Shingrix

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 4/22/2022
Shingrix Side Effects Center

What Is Shingrix?

Shingrix (zoster vaccine recombinant, adjuvanted) is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.

What Are Side Effects of Shingrix?

Common side effects of Shingrix include:

  • injection site reactions (pain, redness, and swelling),
  • muscle pain,
  • fatigue,
  • headache,
  • shivering,
  • fever,
  • nausea,
  • vomiting,
  • diarrhea, or
  • abdominal pain

Dosage for Shingrix

Administer 2 doses (0.5 mL each) of Shingrix at 0 and 2 to 6 months.

What Drugs, Substances, or Supplements Interact with Shingrix?

Shingrix may interact with immunosuppressive therapies. Tell your doctor all medications and supplements you use and all vaccines you recently received.

Shingrix During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Shingrix; it is unknown if it would affect a fetus. It is unknown if Shingrix passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Shingrix (zoster vaccine recombinant, adjuvanted) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Shingles Rash Pictures, Symptoms, Vaccine Facts See Slideshow
Shingrix Consumer Information

You should not receive the second shot if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving inactivated zoster vaccine. When you receive the second shot, tell the doctor if the first shot caused any side effects.

Becoming infected with shingles is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people receiving this vaccine had nervous system problems within 42 days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have:

  • weakness or tingling;
  • trouble speaking or swallowing;
  • problems with balance or eye movement; or
  • loss of bladder or bowel control.

Call your doctor at once if you have a high fever.

Common side effects include:

  • headache, muscle pain;
  • feeling tired;
  • stomach pain, nausea, vomiting, diarrhea;
  • fever, shivering; or
  • pain, redness, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the entire detailed patient monograph for Shingrix (Zoster Vaccine Recombinant, Adjuvanted Suspension for Intramuscular Injection)

QUESTION

Shingles is a painful rash caused by the same virus that causes chickenpox. See Answer
Shingrix Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. There is the possibility that broad use of SHINGRIX could reveal adverse reactions not observed in clinical trials.

Overall, 17,041 adults aged 50 years and older received at least 1 dose of SHINGRIX in 17 clinical studies.

The safety of SHINGRIX was evaluated by pooling data from 2 placebo-controlled clinical studies (Studies 1 and 2) involving 29,305 subjects aged 50 years and older who received at least 1 dose of SHINGRIX (n = 14,645) or saline placebo (n = 14,660) administered according to a 0- and 2-month schedule. At the time of vaccination, the mean age of the population was 69 years; 7,286 (24.9%) subjects were aged 50 to 59 years, 4,488 (15.3%) subjects were aged 60 to 69 years, and 17,531 (59.8%) subjects were aged 70 years and older. Both studies were conducted in North America, Latin America, Europe, Asia, and Australia. In the overall population, the majority of subjects were white (74.3%), followed by Asian (18.3%), black (1.4%), and other racial/ethnic groups (6.0%); 58% were female.

Solicited Adverse Events

In Studies 1 and 2, data on solicited local and general adverse events were collected using standardized diary cards for 7 days following each vaccine dose or placebo (i.e., day of vaccination and the next 6 days) in a subset of subjects (n = 4,886 receiving SHINGRIX, n = 4,881 receiving placebo with at least 1 documented dose). Across both studies, the percentages of subjects aged 50 years and older reporting each solicited local adverse reaction and each solicited general adverse event following administration of SHINGRIX (both doses combined) were pain (78.0%), redness (38.1%), and swelling (25.9%); and myalgia (44.7%), fatigue (44.5%), headache (37.7%), shivering (26.8%), fever (20.5%), and gastrointestinal symptoms (17.3%), respectively.

The reported frequencies of specific solicited local adverse reactions and general adverse events (overall per subject), by age group, from the 2 studies are presented in Table 1.

Table 1. Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Daysa of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Olderb (Total Vaccinated Cohort with 7-Day Diary Card)

Aged 50 - 59 YearsAged 60 - 69 YearsAged ≥70 Years
SHINGRIX
%
Placeboc
%
SHINGRIX
%
Placeboc
%
SHINGRIX
%
Placeboc
%
Local Adverse Reactionsn = 1,315n = 1,312n = 1,311n = 1,305n = 2,258n = 2,263
Pain88.414.482.811.169.28.8
Pain, Grade 3d10.30.56.90.54.00.2
Redness38.71.238.41.637.71.2
Redness, >100 mm2.80.02.60.03.10.0
Swelling30.50.826.51.023.01.1
Swelling, >100 mm1.10.00.50.01.30.0
General Adverse Eventsn = 1,315n = 1,312n = 1,309n = 1,305n =2,252n = 2,264
Myalgia56.915.249.011.235.19.9
Myalgia, Grade 3e8.90.95.30.82.80.4
Fatigue57.019.845.716.836.614.4
Fatigue, Grade 3e8.51.85.00.83.50.8
Headache50.621.639.615.629.011.8
Headache, Grade 3e6.01.73.70.21.50.4
Shivering35.87.430.35.719.54.9
Shivering, Grade 3e6.80.24.50.32.20.3
Fever27.83.023.93.414.32.7
Fever, Grade 3f0.40.20.50.20.10.1
GIg2.4.310.716.78.713.57.6
GI, Grade 3e2.10.70.90.61.20.4
Total vaccinated cohort for safety included all subjects with at least 1 documented dose (n).
a 7 days included day of vaccination and the subsequent 6 days.
b Data for subjects aged 50 to 59 years and 60 to 69 years are based on Study 1. Data for subjects 70 years and older are based on pooled data from Study 1: NCT01165177 and Study 2: NCT01165229.
c Placebo was a saline solution.
d Grade 3 pain: Defined as significant pain at rest; prevents normal everyday activities.
e Grade 3 myalgia, fatigue, headache, shivering, GI: Defined as preventing normal activity.
f Fever defined as ≥37.5°C/99.5°F for oral, axillary, or tympanic route, or ≥38°C/100.4°F for rectal route; Grade 3 fever defined as >39.0°C/102.2°F.
g GI = Gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.

