Adverse Events Following Immunization

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 / DRU* Full Name of Reporter*	Facility/DRU Region and Province Designation of Reporter	Type of Facility/DRU* PRC Registration Number	Contact Number* (Landline or Mobile) Email address
II. PATIENT INFORMATION
First Name*	Middle Name*	Last Name/Surname*	Suffix
Date of Birth* Age* Sex* Male Female, check if either applies: Pregnant Lactating Civil Status PhilHealth Number Nationality* Priority Group (when applicable) A1 A2 A3 A4 A5 B1 B2 B3 B4 B5 B6 C Specify profession/comorbidity for A1/A3:
COMPLETE CURRENT ADDRESS AND CONTACT INFORMATION
House No./Lot/Building* Street/Purok/Sitio* Barangay* Municipality* Province* Region* Contact Number* (Landline or Mobile)
III. VACCINATION DETAILS NOTE: Please provide the latest information on latest dose/s received by the patient. You may attach a photocopy of vaccine card/s or provide the other previous vaccination details on the table provided in Appendix 4 as an attached sheet to this form.
1. Dose number* 2. Name of Vaccine* 3. Place of Vaccination (Local/Abroad) 4. Date of Vaccination* 5. Time of Vaccination* AM PM AM PM 6. Route of Administration* 7. Batch/Lot Number* 8. Expiry Date 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 (if any) 16. Date of Reconstitution 17. Time of Reconstitution AM PM AM PM 18. Diluent Batch/Lot Number 19. Diluent Expiry Date 20. Vaccine procured from DOH Local Gov't Unit Private Unknown Others DOH Local Gov't Unit Private Unknown Others
IV. ADVERESE EVENT/S (check all that apply)
Symptom* Date of onset* Time of onset* Please describe the events, including the timeline of occurrences: Chest pain AM PM Chills AM PM Colds AM PM Dizziness AM PM Feeling unwell (malaise) AM PM Fever ≥ 38.0°C AM PM Headache AM PM Itching AM PM Joint Pain AM PM Muscle or body aches AM PM Nausea AM PM Numbness AM PM Rash all over the body AM PM Tiredness AM PM Vaccination site pain AM PM Vomiting AM PM Increased BP AM PM With Hypertension?* Yes No Unknown Other Symptom/s (State all in order) Date of onset (mm/dd/yyy) (State all in order) Time of onset (AM/PM) (State all in order) Patient 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* Patient Management 1. Date the patient was seen or went for a consult: 2. Patient’s Current Status: Received treatment and sent home; Date: Treated and went HAMA; Date of discharge: Currently admitted; Date of admission: Admitting diagnosis: Serious Case*If answered Yes, please fill out pages 2 to 5. No Yes; Life-threatening Disability Hospitalization Congenital anomaly Other important medical event, specify:
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 who attended to the patient shall fill out the form should the attending physician be unavailable. NOTE: The operational definition of serious AEFI cases is 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 Other source of information Nurse Midwife Parent/Guardian Neighbor Barangay Health Worker 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: If the patient Died 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 No consent Other reason/s 3. If verbal autopsy was done; Source 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 occurrence/s.* 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 Past Medical History, OB-GYN History, and Birth and Developmental History Family Medical History (specific to the disease) Personal Social History (i.e. drinking, smoking, etc.) Physical Examination on first interactionThe 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?* 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. 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? 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.
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. RELEVANT PATIENT INFORMATION PRIOR TO IMMUNIZATION
Information Yes/No N/A Remarks"Similar events" 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.)?* / 3. For adult women, currently pregnant? currently breast feeding? / / If pregnant, indicate AOG: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 or Is the patient on any concurrent medication for any illness prior to the vaccination?* (indicate the name of drug, indication, doses, & date) / 6. History of hospitalization in the past 30 days; if with history, indicate the inclusive date/s and cause/s* / 7. Recent history of trauma; if with recent history of trauma, indicate the date, cause and site* / 8. 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 9. Did the patient have any illness/disease that has been laboratory confirmed (i.e. COVID-19?)* /
X. FOR THE HEALTH CARE PROVIDER
1. As of the last assessment of the physician, what was the level of consciousness of the patient? Alert (Conscious) Responsive to pain stimuli Verbally responsive Unresponsive 2. What are the other examinations intended to be done to support the diagnosis but were not done and what are or were the limitations in not performing these studies or 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 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?* No Yes; please provide details. 4. Did the patient or next of kin inquire whether this event is/was caused by the vaccine?* Never manifested Once Unknown 5.Are there efforts done by the HCP to educate or reassure 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?* No Yes; please indicate procedure or measures taken. 6. Prior to discharge, is the patient or next of kin requesting for this event to be investigated and consequently undergo causality assessment?* No, the patient/next of kin declines. Unknown or Not asked Yes FOR COVID ONLY 6. As stated in the PhilHealth Circular No. 2021-0007, is the patient or next of kin considering to file claims for the PhilHealth Vaccine Injury Compensation Package (VICP)?* No Yes Unknown Not Applicable DISCLAIMER: The submission of this form to the Hospital ESU, Local ESU, Regional ESU, or EB does not automatically mean filing of claims to PhilHealth. Please go to nearest PhilHealth Office for filing of claims to the VICP.
