**Date site aware of event \_\_\_\_\_\_\_\_\_\_\_\_\_Initial Report Date
\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Follow-up #\_\_\_ Report
Date\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**Follow-up #\_\_\_ Date\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Follow-up #\_\_\_
Date\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Follow-up #\_\_\_
Date\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**1. Age at onset of SAE \_\_\_\_\_\_\_\_\_\_ Gender:** Male Female
**Weight:** \_\_\_\_\_\_\_\_\_ lbs./ kgs./ gms.

+------------------+------------------+-------------------------------+
| **3. Study       |                  | **4. Vaccination Date         |
| Vaccine Name and |                  | (include all doses given)**   |
| Route of         |                  |                               |
| Administration** |                  | (DD/MMM/YYYY)                 |
|                  |                  |                               |
| *Note: If        |                  |                               |
| blinded,         |                  |                               |
| indicate as      |                  |                               |
| such*            |                  |                               |
+------------------+------------------+-------------------------------+
| \_\_\_\_\_\_     | -   IM           | Dose 1:                       |
| \_\_\_\_\_\_\_\_ |                  |                               |
| \_\_\_\_\_\_\_\_ | -   SQ           |                               |
|                  |                  |                               |
| OR               | -   PO           |                               |
|                  |                  |                               |
| Blinded          | -   IN           |                               |
|                  |     (intranasal) |                               |
|                  |                  |                               |
|                  | other            |                               |
|                  | \_\_\_\_\_\_     |                               |
|                  | \_\_\_\_\_\_\_\_ |                               |
+------------------+------------------+-------------------------------+
|                  |                  | Dose 2:                       |
|                  |                  |                               |
|                  |                  | NA                            |
+------------------+------------------+-------------------------------+
|                  |                  | Dose 3:                       |
|                  |                  |                               |
|                  |                  | NA                            |
+------------------+------------------+-------------------------------+
|                  |                  | Dose 4:                       |
|                  |                  |                               |
|                  |                  | NA                            |
+------------------+------------------+-------------------------------+

<table>
<colgroup>
<col style="width: 17%" />
<col style="width: 0%" />
<col style="width: 15%" />
<col style="width: 0%" />
<col style="width: 12%" />
<col style="width: 13%" />
<col style="width: 0%" />
<col style="width: 17%" />
<col style="width: 0%" />
<col style="width: 22%" />
</colgroup>
<tbody>
<tr class="odd">
<td><p><strong>5. Event</strong></p>
<p>(Keyword or Cause of Death)</p></td>
<td colspan="2"><p><strong>6. Onset Date</strong></p>
<p>(DD/MMM/YYYY)</p></td>
<td colspan="3"><p><strong>7. Severity</strong></p>
<p>(Complete only one column. Mark only one box in that
column.)</p></td>
<td colspan="2"><p><strong>8. Relationship</strong></p>
<p>(to Study Product)</p></td>
<td colspan="2"><p><strong>9. If Not Associated</strong></p>
<p>(complete below)</p></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td colspan="2">____/____/____</td>
<td><p>Mild</p>
<p>Moderate</p>
<p>Severe</p>
<p>Life-Threatening</p>
<p>Death</p></td>
<td colspan="2"><p>Grade 1</p>
<p>Grade 2</p>
<p>Grade 3</p>
<p>Grade 4</p>
<p>Grade 5</p>
<p>(Death)</p></td>
<td colspan="2"><p>Not associated</p>
<p>Associated</p></td>
<td><p>Is event related to:</p>
<p>study procedure?</p>
<p>Specify___________</p>
<p>other medical</p>
<p>condition/ illness?</p>
<p>Specify___________</p>
<p>other drug?</p>
<p>Specify___________</p>
<p>other?</p>
<p>Specify___________</p></td>
</tr>
</tbody>
</table>

