Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Urine analysis abnormal, Urine leukocyte esterase positive, Urticaria, Vascular device user, Weight decreased
Clinical narrative: Anaphylaxis; Angioneurotic edema; Anxiety; Asthma; Bizarre dreams; Bloating; central auditory processing disorder; Chronic cystitis; Chronic sinusitis; C:losed fracture of base of thumb (first) metacarpal; Cold urticaria; Constipation; Convergence insufficiency; Depression; Deviated nasal septum; Diarrhea; Dysautonomia; Dysgeusia; Eating disorder; Enterococcal urinary tract infection; Facial swelling; fatigue; Feeling hot; Flat foot; Foggy feeling in head; Food allergy; Gastrointestinal motility disorder; Gastroparesis; Hoarse voice; Hypermobility syndrome; hypertension; lgA deficiency; insomnia; intensive care; itchy throat; Leukocytosis; Lichen simplex chronicus; Lichenification; Lip swelling; Major depressive disorder, single episode in full remission; Neck swelling; Neuropathy; Orthostatic dizziness; Osteoporosis; Pain foot; Pain in thumb; Peanut allergy; Pelvic pain female; Psoriasis; Red face; Seasonal allergic rhinitis; Short of breath; Shortness of breath; Sicca syndrome; Sleep unwell; Steroid therapy; Swallowing difficult; Swollen lips; Tachycardia; Temperature regulation disorder; tendinitis; tenosynovitis; thoracic outlet syndrome; thumb sprain; tongue swelling non-specific; Urinary tract infection; Urticaria heat; Viral warts; Weight loss; Abdominal cramps; Adverse drug reaction; Allergic reaction; Allergy to animal; Allergy to chemicals; Urine WBC increased; Vitamin D decreased; WBC increased; Absolute monocyle count increased; Absolute netrophil count increased; ALT increased; Anion gap increased; AST increased; Bacteria urine identified; Blood alkaline phosphatase decreased; Blood pyruvic acid increased; Calcium increased; Carnitine decreased; Casts urinary hyaline; Cloudy urine; Creatinine decreased; Creatinine urine decreased; Electrophoresis abnormal; Enterococcus test positive; Epithelial cells urine; Gene mutation identification test positive; Glucose decreased; Glucose increased; Glucose urine present; Hematocrit decreased; Hemoglobin decreased; lgA decreased; Iron saturation decreased; Lymphocyte percentage decreased; Lymphocyte percentage  increased; Magnesium increased; Neutrophil percentage decreased; Neutrophil percentage increased; Occult blood positive; Phosphorus low; Potassium decreased; Protein total decreased; Protein total increased; Protein urine present; RBC decreased; Sodium decreased; Sodium increased; TSH decrease; Urine culture positive; Urine leukocyte esterase positive; Urine mucus increased; Urine RBC increased; Immediate post-injection reaction; Laboratory test abnormal; Mast cell activation syndrome; Postural orthostatic tachycardia syndrome; Sjogren's syndrome; Tilt table test positive; Syncope; This report was identified from a line listing obtained on request by the Company from the FDA(HA # 749433) under the Freedom of Information Act, concerning to a 15 year old female patient. The patient was allergic to Cefazolin, coconut, tree nut and Nitrofurantoin. The patient's history condition included hives, rash and swelling. The patient's other illnesses at the time of vaccination and up to one month prior included plantar warts. The patient's chronic or long-standing health conditions included allergic rhinitis, otitis media, hypertrophy of tonsil/adenoids, hyperhydrosis, halo nevus, generalized anxiety disorder, overweight, acquired deformity of toe, heterozygous for Methylene tetrahydrofolate reductase (MTHFR) gene mutation, create eardrum opening, tympanostomy tubes and cauterization inner nose. The patient had no adverse event following any previous vaccine. Other medications included escitalopram oxalate(LEXAPRO).   