Case Investigation Form

Philippine Integrated Disease (for COVID-19 Vaccine AEFI) V2 – 2021.07.07

Surveillance and Response
For all AEFIs, regardless of seriousness, page 1 must be filled up. For identified serious AEFI cases, succeeding pages are mandatory. Immediately notify the Local Epidemiology
Surveillance Unit (ESU). Please fill out all blanks and put a check mark on the appropriate box. Never leave an item blank (write N/A). Items with * (asterisk) are mandatory fields.
I. REPORTER’S INFORMATION
Name of Facility/Disease Reporting Unit (DRU)* Facility/DRU Region and Province* Type of Facility/DRU* Contact Number* (Landline or Mobile)

Full Name of Reporter* Designation of Reporter PRC Registration Number Email address

II. PATIENT INFORMATION

First Name* Middle Name Last Name* Suffix

Birthday (MM/DD/YYYY)* Age* Sex*  Male  Female, check if either applies: Civil status PhilHealth Number
 Pregnant  Lactating
Nationality* Priority Group*  A1  A2  A3  A4  A5  B1  B2  B3  B4  B5  B6 C
Specify profession/comorbidity*: _____________________________________
COMPLETE CURRENT ADDRESS AND CONTACT INFORMATION
House No./Lot/Building* Street/Purok/Sitio* Barangay*

Municipality/City* Province* Region* Contact Number* (Landline or Mobile)

III. VACCINATION DETAILS Check if applicable: With previously reported event (i.e. anaphylaxis) Heterologous (vaccination)
NOTE: Should the page be insufficient for reporting the vaccine details, please provide the latest information of the four latest doses received by the patient on this
page and provide the other previous vaccination details on the same table as found in Appendix 4 as an attached sheet to this form.
For vaccinations done abroad or for those with multiple vaccination records, please attach the copy/ies of the vaccination card/s upon submission of this document.
Details Older dose Latest dose
1. Dose number*
2. Name of Vaccine*
3. Place of Vaccination* (Local/Abroad) Local Local Local Local
4. Date of Vaccination* (MM/DD/YYYY)
5. Time of Vaccination* (hh:mm)
6. Site of Injection* (Right/Left arm)
7. Batch/Lot Number*
8. Expiry Date (MM/DD/YYYY)
9. Vaccination Site Name*
10. Vaccination Site Country
11. Vaccination Site Region*
12. Vaccination Site Province*
13. Vaccination Site City/Municipality*
14. Vaccination Site Barangay*
15. Diluent
16. Date of Reconstitution (MM/DD/YYYY)
17. Time of Reconstitution (hh:mm) AM/PM AM/PM AM/PM AM/PM
18. Diluent Batch/Lot Number
19. Diluent Expiry Date (MM/DD/YYYY)
 DOH  Local Gov’t Unit  DOH  Local Gov’t Unit  DOH  Local Gov’t Unit  DOH  Local Gov’t Unit
20. Vaccine procured from  Private  Unknown  Private  Unknown  Private  Unknown  Private  Unknown
 Others:_________________  Others:_________________  Others:_________________  Others:_________________

IV. ADVERSE EVENT/S (check all that apply)

Date of onset Time of onset Date of onset Time of onset
Symptom* Symptom*
(MM/DD/YYYY)* (hh:mm)* (MM/DD/YYYY)* (hh:mm)*
 Chest pain AM/PM  Joint Pain AM/PM
 Chills AM/PM  Muscle or body aches AM/PM
 Colds AM/PM  Nausea AM/PM
 Dizziness AM/PM  Numbness AM/PM
 Feeling unwell (malaise) AM/PM  Rash all over the body AM/PM
 Fever ≥ 38.0oC AM/PM  Tiredness AM/PM
 Headache AM/PM  Vaccination site pain AM/PM
 Itching AM/PM  Vomiting AM/PM
 Increased BP With Hypertension?*  No  Yes  Unknown
Indicate pre- and post- AM/PM
Pre-vaccination*: _______ / _______ Post-vaccination*: _______ / _______
vaccination blood pressure
Other Symptom/s Date of onset (MM/DD/YYYY) Time of onset (hh:mm)
AM/PM
AM/PM
Outcome*  Alive:  Recovering from the reported AEFI  Fully recovered from the AEFI and back to premorbid condition
 With permanent disability resulting from the AEFI, specify: __________________________________

