Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Laboratory test normal, Lymphadenopathy, Myocardial necrosis marker normal, Nausea, Troponin I increased
Clinical narrative: This Initial solicited case was received from the investigator in a trial on 16 April 2010. Initial report received on 16 April 2010 from an investigator participating in a trial. A 26-year-old female subject received ACAM2000, (lot number not reported) and Tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. On 10 April 2010, five days after vaccination, the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related. Follow-up received from the investigator on 29 April 2010. The subject was seen for Visit 2 on 14 April 2010 and in addition to the symptom of chest pressure, the subject reported the following adverse events: mild shortness of breath, mild fatigue, nausea, sweats and mild swollen lymph nodes in the neck on left side. The onset for all symptoms was 10 April 2010 (five days after vaccination). None of these events were assessed as serious. At Visit 2, the subject had a Troponin I drawn which was less than 0.10 (negative) and an electrocardiogram which on final report was normal. The subject reported that several tests were performed (electrocardiogram, echocardiogram, and laboratory work) and all were normal. The subject was discharged with prescriptions for Ibuprofen (400 mg), Acetaminophen (325 mg) and Nexium (40 mg). The subject was placed on light duty with orders to report back to Cardiology in 4 weeks. The final diagnosis is pending. Hospital records have been requested. Follow-up information was received via Q-Scan search of the VAERS database on 30 July 2010. The VAERS case ID number was reported as 385498. No other relevant medically significant information was received. Follow-up information received from the investigator on 04 August 2010. The copy of hospital medical records was provided. At study visit 2 which occurred on 14 April 2010, the subject reported symptoms including chest pressure and shortness of breath that had started on 10 April 2010 after receipt of the smallpox vaccine. The subject was referred to the emergency room and was subsequently admitted for overnight cardiac monitoring given a suspicion for vaccine-induced myopericarditis. These events were reported by the investigator to the IRB on 15 April 2010, prior to availability of medical records. While hospitalized, work up included ECG, serial cardiac enzymes, chest x-ray and ECHO, all of which were negative. As a precaution, the subject was discharged on a 12 week light duty profile with low dose NSAIDS (Motrin) to treat possible myopericarditis, and Nexium to mitigate possible gastrointestinal side effects of NSAIDS. The subject had a negative exercise stress test on 12 May 2010. No other follow-up visit or diagnosis was available in the medical record. Per the investigator's discussion with the cardiologist, the subject had no evidence of myopericarditis. The etiology of her chest pain (pressure) remains unidentified. The investigator had determined that the relationship between her hospitalization for chest pressure and her receipt of the smallpox vaccines is "remote." It was noted the subject was started on Doxycycline on 29 April 2010 (indication not reported). Per the investigator: "Causality in this study is assigned based on the relationship of the adverse event to receipt of the smallpox vaccine, though the vaccine is not part of this study's procedures. While the subject's hospitalization is likely related to her participation in this study (i.e., she may not have come to medical attention had the study team not referred her to the ER), her presenting symptoms are NOT likely due to receipt of the vaccine. This AE is deemed "resolved." No further follow-up will occur." Follow-up information received from an investigator from a trial on 09 May 2011. The stop date for the chest discomfort was confirmed to be 15 April 2010. The outcome remained recovered on 12 May 2010. According to the investigator, the relationship of chest discomfort was reported as "remote" (not related) to the study product. List of documents held by sender (29 April 2010): Discharge physician summary, diagnostic test results. Follow-up information was received on 26 January 2012 from the investigator. The subject in this case has also been captured in case number 2010-04306 (VAERS #387275 and #412623). New VAERS listing received on 10 August 2015 with no new information. Upon internal review, the following data was amended: Reporter causality was changed to not associated from associated and IB unexpectedness was kept blank as listedness was filled. Follow up information received on 08 November 2016: The subject had medical history of frequent or severe headaches, and allergy. The subject received concomitant medications Ibuprofen 1 tab orally as needed for headaches and Excedrin 1 tab orally as needed for headaches. A questionnaire of smoking and drinking habits was received. The relationship of the reported events with concomitant medications Ibuprofen and Excedrin was not reported. Sender's Comments: Follow up information received on 08 November 2016: Medical assessment: This is a report of a 26-year-old with no relevant medical conditions who experienced severe chest pressure several days post-vaccination with ACAM2000 and a tetanus vaccine. The clinical description/context was initially consistent with a possible myopericarditis, which is a known event following vaccination with live vaccinia virus. It is to be noted that the troponin I, ECG, and echocardiogram were normal. Based on cardiology evaluation, myopericarditis was ruled out, and the final diagnosis was chest pressure, unknown etiology. The patient recovered fully. She had significant history of smoking and alcohol. Per the investigator's follow-up, the case is assessed as not related. Further information is not expected.