Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Lymphocyte count, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell volume decreased
Clinical narrative: gag reflex; speech difficulties; stomach pain; sleep problem; loss of consciousness; confusion; headache; concussion; Salivary gland enlargement; enlarged tonsils; ASO quantitation 196 IU/mL (normal range: 0-150); neutrophils percentage increased; Lymphocyte percentage decreased; anion gap increased; albumin increased; Urine cannabinoids NOS decreased; chronic recurrent nausea; periumbilical abdominal pain; abnormal weight loss; chronic vomiting; viral intestinal infection; proteins in urine; blood in urine; mucus in urine; bacteria in urine; billirubin in urine; ketones in urine; ADHD; inappropriate schedule of vaccine administered; This spontaneous report was received from a physician, referring to 14-year-old male patient. Patient's current condition included allergy to amoxicillin (hives and nausea only), his concomitant medications included lisdexamfetamine and his historical vaccines included: DTAP (INFANRIX) vaccine, DTaP-IPV vaccine, DTaP/Hep B/IVP vaccine, Haemophilus (Hib) vaccine, Hep A (Ped/adol) vaccine, Hepatitis B (Adol/ped), HiB, IPV, Influenza (Trival) Im preservative free, Influenza (nasal), measles mumps and rubella vaccine, measles mumps rubella and varicella vaccine, meningococcal conjugate vaccine, pneumococcal conjugate 7-valent vaccine, pneumococcal conjugate vaccine PCV13 (PREVNAR 13), Tdap vaccine and varicella vaccine. Patient's historical conditions included concussion and appendectomy.  On 07-AUG-2017, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (intramuscularly in left deltoid, lot #N009801, expiration date was not reported but upon internal validation was established as 20-NOV-2019, exact dose was not provided) and on 29-JUL-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 mL, intramuscularly in left arm, lot #S008154 was valid for formulation pre-filled syringe, expiration date was not reported but upon internal validation was extablished as 20-NOV-2021) for prophylaxis (Inappropriate schedule of vaccine administered).  On unknown day, the patient seemed to have hyperactive gag reflex and experienced a speed difficulties and stomach pain. On 29-JUL-2019, the patient developed attention deficit hyperactivity syndrome (ADHD). On the same day, urinary analysis (UA), point of care (POC) color was yellow, UA POC clarity was clear, UA, POC glucose was negative, UA, POC protein was negative and weight was 75.8 kg. On 23-OCT-2019, the patient experienced viral intestinal infection and abnormal weight loss. On the same day, there were proteins, mucus, bacteria, bilirubin, ketones and blood in urine. On the same day, laboratory results for urine showed: color was yellow, clarity was slightly-cloudy, bilirubin was negative, urobilinogen was less than 2.0 mg/dL, traces of ketones, glucose was negative, protein was 30 mg/dL, blood was assessed as small, nitrite was negative, lleukocyte esterase was negative, red blood cell was 3-4/hpf, white blood cells, was 0-5/hpf, traces of bacteria, mucus was assessed as many, UA POC Color was yellow, UA, POC clarity was clear, UA, POC glucose was negative, UA POC bilirubin was small, UA POC ketone was 15 mg/dL, UA POC blood was trace, UA POC protein was trace, UA POC urobilinogen was 0.2 EU/dL, UA POC, nitrite was negative and weight was 70 kg. On 15-NOV-2019, the patient experienced chronic recurrent nausea and vomiting, weight loss and periumbilical abdominal pain. On the same day, ultrasound (US) abdomen right upper quadrant (RUQ) liver gallbladder pancreas showed no focal liver lesion. Normal size and echotexture. Normal hepatopetal flow was seen in the portal vein. No intrahepatic biliary duct dilation. The common bile duct measured 2 mm in diameter. No cholelithiasis, gallbladder wall thickening, pericholecystic fluis, or sonographic Murphys sing. No pancreatic duct dilation or focal lesion was seen in the partially imaged pancreas. The right kidney measured 11.6 cm in length. There was no hydronephrosis. Other findings were negative. Conclusion: unremarkable right upper quadrant ultrasound, no cholelithiasis or biliary ductal dilatation. On 16-MAR-2020, the weigth was 66.4 kg. On 17-JUN-2020, the tests showed neutrophil percentage increased, anion gap increased, albumin increased, urine cannabinoids increased and lymphocyte percentage decreased. On the same day, the patient experienced chronic recurrent nausea. On 