Sex: M
Vaccine: SMALL
Symptoms: Herpes simplex, Herpes simplex test positive, Hyperhidrosis, Impaired work ability, Myocarditis
Clinical narrative: Myopericarditis / Probable Myopericarditis; Left-sided pleuritic chest pain; PR depressions; Trace effusion; Information received from the review of scientific literature on 02JUL2018.  This is case 5 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT)   The article notes a 27-year-old male who presented to the ED with left-sided pleuritic chest pain 11 days after receiving ACAM2000. His pain was worse with movement, but otherwise non-exertional or positional. His ECG showed diffuse ST elevations and PR depressions. The patient's chest x-ray and bedside transthoracic echocardiogram were unremarkable and his troponin-I was elevated at 0.25. Cardiology was consulted from an outside hospital, and the patient was then transferred for further evaluation and treatment of myopericarditis. The patient was given toradol and started on colchicine prior to transfer. As an inpatient, his formal echocardiogram showed trace effusion, but otherwise, there were no structural changes and he had a normal ejection fraction. Ibuprofen and colchicine were continued and he was followed by Cardiology as an outpatient. The patient was then placed on a 6-month medical profile. Approximately 1 month after initial presentation to the ED, the patient returned with 1 day of similar chest pain. He had been compliant with medication and his initial ECG was normal without signs of ST elevation of PR depression. On repeat ECG, he showed non-specific ST changes in leads II, III, and aVL. His troponin-I was within normal limits and a bedside transthoracic echocardiogram was normal as well. Due to dynamic changes in ECG and recent history of myopericarditis, the patient was transferred to an outside hospital for further evaluation. The patient's outcome was not reported in the article.  Follow up information was obtained on 04APR2021 during a review of scientific literature:  This is case 1 of 5 reported cases within the article: (cross reference: 21000041LT, 18000140LT, 18000141LT, and 18000143LT).    The additional information received included: additional laboratory values, diagnosis and outcome information.   The patient was reported to be a 27 year old healthy 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 ECG showed diffuse T wave abnormalities with no pericardial effusion. His significant laboratory findings included  HSV 1 (Glycoprotein G Ab IgG): Positive, Epstein Barr Virus Capsid Ab IgG: Positive; Epstein-Barr Virus Nuclear Ab IgG: Positive, Adenovirus Aba: Positive, Parvo B19 (IgG/IgM): IgG+/ IgM+, Coxsackie A7, A9, A16, A24 (IgG/IgM): IgG+/IgM+. For other tests with negative results please refer to relevant test section.  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 at Facility 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 at Facility 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. The information received on 04APR2021 does not change the previous assessment. Additional symptoms associated with myopericaditis are not recorded as adverse events as per database 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. The information received on 04APR2021 does not change the previous assessment. Additional symptoms associated with myopericaditis are not recorded as adverse events as per database points to consider. US-emergentbiosolutions-18000139LT: US-emergentbiosolutions-18000140LT: US-emergentbiosolutions-18000143LT: US-emergentbiosolutions-18000138LT: US-emergentbiosolutions-18000141LT: US-emergentbiosolutions-21000041LT: