Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Cervical dysplasia, Rhinorrhoea, Smear cervix abnormal, Smear cervix normal
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a sulfonamide allergy who on 16-FEB-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL (Lot# 656049/0187U) in the right deltoid.  On 20-APR-2007 she was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot #657621/0387U) in the left deltoid.  On 20-AUG-2007 she was vaccinated IM with a third 0.5 ml dose of GARDASIL (Lot #658556/1060U) in the left deltoid.  Concomitant therapy included ORTHO TRI-CYCLEN.  The patient had a negative papanicolaou test on 20-APR-2008 and a positive test on 12-MAY-2008.  The patient sought medical attention in the office.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 7/8/2008. Initial and follow up information has been received from a physician and a healthcare professional concerning a 19 year old female with a sulfonamide allergy, irritable bowel syndrome, condyloma acuminatum, and carrier of genetic disease (PKU), a history of immunizations and a family history of IBS (mother), acute ischemia (paternal grandmother), acute myocardial infarction, heart transplant recipient and cancer (maternal grandmother), acute myocardial infarction, diabetes mellitus and hypertension (maternal grandfather). On 16-FEB-2007 at 3:00 PM the patient was vaccinated IM with a first 0.5 ml dose of GARDASIL (Lot# 656049/0187U) in the right deltoid. On 20-APR-2007 at 3:00 PM, she was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot #657621/0387U) in the left deltoid. On 20-AUG-2007 at 9:00 AM, she was vaccinated IM with a third 0.5 ml dose GARDASIL (Lot #658556/1060U) in the left deltoid. Concomitant therapy included OTHRO TRI-CYCLEN and multivitamins. On 20-APR-2008, the patient had a papanicolaou test, negative for intraepithelial lesion or malignancy and HPV DNA (high risk) was not detected. On 12-MAY-2008, the patient was seen for an office visit and presented for an annual papanicolaou test. The patient wanted "skin tags" checked in private area and a red spot. On physical examination the genitalia showed abnormalities on left inner thigh with a condyloma (flat) and a small carbuncle. Pelvic examination showed cervical discharge, mucoid cervical discharge and a sample was taken for papanicolaou smear and cultures (culture results not reported). The patient's papanicolaou test was positive for low grade squamous intraepithelial lesion and HPV DNA (High Risk) was detected. The patient assessment included condyloma acuminatum. The patient also presented with mucous drainge "X weeks". The patient had self treated with over the counter allergy, cold and sinus medications. On physical exam the nasal examination showed purulent nasal discharge on both sides without sinus tenderness. The patient assessment included an allergy and sinusitis. Additionally, the patient's active problems included folliculitis. Treatment ordered included cefuroxime axetil 250 mg tablet, take one tablet every 12 hours, ALDARA cream 5% apply to affected areas three times weekly, wash off after 6-10 hours, over the counter CLARITAN or ZYRTEC, rest fluids and to call if symptoms worsen. The physician counseled the patient regarding diet, exercise and sexual practices. At the time of the report the outcome was unknown. Previous vaccinations included IPV (unspecified) (21-OCT-1978, 22-DEC-1998, 04-APR-1990 and 18-AUG-1992), diptheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (22-DEC-1998, 15-FEB-1989, 04-APR-1990 and 18-AUG-1992), HIB (unspecified carrier) (08-AUG-1990), MMR II (manufacturer unknown) (13-NOV-1999 and 01-SEP-1993), HEP B (manufacturer unknown) (03-JUL-1995, 22-AUG-1995 and 12-MAR-1996), ADACEL (03-APR-2006), tuberculin purified protein derivative (03-APR-2006) and meningococcal AC polysaccharide vaccine (03-APR-2006). Additional information is not expected.