17-JUN-2020, white blood cells (WBC) count was 10.3 k/cu mm, red blood cells (RBC) count was 5.3 k/cu mm, hemoglobin (HGB) was 15.2 gm/dL, mean cell hemoglobin was 29 pg, serum glutamic-oxaloacetic transaminase AST (SGOT) was 22 IU/L, serum glutamic-pyruvic transminase ALT (SGPT) was 23 IU/L, alkaline Phos was 199 IU/L, platelets count (PLT) was 292 k/cu mm, mean platelet volume (MPV) was 10.9 fL, red (cell) distribution width (RDW) was 12 %, sedimentation rate was 2 mm/hr, nucleated red blood cells (nRbC) was 0, absolute neutrophils was 7.1 k/cu mm, absolute lymphocytes was 2.0 k/cu mm, absolute monocytes was 0.9 k/cu mm, absolute eosinophils was 0.3 k/cu mm, absolute basophils was 0.1 k/cu mm, absolute nucleated RBC was 0.0 k/cu mm, automated percent immature granulocytes was 0 %, automated absolute immature granulocytes was 0.0 *10^3uL, glucose was 97 mg/dL, urea nitrogen was 13 mg/dL, cannabinoids in urine were positive, UA, color was yellow, UA, clarity was clear, UA glucose was negative, UA bilirubin was negative, UA ketones was negative, UA blood was negative, urine protein was negative, UA urobilinogen was 0.2 mg/dL, UA nitrite was negative, UA leukocytes were negative, eosinophils percentage was 3%, anion gap was 17 mmol/L, basophil percentage was 1%, albumin was 5.2 g/dL, total bilirubin was 0.8 mg/dL, calcium was 10.3 mg/dL, chloride was 100 mEq/L, potassium was 4 mEq/L, sodium was 141 mEq/L, carbon dioxide (CO2) was 24 mEq/L, mean cell hemoglobin concentration (MCHC) was 33 %, mean cell volume (MCV) was 78 fL, monocyte percentage was 9 %, neutrophils percentage was 68 %, total protein was 7.4 g/dL and weight was 62.1 kg. On 09-JUL-2020, patient's test was positive for streptococcus (antistreptolysin O increased). Antistreptolysin O (ASO) quantitation was196 IU/mL. On 07-OCT-2020, the patient experienced chronic vomiting. On the same day, weight was 62.3 kg. On 12-MAY-2021, the weight was 72.5 kg and Examination showed that patient was oriented to person, place and time. He appeared well-developed and well-nourished, Head: normocephalic and atraumatic, Right and left ear: tympanic membrane, ear canal and external ear normal. Nose: normal, Mouth: mucous membranes are moist, Pharynx: oropharynx is clear and moist Pupils: are equal, round and reactive to light, EOM are normal, Thyroid: no thyromegaly, Rate and rythm: normal rate and regular rythm, Pulses: normal, Heart sounds: normal, no murmur heard, Effort: pulmonary effort was normal, Breath sounds: normal, General: bowel sounds were normal, there was no distension, Palpations: abdomen was soft, there was no mass, Tenederness: there ws no abdominal tenderness, General: normal range of motion, Cervical back: normal range od motion and neck supple, Cervical: no cervical adenopathy, General: skin was warm and dry, Findings: no rash, General: no deficit present, Coordination: normal, Deep Tendon Reflexes: reflexes were normal and symmetric. On 08-NOV-2021, weight was 70.4 kg and examination showed: Normal appearance, patient was well-developed, Head: normocephalic and atraumatic, Right and left ear: tympanic membrane, ear canal and external ear normal. Nose: normal, Mouth: mucous membranes are moist, Pharynx: oropharynx is clear, no posterior oropharyngeal erythema, Extraocular movements: intact, Pupils: are equal, round and reactive to light, Thyroid: no thyromegaly, Rate and rythm: normal rate and regular rythm, Pulses: normal, Heart sounds: normal, no murmur heard, Effort: pulmonary effort was normal, Breath sounds: normal, General: bowel sounds were normal, there was no distension, Palpations: abdomen was soft, there was no mass, Tenederness: there ws no abdominal tenderness, General: normal range of motion, Cervical back: normal range od motion and neck supple, Cervical: no cervical adenopathy, General: skin was warm and dry, Findings: no rash, General: no deficit present, Coordination: normal, Deep Tendon Reflexes: reflexes were normal and symmetric. On 26-APR-2022, the patient experienced enlarged tonsils and salivary gland enlargement. On the same day, POC color UA was yellow, POC clarity UA was clear, POC glucose UA was negative, POC, protein UA was negative, weight was 67.3 kg and examination swowed: Normal appearance, patient was well-developed, Head: normocephalic and atraumatic, Salivary glands: right salivary gland was diffusely enlarged (3+), left salivary gland was diffusely enlarged (3+), Right and left ear: tympanic membrane, ear canal and external ear normal. Nose: