# Presentation: 303609

## The Department of Defense Smallpox Vaccination Program

- UNCLASSIFIED

**Military Vaccine Agency**
**LTC Stephen Ford**
**Deputy Director, Scientific Affairs**
**17 May 2007**

_**www.smallpox.mil**_**               **_**www.vaccines.mil/smallpox   **_

## Background

**Background**
** ****December 2002 President directs smallpox immunization**
** ****December 16, 2002 the Department of Defense (DoD) initiates vaccination of select US forces, emergency essential civilians  and contractors deployed in support of US Central Command missions**
** ****To date over 110,000 medical exemptions for contraindications in over 1.2 million Service members vaccinated**

## Program Principles:

**Program Principles:**
** ****Multi-media**** ****Education****: leaders, healthcare workers, and vaccinees**
** ****Screening****: standardized form to identify ACIP-recognized contraindications**
** ****Adverse event monitoring****: multiple communication channels, standard case definitions, pregnancy registry, long-term follow-up**
** ****Quality**** ****standards for immunization****: before, during, and after vaccination**

**Education: Smallpox Trifold**

- Augmented with PowerPoint
- slides and other training
- aids/materials

**Education: Household Contacts**

**Screening: Medical Note for Contraindications**

**Monitoring**:
**Smallpox**
**Vaccine**
**Pregnancy**
**Registry**

## Joint regulation (Immunizations and Chemoprophylaxis) requires reporting of adverse events resulting in:

hospitalization
a life-threatening event (for example anaphylaxis)
time lost from duty more than 24 hours (more than 1 duty shift)
any event related to suspected contamination of a vaccine vial
any event warranting a permanent medical exemption (a contraindicating event)

**hospitalization**
**a life-threatening event (for example anaphylaxis)**
**time lost from duty more than 24 hours (more than 1 duty shift)**
**any event related to suspected contamination of a vaccine vial**
**any event warranting a permanent medical exemption (a contraindicating event)**

* *

**Monitoring: Reportable Events**

**Notes:**
Possible

A 22-year-old soldier assigned to 452d Combat Support Hospital, processing at Fort McCoy, was admitted to St. Francis Medical Center, LaCrosse, WI, for a lingering respiratory syndrome. On 1 Apr 03, she developed high fevers (40°C). On 2 Apr 03, she had a seizure. She was transferred to the Mayo Clinic, where she became unresponsive and died. Autopsy found no encephalitis, no meningitis, no vaccinia by PCR in her spinal fluid.  Autopsy revealed that she had pericarditis, although there is no indication that this was a cause of her death. CDC officers enrolled this case in their "unexplained death" program. She received smallpox, measles-mumps-rubella, anthrax, hepatitis B, and typhoid vaccinations on 2 Mar 03. DoD worked with CDC, Minnesota, Olmstead County, and Mayo Clinic scientists to identify the factors leading to her death. These records were provided to two independent panels of civilian physicians who concluded that vaccination may have caused her illness, but that no one vaccine could be specifically implicated.

Unlikely / unrelated

A 55-year-old male National Guard soldier called to active duty had a heart attack on March 25, 2003, at a U.S. installation. He died late on March 26, 2003. The heart attack occurred 5 days after smallpox vaccination. Autopsy findings indicate that this man had substantial narrowing of the blood vessels in his heart that existed before vaccination, as well as prior heart disease. At this stage of the investigation, this evidence of pre-existing illness, coupled with other findings and risk factors in his medical history, indicate that smallpox vaccination was unlikely to be the cause of his death. Evidence shows that he did NOT have myo/pericarditis. Additional tests will be conducted, including tests at the Armed Forces Institute of Pathology (AFIP). 

A 39 y/o civilian developed a deep-vein thrombosis (blood clot) that passed into his lungs and blocked a pulmonary artery, leading to his death 31 days after smallpox vaccination. Autopsy showed that he had a genetic predisposition to forming blood clots. Because of this, his death is considered unlikely to be related to vaccination. 

A 47 y/o male soldier was found unresponsive several hours after vigorous physical training, which was 2 days after smallpox vaccination. He was found to have atherosclerotic coronary vascular disease (ASCVD, “hardening of the arteries”) with substantial narrowing of the blood vessels in his heart that existed before vaccination. He had smoked cigarettes for 15 years and had high blood pressure. 

