Sex: M
Vaccine: ADEN_4_7, DTP, IPV, MNQ
Symptoms: Haemoglobin decreased, PO2 decreased, Protein total decreased, Toxicity to various agents
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 353459USA. A male patient between the ages 19-24 years, who experienced Poisoning by unspecified drug or medicinal substance (Serious, since 12-Apr-2012, until 12-Apr-2012); Joint pain localized in knee (Serious, since 11-Apr-2012, until 11-Apr-2012) while enrolled in a Teva study. Adenovirus vaccine was administered on 30-Jul-2012. The event Poisoning by unspecified drug or medicinal substance the patient was hospitalized on 12-Apr-2012, and treated with IV medications, complications and social reasons. Treatment medications included non-drug treatment medication included prescription and OTC and charcoal (since 12-Apr-2012, until 12-Apr-2012) (unknown indication, frequency, dose, route and unit) severity was not assessed, outcome was not resolved and seriousness was unknown. The event of Joint pain localized in knee the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC. Treatment medications included theragesic (since 11-Apr-2012, until 11-Apr-2012) (topical, unknown dose, unit, frequency); ibuprofen (since 11-Apr-2012, until 21-Apr-2012) (800mg, PO, TID) unknown indication; severity was not assessed, outcome not resolved and seriousness was disability/incapacity. Adverse events within 42 days of vaccination: Joint pain localized in knee (Serious, since 18-Apr-2012, until 18-Apr-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, outcome resolved, severity and seriousness were not assessed. At the time of the report the outcome of the AEs were: Poisoning by unspecified drug or medicinal substance: not recovered/not resolved, Joint pain localized in knee: not recovered/not resolved. 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 Hepatitis A vaccine w/Hepatitis B vaccine (since 04-Apr-2012); Diphtheria-Tetanus-Pertussis Vaccine (since 30-Mar-2012); Meningococcal vaccine (since 30-Mar-2012); IPV (since 30-Mar-2012); Influenza vaccine (since 30-Mar-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus vaccine - Not available. Lab tests 12-Apr-2012, Creatine: 18.4 Unknown; 12-Apr-2012, PO2: 65 Unknown; 12-Apr-2012, Lactate: 2.13 Unknown; 12-Apr-2012, CO2: 19 Unknown; 12-Apr-2012, Phosphate: 2.4 Unknown; 12-Apr-2012, Anion Gap: 15 Unknown; 12-Apr-2012, Magnesium Normal; 12-Apr-12, CO2: 21 Unknown; 12-Apr-2012, Glucose: 119 Unknown; 13-Apr-2012, Hemoglobin: 13.9 Unknown; 13-Apr-2012, Hematocrit: 40.7 Unknown; 13-Apr-2012, Magnesium Normal; 13-Apr-2012, CO2: 21 Unknown; 13-Apr-2012, Chloride: 109 Unknown; 13-Apr-2012, Protein: 6.1 Unknown; 14-Apr-2012, Phosphate: 2.2 Unknown. 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 "unknown" in severity. The medical monitor has assessed the causal relationship of the event as Not assessable to the Adenovirus Vaccine.