Note: This document contains side effect information about zoster vaccine live. Some dosage forms listed on this page may not apply 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
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]