 Died:  Dead on Arrival  Died in the health facility  Died at home

Date died (MM/DD/YYYY)*: _______________________
Patient Management 1. Date the patient was seen or went for a consult (MM/DD/YYYY): _______________________
2. Patient’s Current Status:
Received treatment and sent home  Treated and went home against medical advice Date of discharge (MM/DD/YYYY): ___________________
Currently admitted; Date of admission (MM/DD/YYYY): ___________________ Admitting Diagnosis: ___________________________
Serious case* No  Yes;  Death  Life-threatening  Disability  Hospitalization  Congenital anomaly
If answered Yes on any of these,
please fill out pages 2 to 5.  Other important medical event, specify: ______________________________________

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response
activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the information sought
to be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on the part
of the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
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 Instructions: Pages 2 to 5 of this Case Investigation Form shall be filled out by the attending physician. The Disease Surveillance Officer or any healthcare
professional whom attended to the patient shall fill out the form should the attending physician be unavailable.
NOTE: The operational definition of serious AEFI cases may be found in Appendix 2. Please be guided accordingly.

V. EXAMINATION DETAILS
Last Name of Physician* First Name of Physician* Middle Name of Physician

Contact Number* PRC Registration Number* Date Investigated (MM/DD/YYYY)*

 Nurse  Midwife  Parent/Guardian  Neighbor  Barangay Health Worker

Other source of Information
 Others, specify: ______________________
Last Name of other source of information First Name of other source of information Middle Name of other source of information

Contact Number (Landline or Mobile) PRC Registration Number (if applicable) Relation/Designation of other source of information

VI. MODE OF EXAMINATION (check all that apply)

 Interview  Medical record/s  Physical examination  Laboratory result  Other/s, specify: ________________________

1. Was autopsy recommended or suggested to the family or next of kin?  Yes  No

2. If autopsy was recommended but not done, please check all the reason/s why it was not done
 Local unavailability of pathologist/NBI/PNP  Financial challenge
If the patient
DIED  No consent  Other reason/s: ______________________________________________

3. If verbal autopsy was done; Source’s Name: ____________________________________

Source’s Relationship: ________________________________

VII. CLINICAL DETAILS -- Attach copies of ALL available documents including case sheet/s, health screening form, copy of vaccination card, discharge
summary, case notes, lab and autopsy reports, prescriptions, and others. Separate sheet/s may be attached to complete the information.

1. What is your complete diagnosis or

problem list?*

2. Please narrate the chronology of the

events, including the date and time of

You may also use a separate sheet or attach

another document listing the complete
diagnosis. Refer to the Brighton Collaboration,
Clinical Practice Guidelines, or International
Classification of Diseases for the diagnosis.

History and PE What are the findings that support the diagnosis?* What are the findings that DO NOT support the diagnosis?*

Review of Systems

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response
activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the information sought to
be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on the part of
the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
2
 Past Medical History
and OB-GYN History

Family Medical
History

Personal Social
History

Physical Examination
on first interaction

The patient’s height (in cm)

and weight (in kg) may be
placed here.

3. Based on your expertise, among the

diagnoses mentioned in #1, which
diagnosis do you think contributed the
most or triggered the series of events
towards hospitalization, disability, or
death?*

 Yes; cite the case definition, if you are aware of it.

 No; If NOT STRONGLY SUPPORTED AND DEDUCED OR SIMPLY TERMED AS “PROBABLE” OR
“TO CONSIDER”, which of the events in the chronology of events leading to hospitalization or death is
strongly supported by history and PE to fit a case definition?

4. Is this selected diagnosis, now termed as

the "event being assessed", strongly
supported by objective findings in the
history and PE to fit a case definition,
from any criteria whether in the Brighton
classification, local guideline, or
international guideline?*

You may use a separate sheet or attach another

document.

NOTE: Be specific as to which symptoms occurred prior to vaccination or are recurring since before vaccination, while manifested after Findings from
specialist consultation or referrals may also be included. For laboratory findings, include the date, time and normal range of values. For histopathologic,
laboratory, radiologic, electrophysiological studies, you may attach them as reference. Any dermatologic findings or imaging may be attached.

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response
activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the information sought to
be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on the part of
the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
3
 VIII. COURSE IN THE HOSPITALIZATION – You may opt to attach a medical abstract outlining the chronological course of hospitalization in SOAP format.
Date/Time Subjective Findings Objective Findings Assessment Plan/Management Done

IX. TREATMENT COVERAGE

1. Was the treatment charged from a funding source?*  Yes, completely charged  Yes, partially charged to the patient and funding source
 No, fully charged to the patient  Not applicable/No treatment was needed or given

2. If yes, what were the funding sources tapped?  Malasakit Program  PhilHealth  Other funding source: _______________________

X. RELEVANT PATIENT INFORMATION PRIOR TO IMMUNIZATION

Remarks
Information Yes / No N/A “Similar event” refers to a clinical event which had happened to the patient in the past
and was ALSO experienced by the patient after COVID-19 vaccination.
1. Did a similar diagnosis, episode/s, or event/s occur in
the past, independent of any vaccination?*
/

2. Was the patient exposed to a potential factor (other

than vaccine) prior to the event (e.g. allergen, drug, /
herbal product, etc.)?*
If pregnant, indicate AOG:

3. For adult women, currently pregnant? / 

currently breastfeeding? / 
The additional form for case-based survey of pregnant women inoculated with COVID-19 vaccine is
provided in Appendix 5 and must be answered in the case of pregnant individuals vaccinated.

