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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Zostavax:Headache; pain, swelling, redness, itching, warmth, and bruising at the injection site.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
Zostavax Side Effects - for the Professional
Zostavax
The rate of serious adverse events (SAEs) from Days 0 to 42 postvaccination may be increased in recipients of Zostavax compared to recipients of placebo (Table 1, 6.1.1).
The most frequent vaccine-related adverse events, reported in ≥1% of subjects vaccinated with Zostavax, were headache and injection site reactions (6.1.1).
To report vaccine exposure during pregnancy call 1-800-986-8999.
To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or VAERS at 1-800-822-7967 and www.fda.gov/vaers.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 07/2009
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2.1 Recommended Dose and Schedule 2.2 Preparation for Administration 5.1 Transmission of Vaccine Virus 5.3 Preventing and Managing Allergic Vaccine Reactions 5.4 Limitations of Vaccine Effectiveness 6.1 Clinical Trials Experience 7.1 Concomitant Administration with Other Vaccines 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING |
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FULL PRESCRIBING INFORMATION Top
Side Effects by Body System
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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