Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Fatigue, Impaired work ability
Clinical narrative: This case was received on 18 March 2011 via a third party query tool search on the VAERS database, under reference number 414656. A 20-year-old male patient received on 21 December 2010 a left upper arm percutaneous injection of ACAM2000 (lot number W04003A). The patient had no current illnesses, and no medical history. The patient had no known drug allergies (NKDA), no known food, nut, dye, shellfish, latex, or environmental allergies. The patient had no chronic diseases (dz), no prior coronary vascular disease (CVD), no genetic or auto-immune dz, no prior hospitalizations or surgeries. The patient had a history of a fractured (fx) right thumb at age 15 years. He had no tobacco use, no ETOH or illicit drug use. The patient received about one month ago the following vaccines: dose 1 Anthrax (AVA) vaccine and Hepatitis A/B (dose not reported). His family history was as follows: mother (50) live (L) had diabetes mellitus type 2 (DM2) and was obese; father (50) live (L) and healthy; sister 17 (L) and healthy. On 30 December 2010, the patient reported to the vaccine call center that he developed chills, body ache, fatigue and neck pain without rigidity on 29 December 2010. The patient was seen in the Emergency Room (ER) at the hospital on 30 December 2010 due to his concern that his smallpox lesion (vaccinia) was "spreading". The patient reported having 2 spots that were like his vaccine site with one about 1 inch below the original shot site on the left upper arm and another on the hairline at the base of the neck. The patient was advised by the ER to come back when his temperature was greater than 104. The patient later that evening on 30 December 2010 called the vaccine call center to report that he had a temperature of 101 degrees Fahrenheit (F), mild pleuritic shortness of breath (SOB) and new onset, dull, constant midsternal, non-radiating chest pain/pressure in the center of his chest which was rated as a 2 out of 10 initially on the pain scale. The pain increased in a supine position and he felt better when sitting up and leaning forward. At the peak of his chest pain around 10:00 PM, which was a 4-5 out of 10 on the pain scale, the patient had slight nausea without vomiting or diaphoresis. He stated that it hurt to take a deep breath. The patient was advised by a call center to have someone drive him to the ER immediately and have the ER doctor contact the call center. The patient was admitted to the hospital sometime after midnight on 31 December 2010. The patient was responding to nonsteroidal anti-inflammatory drugs (NSAIDS) for his chest pain and his shortness of breath resolved in the ER. The patient's electrocardiogram (EKG) done in the ER was reported as normal but the blood work indicated a mild elevation of the troponins. Serial EKGs were repeated from 31 December to 02 January 2011 and all were normal. His serial cardiac enzymes drawn were trending downward. The patient was discharged from the hospital to home with his parents on 02 January 2011. His discharge orders was for "restricted activity" for 6 weeks with on fire-fighting or heavy lifting, continue with the prescription of oral (po) ibuprofen 800 milligrams (mg) three times a day (tid) with food (WF) for 1 week, no deployment for 6 months, and cardiology follow-up in 6 months. On 04 January 2011, the patient's outpatient echocardiogram was performed. On 06 January 2011, the patient followed-up with "POM" and the doctor reported that his echocardiogram results were normal and that this heart was good. The patient denied any recurrent chest pain or shortness of breath. The patient stated that he felt "back to normal". The outcome was reported as unknown. 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 from the investigator on 06 June 2011. It was determined that this subject had been enrolled in the study. The 20-year-old male subject was found to have Acute idiopathic pericarditis and Unspecified disease of the pericardium 11 and 9 days respectively after he had received an injection of smallpox (vaccinia) vaccine, live (ACAM2000). Troponin I result was not available. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.