Age: 9.0
Sex: M
Vaccine: VARCEL
Clinical narrative: Large local reaction starting day after vaccination 13X11 cm of erythema and 7X7 cm induration. Temp 100.2F This is in follow-up to report (s) previously submitted on 5/16/2008. Information has been received from a physician concerning a 9 year old male who was vaccinated on left thigh with a second dose of VARIVAX. Subsequently the patient developed injection site erythema 23x11 cm and injection site unduration 7x7 cm. It  was reported that the patient was seen in office but no treatment was undertaken. The patient's reaction improved by 50 % next day and it resolved rapidly. Follow-up information has been received from the reporting physician indicating that on 23-OCT-2007 the patient was vaccinated SC with his second dose of VARIVAX (lot3658589/1274U) in the thigh. On 24-OCT-2007 the patient developed a large local reaction with 13 x 11 cm erythema, 7 x 7 cm induration and swelling and a temperature of 100.2. On 27-OCT-2007 the patient was recovered. Additional follow-up information has been received from the author of a published literature article as stated above. "A 10-year-old boy presented to the clinic with a chief complaint of a reaction on his leg 2 days after receiving a single subcutaneous dose of VARIVAX in the left thigh (different vaccine lot number than first case). An area of redness and purlish discloloration about the vaccination site were noted the day after vaccination and were observed to be increasing in site. Upon presentation to clinic, the patient has an oral temperature of 100.2 F and otherwise appeared well. A swollen, nontender 13 cm by 11 cm area of erythema and induration measuring 7 cm in diameter were noted about the injection site. Vesicular lesions and inguinal adenopathy were not appreciated and the patient's reange of motion in the left lower extremity appeared normal. The patient was able to walk without difficulty. He had received a previous dose of VARIVAX at 13 months of age. The area of erythema was demarcated with a pen and the parents were instructed to call or return if the swelling or erythema increased. Although cephalexin was prescribed, upon questioning the next day, the p m t s had not administered any antibiotic and the demarcated area or erythema had decreased by 50%. By subsequent parental report, a sign of the local reaction were resolved within 4 days. The authors stated, "Within a 7-month period, 2 children presented to our clinic complaining of large areas of contender, swelling, induration, and erythema at the injection site 24 hours after receiving a second dose of VARIVAX. During this same time period, the clinic administered 143 doses of MMRV vaccine and 729 doses of VARIVAX to children 3 years of age an older, the majority of which given the age of the recipients were likely second doses of VARIVAX. Although both children in the current report received vaccine in the thigh, it is not common practice for our clinic to administer vaccines in the lower extremity of older children. In that situations when older children are difficult to restrain she administered vaccine in the thigh. According to the package insert for VARIVAX, the preferred site of administration for VARIVAX is the outer aspect  of the upper arm. It is unclear if the site of administration in these cases was related to the reaction noted. To date, we have not observed similar side effects when vaccine was administered in the arm. Previous investigations, with both VARIVAX and MMRV vaccine, have noted an increased rate of local reactions for those receiving the varicella antigen for the second time." "It is possible in the cases we observed that the addition to prior exposures to attenuated varicella virus, the children had also been bossted by exposure to wild-type varicella, thereby increasing their cumulative exposure to varicella antigen. Alternately, the reactions we observed might be explained by a repeat exposure to excipients contained in the vaccine such as hydrolyred gelatin, neomycin or fetal bovine serum." The article also discussed the experience of a 7 year old male patient while on therapy with VARIVAX (Oka/Merck) (WAERS # 0703USA03577). Additional information is not expected.