Age: 18.0
Sex: M
Vaccine: ADEN_4_7, DTP, HEPAB, MEN
Symptoms: Allergy to arthropod sting, Anaphylactic reaction, Anaphylactic shock, Hypersensitivity
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 353398USA. A male patient between the ages of 19-24 years, who experienced Other Anaphylactic shock, NEC (confirmed) (serious, since 13-Jul-2012, until 13-Jul-2012); Allergic Reaction (confirmed) (serious, since 16-Jul-2012, until 16-Jul-2012); Wasp venom anaphylaxis (confirmed) (serious, since 18-Jul-2012, until 18-Jul-2012) while enrolled in a study. The patient was an active recruit. Adenovirus vaccine was administered on 12-Jul-2012. For the event of Other Anaphylactic Shock, NEC 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 of disability/ incapacity; for the event of Allergic Reaction the patient was treated at outpatient visit, treatments medications included non-drug treatment, severity was not assessed, outcome resolved, seriousness of disability/ incapacity; for the event of Wasp Venom Anaphylaxis the patient was treated at outpatient visit, treatments medications included non-drug treatment, severity and outcome were not assessed, seriousness of disability/ incapacity. Treatment medications included: epinephrine (0.3mg/mL, as directed PRN, injection) started on 16-Jul-2012, stopped on 16-Jul-2012, unknown indication; ZANTAC (unknown, dose, unit, route, frequency) started on 13-Jul-2012, stopped on 13-Jul-2012; diphenhydramine (25mg, TID, PO) started on 13-Jul-2012, stopped on 16-Jul-2012, unknown indication; BENADRYL (unknown, dose, unit, route, frequency) started on 13-Jul-2012, stopped on 13-Jul-2012; Steroid (unknown, dose, unit, route, frequency) started on 13-Jul-2012, stopped on 13-Jul-2012. Adverse events within 42 days of vaccination: Follow up exam (since 14-Jul-2012, until 14-Jul-2012), the patient was treated at outpatient visit, treatments medications included non-drug treatment medication, severity was not assessed, outcome resolved, seriousness of disability/ incapacity. At the time of the report the outcome of the AEs were: Other Anaphylactic Shock, NEC: not recovered/not resolved, Allergic Reaction: recovered/resolved, Wasp Venom Anaphylaxis: 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 included Hepatitis A vaccine w/Hepatitis B vaccine (unknown, since 12-Jul-2012); DTP vaccine (unknown, since 12-Jul-2012); Meningococcal vaccine (unknown, since 12-Jul-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 (pending query by medical monitor) to the Adenovirus Vaccine.