ACAM2000® Myopericarditis Registry

9001538848

ACAM2000 ® Myopericarditis Registry

Consent
For office use only

Subject ID

MARKING INSTRUCTIONS
• Use BLACK or BLUE ink.
• Shade circles like this:
• Mistakes must be crossed out with an "X".
• Print in CAPITAL LETTERS and avoid contact with the edge of the box. EXAMPLE:

A B C D E F G H

I

J K L M N O P Q R S T U V W X Y Z

• Answer every question to the best of your ability.
• It will take approximately 30 minutes to complete the questionnaire.

DoD RCS # DD-HA(SA)2424 (expires 12/31/2013)
Protocol # NHRC.2009.0015

1. What is your current mailing address?
Address Line 1:
Address Line 2
(optional):
City (or FPO/APO):
State/Province/Region
(or AA/AE/AP):

ZIP/Postal Code:

Country:

2. Phone number:

To update your contact information, please contact us by email at
[email protected] or by phone at 619-553-9255.
7. What is your Rank/Grade? (For example: E-01, W-05,
O-10, etc.)

3. What is today's date?
M

M

D

D

/

Y

Y

Y

Y

-

/

8. What is your branch of service?
4. What is your sex?

Male

Female

5. What is your date of birth?
M

M

D

/

D

Y

/

1

Y

Y

Army

Air Force

Navy

Coast Guard

Marine Corps

Y

9

9. What is your current military status?
Regular Active Duty

6. What are the last four digits of your Social Security
number?

Active Reserve/Guard
Reserve/Guard (not active)
Separated
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12. Are you Hispanic/Latino?

10. What is your current marital status?
(Choose the single best answer)
Single, never married

Yes, Hispanic/Latino

Separated (no longer living as a married couple)

No, not Hispanic/Latino

Married (not separated)
Divorced
Widowed
13. What is your race? (Mark one or more races to
indicate what race you consider yourself to be.)

11. What is the highest level of education that you have
completed? (Choose the single best answer)

American Indian/Alaska Native

Less than high school completion/diploma

Asian

High school degree/GED/or equivalent

Black or African American

Some college, no degree

Native Hawaiian or Other Pacific Islander

Associate's degree

White

Bachelor's degree
Master's, doctorate, or professional degree

M
14. What date did you receive your most recent smallpox vaccination?

M

D

D

/

Y

/

2

Y

Y

Y

0

15. What is the facility name/location where you received your most
recent smallpox vaccination?

16. Did you complete a pre-vaccination screening form before you received your
most recent smallpox vaccination?

No

Yes

Uncertain

17. On the day you received your most recent smallpox vaccine, did you receive any other vaccinations?
No

Yes

18. Between the 30 days before and the 30 days after you received your most recent smallpox vaccine, did you receive any
other vaccinations?
No
Yes
If you marked "NO," to BOTH questions 17 and 18 skip to question 20.
If you marked "YES" to EITHER question, please proceed to question 19.

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19. Please list all of the other vaccinations you received on the day you received your most recent smallpox vaccine, or in
the 30 days before or the 30 days after you received your most recent smallpox vaccination.
M M

Y

Y

Y Y

M M

Y

a.

/

f.

/

b.

/

g.

/

c.

/

h.

/

d.

/

i.

/

e.

/

j.

/

Y

Y Y

20. How many anthrax vaccine doses did you receive on or before the date of your last smallpox vaccination?

For questions 21 and 22, a "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".
21. Prior to your most recent smallpox vaccination, did you OR a close contact have
any of the following health conditions?
a. Currently have cancer, or were treated for cancer in the 3 months prior to
receiving the smallpox vaccine?

No

Yes, me

Yes, contact

b. Ever had an organ or bone marrow transplant?

No

Yes, me

Yes, contact

c. Have a disease that affects the immune system like HIV/AIDS, lymphoma,
leukemia, or a primary immune deficiency disorder?

No

Yes, me

Yes, contact

d. Have systemic lupus erythematosis or another severe autoimmune disease
that may weaken the immune system?

No

Yes, me

Yes, contact

e. Have Darier's disease, a skin disease that usually begins in childhood?

No

Yes, me

Yes, contact

No

Yes, me

Yes, contact

No

Yes, me

Yes, contact

a. Took steroids such as prednisone or related medicine either by mouth or
intravenously for 2 weeks or longer in the month before you received the
smallpox vaccine?

