Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 year old white male with no allergies or medical history who on Sept 5 2000 was vaccinated SC in the left arm with a first 0.5 ml dose of varicella virus vaccine live (lot 63177/1352J). There was no illness at the time of vaccination. It was noted that the patient did not have an immunosuppressive disorder and was not on any corticosteroids or immunosuppressive therapy at the time of vaccination or at the onset of shingles. There was no concomitant medication. On Nov 13 2005, the patient was hospitalized with severe shingles of the sciatic never distribution with lesions and vesicles of the lower back and a very large vesicle on his right leg. The adverse events were reported as starting in Mid Nov 2005. He was treated with IV acyclovir, cephalexin (Keflex), and hydroxyzine hydrochloride (Atarax). He was discharged after three days with oral acyclovir continued. A varicella direct fluorescent antibody and a direct fluorescent assay was positive. They were not able to grow this in culture and no swab was taken for wild type varicella versus vaccine failure. Further laboratory test results are awaited. It was also reported that the patients unvaccinated 11 month old niece had chickenpox shortly after his hospitalization (one week) and one of his sisters is pregnant and will receive varicella zoster immune globulin. At the time of the report, the patient was improving with healing lesions. A product quality complaint was not involved. Follow up information received from a physician indicated that the varicella DFA was positive. He also indicated that as of Nov 30 2005, the patients lesions were healing and had mostly scabbed over. He has not seen the patient since that time, and had recommended follow up if there were complications. Additional follow up information received form a physician indicated that the child may have had chickenpox prior to his vaccination, but this is not certain because of the unreliable family history (mother has 10 children and cannot remember for sure who has chickenpox). The child has fully recovered. Additional follow up information indicated that the specimen was obtained on 11/12/2005 and sent to the lab on 11/12/2005. The specimen was a vesicle (noted to be a bullous lesion). The specimen arrived in the lab on 12/15/2005. The VZV DNZ was amplified and the VZV strain identification showed wild type. Additional follow up information indicated on 11/12/2005, the patient developed severe herpes zoster involving the right sciatic nerve distribution with large vesicles. The patient was hospitalized for 3 days for IV acyclovir and pain control. Some of the wound culture material was sent for PCR analysis. It was positive for wild type virus. The mother indicated that in retrospect, the child had a mild case of chickenpox in the past, but could not remember if it had occurred before or after vaccination, although the mother though it was before vaccination (it was noted that the mother had 14 children). The outcome was reported as recovered on 11/30/2005. The physician indicated that the case appeared to be a case of vaccine failure. Severe shingles of the sciatic nerve distribution was considered to be disabling (temporary with severe pain) and an other important medical event by the reporter (OMIC). Other business partner numbers included E200505291.