GUIDELINES FOR

PHASE 2 COVID-19
VACCINATION
PROGRAMME
IN TERENGGANU

JABATAN KESIHATAN NEGERI TERENGGANU

5 April 2021
 TABLE OF CONTENTS

Items Page
1. Introduction 1

2. Carta Alir Pre-Vaccination Assessment Bagi Program 2

Vaksinasi COVID-19 Fasa 2

3. COVID-19 Pre-Vaccination Assessment Checklist for 3

Phase 2

4. Sinovac (CoronaVac) Pre-Vaccination Checklist Form 4

5. Guidelines For Medical Conditions In Pre-Vaccination 5 – 14

Assessment

6. Guidelines For COVID-19 Vaccination For Individual 15 – 41

With Allergic / Hypersensitivity Disorders

7. Guidelines For Post Vaccination Anaphylaxis 42 – 53

Management

i
 LIST OF ABBREVIATIONS

ABC Airway, Breathing, Circulation

ACEI Angiotensin Converting Enzyme Inhibitor
ADEM Acute Disseminated Encephalomyelitis
ADR Adverse Drug Reaction
AEFI Adverse Event Following Immunization
AGEP Acute Generalised Exanthematous Pustulosis
AF Atrial Fibrillation
ANC Absolute Neutrophil Count
Anti-TNF Antitumor Necrosis Factor Therapy
ART Antiretroviral Therapy
BMI Body Mass Index
BP Blood Pressure
BPD Bronchopulmonary Dysplasia
CBG Capillary Blood Glucose
CABG Coronary Artery By Pass Grafting
CCS Canadian Cardiovascular Society Angina Grade
CKD Chronic Kidney Disease
CLD Chronic Lung Disease
CNS Central Nervous System
CN VII palsy Cranial Nerve VII Palsy
COPD Chronic Obstructive Pulmonary Disease
COVID-19 Coronavirus Disease 19
CSU/A Chronic Spontaneous Urticaria/Angioedema
CVA Cerebrovascular Accident
DM Diabetes Mellitus
DOAC Direct Oral Anticoagulant
DRESS Drug Reaction with Eosinophilia and Systemic Symptoms
EES Erythromycin Ethyl Succinate
ESRF End Stage Renal Failure
F Female
FMS Family Medicine Specialist
GBFDE Generalised Bullous Fixed Drug Reaction
GBS Guillain Barre Syndrome
HAART Highly Active Antiretroviral Therapy
HIV Human Immunodeficiency Virus
ICU Intensive Care Unit
IgE Immunoglobulin E
IHD Ischemic Heart Disease
IM Intramuscular
ii
INR International Normalised Ratio
IRIS Immune Reconstitution Syndrome
ISSR Immunisation Stress Related Response
IV Intravenous
JKJAV Jawatankuasa Khas Jaminan Akses Vaksin COVID-19
LMA Laryngeal Mask Airway
LMWH Low Molecular Weight Heparin
M Male
MDI Metered-Dose Inhaler
MI Myocardial Infarction
MPE Maculopapular Eruption
NOAC Novel Oral Anticoagulant
NPRA National Pharmaceutical Regulatory Agency
NSAIDs Non-Steroidal Anti-Inflammatory Drugs
NYHA New York Heart Association
Ois Opportunistic Infections
PEF Peak Expiratory Flow
PEG Polyethylene Glycol
PhIS Pharmacy Information System
PLHIV People Living With HIV
POA Period of Amenorrhea
POG Period of Gestation
PVA Pre-Vaccination Assessment
PPV Pusat Pemberian Vaksin
PTB Pulmonary Tuberculosis
PTCA Percutaneous Transluminal Coronary Angioplasty
PVD Peripheral Vascular Disease
RA Rheumatoid Arthritis
SBP Systolic Blood Pressure
SCARs Severe Cutaneous Adverse Drug Reactions
SJS Stevens-Johnson Syndrome
SLE System Lupus Erythematous
SOB Shortness of Breath
TEN Toxic Epidermal Necrolysis
TIA Transient Ischaemic Attack
VTE Venous Thromboembolism

iii
 ACKNOWLEDGEMENT
CHAIRPERSON:
Dr. Nor Azimi Binti Yunus
Pengarah Kesihatan Negeri, JKN Terengganu
ADVISORS:
Dr. Saifur Rahman Bin Muhammad
Timbalan Pengarah Kesihatan Negeri (Perubatan), JKN Terengganu
Dr. Hjh. Kasemani Binti Embong
Timbalan Pengarah Kesihatan Negeri (Kesihatan Awam), JKNT Terengganu

LIST OF CONTRIBUTORS
A. AEFI Committee Members:
1. Dr. Siti Salmy Binti Mat Nor
Timbalan Pengarah Perubatan IV, HSNZ
2. Dr. Ahmad Kashfi Bin Hj. Ab Rahman
Pakar Perunding Perubatan Penyakit Berjangkit, HSNZ
3. Dr. Mohd Lotfi Bin Hamzah
Pakar Perunding Perubatan Kecemasan, HSNZ
4. Dr. Norazura Binti Mohamad
Pakar Perubatan Dermatologi, HSNZ
5. Dr. Suhazeli Bin Abdullah
Pakar Perubatan Keluarga, PKD Hulu Terengganu
6. Dr. Nurul Ashikin Binti Adnan
Pakar Perubatan, HSNZ
7. Dr. Nurul Izza Binti Md Yusof
Pakar Perubatan, HSNZ
8. Dr. Nurfadhilah Binti Yusof
Pakar Perubatan, HSNZ
9. Pn. Zuhaini Binti Mukrim
Ketua Pegawai Farmasi, HSNZ
10. Cik Nurul Faezah Binti Mohd Yusof
Pegawai Farmasi, HSNZ
11. Dr. Siti Nurbahiah Binti Haron
Ketua Penolong Pengarah Perubatan, HSNZ
12. Dr. Ahmad Fadhli Bin Sakri
Ketua Penolong Pengarah Perubatan III, HSNZ
13. Dr. Juhaida Binti Mohd Noor
Pegawai Perubatan Unit Kawalan Infeksi, HSNZ

iv
B. Other Contributors:
1. Dr. Husnina Binti Ibrahim
Pakar Perubatan Kesihatan Awam
Ketua Penolong Pengarah Kanan (Primer) / Ketua Unit Pembangunan
Kesihatan Keluarga, JKN Terengganu
2. Dr. Mazlinah Binti Muda
Pakar Perunding Perubatan Keluarga, PKD Marang
3. Dr. Norhana Binti Yazid
Pakar Perunding Perubatan Keluarga, PKD Kuala Terengganu
4. Dr. Mohd Anuar Bin Abd Rahman
Pegawai Kesihatan Daerah, PKD Kemaman
5. Dr. Nurnajayati Binti Omar
Pakar Perubatan Kesihatan Awam
Ketua Penolong Pengarah Kanan (Kesihatan Keluarga), JKN Terengganu
6. Dr. Norazmalayati Binti Mat Amin
Ketua Penolong Pengarah Kanan (Kesihatan Keluarga I), JKN Terengganu
7. Dr. Sunita Binti Suhimi
Ketua Penolong Pengarah Kanan (Primer II), JKN Terengganu

v
INTRODUCTION

The first phase of COVID-19 Immunisation Program in Terengganu has started from
February until April 2021. It covers approximately 24,570 vaccinees. This includes those
frontliners in health care, police, Volunteer Department (RELA), The Fire and Rescue
Department of Malaysia (BOMBA), civil defense sectors etc.

The second phase, starts from April till August will target about 258,000 high risk groups
comprising of senior citizens above 60, people with co-morbidities and people with
disabilities.

Co-morbid is defined as a person who is suffering from two or more unrelated

diseases/medical conditions simultaneously. Those with co-morbidities are at high risk of
suffering from severe COVID-19 disease if infected. Thus, those with co-morbidities
should be vaccinated to protect themselves from suffering the effects of severe infection.

Hence, to ensure Terengganu covers as many as possible its co-morbid patients this
interim generic guideline has been prepared to assist our health facilities in screening and
doing pre-vaccination assessment to the co-morbid patients both at the hospitals and
health clinics setting.

1
 Carta Alir Saringan Pra Vaksinasi Bagi Program Vaksinasi COVID-19 Fasa 2
Jabatan Kesihatan Negeri Terengganu

Mula

PENILAIAN PERTAMA
Penilaian status kesihatan / comorbid pesakit oleh Pegawai Perubatan
di Klinik Kesihatan / Hospital Daerah / Klinik Pakar

YA TIDAK
Lulus

TIDAK PASTI

PENILAIAN KEDUA
Rujukan ke Second Pre-Vaccination
Assessment Clinic / Committee
• FMS di Klinik Kesihatan
• Pakar di Hospital

YA TIDAK
Lulus

LULUS BERSYARAT
Pendaftaran dalam Rujukan ke
website JKJAV AEFI Committee
https://www.vaksincovid.gov.my/daftar/
Penetapan temujanji vaksinasi HSNZ
untuk temujanji automatik
dalam aplikasi MySejahtera (jika perlu)
dari aplikasi MySejahtera
oleh FMS / Pakar
(Format CITF Pre Vaccination)
LULUS BERSYARAT
GAGAL

Pesakit
Pesakit menerima vaksinasi di
menerima Pesakit tidak
Klinik Kesihatan / Hospital
vaksinasi di layak
mengikut temujanji ditetapkan
lokasi pilihan menerima
vaksinasi

Tamat

2
 COVID -19 PRE-VACCINATION ASSESSMENT CHECKLIST FOR PHASE 2
JABATAN KESIHATAN NEGERI TERENGGANU
*Untuk diisi dua salinan. Satu salinan diberi kepada pesakit untuk dibawa semasa temujanji vaksin di PPV

Name: IC No.:
Clinic / Hospital : Phone No:
Address: Postcode:

Agreed for Vaccination: YES/NO My Sejahtera Registration: YES/NO MySJ ID:

History of COVID -19 Positive: YES/NO Date:
Pregnancy: NO / YES (POA/POG: _________) Breastfeeding: YES/NO
Diagnosis/Comorbid
(*to mention if patient on warfarin/NOAC/chemotherapy/transplant/immunomodulator/biologics/ immunosuppressant

1. Refer to Table 1. Common

2. Medical Conditions for Pre
3.
Vaccination Assessment
4.
page 7 – 13.
5.

Allergies: Yes / No
If yes please proceed further assessment by using Guideline on Drug Hypersensitivity and Allergy.
Risk Category Decision (Please tick as appropriate)
High Refer to Table 1.4 Precaution and contraindication of Refer AEFI Committee
Medium vaccine page 20 – 21 and Flowchart for Refer for Second Assessment
hypersensitivity population before initiating first (Dermato / Allergist)
Low dose of COVID-19 vaccine page 36. Conditional Pass

COVID-19 VACCINE DECISION:

First Assessment: Date
Patient‘s preferred location for vaccination: ___________________________
PASS Doctor’s signature & chop
CONDITIONAL PASS (Lulus Bersyarat)
□ Vaccination under hospital setting
□ Premedication: ______________________________
□ Special precaution: ___________________________
FOR SECOND ASSESSMENT
DEFER VACCINATION (ditangguhkan) until ____________________
FAIL
□ Absolute fail
□ Not for mRNA vaccine (to consider other type of vaccine)

Second Assessment: Date

Patient‘s preferred location for vaccination: ___________________________
PASS Doctor’s signature & chop
CONDITIONAL PASS (Lulus Bersyarat)
□ Vaccination under hospital setting
□ Premedication: ______________________________
□ Special precaution: ___________________________
REFER TO AEFI COMMITTEE
DEFER VACCINATION (ditangguhkan) until ____________________
FAIL
□ Absolute fail
□ Not for mRNA vaccine (to consider other type of vaccine) 3
 SINOVAC (CORONAVAC) PRE-VACCINATION CHECKLIST
JABATAN KESIHATAN NEGERI TERENGGANU
*Untuk diisi di Pusat Pemberian Vaksin semasa temujanji

Name: IC No:
Clinic / Hospital : Phone No:
Address: Postcode:

Agreed for Vaccination: My Sejahtera Registration: MySJ ID:

YES / NO YES / NO

Criteria (Please tick Yes / No) YES NO

1. Age < 18 or > 45 years)
2. Allergies
3. Relevant comorbidities
4. Immunosuppressed eg. RVD / on biologics / steroid
5. History of COVID-19 positive within 3 months duration
6. Pregnancy
7. Breastfeeding
* If ALL NO, to proceed with Sinovac (CoronaVac) vaccination
* If ANY YES, to defer and need for reassessment (PVA)
* To defer if pregnant / breastfeeding until safety and efficacy data available

Decision for Sinovac (CoronaVac) vaccination (please tick)

To proceed the vaccination
To defer and need for reassessment (PVA)

Doctor’s signature & chop:

Date:__________________

4
 GUIDELINES FOR
MEDICAL CONDITIONS IN
COVID-19
PRE-VACCINATION
ASSESSMENT

JABATAN KESIHATAN NEGERI TERENGGANU

5
INTRODUCTION

Phase 2 eligibility criteria:

Vaccination recommended for general adult population more than 18 years old and above

Priority was given to: -

a) Those aged 18 years old and above with comorbid

b) Elderly more than 60 years old without comorbid

All patients with comorbidities should undergo thorough pre vaccination assessment. This can
be done at local clinics or hospitals by referring to Table 1. Common Medical Conditions for Pre
Vaccination Assessment.

In general, we have to DEFER or POSTPONE vaccination in cases as below:

1. Person who had acute illness and had been hospitalized

2. Person who had COVID-19 infection within 3 months duration
3. Person being quarantine for being close contact to the positive COVID-19 cases
4. Persons who received any vaccination within 2 weeks

6
 Table 1. Common Medical Conditions for Pre Vaccination Assessment
(modified from Draft Guidelines For COVID-19 Vaccination using COMIRNATY Vaccine (Pfizer Biontech))

MEDICAL TO GIVE VACCINATION TO DEFER

CONDITIONS VACCINATION
CARDIOLOGY
• NYHA class 3 and 4
• Heart failure any • Last admission more than 6 months
• Recent admission
cause • Stable on current medication for 3 months
within 6 months
• Significant left • NYHA class 1 and 2
• Recent escalation of
ventricular systolic
treatment within 3
dysfunction (LVEF
less than 40 per months
cent).
• Moderate or
severe valvular
heart disease
• Congenital heart
disease with
severe PAH or
idiopathic PAH

• CCS class 3 and 4

• Coronary artery • CCS class 1-2
• Recent admission
disease with past • Stable on current medication past 3 months
within 6 months
CABG/PTCA/MI • Last Admission more than 6 months
• Recent escalation of
treatment within 3
months

• Patient on TO GIVE VACCINATION NEED SECOND

anticoagulant ASESSMENT • INR > 4
(warfarin, NOAC, • INR <3
• INR 3-4
SC Clexane and * on the day of vaccination,
fondaparinux) *To consult
warfarin should be taken
a. AF cardiology team
after vaccination
b. PVD regarding safety
c. VTE * DOAC / LMWH / and benefit of
d. CVA fondaparinux should be vaccination.
delay on the day of
vaccination

7
 MEDICAL TO GIVE VACCINATION TO DEFER
CONDITIONS VACCINATION
• HYPERTENSION
TO GIVE VACCINATION • BP > 180/100

• BP < 160/90 • BP > 160 –

180/ 90 -100
*To stabilize BP
before
vaccination.
* Conditional pass
with BP prior
vaccination at PPV

ENDOCRINOLOGY
• DIABETES
TO GIVE VACCINATION • CBG > 25
MELLITUS
• CBG < 15 • CBG > 15 – 25
* To stabilize CBG
before
vaccination.
* Conditional pass
with CBG prior
vaccination at PPV

8
 MEDICAL TO GIVE VACCINATION TO DEFER
CONDITIONS VACCINATION
NEUROLOGY
• Cerebrovascular • Ischaemic stroke secondary to • Stroke other cause
accident (CVA) atherosclerosis, penetrating artery disease like vasculitis,
and emboli more 3 months duration. thrombophilia and
inherited
disorder.

* reassessment by
neurology team until
more safety data on
mRNA vaccine available
• No recent increase of medication for past 3 • Escalation of therapy
• Epilepsy
months. in past 3 months.

• Other TO GIVE NEED SECOND

neurological VACCINATION ASESSMENT
disease priority to
vaccine • Cerebral Palsy • Severe neurological
• Severe or condition
profound (GBS/Transverse
learning myelitis and
disabilities demyelinating
• Down’s disease)
Syndrome
* reassessment by
• Multiple
neurology team.
Sclerosis
• Dementia
• Parkinson’s
Disease
• Motor Neuron
Disease /related
disease
• Hereditary /
degenerative
disease of CNS

9
 MEDICAL CONDITIONS TO GIVE VACCINATION TO DEFER
VACCINATION
MALIGNANCIES
• Life expectancy < 1
• Any solid cancer • ANC recovered post chemotherapy months
• Haematological • Clinical frailty scale ≤7 • Clinical frailty index
malignancies >8
(Leukaemia, multiple • On active
myeloma, chemotherapy,
myelodysplastic radiotherapy,
syndrome, and immunotherapy, or
myeloproliferative targeted therapy.
neoplasm) * To be decided by
primary team
• No hospitalisations for last 1 month in • PTB on intensive
RESPIRATORY
COPD / CLD and 3 months in asthma phase
• COPD • PTB on maintenance phase
• Bronchial asthma
• Chronic lung disease
• Long term ventilation
• PTB
• HIV on HAART less
INFECTIOUS DISEASE • HIV on stable HAART more than 6
than 6 months
months regardless of CD4 count
• Primary immunodeficiency diseases

LIVER DISEASE • Liver cirrhosis any cause • Patient with

• Chronic Hepatitis prolong INR to
• Biliary atresia follow
recommendation
on anticoagulant
group
• Grade 4
encephalopathy
• Acute liver failure

10
 MEDICAL CONDITIONS TO GIVE VACCINATION TO DEFER
VACCINATION
HEMATOLOGICAL DISORDER TO GIVE NEED SECOND
VACCINATION ASESSMENT • On anti –CD20
• Sickle cell disease/bone • Platelets count
marrow failure/aplastic • Platelet > 50 monoclonal
less than 50 antibodies eg:
• Hemoglobinopathies, • Mild
• Moderate to Rituximab last dose
enzymopathies and rare haemophilia
severe 6 months
inherited anaemias. • Last dose anti –
haemophilia
CD20
• Von Willebrand
monoclonal
disease
antibodies eg:
• Other rare
Rituximab last
bleeding disorder
dose 6 months
ago. * For second
assessment by
haematology team
• Asplenia / spleen • Post splenectomy due to thalassemia/
dysfunction injury

RHEUMATOLOGICAL DISEASE • Prednisolone dose >

• Autoimmune Disease who requires
20 mg daily
long term immunosuppressant /
immunomodulator (need timing and • Severe active
autoimmune
dose adjustment as physician advised).
disease
• Prednisolone dose < 20 mg daily

NEPHROLOGY • CKD stage 3-5 and ESRF

• Nephrotic Syndrome

DERMATOLOGY
• Skin conditions require long term • Prednisolone dose >
immunosuppressant / 20 mg daily
immunomodulator (may need timing
and dose adjustment as physician
advised).

11
 MEDICAL CONDITIONS TO GIVE VACCINATION TO DEFER
VACCINATION
POST TRANPLANT PATIENT • At least 3 months after transplantation • Grade 3 and 4 graft
versus host disease
• Post-cardiac
transplant/left
ventricular assist device
(LVAD)
• Kidney transplantation
• Bone Marrow / Stem Cell
Transplant
• Solid organ transplant
recipients

• Pregnancy and • Vaccinate between 14-33 weeks of

breastfeeding gestation.
• No contraindication for vaccination in
breast feeding.

• Obesity • Priority in BMI ≥ 30 kg/m2

• Severe mental illness • Stable on medication • Patient unable to

• Able to give consent give consent

12
Table 2. Guidance Regarding Use and timing of COVID-19 Vaccination and
Immunomodulatory therapies

13
 Table 3. Clinical Frailty Scale

REFERENCES

1. COVID 19 vaccination for Patients with Haematological Disorder Consensus Statement, Malaysia
Society of Haematology March 2021
2. COVID 19 Vaccination in Patients with Liver Disease, AASLD
3. Malaysian Consensus on COVID-19 Vaccination for patients with Rheumatic and Musculoskeletal
Disease (RMD) and Autoimmune and Inflammatory Rheumatic Diseases (AIIRD), Version 1, 3rd
March 2021
4. BTS Guidance: COVID 19 Vaccination information.
5. Draft Guidelines For COVID-19 Vaccination using COMIRNATY Vaccine (Pfizer-Biontech), MOH,
2nd March 2021.

14
 GUIDELINES FOR
COVID-19 VACCINATION
FOR INDIVIDUAL WITH
ALLERGIC /
HYPERSENSITIVITY
DISORDERS

JABATAN KESIHATAN NEGERI TERENGGANU

15
INTRODUCTION

Vaccine often cause adverse events. However the vast majority of adverse events following
immunization (AEFI) are a consequence of the vaccine stimulating a protective immune response,
and not allergic in etiology. Allergic reactions to vaccines are generally due to adjuvants and other
excipients / components in the vaccine such as preservatives and antibiotics, rather than to the
active ingredients itself. The 2 most common preservatives used in vaccine are Polyethylene
Glycol (PEG) and polysorbate 80 (which is derivatives from PEG itself).

Healthcare workers must properly assess and able to differentiate between allergic and AEFI by
using Table 1.1 to 1.3. Healthcare workers also need to properly assess the indications and
contraindications for vaccine against COVID-19 by using Table 1.4 to 1.5 and Flow Chart For
Hypersensitivity Population Before Initiating First Dose Of COVID-19 Vaccine as a guide in
decision making.

For a more comprehensive lists of vaccine and medications containing PEG and polysorbate,
healthcare workers can refer to Table 1.6.1 to 1.6.3.

16
1.0 Guidance on the indications and contraindications to COVID-19 vaccinations for selected
hypersensitive population
Table 1.1 Grading System of Hypersensitivity Reaction

WAO GRADING SYSTEM FOR GENERALISED HYPERSENSITIVITY REACTIONS

NOT ANAPHYLAXIS ANAPHYLAXIS

Grade 1 Grade 2 Grade 3 Grade 4 Grade 5
Symptoms Symptoms
/signs from 1 /signs in Lower airway Lower airway Lower or upper
organ system Grade 1 > 2 Mild bronchospam Bronchospasm airway
organ -cough -severe Respiratory failure
Cutaneous -wheezing bronchospasm
-urticaria -Shortness of
-erythema breath
-itchiness
-angioedema (not GIT Upper airway Cardiovascular
laryngeal) -abdominal cramps -laryngeal edema -collapse/hypotension
-Vomiting with stridor
Upper -diarrhea
Respiratory Loss of consciousness
-sneezing (vasovagal excluded)
Uterine cramps
-rhinorrhea
-nasal pruritus
-nasal congestion
-itchy throat
-cough (not
related with
Any Any Any symptoms/signs
bronchospasm)
symptoms/signs symptoms/signs From Grades 1,3 or 4
from Grade 1 From Grades 1 or would be included
Conjunctival
would be included 3 would be
-erythema
included
-pruritus
-tearing

Other
-nausea
-Metallic taste

17
 Table 1.2: Diagnosis Criteria of Anaphylaxis

Diagnosis criteria for anaphylaxis

Anaphylaxis is highly likely if any ONE of the criteria presents:

Criteria 1 Criteria 2

Acute onset of illness (minutes to several hours) with Acute onset of hypotension1 or
mucocutaneous involvement (either skin, mucosal or both) AND bronchospasm2 or laryngeal
at least one of the following: involvement3 after exposure to a
known* or highly likely* allergen
● Respiratory symptoms/signs (eg.dyspnoea, wheezing,
(minutes or several hours), even
hypoxia, stridor, reduced PEF)
in the absence of typical skin
● Episode of hypotension or with associated involvement.
manifestations (eg. hypotonia, syncope, collapse,
incontinence

● Severe gastrointestinal symptoms (eg. crampy

abdominal pain, repetitive vomiting)

Adapted from the diagnostic criteria of anaphylaxis (WAO) 20205

1 Hypotension is defined as systolic BP < 90mmHg or reduction in systolic BP greater than 30% from the
individual’s baseline.
2 Excludes lower respiratory symptoms triggered by common inhalant allergens or food allergens perceived

to cause “inhalational” reactions.

3Laryngeal symptoms include stridor, vocal changes, odynophagia.

18
 Table 1.3: List of Possible Adverse Event

Type of reaction

Very Common Local: Injection site swelling and erythema

(≥1/10) General: arthralgia, fatigue, fever, headache, myalgia

Common Local: injection site pain, erythema

(≥ 1/100 to <1/10) General:nausea

Uncommon Local: injection site pruritus

(≥ 1/1,000 to <1/100) General: insomnia, lymphadenopathy, malaise, extremity pain

Rare Local: -

(≥ 1/10,000 to<1/1,000) General: acute peripheral facial paralysis / Bell’s Palsy

An AEFI will be considered serious, if it:

❖ results in death,

❖ is life-threatening,

❖ requires in-patient hospitalization or prolongation of existing hospitalization,

❖ results in persistent or significant disability/incapacity,

❖ is a congenital anomaly/birth defect, or

❖ requires intervention to prevent permanent impairment or damage.

