An adverse event kit is specially designed for immunization program managers on surveillance of adverse events following immunization and the kit consists of a set of pharmaceuticals and instruments used for the management of adverse event following immunization. The kit consists of materials for all age groups. The quantities of this solution are based on a scenario where ten staff members are vaccinating in one site for 1000 people (administration of vaccine doses to a large population over a short period of time). The kit can be used in any mass vaccinating campaign with established immunization safety surveillance system/vaccine safety surveillance systems (It is essential to have immunization safety surveillance system in any type of vaccinating facility).

The solution has been adapted from WHO; Immunization Safety Surveillance Guidelines, Massachusetts Department of Public Health, Immunization program Guidelines & Immunization Action Coalition (IAC). Guidelines.

Preventing and managing adverse events at mass vaccination program is critical. All adverse events should be promptly identified and appropriate medical care should be provided. Therefore, vaccine providers should know how to recognize allergic reactions including their types, and treatment protocols. To improve the adverse event detection capacity, health workers at all levels of the vaccination program should undergo prior trainings and awareness sessions. In order to prevent and minimize adverse events following immunization;

1. Patients should be screened for contraindications and precautions before vaccination every time.
2. Always have patients sitting down when being vaccinated.
3. Consider observing patients for 15 minutes after vaccination (This can be done in a separate waiting area to keep the flow moving).
4. Observe for signs of adverse events.

Also, it is of utmost importance to treat and report all adverse events in an event of any immunization or vaccination program. During mass immunization and special vaccination programs a large number of individuals in a particular target group is vaccinate in a specified given time period and therefore, an excess number of adverse events may be reported within a short time period. If, these are not properly investigated or analyzed, it can cause undue concern among public and may affect the immunization or vaccination programs. Also, during special immunization programs, a new vaccine may be introduced with no prior experience or with little information on adverse reactions. There is a possibility of detecting signals through strengthening surveillance during such special immunization programs to ensure the quality and safety of the vaccines.

Important:

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation that happens during or after the treatment with a drug or other therapy and which does not necessarily have a causal relationship with this treatment. An Adverse event following immunization (AEFI) is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.

AEFIs are grouped into five categories

• Vaccine product-related reaction
• Vaccine quality defect-related reaction
• Immunization error-related reaction
• Immunization anxiety-related reaction
• Coincidental event

Vaccine reactions can be classified into two groups

• Minor reactions; Usually occur within a few hours of injection which resolve after short period of time and pose little danger. Local reactions include pain, swelling or redness at the site of injection and systemic reactions includes fever, malaise, muscle pain, headache or loss of appetite.
• Severe reactions; Usually do not result in long-term problems and could be disabling or rarely life threatening. Include seizures and allergic reactions caused by the body’s reaction to a particular component in a vaccine.

Medications for managing vaccine reactions

Epinephrine: The first-line and most important therapy in anaphylaxis is epinephrine and there is no known equivalent substitute. There are no absolute contraindications to epinephrine in the setting of anaphylaxis.

Drug dosing information

• Drug; Epinephrine in a 1.0 mg/mL aqueous solution (1:1000 dilution).
• Route of administration; Administer epinephrine intramuscular (IM) dose using a premeasured or prefilled syringe or an autoinjector in the mid-outer thigh.
• Dose; Epinephrine 1.0 mg/mL 0.5 mL for adults and age <1years: 0.05mL, 2-6 years: 0.15 mL, 6-12 years: 0.3 mL & age > 12 years: 0.5ml for children (If using another epinephrine formulation, the recommended dose is 0.01 mg/kg, ranging for adults from 0.3 mg to maximum dose of 0.5 mg).
• Frequency of administration: Epinephrine dose may be repeated 2 additional times every 5–15 minutes (or sooner as needed) while waiting for emergency management team to arrive.

Note: Persisting or worsening cough associated with pulmonary oedema is an important sign of adrenaline overdose and toxicity

Optional treatments: H1 antihistamines relieve itching and urticaria (hives). These medications DO NOT relieve upper or lower airway obstruction, hypotension, or shock. Consider giving for relief of itching and hives.

• Diphenhydramine; Oral 12.5 mg/5 mL liquid, 25 or 50 mg capsules/tablets or injectable 50 mg/mL solution.
• Hydroxyzine; Oral 10 mg/5 mL or 25 mg/5 mL liquid, 25 mg capsules.

* This treatment guide is optional and countries may practice their own country-specific protocols for treatment of anaphylaxis with drugs of choice, steps to be followed.

Other supplies

Syringes; Syringes with needles are used for administration of epinephrine, diphenhydramine, or hydroxyzine.

*Note: The needle used for injection needs to be sufficiently long to ensure that the adrenaline is injected into muscle.

Alcohol wipes; Alcohol wipes are used to clean the skin before administration of injections and it is recommended to use wipes or sprays containing at least 70 percent alcohol to disinfect touch screens.

Tourniquet; Tourniquet is used to distend the veins for phlebotomy, when required to draw blood for investigations.

Stethoscope; Stethoscope is used to measure vital signs at the event of AEs and the kit contains stethoscopes for both adults and pediatric patients.

Sphygmomanometer with cuffs; Sphygmomanometers are used to measure blood pressure. The kit contains manual sphygmomanometers with inflatable rubber cuffs for both adults and pediatric patients. 

Tongue depressors; Single use, sterile devise used for examination of mouth and throat. 

Flashlight; Provides light to examine a specific area of the patient’s body during AEs (Specially for the examination of the mouth and throat).

Resuscitator sets: Resuscitator provides continuous positive airway pressure to patients and the kit contains three different sizes for adult, children and infant age groups. The resuscitator set includes self-inflating ventilation bag, oxygen reservoir bag, airway guedels, masks and other accessories for resuscitation. 

* The resuscitator sizes could be modified based on the patient population.   

Gloves; Gloves are only recommended for staff during investigating patients to reducing risk of injury. exposure to blood or other potentially infectious materials. Latex-free gloves are recommended due to allergies. 

* The glove sizes could be modified based on the common size used in the location.     

Hand sanitizer; Alcohol based hand sanitizer to perform hand hygiene before and after examine patients.   

Batteries; Non-rechargeable, alkaline batteries compatible with kit devices are included for usage. Do not use, if batteries are physically damaged or exposed to heat and make sure to discard them according to the manufacturer’s instructions. 

Timer; Timer indicating minutes and seconds for vital signs measurements and accurate timing of medication.

Labels; Label stickers for accurately and efficiently identify medication, charts, specimens and patient information at vaccination site.

Oxygen cylinder with flowmeter; To provide oxygen at desired flow rate during the event of AEs. It is important to maintain good oxygen saturation level during adverse events, specially to minimize factor of post-bronchoscopy respiratory adverse events. 

Pulse oximeters; Pulse oximetry is used to detect oxygen saturation level when clinically indicated. 

Pen; For documentation purpose.

Source:

WHO Safety Surveillance, Immunization Safety Surveillance Guidelines  Massachusetts Department of Public Health, Immunization program Guidelines & Immunization Action Coalition (IAC) Guidelines.