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. ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 in 2006 to prevent shingles. ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø monitors vaccine safety

ÐÇ¿ÕÓéÀÖ¹ÙÍø and FDA are committed to monitoring the safety of vaccines. Once vaccines are licensed or authorized by FDA for use in the United States, ÐÇ¿ÕÓéÀÖ¹ÙÍø, FDA, and other federal agencies work together to monitor them using 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:
  2. /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.
  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.
  • English D. Willis, Meredith Woodward, Elizabeth Brown, Zoran Popmihajlov, Patricia Saddier, Paula W. Annunziato, Neal A. Halsey, Anne A. Gershon, . Vaccine. 2017 Dec 19:35(52):7231-7239.
  • Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, et al. NEJM. 2016:375(11), 1019-32.
  • Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barberà J, Vesikari T. . NEJM. 2015:372(22):2087-96.
  • Cohen J. , NEJM. 2015:372:2149-2150 [Link:
  • Baxter R, Tran TN, Hansen J, Emery M, Fireman B, et al. Vaccine. 2012 Oct 19;30(47):6636-41.
  • Gagliardi AM, Gomes Silva BN, Torloni MR, Soares BG. . Cochrane Database Syst Rev. 2012 Oct 17;10:CD008858.
  • Hales CM, Harpaz R, Ortega-Sanchez I, Bialek SR. Update on Recommendation for Use of Herpes Zoster Vaccine . MMWR. 2014 Aug 22; 63(33):729-731.
  • Harpaz R, Ortega-Sanchez IR, Seward JF. Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (ÐÇ¿ÕÓéÀÖ¹ÙÍø). MMWR Recomm Rep. 2008 Jun 6;57(RR-5):1-30.
  • Mills R, Tyring SK, Levin MJ, Parrino J, Li X, et al. Vaccine. 2010 Jun 7;28(25):4204-9.
  • Morrison VA, Oxman MN, Levin MJ, Schmader KE, Betts RF, et al. . J Infect Dis. 2013;208(4):559-563.
  • Murray AV, Reisinger KS, Kerzner B, Stek JE, Sausser TA, et al. Hum Vaccin. 2011 Nov;7(11):1130-6.
  • Schmader KE, Levin MJ, Gnann JW Jr, McNeil SA, Vesikari T, et al. Clin Infect Dis. 2012 Apr;54(7):922-8.
  • Simberkoff MS, Arbeit RD, Johnson GR, Oxman MN, Boardman KD, et al. Ann Intern Med. 2010 May 4;152(9):545-54.
  • Tseng HF, Liu A, Sy L, Marcy SM, Fireman B, et al. J Intern Med. 2012 May;271(5):510-20.
  • Vermeulen JN, Lange JM, Tyring SK, Peters PH, Nunez M, et al. Vaccine. 2012 Jan 20;30(5):904-10.
  • Weinmann S, Naleway AL, Koppolu P, Baxter R, Belongia EA, Hambidge SJ, Irving SA, Jackson ML, Lewin B, Liles E, Marin M, Smith N, Weintraub E, Chun C. Pediatrics. 2019 Jul; 144(1). Pii: e20182917. Epub 2019 Jun 10.
  • Donahue JG, Kieke BA, Gargiullo PM, Jumaan AO, Berger NR, McCauley JS, et al. . Am J Public Health. 2010;100(6):1116-1122.
  • Mullooly JP, Riedlinger K, Chun C, Weinmann S, Houston H. . Epidemiol Infect.2005;133(2):245-253.
  • Zerbo O, Bartlett J, Fireman B, Lewis N, Goddard K, Dooling K, Duffy J, Glanz J, Naleway A, Donahue JG, Klein N. . Ann Intern Med. 2024 Jan 9. doi: 10.7326/M23-2023. Online ahead of print.
  • Nelson JC, Ulloa-Perez E, Yu O, Cook AJ, Jackson ML, Belongia EA, Daley MF, Harpaz R, Kharbanda EO, Klein NP, Naleway AL, Tseng HF, Weintraub ES, Duffy J, Yih WK, Jackson LA. . Am J Epidemiol. 2022 Oct 4. doi: 10.1093/aje/kwac170. Online ahead of print.