4. Did this patient have an illness, pre-existing condition

or risk factor that could have contributed to the /
event?*

5. Was/Is the patient on any concurrent medication for

any illness prior to the vaccination?* (indicate the name /
of drug, indication, doses, & date)

6. Has the patient tested COVID-19 positive prior to Specimen Collection Date
vaccination?*
/ (MM/DD/YYYY):

7. History of hospitalization in the past 30 days; if yes,

indicate the inclusive dates and cause*
/

8. Recent history of trauma; if yes, indicate the date, cause

and site*
/

9. Did a similar diagnosis, episode/s, or event/s occur in the past after the administration of a similar vaccine?*  No  Yes, complete the table
Vaccine Relative date of vaccination Adverse Event experienced

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response
activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the information sought to
be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on the part of
the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
4
 XI. FOR THE HEALTH CARE PROVIDER
1. As of the last assessment of the physician, what was  Alert (Conscious)  Verbally responsive
the level of consciousness of the patient?  Responsive to pain stimuli  Unresponsive

2. What are the other examinations intended to be done to

support the diagnosis but were not done and what
are/were the limitations in not performing these studies
of examinations? You may indicate lack of facility, lack of
equipment, lack of fund, among others.

3. In the medical opinion of the licensed physician or  No  Yes; please provide details.
person completing these clinical details, is it possible
that the illness or injury suffered by the patient after the
administration of vaccine dose/s was caused by, or
resulted from, any previous illness or injury of the patient?*

4. Did the patient or next of kin inquire whether this  Never manifested  Once  Frequently  Unknown
event is/was caused by the vaccine?*

5. Are there efforts done by the HCP to educate or reassure  No  Yes; please indicate procedures or measures taken.
the vaccine recipient or next of kin, that any event
following immunization may not be automatically
considered to be due to the vaccine and that further
investigation and assessment must still be performed?*

6. As stated in the PhilHealth Circular No. 2021-0007, is the

patient or next of kin considering to file claims for  No  Yes  Unknown
the PhilHealth Vaccine Injury Compensation Package?*

7. Prior to discharge, is the patient or next of kin requesting  No, the patient/next of kin declines.  Yes
for this event to be investigated and consequently for
 Unknown or Not asked
causality assessment?*
XII. CONSENT FROM THE PATIENT OR NEXT OF KIN
I, the patient or parent/guardian of the patient, hereby give consent to the respective public health authorities to acquire pertinent information
and details on the case and share these as needed, to contact the person vaccinated and/or parent or guardian regarding the event, and to
conduct investigation and/or causality assessment based on the provided information, as needed.

__________________________________________________________
SIGNATURE OVER PRINTED NAME OF PATIENT OR NEXT OF KIN AND DATE
I, the patient or parent/guardian of the patient, will not provide consent to the statements above. This shall signify and shall be agreed upon on
that any claims or suits filed by the patient and/or relative in this form reflected in the future due to incomplete data shall be invalid.

__________________________________________________________
SIGNATURE OVER PRINTED NAME OF PATIENT OR NEXT OF KIN AND DATE
XIII. CONSENT FROM THE HEALTH CARE PROVIDER
I, the health care provider whom attended to the patient, do attest that the information stated above are factual and are based on the expertise and
proper evidence collected and I hereby consent to be contacted for further follow up regarding this case as deemed necessary.

