Medication Administration: COVID-19 Vaccine (Ambulatory) - CE - INACTIVE

ALERT

Take steps to eliminate interruptions and distractions during medication preparation.

OVERVIEW

The coronavirus disease 2019 (COVID-19) vaccines are for the prevention of COVID-19. The Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines are U.S. Food and Drug Administration (FDA)-approved^{undefined#ref4">4,5,6} for active immunization for the prevention of COVID-19. The adult formulations of the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine are for patients 12 years old and older.^4,5 The Janssen COVID-19 vaccine is for patients 18 years old and older.⁶ Vaccination does not ensure immunity.

Both the Pfizer-BioNTech and the Moderna vaccines contain lipid nanoparticle-formulated, nucleoside-modified messenger ribonucleic acid (mRNA), encoding the spike glycoprotein (S) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Janssen COVID-19 vaccine contains a recombinant replication-incompetent adenovirus type 26 vector, encoding the viral spike glycoprotein (S) of SARS-CoV-2.

The Pfizer-BioNTech COVID-19 vaccine is administered intramuscularly as a series of two doses (0.3 ml each), three weeks apart.⁴ The Moderna COVID-19 vaccine is administered intramuscularly as a series of two doses (0.5 ml each), one month apart.⁵ The Janssen COVID-19 vaccine is administered intramuscularly as a single dose (0.5 ml).⁶ This vaccination series should be followed by an initial booster dose. The FDA has authorized a second booster dose to be given 4 months after the initial booster of either the Pfizer-BioNTech or the Moderna COVID-19 vaccine for those over age 50, for certain immunocompromised individuals, or for those at higher risk for severe COVID-19.¹

The COVID-19 vaccine is contraindicated in patients with a history of a severe allergic reaction to any component of the vaccine, including polyethylene glycol (PEG).² As with any biologic product, procedures should be in place to manage allergic reactions. Epinephrine (1 mg/ml) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the vaccine should be readily available.⁴

If the patient expresses concern regarding the accuracy of a medication, the medication should not be given. The concern should be explored, the practitioner notified, and the order verified.

SUPPLIES

See Supplies tab at the top of the page.

EDUCATION

• Provide developmentally and culturally appropriate education based on the desire for knowledge, readiness to learn, and overall neurologic and psychosocial state.
• Instruct the patient regarding the potential side effects and adverse reactions to the medication.
• Explain the risks related to the procedure, including hematoma formation, nerve injury, and allergic reaction to the vaccine.
• Provide the patient with information that is consistent with the Fact Sheet for Recipients and Caregivers before receiving the vaccine.⁷
• Instruct the patient receiving the Janssen COVID-19 vaccine to be aware of possible signs and symptoms of a blood clot with low platelets for 3 weeks postvaccination.⁶ These include:
  • Severe or persistent headaches or blurred vision
  • Shortness of breath
  • Chest pain
  • Leg swelling
  • Persistent abdominal pain
  • Easy bruising or tiny blood spots under the skin beyond the injection site
• Instruct the patient to bring an up-to-date list of medications (over-the-counter [OTC], supplements, and prescriptions) to every practitioner visit.³
• Explain the importance of keeping the vaccine schedule as much as possible.
• Encourage questions and answer them as they arise.

PROCEDURE

1. Perform hand hygiene and don gloves. Don additional personal protective equipment (PPE) based on the patient’s need for isolation precautions or the risk of exposure to bodily fluids.
2. Introduce yourself to the patient.
3. Verify the correct patient using two identifiers.
4. Explain the procedure and ensure that the patient agrees to treatment.
5. Ensure that evaluation findings are communicated to the clinical team leader per the organization’s practice.
6. Obtain the patient’s medication history.
7. Evaluate the patient’s body build, muscle size, and weight before giving an intramuscular medication.
8. Evaluate the patient for specific contraindications or precautions (e.g., previous anaphylaxis with a vaccine) related to vaccine administration and advise the practitioner accordingly.
9. Evaluate the patient’s history of allergies, including medication or food allergies and previous allergic reactions.
10. Evaluate the patient’s knowledge regarding the vaccine to be received.
11. Obtain the vaccine and verify the expiration date.
12. Assemble the appropriate-size needles, syringes, and other administration supplies, as needed.
13. Ensure the six rights of medication safety: right medication, right dose, right time, right route, right patient, and right documentation.
14. If the dose is not already drawn up by the pharmacy, clean the vaccine vial stopper with a single-use antiseptic swab and draw up the prescribed dose.
    1. Inspect the vaccine suspension before administration. It should appear as a white to off-white suspension and may contain white or translucent product-related particles.