A 22 y/o male soldier was found unresponsive in his barracks 5 days after smallpox vaccination. Toxicology tests found lethal concentrations of methadone, benzodiazepines (like Valium), ethanol, and other chemicals in his blood. His cause of death was reported as “drug overdose due to multi-drug ingestion." 

## Screened: over 1.3M	  Vaccinated: over 1.2M
Exemption process working well
Eczema vaccinatum - 1        Progressive vaccinia – 0
VIG treatments more rare than expected   
Education working well
Autoinoculation - 86
Contact transfer vaccinia - 61:    “Don’t let guard down at home.”
Case evaluation of serious adverse events:
Encephalitis – 4
Myo-pericarditis -140
Most vaccinia-associated myopericarditis patients experience complete resolution of MP symptoms and objective findings by 6 months
Deaths in the peri-vaccination period- 3

- Exemption process working well
- Eczema vaccinatum - 1        Progressive vaccinia – 0
- VIG treatments more rare than expected
- Education working well
- Autoinoculation - 86
- Contact transfer vaccinia - 61:    **“Don’t let guard down at home.”**
- Case evaluation of serious adverse events:
- Encephalitis** – ****4**
- Myo-pericarditis** -****140**
**Most vaccinia-associated myopericarditis patients experience complete resolution of MP symptoms and objective findings by 6 months**
**Deaths**** ****in the peri-vaccination period-**** 3**

* *

**Monitoring: Adverse Events as of 9 May 2007**

**Notes:**
Possible

A 22-year-old soldier assigned to 452d Combat Support Hospital, processing at Fort McCoy, was admitted to St. Francis Medical Center, LaCrosse, WI, for a lingering respiratory syndrome. On 1 Apr 03, she developed high fevers (40°C). On 2 Apr 03, she had a seizure. She was transferred to the Mayo Clinic, where she became unresponsive and died. Autopsy found no encephalitis, no meningitis, no vaccinia by PCR in her spinal fluid.  Autopsy revealed that she had pericarditis, although there is no indication that this was a cause of her death. CDC officers enrolled this case in their "unexplained death" program. She received smallpox, measles-mumps-rubella, anthrax, hepatitis B, and typhoid vaccinations on 2 Mar 03. DoD worked with CDC, Minnesota, Olmstead County, and Mayo Clinic scientists to identify the factors leading to her death. These records were provided to two independent panels of civilian physicians who concluded that vaccination may have caused her illness, but that no one vaccine could be specifically implicated.

Unlikely / unrelated

A 55-year-old male National Guard soldier called to active duty had a heart attack on March 25, 2003, at a U.S. installation. He died late on March 26, 2003. The heart attack occurred 5 days after smallpox vaccination. Autopsy findings indicate that this man had substantial narrowing of the blood vessels in his heart that existed before vaccination, as well as prior heart disease. At this stage of the investigation, this evidence of pre-existing illness, coupled with other findings and risk factors in his medical history, indicate that smallpox vaccination was unlikely to be the cause of his death. Evidence shows that he did NOT have myo/pericarditis. Additional tests will be conducted, including tests at the Armed Forces Institute of Pathology (AFIP). 

A 39 y/o civilian developed a deep-vein thrombosis (blood clot) that passed into his lungs and blocked a pulmonary artery, leading to his death 31 days after smallpox vaccination. Autopsy showed that he had a genetic predisposition to forming blood clots. Because of this, his death is considered unlikely to be related to vaccination. 

A 47 y/o male soldier was found unresponsive several hours after vigorous physical training, which was 2 days after smallpox vaccination. He was found to have atherosclerotic coronary vascular disease (ASCVD, “hardening of the arteries”) with substantial narrowing of the blood vessels in his heart that existed before vaccination. He had smoked cigarettes for 15 years and had high blood pressure. 

A 22 y/o male soldier was found unresponsive in his barracks 5 days after smallpox vaccination. Toxicology tests found lethal concentrations of methadone, benzodiazepines (like Valium), ethanol, and other chemicals in his blood. His cause of death was reported as “drug overdose due to multi-drug ingestion." 