On 01-FEB-2012, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# 1171AA with unknown expiry date)(dose, strength and anatomical location were not reported) intramuscularly for prophylaxis.   On 01-FEB-2012, immediately following 3rd vaccination in series, the patient experienced syncope and later developed postural orthostatic tachycardia (POTS), mast cell activation syndrome (MCAS), sjogren's syndrome, immediate post-injection reaction, tilt table test positive and laboratory test abnormal. The patient's lab tests included MCAS confirmed in July 2016, Tilt table testing confirmed POTS in February 2017, sjogren's syndrome diagnosed in May 2018. The outcome of the events was reported as not recovered. The causality assessment was not provided by the reporter.  The agency considered the events were serious due to disability.  Lot number #1171AA is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Follow up information was identified from a line listing obtained on request by the Company from the Food and Drug Administration (FDA) (agency# 749433) under the Freedom of Information Act on 29-OCT-2019.  On 30-JUL-2018, primary care provider (PCP) Medical records received, the patient was diagnosed with tendinitis, tenosynovitis, fracture jell first metacarpal bone, asthma, peanut allergy, refractory mast cell activation, POTS and allergy to coconut oil. The patient had no adverse event following any previous vaccine.   On 30-JUL-2018, consultant medical records received, the patient was diagnosed with viral warts, psoriasis, lichenification, lichen simplex chronicus and left thumb sprain. The patient had multiple PCP visits/ emergency department (ED) for various complaints. She had left foot pain of 2 hours duration, was standing of tiptoes and came down tunny followed by sharp pain. She received physical therapy but had continued pain. The patient had visit for left sided pelvic pain. The patient had advised nonsteroidal antiinflammatory drugs (NSAIDs). The patient had pain in thumb, asthma, asthma exacerbation, deviated nasal septum, chronic sinusitis, lgA deficiency selective, flat foot, psoriasis, recurrent anaphylaxis after eating popcorn in movie theater, anaphylaxis in hospital after eating breakfast potatoes containing cayenne pepper and cumin, urinary tract infection, RX prednisone taper and keflex, several hospitalizations for anaphylactic reaction, ate fig bar followed by diarrhea, got hot, lips swollen with red ring around them, hoarse, face and neck puffy, enterococcal urinary tract infection, allergic rhinitis, allergic to cats, tree and pollen,  and hives. The patient had therapy with epinephrine, solumedrol, benadryl. The patient had episodes of angioneurotic edema and had intensive care. The patient had major depressive disorder in remission, allergic reaction after licking holiday envelopes, lip and tongue swelling. The patient had refractory mast cell activation consider Geevec and taken continuous Benadryl infusion. The patient had reaction to Gleevec, included swollen lips, rash, itchy throat, generalized urticaria within 20-30 minutes after administration and then improved with steroid. The patient had wheezing, shortness of breath, admitted with angioedema and allergy to macrobid/urticarial rash.  On 30-JUL-2018, the patient's relevant lab tests showed complete blood count-White blood cell count (CBC-WBC) 12.4 thou/uL (H), Red blood cell count (RBC) 3.47 m/uL (L), Hemoglobin (HGB) 10.3 g/dL (L), Hematocrit 31.4% (L), Neutrophil count (Neut) 45% (L), Neut 89% (H), Lymph 49% (H), Lymph 9% (L), Absolute neutrophil count (Abs Neut) 11.0 k/uL (H), Absolute Monocyte count (Abs Mono) 0.9 k/uL (H), Blood alkaline phosphatase (CHEM - Alk Phos) 24 u/L (L), Potassium 3.0 mmol/L (L), Sodium 135 mmol/L (L), Glucose 116 mg/dL (H), Glucose 65 mg/dL (L), Total Protein 6.2 g/dL (L) and TSH 0.31 ulU/mL (L). Urinalysis test showed Leuk Esterase 1+, Protein 1+, Glucose 2+, WBC 5-10 hpf, epithelial cells many, Mucous 3+. Urine Culture test showed positive for enterococcus.  