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This is VAERS ID 277115

Case Details

VAERS ID: 277115 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Pennsylvania  
   Days after vaccination:30
Submitted: 2007-04-19
   Days after onset:154
Entered: 2007-04-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Biopsy breast abnormal, Breast cancer, Breast mass, Cervical dysplasia, Condition aggravated, Human papilloma virus test positive, Mammogram abnormal, Mastectomy, Papilloma viral infection, Pregnancy test negative, Smear cervix abnormal, Surgery
SMQs:, Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Breast malignant tumours (narrow), Breast tumours of unspecified malignancy (broad), Uterine and fallopian tube malignant tumours (broad), Non-haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Low grade squamous intraepithelial lesion, Cervical dysplasia, cervical intraepithelial neoplasia I
Preexisting Conditions:
Diagnostic Lab Data: Breast biopsy 01/19/07 - invasive and intraductal breast carcinoma, Cervical smear 08/18/06 - ASC low grade squamous cell intraepithelial lesion encompassing HPV, mild dysplasia, CIN 1, cervical smear 03/21/07 - ASCUS, positive for HPV virus, mammography 01/09/07 - recommend biopsy, colonscopy 09/15/06, beta-human chorionic 12/15/06 - negative
CDC Split Type: WAES0704USA02501

Write-up: Information has been received from a registered nurse, concerning a 26 year old female patient with a low grade squamous intraepithelial lesion, cervical dysplasia and cervical intraepithelial neoplasia-1 (18-AUG-2006), who on 16-OCT-2006 was vaccinated with the first dose, 0.5ml, IM in the left arm, of Gardasil (Lot #654540/0800F). There was no concomitant medication. On 15-DEC-2006, at an office visit scheduled to determine if she was pregnant, the patient reported that she felt a small lump in her left breast that had been there since approximately 15-NOV-2006 ("approximately one month''). The nurse added that the patient was sent to the hospital for a pregnancy test, which was negative. On 09-JAN-2007, the patient had a mammogram of the left breast which recommended that she undergo a biopsy, and on 17-Jan-2007, an ultrasound guided core biopsy of the left breast was performed; on 19-Jan-2007, the biopsy result showed "invasive and intraductal breast carcinoma." On 20-Jan-2007 the patient was vaccinated with the second dose, 0.5 ml, IM in the left arm, of Gardasil (Lot #654540/0800F). On 21-MAR-2007, a repeat Pap smear result was positive for human papilloma virus, and the nurse added that the usual treatment to remove the abnormal cells with the loop electrosurgical excision procedure (LEEP), was not performed due to the patient''s breast cancer diagnosis. The nurse stated that the patient was scheduled to be seen by 2 surgeons for consideration and opinions of a bilateral mastectomy, and indicated that the patient would undergo chemotherapy following the surgery. The reporter considered the patient''s invasive and intraductal breast carcinoma and/or positive human papilloma virus results to be immediately life-threatening and an other significant medical event. Additional information has been requested.

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