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Zostavax Side Effects

Generic Name: zoster vaccine live

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: parenteral for injection for sub-q use

Side effects include:

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

For Healthcare Professionals

Applies to zoster vaccine live: subcutaneous powder for injection


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


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]


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]


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]


Common (1% to 10%): Respiratory infection, flu syndrome, rhinitis, respiratory disorder
Very rare (less than 0.01%): Asthma exacerbation[Ref]


Common (1% to 10%): Diarrhea
Postmarketing reports: Nausea[Ref]


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]


Common (1% to 10%): Pain in extremity
Very rare (less than 0.01%): Polymyalgia rheumatica
Postmarketing reports: Arthralgia, myalgia[Ref]


Very rare (less than 0.01%): Anaphylactic reaction
Postmarketing reports: Hypersensitivity reactions including anaphylactic reactions[Ref]


Very rare (less than 0.01%): Varicella
Postmarketing reports: Herpes zoster (vaccine strain)[Ref]


Frequency not reported: Lymphadenopathy[Ref]


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


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

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

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

Some side effects of Zostavax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.