19
 Table 1.4: Precautions and Contraindications of Vaccine in Hypersensitivity Population

RELATIVE CONTRAINDICATION
PROCEED WITH VACCINATION CONTRAINDICATION FOR VACCINE COVID 19

(LOW RISK) (MEDIUM RISK) (HIGH RISK)

Low risk category A For Comirnaty® (Pfizer- 1. Severe allergic

History of Grade 1 and Grade 2 BioNTech vaccine) reaction
Hypersensitivity Reaction / Non Ig E (anaphylaxis/SCARs)
related Hypersensitivities /patient with 1. History of immediate after previous dose or
atopy disease allergy reactions to any ingredients of
(usually anaphylaxis) to Covid-19 vaccine.
1. Localized urticaria to an multiple, different drug 2. Allergic reaction of
unknown medication. classes with the trigger any severity after a
2. Contact allergies to nickel, unidentified. previous dose or any
perfumes, cosmetics, detergent 2. History of anaphylaxis known (diagnosed)
and/or chemical. to vaccine or allergy to any
3. Reported foodstuff, parenteral monoclonal ingredient§ of the
environmental (e.g. dust mites, antibody preparation. COVID-19 vaccine.
pollens) and/or latex allergies 3. History of idiopathic
NOT amounting to anaphylaxis.
anaphylaxis.
4. Reported immediate type of For CoronaVac® (Sinovac)
identified antibiotic 1. Allergic towards any
hypersensitivities NOT vaccine.
amounting to anaphylaxis.
5. Reported NSAIDs
hypersensitivities (urticaria
and/or angioedema not
involving the larynx with or
without bronchospasm).
6. Severe cutaneous adverse drug
reactions (SCARs)* or other
non-IgE mediated
hypersensitivities** to
identified medications / agents.
7. Allergic rhinosinusitis or
rhinoconjunctivitis.
8. Stable asthma
9. Atopic dermatitis

20
 Low Risk Category B
(History of anaphylaxis (Grade 3 /
Grade 4 / Grade 5 Hypersensitivity
reaction / Special diasease

1. Identified group of drug-

induced anaphylaxis (excluding
biologics, chemotherapy and
vaccines).
2. Reported angioedema and/or
anaphylaxis to identified
foodstuff, environmental (e.g.
oral mite syndrome) and/or
latex
3. Venom anaphylaxis
4. ACE inhibitor-induced
angioedema
5. Chronic Spontaneous
Urticaria/Angioedema
6. Systemic mastocytosis/mast
cell activation syndrome
7. Hereditary angioedema or
acquired angioedema

RECOMMENDATION: RECOMMENDATION: RECOMMENDATION:

1. Proceed with vaccination 1. For no 1-3, if 1. Do not vaccinate
provided they are well suspected PEG or with the vaccine
controlled disease. polysorbate allergy, in question.
2. Observation for 15-30 minutes choose another Covid- 2. Choose a
might be advisable. 19 vaccine without different COVID-
PEG/Polysorbate. 19 vaccine if
PLEASE REFER THE FLOW CHART 2. Defer vaccination, available and not
HYPERSENSITIVITY POPULATION referral to Hospital contraindicated.
Vaccination Centre. 3. Consider referral
to allergist-
immunologist if
other vaccine not
available.

* SCARs – Severe adverse cutaneous reaction including TEN, SJS,DRESS,AGEP,GBFDE, Acute erythrodermic

** Non IgE related Hypersensitivities eg Fixed drug eruption, Maculopapular eruption, Drug induced
photodermatitis, vasculitis, erythema multiforme

21
Table 1.5: Guidance of indication and contraindication Covid-19 vaccine In Hypersensitivity
population.

Types of hypersensitivity Vaccination decision

Drug Hypersensitivities
• Persons with a history of
immediate type of penicillin
allergy Low Risk Category A
• Persons with a history of Can receive COVID-19 vaccines
immediate type of antibiotics Observed 30 minutes
allergy other than penicillin
Low Risk Category B
Can receive COVID-19 vaccines
Persons with a history of anaphylaxis
Vaccination under Hospital setting
to penicillin or other types of
Observed 30 minutes
antibiotics

Low Risk Category A

Can receive COVID-19 vaccines
Observed 30 minutes
Persons with NSAIDs hypersensitivity
Many will have multiple chemically unrelated
(urticaria/angioedema not involving
NSAIDs cross-intolerant reactions.
the larynx/bronchospasm)
About 15-20% of these will have reactions involving
two systems (skin/mucosa and bronchospasm)
termed ‘blended’ reactions1, with resolution from
antihistamines and corticosteroid institution.

Low Risk Category A

Persons with NSAIDs-induced fixed
Can receive COVID-19 vaccines
drug eruptions or SCARs
Observed 30 minutes

Low Risk Category B

Can receive COVID-19 vaccines
Vaccination under Hospital setting
Persons with NSAIDs-induced Observed 30 minutes
anaphylaxis
NSAIDs-induced anaphylaxis may be due to an IgE-
mediated reaction (skin test positive) and does not
cross react with other chemically unrelated NSAIDs
group.

22

• Biologics and/or chemotherapy
hypersensitivity
• PEGylated biologics/chemotherapy
hypersensitivity
History of unexplained recurrent
anaphylaxis to unidentified injectable
medications (eg. multiple groups of
chemically unrelated drugs or
idiopathic anaphylaxis)
Mild allergic reaction (non-
generalized urticaria) to an
unidentified medication
Vaccine hypersensitivity
• Persons with history of influenza
vaccine hypersensitivity
• Persons with history of
hypersensitivity to other non-
COVID-19 vaccines
*NSAIDs can be a co-factor for food-induced IgE-
mediated anaphylaxis, e.g. wheat component
(omega-5-gliadin) sensitization should be ruled out.
Medium Risk -Relative Contraindication
Do not give vaccine containing PEG or polysorbate
May consider other type of COVID-19 vaccine
without PEG or polysorbate
May consider referring for investigations of
polysorbate 80 and PEG hypersensitivity.
Medium Risk -Relative Contraindication
Do not give vaccine containing PEG or polysorbate
May consider other type of COVID-19 vaccine
without PEG or polysorbate
*These individuals should be investigated for the
underlying cause
*Consider referral for PEG and polysorbate 80
testing
If skin test positive for PEG or polysorbate 80,
contraindicated to receive vaccine containing PEG
or polysorbate.
Consider other types of COVID-19 vaccines without
PEG or polysorbate
Low Risk Category A
Can receive COVID-19 vaccines
Observed 30 minutes
Medium Risk-Relative Contraindication
Do not give vaccine containing PEG or polysorbate
May consider other type of COVID-19 vaccine
without PEG or polysorbate
23
 May consider referring for investigations of
polysorbate 80 and PEG hypersensitivity

*Many non-COVID-19 vaccines contain polysorbate

20 or polysorbate 80

Contrast media hypersensitivity

Persons with history of contrast media
Low Risk Category A
hypersensitivity reaction (not
Can receive COVID-19 vaccines
anaphylaxis)
Observed 30 minutes

Low Risk Category B

Can receive COVID-19 vaccines
Persons with history of contrast media Vaccination under Hospital setting
anaphylaxis Observed 30 minutes

Contraindicated to receive the Moderna mRNA

vaccine.

Can receive the Cominarty (Pfizer) or ChAdOx1-S

Persons with history gadolinium-based
(Oxford, AstraZeneca) or Sputnik V vaccines
contrast media hypersensitivity
reaction during MRI
*Gadolinium-based contrast media hypersensitivity
reaction has been reported to be due to the
excipient TROMETAMOL2, a component contained
in the Moderna vaccine.

Contact Allergy
Persons with history of reactions or Low Risk Category A
contact allergy with patch test positive Can receive COVID-19 vaccines
to nickel, perfumes, and cosmetics Observed 30 minutes

Identified food, environment and latex

Persons with history of allergic
reaction to specific identified foodstuff Low Risk Category A
(e.g. shellfish, wheat, peanut, soy, Can receive COVID-19 vaccines
cow’s milk, egg, gelatin), environment Observed 30 minutes
(e.g. house dust mites, pollens), latex.

24

Persons with convincing history of
anaphylaxis to specific identified
foodstuff (e.g. shellfish, wheat, peanut,
soy, cow’s milk, egg), environment,
(e.g. house dust mites, pollens), latex
Venom allergy
Persons with history of venom
anaphylaxis (e.g. insect or bee or wasp
stings)
Urticaria/Angioedema
Persons with history of Chronic
Spontaneous Urticaria/Angioedema
The current COVID-19 vaccines do not contain
derivatives from shellfish, wheat, peanut, soy,
cow’s milk, egg, gelatin.
The vial stopper of all COVID-19 vaccines is made
from synthetic rubber. Thus, there is no issue
concerning latex contamination.
Low Risk Category B
Can receive COVID-19 vaccines
Vaccination under Hospital setting
Observed 30 minutes
*Vaccines may be manufactured in a
manufacturing facility where trace amounts of e.g.
shellfish, wheat, peanut, soy, cow’s milk, egg may
be present.
Low Risk Category B
Can receive COVID-19 vaccines
Vaccination under Hospital setting
Observed 30 minutes
Low Risk Category B
Can receive COVID-19 vaccines
Vaccination under Hospital setting
Observed 30 minutes
However, these individuals should take their
normally prescribed daily antihistamine(s) as usual,
even on the day of vaccination.
These individuals should be observed longer in a
controlled environment.
25
 *Persons with Chronic Spontaneous Urticaria may
experience mild (non-generalized) urticaria after
vaccination. Urticaria is often triggered by stressors
(for these individuals).

