######## Annex 4 

**Vaccine Adverse Event**

**Reporting**

Vaccine Safety

Monitoring and Reporting of Adverse Events Following Smallpox
Vaccination

During the smallpox era, routine use of smallpox vaccine was associated
with significant morbidity and mortality. When nonselective vaccination
of the U.S. population was conducted, 5 to 10 deaths, several hundred
hospitalizations, and several thousand nonhospitalized complications
resulted from the vaccine each year.

Recommendations for routine smallpox vaccinations were rescinded in the
United States in 1971, and familiarity with its adverse reactions has
diminished. Therefore, careful monitoring of adverse events needs to be
conducted to familiarize health professionals with the safety profile of
the vaccine.

Additionally, reintroduction of the smallpox vaccine may reveal known
safety concerns with increased frequency or ones not previously known.
Known side effects and adverse reactions of the vaccinia (smallpox)
vaccine and guidance for clinicians are included in the recommendations
of the CDC's Advisory Committee on Immunization Practices (ACIP) for
vaccinia vaccine \[CDC. MMWR 2001;50(No.RR-10); CDC.MMWR 2003;52(RR-4)\]
and in other sections of this response plan, such as Guide B:

-   [www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part1of3.pdf](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part1of3.pdf)

-   [www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part2of3.pdf](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part2of3.pdf)

-   [www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part3of3.pdf](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part3of3.pdf)

Timely recognition of and response to vaccine adverse events (VAEs) is
important to protect the public from unnecessary risk and to maintain
confidence in the immunization effort. Individuals who are most
susceptible to adverse effects of smallpox vaccine are those with active
skin disorders (e.g., atopic dermatitis/eczema, burns, impetigo, and
varicella zoster) and immunodeficiency states (e.g., HIV, AIDS,
leukemia, lymphoma, generalized malignancy, agammaglobulinemia, or
therapy with alkylating agents, antimetabolites, radiation, or large
doses of corticosteroids). The following complications may follow either
primary vaccination or revaccination:

-   Encephalitis

-   Encephalomyelitis

-   Encephalopathy

-   Transverse myelitis

-   Acute infectious polyneuritis

-   Progressive vaccinia (also known as vaccinia necrosum, vaccinia
    gangrenosa)

-   Eczema vaccinatum

-   Generalized vaccinia

-   Inadvertent inoculation

-   Autoinoculation

-   Contact transmission

-   Ocular vaccinia (when transmission occurs in or around the eye

-   Generalized rashes (erythematous, urticarial, nonspecific)

-   Secondary pyogenic infections at the site of vaccination

-   Myo/pericarditis

Such complications may result in severe disability (e.g., blindness from
inoculation of the eye), permanent neurological sequelae, and/or death.

This document is intended to act as a guide for monitoring the safety of
smallpox vaccine following a smallpox outbreak. (One single laboratory
confirmed case is an outbreak). It addresses:

-   The need for vaccine safety monitoring,

-   Identifies the range of potential safety activities,

-   Describes the safety actions that should take place before and at
    the time of vaccination,

-   The process for reporting adverse events following smallpox vaccine
    under different vaccination scenarios,

-   Provides relevant safety contact information, and

-   Includes copies of the adverse event reporting forms.

This document provides useful information for smallpox response teams
and for state and local health departments involved in any aspect of
vaccine safety.

# Availability of smallpox (vaccinia) vaccine 

The vaccine currently being used for smallpox vaccination of response
teams is a licensed product that is only available from the CDC.
However, in the setting of an outbreak, it is possible that more vaccine
might be needed than is currently licensed. If licensed vaccine supplies
are not sufficient for the number of vaccination needed in an outbreak,
some vaccine may be provided under Investigational New Drug (IND)
protocols. For vaccine used under IND status there are increased
emphases on and requirements for the monitoring of vaccine adverse
events. Monitoring of vaccine adverse events is the joint responsibility
of the designated state adverse event coordinators and the CDC, through
the established reporting mechanisms.

In the event of an outbreak, questions regarding VAE monitoring and
reporting should first be addressed to the state adverse event
coordinators and CDC Response Team vaccine safety member(s). Questions
may also be forwarded to a designated state or national response line.

