Varivax Adverse Reactions

In clinical trials, VARIVAX was administered to over 11,000 healthy children, adolescents, and adults. VARIVAX was generally well tolerated.
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 site.
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 follows: (See Table 2.)

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In addition, the most frequently (≥1%) reported adverse experiences, without regard to causality, are listed in decreasing order of frequency: upper respiratory illness, cough, irritability, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, headache, malaise, abdominal pain, other rash, nausea, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, arthralgia, itching.
Pneumonitis has been reported rarely (<1%) in children vaccinated with VARIVAX; a causal relationship has not been established.
Febrile seizures have occurred rarely (<0.1%) in children vaccinated with VARIVAX; a causal relationship has not been established.
Clinical safety of refrigerator-stable VARIVAX (n=635) was compared with that of the previously licensed formulation of VARIVAX (n=323) for 42 days postvaccination in U.S. children 12 to 23 months of age. The safety profiles were comparable for the two different formulations. Pain/tenderness/soreness (24.8 to 28.9%) and erythema (18.4 to 21.0%) were the most commonly reported local reactions. The most common systemic adverse events (reported by ≥10% of subjects in one or more treatment groups, irrespective of causal relationship to vaccination) were: fever ≥102°F, oral equivalent (27.0 to 29.2%), upper respiratory infection (26.9 to 29.7%), otitis media (12.0 to 14.1%), cough (11.0 to 15.1%), rhinorrhea (8.7 to 10.6%), and irritability (6.5 to 11.9%). Six subjects reported serious adverse experiences; all were judged by the investigators as being unrelated to vaccination.
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 was generally well tolerated, with a safety profile generally comparable to that of the 1-dose regimen. The incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was slightly higher Postdose 2 (overall incidence 25.4%) than Postdose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower Postdose 2 (66.3%) than Postdose 1 (85.8%).
Adolescents and Adults 13 Years of Age and Older: 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 frequency of fever, injection-site complaints, or rashes were reported as follows: (See Table 3.)

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In addition, the most frequently (≥1%) reported adverse experiences, without regard to causality, are listed in decreasing order of frequency: upper respiratory illness, headache, fatigue, cough, myalgia, disturbed sleep, nausea, malaise, irritability, diarrhea, stiff neck, lymphadenopathy, chills, abdominal pain, loss of appetite, arthralgia, otitis, itching, vomiting, other rashes, lower respiratory illness, allergic reactions (including allergic rash, hives), and dizziness.
As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials.
The following additional adverse reactions have been reported regardless of causality since the vaccine has been marketed: Body As A Whole: Anaphylaxis (including anaphylactic shock) and related phenomena such as angioneurotic edema, facial edema and peripheral edema; anaphylaxis in individuals with or without an allergic history.
Eye Disorders: Necrotizing retinitis (reported only in immunocompromised individuals).
Gastrointestinal Disorders: Nausea; vomiting.
Hemic and Lymphatic System: Aplastic anemia, thrombocytopenia (including idiopathic thrombocytopenic purpura (ITP)), lymphadenopathy.
Infections and Infestations: Varicella (vaccine strain).
Nervous/Psychiatric: Encephalitis^†; cerebrovascular accident; transverse myelitis; Guillain-Barré syndrome; Bell's palsy; ataxia; febrile and non-febrile seizures; aseptic meningitis; meningitis^†; dizziness; paresthesia; irritability; syncope.
Respiratory: Pharyngitis; pneumonia/pneumonitis; upper respiratory tract infection.
Skin: Stevens-Johnson syndrome; erythema multiforme; Henoch-Schönlein purpura; secondary bacterial infections of skin and soft tissue, including cellulitis; herpes zoster^†.
^†Cases caused by wild-type varicella or vaccine strain varicella have been reported in immunocompromised or immunocompetent individuals.