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Recommendations for the Administration of Smallpox Immunizations

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									   RECOMMENDATIONS FOR THE ADMINISTRATION OF SMALLPOX
IMMUNIZATIONS TO MEMBERS OF THE RICHARDSON FIRE DEPARTMENT




                LEADING COMMUNITY RISK REDUCTION




                       By: Ed Hotz
                           Richardson Fire Department
                           Richardson, Texas




       An applied research project submitted to the National Fire Academy
                  as part of the Executive Fire Officer Program


                                September 2003
                                                                                                     2


                                           ABSTRACT

       The problem addressed by this applied research project was that the Richardson Fire

Department had not established guidelines for the administration of smallpox immunizations to

its members. The purpose of this applied research project was to develop recommended

guidelines for a smallpox immunization program within the Richardson Fire Department. This

was an action research project. The research questions answered were:

   1. What are the potential complications or side effects of smallpox vaccine?

   2. What are the contraindications for smallpox vaccination?

   3. When should a smallpox immunization program be initiated within the Richardson Fire

       Department and who should be inoculated?

       The procedures used to complete this project included a literature review and personal

interviews with the Dallas County Health Department Epidemiologist, the Employee Health

Coordinator of the Richardson Regional Medical Center, and the Richardson Fire Department

Medical Director. The results of this study identified the potential complications or side effects

of smallpox immunization, determined the contraindications for administration of the vaccine,

and established when a vaccination program should be initiated and who should be inoculated.

The product of this action research project was a list of recommended guidelines for the

administration of smallpox immunizations to members of the Richardson Fire Department.

       The recommendations weighed the associated risks of vaccine administration against the

likelihood of infection and vary according to circumstances. It was recommended that routine

preventative vaccinations be offered on an optional basis and not be given to members within

identified risk groups, that vaccination efforts be increased during an outbreak, and that post

exposure vaccination should not be optional.
                                                                                                                                              3


                                                    TABLE OF CONTENTS

ABSTRACT.................................................................................................................................... 2

TABLE OF CONTENTS................................................................................................................ 3

TABLES....………………………………………………………………………………………...4

INTRODUCTION .......................................................................................................................... 5

BACKGROUND AND SIGNIFICANCE...................................................................................... 5

LITERATURE REVIEW ............................................................................................................... 7

PROCEDURES............................................................................................................................. 12

RESULTS ..................................................................................................................................... 16

DISCUSSION ............................................................................................................................... 22

RECOMMENDATIONS.............................................................................................................. 25

REFERENCES ............................................................................................................................. 27

Appendix A (Summary of Vaccinia Related Adverse Events)..................................................... 30

Appendix B (Smallpox Fact Sheet People Who Should Not Get the Smallpox Vaccine) .......... 32

Appendix C (Smallpox Fact Sheet Small,pox Vaccination: An Important Decision .................. 33

Appendix D (Patient Medical History and Consent Form) .......................................................... 36

Appendix E (RFD Recommended Guidelines for Smallpox Vaccine Administration)……………41
                                                                                     4


                                      TABLES

Table 1 (Adverse Events Associated with Smallpox Vaccination Among Civilians).……..……17

Table 2 (Smallpox Vaccine Contraindications)…………………………………………….…....19
                                                                                                     5


                                        INTRODUCTION

        The problem addressed by this applied research project is that the Richardson Fire

Department does not have established guidelines for the administration of smallpox

immunizations to its members. The purpose of this applied research project is to develop

recommended guidelines for a smallpox immunization program within the Richardson Fire

Department. This study is an action research project. The research questions answered are:

    1. What are the potential complications or side effects of smallpox vaccine?

    2. What are the contraindications for smallpox vaccination?

    3. When should a smallpox immunization program be initiated within the Richardson Fire

        Department and who should be inoculated?

                            BACKGROUND AND SIGNIFICANCE

        Smallpox (variola) is a serious viral disease that starts with fever, aches, fatigue, and

vomiting. It progresses to a rash with blisters that scar over much of the body. It spreads directly

from person-to-person through airborne transmission and historically has up to a 30 percent

mortality rate. Being a virus, it is not responsive to antibiotics, and other than supportive care

there is no known effective treatment. The experiences of past generations with outbreaks of

smallpox have resulted in pain, suffering, disfiguration, and countless deaths. The use of

smallpox as a method of mass destruction is not new. Accounts of the white man introducing the

virus to Native Americans have been well documented. Vaccination efforts worldwide were able

to successfully eradicate the disease, and the last naturally occurring case was reported in

Somalia in 1977. The last reported case in the United States was in 1949, and routine vaccination

in this country was discontinued in 1972. Except for laboratory stockpiles the virus no longer

exists naturally.
                                                                                                      6


       The events of September 11, 2001 and the war on terrorism have heightened the

awareness of potential terrorist attack. Weapons of mass destruction can include nuclear,

biological, and chemical weapons. Smallpox virus is one of the more notable and frequently

discussed biological agents because of the risk of rapid spread and potential for devastating

results if dispersed by terrorists. It is suspected that certain terrorist groups may have obtained

the virus from laboratories and are planning to weaponize it. This has led to concerns about what

precautions should be taken. The present debate over how many persons and who should be

vaccinated is centered on the safety of the vaccine. The vaccinia virus used to immunize

individuals against smallpox is transmissible from recently vaccinated hosts to susceptible

contact individuals. In addition, there are significant side effects including death for certain

percentages of vaccine recipients or their contacts as well as contraindications for vaccine

administration to at risk groups.

        Should a future terrorist strike include the dispersal of smallpox virus, health care

providers will most assuredly be exposed to the virus or its victims. The CDC developed a plan

announced by President Bush on December 13, 2002 to better protect the American people

against the threat of smallpox attack. The plan calls for vaccinating key military personnel,

health care workers, emergency responders, and finally the general public. Health care workers’

and emergency responders’ participation in the program is strictly voluntary. First responders

throughout the nation, including the Richardson Fire Department (RFD), will be challenged with

deciding what steps to take to protect its members. Richardson Texas is located in Dallas County

in what is known as the Telecom Corridor and is a prime terrorist target. It is imperative that

planning and preparation take place. This project is an effort to establish recommended

guidelines for the administration of smallpox vaccine to members of the RFD. The problem
                                                                                                      7


addressed by this Applied Research Project relates to Assessing Community Risks and

Intervention Strategies (Units 2 and 4) within the Leading Community Risk Reduction course of

the National Fire Academy’s Executive Fire Officer Program.

                                    LITERATURE REVIEW

The potential complications or side effects of smallpox vaccine

       Schraeder and Campion (2003) discussed the concerns surrounding the use of smallpox

vaccine and indicated that the public needs to understand the risks associated with the vaccinia

virus including the possibility of transmission to others. They wrote that serious side effects are

more likely to be seen with increased use of the vaccine, and that only 27 percent of the public

understands that physical contact with a recently vaccinated person can result in serious

infection. They pointed out how first responders who have chosen to be vaccinated have

accepted a small degree of risk to help protect the health of the public.

       Mack (2003) asserts that vaccinia is a dangerous live vaccine with a likelihood of

complications for recipients or their pregnant or eczematous contacts. He reported that even with

screening and the concurrent administration of vaccinia immune globulin (used to minimize

complications) the death rate from inoculations was one to two per million. He predicted that

there would be at least three deaths per million vaccinates. Bozette et al. (2003) wrote that policy

makers would have to balance the potential for saving lives against the likelihood of losing lives

from complications induced by the vaccine. They further wrote that prior vaccination

significantly reduces the risk of disease among health care workers in the event of an attack, and

that it helps to eliminate a major route of exposure for their families.

