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Healthy People, Healthy SaskatchewanThe Saskatchewan Health Authority works in the spirit of truth and reconciliation, acknowledging Saskatchewan as the traditional territory of First Nations and Métis People.

Seasonal Influenza Immunization Module

2020 - 2021

Professional Expectation

The information contained in this learning module is suggested content for new and seasonal influenza immunizers. The person responsible for immunization provision in a given agency, department or service is responsible for determining the immunizer’s educational needs and assessing immunization competency, including anaphylaxis management, based on the requirements set out by their licensing professional association and local policy.

Setting the Stage for Learning

Information in this learning module is:

• Designed for Health Care Providers who are new immunizers or for those who administer seasonal influenza vaccine each year and require a refresher.

• Intended to be used in conjunction with the Influenza Immunization Reference Guide and Quiz.

• Designed for independent or facilitated learning.

Note: website links only work in slide show mode

Setting the Stage for Learning

The slides are divided into the following sections:

• Section 1 Influenza Disease

• Section 2 Influenza Vaccine

• Section 3 Management of Biological Products

• Section 4 Vaccine Administration

• Section 5 Common reactions and Adverse Events Following Immunization

• Section 6 Reporting Adverse Events Following Immunization (AEFI)

• Section 7 Resources

Section 1: Influenza Disease

Influenza DiseaseLearning Objectives

Learning Objectives¹

The immunizer will be able to perform the following:

a. Describe the key epidemiologic features of the influenza virusb. Acquire a better understanding of the influenza diseasec. Describe the symptoms of influenza and how the virus is transmittedd. A better understanding of influenza disease trends in Saskatchewan

Influenza DiseaseAgent

Infectious agent²ʼ³

• Influenza disease is a caused primarily by Influenza A and B viruses.

• Influenza A viruses are classified into subtypes based on two surface proteins hemagglutinin (HA) and neuraminidase (NA).

• Influenza B viruses have evolved into two distinct lineages -B/Yamagata and B/Victoria

Influenza Disease

• Over time, antigenic variation (antigenic drift) of strains occurs within an influenza A subtype or B lineage.

• The ever-present possibility of antigenic drift requires seasonal influenza vaccines to be reformulated annually. Antigenic drift may occur in one or more influenza virus strains.³

• The World Health Organization (WHO) recommends the composition of the influenza virus vaccines twice a year.

Agent

Influenza Disease

Clinical Disease²:

• Sudden onset of fever, cough, and muscle aches. Other symptoms -headache, chills, loss of appetite, fatigue and sore throat. Nausea, vomiting, and diarrhea may occur, especially in kids.

• In general, only about 50% of infected persons will develop the classic clinical symptoms of influenza.⁴

• Respiratory illness that can cause mild to severe disease leading to hospitalization and death.

• Globally the attack rate is estimated at: 5-10% in adults and 20-30% in children.

• Most people will recover in 10 days, but some are at a greater risk for severe complications.

Clinical Disease

Influenza Disease

Clinical Disease:

• Young children, older adults, and those with certain illnesses or risk factors have a higher risk for serious complications, including viral pneumonia, secondary bacterial pneumonia and worsening of medical conditions.

Reservoir²:

• Influenza A can infect human and other animal species

• Influenza B limited to humans.

Reservoir

Influenza Disease

Transmission²:

• Spreads easily through droplet spread through coughing, sneezing, and direct/indirect contact with respiratory secretions.

• Indirect contact from counters, door knobs and then touching your eyes, nose and mouth.

• Usually seasonal with higher rates in late fall and early winter.

Transmission

Influenza Disease

Incubation²:

• 2 days but can range from 1-4 days.

• Adults can spread the disease 1 day before symptom onset to approximately 5 days after the start of symptoms

• Children may spread the virus for 10 days or longer⁴

Incubation

Watch the Video: WHO: Influenza, an unpredictable threat

https://www.youtube.com/watch?v=yhhJfT86Bgg

https://youtu.be/yhhJfT86Bgg

https://www.youtube.com/watch?v=yhhJfT86Bgg

Influenza DiseaseDisease trends in Saskatchewan

Section 2: Influenza Vaccine

Section 2 Influenza VaccineLearning Objectives

Learner Objectives

The influenza immunizer will be able to:a. Name the strains in the 2020-2021 vaccine and know when the

Influenza immunization program starts in Saskatchewan.

b. Identify and become familiar with the publicly funded vaccine products and who is eligible for the products.

c. Describe the Influenza dosing schedule.

d. Identify those highly recommended to receive the influenza vaccine including the high risk populations.

e. Understand the effectiveness of the influenza vaccine.

