Shingles (Herpes Zoster) Vaccine Safety

Key points

Getting vaccinated is the best way to prevent shingles.

Overview

Shingles, or herpes zoster, is a painful skin rash that develops on one side of the face or body.

Available vaccines & manufacturer package inserts

  • The FDA licensed Shingrix in 2017 to prevent shingles. CDC recommends that adults age 50 years and older receive two doses of Shingrix. 1
    • Shingrix is the preferred vaccine to prevent shingles.1
  • The FDA licensed Zostavax in 2006 to prevent shingles. CDC recommends one dose of Zostavax for adults age 60 years and older. This vaccine may be used in certain cases, such as when a person prefers Zostavax or is allergic to Shingrix.2

Who should & should not get the vaccine

Many people should get vaccinated; others should consult with their healthcare provider first.

Common side effects

Shingrix

  • Pain, redness, and swelling at the injection site.
  • Muscle pain.
  • Tiredness.
  • Headache.
  • Shivering.
  • Fever.
  • Upset stomach.

Most side effects are mild to moderate— lasting 2-3 days—and could affect normal daily activities. Side effects are more common in younger people.

Zostavax

  • Redness, pain, swelling, warmth, or itching at the injection site.
  • Headache.

Most side effects are mild to moderate, and last 1-3 days.

When to call 911‎

Severe allergic reactions following vaccination are rare, but can be life threatening. If someone experiences symptoms of a severe allergic reaction, which can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.

Vaccines, like any medicine, can have side effects. Because the two herpes zoster vaccines are different in composition, their potential side effects can differ.

Report possible adverse events to VAERS‎

The Vaccine Adverse Event Reporting System (VAERS) is an early warning system, co-managed by CDC and FDA, that monitors for potential vaccine safety problems. Healthcare providers and vaccine manufacturers are required by law to report certain adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) following vaccination to VAERS; patients and caregivers can also submit reports.

A closer look at the safety data

Both Shingrix and Zostavax shingles vaccines have been shown to be safe and well tolerated. Common side effects, such as soreness and redness at the injection site, are usually mild to moderate in intensity and resolve quickly on their own.

Shingrix

In 8 clinical trials of more than 10,000 participants:

  • Grade 3 reactions (vaccination-related reactions severe enough to prevent normal activities) were common (17%) after patients received Shingrix.
  • About 1 out of 10 adults who received Shingrix reported grade 3 injection-site symptoms such as pain, redness, and swelling.
  • About 1 out of 10 reported grade 3 systemic reactions such as myalgia (muscle pain), fatigue (feeling tired), headache, shivering, fever, and gastrointestinal illness.
  • Most people (78%) who got Shingrix reported at least some pain at the injection site.

Zostavax

  • A 2013 study showed that patients with a history of a previous shingles rash had the same side effects after Zostavax as those with no history of shingles. 3
  • A 2012 study found a small risk for allergic reactions 1 to 7 days after Zostavax.4
  • In rare cases, people who got vaccinated with Zostavax experienced a blister-like rash; some were found to have been caused by the vaccine.

How CDC monitors vaccine safety

CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.

Resources

  1. Dooling KL, Guo A, Patel M, et al. Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. MMWR Morb Mortal Wkly Rep 2018;67:103–108. DOI: http://dx.doi.org/10.15585/mmwr.mm6703a5
  2. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm
  3. Morrison, V. A., Oxman, M. N., Levin, M. J., Schmader, K. E., Guatelli, J. C., Betts, R. F., Gelb, L. D., Pachucki, C. T., Keay, S. K., Menzies, B., Griffin, M. R., Kauffman, C. A., Marques, A. R., Toney, J. F., Simberkoff, M. S., Serrao, R., Arbeit, R. D., Gnann, J. W., Greenberg, R. N., Holodniy, M., ... Shingles Prevention Study Group (2013). Safety of zoster vaccine in elderly adults following documented herpes zoster. The Journal of infectious diseases, 208(4), 559–563. https://doi.org/10.1093/infdis/jit182
  4. Tseng, H. F., Liu, A., Sy, L., Marcy, S. M., Fireman, B., Weintraub, E., Baggs, J., Weinmann, S., Baxter, R., Nordin, J., Daley, M. F., Jackson, L., Jacobsen, S. J., & Vaccine Safety Datalink (VSD) Team (2012). Safety of zoster vaccine in adults from a large managed-care cohort: a Vaccine Safety Datalink study. Journal of internal medicine, 271(5), 510–520. https://doi.org/10.1111/j.1365-2796.2011.02474.x