"What is Shingles?
Shingles is a painful skin rash, often with blisters. It is also called Herpes Zoster, or just Zoster.
A shingles rash usually appears on one side of the face or body and lasts from 2 to 4 weeks. Its main sym"...
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 to rates in the clinical trials of another vaccine and may not reflect the rates observed in clinical practice. Vaccine-related adverse reactions reported during clinical trials were assessed by the study investigators to be possibly, probably, or definitely vaccine-related and are summarized below.
In clinical trials2-9, VARIVAX was administered to over 11,000 healthy children, adolescents, and adults.
In a double-blind, placebo-controlled study among 914 healthy children and adolescents who were serologically confirmed to be susceptible to varicella, the only adverse reactions that occurred at a significantly (p < 0.05) greater rate in vaccine recipients than in placebo recipients were pain and redness at the injection site2.
Children 1 to 12 Years of Age
One-Dose Regimen in Children
In clinical trials involving healthy children monitored for up to 42 days after a single dose of VARIVAX, the frequency of fever, injection-site complaints, or rashes were reported as shown in Table 1:
Table 1: Fever, Local Reactions, and Rashes (%) in
Children 1 to 12 Years of Age 0 to 42 Days After Receipt of a Single Dose of
|Reaction||N||% Experiencing Reaction||Peak Occurrence During Post vaccination Days|
|Fever ≥ 102.0°F (38.9°C) Oral||8827||14.7%||0 to 42|
|Injection-site complaints (pain/soreness, swelling and/or erythema, rash, pruritus, hematoma, induration, stiffness)||8916||19.3%||0 to 2|
|Varicella-like rash (injection site)||8916||3.4%||8 to 19|
|Median number of lesions||2|
|Varicella-like rash (generalized)||8916||3.8%||5 to 26|
|Median number of lesions||5|
In addition, adverse events occurring at a rate of ≥ 1% are listed in decreasing order of frequency: upper respiratory illness, cough, irritability/nervousness, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, diaper rash/contact rash, headache, teething, malaise, abdominal pain, other rash, nausea, eye complaints, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, heat rash/prickly heat, arthralgia, eczema/dry skin/dermatitis, constipation, itching.
Pneumonitis has been reported rarely ( < 1%) in children vaccinated with VARIVAX.
Febrile seizures have occurred at a rate of < 0.1% in children vaccinated with VARIVAX.
Two-Dose Regimen in Children
Nine hundred eighty-one (981) subjects in a clinical trial received 2 doses of VARIVAX 3 months apart and were actively followed for 42 days after each dose. The 2-dose regimen of varicella vaccine had a safety profile comparable to that of the 1-dose regimen. The overall incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was 25.4% Postdose 2 and 21.7% Postdose 1, whereas the overall incidence of systemic clinical complaints in the 42-day follow-up period was lower Postdose 2 (66.3%) than Postdose 1 (85.8%).
Adolescents (13 Years of Age and Older) and Adults
In clinical trials involving healthy adolescents and adults, the majority of whom received two doses of VARIVAX and were monitored for up to 42 days after any dose, the frequencies of fever, injection-site complaints, or rashes are shown in Table 2.
Table 2: Fever, Local Reactions, and Rashes (%) in
Adolescents and Adults 0 to 42 Days After Receipt of VARIVAX
|Reaction||N||% Post Dose 1||Peak Occurrence in Post vaccination Days||N||% Post Dose 2||Peak Occurrence in Post vaccination Days|
|Fever ≥ 100.0°F (37.8°C) Oral||1584||10.2%||14 to 27||956||9.5%||0 to 42|
|Injection-site complaints (soreness, erythema, swelling, rash, pruritus, pyrexia, hematoma, induration, numbness)||1606||24.4%||0 to 2||955||32.5%||0 to 2|
|Varicella-like rash (injection site)||1606||3%||6 to 20||955||1%||0 to 6|
|Median number of lesions||2||2|
|Varicella-like rash (generalized)||1606||5.5%||7 to 21||955||0.9%||0 to 23|
|Median number of lesions||5||5.5|
In addition, adverse events reported at a rate of ≥ 1% are listed in decreasing order of frequency: upper respiratory illness, headache, fatigue, cough, myalgia, disturbed sleep, nausea, malaise, diarrhea, stiff neck, irritability/nervousness, lymphadenopathy, chills, eye complaints, abdominal pain, loss of appetite, arthralgia, otitis, itching, vomiting, other rashes, constipation, lower respiratory illness, allergic reactions (including allergic rash, hives), contact rash, cold/canker sore.
Broad use of VARIVAX could reveal adverse events not observed in clinical trials.
The following additional adverse events, regardless of causality, have been reported during post-marketing use of VARIVAX:
Body as a Whole
Necrotizing retinitis (in immunocompromised individuals).
Hemic and Lymphatic System
Infections and Infestations
Varicella (vaccine strain).
Read the Varivax (varicella virus vaccine live) Side Effects Center for a complete guide to possible side effects
No cases of Reye syndrome have been observed following vaccination with VARIVAX. Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with VARIVAX, as Reye syndrome has been reported following the use of salicylates during wild-type varicella infection [see WARNINGS AND PRECAUTIONS].
Immune Globulins And Transfusions
Blood, plasma, and immune globulins contain antibodies that may interfere with vaccine virus replication and decrease the immune response to VARIVAX. Vaccination should be deferred for at least 5 months following blood or plasma transfusions, or administration of immune globulin(s)1.
Following administration of VARIVAX, immune globulin(s) should not be given for 2 months thereafter unless its use outweighs the benefits of vaccination1. [See WARNINGS AND PRECAUTIONS]
Tuberculin Skin Testing
Tuberculin skin testing, with tuberculin purified protein derivative (PPD), may be performed before VARIVAX is administered or on the same day, or at least 4 weeks following vaccination with VARIVAX, as other live virus vaccines may cause a temporary depression of tuberculin skin test sensitivity leading to false negative results.
2. Weibel, R.E.; et al.: Live Attenuated Varicella Virus Vaccine. Efficacy Trial in Healthy Children. N Engl J Med. 310(22): 1409-1415, 1984.
3. Arbeter, A.M.; et al.: Varicella Vaccine Trials in Healthy Children. A Summary of Comparative and Follow-up Studies. Am J Dis Child. 138: 434-438, 1984.
4. Weibel, R.E.; et al.: Live Oka/Merck Varicella Vaccine in Healthy Children. Further Clinical and Laboratory Assessment. JAMA. 254(17): 2435-2439, 1985.
5. Chartrand, D.M.; et al.: New Varicella Vaccine Production Lots in Healthy Children and Adolescents. Abstracts of the 1988 Inter-Science Conference Antimicrobial Agents and Chemotherapy: 237(Abstract #731).
6. Johnson, C.E.; et al.: Live Attenuated Varicella Vaccine in Healthy 12- to 24-Month-Old Children. Pediatrics. 81(4): 512-518, 1988.
7. Gershon, A.A.; et al.: Immunization of Healthy Adults with Live Attenuated Varicella Vaccine. J Infect Dis. 158(1): 132-137, 1988.
8. Gershon, A.A.; et al.: Live Attenuated Varicella Vaccine: Protection in Healthy Adults Compared with Leukemic Children. J Infect Dis. 161: 661-666, 1990.
9. White, C.J.; et al.: Varicella Vaccine (VARIVAX) in Healthy Children and Adolescents: Results From Clinical Trials, 1987 to 1989. Pediatrics. 87(5): 604-610, 1991.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/21/2015
Additional Varivax Information
Report Problems to the Food and Drug Administration
Find out what women really need.