1 - AEFI Management - May 6, 2021
1 - AEFI Management - May 6, 2021
                                                                                                 INTERIM
                                                           AEFI MANAGEMENT
                                                              PATHWAYS
                                                                           For Healthcare Providers
                                                                                                         Version 1
  Different stakeholders and experts are encouraged to review the fact sheets and algorithms for improvement. The first versions were started by the core team of DOH DPCB and
  were subjected to experts for vetting. These recommendations are subject to change in the future and will be updated based on the most recent evidence available.
Field implementers, end-users, and other stakeholders are encouraged to comment and send their feedback through dpcbcovid@doh.gov.ph.
The Interim AEFI Management - Health Care Providers Fact Sheet is divided into:
                                                           5 TYPES OF REACTIONS
                                                                 Localized reactions
                                                                                                             The definitions, management, and referral criteria for specific types of
                                                                 Systemic reactions                          AEFI are provided as generally based on various references namely:
                                                                                                                Locally available clinical guidelines and established manual of
                                                                                                                procedures on AEFI management
                                                                  Allergic reactions
                                                                                                                Published consensus and opinions of COVID-19 task force,
                                                                                                                experts, and technical working groups
                                                                Neurologic reactions                            Position statements of medical societies
                                                                                                                International Public Health institutions and organizations
                                                                Hematologic reactions
                                                                                                                                                                                                                                                  1
INTERIM AEFI MANAGEMENT V1
Health Care Providers Fact Sheet Version 1
These recommendations will be updated based on most recent evidence.
      health care providers, local and regional epidemiology and                  AEFIs that result in      Health care provider examining the patient suspects that the AEFI resulted in a substantial disruption of a
                                                                                persistent or significant   person's ability to conduct normal activities of daily living, specifically in significant, persistent or permanent
      surveillance units (ESU) shall cooperate and collaborate to
                                                                                        disabilty           change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or
      comprehensively complete the other pages.                                                             quality of life.
      Immediate notification shall be done to the respective Local                 AEFIs that result in     (1) the exposure is prior to conception or during pregnancy; AND
      Vaccine Operation Center and/or Local Epidemiology and                    Congenital Anomaly or       (2) the health care provider examining the patient suspects that the drug resulted to a congenital anomaly or
                                                                                       Birth Defect         birth defect.
      Surveillance Unit, and Regional Vaccine Operation Center and/or
                                                                                    AEFIs that are          Health care provider examining the patient suspects that the patient was at substantial risk of dying at the
      Regional Epidemiology and Surveillance Unit based on locally set           considered to be life-     time of the adverse event.
      or regionally set mechanisms.                                                   threatening
      All local ESUs and hospitals ESUs shall update their respective              AEFIs that require
                                                                                                            (1) the health care provider examining the patient suspects that medical or surgical intervention was
      RESUs or their representatives designated by the CHDs by                  intervention to prevent
                                                                                                            necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body
                                                                                       any of the
      submitting updated CIFs and informing of the latest clinical status,                                  structure; AND
                                                                                   abovementioned
      investigation status, and other pertinent information on a daily                                      (2) either situation is suspected to be due to the exposure.
                                                                                       outcomes
      basis.
  All hospitals, through their designated hospital Epidemiology and             When further clarity is needed to define the seriousness of an AEFI, the Regional Epidemiology and Surveillance Unit shall have the
  Surveillance Units, shall encode page 1 of the CIF from all newly             authority to provide immediate guidance and classification of seriousness of the AEFI, as referred by the inquiring health care provider.
  detected AEFIs within their institution directly to VigiFlow at                   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.
  vigiflow.who-umc.org before 6:00 PM of each day, including weekend
                                                                                    The RESU, upon application of the above guidelines, and their judicious understanding of the case, may provide the classification as to
  and holidays.                                                                     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.
                                                                                                                                                                                                                                  3
INTERIM AEFI MANAGEMENT V1
Health Care Providers Fact Sheet Version 1
These recommendations will be updated based on most recent evidence.
                                                                       TABLE OF CONTENTS
           LOCALIZED REACTIONS                                                    6
SYSTEMIC REACTIONS 7
               Hypotension                                                        7
               Hypertensive Emergency                                             7
               Hypertensive Urgency                                               7
               Dizziness                                                          7
               Fever                                                              8
               Myalgia                                                            8
               Fatigue                                                            8
               Nausea/ Vomiting                                                   8
ALLERGIC REACTIONS 9
               Anaphylaxis                                                        9
               Allergic Skin Reactions                                            11
NEUROLOGIC REACTIONS 12
                Convulsions/ Seizures                                             12
                Headache                                                          12
                Vasovagal Syncope                                                 13
                                                                                           4
INTERIM AEFI MANAGEMENT V1
Health Care Providers Fact Sheet Version 1
These recommendations will be updated based on most recent evidence.
                                                                       TABLE OF CONTENTS
             HEMATOLOGIC REACTIONS                                                14
ALGORITHMS 16
                Localized Reactions
                        Pain, Redness, or Swelling Pathway                        16
                        Arthralgia Pathway                                        16
                        Injection Site Abscess Pathway                            17
                Systemic Reactions
                        Dizziness/ Hypotension Pathway                            18
                        Elevated BP Pathway                                       19
                        Other Systemic Reactions Pathway                          20
                Allergic Reactions
                        Anaphylaxis Pathway                                       22
                        Allergic Skin Reactions Pathway                           23
                Neurologic Reactions
                        Convulsions/ Seizures                                     24
                        Headache                                                  25
                        Vasovagal Syncope                                         26
                Hematologic Reactions
                        Vaccine Induced Thrombotic
                        Thrombocytopenia (VITT) Pathway                           27
                        COVID-19 Vaccine-Associated Immune
                        Thrombocytopenia (ITP) Pathway                            28
                                                                                           5
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                             LOCALIZED REACTIONS
                REACTION                                  DEFINITION                                                                                                MANAGEMENT                                                     REFERRAL CRITERIA
                                                                                                                     Over the counter medications (ibuprofen, acetaminophen, antihistamine) can be prescribed
                                           Pain, redness or swelling at the injection site that
               PAIN OR REDNESS                                                                                       Application of clean, cool, wet cloth over the area                                                     If reaction persists for more than 7 days, refer to
                                               Extends past the nearest joint or
                 OR SWELLING                                                                                         Use or exercising the arm.                                                                              the higher level of care.
                                               Persist for 0-7 days
                                                                                                                     Increase oral fluid intake.                                                                                                             EBR [DOH-AEFI Manual]
                                                                          FBR [Brighton Collaboration]
                                                                                                                                                                                                                FBR [CDC]
                                           Joint pain usually includes small peripheral joints                                                                                                                               If reaction persists and interferes with daily
                                                                                                                     May give analgesics
                 ARTHRALGIA                    Persistent: lasting longer than 10 days                                                                                                                                       activities, refer to the higher level of care.
                                                                                                                     Encourage gentle movement of the joint(s) involved to prevent stiffness
                                               Transient: 10 days or less                                                                                                                                                                                   EBR [DOH-AEFI Manual]
                                                                                                                                                                                                               FBR [NCRIS]
                                                                                EBR [DOH-AEFI Manual]
                                                               Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR     CONSENSUS BASED RECOMMENDATION
                                                               National Centre for Immunisation Research and Surveillance, Australia. July 2019. Injection Site Reactions Information Sheet
         PBR     PRACTICE BASED RECOMMENDATION                 Department of Health - Research Institute of Tropical Medicine. 2017. National Antibiotic Guidelines.