*Persons with Chronic Spontaneous Urticaria on

immunosuppressive therapy such as cyclosporin
should be able to receive the currently available
COVID-19 vaccines as none are live attenuated
vaccines.

Low Risk Category B

Persons with angiotensin ACEi-induced Can receive COVID-19 vaccines
angioedema Vaccination under Hospital setting
Observed 30 minutes

Low Risk Category B

Persons with hereditary angioedema Can receive COVID-19 vaccines
type I, II and III or acquired Vaccination under Hospital setting
angioedema Observed 30 minutes

Atopy

Low Risk Category A

Can receive COVID-19 vaccines
Observed 30 minutes

*Underlying asthma is NOT a contraindication to

receive the vaccine

Persons with underlying asthma on *Poorly controlled asthma should be assessed by

medication the treating physician for suitability and timing of
the COVID-19 vaccination.

*Asthmatic persons on high dose oral prednisolone

(>20 mg/day) should defer vaccination until oral
prednisolone can be stopped.

*Atopic or eosinophilic asthmatic persons on

omalizumab, benralizumab, dupilumab,

26
 mepolizumab, reslizumab can receive the mRNA or
viral-vector COVID-19 vaccines.

For inactivated virus vaccines, vaccinations should

be placed approximately midway through the
treatment interval (i.e., between two applications
of the respective biologics).

Low Risk Category A

Can receive COVID-19 vaccines
Persons with allergic rhinitis
Observed 30 minutes

Low Risk Category A

Can receive COVID-19 vaccines
Persons with atopic dermatitis
Observed 30 minutes

Mast cell disorder

Low Risk Category B

Can receive COVID-19 vaccines
Vaccination under Hospital setting
Observed 30 minutes
Persons with systemic mastocytosis or
mast cell activation disorder
*Persons with mast cell disorder with raised mast
cell tryptase requiring treatment should continue
their antihistamines, mast cell stabilizers, imatinib
during vaccination.5

27
1.6 List of vaccines and medications containing PEG and polysorbate

Table 1.6.1 Common VACCINES containing POLYSORBATE and PEG

Excipient Vaccine type Vaccine Amount per dose

Polysorbate 20 Influenza Flublok&Flublock quad < 27.5 µg (Tween 20)
Polysorbate 20 Hepatitis A Havrix 0.05 mg/ml
Polysorbate 20 Hepatitis A & B Twinrix Unknown
Polysorbate 20 SARS-COv-2 (Sanofi)
Polysorbate 80 Tdap Boostrix < 100 µg (Tween 80)
Polysorbate 80 Influenza Fluad 1.175 mg
Polysorbate 80 Influenza Fluarix quad < 0.055 mg (Tween 80)
Polysorbate 80 Influenza Flucelvax quad < 1500 µg (Tween 80)
Polysorbate 80 Influenza Flulaval quad < 887 µg
Polysorbate 80 HPV Gardasil & Gardasil-9 50 µg
Polysorbate 80 Hepatitis B Heplisav-B 0.1 mg/mL
Polysorbate 80 DTaP Infanrix < 100 µg (Tween 80)
Polysorbate 80 Japanese encephalitis JE-Vax <0.0007%
Polysorbate 80 DTaP + IPV Kinrix < 100 µg (Tween 80)
Polysorbate 80 DTaP + HepB + IPV Pediarix < 100 µg (Tween 80)
Polysorbate 80 Pneumococcal 13-valent Prevnar-13 100 µg
Polysorbate 80 DTaP + IPV Quadracel 10 ppm
Polysorbate 80 Rotavirus RotaTeq ?
Polysorbate 80 Zoster Shingrix 0.08 mg
Polysorbate 80 Meningococcal group B Trumenba 0.018 mg
Polysorbate 80 DTaP+IPV+HepB+Hib Vaxelis <0.0056%
Polysorbate 80 SARS-CoV-2 (Astrazeneca)
SARS-CoV-2
(Johnson & Johnson)
Sputnik V
(Gamaleya)
PEG2000 SARS-CoV-2 (Moderna)
SARS-CoV-2 (Pfizer)

28
 Table 1.6.2 Common PEG ontaining DRUGS
Generic name (brand name)
Methylprednisolone acetate
(Depo-medrol)
Methoxy polyethylene glycol-
epoeitin beta (Micera)
Pegfilgrastim (Neulasta)
Peginterferon alfa-2b (PEG-
Intron)
Medroxyprogesterone acetate
(Depo-provera)
Brilliant Blue G Ophthalmic
Solution (TissueBlue)
Sulfur hexafluoride (Lumason)
Biomatoprost implant (Durysta)
Transtuzumab (Herceptin,
Herzuma, Kanjinti, Ogivri,
Ontruzan)
Rilonacept (Arcalyst)
Perflutren lipid microsphere
(Definity)
Molecular weight General description
PEG 3350 Anti-inflammatory glucocorticoid for
intramuscular, intra-articular, soft
tissue or intralesional injection
30-kD methoxy PEG Used to treat anemia in adults with
butanoic acid chronic kidney disease
20-kD monomethoxy Used to help reduce the chance of
PEG infection due to low white blood cell
count in people with certain types of
cancer (nonmyeloid), who receive
anticancer medicines (chemotherapy)
that can cause fever and low blood
cell count
12000 daltons Treatment of HCV in combination
with other antiviral drugs in patients
over 5 years of age with
compensated liver disease
PEG 3350 Contraceptive and adjunctive therapy
and palliative treatment of
inoperable, recurrent, and metastatic
endometrial or renal carcinoma
PEG 3350 Disclosing agent indicated to
selectively stain the internal limiting
membrane
PEG 4000 Ultrasound contrast agent
PEG, (unspecified) Reduction of intraocular pressure in
patients with open-angle glaucoma or
ocular hypertension
PEG 3350 Adjuvant treatment of HER2
overexpressing node-positive or
node-negative breast cancer
PEG 3350 IL-1 blocker for treatment of
cryopyrin-associated periodic
syndromes
PEG 5000 Contrast agent used to brighten and
clarify images of the heart during
echocardiograms
29
 Table 1.6.3 Common POLYSORBATE containing DRUGS

Drug class Generic name (brand name) Polysorbate

Antiarrhythmic Amiodarone hydrochloride (generics only) Polysorbate 80
Antidiabetic Exanatide (BydureonBcise) Polysorbate 20
Insulin glargine (Lantus, Semglee) Polysorbate 20
Insulin glulisine (Apidra) Polysorbate 20
Dulaglutide (Trulicity) Polysorbate 80
Antidote Hyaluronidase (Hylenex Recombinant) Polysorbate 80
Antifungal Anidulafungin (Eraxis) Polysorbate 80
Anti-inflammatory Interferon beta 1b (Avonex, Plegridy) Polysorbate 20
Omalizumab (Xolair) Polysorbate 20
Antineoplastic Ofatumumab (Kesimpta) Polysorbate 80
Siltuximab (Sylvant) Polysorbate 80
Antipsychotic Paliperidone palmitate (Invega Trinza, Invega Polysorbate 20
Sustenna)
Aripiprazole lauroxil (Aristada) Polysorbate 20
Antiretroviral Ibalizumab (Trogarzo) Polysorbate 80
Antipsoriatic Adalimumab (Humira, Imraldi) Polysorbate 20
(Imraldi)
polysorbate 80
(humira)
Golimumab (Simponi) Polysorbate 80
Guselkumab (Tremfya) Polysorbate 80
Infliximab – dyyb (Inflectra, Remicade, Renflexis) Polysorbate 80
Ustekinumab (Stelara) Polysorbate 80
Antiviral Interferon-alfa-2b (Intron A) Polysorbate 80
Biological response Interferon-gamma-1b (Actimmune) Polysorbate 20
modifier

