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Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning her 18 year old daughter who on 10/01/2006 was vaccinated with HPV vaccine IM in right deltoid. On 10/2/06, within 24 hours, the pt experienced itchy rash on her elbows, feet, buttocks and back. She was given Benadryl and topical steroid cream to treat the symptoms. The pts itchy rash on her elbows, feet, buttocks and back persisted. Additional information has been requested. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experience (WAES #''s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experience (WAES #''s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information is not expected. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No 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-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. Follow up information has been received from a physician who provided laboratory tests regarding the patient''s positive high risk HPV and abnormal PAP status post LEEP after receiving active vaccine # 3. The cytology report indicated abnormal PAP/Biopsy within 3 years: narrative description was low grade squamous intraepithelial lesion. An HPV DNA, low/high risk test was performed; result was positive for HPV high risk. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006; 1/5/2007. Information has been received spontaneously from a gynecologist concerning a 22-year-old female patient who had participated in an GARDASIL 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 GARDASIL 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 negative to all 4 vaccine types. In October 2003 she had been PCR negative to all vaccine types. AN April 2005 PCR result from a biopsy was negative for the vaccine types. Additional study results: 07-DEC-2004 "ASC-H". 04-APR-2005 colposcopy biopsy vegative for lesion, descrepancy noted - biopsy was of less severity than the papanicolaou test result and repeat colposcopy, PAP, and endocervical curettage (among other choices) were needed per protocol. 21-SEP-2005 low-grade squamous intraepithelial lesions.; 13-OCT-2005 colposcopy cervical intracithelial neoplasia -1; 25-JAN-2006 atypical squamous cell of undetermined significance (HPV+); 30-MAR-2006 CIN-2; 12-MAY-2006 loop electrosurgical excision procedure = 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. Follow up information has been received from a physician at a student health center who provided laboratory test regarding the patient ''s positive high risk HPV and abnormal PAP status post LEEP after receiving active vaccing x 3. The cytology report indicated abnormal PAP/Biopsy within 3 years; narrative description was low grade squamous intraepithelial lesion. An HPV DNA, low/high risk test was performed, result was positive for HPV high risk. This is a consolidation of 4 reports concerning the same patient. Additional information is not expected. It has been determined that WAES0704USA00327, 0704USA00561 and 0704USA00572 are duplicates of WAES0610USA04009, WAES #0601USA04009 was previously submitted on 14-NOV-2006 and on 05-JAN-2007. | |||||||||||||||||||||||
Administered by: Private Purchased by: Private
Life Threatening? No Write-up: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experience (WAES #''s 0610USA04385, 0610USA04386 and 0610USA03730). Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experience (WAES # WAES0610USA04385, WAES0610USA04386, and 0610USA03730). Additional information is not expected. | |||||||||||||||||||||||
Administered by: Private Purchased by: Private
Life Threatening? No Write-up: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experiences (WAES #''s 0610USA04384, 0610USA04386 and 0610USA03730). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patientt who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES #''s 0610USA04384, 0610USA04356 and 0610USA03730). Additional information is not expected. | |||||||||||||||||||||||
Administered by: Private Purchased by: Private
Life Threatening? No Write-up: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 mL dose of GARDADIL (lot #653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES0620USA04384, WAES0610USA04385 and WAES0610USA03730). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES #''s 0610USA04384, 0610USA04385 and 0610USA03730). Additional information is not expected. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a 26 year old female medical assistant (not CMA) with migraines, sulfonamide allergy and drug hypersensitivity to over the counter cold medications, who on 27-SEP-2006, was vaccinated IM with a 0.5ml dose of HPV (lot # 653735/0688F). Concomitant therapy included ethinyl estradiol/norethindrone (OVCON 35), netaxalone (SKELAXIN) and acetaminophen/hydrocodone bitartrate (VICODIN TABLETS). On 27-SEP-2006, the patient experienced severe pain at the injection site while the medication was being injected. The medical assistant also reported the pain as a sore bruised feeling that lasted for 4 to 5 days. On approximately 27-SEP-2006, the patient also experienced slight fever for 4 to 5 days. On 04-OCT-2006, she had physical therapy and the sore bruised feeling came back. Subsequently, the medical assistant recovered, however it was unknown if she recovered from the sore bruised feeling that came back on 04-OCT-2006. There was no product quality complaint involved. The patient sought unspecified medical attention. Additional information has been requested. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a registered nurse concerning a female patient who on 06-OCT-2006 was vaccinated in the right arm with the first dose of HPV (lot # not provided). On 06-OCT-2006, the patient experienced lightheadedness and numbness in her left arm. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from lightheadedness and numbness in her left arm and was able to leave the office. Additional information has been requested. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a 14 year old female patient who on 05-OCT-2006 was vaccinated IM with a dose of HPV. Concomitant therapy included hepatitis A virus vaccine (unspecified), administered at the same time and in the same arm. The physician reported that the patient was experiencing "severe spasmatic pain in her arm", and that the muscle would tense up for a 5 to 10 minute time frame. An hour later the pain would subside. Medical attention was sought. The patient recovered the next day, 06-OCT-2006. Additional information has been requested. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a 25 year old female with anxiety, depression and a lump in her vagina who on 02-OCT-2006 was vaccinated with IM in the upper arm with a 0.5 mL first dose of HPV (lot 653978/0955F). Concomitant therapy included bupropion HCl (WELLBUTRIN XL), diclofenac potassium (CATAFLAM) and paroxetine HCl (PAXIL). On 02-OCT-2006, ten minutes post vaccination, the patient passed out for a few seconds. The patient received unspecified medical attention. Subsequently, on 02-OCT-2006, the patient recovered. Additional information has been requested. 01/05/2007 Information has been received from a physician concerning a 25 year old female with anxiety, depression and a lump in her vagina who at 8:30 AM on 02-OCT-2006 was vaccinated intramuscularly in the upper right arm with a 0.5 ml first dose of GARDASIL (lot 653978/0955F). Concomitant therapy included WELLBUTRIN XL, CATAFLAM and PAXIL. The patient stated that she faints when given shots. On 02-OCT-2006, ten minutes post vaccination, the patient passed out for a few seconds. The patient felt fine after vaccination. The patient was advised to sit in the waiting room for at least 10 minutes before driving. Someone went to check on the patient, and the patient stated she thought she went out. The patient walked to a room to lie down. The patient felt fine later, left office, and was considered recovered. No additional information is expected. | |||||||||||||||||||||||
Link To This Search Result:
https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=21&VAX[]=HPV2&VAX[]=HPV4&VAX[]=HPV9&VAX[]=HPVX&VAXTYPES=HPV&SUB_YEAR_HIGH=2017&SUB_MONTH_HIGH=10
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