VAERS ID:

268483  

Vaccinated:

2006-09-05

Age:

22.0  

Onset:

2006-09-05, Days after vaccination: 0

Gender:

Female  

Submitted:

2006-12-04, Days after onset: 90

Location:

Maryland  

Entered:

2006-12-07, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: Colposcopy 9/06, ultrasound 9/06/06 no fetal pole, ultrasound 9/20/06 16P 5 wk 3 days.

Previous Vaccinations:

Other Medications: UNK

Preexisting Conditions: Papanicolaou smear abnormal.

CDC 'Split Type': WAES0610USA00280

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0702F

1

 

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Laboratory test abnormal, Unintended pregnancy

Write-up: Information has been received from a healthcare worker for the pregnancy registry for HPV vaccine concerning a 22 year old female pt whit a history of abnormal pap who on 6/29/06 was vaccinated with her first dose of HPV vaccine , lot 653650/0697F. On 9/5/06 the pt was vaccinated with her second dose of HPV vaccine, lot 653650/0702F. The reporter indicated that the pt received the 2nd vaccination but did not realize she was about 6 weeks pregnant at the time. Medical attention was sought. An ultrasound and colposcopy was performed. The reporter indicated that there was no fetal pole at the time of the ultrasound and that it would be repeated. There was no adverse experience reported. Follow up information has been received from a physician concerning the female pt, whose last menstrual period was approximately 9/9/06. The estimated date of conception was 8/30/06. An ultrasound performed 9/20/06 showed 16P 5 wk 3 days. This is the pts first pregnancy. The estimated delivery date is 5/21/07. Follow up information has been received. On 11/8/06 the pt underwent an elective termination of her pregnancy at 12 week from LMP. Upon internal review, elective termination of pregnancy was considered to be an other important medical event (OMIC). Additional information is not expected.


VAERS ID:

270062  

Vaccinated:

2006-10-25

Age:

25.0  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-01-03

Location:

Unknown  

Entered:

2007-01-04, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: Serum alpha human 12/06 85

Previous Vaccinations:

Other Medications: NONE

Preexisting Conditions: Pregnancy; live birth, Pregnancy NOS (LMP unknown), irregular periods.

CDC 'Split Type': WAES0612USA04054

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Ectopic pregnancy, Laboratory test abnormal

Write-up: Information has been received from a licensed practical nurse concerning a 25 year old female with no drug reactions/allergies, and unknown date of last menstrual period due to irregular periods and a history of 2 live children (number of pregnancies was not reported) who on 25 Oct 2006 was vaccinated with first dose of HPV vaccine. There was no concomitant medication. The patient sought medical attention. Around 25 Nov 2006, (Thanksgiving time), the patient presented to the office. She had an ectopic pregnancy, went to the emergency room and was administered methotrexate to abort the child. She was monitored for several hours and released. The patient was not hospitalized. It was unk if the patient was pregnant when she was vaccinated with HPV Vaccine due to irregular periods, unknown LMP. At the time of reporting, the patient was recovering, her quantitative HCG was at 85, it should be at 2, but was going downward. The reporter felt that the event required intervention to prevent serious criteria (other important medical event) (OMIC). This report is part of the pregnancy registry. Additional information has been requested.


VAERS ID:

270302  

Vaccinated:

2006-11-20

Age:

24.0  

Onset:

2006-11-20, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-01-08, Days after onset: 49

Location:

New York  

Entered:

2007-01-09, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: 12/04/06 blood work positive for pregnancy, 11/20/06 negative for pregnancy, 11/20/06 fluid in pelvis no IUP seen, Urine beta human positive.

Previous Vaccinations:

Other Medications: UNK

Preexisting Conditions: Miscarriage, Abortion spontaneous.

CDC 'Split Type': WAES0612USA01040

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0955F

0

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Unintended pregnancy

Write-up: Initial and follow up information has been received from a licensed practical nurse through the manufacturer pregnancy registry concerning a 24 year old female with a history of two miscarriages in the past and not planning on being pregnant, a spontaneous abortion (March 2006) and no known allergies reported. On 20 Nov 2006, the patient was vaccinated intramuscularly in the left deltoid with the first 0.5ml dose of HPV vaccine (lot #653978/0955F). On 20 Nov 2006, the patient had a pelvic ultrasound performed due to pelvic pain. The pelvic ultrasound revealed fluid in pelvis and no intrauterine pregnancy was seen (previously reported as was negative for pregnancy). On an unspecified date, post vaccination, the patient presented to the office stating that she took a urine home pregnancy test and it was positive. On 04 Dec 2006, the patient had blood work drawn which revealed positive for pregnancy. The patient was approximately 6 weeks gestation with last menstrual period noted as approximately 21 Oct 2006. The patient was scheduled for a follow up blood test on 07 Dec 2006 and an ultrasound and blood lab was scheduled on 11 Dec 2006. On 17 Dec 2006 the patient experienced spontaneous abortion. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Upon internal review, the spontaneous abortion was considered to be an other important medical event (OMIC).


