Appendix A - Garrett County Health Department

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Appendix A Category A Diseases •

Anthrax (Bacillus anthracis)



Botulism (Clostridium botulinum toxin)



Plague (Yersinia pestis)



Smallpox (variola major)



Tularemia (Francisella tularensis)



Viral hemorrhagic fevers (filoviruses [e.g., Ebola, Marburg] and arenaviruses [e.g., Lassa, Machupo])

Category A Diseases/Agents The U.S. public health system and primary healthcare providers must be prepared to address various biological agents, including pathogens that are rarely seen in the United States. High-priority agents include organisms that pose a risk to national security because they can be easily disseminated or transmitted from person to person; result in high mortality rates and have the potential for major public health impact; might cause public panic and social disruption; and require special action for public health preparedness.

Appendix A

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Appendix A

Table of Contents Anthrax…………………………………………………………….1

Botulism…………………………………………………………...3

Plague……………………………………………………………...6

Smallpox…………………………………………………………..9

Tularemia………………………………………………………….30

Viral Hemorrhagic Fever………………………………………..40

Appendix A

FACT SHEET

Anthrax Description of Agent: Inhalation anthrax is a highly lethal infection caused by inhalation of aerosols of the spore form of the bacteria Bacillus anthracis. In naturally occurring cases, anthrax may be spread by entry through skin wounds, causing a localized infection. Signs and Symptoms: Incubation period for inhalation anthrax is 1-6 days. Fever, malaise, fatigue, cough, and mild chest discomfort are followed by severe respiratory distress with dyspnea, diaphoresis, stridor, and cyanosis. Shock and death occur within 24-36 hours of severe symptoms. In cutaneous anthrax, a papule develops, then vesicles, followed by a black eschar surrounded by moderate to severe edema. The lesions are usually not painful. Without treatment, the disease may progress to septicemia and death, with a case-fatality rate of 20%. With treatment, fatalities are rare. Diagnosis: Physical findings are nonspecific in inhalation cases with initial complaints of malaise, fever, headache, and possibly some substernal chest pain. A widened mediastinum is often seen on x-ray. Anthrax is detectable by Gram stains of the blood and by blood culture late in the course of illness. Treatment: Although usually not effective for inha lation cases after symptoms are present, high-dose antibiotic treatment with penicillin, ciprofloxacin, or doxycycline should be undertaken. Without antibiotic sensitivities, treatment should be started with IV ciprofloxacin (400 mg q 8-12 hr) or IV doxycycline (200 mg initially, followed by 100 mg q 12 hr). Supportive therapy may be necessary. Prophylaxis: There is a licensed vaccine for use in those considered to be at risk of exposure. The vaccine is administered at 0, 2, and 4 weeks for the initial series, followed by boosters at 6, 12, and 18 months and then an annual booster. Oral ciprofloxacin (500 mg po bid) or doxycycline (100 mg po bid) should be given for known or imminent exposure. After confirmed exposure, all unimmunized individuals should have two 0.5 ml doses of the vaccine 2 weeks apart, and those vaccinated with less than three doses prior to exposure should have a single 0.5 ml booster. Anyone vaccinated with the initial three dose series in the previous 6 months does not need a booster. Everyone exposed should continue antibiotics for 4 weeks. If no vaccine is available, antibiotics should be used beyond 4 weeks and withdrawn under medical supervision. Decontamination: Secretion and lesion precautions should be practiced. Anthrax has not been transmitted by the aerosol route person-to-person. After an invasive procedure or autopsy is performed, the instruments and area used should be thoroughly disinfected with a sporicidal agent (iodine or 0.5% sodium hypochlorite).

1 Appendix A

TREATMENT PROTOCOL

Anthrax 1.

General:

Anthrax is a highly lethal infection spread by inhalation or entry through an opening in the skin. The inhalation route will result in a more rapid and deadly infection. The incubation period for both routes is 1-6 days. Fever, malaise, fatigue, cough, and mild chest discomfort are followed by severe respiratory distress with dyspnea, diaphoresis, stridor, and cyanosis. Shock and death occur within 24-36 hours of severe symptoms. 2.

Treatment: a.

Evaluate the patient for fever, cyanosis, and respiratory distress.

b.

The patient should be given oxygen during transport, as needed.

c. All patients should receive cardiac monitoring and evaluation of oxygenation saturation via pulse oximeter. d.

Obtain IV access with lactated Ringer’s at KVO rate.

e. Although usually not effective after severe symptoms are present, highdose antibiotic treatment with penicillin, ciprofloxacin, or doxycycline should be undertaken. Without antibiotic sensitivities, treatment should be started with IV ciprofloxacin (400 mg q 8-12 hr) or IV doxycycline (200 mg initially, followed by 100 mg q 12 hr). Supportive therapy may be necessary. f.

Before transporting the patient, check for additional victims.

g. Transport the patient to the most appropriate medical facility as directed by medical consultation. h. Secretion and lesion precautions should be practiced. Anthrax has not been transmitted by the aerosol route person-to-person. After an invasive procedure or autopsy is performed, the instruments and area used should be thoroughly disinfected with a sporicidal agent (iodine or chlorine). Wiping the ambulance interior with a 70% alcohol or other disinfectant is probably unnecessary, but would not be unreasonable. That need not be completed before the next run. i. Public health officials may recommend that others who may have been initially exposed take prophylactic antibiotics and immunizations before they show signs of illness. If a registry is established, all emergency personnel should identify themselves and indicate when, where, and to what extent they might have been exposed. 2 Appendix A

Maryland Department of Health and Mental Hygiene Epidemiology and Disease Control Program

Patients with Suspected Anthrax: Initial Case Information Form Today’s Date:

Person completing this form: Phone number or beeper:

------------------------------------------------------------------

Clinical Contact Name :

Position:

Phone:

Beeper:

------------------------------------------------------------------

Patient Demographic Info Name (Last, First, MI): Address:

County:

City, State, Zip:

Phone #:

Age: _____

(DOB:

/

/

)

Sex: _______

Ethnicity: Are you Hispanic or Latino?

[ ] Yes

[ ] No

[ ] Unknown

Race (check all that apply): [ ] American Indian or Alaska Native [ ] Black or African American

[ ] Asian

[ ] White

[ ] Other

[ ] Unknown

[ ] Native Hawaiian or other Pacific Islander Employer Address:

Employer:

------------------------------------------------------------------

Exposure Site (Please circle site & complete blanks, if appropriate) a. b. c. d. e. f.

Hart Senate Office Building Brentwood USPS Facility P Street Mail Facility Other mail facility: (please specify): ________________________________ State Department Mail Facility Other site: (please specify): ______________________________________

------------------------------------------------------------------

Symptoms & Clinical Information Date of Onset (first symptom):

/

/

Date of Presentation to Medical Care provider: Admitted to the Hospital? Hospital Name:

[ ] Yes (Date:

/

/ /

/ )

[ ] No

[ ] Unknown

Hospital State:

History of Present Illness:

(Continued on next page)

DHMH 4590 Rev 10-02 Maryland DHMH 201 West Preston Street, Baltimore, MD 21201 Phone 410-767-6700 Fax 410-669-4215

1

Maryland Department of Health and Mental Hygiene Epidemiology and Disease Control Program

Patients with Suspected Anthrax: Initial Case Information Form Patient Name : Please check all that apply: [ ] Asymptomatic [ ] Fever

[ ] Chills

[ ] Cough

if so

[ ] Hemoptysis

[ ] Myalgia

[ ] Productive

or

[ ] Fatigue

[ ] Non-productive

[ ] Dyspnea

[ ] Chest Pain

[ ] Vesicular

[ ] Black

[ ] Edema

[ ] Adenopathy

[ ] SOB

[ ] Rhinitis [ ] Cutaneous

if so

[ ] Eschar

Chest Xray(s): Date

Findings

____________

[ ] Normal

[ ] Infiltration

[ ] Effusions

[ ] Wide Mediastinum

[ ] Pending

[ ] Other: CXR Read by Radiologist? [ ] YES

[ ] NO

Chest CT Scan: Date

Findings

____________

[ ] Normal

[ ] Pleural effusions

[ ] Other:

[ ] Pending

[ ] Wide Mediastinum

------------------------------------------------------------------

Laboratory (If ordered, enter collection date & circle the test name; add results if available.) Date _________

WBC:

Differential:

Cultures: (Codes: ND-Not Done, NG-No Growth, NF-Normal Flora, PendPending, Pos-Positive) _________ Blood ___________ _________ Sputum ___________

[ ] ND

[ ] NG

[ ] NF

[ ] Pend

[ ] Pos:

[ ] ND

[ ] NG

[ ] NF

[ ] Pend

[ ] Pos:

_________ Nasal Swab [ ] ND ___________

[ ] NG

[ ] NF

[ ] Pend

[ ] Pos:

_________

Other:

Site: ________

Result: ________________________________

Serum Specimens collected for anthrax serology to be done by CDC? Acute serum date:

[ ] Yes

Convalescent serum:

[ ] No

[ ] Yes

Date: [ ] No

/ Date:

[ ] Yes

[ ] No

/ /

/

------------------------------------------------------------------

Additional Results / Comments Maryland DHMH 201 West Preston Street, Baltimore, MD 21201 Phone 410-767-6700 Fax 410-669-4215

2

Guidelines for Field Screening of Suspected White Powder Incidents

Maryland Department of the Environment Emergency Response Division 1800 Washington Blvd., Suite 105 Baltimore, MD 21230 Contact the MDE Emergency Response Division, (410) 537-3975 with any questions regarding this document

Revision 1 September 16, 2002

CONTENTS Preface

1

Field Screening of “White Powders”

2

Attachment 1: Field Screening Kit Contents

3

Attachment 2: Glucose Strip Results Guide

4

Attachment 3: Iodine Test Results Guide

5

Attachment 4: Field Screening Results of Common Substances

6

Attachment 5: Field Screening Results Worksheet

7-8

Revision 1 September 16, 2002

1

PREFACE Public concerns about anthrax contamination have resulted in a large number of responses to “white powder” emergencies. These calls may be the result of genuine citizen concern, a deliberate chemical or biological agent release or (occasionally) a deliberate hoax. In an effort to assist local responders and reduce the volume of unnecessary laboratory analysis, the Maryland Department of the Environment’s Emergency Response Division collected a series of basic tests to identify the most common substances found at “white powder” scenes. The methods described in this document are for the rapid field screening of so-called “white powder” samples that do not appear to be part of a highly credible threat. Field experience has demonstrated that a large variety of common “white powder” materials can be rapidly identified in the field using basic chemical tests. Responders should exercise the following precautions at all times during the screening process: §

Evaluate the credibility of the threat in cooperation with law enforcement personnel.

§

Wear appropriate personal protective equipment to prevent inhalation or contact hazards. At a minimum, this must consist of a Level “C” protective garment with hood, gloves, shoe coverings and an airpurifying respirator or powered air-purifying respirator with P100/HEPA filtration.

§

Forward any sample that cannot be conclusively identified to a qualified laboratory for further analysis of chemical, biological or radiological hazards.

§

Carefully document the results of any field screening tests. Take photographs where possible.

The procedures described by this document should only be used by trained hazardous materials technicians. Other hazards may exist which may not be identified by these screening methods.

Revision 1 September 16, 2002

2

Field Screening of “White Powders” 1. Check the sample for the presence of radiation using a Geiger-Mueller instrument with “pancake” probe. Measure approximately 1 inch from the sample and be careful not to touch the sample with the instrument probe. If radiation above normal background levels is present, secure the area and contact the Maryland Department of the Environment Emergency Response Division for assistance. 2. Place smaller samples of the solid into three separate plastic weighing dishes. 3. Pipette a moderate quantity of distilled or sterile water (NOT saline) onto the sample in the first dish. If the sample reacts with the water, this may indicate the presence of water-reactive materials such as seltzer tablets or similar. 4. Mix the solid material with water until it has dissolved as much as possible. While mixing, observe the solution for the presence of excessive bubbles that would indicate the presence of powdered soap. Test the solution using pH paper and urine glucose strips. A pH of less than 4 or greater than 10 is generally indicative of a chemical product, not a biological agent. Consult the chart found at Attachment 2 for urine glucose test strip readings. 5. Pipette a small quantity of acetic acid onto the sample in the second dish. If the sample reacts with acetic acid, it indicates the presence of a base material—usually baking soda or baking powder. 6. Pipette a small quantity of diluted iodine solution onto the sample in the third dish. If the iodine solution turns a very dark purple, then the material is a starch such as corn starch, flour or baby powder. Consult Attachment 3 for a visual example of a successful iodine test for starch. 7. Upon completion of successful screening, careful dispose of materials inside a zipper lock plastic bag and dispose of using standard methods. Products used in this procedure do not qualify as hazardous waste in these quantities. 8. For additional field information, pipette small quantities of dissolved solids (from Step 4) onto test portions of a chemical classifier strip (Spill-Fyter or similar) and read results.

Revision 1 September 16, 2002

3

Attachment 1: Field Screening Kit Contents Always wear appropriate personal protective equipment when conducting field screening of suspicious powders.

1. Plastic weighing dishes, 1 inch by 1 inch (75 each) 2. Disposable pipettes (25 each) 3. Tongue depressors (25 each) 4. Deionized Ultra Filtered (DIUF) water or sterile distilled water (8 oz in standard plastic sample bottle) 5. Acetic Acid, 5% (8 oz in standard plastic sample bottle). Household white vinegar may be used for this application. 6. Iodine solution (8 oz in standard plastic sample bottle). The most effective iodine solution is created by obtaining Lugol’s Solution from a laboratory supplier and mixing six parts distilled water to one part Lugol’s solution. Betadine, Tincture of Iodine or similar preparations contain additional constituents that greatly reduce the effectiveness of the starch test. 7. pH Paper test strips (1 package) 8. Glucose urine test sticks (1 package), available from most pharmacies. 9. One gallon plastic zipper lock bags for disposal of materials. 10. Spill-Fyter chemical classifier strips (10 each)

Revision 1 September 16, 2002

Attachment 2: Glucose Strip Results Guide

5

Attachment 3: Iodine Test Results Guide

Revision 1 September 16, 2002

6

Attachment 4: Field Screening Results of Common Substances

Material

Water Soluble

pH below standard

pH above standard

Color Change w/ Iodine

Bubbles w/ Acetic Acid

Glucose Strip turns blue

BAKING POWDER BAKING SODA BABY POWER COMET FLOUR SUGAR SALT SWEETN-LOW NUTRAS WEET EQUAL COFFEE MATE

PARTIAL

NO

YES

YES

YES

NO

YES

NO

YES

NO

YES

NO

NO

NO

NO

YES

NO

NO

PARTIAL NO YES YES YES

NO NO NO NO NO

YES NO NO NO NO

NO YES NO NO

SLIGHTLY NO NO NO NO

NO NO YES NO YES

YES

NO

NO

NO

YES

YES PARTIAL

NO NO

NO NO

NO NO

YES YES

YES NO

Revision 1 September 16, 2002

SPIL-FYTER shows present for #1 Base, #2 Oxidizer, #5 Iodine, Chlorine, Bromine

YES

7

Attachment 5: Field Screening Results Worksheet DATE: ________________ LOCATION SAMPLE OBTAINED: ___________________________________ INDIVIDUAL PERFORMING SCREENING: _____________________________

TEST 1 •

Survey sample with Geiger counter

Geiger counter reading: ________________________ (include units, mR/Hr or R/Hr) Remarks: ________________________________________________________ ________________________________________________________________ ________________________________________________________________ TEST 2 •

Add distilled water or DIUF to solid

REACTION?

YES

NO

pH result from paper: ____________ Glucose strip result/color: ______________ Remarks: ________________________________________________________ ________________________________________________________________ ________________________________________________________________

Revision 1 September 16, 2002

8

TEST 3 •

Add acetic acid/white vinegar to solid

REACTION?

YES

NO

Remarks: ________________________________________________________ ________________________________________________________________ ________________________________________________________________

TEST 4 •

Add diluted Lugol’s solution to solid

COLOR CHANGE TO DARK PURPLE?

YES

NO

Remarks: ________________________________________________________ ________________________________________________________________ ________________________________________________________________ DISPOSITION OF SAMPLE Determined non-hazardous, disposed in regular trash Hazard undetermined, sent to State Lab (date: _________________)

**INCLUDE A COPY OF THIS WORKSHEET WITH ANY SCREENED SAMPLE PROVIDED TO THE STATE LABORATORY**

Revision 1 September 16, 2002

Guidelines for Collecting Qualitative Environmental Samples of Anthrax Adapted from Centers for Disease Control “Procedures for Collecting Environmental Samples of Anthrax” (October 23, 2001 draft)

Maryland Department of the Environment 2500 Broening Highway Baltimore, MD 21224 Contact Mike Sharon, MDE Emergency Response Division, (410) 631-3868 or [email protected] with any questions regarding this document

Revision 1 October 31, 2001

CONTENTS Preface

1-2

Collecting Qualitative Surface Wipe Samples

3

Attachment 1: Personal Protective Equipment

4

Attachment 2: Operational Concept for Facility Assessment

5-7

Revision 1 October 31, 2001

1

PREFACE These guidelines are intended for the use of state and local personnel in Maryland who are called upon to collect environmental samples to be analyzed for the presence of anthrax. The methods described in this document are for the collection of qualitative samples; i.e. samples which will be used only to determine the presence or absence of anthrax and not to quantify the amount of anthrax present at a particular location. If a test indicates the presence of anthrax at a particular location, additional detailed sampling must be conducted to quantify the amount and extent of anthrax contamination. The decision to sample for Bacillus anthracis should be made by medical, environmental or industrial hygiene professionals familiar with the organism and environmental sampling methodologies described herein. Representatives from local, state and federal authorities should be consulted during the decision making process. The decision to conduct environmental sampling should be based on the nature and location of the suspected contamination, medical diagnoses and impressions, potential contaminate migration, the activity for which the facility is used and the reliability and uncertainty associated with the data to be generated. Environmental sampling may be done to help determine the extent and degree of contamination, support decisions on when cleanup is needed and provided guidance on when cleanup is adequate for re-entry into an area. Environmental exposure standards for Bacillus anthracis spores do not exist. Investigators who review and interpret the results of environmental sampling for Bacillus anthracis spores must consider these uncertainties and use professional judgement in interpreting any positive or negative findings. Before sampling, consult the building’s engineer to determine airflow patterns and the design of the heating, ventilation and air conditioning system. Since most building ventilation systems recirculate air to other locations in the building, the ventilation system serving the contaminated area should be shut off to prevent further airborne spread of anthrax spores. Depending on the size of the area involved, the types of surfaces potentially contaminated and the extent of contamination, it may be necessary to seal the contaminated area to prevent the spread of contamination through the movement of people or equipment. § §

If the contaminated area is small, discrete and only lightly contaminated, it may suffice to cordon off the area If the contaminated area is large, seal off the affected area using polypropylene sheeting and tape in the same way areas are sealed off for asbestos abatement. Air vents in the area should also be sealed with polypropylene sheeting and tape. Revision 1 October 31, 2001

2

Environmental sampling by experienced investigators will provide the best probability of locating and identifying Bacillus anthracis spores if they are present. The sampling method and number of samples collected will be influenced by the nature, circumstances and setting of the potential contamination. A sufficient number of samples must be taken to increase the probability that the sampling is representative. Additional sampling locations may provide more specific information on the source of the contamination. The methods used may involve bulk, surface or air sampling strategies. In this document, only qualitative surface samples will be discussed. The first priority should be to collect samples in locations that are near suspected release sources. Later samples should be collected by moving outward in concentric circles to follow the path by which spores would disperse outside of the immediate zone of release. Note that if the aerosol containing the Bacillus anthracis has an aerodynamic size of less than 10 microns, the particles may remain suspended in the air for extended periods of time. In such cases, the spores can quickly spread throughout an air space and into adjacent areas served by the same ventilation system. Spores can be carried further if they attach to clothing, shoes or other objects—so more distant sampling may be needed. Personnel who enter the contaminated area must wear appropriate personal protective equipment (see Attachment 1) and follow a safety plan developed for a particular site.

Revision 1 October 31, 2001

3

Collecting Qualitative Surface Wipe Samples For use on large, non-porous surfaces such as table tops, counters, desks, file cabinets and non-carpeted floors.

1. Don sterile, non powdered examination gloves over gloves worn as part of standard personal protective equipment. 2. Remove a sterile 2” X 2” or 4” X 4” gauze pad from package. 3. Moisten the gauze with sterile water or sterile saline solution (non-buffered). 4. Wipe the surface. Recommended wipe area is approximately 1 square foot. Avoid letting the gauze pad dry completely. Suggested sampling technique: Make 3 to 4 vertical S-strokes; fold the exposed side of the pad; make 3 to 4 horizontal S-strokes over same area. 5. Place the sampled gauze into a self-sealing bag (Ziploc bag, Whirlpack or similar).* 6. Label the bag with the exact location, time and date of sample and place it into a second self-sealing bag. 7. Clean the outside of the second sealed bag with alcohol wipes or a .5% bleach solution just prior to leaving the contaminated area. 8. Place the cleaned, sealed bags in another unused self-sealing bag or 5-gallon bucket with lid. 9. Submit the samples to the DHMH laboratory for analysis. To collect another sample, repeat steps 1-8. Change gloves between samples.

*The use of trade names is for identification and information only and does not constitute an endorsement by the Maryland Department of the Environment.

