• All vaccines must be documented on the patient’s permanent medical record. Providers who administer vaccines covered by the National Vaccine Injury Compensation Program, which includes all vaccines recommended on the child and adolescent vaccination schedules published by the Advisory Committee on Immunization Practices, are required to document several pieces of information regarding the vaccination.
• These include the vaccine name, manufacturer and lot number, the date the vaccine was administered, the name and title of the person administering the vaccine, the address of the facility where it was administered, and the publication date on the vaccine information statement (VIS) form given to the patient with vaccination (CDC, 2021).

• Many states require providers to submit data to a state-sponsored immunization information system. These confidential digital databases collect data on all immunization doses provided to patients within the state. 
  Since many patients have received vaccinations from more than one healthcare provider, immunization information systems ensure immunization records are collected in a centralized location to keep them easily accessible and updated. This helps improve access to immunization histories for patient recordkeeping and providers’ clinical needs (CDC, 2021).

Reporting Adverse Reactions to Vaccines

Reporting Vaccine Administration Errors:

Vaccine administration errors and adverse events related to vaccination must be reported to the Vaccine Adverse Event Reporting System (VAERS). 
This national surveillance system is managed by the CDC and the Food and Drug Administration (FDA) and is designed to monitor vaccine safety in the United States. It collects reports of vaccination errors and adverse events that occur after the administration of a vaccine.

VAERS Review Process for Adverse Event Reports:

Adverse event reports are reviewed by VAERS staff to determine if further investigation is needed to see if an adverse event may be vaccine related. 
This information is then further monitored and compared against new reports that come in to confirm if an adverse event is related to vaccination (CDC, 2021).

Submitting Reports to the VAERS System:

The VAERS system is reliant on adverse event reports submitted to their system. While healthcare providers and manufacturers of vaccines most commonly submit these reports, anyone can submit a report to the VAERS system. 
Healthcare providers are required to report adverse events after immunization and are encouraged to report events even if it is unclear if it was related to vaccination. Reports can be made online at vaers.hhs.gov (CDC, 2021).

Vaccine-Related Adverse Reactions

Administration of any vaccine has the potential to create an adverse reaction. Patients should be screened every time for contraindications and precautions before receiving an immunization to decrease the risk of an adverse event developing. 
Reactions that develop as a result of vaccination can range from minor to life-threatening. Vaccine providers should ensure they can identify and prevent adverse reactions to vaccinations. All providers should be certified in cardiopulmonary resuscitation (CPR) and be trained in the administration of epinephrine (CDC, 2021; Immunization Action Coalition, n.d.).

Local Reactions:

Vaccinations commonly cause reactions at the injection site. A cold compress can treat itching, redness, soreness, or swelling. A pain reliever, such as acetaminophen, or anti-itch medication, such as hydrocortisone cream, can be used if local reactions are significant. 
Slight bleeding is common and can be treated with slight pressure and an adhesive bandage. Continuous bleeding can be treated with a thick layer of gauze pads over the injection site applied with firm pressure and raising the injection site above the level of the patient’s heart (Immunization Action Coalition, n.d.).

What Would You Do?

You are administering a vaccine to Andrea, a 30-year-old female with no prior history of vaccine allergies or anaphylaxis. About 10 minutes after the injection, Andrea starts complaining of dizziness, shortness of breath, and tightness in her throat. You also notice hives on her face and neck. What do you do?

Severe allergic reations:

• Respond to anaphylaxis: Life-threatening allergic reactions, known as anaphylaxis, are rare events that can be caused by vaccination. Many fear this reaction, but it is essential to remember that it is so rare that most vaccine providers will never see a true case of anaphylaxis caused by a vaccine. 
  However, it is important to be prepared to diagnose and respond to this medical emergency if it does arise (CDC, 2021; Immunization Action Coalition, n.d.).
• Recognizing Anaphylaxis Symptoms: Anaphylaxis is associated with several symptoms that can affect several organ systems. Respiratory symptoms can range from nasal congestion to wheezing, coughing, shortness of breath, and a sensation of the throat closing. 
  Skin and mucosal symptoms can include itching, hives, flushing, and swelling of the face, throat, eyes, and lips.
• Varied Symptoms of Anaphylaxis: Cardiovascular symptoms can occur, including dizziness, low blood pressure, and a racing heartbeat. Gastrointestinal symptoms are also possible, including nausea, vomiting, diarrhea, and abdominal pain. Since it can affect so many organ systems, the presentation of anaphylaxis is highly variable. 
  Symptoms of anaphylaxis typically develop within 30 minutes after vaccination (CDC, 2021; Immunization Action Coalition, n.d.).

