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Zostavax

"March 24, 2011 - People age 50 and older can now get Merck's Zostavax shingles vaccine, the FDA today ruled.

The vaccine already was approved for people age 60 and older. The approval is based on a Merck clinical trial that showed the"...

Zostavax

Zostavax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zostavax (Zoster Vaccine Live) is a live vaccine used to prevent herpes zoster virus (shingles) in people age 60 and older. Zostavax will not treat shingles or nerve pain caused by shingles (post-herpetic neuralgia). Common side effects include redness, itching, swelling, warmth, bruising, and pain at the injection site. Headache may also occur.

Zostavax is administered by a doctor as a single 0.65-mL dose subcutaneously (under the skin) in the deltoid region of the upper arm. There may be other drugs that can affect Zostavax. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Zostavax is not recommended for use during pregnancy. Pregnancy should also be avoided for 3 months after receiving this vaccine. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Zostavax (Zoster Vaccine Live) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zostavax in Detail - Patient Information: Side Effects

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

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell the doctor if the previous shots 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 any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, swollen glands, sore throat, flu symptoms;
  • breathing problems; or
  • severe or painful skin rash.

Less serious side effects include:

  • pain, warmth, redness, bruising, itching, or swelling where the shot was given;
  • diarrhea;
  • joint or muscle pain;
  • headache; or
  • mild skin rash.

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 Zostavax (Zoster Vaccine Live) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zostavax Overview - Patient Information: Side Effects

SIDE EFFECTS: Redness, itching, swelling, warmth, bruising, and pain at the injection site may occur. Headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: chickenpox.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Zostavax (Zoster Vaccine Live)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zostavax FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequent adverse reactions, reported in ≥ 1% of subjects vaccinated with ZOSTAVAX, were headache and injection-site reactions.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, rates of adverse reactions observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

ZOSTAVAX Efficacy and Safety Trial (ZEST) in Subjects 50 to 59 Years of Age

In the ZEST study, subjects received a single dose of either ZOSTAVAX (N=11,184) or placebo (N=11,212). The racial distribution across both vaccination groups was similar: White (94.4%); Black (4.2%); Hispanic (3.3%) and Other (1.4%) in both vaccination groups. The gender distribution was 38% male and 62% female in both vaccination groups. The age distribution of subjects enrolled, 50 to 59 years, was similar in both vaccination groups. All subjects received a vaccination report card (VRC) to record adverse events occurring from Days 1 to 42 postvaccination.

In the ZEST study, serious adverse events occurred at a similar rate in subjects vaccinated with ZOSTAVAX (0.6%) or placebo (0.5%) from Days 1 to 42 postvaccination.

In the ZEST study, all subjects were monitored for adverse reactions. An anaphylactic reaction was reported for one subject vaccinated with ZOSTAVAX.

Most Common Adverse Reactions and Experiences in the ZEST Study

The overall incidence of vaccine-related injection-site adverse reactions within 5 days post-vaccination was greater for subjects vaccinated with ZOSTAVAX as compared to subjects who received placebo (63.6% for ZOSTAVAX and 14.0% for placebo). Injection-site adverse reactions occurring at an incidence ≥ 1% within 5 days post-vaccination are shown in Table 1.

Table 1: Injection-Site Adverse Reactions Reported in ≥ 1% of Adults Who Received ZOSTAVAX or Placebo Within 5 Days Post-Vaccination in the ZOSTAVAX Efficacy and Safety Trial

Injection-Site Adverse Reaction ZOSTAVAX
(N = 11094) %
Placebo
(N = 11116) %
Solicited*
  Pain 53.9 9.0
  Erythema 48.1 4.3
  Swelling 40.4 2.8
Unsolicited
  Pruritis 11.3 0.7
  Warmth 3.7 0.2
  Hematoma 1.6 1.6
  Induration 1.1 0.0
*Solicited on the Vaccination Report Card

Systemic adverse reactions and experiences reported during Days 1-42 at an incidence of ≥ 1% in either vaccination group were headache (ZOSTAVAX 9.4%, placebo 8.2%) and pain in the extremity (ZOSTAVAX 1.3%, placebo 0.8%), respectively.

The overall incidence of systemic adverse experiences reported during Days 1-42 was higher for ZOSTAVAX (35.4%) than for placebo (33.5%).

Shingles Prevention Study (SPS) in Subjects 60 Years of Age and Older

In the SPS, the largest clinical trial of ZOSTAVAX, subjects received a single dose of either ZOSTAVAX (n=19,270) or placebo (n=19,276). The racial distribution across both vaccination groups was similar: White (95%); Black (2.0%); Hispanic (1.0%) and Other (1.0%) in both vaccination groups. The gender distribution was 59% male and 41% female in both vaccination groups. The age distribution of subjects enrolled, 59-99 years, was similar in both vaccination groups.