Note: This procedure differs from CDC draft guidance in two respects. First, CDC suggests the use of a non-cotton 3” X 3” sterile pad. The DHMH laboratory has approved the use of cotton gauze pads as detailed above. Second, CDC suggests placing the swipes into a conical vial. The DHMH laboratory has approved the use of the “double bag” technique as described above.

Revision 1 October 31, 2001

4

Attachment 1: Personal Protective Equipment Personal protective equipment should only be worn by properly trained, fitted and qualifed personnel. LEVEL C Note: Level C protection is recommended for facility assessments unless other conditions (noted under Level B and Level A) are present. Responders may use a full facepiece respirator with a P100 filter or powered airpurifying respirator (PAPR) with high efficiency particulate air (HEPA) filters when it can be determined that: - An aerosol-generating device was not used to create high airborne concentration - Dissemination was by a letter or package that can be easily bagged.

These type of respirators reduce the user’s exposure by a factor of 50 if the user has been properly fit tested. In these circumstances, standard Tyvek suits with hoods; latex gloves and shoe covers will provide sufficient protection.

LEVEL B Responders may use a Level B protective suit with an exposed or enclosed NIOSH- approved pressure-demand SCBA if the situation can be defined in which: - The suspected biological aerosol is no longer being generated - Other conditions may present a splash hazard.

LEVEL A Responders should use a NIOSH-approved, pressure-demand SCBA in conjunction with a Level A protective suit in responding to a suspected biological incident where any of the following information is unknown or the event is uncontrolled: - The type(s) of airborne agent(s) - The dissemination method - Dissemination via an aerosol-generating device is still occurring or it has stopped but there is no information on the duration of dissemination, or what the exposure concentration might be Revision 1 October 31, 2001

5

Attachment 2: Operational Concept for Facility Assessment PHASE 1: Dispatch and Arrival §

Sites to be tested will be identified and assessment team dispatched

§

Scene will be secured to the maximum extent possible by local law enforcement, facility security staff or State Police.

§

Upon arrival, an in-briefing will be conducted with the facility point of contact. Information to be discussed will include: a. b. c. d. e.

Diagrams of facility and mailroom Discussion of flow of mail through facility Airflow patterns in the facility Identification of potential numbers of affected staff Briefing by assessment team on procedures to be followed during the assessment f. Procedures for referral of media inquiries

§

Assessment team will set up decon stations and don appropriate personal protective equipment.

§

If staff members are present, they should be removed from the area to be assessed for the duration of sampling activity. This is to allow the assessment team maximum freedom of movement and to prevent needlessly alarming staff members.

PHASE 2: Facility Assessment §

Assessment team will enter the facility and take swipe samples along the probable path of mail through the mailroom as well as other suspected sources of contamination.

§

Qualitative swipe samples will be taken in accordance with guidelines found in this document. Individual swipes should be taken at the beginning and end or mail sorting equipment flow paths; composite swipes will be taken along the rest of the flow path.

§

Other swipes will be taken by the assessment team as determined during Phase 1. Specific swipe locations are unique to each facility.

Revision 1 October 31, 2001

6

§

If present, National Guard Civil Support Team personnel will conduct two hand-held biological assays with verification assays (for a total of four assays per facility). These assays will consist of composite samples from probable entry and exit paths or mail flow or other locations of suspected contamination. (Note: hand-held assays are field tests only and do not conclusively determine the presence or absence of anthrax spores. They are not a substitute for laboratory analysis).

§

All swipe samples will be bagged and labeled in accordance with DHMH laboratory procedures. A log will be kept detailing the exact number and location of samples within each facility.

§

In the event of a positive result from a hand-held assay, a third assay and verification (from a separate lot) will be conducted. In the event this assay also tests positive, the team will immediately contact the local health officer and State Emergency Operations Center for further instructions.

PHASE 3: Demobilization and Reporting §

Upon conclusion of facility assessment, the team will exit the facility and begin personal decontamination.

§

Personal decontamination will consist of dry decontamination (removal of protective clothing) to the maximum extent possible. In the event items of protective clothing such as protective boots need decontamination, a solution of .5% household bleach (10 parts water to 1 part household bleach) will be applied. Decon solution may be disposed of in a sanitary sewer or other sanitary drain. All assessment personnel will wash their hands with soap and water as part of the decontamination process.

§

An out-briefing will be conducted with the facility point of contact. This outbriefing will include: a. Discussion of swipes taken and other procedures b. Point of contact information for follow-up questions from the facility c. Clear discussion that laboratory analysis will provide the determination of the presence/absence of anthrax. Share information regarding the anticipated availability of lab results (normally 3-5 days). d. Lab results will be provided by DHMH to the local health department for communication to the facility.

§

Preliminary results of the out-briefing and assessment (if conducted by a State team) will be communicated back to DHMH and MDE. Revision 1 October 31, 2001

7

§

A log will be maintained of all samples collected at an individual facility. Expended hand-held assays will be maintained by the MDE Emergency Response Division pending the results of laboratory analysis.

Revision 1 October 31, 2001

FACT SHEET

Botulinum Toxins Description of Agent: Botulinum toxins are poisonous substances produced by a bacterium, Clostridium Botulinum. They are usually formed in canned foods and eaten butcan be spread by aerosol and inhalation. The toxin blocks acetylcholine release at the neuromuscular junction and in the central and peripheral nervous systems. Signs and Symptoms: Ptosis, generalized weakness, dizziness, dry mouth and throat, blurred vision and diplopia, dysarthria, dysphonia, and dysphagia followed by symmetrical descending flaccid paralysis and development of respiratory failure. Symptoms begin as early as 24-36 hours but may take several days after inhalation of toxin. Diagnosis: Clinical diagnosis. No routine laboratory findings. Biowarfare or terrorist attack should be suspected if numerous collocated casualties have progressive descending bulbar, muscular, and respiratory weakness. Treatment: Intubation and ventilatory assistance for respiratory failure. Tracheostomy may be required. Administration of Botulinum antitoxin as soon as possible--trivalent licensed product made by CDC or heptavalent IND product--may prevent or decrease progression to respiratory failure and hasten recovery. Skin testing must be performed before administration of the antitoxin. Prophylaxis: Pentavalent toxoid (types A, B, C, D, and E) is available as an IND product for those at high risk of exposure. The dosage schedule is 0, 2, and 12 weeks, with yearly boosters. Decontamination: Hypochlorite and/or soap and water. Toxin is not dermally active and secondary aerosols are not a hazard from patients.

3 Appendix A

TREATMENT PROTOCOL

Botulinum Toxins 1.

General:

Botulinim toxin is a poisonous substance produced by a bacterium, Clostridium Botulinum. It is usually formed in canned foods and eaten but can be spread by aerosol and inhalation. Onset of symptoms is hours to days after taking the poison into the body, so there is virtually no chance that emergency responders would be endangered by the poison carried by a victim. Symptoms typically include drooping eyelids, blurred or double vision, trouble swallowing, dry mouth, and sore throat, followed by a flaccid (limp) paralysis that begins near the head and moves downward. Death most often results from respiratory failure, so respiratory support is the most important aspect of prehospital care. Symptoms begin as early as 24-36 hours but may take several days after inhalation of toxin. 2.

Treatment:

a. Evaluate the patient for paralysis, cyanosis, respiratory distress, and signs of pneumonia superimposed on paralysis. b.

The patient may require artificial respiration during transport.

c. All patients should receive cardiac monitoring and evaluation of oxygenation saturation via pulse oximeter. d. Patient should be given oxygen during transport, as needed, but mechanical ventilation may be more important than oxygen. e. IV access is not critical, but will be helpful in the hospital setting, where a specific antitoxin will be administered and where the patient will probably remain for a few days to several weeks. If desired, obtain IV access with lactated Ringer’s at KVO rate. f. Intubation and ventilatory assistance may be necessary for respiratory failure. Tracheostomy may be required. Administration of Botulinum antitoxin — trivalent licensed product made by CDC or heptavalent IND product — may prevent or decrease progression to respiratory failure and hasten recovery. Skin testing must be performed before administration of the antitoxin. g.

Before transporting the patient, check for additional victims.

h. Transport the patient to the most appropriate medical facility as directed by medical consultation.

4 Appendix A

i. Decontaminate with hypochlorite and/or soap and water. Toxin is not dermally active and secondary aerosols are not a hazard from patients.

5 Appendix A

FORM APPROVED OMB NO.0920-0004

INVESTIGATION OF A FOODBORNE OUTBREAK

CDC USE ONLY

This form is used to report foodborne disease outbreak investigations to CDC. A foodborne outbreak is defined as the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food in the United States. This form has two parts: Part 1 asks for the minimum data needed and Part 2 asks for additional information. For this investigation to be counted in the CDC annual summary, Part 1 must be completed. We encourage you to complete as much of Part 1 and Part 2 as you can.

__ __–__ __ __ __ __ __

STATE USE ONLY ____________________

Part 1: Required Information 1. Location of Exposure:

2. Dates:

3. Numbers of Cases Exposed:

Date first case became ill:

State: ___ ___ ! Multi-state exposure

___ ___ / ___ ___ / ___ ___ ___ ___ Month

Day

Lab-confirmed cases:

Year

Date of first known exposure: ___ ___ / ___ ___ / ___ ___ ___ ___

County: ________________ ! Multi-county exposure

Month

List other states/counties in Comments, bottom of this page

Day

Year

Date of last known exposure: ___ ___ / ___ ___ / ___ ___ ___ ___ Month

4. Approximate Percentage of Total Cases in Each Age Group: <1 year: _____%

20-49 yrs: _____%

1-4 yrs: _____%

> 50 yrs: _____%

5. Sex: (Estimated

Day

Probable cases:

_____ (A)

_____ (B)

Estimated total ill: _____ (If greater than sum of A+B)

Year

6. Investigation Methods: (Check all that apply)

percent of total cases)

! ! ! ! !

Male: _____ % Female: _____ %

Interviews of cases only Case-control study Cohort study Food preparation review Food product traceback

! Investigation at factory or production plant ! Investigation at original source (farm, marine estuary, etc.) ! Environment / food sample cultures

5-19 yrs: _____%

7. Implicated Food(s): (based on

8. Etiology: (Name the bacteria, virus, parasite, or toxin. If available, include details such as phage

Reasons listed in Item 15 on page 3)

type, virulence factors, molecular fingerprinting, antibiogram, metabolic profile.

Etiology

___________________________

Serotype (if avail.)

Other Characteristics (if avail.)

___________________________ ___________________________ ___________________________

! Confirmed* ! Suspected

___________________________

! Could not be determined ! Unknown etiology ! Multiple etiologies (list in Comments)

Isolated/identified from (check all that apply) ! Patient specimen(s) ! Food specimen(s) ! Environment specimen(s) ! Food Worker specimen(s)

* see criteria at http://www.cdc.gov/ncidod/dbmd/outbreak/ or MMWR2000/Vol 49/SS-1/Appendix B

9. Contributing Factors: (See list on page 2, check all that apply)

10. Agency reporting this outbreak:

! Contributing factors unknown Contamination Factor: ! C1 ! C2 ! C3 ! C10

! C11

! C12

______________________________________ Contact Person:

! C4

! C5

! C6

! C13

! C14

! C15 (describe in Comments)

Proliferation/Amplification Factor (bacterial outbreaks only): ! P1 ! P2 ! P3 ! P4 ! P5 ! P6 ! P10

! P11

! P12 (describe in Comments)

! C7

! P7

! C8

! P8

! N/A

Survival Factor (microbial outbreaks only): ! S1 ! S2 ! S3 ! S4 ! S5 (describe in Comments)

! N/A

! No Was food-worker implicated as the source of contamination?! Yes If yes, please check only one of following: ! laboratory and epidemiologic evidence ! epidemiologic evidence (w/o lab confirmation) ! lab evidence (w/o epidemiologic confirmation) ! prior experience makes this the likely source (please explain in Comments)

! C9 ! N/A ! P9

NAME:

_________________________________

TITLE:

_________________________________

PHONE NO:

____________________________

FAX NO:

_______________________________

E-MAIL:

________________________________

Date of completion of this form: ___ ___ / ___ ___ / ___ ___ ___ ___ Month

Day

Year

! Initial Report ! Updated Report ! Final Report ! Additional data suggests this is not a foodborne outbreak

Comments: ________________________________________________________________________________________________

Page 1 CDC 52.13

REV. 10/2000

This questionnaire is authorized by law (Public Health Service Act, 42 USC §241). Although response to the questions asked is voluntary, cooperation of the patient is necessary for the study and control of disease. Public reporting burden for this collection of information is estimated to average 15 minutes per response. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to PHS Reports Clearance Officer; Rm 721-H, Humphrey Bg; 200 Independence Ave. SW; Washington, DC 20201; ATTN: PRA, and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503.

The following codes are to be used to fill out Part 1 (question 9) and Part 2 (question 15). Contamination Factors:1 C1 - Toxic substance part of tissue (e.g., ciguatera) C2 - Poisonous substance intentionally added (e.g., cyanide or phenolphthalein added to cause illness) C3 - Poisonous or physical substance accidentally/incidentally added (e.g., sanitizer or cleaning compound) C4 - Addition of excessive quantities of ingredients that are toxic under these situations (e.g., niacin poisoning in bread) C5 - Toxic container or pipelines (e.g., galvanized containers with acid food, copper pipe with carbonated beverages) C6 - Raw product/ingredient contaminated by pathogens from animal or environment (e.g., Salmonella enteriditis in egg, Norwalk in shellfish, E. coli in sprouts) C7 - Ingestion of contaminated raw products (e.g., raw shellfish, produce, eggs) C8 - Obtaining foods from polluted sources (e.g., shellfish) C9 - Cross-contamination from raw ingredient of animal origin (e.g., raw poultry on the cutting board) C10 - Bare-handed contact by handler/worker/preparer (e.g., with ready-to-eat food) C11 - Glove-handed contact by handler/worker/preparer (e.g., with ready-to-eat food) C12 - Handling by an infected person or carrier of pathogen (e.g., Staphylococcus, Salmonella, Norwalk agent) C13 - Inadequate cleaning of processing/preparation equipment/utensils – leads to contamination of vehicle (e.g., cutting boards) C14 - Storage in contaminated environment – leads to contamination of vehicle (e.g., store room, refrigerator) C15 - Other source of contamination (please describe in Comments) Proliferation/Amplification Factors:1 P1 - Allowing foods to remain at room or warm outdoor temperature for several hours (e.g., during preparation or holding for service) P2 - Slow cooling (e.g., deep containers or large roasts) P3 - Inadequate cold-holding temperatures (e.g., refrigerator inadequate/not working, iced holding inadequate) P4 - Preparing foods a half day or more before serving (e.g., banquet preparation a day in advance) P5 - Prolonged cold storage for several weeks (e.g., permits slow growth of psychrophilic pathogens) P6 - Insufficient time and/or temperature during hot holding (e.g., malfunctioning equipment, too large a mass of food) P7 - Insufficient acidification (e.g., home canned foods) P8 - Insufficiently low water activity (e.g., smoked/salted fish) P9 - Inadequate thawing of frozen products (e.g., room thawing) P10 - Anaerobic packaging/Modified atmosphere (e.g., vacuum packed fish, salad in gas flushed bag) P11 - Inadequate fermentation (e.g., processed meat, cheese) P12 - Other situations that promote or allow microbial growth or toxic production (please describe in Comments) Survival Factors:1 S1 - Insufficient time and/or temperature during initial cooking/heat processing (e.g., roasted meats/poultry, canned foods, pasteurization) S2 - Insufficient time and/or temperature during reheating (e.g., sauces, roasts) S3 - Inadequate acidification (e.g., mayonnaise, tomatoes canned) S4 - Insufficient thawing, followed by insufficient cooking (e.g., frozen turkey) S5 - Other process failures that permit the agent to survive (please describe in Comments) Method of Preparation:2 M1 - Foods eaten raw or lightly cooked (e.g., hard shell clams, sunny side up eggs) M2 - Solid masses of potentially hazardous foods (e.g., casseroles, lasagna, stuffing) M3 - Multiple foods (e.g., smorgasbord, buffet) M4 - Cook/serve foods (e.g., steak, fish fillet) M5 - Natural toxicant (e.g., poisonous mushrooms, paralytic shellfish poisoning) M6 - Roasted meat/poultry (e.g., roast beef, roast turkey) M7 - Salads prepared with one or more cooked ingredients (e.g., macaroni, potato, tuna) M8 - Liquid or semi-solid mixtures of potentially hazardous foods (e.g., gravy, chili, sauce) M9 - Chemical contamination (e.g., heavy metal, pesticide) M10 - Baked goods (e.g., pies, eclairs) M11 - Commercially processed foods (e.g., canned fruits and vegetables, ice cream) M12 - Sandwiches (e.g., hot dog, hamburger, Monte Cristo) M13 - Beverages (e.g., carbonated and non-carbonated, milk) M14 - Salads with raw ingredients (e.g., green salad, fruit salad) M15 - Other, does not fit into above categories (please describe in Comments) M16 - Unknown, vehicle was not identified 1

Frank L. Bryan, John J. Guzewich, and Ewen C. D. Todd. Surveillance of Foodborne Disease III. Summary and Presentation of Data on Vehicles and Contributory Factors; Their Value and Limitations. Journal of Food Protection, 60; 6:701-714, 1997. 2 Weingold, S. E., Guzewich JJ, and Fudala JK. Use of foodborne disease data for HACCP risk assessment. Journal of Food Protection, 57; 9:820-830, 1994. Page 2 CDC 52.13

REV. 10/2000

Part 2: Additional Information (Please complete as much as possible) 11. Numbers of: OUTCOME / SYMPTOM

12. Incubation Period: Cases with Outcome / Symptom

Total cases for whom you have information available

13. Duration of Acute Illness Among Those Who Recovered:

(circle appropriate units)

(circle appropriate units)

Shortest: _____

(Hours, days)

Shortest: _____

(Hours, days)

Healthcare Provider Visit

Longest:

_____

(Hours, days)

Longest: _____

(Hours, days)

Hospitalization

Median:

_____

(Hours, days)

Median:

(Hours, days)

Death

! Unknown

_____

! Unknown

Vomiting Diarrhea

* Use the following terms, if appropriate, to describe other common characteristics of cases:

Bloody stools Feverish Abdominal cramps * * *

myalgia paresthesia septicemia sore throat tachycardia thromobocytopenia temperature reversal urticaria wheezing

descending paralysis flushing headache hemolytic uremic syndrome (HUS) hypotension itching jaundice lethargy

anaphylaxis arthralgia bradycardia bullous skin lesions bradycardia cough coma diplopia

*

14. If Cohort Investigation Conducted: Event-specific Attack Rate = __________________ / _____________________________________ x 100 = ______ % # ill

total # of persons for whom you have illness info.

15. Implicated Food(s): (Please provide known information.) Name of Food

Main Ingredients

Contaminated Ingredient

Reason(s) Suspected (see below)

Method of Preparation (see list on page 2)

e.g., lasagna

pasta, sauce, eggs, beef

eggs

4

M1

! Food vehicle could not be determined Reason Suspected (choose all that apply): 1 - Statistical evidence from epidemiological investigation 2 - Laboratory evidence (e.g., identification of agent in food) 3 - Compelling supportive information

4 - Other data (e.g., same phage type found on farm that supplied eggs) 5 - Specific evidence lacking but prior experience makes this likely source

16. Where was Food Prepared? (Check all that apply) ! ! ! ! ! ! ! ! ! !

Restaurant or deli Day care center School Church, temple, etc. Camp Caterer Grocery store Hospital Workplace cafeteria Nursing home

17. Where was Food Eaten? (Check all that apply)

! ! ! ! ! !

Prison, jail Private home Picnic Fair, festival, other temporary/mobile service Contaminated food imported into U.S. Commercial product, served without further preparation ! Other (please describe)

! ! ! ! ! ! ! !

Restaurant or deli Day care center School Church, temple, etc. Camp Grocery Store Hospital Workplace cafeteria

! ! ! ! !

Nursing home Prison, jail Private home Picnic Fair, festival, or mobile location ! Other (please describe) __________________

_____________________________

18. Other Available Info: ! Unpublished agency report (please attach) ! Epi-Aid ! Publication (please reference) _____________________________ ! Not available

19. Remarks: Briefly describe important aspects of the outbreak not covered above (e.g., restaurant closure, product recall, immunoglobulin administration, economic impact, etc.)