                                                               Brighton Collaboration. 2004.                                                                                                                                                                                         6
         FBR     FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                                SYSTEMIC REACTIONS
               REACTION                                 DEFINITION                                                                                                 MANAGEMENT                                                                         REFERRAL CRITERIA
                                         May be absolute (e.g. sBP <90 mmHg, mean
                                                                                                                    Consider anaphylaxis (refer to major and minor criteria of anaphylaxis)
               HYPOTENSION               arterial pressure <65 mmHg) , or relative (e.g. a                                                                                                                                                      Refer to the EMERGENCY ROOM IMMEDIATELY
                                                                                                                    Secure IV access and may initiate infusion of 2 to 3 liters of 0.9% NaCl in 10-20 minutes
                                         drop in sBP >40 mmHg)                                                                                                                                                                                                                         FBR [UpToDate]
                                                                                                                    Refer to the EMERGENCY ROOM IMMEDIATELY
                                                                                     FBR [UpToDate]
                                                                                                                                                                                                                               FBR [UpToDate]
                                                                                                                    May proceed with vaccination, but observe client for 30-60 minutes post-vaccination to monitor
                                                                                                                    for evolving signs or symptoms of hypertensive emergency, as well as hypotension (anaphylaxis)
                                          Elevations of the sBP >180 mmHg and/or dBP
                                                                                                                    Have the patient relax in a comfortable environment, do deep breathing exercises, or allow the                              If with evolving signs and symptoms of
                                          <120 mmHg WITHOUT symptoms of target organ
               HYPERTENSIVE                                                                                         patient to void. Re-check BP reading after 30 minutes. If previously diagnosed Hypertensive,
                                          damage or hypertensive-mediated organ damage                                                                                                                                                          hypertensive emergency, refer to the
                 URGENCY                                                                                            adjust or resume medication if with poor compliance. If no previous diagnosis of hypertension,
                                          such as Acute Coronary Syndrome, Heart failure,                                                                                                                                                       EMERGENCY ROOM IMMEDIATELY
                                                                                                                    may start medication with Renin-Angiotensin-Aldosterone System inhibitor, Calcium channel
                                          Stroke and Acute kidney injury                                                                                                                                                                                                               PBR [PHA-PSH]
                                                                                                                    blocker, or in combination; Calcium channel blocker for reproductive women
                                                                                       PBR [PHA-PSH]
                                                                                                                    Counsel to seek further consultation for proper work-up in the soonest possible time
                                                                                                                                                                                                                               PBR [PHA-PSH]
         CBR    CONSENSUS BASED RECOMMENDATION               Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
                                                             UpToDate Inc. 2011-2021
         PBR    PRACTICE BASED RECOMMENDATION
                                                             Philippine Heart Association and Philippine Society of Hypertension. 2021. Algorithm on the Management of Blood Pressure Elevation Before and After Vaccination
                                                                                                                                                                                                                                                                                                        7
         FBR    FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                               SYSTEMIC REACTIONS
               REACTION                                 DEFINITION                                                                                                MANAGEMENT                                                         REFERRAL CRITERIA
                                         Endogenous elevation of at least one measured
                                         body temperature of ≥ 38 C                                                                                                                                                            If fever does not resolve after 3 days with
                  FEVER                                                                                            May treat symptomatically with Paracetamol                                                                  treatment or with extremely high temperature
                                            Mild: 38 C to 38.9 C
                                                                                                                                                                                                       EBR [DOH-AEFI Manual]
                                            High: 39 C to 40.4 C                                                                                                                                                                    Refer to the higher level of care
                                            Extreme: 40.5 or higher                                                                                                                                                                                           EBR [DOH-AEFI Manual]
                                                                             EBR [DOH-AEFI Manual]
                                         The unpleasant sensation of being about to vomit,                          Rule out anaphylaxis (Ammended NIAID/FAAN criteria for the diagnosis of anaphylaxis)                       If symptoms persist, or if with signs and
                                         can occur alone or can accompany vomiting (the                             For nausea, may treat with oral antiemetics, metoclopramide, if necessary                                  symptoms of moderate to severe dehydration,
           NAUSEA/ VOMITING              forceful expulsion of gastric contents)                                    For vomiting, give oral rehydration salts for volume per volume replacement to prevent                     refer to the higher level of care
                                         Severe enough to interfere with daily routine                              dehydration                                                                                                                                     FBR [UpToDate] ]
                                                                                      FBR [UpToDate]                                                                                                         FBR [UpToDate]
LEGEND
         CBR   CONSENSUS BASED RECOMMENDATION                Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         PBR   PRACTICE BASED RECOMMENDATION                 UpToDate Inc. 2011-2021
                                                                                                                                                                                                                                                                                       8
         FBR   FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                            ALLERGIC REACTIONS
               REACTION                                  DEFINITION                                                                                                MANAGEMENT                                                                  REFERRAL CRITERIA
                                                                                                                     If the patient presents the defined symptoms and within the level of diagnostic certainty,
                                         Anaphylaxis is highly likely when one of the
                                         following 2 criteria are fulfilled:                                      1. URGENTLY
                                              Acute onset of an illness (minutes to several                               Put the patient in reclining position with legs up
                                              hours) with simultaneous involvement of the                                 Administer Epinephrine (Adrenaline)
                                              skin, mucosal tissue, or both (e.g., generalized                                0.5 mL per dose, intramuscularly ONLY on mid-outer thigh even through clothing, OR
                                              hives, pruritus or flushing, swollen lips-tongue-                               0.3 mg in auto-injector, intramuscularly ONLY on mid-outer thigh even through clothing
                                              uvula) AND AT LEAST ONE OF THE                                      2. THEN
                                              FOLLOWING:                                                                  Secure IV access and start infusion with 0.9% NaCl (10-20 mL/min)                                               If symptoms did not resolve after the execution
                                                  Respiratory compromise (e.g., dyspnea,                                  Clear the airway                                                                                                of management steps 1 and 2
                                                  wheeze-bronchospasm, stridor, reduced                                   Administer OXYGEN via face mask (at least 10 LPM)                                                                    Call emergency assistance and refer to the
                                                  PEF, hypoxemia)                                                         Administer GLUCOCORTICOID (Hydrocortisone 200 mg IV)
               ANAPHYLAXIS                                                                                                                                                                                                                     higher level of care.
                                                  Reduced BP or associate symptoms of                                     Administer ANTI-HISTAMINE (e.g. Diphenhydramine 50 mg IV)
                                                                                                                                                                                                                                               Perform conditional management steps 4, 5,
                                                  end-organ dysfunction (e.g., hypotonia                                  Monitor vital signs**
                                                                                                                                                                                                                                               and 6 in the previous box (MANAGEMENT)
                                                  [collapse], syncope, incontinence)                              3. IF RESOLVED
                                                  Severe gastrointestinal symptoms (e.g.,                                 Discharge 4-8 hours after full resolution of symptoms
                                                                                                                                                                                                                                                                               PBR [PSAAI]
                                                  severe crampy abdominal pain, repetitive                                Refer and advise follow-up to allergy service for consult as outpatient.
                                                  vomiting), especially after exposure to non-
                                                                                                               **IF NOT RESOLVED,
                                                  food allergens
                                              Acute onset of hypotension or bronchospasm
                                                                                                                     4. IF blood pressure drops
                                              or laryngeal involvement after exposure to
                                                                                                                          Infuse 2000-3000 mL of 0.9% NaCl intravenously in 10-20 minutes
                                              known or highly probable allergens for that
                                                                                                                     5. IF no improvement in 5-10 minutes
                                              patient (minutes to several hours), even in the
                                                                                                                          REPEAT EPINEPHRINE INTRAMUSCULARLY
                                              absence of typical skin involvement.
                                                                                                                     6. IF with bronchospasm
                                                                                                                          Give salbutamol MDI
                                                                 FBR [Brighton Collaboration, WAO]
                                                                                                                              4-10 puffs via large volume spacer
                                                                                                                                                                                                                            PBR [PSAAI]
SOURCES
                                                              Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR   CONSENSUS BASED RECOMMENDATION                 Brighton Collaboration. 2004
         PBR   PRACTICE BASED RECOMMENDATION                  Philippine Society of Allergy, Asthma, and Immunology. 2021. Algorithm on Diagnosis and Management of Severe Allergic Reactions After COVID-19 Vaccination.