__________________________________________________________
SIGNATURE OVER PRINTED NAME OF HEALTH CARE PROVIDER AND DATE

NOTE: The Disease Surveillance Officer (DSO) of the hospital is required to complete all the needed and pertinent information in this case
investigation form (CIF) based on the attached documents or files before submission to the Local Epidemiology Surveillance Unit (LESU)
or the Hospital ESU (HESU). The LESU/HESU shall return the CIF to the DSO should it be incompletely or wrongly filled.
XIV. INVESTIGATION DETAILS – Please indicate whether the investigator is from the Hospital or Local ESU.
Last Name of Investigator* First Name of Investigator* Middle Name of Investigator

Designation of the Investigator* Contact Number* (Landline or Mobile) Date of Investigation (MM/DD/YYYY)*

Privacy statement
Public health authorities, to which at the national level is the Department of Health, collects personal information and other necessary data relating to adverse
events following immunization (AEFIs) as stated in the Revised IRR of Republic Act No. 11332 or the “Mandatory Reporting of Notifiable Diseases and Health
Events of Public Health Concern Act.” The information collected in this report is used to assist in the surveillance and post market monitoring of the safety of
the COVID-19 vaccines. All reports of AEFIs are assessed and encoded into the respective information system. The information collected may come from
someone other than the patient to whom the personal information relates. This is in consideration of cases where the patient may be unable to report the case
or where the information is passed from the next of kin/guardian or an entity other than the former mentioned.

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response
activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the information sought to
be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on the part of
the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
5
 THIS PAGE SHOULD BE FILLED OUT BY THE LOCAL ESU, LOCAL HEALTH OFFICE, OR OTHER INVESTIGATOR THAT MAY PROVIDE THE NEEDED INFORMATION.

Name of Investigator/Person Last Name First Name Middle Initial

answering this form*
Designation of Investigator* Office/Department/ESU*
XV. IMMUNIZATION PRACTICES Method/Manner of Investigation:  Visual observation of vaccinators  On-site inspection  Verbal Interview
Syringes and Needles Used Yes / No / N/A Remarks
Were auto-disable syringes used for //
immunization? If NO, specify the type:  Glass  Disposable  Recycled disposable  Pre-filled syringes
Specific key findings/additional observations and comments:

Reconstitution Procedure (when applicable ) Method/Manner of Investigation: Visual observation of vaccinators Others:
1. Was the same reconstitution syringe used for
//
multiple vials of the same vaccine?
2. Was the same reconstitution syringe used
//
for reconstituting different vaccines?
3. Was there a separate reconstitution syringe //
used for each vaccine vial?
4. Was there a separate reconstitution syringe //
used for each vaccination?
5. Are the vaccines and diluents used as //
recommended by the manufacturer?
Specific key findings/additional observations and comments:

Injection technique of vaccinator/s Method/Manner of Investigation:  Visual observation of vaccinators  On-site inspection  Checking of forms
1. Was the correct dose and route of administration followed? / /
2. Time of reconstitution mentioned on the vial (in case of freeze dried
vaccines) [hh:mm:AM/PM]
3. Was aseptic non-touch technique followed? //
4. Was contraindication screened prior to
//
vaccination?
5. How many AEFI case/s were reported from the vaccination site
that administered the vaccine in the last 30 days?
(If unknown, state the reason why)
Specific key findings/additional observations and comments:

XVI. COLD CHAIN AND TRANSPORT Method/Manner of Investigation:  Visual observation of cold chain facility/equipment  Others: ______________
Last vaccine storage point Yes / No Remarks
1. Type of vaccine storage  Freezer  Refrigerator  Dry Store  Other, specify: __________________
2. Temperature of vaccine storage: ___________ oC
3. Was the correct procedure of storing vaccines,
/
diluents, and syringes followed?
4. Is there any other item (other than vaccines
/
and diluents) in the refrigerator or freezer?
5. Were partially used reconstituted vaccines
/
stored in the refrigerator?
6. Were unusable vaccines stored in the refrigerator? /
If yes, check all the apply:  Expired  No label  VVM Stage 3/4  Frozen  Other, specify: _______________
7. Were unusable diluents in the storage area? /
If yes, check all that apply:  Expired  Manufacturer not matched  Cracked  Dirty ampule  Other, specify: _______________
Specific key findings/additional observations and comments:

Vaccine transportation Method/Manner of Investigation:  Visual observation of vaccinators  On-site inspection  Checking of forms
1. Vaccine carrier used  Polyurethane Foam Insulation  Insulated Plastic Container  Styrofoam  Other, specify: _______________
2. Was the vaccine carrier sent to the site on the
/
same day of vaccination?
3. Was the accine carrier returned from the site
/
on the same day of vaccination?
4. For the condition of the vaccine carrier,
/
was ice pack used?
Specific key findings/additional observations and comments:

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response
activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the information sought to
be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on the part of
the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
6
 THIS PAGE SHOULD BE FILLED OUT BY THE LOCAL ESU, LOCAL HEALTH OFFICE, OR OTHER INVESTIGATOR THAT MAY PROVIDE THE NEEDED INFORMATION.
Name of Investigator/Person Last Name First Name Middle Initial
answering this form*
Designation of Investigator* Office/Department/ESU*
XVII. VACCINE DETAILS (Indicate vaccines provided at the site linked to AEFI on the corresponding day)
Number of recipients Vaccine/s
immunized for each Given
brand/type of vaccine
at the vaccination site.
Total Doses
Attach record if available. Given
Provide an explanation for each YES answer Yes / No / # Remarks

When was the patient immunized?

