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This is VAERS ID 267466

History of Changes from the VAERS Wayback Machine

First Appeared on 12/30/2006

VAERS ID: 267466
Age:21.0
Gender:Female
Location:Alabama
Vaccinated:2006-08-28
Onset:2006-09-22
Submitted:2006-11-14
Entered:2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE, QUADRIVALENT (GARDASIL) / MERCK & CO. INC. 0689F / 0 - / IM

Administered by: Other      Purchased by: Unknown
Symptoms: Chills, Headache, Herpes simplex, Insomnia, Laboratory test abnormal

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: Medical History: Vaginosis bacterial, yeast infection
Diagnostic Lab Data: body temp 101-103F; clinical seriology test, 10/23/06, positive; serum Epstein Barr 10/23/2006 negative, serum herpes simplex 10/23/06 positive; serum herpes simplex negative; WBC count normal
CDC 'Split Type':

Write-up:Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccin"e (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was /"off and on/". She described the fever as spiking at night after 6-7pm. Her fe


Changed on 12/8/2009

VAERS ID: 267466 Before After
Age:21.0
Gender:Female
Location:Alabama
Vaccinated:2006-08-28
Onset:2006-09-22
Submitted:2006-11-14
Entered:2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE, QUADRIVALENT (GARDASIL) HPV (GARDASIL) / MERCK & CO. INC. 0689F / 0 - / IM

Administered by: Other      Purchased by: Unknown Other
Symptoms: Chills, Headache, Herpes simplex, Insomnia, Laboratory test abnormal, Pain, Pyrexia, Rhinorrhoea

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: Medical History: Vaginosis bacterial, yeast infection
Diagnostic Lab Data: body temp 101-103F; clinical seriology test, 10/23/06, positive; serum Epstein Barr 10/23/2006 negative, serum herpes simplex 10/23/06 positive; serum herpes simplex negative; WBC count normal
CDC 'Split Type': (blank) WAES0610USA14581

Write-up:Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccin"e vaccine (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was /"off "off and on/". on". She described the fever as spiking at night after 6-7pm. Her fe fevers would reach 101-103 F and they resolved with rest plus the use of acetaminophen (Tylenol). After " a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chill, body aches, waking in the night. The CMA stated that the patient reported these symptoms to the physician''s office on 23 Oct 2006. Laboratory tests performed on that date included HSV(herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative); and EBV(Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed rate and CBC=white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30 Oct 2006 she received a second dose of Gardisil. The CMA noted that the patient was fine "so far". Additional information has been requested.


Changed on 1/5/2010

VAERS ID: 267466 Before After
Age:21.0
Gender:Female
Location:Alabama
Vaccinated:2006-08-28
Onset:2006-09-22
Submitted:2006-11-14 2007-04-06
Entered:2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 0 - UN / IM

Administered by: Other Private      Purchased by: Other Private
Symptoms: Chills, Headache, Herpes simplex, Insomnia, Laboratory test abnormal, Pain, Pyrexia, Rhinorrhoea

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: Medical History: Vaginosis bacterial, yeast infection
Diagnostic Lab Data: body temp 101-103F; clinical seriology test, 10/23/06, positive; serum Epstein Barr 10/23/2006 negative, serum herpes simplex 10/23/06 positive; serum herpes simplex negative; WBC count normal normal; absolute blood atypical, 10/23/06, 13%, 0-6,
CDC 'Split Type': WAES0610USA14581

Write-up:Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccine (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7pm. Her fevers would reach 101-103 F and they resolved with rest plus the use of acetaminophen (Tylenol). After " a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chill, body aches, waking in the night. The CMA stated that the patient reported these symptoms to the physician''s office on 23 Oct 2006. Laboratory tests performed on that date included HSV(herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative); and EBV(Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed rate and CBC=white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30 Oct 2006 she received a second dose of Gardisil. The CMA noted that the patient was fine "so far". Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28-AUG-2006 was vaccinated IM in left deltoid with her first dose of GARDASIL lot #653736/0689F. Concomitant therapy included ORTHO TRI-CYCLEN. On 22-SEP-2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7 p.m. Her fevers would reach 101-103 F and they resolved with rest plus the use of TYLENOL. After "a c


Changed on 7/31/2010

VAERS ID: 267466 Before After
Age:21.0
Gender:Female
Location:Alabama
Vaccinated:2006-08-28
Onset:2006-09-22
Submitted:2007-04-06
Entered:2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 0 UN / IM

