Sex: M
Vaccine: ADEN_4_7
Symptoms: Gastrointestinal examination, Guillain-Barre syndrome, Haematocrit decreased, Haemoglobin decreased, Immunoglobulin therapy
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using adenovirus Type 4 and Type 7, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353371USA. A male patient between the ages of 19-24 years, who experienced acute infective polyneuritis (confirmed) (Serious, since 26-Dec-2011); syncope and collapse (Serious, since 06-Jan-2012); Rash and other nonspecific skin eruption (Limited to hospitalization) (since 06-Jan-2012) while enrolled in a Teva study (DR-501-402 ). Adenovirus was administered on 30-Nov-2011. The patient was hospitalized for complications treatment medication included: acetaminophen (10,g/mL; unknown frequency, IV) started on 30-Dec-2011, stopped on 31-Dec-2011, unknown indication; acetaminophen (325mg, unknown frequency, oral) started on 28-Dec-2011, stopped on 04-Jan-2011, unknown indication; acetaminophen (32mg/mL, PRN Q6 H, oral) started on 02-Jan-2012, stopped on 03-Jan-2012, unknown indication; acetaminophen (500mg, PRN Q6H, oral) started on 27-Dec-2011, stopped on 24-Jun-2011, unknown indication; acetylcysteine (20%solution, Q6H, oral) started on 31-Dec-2011, stopped on 02-Jul-2011, unknown indication; albuterol sulfate (3mg/mL, PRN Q6H/Q6H, inhalation) started on 28-Dec-2011, stopped on 25-Jun-2012, unknown indication; azithromycin (500mg, in known frequency, IM) started on 29-Dec-2011, stopped on 08-Jan-2012, unknown indication; bactrovir (500 U/g, unknown frequency, topical) started on 04-Jan-2012, stopped on 02-Jul-2012, unknown indication; bisacodyl (10mg, unknown frequency, rectal) started on 01-Jan-2012, stopped on 04-Jul-2012, unknown indication; ceftriaxone sodium ( 2g, Q24 H, IM) started on 29-Dec-2011, stopped on 08-Jan-2012, unknown indication; chlorhexidine gluconate (0.12% solution, BID, oral) started on 28-Dec-2011, stopped on 07-Jan-2012, unknown indication; ELIXIE (frequency unknown, oral) started on 02-Jan-2012, stopped on 03-Jan-2012, unknown indication; dextromethorphan and guaifenesin (5mL/PRN Q6H, oral) started on 05-Jan-2012, stopped on 03-Jul-2012, unknown indication; diphenhydramine (50 mg/mL, PRN Q8H, IM) started on 27-Dec-2011, stopped on 24-Jun-2012, unknown indication; etomidate (2mg/mL, unknown frequency, IM) started on 28-Dec-2011, stopped on 29-Dec-2011, unknown indication; fentanyl citrate 9 0.05mg/mL, PRN QH, IM) started on 28-Dec-2011, stopped on 03-Jan-2012, unknown indication; guaifenesin (600mg/mL, Q12 H, oral) started on 02-Jan-2012, stopped on 10-Apr-2012, unknown indication; heparin sodium ( 20,000 U/mL, Q12 H, injection) started on 30-Dec-2011, stopped on 09-Jan-2012, unknown indication; immune globulin IgG human ( 10% solution, QD, injection) started on 27-Dec-2011, stopped on 01-Jan-2012, unknown indication; lactated ringers (unknown dose, unit, frequency, IV) started on 27-Dec-2011, stopped on 26-Jan-2012, unknown indication; Lactulose (10/15 g/mL, Qd, oral) started on 01-Jan-2012, stopped on 29-Jun-2012, unknown indication; levalbuterol HCL (0.63/3 mg/mL, PRN Q2H, inhalation) started on 29-Dec-2011, stopped on 02-Jan-2012, unknown indication; levofloxacin (25mg/mL, unknown frequency, IM) started on 29-Dec-2011, stopped on 08-Jan-2012, unknown indication; lidocaine and epinephrine ( 1% solution, unknown frequency, IM) started on 28-Dec-2011, stopped on 29-Dec-2011, unknown indication; lorazepam (2mg/mL, ORN Q6H, injection) started on 29-Dec-2011, stopped on 30-Dec-2011, unknown indication; magnesium sulfate (500 mg/mL, unknown frequency, injection) started on 29-Dec-2011, stopped on 30-Dec-2011, unknown indication; midazolam hydrochloride (1mg/mL, PRN QH, injection) started on 28-Dec-2011, stopped on 29-Dec-2011; unknown indication; moxifloxacin HCL (400 mg/mL, QD, oral) started on 05-Jan-2012, stopped on 15-Jan-2012, unknown indication; moxifloxacin hydrochloride and NACL (1.6/250 mg/mL, QD, injection) started on 03-Jan-2012, stopped on 14-Jan-2012, unknown indication; MYLANTA (dose, frequency, unit