Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Alopecia, Biopsy skin abnormal, Burning sensation, CD4 lymphocytes abnormal, Follicular mucinosis
Clinical narrative: Information has been received from a physician's assistant concerning a 12 year old male patient with drug reaction/allergy to amoxicillin who in October 2011, was vaccinated with the first dose of GARDASIL, 0.5 ml, IM (lot number not reported). Concomitant therapy included albuterol, BENADRYL, ASMANEX and montelukast sodium (MSD). It was reported that in November 2011 the patient developed follicular mucinosis. The patient sought medical attention via contacting physician. Lab diagnostic studies included "biopsy of the skin". The treatment given for AE included unspecified topical steroids. At the time of the report the patient's outcome was not recovered. Follow-up information has been received from a physician and medical records concerning a 12 year old male (56 inches, 100 pounds) with asthma and amoxicillin allergy who on 01-NOV-2011 was vaccinated with the first dose of GARDASIL, 0.5 ml, IM right deltoid (lot #666596/0766Z). The patient was also vaccinated with the first dose of MENACTRA (lot #U3513AA) IM right deltoid and the first dose of ADACEL (lot # U3249AA) IM left deltoid. The physician reported that a rash with red spots and burning and itching began in November 2011. The patient received a second dose of GARDASIL, 0.5 ml, IM right deltoid (lot # 666598/0786Z) on 04-JAN-2012. On 30-JAN-2012, the patient was seen in referral for evaluation of erythematous plaques with alopecia on the frontal scalp, neck and torso. The spots came out three weeks after the patient was vaccinated (approximately 22-NOV-2011) with the first dose of GARDASIL. It started with a patch on the right neck, and then he got multiple additional plaques that became waxy and thick, including one on the right frontal scalp with complete alopecia. A red indurated plaque on the right macular cheek had been biopsied and interpreted as follicular mucinosis with an atypical lymphoid infiltrate that was CD4 positive. The patient was presented. There was a discussion about treatment for both follicular MF and follicular mucinosis. One treatment that had been discussed was hydroxychloroquine and another recommendation was topical tazarotene. The question had been raised as to whether or not it was follicular mucinosis or follicular MF. Assessment: follicular mucinosis; rule out mycosis fungoides. A prescription was given for topical tazarotene. Punch biopsy of right lateral neck: follicular mucinosis. On 16-FEB-2012, the patient was seen at an office visit with follicular mucinosis with involvement in his right cheek, right forehead, neck, right hip, left anterior shoulder, left abdomen and a new spot on the left anterior thigh. The patient's case was presented at a Multidisciplinary cutaneous lymphoma conference and it was thought that the histology was consistent with follicular mucinosis and did not have features diagnostic of follicular MF. The patient had been using tazarotene gel empirically once daily for a couple of weeks. The lesions had become very inflamed and the patient also expressed concern regarding a lump he had felt in his left lateral neck. Assessment: the physician was very pleased with the early response to tazarotene gel, which where clearly thinning out plaques. The physician had been concerned with the new lesion on the left anterior thigh. Based on the initial thinning of the plaques, the physician felt tazarotene gel was a reasonable treatment option. The patient was reassured that the 1 cm lump in his left neck was statistically likely to be a reactive lymph node. If other lump began to develop a reassessment would be made and a lymph node biopsy would be considered. It would be extremely unusual for him to have lymph node involvement with CTCL with disease this minimal. The patient was to continue tazarotene daily for two weeks and then increase it to twice daily for two weeks. The patient was not to treat the eroded areas on the posterior neck and right anterior neck until they were completely reepithelialized. Upon internal review, follicular mucinosis was determined to be an other important medical event. All available medical records will be provided upon request. Additional information has been requested.