Sex: M
Vaccine: ADEN_4_7
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Coagulation test, Cytomegalovirus test positive
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, 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 GUILLAIN-BARRE SYNDROME (confirmed) (Serious, since 28-Dec-2011, until 04-Jan-2012), while enrolled in a study. Adenovirus vaccine was administered on 12-Dec-2011. The patient was hospitalized for complication and IV treatment which included: enoxaparin (40mg, QD, injection) started on 28-Dec-2011, stopped 07-Apr-2012 unknown indication; immune globulin gamma (10% solutions, QD, injection) started on 29-Dec-2011, stopped on 31-Dec-2011 unknown indication; magnesium oxide (400mg, unknown frequency, oral) started on 29-Dec-2011, stopped on 31-Dec-2011 unknown indication; penicillin G (2mL, one time, injection) started on 01-Dec-2011, stopped on 31-Dec-2011 unknown indication; potassium chloride (10meq, QD, oral) started on 28-Dec-2011, stopped on 29-Dec-2011 unknown indication; diphenhydramine (25mg, unknown frequency, oral) started on 01-Jan-2012 unknown if still ongoing, unknown indication; potassium chloride (20 meq, QD, oral) started on 29-Dec-2011, stopped on 30-Dec-2011 unknown indication; normal saline (1000mL, bolus, IV) started on 28-Dec-2011, stopped on 28-Dec-2011 unknown indication. The patient also received MCVP4 on 18-Nov-2011 (lot#U4078AA manufacturer PCM), Tdap on 18-Nov-2011 (lot#AC52B074AA manufacture SKB), and influenza on 18-Nov-2011 (lot#UT423AA, manufacture PMC); IPV on 18-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: GUILLAIN-BARRE SYNDROME : not recovered/not resolved. Adverse events within 42 days of vaccination: Headache onset on 03-Jan-2012 resolution date on 03-Jan-2012 (outpatient visit, treated with non-drug treatment medication included prescription and OTC) outcome not resolved, severity and seriousness unknown; nausea onset on 03-Jan-2012 resolution date on 03-Jan-2012 (outpatient visit, treated with non-drug treatment medication included prescription and OTC) outcome not resolved, severity and seriousness unknown; Guillain-Barre Syndrome (hospital follow up education assessment) onset on 04-Jan-2012 resolution date 04-Jan-2012 (outpatient visit, non-drug treatment) outcome, severity and seriousness not assessed. 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 included Penicillin G (Injection, Intramuscular, since 01-Dec-2011, until 31-Dec-2011, one time). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus vaccine - Not applicable. Lab tests 28-Dec-2011, Lumbar puncture: normal, 28-Dec-2011, CBC: results not available, 28-Dec-2011, CMP: results not available, 28-Dec-2011, COAGS: results not available, 28-Dec-2011, CK level: results not available, 30-Dec-2011, Respiratory virus culture: normal, 30-Dec-2011, Influenza A rapid: normal, 30-Dec-2011, Influenza B rapid: normal, 30-Dec-2011, Cytomegalovirus: Ab IgG positive; Ab IgM negative, 31-Dec-2011, CBC: abnormal RDW CV 14.4; monocytes 1.0; monocytes 14.8, 31-Dec-2011, Renal function panel: WNL, 04-Jan-2012, Comp metabolic panel: abnormal- protein 8.7; aspartate 207; alanine 280, 04-Jan-2012, CBC: abnormal- HCT-40.9; RBC-4.34; RDW-CV-14.1; Monocytes-13.6, 04-Jan-2012, Mycoplasma pneumonia: results not available, 04-Jan-2011, Respiratory virus culture: normal, 04-Jan-2011, Creatine kinase: 363 IU/L. This case was considered serious based on the following criteria: (Hospitalization Required). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as possibly related to the Adenovirus vaccine.