SKYZoster Adverse Reactions

Local (injection site) reaction: Pain, erythema/redness, and induration/swelling may occur.
Systemic reaction: Myalgia, fatigue/malaise, headache, diarrhea, vomiting and fever may occasionally occur after vaccination.
Safety of SKYZoster was evaluated in 842 subjects aged 50 years and older and 401 subjects (47.62%) experienced adverse drug reactions.
Solicited adverse drug reactions^† (local and systemic reactions) are summarized in Table 1 as follows. (See Table 1.)

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Unsolicited adverse drug reactions were reported in 19 (2.26%) out of 842 subjects during 6 weeks post-vaccination of SKYZoster. The most frequently reported unsolicited adverse drug reaction was skin and subcutaneous tissue disorders with 6 subjects (0.71%) reporting 7 cases. With regard to the outcomes of adverse drug reactions, all subjects were recovered without sequelae. Adverse drug reactions occasionally observed (≥ 0.1 and < 5%) during the study period are shown as follows. (See Table 2.)

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6 cases of serious adverse events were reported in 6 (0.71%) out of 842 subjects during 6 weeks post-vaccination reporting period (gastric cancer, bronchitis, contusion, lower limb fracture, pancreatitis, ligament sprain). All of these serious adverse events were determined to not have a causal relationship with SKYZoster.
Varicella-like and zoster-like rashes were diagnosed in 3 out of 842 subjects vaccinated with SKYZoster during 6 weeks post-vaccination reporting period and their causal relationship with SKYZoster could not be ruled out.
In phase I clinical trial, no subjects from the SKYZoster group and Zostavax group reported varicella-like or zoster-like rash during 6 weeks post-vaccination reporting period.
In phase II/III clinical trial, 2 subjects reported varicella-like and zoster-like rash within 6 weeks post-vaccination. The specimen acquired from the subjects with zoster-like rash could not be determined as the specimen was inadequate for Polymerase Chain Reaction (PCR) testing. From the PCR testing result of the varicella-like rash specimen, varicella-zoster virus was detected, but not able to determine the virus strain (wild type or Oka/SK strain).
In phase III clinical trial, one subject from each SKYZoster and Zostavax group reported varicella-like and zoster-like rashes. Of the reported cases, one case of varicella-like rash was reported in the SKYZoster group and while the PCR testing detected varicella-zoster virus, it could not determine virus strain (wild type or Oka/SK strain). The PCR testing on one case of zoster-like rash reported in Zostavax group also detected varicella-zoster virus but the virus strain (wild type or Oka/Merck) could not be determined.