Sex: F
Vaccine: SMALL
Symptoms: Dizziness, Dyspnoea, Enterovirus test negative, Epstein-Barr virus antibody positive, Epstein-Barr virus test negative
Clinical narrative: Chest pain; Shortness of breath; Fever; Chills; Dizziness; Diaphoresis; This case was obtained on 04APR2021 in the review of scientific publications.  This is case 5 of 5 (cross reference: 18000140LT, 18000141LT, 18000142LT, and 18000143LT).   A 23 year old healthy female experienced suspected myopericarditis following vaccination with ACAM2000.  In April 2018, the patient received a first dose of ACAM2000 (Lot Unknown). Approximately 8-11 days after vaccination, she presented to the Emergency department with an acute onset of chest pain but without complaints of recent body aches, fever, or respiratory symptoms that may be suggestive of influenza-type illness. Other clinical signs at presentation included shortness of breath, diaphoresis, dizziness, chills and fever. Her troponin was negative. She received follow up care with a cardiologist for 6 months and underwent serial cardiac imaging. Additionally she was placed on limited duty with no exercise for six weeks with non-deployable status for at least six months.  She was followed by a Cardiologist until complete recovery at between three and nine months.  Laboratory Data included:  Flu A/B (rapid Ag) - Negative Coxsackie A7, A9, A16, A24, (IgG/IgM) - A-9/A-24 IgG*/IgM- Parvo B19 (IgG/IgM) - IgG+/IgM- Epstein Interpretation - Past Infection Epstein Barr Virus Capsid Ab IgG - Positive Epstein Barr Virus Ab - Negative Epstein-Barr Virus Capsid Ab IgM - Negative  Epstein Barr Virus Early Ab IgG - Negative Epstein Barr Virus Nuclear Ab IgG - Positive Adenovirus Ab - Negative Cytomegalovirus DNA PCR - Negative Viral Culture - Negative Enterovirus - Negative Parechovirus - Negative  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 comments: This article was a retrospective analysis and detail of the cases were not specific. This case was associated with a suspected  myocarditis. In the manuscript categorized myocarditis or pericarditis as "data insufficient to adjudicate" in cases of subclinical myopericarditis. The same case applies in this case. The patient had chest pain but troponin was normal, no indication that an ECG was done, she was treated as an outpatient and the follow up with cardiologists did not make the diagnosis. For this reason, myocarditis was not recorded as an adverse event but the symptoms. The company considers that the chest pain, dyspnea, fever and chills are possible related but dizziness and hyperhidrosis as not assessable. More information will be requested.; Sender's Comments: Company comments: This article was a retrospective analysis and detail of the cases were not specific. This case was associated with a suspected  myocarditis. In the manuscript categorized myocarditis or pericarditis as "data insufficient to adjudicate" in cases of subclinical myopericarditis. The same case applies in this case. The patient had chest pain but troponin was normal, no indication that an ECG was done, she was treated as an outpatient and the follow up with cardiologists did not make the diagnosis. For this reason, myocarditis was not recorded as an adverse event but the symptoms. The company considers that the chest pain, dyspnea, fever and chills are possible related but dizziness and hyperhidrosis as not assessable. More information will be requested. US-Emergentbiosolutions-18000140LT:Argus Case corresponding to Patient 4 US-EMERGENT BIOSOLUTIONS-18000141lT:Argus Case corresponding to Patient 2 US-Emergentbiosolutions-18000142LT:Argus Case corresponding to Patient 1 US-Emergentbiosolutions-18000143LT:Argus Cse corresponding to Patient 3 US-EMERGENT BIOSOLUTIONS-21000041LT:Argus Case corresponding to Patient 2