XI. CONSENT FROM THE PATIENT OR PARENT/GUARDIAN
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
XII. 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.
XIII. 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* Name of Investigator/Person answering this form* Last Name First Name Middle Name Designation of Investigator* Office/Department/ESU*
XIV. IMMUNIZATION PRACTICES Method/Manner of Investigation: Visual observation of vaccinators On-site inspection Verbal Interview
Vaccinator Name Vaccinator Profession Syringes and Needles Used Yes/No/N/A Remarks Were auto-disable syringes used for immunization? / / 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 same vaccine? / / 2. Was the same reconstitution syringe used for reconstituting different vaccines? / / 3. Was there a separate reconstitution syringe for each vaccine vial? / / 4. Was there a separate reconstitution syringe 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 Others 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:
XV. COLD CHAIN AND TRANSPORT Method/Manner of Investigation: Visual observation of cold chain facility/equipment Others
XV. COLD CHAIN AND TRANSPORT Yes/No Remarks 1. Type of vaccine storage Freezer Refrigerator Dry Store Others, specify 2. Temperature of vaccine storage:°C 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 the apply: Expired No label VVM Stage 3/4 Frozen Other, Specify Specific key findings/additional observations and comments:
Vaccine transportation Method/Manner of Investigation: Visual observation of vaccinators On-site inspection Checking of form
1. Type of vaccine storage Polyurethane Foam Insulation Insulated Plastic Container Styrofoam Others, specify 2. Was the vaccine carrier sent to the site on the same day of vaccination? / 3. Was the vaccine 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:
XVI. VACCINE DETAILS (Indicate vaccines provided at the site linked to AEFI on the corresponding day)
Number of recipients immunized for each brand/type of vaccine at the vaccination site.Attach record if available. Vaccine/s Given Total Doses 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 first few doses of the vial administered Within the last vaccinations of the sessions Within the last doses of the vial administered Unknown 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 that the vaccine given to this patient had a quality defect or is substandard or falsified? / 8. Is it possible for this event to be considered a 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 12. At the best of your knowledge, is this case part of a known cluster of AEFI? Yes No Unknown
Appendix 1. AEFI Definitions
Non-serious AEFIAn event that is not serious and that has no potential to risk to the health of the recipient of the vaccine, but must be carefully monitored as they may signal a potentially larger problem with the vaccine or the vaccination, or may have an impact on the vaccination acceptability in general. Serious AEFIAn event that results in death, is life-threatening, requires in-patient hospitalization or prolonged existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly or birth defect. May also refer to any medical event that requires intervention to prevent one or 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 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. For AEFIs that result in hospitalization 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. 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. 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. 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. 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. 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. 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. 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. The RESU, upon application of the above guidelines, and their judicious understanding of the case, may provide the classification as to seriousness. 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. The Epidemiology Bureau shall regularly review the submissions of the RESUs for harmonization and further standardization of the criteria for seriousness of AEFIs.
