Sex: F
Vaccine: ADEN_4_7, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Anaphylactic shock, Urticaria
Clinical narrative: A report was received from an observational study. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A female patient between the ages of 19-24 years, who experienced other anaphylactic shock (NEC) (Confirmed) (Serious, since 14-Sep-2012, until 14-Sep-2012); urticaria (Serious, since 15-Sep-2012, until 19-Sep-2012) while enrolled in a Teva study. Adenovirus vaccine was administered on 13-Sep-2012. The patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity was not assessed, outcome not resolved, seriousness and disability/incapacity. The event on urticaria the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity was not assessed, outcome resolved, seriousness of disability/incapacity. Treatment medications included: epinephrine (since 14-Sep-2012, until 14-Sep-2012) (unknown dose, unit, frequency and indication): SOLUMEDROL (125mg, unknown frequency, IV) started on 12-Sep-2012, stopped on 14-Sep-2012, unknown indication; ZANTAC (50mg, unknown frequency, IV) started on 14-Sep-2012, stopped on 14-Sep-2012, unknown indication; prednisone (10mg, unknown frequency, PO) started on 14-Sep-2012, stopped on 20-Sep-2012, unknown indication; ATARAX (20mg, unknown frequency, PO) started on 14-Sep-2012, stopped on 17-Sep-2012, unknown indication. At the time of the report the outcome of the AEs were: other anaphylactic shock (NEC): not recovered/not resolved, urticaria: recovered/resolved. Adverse events within 42 days of vaccination: Urticaria follow-up (since 15-Sep-2012, until 15-Sep-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity was not assessed, outcome resolved, seriousness of disability/incapacity; follow-up exam (since 17-Sep-2012, until 17-Sep-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity and outcome were not assessed, seriousness of disability/incapacity; anaphylaxis follow-up allergist (since 20-Sep-2012, until 20-Sep-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity and outcome were not assessed, seriousness of disability/incapacity. 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 DTP vaccine (since 13-Sep-2012); meningococcal vaccine (since 13-Sep-2012); influenza vaccine (since 13-Sep-2012); hepatitis A vaccine w/ hepatitis B vaccine (since 13-Sep-2012). The patient's past medication were unspecified. Action taken with suspect drugs: adenovirus vaccine - not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Disability or Permanent Damage). 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.