       Henderson et al. (1999) listed postvaccinial encephalitis, progressive vaccinia (vaccinia

gangrenosa), eczema vaccinatum, generalized vaccinia, inadvertent inoculation, and various
                                                                                                    8


rashes as potential complications to administration of smallpox vaccine. Cono, Casey, and Bell

(2003) included inadvertent inoculation, ocular vaccinia, generalized vaccinia, eczema

vaccinatum, progressive vaccinia, postvaccinial encephalopathy and encephalomyelitis, and fetal

vaccinia in their list of adverse reactions. Appendix A lists a summary of adverse reactions from

their report.

        Rocki Kaiser (personal communication, September 2, 2003) the Employee Health

Coordinator for Richardson Regional Medical Center with over 1000 employees stated that only

nine employees participated in Phase I of the vaccination program and reported that there were

no adverse reactions. Dallas County Health Department Epidemiologist, Dr. Assufa Tulu

(personal communication September 12, 2003), reported that 300 public health and hospital

workers have been vaccinated county wide in Phase I without any significant adverse reactions,

and that Phase II vaccination of first responders has yet to be initiated in Dallas County. The

United States Department of Health and Human Services Centers for Disease Control and

Prevention (CDC) (2003) maintains a nationwide database of reported side effects. Table 1 lists

those reported in civilians from January 4, 2003 until August 29, 2003. In a report for the United

States Department for Defense (DOD), Grabenstein and Winkenwerder (2003) reported over

450,000 vaccinations given to military personnel from December 13, 2002 through May 28,

2003 with adverse reactions below historical levels that included one case of encephalitis, 37

cases of acute myopericarditis, and no deaths.

The contraindications for smallpox vaccination

        Mack (2003) included immunosuppressed patients with chronic disease or transplanted

organs and carriers of the human immunodeficiency virus with or without AIDS, especially those

with skin lesions in his list of contraindications. Henderson et al. (1999) listed five groups of
                                                                                                    9


persons at special risk for smallpox vaccine complications. They suggested that the routine

prophylactic use of smallpox vaccine should be contraindicated in these groups. They also

considered the risk of post vaccination complications in these groups to be less than the risk of

effects from the smallpox virus itself in a post exposure situation. In post exposure situations,

they also recommend the simultaneous use of vaccinia immune globulin along with the vaccine

to reduce the possibility of side effects. The five special risk groups for smallpox vaccine

complications listed by them are:

       1. Persons with eczema or other exfoliative skin conditions

       2. Patients with leukemia, lymphoma, or generalized malignancy being treated with

           chemotherapy, radiation, or corticosteroids

       3. Patients with HIV infection

       4. Persons with hereditary immune mediated deficiency disorders

       5. Pregnant women

       Cono, Casey, and Bell (2003) listed the following contraindications for vaccine

candidates or their close contacts:

       1. A history of atopic dermatitis (eczema) independent of disease severity or activity

       2. Active acute, chronic or exfoliative skin conditions that disrupt the epidermis

       3. Pregnant women or those desiring to become pregnant within 28 days of inoculation

       4. Immunocompromised individuals due to human immunodeficiency virus or acquired

           immunodeficiency syndrome, autoimmune conditions, cancer, radiation,

           immunosuppressive medications, or other immunodeficiencies

       5. Candidates with a history of Darier disease or those having household contacts with

           the active disease
                                                                                                10


       Cono, Casey, and Bell (2003) also listed the following contraindications that apply only

to the vaccine candidates and not their close contacts:

       1. Persons with smallpox vaccine component allergies

       2. Women who are breastfeeding

       3. Those taking topical ocular steroid medications

       4. Those with moderate to severe intercurrent illness

       5. Persons less than 18 years of age.

       The CDC (2003) has produced several smallpox fact sheets. People Who Should Not Get

the Smallpox Vaccine (Appendix B) and Smallpox Vaccination: An Important Decision

(Appendix C) both list contraindications. The CDC also produced a Pre-Event Screening

Worksheet for Smallpox Vaccine to be used as a tool to screen vaccine candidates. Their Pre-

Event Screening Worksheet for Smallpox Vaccine: Important Interim Supplementary Information

added heart disease to the list of contraindications as of March 31, 2003. Rocki Kaiser (personal

communication, September 2, 2003), Employee Health Coordinator for Richardson Regional

Medical Center, and Dr. Assufa Tulu (personal communication September 12, 2003), Dallas

County Health Department Epidemiologist, both indicated that they use these worksheets to

identify candidates with contraindications prior to smallpox vaccine administration.

When should a smallpox immunization program be initiated and who should be inoculated

       Trupin (2000) emphasized that smallpox is explosively contagious. He defined it as a hot

agent in the biosafety Level 4 category and advised that a single case anywhere in the world

would be considered a global medical emergency. He added that a single case in the United

States would cause local, state, and federal authorities to assume emergency powers, and added

that vaccination would provide approximately 10 years of protection to recipients. Bozette et al.
                                                                                                    11


(2003) endorsed a policy of vaccinating all eligible health care workers and first responders prior

to an attack. West (2002) in a list of infection control tips for the smallpox virus said that

exposed persons should be prophylactically treated with vaccine within three days of the

exposure.

       The New Jersey Department of Health and Senior Services (2002) reported that

approximately half of the United States population has never been vaccinated for smallpox. It

also reported that the other half was vaccinated prior to 1972 and that medical experts say it is

unknown whether those who were vaccinated are still protected. The report indicated that there

was no known imminent threat of a smallpox outbreak, but that New Jersey should be prepared

for this and other forms of bioterrorism. Their plan calls for vaccinating key personnel now who

would be involved in future investigations of or care for smallpox victims.

       On December 13, 2002 President Bush announced the National Smallpox Vaccination

Program (NSVP) developed by the CDC (2002). It provides pre-event smallpox vaccine for key

health care workers in Phase I, emergency responders in Phase II, and the general public in Phase

III. All inoculations are to be given on a voluntary basis. The EMS Insider (2003) reported that

on March 6, 2003 the CDC told the states they could immediately begin offering smallpox

immunizations to first responders and outlined a plan to compensate individuals injured or killed

by the vaccine. Brocato and Miller (2002) suggested that pre-hospital providers research the

possibility of a vaccination program for their agencies and recommended that they consult their

medical director as to the appropriateness. The medical director for the RFD, Dr. Robert

Simonson (personal communication, September 18, 2003), stated that the smallpox fervor has

died down, that first responder inoculations “never really got off the ground” in the Dallas area,
                                                                                               12


and that any smallpox vaccine program should be voluntary. He also stated that CDC

recommendations would be the trigger for any renewed interest in the program.

       The International Association of Fire Chiefs (IAFC) (2003) adopted a policy January 9,

2003 recommending that fire departments participate in Phase II of the National Smallpox

Program and published a 39 page Fire Chief’s Guide to Smallpox Vaccination. Phase II

described in the guide makes the vaccine available on a voluntary basis to emergency medical

and fire service personnel. Included in the appendices to the guide are smallpox fact sheets

published by the CDC with references to their website. The Texas Department of Health (2003)

on their bioterrorism web page and the United States Food and Drug Administration (2003) on

their counterterrorism web page also provide links to the CDC for smallpox information and

vaccine recommendations.

Summary

       The various smallpox vaccine complications reported in the literature review can be used

to develop a list of vaccine side effects that can be utilized by vaccine candidates to make

informed decisions as to whether they should receive inoculations or not. In the same manner the

contraindications identified can be used to determine groups of individuals who should not

receive routine inoculations. The opinions collected in the literature review, including CDC

guidelines for smallpox vaccine administration, provide information that will assist in

determining to whom and when the vaccine should be given.

