Sex: M
Vaccine: ADEN_4_7, FLU3
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Pericarditis, Protein total 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 353242USA. A male patient between the ages of 19-24 years who experienced acute pericarditis (Confirmed) (Serious, since 05-Mar-2012), viral pericarditis (Serious, since 07-Mar-2012, until 07-Mar-2012); chest pain (Serious, since 08-Mar-2012, until 08-Mar-2012) while enrolled in a Teva study. Adenovirus vaccine was administered on 21-Feb-2011. The patient was hospitalized on 05-Mar-2012 and discharged on 06-Mar-2012, treatment medications included: ibuprofen (800mg, PRN TID, PO) started on 05-Mar-2012, stopped on 12-Jun-2012, unknown indication; sodium chloride (0.9%, TID, injection) started on 05-Mar-2012, stopped on 12-Jun-2012, unknown indication; ducosate sodium (100mg, BID, PO) started on 05-Mar-2012, stopped on 12-Jun-2012, unknown indication; omeprazole (20mg, QD, PO) started on 05-Mar-2012, stopped on 12-Jun-2012, unknown indication; magnesium sulfate (80mg/mL, unknown frequency, injection) started on 06-Mar-2012, stopped on 07-Mar-2012, unknown indication; indomethacin (25mg, Q8H, PO) started on 09-Mar-2012, stopped on 08-Mar-2012, unknown indication; ZOFRAN (4mg, Q6H, PO) started on 15-Mar-2012, stopped on 16-Mar-2012, unknown indication. At the time of the report the outcome of the AEs were: Acute pericarditis: not recovered/not resolved, viral pericarditis: recovered/resolved, chest pain: recovered/resolved. Adverse events within 42 days of vaccination: Viral pericarditis follow up (since 07-Mar-2012, 07-Mar-2012) treated as outpatient visit, treatments medications included non-drug treatment, severity unknown, seriousness of disability/incapacity, outcome resolved; chest pain follow up started on 08-Mar-2012, stopped on 08-Mar-2012, treated at outpatient visit, treatments medications included non-drug treatment, severity unknown, seriousness of disability/incapacity, outcome 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 meningococcal vaccine (since 16-Feb-2012); influenza vaccine (since 21-Feb-2012); IPV (since 16-Feb-2012); DTP vaccine (since 16-Feb-2012). The patient's past medication were unspecified. Action taken with suspect drugs: adenovirus vaccine - not applicable. Lab tests 06-Mar-2012, EKG: Diffuse elev suggest pericarditis; 05-Mar-2012, portable chest: WN study; 05-Mar-2012, Troponin 1 cardiac: 0.116 ng/mL; 05-Mar-2012, ESR: normal; 05-Mar-2012, Creatine kinase: 506 Unknown; 06-Mar-2012, Creatine kinase: 416 Unknown; 06-Mar-2012, Magnesium: 1.5 Unknown; 06-Mar-2012, Creatine kinase: 381 Unknown; 06-Mar-2012, Troponin 1 Cardiac: Normal Unknown; 06-Mar-2012, Lymphocyte count: 11 %; 06-Mar-2012, Albumin: 3.2 Unknown; 06-Mar-2012, Reticulocytes: 2.1 %; 06-Mar-2012, Iron panel: 239 microg/dL; 06-Mar-2012, Haptoglobin: 92 mg/dL; 06-Mar-2012, Lactate dehydrogen: normal; 08-Mar-2012, WBC: 12.0, Unknown; 08-Mar-2012, Glucose: 58 mg/dL; 08-Mar-2012, Creatine kinase: 212 Unknown; 08-Mar-2012, Lactate dehydrogenase: normal; 05-Mar-2012, CKMB: 3.48 Unknown; 08-Mar-2012, CKMB: 2.73 Unknown; 08-Mar-2012, Hemoglobin: 11.7 Unknown; 08-Mar-2012, Hematocrit: 36.5 Unknown; 08-Mar-2012, MCV: 75.3 Unknown; 08-Mar-2012, MCH: 24.1 Unknown; 08-Mar-2012, Lymphocytes: 12.6 Unknown; 08-Mar-2012, CKMB: 2.73 Unknown; 06-Mar-2012, Chloride: 111 Unknown; 06-Mar-2012, Calcium: 8.0 Unknown; 06-Mar-2012, Protein: 6.0 Unknown. This case was considered serious based on the following criteria: (Hospitalization Required, Disability or Permanent Damage). 13-Sep-2013 Additional information was received. No serologies were done, no echocardiogram was performed. 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.