Appendix 3. Flow of AEFI Surveillance
Surveillance Cycle Step Definition Purpose Personnel responsible/involved Detection, Notification Identification and recognition of all cases corresponding to locally suitable AEFI case definitions, AEFI clusters, and all other events believed to be due to immunization To recognize and detect AEFI as they occur or when appropriate, to treat or refer patients for treatment Vaccine recipient, Parents of immunized infants and children, health care workers, staff in immunization of healthcare facilities Reporting Transmission of information relevant to AEFIs by means of standardized form, telephone call, direct conversation, or specific application To provide key descriptive epidemiological data (time, place and person) that are critical for identifying clusters and for signal detection Vaccine recipient, Parents of immunized infants and children, health care workers, staff in immunization of healthcare facilities Investigation Collection of pertinent details of the patient, vaccine and other drugs potentially received, the event, immunization services To establish a more specific case definition (as needed) and formulate a hypothesis to what cause the AEFI Healthcare worker who detected the case Causality Assessment Systematic review and evaluation of available data about an adverse event following COVID-19 vaccination To determine the likelihood of a causal association between the event(s) and the vaccine received Regional and National AEFI Committees Case ClassificationsA. Consistent causal association to immunizationA1. 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 manufacturerA3. 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. IndeterminateB1. 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 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. Algorithm (WHO Causality Assessment Manual 2019) References Council for International Organizations of Medical Sciences. Definition and application of terms for vaccine pharmacovigilance. 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 revised WHO classification second edition, 2019 update. WHO 2019 Available from https://www.who.int/publications-detail-redirect/causality-assessment-aefi-user-manual-2019
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 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) 6. Site of Injection* Left Arm Right Arm Left Arm Right Arm Left Arm Right Arm Left Arm Right Arm Left Arm Right 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) 18. Batch/Lot Number* 19. Expiry Date (MM/DD/YYYY)
Appendix 5. Additional form for case-based survey of pregnant women inoculated with COVID-19 vaccine
I. PREGNANT INFORMATION
Occupation of Individual* Health care worker (e.g., hospitals, treatment facilities, vaccination sites, etc.) Frontliner Others, please specify Name of Current Employer, Office or Agency Work Address Barangay: City: Province: Confirmation of pregnancy by test* YES, please specify means of confirmation NO Gestational age at time of vaccination* Weeks Trimester: 1st 2nd 3rd Date of Last Menstrual Period Current status of pregnancy* Still pregnant Abortion (fetal death of less than 14 weeks) Carried preterm and delivered Carried to term and delivered Date of delivery Type of delivery Status of Mother* Died (maternal death) Alive (with no comorbidities) Alive (with comorbidities), specify Status of Neonate* Died (Intrauterine fetal death -- death inside the womb) Died (Born dead and non-responsive despite signs of activity prior to the puerperal stage) Alive Vital Statistics of the Neonate Birth weight (grams): Birth length (cm): Head circumference (cm): 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) LBW or SGA infants Others, please specify Gestational diabetes Neonatal death Premature delivery None or not applicable Conditions that increase the risk for obstetric complications for current pregnancy Incompetent cervix Others, please specify Placenta previa Oligo-polyhydramnios None or not applicable Active/recent maternal infection with HIV, HepB, Hep C, TB, Malaria, STI, maternal group B, Streptococcus, and other Chronic infections YES, please specify NO Existing medical conditions or comorbidities prior to pregnancy Maternal medical complication in past pregnancies 1st COVID-19 vaccine dose Normal Morbidity present, please specify morbidity and signs and symptoms 2nd COVID-19 vaccine dose Normal Morbidity present, please specify morbidity and signs and symptoms Other COVID-19 vaccine dose Normal Morbidity present, please specify morbidity and signs and symptoms Administration of other vaccines during pregnancy* YES, please list all vaccines and date of inoculation NO Past history of adverse reactions to vaccines before pregnancy* YES, please list all vaccines and date of inoculation NO Administration of concomitant medications including immunomodulatory agents during pregnancy YES, please list all vaccines and date of inoculation NO Maternal use of alcohol, drugs, use of nutritional or other supplements YES, please list all vaccines and date of inoculation NO Receipt of blood products one month before or after vaccination YES, please list all vaccines and date of inoculation NO
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-19 vaccines in animal studies, clinical trials and post-introduction pharmacovigilance.This tier is specific for immunization errors and hospitalized cases, and appropriate for the conduct of hospital-based or sentinel-site surveillance. These are non-serious cases, which are theoretical concerns and are relatively common.These cases can be included in a cohort-event monitoring surveillance (out-patient setting). List Vaccine-associated enhanced disease* Multisystem inflammatory syndrome in adults and children* Myocarditis* Pericarditis* Thrombosis with Thrombocytopenia Syndrome* Thrombosis Thrombocytopenia* Acute disseminated encephalomyelitis* Encephalitis* Myelitis* Acute respiratory distress syndrome* Anaphylaxis* (may not be hospitalized) Toxic Shock Syndrome Injection site cellulitis/abscess (may not be hospitalized) Acute kidney injury Acute liver injury Anosmia/ageusia Bell’s Palsy* Chilblain-like lesions Erythema multiforme Acute pancreatitis Rhabdomyolysis Subacute thyroiditis
Has existing Brighton Collaboration case definitions *Has published laboratory-based criteriaNOTE: This list is subject to periodic review and updates, following developments from the Brighton Collaboration website.DISCLAIMER: For all cases presenting similar symptom as listed by Brighton Collaboration, these MAY be for investigation depending on the answers submitted in this form.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.pdfNOTE: 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

Case Report Form

Adverse Events Following Immunization