Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride normal, Blood creatinine normal
Clinical narrative: Abdominal pain; Blanching of skin; Conjunctivitis; Cough; Edema hands; Edematous feet; Erythematous rash; Joint pain; Maculopapular rash; Mucosal dryness; Oral intake reduced; Painful rash; Pharyngeal erythema; Pruritic rash; Serum sickness-like reaction; Throat pain; Neutrophil count increased; Osmolality decreased; Protein total decreased; C-reactive protein increased; Haematocrit normal; Haemoglobin normal; Red blood cell sedimentation rate normal; Platelet count normal; White blood cell count increased; Pyrexia; Rash; Respiratory viral panel; Streptococcus test negative; Throat tightness; Viral test negative; Lymphocyte percentage decreased; Monocyte percentage decreased; Mononucleosis heterophile test negative; Mycoplasma test negative; Neutrophil percentage increased; Carbon dioxide normal; Culture throat negative; Dyspnoea; Glycosylated haemoglobin decreased; ALANINE  AMINOTRANSFERASE NORMAL; Aspartate aminotransferase normal; Blood alkaline phosphatase normal; Blood bilirubin normal; Blood calcium decreased; Blood chloride normal; Blood creatinine normal; Blood culture negative; Blood glucose normal; Blood potassium normal; Blood sodium normal; Blood urea normal; This report was identified from a line listing obtained on request by the Company from the FDA (agency# 751086) under the Freedom of Information Act, referring to an 11 year old female patient. Information about the patient's medical history, current illness was unknown.     On 23-MAY-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose 2, in left arm, lot # N022728 with expiration date auto-populated as 31-MAY-2020; strength and dose were not reported) intramuscular for prophylaxis.  Other suspect therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (dose 2, in right arm, lot # 7Y29Z; strength and dose were not reported) and meningococcal acyw conj vaccine (crm197) (MENVEO) (dose 2, in left arm, lot # M17023; strength and dose were not reported).      On 24-MAY-2018, the patient experienced rash, sensation of throat tightness/difficulty breathing and fever. Then she was treated with diphenhydramine hydrochloride (BENADRYL), hydroxyzine, prednisone, intravenous fluids, topical steroids.  The tests on 24-MAY-2018 included: alanine aminotransferase 8(unit not provided) (normal), aspartate aminotransferase 13(unit not provided) (normal), viral test negative, streptococcus test negative, Viral respiratory panel negative, neutrophil percentage 93% (increased), mycoplasma test negative, mononucleosis heterophile test negative, monocyte percentage 1% (decreased), lymphocyte percentage 6% (decreased), glycosylated haemoglobin 3.7(unit not provided) (decreased), dyspnoea, culture throat negative, carbon dioxide 24(unit not provided) (normal), blood urea 11(unit not provided) (normal), blood sodium 136 (unit not provided) (normal), blood potassium 3.8 (unit not provided) (normal), blood glucose 133(unit not provided) (normal), blood culture negative, blood creatinine 0.59(unit not provided)normal, blood chloride 103 (unit not provided) (normal), blood calcium  8.1(unit not provided) (decreased), blood bilirubin  0.7(unit not provided) (normal), blood alkaline phosphatase  113(unit not provided) (normal).  The Complete Blood Count (CBC) tests included: white blood cell count (27-MAY-2018): 17.3(unit not provided) (increased); Hemoglobin (27-MAY-2018): 14.9(unit not provided) (normal); Hematocrit (27-MAY-2018): 43.7(unit not provided) (normal); Platelet count (27-MAY-2018): 375.4(unit not provided) (normal);  Other tests included Sedimentation Rate (27-MAY-2018): 2 (unit not provided), Sedimentation Rate (28-MAY-2018): 10 (unit not provided) (normal); C-reactive protein (27-MAY-2018): 50.7 (unit not provided), C-reactive protein (28-MAY-2018): 101.2 (unit not provided)(increased).  The patient was hospitalized due to events. At the reporting time, the outcome of the events was not recovered. The causality between the vaccines and the events was not reported.  Follow-up information has been received from a physician on 29-OCT-2019. According to the nurse follow up on 04-JUN-2018, the hospital records of discharge (D/c) indicated that the patient was diagnosed as serum sickness-like reaction. The patient developed rash. Presented to outside emergency room (ER). Discharged with hydrocortisone cream and oral steroids. Rash worsened, the patient returned to ER. Treated with "IVF" and diphenhydramine (BENADRYL) with improvement of rash, the patient was recommended stopping steroids and she was discharged home. The patient developed shortness of breath (SOB), cough, diffuse maculopapular painful rash, fever to 105 Fahrenheit, joint pain. On an unknown date the patient presented to this ER. Physical Examination (PE): tacky mucous membranes, conjunctivitis, difficulty taking full deep breath, diffuse maculopapular pruritic blanching erythematous rash to face/torso/back/arm/legs/palms/soles with distinct borders. The patient was admitted and treated with "IVF", prednisone, diphenhydramine (BENADRYL). The patient had diffused abdominal pain, throat pain, not tolerating oral (PO). hands and feet mildly edematous with erythema, mild posterior pharyngeal erythema, possible white strawberry tongue consulted with the Infectious Disease (ID) doctor, diphenhydramine (BENADRYL) was changed to hydroxyzine (VISTARIL), which was more effective. Tolerating oral fluids. The medical prescriptions included prednisone, hydrocortisone cream, hydroxyzine (VISTARIL), the patient was discharged home in improved condition with the medical prescriptions, lab/ diagnostic records included: White blood cell count 17.3 K/mm3 (H), lymphocyte percentage 6% (L), monocyte percentage 1% (L), neutrophil percentage 93% and 16.1 K/mm3 (H). albumin 3.7 g/dL (N), protein 6.1 g/dL (L). C-reactive protein test 50.7 (H). Ca 8.1 mg/dL (L), osmolality 273 mOsm/kg (L). It was also reported that the patient went to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care and hospitalized for 2 days, due to events. At the reporting time, the outcome of the events was not recovered. The causality between the vaccines and the events was not reported.  Follow up information was received via telephone call stating that as of 17-JAN-2020, a telephone call was placed to the reporting physician who at the time, was not available.