## Screened: over 1.3M	  Vaccinated: over 1.2M
Exemption process working well
Eczema vaccinatum - 1        Progressive vaccinia – 0
VIG treatments more rare than expected   
Education working well
Autoinoculation - 86
Contact transfer vaccinia - 61:    “Don’t let guard down at home.”
Case evaluation of serious adverse events:
Encephalitis – 4
Myopericarditis -140
Most vaccinia-associated myopericarditis patients experience complete resolution of MP symptoms and objective findings by 6 months
Deaths in the post-multiple vaccination period- 2

- Exemption process working well
- Eczema vaccinatum - 1        Progressive vaccinia – 0
- VIG treatments more rare than expected
- Education working well
- Autoinoculation - 86
- Contact transfer vaccinia - 61:    **“Don’t let guard down at home.”**
- Case evaluation of serious adverse events:
- Encephalitis** – ****4**
- Myopericarditis** -****140**
**Most vaccinia-associated myopericarditis patients experience complete resolution of MP symptoms and objective findings by 6 months**
- Deaths in the post-multiple vaccination period-** 2**

* *

**Monitoring: Adverse Events as of 9 May 2007**

**Notes:**
Possible

A 22-year-old soldier assigned to 452d Combat Support Hospital, processing at Fort McCoy, was admitted to St. Francis Medical Center, LaCrosse, WI, for a lingering respiratory syndrome. On 1 Apr 03, she developed high fevers (40°C). On 2 Apr 03, she had a seizure. She was transferred to the Mayo Clinic, where she became unresponsive and died. Autopsy found no encephalitis, no meningitis, no vaccinia by PCR in her spinal fluid.  Autopsy revealed that she had pericarditis, although there is no indication that this was a cause of her death. CDC officers enrolled this case in their "unexplained death" program. She received smallpox, measles-mumps-rubella, anthrax, hepatitis B, and typhoid vaccinations on 2 Mar 03. DoD worked with CDC, Minnesota, Olmstead County, and Mayo Clinic scientists to identify the factors leading to her death. These records were provided to two independent panels of civilian physicians who concluded that vaccination may have caused her illness, but that no one vaccine could be specifically implicated.

Unlikely / unrelated

A 55-year-old male National Guard soldier called to active duty had a heart attack on March 25, 2003, at a U.S. installation. He died late on March 26, 2003. The heart attack occurred 5 days after smallpox vaccination. Autopsy findings indicate that this man had substantial narrowing of the blood vessels in his heart that existed before vaccination, as well as prior heart disease. At this stage of the investigation, this evidence of pre-existing illness, coupled with other findings and risk factors in his medical history, indicate that smallpox vaccination was unlikely to be the cause of his death. Evidence shows that he did NOT have myo/pericarditis. Additional tests will be conducted, including tests at the Armed Forces Institute of Pathology (AFIP). 

A 39 y/o civilian developed a deep-vein thrombosis (blood clot) that passed into his lungs and blocked a pulmonary artery, leading to his death 31 days after smallpox vaccination. Autopsy showed that he had a genetic predisposition to forming blood clots. Because of this, his death is considered unlikely to be related to vaccination. 

A 47 y/o male soldier was found unresponsive several hours after vigorous physical training, which was 2 days after smallpox vaccination. He was found to have atherosclerotic coronary vascular disease (ASCVD, “hardening of the arteries”) with substantial narrowing of the blood vessels in his heart that existed before vaccination. He had smoked cigarettes for 15 years and had high blood pressure. 

A 22 y/o male soldier was found unresponsive in his barracks 5 days after smallpox vaccination. Toxicology tests found lethal concentrations of methadone, benzodiazepines (like Valium), ethanol, and other chemicals in his blood. His cause of death was reported as “drug overdose due to multi-drug ingestion." 

**Monitoring: Case Definitions ****(MMWR 2003;52:492-6)**

**Notes:**
Possible

A 22-year-old soldier assigned to 452d Combat Support Hospital, processing at Fort McCoy, was admitted to St. Francis Medical Center, LaCrosse, WI, for a lingering respiratory syndrome. On 1 Apr 03, she developed high fevers (40°C). On 2 Apr 03, she had a seizure. She was transferred to the Mayo Clinic, where she became unresponsive and died. Autopsy found no encephalitis, no meningitis, no vaccinia by PCR in her spinal fluid.  Autopsy revealed that she had pericarditis, although there is no indication that this was a cause of her death. CDC officers enrolled this case in their "unexplained death" program. She received smallpox, measles-mumps-rubella, anthrax, hepatitis B, and typhoid vaccinations on 2 Mar 03. DoD worked with CDC, Minnesota, Olmstead County, and Mayo Clinic scientists to identify the factors leading to her death. These records were provided to two independent panels of civilian physicians who concluded that vaccination may have caused her illness, but that no one vaccine could be specifically implicated.