Administered by: Private      Purchased by: Private
Symptoms: Body temperature increased, Chills, Headache, Herpes simplex, Insomnia, Laboratory test abnormal, Pain, Pyrexia, Rhinorrhoea, White blood cell count abnormal, Neutrophil percentage decreased, Lymphocyte percentage decreased, Epstein-Barr virus antigen positive, Epstein-Barr virus antibody negative, Band neutrophil percentage decreased, Eosinophil percentage, Monocyte percentage, Lymphocyte percentage, Herpes simplex serology positive, Epstein-Barr virus test negative

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: Medical History: Vaginosis bacterial, yeast infection
Diagnostic Lab Data: body temp 101-103F; clinical seriology test, 10/23/06, positive; serum Epstein Barr 10/23/2006 negative, serum herpes simplex 10/23/06 positive; serum herpes simplex negative; WBC count normal; absolute blood atypical, 10/23/06, 13%, 0-6,
CDC 'Split Type': WAES0610USA14581

Write-up:Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccine (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7pm. Her fevers would reach 101-103 F and they resolved with rest plus the use of acetaminophen (Tylenol). After " a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chill, body aches, waking in the night. The CMA stated that the patient reported these symptoms to the physician''s office on 23 Oct 2006. Laboratory tests performed on that date included HSV(herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative); and EBV(Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed rate and CBC=white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30 Oct 2006 she received a second dose of Gardisil. The CMA noted that the patient was fine "so far". Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28-AUG-2006 was vaccinated IM in left deltoid with her first dose of GARDASIL lot #653736/0689F. Concomitant therapy included ORTHO TRI-CYCLEN. On 22-SEP-2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7 p.m. Her fevers would reach 101-103 F and they resolved with rest plus the use of TYLENOL. After "a c


Changed on 1/4/2011

VAERS ID: 267466 Before After
Age:21.0
Gender:Female
Location:Alabama
Vaccinated:2006-08-28
Onset:2006-09-22
Submitted:2007-04-06
Entered:2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 0 UN / IM

Administered by: Private      Purchased by: Private
Symptoms: Body temperature increased, Chills, Headache, Herpes simplex, Insomnia, Laboratory test abnormal, Pain, Pyrexia, Rhinorrhoea, White blood cell count abnormal, Neutrophil percentage decreased, Lymphocyte percentage decreased, Epstein-Barr virus antigen positive, Epstein-Barr virus antibody negative, Band neutrophil percentage decreased, Eosinophil percentage, Monocyte percentage, Lymphocyte percentage, Herpes simplex serology positive, Epstein-Barr virus test negative

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: Medical History: Vaginosis bacterial, yeast infection
Diagnostic Lab Data: body temp 101-103F; clinical seriology test, 10/23/06, positive; serum Epstein Barr 10/23/2006 negative, serum herpes simplex 10/23/06 positive; serum herpes simplex negative; WBC count normal; absolute blood atypical, 10/23/06, 13%, 0-6, high; band neutrophil count, 10/23/06, 5.0%, 0-5; eosinophil count, 10/23/06, 1.0%, 0-5; lymphocyte count, 10/23/06, 32.0%, 15-43; monocyte count, 10/23/06, 7.0%, 5-15; neutrophil count, 10/23/06, 42.0%, 43-75, Low; body temp, 101-103F; white blood cell, 10/23/06, moderate smudge cells; serum Epstein-Barr VCA, 10/23/06, positive; serum Epstein-Barr VCA, 10/23/06, - negative; serum EBNA antibody, 10/23/06, - positive; serum herpes simplex, 10/23/06, - positive; serum herpes simplex 10/23/06, 7.41 X1000 4.8
CDC 'Split Type': WAES0610USA14581