+-----------------------------------------------------------------------+
| **10. Study Vaccine Status(choose one)**: **Due to event, dose was:** |
| Increased Reduced Unchanged                                           |
|                                                                       |
| Permanently Discontinued Temporarily Withheld Not applicable for one  |
| time dose                                                             |
|                                                                       |
| Other, specify:                                                       |
+-----------------------------------------------------------------------+
| **11. Outcome of Event is** (choose only one):                        |
|                                                                       |
| Ongoing                                                               |
|                                                                       |
| -   Resolved without sequelae Date \_\_\_\_/\_\_\_\_\_/\_\_\_\_\_     |
|     (DD/MMM/YYYY)                                                     |
|                                                                       |
| Resolved with sequelae Date \_\_\_\_\_/\_\_\_\_/\_\_\_\_\_\_          |
| (DD/MMM/YYYY)                                                         |
|                                                                       |
| State sequelae:                                                       |
| \_\_\_\_\_\_\_\                                                       |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
|                                                                       |
| Death Date of Death: \_\_\_\_/\_\_\_\_\_/\_\_\_\_(DD/MMM/YYYY)        |
|                                                                       |
| Autopsy: Not Done Done (Provide Report) Planned Status Unknown        |
+-----------------------------------------------------------------------+

**12. List Relevant Laboratory/Diagnostic Results below OR attach copies
of the results.**

**(i.e.: MRI, CT Scan, Ultrasound)**

No relevant laboratory tests **OR** Pending-specify
test\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

No relevant diagnostic tests **OR** Pending-specify
test\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

+------------+----------+----------+---------+------------+----------+
| **Test**   | **Co     | **       | **Site  | **         | **Result |
|            | llection | Result** | Normal  | Collection | of test  |
|            | Date**   |          | Range** | Date of    | previous |
|            |          |          |         | test       | to this  |
|            | (DD/M    |          |         | previous   | SAE**    |
|            | MM/YYYY) |          |         | to this    |          |
|            |          |          |         | SAE**      |          |
+------------+----------+----------+---------+------------+----------+
|            |          |          |         |            |          |
+------------+----------+----------+---------+------------+----------+
|            |          |          |         |            |          |
+------------+----------+----------+---------+------------+----------+
|            |          |          |         |            |          |
+------------+----------+----------+---------+------------+----------+
|            |          |          |         |            |          |
+------------+----------+----------+---------+------------+----------+
|            |          |          |         |            |          |
+------------+----------+----------+---------+------------+----------+

**13. Concomitant Medications or Vaccines** No relevant concomitant
medications/vaccines

**List relevant concomitant medications/vaccines the subject was taking
1 month prior to SAE onset.**

+---------------+------------+-------------+----------+--------+-----+
| **Medicat     | **Start    | **Stop      | **Total  | **     | **  |
| ion/Vaccine** | Date       | Date**      | Daily    | Indica | Sus |
|               | DD/        |             | Dose**   | tion** | pec |
|               | MMM/YYYY** | **DD        |          |        | t** |
|               |            | /MMM/YYYY** |          |        |     |
+---------------+------------+-------------+----------+--------+-----+
| 1\.           |            |             | \_\_     |        | Yes |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        | No  |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | Unknown? |        |     |
+---------------+------------+-------------+----------+--------+-----+
| 2\.           |            |             | \_\_     |        | Yes |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        | No  |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | Unknown? |        |     |
+---------------+------------+-------------+----------+--------+-----+
| 3\.           |            |             | \_\_     |        | Yes |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        | No  |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | Unknown? |        |     |
+---------------+------------+-------------+----------+--------+-----+
| 4\.           |            |             | \_\_     |        | Yes |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        | No  |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | Unknown? |        |     |
+---------------+------------+-------------+----------+--------+-----+
| 5\.           |            |             | \_\_     |        | Yes |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        | No  |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | Unknown? |        |     |
+---------------+------------+-------------+----------+--------+-----+
| 6\.           |            |             | \_\_     |        | Yes |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        | No  |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | \_\_\_\_ |        |     |
|               |            |             | Unknown? |        |     |
+---------------+------------+-------------+----------+--------+-----+

**14. Previous severe reactions following any vaccines** No severe
previous vaccine reactions

  --------------------- ------------------------------------- ------------
  **Vaccine**           **Reaction**                          **Date**

                                                              

                                                              

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