Unlikely / unrelated

A 55-year-old male National Guard soldier called to active duty had a heart attack on March 25, 2003, at a U.S. installation. He died late on March 26, 2003. The heart attack occurred 5 days after smallpox vaccination. Autopsy findings indicate that this man had substantial narrowing of the blood vessels in his heart that existed before vaccination, as well as prior heart disease. At this stage of the investigation, this evidence of pre-existing illness, coupled with other findings and risk factors in his medical history, indicate that smallpox vaccination was unlikely to be the cause of his death. Evidence shows that he did NOT have myo/pericarditis. Additional tests will be conducted, including tests at the Armed Forces Institute of Pathology (AFIP). 

A 39 y/o civilian developed a deep-vein thrombosis (blood clot) that passed into his lungs and blocked a pulmonary artery, leading to his death 31 days after smallpox vaccination. Autopsy showed that he had a genetic predisposition to forming blood clots. Because of this, his death is considered unlikely to be related to vaccination. 

A 47 y/o male soldier was found unresponsive several hours after vigorous physical training, which was 2 days after smallpox vaccination. He was found to have atherosclerotic coronary vascular disease (ASCVD, “hardening of the arteries”) with substantial narrowing of the blood vessels in his heart that existed before vaccination. He had smoked cigarettes for 15 years and had high blood pressure. 

A 22 y/o male soldier was found unresponsive in his barracks 5 days after smallpox vaccination. Toxicology tests found lethal concentrations of methadone, benzodiazepines (like Valium), ethanol, and other chemicals in his blood. His cause of death was reported as “drug overdose due to multi-drug ingestion." 

##  Defense Medical Surveillance System (DMSS): 
large linked database analogous to Vaccine Safety Datalink project
Includes demographic, occupational, medical encounters, immunization registry, and serial serum specimens
 Lack of an association of ischemia or chest pain after smallpox vaccination (manuscript under review)
 Electronic medical record Armed Forces Health Longitudinal Technology Application (AHLTA) being phased-in

**large linked database analogous to Vaccine Safety Datalink project**
**Includes demographic, occupational, medical encounters, immunization registry, and serial serum specimens**
** ****Lack of an association of ischemia or chest pain after smallpox vaccination (****manuscript under review****)**
** ****Electronic medical record ****Armed Forces Health Longitudinal Technology Application** **(AHLTA) being phased-in**
**	**

* *

**Monitoring: DoD Cohort Studies Contrasting Vaccinated and Unvaccinated Personnel**

**Notes:**
Possible

A 22-year-old soldier assigned to 452d Combat Support Hospital, processing at Fort McCoy, was admitted to St. Francis Medical Center, LaCrosse, WI, for a lingering respiratory syndrome. On 1 Apr 03, she developed high fevers (40°C). On 2 Apr 03, she had a seizure. She was transferred to the Mayo Clinic, where she became unresponsive and died. Autopsy found no encephalitis, no meningitis, no vaccinia by PCR in her spinal fluid.  Autopsy revealed that she had pericarditis, although there is no indication that this was a cause of her death. CDC officers enrolled this case in their "unexplained death" program. She received smallpox, measles-mumps-rubella, anthrax, hepatitis B, and typhoid vaccinations on 2 Mar 03. DoD worked with CDC, Minnesota, Olmstead County, and Mayo Clinic scientists to identify the factors leading to her death. These records were provided to two independent panels of civilian physicians who concluded that vaccination may have caused her illness, but that no one vaccine could be specifically implicated.

Unlikely / unrelated

A 55-year-old male National Guard soldier called to active duty had a heart attack on March 25, 2003, at a U.S. installation. He died late on March 26, 2003. The heart attack occurred 5 days after smallpox vaccination. Autopsy findings indicate that this man had substantial narrowing of the blood vessels in his heart that existed before vaccination, as well as prior heart disease. At this stage of the investigation, this evidence of pre-existing illness, coupled with other findings and risk factors in his medical history, indicate that smallpox vaccination was unlikely to be the cause of his death. Evidence shows that he did NOT have myo/pericarditis. Additional tests will be conducted, including tests at the Armed Forces Institute of Pathology (AFIP). 

A 39 y/o civilian developed a deep-vein thrombosis (blood clot) that passed into his lungs and blocked a pulmonary artery, leading to his death 31 days after smallpox vaccination. Autopsy showed that he had a genetic predisposition to forming blood clots. Because of this, his death is considered unlikely to be related to vaccination. 

