Sex: F
Vaccine: ADEN_4_7, MNQ
Symptoms: Chlamydial infection, Dizziness, Drug hypersensitivity, Nausea, Paraesthesia
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 female patient between the ages of 19-24 years, who experienced poisoning by unspecified drug or medicinal substance (Serious, since 01-Feb-2012, until 01-Feb-2012); tingling - follow up reaction to PCN (Serious, since 03-Feb-2012, until 03-Feb-2012); nausea with vomiting, follow up lightheadedness (Serious, since 25-Feb-2012, until 25-Feb-2012) while enrolled in a Teva study. The patient was an active recruit. Adenovirus vaccine was administered on 01-Feb-2012. At the time of the report the outcome of the AEs were: poisoning by unspecified drug or medicinal substance: unknown, tingling - follow up reaction to PCN: recovered/resolved, nausea with vomiting, follow up lightheadedness: recovered/resolved. Adverse events within 42 days of vaccination: Observation for susp condition follow-up (since 01-Feb-2012, until 01-Feb-2012), (outpatient visit, treated with treatment medication included prescription and OTC) outcome not resolved, severity and seriousness not assessed; Chlamydia infection (since 14-Feb-2012, until 14-Feb-2012), (outpatient visit, treated with treatment medication included prescription and OTC), outcome not resolved, severity and seriousness not assessed; patient education action plan (since 23-Feb-2012, until 23-Feb-2012), (outpatient visit, treated with non drug treatment, outcome, severity and seriousness not assessed; nausea with vomiting (since 25-Feb-2012, until 25-Feb-2012), (outpatient visit, treated with treatment medication included prescription and OTC) outcome not resolved, severity and seriousness not assessed. Concomitant medications within 42 days of vaccination: Azithromycin (since 14-Feb-2012, until 15-Feb-2012), (1g, as directed, PO) unknown indication; penicillin G (since 14-Feb-2012, until 14-Feb-2012), (2mL, 1x, IM) unknown indication; ondansetron (since 24-Feb-2012, until 27-Feb-2012), (4mg, Q6H, PO) unknown indication; acetaminophen (since 24-Feb-2012, until 05-Mar-2012), (325mg, Q6H, PO) unknown indication; pseudoephedrine and codeine and guaifenesin (since 25-Feb-2012, until 06-Mar-2012), (6/2/20mg/mL, QHS, PO) unknown indication; naproxen (since 25-Feb-2012, until 06-Mar-2012), (500mg, BID, PO) unknown indication; promethazine (since 25-Feb-2012, until 28-Feb-2012), (25mg, Q 4-6H, PO) unknown indication. 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 26-Jan-2012); Meningococcal Vaccine (since 01-Feb-2012); IPV (since 26-Jan-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 were not reported. 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.