____________________________________________________________ ____________________________________________________________ ____________________________________________________________ ____________________________________________________________ ____________________________________________________________

State Health Departments: Please FAX this document to Foodborne and Diarrheal Diseases, DBMD, CDC, at (404) 639-2205. Page 3 CDC 52.13

REV. 10/2000

FACT SHEET

Plague Description of Agent: Plague is an infectious disease caused by the bacteria Yersinia pestis. In nature, plague is most often spread by fleas that feed on infected rodents, then incidentally bite humans. When spread by that route, it classically causes a local abscess with formation of very large, abscessed, regional lymph nodes called buboes. Plague can also spread by aerosol and inhalation of sputum droplets from a coughing patient. In that manner, a primary pneumonic form develops and progresses rapidly to death without treatment. The plague can also be spread from person to person. Signs and Symptoms: Pneumonic plague: incubation period is 2-3 days. High fever, chills, headache, hemoptysis, and toxemia progress rapidly to dyspnea, stridor, and cyanosis. Death results from respiratory failure, circulatory collapse, and a bleeding diathesis. Bubonic plague: incubation period is 2-10 days. Symptoms are malaise, high fever, and tender lymph nodes (buboes); they may progress spontaneously to the septicemic form, with spread to the CNS, lungs, and elsewhere. Diagnosis: Clinical diagnosis. A presumptive diagnosis can be made by Gram or Wayson stain of lymph node aspirates, sputum, or CSF. Plague can also be cultured. Treatment: Early administration of antibiotics is very effective, but must be started within 24 hours of the onset of symptoms in pneumonic plague. The treatment of choice is streptomycin 30 mg/kg/day IM in 2 divided doses x 10 days. Intravenous doxycycline 200 mg, then 100 mg q 12 hr x 10-14 days is also effective. Chloramphenicol is necessary to treat plague meningitis. Supportive therapy for pneumonic and septicemic forms is required. Prophylaxis: A licensed, killed vaccine is available. An initial dose is needed, followed by a second smaller dose 1-3 months later, and a third 3-6 months later. A booster dose is given at 6, 12, and 18 months and then every 1-2 years. This vaccine does not protect against aerosol exposure. After face-to-face contact with a pneumonic plague patient or after a confirmed or suspected attack with aerosolized plague, doxycycline 100-mg po bid x 7 days or for the duration of exposure, whichever is longer, should be used. Decontamination and Isolation: Secretion and lesion precautions should be observed for patients with bubonic plague. Strict isolation of patients with pneumonic plague is needed. Respiratory isolation with the use of a filtered respirator for those with direct contact with patients, and secretion precautions are necessary until the patient has been on antibiotics for at least 48 hours and there has been a favorable response to treatment. Heat, disinfectants, and exposure to sunlight render the bacteria harmless.

6 Appendix A

TREATMENT PROTOCOL

Plague 1.

General:

Plague is an infectious disease caused by a bacterium called Yersinia pestis (formerly Pasteurella pestis). In nature, plague is most often spread by fleas that feed on infected rodents, then incidentally bite humans. When spread by that route, it classically causes a local abscess with formation of very large, abscessed, regional lymph nodes called buboes (hence the term "bubonic plague"). The incubation period is 2-10 days. Symptoms of malaise, high fever, and tender lymph nodes may progress spontaneously to the septicemic form and spread to the CNS, lungs, and elsewhere. Plague can also spread by aerosol and inhalation of sputum droplets from a coughing patient. In that manner, a primary pneumonic form develops and progresses rapidly to death. Person-to-person spread from a pneumonic plague victim can occur; protective measures are needed to protect against plague as well as other, more common, diseases. Pneumonic plague: Incubation period is 2-3 days. Symptoms of high fever, chills, headache, hemoptysis, and toxemia may progress rapidly to dyspnea, stridor, and cyanosis. Death results from respiratory failure, circulatory collapse, and a bleeding diathesis. 2.

Treatment:

a. Wear a properly fit-tested mask with a high-efficiency particulate (HEPA) filter, following the guidelines for control of tuberculosis. b. If breathing allows, the patient should be masked to stop as many of the cough droplets as possible before they evaporate to form small-diameter droplet nuclei, which are harder to filter out. c.

Evaluate the patient fo r fever, cyanosis, and respiratory distress.

d.

The patient should be given oxygen during transport, as needed.

e. All patients should receive cardiac monitoring and evaluation of oxygenation saturation via pulse oximeter. f.

Obtain IV access with lactated Ringer’s at KVO rate.

g. The early administration of antibiotics is very effective, but must be started within 24 hours of the onset of symptoms in pneumonic plague. The treatment of choice is streptomycin 30 mg/kg/day IM in 2 divided doses x 10 days. Intravenous doxycycline 200 mg, then 100 mg q 12 hr x 10-14 days is also effective. Chloramphenicol is 7 Appendix A

TREATMENT PROTOCOL

Plague (continued) necessary for plague meningitis. Supportive therapy for pneumonic and septicemic forms is required. h.

Before transporting the patient, check for additional victims.

i. Transport the patient to the most appropriate medical facility as directed by medical consultation. j. Secretion and lesion precautions should be observed for patients with bubonic plague. Strict isolation of patients with pneumonic plague is needed. Respiratory isolation and secretion precautions are necessary until the patient has been on antibiotics for at least 48 hours and there has been a favorable response to treatment. Heat, disinfectants, and exposure to sunlight render bacteria harmless. k. Wiping the ambulance interior with a 70% alcohol or other disinfectant must be done if there is gross contamination with secretions or pus; this is a reasonable precaution in all cases. The organisms do not survive well outside a host; therefore, in an emergency with heavy demand on transport resources, decontamination need not be done before the next run unless there is gross contamination. l. Public health officials usually recommend that others who may have been exposed take prophylactic antibiotics before they show signs of illness. If a registry is established, all emergency personnel should identify themselves and indicate when, where, and to what extent they might have been exposed. Quarantine may be imposed on those who cannot take or who refuse to take prophylactic treatment.

8 Appendix A

SMALLPOX FACT SHEET

Smallpox Overview The Disease

Smallpox is a serious, contagious, and sometimes fatal infectious disease. There is no specific treatment for smallpox disease, and the only prevention is vaccination. The name smallpox is derived from the Latin word for —spotted“ and refers to the raised bumps that appear on the face and body of an infected person. There are two clinical forms of smallpox. Variola major is the severe and most common form of smallpox, with a more extensive rash and higher fever. There are four types of variola major smallpox: ordinary (the most frequent type, accounting for 90% or more of cases); modified (mild and occurring in previously vaccinated persons); flat; and hemorrhagic (both rare and very severe). Historically, variola major has an overall fatality rate of about 30%; however, flat and hemorrhagic smallpox usually are fatal. Variola minor is a less common presentation of smallpox, and a much less severe disease, with death rates historically of 1% or less. Smallpox outbreaks have occurred from time to time for thousands of years, but the disease is now eradicated after a successful worldwide vaccination program. The last case of smallpox in the United States was in 1949. The last naturally occurring case in the world was in Somalia in 1977. After the disease was eliminated from the world, routine vaccination against smallpox among the general public was stopped because it was no longer necessary for prevention.

Where Smallpox Comes From

Smallpox is caused by the variola virus that emerged in human populations thousands of years ago. Except for laboratory stockpiles, the variola virus has been eliminated. However, in the aftermath of the events of September and October, 2001, there is heightened concern that the variola virus might be used as an agent of bioterrorism. For this reason, the U.S. government is taking precautions for dealing with a smallpox outbreak.

Transmission

Generally, direct and fairly prolonged face-to-face contact is required to spread smallpox from one person to another. Smallpox also can be spread through direct contact with infected bodily fluids or contaminated objects such as bedding or clothing. Rarely, smallpox has been spread by virus carried in the air in enclosed settings such as buildings, buses, and trains. Humans are the only natural hosts of variola. Smallpox is not known to be transmitted by insects or animals. A person with smallpox is sometimes contagious with onset of fever (prodrome phase), but the person becomes most contagious with the onset of rash. At this stage the infected person is usually very sick and not able to move around in the community. The infected person is contagious until the last smallpox scab falls off.

Smallpox Disease Incubation Period (Duration: 7 to 17 days)

Not contagious

Initial Symptoms (Prodrome) (Duration: 2 to 4 days)

Sometimes contagious* Early Rash

Exposure to the virus is followed by an incubation period during which people do not have any symptoms and may feel fine. This incubation period averages about 12 to 14 days but can range from 7 to 17 days. During this time, people are not contagious. The first symptoms of smallpox include fever, malaise, head and body aches, and sometimes vomiting. The fever is usually high, in the range of 101 to 104 degrees Fahrenheit. At this time, people are usually too sick to carry on their normal activities. This is called the prodrome phase and may last for 2 to 4 days. A rash emerges first as small red spots on the tongue and in the mouth.

(Duration: about 4 days)

Most contagious Rash distribution:

These spots develop into sores that break open and spread large amounts of the virus into the mouth and throat. At this time, the person becomes most contagious. Around the time the sores in the mouth break down, a rash appears on the skin, starting on the face and spreading to the arms and legs and then to the hands and feet. Usually the rash spreads to all parts of the body within 24 hours. As the rash appears, the fever usually falls and the person may start to feel better. By the third day of the rash, the rash becomes raised bumps. By the fourth day, the bumps fill with a thick, opaque fluid and often have a depression in the center that looks like a bellybutton. (This is a major distinguishing characteristic of smallpox.)

Pustular Rash (Duration: about 5 days)

Contagious

Pustules and Scabs

Fever often will rise again at this time and remain high until scabs form over the bumps. The bumps become pustules–sharply raised, usually round and firm to the touch as if there‘s a small round object under the skin. People often say the bumps feel like BB pellets embedded in the skin. The pustules begin to form a crust and then scab.

(Duration: about 5 days)

Contagious

Resolving Scabs (Duration: about 6 days)

Contagious

By the end of the second week after the rash appears, most of the sores have scabbed over. The scabs begin to fall off, leaving marks on the skin that eventually become pitted scars. Most scabs will have fallen off three weeks after the rash appears.

The person is contagious to others until all of the scabs have fallen off. Scabs resolved Scabs have fallen off. Person is no longer contagious. Not contagious *Smallpox may be contagious during the prodrome phase, but is most infectious during the first 7 to 10 days following rash onset.

For more information, visit www.cdc.gov/smallpox, or call the CDC public response hotline at (888) 246-2675 (English), (888) 246-2857 (Español), or (866) 874-2646 (TTY) December 9, 2002

Form 3B: Smallpox Case Travel/Activity Worksheet – Exposure Period 1. State FF

Please print

2. Case # ________________

OMB NO. 0920-0008 Exp. Date: 06/2003

3. CASE NAME: ___________________________________________________________________________________________________ / __________ / ________________________________ Last First Middle Suffix Nickname/Alias 4. Interviewer Name:________________________________________________________________________________________________ 5. Interview Date: ______/______/__________ Last First Middle MM DD YYYY 6. Date of case fever onset: ______/______/__________ MM DD YYYY

START HERE

RECORD ANY ADDITIONAL INFORMATION ON THE REVERSE SIDE OF THIS FORM

SUNDAY

MONDAY

TUESDAY

WEDNESDAY

THURSDAY

FRIDAY

SATURDAY

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Page 1 of 1 Form 3B (Draft 11/26/2002) Version 3.0

Form 3A: Smallpox Case Exposure Investigation Form

1. STATE

Case # ____________________

2.

OMB NO. 0920-0008 Exp. Date: 06/2003

3. INTERVIEW DATE:

Case Exposure/Source Information

Month

Day

Year

Case Information 4. CASE NAME: ___________________________________________________________________________________________________ / __________ / ________________________________ (Last) (First) (Middle) (Suffix) (Nickname)

5. ADDRESS: _______________________________________________________________________________________________________ Street Address, Apt #.

6. Case Classification:

FF

City

F Confirmed

F Probable

FFFFF State

F Suspect

Zip Code

F Unknown

Information on possible source of infection - INDIVIDUALS F Yes

7. DO YOU KNOW FROM WHOM YOU CAUGHT THIS ILLNESS? IF NO OR UNKNOWN, GO TO QUESTION 10.

F No

F Unknown

IF YES, GIVE NAME, ADDRESS, AND TELEPHONE NUMBER

____________________________________________________________ Name (LAST, FIRST)

Street Address, Apt #.

FF FFFFF FFF-FFF-FFFF

City

State

Zip Code

Area Code

Number

8. DATE OF LAST EXPOSURE: Month

Day

Year

9. DID THE PERSON HAVE ANY OF THE FOLLOWING SIGNS OR SYMPTOMS (MARK ALL THAT APPLY):

F F F F

F FEVER F COUGH

RASH: PAPULES/BUMPS RASH: VESICLES RASH: PUSTULES (FLUID FILLED) RASH: CRUSTS/SCABS

F SEVERELY ILL F IMMOBILE

10. DO YOU KNOW OF ANY OTHER PERSON WITH AN ILLNESS LIKE YOURS: IF YES, GIVE NAME, ADDRESS, AND TELEPHONE NUMBER

F Yes

F No

____________________________________________________________ Name (LAST, FIRST)

Street Address, Apt #.

F OTHER, DESCRIBE: _____________________________

F Unknown

FF FFFFF FFF-FFF-FFFF

City

State

Zip Code

Area Code

Number

11. DURING THE DATES FROM ____________________________________ TO ___________________________________ BEFORE YOUR RASH ONSET, WERE YOU IN CONTACT WITH (Insert date: 21 days before rash onset) (Insert date: 7 days before rash onset) DO YOU KNOW OF ANYONE WHO APPREARED TO HAVE: 11a. CHICKENPOX:

F Yes

F No

F Unknown

11b. A SEVERE RASH ON THE FACE AND/OR ARMS:

F Yes

F No

F Unknown

IF YES TO 11a OR 11b, GIVE THE NAME, ADDRESS AND TELEPHONE NUMBER OF THE INDIVIDUALS:

____________________________________________________________ Name (LAST, FIRST)

Street Address, Apt #.

FF FFFFF FFF-FFF-FFFF

City

State

Zip Code

Area Code

Number

DATE OF LAST EXPOSURE: Month

Day

Year

____________________________________________________________ Name (LAST, FIRST)

Street Address, Apt #.

FF FFFFF FFF-FFF-FFFF

City

State

Zip Code

Area Code

Number

DATE OF LAST EXPOSURE: Month

Day

Year

Information on possible source of infection - PLACE F Yes

12. DO YOU KNOW WHERE YOU CAUGHT THIS ILLNESS?

F No

IF YES, NAME OF PLACE/EVENT: ___________________________________________________

F Unknown TYPE OF PLACE/EVENT:____________________________________________________ (i.e., restaurant, store, theater, sports event, office, etc)

ADDRESS / LOCATION: _____________________________________________________________________________________________________ Street Address, Apt #.

FF

City

DESCRIBE LOCATION: ___________________________________________________________________________

TELEPHONE:

Zip Code

FFF-FFF-FFFF Area Code

13. POSSIBLE DATE OF EXPOSURE:

FFFFF

State

Number

14. TIME: ____________________ AM / PM Month

Day

Year

15. ESTIMATED NUMBER OF PERSONS POTENTIALLY EXPOSED AT THE SAME PLACE AND TIME AS CASE: _____________

LIST OTHERS POTENTIALLY EXPOSED (NAME, ADDRESS, TELEPHONE) ON REVERSE SIDE OF THIS FORM OR ON AN ADDITIONAL PIECE OF PAPER.

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Page 1 of 2 Form 3A (Draft 11/26/2002) Version 3.0

Form 3A: Smallpox Case Exposure Investigation Form

STATE

Case # ____________________

LIST OF NAMES AND ADDRESSES/TELEPHONE NUMBERS: _____________________________________________________________ Name/Location

Street Address, Apt #

City

State

_____________________________________________________________ Name/Location

Street Address, Apt #

City

Street Address, Apt #

City

Street Address, Apt #

City

Name/Location

Street Address, Apt #

City

Street Address, Apt #

City

Name/Location

Street Address, Apt #

City

Street Address, Apt #

City

Name/Location

Street Address, Apt #

Zip Code

City

Number

Area Code

Number

Area Code

Number

FF FFFFF FFF-FFF-FFFF Zip Code

Area Code

Number

FF FFFFF FFF-FFF-FFFF Zip Code

Area Code

Number

FF FFFFF FFF-FFF-FFFF Zip Code

Area Code

Number

FF FFFFF FFF-FFF-FFFF State

_____________________________________________________________

Area Code

FF FFFFF FFF-FFF-FFFF

State

_____________________________________________________________ Name/Location

Zip Code

State

_____________________________________________________________

Number

FF FFFFF FFF-FFF-FFFF

State

_____________________________________________________________ Name/Location

Zip Code

State

_____________________________________________________________

Area Code

FF FFFFF FFF-FFF-FFFF State

_____________________________________________________________ Name/Location

Zip Code

State

_____________________________________________________________ Name/Location

FF FFFFF FFF-FFF-FFFF

Zip Code

Area Code

Number

FF FFFFF FFF-FFF-FFFF State

Zip Code

Area Code

Number

SAMPLE QUESTIONS FOR FORM 3B: SMALLPOX CASE TRAVEL/ACTIVITY WORKSHEET – EXPOSURE PERIOD: For the next few questions, I’d like you to think back to the 14 day period between 1 and 3 weeks before you developed a rash that we have marked on the calendar. Let’s start with weekdays. (Offer dates, holidays, etc., as available to anchor the case’s recall to this time period. Consider routine weekday activities in a systematic way going either back from day 7 or forward from day 21 from fever onset depending on what seems easier to do.) For weekends, ask about usual routines and then occasional activities. Prompt especially for attendance at public events. A question to capture this type of attendance follows after questions regarding usual activities. WHAT IS YOUR USUAL ROUTINE: DO YOU WORK?

F Yes

F No

VOLUNTEER ON A REGULAR BASIS?

F Yes

F No

DO YOU GO TO SCHOOL?

F Yes

F No

HAVE ANOTHER EVERY DAY ACTIVITY?

F Yes

F No

DURING THIS 14-DAY PERIOD AS SHOWN ON THIS CALENDAR, DID YOU SPEND ANY TIME REGULARLY (3 OR MORE TIMES A WEEK) IN THE FOLLOWING PLACES? (Check all that apply.)

F Yes

F No

RESTAURANT:

F Yes

F No

YOUR CHILD’S SCHOOL OR DAY CARE CENTER:

F Yes

F No

GROCERY STORE:

F Yes

F No

OTHER, SUCH AS PLACE OF WORSHIP, GYM, ETC:

F Yes

F No

WORK:

F Yes

F No

SCHOOL:

IF YES, SPECIFY: ______________________________________________

Please complete FORM 3C – CASE EXPOSURE TRANSPORTATION WORKSHEET for all transportation questions. IF YOU WORK, GO TO SCHOOL, OR TRANSPORT YOUR CHILDREN OR OTHER FAMILY MEMBERS, HOW DO YOU TRAVEL TO AND FROM THESE PLACES? CAR ALONE, BICYCLE, WALK:

F Yes

F No

BUS, TRAIN OR SUBWAY:

F Yes

F No

OTHER, SPECIFY (E.G. PLANE):

F Yes

F No

CAR WITH OTHER PEOPLE IN THE VEHICLE AT LEAST SOMETIMES: F Yes

F No

F Yes

F No

TAXI:

IF YES, SPECIFY: ______________________________________________

NOTE: For regular travel schedule such as to and from work, indicate range of days and times if this is the same each day. DURING THE 14-DAY TIME PERIOD DESIGNATED ABOVE, DID YOU TRAVEL OUT OF TOWN (IF CITY, OUT OF URBAN AREA, IF RURAL, OUT OF COUNTY)?

F Yes

F No

DURING THE 14-DAY TIME PERIOD DESIGNATED ABOVE, DID YOU VISIT ANY OF THE FOLLOWING ACTIVITIES AT LEAST ONCE:

F Yes

HOTEL/CONVENTION CENTER:

SHOPPING MALL OR LARGE STORE: F Yes

F No

CHURCH, TEMPLE, MOSQUE OR OTHER PLACE OF WORSHIP:

F Yes

F No

F

DOCTOR’S OFFICE, EMERGENCY ROOM, CLINIC OR HOSPITAL:

F Yes

F No

AIRPORT:

F Yes

F No

THEATER (MOVIES/PLAY):

F Yes

F No

CONCERT:

F Yes

F No

PUBLIC SPORTING EVENT:

F Yes

F No

BUS, TRAIN OR SUBWAY:

F Yes

F No

FAIR, FESTIVAL OR CARNIVAL: F Yes

F No

ANY OTHER GATHERING WITH MORE THAN 100 OTHER PEOPLE: F Yes

Page 2 of 2 Form 3A (Draft 11/26/2002) Version 3.0

F No

IF YES, SPECIFY: ______________________________________________

OMB NO. 0920-0008 Exp. Date: 06/2003

Form 2F: Smallpox Case Primary Contact’s Household Members Surveillance Form Please print I. CASE INFORMATION (Filled out by interviewer) 1. *CASE ID#: ______________________________________

II. PRIMARY CONTACT INFORMATION (Questions marked with (*) to be filled out by interviewer) *2. DATE OF HOUSEHOLD VISIT: ______/______/__________ MM DD YYYY *3. NAME OF PRIMARY CONTACT: __________________________________________________________________________________________________ / __________ / ________________________________ Last First Middle Suffix Nickname/Alias *4. PRIMARY CONTACT FORM 2D# _____________________________________________

III. INFORMATION ABOUT PRIMARY CONTACT’S HOUSEHOLD MEMBERS (Filled out by primary contact or household member) 5. *Form 2D #

6. Last name

7. First name

12. If anyone develops any of the severe vaccine adverse reactions shown on the Vaccination Information Statement, call:

8. MI

9. Sex

10. Date vaccinated

11. Call Back Date

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

______/______/_______ MM DD YYYY

13. *[Insert telephone number or sticker here]

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Page ___ of ___ Form 2F (Draft 11/26/2002) Version 3.0

OMB NO. 0920-0008 Exp. Date: 06/2003

Form 2E: Smallpox Case Household and Primary Contact Surveillance Form Please print I. CASE INFORMATION (Filled out by interviewer) 1. *CASE ID#: ______________________________________

II. HOUSEHOLD OR PRIMARY CONTACT INFORMATION (Questions marked with (*) to be filled out by interviewer) *2. DATE OF HOUSEHOLD VISIT: ______/______/__________ MM DD YYYY *3. NAME OF CASE HOUSEHOLD OR PRIMARY CONTACT: __________________________________________________________________________________________________ / __________ / ________________________________ Last First Middle Suffix Nickname/Alias *4. SEX (Circle): Male

Female

5. AGE: ______________________

*7. DATE OF LAST EXPOSURE TO CASE: ______/______/__________ MM DD YYYY

6. HOUSEHOLD CONTACT/PRIMARY CONTACT FORM 2D# _____________________________________________

9. CALL BACK DATE (7 days after vaccination)

8. DATE VACCINATED: ______/______/__________ MM DD YYYY

III. HOUSEHOLD OR PRIMARY CONTACT CLINCAL SIGNS TRACKING (Filled out by Household or Primary Contact)

______/______/__________ MM DD YYYY

11. *[Insert telephone number or sticker here]

10. Record your temperature each day in the boxes below. If fever is 101° F or greater for two consecutive days, call the number provided immediately: Temperature Daily Record

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

Day 8

Day 9

Day 10

Day 11

Day 12

Day 13

Day 14

Day 15

Day 16

Day 17

Day 18

Day 19

Day 20

Day 21

Day 11

Day 12

Day 13

Day 14

Day 15

Day 16

Day 17

Day 18

Day 19

Day 20

Day 21

12. If rash develops, mark the day the rash started below, and call the number provided: Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

Day 8

Day 9

Day 10

Rash

13. If you develop any of the severe vaccine adverse reactions shown on the Vaccination Information Statement, call:

14. *[Insert telephone number or sticker here]

15. For non-emergencies or if you have questions, call:

16. *[Insert telephone number or sticker here]

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Page ___ of ___ Form 2E (Draft 11/26/2002) Version 3.0

OMB NO. 0920-0008 Exp. Date: 06/2003

Form 2D: Smallpox Contact Tracing Form 1.