 Within the first vaccinations of the session  Within the last vaccinations of the sessions  Unknown
 Within the first few doses of the vial administered  Within the last doses of the vial administered  Unknown

1. Was the recommendation for the use of this

vaccine NOT followed?
/

2. Based on the investigation, could the vaccine

(ingredient/s) administered been unsterile (i.e. /
breach on syringe, breach on needles used)?

3. Based on the investigation, was the vaccine’s

physical condition (e.g. color, turbidity, foreign
substances, etc.) abnormal at the time of
/
administration?

4. Based on the investigation, was there an error in

vaccine reconstitution/preparation by the
vaccinator (e.g. wrong product, wrong diluent,
/
improper mixing, improper syringe filling, etc.)?

5. Based on the investigation, was there an error in

vaccine handling (e.g. break in cold chain during
transport, storage, and/or immunization session,
/
etc.)?

6. Based on the investigation, was the vaccine

administered incorrectly (e.g. wrong dose, site or /
route of administration, wrong needle size, etc.)?

7. Is it possible for the vaccine given to this patient

had a quality defect or is substandard or /
falsified?
If yes, describe, even in your own words, how the patient was or the patient’s status
before, during, and/or after the vaccination within the site as observed by workers,
8. Is it possible for this event to be considered a relatives, etc.
stress-related response to immunization (e.g.
acute stress response, vasovagal reaction, /
hyperventilation, dissociative neurological
symptom reaction, etc.)?

9. Specify the number of OTHER recipient/s

immunized from the concerned vaccine vial/ampule
10. Specify the number of OTHER recipient/s immunized
with the concerned vaccine in the same session

11. Specify the number of OTHER recipient/s immunized

with the concerned vaccine having the same batch
number in other location/s (specify location/s)  Data is not being gathered at the LVOC level or is unknown

If yes, please provide the details on the following:

12. At the best of your knowledge, is this case part of  Yes  No 1. Number of known/recorded clustered cases: ____________
a known cluster of AEFI?  Unknown 2. Did all the cases in the cluster receive vaccine from the same vial?
 Yes  No, number of vials used in the cluster: _________________

Privacy statement
Public health authorities, to which at the national level is the Department of Health, collects personal information and other necessary data relating to adverse events
following immunization (AEFIs) as stated in the Revised IRR of Republic Act No. 11332 or the “Mandatory Reporting of Notifiab le Diseases and Health Events of Public
Health Concern Act.” The information collected in this report is used to assist in the surveillance and post market monitoring of the safety of the COVID-19 vaccines. All
reports of AEFIs are assessed and encoded into the respective information system. The information collected may come from som eone other than the patient to whom
the personal information relates. This is in consideration of cases where the patient may be unable to report the case or where the inform ation is passed from the next of
kin/guardian or an entity other than the former mentioned.

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response
activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the information sought to
be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on the part of
the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
7
Appendix 1. AEFI Definitions
Non-serious AEFI Serious AEFI
An event that is not serious and that has no potential to risk to the An event that results in death, is life-threatening, requires in-patient
health of the recipient of the vaccine, but must be carefully hospitalization or prolonged existing hospitalization, results in persistent or
monitored as they may signal a potentially larger problem with the significant disability/incapacity, or is a congenital anomaly or birth defect. May
vaccine or the vaccination, or may have an impact on the also refer to any medical event that requires intervention to prevent one or
vaccination acceptability in general. more outcomes above.

Adverse Event of Special Interest (AESI) - An adverse event of special interest (serious or non-serious) is one of scientific and medical concern
specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be
appropriate.

Appendix 2. Operational Definition for Serious AEFI

1. For AEFIs that result in death, these are to be classified as serious if the health care provider examining the patient suspects that the drug
resulted in or contributed to death.

2. For AEFIs that result in hospitalization, these are to be classified as serious if (1) the health care provider examining the patient suspects
that the AEFI resulted to admission of the patient to the hospital or prolongation of hospitalization of the patient; AND (2) the admission is
considered medically justified to deliver active medical or surgical intervention, and not just observation or medical monitoring.

a. For AEFIs detected in emergency visits that do NOT result in admission to the hospital; OR observation or medical
monitoring are the activities performed, the AEFI should be evaluated for the other definitions.

