Zostavax Side Effects

Generic Name: zoster vaccine live

Please note - some side effects for Zostavax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Zostavax - for the Consumer

Zostavax

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zostavax:

Headache; pain, swelling, redness, itching, warmth, and bruising at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using Zostavax:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Zostavax Side Effects - for the Professional

Zostavax

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates 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.

6.1.1 Shingles Prevention Study

In clinical trials, Zostavax has been evaluated for safety in approximately 21,000 adults. In the largest of these trials, the Shingles Prevention Study (SPS), 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 1).

Table 1: Number of Subjects with ≥1 Serious Adverse Events (0-42 Days Postvaccination) in the Shingles Prevention Study

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

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

Adverse Events Reported in the AE Monitoring Substudy of the SPS

Injection-site and systemic adverse events reported at an incidence ≥1% are shown in Table 2. Most of these adverse events 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).

Table 2: Injection-Site and Systemic Adverse Experiences Reported by Vaccine Report Card in ≥1% of Adults Who Received Zostavax or Placebo (0-42 Days Postvaccination) in the AE Monitoring Substudy of the Shingles Prevention Study

Adverse Experience	Zostavax (N = 3345) %	Placebo (N = 3271) %
* Designates a solicited adverse experience. Injection-site adverse experiences were solicited only from Days 0-4 postvaccination.
Injection Site     Erythema*     Pain/tenderness*     Swelling*     Hematoma     Pruritus     Warmth	33.7 33.4 24.9 1.4 6.6 1.5	6.4 8.3 4.3 1.4 1.0 0.3
Systemic     Headache	1.4	0.8

The numbers of subjects with elevated temperature (≥38.3ºC [≥101.0ºF]) 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%]).

6.1.2 VZV Rashes Following Vaccination

Within the 42-day post vaccination 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 noninjection-site, zoster-like rashes, 10 specimens were available and adequate for PCR testing. The Oka/Merck strain was identified by PCR analysis from the lesion specimens of two subjects who reported varicella-like rashes (onset on Day 8 and 17).

Post-Marketing Experience

The following additional adverse reactions have been identified during post-marketing 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.

Skin and subcutaneous tissue disorders: rash

Musculoskeletal and connective tissue disorders: arthralgia; myalgia

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

Hypersensitivity: 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}

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included angina pectoris, coronary artery disease, coronary occlusion, cardiovascular disorder, myocardial ischemia, congestive heart failure, and myocardial infarction.

Local

Local side effects have included injection site erythema, pain, tenderness, swelling, hematoma, pruritus, and warmth.

Nervous system

Nervous system side effects have included headache and asthenia.

Respiratory

Respiratory side effects have included pulmonary edema, respiratory infection, respiratory disorder, and asthma exacerbation.

Dermatologic

Dermatologic side effects have included zoster-like and varicella-like rashes and skin disorders.

Gastrointestinal

Gastrointestinal side effects have included diarrhea.

General

General side effects have included fever, flu syndrome, and rhinitis.

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