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Zostavax Side Effects

Generic name: zoster vaccine live

Medically reviewed by Drugs.com. Last updated on Jun 30, 2022.

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 suspension reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of this drug?

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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]

Frequently asked questions

References

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

2. "Product Information. Zostavax (zoster vaccine live)." Merck & Company Inc (2006):

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

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.