#### 

#### Reporting Vaccine Adverse Events

##### Report all adverse events to VAERS

The Vaccine Adverse Event Reporting System (VAERS) will receive all
vaccine adverse event reports. The VAE reports will be reviewed by the
CDC and the Food and Drug Administration (FDA). The VAERS form and
instructions on reporting to VAERS are provided in Annex 4 (Figures 1
and 2). Standardized followup of VAERS reports will be conducted (Figure
3).

Adverse events following smallpox vaccination that are judged to be
serious, unexpected, or for which Vaccinia Immune Globulin (VIG) or
cidofovir (CDV) are indicated, should be reported without delay to the
state adverse event coordinator.

A VAERS report should be filed within 48 hours for serious or unexpected
VAEs; all other VAEs should be reported within 7 days of VAE
identification.

##### 

##### Follow-up Surveillance Actions

Depending on the extent of vaccine administration and whether vaccine is
used under an IND protocol, a number of surveillance activities will be
conducted.

-   *Active surveillance* for adverse events will be conducted only if
    IND vaccine is used and the number of vaccine doses administered is
    limited (e.g., several thousand vaccine doses over a several week
    period). Vaccine recipients will be provided with a diary report
    card to document their response to the vaccine (Figure 4).

-   To make certain that serious VAEs are identified, active
    surveillance will be conducted for persons receiving vaccinia immune
    globulin (VIG) or cidofovir -- pharmaceutical agents indicated for
    the treatment of certain severe vaccine complications. Active
    surveillance for VIG and cidofovir use will not be limited based on
    the number of vaccine doses administered or IND status of the
    vaccine.

-   *Stimulated passive surveillance* and followup of serious adverse
    events will be conducted regardless of the number of vaccine doses
    administered or license status of vaccine. VAERS is a passive
    surveillance system because reports are not actively solicited.
    However, because of the advice to vaccinees, healthcare providers,
    vaccination programs, and health departments to report adverse
    events to VAERS, the passive system is "stimulated."

When there is a recognized smallpox outbreak, the following actions
should be undertaken.

####### **Prior to administering vaccine** 

Vaccine providers, immunization programs, and hospitals in the vicinity
of the outbreak should be given:

-   Hard copies of VAERS form (Figures 1 and 2),

-   Instructions on how to access the VAERS report form and submit
    electronically to [www.vaers.org](http://www.vaers.org/). Electronic
    reporting is preferred to other submission methods of VAERS reports,
    and

-   CDC vaccination packet for post-event vaccination which may include
    (but are not limited to):

    a.  Vaccine Information Statements (VIS) that contain instructions
        on how to contact VAERS and state health department adverse
        event personnel.

    b.  Clinical description of known vaccine complications (i.e.,
        inadvertent inoculation, generalized vaccinia, eczema
        vaccinatum, progressive vaccinia, post-vaccinial encephalitis,
        myo/pericarditis, and fetal vaccinia).

    c.  Instructions for care of the vaccination site.

VIG information and indications for use (See Guide B, Section 8 of this
plan), where and how to obtain this information. The contact point for
VIG is:

> **Clinician Information Line**
>
> **Phone: 1.877.554.4625**

State health departments should take the following actions:

-   Identify physicians trained in the evaluation and management of
    patients with adverse events following smallpox vaccination. These
    physicians must be able to comply with the guidance contained herein
    and, if necessary, IND protocols,

-   Designate a person (state adverse events coordinator) who is trained
    and available for coordinating vaccine safety activities of
    surveillance and reporting,

-   Designate staff who are trained and available for active
    surveillance tracking, followup of serious reports submitted to
    VAERS (Figure 4), for providing assistance in completing VAERS
    forms, and for telephone followup of adverse event reports
    identified by contact tracing personnel during their followup of
    smallpox contact vaccine recipients, and

-   Implement a response line for vaccination and VAE inquiries.