VAERS ID:

270528  

Vaccinated:

2006-10-09

Age:

37.0  

Onset:

2006-10-22, Days after vaccination: 13

Gender:

Female  

Submitted:

2007-01-12, Days after onset: 82

Location:

Florida  

Entered:

2007-01-16, Days after submission: 4

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: UNK

Preexisting Conditions:

CDC 'Split Type': WAES0611USA06403

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0868F

 

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Medication error, Unintended pregnancy

Write-up: Information has been received through the manufacturer pregnancy registry and from a medical assistant concerning a 37 year old female who on 09-OCT-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (lot # 653736/0868F). It was reported that on 22-OCT-2006 "the patient discovered she was 7 weeks pregnant) method of confirmation of pregnancy was reported to be a pap smear. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information was received from a medical assistant who reported that on 15-DEC-2006 the patient experienced vaginal spotting. That same day the patient was seen by her obstetrician who performed an abdominal ultrasound. The ultrasound confirmed that there was no fetal heartbeat. On an unspecified date a total serum human chorionic gonadotropin test was performed, results not provided. On 18-DEC-2006, the patient underwent an uncomplicated uterine dilation and curettage as an outpatient. On 02-JAN-2007 the patient was seen by her obstetrician for a post-operative exam which revealed that the patient had a full recovery without complications. The patient was advised to return to full regular activity. Upon internal review, the spontaneous abortion was considered to be an other medical event (OMIC). Additional information has been requested.


VAERS ID:

270529  

Vaccinated:

2006-11-16

Age:

18.0  

Onset:

2006-11-16, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-01-12, Days after onset: 57

Location:

Kentucky  

Entered:

2007-01-16, 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: beta-human chorionic 11/16/06 - negative; beta-human chorionic 12/05/06 - positive

Previous Vaccinations:

Other Medications: Depo-Provera; Nasonex

Preexisting Conditions: Pregnancy (LMP = 10/28/2006); Seasonal allergy; Contraception

CDC 'Split Type': WAES0612USA00985

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0800F

 

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Medication error, Unintended pregnancy

Write-up: Information has been received from a registered nurse for the pregnancy registry for Gardasil concerning an 18 year old white female with seasonal allergies and no medical history, who on 16-NOV-2006 was vaccinated IM with a 0.5 ml dose of Gardasil (lot# 654540/0800F). Concomitant therapy included Depo-Provera and Nasonex. On 16-NOV-2006, the patient''s pregnancy test was negative. On 05-DEC-2006, the patient''s pregnancy test was positive. It was noted that the patient may have an abortion but that was not related to the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information indicated that the patient''s LMP was on 28-OCT-2006 (estimated delivery date is 04-AUG-2007). On 03-JAN-2007 (reported as 03-JAN-2006), the patient had an elective termination. Upon internal review, elective termination was considered to be an other important medical event (OMIC). No further information was available.


VAERS ID:

271583  

Vaccinated:

2007-01-08

Age:

20.0  

Onset:

2007-01-08, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-01-31, Days after onset: 23

Location:

Maryland  

Entered:

2007-02-01, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: ultrasound 01/18/2007 - 7 week 3 day gestational dates urine beta-human 01/08?/07

Previous Vaccinations:

Other Medications: Celexa, Risperdal

Preexisting Conditions: Abdominal pain, Rectal bleeding, Papilloma viral infection, Sexually transmitted disease, Termination of pregnancy elective.

CDC 'Split Type': WAES0701USA01621

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

1427F

1

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy, Pregnancy test positive, Ultrasound scan, Urine human chorionic gonadotropin positive

Write-up: Initial and follow up information has been received from a health professional concerning a 20 year old female patient with a history of 2 therapeutic abortions (2000 and 2004) abdominal pain, mild rectal bleeding, papilloma viral infection and sexually transmitted disease who on 08-JAN-2007 was vaccinated IM into the left deltoid with a second 0.5 ml of Gardasil vaccine (yeast) (lot#655619/1427F). Concomitant therapy included Risperdal and Celexa. The patient was reportedly pregnant at this time and did not tell the office. An HCG pregnancy test was done. The patient is scheduled for a prenatal visit on 19-JAN-2007. Her LMP was approximately 11-OCT-2006 and EDD 19-JUL-2007. An ultrasound on 18-JAN-2007 for gestational dates revealed of 7 weeks of 7 weeks and 3 days. The patient had an elective termination on 23-JAN-2007. There was no further information available. The patient received a first 0.5 ml dose of Gardasil vaccine (yeast) (lot#654540/0800F) on 23-OCT-2006 IM into the left deltoid. Upon internal review, elective termination was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

