Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Oropharyngeal pain, Pain, Pain in extremity, Photosensitivity reaction
Clinical narrative: Initial report was received on 07 September 2011 from another manufacturer, report number WAES 1108USA03749. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female patient with penicillin allergy and smoking cigarettes and a history of headaches, migraines, ear pain, muffled hearing, nasal congestion, joint pain, frothy vaginal discharge, chlamydia who on 12-JUN-2008 was vaccinated IM with the second dose of GARDASIL (lot number 659964/1978U). Concomitant therapy included a dose of ADACEL (lot number 52B024DB) given on 05-JAN-2009 into the right arm. On an unspecified date, the patient started having joint issues, headaches after series completed, had a butterfly rash. Tested negative for rheumatoid, which did run in family....when 18-diagnosed and tested positive for both discoid lupus and systemic lupus...no family history of. The following information was obtained through follow up and/or provided by the government. 14-JUL-2011 PCP medical records received. Service date 12-JUN-2008 to 28-JAN-2010. Diagnosis: Healthy Teen with Systemic Lupus. Patient presents with occasional insomnia, area of alopecia / balding spot, vaginosis. 21-JUL-2011 Consultation records received. Service dates 05-MAY-2009 to 29-NOV-2010. Diagnosis: Cutaneous lupus erythematosis. Systemic and Discoid Lupus. Patient presented with rash on face, prior burning/itching and now alopecia. Erythematous papules on nose. Developed joint pain and swelling. Rheumatology consultation - patient presented with alopecia, malar rash, arthralgia, photosensitivity. Migraines, fatigue and tiredness. Constant pain, morning stiffness. Nose bleed, easy losing temper and anxiety. Difficulty memorizing. Crepitus knees. Impetigo on scalp and paranasal - oozing patches with honey colored crust. Folliculitis, pustules. 04-AUG-2011 Dermatology, Rheumatology Consultant records received. Service dates 14-DEC-2009 to 31-MAY-2011. Additional information abstracted. Diagnosis: Cigarette and cocaine abuse. Cellulitis. Discoid lupus with eczema and secondary bacterial infection. Drug induced rash. Patient presented for tonsillectomy. Joint pain, ankle swelling. Subsequently with recent history of recurrent skin infections of ears, legs, and scalp that were positive for MRSA. Two weeks ago developed crusting pustular lesions on scalp which progressed to ears and dorsal surfaces of hands, groin and axillary areas. Pruritus and pain. Initially diagnosed as eczema but worsened with steroids. Admitted with cellulitis, administered IV antibiotics and steroids. Developed generalized sulfa allergic reaction. Maculopapular rash to chest, buttocks, flexor creases of elbow. Mild malar rash. Photosensitivity. Sore throat, trouble swallowing, swollen neck glands. Pain and swelling of knees, elbows and hands. Morning stiffness. Just months ago, the patient was in hospital twice for unknown skin issues, had had staphylococcus aureus and MRSA infection, skin breakdowns, hair thinning and loss. The patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization and needed ER visit. The original reporting source was not provided. The VAERS ID # is 427083. No further information is available." Note: The lot number reported for ADACEL is not a valid sanofi pasteur lot number. Documents held by sender: none.