Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Herpes simplex test, Herpes zoster, Pain, Peripheral swelling
Clinical narrative: Information has been received from a registered nurse concerning an 18-month-old female with no known drug allergies and with asthma, reactive airway disease, and an upper respiratory infection who on 12-NOV-2002 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 (31-DEC-2002), PULMICORT for asthma (capsules at 0.5mg q12h) (started on 18-DEC-2002; discontinued on 16-MAY-2003) ("moderate compliances"), CEFZIL for an upper respiratory infection (29-APR-2003), and albuterol nebulizers (18-DEC-2002). On 19-MAY-2003 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 patient was reported as not recovered. There was no product quality complaint. The results of the PCR analysis revealed that the specimen contained the OKA/MERCK vaccine strain virus. The specimen was obtained on 19-MAY-2003 and sent to the laboratory on 27-MAY-2003. The source of the specimen was a lesion and the type was a vesicle. The specimen arrived in the laboratory on 28-MAY-2003. 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 19-MAY-2003 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 04-JUN-2003. No photo was taken. Additional follow up information indicated that on 19-MAY-2003 it was noted that the patient 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 patient 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 patient or her siblings. On 27-MAY-2003, the recovery status of this patient was reported as "ongoing case now". Additional follow up information from the registered nurse indicated that the site of the herpes zoster was originally reported as the right sacral dermatome. However, information that arrived on 10-JUN-2003 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 19-MAY-2003 the patient developed herpes zoster at the left lateral thigh. It was a typical blister, pustule, and crust formation. The patient is recovered as of 01-JUL-2003. No further information is expected. This is an amended report. The PT was changed from varicella zoster virus infection to Herpes Zoster. Sender's Comments: MERCK 0305USA01965: Mfr number.