COMPLICATIONS

Potential complications of shingles can be serious

SHINGRIX is not indicated for the prevention of PHN or other herpes zoster-related complications.1

Postherpetic neuralgia (PHN)

PHN is a chronic, often debilitating condition that persists in the area where the shingles rash was located. The pain can last ≥90 days after rash onset, and in some cases, it can last years.2,3
The risk of PHN increases with age. PHN occurs in 10% to 18% of patients with shingles.2,3

Woman suffering from postherpetic neuralgia

Herpes zoster ophthalmicus (HZO)

HZO can lead to ocular complications and, in rare cases, vision loss.3

HZO occurs in 10% to 25% of patients with shingles.3

Close up of a man's eye with a herpes zoster opthalmicus outbreak

Cutaneous

Cutaneous complications from secondary bacterial infections, such as cellulitis, can result from shingles.4

Cutaneous complications have been observed in 2.3% of patients with shingles.4,*,†

Microscopic view of a cutaneous bacterial infection

Neurologic

While rare, shingles can lead to neurologic complications such as facial palsy, hearing loss, and encephalitis.4

Certain neurologic complications have been observed in 0.5% of patients with shingles.4,*,‡

Man suffering from partial facial palsy

Stroke

Shingles has been associated with a short-term increased risk of stroke. In a population-based study, 0.7% of patients had a stroke within 3 months post-shingles episode compared to 0.4% of people who did not have shingles. The odds of stroke were 53% higher among patients with shingles than among patients who did not have shingles [OR: 1.53 (95% CI: 1.01-2.33)].5,§

Man experiencing facial drooping caused by stroke
  • *

    Data from a US retrospective cohort study assessing commercial health insurance claims in immunocompetent adults ≥50 years with a diagnosis of shingles (N=236,180) from 2008 to 2013.4

  • †

    Cutaneous complications included cellulitis and zoster gangrenosum.4

  • ‡

    Neurologic complications included aseptic meningitis, cranial nerve palsies, deafness, diaphragmatic paralysis, encephalitis, motor neuropathy, sensory loss, transverse myelitis, Guillain-Barré syndrome, hemiparesis, Bell's palsy.4

  • §

    Data from a population-based community cohort study (January 1986 to October 2011) in adult residents of Olmsted County, Minnesota, 50 years and older; this retrospective study compared rates of post-HZ stroke with a cohort of age and sex-matched individuals. Risk was adjusted for several known risk factors and confounding factors for stroke. Among the patients with HZ (n=4478), 0.7% had a stroke within 3 months post-HZ compared to 0.4% in the non-HZ cohort (n=16,800).5

 

CI=confidence interval; HZ=herpes zoster; OR=odd ratio.

EXPLORE SHINGRIX CLINICAL TRIAL RESULTS

SEE THE DATA

Indication & Important Safety Info

Indication

Important Safety Information

Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

  • in adults aged 50 years and older.
  • in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Important Safety Information

  • 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
  • In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX
  • Syncope (fainting) can be associated with the administration of injectable vaccines, including SHINGRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Solicited local adverse reactions reported in individuals aged 50 years and older were pain (78%), redness (38%), and swelling (26%)
  • Solicited general adverse reactions reported in individuals aged 50 years and older were myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), and gastrointestinal symptoms (17%)  
  • Solicited local adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were pain (88% and 83%), redness (30% and 35%), and swelling (21% and 18%)  
  • Solicited general adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were fatigue (64% and 54%), myalgia (58% and 52%), headache (44% and 30%), gastrointestinal symptoms (21% and 28%), shivering (31% and 25%), and fever (28% and 18%)
  • The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women
  • It is not known whether SHINGRIX is excreted in human milk. Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion
  • Vaccination with SHINGRIX may not result in protection of all vaccine recipients

 

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or
1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

References

  1. Prescribing Information for SHINGRIX.
  2. Clinical features of shingles (herpes zoster). Centers for Disease Control and Prevention. May 10, 2024. Accessed April 9, 2025. https://www.cdc.gov/shingles/hcp/clinical-signs/index.html
  3. Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-30.
  4. Meyers JL, Candrilli SD, Rausch DA, Yan S, Patterson BJ, Levin MJ. Costs of herpes zoster complications in older adults: a cohort study of US claims database. Vaccine. 2019;37(9):1235-1244.
  5. Yawn BP, Wollan PC, Nagel MA, Gilden D. Risk of stroke and myocardial infarction after herpes zoster in older adults in a US community population. Mayo Clin Proc. 2016;91(1):33-44.

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