Influenza VaccineProvincial Influenza Immunization Policy

Influenza Program DatesMonday October 19, 2020 to Wednesday March 31, 2021

2nd dose for children <9 years offered up to Friday April 30, 2021

The National Advisory Committee on Immunization (NACI) sets the guidelines for the National Influenza Program each season. The Government of Saskatchewan sets the direction for the Influenza Program each year.

https://www.ehealthsask.ca/services/Manuals

https://www.ehealthsask.ca/services/Manuals

Influenza VaccineProvincial Start Date

The World Health Organization’s (WHO) recommendations on the composition of influenza virus vaccines are typically available in February of each year for the upcoming season in the Northern Hemisphere².

2020-2021 Influenza Vaccine Strains²

• A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like virus;

• A/Hong Kong/2671/2019 (H3N2)-like virus;

• B/Washington/02/2019 (B/Victoria lineage)-like virus; and

• B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.*

*Trivalent Influenza Vaccine does not include B/Phuket/3073/2013-like virus

Influenza Vaccine

Sanofi Pasteur® – Fluzone Quadrivalent Multidose

• Dose: 0.5 ml

• Route: Intramuscular only

• 10 dose vial

• Approved for ages 6 months and up

• Vaccine will be provided to all immunizers

• Contains 15 µg HA per strain

Fluzone® Quadrivalent

Influenza Vaccine

GlaxoSmithKline – FluLaval® Tetra multidose (Quadrivalent)

• Dose: 0.5 ml


• 10 dose vial


• Vaccine will be provided to all immunizers


FluLaval® Tetra

Influenza Vaccine

Sanofi Pasteur® – Fluzone Quadrivalent

Thimerosal free*

• Dose: 0.5 ml


• Pre-filled syringes 10 per box



• Vaccine will be provided to SHA, AHA,

and FNJ public health only

* thimerosal free are prioritized for people who self-identify as having a diagnosed thimerosal allergy (documentation is not required). It may be administered to others who request it. Refer client to public health.

Fluzone® Quadrivalent thimerosal - free

Influenza vaccine

Sanofi Pasteur – Fluzone High dose trivalent

• Dose: 0.5 ml


• Prefilled syringe – 10 per box

• Approved only for the ages of 65 years and up*Will be publicly funded for those 65 years and older in

long term care facilities and personal care homes.


Note: Trivalent Vaccine has the following strains:

A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like virus;

A/Hong Kong/2671/2019 (H3N2)-like virus;

B/Washington/02/2019 (B/Victoria lineage)-like virus

Fluzone High Dose - trivalent

Influenza VaccineLive Attenuated Influenza Vaccine

**Live attenuated influenza vaccine (LAIV) will not be publicly funded. Flu Mist (nasal spray) is available in Canada

for purchase only.

• The Ministry of Health does not reimburse the cost of privately-purchased influenza vaccines. (Saskatchewan Influenza Immunization Policy 2020-2021).

Influenza Vaccine

All current Influenza vaccines are latex free.

Ingredients and overview

Ingredients and overview

Influenza Vaccine

Adapted from Saskatchewan Influenza Immunization Policy

2020-2021⁵

Influenza Vaccine

National Advisory Committee on Immunization and thimerosal:⁶

Thimerosal is an organic mercury compound that is an effective preservative and only used in multidose vaccines (influenza). It stops the growth of bacteria and fungi.

It is metabolized to ethylmercury and thiosalicylate and broken down quickly by the body.

It is different than the naturally occurring element mercury found in the air, soil and water in our environment that can build up in our system and cause neurotoxicity.

Numerous studies have shown evidence that clearly refutes an association between thimerosal and neurodevelopmental disorders. NACI has concluded there is no legitimate reason to avoid thimerosal containing products for children or older individuals, pregnant women.