##### At time of vaccination

> Vaccine recipients or their parent/guardians should be given the
> following:

-   Vaccination packet containing the VIS with instructions on how to
    contact VAERS and state health department personnel, and

-   Instructions for active surveillance and VAE diary card if IND
    vaccine is used (Figure 5)

# Additional Vaccine Safety Activities

In a large immunization effort reports of adverse events both
coincidentally and causally associated with the smallpox vaccine are to
be expected. Standardized followup of VAEs reported to VAERS (Figure 4)
will be performed to increase understanding of the safety profile of the
vaccine and to identify potential risk factors.

# Advisory Committee on Immunization Practices:

#  Smallpox Vaccine Safety Working Group 

The Advisory Committee on Immunization Practices (ACIP) Smallpox Vaccine
Safety Working Group (SVS WG) will be established as a standing
committee to review unusual or unexpected adverse events or changes in
the expected rates of adverse events that could change vaccination
policy. The SVS WG reports to the full ACIP and will consist of members
from the ACIP, the Department of Defense Armed Forces Epidemiology
Board, and other experts (e.g., smallpox eradication experts) as
required. The committee shall meet (via conference call weekly and more
often or on an emergency basis) as needed to review emerging concerns
from smallpox vaccine VAERS reports.

# 

# Clinical tools for assessment of adverse reactions

Clinical tools to assist clinicians in the evaluation and management of
dermatologic, neurologic, and ophthalmologic adverse events following
smallpox vaccination have been developed and are available at:

[www.bt.cdc.gov/agent/smallpox/vaccination/clinicians.asp](http://www.bt.cdc.gov/agent/smallpox/vaccination/clinicians.asp)

The tools provide information related to differential diagnosis and
includes suggestions for clinical criteria or diagnostic tests to
confirm a diagnosis. The management tool discusses supportive care and
the indications for and instruction pertaining to the use of Vaccinia
Immune Globulin and cidofovir.

# Reports from vaccination clinics

In order to calculate the rate of reported adverse events, timely
information on the number of doses of vaccine administered and the
proportion of successful take responses are needed. Data should be
available weekly or the timeliness of vaccine safety monitoring would be
greatly diminished. Reported rates of VAEs will be compared to the
expected rates based on historical published information, the experience
from the pre-event vaccination program, and the cut points identified by
the ACIP SVS WG. The data available from each clinic should include, for
each vaccine recipient, information on age, gender, vaccine lot, and
clinic location. Thus, the calculated rates of VAEs will be age and
gender specific. It will also be possible to quickly detect unusual VAE
rates for specific vaccine lots. The PreEvent Vaccination System (PVS)
or the certified state equivalent system will likely be used to enter
the demographic and vaccination information from the vaccination
clinics.

# 

# Monitoring serious adverse events using VIG or cidofovir

To monitor the most serious adverse events, presumably those most likely
to be treated with VIG and/or cidofovir (under an IND), the requests for
VIG and/or cidofovir will be tracked. Requests to CDC for VIG and CDV
will be received through the CIL. State adverse event coordinators will
conduct case followup for all vaccine recipients or contacts of vaccine
recipients requiring such treatment and forward the follow-up
information to CDC, as is required under the IND protocol. VAERS reports
will also be reviewed for indications of either VIG or CDV use.

#### Instructions for Reporting to VAERS

**(Refer to Figures 1 and 2 for a sample VAERS form.)**

#### 

# Getting a VAERS form

Additional report forms and assistance in completing the form are
available via a 24-hour toll-free telephone number: **1-800-822-7967**.
The reporting form can be downloaded from the VAERS Web page at
[www.vaers.org](http://www.vaers.org/)[.]{.underline} A sample copy of
the VAERS form, which can be copied for reporting purposes, is also
available in the American Academy of Pediatrics' *Red Book*. The Vaccine
Information Statements developed by DHHS also contain instructions on
how to report adverse events to VAERS.