30
Drug class Generic name (brand name) Polysorbate
Cancer treatment Ado-trastuzumab (Kadcyla) Polysorbate 20
Atezolizumab (Tecentriq) Polysorbate 20
Avelumab (Bavencio) Polysorbate 20
Bevacizumab (Avastin, Zirabev) Polysorbate 20
Daratumumab/hyaluronidase (DarzalexFaspro) Polysorbate 20
Denosumab (Prolia, Xgeva) Polysorbate 20
Dinutuximab (Unituxin) Polysorbate 20
Enfortumab (Padcev) Polysorbate 20
Olaratumab (Lartruvo) Polysorbate 20
Palifermin (Kepivance) Polysorbate 20
Pertuzumab/trastuzumab/hyaluronidase (Phesgo) Polysorbate 20
Polatuzumabvedotin (Polivy) Polysorbate 20
Tafasitamab (Monjuvi) Polysorbate 20
Trastuzumab (Herceptin, Herceptin Hylecta, Polysorbate 20
Herzuma, Kanjinti, Ontruzant, Trazimera)
Belantamab (Blenrep) Polysorbate 80
Brentuximab vedotin (Adcetris) Polysorbate 80
Cemiplimab (Libtayo) Polysorbate 80
Docetaxel (Taxotere) Polysorbate 80
Durvalumab (Imfinzi) Polysorbate 80
Elotuzumab (Empliciti) Polysorbate 80
Etoposide (Toposar, VePesid) Polysorbate 80
Fam-trastuzumab deruxtecan (Enhertu) Polysorbate 80
Fosaprepitantdimeglumine (EMEND, Fosaprepitant) Polysorbate 80
Inotuzumabozogamicin (Besponsa) Polysorbate 80
Ipilimumab (Yervoy) Polysorbate 80
Isatuximab (Sarclisa) Polysorbate 80
Mogamulizumab (Poteligeo) Polysorbate 80
Moxetumomabpasudotox (Lumoxiti) Polysorbate 80
Nivolumab (Opdivo) Polysorbate 80
Ofatumumab (Arzerra) Polysorbate 80

31
Drug class Generic name (brand name) Polysorbate
Pembrolizumab (Keytruda) Polysorbate 80
Ramucirumab (Cyranza) Polysorbate 80
Rituximab (Truxima, Rituxan, Ruxience) Polysorbate 80
Temsirolimus (Torisel) Polysorbate 80
Temozolomide (Temodar) Polysorbate 80
Contraceptive Medroxyprogesterone acetate (depo-provera, Polysorbate 80
depo-provera CI, Depo-subQprovera 104)
Corticosteroid Methylprednisolone acetate (Depo-medrol) Polysorbate 80
Triamcinolone acetonide (Aristocort forte, Polysorbate 80
Aristopan, Kenalog-40, Kenalog-10, Protherix,
Triesence, TriloanSuik, Triloan II Suik, Ziretta)
Sincalide (Kinevac) Polysorbate 20
Tuberculin purified protein derivative (Aplisol, Polysorbate 80
Tubersol)
Disease-modifying Anakinra (Kinert) Polysorbate 80
antirheumatic drug
Tocilizumab (Actemra) Polysorbate 80
Enzyme Velaglucerase alfa (Vpriv) Polysorbate 20
Imiglucerase (Cerezyme) Polysorbate 80
Taliglucerase alfa (Elelyso) Polysorbate 80
Polysorbate 80
Erythoid maturation Luspatercept (Reblozyl) Polysorbate 80
agent
Factor Xa inhibitor Coagulation factor Xa (recombinant), Polysorbate 80
antidote inactivated-zhzo (Adexxa)
Gonadotropin Follitropin (Menopur, Follistim) Polysorbate 20
Growth hormone Somatotropin (Nutropin AQ Nuspin 5) Polysorbate 20
analog
Hematopoietic growth Erythropoeitin (Retacrit) Polysorbate 20
factor
Pegfilrastim (Fulphila, Neulasta, Nyvepria, Polysorbate 20
Udenyca)
Romiplostim (Nplate) Polysorbate 20
Darbepoetin alfa (Aranesp) Polysorbate 80
Filgrastim (Neupogen, Nivestym, Granix, Zarxio) Polysorbate 80
Hepatitis B/Hepatitis C Peginterferon (Pegays, Pegintron) Polysorbate 80
agent

32
Drug class Generic name (brand name) Polysorbate
Hemostatic Vitamin k (Phytonadione) Polysorbate 80
Immune globulin Hepatitis B Immune globulin (HepaGam B, Polysorbate 80
Nabi-HB)
Rho (d) immune globulin (WinRho) Polysorbate 80

Immunomodulator Intereron beta-1a (Avonex, Avonex Pen) Polysorbate 20

Emapalumab (Gamifant) Polysorbate 80
Immunosuppressant Mycophenolate mofetil (Cellcept IV) Polysorbate 80
Inflammatory bowel Vedolizumab (Entyvio) Polysorbate 80
disease agent
Interleukin inhibitor Sarilumab (Kevzara) Polysorbate 20
Dupilumab (Dupixent) Polysorbate 80
Mepolizumab (Nucala) Polysorbate 20
Secukinumab (Cosentyx) Polysorbate 80
Tildrakizumab – asmn (Ilumya) Polysorbate 80
Kallikrein inhibitor Lanadelumab (Takhzyro) Polysorbate 80
Leptin analog Metreliptin (Myalept) Polysorbate 20
Macular Aflibercept (Eylea) Polysorbate 20
degeneration agent
Ranibizumab (Lucentis) Polysorbate 20
Brolucizumab (Beovu) Polysorbate 80
mAb treatment Ocrelizumab (Ocrevus) Polysorbate 20
Remdesivir (Veklury) Polysorbate 20
Romosozumab (Evenity) Polysorbate 20
Teprotumumab (Tepezza) Polysorbate 20
Atoltivimab/maftivimab/odesivimab-ebgn Polysorbate 80
(Inmazeb)
Banlanivimab Polysorbate 80
Burosumab (Crysvita) Polysorbate 80
Canakimumab (Iliris) Polysorbate 80

33
Drug class Generic name (brand name) Polysorbate
Casirivimab/Imdevimab Polysorbate 80
Eptinezumab (Vyepti) Polysorbate 80
Fremanezumab (Ajovy) Polysorbate 80
Inebilizumab (Uplizna) Polysorbate 80
Raxibacumab Polysorbate 80
Natalizumab (Tysabri) Polysorbate 80
Dantrolene sodium (Dantrium, Ryanodex) Polysorbate 80
Crizanlizumab Polysorbate 80
Alirocumab (Praluent) Polysorbate 20
Evolocumab (Repaha) Polysorbate 80
Belimumab (Benlysta) Polysorbate 80
Tenecleptase (Tnkase) Polysorbate 20
Alteplase (CathfloActivase) Polysorbate 80
Reteplase (Retavase) Polysorbate 80
Calcitriol (Calcijex, Rocaltrol) Polysorbate 20
Doxercalciferol (Hectorol) Polysorbate 20
Vitamins A, B1, B2, B6, C, D3, E, K (Infuvite) Polysorbate 80

34
 FLOW CHART FOR FIRST DOSE VACCINE COVID -19

Registration

Contraindication Medium risk Low risk

Not for mRNA

Defer vaccine Consent
vaccine

*See flow chart

Referral to Hospital
Hypersensitivity
Vaccination centre
population

*See flow chart

Hypersensitivity
population

35
 FLOW CHART FOR HYPERSENSITIVITY POPULATION BEFORE INITIATING FIRST DOSE OF
COVID-19 VACCINE

Hypersensitivity population

LOW RISK LOW RISK MEDIUM RISK

Category A (History of Grade 1 and
Grade 2 Hypersensitivity reaction /
Non Ig E Drug Hypersensitivity /
Atopy disease
❖ Localized urticaria to an
unknown medication
❖ Contact allergies to nickel,
perfumes, cosmetics, detergent
and/or chemical
❖ Reported foodstuff,
environmental (e.g. dust mites,
pollens) and/or latex allergies
NOT amounting to anaphylaxis
❖ Reported immediate type of
identified antibiotic
hypersensitivities NOT
amounting to anaphylaxis
❖ Reported NSAIDs
hypersensitivities (urticaria
and/or angioedema not
involving the larynx with or
without bronchospasm)
❖ Allergic rhinosinusitis or
rhinoconjunctivitis
❖ Stable asthma
❖ Atopic dermatitis
❖ Severe cutaneous adverse drug
reactions (SCARs)* or other
non-IgE mediated
hypersensitivities** to
identified medications/agents
Vaccinate as per usual precaution
*Extend observation for 30 minutes
Category B (History of Anaphylaxis
/ *Special condition)
❖ Identified group of drug-induced
anaphylaxis (excluding biologics,
chemotherapy and vaccines).
❖ Reported angioedema and/or
anaphylaxis to identified
foodstuff, environmental (e.g.
oral mite syndrome) and/or
latex.
❖ Venom anaphylaxis.
❖ ACE inhibitor-induced
angioedema.
* Chronic Spontaneous
Urticaria/Angioedema
* Systemic mastocytosis/mast
cell activation syndrome
* Hereditary angioedema or
acquired angioedema
❖ Vaccinate with extra
precaution
- Vaccination under hospital
setting
- Observation 30 minutes
- Standby (a facility with
trained personnel in handling
anaphylaxis with adequate
resuscitation equipment)
❖ History of immediate
allergy reactions (usually
anaphylaxis) to multiple,
different drug classes with
the trigger unidentified or
suspected drug containing
PEG/Polysorbate
❖ History of anaphylaxis to
vaccine or parenteral
monoclonal antibody
preparation.
❖ History of idiopathic
anaphylaxis
❖ Other non COVID-19
vaccine hypersensitivity
❖ DO NOT vaccinate with
PEG or polysorbate
containing COVID-19
vaccines
❖ Consider other types of
COVID-19 vaccines witout
PEG or polysorbate
❖ Consider refer to Allergist /
Immunologist

