Sex: M
Vaccine: SMALL
Symptoms: Herpes simplex, Hyperhidrosis, Myocarditis, Pleuritic pain, Pyrexia
Clinical narrative: Myopericarditis; Centrally located pleuritic chest pain; Activity restrictions/non-deployable; Information received from the review of scientific literature on 02-JUL-2018. This is case 6 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT). Reference.  The article notes an otherwise previously healthy 19-year-old active duty male who presented to the ED with centrally located pleuritic chest pain approximately 10 days after receiving ACAM2000. His pain started the previous night and had been constant and sharp. The patient's ECG was normal without any PR depressions or ST elevations. His troponin-I was positive at 0.83. A transthoracic bedside echocardiogram showed no pericardial effusion and a normal gross ejection fraction. Cardiology from an outside hospital was consulted and the patient was transferred for further evaluation and treatment of myocarditis. An echocardiogram as an inpatient showed systolic dysfunction without signs of heart failure. The patient was discharged 4 days later with instructions to take colchicine and metoprolol. He was being followed by cardiology as an outpatient, was started on ibuprofen, and was placed on activity restrictions for 30 days pending cardiology follow-up, and made non-deployable. The patient's outcome was not reported in the article.  Additional information has been requested.  Follow up information was obtained on 04APR2021 during a review of scientific literature: 2021, (MAR15) [cited 2021 Apr 04] 1-7.    This is case 3 of 5 reported cases within the article: (cross reference: 21000041LT, 18000140LT, 18000141LT, and 18000142LT).    The additional information included: additional laboratory values, diagnosis and outcome information.   The patient was reported to be a healthy 19 year old male who received a primary dose of ACAM2000 in April 2018; and was subsequently diagnosed with probable Myopericarditis.  Additional symptoms reported included: shortness of breath, diaphoresis, dizziness, chills and fever.  His significant laboratory findings included HSV 1 (Glycoprotein G Ab IgG): Positive; prior Epstein interpretation positive for past infection; Epstein Barr virus Ab Igg positive and an echocardiogram showed systolic dysfunction without heart failure. The patient received follow-up care with a cardiologist for 6 months and serial cardiac imaging. He was placed on limited duty with no exercise for 6 weeks and a non-deployable status for at least 6 months. He was followed by a cardiologist until complete recovery at between 3 and 9 months.   The authors concluded that there was no significant difference observed between the rate seen and the published rates that occurred during the clinical trials. The available evidence suggested that the 5 cases were not an unexpected elevation in the rate of the disease or condition, but rather a predictable number of myopericarditis cases proportional to the increased number of vaccinations performed during a short period of time.  Company comment: This report originated from a literature article describing myopericarditis following smallpox vaccination.  The event of myopericarditis is considered a medically significant event. The ACAM2000 product information states under the warning section: Myocarditis and pericarditis  cases observed at a rate of 5.7 per 1000 primary vaccines (95% CI: 1.9-13.3). These events are labeled and considered related to the ACAM2000 vaccine. Information received on 04APR201 does not change the previous assessment. Because pericarditis was ruled out, tmyocarditis was the final diagnosis.  Additional symptoms associated to myocarditis were not recorded as adverse events as per MedDRA points to consider.; Sender's Comments: Company comment: This report originated from a literature article describing myopericarditis following smallpox vaccination.  The event of myopericarditis is considered a medically significant event. The ACAM2000 product information states under the warning section: Myocarditis and pericarditis  cases observed at a rate of 5.7 per 1000 primary vaccines (95% CI: 1.9-13.3). These events are labeled and considered related to the ACAM2000 vaccine. Information received on 04APR201 does not change the previous assessment. Because pericarditis was ruled out, tmyocarditis was the final diagnosis.  Additional symptoms associated to myocarditis were not recorded as adverse events as per MedDRA points to consider. US-EMERGENT BIOSOLUTIONS-18000139LT: US-EMERGENT BIOSOLUTIONS-18000140LT: US-EMERGENT BIOSOLUTIONS-18000138LT: US-EMERGENT BIOSOLUTIONS-18000142LT: US-EMERGENT BIOSOLUTIONS-18000141LT: US-EMERGENT BIOSOLUTIONS-21000041LT:Article: Myopericarditis Associated With Smallpox Vaccination Among  Personnel 2018