Ask the Experts: Zoster (Shingles): Vaccine Safety

Results (3)

In pre-licensure clinical trials of Shingrix in immunocompetent adults age 50 years or older, the most common adverse reactions were pain at the injection site (78%), myalgia (45%), and fatigue (45%). Any grade 3 adverse event (reactions related to vaccination which were severe enough to prevent normal activities) was reported in 17% of vaccine recipients compared with 3% of placebo recipients. Grade 3 injection-site reactions (pain, redness, and swelling) were reported by 9% of vaccine recipients, compared with 0.3% of placebo recipients. Grade 3 solicited systemic events (myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms) were reported by 11% of vaccine recipients and 2.4% of placebo recipients. The occurrence of local grade 3 reactions did not differ by vaccine dose. However systemic grade 3 reactions were reported more frequently after dose 2.

Rates of serious adverse events (an undesirable experience associated with the vaccine that results in death, hospitalization, disability or requires medical or surgical intervention to prevent a serious outcome) were similar in vaccine and placebo groups.

Among immunocompromised recipients of RZV, local grade 3 reactions occurred in 10.7% to 14.2% of RZV recipients, and systemic grade 3 reactions occurred in 9.9% to 22.3% of RZV recipients, compared with 0% to 0.3% and 6.0% to 15.5%, respectively, among placebo recipients. Limited studies have found no evidence of an increased risk of immune-mediated diseases, graft-versus-host-disease, or transplant rejection among certain categories of immunocompromised RZV recipients.

Last reviewed: March 9, 2022

Before vaccination, providers should counsel Shingrix recipients about common expected systemic and local adverse reactions (see related question). Reactions to the first dose do not strongly predict reactions to the second dose.

If a patient experiences side effects, any local (e.g., redness, pain, swelling at the injection site) or systemic (e.g., fever, chills, headache, body aches) reactions typically go away within 72 hours after vaccination. It is generally not recommended to take medication for pain or fever (e.g., acetaminophen or ibuprofen) before vaccination; however, such medications may be taken to alleviate local or systemic symptoms after vaccination, if needed. Shingrix recipients should be encouraged to complete the series even if they experienced a grade 3 reaction to the first dose.

Last reviewed: March 9, 2022

No. Shingrix contains only a small part of the varicella zoster virus that causes shingles. Shingrix does not contain any live varicella zoster virus.

Last reviewed: March 9, 2022

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