3.

Last Name:

City:

First Name:

State:

4.

MI:

Zip:

5.

M M 10. Height:

12. Hair :

11. Size/Build:

13. Complexion:

Exposure Dates:

25.

D

N

Alias:

DOB:

D

2.

6.

Y

Y

Y

Age (Yrs):

7.

Y 26.

Non/H

8.

Street Address:

N

Apt #:

Race - Mark all that apply:

AI/AN Asian B/AA

16. English Spoken:

U

Reported Case Number:

Ethnicity: H

Y

15. Primary Language Spoken:

14. Pregnant?:

Y 24.

Suffix:

H/PI

O/U

9.

White

Sex:

M

21.

Phone Number - Cell:

22.

Phone Number - Work:

23.

Phone Number - Other:

Name of Employer/School:

17.

Date Interview of Reported Case:

Phone Number - Home:

F

U 18.

20.

Address of Employer/School:

19. Work Hours :

Date of First Exposure:

M M

D D

2

0

Y

Y

Date of Last Exposure:

M M

D D

27. Contact Type

M M 30.

2

0

Y

D

D

2

0

Y

Y

State Location, Epi Notes, and Other Relevant Information:

Y

28. Priority

(Mark One)

Code *

Primary Contact OOJ Primary Contact 27. (continued) 29.

Secondary Contact

Primary Contact Form 2D Number:

OOJ Secondary Contact

1 = Highest Priority - Case household contacts: All immediate family members; others spending > 3 hours in the household since case’s onset of rash. 2 = Non household contacts with contact <6 feet with Case with rash for >= 3 hours.

31.

33.

5 = Non household contacts with contact >= 6 feet with Case with rash for < 3 hours.

D

D

2

0

Y

Y 34. Notified By:

Date of Contact Notification:

M M

D 35.

M M 37.

D

2

0

Y

Y

D D

2

0

Y

Y 38. Follow-up By:

D D

2

0

Y

Referred for Vaccination, Fever or Rash or Cough Not Present

1B

Referred for Clinical Assessment, Fever or Rash or Cough Present

1C

Already Hospitalized as Suspected Case, Fever or Rash or Cough Present Isolated, Not Vaccinated (within last 6 months), Fever or Rash or Cough Not Present

1E

Previously Vaccinated (within last 6 months), Fever or Rash or Cough Not Present

Department of Health and Human Services Centers for Disease Control and Prevention

Date of Vaccination:

41. Reviewed By:

42.

M M

D

D

2

0

Y

Major

None

Equivocal

Unknown

2A

Unable to Locate

2B

Moved From Jurisdiction, To: ________________________

3. Deceased

1D

Reported Vaccination Take Status:

Y

2. Not Located

1A

36. Dispo’ed By:

Disposition Date:

Follow-up Assignment Date:

M M

A0001234

32. Initiated By:

Date Form 2D Initiated:

M M

3 = Non household contacts with contact <6 feet with Case with rash for < 3 hours. 4 = Non household contacts with contact >= 6 feet with Case with rash for >= 3 hours.

Disposition (Select One)

1. Located

Case Contact Priority Codes *

Form 2D Number -

39.

(Complete only for Secondary Contacts)

4.

3A

Smallpox Suspected

3B

Unrelated to Smallpox

4

Other : 40.

Y

________________________

Smallpox Case ID:

State

Comments:

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Form 2D (Draft 11/26/2002) Version 3

Form 2C: Smallpox Case Transportation Worksheet – Infectious Period 1. State FF

Please print

2. Case # ________________

OMB NO. 0920-0008 Exp. Date: 06/2003

3. CASE NAME: ___________________________________________________________________________________________________ / __________ / ________________________________ Last First Middle Suffix Nickname/Alias 4. Interviewer Name: _________________________________________________________________________________________________ 5. Interview Date: ______/______/__________ Last First Middle MM DD YYYY 6. Date of fever onset: ______/______/__________ MM DD YYYY

COMPLETE AS MUCH INFORMATION AS POSSIBLE FOR EACH TYPE OF TRANSPORTATION USED BY CASE SINCE FEVER ONSET. 7. Date of Travel

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

8. Time of Travel (____:____) [AM /PM (Circle)]

9. Transport Type (e.g., bus, train, plane, car)

10. Carrier/Company Name

11. Route/ Flight #

12. Origin City

13. Origin State

14. Origin Country

15. Destination City

16. Destination State

17. Destination Country

_____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Page ___ of ___ Form 2C (Draft 11/26/2002) Version 3.0

Form 2B: Smallpox Primary Contact/Site Worksheet

1. State FF

Please print

OMB NO. 0920-0008 Exp. Date: 06/2003

2. Case # ________________

3. CASE NAME: ___________________________________________________________________________________________________ / __________ / ________________________________ Last First Middle Suffix Nickname/Alias 4. Interviewer Name: _________________________________________________________________________________________________ Last First Middle

5. Interview Date: ______/______/__________ MM DD YYYY

6. Date of fever onset: ______/______/__________ MM DD YYYY *Contact Priority Category Codes: 1 = (Highest priority) Case household contacts: all immediate family members; others spending ≥ 3 hours in the household since case’s onset of rash 2 = Non- household contacts with contact < 6 feet with case with rash for ≥ 3 hours 3 = Non-household contacts with contact < 6 feet with case with rash for < 3 hours 7. Name of Person (Last, First) and/or Name of Site

8. Date of First Exposure

9. Date of Last Exposure

____/____/_____

____/____/_____

MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

MM

DD

DD

DD

DD

DD

DD

DD

DD

DD

DD

<3

≥3

<6ft

≥6ft

<3

≥3

<6ft

≥6ft

<3

≥3

<6ft

≥6ft

<3

≥3

<6ft

≥6ft

<3

≥3

<6ft

≥6ft

<3

≥3

<6ft

≥6ft

<3

≥3

<6ft

≥6ft

<3

≥3

<6ft

≥6ft

<3

≥3

YYYY

____/____/_____ MM

≥6ft

YYYY

____/____/_____ MM

<6ft

YYYY

____/____/_____ MM

≥3

YYYY

____/____/_____ MM

<3

14.Notes:

YYYY

____/____/_____ MM

≥6ft

13.Form 2D #

YYYY

____/____/_____ MM

<6ft

12.Contact Priority Category*

YYYY

____/____/_____ MM

11. Longest Duration in Hours (Circle)

YYYY

____/____/_____ MM

10. Closest Distance in feet (Circle)

YYYY

____/____/_____ MM

4 = Non-household contacts with contact ≥ 6 feet with case with rash for ≥ 3 hours 5 = Non-household contacts with contact ≥ 6 feet with case with rash for < 3 hours

YYYY

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Page ___ of ___ Form 2B (Draft 11/26/2002) Version 3.0

OMB NO. 0920-0008 Exp. Date: 06/2003

Form 2A: Smallpox Case Travel/Activity Worksheet - Infectious Period 1. State FF

Please print

2. Case # ________________

3. CASE NAME: ___________________________________________________________________________________________________ / __________ / ________________________________ Last First Middle Suffix Nickname/Alias 4. Interviewer Name: _______________________________________________________________________________________________ Last First Middle

5. Interview Date: ______/______/__________ MM DD YYYY

6. Date of fever onset: ______/______/__________ MM DD YYYY

F=Fever, R=Rash, C=Cough

START HERE

SUNDAY

RECORD ANY ADDITIONAL INFORMATION ON THE REVERSE SIDE OF THIS FORM

MONDAY

DATE:

TUESDAY

DATE: FF FR FC

DATE: FF FR FC

DATE:

DATE:

DATE:

DATE:

DATE:

DATE:

DATE: FF FR FC

DATE:

DATE:

DATE: FF FR FC

DATE:

DATE:

DATE:

DATE:

DATE: FF FR FC

DATE:

DATE:

FF FR FC

DATE: FF FR FC

DATE: FF FR FC

FF FR FC

FF FR FC

FF FR FC

DATE: FF FR FC

DATE: FF FR FC

FF FR FC

FF FR FC

SATURDAY

DATE: FF FR FC

FF FR FC

FF FR FC

FRIDAY

DATE: FF FR FC

FF FR FC

FF FR FC

FF FR FC

THURSDAY

DATE: FF FR FC

FF FR FC

FF FR FC

WEDNESDAY

FF FR FC

DATE: FF FR FC

FF FR FC

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Page 1 of 1 Form 2A (Draft 11/26/2002) Version 3.0

Form 1: Smallpox Post-Event Surveillance Form

1. State

Please print

OMB NO. 0920-0008 Exp. Date: 06/2003

2. Case # ________________

Circled numbers indicate the minimum required fields. Every attempt should be made to at least complete the circled items. 3. CASE NAME: ___________________________________________________________________________________________________ / __________ / ________________________________ Last First Middle Suffix Nickname/Alias 4. ADDRESS: ___________________________________________________________________________________________________________________________________________ Street Address, Apt #. City State Zip Code 5. TELEPHONE: Home:

Area Code

Work:

Number

Area Code

CASE INFORMATION Day F Years

8. AGE UNIT:

9. GENDER: 10. ETHNICITY:

F Male F Female F Hispanic F Non-Hispanic

11. RACE (Check all that apply):

F Am. Indian/Alaska Native F Black/African Am. F Native Hawaiian/Pacific Islander

Number

29. DURING THE PAST MONTH, ANY PRESCRIBED IMMUNOCOMPROMISING OR IMMUNOMODULATING MEDICATIONS INCLUDING STEROIDS:

Year F Months

7. AGE: ______

Area Code

VACCINATION AND MEDICAL HISTORY, CON’T

6. DATE OF BIRTH: Month

Other:

Number

F Yes

F Day

F No

IF YES, PLEASE SPECIFY: ___________________________________________________ 30. FOR WHAT MEDICAL CONDITION: _____________________________________________

F Asian F White F Unknown

12. COUNTRY OF BIRTH: _________________________________________

REPORTING SOURCE AND INFORMATION 13. DATE FIRST REPORTED TO PUBLIC HEALTH:

CURRENT ILLNESS 31. HAS THE PATIENT HAD A FEVER AS PART OF THIS ILLNESS IN THE 4 DAYS PRIOR TO RASH ONSET?

F Yes

F No

F Unknown

IF YES, ESTIMATED DATE OF FEVER ONSET: Month

Day

Year

32. WAS TEMPERATURE MEASURED Month

Day

Year

WITH A THERMOMETER?

F Yes

F No

14. REPORTED BY: ______________________________________________________ Name/Institution 15. REPORTED BY PHONE NUMBER: Area Code Number

33. MAXIMUM TEMPERATURE: ___________ F° / C° (Circle)

16. FORM INITIATED BY:___________________________________________________ (INTERVIEWER NAME) Last First Middle

35. DATE OF RASH ONSET:

17. INTERVIEW DATE:

36. COUGH WITH RASH/ILLNESS?

Month

Day

Year

18. INFORMATION PROVIDED BY: ___________________________________________________________ Informant: Last First Middle

Area Code

Number

20. PRIMARY INTERVIEW LANGUAGE SPOKEN: ___________________________________

VACCINATION AND MEDICAL HISTORY

AGE (YEARS) ___________

F Yes F One

F No F Unknown F More than one

OR YEAR ___________ OF LAST DOSE

23. SMALLPOX VACCINATION SCAR PRESENT: F Yes 24. SMALLPOX VACCINATION DURING THIS OUTBREAK: F Yes

F Equivocal

Month

Day

F Yes

F No

Month

Day

Year

Year

F Unknown

37. DATE OF COUGH ONSET? Year

F No

F Unknown

F No

F Unknown

Headache: F Yes F No F Unknown Backache: F Yes F No F Unknown Chills: F Yes F No F Unknown Vomiting: F Yes F No F Unknown F Other (e.g., abdominal pain, delirium) Specify: _________________________________________ 39. DISTRIBUTION OF LESIONS:

F Generalized, predominantly face and distal extremities (centrifugal) F Generalized, predominantly trunk (centripetal) F Localized, not generalized F Other, specify: __________________________________________ 40. CLINICAL TYPE OF SMALLPOX:

F Ordinary/Classic type:

IF YES, DATE OF VACCINATION: 25. VACCINE “TAKE” RECORDED AT 7 DAYS (6-8 DAYS): IF YES, RESULT: F Major

Day

38. SYMPTOMS DURING THE 4 DAYS PRECEDING RASH ONSET (Check all the apply):

19. TELEPHONE NUMBER OF INFORMANT:

21. SMALLPOX VACCINATION PRIOR TO THIS OUTBREAK: IF YES, NUMBER OF DOSES:

F Unknown

34. DATE OF MAXIMUM FEVER: Month

22. IF KNOWN:

F Unknown

Month

Day

F Yes F No F None F Unknown

Year

F Unknown

F Variola sine eruptione F Modified type F Flat type F Hemorrhagic type:

F Discrete lesions F Semi-confluent – Face only F Confluent – Face and other site

F Early F Late

26. IF NOT VACCINATED DURING THIS OUTBREAK, GIVE REASON:

F Patient refusal F Patient forgot F Medical contraindication F Unaware of need to be vaccinate F Vaccination site unavailable/unknown F Other, specify: ___________________________ 27. IF FEMALE, PREGNANT:

F Yes

F No

F Unknown

28. PRE-EXISTING IMMUNOCOMPROMISING MEDICAL CONDITIONS (i.e., LEUKEMIA, OTHER CANCERS, HIV/AIDS): F Yes F No F Unknown IF YES, PLEASE SPECIFY: ________________________________________________

CLINICAL TYPES OF SMALLPOX: Ordinary/Classic type: Raised, pustular lesions with 3 sub-types: Discrete: Areas of normal skin between pustules, even on face Semi-confluent: Confluent rash on face, discrete elsewhere Confluent: Confluent rash on face and forearms Modified type: Like ordinary type but with an accelerated, less severe course Variola sine eruptione: fever without rash caused by variola virus, serological confirmation required. This condition is rare; epidemiological significance is considered to be limited. Flat type: Pustules remain flat; usually confluent or semi-confluent Hemorrhagic type: Widespread hemorrhages in skin and mucous membranes Early: With purpuric rash Late: With hemorrhage into base pustules

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Page 1 of 2 Form 1 (Draft 11/26/2002) Version 3.0

Form 1: Smallpox Post-Event Surveillance Form Please print

Case # ________________

State

CLINICAL COURSE

LABORATORY, CON’T VARIOLA SPECIFIC TESTS

41. DATE LAST SCAB FELL OFF: OR CHECK IF UNKNOWN F

Month

42. DID THE PATIENT DEVELOP ANY COMPLICATIONS: IF YES, CHECK ALL THAT APPLY:

F Yes

Day

F No

Year

F Unknown

F Skin, infected lesions/abscesses F Corneal ulcer or keratitis F Encephalitis F Arthritis F Other, specify: _____________________

F Pneumonia F Hemorrhagic F Shock F Bacterial sepsis

43. ANTIVIRAL MEDICATION (CIDOFOVIR): IF YES, DATE CIDOFOVIR STARTED:

F Yes

F No

F Unknown

Month

Day

Year

F Yes

F No

F Unknown

DURATION: _______________ DAYS 44. OTHER ANTIVIRAL MEDICATIONS GIVEN:

IF YES, SPECIFY: _____________________________________________________

TEST

DATE

RESULT

WHERE

52. VARIOLA PCR FROM CLINICAL SPECIMEN F Yes F No F Unknown

______/______/________ MM DD YYYY SPECIMEN TYPE: F Skin lesion F Blood F Crust F CSF F Oropharyngeal F Unknown F Other, specify

F Positive F Negative F Indeterminate

F CDC F DOD F State F Local F Other Lab Specify:

TEST

DATE

RESULT

WHERE

53. VARIOLA CULTURE WITH VARIOLA PCR CONFIRMATION F Yes F No F Unknown

______/______/________ MM DD YYYY SPECIMEN TYPE: F Skin lesion F Blood F Crust F CSF F Oropharyngeal F Unknown F Other, specify

F Positive F Negative F Indeterminate

F CDC F DOD F State F Local F Other Lab Specify:

TEST

DATE

RESULT

WHERE

54. VACCINIA PCR F Yes F No F Unknown

______/______/________ MM DD YYYY SPECIMEN TYPE: F Skin lesion F Blood F Crust F CSF F Oropharyngeal F Unknown F Other, specify

F Positive F Negative F Indeterminate

F CDC F DOD F State F Local F Other Lab Specify:

CLINICAL OUTCOME 45. WAS CASE ADMITTED TO HOSPITAL?

F Yes

F No

VACCINIA SPECIFIC TEST F Unknown

IF YES, HOSPITAL NAME: ______________________________________________ HOSPITAL LOCATION: ______________________________________________ DATE ADMITTED:

Month

Day

DATE DISCHARGED:

Year

Month

Day

Year

F Yes

F No

F Unknown

46. WAS CASE ADMITTED/TRANSFERRED TO 2ND HOSPITAL?

IF YES, HOSPITAL NAME: ______________________________________________

55. OTHER TESTING PERFORMED: F Yes IF YES, SPECIFY: _______________________

F Unknown

EPIDEMIOLOGIC 56. TRANSMISSION SETTING: F Athletics

F Daycare F Home F Military F Work

HOSPITAL LOCATION: ______________________________________________ DATE ADMITTED:

F No

DATE DISCHARGED:

F College F Dr. Office F Hospital F School F Other

F Community F Correctional facility F Int’l travel F Place of worship F Unknown

If Other, specify: __________ Month

Day

Year

Month

47. DID THE PATIENT DIE FROM SMALLPOX ILLNESS OR ANY SMALLPOX COMPLICATIONS? F Yes

Day

Year

F No

F Unknown

Day

Year

IF YES, DATE OF DEATH:

CASE CLASSIFICATION 57. DOES THIS CASE MEET THE CLINICAL CASE DEFINITION:

F Yes

F No

F Unknown

F Yes

F No

F Unknown

58. IS THIS CASE EPIDEMIOLOGICALLY Month

IF YES, NAME/CASE #, IF KNOWN:______________________________________

LABORATORY 48. WAS SPECIMEN COLLECTED FOR TESTING: F Yes* F No

F Unknown

F Yes* F No

F Unknown

49. WAS LAB TESTING DONE FOR SMALLPOX:

LINKED TO A CONFIRMED CASE:

59. IS THIS CASE LABORATORY-CONFIRMED: IF YES, BY WHAT METHOD: 60. WHAT IS THE CASE CLASSIFICATION:

F Confirmed

IF QUESTIONS 48 AND 49 ARE “NO” OR “UNKNOWN” THEN GO TO QUESTION 56.