                                                              World Allergy Organization. 2020. World Allergy Organization Anaphylaxis Guidance.
                                                                                                                                                                                                                                                                                             9
         FBR   FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                                 ALLERGIC REACTIONS
               REACTION                                                      DEFINITION                                                                                                           MANAGEMENT                           REFERRAL CRITERIA
                                                MAJOR
               ANAPHYLAXIS**                                           Generalized urticaria (hives) and generalized erythema
                                               Dermatologic
                                                                       Angioedema, localized or generalized
           Anaphylaxis is rare but             or mucosal
           potentially life threatening
                                                                       Generalized pruritus with skin rash
           allergic reaction occurring 0-24
           hours after immunization. It is a                           Measured hypotension
           clinical syndrome characterized                             Clinical diagnosis of uncompensated shock, indicated by the
           by sudden onset, rapid              Cardiovascular          combination of at least 3 of the ff:
           progression of signs and
                                                                           tachycardia
           symptoms, and involving
           multiple (≥2) organ systems as                                  capillary refill time >3 sec
           follows:                                                        reduced central pulse volume
               LEVEL 1 of diagnostic
               certainty                                               Bilateral wheeze
                    ≥ 1 major dermatological                           Stridor
                    AND
                                                                       Upper airway swelling (lip, tongue, uvula, larynx)
                    ≥ 1 major cardiovascular
                    AND/OR ≥1 major            Respiratory             Respiratory distress - 2 or more of the ff:
                    respiratory criterion                                  tachypnea
               LEVEL 2 of diagnostic                                       increased use of accessory respiratory muscles
               certainty
                                                                           recession
                    ≥ 1 major cardiovascular
                    AND ≥1 major                                           cyanosis
           respiratory criterion                                           grunting                                                                                                                  SEE PREVIOUS PAGE                    SEE PREVIOUS PAGE
                    ≥ 1 major cardiovascular
                    OR ≥1 major                 MINOR
           respiratory criterion AND                                    Generalized pruritus without skin rash
                    ≥ 1 minor criterion        Dermatologic             Generalized prickly sensation
                    involving ≥1 different
                                               or mucosal               Localized injection site urticaria
           system (other than
           cardiovascular or respiratory                                Red and itchy eyes
           systems) OR
                                                                        Reduced peripheral circulation as indicated by the combination of at
                    (≥ 1 major dermatologic)
                    AND (≥1 minor                                       least of 2 of:
                                               Cardiovascular
           cardiovascular AND/OR minor                                      tachycardia and a capillary refill time >3 sec without hypotension
           respiratory criterion)                                           a decreased level of consciousness
               LEVEL 3 of diagnostic
               certainty                                                Persistent dry cough
                    ≥ 1 minor cardiovascular                            Hoarse voice
                    OR ≥1 respiratory
                                               Respiratory              Difficulty breathing without wheeze or stridor
                    criterion AND                                                                                                                                            **This reference is based on Brighton Collaboration
                    ≥ 1 minor criterion of                              Sensation of throat closure
                                                                                                                                                                             and will serve as an additional reference. The
                    each of ≥2 different                                Sneezing, rhinorrhea
           systems/categories                                                                                                                                                algorithm below (page 22) is based on the definition
                                                                        Diarrhea                                                                                             of the World Allergy Organization (previous page) and
           Check major and minor criteria                               Abdominal pain
                                               Gastrointestinal                                                                                                              was used as the main reference for the definition of
           below:                                                       Nausea
               FBR [Brighton Collaboration]                                                                                                                                  anaphylaxis.
                                                                        Vomiting                                               FBR [Brighton Collaboration]
LEGEND
                                                                   Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR     CONSENSUS BASED RECOMMENDATION                    Brighton Collaboration. 2004
         PBR     PRACTICE BASED RECOMMENDATION                     Philippine Society of Allergy, Asthma, and Immunology. 2021. Algorithm on Diagnosis and Management of Severe Allergic Reactions After COVID-19 Vaccination.
                                                                   World Allergy Organization. 2020. World Allergy Organization Anaphylaxis Guidance.
                                                                                                                                                                                                                                                              10
         FBR     FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                           ALLERGIC REACTIONS
               REACTION                                 DEFINITION                                                                                                MANAGEMENT                                                                   REFERRAL CRITERIA
                                         An allergic reaction of the skin including any one of
                                                                                                                   Rule out anaphylaxis (Ammended NIAID/FAAN criteria for the diagnosis of anaphylaxis)
                                         the following: urticaria (hives), erythema, pruritus,
                                                                                                                   Give antihistamines (oral/IV), glucocorticoids (oral/IV), and observe for 4 hours
                                         prickly (or tingling) sensation, localized or                                                                                                                                                   If symptoms did not resolve, refer to the higher
               ALLERGIC SKIN                                                                                           Secure IV line if medication will be given intravenously
                                         generalized edema (in the deeper layers of the                                                                                                                                                  level of care.
                 REACTION                                                                                          Discharge 4-8 hours after full resolution of symptoms
                                         skin, subcutaneous tissues or mucosa lining the                                                                                                                                                                                         PBR [PSAAI]
                                                                                                                   Refer and advise follow-up to allergy service for consult as outpatient.
                                         throat, airways and gut) ONLY
                                                                                                                                                                                                                           PBR [PSAAI]
                                                                                        FBR [BC CDC]
LEGEND
                                                             Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR    CONSENSUS BASED RECOMMENDATION
                                                             Brighton Collaboration. 2004.
         PBR    PRACTICE BASED RECOMMENDATION                Philippine Society of Allergy, Asthma, and Immunology. 2021. Algorithm on Diagnosis and Management of Severe Allergic Reactions After COVID-19 Vaccination.
                                                             BC Centre for Disease Control.                                                                                                                                                                                                    11
         FBR    FOREIGN BASED RECOMMENDATION                 World Allergy Organization. 2020. World Allergy Organization Anaphylaxis Guidance.
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                 NEUROLOGIC REACTIONS
               REACTION                                 DEFINITION                                                                                                MANAGEMENT                                                                      REFERRAL CRITERIA
                                                                                                                  Lay patient on his/her side. DO NOT try to hold down the patient. Keep sharp objects away to avoid
                                                                                                                  other injuries
                                                                                                                  Provide supportive care
                                                                                                                      Oxygen support
                                                                                                                      Secure IV access as much as possible
                                                                                                                      Benzodiazepine for initial treatment
                                                                                                                          Intravenous
                                                                                                                               Lorazepam 0.1 mg/kg (maximum 4mg); maximum cumulative adult dose 8mg, OR
                                                                                                                               Diazepam 0.15 - 2 mg/kg (maximum 10mg); maximum cumulative adult dose 20mg, OR
                                                                                                                               Clonazepam 0.015 mg/kg (maximum 1mg); maximum cumulative adult dose 2mg
                                          Occurrence of generalized convulsions that are not                                                                                                                                                Refer to the EMERGENCY ROOM IMMEDIATELY
                                                                                                                               All can be repeated after 5 minutes if no effect observed, up to the maximum cumulative
               CONVULSIONS/               accompanied by focal neurological signs or                                                                                                                                                                                FBR [British Epilepsy Association]
                                                                                                                               dose stated
                 SEIZURES                 symptoms
                                                                                                                          Non-intravenous
                                                                             EBR [DOH AEFI Manual]
                                                                                                                               Midazolam IM/IN/buccal 10mg; 5mg in elderly or <40kg (maximum cumulative adult
                                                                                                                               dose 20mg, 10mg <40kg), OR
                                                                                                                               Diazepam 10mg rectal; 5mg in elderly or <40kg, OR
                                                                                                                               Lorazepam intranasal 4mg; 0.1mg/kg <40kg
                                                                                                                               All can be repeated after 10 minutes if no effect observed, up to the maximum
                                                                                                                               cumulative dose stated
                                                                                                                          NOTE: All benzodiazepines can cause respiratory depression, sedation and hypotension at
                                                                                                                          higher doses and in susceptible patients
                                                                                                                  Refer to the EMERGENCY ROOM IMMEDIATELY
                                                                                                                                                                                                       FBR [British Epilepsy Association]
         CBR    CONSENSUS BASED RECOMMENDATION               Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
                                                             British Epilepsy Association. 2019. Medical Management of Status Epilepticus: Emergency Room to Intensive Care Unit
         PBR    PRACTICE BASED RECOMMENDATION
                                                             UpToDate Inc. 2011-2021
                                                                                                                                                                                                                                                                                                         12
         FBR    FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                      NEUROLOGIC REACTIONS
               REACTION                                 DEFINITION                                                                                                MANAGEMENT                                                                      REFERRAL CRITERIA
                                                                                                                   Prevent injuries
                                                                                                                   Differentiate fainting attack from anaphylaxis
                                                                                                                      Cardiovascular                Bradycardia,    weak      pulse,                   Tachycardia, weak pulse, carotid      Refer to the higher level of care if persistent
                                        Fainting episode as body reacts to various triggers
               VASOVAGAL                                                                                                                            carotid pulse felt, reversed by                    pulse may be weak, hypotension        despite supportive treatment and reassurance.
