Sex: F
Vaccine: ADEN_4_7, MNQ
Symptoms: Hypersensitivity, Ligament sprain, Liver function test normal, Lymphocyte count increased, Monocyte count increased
Clinical narrative: 13-Sep-2013, Medically significant event, Teva Non-Interventional Study. 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 female patient between the ages of 19-24 years who experienced Other Anaphylactic Shock, NEC (Confirmed) (Serious, since 30-Jan-2012, until 30-Jan-2012); Urticaria (Serious, since 31-Jan-2012, until 31-Jan-2012); Allergic reaction SOB/ Edema (Serious, since 06-Feb-2012, until 08-Feb-2012), and Knee Sprain Right (Serious, since 30-Jan-2012 until 30-Jan-2012) while enrolled in a Teva study. The patient was an active recruit. Adenovirus vaccine was administered on 01-Feb-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 Knee Sprain Right the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity was mild, outcome not resolved, seriousness of disability/ incapacity. Allergic Reaction SOB/ Edema the patient was treated at outpatient visit, treatments medications included non-drug treatment medication including prescription and OTC, severity was not assessed, outcome not resolved, seriousness of disability/ incapacity. Treatment medications included: ibuprofen (800mg, TID, PO) started on 30-Jan-2012, stopped on 03-Feb-2012 for pain; THERA-GESIC (unknown dose and unit, AAA, topical) started on 30-Jan-2012, stopped on 29-Feb-2012 for unknown indication; calcium +D (600/400mg, BID, PO) started on 30-Jan-2012, stopped on 29-Feb-2012 for unknown indication; BENADRYL (25mg, stat, IV) started on 30-Jan-2012, stopped on 30-Jan-2012 for urticaria; ZANTAC (50mg, stat, IV) started on 30-Jan-2012, stopped on 30-Jan-2012 for urticaria; SOLUMEDROL (80mg, stat, IV) started on 30-Jan-2012, stopped on 30-Jan-2012 for urticaria; ZANTAC (150mg, BID, PO) started on 30-Jan-2012, stopped on 14-Feb-2012 for unknown indication; ZYRTEC (10mg, BID, PO) started on 30-Jan-2012, stopped on 29-Feb-2012 for unknown indication; PEN G (2 mL, once, IM) started on 03-Feb-2012, stopped on 04-Feb-2012 for prophylaxis; prednisone (50mg, 1QD x 5D, PO) started on 06-Feb-2012, stopped on 11-Feb-2012 for unknown indication; epinephrine (0.3mg, KIT, injection) started on 15-Feb-2012, stopped on 16-Mar-2012 for unknown indication; acetaminophen (325mg, Q 4-6 H PRN, PO) started on 27-Feb-2012, stopped on 04-Mar-2012 for unknown indication; pseudoephedrine (30mg, Q6H, PO) started on 27-Feb-2012, stopped on 26-Feb-2012 for unknown indication; benzonatate (100mg, TID, PO) started on 28-Feb-2012, stopped on 04-Mar-2012 for unknown indication; naproxen (500mg, BID, PO) started on 28-Feb-2012, stopped on 14-Mar-2012 for unknown indication; guaifenesin pseudoephedrine (600 +60mg, BID, PO) started on 28-Feb-2012, stopped on 08-Mar-2012 for unknown indication. At the time of the report the outcome of the AEs were: Other Anaphylactic Shock, NEC : not recovered/not resolved, Knee Sprain Right : not recovered/not resolved, Allergic Reaction SOB/ Edema : not recovered/not resolved. Adverse events within 42 days of vaccination: Urticaria-recurrent periodic-chronic urticaria follow up eval (since 28-Feb-2012, until 28-Feb-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment medication, severity and seriousness were not assessed, outcome not resolved. Admin purpose med board (since 05-Mar-2012, until 05-Mar-2012) the patient was treated at outpatient visit, outcome, severity and seriousness were not assessed. Urticaria follow up (since 31-Jan-2012, until 31-Jan-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 of disability/ incapacity. Urticaria follow up allergic reaction (since 02-Feb-2012, until 02-Feb-2012) the patient was treated at outpatient visit, severity and seriousness were not assessed, outcome resolved. Allergic reaction follow up (since 08-Feb-2012, until 08-Feb-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. Brace foot/arch support (since 10-Feb-2012, until 10-Feb-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment, severity, outcome and seriousness were not assessed, urticaria follow up allergy eval (since 15-Feb-2012, until 15-Feb-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment, outcome not resolved, severity and seriousness were not assessed. Follow up visit lab results reviewed (since 16-Feb-2012, until 16-Feb-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment, outcome not resolved severity and seriousness were not assessed. Follow up lab results allergic reaction (since 21-Feb-2012, until 21-Feb-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment, outcome not resolved, severity and seriousness were not assessed. Cold pack pain pack (since 23-Feb-2012, until 23-Feb-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity, outcome and seriousness were not assessed. Admin purpose separation (since 06-Mar-2012, until 06-Mar-2012) the patient was treated at outpatient visit, severity, outcome and seriousness were not assessed. The medical history of the patient included Knee Sprain - Right which occurred on an unknown date prior to date of vaccination. 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 (since 26-Jan-2012); Meningococcal vaccine (since 01-Feb-2012); Influenza Vaccine (since 26-Jan-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus Vaccine - Not applicable. Lab tests: 15-Feb-2012, Neutrophils 27.4, 15-Feb-2012, Eosinophils 9.6, 15-Feb-2012, lymphocytes 49.5, 15-Feb-2012, neutrophils 11.7, 15-Feb-2012, monocytes 12.8, 15-Feb-2012, ESR: normal, 15-Feb-2012, Hep function panel: normal, 15-Feb-2012, TSH sensitive: normal, 15-Feb-2012, Thyroid peroxidase: 57 IU/mL, 15-Feb-2012, Thyroidglobulin profile: normal, 15-Feb-2012, Tryptase: normal. This case was considered serious based on the following criteria: (Disability or Permanent Damage). The medical monitor has assessed the causal relationship of the event Other Anaphylactic Shock, NEC, as not related to the Adenovirus Vaccine. Event of Anaphylactic shock with a start date of 30-Jan-2012. Date of Adenovirus Vaccine administration was 01-Feb-2012. There was no causality assessment for events of Allergic Reaction/SOB/Edema, Urticaria or Knee Sprain Right. Information was received on 25-Sep-2013 concerning dates of event and vaccine administration. Start date for event Other Anaphylactic Shock, NEC was confirmed as 30-Jan-2012. Stop date corrected to 02-Feb-2013. Vaccine administration confirmed as given on 01-Feb-2012.