                                         PROCEDURES

       The problem statement identified the need to develop recommended guidelines for

smallpox vaccine administration within the Richardson Fire Department. A study was initiated to

determine the risks and contraindications to smallpox vaccine, who should receive the vaccine,
                                                                                                  13


and when an inoculation program should be initiated. Answering the first research question

identified reported complications to smallpox vaccination. A review of relevant literature that

included reports from the CDC and DOD was performed and vaccination program administrators

were consulted to make this determination. This provided a list of documented complications and

side effects. Answering the second research question identified contraindications and

determined the groups with an increased risk of complications associated with smallpox vaccine.

This was accomplished by a review of the literature and consultation with Phase I vaccination

program administrators who were asked how they identify candidates with contraindications

prior to smallpox vaccine administration. Answering the third research question determined

when the program should be initiated and who should receive the vaccine. This question

combined who and when because it is difficult to answer one without the other.

Contraindications and conditions existing when the vaccine is given often dictate who should

receive the vaccine. Information obtained from a review of the literature, including the

recommendations of the IAFC and the CDC, and an interview with the RFD Medical Director

was used to determine when the program should commence and who should be inoculated. The

information obtained from this research project was used to formulate recommended guidelines

for providing smallpox vaccinations to RFD members.

Assumptions

       Local fire departments will not be the only responsible health care providers preparing

for potential bioterrorist attacks. This will be accomplished with multiple local, state, and federal

agencies working together. The assumption is that the Richardson Fire Department will seriously

consider pre-event smallpox immunization recommendations and comply with specific post-

event recommendations made by the Dallas County Health Department, the Texas Department of
                                                                                                 14


Health, and the CDC. The selected subject matter experts chosen for the interviews were

assumed to provide accurate information because of their respective positions.


Limitations

       The final recommendations found in this study are primarily intended for use by

emergency medical providers and not the public in general. Answers to the third research

question are limited due to the submission deadline of this project. A meeting with the Dallas

County Health Department to provide details for Phase II vaccination of emergency responders

in Dallas County was scheduled to take place shortly after submission of this paper. A majority

of the information obtained in the current literature review regarding vaccine complications,

adverse events, and contraindications is based on older reports. The number of smallpox

vaccinations administered and side effects reported in recent years are limited. In addition, these

reports are from vaccinations given to military personnel and health care workers who represent

a limited segment of the population.

Definitions

Eczema Vaccinatum: Eczema vaccinatum is a serious complication in which vaccinal skin

lesions extend to cover all or most of the area once or currently covered with eczema.

Erythema Multiforme Major (Stevens-Johnson syndrome): A toxic or allergic rash in response

to the vaccine that can take various forms and range from moderate to severe.

Fetal Vaccinia: A vaccinia virus infection of a fetus resulting from exposure to smallpox vaccine

during pregnancy.

Generalized Vaccinia: Generalized vaccinia is a secondary eruption that almost always follows

primary vaccination. It is characterized by generalized vaccinia, and results from blood-born
                                                                                                   15


dissemination of the virus. The lesions emerge 6-9 days following vaccination, are generalized or

few in number, and are usually self-limiting.

Inadvertent Inoculation: Inadvertent inoculation is transmission to close contacts or

autoinoculation to sites such as the face, eyelid, mouth, and genitalia.

Myocarditis/pericarditis: Inflammation of the heart or membrane around the heart ranging from

mild to life threatening in severity

Ocular Vaccinia: Eye infection that can be mild to severe (leading to loss of vision) usually

resulting from touching the eye with vaccinia virus on your hand.

Phase I: The initial pre-event vaccination of public health and hospital workers on a voluntary

basis.

Phase II: The initial pre-event vaccination of emergency responders on a voluntary basis.

Pre-event: The period prior to a release or outbreak of smallpox virus.

Post-event: The period following a confirmed report of or outbreak of smallpox virus.

Postvaccinial Encephalitis: Postvaccinial encephalitis occurs 8-15 days following vaccination

and is characterized by fever, headache, vomiting, drowsiness, and sometimes spastic paralysis,

meningitis, coma, and convulsions.

Progressive Vaccinia: The vaccinial lesion fails to heal and progresses to involve adjacent skin

with necrosis of tissue that spreads to other parts of the skin, bones, and to viscera.

Vaccinia: A virus disease of cattle that is communicated to man and produces immunity to

smallpox (variola) virus.

Virus: Viruses are obligate intracellular parasites of living but non-cellular nature, consisting of

DNA or RNA and a protein coat. They range in diameter from 20-300nm.
                                                                                                    16


                                             RESULTS

The potential complications or side effects of smallpox vaccine

       Mack (2003) stressed that the vaccinia vaccine used for smallpox is a live virus with a

death rate of three per million. Bozette et al. (2003) also indicated the likelihood for loss of lives

secondary to vaccine usage. Schraeder and Campion (2003) and Mack (2003) expressed

concerns that physical contact with a recently vaccinated person can result in a serious infection

in the exposed individual. Henderson et al. (1999) listed postvaccinial encephalitis, progressive

vaccinia (vaccinia gangrenosa), eczema vaccinatum, generalized vaccinia, inadvertent

inoculation, and miscellaneous rashes as potential complications secondary to smallpox vaccine.

Cono, Casey, and Bell (2003) included inadvertent inoculation, ocular vaccinia, generalized

vaccinia, eczema vaccinatum, progressive vaccinia, postvaccinial encephalopathy and

encephalomyelitis, and fetal vaccinia in their list of adverse reactions that appear in Appendix A.

       Rocki Kaiser (personal communication, August 23, 2003) the Employee Health

Coordinator for Richardson Regional Medical Center did not witness adverse affects to any of

the nine hospital staff members who elected to receive the vaccine. Dr. Assufa Tulu (personal

communication September 12, 2003) reported no significant reactions in 300 Dallas County

public health and hospital workers who had received inoculations. Grabenstein and

Winkenwerder (2003) reported one case of encephalitis and 37 cases of acute myopericarditis in

over 450,000 vaccinations given to military personnel from December 13, 2002 through May 28,

2003. There were no deaths during this period. Between January 24 and August 29, 2003 the

CDC (2003) recorded adverse reactions associated with smallpox vaccine along with other

adverse events reported after smallpox vaccine was administered to civilians. These adverse

events are listed in Table 1.
                                                                                                  17


Table 1
    Adverse Events Associated with Smallpox Vaccination Among Civilians
                            (Reported by CDC)

Adverse Event                                                        Total number of cases
                                                                     January 24–August 29, 2003

Eczema vaccinatum                                                                0
Erythema multiforme major/Stevens-Johnson syndrome                               0
Fetal vaccinia                                                                   0
Generalized vaccinia                                                             3
Inadvertent inoculation, nonocular                                              21
Myocarditis/pericarditis                                                        22
Ocular vaccinia                                                                  3
Postvaccinial encephalitis                                                       1
Progressive vaccinia                                                             0
Pyogenic infection of vaccination site                                           0
Other serious adverse events reported (events that result in
hospitalization, permanent disability, life-threatening illness or
death). These events occurred around the time of vaccination,                   81
but it is unknown whether they were caused by smallpox
vaccine.
Other non-serious adverse events reported (include expected
self-limited responses to smallpox vaccination) e.g., fatigue,
                                                                                664
headache, itching, redness and swelling at the vaccination site,
swollen and/or sore lymph nodes, fever, muscle aches and chill


The contraindications for smallpox vaccination

       Mack (2003) emphasized that immunosuppressed patients with chronic disease or

transplanted organs, and carriers of the human immunodeficiency virus with skin lesions are

particularly vulnerable to complications. Henderson et al. (1999) listed five groups of persons at

special risk for smallpox vaccine complications. The five special risk groups for smallpox

vaccine complications listed by them are:

1. Persons with eczema or other exfoliative skin conditions
                                                                                                18


2. Patients with leukemia, lymphoma, or generalized malignancy being treated with

   chemotherapy, radiation, or corticosteroids

3. Patients with HIV infection

4. Persons with hereditary immune mediated deficiency disorders

5. Pregnant women

       Cono, Casey, and Bell (2003) listed the following contraindications for vaccine

candidates or their close contacts:

1. A history of atopic dermatitis (eczema) independent of disease severity or activity

2. Active acute, chronic or exfoliative skin conditions that disrupt the epidermis

3. Pregnant women or those desiring to become pregnant within 28 days of inoculation

4. Immunocompromised individuals due to human immunodeficiency virus or acquired

   immunodeficiency syndrome, autoimmune conditions, cancer, radiation, immunosuppressive

   medications, or other immunodeficiencies.

