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Zostavax Side Effects

Generic name: zoster vaccine live

Medically reviewed by Drugs.com. Last updated on Nov 25, 2020.

Note: This document contains side effect information about zoster vaccine live. Some of the dosage forms listed on this page may not apply to the brand name Zostavax.

For the Consumer

Applies to zoster vaccine live: subcutaneous powder for suspension

Side effects requiring immediate medical attention

Along with its needed effects, zoster vaccine live (the active ingredient contained in Zostavax) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zoster vaccine live:

Less common

  • Collection of blood under the skin, a deep, dark purple bruise, itching, pain, redness, swelling, or a hard lump at the injection site

Incidence not known

  • Blurred vision
  • change in color vision
  • cough
  • difficulty seeing at night
  • difficulty swallowing
  • dizziness
  • eye redness
  • fast heartbeat
  • fever
  • hives, itching, skin rash
  • increased sensitivity of the eyes to sunlight
  • pain around the eyes
  • painful blisters on the trunk of the body
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • temporary swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • unusual tiredness or weakness
  • vision loss

Side effects not requiring immediate medical attention

Some side effects of zoster vaccine live may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Incidence not known

  • Difficulty in moving
  • joint pain or swelling
  • muscle ache, cramp, pain, or stiffness
  • nausea

For Healthcare Professionals

Applies to zoster vaccine live: subcutaneous powder for injection

General

The most common adverse events were headache and injection site reactions.[Ref]

Local

Very common (10% or more): Injection site pain (up to 53.9%), injection site erythema (48.1%), injection site swelling (40.4%), pruritus (11.3%)

Common (1% to 10%): Warmth, hematoma, induration

Postmarketing reports: Injection site rash, injection site urticaria, transient injection site lymphadenopathy[Ref]

Nervous system

Common (1% to 10%): Headache, asthenia[Ref]

Other

The most common reported cause of death was cardiovascular disease (10 in the vaccine group, 8 in the placebo group). The overall incidence of death occurring at any time during the study was similar between groups: 793 deaths (4.1%) in the vaccine group and 795 deaths (4.1%) in the placebo group.[Ref]

Common (1% to 10%): Death, fever, asthenia[Ref]

Cardiovascular

Common (1% to 10%): Congestive heart failure or pulmonary edema[Ref]

Congestive heart failure or pulmonary edema occurred in 1.5% of patients receiving the vaccine versus 1.2% of patients receiving placebo in the AE monitoring substudy.[Ref]

Respiratory

Common (1% to 10%): Respiratory infection, flu syndrome, rhinitis, respiratory disorder

Very rare (less than 0.01%): Asthma exacerbation[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea

Postmarketing reports: Nausea[Ref]

Dermatologic

Common (1% to 10%): Skin disorder

Rare (less than 0.1%): Non-injection site varicella-type rash, non-injection site zoster-like rash

Postmarketing reports: Rash[Ref]

Musculoskeletal

Common (1% to 10%): Pain in extremity

Very rare (less than 0.01%): Polymyalgia rheumatica

Postmarketing reports: Arthralgia, myalgia[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reaction

Postmarketing reports: Hypersensitivity reactions including anaphylactic reactions[Ref]

Immunologic

Very rare (less than 0.01%): Varicella

Postmarketing reports: Herpes zoster (vaccine strain)[Ref]

Hematologic

Frequency not reported: Lymphadenopathy[Ref]

Ocular

Postmarketing reports: Necrotizing retinitis (patients on immunosuppressive therapy)[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Zostavax (zoster vaccine live)." Merck & Company Inc, West Point, PA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.