Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Eye pain, Headache, Insomnia, Nasal congestion, Nausea
Clinical narrative: Information has been received from a Nurse Practitioner concerning an 18 year old male patient with lactose intolerance and no allergies who on 04-JAN-2011 was vaccinated with a 0.5 ml intramuscular first dose of GARDASIL (lot # 1231Z). There was no concomitant medication. One week later, on approximately 11-JAN-2011, the patient experienced "a diffuse pink rash with pimples" involving his arms, trunk and back. The patient subsequently recovered on an unspecified date. On 09-MAR-2011, the patient received a 0.5 ml intramuscular second dose of GARDASIL (lot # 1231Z). One week later, on approximately 16-MAR-2011, the patient experienced "huge red sores" on his upper arms, trunk, back and the back of his neck. Some of the sores were open. The sores were painful and pruritic. Patient sought medical attention by an office visit. A culture of the lesions was performed on 15-MAR-2011 (results not reported) and treatment with clindamycin had been initiated. The patient had been referred to an unspecified dermatologist. At the time of this report, the patient had not recovered from the event occurred after second dose of GARDASIL. Follow up information has been received on 29APR2011 from a physician and medical records concerning a 19 year old male (188lb, 72") with lactose intolerant (nausea), gastrooesophageal reflux disease and history of pharyngitis streptococcal and two surgeries to remove facial cyst (2006). Concomitant medication included NEXIUM (one daily at night). Patient received first dose of GARDASIL on 04JAN2011 (lot# 1231Z). On 09MAR2010, the patient received his second dose of GARDASIL (lot # 1231Z) intramuscularly left arm at 09:30. Physician noted that patient had adverse event of rash following the prior vaccination. On 15Mar2011 he presented to his primary physician with the following complaints: cyst on left wrist (on and off for three to four months) that started hurting the past couple of days, right side and back of neck had a cyst for three to four days, left eye began hurting and draining yesterday, rash on arms and chest for three days. Patient stated that rash on arms and chest began two days after GARDASIL injection (09MAR2010) and stated there was no itching or drainage. The patient reported that after the first dose of GARDASIL he also had pimples in the same area. On exam physician noted that his head and neck posteriorly had large open sores with yellow crusting. Patient's left wrist had firm moveable cyst. Physician assessment noted rash and other nonspecific skin eruption, ganglion, eye symptom complaints, cellulitis and abscess. Physician ordered clindamycin capsule 300mg orally every six hours, ALTABAX 1% apply topically twice a day. Culture was obtained and on 18MAR2011 aerobic culture results were positive. Physician notified patient of results and antibiotic was changed to BACTRIM. 15MAR2011 at dermatologist visit patient had bisacted punch biopsy obtained from right upper arm. Results mild epidermal spongiosis. Findings are relatively non specific and not entirely diagnostic. There were changes of mild epidermal spongiosis that could correlative with a mild or revolving eczematous dermatitis at the site. A diagnostic interface dermatitis was not present to favor a lesion of erythema multiforme or Stevens-Johnson syndrome. On 15MAR2011 at 23:01 patient presented to emergency room complaints of pruritic painful rash over trunk, upper extremities, neck and face. It was noted that patient had seen primary physician same day and was given ointment and clindamycin. Patient then went to see the dermatologist and had biopsy taken from the lesion and placed on prednisone 60mg daily. It was noted that patient's symptoms began slowly approximately four days after of GARDASIL. Patient's pain scale 8/10 it was noted that patient had no fever, headache, fluctuance or mucosal surface lesions. Physician reported diagnosis: rash. Physician noted differential diagnosis of viral exanthem, shingles, scabies, non specific rash, antibiotic related rash, poison oak, poison ivy, Methicillin-resistant Staphylococcus aureus (MRSA) infection (community acquired), fungal infection, erythema multiforme, contact dermatitis, chicken pox and cellulitis. Patient received VALIUM 10mg orally and VISTARIL 50 mg orally in the emergency room. Patient's pain scale 5/10 and he was discharged to home in stable condition and given prescription for VISTARIL 25mg every six hours as needed for symptoms and instructed to continue home medications and or supplements that were taken prior to hospital visit. On 18JAN2011 patient presented to primary care physician with complaints of possible allergic reaction- GARDASIL, stomach ache, fever, diarrhea, rash, trouble breathing. Physician noted with review of symptoms that the patient had fever, sleep and appetite decreased, headache, nasal congestion, cough, sore throat, ringing in ears, vomiting, diarrhea, nausea, abdominal pain and rash. On exam physician noted patient well nourished and hydrated, oral cavity with mild erythema. Patient's trunk, back, left upper arm erythemic tender papules and generalized diffuse pink pruritic rash. Physician assessment: pharyngitis, cold sores, rash and other nonspecific skin eruption and viral infection. Throat culture obtained was negative. Physician ordered ZOVIRAX topical ointment 5% apply topically every three hours for cold sores and BENADRYL 25mg, two tablets three times a day for rash. At the time of the report the physician reported that the patient had recovered and date of recovery (exact date not reported) only that resolved in time. All available medical records will be provided upon request. Additional information has been requested.