The incidence of solicited local and general symptoms was lower in subjects aged 70 years and older compared with those aged 50 to 69 years.

The majority of solicited local adverse reactions and general adverse events seen with SHINGRIX had a median duration of 2 to 3 days.

There were no differences in the proportions of subjects reporting any or Grade 3 solicited local reactions between Dose 1 and Dose 2. Headache and shivering were reported more frequently by subjects after Dose 2 (28.2% and 21.4%, respectively) compared with Dose 1 (24.4% and 13.8%, respectively). Grade 3 solicited general adverse events (headache, shivering, myalgia, and fatigue) were reported more frequently by subjects after Dose 2 (2.3%, 3.1%, 3.6%, and 3.5%, respectively) compared with Dose 1 (1.4%, 1.4%, 2.3%, and 2.4%, respectively).

Unsolicited Adverse Events

Unsolicited adverse events that occurred within 30 days following each vaccination (Day 0 to 29) were recorded on a diary card by all subjects. In the 2 studies, unsolicited adverse events occurring within 30 days of vaccination were reported in 50.5% and 32.0% of subjects who received SHINGRIX (n = 14,645) and placebo (n = 14,660), respectively (Total Vaccinated Cohort). Unsolicited adverse events that occurred in ≥1% of recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo included chills (3.5% versus 0.2%), injection site pruritus (2.2% versus 0.2%), malaise (1.7% versus 0.3%), arthralgia (1.7% versus 1.2%), nausea (1.4% versus 0.5%), and dizziness (1.2% versus 0.8%).

Gout (including gouty arthritis) was reported by 0.18% (n = 27) versus 0.05% (n = 8) of subjects who received SHINGRIX and placebo, respectively, within 30 days of vaccination; available information is insufficient to determine a causal relationship with SHINGRIX.

Serious Adverse Events (SAEs)

In the 2 studies, SAEs were reported at similar rates in subjects who received SHINGRIX (2.3%) and placebo (2.2%) from the first administered dose up to 30 days post last vaccination. SAEs were reported for 10.1% of subjects who received SHINGRIX and for 10.4% of subjects who received placebo from the first administered dose up to 1 year post last vaccination. One subject (<0.01%) reported lymphadenitis and 1 subject (<0.01%) reported fever greater than 39°C; there was a basis for a causal relationship with SHINGRIX.

Optic ischemic neuropathy was reported in 3 subjects (0.02%) who received SHINGRIX (all within 50 days after vaccination) and 0 subjects who received placebo; available information is insufficient to determine a causal relationship with SHINGRIX.

Deaths

From the first administered dose up to 30 days post last vaccination, deaths were reported for 0.04% of subjects who received SHINGRIX and 0.05% of subjects who received placebo in the 2 studies. From the first administered dose up to 1 year post last vaccination, deaths were reported for 0.8% of subjects who received SHINGRIX and for 0.9% of subjects who received placebo. Causes of death among subjects were consistent with those generally reported in adult and elderly populations.

Potential Immune-Mediated Diseases

In the 2 studies, new onset potential immune-mediated diseases (pIMDs) or exacerbation of existing pIMDs were reported for 0.6% of subjects who received SHINGRIX and 0.7% of subjects who received placebo from the first administered dose up to 1 year post last vaccination. The most frequently reported pIMDs occurred with comparable frequencies in the group receiving SHINGRIX and the placebo group.

Dosing Schedule

In an open-label clinical study, 238 subjects 50 years and older received SHINGRIX as a 0- and 2-month or 0- and 6-month schedule. The safety profile of SHINGRIX was similar when administered according to a 0- and 2-month or 0- and 6-month schedule and was consistent with that observed in Studies 1 and 2.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of SHINGRIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

General Disorders And Administration Site Conditions

Decreased mobility of the injected arm which may persist for 1 or more weeks.

Immune System Disorders

Hypersensitivity reactions, including angioedema, rash, and urticaria.

Read the entire FDA prescribing information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted Suspension for Intramuscular Injection)

IMAGES

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© Shingrix Patient Information is supplied by Cerner Multum, Inc. and Shingrix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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