                                        before, during, or after vaccination, perhaps triggered
                                                                                                                                                    supine position                                    not reversed by supine position                                     EBR [DOH-AEFI Manual]]
                SYNCOPE                 by pain or emotional reaction to immunization
                                        process itself
                                                                               FBR [UpToDate, CDC]                    Gastrointestinal              Vomiting                                           Vomiting,   diarrhea,   abdominal
                                                                                                                                                                                                       cramps
                                                                                                                        Panic attack: No hypotension, pallor, wheeze, or urticarial rash or swelling. May have flushing or
                                                                                                                        blotchy skin
                                                             Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR   CONSENSUS BASED RECOMMENDATION                British Epilepsy Association. 2019. Medical Management of Status Epilepticus: Emergency Room to Intensive Care Unit
         PBR   PRACTICE BASED RECOMMENDATION                 UpToDate Inc. 2011-2021
                                                             US CDC                                                                                                                                                                                                                                 13
         FBR   FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                            HEMATOLOGIC REACTIONS
               REACTION                                 DEFINITION                                                                                             MANAGEMENT                                                                                   REFERRAL CRITERIA
                                                                                                                   Ask patient about COVID-19 vaccine history and note the date that they received the doses, if any
                                                                                                                   Draw a complete blood count (CBC)
                                                                                                                   If platelet count is equal or less than 150 x 1,000,000,000 / L, AND their symptoms occur within
                                                                                                                   28 days after the COVID-19 vaccination, screen for VITT
                                                                                                                   Suspect VITT patients need to be referred to a higher level of care for further testing:
                                                                                                                        D-dimer
                                                                                                                        fibrinogen levels
                                                                                                                        Blood films to confirm thrombocytopenia
                                                                                                                        Platelet factor 4 (PF4) antibody assay (ELISA Heparin-Induced Thrombocytopenia (HIT)
                                                                                                                        assay)
                                        A condition of blood clots associated with low
                                                                                                                        Imaging (e.g. CT or MRI) to rule out in particular CVST
                                        platelet counts, that occurs following receipt of the
                                                                                                                        Functional platelet activation assay
                                        vaccine
                                                                                                                   Cases are often characterized also with very raised D-Dimer levels (>4000 mcg/L or more than 4x
                                        Most cases occurred 4 to 28 days after receipt of a
                                                                                                                   the threshold) above the level expected for VTE and many develop low fibrinogen levels
                                        vector vaccine such as Astrazeneca or J&J
                                                                                                                   Antibodies to PF4, as detected by ELISA HIT assay, have also been identified in this syndrome
                                        May present with cerebral sinus vein thrombosis
                                                                                                                   Secondary/ Tertiary Care:
                                        (CSVT), or with other arterial or venous clots
                                                                                                                        DO NOT GIVE HEPARIN
          VACCINE-INDUCED               Clinical Presentation
                                                                                                                        Platelet transfusions are not recommended unless a life-threatening hemorrhage is present
                                            Persistent and severe headache                                                                                                                                                                            Refer to the higher level of care immediately
            THROMBOTIC                                                                                                  (or patient requires urgent surgery)
                                            Focal neurological symptoms                                                                                                                                                                                                                FBR [United Nations]]
         THROMBOCYTOPENIA                                                                                               Consult a hematologist
                                                                                                                                                                                                                                                                                              PBR [PCHTM]
                                            Seizures, or blurred or double vision (suggesting
               (VITT)                                                                                                   Give intravenous immunoglobulin 0.5 – 1.0g/kg/day for 2 days for severe or life-threatening
                                            CSVT or arterial stroke)
                                                                                                                        clots, if available. Further, IVIG may require balancing bleeding and thrombotic risk
                                            Shortness of breath or chest pain (suggesting
                                                                                                                        Start Steroids (Methylprednisolone 1mg/kg)
                                            pulmonary embolism or acute coronary
                                                                                                                        Use first line anticoagulants: direct oral anti-Xa inhibitors (e.g. rivaroxaban, apixaban,
                                            syndrome)
                                                                                                                        edoxaban), direct thrombin inhibitors (argatroban, bivalirudin), indirect (anti-thrombin-
                                            Abdominal pain (suggesting portal vein
                                                                                                                        dependent) Xa inhibitors (danaparoid) or Fondaparinux
                                            thrombosis)
                                                                                                                        Until VITT has been ruled out, anticoagulation with heparin (both unfractionated heparin and
                                            Limb swelling, redness, pallor, or coldness
                                                                                                                        low molecular weight heparins) should NOT be given
                                            (suggesting deep vein thrombosis or acute limb
                                                                                                                        Vitamin K antagonist (warfarin) is contraindicated during acute severe thrombocytopenia and
                                            ischemia)
                                                                                                                        disseminated intravascular coagulation
                                                                               FBR [United Nations]
                                                                                                                        Consider instituting early therapeutic plasma exchange or fibrinogen substitution to >1.0 g/L
                                                                                                                        if platelet count remains below 30 x 1,000,000,000/L despite IVIG and steroids or fibrinogen
                                                                                                                        level is less than 1 g/L
                                                                                                                        Specialized guidance available at: UK: Guidance Produced from the Expert Haematology
                                                                                                                        Panel (EHP) focused on Covid-19 Vaccine induced Thrombosis and Thrombocytopenia
                                                                                                                        (VITT) https://b-s-h.org.uk/media/19530/guidance-version-13-on-mngmt-of-thrombosis-with-
                                                                                                                        thrombocytopenia-occurring-after-c-19-vaccine_20210407.pdf
                                                                                                                                                                                                                       FBR [United Nations]
                                                                                                                                                                                                                             PBR [PCHTM]
LEGEND
         CBR   CONSENSUS BASED RECOMMENDATION                United Nations. April 2021. Interim Guidelines: Diagnosis and Management of Vaccine-Induced Prothrombotic Immune Thrombocytopenia (VIPIT) following AstraZeneca COVID-19 Vaccinations.