3. For AEFIs that result in persistent or significant disability, these are to be classified as serious if the health care provider examining the
patient suspects that the AEFI resulted in a substantial disruption of a person's ability to conduct normal activities of daily living, specifically
in significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities,
and/or quality of life.

4. For AEFIs that result in congenital anomaly or birth defect, these are classified as serious if (1) the exposure is prior to conception or during
pregnancy; AND (2) the health care provider examining the patient suspects that the drug resulted to a congenital anomaly or birth defect.

5. For AEFIs that are considered to be life-threatening, these are to be classified as serious if the health care provider examining the patient
suspects that the patient was at substantial risk of dying at the time of the adverse event.

6. For AEFIs that require intervention to prevent any of the above-mentioned outcomes, these are to be classified as serious if (1) the
health care provider examining the patient suspects that medical or surgical intervention was necessary to preclude permanent impairment
of a body function, or prevent permanent damage to a body structure; AND (2) either situation is suspected to be due to the exposure.

7. When further clarity is needed to define the seriousness of an AEFI, the Regional Epidemiology and Surveillance Unit shall have the authority
to provide immediate guidance and classification of seriousness of the AEFI, as referred by the inquiring health care provider.

a. The health care provider examining the patient must confer first with the RESU within their region for AEFIs that they may have
doubts on the classification of seriousness.

b. The RESU, upon application of the above guidelines, and their judicious understanding of the case, may provide the classifica tion
as to seriousness.

c. The RESU shall regularly inform the Epidemiology Bureau of (1) these specific cases; (2) the decisions made as to classification of
seriousness; and (3) considerations taken to give rise to these decisions.

d. The Epidemiology Bureau shall regularly review the submissions of the RESUs for harmonization and further standardization of the
criteria for seriousness of AEFIs.

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response
activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the information sought to
be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on the part of
the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
8
Appendix 3. Flow of AEFI Surveillance
Surveillance Cycle Definition Purpose Personnel
Step responsible/involved

Detection, Identification and recognition of all To recognize and detect AEFI as they Vaccine recipient, Parents of
Notification cases corresponding to locally suitable occur or when appropriate, to treat or refer immunized infants and children,
AEFI case definitions, AEFI clusters, patients for treatment health care workers, staff in
and all other events believed to be due immunization of healthcare
to immunization facilities

Reporting Transmission of information relevant to To provide Vaccine recipient, Parents of

AEFIs by means of standardized form, key descriptive epidemiological data immunized infants and children,
telephone call, direct conversation, or (time, place and person) that are critical health care workers, staff in
specific application for identifying immunization of healthcare
clusters and for signal detection facilities

Investigation Collection of pertinent details of the To establish a more specific case Healthcare worker who detected
patient, vaccine and other drugs definition (as needed) and formulate a the case
potentially received, the event, hypothesis to what cause the AEFI
immunization services

Systematic review and evaluation of To determine the likelihood of a causal Regional and National AEFI
available data about an adverse event association between the event(s) and the Committees
following COVID-19 vaccination vaccine received

Case Classifications Algorithm (WHO Causality Assessment Manual

A. Consistent causal association to immunization 2019)
A1. Vaccine product-related reaction: An AEFI that is caused or
precipitated by a vaccine
due to one or more of the inherent properties of the vaccine product.
A2. Vaccine quality defect-related reaction: An AEFI that is caused
or precipitated by
a vaccine due to one or more quality defects of the vaccine product,
including the
administration device, as provided by the manufacturer
A3. Immunization error-related reaction: An AEFI that is caused by
inappropriate vaccine
handling, prescribing or administration and that thus, by its nature, is
preventable.
A4. Immunization anxiety/stress related response: An AEFI
arising from anxiety about the immunization.

B. Indeterminate
B1. Consistent temporal relationship but insufficient evidence
for causality: Temporal relationship is consistent but there is
insufficient definitive evidence that vaccine caused the event (it may
be a new vaccine-linked event). This is a potential signal and needs
Causality Assessment
to be considered for further investigation.
B2. Conflicting trends of consistency and inconsistency with
causality: Reviewing factors result in conflicting trends of
consistency and inconsistency with causal association to
immunization (i.e. it may be vaccine-associated as well as
coincidental and it is not possible clearly to favour one or the other).

C. Inconsistent causal association to immunization

(Coincidental): An AEFI that is caused by something other than the
vaccine product, immunization error or immunization anxiety. This
could be due to underlying or emerging condition(s) or conditions
caused by exposure to something other than the vaccine.

D. Ineligible and unclassifiable cases: Available information on

these cases shall be filed in a repository or an electronic database for
periodic review to see additional information for classification and to
perform analysis on signal detection.

