Immunization in a Nonhospital Setting: Managing Adverse Events

Pharmacy Times, September 2015 Specialty Pharmacy, Volume 81, Issue 9

Widespread vaccine use benefits the public by producing unprecedented good health. Vaccine-related adverse events, which can be perceived or real, can decrease vaccination rates, however.

Widespread vaccine use benefits the public by producing unprecedented good health. Vaccine-related adverse events (AEs), which can be perceived or real, can decrease vaccination rates, however. Therefore, immunizers who screen patients carefully—acknowledging labels’ precautions and contraindications before administering vaccines (Table 11-3)—minimize the likelihood of AEs and boost the public’s trust.

Reaction Types

Stringent regulatory standards and continuous product testing and monitoring situate vaccines among the safest pharmaceuticals.4 Vaccine pharmacovigilance data tell us 5 general types of immunization reactions occur (Table 22,4,5,8-11). Pharmacists should note that coincidental events sometimes occur, but are mistakenly attributed to a vaccination; for example, genetic conditions or unrecognized injuries acquired before, during, or after birth may first become apparent around the time of a vaccination. Some parents, looking for a cause, will blame the vaccination.1,5 When discussing vaccines with patients, health care providers need to describe the associated risks and balance that discussion with the risks associated with refusing a vaccination.6 The discussion should also include points about individual versus societal benefits (eg, herd immunity).7

One local reaction is more than trivial or inconvenient. Nicolau syndrome, a rare, localized site reaction, can follow any intramuscular injection. Pain develops quickly, followed by swelling, a bluish discoloration, and hemorrhagic patches. This reaction can progress to cutaneous and soft tissue necrosis. Immediate referral to a dermatologist is critical. Pentoxifylline, heparin, or hyperbaric oxygen may improve local circulation. Intralesional corticosteroids may decrease inflammation.9

Serious AEs are rare, occurring in far less than 1% of people. Coincidental AEs, including death, that may occur around the time of administration may be temporarily associated with the vaccination, as previously mentioned.1 The Institute of Medicine reports that the majority of deaths reported near administration were not caused by the vaccine; the timing made them appear coincidental.12 Continuous monitoring by staff at the Vaccine Adverse Event Reporting System confirms this finding.13

Emergency Response

If the injection site itches or swells immediately after vaccination, observe the patient closely for generalized symptoms. If these develop, call 911 and have someone stay with the patient until the ambulance arrives. In addition:

  • Administer a dose of aqueous epinephrine 1:1000 dilution intramuscularly, 0.01 mL/kg. Adult doses range from 0.3 mL to 0.5 mL, with a maximum single dose of 0.5 mL. Perform CPR, if necessary, and maintain the patient’s airway. Repeat the epinephrine dose every 10 to 20 minutes for up to 3 doses, noting the dose, time, and patient’s response for emergency medical personnel when they arrive.
  • Monitor blood pressure and pulse every 5 minutes. Ask the patient to lie flat on his or her back. If the patient’s breathing is labored and blood pressure is adequate, elevate the patient’s head. If the patient’s blood pressure is low, elevate the legs.
  • Once the patient is en route to the hospital, notify the patient’s primary care physician and provide all information related to the incident. Also, update the patient’s medication profile.14

To prepare for an emergency response like the one above, pharmacies should hold emergency drills regularly to prepare staff. Additionally, every immunizer needs to know about immunize.org, which has a chart describing adverse reaction management at www.immunize.org/ catg.d/p3082.pdf. This is a useful resource for pharmacies because it provides the protocol described above in a detailed, visual format.14

End Note

The decision to vaccinate—or not—is influenced by patients’ understanding of a vaccination and the disease it prevents, as well as by patients’ bias and emotions.15 Some research indicates that providing a balanced explanation of risks and benefits and listening carefully to patient concerns can discredit background anti-vaccination messages. Accumulating evidence suggests there are genetic determinants of AEs from vaccines. For example, with the MMR vaccine, febrile seizures occur in 3 to 16 children per 10,000 immunized patients. This AE has been associated with specific chromosome/single nucleotide polymorphism on key immunoreceptor genes. In the future, personalized medicine in vaccinology—called adversomics— will screen for this genetic variation.3,18

Acknowledge that vaccines, like all medical interventions, are not 100% safe and effective. Respect patients’ opinions, and always provide accurate, understandable evidence. Address patient concerns, including potential pain and discomfort.8,16,17 For now, individuals are more likely to be seriously or fatally injured by vaccine-preventable diseases than by the vaccines designed to prevent them.12

Table 2: Immunization Reactions: Telltale Signs and Tips

Reaction Type

Telltales and Tips

Localized

· Often presents with itching, soreness, or pain at the injection site

· Usually described as trivial or inconvenient

· If bleeding occurs, apply firm pressure with gauze

· Analgesics, cold compresses, and antipruritics relieve pain and increase comfort

Immunization anxiety—related reaction

· Psychological fright and syncope (twitching during a syncopal episode

is sometimes interpreted as seizure activity by observers)

· Patients who have had this type of reaction previously should sit or

recline before and during vaccination

· If faintness or fainting occurs, have patients lie flat or sit with their head

between their knees for several minutes, loosen tight clothing and

maintain an open airway, and cool their faces and necks with damp

cloths

Systemic

· Neurologic events, including febrile seizures, meningitis, encephalitis,

and brachial neuritis, have been reported very rarely; these generally

occur 6 days to 3 weeks after vaccination

· Risk increases in children with an immunodeficiency

· Rare, erythema multiforme is an acute, usually self-limiting, immune-

mediated reaction characterized by target-like lesions

· Stevens-Johnson syndrome is possible, but rare

Allergic

· Rare and difficult to predict

· Believed to be overdiagnosed

· Usually related to egg, milk, antibiotic, or vaccine component allergy

· Affects the cutaneous, respiratory, cardiovascular, and gastrointestinal

systems

· Children may present with respiratory symptoms followed by cutaneous

symptoms

· Egg sensitivity is not an absolute contraindication to influenza vaccine;

consult current guidelines

Anaphylaxis

· Rare; when it occurs, activate an emergency response

· Sudden or gradual onset of generalized itching, erythema, or hives;

swelling of the lips, face, or throat; severe bronchospasm; shortness of

breath; shock; abdominal cramping; or cardiovascular collapse

Adapted from references 2, 4, 5, and 8-11.

Ms. Wick is a visiting professor at the University of Connecticut School of Pharmacy and a certified immunizer.

References

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  • Moro PL, Arana J, Cano M, Lewis P, Shimabukuro TT. Deaths reported to the Vaccine Adverse Event Reporting System, United States, 1997-2013. Clin Infect Dis. 2015. pii: civ423.
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