* SCARs – Severe adverse cutaneous reaction including TEN, SJS,DRESS,AGEP,GBFDE, Acute erythrodermic

** Non IgE related Hypersensitivities eg Fixed drug eruption, Maculopapular eruption, Drug induced
photodermatitis, vasculitis, erythema multiforme
36
 FLOW CHART FOR CONSIDERATIONS IN VACCINATING SELECTED
GROUPS OF HYPERSENSITIVE POPULATION

(AFTER 1st VACCINATION)

ADVERSE EVENT
FOLLOWING
IMMUNIZATION

NON ALLERGIC REACTION ( localized, ALLERGIC REACTION OF ANY SEVERITY

non urticarial, non specific (LOCALISED OR GENERALISED)
symptoms,vasovagal/panic attack)

PROCEED SECOND Omit second dose

DOSE
Choose different Covid-19
REPORT AEFI vaccine
Refer immunologist/allergist
if no vaccine avalable

37
 FLOW CHART FOR SECOND DOSE VACCINE COVID -19

Registration

No reaction to 1st
dose Reaction to 1st dose

Received
second
dose
Non allergic Allergy/Anaphylaxis
reaction/non specific
symptoms/AEFI
Observation
30 minutes

Reconsent Not for second

dose mRNA
Vaccine

Observation for 30 minutes

38
Table 1.7 Example of case scenarios for allergy assessment BEFORE the first dose
of COVID-19 vaccine

Allergy details Vaccination decision Precaution

60/M with urticaria, lips swelling and Low Risk Category B Vaccination under
shortness of breath (SOB) to Aspirin 10 Can vaccinate Hospital setting
years ago. Anaphylaxis to Aspirin Observe for 30 minutes
after vaccination
35/F/underlying SLE with history of wheals Low Risk Category B Vaccination under
and angioedema to Naproxen and Voltaren. Can vaccinate Hospital setting
Given adrenaline injection x1, NSAIDs hypersensitivity Observe for 30 minutes
hydrocortisone and chlorpheniramine at with anaphylaxis after vaccination
casualty when she had angioedema and
SOB due to NSAIDs
45/F with chronic spontaneous urticaria. Low Risk Category B Vaccination under
She had history of angioedema and throat Can vaccinate Hospital setting
swelling to paracetamol, ibuprofen Continue antihistamines Observe for 30 minutes
(Brufen®) and mefenamic acid (Ponstan®). as usual. after vaccination
Her symptoms currently controlled with NSAIDs
oral cetirizine 20mg bd hypersensitivity/Chronic
Spontaneous Urticaria
20/M with history of wheals and itchy eyes Low Risk Category A Vaccination as per
after eating shellfish (prawn and crab). His Can vaccinate usual
symptoms resolved spontaneously within Allergy or Intolerance to Observe for 30 minutes
24 hours. seafood after vaccination
75/F with DRESS to allopurinol 15 years ago. Low Risk Category A Vaccination as per
She has eczema after resolution of DRESS Can vaccinate usual
under dermatology follow up. DRESS to drugs other than Observe for 30 minutes
vaccine is not a after vaccination
contraindication
35/M with HIV, history of maculopapular Low Risk Category A Vaccination as per
rash to sulfamethoxazole and trimethoprim Can vaccinate usual
(Bactrim®), CD4 = 240, viral load MPE (type IV Observe for 30 minutes
undetectable. hypersensitivity) to after vaccination
No throat swelling, no shortness of breath. sulfamethoxazole and
trimethoprim (Bactrim®)

39
 Allergy details Vaccination decision
43/F with generalized rash after flu vaccine Medium Risk
last year. Do not give vaccine with
Had throat swelling, hypotension and no PEG or polysorbate
shortness of breath. Anaphylaxis to previous
influenza vaccine. Most
influenza vaccines contain
polysorbate.*
30/M epilepsy, history of SJS secondary to Low Risk Category A
carbamazepine 5 years ago. Can vaccinate
SJS/TEN to drugs other
than vaccine is not a
contraindication
66/M holding an allergy card Fixed drug Low Risk Category A
eruption to Penicillin. Can vaccinate
Fixed drug eruption is not
a contraindication
58/F had angioedema and wheals Medium Risk
associated with SOB after taken Forlax® Do not give vaccine with
(Macrogol 4000) for constipation. PEG or polysorbate
Immediate
hypersensitivity to Forlax®
(Macrogol 4000). Forlax®
contains PEG*.
60/F with DM, IHD, hypertension and Low Risk Category B
perindopril induced angioedema. Can vaccinate
ACE inhibitor induced
angioedema
25 /M poorly control bronchial asthma. He Defer vaccination
is currently wheezing despite on nebulizer.
* Polyethylene glycol (PEG) is an ingredient in Comirnaty® (Pfizer-BioNTech); and polysorbate 80 is an
ingredient in ChAdOx1 (Oxford/AstraZeneca;Covishield in India), Sputnik V (Gamaleya Research Inst) and
Janssen COVID-19 Vaccine (Janssen Biotech Inc.). PEG and polysorbate are structurally related, cross-
hypersensitivity between these compounds may occur.
Precaution
May consider other
type of COVID-19
vaccine without PEG*
or polysorbate.
May refer to
immunologist for
assessment.
Vaccination as per
usual
Observe for 30 minutes
after vaccination
Vaccination as per
usual
Observe for 30 minutes
after vaccination
May consider other
type of COVID-19
vaccine without PEG*
or polysorbate.
May refer to
immunologist for
assessment.
Vaccination under
Hospital setting
Observe for 30 minutes
after vaccination
To get assessment by
physician and optimize
the bronchial asthma
control.
40
REFERENCES

1. Australasian Society of Clinical Immunology and Allergy (ASCIA) (2021). Allergy,

Immunodeficiency, Autoimmunity and COVID-19 Vaccination Position Statement. [online]
Available at: <https://www.allergy.org.au/hp/papers/ascia-hp-position-statement-covid-
19-vaccination> [Accessed 17 March 2021].

2. Turner PJ, Ansotegui IJ, Campbell DE, Cardona V, Ebisawa M, Yehia E-G, et al. (2021).
COVID-19 vaccine-associated anaphylaxis: A statement of the World Allergy Organization
Anaphylaxis Committee. World Allergy Organization Journal, 100517.

3. Nicholas G. Kounis1, Ionna Koniari2, Cesaro de Gregorio3, Dimitris Velissaris4, Konstantinos

Petalas5, Aikaterini Brinia6, Stelios F. Assimakopoulos7, Christos Gogos8, Sophia N. Kouni9,
George N. Kounis10, Gia Franco Calogiuri11,12 and Ming-Yow Hung13,14,15

4. Consensus statement Covid-19 Vaccination for individuals with allergic/Hypersensitivity

Disorders, Section of Clinical Immunologists and Allergists, College of Physician’s,
Singapore.

5. Cardona V, Ansotegui IJ, Ebisawa M, El-Gamal Y, Fernandez Rivas M, Fineman S, et al.

(2020). World allergy organization anaphylaxis guidance 2020. The World Allergy
Organization journal, 13(10),100472.

6. Banerji A, Wickner PG, Saff R, Stone CA Jr, Robinson LB, Long AA et al.(2020, Dec 31).
mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current
Evidence and Suggested Approach. J Allergy Clin Immunol Pract.,S2213-2198(20), 31411-
2.

7. COVID C, Team R. (2021). Allergic reactions including anaphylaxis after receipt of the first
dose of Moderna COVID-19 Vaccine—United States, December 21, 2020–January 10,
2021. Morbidity and Mortality Weekly Report, 70(4),125.

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 GUIDELINES FOR
POST VACCINATION
ANAPHYLAXIS
MANAGEMENT

JABATAN KESIHATAN NEGERI TERENGGANU

42
INTRODUCTION

Anaphylaxis is a serious systemic hypersensitivity reaction which is usually acute in onset and
may result in death. Severe anaphylaxis is characterized by potentially life-threatening
compromise in airway, breathing and/or circulation and may present without the classical skin
features or circulatory shock. The incidence of anaphylaxis following COVID-19 vaccination is
generally rare.