A 47 y/o male soldier was found unresponsive several hours after vigorous physical training, which was 2 days after smallpox vaccination. He was found to have atherosclerotic coronary vascular disease (ASCVD, “hardening of the arteries”) with substantial narrowing of the blood vessels in his heart that existed before vaccination. He had smoked cigarettes for 15 years and had high blood pressure. 

A 22 y/o male soldier was found unresponsive in his barracks 5 days after smallpox vaccination. Toxicology tests found lethal concentrations of methadone, benzodiazepines (like Valium), ethanol, and other chemicals in his blood. His cause of death was reported as “drug overdose due to multi-drug ingestion." 

##  DoD sharing experience with CDC, IOM, and State Health Departments (Dec ’02 to present)
 First case definitions for generalized vaccinia and myocarditis
 Participation on multiple working groups with CDC, ACIP, and the Defense Health Board (formerly the AFEB)
 Scientific publications, such as:
Arness et al. Myopericarditis following smallpox vaccination. Am J. Epidemiol 2004;160:642-51	
Eckert et al. Incidence and follow-up of inflammatory cardiac complications following smallpox vaccination J Am Coll Cardiol 2004;44:201-5
Barkdoll. Secondary and tertiary transfer of vaccinia virus among US personnel-United States and worldwide, 2002-2004. MMWR 2004;53:103-5. 
Sejvar et al. Neurologic adverse events associated with smallpox vaccination in the US, 2002-2004. JAMA 2005;294:2744-50.

** ****First case definitions for generalized vaccinia and myocarditis**
** ****Participation on multiple working groups with CDC, ACIP, and the Defense Health Board (formerly the AFEB)**
** ****Scientific publications, such as:**
**Arness et al. Myopericarditis following smallpox vaccination. Am J. Epidemiol 2004;160:642-51****	**
**Eckert et al. Incidence and follow-up of inflammatory cardiac complications following smallpox vaccination J Am Coll Cardiol 2004;44:201-5**
**Barkdoll. Secondary and tertiary transfer of vaccinia virus among US personnel-United States and worldwide, 2002-2004. MMWR 2004;53:103-5.**** **
**Sejvar et al. Neurologic adverse events associated with smallpox vaccination in the US, 2002-2004. JAMA 2005;294:2744-50.**

* *

**Monitoring: DoD Commitment to Scientific Communication**

**Notes:**
Possible

A 22-year-old soldier assigned to 452d Combat Support Hospital, processing at Fort McCoy, was admitted to St. Francis Medical Center, LaCrosse, WI, for a lingering respiratory syndrome. On 1 Apr 03, she developed high fevers (40°C). On 2 Apr 03, she had a seizure. She was transferred to the Mayo Clinic, where she became unresponsive and died. Autopsy found no encephalitis, no meningitis, no vaccinia by PCR in her spinal fluid.  Autopsy revealed that she had pericarditis, although there is no indication that this was a cause of her death. CDC officers enrolled this case in their "unexplained death" program. She received smallpox, measles-mumps-rubella, anthrax, hepatitis B, and typhoid vaccinations on 2 Mar 03. DoD worked with CDC, Minnesota, Olmstead County, and Mayo Clinic scientists to identify the factors leading to her death. These records were provided to two independent panels of civilian physicians who concluded that vaccination may have caused her illness, but that no one vaccine could be specifically implicated.

Unlikely / unrelated

A 55-year-old male National Guard soldier called to active duty had a heart attack on March 25, 2003, at a U.S. installation. He died late on March 26, 2003. The heart attack occurred 5 days after smallpox vaccination. Autopsy findings indicate that this man had substantial narrowing of the blood vessels in his heart that existed before vaccination, as well as prior heart disease. At this stage of the investigation, this evidence of pre-existing illness, coupled with other findings and risk factors in his medical history, indicate that smallpox vaccination was unlikely to be the cause of his death. Evidence shows that he did NOT have myo/pericarditis. Additional tests will be conducted, including tests at the Armed Forces Institute of Pathology (AFIP). 

A 39 y/o civilian developed a deep-vein thrombosis (blood clot) that passed into his lungs and blocked a pulmonary artery, leading to his death 31 days after smallpox vaccination. Autopsy showed that he had a genetic predisposition to forming blood clots. Because of this, his death is considered unlikely to be related to vaccination. 