272272  

Vaccinated:

2006-10-17

Age:

23.0  

Onset:

2006-10-16, Days after vaccination: -1

Gender:

Female  

Submitted:

2007-02-14, Days after onset: 121

Location:

Washington  

Entered:

2007-02-15, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: Test, Date, Value, Unit, Normal Range, Comment diagnostic nonstress test, 06/26/06, "maternal serum alphafetoprotein-in range normal" fetal nonstress test, 11/15/06 fetal nonstress test, 11/15/06 fetal nonstress test, 11/16/06 fetal nonstress test, 11/20/06 ultrasound, 04/21/06, "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" ultrasound, 04/14/06, "positive intrauterine pregnancy (IUP), gestational sac only, negative fetal heart tone, right corpu ultrasond, 05/02/06, "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" ultrasound, 05/02/056, "gestational age, threatened abortion" ultraound, 11/06/06, "amniotic fluid index=28.4" "rule out ruptured membranes"

Previous Vaccinations:

Other Medications:

Preexisting Conditions: Hospitalisation: premature labour, yeast infection, artificial rupture of membrane, abortion threatened. Pregnancy NOS (LMP=3/1/2006), kidney infection, smoker, premature labour, cervical dysplasia, cervical incompetence, allergic reaction to antibiotic, hypersensitivity

CDC 'Split Type': WAES0610USA12632

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

 

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion threatened, Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Foetal non-stress test, No adverse effect, Pregnancy, Ultrasound scan, Wrong drug administered

Write-up: Initial and follow up information has been received through the Merck regulatory pregnancy registry from a registered nurse at a health department and an unspecified family member concerning a 23 year old white female smoker who was 34 weeks pregnant with cervical incompetence, allergies to erythromycin and moxifloxacin hydrochloride (AVALOX) and had a history of premature labour from a prior pregnancy, a history of 3 pregnancies and 2 live births, a yeast infection, a threatened abortion, "ruptured membranes/delivery" and cervical dysplasia that had required a LEEP surgery, however, this procedure was not performed as the patient became pregnant. On 14-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), gestational sac only, negative fetal heart tone, right corpus". On 21-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus". On 02-MAY-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" and "gestational age, threatened abortion". On 26-JUN-2006, the patient underwent a maternal serum alphafetoprotein (MSAFP) which revealed "in range normal". It was reported that on an unspecified date, the patient had been hospitalized due to "lower back contractions". The patient had been diagnosed with a kidney infection and was advised to see her primary care physician for a flu shot. On 17-OCT-2006, (conflicting information also reported as 20-OCT-2006), the patient went to her physician and received one dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) administered intramuscularly instead of the flu shot. Concomitant therapy included prenatal vitamins and unspecified therapies (reported as "tributylene", "suflexan" and "cyclomenzaprene"). On 16-OCT-2006 (conflicting information also reported as 20-OCT-2006), the patient was not having any adverse reaction. It was reported that the patient had already been experiencing pre-term labour, prior to receiving the shot. The patient sought unspecified medical attention. On 24-OCT-2006, the patient received a 1 cc flu shot. On 02-NOV-2006, the patient received betamethasone (CELESTONE), 12 mg, intramuscularly to "decrease contractions". On 06-NOV-2006, the patient underwent an ultrasound which revealed "amniotic fluid index=28.4" and "rule out ruptured membranes". On 15-NOV-2006, 16-NOV-2006, and 20-NOV-2006, the patient underwent a fetal nonstress test (NST) (results not reported). On an unspecified date, the patient received acetaminophen/codeine phosphate (TYLENOL WITH CODEINE #3) for migraines. At the time of this report, the outcome of the events were unknown. The reporter stated that the patient had been hospitalized "prior to receiving the hpv rl1 6 11 16 18 vlp vaccine (yeast) vaccination for an unrelated kidney infection and lower back contractions". Additional information has been requested.


VAERS ID:

272506  

Vaccinated:

2006-10-01

Age:

  

Onset:

2006-10-01, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-02-14, Days after onset: 136

Location:

Pennsylvania  

Entered:

2007-02-15, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: UNK

Previous Vaccinations:

Other Medications: UNK

Preexisting Conditions: UNK

CDC 'Split Type': WAES0701USA03939

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

 

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Vaginal haemorrhage

Write-up: Information has been received from two nurses at a physician''s office concerning a female (age not reported) who in October 2006 was vaccinated with the first dose of Gardasil (yeast). In October 2006, the patient developed excessive vaginal bleeding (during her period). The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.