5. Candidates with a history of Darier disease or their household contacts with the active

   disease.

They listed the following contraindications that apply only to the vaccine candidates and not

their close contacts:

1. Persons with smallpox vaccine component allergies

2. Women who are breastfeeding

3. Those taking topical ocular steroid medications

4. Those with moderate to severe intercurrent illness

5. Persons less than 18 years of age.

   A summary of contraindications obtained from CDC fact sheets are found in Table 2.
                                                                                                    19


                                        Table 2
                           Smallpox Vaccine Contraindications
Unless they have been exposed to the smallpox virus* individuals should not get the smallpox
vaccine if they:

   •   Are allergic to the vaccine or any of its ingredients
   •   Are younger than 12 months or older than 65 years of age.
   •   Have a moderate or severe short-term illness
   •   Are currently breastfeeding
   •   Are using steroid drops in their eyes.
   •   Have been diagnosed by a doctor as having a heart condition with or without symptoms
   •   Have 3 or more of the following risk factors:
          •   High blood cholesterol diagnosed by a doctor;
          •   Diabetes or high blood sugar diagnosed by a doctor
          •   A first degree relative (for example, mother, father, brother, sister) who had a
              heart condition before the age of 50
          •   You smoke cigarettes now. (While this may be a temporary exclusion, these
              people should not get the vaccine at this time.)

Individuals who have any of the following conditions, or live with someone who does,
should NOT get the smallpox vaccine unless they have been exposed to the smallpox virus*:
   •   Eczema or atopic dermatitis (even if it is not currently active, mild, or experienced as a
       child).
   •   Other skin conditions such as burns, chickenpox, shingles, impetigo, herpes, severe acne,
       or psoriasis (Individuals should not get the vaccine until the condition has completely
       healed).
   •   Weakened immune system (for instance, from cancer treatment, an organ transplant,
       HIV, or medications such as steroids to treat autoimmune disorders and other illnesses).
   •   Pregnancy or plans to become pregnant within 1 month of vaccination.

*People who have been directly exposed to the smallpox virus should get the vaccine
regardless of their health status.
                                                                                                  20


       The CDC (2003) has produced several smallpox fact sheets. People Who Should Not Get

the Smallpox Vaccine (Appendix B) and Smallpox Vaccination: An Important Decision

(Appendix C) both list contraindications. The CDC also produced a Pre-Event Screening

Worksheet for Smallpox Vaccine to be used as a tool to screen vaccine candidates. Their Pre-

Event Screening Worksheet for Smallpox Vaccine: Important Interim Supplementary Information

added heart disease to the list of contraindications as of March 31, 2003. Rocki Kaiser (personal

communication, September 2, 2003), Employee Health Coordinator for Richardson Regional

Medical Center, and Dr. Assufa Tulu (personal communication September 12, 2003), Dallas

County Health Department Epidemiologist, both indicated that they use these worksheets to

identify candidates with contraindications prior to smallpox vaccine administration.


When should a smallpox immunization program be initiated and who should be inoculated

       Trupin (2000) advised that a single case of smallpox anywhere in the world would be

considered a global medical emergency, and that one in the United States would cause

authorities to assume emergency powers. West (2002) emphasized that exposed persons should

be treated with vaccine within 3 days of the exposure.

       Bozette et al. (2003) endorsed a policy of vaccinating all eligible health care workers and

first responders prior to an attack. The New Jersey Department of Health and Senior Services

(2002) plan calls for vaccinating key personnel now who would be involved in future

investigations of and care for potential cases of smallpox. Brocato and Miller (2002) suggested

that pre-hospital providers should research the possibility of a vaccination program for their

agencies, and that they should consult their medical director as to the appropriateness. These

sources all support a pre-event smallpox vaccination program. The medical director for the RFD,

Dr. Robert Simonson (personal communication, September 18, 2003), indicated that the early
                                                                                                 21


2003 fervor over smallpox had died down and recommended that the vaccine be offered to first

responders on a voluntary basis and only if there was strong support from the state and county

health departments. He also advised to seriously consider CDC recommendations and expected

the state and county to do the same.

       The CDC (2002) NSVP recommends pre-event voluntary smallpox vaccine for key

health care workers in Phase I, emergency responders in Phase II, and the general public in Phase

III. The CDC (2003) lists the contraindications for vaccine administration (Appendix B),

recommends careful screening of pre-event vaccine candidates, and emphasizes that if people are

directly exposed to the smallpox virus they should receive the vaccine regardless of health status.

The EMS Insider (2003) relayed the March 6, 2003 CDC decision to allow states to immediately

begin offering smallpox immunizations to first responders.

       The IAFC (2003) recommended that fire departments participate in Phase II of the NSVP

that makes the vaccine available on a voluntary basis to emergency medical and fire service

personnel. The Texas Department of Health (2003) and the United States Food and Drug

Administration (2003) both referenced the CDC for smallpox information and vaccine

recommendations.

       These findings resulted in the following points:

1. Pre-event smallpox vaccine should be made available to first responders on a voluntary basis.

2. March 6, 2003 the CDC recommended the initiation of Phase II (first responder inoculations)

   of the NSVP that is endorsed by the IAFC and has the support of State Health Departments.

   This clears the way for immediate implementation.

3. Pre-event vaccine candidates should be carefully screened to determine contraindications and

   avoid vaccine administration in those circumstances.
                                                                                                   22


4. In the event of an outbreak, vaccination efforts should be increased.

5. Post-exposure vaccinations should be considered mandatory within three days after the

   exposure regardless of health status.

       The results of this applied research project were compiled into a list of recommendations

to be utilized for the development of standard operating guidelines for the administration of

smallpox vaccinations to members of the RFD. The recommended guidelines are listed in

Appendix E.

                                           DISCUSSION

The potential complications or side effects of smallpox vaccine

       Schraeder and Campion (2003) along with Mack (2003) stressed the risks associated with

vaccinia inoculation. Bozette et al. (2003) emphasized how policy makers will have to carefully

weigh the risks of vaccine-associated complications against the benefits of the reduced risk for

smallpox disease in the face of an outbreak. The complications and side effects of smallpox

vaccine administration have been well documented. With the exception of Grabenstein and

Winkenwerder’s (2003) DOD report and the CDC’s (2003) summary of civilian reactions found

in Table 1, a majority of the data contained in recent articles reviewed by the author was derived

from reports prior to the discontinuation of routine smallpox vaccinations in 1972. Most sources

reviewed appeared to have obtained information either directly or indirectly from the CDC.

       Henderson et al. (1999) and Cono, Casey, and Bell (2003) listed previously reported

complications. Of the two, the latter had a more comprehensive list that is found in Appendix A.

It is the author’s opinion that the CDC is the most definitive source of information on smallpox.

