Note: This document contains side effect information about zoster vaccine, inactivated. Some dosage forms listed on this page may not apply to the brand name Shingrix.

Applies to zoster vaccine, inactivated: intramuscular suspension.

Serious side effects of Shingrix

Along with its needed effects, zoster vaccine, inactivated (the active ingredient contained in Shingrix) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zoster vaccine, inactivated:

Rare

• Ankle, knee, or great toe joint pain
• blindness
• blurred vision
• decreased vision
• eye pain
• fever greater than 39 degree Celsius
• joint stiffness or swelling
• lower back or side pain
• swollen, painful, or tender lymph glands in the neck, armpit, or groin

Incidence not known

• Hives, welts, or itching
• inability to move the arms and legs
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• sudden numbness and weakness in the arms and legs

Other side effects of Shingrix

Some side effects of zoster vaccine, inactivated may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• difficulty in moving
• fever
• headache
• muscle aches, cramps, pains, or stiffness
• nausea
• pain, redness, and swelling at the injection site
• shivering
• stomach pain
• unusual tiredness or weakness
• vomiting

Less common

• Chills
• dizziness
• general feeling of discomfort or illness
• itching at the injection site

For Healthcare Professionals

Applies to zoster vaccine, inactivated: intramuscular powder for injection.

Local

Very common (10% or more): Local pain (88.4%), local redness (38.7%)

Common (1% to 10%): Injection site pruritus^[Ref]

Other

Very common (10% or more): Fatigue (57%), shivering (35.8%), fever (27.8%)

Common (1% to 10%): Malaise

Uncommon (0.1% to 1%): Death^[Ref]

Deaths were reported for 0.8% of patients in the treatment group during the first year after vaccination versus 0.9% of placebo patients. Causes of death were consistent with those generally reported in adult and elderly populations.^[Ref]

Nervous system

Very common (10% or more): Headache (50.6%)

Common (1% to 10%): Dizziness^[Ref]

Gastrointestinal

Very common (10% or more): Gastrointestinal symptoms (24.3%)

Common (1% to 10%): Nausea^[Ref]

Metabolic

Uncommon (0.1% to 1%): Gout (including gouty arthritis)^[Ref]

Ocular

Rare (less than 0.1%): Optic ischemic neuropathy^[Ref]

Hematologic

Very rare (less than 0.01%): Lymphadenitis^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (56.9%)

Common (1% to 10%): Chills, arthralgia^[Ref]