No

Yes, me

Yes, contact

b. Took medicines in the 3 months prior to receiving the smallpox vaccine that
affect the immune system (such as methotrexate, cyclophosphamide,
cyclosporine)?

No

Yes, me

Yes, contact

c. Had radiation therapy in the 3 months prior to receiving the smallpox
vaccine?

No

Yes, me

Yes, contact

f.

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)?
g. Have ever been told by a health care provider you or a close contact has
atopic dermatitis (often called "eczema"), even if the condition is mild, not
currently active, or only had it as a baby or child?

22. Prior to your most recent smallpox vaccination, did you OR a close contact take
any of the following treatments or medications?

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23. Prior to your most recent smallpox vaccination did you EVER have any of the
following heart conditions?

a. A previous heart attack, angina, or other coronary artery disease (disease in the vessels
that bring blood to the heart)?

No

Yes

b. Cardiomyopathy (heart muscle becomes enlarged and doesn't work as it should)?

No

Yes

c. Congestive heart failure?

No

Yes

d. Stroke or transient ischemic attack (a "mini-stroke" that produces stroke-like symptoms
but no lasting damage)?

No

Yes

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

No

Yes

f.

No

Yes

g. Chest pressure?

No

Yes

h. Palpitations/pounding heart unrelated to physical activity (such as walking up stairs)?

No

Yes

i.

Abnormal ECG (electrocardiogram)?

No

Yes

j.

Myocarditis and/or pericarditis?

No

Yes

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

No

Yes

l.

No

Yes

m. Do you have a heart murmur or other heart condition that makes it necessary for you
to take antibiotics before getting dental work done?

No

Yes

n. Any other heart condition under the care of a doctor?

No

Yes

Chest pain unrelated to physical activity?

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

If "YES", please specify:

24. Family cardiac history:
a. Did your biological grandmother(s), mother, or sister(s) develop heart disease
before they were 65 years of age?
b. Did your biological grandfather(s), father, or brother(s) develop heart disease
before they were 55 years of age?

No

Yes

Unsure

No

Yes

Unsure

c. Do you have a first degree relative (for example, mother, father, sister, or
brother) who developed a heart condition before the age of 50?

No

Yes

Unsure

d. Do you have a family history of myocarditis?

No

Yes

Unsure

e. Do you have a family history of pericarditis?

No

Yes

Unsure

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25. Prior to your most recent smallpox vaccination, did you have a history
of any of the following:
a. Headaches

No

Yes

b. Memory loss

No

Yes

c. Psychiatric illness

No

Yes

d. Seizures

No

Yes

e. Dizziness/Fainting spells

No

Yes

f.

No

Yes

g. Shortness of breath

No

Yes

h. Blood clots

No

Yes

i.

Asthma (include exercise induced)

No

Yes

j.

Eczema

No

Yes

k. Diabetes or high blood sugar

No

Yes

l.

No

Yes

m. HIV

No

Yes

n. Meningitis

No

Yes

o. Encephalitis

No

Yes

Numbness or paralysis

Chronic fatigue syndrome

26. Have you EVER been diagnosed with any of the following infections or illnesses?
If "YES", what is the most recent year that you received this diagnosis?

If "YES", most recent
year of diagnosis?

a. Coxsackie Virus (group B)

No

Yes

Don't know

b. Enterovirus

No

Yes

Don't know

c. Adenovirus

No

Yes

Don't know

d. Parvovirus B19

No

Yes

Don't know

e. Human Herpesvirus 6

No

Yes

Don't know

f.

No

Yes

Don't know

g. Influenza (flu)

No

Yes

Don't know

h. Lyme disease

No

Yes

Don't know

i.

No

Yes

Don't know

Epstein-Barr virus

Other
If other, please specify:

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27. Have you EVER had any of the following surgeries:

If Yes, what was the
date of the surgery?

a. Angioplasty (percutaneous coronary interventions
[PCI], balloon angioplasty, or coronary artery
balloon dilation)

No

b. Cardiac stent procedure

No

Yes

/

Unknown
M M

Yes

M M

No

d. Minimally invasive heart surgery (including robot
assisted heart surgery)

No

e. Artificial heart valve surgery (heart valve
replacement surgery)

No

f.