Write-up:Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccine (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7pm. Her fevers would reach 101-103 F and they resolved with rest plus the use of acetaminophen (Tylenol). After " a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chill, body aches, waking in the night. The CMA stated that the patient reported these symptoms to the physician''s office on 23 Oct 2006. Laboratory tests performed on that date included HSV(herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative); and EBV(Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed rate and CBC=white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30 Oct 2006 she received a second dose of Gardisil. The CMA noted that the patient was fine "so far". Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28-AUG-2006 was vaccinated IM in left deltoid with her first dose of GARDASIL lot #653736/0689F. Concomitant therapy included ORTHO TRI-CYCLEN. On 22-SEP-2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7 p.m. Her fevers would reach 101-103 F and they resolved with rest plus the use of TYLENOL. After "a c couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chills, body aches, and waking in the night. The CMA stated that the patient also took unspecified allergy and cold medicine for a runny nose during the past month. The patient reported these symptoms to the physician''s office on 23-OCT-2006. Laborary tests performed on that date included HSV (herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative) ; and EBV (Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed-rate and CBC = white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30-OCT-2006 she received a second dose of GARDASIL. The CMA noted that the patient was fine "so far". Additional follow up information has been received from a physician concerning the 21 year old black female student who on 28-AUG-2006 at 11:30 a.m. was vaccinated IM in left arm with her first dose of GARDASIL lot #653736/0689F. The physician reported that the patient made an appointment on 23-OCT-2006 with fever X 2 weeks. Diagnostic laboratory tests were performed, including positive EBNA (Epstein-Barr virus nuclear antigen antibody) and EBV VCA IgG (Epstein-Barr viral capsid antigen immunoglobulin G antibody), which indicated past infection. EBV VCA IgM (Epstein-Barr viral capsid antigen immunoglobulin M antibody) was negative (see laboratory data section for other results). The patient had mononucleosis. The physician indicated she had recovered. Additional information is not expected.


Changed on 6/14/2014

VAERS ID: 267466 Before After
Age:21.0
Gender:Female
Location:Alabama
Vaccinated:2006-08-28
Onset:2006-09-22
Submitted:2007-04-06
Entered:2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 0 UN / IM

Administered by: Private      Purchased by: Private
Symptoms: Body temperature increased, Chills, Headache, Herpes simplex, Insomnia, Laboratory test abnormal, Pain, Pyrexia, Rhinorrhoea, White blood cell count abnormal, Neutrophil percentage decreased, Lymphocyte percentage decreased, Epstein-Barr virus antigen positive, Epstein-Barr virus antibody negative, Band neutrophil percentage decreased, Eosinophil percentage, Monocyte percentage, Lymphocyte percentage, Herpes simplex serology positive, Epstein-Barr virus test negative

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: Medical History: Vaginosis bacterial, yeast infection
Diagnostic Lab Data: body temp 101-103F; clinical seriology test, 10/23/06, positive; serum Epstein Barr 10/23/2006 negative, serum herpes simplex 10/23/06 positive; serum herpes simplex negative; WBC count normal; absolute blood atypical, 10/23/06, 13%, 0-6, high; band neutrophil count, 10/23/06, 5.0%, 0-5; eosinophil count, 10/23/06, 1.0%, 0-5; lymphocyte count, 10/23/06, 32.0%, 15-43; monocyte count, 10/23/06, 7.0%, 5-15; neutrophil count, 10/23/06, 42.0%, 43-75, Low; body temp, 101-103F; white blood cell, 10/23/06, moderate smudge cells; serum Epstein-Barr VCA, 10/23/06, positive; serum Epstein-Barr VCA, 10/23/06, - negative; serum EBNA antibody, 10/23/06, - positive; serum herpes simplex, 10/23/06, - positive; serum herpes simplex 10/23/06, 7.41 X1000 4.8
CDC 'Split Type': WAES0610USA14581

Write-up:Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccine (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7pm. Her fevers would reach 101-103 F and they resolved with rest plus the use of acetaminophen (Tylenol). After " a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chill, body aches, waking in the night. The CMA stated that the patient reported these symptoms to the physician''s office on 23 Oct 2006. Laboratory tests performed on that date included HSV(herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative); and EBV(Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed rate and CBC=white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30 Oct 2006 she received a second dose of Gardisil. The CMA noted that the patient was fine "so far". Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28-AUG-2006 was vaccinated IM in left deltoid with her first dose of GARDASIL lot #653736/0689F. Concomitant therapy included ORTHO TRI-CYCLEN. On 22-SEP-2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7 p.m. Her fevers would reach 101-103 F and they resolved with rest plus the use of TYLENOL. After "a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chills, body aches, and waking in the night. The CMA stated that the patient also took unspecified allergy and cold medicine for a runny nose during the past month. The patient reported these symptoms to the physician''s office on 23-OCT-2006. Laborary tests performed on that date included HSV (herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative) ; and EBV (Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed-rate and CBC = white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30-OCT-2006 she received a second dose of GARDASIL. The CMA noted that the patient was fine "so far". Additional follow up information has been received from a physician concerning the 21 year old black female student who on 28-AUG-2006 at 11:30 a.m. was vaccinated IM in left arm with her first dose of GARDASIL lot #653736/0689F. The physician reported that the patient made an appointment on 23-OCT-2006 with fever X 2 weeks. Diagnostic laboratory tests were performed, including positive EBNA (Epstein-Barr virus nuclear antigen antibody) and EBV VCA IgG (Epstein-Barr viral capsid antigen immunoglobulin G antibody), which indicated past infection. EBV VCA IgM (Epstein-Barr viral capsid antigen immunoglobulin M antibody) was negative (see laboratory data section for other results). The patient had mononucleosis. The physician indicated she had recovered. Additional information is not expected.


