Sex: M
Vaccine: ADEN_4_7, DTP, FLU3, MNQ, PPV
Symptoms: Arthralgia, Bone scan normal, Chest X-ray normal, Conjunctivitis, Haematocrit 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 case 353459USA. A male patient between the ages of 19-24 years, who experienced poisoning by unspecified drug or medicinal substance (Serious, since 27-Jun-2012, until 27-Jun-2012); joint pain localized in hip right side (Serious, since 28-Jun-2012, until 28-Jun-2012); joint pain localized in hip right side (Serious, since 11-Jul-2012, until 11-Jul-2012) while enrolled in a Teva study. The patient was an active recruit. Adenovirus vaccine was administered on 31-May-2012. The event of poisoning by unspecified drug or medicinal substance the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, outcome not resolved, severity and seriousness were not assessed. The event of joint pain localized in hip right side (Serious, since 28-Jun-2012, until 28-Jun-2012), the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, outcome not resolved, severity moderate, seriousness was not assessed. The event of joint pain localized in hip right side (Serious, since 11-Jul-2012, until 11-Jul-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, outcome not resolved, severity and seriousness were not assessed. Adverse events within 42 days of vaccination: Upper respiratory infection (since 11-Jun-2012, until 11-Jun-2012) the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, outcome, severity and seriousness were not assessed. Upper respiratory infection new onset of eye symptoms (since 18-Jun-2012, until 18-Jun-2012), the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, outcome not resolved, severity and seriousness were not assessed. Joint pain localized in hip follow-up from bone scan (since 05-Jul-2012, until 05-Jul-2012), the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, outcome not resolved, severity and seriousness were not assessed. Concomitant Medications within 42 days of vaccination: VIGAMOX (started 18-Jun-2012, stopped on unknown, continuing unknown) (0.5%, 1 gtt in affected eye x 7 D, eye) for conjunctivitis; naproxen (started on 28-Jun-2012 stop date unknown, ongoing unknown), (500mg, TID, PO) for hip pain; hydrocodone/acetaminophen (started on 05-Jun-2012, stopped on 05-Jul-2012) 5/500mg, PRN, PO) unknown indication; ibuprofen (started on 11-Jun-2012, stopped on 15-Jun-2012) (800mg, TID, PO) unknown indication; pseudoephedrine (started on 11-Jun-2012, stopped on 21-Jun-2012) (120mg, BID, PO) for URI; Guaifenesin (started on 11-Jun-2012, stopped on 16-Jun-2012) 600mg, BID, PO) for URI. At the time of the report the outcome of the AEs were: poisoning by unspecified drug or medicinal substance : not recovered/not resolved, joint pain localized in hip right side : not recovered/not resolved, joint pain localized in hip right side : 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 DTP (since 31-May-2012); Meningococcal Vaccine (since 31-May-2012); PCV (since 31-May-2012); Influenza Vaccine (since 31-May-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus Vaccine - Not applicable. Lab tests 03-Jul-2012, Bone scan: no stress fracture or changes, 18-Jun-2012, Chest x-ray: negative, 28-Jun-2012, X-ray Right hip series: no fracture or dislocation, 18-Jun-2012, Hematocrit: 39.5 Unknown, 18-Jun-2012, Hemoglobin: 13.1 Unknown. This case was considered serious based on the following criteria: (Disability or Permanent Damage, Other Serious (Important Medical Events)). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not assessable to the Adenovirus Vaccine.