unknown, oral) started on 03-Jan-2012, stopped on 01-Jul-2012, unknown indication; ondansetron hcl (4mg/mL, unknown frequency, oral) started on 31-Dec-2011, stopped on 01-Jan-2012, unknown indication, ometazoline HCL (0.055, unknown unit, PRN QD, nasal) started on 30-Dec-2011, stopped on 02-Jan-2012, unknown indication; pantoprazole sodium ( 40mg/mL, QD, injection) started on 28-Dec-2011, stopped on 25-Jun-2012, unknown indication; polyethylene glycol 3350 (unknown dose, powde, Gb, oral) started on 31-Dec-2011, stopped on 28-Jun-2012, unknown indication ; potassium chloride ( 10%, unknown unit, oral ) started on 01-Jan-2012, stopped on 21-Jan-2012, unknown indication; promethazine hydrochloride (25mg/ml, unknown frequency, injection) started on 03-Jan-2012, stopped on 04-Jan-2012, unknown indication; simethicone ( 80 mg/mL, unknown frequency, oral) started on 31-Dec-2011, stopped on 01-Jan-2012, unknown indication; sodium chloride (0.9% solution, unknown frequency, Q5ADC) started on 02-jan-2012, stopped on 12-Jan-2012, unknown indication; Zosyn (4.5g, Q6H, injection) started on 02-Jan-2012, stopped on 12-Jan-2012, unknown indication; vancomycin hydrochloride (1g, Q12H, injection) started on 02-Jan-2012, stopped on 12-Jan-2012, know indication. The patient also received MCV4P on 25-Nov-2011 (lot#UY4099AA manufacture PCM), Tdap on 25-Nov-2011 (lot# AC52B072AA manufacture SKB), and influenza on 25-Nov-2011 (lot#UT4223AA, manufacture PMC); IPV on 25-Nov-2011 (lot#G1500 manufacture PMC); Hep A (Adult) on 23-Nov-2011 (lot#AHAVB493AA, manufacture SKB). At the time of the report the outcome of the AEs were: Acute infective polyneuritis : not recovered/not resolved. Syncope and collapse: outcome unknown; Rash and other nonspecific skin eruption (Limited to hospitalization) outcome unknown. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to adenovirus vaccination. The patient's concomitant medication were influenza, DTAP, IPV, Hepatitis A. The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus vaccine -Not applicable Lab tests 26-Dec-2011, EKG: results not available; 26-Dec-2011, UA, results not available; 26-Dec-2011, Myoglobin, results not available; 26-Dec-2011, CT, results not available; 26-Dec-2011, GI panel, results not available; 30-Dec-2011, Portable AP of chest, Rt middle and lower lobe collapse, Lt apical pneumothorax; 30-Dec-2011, Portable AP of chest, Rt pneumothorax (apical; no lt pneumothorax; 30-Dec-2011, KUB abdomen, normal; 01-Jan-2012, Portable AP of chest; new linear opacity at rt lower lung; 01-Jan-2012, KUB abdomen, normal; 02-Jan-2012, Portable AP of chest, 00.30 sm pleural effusion rt lung R LL collapse; 02-Jan-2012, Portable AP of chest, 13.54 rt LL atelectasis diff irreg opt over lung mediastinum; 03-Jan-2012, Portable AP of chest, improved R LL opacities atelectasis, infection not excluded; 04-Jan-2012, Blood gas arterial; pH 7.425; PO2 B1; O2 sat 95.5; bicarb 26.9; 04-Jan-2012, Blood gas arterial; haemoglobin 12.6; nat 137; metheglobin 0.2; 04-Jan-2012, Vancomycin trough, 7.0; 04-Jan-2012, Mycoplasma pneumonia, normal; 05-Jan-2012, CBC, hemoglobin 11.7; HCT 34.5; RBC 4.12;plat 501; monocyte 16.1; eosin 7.8; 05-Jan-2012, Hepatic function panel; albumin 3.3; alanine 74; aspartate amino trans 54; 05-Jan-2012, Renal function panel, albumin 3.3; urea nitrogen 23.1; 06-Jan-2012, CBC: H-12.8; HCT 37.6; RBC 4.48; plat 585; monocy 14.3; eosin 9.1; 06-Jan-2012, Hepatic function panel; aspartate amino 68; alanine amino 90; protein 8.4; 06-Jan-2012, Magnesium, 2.23; 06-Jan-2012, Renal function panel, WNL This case was considered serious based on the following criteria: (Hospitalization Required, Disability or Permanent Damage, Other Serious (Important Medical Events). This event was assessed as acute infective polyneuritis as severe: syncope and collapse "unknown" in severity. The medical monitor has assessed the causal relationship of the event of acute infective polyneuritis as possibly related; Syncope and collapse and rash other nonspecific skin eruption (Limited to hospitalization) as not related to the adenovirus vaccine.