* Information on specimen collection and testing can be found in the patient’s medical chart or provided by the laboratory

ORTHOPOX GENERIC TESTS TEST

DATE

RESULT

WHERE

50. ORTHOPOX PCR F Yes F No F Unknown

______/______/________ MM DD YYYY SPECIMEN TYPE: F Skin lesion F Blood F Crust F CSF F Oropharyngeal F Unknown FOther, specify

F Positive F Negative F Indeterminate

F CDC F DOD F State F Local F Other Lab Specify:

TEST

DATE

RESULT

WHERE

51. ELECTRON MICROSCOPY (EM) F Yes F No F Unknown

______/______/________ MM DD YYYY SPECIMEN TYPE: F Skin lesion F Other, specify FUnknown

F Pox Virus Identified F Pox Virus Not Identified F Indeterminate

F CDC F DOD F State F Local F Other Lab Specify:

Page 2 of 2 Form 1 (Draft 11/26/2002) Version 3.0

F Yes F No F Unknown F PCR F Culture/PCR F Probable

F Suspect

61. IF NOT SMALLPOX, SPECIFY FINAL DIAGNOSIS: ________________________________ Smallpox Clinical Case Definition: An illness with acute onset of fever ≥ 101°F followed by a rash characterized by firm, deep seated vesicles or pustules in the same stage of development without other apparent cause. Laboratory Criteria for Confirmation*: Polymerase chain reaction (PCR) identification of variola DNA in a clinical specimen; OR Isolation of smallpox (variola) virus from a clinical specimen (Level D laboratory only). Note: Orthopox PCR and negative stain electron microscopy (EM) identification of a pox virus in a clinical specimen suggest orthopox virus infection but are not diagnostic of variola and/or vaccinia. (Level D laboratory or approved Level C laboratory) •Level

D laboratories include the CDC and USAMRIID. Initial confirmation of a smallpox outbreak requires testing in a Level D laboratory. Level C laboratories will assist with testing of clinical specimens following initial confirmation of an outbreak by CDC. Smallpox Case Classification: Confirmed case = A case of smallpox that is laboratory confirmed, OR a case that meets the clinical case definition that is epidemiologically linked to a laboratory confirmed case. Probable case = A case that meets the clinical case definition, OR a case that has an atypical presentation that has an epidemiological link to a confirmed case of smallpox. Atypical presentations of smallpox are: a) hemorrhagic type, b) flat, type not appearing as typical vesicles nor progressing to pustules and variola sine eruptione. Suspect case = A case with a febrile rash illness with fever preceding development of rash by 1-4 days.

Form 3C: Smallpox Case Transportation Worksheet – Exposure Period 1. State FF

Please print

2. Case # ________________

OMB NO. 0920-0008 Exp. Date: 06/2003

3. CASE NAME: ___________________________________________________________________________________________________ / __________ / ________________________________ Last First Middle Suffix Nickname/Alias 4. Interviewer Name: _________________________________________________________________________________________________ 5. Interview Date: ______/______/__________ Last First Middle MM DD YYYY 6. Date of fever onset: ______/______/__________ MM DD YYYY

COMPLETE AS MUCH INFORMATION AS POSSIBLE FOR EACH TYPE OF TRANSPORTATION USED BY CASE 19 DAYS PRIOR TO FEVER ONSET. 7. Date of Travel

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

____/____/_____ MM

DD

YYYY

8. Time of Travel (____:____) [AM /PM (Circle)]

9. Transport Type (e.g., bus, train, plane, car)

10. Carrier/Company Name

11. Route/ Flight #

12. Origin City

13. Origin State

14. Origin Country

15. Destination City

16. Destination State

17. Destination Country

_____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM _____ : _____ AM / PM

Public reporting burden of this collection of information is estimated to average ___ minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, Georgia 30333; ATTN: PRA (0920-0008).

Page ___ of ___ Form 3C (Draft 11/26/2002)

Smallpox Pre-Vaccination Information Packet: Contents and Instructions The following information is for state and hospital personnel implementing smallpox vaccination programs. Contents

1. Cover Letter – A letter from Dr. Julie Louise Gerberding, M.D., MPH., Director of the Centers for Disease Control and Prevention (CDC) to potential vaccinees explaining the purpose of the national smallpox preparedness program, encouraging individuals to know their health status and to err on the side of caution in making their vaccination decision and detailing the contents of the Smallpox Pre-Vaccination Information Packet. 2. Smallpox Vaccine Information Statement (VIS) - This document, entitled “Smallpox Vaccine: What You Need to Know,” contains information about smallpox disease, the benefits and risks of smallpox vaccine, contraindications, vaccination site care instructions, what to do if a reaction occurs after vaccination, and where to get more information. 3. Pre-Event Screening Worksheet for Smallpox Vaccine – a worksheet with questions to help individuals determine whether or not they should receive smallpox vaccine because of certain medical conditions that would place them at a greater risk for an adverse reaction from the vaccine. Some of these questions are of a personal and sensitive nature. Those implementing smallpox vaccination clinics should be prepared to discuss, but not collect, this sheet. 4. Someone You are Close to May Get Smallpox Vaccine: What You Should Know and Do - a fact sheet that informs close contacts of people considering vaccination about the health conditions that put people at risk if they are in close physical contact with someone who has been vaccinated. This sheet also provides information about the steps close contacts can take to protect themselves. 5. Smallpox Vaccine: Decision Point for the Smallpox Vaccine Candidate – a short video intended as an overview for use at vaccination clinic sites to supplement the written materials listed above. 6. Patient Medical History and Consent Form – a form for clinic personnel to record patient information. The form also confirms the absence of contraindications and contains a consent signature line for the patients. This document must be retained by the clinic for 5 years or the length of time required by state law, whichever is longer. 7. Temporary Proof of Vaccination and Site Check Reminder Sheet – This form serves as temporary proof of vaccination, contains follow-up appointment information, and provides vaccine recipients with a phone number to call if they think they are having an adverse reaction to the vaccine.

Instruction for Use

This package of materials is to be used as part of the national smallpox preparedness program to help ensure that potential vaccinees are adequately informed of the benefits and risks of smallpox vaccination, to assist in screening out individuals who should not receive the vaccine, and to obtain signed consent from those individuals who receive smallpox vaccine. In particular circumstances as provided by law, the federal government may assume liability for injury or death attributable to a smallpox vaccination. The materials contained in this packet fulfill federal obligations to inform vaccinees about the risks and benefits of the smallpox vaccine. Use of the items in this packet as instructed below is mandatory. Do NOT alter the materials or replace them with alternative documents. (Version 2)

November 15, 2003

Page 1 of 3

Smallpox Pre-Vaccination Information Packet: Contents and Instructions (continued from previous page) •

Provide items 1, 2, 3, and 4 to potential vaccinees as early as possible before they make an appointment for vaccination. Potential vaccinees should be given adequate time to obtain HIV or pregnancy testing, discuss contraindications with household contacts, talk to their health care providers, and check medical records.



Provide items 1-4 again to persons when they present to the clinic to receive smallpox vaccination. Give all individuals an opportunity to read the materials and view the “Decision Point” video (item 5) before they consent to be vaccinated. Offer to read the documents for individuals, especially if you suspect that they have difficulty understanding the material due to reading ability or language barriers. Questions and concerns should be elicited from potential vaccinees and addressed by a trained health care provider.



Use the Patient Medical History and Consent Form (item 6) to confirm the absence of contraindications. Obtain signed consent and date on this form from all vaccinees. This document must be retained by the clinic for 5 years or the length of time required by state law, whichever is longer.



Following immunization, provide vaccinees the Temporary Proof of Vaccination and Site Check Reminder Sheet (item 7). Clinic sites should insert local or state telephone numbers for adverse event reporting.



Provide vaccinees a record of immunization following vaccination site examinations. It is the responsibility of each state to determine what type of permanent record of immunization they will use. Adult immunization cards may be obtained from the Immunization Action Coalition at www.immunize.org.

Providing the materials in this packet does not preclude clinic personnel from verbally educating potential vaccinees. Provide all individuals considering vaccination the opportunity to discuss the topics covered in these materials with a trained health care provider. The materials in this packet may be revised periodically. Each state is responsible for ensuring that all of their participating smallpox vaccination clinics use the most current versions of the materials. All current print materials are available on the CDC’s smallpox website at www.cdc.gov/smallpox.

States May Alter and/or Supplement the Materials Only as Follows

As stated previously, CDC requires use of the materials in this packet, without alteration. States, however, may alter or supplement the materials only as follows: •

Some states may wish to supplement the CDC packet with statements on workers compensation coverage, health insurance coverage and/or wage issues. CDC does not need to review such materials. • Some states may wish to include a cover letter when providing the CDC information packet. In general, we recommend that such letters be short given the amount of other materials to be provided to potential vaccinees. Cover letters and other supplemental materials must not contradict information already in the CDC information packet. CDC does not need to review cover letters that merely address logistical issues related to volunteering for the response teams and arrangements for being immunized. • In particular circumstances, with CDC's concurrence, states may choose to apply further restrictions in availability of smallpox vaccination within their jurisdictions. States may explain these Page 2 of 3 (Version 2) November 15, 2003

Smallpox Pre-Vaccination Information Packet: Contents and Instructions (continued from previous page)



• •

restrictions by using supplemental materials, provided they are approved by CDC. Specifically, some states have expressed interest in excluding from smallpox vaccination in the early phases of the program individuals who have children less than one year of age in their household. The ACIP has noted that this is not a contraindication to receipt of smallpox vaccine. However, as noted, states may choose to further restrict availability of the smallpox vaccine to certain populations. Materials should not describe such a state restriction as a "contraindication." The CDC Patient Medical History and Consent Form must be used. If a state determines that state law requires an additional consent form, CDC needs to review and approve the additional form. Such requests must be accompanied by an explanation of the specific provisions of state law that require an additional consent form. CDC does not object to states reformatting the Patient Medical History and Consent Form to ease data entry as long as the content is identical to the original form. The CDC Patient Medical History and Consent Form no longer includes fields to collect employer information or a medical screener signature. Some states may wish to continue to collect employer, employer address, and medical screener signatures and may do so without obtaining approval from CDC.

Each state is responsible for ensuring that all of their participating smallpox vaccination clinics use the entire CDC smallpox vaccine information packet and approved state supplements, without alteration. Submit all proposed supplemental materials to Raymond Strikas, M.D., [email protected], 404-639-8813, and Denise Jackson, at [email protected], 404-639-8775. CDC will reply to requests for approval within two working days with approval, disapproval with explanation, or note we need more time to review.

For more information, visit www.cdc.gov/smallpox or call the CDC Clinician Information Line at (877) 554-4625 (English) (Version 2)

November 15, 2003

Page 3 of 3

VACCINE I NFORMATION S TATEMENT (VIS)

SMALLPOX VACCINE W H A T

1

Y O U

N E E D

WHAT IS SMALLPOX?

Smallpox is a serious disease that can kill up to 3 out of 10 people who get it. Smallpox can also cause— a severe rash, which can leave scars when healed. high fever.

Smallpox is caused by a virus called "variola," which spreads from person to person. Usually, face-to-face contact lasting 3 or more hours is needed to spread smallpox from one person to another. Smallpox can also be spread through direct contact with infected body fluids or objects such as bedding or clothing that have smallpox virus on them. Smallpox killed millions of people over the centuries. Smallpox vaccination was developed in 1796. As a result, the last outbreak of smallpox in the United States was in 1949.The world's last case of naturally occurring smallpox was in 1977. Routine vaccination of the American public against smallpox ended in 1972.

2

WHAT IS THE SMALLPOX VACCINE?

Smallpox vaccine is made from a living virus called "vaccinia." Vaccinia virus is like smallpox virus, but less harmful. The smallpox vaccine can NOT give you smallpox. The vaccine is not a shot like other vaccines.The needle is pricked into the skin a number of times in a few seconds (usually in the upper arm).The pricking is not deep, but will cause one or two small drops of blood to form.The place on the skin where the vaccine is given is called the "vaccination site."

Smallpox VIS — 11/15/03 — Page 1 of 6 — Version 1I

K N O W

Getting the vaccine— before exposure will protect most people from

smallpox (the vaccine is about 95% effective). up to 3 days after exposure can prevent the

disease or at least make it less severe. 4-7 days after exposure can still make the

disease less severe and decrease the chance of death.

tiredness. severe headaches and backache. blindness.

T O

Smallpox vaccine protects people from getting smallpox for 3 to 5 years. Protection from severe illness and death can last 10 years or more.

3

WHY GET VACCINATED NOW?

Smallpox vaccine protects people from smallpox. Some people should get the vaccine because they work with smallpox or related viruses in laboratories. Others are being offered the vaccine so they can assist in responding to a smallpox outbreak. Smallpox virus is kept in two approved laboratories in the United States and Russia.There is concern that terrorists may have obtained the smallpox virus and could use it as a weapon. If this happened, many people could become ill and many could die. The U.S. needs teams of health care providers and others to be vaccinated so they can respond quickly if a smallpox attack happens.These teams will do many things to help control a smallpox outbreak, including quickly vaccinating people who have been exposed to the disease.

4

WHO SHOULD GET

Have

?

SMALLPOX VACCINE AND WHEN

When There is NO Smallpox Outbreak— You should get the smallpox vaccine if you— Are a lab worker who works with smallpox or

viruses like it. Are a member of a smallpox response team.

Immune System Problems Rarely, when a person with a weakened immune system gets the smallpox vaccine, their vaccination site does not heal. Instead, it spreads to other parts of the body.This reaction can be life-threatening. Anyone with a weakened immune system should NOT get the smallpox vaccine, including anyone who: 

When There IS a Smallpox Outbreak— You should get the smallpox vaccine if you— Are directly exposed to smallpox virus.

If there is a smallpox outbreak, public health experts will say who else should get the vaccine. Vaccinated persons may need to get the vaccine again at least every 3-10 years, depending on their risk of exposure to smallpox or related viruses.

5



Has lupus or another severe autoimmune disease that weakens the immune system.



Has leukemia, lymphoma, or most other cancers.



Is taking cancer treatment with radiation or drugs, or has taken such treatment in the past 3 months.



Is taking, or has recently taken, drugs that affect the immune system.These include high-dose steroids (for 2 weeks or longer within the past month), some drugs for autoimmune disease, or drugs taken for an organ or bone marrow transplant.

WHO SHOULD NOT GET THE SMALLPOX VACCINE, OR SHOULD WAIT

?

When There is NO Smallpox Outbreak— You should NOT get the smallpox vaccine if you— Have Skin Problems

People with skin problems are at risk of developing rashes which can be severe if they get the smallpox vaccine. 





Anyone who has atopic dermatitis (often called eczema) or had it in the past, should not get the smallpox vaccine. Anyone who has Darier's disease (a skin disease that usually begins in childhood) should not get the smallpox vaccine. Anyone who has a skin problem that has made many breaks in the skin (such as an allergic rash, bad burn, impetigo, psoriasis, pityriasis rosea, poison oak, poison ivy, chickenpox, shingles, herpes, or very bad acne) should not get the vaccine now.They should wait until the skin heals before getting the smallpox vaccine.

Smallpox VIS — 11/15/03 — Page 2 of 6 — Version II

Has HIV/AIDS, primary immune deficiency disorders, humoral (antibody) immunity problems (such as agammaglobulinemia or lack of normal antibodies), or other diseases that affect the immune system.

Have Heart Problems

Smallpox vaccination may cause heart inflammation that can be mild to life-threatening. It is not known who is at risk for this problem. As a precaution, anyone who has been told by a doctor that they have a heart condition should NOT get the smallpox vaccine, even if they feel well.This includes anyone who has: 

Known heart disease, such as past heart attack or angina (chest pain caused by lack of blood to the heart).



Congestive heart failure



Cardiomyopathy (heart muscle becomes enlarged and does not work as well as it should)



Stroke or transient ischemic attack (a "mini-stroke" that causes stroke-like symptoms, but no lasting damage)



Chest pain or shortness of breath with activity (such as walking up stairs)



Other heart conditions that require the care of a doctor

In addition, anyone with 3 or more of the following risk factors should NOT get the smallpox vaccine: 

Have been told by a doctor that you have high blood pressure.



Have been told by a doctor that you have high blood cholesterol.



Have been told by a doctor that you have diabetes or high blood sugar.



Have a first degree relative (for example, mother, father, sister or brother) who had a heart condition before the age of 50.



are breastfeeding. Follow this advice even if you are pumping and then bottle-feeding breast milk. It is not known if smallpox vaccine virus or antibodies can be passed to babies through breast milk. Other

Reasons—Do NOT Get the Smallpox Vaccine if You—  Are very allergic to polymyxin B, streptomycin, chlortetracycline, neomycin, or latex. 

Had a bad reaction the last time you got the smallpox vaccine.



Are using steroid drops in your eyes.



Are moderately or severely ill the day of your vaccination appointment.Wait until you are better before getting the smallpox vaccine.

Smoke cigarettes now

Are

Pregnant or Breastfeeding Babies of mothers who have been vaccinated while pregnant or during the month before they become pregnant can get a very rare but serious infection from the vaccine. 

Do NOT get the smallpox vaccine if you are pregnant, think there is a chance you are pregnant, or think you might become pregnant within 4 weeks after vaccination.



Sexually active women are encouraged to take a pregnancy test before getting the vaccine.The test should be done the day their vaccination is scheduled. But be aware that even the best tests may not detect early pregnancies (those less than 2 weeks).



Do NOT get the smallpox vaccine if you

Take steps to prevent pregnancy during the month before and the month after vaccination:

You

should NOT get the smallpox vaccine if you live with or have close physical contact with anyone (such as a sex partner) who— 

Has any of the skin problems listed above.



Has any of the immune system problems listed above.



Is pregnant or may become pregnant within 4 weeks of your vaccination.

The smallpox vaccine may pose a similar risk to them.



Do not have sex, or



Use effective birth control every time you have sex. Effective birth control methods include male or female sterilization, hormonal methods (such as birth control pills, implants, patches or injections) and intrauterine devices (IUDs). Condoms and the use of spermicide with diaphragms, sponges, or cervical caps are also acceptable methods, although they are less effective. Do NOT rely solely on the rhythm or ‘natural family’ planning method.

Smallpox VIS — 11/15/03 — Page 3 of 6 — Version II

Smallpox vaccine is not routinely recommended for anyone under 18 years of age or for older people. People age 65 or older who do not have any of the conditions listed above should talk to their health care provider before getting the vaccine.

If There IS a Smallpox Outbreak— These restrictions may not apply. Public health experts will say who should get the vaccine at that time.

6

To Help Prevent Spread of the Virus:

WHAT SHOULD YOU EXPECT AFTER VACCINATION

?

Normal Reactions Week 1: Three or 4 days after vaccination, a red, itchy bump will form at the “vaccination site". Most times, this spot is about the size of a dime. It can be larger than 3 inches. The bump becomes a blister. It will fill with pus and then start to drain. A health care provider should check your vaccination site 6–8 days after you get the vaccine to make sure the vaccination worked and everything is o.k. Week 2: The blister will dry up and a scab will form. Week 3: The scab will fall off. It will leave a small scar. ½ inch

½ inch

 Cover the area loosely with a gauze bandage

held in place with first aid tape.While at work, health care workers should also cover the gauze with a semi-permeable bandage (this type of bandage allows air to flow through but not fluids).  Change the bandage often (at least every 3 days).  Try not to touch your vaccination site.  Do not let others touch the site or items that

have touched it such as bandages, clothes, sheets, or towels.  Always wash your hands with soap and water

or alcohol-based hand wash if you touch the site or if you touch bandages, clothes, sheets, or towels that have touched the site.  Keep the vaccination site dry. If the gauze bandage

gets wet, change it right away. Cover your vaccination site with a waterproof bandage while bathing.  Don't scratch or put ointment on the

Day 4 ½ inch

Day 7 ½ inch

vaccination site.  Don't touch your eyes, any part of your body, or

another person after changing the bandage or touching the vaccination site until you have washed your hands.  Wear a shirt that covers the vaccination site and

Day 14

Day 21

The lymph nodes under your arm may swell and be sore.The vaccination site may itch.You may also feel tired, have a mild fever, headache, or muscle aches. You may not get a blister if the vaccine did not work properly or if you are already immune to smallpox. In this case, you will need to get the vaccine again. If you still do not get a blister after getting the vaccine a second or third time, a health care provider will tell you if you are, or are not, considered immune.

What You Will Need to Do The virus in the vaccine is alive. It can be spread from the vaccination site to other parts of your body or to other people through close physical contact. This can happen until the scab falls off. In the past, the vaccine virus was spread from vaccinated people to others about 2 to 6 times out of every 100,000 people vaccinated for the first time (this usually happened between people who lived together).

Smallpox VIS — 11/15/03 — Page 4 of 6 — Version II

bandage.This helps protect those you have close contact with such as young children or the person you share a bed with.  Don't share towels.  Do your own laundry. Use a separate laundry

hamper for clothes, towels, sheets, and other items that may come into contact with your vaccination site or pus from the site. Machine wash items that have touched the vaccination site in hot water with detergent and/or bleach.  Put used bandages in plastic zip bags, then throw

them away in the regular trash.  After the scab falls off, put it in a plastic zip bag

and throw it away.

If you do not feel like you can follow these instructions, do not get vaccinated.

7

WHAT ARE THE RISKS FROM THE SMALLPOX VACCINE

?

A vaccine, like any medicine, can cause serious problems.There is a very small risk of smallpox vaccine causing serious harm, or death. The following information is about known reactions to smallpox vaccine.There may be other unknown side effects.

People who did not get the vaccine can also have the side effects described below if they touch someone's vaccination site or items that have touched the site (like bandages, clothes, sheets, or towels). Following instructions on how to care for the vaccination site (such as covering the site and washing hands) can help prevent spread of the vaccine virus to others.

MILD TO MODERATE PROBLEMS

HOW OFTEN DID IT HAPPEN IN THE PAST ?

Feel sick enough to miss work

About 1 out of 10 to 20 people vaccinated

Fever of over 100ºF

About 1 out of 10 people vaccinated

Mild rash that gets better without medicine

About 1 out of 12 people vaccinated

Blisters on other parts of the body

About 1 out of 10,000 people vaccinated

MODERATE TO SEVERE PROBLEMS CALL OR VISIT A HEALTH CARE PROVIDER

HOW OFTEN DID IT HAPPEN IN THE PAST ?

Eye infection from touching your eye if you have vaccine virus on your hand.This can lead to a loss of vision in the infected eye.