Thimerosal

Eligibility and highly recommended

Influenza Vaccine

Influenza vaccine is recommended for all Individuals six months of age and older who do not have contraindications to influenza vaccine

The Following are populations for whom Influenza vaccination is recommended:

• All HCWs, health care students, emergency response workers, visitors and volunteers who, through their activities, are capable of transmitting influenza to those at high-risk influenza complications in independent practices, facilities, residences and community settings.*• Adults (including pregnant women) and children ≥6 months with a chronic health condition including but not limited to:

Cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis & asthma);

Diabetes mellitus and other metabolic diseases; cancer and other immune-compromising conditions (due to underlying disease, therapy or

both); Renal disease; Anemia or hemoglobinopathies; Neurologic or neurodevelopmental disorders and seizure disorders (and for children include

febrile seizures and isolated developmental delay) but excludes migraine and psychiatric conditions without neurological conditions.


Influenza Vaccine

Morbid obesity (adults BMI ≥ 40, child BMI assessed as ≥ 95th percentile adjusted for sex and age).

• Children and adolescents with the following conditions: Those undergoing treatment for long periods with acetylsalicylic acid, because of the

potential increase of Reye syndrome associated with influenza.• People of any age who are residents of nursing homes, long-term care facilities and other chronic care facilities.• People ≥ 65 years of age.• All children six to 59 months of age (younger then five years old).• Indigenous peoples.• Shelter residents and those who are street involved.• Visitors to health care facilities and other patient care locations.• Household and close contacts of individuals at high-risk of influenza-related complications whether or not the individual at high-risk has been immunized.• Household and close contacts of infants less than six months of age.• Members of households who are expecting a newborn during the influenza season.


Influenza Vaccine

• Those providing regular childcare to children ≤ 59 months of age, whether in or out of the home.• Those who provide services within closed or relatively closed settings to persons at high-risk.• People who provide essential community services (e.g. provincial corrections staff who have direct contact with inmates).• People in direct contact during culling operations with poultry infected with avian influenza.• People working with live or dead poultry or swine.• Health sciences students (human and animal health).• Travelers – influenza occurs year-round in the tropics. In temperate northern and southern countries, influenza activity peaks generally during the winter season (November to March in the Northern Hemisphere and April to October in the Southern Hemisphere).

*NACI considers the receipt of influenza vaccination to be an essential component of the standard of care for all HCWs and other care providers for their own protection and that of their patients. This group should consider annual influenza vaccination as part of their responsibilities to provide the highest standard of care.

Influenza Vaccine

Influenza Vaccine by Age and Dosage

Schedule

Age Vaccine Dosage (mL) Number of doses required per season

6 months to 8 years QIV 0.5 mL IM 1 or 2 *

≥ 9 years ≥ 65 years(excludes residents of LTC and personal care homes)

QIV 0.5 mL IM 1

LTC and personal care home residents ≥ 65 years

TIV (FLUZONE® High-Dose) or (QIV if

TIV unavailable)

0.5 mL IM 1

*Children 6 months to less than 9 years of age receiving seasonal influenza vaccine for the first time in their life should be given 2 doses of influenza vaccine, with one month apart (minimum interval 4 weeks) between doses. Children 6 months to less than 9 years of age who have been properly vaccinated with one or more doses of seasonal influenza vaccine in the past should receive 1 dose of influenza vaccine per season thereafter.

Influenza Vaccine

• Flu vaccines are interchangeable for children requiring two doses.

• The first time that a child younger than nine years old receives seasonal multivalent influenza vaccine, a two-dose schedule 1 month apart is required. An interval of less than 28 days is a medication administration error.

NOTE: If they have previously received one or more doses of an influenza vaccine, they only require one dose per season there after.

Schedule

Influenza Vaccine

• The duration of immunity following inactivated influenza vaccination is less than 1 year because of waning of vaccine-induced antibody and antigenic drift of circulating influenza viruses.⁴

• Vaccine Protective levels of humoral antibodies are generally achieved by 2 weeks after vaccination; however, there may be some protection afforded before that time²

• Fluzone High-Dose (IIV3-HD) provides superior protection compared with the standard trivalent inactivated influenza vaccine in adults 65 years of age and older.

