Most serious warnings and precautions:
- Administration: Do not administer the vaccine intravascularly, intradermally or subcutaneously.
Other relevant warnings and precautions:
- A protective immune response may not be elicited in all vaccinees
- Not for prevention of primary varicella infection or treatment of HZ or postherpetic neuralgia
- Postpone in those with acute severe febrile illness
- Use with caution in those with thrombocytopenia or any coagulation disorder
- Syncope following or before any vaccination as a psychogenic response
- Use in special populations such as pregnant or nursing women or pediatrics (<18 years of age) has not been established
- Limited data in immunocompromised adults 50 years of age or older
- Solicited local and general adverse reactions that occurred in clinical trials within 7 days of vaccination in subjects aged 50–69 and ≥70 years respectively were: pain (85.6%, 69.2%), redness (38.5%, 37.7%), swelling at the injection site (28.5%, 23.0%), myalgia (53.0%, 35.1%), fatigue (51.3%, 36.6%), headache (45.2%, 29.0%), shivering (33.1%, 19.5%), fever (25.9%, 14.3%), gastrointestinal symptoms (20.5%, 13.5%)
- Unsolicited adverse reactions that occurred in clinical trials within 30 days of vaccination in ≥1% of subjects and ≥2-fold higher than placebo recipients included chills (3.5%), injection site pruritus (2.2%), and malaise (1.7%)
For more information
Please consult the product monograph at gsk.ca/SHINGRIX/PM for important information relating to dosing and administration, adverse reactions, contraindications and drug interactions which have not been discussed in this piece. To request a product monograph, or to report an adverse event please call 1-800-387-7374.
* Clinical significance has not been established.
† Modified Total Vaccinated Cohort (mTVC) was the primary efficacy analysis and included all subjects randomized in the study who received a second dose of the vaccine and did not develop a confirmed case of shingles within one month after the second dose.