They maintain an exhaustive amount of data and reports including regular updates on recent

vaccine reactions from both civilians and the DOD.
                                                                                                     23


The contraindications for smallpox vaccination

       The largest amount of information on vaccine contraindications came from CDC reports.

Henderson et al. (1999) and Mack (2003) listed the conditions where smallpox vaccine is

contraindicated. Cono, Casey, and Bell (2003) developed one list of contraindications that apply

only to the vaccine candidates (not to their close contacts) and another list of contraindications

where the conditions exist in either the vaccine candidate or their close contacts. This indicates

the need for vaccine candidates to consider not only their own conditions but also those of close

contacts to determine whether contraindications to the vaccine exist or not.

       The CDC (2003) makes the same distinction in their fact sheets People Who Should Not

Get the Smallpox Vaccine (Appendix B) and Smallpox Vaccination: An Important Decision

(Appendix C). The CDC has produced pre-event screening worksheets that are to be used by the

candidates and those administering the inoculations to determine whether or not the vaccine

should be given. These instruments are comprehensive, kept current, and are valuable resources

for vaccine candidates to utilize in making informed decisions.

When should a smallpox immunization program be initiated and who should be inoculated

       Trupin (2000), Bozette et al. (2003), and West (2002) stressed the importance of either

having pre-event immunizations or vaccine administration within three days post-exposure. The

New Jersey Department of Health and Senior Services (2002) adopted a plan to vaccinate key

personnel prior to the imminent threat of an outbreak. Brocato and Miller (2002) recommended

that agencies consult their medical directors for recommendations. The EMS Insider (2003)

reported that the CDC gave the green light for states to begin administering vaccine to first

responders March 6, 2003. The CDC (2002) developed a nationwide plan to administer vaccine,

and the IAFC (2003) adopted a policy recommending fire departments participate in Phase II of
                                                                                                 24


the plan on a voluntary basis. The United States Food and Drug Administration (2003) and the

Texas Department of Health (2003) both refer to the CDC for information on the smallpox

vaccination program. Dr. Assufa Tulu (personal communication, September 12, 2003) reported

that first responder vaccinations in Dallas County have not been initiated yet. The medical

director for the RFD, Dr. Robert Simonson (personal communication, September 18, 2003),

indicated that the early 2003 concerns over smallpox had died down and recommended that the

vaccine be offered to first responders on a voluntary basis only. He advised the RFD to follow

CDC, state, and county recommendations closely.

       The fervor stirred by the invasion of Iraq has died, and there appears to be much less

urgency to proceed with Phase II of the program. However, at the time that this project was

submitted, the Texas Department of Health and the Dallas County Health Department maintain

plans to proceed with implementation of Phase II of the NSVP. This study has identified a

number of implications for the RFD. First, that administration of pre-event smallpox vaccine to

first responders should be made available to members on a strictly volunteer basis, with full

disclosure of possible side effects, and strict observance of contraindications. Second, that

vaccine candidates be allowed to make the most informed decisions possible. To assist the

organization should perform a situational analysis when conditions change and keep its

recommendations current. If the threat level increases, or if an outbreak occurs, vaccination

efforts should increase and members should be encouraged to participate in the program. Lastly,

vaccinations should be considered mandatory for all post-exposure cases because of the much

greater risk from disease.
                                                                                                    25


                                    RECOMMENDATIONS

       The possibility of smallpox being used as a potential biological weapon against an

unprotected population confirms the need for preparation and protection. The vaccinia virus

vaccine used to immunize against smallpox is not without its potential complications and

contraindications. Therefore, when making recommendations for a vaccination program, the

risks associated with the administration of the vaccine must be weighed against the probability of

exposure and the subsequent consequences of an outbreak of smallpox virus. The following

recommendations have emerged from this study:

1. The Richardson Fire Department should establish standard operating guidelines for the

   administration of smallpox vaccine to its members.

2. Participation in the program should be strictly voluntary.

3. Full disclosure of all possible side effects should be given to vaccine candidates utilizing a

   current list of reported vaccine associated complications and current CDC fact sheets on

   smallpox.

4. Pre-event screening worksheets along with Patient Medical History and Consent Forms

   (Appendix 4) available from the CDC should be utilized for all vaccine candidates to

   determine if any contraindications exist. If any are discovered, they should be prohibited

   from receiving the vaccine. Forms should be signed prior to vaccine administration.

5. Should a confirmed smallpox exposure take place, the member exposed should receive the

   vaccine even if contraindications exist. In those cases concurrent vaccinia immune globulin

   should be administered.
                                                                                                   26


6. The Richardson Fire Department should consult the CDC, Texas Department of Health,

   Dallas County Health Department, and their Medical Director’s recommendations when

   establishing vaccine program guidelines.

       Finally, it is recommended that not only the RFD but also any EMS or fire service

organization with a goal of better protecting its members from future bioterroists should

seriously consider participating in a smallpox vaccination program. A proactive response calls

for decisions to be made prior to the possible introduction of smallpox virus into the populous.

Each organization should develop guidelines for decision making in the event of an emergency.

The CDC, state and local health officials, and the responding agency’s medical director should

be consulted to establish guidelines for vaccine administration prior to the implementation of any

smallpox immunization program.
                                                                                                 27


                                        REFERENCES

       Brocato, C.E. & Miller, G.T. (2002). The next agent of terror: Understanding smallpox &

its implications for prehospital crews. Journal of emergency medical services, 27 (30), 44-55.

San Diego, CA: Jems Communications

       Bozette, S.A. et al. (2003). A model for a smallpox vaccination policy. New England

journal of medicine, 348 (5), 416-425. Waltham, MA: Massachusetts Medical Society

       Cono, J., Casey, C.G., & Bell, D.M. (2003). Smallpox vaccination and adverse reactions:

Guidance for clinicians. Retrieved July 31, 2003 from

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5204a1.htm

       EMS Insider. (2003). First responder smallpox vaccinations begin. EMS insider, 30 (4),

4-5. San Diego, CA: Jems Communications

       Grabenstein J.D. and Winkenwerder W. (2003). US military smallpox vaccination

program experience. Retrieved September 19, 2003 from

http://www.smallpox.army.mil/event/SPSafetySum.asp

       International Association of Fire Chiefs. (2003). Fire chief’s guide to smallpox

vaccination. Fairfax, VA: IAFC

       Henderson, D.A. et al. (1999). Smallpox as a biological weapon: Medical and public

health management. Journal american medical association. 281 (22), 2127-2137. Chicago, IL:

American Medical Association

       Mack, T. (2003). A different view of smallpox and vaccination. New England journal of

medicine. 348 (5), 460-463. Waltham, MA: Massachusetts Medical Society
                                                                                                28


       New Jersey Department of Health and Senior Services. (2002). New jersey announces

smallpox vaccination plan. Retrieved April 2, 2003 from

http://www.state.nj.us/health/news/p21209a.htm

       Schraeder, T.L. & Campion, E.W. (2003). Smallpox vaccination-the call to arms. New

england journal of medicine, 348 (5), 381-382. Waltham, MA: Massachusetts Medical Society

       Texas Department of Health. (2003). Bioterrorism. Retrieved August 18, 2003 from

http://www.tdh.texas.gov/stateepi/anthrax.htm

       Trupin, R. (2000). Smallpox: Diseases associated with biological warfare. Retrieved

April 2, 2003 from http:/www.nursingceu.com/NCEU/courses/smallpox/

       United States Department of Health and Human Services Centers for Disease Control and

Prevention. (2003). Adverse events associated with smallpox vaccination among civilians.

Retrieved September 5, 2003 from http://www.cdc.gov/od/oc/media/spcivil.htm

       United States Department of Health and Human Services Centers for Disease Control and

Prevention. (2003). Other adverse events reported after smallpox vaccination among civilians.