Effectiveness and immunogenicity

Section 3: Management of Biological Products

Section 3: Management of Biological Products

Learning Objectives¹:

The influenza immunizer will be able to perform the following:

a. Describe the requirements for vaccine storage, handling, and transportation and their importance in maximizing the potency and efficacy of influenza vaccine.

b. Explain the actions needed to report and manage breaks in the cold chain or other insults that compromise vaccine integrity.

Learning Objectives

http://www.phac-aspc.gc.ca/publicat/2007/nvshglp-ldemv/pdf/nvshglp-ldemv-eng.pdf

Management of Biological Products

• The cold chain refers to the process used to maintain optimal conditions during the transport, storage, and handling of vaccines.

The recommended temperature for refrigerated vaccines is +2°C to +8°C

Management of biological products

• Vaccines are sensitive biological products which may become less effective, or even destroyed, when exposed to temperatures outside the recommended range.

• Influenza vaccines when exposed to light may lose their effectiveness.

• Understanding the principles of cold chain is a key concept in the handling and the storage of vaccines.

Management of biological productsStorage of Products

Principles

• Always store refrigerated biological products between 2°C and 8°C in a dedicated refrigerator for biological products.

• Never use a bar or half-sized refrigerator for product storage.

• Do not keep food or drinks in vaccine refrigerator.

• Keep vaccines in the original package – light sensitive.

• Return products to fridge as quickly as possible to the fridge after use and on return from an off site immunization clinic.

• Always use products with the nearest expiry date first.

• Ensure vaccine is not expired.

Management of biological productsExpiry dates

Expiry dates

• Is the date by which the vaccine/diluent should be used by, or needs to be wasted.

• Expiry dates on the influenza multi dose vials may vary – always review product monograph for vaccine expiry date. FluLaval Tetra multidose – date when first opened. Expired 28 days after

opening

Fluzone Quadrivalent multidose – good until expiry date on vial

• If the vaccine expiry date is marked by the month and year, the vaccine may be used up to the last day of the month.

Management of biological productsCold Chain Break

What to do if you have a Cold Chain Incident?

DO NOT discard vaccine

1. IMMEDIATELY place exposed vaccines in paper bag and clearly label “DO NOT USE – Cold chain break” and add date of exposure. Store exposed vaccines separately in fridge under appropriate conditions.

2. Follow the directions found in the Saskatchewan Influenza Immunization Policy 2020-2021

DO NOT USE – cold chain exposure. May 14, 2020

Section 4: Vaccine Administration

Section 4: Vaccine Administration

Learning Objectives¹

The Influenza immunizer will be able to perform the following:

a. Obtain an informed consent for influenza from the client/guardian.

b. Prepare a checklist for pre-immunization patient assessment, including precautions, contraindications, and indications for rescheduling.

c. Ensure the ten "Rights" of immunization are always maintained with each client.

d. Demonstrate the steps involved in vaccine preparation, administration, and disposal.

f. Demonstrate appropriate technique for immunization including age-appropriate injection sites and proper client positioning.

Learning Objectives

Vaccine Administration

ALWAYS use two identifiers to ensure you have the right client• First and last name

• Date of birth

• Health card number

OBTAINING INFORMED CONSENT FOR A VACCINE⁸

1. Determine the authority for the client or representative to provide informed consent. If it is a child, is the legal guardian present.

2. Assess capability to give informed consent – was the discussion understood?

Obtaining informed consent

Vaccine AdministrationObtaining informed consent

3. Provide standard information:Provide the vaccine information sheet

Benefits of vaccination

Risks of not being vaccinated

Common side effects of vaccines.

Possible serious, severe or unusual adverse events and their frequency.