VAERS ID:

272591  

Vaccinated:

2006-10-01

Age:

  

Onset:

2006-10-01, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-02-14, Days after onset: 136

Location:

Pennsylvania  

Entered:

2007-02-15, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data: UNK

Previous Vaccinations:

Other Medications: UNK

Preexisting Conditions: UNK

CDC 'Split Type': WAES0701USA04698

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

 

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Vaginal haemorrhage

Write-up: Information has been received from two nurses at a physician''s office concerning one of the nurses'' daughter (age not reported). On an unspecified date, the patient was vaccinated with the first dose of Gardasil. Subsequently, the patient developed excessive vaginal bleeding (during her period). At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID:

272600  

Vaccinated:

2006-11-13

Age:

22.0  

Onset:

2006-12-01, Days after vaccination: 18

Gender:

Female  

Submitted:

2007-02-14, Days after onset: 75

Location:

Pennsylvania  

Entered:

2007-02-15, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: DEPO-PROVERA

Preexisting Conditions: UNK

CDC 'Split Type': WAES0701USA04984

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0688F

0

IM

 

 

Administered by: Private     Purchased by: Other

Symptoms: Dyspnoea, Muscle spasms, Vaginal haemorrhage

Write-up: Information has been received from a 22 year old female certified medical assistant who on 12-SEP-2006 was vaccinated IM with the first dose of Gardasil (yeast) (Lot#653735/0688F). On 13-NOV-2006 the patient received the second dose of Gardasil (yeast) (Lot#653735/0688F). Concomitant therapy included Depo-Provera. On an unspecified date in December 2006, the patient began with vaginal bleeding "on and off for several weeks. On 13-JAN-2007 the patient started with a flow that was very heavy lasting seven days, with cramping and shortness of breath. At the time of this report it was unknown if the patient had recovered from the events. Additional information has been requested.


 

 

 

 

 

 

 

VAERS ID:

272569  

Vaccinated:

2007-01-25

Age:

13.0  

Onset:

2007-01-27, Days after vaccination: 2

Gender:

Female  

Submitted:

2007-02-19, Days after onset: 23

Location:

New Hampshire  

Entered:

2007-02-19, Days after submission: 0

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data: will be getting tsh, ferritin, and cbc

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type':

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

FLUN

MEDIMMUNE, INC./WYETH LABORATORIES, INC

500438p

 

IN

 

HPV4

MERCK & CO. INC.

0960f

 

IM

LA

TDAP

GLAXOSMITHKLINE BIOLOGICALS

 

 

IM

RA

 

Administered by: Private     Purchased by: Public

Symptoms: Vaginal haemorrhage

Write-up: pt recieved HPV #1 on 1/25/07 since vaccine has had period for past 22 days. has not had issues with vaginal bleeding between period before vaccine.


VAERS ID:

272865  

Vaccinated:

2007-01-11

Age:

13.0  

Onset:

2007-01-12, Days after vaccination: 1

Gender:

Female  

Submitted:

2007-02-21, Days after onset: 40

Location:

Michigan  

Entered:

2007-02-22, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: Denies sexual activity, PG test neg.

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type':

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

1425F

0

 

 

 

Administered by: Private     Purchased by: Private

Symptoms: Non-consummation, Pregnancy test negative, Vaginal haemorrhage

Write-up: Vaginal bleeding started day after receiving Gardasil vaccine. Bleeding is persistent (Moderate-severe) and still present LMP 12/28/02 ended 01/02/07. Onset menses 10 year age.


VAERS ID:

273848  

Vaccinated:

0000-00-00

Age:

  

Onset:

2007-02-28

Gender:

Female  

Submitted:

2007-03-12, Days after onset: 11

Location:

Unknown  

Entered:

2007-03-13, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = unknown).

Diagnostic Lab Data: UNK

Previous Vaccinations:

Other Medications: UNK

Preexisting Conditions:

CDC 'Split Type': WAES0703USA00274

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a registered nurse through a pregnancy registry concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. The patient was pregnant, and on 28-FEB-2007 the patient had a miscarriage or abortion after receiving the first dose of Gardasil. The patient sought unspecified medical attention. At the time of this report, the nurse was unsure if the patient had a miscarriage or abortion. Upon internal review, the patient''s miscarriage or abortion was considered an other important medical event. Additional information has been requested.


