Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: CSF protein increased, Chest X-ray abnormal, Clavicle fracture, Computerised tomogram head normal, Eosinophil percentage decreased
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 cases 353362USA and 353398USA. A male patient between the ages of 25-29 years, who experienced Syncope and collapse (Confirmed) (Serious, since 02-Jun-2012, until 02-Jun-2012); Other anaphylactic shock, NEC (Confirmed) (Serious, since 03-Jun-2012, until 03-Jun-2012); Allergic reaction throat tightens/ hives (Confirmed) (Serious, since 04-Jun-2012, until 04-Jun-2012) ; Headache (Confirmed) (Serious, since 06-Jun-2012, until 06-Jun-2012); Urticaria(Serious, since 07-Jun-2012, until 07-Jun-2012) while enrolled in a study. The patient was an active recruit. Adenovirus vaccine was administered on 01-Jun-2012. For the event of Syncope and collapse 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 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, seriousness of disability/ incapacity, outcome resolved. For the event of Allergic reaction throat tightens/ hives 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 Headache 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 Urticaria 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. Treatment medications were epinephrine (.5mg, unknown frequency, IM) started on 03-Jun-unknown, stopped on 03-Jun-unknown, indication unknown; SOLUMEDROL (125mg, unknown frequency, IV) started on 03-Jun-unknown, stopped on 03-Jun-unknown, unknown indication; BENADRYL (50mg, unknown frequency, IV) started on 03-Jun-unknown, stopped on 03-Jun-unknown, indication unknown); SOLUMEDROL (125mg, unknown frequency, IV) started on 03-Jun-unknown, stopped on 03-Jun-unknown, unknown indication; ZANTAC (50mg, unknown frequency, IV) started on 03-Jun-unknown, stopped on 03-Jun-unknown, indication unknown; SOLUMEDROL (dose, frequency, unit, route unknown) started on 03-Jun-unknown, stopped on 03-Jun-unknown, unknown indication; normal saline (1000mL, unknown frequency, IV) started on 04-Jun-2012, stopped on 04-Jun-2012, unknown indication; methylprednisolone (125mg, 60 mg now, IM) started on 04-Jun-2012, stopped on 04-Jun-2012, unknown indication; BENADRYL (50mg, now, injection) started on 04-Jun-2012, stopped on 04-Jun-2012, indication unknown; Normal saline (1000mL, now, IV) started on 04-Jun-2012, stopped on 04-Jun-2012, unknown indication; epinephrine (0.3mg, KIT, injection) started on 03-Jun-2012, stopped on 03-Jun-2012, indication unknown; prednisone (50mg, QD, PO) started on 03-Jun-2012, stopped on 08-Jun-2012, indication unknown; diphenhydramine (25mg, Q8H, PO) started on 03-Jun-2012, stopped on 08-Jun-2012, indication unknown; ranitidine (150 mg, BID, PO) started on 03-Jun-2012, stopped on 08-Jun-2012, indication unknown; ibuprofen (800mg, TID, PO) started on 04-Jun-2012, stopped on 08-Jun-2012, indication unknown; desonide (0.05%, after shave, topical) started on 05-Jun-2012, stopped on 05-Jun-2012, indication unknown; cetirizine (10mg, QD, PO) started on 05-Jun-2012, stopped on 05-Jun-2012, indication unknown; codeine and acetaminophen (30/30mg, QH, PO) started on 06-Jun-2012, stopped on 06-Jun-2012, indication unknown; acetaminophen (325mg, 2Q6H, PO) started on 29-Jun-2012, stopped on 29-Jun-2012, indication unknown; methocarbamol (500mg, QID, PO) started on 29-Jun-2012, stopped on 29-Jun-2012, indication unknown; clotrimazole (1% cream, BID, topical) started on 29-Jun-2012, stopped on 29-Jun-2012, indication unknown; At the time of the report the outcome of the AEs were: Syncope and collapse : not recovered/not resolved, Other anaphylactic shock, NEC : recovered/resolved, Allergic reaction throat tightens/ hives : not recovered/not resolved, Headache : not recovered/not resolved, Urticaria : 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 w/Hepatitis B vaccine (since 06-Jun-2012); IPV(unknown; since 01-Jun-2012); Meningococcal vaccine (unknown; since 01-Jun-2012); Diphtheria-tetanus-pertussis vaccine (unknown; since 01-Jun-2012); Influenza vaccine (unknown; since 01-Jun-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus vaccine - Not applicable. Lab tests 02-Jun-2012, Lumbar puncture: results unavailable. 02-Jun-2012, Portable chest: remote R midclavicular deformity fracture. 02-Jun-2012, CT head: normal. 02-Jun-2012, CSF protein: 52.8 mg/dL. 02-Jun-2012, CSI culture: normal. 02-Jun-2012, CBC: WBC-10.3, Neut-81.5, lymph-11.1; esosino-0.7. 02-Jun-2012, Renal panel: glucose 127 mg/dL. 02-Jun-2012, CSF glucose: normal. 29-Jun-2012, CMP comprehensive metabolic: lipemia index 79. 02-Jun-2012, Cell count body fluid: normal. 29-Jun-2012, CBC: HCT 40.8%. 29-Jun-2012, urinalysis panel: normal. This case was considered serious based on the following criteria: (Disability or Permanent Damage). This event Syncope and collapse was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not assessed to the Adenovirus vaccine. This event Other anaphylactic shock, NEC was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as possibly related to the Adenovirus vaccine.