VAERS can be contacted at:

**VAERS**

###### P.O. Box 1100 

> Rockville, Maryland 20849-1100
>
> *Phone:* 1-800-822-7967
>
> *FAX:* 1-877-721-0366
>
> *E-Mail:* [www.vaers.org](http://www.vaers.org/)

# Submitting the VAERS form

> *Electronic:* The preferred method of reporting is electronic. The
> instructions for reporting and the electronic report form are
> available at VAERS Web page [www.vaers.org](http://www.vaers.org/).
>
> *Mail:* The VAERS form is preaddressed and postage paid. It may be
> sent directly to VAERS at the following address:

#  VAERS

> **P.O. Box 1100**
>
> **Rockville, Maryland 20849-1100**
>
> *FAX:* The form can also be FAXED toll-free to **1.877.721.0366.**

# Completing the VAERS form

Instructions for completing the VAERS form are on the back of the form
(Figure 2). To complete the VAERS form, as much of the requested
information as possible should be obtained. Each report should be
reviewed for completeness, accuracy, and legibility with specific
attention to the following:

> ***Dates***: All dates should be internally consistent. For example:
> the vaccine date cannot precede the birth date; the report date cannot
> precede the vaccine date, etc. All date fields require entry of the
> full month, date, and year.
>
> ***Patient name***: Verify that the patient's first and last names are
> correct. This assists in the identification of duplicate reports and
> facilitates the ability to conduct followup.
>
> ***Reporter information:*** (This is in the upper right corner of
> form.) The reporter's name and complete mailing address are required.
> Requests for missing or follow-up information are sent to this
> address.
>
> ***Critical boxes***: Certain items are crucial to the analysis of
> VAERS data and have been designated as critical boxes. If all critical
> boxes are complete, no missing data will be requested and the report
> is considered complete. Critical boxes are differentiated by a square
> around their respective item numbers on the form as follows:

Date of birth

Age of patient at the time of vaccination

> Narrative description of adverse events, symptoms, etc. (For
> electronic reports, "copy and paste" from other electronic documents
> can be used)

Determines whether a report is regarded as serious or nonserious, and
identifies the most serious reports for 60-day and annual followup

> **Serious Reports**
>
> • Patient died/date patient died
>
> • Life threatening illness
>
> • Resulted in permanent disability
>
> • Resulted in prolongation of hospitalization
>
> • Required hospitalization and number hospitalized days
>
> **Nonserious Reports**
>
> • Required emergency room or doctor's visit
>
> • None of the above
>
> Date of vaccination (and time, if known)
>
> Date of onset of adverse event (and time, if known)
>
> All vaccines given on the date listed in Box 10, including name of
> vaccine, vaccine manufacturer, vaccine lot number, route and site of
> administration, and number of previous doses given
>
> Used to identify potential public health reports
>
> The National Childhood Vaccine Injury Act requires tracking of
> vaccine(s) administered; the immunization project report number is
> assigned by the state health adverse events coordinator (SHC) and is
> an identifier between the SHC and the VAERS ID
>
> ***Timely Reporting***: All reports are to be sent to VAERS as they
> occur, especially any serious reports. Do not send batches of reports.
> Do not wait for complete documentation before sending to VAERS,
> especially if the report appears serious. VAERS data is downloaded on
> a daily basis so that review and followup of serious reports can be
> conducted. Timely reporting is essential to timely follow-up
> investigation, especially if clinical specimens may need to be
> obtained.
>
> ***VAERS ID:*** VAERS will send a confirmation notice to the reporter
> for all reports received, whether mailed, faxed, or sent
> electronically. A unique VAERS ID number, or Electronic Report Number
> (ERN) if report submitted electronically, will be provided with the
> confirmation notice. Any follow- up correspondence about a report must
> include the VAERS ID number or ERN number. Reports are entered into
> the VAERS database under the unique ID number. It is also helpful to
> have the patient's name and date of birth, if available, to help
> identify the specific report.
>
> ***Missing, corrected, or supplemental information:*** Information
> such as medical records or autopsy reports may be submitted to VAERS
> by mail or fax:
>
> Using a blank VAERS form, record the following information in the
> appropriate boxes: VAERS ID, the SHC immunization project number (if
> appropriate), the patient's name and date of birth, the corrected or
> missing information you are providing, your name and phone number.
>
> *Mail to:*
>
> **VAERS**
>
> **P.O. Box 1100**
>
> **Rockville, MD 20849-1100**
>
> ***FAX:* Submit information to: 1.877.721.0366**