                                                             Specialized guidance available at: UK: Guidance Produced from the Expert Haematology Panel (EHP) focused on Covid-19 Vaccine induced Thrombosis and Thrombocytopenia (VITT)
         PBR   PRACTICE BASED RECOMMENDATION                 https://b-s-h.org.uk/media/19530/guidance-version-13-on-mngmt-of-thrombosis-with-thrombocytopenia-occurring-after-c-19-vaccine_20210407.pdf
                                                                                                                                                                                                                                                                                                               14
         FBR   FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                              HEMATOLOGIC REACTIONS
               REACTION                                 DEFINITION                                                                                               MANAGEMENT                                                                                            REFERRAL CRITERIA
                                                                                                                                                                                                                            LOCALIZED REACTIONS
                                                                                                                                                               PAIN, REDNESS, OR SWELLING, AND ARTHRALGIA PATHWAYS
                                           There is
                                                                                                                                                                               Over the counter medications (ibuprofen, acetaminophen, antihistamine) can be prescribed
                                 PAIN, REDNESS, OR                                                                                                                             Application of clean, cool, wet cloth over the area
                                                                                                                                                               N
                                    SWELLING                                                        Persist for more than 7 days?                                              Use or exercising the arm.
                               at the injection site, or extends                                                                                                               Increase oral fluid intake.
                                                                                                                                                                                                                                                                     FBR [CDC]
                                    past the nearest joint
                                                                Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR   CONSENSUS BASED RECOMMENDATION
                                                                National Centre for Immunisation Research and Surveillance, Australia. July 2019. Injection Site Reactions Information Sheet
         PBR   PRACTICE BASED RECOMMENDATION                    Department of Health - Research Institute of Tropical Medicine. 2017. National Antibiotic Guidelines.
                                                                Brighton Collaboration. 2004.                                                                                                                                                                                    16
         FBR   FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                            LOCALIZED REACTIONS
                                               There is an                                                                                                                                                  INJECTION SITE ABSCESS PATHWAY
                                 INJECTION SITE ABSCESS
                         at the injection site, or extends past the nearest joint
                                                              N
                                                                                                                                                                                                                     May refer to a higher level of
                                                                                                                                                                                                                     care and treat as in-patient
                                                                                                                                                                                                                               EBR [DOH-AEFI Manual]
                                          With diabetes or                                        Y
                                        immunosuppression
                                                                                                                                                                                                                            REPORT AEFI
                                                                                                                                                                                                                      through reporting platforms
                                                                  Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR   CONSENSUS BASED RECOMMENDATION
                                                                  National Centre for Immunisation Research and Surveillance, Australia. July 2019. Injection Site Reactions Information Sheet
         PBR   PRACTICE BASED RECOMMENDATION                      Department of Health - Research Institute of Tropical Medicine. 2017. National Antibiotic Guidelines.
                                                                  Brighton Collaboration. 2004.                                                                                                                                                              17
         FBR   FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                   The patient is
                                                                                                                                                                    experiencing
                                                                                                                                                                                                                                                              SYSTEMIC REACTIONS
                                                                                                                                                                  DIZZINESS
                                                                                                                                                                                                                                                            DIZZINESS/ HYPOTENSION PATHWAY
                                                                                                                                                                                       N
                                                                                                                                                                                                                                                                                      REFER TO ER                      REFER TO
                                                                                                                                                                    Characterize                                                              REPORT AEFI
                                                                                                                                                                                                                                                                                     IMMEDIATELY                      ANAPHYLAXIS
                                                                                                                                                                    the dizziness                                                       through reporting platforms
                                                                                                                                                                                                                                                                                                 FBR [UpToDate]        PATHWAY
                                                                                                   1
         Acute onset of an illness with simultaneous involvement of the skin and/ or
         mucosal tissue (e.g., generalized hives, pruritus or flushing, swollen lips-                                                                          postural instability?
         tongue-uvula)                                                                                                                                                FBR [UpToDate]                                                                                                                  N
         AND at least                                Airway/ Breathing                                                                                                                                                                                                        Other categories or symptoms of
          one of the
          following:
                                                                            Respiratory compromise                                                                                     Y                                                                                      dizziness:
                                                         (eg, dyspnea, wheeze-bronchospasm, stridor,                                                                                                                                                                              Disequilibrium - feeling of
                                                                            reduced PEF, hypoxemia)                                                                                                                                                                               unsteadiness or impending fall
                                                      Circulation
                                                                                                                                                                 Patient may be                                                                                                   that occurs primarily when
                                                                                                                                                               experiencing vertigo                                                                                               walking
                                                        Reduced BP or associated symptoms of end-
                                                                                                                                                                                                                                                                                  Presyncope - sense of feeling
                                                                                   organ dysfunction
                                                      (eg, hypotonia/collapse, syncope, incontinence)                                                                                                                                                                             faint or on the verge of losing
                                                                                                                                                                                                                                                                                  consciousness
                                                     Severe Gastrointestinal Symptoms
                                                                                                                                         Reassure and establish a supportive environment.                                                                                         Lightheadedness - usually
                                                        (e.g. Severe crampy abdominal pain, repetitive                                                                                                                                                                            nonspecific but can refer to
                                                                                                                                         May be given symptomatic treatment
                                                                                            vomiting)                                                                                                                                                                             feeling disconnected from the
                                                                                                                                         (e.g. 1st generation antihistamines or antiemetics, if
                                                                                                                                                                                                                                                                                  environment or sometimes
                   Acute onset of hypotension* or bronchospasm or laryngeal involvement**                                                necessary)
          2        after exposure to a known or highly probable allergen for that patient, even
                   in the absence of typical skin involvement
                                                                                                                                                                                                                                                                                  may
                                                                                                                                                                                                                                                                                  sensation
                                                                                                                                                                                                                                                                                           refer   to   spinning
                                                                                                                                                                                                                                                                                                 FBR [UpToDate]
     * Hypotension is defined as a decrease in systolic BP greater than 30% from that person's baseline, OR:                                         Persistence despite medication?
         i. Infants and children under 10 years: systolic BP less than (70 mmHg + [2 x age in years])
         ii. Adults and children over 10 years: systolic BP less than <90 mmHg                                                                                                                                          Consider referring to a higher                     REPORT AEFI
     ** Laryngeal symptoms include: stridor, vocal changes, odynophagia.
                                                                                                                                                                                                                       level of care for further work-up             through reporting platforms
                                                                                                                                                                                                                                 EBR [DOH-AEFI Manual]
LEGEND
           CBR          CONSENSUS BASED RECOMMENDATION                                    Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
                                                                                          UpToDate Inc. 2011-2021
           PBR          PRACTICE BASED RECOMMENDATION
                                                                                          Philippine Heart Association and Philippine Society of Hypertension. 2021. Algorithm on the Management of Blood Pressure Elevation Before and After Vaccination
                                                                                                                                                                                                                                                                                                                                       18
           FBR          FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                      N
                                                                                                 N
                           May proceed with                                                                                                                                                                             Consider
                                                                                  HYPERTENSIVE
                         vaccination following                                                                                                                                                                          anaphylaxis (refer to
                                                                                    URGENCY
                          special precautions                                                                                                                                                                           Amended NIAID/
                                                                                                                                                                                                                        FAAN criteria for the
                                                                                                                                                                                                                        diagnosis of
                                                                                                                                                                                                                        anaphylaxis)                        REFER TO ER                       REFER TO
                       Have the patient relax in a
                   comfortable environment, do deep                                                                                                                                                                     Secure IV access                   IMMEDIATELY                       ANAPHYLAXIS
                                                                                       Are there evolving
                    breathing exercises, or allow the                                                                                                                                                                   and may initiate                               FBR [UpToDate]         PATHWAY
                                                                                     signs or symptoms of
                        patient to void/ urinate.                                                                                                                                                                       infusion of 2 to 3
                                                                                         hypertensive
                   Observe patient for 30-60 minutes                                     emergency?                                                                                                                     liters of 0.9% NaCl in
                           post-vaccination                                                                                                                                                                             10-20 minutes
                                                                                                       N                                                                                                                         FBR [UpToDate]
                                                                                                                                                                                                                                                                                      REPORT AEFI
                                                                                                                                                                                                                                                                                through reporting platforms
                                                                                                       N
                                                                                                                                                                                                                    N
                                                                                                       N
                                                                                                                                                                          May start medication with RAAS inhibitor, CCB, or in
                                                                                                                                                                             combination; CCB for reproductive women
                                                                                                                                                                                                     PBR [PHA-PSH]
LEGEND
         CBR   CONSENSUS BASED RECOMMENDATION                 Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
                                                              UpToDate Inc. 2011-2021
         PBR   PRACTICE BASED RECOMMENDATION
                                                              Philippine Heart Association and Philippine Society of Hypertension. 2021. Algorithm on the Management of Blood Pressure Elevation Before and After Vaccination
                                                                                                                                                                                                                                                                                                              19
         FBR   FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                                               SYSTEMIC REACTIONS
                                                                                                                                                                                                                               OTHER SYSTEMIC REACTIONS PATHWAYS
Y N
                                                                                                                                                                                                               REPORT AEFI
                                                                                                                                                                                                         through reporting platforms
                         There is
                      MYALGIA
           or muscle pain and soreness
         CBR       CONSENSUS BASED RECOMMENDATION                            Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
                                                                             UpToDate Inc. 2011-2021
         PBR       PRACTICE BASED RECOMMENDATION
                                                                             Philippine Heart Association and Philippine Society of Hypertension. 2021. Algorithm on the Management of Blood Pressure Elevation Before and After Vaccination
                                                                                                                                                                                                                                                                                                                   20
         FBR       FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                        The patient is
                                                                                                                     NAUSEOUS and/or VOMITING
                                                                                                                                                                                                                                                                SYSTEMIC REACTIONS
                                                                                                                                                                                                                                            OTHER SYSTEMIC REACTIONS PATHWAYS
                                                                                                                                   Rule out anaphylaxis
                            AMENDED NIAID/ FAAN CRITERIA
                             for the Diagnosis of Anaphylaxis
  Anaphylaxis is highly likely when any one of the following TWO CRITERIA is fulfilled:
                                                                                                                                     Highly considering
                                                                                                                                                                         Y
                                                                                                                                       Anaphylaxis?