Retreived September 5, 2003 from

http://www.cdc.gov/http://www.smallpox.army.mil/event/SPSafetySum.aspod/oc/media/spother.

htm

       United States Department of Health and Human Services Centers for Disease Control and

Prevention. (2003). People who should not get the smallpox vaccine. Retrieved June 30, 2003

from http://www.bt.cdc.gov/agent/smallpox/vaccination/contraindications-public.asp

       United States Department of Health and Human Services Centers for Disease Control and

Prevention. (2003). Pre-Event Screening Worksheet for Smallpox Vaccine. Retrieved June 30,

2003 from http://www.bt.cdc.gov/agent/smallpox/vaccination/pdf/screening-worksheet.pdf
                                                                                            29


       United States Department of Health and Human Services Centers for Disease Control and

Prevention. (2003). Pre-Event Screening Worksheet for Smallpox Vaccine: Important Interim

Supplementary Information. Retrieved June 30, 2003 from

http://www.bt.cdc.gov/agent/smallpox/vaccination/pdf/screening-worksheet2.pdf

       United States Department of Health and Human Services Centers for Disease Control and

Prevention. (2002). Protecting americans: Smallpox vaccination program. Retrieved March 30,

2003 from http://www.bt.cdc.gov/agent/smallpox/vaccination/vaccination-program-

statement.asp

       United States Department of Health and Human Services Centers for Disease Control and

Prevention. (2003). Smallpox Vaccination: An Important Decision. Retrieved June 39, 2003 from

http://www.bt.cdc.gov/agent/smallpox/vaccination/important-decision.asp

       United States Food and Drug Administration. (2003). Counterterrorism. Retrieved

August 18, 2003 from http://www.fda.gov/oc/opacom/hottopics/bioterrorism.html

       West, K. (2002). Infection control tips: Smallpox. Journal of emergency medical

services, 27 (3), 50. San Diego, CA: Jems Communications
                                             30


                Appendix A

Summary of Vaccinia Related Adverse Events
                                                     31


Summary of Vaccinia Related Adverse Events (cont.)
                                                                                                                     32


                                                   Appendix B
SMALLPOX FACT SHEET

People Who Should NOT Get the Smallpox Vaccine
(Unless they are exposed to smallpox)

Some people are at greater risk for serious side effects from the smallpox vaccine. Individuals who have any of the
following conditions, or live with someone who does, should NOT get the smallpox vaccine unless they have
been exposed to the smallpox virus:

    •    Eczema or atopic dermatitis. (This is true even if the condition is not currently active, mild or experienced
         as a child.)
    •    Skin conditions such as burns, chickenpox, shingles, impetigo, herpes, severe acne, or psoriasis. (People
         with any of these conditions should not get the vaccine until they have completely healed.)
    •    Weakened immune system. (Cancer treatment, an organ transplant, HIV, Primary Immune Deficiency
         disorders, some severe autoimmune disorders and medications to treat autoimmune disorders and other
         illnesses can weaken the immune system.)
    •    Pregnancy or plans to become pregnant within one month of vaccination.

In addition, individuals should not get the smallpox vaccine if they:

    •    Are allergic to the vaccine or any of its ingredients (polymyxin B, streptomycin, chlortetracycline,
         neomycin).
    •    Are younger than 12 months of age. However, the Advisory Committee on Immunization Practices (ACIP)
         advises against non-emergency use of smallpox vaccine in children younger than 18 years of age. In
         addition, the vaccine manufacturer’s package insert states that the vaccine is not recommended for use in
         geriatric populations in non-emergency situations. The term geriatric generally applies to people age 65 and
         above.
    •    Have a moderate or severe short-term illness. (These people should wait until they are completely
         recovered to get the vaccine.)
    •    Are currently breastfeeding.
    •    Are using steroid drops in their eyes. (These people should wait until they are no longer using the
         medication to get the vaccine).
    •    Have been diagnosed by a doctor as having a heart condition with or without symptoms, including
         conditions such as previous myocardial infarction (heart attack), angina (chest pain caused by lack of blood
         flow to the heart), congestive heart failure, cardiomyopathy (heart muscle becomes inflamed and doesn't
         work as well as it should), stroke or transient ischemic attack (a "mini-stroke" that produces stroke-like
         symptoms but not lasting damage), chest pain or shortness of breath with activity (such as walking up
         stairs), or other heart conditions being treated by a doctor. (While this may be a temporary exclusion, these
         people should not get the vaccine at this time.)
    •    Have 3 or more of the following risk factors: high blood pressure diagnosed by a doctor; high blood
         cholesterol diagnosed by a doctor; diabetes or high blood sugar diagnosed by a doctor; a first degree
         relative (for example, mother, father, brother, sister) who had a heart condition before the age of 50; and,
         you smoke cigarettes now. (While this may be a temporary exclusion, these people should not get the
         vaccine at this time.)

Again, people who have been directly exposed to the smallpox virus should get the vaccine, regardless of their
health status.

Don’t Hesitate!
If offered the smallpox vaccine, individuals should tell their immunization provider if they have any of the above
conditions, or even if they suspect they might.
                                                                                                                  33


                                                  Appendix C
SMALLPOX FACT SHEET

Smallpox Vaccination: An Important Decision
The smallpox vaccine was used to eradicate smallpox disease from the Earth. However, supplies of the smallpox
virus still exist, and concern that smallpox might be used as a weapon has led the United States government to
prepare for a fast and effective response to a smallpox outbreak.

Part of this preparedness effort is the creation of smallpox healthcare teams that would respond to a smallpox
emergency. Members of these teams would investigate, manage and control a smallpox outbreak. Membership on
these teams is voluntary, but vaccination of team members is required for their own safety and to ensure that team
members cannot transmit smallpox.

Individuals considering smallpox vaccination should be well informed about smallpox disease; the vaccine and
its side effects—including potentially life-threatening reactions; and health conditions that indicate an individual
should not be vaccinated as part of this preparedness effort because they are at increased risk of experiencing
adverse reactions to the vaccine. This fact sheet provides an overview of the information that will be provided to
those offered the vaccine.

Smallpox Disease

    •   The deliberate release of smallpox is now regarded as a possibility.
    •   Smallpox is a serious, contagious and potentially deadly disease that can be prevented through vaccination.
    •   Vaccination within 3 days of exposure to smallpox will prevent or significantly lessen the severity of
        symptoms in most people. Vaccination 4 to 7 days after exposure offers some protection from disease or
        may reduce disease severity.

The Smallpox Vaccine

    •   The vaccine is safe and effective for most people who receive it. This same vaccine was used to eradicate
        naturally occurring smallpox.
    •   The vaccine to be used for smallpox response teams is licensed and passes all tests required by the Food
        and Drug Administration.
    •   The smallpox vaccine provides high-level immunity from smallpox for 3 to 5 years, with decreasing
        immunity thereafter.
    •   Persons receiving smallpox vaccinations previously (before 1980) should assume they have little or no
        immunity to smallpox today and will require a new vaccination if they wish to be a member of smallpox
        response team.
    •   Smallpox vaccine contains live vaccinia virus to protect against smallpox. The virus can spread to other
        parts of the body and to other people. The vaccine site ought to be cared for carefully for this reason.
    •   Smallpox vaccine does not contain smallpox virus and cannot give you smallpox.
    •   The vaccine can have side effects ranging from normal, typically mild reactions to potentially life-
        threatening reactions causing death (see “Possible Reactions to the Vaccine” in this fact sheet).
    •   People with certain conditions are at greater risk of experiencing serious reactions and should not get the
        vaccine unless they have been exposed to smallpox (see “Who Should Not Get the Vaccine” in this fact
        sheet).
                                                                                                                         34

    •    Careful screening can identify people more likely to have serious reactions and thus help prevent them.

