Age: 1.6
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Erythema, Infection, Oedema
Clinical narrative: Information has been received from a RN concerning an 18 month old Hispanic female with no known drug allergies and with asthma, reactive airway disease, and an upper respiratory infection who on 11/12/02 was vaccinated SC in the right thigh with a 0.5mL first dose of varicella virus vaccine live (LOT  # 643125/0546M).  There was no illness at the time of vaccination. Recent concomitant therapy included oral prednisone (9mg) (manufacturer unknown) for asthma (12/31/02), budesonide for asthma (capsules at 0.5mg every 12 hours) (started on 12/18/02; discontinued on 05/16/03)("moderate compliances"), cefprozil for an upper respiratory infection (04/29/03), and albuterol nebulizers (12/18/02).  On 05/19/03 the child was seen in the physician's office and diagnosed with varicella zoster and a possible diagnosis of shingles. The child presented with vesicular lesions, red and swollen on her right thigh wrapping around her waist and down her right leg. Additionally, the child had a vesicular lesion on her left neck. The child was noted to be afebrile, slightly itchy, and without complaints of pain. The child was not being treated at the time of the report with any antivirals. A varicella viral culture and varicella PCR were sent. The pt was reported as not recovered. There was no product quality complaint. The results of the PCR analysis revealed that the specimen contained the manufacturer vaccine strain virus. The specimen was obtain on 05/19/03 and sent to the lab on 05/27/03.  The source of the specimen was a lesion and the type was a vesicle. The specimen arrived in the lab on 05/28/03.  The results indicated that VZV DNA was amplified and the VZV stain identification showed vaccine-type.  There was no rash that occurred at the site of injection or elsewhere within 42 days of the vaccination. The adverse experience occurred on 05/19/03 and was described as a vesicular erythematous rash with multiple lesions on the right sacral dermatome and along the right leg. The adverse experience was reported as herpes zoster. There was no other systemic symptoms. The maximum temperature was 98.3 degrees. There was no recent exposure to chickenpox or shingles. The direct fluorescent antibody is pending as of 06/04/03.  No photo was taken. Additional follow up information indicated that on 05/19/03 it was noted that the pt had "redness with vesicles following nerve patterns from mid back to left buttocks around to front of left thigh".  It was also noted that the pt had mild pain and itching. The reporter indicated that "culture swabs for Herpes Simplex 1+2" were obtained. There were  no adverse events following prior vaccinations of the pt or her siblings. On 05/27/03, the recovery status of this pt was reported as "ongoing case now".  Additional follow up information from the RN indicated that the site of the herpes zoster was originally reported as the right sacral dermatome. However, information that arrived on 06/10/03 indicated that the dermatome of the herpes zoster is reported as the left buttocks and thigh. After review of the medical chart, it was determined that the site of the herpes zoster was the left side, not the right side as originally reported. Since the injection of the vaccine was administered into the right thigh, there is not a correlation between the site of injection and the dermatome of herpes zoster. It was also noted that the child was seen in June and July and the herpes zoster was resolving. Additional follow up information from the physician indicated that on 05/19/03 the pt developed herpes zoster at the left lateral thigh. It was a typical blister, pustule, and crust formation. The pt is recovered as of 07/01/03.  No further information is expected.