                                                                                                1
  Acute onset of an illness with simultaneous involvement of the skin and/ or
  mucosal tissue (e.g., generalized hives, pruritus or flushing, swollen lips-
  tongue-uvula)
    2
                                                                                                                                                                                                                                                                                        FBR [UpToDate]
               after exposure to a known or highly probable allergen for that patient, even
               in the absence of typical skin involvement
                                                                                                                                                      N
  * Hypotension is defined as a decrease in systolic BP greater than 30% from that person's baseline, OR:
      i. Infants and children under 10 years: systolic BP less than (70 mmHg + [2 x age in years])
      ii. Adults and children over 10 years: systolic BP less than <90 mmHg
                                                                                                                                                                          Y                                                                                                              REPORT AEFI
  ** Laryngeal symptoms include: stridor, vocal changes, odynophagia.                                                              Signs of Moderate to                                                                                    Refer to higher level of care
                                                                                                                                   Severe Dehydration?                                                                                                FBR [UpToDate]               through reporting platforms
                                                                                                                                                      N
                                                                         May treat symptomatically:
                                                                              For nausea, may treat with oral antiemetics, metoclopramide, if necessary
                                                                              For vomiting, give oral rehydration salts for volume per volume replacement to prevent dehydration
                                                                                                                                                                                                        FBR [UpToDate]
                                                                            REPORT AEFI
                                                                                                                   N                Symptoms persist
                                                                                                                                                                          Y
                                                                      through reporting platforms                                  despite symptomatic
                                                                                                                                       treatment?
LEGEND
         CBR         CONSENSUS BASED RECOMMENDATION                                       Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
                                                                                          UpToDate Inc. 2011-2021
         PBR         PRACTICE BASED RECOMMENDATION
                                                                                          Philippine Heart Association and Philippine Society of Hypertension. 2021. Algorithm on the Management of Blood Pressure Elevation Before and After Vaccination
                                                                                                                                                                                                                                                                                                                                        21
         FBR         FOREIGN BASED RECOMMENDATION
INTERIM AEFI MANAGEMENT V1
Health Care Providers Fact Sheet Version 1
These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                             ALLERGIC REACTIONS
                                                   Assess the patient for
                                                         possible
                                                    ANAPHYLAXIS
                                                                                                                                                                                                                                    ANAPHYLAXIS PATHWAY
                                                   Patient presents with:                                                                                                                                                                      AMENDED NIAID/ FAAN CRITERIA
                                          (1) Acute onset of generalized hives,                                                                                                                                                                 for the Diagnosis of Anaphylaxis
                                     pruritus or flushing, swollen lips-tongue-uvula,
                                                                                                                                                                                                                     Anaphylaxis is highly likely when any one of the following TWO CRITERIA is fulfilled:
                                            AND at least one of the following:
                            a. Respiratory compromise (eg dyspnea, wheezing-bronchospasm)                                                   REFER TO
                                                                                                                                                                                                                                                                                                                   1
                                                                                                                                                                                                                     Acute onset of an illness with simultaneous involvement of the skin and/ or
                            b. Reduced BP or associated symptoms of end-organ dysfunction
                        c. Severe gastrointestinal symptoms (adbominal pain, repetitive vomiting)
                                                                                                                                N       SYSTEMIC AND/OR                                                              mucosal tissue (e.g., generalized hives, pruritus or flushing, swollen lips-
                                                                                                                                                                                                                     tongue-uvula)
                                                             OR                                                                          ALLERGIC SKIN
                                                                                                                                           REACTIONS                                                                 AND at least                                     Airway/ Breathing
                   (2) Acute onset of hypotension or bronchospasm or laryngeal involvement after
                                                                                                                                                                                                                      one of the
                     exposure to a known or highly probable allergen (several minutes to hours),                                            PATHWAY                                                                                                                                         Respiratory compromise
                                                                                                                                                                                                                      following:
                                                                                                                                                                                                                                                                         (eg, dyspnea, wheeze-bronchospasm, stridor,
                                    even in the absence of typical skin involvement.
                                                                                                                                                                                                                                                                                            reduced PEF, hypoxemia)
                                      (See table on Amended NIAID/FAAN criteria
                                                                                                                                                                                                                                                                      Circulation
                                            for the diagnosis of anaphylaxis)
                                                                                                                                                                                                                                                                        Reduced BP or associated symptoms of end-
                                                        FBR [WAO]
                                                                                                                                                                                                                                                                                                   organ dysfunction
                                                                                                                                                                                                                                                                      (eg, hypotonia/collapse, syncope, incontinence)
                                                    Y                                                                                                                                                                                                                 Severe Gastrointestinal Symptoms
                                                                                                                                                                                                                                                                        (e.g. Severe crampy abdominal pain, repetitive
                     Put the patient in reclining position with legs up
                                                                                                                                                                                                                                                                                                            vomiting)
                     Administer Epinephrine (Adrenaline)
                         0.5 mL per dose, intramuscularly ONLY on mid-outer thigh even through clothing, OR
                                                                                                                                                                                                                                  Acute onset of hypotension* or bronchospasm or laryngeal involvement**
                         0.3 mg in auto-injector, intramuscularly ONLY on mid-outer thigh even through clothing
                                                                                                                                                                                                                       2          after exposure to a known or highly probable allergen for that patient, even
                                                                                                                                                                                                                                  in the absence of typical skin involvement
                                 Secure IV access and start infusion with 0.9% NaCl (10-20 mL/min)
                                                                                                                                                                                                                     * Hypotension is defined as a decrease in systolic BP greater than 30% from that person's baseline, OR:
                                 Clear the airway                                                                                                                                                                        i. Infants and children under 10 years: systolic BP less than (70 mmHg + [2 x age in years])
                                 Administer OXYGEN via face mask (at least 10 LPM)                                                                                                                                       ii. Adults and children over 10 years: systolic BP less than <90 mmHg
                                 Administer GLUCOCORTICOID (Hydrocortisone 200 mg IV)                                                                                                                                ** Laryngeal symptoms include: stridor, vocal changes, odynophagia.
