ZOSTAVAX is contraindicated in persons with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; with a history of primary or acquired immunodeficiency states including leukemia; lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; or with AIDS or other clinical manifestations of infection with human immunodeficiency viruses. ZOSTAVAX is also contraindicated in persons on immunosuppressive therapy. ZOSTAVAX is not indicated in women of childbearing age and should not be administered to pregnant females.

Vaccine-related, injection-site and systemic adverse events in ≥ 1% of individuals in the Adverse Event Monitoring Substudy (AEMS), a subgroup of individuals from the Shingles Prevention Study (SPS) who received ZOSTAVAX (n=3,345), included headache (1.4%) and the following injection-site reactions: erythema (33.7%), pain/tenderness (33.4%), swelling (24.9%), hematoma (1.4%), pruritus (6.6%), and warmth (1.5%). Most of these adverse experiences were reported as mild in intensity.

From Day 0 to 42 postvaccination, in the overall study population, serious adverse experiences (SAEs) occurred at a similar rate (1.4%) in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS, the rate of SAEs was increased in the group who received ZOSTAVAX (1.9%) as compared to the placebo group (1.3%) from Day 0 to 42 postvaccination. Over the course of the entire study, in the overall study population, 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).

Among reported serious adverse events in the SPS (Days 0–42 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 AEMS. 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 SPS study cohort (Days 0–42 postvaccination).

Transmission of vaccine virus may occur rarely between vaccinees and susceptible contacts.

ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox).

Vaccination with ZOSTAVAX may not result in protection of all vaccine recipients.

For details about the indications, contraindications, warnings, precautions, adverse reactions, and dosage and administration for ZOSTAVAX, please read the Prescribing Information and Patient Product Information.