About 1 out of 45,000 people vaccinated

Rash on entire body which usually goes away without problems

About 1 per 15,000 people vaccinated

Inflamed heart (can be mild to life-threatening)

About 1 out of 10,000 people vaccinated for the first time

SEVERE OR LIFE-THREATENING PROBLEMS GET TO A HEALTH CARE PROVIDER IMMEDIATELY

HOW OFTEN DID IT HAPPEN IN THE PAST ?

Severe rash on people with eczema or atopic dermatitis, which can lead to scarring or death.

About 1 out of 26,000 people vaccinated

Encephalitis (severe brain swelling), which can lead to permanent brain damage or death.

About 1 out of 83,000 people vaccinated

Skin and tissue destruction starting at the vaccination site and spreading to the rest of the body, which can lead to scarring or death (usually happens in people with very weakened immune systems).

About 1 out of 667,000 people vaccinated

Vaccinia virus infection in unborn child that can lead to premature delivery, skin rash with scarring, stillbirth, or death of the child after delivery

Very rare, less than 50 cases have been reported throughout the world in the last 100 years

For every million people vaccinated in the past, up to 52 people had a life-threatening reaction to smallpox vaccine and up to 2 people died. The numbers provided above for severe or life-threatening problems are from studies done in the 1960’s when the smallpox vaccine was still routinely used in the U.S.The numbers reflect how often the problems occurred in infants, children, and adults. The numbers provided for all other problems are from recent studies and experiences vaccinating members of response teams and the military. Smallpox VIS — 11/15/03 — Page 5 of 6 — Version II

8

WHAT IF SOMEONE HAS A MODERATE, SEVERE OR LIFE-THREATENING PROBLEM?

Within a Few Minutes to a Few Hours of Getting the Vaccination, Watch For— Trouble breathing, hoarseness or wheezing. Hives, pale skin, weakness, a fast heart beat,

or dizziness. These could be signs that you are having an allergic reaction to the vaccine.

For the Next 3 to 4 Weeks, Keep Watching For— A vaccination site that is not healing. A rash or sore on other parts of your body. An eye infection. A lasting headache or fever. Confusion, seizures, or trouble staying awake. Chest pain, shortness of breath, rapid or unusual

heartbeat or unusual fatigue.

Cost of Treating Serious Problems In the rare event that you have a serious reaction to the smallpox vaccine, a federal program has been created to help pay for related costs of medical care and lost wages.This program was created to compensate certain people, such as health care workers and emergency responders, injured by the vaccine. It will also cover certain people injured as the direct result of exposure to vaccinia through contact with certain people who received the smallpox vaccine (or with the contacts of such vaccine recipients).The program covers related costs of medical care and lost wages (usually starting after the first five days of missed work) after other available coverage, such as workers’ compensation or health insurance, has been used. The Department of Health and Human Services will make more information about this program available soon, including how to request benefits and/or compensation. For more information contact Paul T. Clark, Director, Smallpox Vaccine Injury Compensation Program, Office of Special Programs, 888-496-0338 or go to www.hrsa.gov/smallpoxinjury.

Any unexpected health problem.

What Should You Do? If you or a close contact have any of these problems, or if you are concerned about any health problem that you have after vaccination—

9 HOW CAN YOU LEARN MORE? Ask your health care provider.They can give you

more information, show you the vaccine package insert or suggest other sources of information.

Call or go to a health care provider right away.

Call your local or state health department.

Tell the health care provider that you received

Visit the Centers for Disease Control and

the smallpox vaccine and when. Ask your doctor or nurse to file a Vaccine

Adverse Event Report (VAERS form) and contact the health department.You can also file a report yourself by visiting the VAERS website at www.vaers.org or by calling 1-800-822-7967.

Treating Serious Problems There are two drugs that may help people who have certain serious side effects from the vaccine:Vaccinia Immune Globulin (VIG) and cidofovir.These drugs are not licensed for this purpose, and may also cause side effects.

Smallpox VIS — 11/15/03 — Page 6 of 6 — Version II

Prevention (CDC) smallpox website at

www.cdc.gov/smallpox Contact the (CDC): 

Call 1-888-246-2675 (English)



Call 1-888-246-2857 (Español)



Call 1-866-874-2646 (TTY)

If you decide to get the smallpox vaccine, please KEEP THIS DOCUMENT for one month following vaccination.

Pre-Event Screening Worksheet for Smallpox Vaccine You have received a smallpox Vaccine Information Statement (“VIS”) called “Smallpox Vaccine: What You Need to Know.” The VIS contains important information about smallpox vaccination. The VIS describes people who should not get the smallpox vaccine or should wait to get the vaccine because of their own health or the health of their “close contacts.” (“Close contact” means a person who you live with. It also means a person you have close physical contact with, such as a sex partner or someone you share a bed with. Friends or people you work with are not “close contacts.”) Please read the VIS very carefully and then answer the questions in this worksheet. The VIS and the questions in this worksheet will help you decide if you should or should not get the smallpox vaccine. Answer each question the best you can. Some questions in this worksheet are very personal. You should not put your name on this worksheet. The worksheet is for you to keep. The staff at the smallpox vaccination clinic will not ask for or collect this sheet. If you wish, you may ask clinic staff questions concerning this sheet. Ask a health care provider for help if you do not understand a question or if you have any concerns. If you need more information, visit www.cdc.gov/smallpox. You can also call (888) 246-2675 (English), (888) 246-2857 (español), or (866) 874-2646 (TTY). The calls are free. •

If you answer “NO” to ALL the questions on this sheet, then you may go to the vaccination clinic to get the vaccine.



If you answer “YES” to one or more questions, follow the advice that is given.



If you don’t know, get answers from your health care provider (or your close contact’s health care provider) before going to the vaccination clinic.

Please read the following important information about HIV infection before completing this form. Up to 300,000 people in the United States may have HIV infection and do not know it. You can have HIV infection and feel fine. If you have HIV infection you can have very bad side effects from the smallpox vaccine. So, before getting the vaccine, it’s important to know if you have HIV infection. If you do not know, get an HIV test. Below is a list of things that may place you at higher risk for having HIV infection. If any of these apply to you, be sure to get tested for HIV before you get the smallpox vaccine.

You should get tested for HIV if you •

Use needles to inject anything NOT prescribed by your doctor



Were stuck by a needle by accident



Had sex with someone who has HIV/AIDS or tested positive for HIV/AIDS



Had sex with a prostitute or someone who takes money or drugs for sex



Had sex with someone who has ever used needles to inject anything NOT prescribed by a doctor



For women: Had sex with a man who has ever had sex with another man



For men: Had sex with another man

(Version 3)

November 15, 2003

Page 1 of 7

Pre-Event Screening Worksheet for Smallpox Vaccine (continued from previous page)

A. Please answer these questions about your health and the health of your close contacts Health Conditions

Have cancer now, or have been treated for cancer in the past 3 months Had an organ or bone marrow transplant

Have a disease that affects the immune system like HIV/AIDS, lymphoma, leukemia, or a primary immune deficiency disorder Have lupus or another severe autoimmune disease that may weaken the immune system

Have Darier’s disease, a skin disease that usually begins in childhood

Have many breaks in the skin (such as those caused by bad burns, impetigo, psoriasis, pityriasis rosea, herpes, very bad acne, poison ivy, poison oak, chickenpox, shingles, or other rashes such as bad diaper rash and rashes caused by prescription medicines) Have ever been told by a health care provider you have atopic dermatitis (often called “eczema”), even if the condition is mild, not currently active, or you had it only as a baby or child

Do you have this condition?

YES

NO

Does a close contact have this condition? YES

NO

↓ Do not get vaccinated

↓ Do not get vaccinated

YES NO ↓ Do not get vaccinated

YES NO ↓ Do not get vaccinated

YES

NO

YES

NO

↓ Do not get vaccinated

↓ Do not get vaccinated

YES

YES

NO

↓ WAIT to get the vaccine until AFTER you check with a doctor YES

NO

↓ Do not get vaccinated YES

NO

↓ WAIT to get the vaccine until AFTER your skin is healed

YES

NO

↓ Do not get vaccinated

NO

↓ WAIT to get the vaccine until AFTER you check with your contact’s doctor YES

NO

↓ Do not get vaccinated YES

NO

↓ WAIT to get vaccinated until AFTER your contact’s skin is healed

YES

NO

↓ Do not get vaccinated

Some people may not know for sure if they ever had atopic dermatitis (or eczema). Answer these questions to help you find out if you or a close contact may have had atopic dermatitis or eczema. (Version 3) November 15, 2003 Page 2 of 7

Pre-Event Screening Worksheet for Smallpox Vaccine (continued from previous page) 1. Do you currently have an itchy red rash that comes and goes but usually lasts more than 2 weeks, or did you have such a rash as a baby or child? YES → You likely have atopic dermatitis (or eczema) and should NOT get vaccinated at this time. Please be sure to answer questions 2 and 3. NO →

SKIP TO question 4

Don’t know → You should discuss any rashes you have with your doctor. If you can, please write down any information given to you by a doctor regarding this rash: ________________________________________________________________________________ 2. Did the itchy rash affect the creases of your elbows or knees? YES → You likely have eczema or atopic dermatitis and should NOT get vaccinated at this time NO Don’t know 3. Did you have food allergies as a baby or child? NO Don’t know YES → Do you also have asthma or hay fever? YES →

You likely have eczema or atopic dermatitis and should NOT get vaccinated at this time

NO 4. Does a close contact currently have an itchy red rash that comes and goes but usually lasts more than two weeks, or did a close contact have this condition as a baby or child? NO → YES or

SKIP TO Section B Don’t know →

More information is needed about your close contact before you get the smallpox vaccine. Please answer questions 5-7. If you do not know the answers to the questions below, please ask the right person to help you answer them. A parent should answer these questions if they apply to a child.

5. Ask your close contact if he or she has an itchy red rash that comes and goes but usually lasts more than 2 weeks, or if this person had such a rash as a baby or child? YES → Your close contact may have eczema or atopic dermatitis. Please gather information so that questions 6 and 7 can be answered. Check with the contact’s doctor about the rash. NO If you can, please write down any information given by a doctor regarding this rash: _________________________________________________________________________________ 6. Did the itchy rash affect the creases of the elbows or knees? (Version 3)

November 15, 2003

Page 3 of 7

Pre-Event Screening Worksheet for Smallpox Vaccine (continued from previous page) YES → Your close contact likely has eczema or atopic dermatitis and you should NOT get vaccinated at this time NO Don’t know 7. Did the person with the rash have food allergies as a baby or child? NO Don’t know YES → Does the person with rash and food allergies also have asthma or hay fever? YES →

Your close contact likely has eczema or atopic dermatitis and you should NOT get vaccinated at this time

NO Don’t know

B. Please answer these questions about treatments or medicines you or your close contact take (Talk to a health care provider if you are not sure about answers to these questions)

Treatments or medicines

Took steroids such as prednisone or related medicine either by mouth or intravenously for 2 weeks or longer in the past month

Took medicines in the last 3 months that affect the immune system (such as methotrexate, cyclophosphamide, cyclosporine). If you don’t know whether or not your medicine affects your immune system, ask your doctor.

Had radiation therapy in the last 3 months

(Version 3)

Are you getting this treatment or taking this medicine?

YES

NO

Is a close contact getting this treatment or taking this medicine? YES

NO

↓ Do not get vaccinated

↓ Do not get vaccinated

Name and dose of medication:

Name and dose of medication:

YES

NO

YES

NO

↓ Do not get vaccinated

↓ Do not get vaccinated

Name and dose of medication:

Name and dose of medication:

YES NO ↓ Do not get vaccinated

YES NO ↓ Do not get vaccinated

November 15, 2003

Page 4 of 7

Pre-Event Screening Worksheet for Smallpox Vaccine (continued from previous page)

Are you getting this treatment or taking this medicine?

Is a close contact getting this treatment or taking this medicine?

YES NO ↓ Do not get vaccinated

YES NO ↓ Do not get vaccinated

Treatments or medicines

Had chemotherapy for cancer in the last 3 months

C. Please answer these questions about pregnancy. The questions do not apply to women who are post-menopausal (have had no menstrual periods for over a year) or have had a hysterectomy or female sterilization. Pregnancy status and pregnancy risk factors Are pregnant or think you might be pregnant. Sexually active women are encouraged to take a pregnancy test before getting the vaccine. The test should be done the day vaccination is scheduled. But be aware that even the best tests may not detect early pregnancies (those less than 2 weeks).

Last menstrual period was not on time and/or was not normal

Had sexual intercourse in the past month and did not always use one or more types of effective birth control, including sterilization (such as vasectomy or tubes tied), birth control pills, implants, patches, injections, IUDs, condoms, and diaphragm with spermicide, cervical cap with spermicide, and contraceptive sponge with spermicide

Does this apply to you? (Women only) YES

NO

↓ Do not get vaccinated

YES

NO

↓ Do not get vaccinated until you check with your doctor to make sure you are not pregnant

YES ↓

NO

Do not get vaccinated at this time

YES Might have sexual intercourse during the (Version 3) November 15, 2003

Does this apply to a close contact? YES

NO

↓ Do not get vaccinated

YES

NO

↓ Do not get vaccinated until your close contact checks with her doctor to make sure she is not pregnant.

YES ↓

NO

Do not get vaccinated at this time

NO Page 5 of 7

Pre-Event Screening Worksheet for Smallpox Vaccine (continued from previous page)

Pregnancy status and pregnancy risk factors

Does this apply to you? (Women only)

month after vaccination and might not always use an effective form of birth control

Does this apply to a close contact? YES ↓

↓ Do not get vaccinated

Do not get vaccinated

YES NO ↓ Do not get vaccinated until you check with your doctor to make sure you are not pregnant

Think menstrual period might be late now

NO

YES NO ↓ Do not get vaccinated until your contact checks with her doctor to make sure she is not pregnant

D. Please answer these questions about your own health (these questions do not apply to close contacts) Health Conditions

Does this apply to you?

Have a heart condition, including any one of the following: •

a previous heart attack (also called myocardial infarction), angina (chest pain caused by lack of blood flow to the heart), or other coronary artery disease (disease in the vessels that bring blood to the heart)



cardiomyopathy (heart muscle becomes enlarged and doesn’t work as it should)



congestive heart failure



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)



any other heart condition under the care of a doctor

YES

NO



Do not get vaccinated (even if you feel well)

Have 3 or more of the following: •

Have been told by a doctor that you have high blood pressure

(Version 3)

November 15, 2003

YES

NO

↓ Page 6 of 7

Pre-Event Screening Worksheet for Smallpox Vaccine (continued from previous page)

Health Conditions • • • •

Have been told by a doctor that you have high blood cholesterol Have been told by a doctor that you have diabetes or high blood sugar Have a first degree relative (for example mother, father, sister or brother) who had a heart condition before the age of 50 Smoke cigarettes now

Using steroid drops in your eyes now

Does this apply to you? Do not get vaccinated

YES NO ↓ Do not get vaccinated

Have a moderate or serious illness

YES

NO

↓ WAIT to get the vaccine until AFTER your are no longer sick Women only: Are breastfeeding or pumping and then bottlefeeding breast milk

Have had a serious allergic reaction to polymyxin B, streptomycin, chlortetracycline, neomycin or latex

Had a very bad reaction to smallpox vaccine in the past

YES

NO

↓ WAIT to get the vaccine until AFTER you stop breastfeeding

YES

NO

↓ Do not get vaccinated

YES

NO

↓ Do not get vaccinated

For more information, visit www.cdc.gov/smallpox, or call the CDC public response hotline at (888) 246-2675 (English), (888) 246-2857 (español), or (866) 874-2646 (TTY) (Version 3)

November 15, 2003

Page 7 of 7

SMALLPOX FACT SHEET (FOR CLOSE CONTACTS OF PEOPLE CONSIDERING VACCINATION)

Someone You Are Close to May Get the Smallpox Vaccine: What You Should Know and Do There are some things you should know and do if someone you have close contact with is thinking about getting the smallpox vaccine. (“Close contact” means anyone living in your household. It also means anyone you have close, physical contact with, like a sex partner or someone you share a bed with. Close contact does not mean friends or co-workers.)

BEFORE Vaccination: What You Should Know The smallpox vaccine is made from a living virus called “vaccinia.” Vaccinia virus is like smallpox virus, but less harmful. The vaccine does not contain the smallpox virus. It can not give you smallpox. The vaccine can protect people from smallpox. For most people, the smallpox vaccine works and is safe. But, people with certain health conditions are more likely to have serious reactions to the smallpox vaccine. These people should not be vaccinated and they should not be in close contact with someone who has been vaccinated.

BEFORE Vaccination: What You Should Do Tell your close contact if you have any of the conditions listed below, or even if you have concerns about any of them. You should NOT be in close contact with someone who has been vaccinated if you: •

Ever had or now have atopic dermatitis, often called “eczema” (even if you had the condition as a baby or child and even if the condition is mild)



Have many breaks in your skin such as those caused by chickenpox, shingles, bad burns, severe acne, poison oak, poison ivy, herpes, psoriasis, pityriasis rosea, impetigo, or other rashes.



Have Darier’s disease, a skin disease that usually begins in childhood



Have a weakened immune system for whatever reason (HIV/AIDS, cancer and cancer treatment, lupus or other severe autoimmune diseases, primary immune deficiency disorder, or medicines that affect the immune system like high-dose steroids, some drugs for autoimmune disease, or drugs taken for an organ or bone marrow transplant)



Are pregnant or might become pregnant within 4 weeks of your close contact’s vaccination

Because of the risk to you (or your baby if you are pregnant), you should not be in close contact with someone who has gotten smallpox vaccine if any of these apply to you.

(Version 2)

November 15, 2003

Page 1 of 2

Someone You Are Close to May Get the Smallpox Vaccine: What You Should Know and Do (continued from previous page)

AFTER Vaccination: What You Should Know There are things you should know if your close contact gets the smallpox vaccine (even if both you and your close contact don’t have any health problems). After vaccination, a bump will form at the place on your close contact’s skin where the vaccine was given (called the “vaccination site”). The bump will turn into a blister. It will fill with pus and start to drain. The blister will dry up and form a scab. After about 2 to 3 weeks, the scab will fall off and leave a small scar. The vaccinia virus in the vaccine (and on your close contact’s vaccination site) is a live virus. Until their scab falls off, a person who has been vaccinated can spread vaccinia virus to other people. This can cause problems such as rash (mild to severe), fever, and head and body aches in the other person. Vaccinia is spread by touching the vaccination site before the scab has fallen off, or by touching items like bandages, clothes, sheets, or towels that have touched the site. In the past, the vaccine virus was spread from vaccinated people to others about 2 to 6 times out of every 100,000 people vaccinated for the first time. This usually happened between people who lived together.

AFTER Vaccination: What You Should Do Until your close contact’s scab falls off: •

Do not touch your close contact’s vaccination site or any items that have touched it (such as bandages, clothes, sheets, towels, or washcloths used by the person who got the vaccine).



Wash with soap and warm water right away if you accidentally touch the vaccination site or items that were in contact with it. Do not touch your eyes or any part of your body until you have washed your hands.



If you share a bed with the vaccinated person, be sure that they wear a gauze bandage held in place with first aid tape. To be extra careful, the person who got the vaccine should wear a shirt or pajamas that cover the bandage. If they do not, you may choose to sleep in another bed.



Don’t share towels or clothing. Keep clothes, towels, sheets, or other items used by the vaccinated person separate. He or she should machine wash items that have touched the vaccination site using hot water with detergent and/or bleach.



Remind the person who got the vaccine to follow the vaccination site care and hand washing instructions they have been given. The vaccination site often becomes itchy, which may lead to scratching, rubbing, or touching of the site. If their hand has vaccinia virus on it and they touch you, you can be infected.

For more information, visit www.cdc.gov/smallpox, or call the CDC public response hotline at (888) 246-2675 (English), (888) 246-2857 (español), or (866) 874-2646 (TTY) (Version 2)

November 15, 2003

Page 2 of 2

SMALLPOX VACCINATION PATIENT MEDICAL HISTORY AND CONSENT FORM For Clinic Use Only: Initial Vaccination:  Revaccination:  (Initial PVN Date: mm

dd

)

Place Patient Vaccination Number (PVN) sticker here

yyyy

PATIENT MUST COMPLETE SECTIONS A, B, C, D, E and F. Please use pen and print. SECTION A GENERAL PATIENT INFORMATION Title: _______ First Name: __________________________________

Middle Name: ______________________

(Mr., Ms., Mrs., Dr., etc.)

Last Name: _______________________________________________

Suffix: _____________________________ (Jr., Sr., MD., etc.)