Possible Reactions to the Vaccine

    •    Minor reactions—including sore arm, fever and body aches—are common.
    •    Serious reactions can occur, including a toxic or allergic reaction at the vaccination site, spread of the
         vaccinia virus to other parts of the body or to other individuals, or spread of the vaccinia virus through the
         blood. (In the past, these occurred in about 1,000 people for every 1 million people vaccinated for the first
         time.)
    •    Life-threatening reactions can occur, including inflammation of the brain, ongoing infection of the skin
         with tissue destruction, and disfiguring and painful skin rashes. (In the past, between 14 and 52 people for
         every 1 million people vaccinated for the first time experienced these reactions.)
    •    Based on past experience, it is estimated that between 1 and 2 people per every 1 million vaccinated may
         die from complications of the vaccine.

Site Care

    •    The vaccination site must be cared for carefully until the scab that forms after vaccination falls off on its
         own (in 2 to 3 weeks).
    •    Proper care (including hand washing, covering the site with gauze, wearing long-sleeved shirts) can
         decrease the risk of spread of the vaccinia virus.
    •    Health care workers involved in direct patient care need to take additional measures for site care, such as
         using semi-permeable dressings.

Who Should Not Receive the Vaccine
Individuals who have any of the following conditions, or live with someone who does, should NOT receive the
smallpox vaccine unless they have been exposed to the virus:

    •    Eczema or atopic dermatitis (even if it is not currently active, mild, or experienced as a child).
    •    Other skin conditions such as burns, chickenpox, shingles, impetigo, herpes, severe acne, or psoriasis
         (Individuals should not get the vaccine until the condition has completely healed).
    •    Weakened immune system (for instance, from cancer treatment, an organ transplant, HIV, or medications
         such as steroids to treat autoimmune disorders and other illnesses).
    •    Pregnancy or plans to become pregnant within 1 month of vaccination.

In addition, individuals should not receive the smallpox vaccine if they:

    •    Are allergic to the vaccine or any of its ingredients.
    •    Are less than 12 months of age. Also, the Advisory Committee on Immunization Practices advises against
         non-emergency smallpox vaccination in those younger than 18 years of age.
    •    Are currently breastfeeding.
    •    Have a moderate or severe short-term illness. (These people should wait until they recover to get
         vaccinated.)
    •    Have been diagnosed by a doctor as having a heart condition with or without symptoms, including
         conditions such as previous myocardial infarction (heart attack), angina (chest pain caused by lack of blood
         flow to the heart), congestive heart failure, and cardiomyopathy (heart muscle becomes inflamed and
         doesn't work as well as it should), stroke or transient ischemic attack (a "mini-stroke" that produces stroke-
         like symptoms but no lasting damage), chest pain or shortness of breath with activity (such as walking up
         stairs), or other heart conditions being treated by a doctor should not get the vaccine at this time. (Heart
         disease may become a temporary exclusion and may change as more information is gathered.)
                                                                                                                  35

    •   Individuals who have 3 or more of the following risk factors should not get the vaccine at this time: high
        blood pressure diagnosed by a doctor; high blood cholesterol diagnosed by a doctor; diabetes or high blood
        sugar diagnosed by a doctor; a first degree relative (for example, mother, father, brother or sister) with a
        heart condition before the age of 50; and/or, currently a cigarette smoker. (These may be temporary
        exclusions and may change as more information is gathered.)

Cost of Treatment of Vaccine Reactions

    •   Treatments for the more serious reactions can be very expensive. There is no federal program to pay these
        expenses. Workers compensation or health insurance may cover these expenses. If not, individuals may end
        up being responsible.
    •   Individuals may lose time from work following vaccination because of illness or because of concern that
        they could transmit the virus to others. There is no program in place to cover this. Individuals should check
        with their employer to see if the employer or workers compensation would cover this.
                                                                                          36


                                             Appendix D

                          Patient Medical History and Consent Form
For Administrative Use Only:
Initial Vaccination:
Revaccination: (Initial Patient Vaccination Number (PVN) ________________)
Date: __/__/____ (mm/dd/yyyy)
Please fill out sections A, B, and D of this form. Please use ink and print.

SECTION A: PATIENT DEMOGRAPHIC INFORMATION
(To be filled out by the patient. Please use ink and print)
Title: ________ First Name: _____________________________Middle Name___________________
(Mr., Ms., Mrs., Dr., etc.)
Last Name: _______________________________________ Suffix (Jr. Sr., M.D., etc.): ____________
SSN: _____-_____-_______ Date of Birth: ___/___/_______ (mm/dd/yyyy)
Gender: Male Female
Street Address:____________________________________________________ Apt. #: ___________
City: __________________________________________ State: ____________ Zip code: _________
County_________________________________________
Contact Information:
Home Phone: (____) ____- _____ Work: (____) ____- _____ ext. _____
Cell Phone: (____) ____- _____ Fax: (____) ____- _____
E-Mail Address: __________________________________________________________________
Occupation: ________________________________ Employer ______________________________
Employer’s Address ___________________________________________________________________
Ethnicity/Race: Hispanic or Latino Asian African American Hawaiian
American Indian or Alaskan White
May we contact you in the future? Yes No
SECTION B: VACCINATION AND MEDICAL HISTORY
(To be filled out by the patient. Please use ink and print)
Vaccination History
Did you ever receive the smallpox vaccine? Use the most recent date if you were vaccinated
more than once.
I have documentation that I was vaccinated on this date: ___/___/_____ (mm/dd/yyyy)
I recall that I was vaccinated on this date, but I don’t have documentation: ___/___/_____
(mm/dd/yyyy)
I was vaccinated in childhood, but I don’t know the date.
No, I was never vaccinated or I don’t know.
Do you have a vaccination scar? Yes No or Don’t Know
Did you have any bad reactions to the vaccine (adverse events)? Yes No or Don’t know
If yes, please describe the
reaction_______________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
For Administrative Use Only: Place
                                                                                                          37


Patient Vaccination Number (PVN)
Sticker here
(Version 4) March 31, 2003 Patient Medical History and Consent Form, Page 1 of 5
Date: __/__/____ (mm/dd/yyyy)

Patient Name: _____________________________________________PVN:_______________
Medical History
Have you received chickenpox (varicella) vaccination in the last month? Yes No
Are you currently taking medication? Yes No
If yes, please list medications:_________________________________________________________
_________________________________________________________________________________
Are you sick today? Yes No
If yes, please describe your illness (you may need to wait to be vaccinated until you get better )
_________________________________________________________________________________
_________________________________________________________________________________
Do any of the following apply to YOU? Yes No
1. Do you have any conditions that weaken the immune system such as HIV/AIDS; leukemia,
lymphoma, or most other cancers; organ transplant; or primary immune deficiency disorders?
2. Do you have a severe autoimmune disease such as lupus that may weaken the immune system?
3. Are you now taking, or have you recently taken, drugs that can weaken the immune system like
steroids (e.g. prednisone), medicines for autoimmune disease, or medicines taken after an organ
transplant?
4. Are you now taking cancer treatment with drugs or radiation or have you taken such treatment in
the past 3 months?
5. Do you now have, or have you ever had eczema or atopic dermatitis (even as a baby or child and
even if the condition is mild)?
6. Do you now have other skin problems that have made many breaks in your skin such as a rash,
severe burn, impetigo, chickenpox, shingles, herpes, psoriasis, or severe acne?
7. Are you now being treated with steroid eye drops?
8. Are you pregnant, breastfeeding, or planning to become pregnant in the next month?
9. Have you ever had a life-threatening allergic reaction to smallpox vaccine, latex or the antibiotics
polymixin B, streptomycin, chlortetracycline, or neomycin?
10. Have you ever been diagnosed by a doctor as having heart disease with or without symptoms
such as previous myocardial infarction (heart attack), angina (chest pain caused by lack of blood
flow to the heart), congestive heart failure, or cardiomyopathy?
11. Have you ever had a stroke or transient ischemic attack (a "mini-stroke" that produces stroke-like
symptoms but no lasting damage)?
12. Do you have chest pain or shortness of breath when you exert yourself (such as when you walk
up stairs)?
13. Do you have any other heart condition for which you are under the care of a doctor?
14. Do you have three of more of the following risk factors?
a. You have been told by a doctor that you have high blood pressure.
b. You have been told by a doctor that you have high blood cholesterol.
c. You have been told by a doctor that you have diabetes or high blood sugar.
d. You have a first degree relative (for example mother, father, brother, or sister) who had a
heart condition before the age of 50.
e. You smoke cigarettes now.
IF YOU ANSWERED YES TO ANY OF THE QUESTIONS ABOVE,
                                                                                                        38