normal, Mouth: mucous membranes are moist, Pharynx: oropharynx is clear, no posterior oropharyngeal erythema, Extraocular movements: intact, Pupils: are equal, round and reactive to light, Thyroid: no thyromegaly, Rate and rythm: normal rate and regular rythm, Pulses: normal, Heart sounds: normal, no murmur heard, Effort: pulmonary effort was normal, Breath sounds: normal, General: bowel sounds were normal, there was no distension, Palpations: abdomen was soft, there was no mass, Tenederness: there ws no abdominal tenderness, Penis: normal, Testes: normal, General: normal range of motion, Cervical back: normal range od motion and neck supple, Cervical: no cervical adenopathy, General: skin was warm and dry, Findings: no rash, General: no deficit present, Coordination: normal, Deep Tendon Reflexes: reflexes were normal and symmetric. On unknown day in August 2022, the patient experienced a concussion, headache and confusion. On 20-SEP-2022, the patient experienced loss of consciousness. On the same day, weight was 68.6 kg, examination showed normal appearance, patient was well-developed, Head: normocephalic and atraumatic, Right and left ear: tympanic membrane, ear canal and external ear normal. Nose: normal, Mouth: mucous membranes are moist, Pharynx: oropharynx is clear, no posterior oropharyngeal erythema, Extraocular movements: intact, Pupils: are equal, round and reactive to light, Thyroid: no thyromegaly, Rate and rythm: normal rate and regular rythm, Pulses: normal, Heart sounds: normal, no murmur heard, Effort: pulmonary effort was normal, Breath sounds: normal, General: bowel sounds were normal, there was no distension, Palpations: abdomen was soft, there was no mass, Tenederness: there ws no abdominal tenderness, General: normal range of motion, Cervical back: normal range od motion and neck supple, Cervical: no cervical adenopathy, General: skin was warm and dry, Findings: no rash, General: no deficit present, Coordination: normal, Deep Tendon Reflexes: reflexes were normal and symmetric.On 12-DEC-2022, the patient experienced a sleep problem. On the same day, weight was 69.3 kg and examination showed review of systems, constitutional: negative for activity change, fatigue and fever, HENT: negative for congestion, ear pain, rhinorrhea and sore throat, Eyes: negative for pain, Respiratory: negative for cough and shortness of breath, Cardiovascular: negative for chest pain, Gastrointestinag: negative for diarrhea, nausea and vomiting, Genitourinary: negative for dysuria, Musculoskeletal: negative for arhralgias and myalgias, Skin: negative for rash, Neurological: negative for dizziness, seizures and syncope, Hematological: does not bruise/bleed easily, Normal appearance, patient was well-developed, Head: normocephalic and atraumatic, Right ear: tympanic membrane, ear canal and external ear normal, Left ear: tympanic membrane, ear canal and external ear normal, Nose: normal, Mouth: mucous membranes are moist, Pharynx: oropharynx is clear, no posterior propharyngeal erythema, Extraoucular movements: extraocular movements intact, Pupils: pupils are equal, round and reactive to light, Thyroid: no thyromegaly, Rate and rythm: normal rate and regular rythm, Heart sounds: normal heart sounds and no murmur heard, Effort: pulmonary effort is normal, Breath sounds: normal breath sounds, Palpations: abdomen is soft, Tenderness: there is no abdominal tenderness, General: normal range of motion, Cervical back: normal range of motion and neck supple, Other: negative for scoliosis, Cervical: no cervical adenopathy, General: skin was warm and dry, no focal deficit present, Mental status: he was alert and oriented to person, place and time, Deep tendon reflex: reflexes are normal and symmetric. On unknown day, the patient recovered from loss of consciousness, vomiting, concussion, confusion, headache, stomach pain and nausea. The outcome of hyperactive gag reflex, viral intestinal infection, ADHD, abnormal weight loss, streptococcus test positive, lymphocyte percentage decreased, neutrophil percentage increased, anion gap increased, albumin increased, urine cannabinoids increased, periumbilical abdominal pain, protein urine present, blood urine present, urine abnormality, bacteria urine identified, bilirubin urine present, urine ketone body present, enlarged tonsils, sleep problem, confusion, speech disorder, salivary gland enlargement was unknown.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of loss of consciousness was considered as medically significant.