Zoster Vaccine

• It is used to prevent shingles.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Irritation where the shot is given.
• Itching.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

History of anaphylactic/anaphylactoid reaction to gelatin, neomycin (excluding contact dermatitis to neomycin), or any other component of the vaccine; immunosuppression or immunodeficiency, including individuals with leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; primary and acquired immunodeficiency states; AIDS or clinical manifestations of HIV; those receiving immunosuppressive therapy (including high-dose corticosteroids); pregnancy

In addition, ACIP recommends that the following immunocompromised patients should not receive zoster vaccine (CDC/ACIP [Harpaz, 2008]):

Patients undergoing hematopoietic stem cell transplant (limited data; assess risk:benefit, if needed, administer ≥24 months after transplantation).

Patients receiving recombinant human immune modulators, particularly antitumor necrosis factor agents (eg, adalimumab, infliximab, etanercept). Safety and efficacy of concurrent administration is unknown and not recommended. Defer vaccination for ≥1 month after discontinuation.

Patients with unspecified cellular immunodeficiency (exception, patients with impaired humoral immunity may receive vaccine).

Shingles prevention:

Manufacturer labeling: Adults ≥50 years: SubQ: 0.65 mL administered as a single dose

ACIP recommendation: Adults ≥60 years: SubQ: 0.65 mL administered as a single dose; there are no data to support readministration of the vaccine (CDC/ACIP [Harpaz, 2008])

Dosage adjustment for concomitant chronic use of acyclovir, famciclovir, or valacyclovir: Discontinue acyclovir, famciclovir, or valacyclovir ≥24 hours before administration of zoster vaccine. Do not use acyclovir, famciclovir, or valacyclovir for ≥14 days after vaccination (CDC/ACIP [Harpaz 2008]).

There are no dosage adjustments provided in the manufacturer’s labeling.

Use during pregnancy is contraindicated. Women should avoid becoming pregnant for 3 months after vaccination (4 weeks per CDC). Risk to the fetus following exposure to wild-type varicella zoster virus is small, and risk following exposure from the attenuated vaccine is probably even less (CDC/ACIP [Harpaz 2008]). Based on information collected from the manufacturer’s pregnancy registry, of women who received a varicella-containing vaccine within 3 months of pregnancy or any time during pregnancy and who were available for analysis, there were no infants born with abnormalities consistent with congenital varicella syndrome. Information specific to exposure following zoster vaccine was limited. Due to the rare incidence of congenital varicella syndrome and the low rates of varicella vaccine exposure in women of reproductive potential, the pregnancy registry has been closed. Although zoster vaccine is not licensed for use in women within traditional reproductive ages, inadvertent exposures will still be monitored. Any exposures to the vaccine during pregnancy or within 3 months prior to pregnancy should continue to be reported to the manufacturer (Merck & Co, 877-888-4231) or to VAERS (800-822-7967) as suspected adverse reactions (Marin 2014).

Applies to zoster vaccine live: parenteral for injection for sub-q use

Side effects include:

Injection site reactions (erythema, pain/tenderness, swelling, pruritus, warmth, hematoma, induration), headache, extremity pain.

Data not available

Administration advice:
-Administer immediately after reconstitution.
-Discard reconstituted vaccine if not used within 30 minutes.
-Do not freeze reconstituted vaccine.

Storage requirements: The manufacturer product information should be consulted.

General:
-The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine.
-For information or to report online go to www.vaers.hhs.gov.

Patient advice:
-Question the patient about reactions to previous vaccines.
-Inform patient of the benefits and risks, including the potential risk of transmitting the vaccine virus to susceptible individuals, such as immunosuppressed or immunodeficient individuals or pregnant women who have not had chickenpox.
-Instruct patient to report any adverse reactions or any symptoms of concern to their healthcare professional.