**Serious reports**

For serious reports, the VAERS program will send a letter to the
reporter requesting information on patient status at 60 days and 1 year.
The reporter may also provide additional information on critical boxes
if not originally available and pertinent supporting documentation may
be attached if available (e.g., medical records, autopsy report).
Include the following information:

-   VAERS ID Number,

-   Patient name,

-   Your name and phone number,

-   Box 3 -- Patient date of birth,

```{=html}
<!-- -->
```
-   Box 7 or 9 -- Patient status (indicate the date that the follow-up
    information was obtained).

-   Report patient status as follows:

> *Recovered* -- if patient health condition is the same as it was prior
> to the vaccine.
>
> *Not recovered* -- if patient health condition has not returned to
> pre-vaccination state of health.
>
> *Unknown* -- if patient condition or whereabouts are unknown.
>
> *Died* -- if patient has expired since initial report. Include date of
> death and supporting documentation (copies of hospital records,
> autopsy report, death certificate, etc.) as available.

# Secondary transmission 

Because vaccine virus can be transmitted from the vaccination site if
not appropriately covered and cared for, adverse events have been known
to occur in contacts of vaccinated persons (e.g., eczema vaccinatum). If
an adverse event is suspected or identified in a contact of a vaccine
recipient, a VAERS report should be submitted with information on the
person experiencing the adverse event. Such reports will be coded as the
result of secondary transmission.

**Local health departments or immunization projects**

Clinic staff and treating health care providers in conjunction with the
state adverse event coordinator are responsible for initiating the VAERS
report when an adverse event is suspected or occurs. Because of the need
to rapidly monitor the occurrence of adverse events and to follow up on
serious reports, local clinic or health department staff are requested
to send reports directly to VAERS, preferably via electronic reporting.
Note this differs from the procedure usually employed for non-smallpox
vaccine reports; for non-smallpox vaccine reports each VAERS report is
sent first to the SHC or VAERS coordinator before being sent to the
VAERS program.

> **Figure 1.** VAERS Reporting Form

![](media/image1.png){width="5.5680555555555555in"
height="7.177083333333333in"}

> **Figure 2.** Instructions for Completion of VAERS Form
>
> ![](media/image2.png){width="5.927083333333333in" height="7.25in"}

**Figure 3.** VAERS Smallpox Follow-up Form

**Smallpox Vaccine VAERS Report Follow-up Worksheet**

**INSTRUCTIONS:** To be used for followup of designated VAERS reports.
Please request additional medical records,

such as hospital discharge summary as appropriate.

# Smallpox Vaccination History 

**Diagnosis and Therapy**

1\. Has the patient been vaccinated with smallpox vaccine before 2002?
*(Please circle answer)*

Never vaccinated Don't Know Vaccinated

If yes, when? In childhood On entry into the military Laboratory worker

2\. Has the patient been vaccinated with smallpox vaccine recently
(2002-3)? If so, when?

Vaccination date:\_\_\_\_/\_\_\_/\_\_\_\_\_ Patient Vaccination Number
(PVN):\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

3\. Do you have a working diagnosis for this patient? YES NO

If yes, what is it?
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

4\. Was VIG used? YES NO

5\. Was cidofovir used? YES NO

6\. PATIENT VACCINATED DESPITE CONTRAINDICATION: N/A APPLICABLE (circle
one)

Did patient have any of these conditions at the time of vaccination?

\_\_\_\_Pregnancy \_\_\_\_Immunosuppression \_\_\_\_Skin Disease
\_\_\_\_Inflammatory Eye Disease

Life-threatening allergic reactions to polymyxin, neomycin,
streptomycin, tetracycline at previous smallpox vaccination?

