Age: 37.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cardiac monitoring normal, Catheterisation cardiac normal, Chest pain, Convulsion, Dehydration
Clinical narrative: This study case was received from the investigator on 22 February 2012, who also provided an adjudication follow-up report with follow-up information received on 28 February 2012. A 37-year-old male subject had received the follow vaccinations on 19 July 2009: an injection of a ACAM2000 (SP Biologics Co.) and an injection of Anthrax Vaccine (manufacturer not reported) (lot numbers, routes and sites of administration not reported). On 20 July 2009, the subject had a normal troponin I, normal echocardiogram, abnormal ECG and abnormal lumbar puncture. On 30 July 2009, the subject was diagnosed with other, chest pain. According to the adjudication follow-up report received, the subject was a non-smoker and past medical history included sickle cell trait, tarsal tunnel, headaches (HA's) x 1 month, and hypertension (HTN). The subject's family history included a parent with a history (hx) of cerebral vascular accident (CVA) x 2, HTN, diabetes mellitus (DM) and lupus. The subject had a hx of "loss of consciousness (LOC) since 14 years ago." At 15 days post-vaccination the subject was seen in the emergency room (ER) three days ago for elevated blood pressure (BP) and syncopal (no warning symptoms), drowsy but conscious, better in about 20 minutes, no shortness of breath (SOB), or chest pain (CP); episode. The subject was sent to the hospital and admitted for days 12-14 post-vaccination, based on questionable electrocardiogram (ECG) and HTN. The subject was evaluated for papillary muscle dysfunction with transesophageal echocardiogram (TEE). The subject's ECHO on 12 days post-vaccination was negative and troponin x 3 were negative. At 23 days post-vaccination, the subject collapsed during morning training, was drowsy but conscious. On arrival, the subject was unconscious, BP 180/100, heart rate (HR) 120/min, BP 140/87 5 minutes later, BP 124/87, 96 beats per minute (bpm) 15 minutes later. Cardiac resuscitation was provided. The subject's ECG was positive for inferior septal myocardial infarction (MI), blood sugar (BS) was 75 and had a fair gag reflex. The subject's signs and symptoms (s/sx) were CP, diaphoretic, pulmonary sx, loc at 1-5 minutes during exercise, recurrent episodes, limb weakness, S1 sound abnormal and S2 sound abnormal. The subject was stabilized and transferred to the hospital. On 24 days post-vaccination, the subject was transferred to the ER, observed for two hours and was stable. The subject was seen having shaking motions every 15 seconds or so in the ER, yet the subject was discharged with a diagnosis of dehydration. Later that evening, the subject developed seizures and was admitted to the hospital ER and later cardiology services. The subject's cardiac monitoring was normal, cardiac catheterization was normal, lumbar puncture (LP) performed found to be positive (+) for viral meningitis. An electroencephalogram (EEG) was done (results not reported) and Lymes results were pending. The subject was discharged on 28 days post-vaccination. The physical exam revealed heart murmur 2/6 best heard at 4th intercostal space (ICS) and no premature ventricular contractions (PVCs) were heard. "A/P; 1) syncope: IMPRESSIONS: unclear etiology. The subject denied prior heart conditions. Does not sound like seizures, per description of soldiers present in ER. LP + meningitis but titer could be secondary to prior infection." On 112 days post-vaccination, the subject was diagnosed with rheumatoid arthritis (RA) and heart murmur with abnormal heart rhythm 16 years ago. The subject had "micardis" in the past few months and was hospitalized three months ago for meningitis, cardiac workup showed he had "problem with his heart." The subject was not diagnosed with Sjorgens Syndrome and experiencing polyarthralgias. On 20 January 2012 a note was added: "Beyond the 90 day post-vaccination time frame, there are extensive medical notes in this electronic medical record (EMR). No results for the tilt table testing were found in the EMR. There is no further notation of myopericarditis other than listed in past history. The subject is occasionally seen for cardiac follow up, but his case continues to be more concentrated on other, more immediate medical problems. The majority of the notes are for care connected with (c/w) additional and continuing medical problems in a multitude of body systems outside the topic of review for study. Having reviewed all these medical notes, it is documented in his record that the subject was medically separated from his unit in 2011." Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.