Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin infection, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a licensed practical nurse concerning her 8 year old son with no known allergies, diabetes, asthma and a history of upper respiratory tract and viral infection who on an unspecified date was vaccinated with a second dose of VARIVAX (Oka/Merck). The first dose was administered in October 2000. Concomitant therapy included ADVAIR and albuterol. The patient's mother reported her son received both the 1st and 2nd dose of VARIVAX (Oka/Merck) and now had shingles. On 23-APR-2008 the patient complained of neck pain. On 24-APR-2008 the patient had what was noticed as a "bug bite" on his neck. On 27-APR-2008 the "bug bite" spread to behind the left ear, and down the neck to the jaw line. The patient was taken to the physician and diagnosed with a skin infection. There were no lab studies performed. The patient was given KEFLEX 250 mg to be taken as 2 tablets 3 times daily. On 27-APR-2008 the medication was started. On 28-APR-2008 the "bug bite" spread more to the back of the left side of the scalp. It traveled to the base of the neck and a line down the jaw line and another one down the chin line. There were rashy pustules over the rest of the neck and pustules in the left ear. Also on 28-APR-2008 the patient was diagnosed with shingles and given ACYCLOVIR. At the time of the report the patient was recovering. It was reported that the rashy pustules were still spreading every night. They were on and up around the left ear lobe and to the cheek, but closer to the face. It was also reported that several areas are scabbing over but a lot are still pustules. There was no product quality complaint involved. The reporter considered the event to be disabling because the patient was out of school all week. Follow-up information from the mother indicated that some of the pustules were scabbing over and that the patient has returned to school. Follow-up information has been received from the physician concerning this 8 year old male child with asthma, and insulin-dependent diabetes mellitus and a history of upper respiratory tract infection and viral infection who on an unspecified date was vaccinated with a second dose of VARIVAX (Oka/Merck). The first dose was administered SQ in the left thigh on 26-OCT-2000 (lot # 634492/0931K). Concomitant therapy also included insulin (unspecified) and FLOVENT. Subsequently, on 28-APR-2008 the patient was diagnosed with shingles. It was noted that the patient developed many zoster lesions on the left side of his neck. The patient also developed pain (rated 4 on a scale of 0 to 10). It was also noted that there was no history of chickenpox or recent exposure to chickenpox or herpes zoster. At the time of the report the patient still had zoster lesions present. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The sample of the lesions was collected on 06-MAY-2008 and sent to the laboratory on 06-MAY-2008. The sample was taken from a papular lesion. The PCR results for the specimen from the papular lesion identified the presence of VZV OKA/MERCK VACCINE STRAIN. Follow-up information indicated no new information. Additional information has been requested.