Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute respiratory failure, Alanine aminotransferase increased, Anaemia, Antineutrophil cytoplasmic antibody positive, Apheresis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with past medical history of asthma, heart murmur and anaemia, treated with GARDASIL (lot number, dose, route and injection site were not reported) on 30-JAN-2012. On 05-MAR-2012 the patient experienced joint pain that progressed over the next couple of weeks to anemia, purpuric rash, vasculitis, pulmonary hemorrhage, respiratory failure. The following information was obtained through follow-up and/or provided by the government. 19-JUN-2012. Hospital records date 28-MAR-2012 to 29-MAR-2012. Diagnosis and surgical: erythema multiforme; anaemia. Critical conditions: runny nose; loose productive cough; Headache; dizziness; muscle aches; nausea and vomiting; arthralgia; rash to feet. Physical examination: perioral vesicular lesions; nonblanching erythematous papulomacular lesions to ankles and hands. Discharged in stable condition to follow up with the primary care physician. Repeat admission from 31-MAR-2012 to 03-APR-2012. Diagnosis: Henoch-Schonlein purpura nd normocytic anaemia of unclear aetiology. Critical condition: worsening purpura; arthralgias; targetoid lesions to sales, feet, legs, palms; myalgias; petechiae; lightheadedness; headache. Recently diagnosed and hospitalized for erythema multiforme secondary to mycoplasma infection. Physical examination: petechiae on feet or ankles, behind knees, perineusm; marked skin pallor. Hospital course characterized by PRBC transfusion and continued leg pain. Discharged in improved condition to follow up primary care physician and specialists. Repeat admission 20-APR-2012 to 05-MAY-2012. Diagnosis: granulomatosis C polyangiitis (aka Wegeners) and apheresis; pulmonary haemorrhage and VDRF; R pneumothorax CT; anaemia. Critical condition: haemoptysis. Hospital course characterized by acute respiratory failure and intubation c mechanical ventilation; PRBC transfusion; apheresis; Cytoxan rx and tachycardia. Discharged in stable condition to follow-up with primary care physician and specialist. The listing indicated that one or more of the events required hospitalization, was considered to be disabling; was considered to be immediately life-threatening and required emergency room visit. The patient did not take other medications. 19-JUN-2012. Hospital records included Gamma-glutamyltransferase (GGT) 46 u/l (High). Antineutrophil cytoplasmic antibody (ANCA) Positive (High). On 19-JUN-2012, laboratories or diagnostics: Haemoglobin (Hgb) 6.4 g/dl (low), Haematocrit (hct) 21% (low), Platelet count (pit) 502 K/mm3 (High), White blood cell count (WBC) 22.3 Klmm3 (High), Neutrophil count (neuts) 83% (High), Lymphocyte count (lymphs) 12% (low), Reticulocyte count (retic) 21% (High). Red blood cell sedimentation rate (ESR) 35 mm/hr (High). Blood sodium (Na) 134 mmol/L (low), Blood calcium (Ca) 7.9 mg/dl (low), Troponin T (T prot) 4.5 g/dl (low), Blood albumin (albumin) 2.1 g/dl (low), Aspartate aminotransferase (AST) 64 u/l (High), Alanine aminotransferase (ALT) 44 u/l (High), Blood lactate dehydrogenase (LDH) 831 u/l (High), Blood thyroid stimulating hormone (TSH) 0.49 u/ml (low). International normalised ratio (INR) 1.26 (High). Red blood cells urine (Ur RBC):10-25/hpf (High). Epstein-Barr virus antibody (EBV IgG). 1:80 (High). Skin biopsy: leukocytoclastic vasculitis, involving superficial and deep dermal blood vessels; positive IgA, IgG, IgM, C3 and fibrinogen immunofluorescence labeling of dermal blood vessels. Chest X-ray (CXR): b. No further information is available. The original reporting source was not provided. The VAERS ID # is 445825-1(S).