YOU SHOULD NOT GET THE SMALLPOX VACCINE AT THIS TIME.
(Continues on next page)
Date: __/__/____ (mm/dd/yyyy) (Version 4) March 31, 2003 Patient Medical History and
Consent Form, Page 2 of 5




Date: __/__/____ (mm/dd/yyyy)
Patient Name:
__________________________________________________________PVN:_______________

Do any of the following apply to your CLOSE CONTACTS? Yes No
(A close contact is someone you live with or have close physical contact with, such as a sex partner.
Close contacts do not include friends or co-workers.)
1. Do any of your close contacts have conditions that weaken the immune system such as
HIV/AIDS, leukemia, lymphoma, or most other cancers; organ transplant; or primary immune
deficiency disorders?
2. Do any of your close contacts have a severe autoimmune disease such as lupus that may weaken
the immune system?
3. Are any of your close contacts now taking, or have they recently taken, drugs that can weaken the
immune system like steroids (e.g. prednisone), medicines for autoimmune disease, or medicines
taken after an organ transplant?
4. Are any of your close contacts taking cancer treatment with drugs or radiation or have they taken
such treatment in the past 3 months?
5. Do any of your close contacts now have, or have they ever had eczema or atopic dermatitis (even
as a baby or child and even if the condition is mild)?
6. Do any of your close contacts now have other skin problems that have made many breaks in their
skin such as a rash, severe burn, impetigo, chickenpox, shingles, herpes, psoriasis, severe diaper
rash, or severe acne?
7. Are any of your close contacts pregnant or planning to become pregnant in the next month?

IF YOU ANSWERED YES TO ANY OF THE QUESTIONS ABOVE,
YOU SHOULD NOT GET THE SMALLPOX VACCINE AT THIS TIME.
Screener comments/notes for clarification (for administrative use
only)________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
(Version 4) March 31, 2003 Patient Medical History and Consent Form, Page 3 of 5
                                                                                                    39

SECTION C: CURRENT VACCINATION INFORMATION AND TAKE EVALUATION
(This section will be filled in by clinic staff)

Date: __/__/____ (mm/dd/yyyy)
Patient Name:
__________________________________________________________PVN:_______________

DISPOSITION
Referred for Vaccination Deferred due to medical contraindications
Vaccination refused
Clinic personnel should pre-enter or attach this information before printing and copying the form.
Vaccination Clinic
Information
Vaccine Batch Information
Name: Vaccine Type: Batch #:
Contact: Program: Batch Date:
Phone: Dilution
Strength:
Fax: Vaccine Lot#: Diluent Lot #:
Address: Vaccine Lot
Manufacturer:
Diluent Lot
Manufacturer:
Referring Organization _______________________________________________________________
Address ___________________________________________________________________________
Date of Vaccination: ___/___/_____
Arm inoculated: Left Right
Vaccine Administered by: _____________________________________________________________
(please enter first name, last name, and professional suffix (M.D., R.N., etc)
Take Response
If take response evaluation is going to be conducted at another clinic site, please copy this page and
send it to that location.
Take Response Clinic:
Name _____________________________________
Address______________________________________________________
Take Response Exam performed by:
_____________________________________________________________
(please enter first name, last name, and professional suffix (M.D., R.N., etc)
Exam Date: ___/___/____
Major
Equivocal
No Take
Additional Comments
Adverse Events should be recorded in VAERS
(Version 4) March 31, 2003 Patient Medical History and Consent Form, Page 4 of 5
                                                                                                            40

SECTION D: CONSENT SIGNATURE
(TO BE RETAINED BY THE VACCINATION CLINIC)

Date: __/__/____ (mm/dd/yyyy)

Patient Name:
__________________________________________________________PVN:_______________

I have:
• received, read and understand the Smallpox Pre-Vaccination Information Package, including 1) the
Vaccine Information Statement (VIS), 2) the VIS supplements (A-E) on reactions after smallpox
vaccination, vaccination site appearance and care, skin conditions, weakened immune system,
pregnancy and breastfeeding, 3) the March 31, 2003 VIS supplement on smallpox vaccine and heart
problems, and 4) the pre-event screening worksheet;
• considered my own health status as well as the health status of my household members and close
physical contacts;
• had the opportunity to discuss my medical concerns with my health care provider or a health care
provider at the vaccination clinic;
• had the opportunity to obtain a referral to seek confidential laboratory testing for medical conditions
that may increase my risk for adverse reactions from the vaccine;
• responded to the questions above to the best of my ability.
I understand the decision to be vaccinated is voluntary and agree to proceed with smallpox
vaccination.

_______________________________________________________
Patient Signature
_____________________
Date
________________________________________________________
Medical Screener
_____________________
Date
Privacy Act Statement
The information requested on this form, including the Social Security Number (SSN), is
collected under the authority of Section 311 of the Public Health Service Act (42 U.S.C. 243),
the NCVIA (42 U.S.C. 300aa-2(a)), and Section 304 of the Homeland Security Act of 2002
(Pub.L. No. 107-296). The information will be used in the analysis and follow-up of significant
events associated with smallpox vaccination and to assure availability of smallpox response
teams. The SSN is being collected for identity verification purposes. Furnishing the requested
information, including SSN, is voluntary; however, with more complete information, public
health objectives, such as adequate monitoring and follow-up of potential adverse events, are
more readily achievable. Identifiable information may be shared with authorized U.S.
Department of Health & Human Services’ personnel and public health or cooperating medical
authorities.

(Version 4) March 31, 2003 Patient Medical History and Consent Form, Page 5 of 5
                                                                                                    41


                                           Appendix E

                                 Richardson Fire Department

           Recommended Guidelines for Smallpox Vaccine Administration

1. The Richardson Fire Department should establish standard operating guidelines for the

   administration of smallpox vaccine to its members.

2. Participation in the program should be strictly voluntary.

3. Full disclosure of all possible side effects should be given to vaccine candidates utilizing a

   current list of reported vaccine associated complications and current CDC fact sheets on

   smallpox.

4. Pre-event screening worksheets along with Patient Medical History and Consent Forms

   available from the CDC should be utilized for all vaccine candidates to determine if

   contraindications exist. If any are discovered the candidate should be prohibited from

   receiving the vaccine. Forms should be signed prior to vaccine administration.

5. Should a confirmed smallpox exposure take place the member exposed should receive the

   vaccine even if contraindications exist. In those cases concurrent administration of vaccinia

   immune globulin should be administered.

6. The Richardson Fire Department should consult the CDC, Texas Department of Health,

   Dallas County Health Department, and the RFD Medical Director’s recommendations when

   establishing vaccine program guidelines.

								
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