Contraindications

4. Allow the opportunity to ask questions and confirm understanding.

The vaccine information sheets provided to the client are great tool for assisting with parts of the informed consent process. They are found on the Ministry of Health website at: https://www.saskatchewan.ca/residents/health/accessing-health-care-services/immunization-services#immunization-forms-and-fact-sheets

https://www.saskatchewan.ca/residents/health/accessing-health-care-services/immunization-services#immunization-forms-and-fact-sheets

Vaccine AdministrationSeasonal Influenza Vaccine Fact sheet


General Screening Questions

1. Are you well today?

2. Do you have any severe allergies?

3. Have you had a reaction to a previous vaccine that you were concerned about?

4. Do you have any history of neurological issues (screening for Guillain-Barre syndrome within 6 weeks of a influenza containing vaccine)?

Screening Questions

Vaccine AdministrationContraindications to Influenza

Contraindications

History of anaphylaxis to previous dose of the specific vaccine.

History of anaphylaxis to any component of the vaccines, except egg.

History of Guillain Barre Syndrome* (GBS) within 6 weeks of receiving a previous influenza vaccine.

Less that 6 months of age.

Serious acute illness

If GBS developed within 6 weeks of previous influenza vaccine – refer to MHO for an assessment for immunization.

*See product monographs for the vaccine ingredients or the Saskatchewan

Immunization Manual, chapter 10.


*Guillain-Barre Syndrome (GBS)

• Is a form of paralysis.

• Is usually temporary.

• Most have full or near complete recovery.

• Associated with 1976 “swine flu” vaccine but no such association with any other influenza vaccine has been found.

• The risk of GBS following Influenza vaccination is about one excess case per million vaccinations. The risk of GBS associated with influenza illness is larger, about 17 cases per million influenza-coded health care encounters, which are a proxy for influenza illness.²

Contraindications


*Egg allergy – is not a contraindication to influenza vaccine.

NOTE

National Advisory Committee on Immunization statement on Influenza vaccine 2017-2018:

NACI has concluded that egg allergic individuals may be vaccinated against influenza using any appropriate product without prior influenza vaccine skin test and with the full dose, irrespective of a past severe reaction to egg and without any particular consideration, including immunization setting.

Egg allergy

Vaccine AdministrationPrecautions

Precautions

Do not delay immunization because of minor acute illness, with or without fever.• In the 2020-2021 Saskatchewan Influenza Immunization Policy (SIIP) it

states, “Vaccine administration should be postponed when possible in persons who have a minor or acute illness, with or without a temperature based on current COVID-19 screening criteria, until their symptoms have abated.”

With the current COVID19 screening, the above recommendations are reflective of community based settings (i.e. home visits, clinics). Clients that do not pass the COVID19 screening criteria in the community setting will be asked to defer immunization.

Vaccine AdministrationPrecautions

Precautions

• It is important to vaccinate Immunocompromised individuals withinactivated vaccines, however the magnitude and duration of vaccine-induced immunity are often reduced⁵.

Vaccine Administration10 Rights of immunization

The 10 “Rights” of Immunization⁸

When preparing any biological product ensure:

Right clientRight assessmentRight client educationRight to refuseRight product*

* Check three times

Right dose*Right route*Right time*Right documentationRight evaluation

Vaccine AdministrationHand washing

Wash hands well or use a

sanitizer

Gloves are not required when administering vaccines unless the vaccinator has open hand lesions or will come intocontact with potentially infectious body fluids.

Vaccine AdministrationImmunization sites

6 months – 11months Site: Vastus Lateralis (mid lateral thigh) Needle Length: 1” (Never 5/8”)

12 months of age and up Site: Preferred site is the deltoid Needle Length: 1” (1.5”for heavier children/adults)

Saskatchewan Immunization Manual Chapter 5: • Influenza should not be given into any other sites.• Injectable influenza vaccine doses must be administered IM to be

considered valid. If given SC, repeat.


Vaccine Preparation of vial

• Cleanse the surface of the rubber stopper with alcohol and allow to dry.

• Gently swirl the vial immediately before removing each dose to ensure contents are fully dispersed.

• Hold/place the vial right side up and insert the needle through the centre of the rubber stopper. Do not insert blunt needles with or without a filter into vials because of coring risk.

• Withdraw 0.5 ml of vaccine. Remove the excess WHILE in the vial. DONOT spray it into the air.

Site assessment and Vaccine preparation


Vaccine Preparation of vial

• DO NOT withdraw contents from multiple vials to make a 0.5 ml vaccine dose.

