SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.
SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).
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Important Safety Information
SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).
- SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
- Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX
- Solicited local adverse reactions in subjects aged 50 years and older were pain (78.0%), redness (38.1%), and swelling (25.9%)
- Solicited general adverse reactions in subjects aged 50 years and older were myalgia (44.7%), fatigue (44.5%), headache (37.7%), shivering (26.8%), fever (20.5%), and gastrointestinal symptoms (17.3%)
- SHINGRIX was not studied in pregnant or lactating women, and it is unknown if it is excreted in human milk. Therefore, it cannot be established whether there is vaccine-associated risk with SHINGRIX in pregnant women or if there are effects on breastfed infants or milk production/excretion
- Vaccination with SHINGRIX may not result in protection of all vaccine recipients
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To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You are encouraged to report vaccine adverse events to the US Department of Health and Human Services.
Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967.
This site is intended for US healthcare professionals only.
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©2020 GSK or licensor.
SGXWCNT200028 October 2020
Produced in USA.