Social Security Number (optional): ____________________ Date of Birth (year is required): _______________ mm

dd

yyyy

Gender:  Male  Female

Street Address: ____________________________________________ Apt. #: _________________ City: ______________________________________________________ State: _________________ Zip code: _________________ County: ___________________________________________________ Your Contact Information: Home Phone: (______) ______ - ________ Cell Phone: (______) ______ - ________ Beeper/Pager: (______) ______ - ________ E-mail Address:

Work: (______) _______ - ________ ext. _________ Fax: (______) _______ - ________ Beeper/Pager PIN #: __________________________

Occupation: _________________________________ Ethnicity/Race (optional, you do not have to provide this information. If you choose to provide this information, you may select more than one category):  Hispanic or Latino Ethnicity  Asian  Black or African American  Native Hawaiian or other Pacific Islander  American Indian or Alaska Native  White Did you serve in the military before 1984?  Yes  No SECTION B PATIENT VACCINATION HISTORY How many times have you already received smallpox vaccination? Do NOT count smallpox vaccinations you received since January 2003 as part of the National Smallpox Vaccination Program (NSVP)  0  1  2  More than 2  Don't know Enter the year of the most recent vaccination prior to the NSVP if known: ___________ Please indicate source of date:  Document (e.g., vaccination card)  self-recall (from memory) If year of your most recent vaccination prior to the NSVP is unknown: (check one)  I was vaccinated in childhood but can't recall the date  I was vaccinated in adulthood but can't recall the date Have you been told (for instance, by a doctor or a parent) that your vaccination was successful?  Yes  No  Don't Know Do you have a vaccination scar?  Yes  No  Don't Know Did you have any bad reaction(s) to the vaccine?  Yes  No  Don't know If yes, you should not get the vaccine at this time if the reaction(s) was serious. Please tell us about the reaction(s) ___________________________________________________________________

Department of Health and Human Services Centers for Disease Control and Prevention

(Version 5)

11/15/2003

Medical History & Consent Form Page 1 of 5

Date: __________________ mm

dd

yyyy

Patient Name: _________________________________________________________ PVN: __________________________________

SECTION C PATIENT CONTACT AFTER VACCINATION During the month following vaccination, you may be contacted for routine follow-up. May we also contact you in the future about participating in a survey?  Yes  No SECTION D REFERRING ORGANIZATION Please provide the following information about the organization that referred you for vaccination. Name: Street Address: City: ________________________ State: __________________________ Zip code: _____________________________ County: _____________________ Phone: (______) ______ - _________ SECTION E PATIENT MEDICAL HISTORY Have you received chickenpox (varicella) vaccination in the last month?  Yes  No If yes, you should not get the smallpox vaccine at this time. Are you currently taking medication?  Yes  No If yes, please list medications (also see questions 3, 4, and 17 below): Are you sick today?  Yes  No If yes, please describe your illness, you may need to wait to get the vaccine Do any of the following apply to YOU?  Yes  No Weakened Immune System 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), some 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? Skin Problems 5. Do you now have, or have you ever had atopic dermatitis, often called eczema (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. Do you have Darier's disease (a skin problem that usually begins in childhood)? Heart Problems 8. Have you ever been diagnosed by a doctor as having a heart condition 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? 9. Have you ever had a stroke or transient ischemic attack (a "mini-stroke" that produces stroke-like symptoms but no lasting damage)? 10. Do you have chest pain or shortness of breath when you exert yourself (such as when you walk up stairs)? 11. Do you have any other heart condition for which you are under the care of a doctor? 12. 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. (Version 5)

11/15/2003

Medical History & Consent Form Page 2 of 5

Date: __________________ mm

dd

yyyy

Patient Name: _________________________________________________________ PVN: __________________________________

SECTION E PATIENT MEDICAL HISTORY continued Pregnant or Breastfeeding 13. Are you pregnant, might be pregnant, or might become pregnant in the next month? 14. In the past month, have you had any sex without using effective birth control or do you think you will have sex without using effective birth control during the month after vaccination? 15. Are you currently breastfeeding or pumping and then bottle-feeding breast milk? Other 16. Have you ever had a life-threatening allergic reaction to smallpox vaccine, latex or the antibiotics polymixin B, streptomycin, chlortetracycline, or neomycin? 17. Are you now being treated with steroid eye drops? IF YOU ANSWERED YES TO ANY OF THE QUESTIONS ABOVE, YOU SHOULD NOT GET THE SMALLPOX VACCINE AT THIS TIME. If you answered NO, please continue with the following questions about your close contacts. 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.) Weakened Immune System 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), some 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? Skin Problems 5. Do any of your close contacts now have, or have they ever had atopic dermatitis, often called eczema (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. Do any of your close contacts have Darier's disease (a skin problem that usually begins in childhood)? Pregnancy 8. Are any of your close contacts pregnant, might be pregnant, or might 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 clinic use only)

(Version 5)

11/15/2003

Medical History & Consent Form Page 3 of 5

Date: __________________ mm

dd

yyyy

Patient Name: _________________________________________________________ PVN: __________________________________

SECTION F SIGNED CONSENT (TO BE KEPT BY THE VACCINATION CLINIC) I have: ●

received, read and understand the Smallpox Pre-Vaccination Information Package, including the Vaccine Information Statement (VIS) and the pre-event screening worksheet;



considered my own health status as well as the health status of my close 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 that getting the vaccine is my choice. I agree to get the smallpox vaccine.

Patient signature

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. Individuals who do not provide all of the requested information (except items marked as optional) will not be eligible to receive the smallpox vaccine. Identifiable information may be shared by the Centers for Disease Control and Prevention with authorized U.S. Department of Health & Human Services' personnel and public health or cooperating medical authorities.

(Version 5)

11/15/2003

Medical History & Consent Form Page 4 of 5

Date: __________________ mm

dd

yyyy

Patient Name: _________________________________________________________ PVN: __________________________________

SECTION G CURRENT VACCINATION INFORMATION (CLINIC STAFF WILL FILL OUT THIS SECTION) Vaccination clinic and vaccine batch information do not need to be filled out if a pre-printed, pre-populated PVS patient medical history and consent form attachment is used.

Vaccination Clinic Information Name: Street Address: City: _____________________________________ State: __________________ Zip code: ______________________ County: ___________________ Phone: (______) ______ - _________ Fax: (______) ______ - __________________ Disposition  Referred for Vaccination  Deferred for medical reasons  Vaccination refused Was a smallpox vaccination scar seen by clinic staff?  Yes  No Vaccinee status?  Primary vaccinee  Revaccinee Vaccination Administration Information Arm vaccinated:  Left  Right  Other: _______________________

Date of Vaccination: mm

dd

yyyy

Vaccine Administered by: Please print first name, last name, and professional suffix (MD, RN, etc.)

Vaccine Batch Information

:

Vaccine Type:

Batch #:

Program:

External #:

Dilution Strength:

Batch Date:

Diluent Lot #:

Vaccine Lot #:

Diluent Lot Manufacturer:

Vaccine Lot Manufacturer:

Take Evaluation and Response Name of the organization/clinic where take will be evaluated: Street Address: City: _____________________________________ State: ___________________ Zip code: _____________________ County: ___________________ Phone: (______) ______ - _________ Take response evaluation performed by: Please print first name, last name, and professional suffix (MD, RN, etc.)

Date of Evaluation (should be 6-8 days after vaccination): _______________ mm

dd

yyyy

Take Response (check only one box)  Major (usually successful vaccination is characterized by a pustular lesion or an area of definite induration or congestion surrounding a central lesion, which might be a scab or an ulcer; go to the CDC website listed below for more information)

 Equivocal (all other responses)  Not available, reason:

(e.g., cannot be contacted, died, hospitalized, refused, other)

Is the vaccinee considered immune for response team work?  Yes (the vaccinee had a Major response or was a revaccinee and had two Equivocal responses)  No Additional comments: To determine vaccinee’s status, see marked italicized items in sections A, B, and G. For more information on determining vaccination status or assessing vaccination responses, go to www.bt.cdc.gov/agent/smallpox/vaccination/statusprocedure.asp

Adverse events should be reported to VAERS at www.vaers.org or 1-800-822-7967

Department of Health and Human Services Centers for Disease Control and Prevention

(Version 5)

11/15/2003

Medical History & Consent Form Page 5 of 5

Temporary Proof of Vaccination and Site Check Reminder Sheet (To be Completed by Clinic Staff and Kept by the Vaccinee)

IMPORTANT: KEEP THIS FORM. BRING IT WITH YOU TO YOUR VACCINATION SITE CHECK. Please bring this sheet with you to your vaccination site check appointment and keep it for the next 4 weeks. This sheet contains the phone number you should call if you think you are having a bad reaction to the vaccine. This sheet is also your proof of vaccination until you come back to the clinic for your vaccination site check. On that date, you will get your permanent immunization card.

TEMPORARY PROOF OF SMALLPOX VACCINATION: ________ Date vaccinated:

Name:

/

/

____

mm/dd/yyyy

PVN: __________________ Clinic:

________________

Clinic Telephone No.: (_______)_________-_____________ Arm Vaccinated:

Left

Right

APPOINTMENT FOR REQUIRED VACCINATION SITE CHECK:

You will need to get your vaccination site checked on the date below to make sure the vaccination worked. Date of Appointment: Clinic Name:

/

/

mm/dd/yyyy

____

Time: _________________ __________________

Street Address______________________________________________ City_________________________________State____________ Zip ___________________________ Clinic Telephone No.: (_______)_________- ________________

IF YOU THINK YOU ARE HAVING A BAD REACTION TO THE VACCINE:

Call: ____________________________, call your health care provider, or visit an emergency room. IMPORTANT: DO NOT DISCARD THIS FORM. BRING IT WITH YOU WHEN YOU RETURN FOR YOUR VACCINATION SITE CHECK.

For more information, visit www.cdc.gov/smallpox, or call the CDC public response hotline at (888) 246-2675 (English), (888) 246-2857 (español), or (866) 874-2646 (TTY) (Version 2) November 15, 2003 Page 1 of 1

TULAREMIA (FRANCISELLA TULARENSIS) OVERVIEW Naturally Occurring Tularemia Tularemia, also know as rabbit fever and deer fly fever, is a zoonotic disease typically acquired by humans after skin or mucous membrane contact with infected animals. Ticks, deer flies and mosquitoes can also transmit the infection. Less commonly, inhalation of contaminated dust or ingestion of contaminated food or water may result in clinical disease. Bioterrorism Epidemiology

Exposure to as few as 10 – 50 aerosolized organisms may result in clinical disease. Person to person transmission does not occur. Large numbers of temporally clustered persons presenting to a clinic or an emergency room with similar symptoms should be reported to the local health officer immediately. Incubation Period

The average incubation period is 3 – 5 days (range 1 – 21 days). Clinical Presentation

Tularemia may present as one of six indistinct, overlapping clinical syndromes: pneumonic, systemic, ulceroglandular, glandular, oculoglandular, and oropharyngeal. The symptoms range from asymptomatic to acute sepsis leading to rapid death. Pneumonic tularemia

Pneumonic tularemia would presumably be the most likely clinical presentation of an intentional bioaerosol release of F. tularensis. The onset of symptoms may be abrupt and include: • Fever, non- to minimally productive cough, substernal tightness, pleuritic chest pain, occasional hemoptysis (rare), chills, headache, malaise, anorexia, and fatigue • Chest x-ray (CXR) may show infiltrates witho ut symptoms. Other CXR findings may include subsegmental/lobar infiltrates, hilar adenopathy, pleural effusion, or miliary infiltrates (may mimic tuberculosis) • Pleural fluid is usually exudative with more than 1000 leukocytes/mm3 • Granulomas may develop and occasionally caseate and may be confused with tuberculosis • Secondary skin rashes can occur within the first two weeks of illness in up to 35% of cases 30 Appendix A

Systemic tularemia • • •

Febrile illness without typical clinical features of other forms of tularemia, Non descript symptoms also include fever, chills, headache, myalgias, cough, sore throat, nausea, vomiting, watery diarrhea (rarely bloody), and abdominal pain, More common in persons with chronic diseases and may lead to rapid death or protracted illness. Oropharyngeal, Ulceroglandular, Glandular, and Oculoglandular Tularemia (unlikely bioaerosol release presentations)





• •

Oropharyngeal tularemia results from the direct invasion of the oropharynx (contaminated food and water) causing a sore throat with exudative tonsillitis and pharyngitis with the formation of ulcer(s); also may involve cervical, preparotid, and retropharyngeal lymph nodes with possible abscess formation. Ulceroglandular and glandular tularemia generally present with enlarged, local tender lymph nodes. Skin lesions can appear before, simultaneously, or after lymphadenopathy. The ulcers start as red, painful papule(s) that progress to necrotic draining ulcers with raised borders. Glandular tularemia is the same as ulceroglandular without the skin lesions. Oculoglandular tularemia results from the inoculation of bacteria onto the eye resulting in photophobia and excessive lacrimation, swollen eyes, painful infected conjunctiva and yellowish conjunctival ulcers.

Laboratory Initial laboratory fi ndings are generally nonspecific. Peripheral white blood cell count ranges from 5,000 – 22, 000 cells per microliter with a normal differential count. Lymphocytosis may occur late in the disease. Hematocrit, hemoglobin, and platelet counts are generally normal. Mild elevations in lactic dehydrogenase, serum transaminases and alkaline phosphatase are common. Rhabdomyolysis may be associated with elevations in serum creatine kinase and urinary myoglobin levels. Cerebral spinal fluid is generally normal although mild abnormalities in protein, glucose and blood cell count may be seen. Tularemia can be diagnosed by recovery of the organism from blood, ulcers, conjunctival exudates, sputum, gastric washings, and pharyngeal exudates. The organism grows poorly on standard culture media and requires cysteine-enriched media. Most diagnoses of tularemia are made serologically. Complications Complications include dehydration, hypotension, renal failure, disseminated intravascular coagulation (DIC), jaundice, hepatitis, meningitis, encephalitis, 31 Appendix A

pericarditis, peritonitis, splenic rupture, rhabdomyolysis, suppuration of lymph nodes, and pleural effusion. Treatment delay and pre-existing medical conditions may contribute to death. Differential Diagnosis Other organisms to consider include Mycoplasma pneumoniae, Legionella pneumophila, Chlamydia psittaci, Chlamydia pneumoniae and Mycobacterium tuberculosis. Treatment (See Tables 1 and 2) Prophylaxis Antibiotic prophylaxis is not commonly used to prevent naturally acquired tularemia. Isolation Standard Precautions are recommended. In addition to Standard Precautions, Contact precautions are recommended for patients with ulceroglandular or oculoglandular tularemia, if lesion drainage is not contained with a dressing.

32 Appendix A

Recommendations 1 for the treatment of patients with tularemia in contained and mass casualty settings and for post-exposure prophylaxis2 are as follows: Table 1: Tularemia – Antibiotic Therapy for Contained Casualty Settings Contained Casualty Setting: assumes a limited number of persons seeking treatment. Start IV antibiotic therapy as soon as diagnosis is suspected. Patient Category Recommended Therapy Adults Preferred Therapy *Gentamicin 5 mg/kg IM or IV 1 time daily3 or *Gentamicin 2 mg/kg loading dose followed by 1.7 mg/kg IM or IV 3 times daily3

Children6

Pregnant Women7

Alternative Choices *Doxycycline 100 mg IV 2 times daily *Ciprofloxacin 400 mg IV 2 times daily4 Chloramphenicol 25 mg/kg IV 4 times daily5 Preferred Therapy *Gentamicin 2.5 mg/kg IM or IV 3 times daily3 Alternative Choices *Doxycycline = 45 kg give adult dose < 45 kg give 2.2 mg/kg IV 2 times daily *Ciprofloxacin 15 mg/kg 2 times daily4 Chloramphenicol 15 mg/kg IV 4 times daily5 Preferred Therapy *Gentamicin 5mg/kg IM or IV 1 time daily3 or *Gentamicin 2 mg/kg loading dose followed by 1.7 mg/kg IM or IV 3 times daily3 Alternative Choices *Doxycycline 100 mg IV 2 times daily *Ciprofloxacin 400 mg IV 2 times daily5

*Antibiotic supplied as part of the National Strategic Stockpile (NSS )

33 Appendix A

Table 2: Tularemia – Antibiotic Therapy for Mass Casualty Settings and Post-exposure Prophylaxis Mass Casualty Setting and Post-exposure Prophylaxis 8 Adults Preferred Choices *Doxycycline 100 mg orally 2 times daily9 *Ciprofloxacin 500 mg orally 2 times daily4 6 Children Preferred Choices *Doxycycline 9 If = 45 kg give adult oral dose If < 45 kg give 2.2 mg/kg orally 2 times daily Ciprofloxacin 15 mg/gm orally 2 times daily4 Pregnant Women7 Preferred Choices *Ciprofloxacin 500 mg orally 2 times daily4 *Doxyc ycline 100 mg orally 2 times daily9 *Antibiotic supplied as part of the National Pharmaceutical Stockpile (NPS) 1.

2.

3. 4. 5.

6.

7. 8.

9.

These recommendations are adapted from the consensus recommendations of the Working Group on Civilian Biodefense and are not necessarily approved by the Food and Drug Administration. In non-bioterrorism response situations, routine treatment guidelines should be followed. Refer to the original publication (Dennis DT, Inglesby TV, Henderson DA, et al. Tularemia as a biological weapon: Medical and public health management, JAMA, in press) for explanations and further discussion. One antimicrobial agent should be selected. Therapy with gentamicin or ciprofloxacin should be continued for 10 days. Treatment with doxycycline or chloramphenicol should be continued for 14 – 21 days. Persons beginning treatment with parenteral doxycycline, ciprofloxacin or chloramphenicol can be switched to oral antibiotics when clinically indicated. Aminoglycosides must be adjusted according to renal function. Neonates up to 1 week of age and premature infants should receive gentamicin 2.5 mg/kg 2 times daily. Other fluoroquinolones can be substituted at doses appropriate for age. Ciprofloxacin dosage should not exceed 1 g daily in children. Concentration should be maintained between 5 and 20 ug/mL. Concentrations greater than 25 ug/mL can cause reversible bone marrow suppression. Children younger than 2 years should not receive chloramphenicol. In children, ciprofloxacin does should not exceed 1 g daily, chloramphenicol should not exceed 4 g daily. Children younger than 2 years should not received chloramphenicol. In neonates, gentamicin-loading dose of 4 mg/kg should be given initially. Alternatives to breastfeeding may be required while the mother is taking certain antibiotics. Consult specific antibiotic package insert for information on breastfeeding. One antibiotic, appropriate for the patient’s age, should be chosen among the alternatives. Duration of prophylaxis in mass casualty situations is 14 days. Duration of treatment with doxycycline or chloramphenicol is 14 – 21 days. Tetracycline may be substituted for doxycycline.

34 Appendix A

TULAREMIA – QUICK REFERENCE Any suspected or confirmed case of tularemia (Francisella tularensis) must be reported to the Garrett County Health Department at 301-334-7777 or 301895-3111 immediately. Bioterrorism Epidemiology: • Exposure to 10 – 50 organisms can result in clinical disease. • Pneumonic tularemia is not transmitted from person to person. • Laboratory personnel are at high risk for infection. Incubation Period: • Average 3 to 5 days (range 1 to 21 days). Clinical Disease: (Six classic forms of tularemia that may overlap) • Pneumonic (most likely presentation): abrupt onset of fever, chills, headache, malaise, anorexia, cough (little or no sputum production), myalgias, pleuritic chest pain, substernal tightness, and rarely hemoptysis. Pneumonia may be primary or secondary to bacteremic dissemination from other tularemia syndromes. • Systemic: fever, chills, myalgias, sore throat, nausea, anorexia, vomiting, abdominal pain, and loose or watery diarrhea. • Oropharyngeal, ulceroglandular, oculoglandular or glandular – (See tularemia overview). Diagnosis: • Laboratory: elevated WBC, lactic acid dehydrogenase, serum transaminase, alkaline phosphatase, and possibly serum creatine kinase and urinary myoglobin levels. Pleural fluid generally exudative with >1000 leukocytes/mm3. • Radiology: Chest x-ray may show infiltrates without symptoms; subsegmental/lobar infiltrates, hilar adenopathy, pleural effusion, granulomas, or miliary infiltrates (may mimic tuberculosis). Treatment: (See overview) • Gentamicin, Ciprofloxacin, or Doxycycline Prophylaxis: (See overview) • Doxycycline (may substitute tetracycline) or Ciprofloxacin Isolation: • Standard Precautions

35 Appendix A

TULAREMIA – FREQUENTLY ASKED QUESTIONS (FAQ) What is tularemia? The bacteria (germs) that cause tularemia are normally transmitted (spread) to humans by contact with dead, infected animals (rabbits, squirrels and birds), by flea and tick bites and by inhaling (breathing) dust or soil that has been contaminated by infected animals. The infection can also be transmitted by drinking contaminated water or by eating undercooked meat. If the bacteria were intentionally released into the air it could be inhaled (breathed) into your lungs and cause an infection such as pneumonia. Is tularemia spread from person-to-person? The infection is not spread from person to person. How will I know if I was exposed to the bacteria? It will depend on how the bacteria were released, where the bacteria were released, and where you were in relation to the release site. The further away you were from the release site the less likely it will be that you were exposed. How soon will symptoms develop (incubation period)? Normally the symptoms start 3 - 5 days after exposure to the bacteria, but the incubation period may be as short a 1-day or as long as 21 days depending on how close you were to the site where the bacteria were released into the air. Not all persons exposed to the bacteria will develop symptoms. What are the symptoms of infection? The symptoms of pneumonia are generally flu-like and may include a sudden onset of fever, chills, headache, tiredness, sore muscles, loss of appetite, cough, and chest pain. You may also develop vomiting, stomach pain, and watery diarrhea. Although rare, you may develop a sore throat with painful, swollen glands or an ulcer on your face, neck or arms with painful, swollen glands. How is the infection treated? If you have symptoms of the infection, your health care provider (doctor or nurse) will give you an antibiotic.