                                 Administer ANTI-HISTAMINE (e.g. Diphenhydramine 50 mg IV)
                                 Monitor vital signs
                                                                                                                                    Discharge 4-8 hours after full resolution of
                                                                                                                                    symptoms
                                                                                                                                    Refer and advise follow-up to allergy service for
                                                           Symptoms            Y
                                                                                                                                    consult as outpatient.
                                                            resolved?
                                                                                                                                                                             PBR [PSAAI]
                                                        N
                         Re-assess blood pressure, symptoms, and breath sounds
                                                                                                                                                                                                                                                      LEGEND
                                                                                                                                              through reporting platforms                                                                                       EBR         EVIDENCE BASED RECOMMENDATION
                                                                                                                                                                                                                                                                CBR         CONSENSUS BASED RECOMMENDATION
            Infuse 2000-3000 mL of                                                               Give salbutamol MDI, 4-                                                                                                                                                    PRACTICE BASED RECOMMENDATION
                                                      REPEAT EPINEPHRINE                                                                                                                                                                                        PBR
            0.9% NaCl intravenously                                                             10 puffs via large volume
                                                       INTRAMUSCULARLY
                in 10-20 minutes                                                                         spacer                                                                                                                                                 FBR         FOREIGN BASED RECOMMENDATION
                                                                                                                                                   SOURCES
                                                                                                                                                             Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
                                                                                                                                                             Brighton Collaboration. 2004
                                                  Call for emergency and refer to
                                                                                                                                                             Philippine Society of Allergy, Asthma, and Immunology. 2021. Algorithm on Diagnosis and Management of Severe Allergic Reactions After COVID-19
                                                       the higher level of care                                                                              Vaccination.
                                                              PBR [PSAAI]                                                                                    World Allergy Organization. 2020. World Allergy Organization Anaphylaxis Guidance.                                                                            22
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                                           ALLERGIC REACTIONS
                                                                                                                                                                                                                                        ALLERGIC SKIN REACTION PATHWAY
                                                                                                                                                                   Y
                    Patient presents with any one of the following:                                   Rule out anaphylaxis
                     urticaria (hives), erythema, pruritus, prickly (or
                                                                                           Y                (Amended
                tingling) sensation, localized or generalized edema (in                               NIAID/FAAN criteria                                   Highly considering
                the deeper layers of the skin, subcutaneous tissues or                                 for the diagnosis of                                   Anaphylaxis?
                   mucosa lining the throat, airways, and gut) ONLY?                                                                                                                                                                                                  AMENDED NIAID/ FAAN CRITERIA
                                                                                                           anaphylaxis)
                                     FBR [BC CDC]                                                                                                                                                                                                                      for the Diagnosis of Anaphylaxis
                                                                                                                                                                  N                                                                          Anaphylaxis is highly likely when any one of the following TWO CRITERIA is fulfilled:
                                                N
                                                                                                                                                                                                                                                                                                                                          1
                                                                                                                                                                                                                                             Acute onset of an illness with simultaneous involvement of the skin and/ or
                                                                                                                                                                                                                                             mucosal tissue (e.g., generalized hives, pruritus or flushing, swollen lips-
                                                                                                                                    Give antihistamines (oral/IV), glucocorticoids (oral/IV),                                                tongue-uvula)
                                                                                                                                    and observe for 4 hours
                     The patient may go home but advise                                                                                 Secure IV line if medication will be given                                                           AND at least                                   Airway/ Breathing
                                                                                                                                                                                                                                              one of the
                          ER consult once signs and                                                                                     intravenously                                                                                                                                                              Respiratory compromise
                                                                                                                                                                                                                                              following:
                      symptoms of allergic reaction are                                                                                                                                              PBR [PSAAI]                                                                                (eg, dyspnea, wheeze-bronchospasm, stridor,
                                                                                                                                                                                                                                                                                                                   reduced PEF, hypoxemia)
                                 experienced.
                                                                                                                                                                                                                                                                                             Circulation
                                                                                                                                                                                                                                                                                               Reduced BP or associated symptoms of end-
                                                                                 Discharge 4-8 hours after full resolution of                                                                                                                                                                                             organ dysfunction
                                                                                 symptoms                                                                          Symptoms                                                                                                                  (eg, hypotonia/collapse, syncope, incontinence)
                                  REPORT AEFI
                                                                                 Refer and advise follow-up to allergy service for                                  resolved?
                            through reporting platforms
                                                                                 consult as outpatient.                                              Y                                         N                                                                                            Severe Gastrointestinal Symptoms
                                                                                                                                                                                                                                                                                               (e.g. Severe crampy abdominal pain, repetitive
                                                                                                                                    PBR [PSAAI]                                                                                                                                                                                    vomiting)
                                                                                                                                                                                                                                              2          after exposure to a known or highly probable allergen for that patient, even
                                                                                                                                                                                                                                                         in the absence of typical skin involvement
                                                                                                                                                                                                                                            * Hypotension is defined as a decrease in systolic BP greater than 30% from that person's baseline, OR:
                                                                                                                                                                                                                                                i. Infants and children under 10 years: systolic BP less than (70 mmHg + [2 x age in years])
                                                                                                                                                                                                                                                ii. Adults and children over 10 years: systolic BP less than <90 mmHg
                                                                                                                                                                                                                                            ** Laryngeal symptoms include: stridor, vocal changes, odynophagia.
LEGEND
                                                                          Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR   CONSENSUS BASED RECOMMENDATION
                                                                          Brighton Collaboration. 2004
         PBR   PRACTICE BASED RECOMMENDATION                              Philippine Society of Allergy, Asthma, and Immunology. 2021. Algorithm on Diagnosis and Management of Severe Allergic Reactions After COVID-19 Vaccination.
                                                                          BC Centre for Disease Control.                                                                                                                                                                                                                                              23
         FBR   FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                              Intravenous Benzodiazepine
                                                              Provide O2 support
                                                                                                                                                                                                 Lorazepam 0.1 mg/kg (max 4 mg); max cumulative adult
                                                                                                                                                                                    Y            dose 8 mg, OR                                             No effect observed
                                                                                                                                                                                                                                                                                      N
                                                       May provide initial treatment of                                                 IV access secured?                                       Diazepam 0.15 - 2 mg/kg (max 10 mg); max cumulative        5 minutes after
                                                             Benzodiazepine*                                                                                                                     adult dose 20 mg, OR                                       administration?
                                                                                                                                                                                                 Clonazepam 0.015 mg/kg (max 1 mg); max cumulative
                                                                           FBR [British Epilepsy Association]
                                                                                                                                                                                                 adult dose 2mg
                                                                                                                                                           N                                                                                                      Y
                                                                                                                        Non-intravenous Benzodiazepine
                                                                                                            Midazolam IM/IN/buccal 10mg; 5mg in elderly or <40kg; max
                                                                                                            cumulative adult dose 20mg, 10mg <40kg), OR                                                        Y                  No available IV
                                                                                                                                                                                                                                                        May give another dose up to
                                                                                                                                                                                                                                                         the max. cumulative dose
                                                                                                            Diazepam 10mg rectal; 5mg in elderly or <40kg, OR                                                                    Benzodizaepine?
                                                                                                            Lorazepam intranasal 4mg; 0.1mg/kg <40kg
                                                                                                                                                            Y
         * NOTE: All benzodiazepines can cause respiratory depression, sedation and
                   hypotension at higher doses and in susceptible patients                                    May give another dose up to the max. cumulative dose
LEGEND
                                                                             Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR       CONSENSUS BASED RECOMMENDATION
                                                                             Brighton Collaboration. 2004
         PBR       PRACTICE BASED RECOMMENDATION                             Philippine Society of Allergy, Asthma, and Immunology. 2021. Algorithm on Diagnosis and Management of Severe Allergic Reactions After COVID-19 Vaccination.
