Sex: F
Vaccine: FLU3, TDAP
Symptoms: Full blood count abnormal, Guillain-Barre syndrome, Haematocrit decreased, Haemoglobin decreased, Headache
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 353371USA. A female patient between the ages of 19-24 years experienced Acute Infective Polyneuritis (confirmed). Event start date was 17-Jan-2012 and the patient was hospitalized for complications and IV treatment which included medications (prescription and OTC and non-drug treatment, unknown), severity was moderate and outcome and seriousness was unknown. Adenovirus vaccine was administered on 12-Dec-2011. The patient also received MCV4P on 21-Jan-2011 (lot#U4078AA manufacture PCM), TDAP on 21-Dec-2011 (lot#AC52B075AA manufacture SKB), and influenza on 21-Dec-2011 (lot#1384911A, manufacture CSL). Adverse events within 42 days of vaccination: Bilateral foot pain and headache onset on 09-Jan-2012 unknown resolution date on 09-Jan-2012 (outpatient visit, treated with non-drug treatment, medication included prescription and OTC) outcome severity and seriousness unknown. Lumbar pain onset on 12-Jan-2012 unknown resolution date on 12-Jan-2012 (outpatient visit, treated with non-drug treatment) outcome severity and seriousness unknown. Arthralgias in multiple sites onset on 23-Jan-2012 unknown resolution date on 23-Jan-2012 (outpatient visit) outcome severity and seriousness unknown. Periostitis and hyperkalemia onset on 24-Jan-2012 unknown resolution date on 24-Jan-2012 (outpatient visit) outcome severity and seriousness unknown. Pain in leg below knee onset on 12-Jan-2012 unknown resolution date on 12-Jan-2012 (outpatient visit, treated with non-drug treatment, medication included prescription and OTC) outcome severity and seriousness unknown. Limb pain onset on 13-Jan-2012 resolution date unknown (medication included prescription and OTC) outcome not resolved, severity and seriousness unknown. Arthralgias in multiple sites onset on 25-Jan-2012 unknown resolution date on 25-Jan-2012 (outpatient visit) outcome severity and seriousness unknown. Concomitant medications within 42 days of vaccination: Acetaminophen start date 11-Jan-2012 (325mg, PRN Q 6 hours, oral) indication unknown, stop date 14-Jan-2012. Ibuprofen start date 18-Jan-2012 (400mg, Q 8 hours, oral) indication unknown, stop date 23-Jan-2012. Ibuprofen start date 21-Dec-2011 (800mg, PRN QID, oral) indication unknown, stop date 02-Jan-2012. Metronidazole start date 30-Dec-2012 (250mg, 2 BID x7 days, oral) indication unknown, stop date 06-Feb-2012. Naproxen start date 30-Jan-2012 (500mg, BID, oral) indication unknown, stop date 31-Jan-2012. Penicillin G benzathine start date 20-Jan-2012 (1.2 MV, frequency unknown, IM) indication unknown, stop date 20-Jan-2012. Vitamin D +calcium start date 21-Dec-2012 (200/500 u/mg, BID, oral) indication unknown, drug continues to be administered. Normal saline start date 19-Jan-2012 (1000mL, X2, IV) indication unknown, stop date 19-Jan-2012. Enoxaparin start date unknown (40/0.4mg/mL, QD, subcutaneous) indication unknown, stop date unknown. Hydrocodone/acetaminophen start date unknown (5/325mg, PRN TID, oral) indication unknown, stop date unknown. Ketorolac start date 131-Jan-2012 (60mg, stat, IM) indication unknown, stop date 13-Jan-2012. Diagnostic test within 42 days of vaccination: Chem 7 + calcium on 24-Jan-2012 were abnormal showed carbon dioxide 30, anion gap 6 and calcium 8.4; liver function panel on 24-Jan-2012, were with in normal limits; potassium on 24-Jan-2012 was normal; hepatitis C on 13-Jan-2012 was normal; CBC with Diff on 23-Jan-2012 abnormal showed RBC 3.83, H-11.8, HCT 34.7; creatine kinase on 23-Jan-2012 were normal; liver function on 23-Jan-2012 were abnormal alanine aminotransferase 70; chem 7 + calcium on 23-Jan-2012, abnormal were K+ 5.3, carbon dioxide 32, anion gap 5; right and left knee on 12-Jan-2012, were normal; creatine kinase on 13-Jan-2012 was normal; chem 7 + calcium on 13-Jan-2012, abnormal carbon dioxide 31; nuclear AB on 134-Jan-2012, was normal negative. This case was considered serious due to "hospitalization". This event was assessed as moderate in severity. The medical monitor has assessed the causal relationship of the event as possibly related to the adenovirus vaccine.