Sex: M
Vaccine: ADEN_4_7, DTP, FLUN3, MNQ
Symptoms: Anaphylactic reaction, Anaphylactic shock
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 unknown male patient between the ages of 19-24 years, who experienced Other anaphylactic shock, NEC (confirmed) (Serious, since 29-Mar-2012, until 29-Mar-2012) while enrolled in a study. The patient was an active recruit. Adenovirus vaccine was administered on 28-Mar-2012. The patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity unknown, seriousness of disability/ incapacity, outcome not resolved. Treatment included: normal saline (1000cc, x1, IV) started on 29-Mar-2012, stopped on 29-Mar-2012, indication unknown); BENADRYL (25mg, TID PRN, PO) started on 29-Mar-2012, stopped on unknown date, indication unknown); hydrocortisone (1%, ointment, topical) started on 29-Mar-2012, stopped on unknown date, indication unknown); MEDROL (4mg, unknown frequency, PO) started on 29-Mar-2012, stopped on 29-Mar-2012, indication unknown); SOLUMEDROL (125mg, week, IVP) started on 29-Mar-2012, stopped on 29-Mar-2012, indication unknown): ibuprofen (x1, IV) started on 29-Mar-2012, stopped on 29-Mar-2012, indication unknown). Adverse events within 42 days of vaccination: Anaphylactic drug reaction (since 30-Mar-2012, until 20-Mar-2012), outpatient visit, treated with non-drug treatment medication included prescription and OTC) outcome not resolved, severity not assessed, seriousness of disability/ incapacity; allergic reaction follow up (since 02-Apr-2012, until 02-Apr-2012), outpatient visit, treated with non-drug treatment medication included prescription and OTC) outcome resolved, severity not assessed, seriousness of disability/ incapacity; allergic reaction follow up (since 04-Apr-2012, until 04-Apr-2012), outpatient visit, treated with non-drug treatment medication included prescription and OTC) outcome resolved, severity and seriousness not assessed; allergic reaction follow up (since 06-Apr-2012, until 06-Apr-2012), outpatient visit, treated with non-drug treatment medication included prescription and OTC) outcome resolved, severity and seriousness not assessed. At the time of the report the outcome of the AEs were: Other anaphylactic shock, NEC : 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 Influenza vaccine(Unknown; since 28-Mar-2012); Meningococcal vaccine(Unknown; since 28-Mar-2012); Diphtheria-tetanus-pertussis vaccine(Unknown; since 28-Mar-2012); FLUMIST(Unknown; since 28-Mar-2012). The patient's past medication were unspecified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. 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.