                                                                             BC Centre for Disease Control.                                                                                                                                                                               24
         FBR       FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                       NEUROLOGIC REACTIONS
                                                                                                                                                                                             HEADACHE PATHWAY
                                                                                                                Is symptom                     Y
                                                                                                                                                    Report to the higher level
                                                                                                             persistent despite
                                                                                                                                                             of care
                                                                                                               medication?
                                                                                                                           N
                                                                                                                                                          REPORT AEFI
                                                                                                          Provide reassurance                           through reporting
                                                                                                                                                            platforms
LEGEND
                                                                                                                                                                                                                                   NEUROLOGIC REACTIONS
                                                                                                                                                                                                                                                          VASOVAGAL PATHWAY
                                                                                                                                                                   N
                                                                                                                                                                                                                                          Panic attack: No hypotension, pallor, wheeze, or urticarial rash or swelling.
                                                                                                                                                                                                                                          May have flushing or blotchy skin
                                                                                                                           Refer to the higher level of care if persistent                                       REPORT AEFI
                                                                                                                            despite supportive care and reaassurance                                           through reporting
                                                                                                                                                                        EBR [DOH AEFI Manual]
                                                                                                                                                                                                                   platforms                                                                       EBR [DOH-AEFI Manual]
LEGEND
                                                                     Department of Health. 2014. Adverese Events Following Immunization (AEFI).: A Manual of Procedure for Surveillance and Response to AEFI
         CBR      CONSENSUS BASED RECOMMENDATION
                                                                     Brighton Collaboration. 2004
         PBR      PRACTICE BASED RECOMMENDATION                      Philippine Society of Allergy, Asthma, and Immunology. 2021. Algorithm on Diagnosis and Management of Severe Allergic Reactions After COVID-19 Vaccination.
                                                                     BC Centre for Disease Control.                                                                                                                                                                                                                           26
         FBR      FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                HEMATOLOGIC REACTIONS
                  Experiencing any of the
                        following:                                                                                                                                                                                                                                                      VITT PATHWAY
                    Persistent and severe
                                                                                Has received a vector
                    headache                                                                                                                                                                                                                                                 Not VITT
                                                                               vaccine (Astrazeneca or
                    Focal neurological                                                                                                                                                                                                                            Treat according to diagnosis
                                                                                J&J) in the last 4 to 28                        N                                                                                                                                           PBR [PCHTM]
                    symptoms
                                                                                         days?
                    Seizures, or blurred or
                    double vision (suggesting                                                         Y
                    CSVT or arterial stroke)
                    Shortness of breath or                                 REFER TO SECONDARY OR                                               REPORT AEFI
                    chest pain (suggesting                               TERTIARY CARE IMMEDIATELY                                           through reporting
                                                                           FBR [United Nations;]; PBR [PCHTM]                                    platforms
                    pulmonary embolism or
                    acute coronary
                    syndrome)
                                                                                      SCREEN FOR
                    Abdominal pain
                    (suggesting portal vein                            VACCINE-INDUCED                                                                                                                                                                                                N
                    thrombosis)                                          THROMBOTIC                                                  Evaluate the ff parameters:                                                                                         N
                    Limb swelling, redness,                                                                                                                                                                 Platelet count is < 150 x
                                                                                                                                        CBC                                                                                                                            With thrombosis?
                                                                   THROMBOCYTOPENIA (VITT)                                                                                                                     1,000,000,000 / L
                    pallor, or coldness                                                                                                 Imaging studies for Thrombosis
                    (suggesting deep vein
                                                                      A condition of blood clots associated                                                                                                                                                                           Y
                    thrombosis or acute limb
                                                                      with low platelet counts, that occurs                                                                                                                  Y
                    ischemia)
                                                                         following receipt of the vaccine
                                                                                                                                                                                                                 Request for
                    FBR [United Nations;]; PBR [PCHTM]                                                                                                                                                                                                         Continue monitoring Platelets
                                                                                                                                                                                                           confirmatory test (anti-
                                                                                                                                                                                                            F4) and coagulation                                   Until VITT has been ruled out,
                                                                                                                                                                                                                                                                the following should not be given:
                                                                                                                                                                                                                    tests                                        Anticoagulation with heparin (both
                                                                                                                                                                                                            (D-dimer, Fibrinogen,                                uF heparin and LMW heparins)
                                                                                                                                                                                                                  PT, aPTT)                                      Platelet transfusions
                                                                                                                                                                                                           HIGH D-dimer** or
                                                                                                      Treat as                                                                          Y                                                                  N
                                                                                                                                                                                                       LOW Fibrinogen, PT, aPTT or
                          Steroids (methylprednisolone 1mg/kg)
                                                                                           CONFIRMED VITT                                                                                                 POSITIVE anti-PF4**
                          IVIG (0.5 – 1.0g/kg/day for 2 days)
                          Non-heparin containing anti-coagulant (Rivaroxaban, Fondaparinux, etc.)                                                   ** If PF4 antibody immunoassay is
                          Avoid platelet transfusions, heparin, LMWH, VKA                                                                               not available and D-Dimer is
                                                                                                                                                     markedly elevated (>4x threshold
                          Consider therapeutic plasma exchange if platelet remains below 30,000
                                                                                                                                                     for VTE), this is highly suggestive
                          despite IVIG and steroids                                                                                                        of VITT. Treat as VITT.
                                                                                        FBR [United Nations;]; PBR [PCHTM]
                                                                                                                                                                  PBR [PCHTM]
LEGEND
                                                                   Philippine College of Hematology and Transfusion Medicine, Inc. 20 April 2021. Philippine College of Hematology and Transfusion Medicine (PCHTM) Review of Hematologic Events Post COVID-19 Vaccination
         CBR   CONSENSUS BASED RECOMMENDATION
                                                                   United Nations. April 2021. Interim Guidelines: Diagnosis and Management of Vaccine-Induced Prothrombotic Immune Thrombocytopenia (VIPIT) following AstraZeneca COVID-19 Vaccinations.
         PBR   PRACTICE BASED RECOMMENDATION                       Specialized guidance available at: UK: Guidance Produced from the Expert Haematology Panel (EHP) focused on Covid-19 Vaccine induced Thrombosis and Thrombocytopenia (VITT): https://b-s-h.org.uk/media/19530/guidance-version-13-on-mngmt-of-thrombosis-with-
                                                                   thrombocytopenia-occurring-after-c-19-vaccine_20210407.pdf                                                                                                                                                                                                       27
         FBR   FOREIGN BASED RECOMMENDATION
    INTERIM AEFI MANAGEMENT V1
     Health Care Providers Fact Sheet Version 1
     These recommendations will be updated based on most recent evidence.
                                                                                                                                                                                                                     HEMATOLOGIC REACTIONS
                                                                                                                                                                                                   COVID-19 VACCINE-ASSOCIATED ITP PATHWAY
                           vaccination
                                                   PBR [PCHTM]
                                                                                                                                                                                        N
                                                                                                                                                                                                                                               Consider
                                                                                                                                                          REFER TO SECONDARY OR
                                                                                                                                                                                                                                 COVID-19 VACCINE-
                                                                                                                                                        TERTIARY CARE FOR FURTHER
                                                                                                                                                                 WORK-UP                                                          ASSOCIATED ITP
                                                                                                                                                                                                                             Consult a hematologist
                                                                                                                                                                      REPORT AEFI
                                                                                                                                                                    through reporting                                        Start treatment with IVIG and high
                                                                                                                                                                        platforms                                            dose corticosteroids
                                                                                                                                                                                                                             Consider thrombopoietic agents and
                                                                                                                                                                                                                             vinca alkaloids, if there is inadequate
                                                                                                                                                                                                                             response with initial treatment
                                                                                                                                                                                                                                                                    PBR [PCHTM]
LEGEND