YES NO

If patient vaccinated despite contraindications, please
elaborate:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

CONTACTS: N/A APPLICABLE (circle one):

7\. Location of Exposure: \_\_\_Home \_\_\_Hospital \_\_\_Other
\_\_\_Workplace \_\_\_Not known

8\. Means of Exposure: \_\_\_Known \_\_\_Not known

If known, please check:

\_\_\_Direct to skin

\_\_\_Needle stick

\_\_\_Contact with dressing

\_\_\_Handled objects

\_\_\_Health care contact within 3 weeks

\_\_\_Sexual

\_\_\_Nursing mother

\_\_\_Other

9\. Is the timing and duration of exposure known? YES NO

If yes, complete: Start date:\_\_\_\_/\_\_\_/\_\_\_\_\_ Start
Time:\_\_\_:\_\_\_AM/PM End Date:\_\_\_\_/\_\_\_/\_\_\_\_\_ End
Time:\_\_\_:\_\_\_AM/PM

10\. Contact information of vaccinee to whom patient exposed:

NAME:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ADDRESS:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

TELEPHONE
NUMBER:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Disposition/outcome: \_\_\_\_\_\_Recovered\_\_\_\_\_\_Recovered with
sequelae (specify)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Recovering
(specify)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_Deceased

VAERS ID:\_\_\_\_\_\_\_\_\_\_\_\_ E-report
#:\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date of
followup\_\_\_\_/\_\_\_/\_\_\_\_\_
Reviewer\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

> **Summary of Contact Information for Vaccine Safety Concerns**
>
> Contact the Clinician Information Line and the state smallpox vaccine
> adverse events coordinator for access to Vaccinia Immune Globulin
> (VIG) or cidofovir for the treatment of indicated vaccine adverse
> events:
>
> **Clinician Information Line**

### 1.877.554.4625

> Contact VAERS for information on the reporting of vaccine adverse
> events:
>
> **VAERS**
>
> ***E-Mail:* [www.vaers.org](http://www.vaers.org/)**

###### P.O. Box 1100

> **Rockville, MD 20849-1100**
>
> ***Phone:* 1.800.822.7967**
>
> ***FAX:* 1.877.721.0366**
>
> **Figure 4.** Smallpox Vaccine Adverse Event Diary Report Card

## 

+-----------------+----------------------+-----------------------------+
| **PATIENT       | **Clinic or site     | **Have you taken any        |
| IDENTIFIERS**:  | where vaccination    | prescription medications    |
|                 | was given**          | for symptoms related to     |
| [\_\_\_\        |                      | this vaccination since the  |
| _\_\_\_\_\_\_\_ | (Stamp here or fill  | day of your smallpox        |
| \_\_\_\_\_\_\_\ | out information      | vaccination?**              |
| _\_\_\_\_\_\_\_ | below)               |                             |
| \_]{.underline} |                      | Yes No If yes, please       |
|                 | \_\_\_\_\_           | list                        |
| Last name First | \_\_\_\_\_\_\_\_\_\_ | :\_\_\_\_\_\_­­­­­­\_\_\_\_\_\_\_ |
| name            | \_\_\_\_\_\_\_\_\_\_ |                             |
|                 | \_\_\_\_\_\_\_\_\_\_ | \                           |
| MI              |                      | _\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| [\_\_\_         | Clinic Name          | \_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| \_]{.underline} |                      | _\_\_\_\_\_\_\_\_\_\_\_\_\_ |
|                 | \_\_\_\_\_           |                             |
| **\_\_\_\_\_\   | \_\_\_\_\_\_\_\_\_\_ | \                           |
| _\_\_\_\_\_\_\_ | \_\_\_\_\_\_\_\_\_\_ | _\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| \_\_\_\_\_\_\_\ | \_\_\_\_\_\_\_\_\_\_ | \_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_** |                      | _\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| SSN Number      | Address              |                             |
|                 |                      | **If medical care was       |
| Mo**\_\_\_\_/** | \_\_\_\_             | sought, where?**            |
| Day**\_\_\_\_/* | \_\_\_\_\_\_\_\_\_\_ |                             |
| *Yr**\_\_\_**\_ | \_\_\_\_\_\_\_\_\_\_ | **\_\                       |
| (               | \_\_\_\_\_\_\_\_\_\_ | _\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| \_\_\_\_\_\_\_) |                      | \_\_\_\_\_\_\_\_\_\_\_\_\_\ |
|                 | City State Zip Code  | _\_\_\_\_\_\_\_\_\_\_\_\_** |
| Date of Birth   |                      |                             |
| Age             | (\_\_\_\_\_\_)\_     | **Address State Zip Code**  |
|                 | \_\_\_\_\_\_\_\_\_\_ |                             |
| Gender Male     | \_\_\_\_\_\_\_\_\_\_ | **\_\                       |
| Female          |                      | _\_\_\_\_\_\_\_\_\_\_\_\_\_ |
|                 | Phone Number         | \_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| Number of       |                      | _\_\_\_\_\_\_\_\_\_\_\_\_** |
| Household       | Date of Vaccination: |                             |
| Cont            | \_\_\_\_\_/\_\_\     | **Phone Provider's name**   |
| acts:\_\_\_\_\_ | _\_\_\_\_/\_\_\_\_\_ |                             |
|                 |                      | **Permission to acquire     |
|                 | Mo Day Year          | medical records?** Yes No   |
|                 |                      |                             |
|                 |                      | **Vaccinee's                |
|                 |                      | signat                      |
|                 |                      | ure:\_\_\_\_\_\_\_\_\_\_\_\ |
|                 |                      | _\_\_\_\_\_\_\_\_\_\_\_\_** |
+-----------------+----------------------+-----------------------------+

