Sex: F
Vaccine: ADEN_4_7, DTP, HEPA, IPV, MNQ
Symptoms: Mononucleosis heterophile test negative, Neutrophil percentage increased, Pain, Red blood cell count decreased, Sinusitis
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 female patient between 25-29 years, who experienced Poisoning by unspecified drug or medicinal substance (Serious, since 30-Aug-2012, until 30-Aug-2012) while enrolled in a Teva study. Adenovirus vaccine was administered on 30-Jul-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. Treatment medications included: morphine started on 30-Aug-2012, stopped on 30-Aug-2012 (4mg, stat, IV) for headache; NARCAN Started on 30-Aug-2012, stopped on 30-Aug-2012 (1mg, stat, IV) for reversed side affects of morphine; ROCEPHINE started on 30-Aug-2012, stopped on 30-Aug-2012 (1gm, stat, IV) for sinusitis; PHENERGAN started on 30-Aug-2012, stopped on 30-Aug-2012 (12.5mg, stat, IV) unknown indication; TORODOL started on 30-Aug-2012, stopped on 30-Aug-2012 (15mg, stat, IV) for unknown indication; normal saline started on 30-Aug-2012, stopped on 30-Aug-2012 (100mL, stat, IV) for unknown indication; ZITHROMAX Z-PAK started on 31-Aug-2012, stopped 31-Aug-2012, stopped on 04-Sep-2012 (650mg, QD, PO) for sinusitis; SUDAFED started on 31-Aug-2012, stopped on 03-Sep-2012 (30 mg, TID, PO) for unknown indication; hydrocodone/acetaminophen started on 31-Aug-2012, stopped on 02-Sep-2012 (5/325mg, 6H PRN, PO) for pain; ibuprofen started on 31-Aug-2012, stopped on 09 Sep-2012 (800mg, TID, PO) unknown indication. Adverse events within 42 days of vaccination: Follow-up of headaches (since 31-Aug-2012, until 31-Aug-2012), 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: recovered/resolved. The medical history of the patient was not specified. The medical history of the patient socially drinks alcohol and unknown type of tobacco use approximately 1 to 22 per day within 30 days prior to Adenovirus vaccination. The patient's concomitant medication included Diphtheria and Tetanus toxoids and Pertussis (since 30-Jul-2012); Meningococcal Vaccine (since 30-Jul-2012); Hepatitis A Vaccine (since 30-Jul-2012); IPV (since 30-Jul-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus vaccine - Not applicable. Lab tests 30-Aug-2012, Chest X-ray PA Lat: normal; 30-Aug-2012, WBC: 13.3 Unknown; 30-Aug-2012, Hemoglobin: 11.3 Unknown; 30-Aug-2012, RBC: 3.41 Unknown; 30-Aug-2012, Hematocrit: 33.4 Unknown; 30-Aug-2012, Lymphocytes: 8.2 Unknown; Monocytes: 1.0 Unknown; 30-Aug-2012, Neutrophils: 83.4 Unknown; 30-Aug-2012, Carbon dioxide: 22 Unknown; 30-Aug-2012, Calcium: 8.2 Unknown; 30-Aug-2012, Rapid Strep: moderate strep, beta hemolytic, not group A; 30-Aug-2012, Visual acuity test: both 20 25; 30-Aug-2012, Monospot panel: normal; 30-Aug-2012, Influenza A and B culture: normal. This case was considered serious based on the following criteria: (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.