|
| VAERS ID: | 267418 | Vaccinated: | 2003-09-01 | | Age: | 19.0 | Onset: | 2006-09-29, Days after vaccination: 1124 | | Gender: | Female | Submitted: | 2007-01-05, Days after onset: 340 | | Location: | New Hampshire | Entered: | 2006-11-16, Days after submission: 353 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: 07-DEC-2004: "ASC-H". 04-APR-2005 colposcopy biopsy negative for lesion, discrepancy noted - biopsy was of less severity than the Papanicolaou (PAP) test result and repeat colposcopy, PAP, and endocervical curettage (ECC) (among other choic | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: Cercical low grade squamous intraepithelial lesions. | | CDC 'Split Type': WAES0610USA04009 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 2 | UN | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Biopsy, Cervical dysplasia, Colposcopy, Colposcopy abnormal, DNA antibody positive, Endocervical curettage, Laboratory test abnormal, Loop electrosurgical excision procedure, Polymerase chain reaction, Smear cervix abnormal | | Write-up: Information has been received spontaneously from a gynecologist concerning a 22 year old female patient who had participated in an HPV study. On 29-SEP-2006 the patient tested positive for high risk HPV. The patient's outcome was unknown. Upon internal request, the patient was unblinded on 25-OCT-2006, she received her first dose of HPV on 06-FEB-2003, her second dose in March 2003, and her third dose in September 2003. She showed strong conversion to all 4 vaccine types. At baseline the patient had been seronegative and polymerase chain reaction test (PCR) negative to all 4 vaccine types. In October 2003 she had been PCR negative to all 4 vaccine types. An April 2005 PCR result from a biopsy was negative for the 4 vaccine types. Additional study results: 07-DEC-2004: "ASC-H". 04-APR-2005 colposcopy biopsy negative for lesion, discrepancy noted - biopsy was of less severity than the Papanicolaou (PAP) test result and repeat colposcopy, PAP, and endocervical curettage (ECC) (among other choices) were needed per protocol. 21-SEP-2005 low grade squamous intraepithelial lesions (LSIL). 13-OCT-2005 colposcopy cervical intraepithelial neoplasia (CIN) -1. 25-JAN-2006 atypical squamous cell of undetermined significance (ASCUS) (HPV+). 30-MAR-2006 CIN-2. 12-MAY-2006 loop electrosurgical excision procedure (LEEP) = CIN-1 overall. 24-JUL-2006 PAP negative. At this point the patient had completed the study. She went to her own doctor and had another abnormal pap positive HR HPV test. The specific cytological diagnosis and the PCR test reports as positive for high risk type but did not indicate which specific HPV type. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2006. Information has been received spontaneously from a gynecologist concerning a 22 year old female patient who had participated in an HPV study. On 29-SEP-2006 the patient tested positive for high risk HPV. The patient's outcome was unknown. Upon internal request the patient was unblinded on 25-OCT |
|
|
| VAERS ID: | 269182 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2006-12-14 | | Location: | New York | Entered: | 2006-12-18, Days after submission: 4 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Pap test - positive | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: UNK | | CDC 'Split Type': WAES0611USA03319 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Smear cervix abnormal | | Write-up: Information has been received from a physician concerning a female patient who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient's pap smear came out positive. Medical attention was sought. Her outcome was unknown. Additional information has been requested. |
|
|
| VAERS ID: | 269202 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2006-12-14 | | Location: | Pennsylvania | Entered: | 2006-12-18, Days after submission: 4 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Pap test 10/?/06-abnormal | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: UNK | | CDC 'Split Type': WAES0611USA04578 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | | | |
| Administered by: Other Purchased by: Other | | Symptoms: Smear cervix abnormal | | Write-up: Information has been received from a physician concerning a female who in October 2006, was vaccinated with the first dose of Gardasil (yeast) (0.5mL). In approximately October 2006, "shortly after the injection", the patient was examined and learned that she developed an abnormal PAP. Unspecified medical attention was sought. No further details were provided. Additional information has been requested. |
|
|
| VAERS ID: | 270259 | Vaccinated: | 2006-11-21 | | Age: | 22.0 | Onset: | 2006-12-05, Days after vaccination: 14 | | Gender: | Female | Submitted: | 2007-01-05, Days after onset: 364 | | Location: | Florida | Entered: | 2007-01-09, Days after submission: 4 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: Ortho Tri-Cyclen Lo | | Preexisting Conditions: papanicolaou smear abnormal, genital wart | | CDC 'Split Type': WAES0612USA00964 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0868F | 0 | IM | LA | |