No

Yes

Unknown

No

Yes

Unknown

Yes

M M

M M

g. Radio frequency ablation (catheter ablation)

No

Yes

Transmyocardial re-vascularization (TMR)

No

Pacemaker

No

Yes

No

Unknown

Yes

Unknown

Y

Y

Y Y

Y

Y

Y Y

Y

Y

Y Y

Y

Y

Y Y

Y

Y

Y Y

Y

Y

Y Y

Y

Y

Y Y

Y

Y

Y Y

/
M M

k. Other

Y Y

/

Unknown
M M

j.

Y

/

Unknown

Yes

Y

/

M M

i.

Y Y

/
M M

M M

h. Cardiomyoplasty (experimental procedure)

Y

/

Unknown
M M

Artherectomy

Y

/

Unknown

Yes

Y Y

/

Unknown

Yes

Y

/

Unknown

c. Bypass surgery (CABG or "cabbage," coronary
artery bypass graft, or open heart surgery)

Y

/
M M

If "YES", please specify:

28. Within 6 months after receiving your most recent smallpox vaccination, did you have any of the following symptoms?
a. Weakness (not related to exercise)

No

Yes

b. Fever

No

Yes

c. Gastrointestinal symptoms

No

Yes

d. Shortness of breath

No

Yes

e. Chest pain

No

Yes

If you did NOT experience chest pain within 6 months after receiving the smallpox vaccine, please skip to
question 31 on page 8. If you marked "YES" to question 28e, please proceed to question 29.
29. The following questions relate to the chest pain you experienced within 6 months after receiving your most recent
smallpox vaccination. Did the pain...
a. Increase when you lie on your back?

No

Yes e. Worsen when leaning forward while sitting?

No

Yes

b. Decrease when you lie on your back?

No

Yes f. Feel tender when you touch it?

No

Yes

c. Improve when lying on one side?

No

Yes g. Other? (if YES, please describe)

No

Yes

d. Worsen when lying on one side?

No

Yes
describe other chest pain
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30. The following questions ask how much your heart condition affected your life during the 4 weeks following your
myopericarditis diagnosis. After each question, select 0, 1, 2, 3, 4, or 5 to show how much your life was affected.
If a question does not apply to you, mark the 0 after that question.
Did your heart condition prevent you from living as
you wanted during the 4 WEEKS following your
myopericarditis diagnosis:

No

Very
Little

Very
Much

Moderately

a. Causing swelling in your ankles or legs?

0

1

2

3

4

5

b. Making you sit or lie down to rest during
the day?

0

1

2

3

4

5

c. Making your walking about or climbing
stairs difficult?

0

1

2

3

4

5

d. Making your working around the house or
yard difficult?

0

1

2

3

4

5

e. Making your going places away from
home difficult?

0

1

2

3

4

5

Making your sleeping well at night
difficult?

0

1

2

3

4

5

g. Making your relating to or doing things
with your friends or family difficult?

0

1

2

3

4

5

h. Making your working to earn a living
difficult?

0

1

2

3

4

5

f.

i.

Making your recreational pastimes, sports
or hobbies difficult?

0

1

2

3

4

5

j.

Making your sexual activities difficult?

0

1

2

3

4

5

k. Making you eat less of the foods you like?

0

1

2

3

4

5

l.

0

1

2

3

4

5

m. Making you tired, fatigued, or low on
energy?

0

1

2

3

4

5

n. Making you stay in a hospital?

0

1

2

3

4

5

o. Costing you money for medical care?

0

1

2

3

4

5

p. Giving you side effects from treatments?

0

1

2

3

4

5

q. Making you feel you are a burden to your
family or friends?

0

1

2

3

4

5

0

1

2

3

4

5

0

1

2

3

4

5

0

1

2

3

4

5

0

1

2

3

4

5

r.

Making you short of breath?

Making you feel a loss of self-control in
your life?

s. Making you worry?
t.

Making it difficult for you to concentrate or
remember things?

u. Making you feel depressed?

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31. In the year prior to receiving your myopericarditis diagnosis, did you take over the counter or prescription
non-steroidal anti-inflammatory drugs (NSAIDs)? NSAIDs include aspirin, ibuprofen, and naproxen, which are
frequently used to relieve fever, pain, and/or inflammation. There are several generic and name brand versions of
NSAIDs, such as Motrin®, Advil®, Aleve®, and Relafen®.
No

Yes

32. Did you take NSAIDs in the 30 days AFTER receiving your myopericarditis diagnosis?
No

Yes, weekly

Yes, 3-4 times/week

Yes, daily

If you marked "NO," to both 31 AND 32, please skip to question 34.
If you marked "YES" to either 31 OR 32, please proceed to question 33.
33. Please list all of the NSAIDs (over the counter and/or prescription) that you have taken beginning the year prior to and
the 30 days after your myopericarditis diagnosis.
Frequency
Type/name of NSAID

Dose
(in mg)

More than
once a day

Daily

4-6 times
a week

2-3 times
a week

Weekly

Rarely

a.
b.
c.
d.