> Please use the following scale to grade symptoms you experience
> following vaccination. Enter the appropriate code into the
> corresponding box for symptoms with new onset following vaccination.
>
> **Figure 5.**

## 

## 

##  

## 

## Figure 6a. Smallpox Vaccine Adverse Event Diary Report Card

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<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 7%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><p><strong>Symptom(s)</strong></p>
<p>New onset following vaccination</p></td>
<td colspan="21"><p><strong>DAY POST VACCINATION</strong></p>
<p>Please note that the day of vaccination is denoted as Day 0 and
others numbered sequentially</p></td>
<td rowspan="2"><p>Week 4</p>
<p>(Days 21-27)</p></td>
</tr>
<tr class="even">
<td><strong>0</strong></td>
<td><strong>1</strong></td>
<td><strong>2</strong></td>
<td><strong>3</strong></td>
<td><strong>4</strong></td>
<td><strong>5</strong></td>
<td><strong>6</strong></td>
<td><strong>7</strong></td>
<td><strong>8</strong></td>
<td><strong>9</strong></td>
<td><strong>10</strong></td>
<td><strong>11</strong></td>
<td><strong>12</strong></td>
<td><strong>13</strong></td>
<td><strong>14</strong></td>
<td><strong>15</strong></td>
<td><strong>16</strong></td>
<td><strong>17</strong></td>
<td><strong>18</strong></td>
<td><strong>19</strong></td>
<td><strong>20</strong></td>
</tr>
<tr class="odd">
<td><strong>Day scab fell off:</strong></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>No Symptoms</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><p>Fever</p>
<p>(Record temperature)</p></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Chills</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Joint pain</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Muscle pain</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Fatigue</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Loss of Appetite</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Cough</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Swelling/tender lymph nodes</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Itching on body</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Headache</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Backache</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Abdominal pain</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Difficulty breathing</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
</tbody>
</table>

> **Figure 6b.** **Smallpox Vaccine Adverse Event Diary Report Card**
> *(continued)*

