Zostavax Side Effects

Generic name: zoster vaccine live

Medically reviewed by Drugs.com. Last updated on Apr 25, 2024.

Note: This document provides detailed information about Zostavax Side Effects associated with zoster vaccine live. Some dosage forms listed on this page may not apply specifically to the brand name Zostavax.

Applies to zoster vaccine live: subcutaneous suspension reconstituted.

Serious side effects of Zostavax

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.

Other side effects of Zostavax

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 adverse events

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

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

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]

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

• Shingrix vs Zostavax - What's the difference between them?
• What are the most common skin conditions? (with photos)

Further information

Zostavax side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer