Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Atrial septal defect, Blood bilirubin abnormal, Blood creatine phosphokinase normal, Catheterisation cardiac normal, Chest discomfort
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 398204. A 30-year-old male patient received ACAM2000 (lot number VV04-003A) on 27 August 2010. No medical history or concurrent illness was reported. On 05 September 2010, also reported as 07 September 2010, the patient presented with flu-like symptoms, including fever (101.6 degrees), body aches, chills, and headache for 24 hours. Upon exam he was noted to have enlarged submandible, cervical, and supra cervical lymph nodes. Left tympanic membrane was bulging. Heart and lung testing was negative, however laboratory testing revealed elevated liver function tests (AST 206, ArT6), and a hepatic ultrasound revealed the liver to be 19cm. The patient was diagnosed with possible pyelonephritis/"BTELS", and he was sent to the emergency department and subsequently hospitalized. He underwent a cardiac catheterization; results were not reported. The patient later recovered on an unspecified date. Note: There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Follow-up information was received on 27 May 2011 from MILVAX under reference number 398204. On day 11 post vaccination, the patient had a troponin level 29.01 and a creatine kinase (CK) 576. His electrocardiogram (ECG) showed changes consistent with ST elevation in leads II, III and AVF. A cardiologist was consulted and the patient was given TNKast, ASA, and heparin drip. Tests were initially performed on the patient at one hospital prior to transfer to a second hospital where he had a cardiac catheterization. On day 13 post vaccination, the patient reported that he was an inpatient at a hospital under evaluation for myocarditis. He had reported having chest pain with an onset 12 days post vaccination which was described as a tight and constant around his heart. The patient's chest pain has eased but he was not pain free yet. A cardiac catheterization was performed which was negative and an echocardiogram (ECHO) was to be performed. On 19 days post vaccination, the patient had a work up at a local hospital where his laboratory tests showed elevated liver function tests (LFTs). His signs and symptoms included chest pain still present at 2/10 on the pain scale which increased with inspiration, fatigue which increased with activity, reduced appetite, diarrhea and dysuria. On day 25 post vaccination, the patient had an ECHO which showed normal left ventricular function, motion and structure. His ejection fraction (EF) was 65%. On 34 days post vaccination, the patient was seen at the clinic for follow-up and reported that he was feeling fine, had no chest pain but had occasionally chest burning. On day 73 post vaccination, the patient had posting of laboratory tests from the hospital (results not reported). On 197 day post vaccination, the patient had a 2D transthoracic ECHO which showed left ventricular function was normal, an EF 65%, atrial septum was aneurismal. An injection of saline showed patent Foramen Ovale. His exercise stress ECHO was negative with good exercise tolerance and maximal exercise. On day 108 post vaccination, the patient was allowed to demobilize due to myopericarditis. He had received medical monitoring at the nearby instillation and by DoD vaccine healthcare centers network (VHC). The VHC recommended a cardiac magnetic resonance imaging (MRI) which was done 107 days post vaccination (results not reported). The patient's substernal chest pain with myocarditis had resolved. The patient still had a 5 month history of positional upper chest discomfort, which makes him want to cough. The patient improves with stretching his head up and back (not pericarditis pattern) and he has no shortness of breath or syncope. He was able to exercise on a bike, run and surf. His troponin level was 0.010 and CK was 90. His bilirubin remained abnormal at 1.1. The patient was assessed with a 5 month history which appears to be upper chest wall musculoskeletal pain which was not consistent with pericarditis based on ECH, exam and preliminary MRI findings. The patient reported that the pain improved with NAPROSYN. It was stated that "I don't believe this is cardiac in nature". It was recommended that the patient gradually returned to previous exercise regimen over 3 months. The patent Foramen Ovale which was found on an otherwise normal ECHO was not clinically significant in this case. The outcome was reported as not recovered for the LFTs and musculoskeletal chest pain. The outcome was reported as recovered for the myocarditis. This case 2010-06938 (keeper case) has been identified as a duplicate case of 2011-02574 (case to be deleted). The following information contains the new information added to this case from case 2011-02574. This is a study case received from the investigator (MILVAX) in a trial on 02 May 2011. The subject had no medical history. He received the ANTHRAX vaccine on 07 August 2010. On 08 September 2010, the subject had an abnormal troponin I of 29.01 and an abnormal electrocardiogram (ECG). Additional information has been requested from the investigator. Documents held by sender: None.