A 47 y/o male soldier was found unresponsive several hours after vigorous physical training, which was 2 days after smallpox vaccination. He was found to have atherosclerotic coronary vascular disease (ASCVD, “hardening of the arteries”) with substantial narrowing of the blood vessels in his heart that existed before vaccination. He had smoked cigarettes for 15 years and had high blood pressure. 

A 22 y/o male soldier was found unresponsive in his barracks 5 days after smallpox vaccination. Toxicology tests found lethal concentrations of methadone, benzodiazepines (like Valium), ethanol, and other chemicals in his blood. His cause of death was reported as “drug overdose due to multi-drug ingestion." 

## Vaccine Healthcare Center Network

**Vaccine Clinical Support & Consultation Services**
**Adverse events & efficacy case management, exemptions**
**Vaccine Safety**
**Surveillance, reporting & adverse events registry, long term follow-up**
**Immunization Healthcare Education**** **
**For Health Care Workers & Service Members, Beneficiaries, DoD, etc.**
**Support for Research**
**Clinical focus, post-licensure, to “enhance vaccine safety, efficacy & acceptability”**

**Advocacy For**
**Quality immunization healthcare delivery**
**Care of complex AE’s**

**Outreach & Support 24/7**
**Clinical Call Center (toll-free)**
**Secure Consultative E-mail**

- Network of MTF-linked Sites
- NOT service specific but regional

## Evolving Working Group Document

*Evolving Working Group Document*
*Based on Case Reviews & Expert Consensus Opinion*

**Post Vaccine Pericarditis-Myocarditis-Myopericarditis Guidelines: A Work in Progress**

## Knowledge, Attitudes, And Beliefs (KAB) Regarding the Vaccine Adverse Event Reporting System (VAERS) Among Department of Defense (DOD) Health Care Workers

**Objectives:**
**To assess the knowledge, attitudes and beliefs of military health care providers regarding the identification and reporting of adverse events following immunizations (AEFI)**
**Convenience sample of military healthcare workers**
**547 surveys distributed; 512 collected (response rate: 93.6%)**
**Overall, ~54% of study respondents were at least somewhat familiar with VAERS before being contacted regarding the survey**
**~48% of all study participants reported having identified a patient with AEFI of any severity at least once**
**Of these, less than half (44.9%) reported the last identified AEFI to VAERS**
**Preferred method of reporting to VAERS was the VAERS web site (65.1%)**

## Smallpox Vaccination and Myopericardial Injury/Inflammation

- Objectives:
- To determine the rate of abnormalities in ECG and/or troponin elevation and/or other clinical indicators suggestive of symptomatic or asymptomatic myopericarditis within 30 days following influenza or smallpox vaccination
- To assess changes in immune & inflammatory activation markers in a subset of vaccinees who develop indicators of either pericarditis or myocarditis & an age, gender & ethnically matched set of asymptomatic controls.
- Collaborators:
- Dr. Christopher Wilson, University of Washington
- CDC/CISA/Kaiser
- Enrollment sites: WRAMC, Fort Bragg, University of Washington: Remote civilian cases
- Funding: NIAID, NIH

## Acknowledgements

- LTC (Dr.) Michael Nelson, Walter Reed Army Medical Center, Department of Allergy and Immunology
- Dr. Limone Collins, Vaccine Healthcare Center Network
- CDR (Dr.) Megan Ryan, Naval Health Research Center
- COL (Dr.) Renata Engler, Vaccine Healthcare Center
- COL Randall Anderson, Military Vaccine Agency
- COL (Ret.) John Grabenstein

## Back-up slides

## Vaccinia Associated Myopericarditis Outcomes

**Symptoms**
**Criteria**
**Any symptom in CDC case definition**
**Any other new persistent symptom (n=0)**
**Other new symptom affecting QOL of life attributable to vaccine by HCP (n=0)**
**CP & fatigue most frequent**
**Late CP usually transient & atypical for ischemia or MP**
**recurrence of typical VAMP CP in 1-2**
**Nonsystematic**

**Objective findings**
**No persistence of clinically relevant findings**
**Nonspecific ECG changes (normal variants)**
**Multiple interpreters**
**Nonsystematic**

## Vaccinia Associated Myopericarditis OutcomesConclusions

**Most VAMP patients experience complete resolution of MP symptoms and objective findings by 6 months**
**Up to ~30% may have nonspecific symptoms (esp. CP & fatigue) &/or ECG findings >6 months after onset of VAMP**
**Avoidance of activities that increase cardiovascular risk should be undertaken for at least 6 months by these**** ****pts**