 30Aug2016 (at 3 days), No growth on 29Aug2016 (at 2 days), No growth on 28Aug2016 (at 1 days). Throat screen for Streptococcus group A on 27Aug2016 was negative. Urine culture on 27Aug2016 showed no growth. Urinalysis on 27Aug2016: urine was yellow and clear and  urine pH was 6.0 (Ref range: 4.8-7.5), urine specific gravity, 1.010 (Ref range: 1.016-1.022); urine glucose was negative; urine Ketones 15 mg/dl, urine bilirubin was negative, urine urobilinogen, 0.2U/dl, urine Blood was moderate, urine Protein was Negative, urine Nitrite was Negative, urine Leukocyte esterase was  Negative. On 27Aug2016 at 14:08 Mono screen was negative; Lactic acid 1.1 mmol/L (Ref range: 0.4-2.0); Glucose 90 mg/dl (Ref range: 74-106); BUN 6 mg/dl (Ref range: 7-18); Creatinine 0.6 mg/dl (Ref range: 0.6-1.3); Sodium 138 mmol/L (Ref range: 136-145); Potassium 3.6 mmol/L (Ref range: 3.6-5.2); CO2 20 mmol/L (Ref range: 21-32);  Chloride 107 mmol/L (Ref range: 100-108); Anion gap (AGAP) 11 mEq/L (Ref range: 5-15); Calcium 8.3 mg/dl (Ref range: 8.5-10.1); Total protein 7.4mg/dl (Ref range: 6.4-8.2); Albumin 3.9 gm/dl (Ref range: 3.4-5.0); Bilirubin total 0.7 mg/dl (Ref range: 0.2-1.0); Alanine aminotransferase (ALT) 20 unit/L (Ref range: 12-78); Aspartate aminotransferase (AST) 13  unit/L (Ref range: 15-37); alkaline phosphatase 75 unit/L (Ref range: 50-130); Beta Human chorionic gonadotropin (HCG) <1 mIU/ml (Ref range: 1-3); Total creatine phosphokinase  80 unit/L (Ref range: 26-192); C-reactive protein 23-600 mg/L (Ref range: <=3.000; Result obtained with auto dilution); White blood cell count  8.3 X10 3/mcL (Ref range: 3.7-11.1); Red blood cell count 4.11 X10 6/mcL (Ref range: 3.70-5.30); hemoglobin 12.3 gm/dL (Ref range: 11.2-15.4); haematocrit  36.8 % (Ref range: 34.0-47.0); Mean cell volume  (MCV) 90 fL (Ref range: 81-98); Mean cell haemoglobin (MCH) 30 pg (Ref range: 27-33); Mean cell haemoglobin concentration (MCHC) 33.4 gm/dL (Ref range: 31.0-35.0); Red cell distribution width (RDW) 12.9  % (Ref range: 11.6-15.2); Platelet count 174 x10 3/mcL (Ref range: 150-400); Mean platelet volume (MPV) 11.4  fL (Ref range: 8.8-12.0); Neutrophil percentage 77.8  % (Ref range: 47.0-78.0); Lymphocyte percentage  10.6 % (Ref range: 11.0-41.0); Monocyte percentage 11.1 % (ref range: 5.0-12.0); Eosinophil percentage 0.1 % (Ref range: 0.0-6.0); Basophil percentage 0.2 % (Ref range: 0.0-1.0); Neutrophil 6.4 x10 3/mcL(Ref range: 1.5-7.9); Lymphocyte 0.9  x10 3/mcL (Ref range: 0.8-3.0); Monocyte 0.9  x10 3/mcL (Ref range: 0.2-1.0); Eosinophil 0.0 x10 3/mcL (Ref range: 0.0-0.4); Basophil 0.0  x10 3/mcL (Ref range: 0.0-0.1). The outcome of the events was recovering. Follow-up (20Sep2016): New information received from a contactable physician includes: vaccination details, products updated, seriousness, hospitalization details, events updated, lab tests, vaccination history, medical history. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.