Sex: F
Vaccine: PNC, VARCEL
Symptoms: Biopsy skin abnormal, Enterovirus test negative, Gram stain negative, Immunology test, Polymerase chain reaction
Clinical narrative: Information has been received from a physician concerning a 15 month old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced rash, "questionable uriticaria". A specimen was collected, sent to a lab and it was negative for VZV; not wild type or vaccine type. The rash resolved and was recurrent over 3 months. It was reported that the patient is a twin and the sibling did not have any reaction to "VARIVAX". No additional information is available at this time. There was no product quality complaint involved. Follow-up information has been received on 20-JUN-2018 from the author. It was reported in a published article, that a previously healthy term 15-month-old female patient presented on 08-SEP-2003 with a 3-week history of a pruritic rash. Lesions first appeared as erythematous papules on the trunk and posterior neck, in association with fever. Many of these papules subsequently became vesicular and additional lesions developed on the trunk, with scattered lesions emerging on the face and arms. New lesions would appear as older lesions crusted over and scabbed. She had neither upper respiratory symptoms nor diarrhea, and she remained active and playful with a normal appetite. One week before the onset of rash, the patient had received her 15-month immunizations, which included varicella virus vaccine live (Oka/Merck) and PREVNAR. There had been no known exposure to varicella and her healthy dizygotic twin sister's skin had remained clear with no evidence of similar lesions despite identical exposures. On initial examination, small vesicles on erythematous bases were noted over her trunk, neck and legs. The patient was referred to a dermatologist who evaluated her 5 weeks after the onset of lesions and noted that the rash was characteristic of varicella. The patient was given moisturizing creams, with minimal relief from pruritus, and she was seen in a clinic 2 weeks later on 17-OCT-2003 with recurring varicella-like lesions. On repeat examination on 09-JAN-2004, the majority of lesions had scabbed over; however, new vesicles continued to erupt, although less frequently and in smaller numbers than on initial presentation. Such lesions were again present during a follow-up examination on 21-APR-2004. At that time, viral throat and rectal swab cultures were performed to evaluate for enteroviruses. These cultures were negative. On 17-OCT-2003, serum was collected for varicella antibody study and biopsies of 2 distinct lesions were obtained. Serologic test was an enzyme-linked immunosorbent assay for the detection of varicella-zoster IgG. Varicella-zoster IgG antibody was detected. No virus was detected from biopsy specimens. PCR studies did not reveal VZV DNA. A normal epidermis with a superficial perivascular dermal infiltrate composed of lymphocytes was revealed. Giemsa stain of the specimen failed to reveal a proliferation of mast cells. These findings were most consistent with urticaria. On 17-OCT-2003, the patient's lesions, including those biopsied, were vesicular with erythematous bases, indistinguishable from varicella clinically. However, despite the characteristic appearance of the lesions, PCR analysis of the biopsy specimens detected neither vaccine nor wild-type varicella virus, and dermatopathologic findings were consistent with urticaria. The authors thought that although the temporal relationship between immunization administration and rash appearance may be coincidental, an etiologic relationship seems likely. They felt that the vesicular lesions may have initially contained varicella vaccine virus that at the time of their study was no longer present or culturable. According to the authors, the persistence of the urticarial rash may, however, represent an immunologic response to the vaccine. Authors summarized that, this patient had recurring papular urticaria with onset after varicella immunization. The rash was initially thought by the authors to be typical of mild varicella and thought to be caused by vaccine virus. It has been determined that case # US-009507513-0503USA02985 is a duplicate of case # US-009507513-0403USA00324. Therefore, case # US-009507513-0503USA02985 is being deleted from our files and the cases are consolidated into case # US-009507513-0403USA00324. Sender's Comments: MERCK 0403USA00324: Mfr number.