• Return the vial to the box and refrigerate immediately or put back into cooler.

NOTE: pre-loading of syringes with Influenza vaccine is discouraged because of the uncertainty of product stability in syringes, risk of contamination, increased potential for administration errors, and biological product wastage.



Vaccine Preparation of Pre-filled syringe

• Gently shake the syringe to ensure there are no particles

• Screw on the appropriate 1” or 1.5” needle.

• You do not need to remove the air in a pre-filled syringe.


Vaccine AdministrationLand marking – 12 months and up

Individuals 12 months and over

• Deltoid muscle is preferred

• IM - 25 gauge 1”

Vaccine AdministrationLand marking – 12 months and up

This vaccine below is placed posterior and also too high. This may have been administered into the bursa.

Intramuscular vaccines in the arm must be placed in the belly of the deltoid. This vaccine to the right is not in the deltoid.

Vaccine AdministrationLand marking – under 12 months

• Infants (under 12 months) – Vastus lateralis

• IM - use a 25 gauge 1”

Vaccine AdministrationLand marking- under 12 months

• middle third of anterior thigh.• slightly lateral to the midline.

• this site can be used for adults when necessary.

Vaccine AdministrationPositioning and Stabilizing

Vaccine AdministrationPositioning and holding

Vaccine Administration Post immunization

Discourage prophylactic antipyretic analgesics.

Does not reduce injection pain & may decrease vaccine immunogenicity.

If required ideally when the child has pain or fever as opposed to prophylactically.

**Advise all clients need to wait for 15 minutes post vaccination**In case of an allergic reaction.

Vaccine AdministrationPost immunization

Always Provide Client with:

• Current Ministry of Health influenza vaccine fact sheet.

• Counsel them when to seek medical attention post-immunization.

• Provide all clients with the wallet card for their record of influenza vaccine.

Section 5: Common Reactions and Adverse Events Following Immunization

Common Reactions and Adverse Events Following Immunization

Learning Objectives

The health professional will be able to perform the following:

a. List the frequencies of the common, uncommon, and rare adverse events associated with vaccines.

b. Inform recipients and/or their caregivers on what to expect and what to do regarding adverse events that could follow immunizations.

c. Recognize signs of anaphylaxis and have a management plan.

Influenza Vaccine common reactions and Adverse Events Following ImmunizationCommon local reactions

Local Reactions – Most common and expected reactions

• Redness, swelling and pain at the injection site the next few of days• This can be more common with the Fluzone HD.• For some, temporary limited movement of the immunized

limb.

This is considered within the expected reaction parameters.

Systemic Reactions may last 1 – 4 days and include:

Headache Myalgia

Malaise Fatigue

Fever Sweating

Chills Arthralgia

Irritability Loss of appetite

Influenza Vaccine common reactions and Adverse Events Following ImmunizationCommon Systemic reactions

Influenza Vaccine common reactions and Adverse Events Following Immunization

Guillan Barre Syndrome (GBS) – may be in excess of one / million vaccines administered

Oculorespiratory Syndrome (ORS)Mostly reported during 2000-2001 season - few since.

Definition: client experiences the following symptoms within 24 hours of influenza immunization

Bilateral Red Eyes PLUS

One or More Respiratory Symptoms

With or Without Facial Swelling

Once it has occurred, does not necessarily occur again.

Rare Adverse events

Oculorespiratory Syndrome (ORS)

Influenza Vaccine common reactions and Adverse Events Following ImmunizationRare Vaccine Side Effects

Bilateral Red Eyes

Without Lower Respiratory Symptoms

(cough, sore throat, hoarseness)

Safe to immunize

Bilateral Red Eyes

With Lower Respiratory Symptoms

(wheezing, chest tightness, difficulty breathing)

Consult MHO


Anaphylaxis

What is Anaphylaxis?• “.. an exaggerated response to an allergen. It is a potentially life

threatening event that requires vigilance on the part of the healthcare practitioner who needs to recognize the condition quickly and initiate early treatment” (Linton and Watson, 2010, p. 35).

• It is a rare complication of immunization, but it should be anticipated in every vaccinee.