       Do not use the vial if the liquid is discolored or if other particles are observed.

       Minimize exposure of the vaccine to indoor room light and avoid exposure to direct sunlight and ultraviolet light.

    2. Note the date and time of dilution on the vaccine vial label as provided by the pharmacy.

       Thawed and diluted vaccine must be administered within 30 minutes.⁵

    3. Discard any unused vaccine 12 hours after dilution.⁵
    4. Using aseptic technique, draw up the prescribed dose.
15. Assist the patient to the appropriate position. Have the patient remove clothing from the designated arm if needed.
16. Cleanse the site with alcohol or an antiseptic swab, per the organization’s practice. Allow the skin to dry completely.
17. Administer the vaccine to the patient per the manufacturer’s instructions for use.
18. Apply gentle pressure to the site; do not massage. Evaluate the site for bleeding and apply a bandage if needed.

    Rationale: Massaging may force some of the vaccine fluid into the subcutaneous space and alter how effectively it is absorbed.

19. Assist the patient to a comfortable position and assist with replacing clothing as needed.
20. Discard the uncapped needle (or needle enclosed in the safety shield) and attached syringe into a puncture-proof and leakproof receptacle.

    Rationale: Discarding the uncapped needle helps prevent injury to the patient and health care team members. Recapping needles increases the risk for a needlestick injury.

21. Monitor the patient for adverse and allergic reactions to the medication. Recognize and immediately treat respiratory distress and circulatory collapse, which are signs of a severe anaphylactic reaction. Follow the organization’s practice for emergency response.
22. Provide the patient with a vaccination card that documents the brand name of the vaccine administered and includes when to return for the second dose of the same COVID-19 vaccine that was administered initially.
23. Discard supplies, remove PPE, and perform hand hygiene.
24. Document the procedure in the patient’s record.

EXPECTED OUTCOMES

• Medication administered per the six rights of medication safety
• Patient able to explain the purpose of vaccine
• Desired effect of vaccine with no adverse reactions or signs of allergies

UNEXPECTED OUTCOMES

• Medication not administered per the six rights of medication safety
• Patient unable to explain the purpose of vaccine
• Adverse reaction to the medication (local reactions are extremely common and resolve quickly)

DOCUMENTATION

• Vaccine name, dose, route, site, and time and date of administration
• Patient’s response to medication, including any adverse reactions
• Unexpected outcomes and related interventions
• Education
• Evaluation findings communicated to the clinical team leader per the organization’s practice

REFERENCES

1. Centers for Disease Control and Prevention (CDC). (2022). Coronavirus (COVID-19) update: FDA authorizes second booster dose of two COVID-19 vaccines for older and immunocompromised individuals. Retrieved July 4, 2022, from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and?utm_medium=email&utm_source=govdelivery (Level VII)
2. Centers for Disease Control and Prevention (CDC). (2022). Pfizer-BioNTech COVID-19 vaccine (also known as COMIRNATY): Overview and safety. Retrieved July 4, 2022, from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html (Level VII)
3. Joint Commission, The. (2022). National Patient Safety Goals for the ambulatory health care program. Retrieved July 4, 2022, from https://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2022/npsg_chapter_ahc_jan2022.pdf (Level VII)
4. U.S. Food and Drug Administration (FDA). (2022). Comirnaty and Pfizer-BioNTech COVID-19 vaccine. Retrieved July 4, 2022, from https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine#additional (Level VII)
5. U.S. Food and Drug Administration (FDA). (2022). Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency use authorization (EUA) of the Moderna COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Retrieved July 4, 2022, from https://www.fda.gov/media/144637/download (Level VII)
6. U.S. Food and Drug Administration (FDA). (2022). Janssen COVID-19 vaccine. Retrieved July 4, 2022, from https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine (Level VII)
7. U.S. Food and Drug Administration (FDA). (2022). Vaccine information fact sheet for recipients and caregivers about Comirnaty (COVID-19 Vaccine mRNA) and the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) for use in individuals 12 years of age and older. Retrieved July 4, 2022, from https://www.fda.gov/media/153716/download (Level VII)

Elsevier Skills Levels of Evidence

• Level I - Systematic review of all relevant randomized controlled trials
• Level II - At least one well-designed randomized controlled trial
• Level III - Well-designed controlled trials without randomization
• Level IV - Well-designed case-controlled or cohort studies
• Level V - Descriptive or qualitative studies
• Level VI - Single descriptive or qualitative study
• Level VII - Authority opinion or expert committee reports