References
Council for International Organizations of Medical Sciences. Definition and application of terms for vaccine pharmacovigilanc e. Report of
the CIOMS/WHO Working Group on Vaccine Pharmacovigilance. 2012. Available from
http://www.who.int/vaccine_safety/initiative/tools/CIOMS_report_WG_vaccine.pdf
World Health Organization. Covid-19 vaccines: safety surveillance manual. WHO 2020. Available from https://www.who.int/docs/default-
source/covid-19-vaccines-safety-surveillance-manual/covid19vaccines_manual_aefi_20210104.pdf
World Health Organization. Causality assessment of an adverse event following immunization (AEFI)): user manual for the revis ed WHO
classification second edition, 2019 update. WHO 2019 Available from https://www.who.int/publications-detail-redirect/causality-
assessment-aefi-user-manual-2019

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response
activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the information sought to
be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on the part of
the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
9
Appendix 4. Additional sheet for Vaccination Details

PATIENT INFORMATION
First Name* Middle Name Last Name* Suffix

VACCINATION DETAILS Check if applicable: With previously reported event (i.e. anaphylaxis) Heterologous (vaccination)
NOTE: Please provide all the necessary information. Should the page be insufficient, please use another sheet.
Details Oldest dose Later dose
1. Dose number*
2. Name of Vaccine*
3. Place of Vaccination* (Local/Abroad)
4. Date of Vaccination* (MM/DD/YYYY)
5. Time of Vaccination* (hh:mm) AM/PM AM/PM AM/PM AM/PM AM/PM
6. Site of Injection* (Right/Left arm)
7. Batch/Lot Number*
8. Expiry Date (MM/DD/YYYY)
9. Vaccination Site Name*
10. Vaccination Site Country
11. Vaccination Site Region*
12. Vaccination Site Province*

13. Vaccination Site City/Municipality*

14. Vaccination Site Barangay*

15. Diluent
16. Date of Reconstitution (MM/DD/YYYY)
17. Time of Reconstitution (hh:mm) AM/PM AM/PM AM/PM AM/PM AM/PM
18. Batch/Lot Number
19. Expiry Date (MM/DD/YYYY)

 DOH  Local Gov’t Unit  DOH  Local Gov’t Unit  DOH  Local Gov’t Unit  DOH  Local Gov’t Unit  DOH  Local Gov’t Unit
20. Vaccine procured from  Private  Unknown  Private  Unknown  Private  Unknown  Private  Unknown  Private  Unknown
 Others:_________________  Others:_________________  Others:_________________  Others:_________________  Others:_________________

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease response activities. Hence, health professionals conducting the interview at point of first contact shall
obtain such details from a suspect case, properly informing the data subject that the information sought to be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal information on
the part of the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
10
 Appendix 5. Additional form for case-based survey of pregnant women inoculated with COVID-19 vaccine
I. PREGNANCY INFORMATION
Occupation of Individual* Name of Current Employer, Work Address
𝥷 Health care worker (e.g., hospitals, treatment facilities, vaccination sites, etc.) Office or Agency Barangay: ________________
𝥷 Frontliner City: ____________________
𝥷 Others, please specify ____________________ Province: _________________

Confirmation of pregnancy by test* Gestational age at time of vaccination* Date of Last Menstrual Period*
𝥷 YES, please specify means of confirmation _ _ weeks (MM/DD/YYYY)
____________________
𝥷 NO Trimester* 𝥷1st 𝥷 2nd 𝥷 3rd __/__/____
Current Status of Pregnancy* Date of delivery Type of
𝥷 Still pregnant 𝥷 Abortion (fetal death of less than 14 weeks) (MM/DD/YYYY) Delivery
𝥷 Carried preterm and delivered 𝥷 Carried to term and delivered
Status of Mother* Status of Neonate* Vital Statistics of the Neonate
𝥷 Died (maternal death) 𝥷 Died (Intrauterine fetal death -- death
𝥷 Alive (with no comorbidities) inside the womb) Birth weight (grams): ___________
𝥷 Alive (with comorbidities), specify 𝥷 Died (Born dead and non-responsive Birth length (cm): ____________
___________________________ despite signs of activity prior to the
Head circumference (cm): ___________
puerperal stage)
𝥷 Alive Gestational age at birth (weeks): ______