The Adverse Event Monitoring Substudy of the SPS, designed to provide detailed data on the safety profile of the zoster vaccine (n=3,345 received ZOSTAVAX and n=3,271 received placebo) used vaccination report cards (VRC) to record adverse events occurring from Days 0 to 42 postvaccination (97% of subjects completed VRC in both vaccination groups). In addition, monthly surveillance for hospitalization was conducted through the end of the study, 2 to 5 years postvaccination.

The remainder of subjects in the SPS (n=15,925 received ZOSTAVAX and n=16,005 received placebo) were actively followed for safety outcomes through Day 42 postvaccination and passively followed for safety after Day 42.

Serious Adverse Events Occurring 0-42 Days Postvaccination

In the overall SPS study population, serious adverse events occurred at a similar rate (1.4%) in subjects vaccinated with ZOSTAVAX or placebo.

In the AE Monitoring Substudy, the rate of SAEs was increased in the group of subjects who received ZOSTAVAX as compared to the group of subjects who received placebo (Table 2).

Table 2: Number of Subjects with ≥ 1 Serious Adverse Events the Shingles Prevention Study

Cohort ZOSTAVAX
n/N %
Placebo
n/N %
Relative Risk (95% CI)
Overall Study Cohort 255/18671 254/18717 1.01
(60 years of age and older) 1.4% 1.4% (0.85, 1.20)
  60-69 years old 113/10100 101/10095 1.12
1.1% 1.0% (0.86, 1.46)
  70-79 years old 115/7351 132/7333 0.87
1.6% 1.8% (0.68, 1.11)
   ≥ 80 years old 27/1220 21/1289 1.36
2.2% 1.6% (0.78, 2.37)
AE Monitoring Substudy Cohort 64/3326 41/3249 1.53
(60 years of age and older) 1.9% 1.3% (1.04, 2.25)
  60-69 years old   22/1726 18/1709 1.21
1.3% 1.1% (0.66, 2.23)
  70-79 years old 31/1383 19/1367 1.61
2.2% 1.4% (0.92, 2.82)
   ≥ 80 years old 11/217 4/173 2.19
5.1% 2.3% (0.75, 6.45)
N=number of subjects in cohort with safety follow-up
n=number of subjects reporting an SAE 0-42 Days postvaccination

Among reported serious adverse events in the SPS (Days 0 to 42 postvaccination), serious cardiovascular events occurred more frequently in subjects who received ZOSTAVAX (20 [0.6%]) than in subjects who received placebo (12 [0.4%]) in the AE Monitoring Substudy. The frequencies of serious cardiovascular events were similar in subjects who received ZOSTAVAX (81 [0.4%]) and in subjects who received placebo (72 [0.4%]) in the entire study cohort (Days 0 to 42 postvaccination).

Serious Adverse Events Occurring Over the Entire Course of the Study

Rates of hospitalization were similar among subjects who received ZOSTAVAX and subjects who received placebo in the AE Monitoring Substudy, throughout the entire study.

Fifty-one individuals (1.5%) receiving ZOSTAVAX were reported to have congestive heart failure (CHF) or pulmonary edema compared to 39 individuals (1.2%) receiving placebo in the AE Monitoring Substudy; 58 individuals (0.3%) receiving ZOSTAVAX were reported to have congestive heart failure (CHF) or pulmonary edema compared to 45 (0.2%) individuals receiving placebo in the overall study.

In the SPS, all subjects were monitored for vaccine-related SAEs. Investigator-determined, vaccine-related serious adverse experiences were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture's syndrome, anaphylactic reaction, and polymyalgia rheumatica).

Deaths

The incidence of death was similar in the groups receiving ZOSTAVAX or placebo during the Days 0-42 postvaccination period; 14 deaths occurred in the group of subjects who received ZOSTAVAX and 16 deaths occurred in the group of subjects who received placebo. The most common reported cause of death was cardiovascular disease (10 in the group of subjects who received ZOSTAVAX, 8 in the group of subjects who received placebo). The overall incidence of death occurring at any time during the study was similar between vaccination groups: 793 deaths (4.1%) occurred in subjects who received ZOSTAVAX and 795 deaths (4.1%) in subjects who received placebo.