Changed on 5/14/2017

VAERS ID: 267466 Before After
Age:21.0
Gender:Female
Location:Alabama
Vaccinated:2006-08-28
Onset:2006-09-22
Submitted:2007-04-06
Entered:2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 0 UN / IM

Administered by: Private      Purchased by: Private
Symptoms: Body temperature increased, Chills, Headache, Herpes simplex, Insomnia, Laboratory test abnormal, Pain, Pyrexia, Rhinorrhoea, White blood cell count abnormal, Neutrophil percentage decreased, Lymphocyte percentage decreased, Epstein-Barr virus antigen positive, Epstein-Barr virus antibody negative, Band neutrophil percentage decreased, Eosinophil percentage, Monocyte percentage, Lymphocyte percentage, Herpes simplex serology positive, Epstein-Barr virus test negative

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: Medical History: Vaginosis bacterial, yeast infection
Diagnostic Lab Data: body temp 101-103F; clinical seriology test, 10/23/06, positive; serum Epstein Barr 10/23/2006 negative, serum herpes simplex 10/23/06 positive; serum herpes simplex negative; WBC count normal; absolute blood atypical, 10/23/06, 13%, 0-6, high; band neutrophil count, 10/23/06, 5.0%, 0-5; eosinophil count, 10/23/06, 1.0%, 0-5; lymphocyte count, 10/23/06, 32.0%, 15-43; monocyte count, 10/23/06, 7.0%, 5-15; neutrophil count, 10/23/06, 42.0%, 43-75, Low; body temp, 101-103F; white blood cell, 10/23/06, moderate smudge cells; serum Epstein-Barr VCA, 10/23/06, positive; serum Epstein-Barr VCA, 10/23/06, - negative; serum EBNA antibody, 10/23/06, - positive; serum herpes simplex, 10/23/06, - positive; serum herpes simplex 10/23/06, 7.41 X1000 4.8
CDC 'Split Type': WAES0610USA14581

Write-up:Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccine (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7pm. Her fevers would reach 101-103 F and they resolved with rest plus the use of acetaminophen (Tylenol). After " a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chill, body aches, waking in the night. The CMA stated that the patient reported these symptoms to the physician''s office on 23 Oct 2006. Laboratory tests performed on that date included HSV(herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative); and EBV(Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed rate and CBC=white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30 Oct 2006 she received a second dose of Gardisil. The CMA noted that the patient was fine "so far". Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28-AUG-2006 was vaccinated IM in left deltoid with her first dose of GARDASIL lot #653736/0689F. Concomitant therapy included ORTHO TRI-CYCLEN. On 22-SEP-2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7 p.m. Her fevers would reach 101-103 F and they resolved with rest plus the use of TYLENOL. After "a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chills, body aches, and waking in the night. The CMA stated that the patient also took unspecified allergy and cold medicine for a runny nose during the past month. The patient reported these symptoms to the physician''s office on 23-OCT-2006. Laborary tests performed on that date included HSV (herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative) ; and EBV (Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed-rate and CBC = white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30-OCT-2006 she received a second dose of GARDASIL. The CMA noted that the patient was fine "so far". Additional follow up information has been received from a physician concerning the 21 year old black female student who on 28-AUG-2006 at 11:30 a.m. was vaccinated IM in left arm with her first dose of GARDASIL lot #653736/0689F. The physician reported that the patient made an appointment on 23-OCT-2006 with fever X 2 weeks. Diagnostic laboratory tests were performed, including positive EBNA (Epstein-Barr virus nuclear antigen antibody) and EBV VCA IgG (Epstein-Barr viral capsid antigen immunoglobulin G antibody), which indicated past infection. EBV VCA IgM (Epstein-Barr viral capsid antigen immunoglobulin M antibody) was negative (see laboratory data section for other results). The patient had mononucleosis. The physician indicated she had recovered. Additional information is not expected.


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