• Anaphylaxis is rare with an estimated range of occurrence of 1-10 episodes per million doses of vaccine administered. (Saskatchewan Immunization Manual chapter 12)

• Anaphylaxis is preventable in most cases and treatable in all.

• Pre-vaccination screening is important as it includes screening for a history of anaphylaxis.

• Anaphylaxis needs to be anticipated in every vaccinee.

• Unconsciousness is rarely the sole manifestation of anaphylaxis and occurs only as a late event in severe cases.


Anaphylaxis


Anaphylaxis

• Sudden on set and involves two systems

• Begin within 15 minutes after exposure

• The client may have a general feeling of unwell, apprehension, sweating, weakness, agitation.

• Fullness in throat

• Other manifestations:

Skin

Respiratory

Gastrointestinal

Cardiovascular

SKIN ⁴ - Up to 90% of people who develop anaphylaxis will have a skin reaction. This can be systemic or local and include:

Flushing / Erythema progressing to pallor and clamminess.

Tingling sensation around mouth or face

Itching

Hives / Urticaria (> 90%)

Around injection site

Generalized

Angioedema (eyes, lips, face, tongue progressive and painless)

Red watery eyes

Influenza Vaccine common reactions and Adverse Events Following ImmunizationAnaphylaxis


Respiratory - 70 % of cases will also have respiratory symptoms such as:

Sneezing, runny nose

Nasal congestion

Wheezing, coughing

Chest tightness / Dyspnea

Hoarseness/slurred speech

Laryngospasm/edema

Difficulty swallowing


Cardiovascular System – can be involved in up to 45% of the time. Chest pain

Lightheadedness/Dizziness

Cyanosis

Hypotension with rapid, weak pulse

Palpitations

Loss of consciousness, shock, coma – rarely seen as an initial presentation of anaphylaxis


Gastrointestinal – up to 45% of peopleNausea / Vomiting (stringy mucous)

Abdominal pain or cramps

Diarrhea

Dysphagia

Other general symptoms may include: uneasiness, restless, agitation.


Infants and young children

Infants and children that do not speak tend to have a different presentation and where the focus is a sudden behavioural change:

Irritability

Cessation of play

Fussiness

Drowsiness

Lethargy


Management of Anaphylaxis:¹º 1. Lie down and assess airway, breathing, and mental status – yell for help

2. Provide epinephrine according to weight and if no weight age. See dosing in Saskatchewan Immunization Manual chapter 12. Provide epinephrine IM in vastus lateralis for higher plasma levels and fastest absorption.

3. Activate EMS (911)4. Continue to monitor pulse, respirations and

BP (no BP for children)5. Can administer epinephrine 3 times in total

with 5 minute intervals as necessary.


A Biphasic reactions (within 8-10 hours)

up to 23% of adults

up to 11% of children

• When one chooses to immunize, appropriate preparation is important for a good outcome in anaphylaxis.

• Anaphylaxis management kits should be readily available where ever vaccines are administered and anticipate a possible anaphylaxis reaction each time they immunize.

• BE PREPARED: Have a plan for the management of anaphylaxis.

Section 6: Reporting Adverse Events Following Immunization

Reporting Adverse Events Following Immunization

Learning Objectives

a. Document all adverse events following immunization on the appropriate form and submit it to the appropriate agencies.

b. Distinguish between what is and what is not a reportable adverse event following immunization.

Objectives

AEFI general definition: Any untoward medical occurrence which follows immunization and which does not necessarily have a casual relationship with the use of a vaccine. Their adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. The general definition of AEFI specifies that the event is not necessarily due to the vaccine².

Expected side effects from immunizations do not require reporting. A faint is not considered an AEFI

Adverse events that are severe, unusual or unexpected require reporting.

Reporting Adverse Events Following Immunization (AEFI)

Definition


Reporting an AEFI

Saskatchewan Public Health Act 1994– It is mandatory to complete the adverse events following immunization form for any reportable AEFI and within certain time frames.

Who should report an AEFI?All vaccine providers

It’s a professional responsibility

Any HCW caring for patients who may have had an AEFI

When should an AEFI be reported? ASAP after the event.

Severe reactions within 24 hours.