On 07-AUG-2018, Emergency Room (ER), hospital records and discharge summary received, the patient was diagnosed with anaphylaxis due to food allergy (muftin), mast cell activation syndrome, dysautonomia, lgA deficiency, regular danlos syndrome, gastric motility disorder, osteoporosis, hypertension, depression, insomnia, leukocytosis secondary to steroid use, chronic constipation, POTS, angioedema, respiratory distress, stridor, hypoxia. The patient presented with episode of anaphylaxis after eating a muffin, include difficulty in swallowing, tongue swelling and shortness of breath. The patient had been taken critical care and given epipen, Intravenous (IV) epinephrine, aenadryl, solumedrol and cellcept dosage increased. The patient had several episodes of near anaphylaxis due to decreases in steroids. The patient discharged on methylprednisolone and benadryl pump to avoid allergens. The patient's condition had much improved in subsequent visit.   On 07-AUG-2018, neurology consultation records received, the patient was diagnosed with dysautonomia-POTS, thermal dysrcgulation, gastrointestinal hypomobility, joint hypermobility/EDS with thoracic outlet syndrome, Medium-chain acyl-CoA dehydrogenase (MCAD), immune deficiency (lgA) and psoriasis. The patient presents with neuropathy, anaphylaxis and weight loss. The patient had eating disorder 2 years ago, eventual diagnosis mast cell activation disorder. The patient had frequent hospitalizations for anaphylaxis. The patient had port-A-cath, tachycardia, orthostatic dizziness, severe fatigue, constipation, bloating, abdominal cramping, recurrent cystitis, thermal dysregulation, sicca, auditory processing disorder, dysgeusia, sleep not restful, weird dreams, anxiety/depression, asthma, convergence deficiency, hot/cold urticarial, lgA deficiency, brain fog and psoriasis. Additionally, the patient had orthostatic symptoms worsening with Clonidine patch which recommend stopping. The patient had possible reaction to Lysol, included short of breath, wheezing, difficulty swallowing, sensation lip and tongue are swelling. The patient had constipation and possible gastroparesis.   On 07-AUG-2018, the patient's relevant lab tests showed CBC-RBC 3.43 m/uL (L), HGB 11.0 g/dL (L), HCT 32.7%(L), WBC 13.5 thou/uL (H), RDW 15.1%(H), Neut 41.3% (L), Lymph 48.4% (H), lgA - <7 mg/dL (L), Neut 77.3% (H), Lymph 16.3% (L), CHEM-Glucose 62 mg/dL (L), Glucose 158 mg/dL (H), Sodium 146 mmol/L (H), Potassium 3.0 mmol/L (L), Alkaline Phosphatase 19 u/L (L), Protein Total 8.4 g/dL (H), Calcium 10.4 mg/dL (H), Crcatinine 0.4 mg/dL (L), Magnesium 2.5 mg/dL (H), AST 38 u/L (H), Anion Gap 15 (H), ALT 97 u/L (H), Phosphorus 1.7 mg/dL (L), Iron Saturation 19% (L), Vitamin D 25-Hydroxy-29.4 ng/mL (L), Carnitine 16 umol/L (L ), Pyruvic Acid 0.118 mmol/L (H), serum protein electrophoresis abnormal, cardiolipin lgG negalive, cardiolipin lgM negative, cardiolipin lgA negative, phosphatidylserine lgM negative, phosphatidylserine lgA negative, Bcta-2- Glycoprotein I lgG/lgM/lgA negative. Mutation test showed MTHFR Mutation 677C and 1298A PCR-Heterozygous. UrinalysisCloudy showed RBC 3-5 /hpf, Occult Blood trace, WBC 6-10/hpt, Bacteria moderate, Hyaline Casts 20-100/lpt, Squamous Epithelial Cells few and Mucus few. Urine Creatininc test showed 25.7 mg/dL (L). The outcome of the events was reported as not recovered. The causality assessment was not provided by the reporter.  Follow-up information has been received on 17-JAN-2020. A phone call was placed to the reporter. The phone call was answered by reception. Reception shared it was best to submit the request in writing since there were no patient identifiers or contact person. A message was left with reception requesting a return phone call.