| Administered by: Other Purchased by: Other | | Symptoms: Anogenital warts, Smear cervix abnormal | | Write-up: Information has been received from a Certified Medical Assistant concerning a 22 year old female patient with genital warts and history of abnormal Pap smears who on 21 Nov 2006 was vaccinated IM in the left deltoid with her first dose of Gardasil (yeast), lot #653736/0868F. Concomitant therapy included Ortho Tri-Cyclen Lo. The patient called to report that prior to the vaccination she had 2 undiagnosed "bumps" in the vulva area. Two weeks after the vaccination, on 05 Dec 2006, the patient had an increase in amount of genital warts (3 more "bumps" appeared in the surrounding area). Medical attention was sought. The patient had undergone a Pap smear and cervical biopsy on 21 Nov 2006 (results were not reported). At the time of the report the patient had not recovered. Additional information has been requested. Follow-up information has been received concerning the female student with genital warts who on 21-NOV-2006 at 2:00 p.m. had received her first dose of GRDASIL, lot # 653736/0868F. The patient stated she had a history of bumps in vaginal area, and was never diagnosed with any disease. On 05-DEC-2006 the bumps increased in size and number. The patient was positive for HPV 6. On 15-JAN-2007 at 3:00 p.m. she was vaccinated IM in left deltoid with her second dose of GRDASIL, lot # 655617/1447F. Her outcome was unknown. Additional information is not expected. |
|
|
| VAERS ID: | 271120 | Vaccinated: | 2006-10-21 | | Age: | 20.0 | Onset: | 2006-10-21, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-01-16, Days after onset: 359 | | Location: | Tennessee | Entered: | 2007-01-22, Days after submission: 6 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: cervical smear, 12/8/06, + High risk HPV types; cervical smear 11/04, negative; cervical smear 12/09/05, negative. | | Previous Vaccinations: | | Other Medications: hormonal contraceptives | | Preexisting Conditions: Penicillin allergy | | CDC 'Split Type': WAES0612USA02744 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0702F | 0 | IM | | |
| Administered by: Other Purchased by: Other | | Symptoms: Injection site erythema, Injection site oedema, Smear cervix, Smear cervix abnormal, Smear cervix normal, Vaginitis bacterial | | Write-up: Information has been received from a nurse practitioner concerning a 19 year old female with an allergy to penicillin who on 21 Oct 2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (Lot #653650/0702F). Concomitant therapy included hormonal contraceptives (unspecified). On 21 Oct 2006 the patient experienced minor redness and swelling at the injection site, which later resolved. On 08 Dec 2006 the patient presented with bacterial vaginosis and had a positive pap smear test for high risk HPV types. It was noted that on an unspecified date in November 2006 and on 09 Dec 2005 the patient's pap smear tests were negative. Subsequently, unspecified medical attention was sought and the patient had not recovered from positive pap smear test. Additional information has been requested. |
|
|
| VAERS ID: | 272528 | Vaccinated: | 2007-01-18 | | Age: | 26.0 | Onset: | 2007-01-18, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-04-06, Days after onset: 11 | | Location: | Michigan | Entered: | 2007-02-15, Days after submission: 8 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: Hypothyroidism | | Diagnostic Lab Data: NONE | | Previous Vaccinations: | | Other Medications: LO/OVRAL, SYNTHROID | | Preexisting Conditions: Papanicolaou smear abnormal | | CDC 'Split Type': WAES0701USA04447 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 1 | UN | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Pruritus generalised, Smear cervix abnormal | | Write-up: Information has been received from a physician concerning a 26 year old female with hypothyroidism and a history of papanicolaou smear abnormal and no history of drug reactions/allergies who on 06-NOV-2006 was vaccinated with first dose of Gardasil (yeast) 0.5 ml IM. On 18-JAN-2007, the patient was vaccinated with a second dose of Gardasil (yeast) (lot # not reported). Concomitant therapy included SYNTHROID and LO/OVRAL. On 18-JAN-2007, fourty-five minutes after receiving the second dose, the patient experienced generalized itching. No additional symptoms were noticed. Medical attention was sought. The physician prescribed BENADRYL and the symptoms resolved. The patient fully recovered on 18-JAN-2007. No further information was available at the time of reporting. Additional information has been requested. This is in follow-upinformation has been received from a physician and a nurse concerning a 26 year old female with hypothyroidism and a history of papanicolaou smear abnormal and no history of drug reactions/allergies who on 06-NOV-2006 was vaccinated with first dose of GARDASIL 0.5 ml IM. On 18-JAN-2007, the patient was vaccinated with a second dose of GARDASIL (lot # not reported). Concomitant therapy included SYNTHROID and LO/OVRAL. On 18-JAN-2007, forty-five minutes after receiving the second dose, the patient experienced generalized itching. No additional symptoms were noticed. Medical attention was sought. The physician prescribed BENADRYL and the symptoms resolved. The patient fully recovered on 18-JAN-2007. No further information was available at the time of reporting. In follow-up it was reported, the patient had no reaction after the first dose of GARDASIL. After the 2nd dose, the patient left the office and later experienced a slight resolved. The patient had no other allergic symptoms. Additional information has been requested. |