Severe Allergic Reactions

Patients who develop local reactions immediately following immunization should be monitored closely to watch for the development of symptoms of anaphylaxis. 

• If symptoms of anaphylaxis develop, emergency medical services should be contacted immediately because most fatalities that occur in response to anaphylaxis are due to delayed treatment. 
• If possible, this should be done by a second person so the primary vaccine provider can remain with the patient and assess their airway, breathing, circulation, level of consciousness, and vital signs. 
• The patient should be monitored closely until emergency medical services arrive, and CPR can be performed if necessary to maintain the patient’s airway. 
• If the patient has difficulty breathing, their head can be elevated, as long as their blood pressure is high enough to prevent loss of consciousness. 
• If the patient’s blood pressure is low, their legs should be elevated. Blood pressure and pulse should be monitored every 5 minutes (CDC, 2021; Immunization Action Coalition, n.d.).

Using Epinephrine for Anaphylaxis

The first-line treatment of anaphylaxis is epinephrine. For patients with anaphylaxis, there are not any absolute contraindications to using this medication. 

• The recommended dose for adults and children greater than 30kg (66lb) is 0.3mg; children under 30kg are given 0.15mg. 
• The recommended dose should be injected into the muscle, preferably in the mid to outer thigh. The dose can be repeated two additional times every 5 to 15 minutes while waiting for emergency medical services to arrive. 
• Emergency medical services should always be contacted if epinephrine is administered so the patient can be monitored due to the risk of cardiac complications following administration (CDC, 2021; Immunization Action Coalition, n.d.).

An optional treatment during anaphylaxis is the use of H1 antihistamines such as diphenhydramine. These medications can be used to help with itching or hives but do not replace the use of epinephrine, as they do not relieve airway obstruction, hypotension, or shock. Liquid diphenhydramine in a dose of 1-2mg/kg can be given every 4 to 6 hours, up to a maximum of 100mg in a single dose (CDC, 2021; Immunization Action Coalition, n.d.).

Reporting Anaphylactic Reactions After Vaccination

Once the patient has been stabilized or transferred to emergency medical services, they should be monitored for several hours because anaphylaxis can recur, even after symptoms have completely resolved. 

• After the patient is transferred to the care of another provider, the vaccine provider should document the incident. 
• The patient’s reaction, vital signs, and medications administered, including the dosage, time, response, and name of the person administering, as well as all other relevant clinical information, should be recorded. 
• The patient’s primary care provider should be notified of the reaction. In addition, the reaction should be reported to the Vaccine Adverse Event Reporting System (VAERS) (CDC, 2021; Immunization Action Coalition, n.d.).

Syncope

Syncope, or a temporary loss of consciousness caused by a reduction in blood pressure, can occur after vaccination. Since syncope can cause falls, leading to injuries, vaccine providers should ensure proper measures are taken to prevent injuries. Patients should be sitting or lying down during vaccination, so if dizziness or a loss of consciousness occurs, they will be in a safer position than standing. Vaccine providers should be encouraged to observe patients for 15 minutes after they receive a vaccination and monitor for symptoms that precede fainting, including dizziness, weakness, and an unhealthy pale appearance known as pallor. If syncope does occur, supportive care should be provided to prevent injuries (CDC, 2021).

How do I distinguish between syncope and anaphylaxis?

It is essential to differentiate between syncope and anaphylaxis when responding to vaccine-related adverse reactions. Accidentally treating a patient for anaphylaxis when they do not have it can lead to increased healthcare costs, potential cardiac complications, unnecessary trauma and anxiety, and avoidance of further immunizations. The following points can help differentiate between the two conditions and prevent confusion (Gustafson, n.d.):

• Anaphylaxis due to vaccination is very rare, while syncope is common, especially among teenage girls.
• Anaphylaxis typically occurs between 5 to 30 minutes after vaccination and has a prolonged recovery period. Syncope is sudden, can occur before, during, or immediately after vaccination, and has a quick recovery period of 1 to 2 minutes.
• Patients with anaphylaxis commonly experience agitation that is often described as a ‘sense of impending doom’, and if a loss of consciousness occurs, it generally occurs gradually. Syncope patients experience dizziness, weakness, and slump to the floor quickly.
• The skin of patients with anaphylaxis commonly appears flushed or red, may have rapidly developing hives spreading from the injection site, and may experience progressive swelling of the face, mouth, or tongue. A syncope patient’s skin is commonly pale, cold, clammy, and perspiring excessively.
• Anaphylaxis patients often experience breathing abnormalities, including coughing, wheezing, or labored breathing, while syncope patients experience normal or shallow breathing.
• The pulse of anaphylaxis patients is typically rapid and weak, while syncope patients have a slower pulse.