<table style="width:100%;">
<colgroup>
<col style="width: 14%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>SKIN FINDINGS:</strong></td>
<td><strong>0</strong></td>
<td><strong>1</strong></td>
<td><strong>2</strong></td>
<td><strong>3</strong></td>
<td><strong>4</strong></td>
<td><strong>5</strong></td>
<td><strong>6</strong></td>
<td><strong>7</strong></td>
<td><strong>8</strong></td>
<td><strong>9</strong></td>
<td><strong>10</strong></td>
<td><strong>11</strong></td>
<td><strong>12</strong></td>
<td><strong>13</strong></td>
<td><strong>14</strong></td>
<td><strong>15</strong></td>
<td><strong>16</strong></td>
<td><strong>17</strong></td>
<td><strong>18</strong></td>
<td><strong>19</strong></td>
<td><strong>20</strong></td>
<td colspan="2">Wk 4</td>
</tr>
<tr class="even">
<td><strong>Vaccine site lesion</strong></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td>Pimple</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td>Vesicle (blister)</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td>Ulcer</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td>Scab</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td>Redness</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td>Swelling</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td>Warmth</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td>Itching</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td>Pain</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td>Streaks on arm</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td>Site reaction &gt;3 inches</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td rowspan="3"><strong>Vaccinia-type lesion</strong> NOT at site of
vaccination. Describe and indicate location</td>
<td><strong>0</strong></td>
<td><strong>1</strong></td>
<td><strong>2</strong></td>
<td><strong>3</strong></td>
<td><strong>4</strong></td>
<td><strong>5</strong></td>
<td><strong>6</strong></td>
<td><strong>7</strong></td>
<td><strong>8</strong></td>
<td><strong>9</strong></td>
<td><strong>10</strong></td>
<td><strong>11</strong></td>
<td><strong>12</strong></td>
<td><strong>13</strong></td>
<td><strong>14</strong></td>
<td><strong>15</strong></td>
<td><strong>16</strong></td>
<td><strong>17</strong></td>
<td><strong>18</strong></td>
<td><strong>19</strong></td>
<td><strong>20</strong></td>
<td colspan="2" rowspan="3"></td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"></td>
<td colspan="7"></td>
<td colspan="7"></td>
</tr>
<tr class="odd">
<td rowspan="3"><p><strong>Non-Vaccinia type rashes</strong> (e.g.,
hives)</p>
<p>Describe and indicate location.</p></td>
<td><strong>0</strong></td>
<td><strong>1</strong></td>
<td><strong>2</strong></td>
<td><strong>3</strong></td>
<td><strong>4</strong></td>
<td><strong>5</strong></td>
<td><strong>6</strong></td>
<td><strong>7</strong></td>
<td><strong>8</strong></td>
<td><strong>9</strong></td>
<td><strong>10</strong></td>
<td><strong>11</strong></td>
<td><strong>12</strong></td>
<td><strong>13</strong></td>
<td><strong>14</strong></td>
<td><strong>15</strong></td>
<td><strong>16</strong></td>
<td><strong>17</strong></td>
<td><strong>18</strong></td>
<td><strong>19</strong></td>
<td><strong>20</strong></td>
<td colspan="2" rowspan="3"></td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7"></td>
<td colspan="7"></td>
<td colspan="7"></td>
</tr>
<tr class="even">
<td colspan="24"><p>Other comments:</p>
<p>(Extra pages as needed)</p></td>
</tr>
<tr class="odd">
<td colspan="23">DATA PRIVACY NOTICE: Data requested are collected under
the authority of Section 301 of the PHS Act. The SSN is being collected
because it is a unique identifier that will enable CDC staff to contact
with participants over time. Every effort will be made to safeguard the
confidentiality of the information provided.</td>
<td></td>
</tr>
</tbody>
</table>

**INSTRUCTIONS TO THE PATIENT:**

> When you have completed this form, immediately return it to the
> responsible party at the clinic or site where you were vaccinated. It
> is imperative that this diary card is returned in a timely manner.
>
> **Do *NOT* delay in returning the diary card to the clinic when
> completed at the end of week 4 following your vaccination.**
>
> If you experience an adverse event prior to completion of this form,
> contact the IND investigator at the clinic where you were vaccinated.
>
> IND Investigator Contact Number:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> In the event that you require emergency care and are unable to notify
> your clinic provider, please seek medical care for a prompt clinical
> consult. Have the emergency care physician contact the IND
> investigator at the clinic where you received the vaccine to report
> your adverse event. See above.
>
> It is important that your adverse event be reported. We encourage you,
> in consultation with your doctor to report adverse events to the
> Vaccine Adverse Event Reporting System (VAERS). The VAERS reporting
> form can be obtained at [www.vaers.org](http://www.vaers.org/) or by
> calling **1.800.822.7967**.