|
|
| VAERS ID: | 275991 | Vaccinated: | 0000-00-00 | | Age: | 19.0 | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-04-10 | | Location: | Tennessee | Entered: | 2007-04-11, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: Sexually active; Cervical intraepithelial neoplasia II | | Diagnostic Lab Data: colposcopy, Pap test 12/??/06 - Results showed CIN 2 or 3 | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: | | CDC 'Split Type': WAES0704USA00736 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 1 | UN | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Cervical dysplasia, Colposcopy, Condition aggravated, Smear cervix abnormal | | Write-up: Information has been received from a physician concerning a 19 year old female patient, sexually active for less than 1 year, who in December 2006 was vaccinated with a first dose of GARDASIL. A papanicolaou smear (PAP) test was done on the same day as the vaccination and the results showed cervical intraepithelial neoplasia (CIN) 2 or 3. After her second injection with GARDASIL vaccine (yeast) she required conization due to the rapid development of CIN. Human Papillomavirus (HPV) types were unknown. The physician felt that rapid development of CIN was an other important medical event. Additional information has been requested. |
|
|
| VAERS ID: | 276165 | Vaccinated: | 2007-02-16 | | Age: | 16.0 | Onset: | 2007-02-27, Days after vaccination: 11 | | Gender: | Female | Submitted: | 2007-04-06, Days after onset: 20 | | Location: | Wisconsin | Entered: | 2007-04-09, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: cervical smear, 02/27/2007, Positive for high risk HPV | | Previous Vaccinations: | | Other Medications: ADDERALL TABLETS, mg; ADVAIR | | Preexisting Conditions: Asthma; Drug hypersensitivity | | CDC 'Split Type': WAES0703USA01098 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Papilloma viral infection, Smear cervix abnormal | | Write-up: Information has been received from a physician concerning a 16 year old female with asthma and allergy to "campha" who on 16, Feb 2007 was vaccinated IM with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), single dose vial. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and amphetamine aspartate/amphetamineSO4/dex (ADDERALL TABLETS). On 27, Feb 2007 the patient was tested for HPV and the pap smear results were positive for high risk HPV. Unspecified medical attention was sought. Her outcome was unknown. Additional information has been requested. |
|
|
| VAERS ID: | 276222 | Vaccinated: | 2006-12-01 | | Age: | 19.0 | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-04-06 | | Location: | Unknown | Entered: | 2007-04-09, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: Food allergy | | Diagnostic Lab Data: Pap test - a few mild abnormal cells | | Previous Vaccinations: | | Other Medications: YAZ | | Preexisting Conditions: | | CDC 'Split Type': WAES0703USA01175 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | UN | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Smear cervix abnormal | | Write-up: Information has been received from a pharmacist concerning her 19 year old daughter with food allergies who in December 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included Yaz. The patient had a routine Papanicolaou (pap) test which revealed a few mild abnormal cells. A colposcopy was scheduled. The patient had not recovered as of the report date. Additional information has been requested. |
|
|
| VAERS ID: | 276812 | Vaccinated: | 2007-01-04 | | Age: | 22.0 | Onset: | 2007-03-08, Days after vaccination: 63 | | Gender: | Female | Submitted: | 2007-04-13, Days after onset: 5 | | Location: | Ohio | Entered: | 2007-04-16, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: Drug hypersensitivity | | Diagnostic Lab Data: Pap test 03/08?/07 - Positive for HPV | | Previous Vaccinations: | | Other Medications: hormonal contraceptives | | Preexisting Conditions: Papanicolaou smear abnormal; Human papilloma virus test negative | | CDC 'Split Type': WAES0703USA03613 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | | |
| Administered by: Other Purchased by: Other | | Symptoms: Human papilloma virus test positive, Smear cervix abnormal | | Write-up: Information has been received from a physician concerning a 22 year old female patient with allergies to codeine (unspecified) and Benadryl and a history of an atypical Papanicolaou smear but negative for human papilloma virus (HPV), who on 04-JAN-2007 was vaccinated, IM, with the first dose of Gardasil and on 08-MAR-2007 was vaccinated, IM, with the second dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 08-MAR-2007, the patient's pap smear results were received as "positive for HPV," and the second dose had already been administered. Additional information has been requested. |
|
|
