Age: 1.46
Sex: F
Vaccine: DTP, HIBV, VARCEL
Symptoms: Ear pain, Erythema, Hypersomnia, Injection site erythema, Injection site hypersensitivity
Clinical narrative: pt recv vax 18MAR97 & 12MAY97 pt was bitten by a tick;18MAY97 pt was seen by a MD w/a low grade fever;28MAY97 pt was placed on therapy w/amoxicillin;31MAY97 pt devel a rash @ the inj site;therapy discontinued on 2JUN97; Follow-up information received. Information has been received from a consumer, the patient's mother, concerning an 18-month old white patient with possible allergies to amoxicillin (*) clavulanate potassium (Augmentin). A history of eczema and eczema at the time of vaccination who on March 18, 1997 was vaccinated subcutaneously (also reported as intravenously) in the left arm with a first does of varicella virus vaccine live (lot # 619674/1544D) Concomitant vaccination on the same day included a fourth dose in the right leg of diphtheria-tetanus-pertussis vaccine (lot #7681484) and a fourth dose in the right arm of haemophilus influenza type B vaccine (Hibtiter) (lot # 14035PE). On the day of the vaccination, the patient developed a spot at the injection site which persisted until "at least" April 26, 1997. On May 12, 1997, the patient was bitten by a tick. She became very fussy. On May 14, 1997, the patient developed a fever. On May 18, 1997, the patient was seen by a physician. On May 28, 1997, the patient was placed on therapy with amoxicillin which she had previously taken without any adverse event. The patient developed a fever again that day to 102-103 degrees F. On May 30, 1997, the patient was sleeping a lot, did not have any appetite, and vomited. On May 31, 1997, the patient developed a "red bubbly pinpoint" rash at the injection site and on her trunk, ears, and around her torso that then spread down her back. Therapy with amoxicillin 'which could have caused the rash' was discontinued on June 2, 1997. Follow-up information was received from a physician. The patient was seen by the physician on June 3, 1997 at which time the rash was gone. From June 2, 1997 to June 10, 1997 the patient spent a lot of time with grandfather and the physician noted that the child may have had exposure to the wild type virus during the first two weeks of June. On June 4, 1997, a blood sample was tested for "mono" and Lyme disease with results unknown. Laboratory evaluation revealed that the patient was slightly anemic. The patient's physician did not think the rash was related to vaccination. It was noted that there were no adverse events following prior vaccination. At the time of the report, it was unknown if the patient recovered. Follow-up information was received from the patient's mother. On May 4, 2003 at the age of 7 years the patient began to break out into a rash with "tiny blister dots" that spread to the neck area. On May 5, 2003, the patient woke in the middle of the night crying that her ear hurt. The ear was very red and swollen. The mother called the patient's doctor who did not believe it was shingles. It was noted that there was no concomitant medication. The doctor prescribed prednicarbate (DERMATOP) and azithromycin (Zithromax). At the time of the report, the rash, ear pain, ear redness and ear swelling had not abated.  It was noted that a product quality complaint was not involved. The initial reported indicated the patient's grandfather experienced shingles (WAES #97091735).