Diagnosis of anaphylaxis is made clinically based on signs and symptoms. Failure to recognize and
delay in treatment could be catastrophic as it can deteriorate rapidly leading to respiratory and
cardiac arrest. Most anaphylaxis cases (70%) occur within 15-30 minutes post vaccination though
it can sometimes take up to several hours for the first symptoms to develop. Diagnoses of
anaphylaxis is presented in Table 1.

Careful assessment and clinical judgement can differentiate anaphylaxis from other mimicking
conditions. Common differential diagnoses presented in Table 2.

Careful assessment and clinical judgement can differentiate anaphylaxis from other mimicking
conditions, provided in Table 3.

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 Table 1. Diagnostic Criteria for Anaphylaxis

DIAGNOSTIC CRITERIA FOR ANAPHYLAXIS

(Adapted from WAO Anaphylaxis Guidance 2020)

Anaphylaxis is highly likely if any ONE of the criteria presents:

Criteria 1 Criteria 2

Acute onset of illness (minutes to several Acute onset of

hours) with mucocutaneous involvement hypotension1 OR
AND at least one of the following: bronchospasm2 OR
a. Respiratory symptoms/signs laryngeal involvement3
b. Episode of hypotension or with after exposure to a
associated manifestations (eg. hypotonia, known* or highly likely* allergen
syncope, collapse, incontinence (minutes or several hours),
c. Severe gastrointestinal symptoms even in the absence of typical skin
involvement.
1
Hypotension is defined as systolic BP < 90mmHg or reduction in systolic BP greater than 30% from the
individual’s baseline.
2
Excludes lower respiratory symptoms triggered by common inhalant allergens or food allergens perceived
to cause “inhalational” reactions.
3
Laryngeal symptoms include stridor, vocal changes, odynophagia.

SYSTEM SYMPTOMS
Mucocutaneous ● Eyes: Periorbital or conjunctival swelling
● Oral mucosa: Lips, tongue or uvula swelling
● Skin: Generalised urticaria, skin redness, itchiness
Respiratory ● Upper airway: Foreign body sensation, stridor, voice
hoarseness, sudden increase/excess in nasal secretions,
difficulty in swallowing, hypoxia
● Lower airway: wheezing, breathlessness, chest tightness,
coughing, decreased peak expiratory flow (PEF), cyanosis,
hypoxia
Cardiovascular ● Early features: syncope, dizziness, tachycardia, hypotension,
prolonged capillary refill time
● Late features: bradycardia, shock, altered mental status
related to reduced cerebral perfusion/hypoxia, cardiac arrest.
Gastrointestinal ● Persistent abdominal cramp
● Repetitive Vomiting
● Diarrhea

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Table 2. Differential Diagnoses (Adapted from WAO Anaphylaxis Guidance 2020)

45
Table 3. Differentiating feature of anaphylaxis, vasovagal reaction and panic attack

46
Managing Anaphylaxis in PPV

All vaccination centers should have enough staff, medication, and equipment to recognize
and treat anaphylaxis. Transport should be available to send patients to specialist centers
if anaphylaxis is diagnosed. The following equipment should be accessible during
anaphylaxis (Table 4):

Table 4. Equipment and Drugs for Managing Anaphylaxis – Basic

Equipment Drugs
1. Transport Stretcher 1. Adrenaline
2. Emergency Cart or Bag 2. Normal Saline
3. Wheelchair 3. Salbutamol
4. Cardiac monitor or Defibrillator 4. Chlorpheniramine
5. Oxygen regulator 5. Hydrocortisone
6. Portable Oxygen Source
7. Emergency Airway Management
Set
a. Bag Valve Mask
b. Laryngoscope,
c. ETT
8. Medications Chart
9. Portable Suction
10. Glucometer
11. Stethoscope
12. Large Bore cannula
(16G,18G and 20G)

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Management of Anaphylaxis
Management of anaphylaxis, steps are critical as part of the initial emergency
management presented in Table 5. The mainstay of treatment is administration of
intramuscular adrenaline 0.5mg ,up to maximum 3 doses.

CONSULT Family Medicine Specialist / Emergency Physician incharge if more than two(2)
IM injections of adrenaline are required.
For Refractory Anaphylaxis, CONSULT Emergency Physician or Physician before
managing further patients.

The emergency management of anaphylaxis with pregnancy and elderly patient is

essentially the same as other patients.

Flowchart of referral of anaphylaxis and allergic reaction patients is presented in Table 5.

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 Table 5. Management of Anaphylaxis in Vaccination Center
MANAGEMENT IN VACCINATION CENTER (PPV- BASIC SETTINGS)
1. Get additional help immediately.
2. Assess Airway Breathing and Circulation
3. Position patient
a) Lie patient in recumbent position with leg raised.
b) In patients who are vomiting or having breathlessness, allow patients to be in the position of comfort22.
c) Pregnant patients can be put on the left lateral position.
4. Monitoring: Vital sign, Pulse oximetry, cardiac monitoring
5. First line Treatment
a) Administer IM Adrenaline 0.5mg/0.5ml (1:1000) (preferably over the mid-lateral thigh)
b) Repeat administer IM Adrenaline 0.5mg every 5-10minutes if necessary.
6. CONSULT Family Medicine Specialist/Emergency Physician incharge IF more than two(2) IM injections of
Adrenaline are required
7. Give 100% oxygen supplementation via high flow mask if SpO2 <95%
8. IV fluid challenge: 500 – 1000 mL
9. Immediate intubation in impending airway obstruction from angioedema.
10. Consider nebulized/ MDI salbutamol with persistent bronchospasm (with AGP precaution)
11. TRANSFER to Emergency & Trauma Department for further management.

Adjunct therapies
1. For Cutaneous signs & symptoms (Should Not be administer before Adrenaline)
i. H1 antagonist: IV Chlorpheniramine 10mg
ii. H2 antagonist: IV Ranitidine 50mg
2. Glucocorticoid: IV Hydrocortisone 200mg – consider for patient with risk of biphasic (severe /refractory)

TREATMENT FOR REFRACTORY ANAPHYLAXIS

(IN EMERGENCY /CRITICAL CARE/ ACUTE CARE SETTINGS)
1. CONSULT Emergency Physician/ Physician
AFTER CONSULTATION;
2. Consider administer another IM Adrenaline 0.5mg (3rd dose)
3. Give IV Adrenaline infusion for refractory symptoms despite 2 /3 doses of IM adrenaline and IV fluid
boluses.
The preferred method of adrenaline infusion will be using an infusion pump.
3mg adrenaline 1:1000 in 47ml of normal saline in a 50ml syringe.
• Initial dose can be set at 0.1mcg/kg/min (e.g. in a 50kg patient, to start infusion adrenaline at
5ml/hour). OR
• Diluting 0.5ml 1:1000 (0.5mg) adrenaline in 500ml normal saline if the infusion pump is not available.
• Initial dose can be set at 2ml per minute (equivalent to 2mcg per minute) - gradually increased up to
10mcg/min (10ml/min)
• Titrate the infusion rate according to the blood pressure and heart rate.
4. I.V. Fluid challenge 500-100ml
5. Consider alternative vasopressors - noradrenaline,
6. For patient on beta blocker and resistant to adrenaline, consider administer
• IV glucagon 1-5mg over 5 minutes
• followed by infusion 5-15mcg/min ( For Hospital with specialist)
7. REFER and TRANSFER to Hospital with Critical Care facilities.

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50
51
 CHECKLIST FOR HYPERSENSITIVITY / ALLERGY REACTION
AFTER FIRST DOSE VACCINATION
*Untuk diberikan kepada setiap pesakit selepas pemberian vaksin.

Name:
IC No:
Date of vaccination:
Type of vaccine:
Pusat Pemberian Vaksin:

Anaphylaxis associated Yes No Insufficient Date/Time Action Assessor

characteristic Name
History of sudden onset with
rapid progression of signs and
symptoms
a. Generalized urticaria
b. Generalized erythema
c. Generalized pruritus
d. Generalized pruritus
without rash
e. Generalized prickle
sensation
f. Localized injection site
urticaria
g. Red and itchy eyes
Cardiovascular
a. Hypotension
b. Tachycardia
c. Capillary refill time
greater than 3 second
d. Decreased level of
consciousness
Respiratory
a. Wheezing
b. Stridor
c. Swelling lip
d. Swelling tongue
e. Swelling throat
f. Swelling uvula
g. Swelling larynx

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h. Tachypnea
i. Increased use of
accessory muscles
j. Persistent dry cough
k. Hoarse voice
l. Difficulty in breathing
without
wheeze/stridor
m. Sensation throat
closure
n. Sneezing/Rhinorrhea

Gastrointestinal
a. Diarrhea
b. Abdominal pain
c. Nausea/Vomiting
Others
a. Fever
b. Other symptoms

53