34. Are you allergic to any medications?
No
Yes, if yes, please specify:

35. Excluding allergies to medications, do you have any allergies? (for example, latex allergy, hay fever, peanut, etc.)
No
Yes, if yes, please specify:

36. Have you ever been diagnosed with an autoimmune disorder (e.g. Graves' disease, rheumatoid arthritis, systemic lupus
erythematosus, etc.)?
If Yes, date of
diagnosis?
No
M M

Y

/

Yes, if yes, please specify:

Page 8

Y

Y Y

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37. In the year prior to receiving your myopericarditis diagnosis, were you taking any prescription medications?
No

Yes

38. Since receiving your myopericarditis diagnosis, have you taken any prescription medications?
No

Yes
If you marked "NO," to both 37 and 38, please skip to question 40.
If you marked "YES" to either 37 or 38, please proceed to question 39.

39. Please list all of the prescription medications you took beginning with the year prior to receiving your myopericarditis
diagnosis up through the current time.

Drug Name

Dose

Frequency

M M

a.

To

From

Indication

Y Y Y Y

M M

Y Y Y Y

Currently
Using?

/
/

/
/

Yes

/
/
/
/
/

/
/
/
/
/

Yes

/
/

Yes

i.

/
/

j.

/

/

Yes

b.
c.
d.
e.
f.
g.
h.

Page 9

Yes

Yes
Yes
Yes
Yes

Yes

Protocol # NHRC.2009.0015

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For questions 40- 47 think back to the time you were diagnosed with myopericarditis.

40. In general, would you say your health was: (Please select only one)
Very good

Excellent

Good

Fair

41. In the month after receiving your myopericarditis diagnosis, how many hours of
sleep did you get in an average 24-hour period?

Poor

hours

42. About how many times each week did you floss your teeth?
None

Once a week

2-3 times/week

4-7 times/week

> 7 times/week

43. Other than conventional medicine, what other health treatments did you use around the time of your
myopericarditis diagnosis?
a. Mind-body medicine: (e.g. biofeedback, hypnosis, spiritual healing)

No

Yes

b. Biologically based practices: (e.g. herbal therapy, high dose/megavitamin therapy, homeopathy)

No

Yes

c. Manipulative and body-based practices: (e.g. acupressure, chiropractic care, massage)

No

Yes

d. Energy medicine: (e.g. acupuncture, energy healing, magnet therapy)

No

Yes

44. Excluding energy drinks, on an average day, how many 8-12 oz beverages containing caffeine did you drink (e.g.
coffee, tea, soda)?
None

1-2 per day

3-5 per day

6-10 per day

11 or more per day

45. On an average day, how many servings of energy drinks did you drink (e.g. Monster, ROCKSTAR, Red Bull, SoBe
Adrenalin Rush, etc.)? NOTE: One can may exceed one serving. For example, one Monster is equal to two servings.
None

1-2 per day

3-5 per day

6-10 per day

11 or more per day

46. About how many times each week did you eat from a fast food restaurant (like hamburgers, tacos, or pizza)?
None

Once a week

2-3 times/week

4-7 times/week

8-14 times/week

15 or more times/week

47. About how many days a week did you eat what is described as a heart healthy diet (e.g. > 5 servings of
fruit and vegetables a day, low fat protein sources, whole grains, limit unhealthy oils)?
None

Once a week

2-3 days/week

Page 10

4-6 days/week

7 days/week

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48. How tall are you? For example, a person who is 5'8"
tall would write 5 feet 08 inches.
feet

inches

49. What was your weight at the time of your myopericarditis diagnosis?

pounds

50. How much did you weigh a year prior to your myopericarditis diagnosis?

pounds

51. At the time of your myopericarditis diagnosis, how much time did you spend participating in...
(Please mark both your typical "days per week" and "minutes per day" doing these activities)
None

a. STRENGTH TRAINING or work that strengthens your
muscles? (e.g. lifting/pushing/pulling weights)
Days per week
b. VIGOROUS exercise or work that causes heavy
sweating or large increases in breathing or heart
rate? (e.g. running, active sports, marching, biking)
c. MODERATE or LIGHT exercise or work that causes
light sweating or slight increases in breathing or
heart rate? (e.g. walking, cleaning, slow jogging)