Reporting an AEFI

Remind the client/parent to contact you ASAP if a serious reaction occurs, rather than waiting until the next visit.

Reporting an AEFI:

• Determine if symptoms fit the reporting criteria listed in the Saskatchewan Immunization Manual Chapter 11 Appendix 11.1

For further information on Adverse events following Immunization –Saskatchewan Immunization Manual Chapter 11.

https://www.ehealthsask.ca/services/Manuals/Documents/sim-chapter11.pdf

https://www.ehealthsask.ca/services/Manuals/Documents/sim-chapter11.pdf


Reporting an AEFI

• For publicly funded vaccines, complete the AEFI to local Public Health. The user guide and form can be found at https://www.canada.ca/en/public-health/services/immunization

/reporting-adverse-events-following-immunization.html

• The completion of information is required in every category as data is analyzed by event, demographic information, product, lot number, manufacturer and number in the series.

• Send to local Public Health Office within 24 hours.

• Wait for the Medical Health Officer to make recommendations for future immunizations.

https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-immunization.html

https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-immunization.html


Reporting an AEFI

Why Report AEFI’s?

• To identify adverse reactions of infrequent occurrence that may be caused by a vaccine.

• To estimate rates of occurrence of more serious adverse reactions following immunization.

• To monitor any unusually high rates of adverse reactions.

• To provide timely information to recipients and health care workers.

• To identify areas needing further investigation.

Section 7: References

References

1. Public Health Agency of Canada (2008). National Immunization Competencies for Health Professionals. Ottawa, ON: Author. Available at http://www.phac-aspc.gc.ca/im/pdf/ichp-cipseng.pdf

2. National Advisory Committee on Immunization (NACI) Statement on Seasonal Influenza Vaccine for 2020-2021 https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/canadian-immunization-guide-statement-seasonal-influenza-vaccine-2020-2021.html

3. Public Health Agency of Canada (2020, July 31). Flu for Health Professionals.https://www.canada.ca/en/public-health/services/diseases/flu-influenza/health-professionals.html#a2

4. Pinkbook. (2019, April 15). Retrieved August 30, 2020, from https://www.cdc.gov/vaccines/pubs/pinkbook/index.html

5. Saskatchewan Ministry of Health. (2020) Saskatchewan Influenza Immunization Policy 2020 – 2021.

6. National Advisory Committee on Immunization (NACI) Thimerosal: Updated Statement, July 2007 Volume 3 https://www.canada.ca/content/dam/phac-aspc/migration/phac-aspc/publicat/ccdr-rmtc/07pdf/acs33-06.pdf

http://www.phac-aspc.gc.ca/im/pdf/ichp-cipseng.pdf

https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/canadian-immunization-guide-statement-seasonal-influenza-vaccine-2020-2021.html

https://www.canada.ca/en/public-health/services/diseases/flu-influenza/health-professionals.html#a2

https://www.cdc.gov/vaccines/pubs/pinkbook/index.html

https://www.canada.ca/content/dam/phac-aspc/migration/phac-aspc/publicat/ccdr-rmtc/07pdf/acs33-06.pdf

References

6. National Advisory Committee on Immunization (NACI) Statement on Seasonal Influenza Vaccine for 2019 - 2020 https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/canadian-immunization-guide-statement-seasonal-influenza-vaccine-2019-2020.html.

8. Saskatchewan immunization manual. https://www.ehealthsask.ca/services/Manuals/Pages/SIM.aspx

9. Public Health Agency of Canada. Canadian Immunization Guide. (Evergreen Ed.)Ottawa, On: Available at: http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php

10. Simons,F.E.R, Ardusso, R.F., Bilo, M.B., El-Gamal, Y.M., Ledford, D.K., Ring, J., Brown, S.G., Park, H., Sheikh, A., (2011). World Allergy Organization guidelines for the assessment and management of anaphylaxis. World Allergy Organization Journal, Feb; 4(2), 13–37.

https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/canadian-immunization-guide-statement-seasonal-influenza-vaccine-2019-2020.html

https://www.ehealthsask.ca/services/Manuals/Pages/SIM.aspx

http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php

Thank you for immunizing and protecting our

population