Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Information has been received from a physician concerning a 7 year old patient who on approximately 09-MAR-2007 was vaccinated with a dose of Varivax. Subsequently, after vaccination, on approximately 09-MAR-2007 the patient had a fairly large local reaction. The patient experienced 4 cm of induration and about 10 cm of erythema. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2007; 5/16/2008. Initial and follow-up information has been received from a physician concerning a 7 year old male with no known allergies or pertinent medical history, who on the morning of 05-MAR-2007 was vaccinated SC in the left thigh with a second dose of VARIVAX (Merck) (lot # 65436/1141F). Concomitant vaccination included a first dose of hepatitis A virus vaccine inactivated (lot # 656497/1213F) given IM in the left vastus lateralis. There was no illness at the time of vaccination. Subsequently, that evening, the patient developed a local site reaction- 12 x 12 cm erythema and 4 x 4 cm induration around the VARIVAX (Merck) (lot # 654526/1141F) injection site (also reported to be a fairly large local reaction). There were no lab tests performed. The patient was treated with KEFLEX. The signs and symptoms resolved "in a few days." The patient was considered recovered. In follow-up, it was reported the reaction resolved rapidly. The patient had no adverse events following prior vaccination. Follow up information was received from the author of a published literature article as stated above. "A 7-year-old boy presented with a chief complaint of a reaction associated with immusation he had received 2 days previously. Doses of VARIVAX (Merck) and hepatitis A virus vaccine inactivated had been administered concomitantly. VARIVAX (Merck) was administered subcutaneously in the left thigh and hepatitis A virus vaccine inactivated was administered intramuscularly at a separate site in the left vastus lateralis. Varicella vaccine contains a minimum of 1350 plaque forming units of Merck varicella virus sucrose, hydrolyzed gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, residual component of MRC-5 cells; trace quantities of sodium phosphate monobasic, EDTA, neomycin and fetal bovine serum. Swelling and redness of the left thigh started the evening after receipt of vaccinations. At presentation to the clinic the patient was noted to be afebrile and was able to ambulate normally. Erythema measuring 12 cm in diameter, induration, measuring 4 cm in diameter, and swelling were noted over the left anterior thigh centered about the site were VARIVAX (Merck) was administered. The area was tender to palpation and vesicular lesions were not noted. A prior dose of VARIVAX (Merck) had been administered when the patient was 12 months of age. This was the primary dose of hepatitis A virus vaccine inactivated. The patient had completed a course of amoxicillin therapy for otitis media within the previous month and his medical history was significant for diagnosis of prematurity being born at 35 weeks gestation. A 10-day course of cephalexin was prescribed to treat putative bacterial cellulitis at the injection site. By subsequent parental telephone report the redness and induration resolved within a few days of presentation." 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 alter receiving a second dose monovalent varicella vaccine. During this same time period, the clinic administered (14) doses of MMRV vaccine and 729 doses of varicella vaccine to children 3 years of age an older, the majority of which given the age of the recipients were likely second doses of varicella vaccine. 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 administers vaccine in the thigh According to the package insert for varicella vaccine, the preferred site of administration for varicella vaccine is the outer aspect of the upper arm. It is unclear if the site of administration in these cases was related to the reactions noted. To date, we have not observed similar side effects when vaccine was administered in the arm. Previous investigations, with both monovalent varicella vaccine and MMRV vaccine, have noted an increased rate of local reactions for those receiving the varicella antigen for a second time." "It is possible in the cases we observed that in addition to prior exposure to attenuated varicella virus, the children had also been boosted by exposure to wild-type varicella, therapy increasing their cumulative exposure to varicella antigen. Alternatively, the reactions we observed might be explained by a repeat exposure to excipients contained in the vaccine such as hydrolyzed gelatin, neomycin or fetal bovine serum." The article also discussed the experience of a 10 year old male patient while on therapy with VARIVAX (Merck) (WAES # 0711USA02069). Additional information is not expected.