Number of pregnancies: _______ Number of term births: ________ Number of premature births: ________
Number of abortions (spontaneous or therapeutic): ________ Number of living children: ________
II. COMORBIDITIES AND PAST MEDICAL HISTORY
Maternal medical complication in past pregnancies
𝥷 Hypertensive disorders (eclampsia) 𝥷 Gestational diabetes 𝥷 Premature delivery
𝥷 LBW or SGA infants 𝥷 Neonatal death
𝥷 Others, please specify ___________________________________ 𝥷 None or not applicable
Conditions that increase the risk for obstetric complications for current pregnancy
𝥷 Incompetent cervix 𝥷 Placenta previa 𝥷 Oligo-polyhydramnios
𝥷 Others, please specify ___________________________________ 𝥷 None or not applicable
Active/recent maternal infection with HIV, 𝥷 YES, please specify 𝥷 NO
HepB, Hep C, TB, Malaria, STI, maternal
group B, Streptococcus, and other Chronic
infections
Existing medical conditions or
comorbidities prior to pregnancy
Maternal status at the time of vaccination
1st COVID-19 vaccine dose 2nd COVID-19 vaccine dose Other COVID-19 vaccine dose

𝥷 Normal 𝥷 Normal 𝥷 Normal

𝥷 Morbidity present, please specify morbidity 𝥷 Morbidity present, please specify 𝥷 Morbidity present, please specify
and signs and symptoms morbidity and signs and symptoms morbidity and signs and symptoms
________________________ _______________________ _______________________
Administration of other vaccines during 𝥷 YES, please list all vaccines and date of inoculation 𝥷 NO
pregnancy*

Past history of adverse reactions to 𝥷 YES, please specify details of reaction 𝥷 NO

vaccines before pregnancy*

Administration of concomitant medications 𝥷 YES, please specify 𝥷 NO

including immunomodulatory agents
during pregnancy

Maternal use of alcohol, drugs, use of 𝥷 YES, please specify 𝥷 NO

nutritional or other supplements

Receipt of blood products one month 𝥷 YES, please specify 𝥷 NO

before or after vaccination

*Mandatory fields for completion

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease
response activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the
information sought to be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal
information on the part of the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
11
 Appendix 6. List of adverse events of special interest (AESI) for lower-middle income countries as prioritized by Brighton
Collaboration
AESI Tier Tier 1 Tier 2

Description Refers to serious AESIs observed or associated with COVID- These are non-serious cases, which are
19 vaccines in animal studies, clinical trials and post- theoretical concerns and are relatively common.
introduction pharmacovigilance.
These cases can be included in a cohort-event
This tier is specific for immunization errors and hospitalized monitoring surveillance (out-patient setting).
cases, and appropriate for the conduct of hospital-based or
sentinel-site surveillance.

List  Vaccine-associated enhanced disease*  Acute kidney injury**

 Multisystem inflammatory syndrome in adults and  Acute liver injury**
children*  Anosmia/ageusia
 Myocarditis*  Bell’s Palsy*
Pericarditis*
 Chilblain-like lesions
 Thrombosis with Thrombocytopenia Syndrome*
 Erythema multiforme
 Thrombosis
 Acute pancreatitis
 Thrombocytopenia*
 Rhabdomyolysis
 Acute disseminated encephalomyelitis*
 Subacute thyroiditis
 Encephalitis*
 Myelitis*
 Acute respiratory distress syndrome*
 Anaphylaxis* (may not be hospitalized)
 Toxic Shock Syndrome
 Injection site cellulitis/abscess (may not be
hospitalized)
*Has existing Brighton Collaboration case definitions
**Has published laboratory-based criteria
Note: This list is subject to periodic review and updates, following developments from the Brighton Collaboration website.

For all cases presenting similar symptom as listed by Brighton Collaboration, these shall be for investigation.

Reference: Brighton Collaboration. Suggested list of core COVID-19 adverse events of special interest (AESIs) for safety monitoring in
low and middle-income countries. 2021 June 17. Available from https://brightoncollaboration.us/wp-
content/uploads/2021/06/LMIC-COVID-19-core-AESI-list-v0.9-June-17-2021.pdf

NOTE: According to Republic Act No. 11332 Revised IRR Rule VI Sec. 6, “The aforementioned details are crucial and indispensable for the formulation of appropriate policies and disease
response activities. Hence, health professionals conducting the interview at point of first contact shall obtain such details from a suspect case, properly informing the data subject that the
information sought to be obtained is being processed in accordance with Republic Act No. 10173, or the “Data Privacy Act of 2012,” and that deliberately providing false or misleading personal
information on the part of the person, or the next of kin in case of person’s incapacity, may constitute as non-cooperation punishable under the Act or this IRR.”
Information provided here is for surveillance and investigation use only in the context of detection of safety signals, addressing vaccine hesitancy, and potential claims from PHIC VICP.
Information submitted here may not be used for medico-legal purposes, or performance of medical or clinical audit to the management of the health care provider/s
12