36 Appendix A

How is the infection prevented? If the local health officer determines that you were exposed to the bacteria, you will be offered an antibiotic. Even if you take the antibiotic, you may develop the infection. If any of the following symptoms develop while you are taking the antibiotic, you should see your health care provider (doctor or nurse) immediately: How long should I take the antibiotic? It is important that you take the antibiotic exactly as directed. The dose and number of treatment days will differ depending on the antibiotic prescribed. If you develop side effects (reaction) to the antibiotic, call your health care provider (doctor or nurse) immediately. Do not give your antibiotic to another person. What should I do if I do not have symptoms? If you do not have any symptoms of the infection, you should continue with your routine daily activities. Please do not go to the hospital emergency room unless you have a fever or other symptoms of the infection. How can I get more information? The local health department will make frequent public anno uncements about who should receive an antibiotic, how to take the antibiotic, and where you can obtain the antibiotic. It is important that you listen to the radio or television for more information. TULAREMIA – HOME CARE INSTRUCTIONS In the event of an intentional release of the bacteria (germs) that causes tularemia, many people may require hospitalization within a few days. Hospitals may become overcrowded and it may become necessary for many sick people to be cared for in their home by relatives or friends. The following information may be helpful in providing care to sick persons at home. • •



Wash your hands with soap and water before you eat or drink, after using the bathroom, and after contact with the sick person. Wear gloves (vinyl or latex) when you have contact with the sick person’s blood and other body fluids (urine, feces, vomit, wound drainage, mucous, or saliva). Wash your hands after removing the gloves. If gloves are not available, wrap plastic bags over your hands and secure with a rubber band. Discard the bags after each use and wash your hands with soap and water. Wash the sick person’s hands after using the bathroom, before eating or drinking, and after contact with pets.

37 Appendix A

• •

• • • • • •

If an antibiotic is recommended, give it exactly as prescribed by the doctor or nurse. If an allergic reaction develops, seek medical advice immediately. Take the person’s temperature at least twice a day. If the temperature goes above 100.4 °F, give Tylenol® (if not allergic) or other medicine such as Motrin® or Advil®. Follow the instructions on the package insert. If the temperature is not controlled by the medicine, call your health care provider (doctor or nurse) or take the person to the nearest designated emergency center or hospital. If the person is having trouble breathing, go immediately to the nearest designated emergency center or hospital. Give the person plenty of fluids such as water or juice. Allow the person to eat solid food as tolerated. Change the sick person’s clothes and bed linens frequently especially if soiled with blood or other body fluids. Wash soiled clothes and bed linens in warm water using any commercial laundry product. Disinfect the bathroom and kitchen with a disinfectant such as Lysol® every day or when surfaces become soiled with blood or other body fluids. As a caregiver, you must take care of yourself. Get plenty of rest, drink fluids frequently and eat a healthy diet. Even if you are not taking an antibiotic, take your temperature in the morning and afternoon for 3 weeks. If you develop a fever above 100.4 °F or if you have flu-like symptoms, seek medical attention immediately.

38 Appendix A

MARYLAND TULAREMIA CASE REPORT FORM Demographic Information: Name:

Date of Birth:

/

Address:

/

Age:

City:

County:

State:

Sex:

Male

Female

Race (Select one or more.

Zip: Ethnicity:

Occupation:

Is the patient Hispanic or Latino?

American Indian or Alaskan Native

If multiracial, select all that apply): Hospitalized?

Native Hawaiian or Other Pacific Islander

Yes

No

Unknown

Yes

No

Unknown

Asian

Black or African American

White

Unknown

Other

Name of Hospital:

Hospital Address: Admission date: Outcome of illness:

/

/

Discharge date:

Alive

Dead

(Date died:

/

/

/

Onset date:

/

)

/

/

Unknown

Source of Infection: History of exposure to:

Rabbits/Hares

Skinning/Dressing Animals

Rodents

Ingesting wild meats

Mosquito bites

Tick attachment

(Type:

)

(Species, if known:

Pets owned?

)

Other (specify)

Clinical Signs, Symptoms and Outcomes: Clinical Presentation:

(Please Check all that apply)

Ulceroglandular Typhoidal Fever >101°F (38.3°C)

Glandular

Oculoglandular

Oropharyngeal

Pneumonic

Highest Temperature:

Chills

Headache Vomiting Sporotrichoid nodules

Cough Pharyngitis

Sore throat Pericarditis

Nausea Lymphangitis

Sepsis

Meningitis

Renal failure

Disseminated intravascular coagulopathy Erythema nodosum

Sterile pyuria

Erythema multiforme

Lymphadenopathy?

Yes

No

Respiratory p resentation?

Yes

No

Local lesion (cracked/dry skin) or Ulcer? Chest X-ray:

Yes

Hyponatremia

Generalized myalgia

No

Weight loss

Axillary

Inguinal

Head

Cervical

Parenchymal infiltrates

Pleural effusions

Hilar adenopathy

Location and size:

Date and other findings:

Creatine kinase elevated serum level?

Yes

No

Value:

History of tularemia vaccination?

Yes

No

Date (s):

Laboratory Findings:

PLEASE ATTACH COPIES OF LAB REPORTS

Isolation of F. tularensis:

Yes

No

Date:

Fourfold or greater change in serum antibody titer to F. tularensis antigen:

/

Yes

No

Elevated serum antibody titer(s) to F. tularensis antigen (w/o documented fourfold or > change) : Date #1:

Result:

Yes

Date #2:

Detection of F. tularensis in clinical specimen by fluorescent assay:

/ No

Result:

Yes

No

Date:

Source of specimen: Other significant lab tests (specify): Treatment: Antibiotic(s) prescribed Name

Person completing form: Provider Name:

Dose

Frequency

Route

Duration

PO

IV

IM

PO

IV

IM

PO

IV

IM

PLEASE RETURN THIS FORM TO : (Name of Local Health Jurisdiction)

Address:

Department of Health and Mental Hygiene DHMH 4599 (Rev 11/02)

Epidemiology and Disease Control Program

Center for Veterinary Public Health

VIRAL HEMORRHAGIC FEVER (VHF) OVERVIEW

Naturally Occurring VHF The viral hemorrhagic fevers are a diverse group of naturally occurring illnesses caused by viruses from four different families: Arenaviridae, Bunyaviridae, Filoviridae, and Flaviviridae. •

The arenaviruses include Argentine (Junin virus), Bolivian (Machupo virus), Brazilian (Sabia virus) and Venezuelan (Guanarito virus) and Lassa (Lassa) hemorrhagic viruses. These viruses are transmitted from rodent reservoirs to humans by inhalation of dust contaminated with rodent feces.



The bunyaviruses include Rift Valley fever (Phlebovirus), Crimean-Congo fever (Nairovirus), and Hantaviruses (hantavirus renal syndrome [HFRS] and hantavirus pulmonary syndrome [HPS]). These viruses are transmitted to humans from a variety of reservoirs including mosquito and domestic animal slaughter (Rift Valley fever), ticks and domestic animal slaughter (CrimeanCongo fever) and rodents (Hantavirus).



The filoviruses include Marburg and Ebola viruses. Their natural reservoir is unknown.



The flaviviruses include yellow fever and dengue fever. Both viruses are mosquito-borne.

Each of these viral families share a number of common features: • • • •

• •

They are all RNA viruses covered or enveloped in a fatty (lipid) coating. Their survival is dependent of an animal or insect host, called a natural reservoir. The viruses are geographically restricted to the areas where their host species live. Humans are not the natural reservoir for any of these viruses. Humans are infected when they are exposed to infected hosts. However, after accidental transmission from the host, humans can transmit some of these viruses to other humans. Human cases or outbreaks of hemorrhagic fevers occur sporadically and irregularly and outbreaks canno t be predicted. With a few noteworthy exceptions, there is no cure or established drug treatment for VHF.

40 Appendix A

Bioterrorism Epidemiology All of the VHF viruses (except dengue virus) are infectious by aerosol and could conceivably be used by an adversary as a bioterrorism agent. Incubation Period The incubation period for each of the VHF varies from 5 – 42 days depending on the virus. Clinical Presentation The VHF syndrome develops to varying degrees in persons infected with these viruses and exposure does not necessarily result in clinical disease. The target organ is the vascular bed and the dominant clinical features are generally a consequence of microvascular damage and changes in vascular permeability. Common presenting complaints include fever, mya lgias, and prostration. On physical examination conjunctival injection, mild hypotension, flushing and petechial hemorrhages may be evident. The disease often progresses to shock and generalized mucous membrane hemorrhage accompanied by neurological, hematological and pulmonary manifestations. Renal insufficiency is proportional to cardiovascular compromise. Some of the clinical characteristics of the various VHF are variable as demonstrated in table 1. Diagnosis A detailed travel history and a high index of suspicion are essential in making the diagnosis of VHF. Patients with arenavirus and hantavirus may recall having seen rodents during the incubation period. Since these viruses are transmitted to humans by aerosolized excreta or environmental contamination, actual contact with the reservoir is not necessary. Large mosquito populations are common in areas where Rift Valley fever or flavavirus transmission occurs. Any patient presenting with VHF syndrome in the United States should be regarded as a possible bioterrorist event and reported to the local health officer immediately. VHF should be suspected in any patient presenting with severe febrile illness and evidence of vascular involvement (subnormal blood pressure, postural hypotension, petechiae, hemorrhagic diathesis, flushing of the face and chest, and non-dependent edema. Symptoms of additional organ involvement may include headache, photophobia, pharyngitis, cough, nausea, vomiting, diarrhea, constipation, abdominal pain, hyperesthesia, dizziness, confusion and tremor. Laboratory findings will vary from disease to disease. White blood cell counts may be normal or elevated. Thrombocytopenia is a component of most VHF, but to a varying extent. Platelet counts may be normal and platelet function tests may be required to explain the bleeding diathesis. Proteinuria and hematuria are 41 Appendix A

both common in VHF and their absence rules out Argentine and Bolivian HF and hantaviral infections. Hematocrit is generally normal or increased due to dehydration. Liver enzymes (AST) are generally elevated. Differential Diagnoses The major differential diagnosis is malaria. Other diagnoses include typhoid fever, rickettsial and leptospiral diseases, non-typhoidal salmonellosis, shigellosis, relapsing fever, fulminant hepatitis and meningococcemia. Conditions leading to DIC such as acute leukemia, lupus erythematosus, idiopathic or thrombic thrombocytopenia purpura and hemolytic uremic syndrome may lead to the misdiagnosis of VHF. Definitive diagnosis is made by specific virologic testing performed at a biosafety level IV laboratory. Medical Management Patients with VHF syndrome require intensive supportive care. Transporting patients, especially by air, should be avoided because of the effects of changes in ambient pressure on lung water balance. Restlessness, confusion, myalgia, and hyperesthesia occur frequently and should be managed by reassurance and other supportive measures, including the judicious use of sedative, pain-relieving, and amnestic medications. Aspirin and other antiplatelet or anticlotting-factor drugs should be avoided. Secondary infections are common and should treated aggressively. Intravenous lines, catheters, and other invasive devices should be avoided unless clearly indicated for the appropriate management of the patient. Treatment of Bleeding The management of bleeding is controversial. Uncontrolled clinical observations support vigorous administration of fresh frozen plasma, clotting factor concentrates, and platelets, as well as the early use of heparin for prophylaxis of disseminated intravascular coagulation (DIC). In the absence of definitive evidence, mild bleeding manifestations should not be treated. Severe hemorrhage indicates that appropriate replacement therapy is required. When definitive laboratory evidence of DIC becomes available, heparin therapy should be initiated if appropriate laboratory support is available. Treatment of Hypotension and Shock Management of hypotension and shock is difficult. Patients often are modestly dehydrated due to heat, fever, anorexia, vomiting and diarrhea, in any combination. There are losses of intravascular volume through hemorrhage and increased vascular permeability. These patients often respond poorly to fluid 42 Appendix A

infusions and develop pulmonary edema. Colloid or crystalloid solutions should be given cautiously. Although not evaluated, dopamine would seem to be the agent of choice for patients with shock who are unresponsive to fluid replacement. Adrenergic vasoconstricting agents, although not clinically evaluated, may be useful in the treatment of profound hypotension. Vasodilators have not been clinically evaluated. Pharmacological doses of corticosteroids (e.g., methylprednisolone 30 mg/kg) provide another possible but untested therapeutic modality in treating shock. Specific Antiviral Therapy The investigational antiviral drug ribavirin is available by compassionate use protocols for treatment of Lassa fever, HFRS, Congo-Crimean HF, and Rift Valley fever. Separate Phase III efficacy trials have indicated that parenteral ribavirin reduces morbidity in HFRS and lowers both morbidity and mortality of Lassa fever. In an HFRS field trail, treatment was effective if started during the first four days of fever and continued for seven days. A compassionate-use protocol, utilizing intravenous ribavirin as a treatment for Lassa fever, is sponsored by the CDC. Doses are slightly different and continued for a 10-day course. The only significant side effect of ribavirin is a modest anemia due to a reversible inhibition of erythropoiesis and mild hemolysis. Ribavirin is teratogenic in laboratory animals and the potential benefits must be weighed against the potential risks in pregnant women with serious illness due to one of the VHF. Safety in infants and children has not been established. Ribavirin has poor in vitro and in vivo activity against filoviruses (Ebola and Marburg) and flaviviruses (dengue and yellow fever). Isolation The viruses that cause hemorrhagic fever pose special challenges for hospital ICP. With the exception of dengue (virus present, but no secondary transmission occurs) and hantavirus (virus not present in the blood or body fluids at the time of clinical illness), VHF patients generally ha ve significant quantities of virus in blood, excretions and secretions. Health care workers must handle all sharps with extreme safety to avoid percutaneous exposure. Lassa, Congo-Crimean HF, Ebola and Marburg viruses may be prone to aerosol nosocomial transmission. Secondary infections among medical personnel who were not parenterally exposed (but still might have had blood contact with nonintact skin or mucosal membranes) are well documented in countries where these diseases occur naturally.

43 Appendix A

Table 1: VHF Differential Diagnostic Variables Viral Hemorrhagic Fever (HF) Argentine and Bolivian HF

Lassa fever

Rift Valley fever Crimean-Congo fever Hantavirus HF with Renal Syndrome Hantavirus Pulmonary Syndrome Marburg and Ebola HF

Yellow fever

Prominent Clinical Variables Epigastric, retroorbital and low back pain, vesicles on palate, hyporeflexia with gait abnormalities, tremors of tongue and upper extremities, hematuria, proteinuria Retrosternal chest pain, back pain, sore throat, peripheral edema, proteinuria, hemorrhage uncommon, hearing loss, elevated AST Retinitis, loss of vision (delayed), jaundice, DIC DIC, thrombocytopenia, jaundice Renal failure, proteinuria, hematuria, oliguria, polyuric, blanching erythemic rash Pulmonary vascular permeability, ARDS, hypoxia, dyspnea, hemorrhage and renal failure rare Photophobia, lymphadenopathy, jaundice, pancreatitis, delirium, coma, maculopapular rash on truck, DIC Jaundice

44 Appendix A

VIRAL HEMORRHAGIC FEVER (VHF) - QUICK REFERENCE Any suspected case of Viral Hemorrhagic Fevers (VHF) MUST BE TREATED AS A PUBLIC HEALTH EMERGENCY and reported to the Garrett County Health Department at 301-334-7777 or 301-895-3111 immediately.

Bioterrorism Epidemiology: Transmission: Except for Hantaviruses, all VHF viruses are highly contagious especially in the terminal stages of the disease; person to person contact with blood, all body fluids and tissue; coughing patients may aerosolize virus into the air may result in transmission. Incubation Period: Varies with each virus; range is 5 – 42 days. Clinical Disease: Varies slightly with each virus. The target organ is the vascular bed and the dominant clinical features are the result of microvascular damage and changes in vascular permeability. Common symptoms include fever, myalgias, prostration, conjunctival injection, hypotension, flushing, petechial hemorrhages, shock and generalized hemorrhage. Diagnosis: Presumptive based on clinical signs and symptoms. Treatment: Supportive care, pain and fever control, sedation, and hydration. Prophylaxis: None Isolation: See Recommendations for Isolation.

45 Appendix A

VIRAL HEMORRHAGIC FEVER (VHF) – FREQUENTLY ASKED QUESTIONS (FAQ) What are viral hemorrhagic fevers? The viruses that cause viral hemorrhagic fevers are common in Africa and in South America but very rare in the United States. Is VHF spread from person-to-person? VHF are commonly spread from person to person by contact with infected blood and other infected body fluids such as urine, feces, vomitus, and droplets coughed into the air by the infected person. How soon will symptoms develop (incubation period)? Normally the symptoms start 5 days or longer after exposure to the virus. Not all persons e xposed to the virus will develop symptoms. What are the symptoms of infection? The symptoms of VHF generally include high fever, sore muscles and extreme weakness. The eyes may become red and the skin may appear to be red (flushed). In the advanced stages of the infection there may be bleeding from the nose, mouth, bowel or bladder. How is the infection treated? There is no medication available to treat VHF infection. What should I do if I DO NOT have symptoms? If you do not have any symptoms of the infection, you should continue with your routine daily activities. Please do not go to the hospital emergency room unless you have a fever or other symptoms of the infection. How can I get more information? The local health department will make freque nt public announcements. important that you listen to the radio or television for more information.

46 Appendix A

It is

VIRAL HEMORRHAGIC FEVERS (VHF) – HOME CARE INSTRUCTIONS In the event of an intentional release of a virus that causes a viral hemorrhagic fever, many people may require hospitalization within a few days. Hospitals may soon become overwhelmed and unable to care for every person who seeks treatment. It may become necessary for many sick people to be cared for in their home by relatives or friends. The following information may be helpful in providing care to sick persons at home. • Listen closely to the local radio or television for special instructions from the local health department. • Advise friends and relatives not to visit. • Wear a mask when you are in close contact with an infected person who is coughing or bleeding from any site. • Wear disposable gloves (vinyl or latex) when you have contact with the infected person’s blood and other body fluids (urine, feces, vomit, drainage, mucous or saliva). Place the gloves in a waste receptacle after each use. Do not wash or reuse gloves. If disposable gloves are not available, place plastic bags on your hands and secure with an elastic band. Wash your hands with soap and water after removing the gloves. • Wear a plastic apron or gown to protect clothes from becoming soiled with blood or other body fluids • Wash your hands with soap and water before you eat or drink, after using the bathroom and after contact with the sick person. • Wash the sick person’s hands after using the bathroom, before eating or drinking and after contact with pets. • After the sick person uses the toilet or after pouring blood or other body fluids into the toilet, pour 1-cup of household bleach into the toilet, wait for 5 minutes and then flush the toilet. • If the person is having trouble breathing, go immediately to the nearest designated emergency center or hospital. • Take the person’s temperature at least twice a day. If the temperature goes above 100.4°F, give Tylenol® (if not allergic). Do not give the person aspirin. Follow the instructions on the package insert. If the temperature is not controlled by the medicine, call your health care provider (doctor or nurse) or take the person to the nearest designated emergency center or hospital. • Give the person plenty of fluids such as water or juice. Allow the person to eat solid food as tolerated. • Change the sick person’s clothes and bed linens frequently especially if soiled with blood or other body fluids. Wear gloves and gowns if the linen is soiled. • Wash soiled clothes and bed linens in hot water using any commercial laundry product. • Disinfect the bathroom and kitchen with a disinfectant such as Lysol® every day and when any surface becomes soiled with blood or other body fluids. • As a caregiver, you must take care of yourself. Get plenty of rest, drink fluids frequently and eat a healthy diet. Take your temperature in the morning and 47 Appendix A

afternoon for 3 weeks. If you develop a fever above 100.4°F or if you begin to bleed from the mouth, bladder or bowel see a doctor or nurse immediately.

48 Appendix A

VIRAL HEMORRHAGIC FEVERS (VHF) – SCREENING FORM Current Date: _____/_____/_____ Medical Record Number: ___________________________ Last Name: _______________________First Name: _________________________MI: _____ Street Address: ________________ City: ________________ State: _____ Zip Code: ______ Home Phone Number: (____) ___________ Occupation: ______________________________ Work Address: ________________ City: ________________ State: _____ Zip Code: _______ Age: ___Date of Birth: ____/____/____ Sex: ____ Date Symptoms Started: _____/____/_____ In the past 3 weeks, have you traveled to other USA cities? If yes, identify city(s): __________________________________________________________________________ In the past 3 weeks, have you traveled to a foreign country(s)? If yes, identify city(s)/country(s)? ___________________________________________________________________________ Have you been camping in past 3 weeks?

NO

YES

Have you had any insect bites in the past 3 weeks?

NO

YES

Have you had contact with sick animals within the past 3 weeks? NO

YES

Are you currently taking any medicine(s)? (Identify all prescription/over-the-counter medicines) ____________________________________________________________________________ Are you allergic to any medicine(s)? NO YES If yes, what medicine(s) are you allergic to? ____________________________________________________________________________

Over the past 3 weeks, have you had any of the following symptoms or ailments? (Check all that apply). Symptoms Fever Headache Cough Sore muscles Trouble walking Bloody diarrhea Red eyes Yellow eyes Reduced urination Pain in the eyes Chest pain Difficulty breathing Swelling of legs, fingers, hands

Yes

Symptoms Bleeding from the nose or mouth Bleeding from the rectum or bladder Cough up blood Extreme weakness Very tired Vomiting blood Red spots of the skin Change in mental status Excessive urination Low back pain Loss of vision Light hurts the eyes

49 Appendix A

Yes

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Appendix A - Garrett County Health Department

Appendix A Category A Diseases • Anthrax (Bacillus anthracis) • Botulism (Clostridium botulinum toxin) • Plague (Yersinia pestis) • Smallpox (v...

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