Minutes per day

Cannot physically do
None

Days per week

Minutes per day

Cannot physically do
None

Days per week

Minutes per day

Cannot physically do

52. Choose the single best description of your USUAL daily activities, at the time of your myopericarditis diagnosis.
You sit during the day and do not walk much.
You stand or walk a lot during the day, but do not carry or lift things often.
You lift or carry light loads, or climb stairs or hills often.
You do heavy work or carry heavy loads often.

53. At the time of your myopericarditis diagnosis, how much time did you spend sitting and watching
TV or videos or using a computer?
Hours per day

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54. The following questions ask how often you felt or behaved
a certain way. In the MONTH following your myopericarditis
diagnosis, how often did you/have you...
Never
a. been upset because of something that happened
unexpectedly?
b. felt that you were unable to control the important
things in your life?
c. felt nervous and/or stressed?
d. dealt successfully with irritating life hassles?
e. felt that you were effectively coping with important
changes that were occurring in your life?
f.

felt confident about your ability to handle your
personal problems?

g. felt that things were going your way?
h. found that you could not cope with all the things that
you had to do?
i.

been able to control irritations in your life?

j.

felt you were on top of things?

k. been angered because of things that happened that
were outside of your control?
l.

found yourself thinking about things that you have to
accomplish?

m. been able to control the way you spend your time?
n. felt difficulties were piling up so high that you could
not overcome them?

Page 12

Almost
Never

Sometimes

Fairly
Often

Very
Often

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These next few questions are about drinking alcoholic beverages. Alcoholic beverages include liquor such as
whiskey, gin, beer, wine, wine coolers, etc. For the purpose of this questionnaire:
One drink = one 12-ounce beer, one 4-ounce glass of wine, or one 1.5-ounce shot of liquor

55. In the year prior to your myopericarditis diagnosis, how often did you have a drink containing alcohol?
Never

Monthly or less

2-4 times a month

2-3 times a week

4 or more times a week

If you marked "Never," skip to question 60.

56. In the year prior to your myopericarditis diagnosis, on those days that you drank alcoholic
beverages, on average, how many drinks did you have?

drinks

57. In the year prior to your myopericarditis diagnosis, how often did you have 5 or more alcoholic
beverages on one occasion?
Never

Monthly or less

2-4 times a month

5-10 times a month

11 or more times a month

58. In a typical week following your myopericarditis diagnosis, how many drinks of alcoholic beverages did you have?
Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

59. Review the answers you provided to question 58.
Does this represent the number of alcoholic beverages you drank in a typical week following
your myopericarditis diagnosis?
No, I usually drink LESS than this amount
No, I usually drink MORE than this amount
Yes, this represents how much I drink in a typical week

Page 13

Sunday

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60. In the year prior to your myopericarditis diagnosis, did you use any of the following tobacco products?

a. Cigarettes

No

Yes

b. Cigars

No

Yes

c. Pipes

No

Yes

d. Smokeless tobacco (chew, dip, snuff)

No

Yes

No

Yes

61. Have you ever smoked at least 100 cigarettes (5 packs)?

If you marked "YES," please continue to question 62.

62. At what age did you start smoking?

years old

63. How many years have or did you smoke an average of at least 3 cigarettes per day
(or one pack per week)?

years

64. When smoking, how many packs per day did you or do you smoke?
Less than half a pack per day
Half to 1 pack per day
1 to 2 packs per day
More than 2 packs per day

65. Have you ever tried to quit smoking?
Yes, and succeeded
Yes, but not successfully
No

Thank you for taking the time to complete this survey. If you have any
questions or concerns regarding this survey, please contact us at:
[email protected]
Page 14

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Because of your frequent military moves, please provide contact information
for someone who will always know your whereabouts.
Alternative point of contact:
Last Name:

First Name:

Relationship:
Address Line 1:
Address Line 2
(optional):
City (or FPO/APO):
State/Province/Region
(or AA/AE/AP):

ZIP/Postal Code:

Country:

Phone number:
Email address:

Page 15

Middle Initial: