Zoster vaccine live Side Effects

It is possible that some side effects of zoster vaccine live may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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

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

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]

References

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.

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