Most Common Adverse Reactions and Experiences in the AE Monitoring Substudy of the SPS

Injection-site adverse reactions reported at an incidence ≥ 1% are shown in Table 3. Most of these adverse reactions were reported as mild in intensity. The overall incidence of vaccine-related injection-site adverse reactions was significantly greater for subjects vaccinated with ZOSTAVAX versus subjects who received placebo (48% for ZOSTAVAX and 17% for placebo).6

Table 3: Injection-Site Adverse Reactions* in ≥ 1% of Adults Who Received ZOSTAVAX or Placebo Within 5 Days Postvaccination from the AE Monitoring Substudy of the Shingles Prevention Study

Adverse Reaction ZOSTAVAX
(N = 3345) %
Placebo
(N = 3271) %
Solicited†
  Erythema 35.6 6.9
  Pain/Tenderness 34.3 8.3
  Swelling 26.1 4.5
Unsolicited
  Hematoma 1.6 1.4
  Pruritis 6.9 1.0
  Warmth 1.6 0.3
*Patients instructed to report adverse experiences on a Vaccination Report Card
†Solicited on the Vaccination Report Card

Headache was the only systemic adverse reaction reported on the vaccine report card between Days 0-42 by ≥ 1% of subjects in the AE Monitoring Substudy in either vaccination group (ZOSTAVAX 1.4%, placebo 0.8%).

The numbers of subjects with elevated temperature ( ≥ 38.3°C [ ≥ 101.0°F]) within 42 days postvaccination were similar in the ZOSTAVAX and the placebo vaccination groups [27 (0.8%) vs. 27 (0.9%), respectively].

The following adverse experiences in the AE Monitoring Substudy of the SPS (Days 0 to 42 postvaccination) were reported at an incidence ≥ 1% and greater in subjects who received ZOSTAVAX than in subjects who received placebo, respectively: respiratory infection (65 [1.9%] vs. 55 [1.7%]), fever (59 [1.8%] vs. 53 [1.6%]), flu syndrome (57 [1.7%] vs. 52 [1.6%]), diarrhea (51 [1.5%] vs. 41 [1.3%]), rhinitis (46 [1.4%] vs. 36 [1.1%]), skin disorder (35 [1.1%] vs. 31 [1.0%]), respiratory disorder (35 [1.1%] vs. 27 [0.8%]), asthenia (32 [1.0%] vs. 14 [0.4%]).

VZV Rashes Following Vaccination

Within the 42-day postvaccination reporting period in the ZEST, noninjection-site zoster-like rashes were reported by 34 subjects (19 for ZOSTAVAX and 15 for placebo). Of 24 specimens that were adequate for Polymerase Chain Reaction (PCR) testing, wild-type VZV was detected in 10 (3 for ZOSTAVAX, 7 for placebo) of these specimens. The Oka/Merck strain of VZV was not detected from any of these specimens. Of reported varicella-like rashes (n=124, 69 for ZOSTAVAX and 55 for placebo), 23 had specimens that were available and adequate for PCR testing. VZV was detected in one of these specimens in the ZOSTAVAX group; however, the virus strain (wild-type or Oka/Merck strain) could not be determined.

Within the 42-day postvaccination reporting period in the SPS, noninjection-site zoster-like rashes were reported by 53 subjects (17 for ZOSTAVAX and 36 for placebo). Of 41 specimens that were adequate for Polymerase Chain Reaction (PCR) testing, wild-type VZV was detected in 25 (5 for ZOSTAVAX, 20 for placebo) of these specimens. The Oka/Merck strain of VZV was not detected from any of these specimens.

Of reported varicella-like rashes (n=59), 10 had specimens that were available and adequate for PCR testing. VZV was not detected in any of these specimens.

In clinical trials in support of the initial licensure of the frozen formulation of ZOSTAVAX, the reported rates of noninjection-site zoster-like and varicella-like rashes within 42 days postvaccination were also low in both zoster vaccine and placebo recipients. Of 17 reported varicella-like rashes and non-injection site zoster-like rashes, 10 specimens were available and adequate for PCR testing, and 2 subjects had varicella (onset Day 8 and 17) confirmed to be Oka/Merck strain.

Postmarketing Experience

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

Gastrointestinal disorders: nausea

Infections and infestations: herpes zoster (vaccine strain)

Skin and subcutaneous tissue disorders: rash

Musculoskeletal and connective tissue disorders: arthralgia; myalgia

General disorders and administration site conditions: injection-site rash; pyrexia; injection-site urticaria; transient injection-site lymphadenopathy

Immune system disorders: hypersensitivity reactions including anaphylactic reactions

Reporting Adverse Events

The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967 or report online to www.vaers.hhs.gov.2

Read the entire FDA prescribing information for Zostavax (Zoster Vaccine Live) »

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Zostavax - User Reviews

Zostavax User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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