Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Coxsackie virus test positive, Cytomegalovirus test negative, Diarrhoea, Electrocardiogram ST segment depression, Electrocardiogram abnormal
Clinical narrative: Case number PHHY2014US049023 is an initial spontaneous report received from the vaccine adverse reporting system (VAERS reference number: 519294) web site on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 296106) on 13 Jun 2014. This report refers to a 21 year old male patient. His medical history and concomitant medications were not reported. He also denied any adverse reactions to these vaccinations in his medical records documented a major take at his SPV site. He was vaccinated with FLUCELVAX (batch number: 007011A) intramuscularly on 06 Nov 2013. He was vaccinated with ACAM2000 (other manufacturer, batch number: VV04003A) intradermally, BIOTHRAX (other manufacturer, batch number: FAV328A) and TYPHIM VI (other manufacturer, batch number: H1482) intramuscularly on 13 Nov 2013. On 30 Dec 2013 after traveling back home, he began to complain a stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. On 31 Dec 2014 by 06:00 am, his vomiting had stopped. His diarrhea ceased on 01 Jan 2014. He had no fever or sweats. He did not eat any new foods or seafood. He and his family members ate same food. His family members were not ill. On 02 Jan 2014, he woke up with a burning pressure on mid chest (scale: 8/10) and he could feel heart beating. His jaw was tight as if he had just chewed or clenched teeth and had tingling pain in his shoulder from left to right. He vomited once and had dry heaves. He stated that during deep breathing it hurt but there was no shortness of breath. Position changes did not affect the pain. He drove himself to nearby emergency room. At the emergency room his EKG showed normal sinus rhythm (NSR) with 1 mm ST depression at V4-5, chest radiograph (CXR) was normal and cardiac enzymes were elevated: creatine kinase was: 391, creatine kinase-MB was: 13.5, creatine kinase percentage was: 3.4, Troponin (POC) was: 0.56, Troponin T was: 0.19. However, basic metabolic panel, complete blood count, prothrombin time and international normalized ratio were normal. His pain was treated with ASA, 1L normal saline bolus and one NORCO 5/325. His pain reduced to pain scale 2/10, which was almost like a sore muscle pain in chest. He was transferred and admitted to a hospital. On the same day at evening about 07:00 pm, his pain again worsened, which was dull intense chest pain (pain scale 8/10). He did not experience nausea or radiating pain. His EKG remained in NSR. He was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (pain scale 0/10). On 02 Jan 2014, cardiac enzymes tests performed which gave the following result; creatine kinase value was: 693, creatine kinase-MB value was: 30.80, creatine kinase percentage was: 4.4, Troponin I value was: 09.69, erythrocyte sedimentation rate was: 02, C-reactive protein was: 24.0, comprehensive metabolic panel or liver function tests were normal. On 03 Jan 2014, his viral studies: human herpes virus-6 IgG1 antibody titer was: 1:160, Coxsackie virus B1, B3 antibody titer 1:8, influenza A/B AB titer was 1:16. Epstein-Barr virus IgG was positive with IgM negative suggesting a past infection. Parvovirus test, Coxsackie virus A, enterovirus, cytomegalovirus, respiratory syncytial virus, Lyme disease, adenovirus, HHV6 DNA and Hepatitis B panel tests were negative. However, hepatitis B surface Ab test was positive. Complete Blood Count, chemistry, prothrombin time/international normalized ratio, urine analysis, magnesium, phosphorus, lipid panel tests were also normal. On 03 Jan 2014, creatine kinase value was: 614, creatine kinase-MB value was: 25.20, creatine kinase percentage was: 4.1, Troponin I was: 6.88 whereas, lipid panel was normal. On 04 Jan 2014, creatine kinase value was: 304, creatine kinase-MB value was: 6.40, creatine kinase percentage was: 2.1, Troponin I was: 4.60. On 05 Jan 2014, creatine kinase value was: 216, creatine kinase-MB value was: 1.92, creatine kinase percentage was: 0.9, Troponin I was: 1.65. On 06 Jan 2014, creatine kinase was: 166; creatine kinase-MB value was: 1.07, creatine kinase percentage was: 0.6, Troponin I was 0.541. On the same day Gadolinium containing MRI (GAD MRI) was also performed but no result was provided. His treatment was continued with routine intravenous then oral non-steroidal anti-inflammatory drugs (NSAIDS) with no reoccurrence of pain as of 07 Jan 2014. The outcome of the event was reported as complete recovery. The events were assessed as serious due to hospitalization. However, causality was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 007011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 296106) on 13 Jun 2014: Updated batch review report.