VAERS ID:

274573  

Vaccinated:

2007-01-11

Age:

13.0  

Onset:

2007-01-11, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-03-14, Days after onset: 61

Location:

Michigan  

Entered:

2007-03-16, Days after submission: 2

 

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: UNK

Preexisting Conditions: UNK

CDC 'Split Type': WAES0702USA03905

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Vaginal haemorrhage

Write-up: Information has been received from a nurse, via a company representative, concerning a 13 year old female patient who on 11-JAN-2007 was vaccinated with the first dose, 0.5ml, IM of HPV. The nurse reported that the patient had developed vaginal bleeding that had "varied from light to heavy and has been continuous since the date of administration." The nurse reported that the patient had been referred to an OBGYN for further evaluation. At the time of this report, the patient had not recovered. Additional information has been requested.


VAERS ID:

274754  

Vaccinated:

2007-01-17

Age:

26.0  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-03-23

Location:

Ohio  

Entered:

2007-03-26, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: UNK

Previous Vaccinations:

Other Medications: UNK

Preexisting Conditions:

CDC 'Split Type': WAES0702USA03451

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

1424F

1

 

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a physician, for the Pregnancy registry for Gardasil, concerning a 26 year old female with pertinent medical history and drug reactions/allergies unspecified who on an unspecified date was vaccinated with first dose of Gardasil (lot # not reported) injection. On an unspecified date, the patient was vaccinated with second dose of Gardasil (lot # not reported) injection. Concomitant therapy was unspecified. Approximately two weeks after receiving the second dose of vaccine, the patient learned that she was pregnant. The patient sought medical attention, she reported the pregnancy to the physician''s office. The date of last menstrual period was not reported. The third dose of Gardasil will not be given to the patient during her pregnancy. The patient has not had any adverse experiences to date. Additional information was received from the physician who reported that the patient had a miscarriage. No further information was available at the time of reporting. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.


VAERS ID:

274755  

Vaccinated:

2007-01-22

Age:

15.0  

Onset:

2007-01-22, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-03-23, Days after onset: 59

Location:

Virginia  

Entered:

2007-03-26, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: beta-human chorionic

Previous Vaccinations:

Other Medications: UNK

Preexisting Conditions:

CDC 'Split Type': WAES0702USA01337

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0868F

0

IM

LA

 

Administered by: Private     Purchased by: Private

Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test

Write-up: Information has been received from a licensed practical nurse concerning a 15 year old female student who on 22-JAN-2007 was vaccinated intramuscularly in the left arm with a 0.5ml first dose of Gardasil (lot #653736/0868F). On 02-FEB-2007, it was discovered that the patient was pregnant. At the time of this report, the patient''s last menstrual period was unknown. The patient sought unspecified medical attention and she was referred to an obstetrician/gynecologist. A pregnancy test was performed. On an unspecified date, the pregnancy was terminated. At the time of this report, the outcome was unknown. No product quality complaint was involved. Upon internal review, pregnancy was terminated was considered to be an other important medical event. Additional information is not expected.


VAERS ID:

274938  

Vaccinated:

2007-01-11

Age:

20.0  

Onset:

2007-01-11, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-03-26, Days after onset: 73

Location:

Georga  

Entered:

2007-03-27, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown) Drug hypersensitivity

Diagnostic Lab Data: urine beta-human 01/11/07 - Not pregnant

Previous Vaccinations:

Other Medications: UNK

Preexisting Conditions: Miscarriage

CDC 'Split Type': WAES0703USA02391

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

 

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin negative

Write-up: Information has been received from a 20 year old female with an allergy to Zomig and a history of multiple miscarriages. On 11-JAN-2007 the patient was vaccinated with her first dose of Gardasil when she was 4 and a half weeks pregnant. The patient took a urine Human chorionic gonadotropin (HCG) test in the doctor''s office that said she was not pregnant, and they administered the vaccination on day. On 17-JAN-2007 the patient discovered she was pregnant. On 21-JAN-2007 she had a miscarriage. Medical attention was sought. Her outcome was unknown. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested. Additional information has been requested.


VAERS ID:

274942  

Vaccinated:

0000-00-00

Age:

19.0  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-03-26

Location:

Arizona  

Entered:

2007-03-27, Days after submission: 1

 

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: UNK

Preexisting Conditions: Miscarriage

CDC 'Split Type': WAES0703USA04238

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

 

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a medical assistant through a pregnancy registry concerning a 19 year old female with a history of miscarriage who was vaccinated with the first dose of Gardasil. It was reported that later the patient found out that she was pregnant. The patient was 2 months pregnant at the time of the vaccination. It was reported that the patient miscarried 2 weeks after the vaccination. At the time of the report it was unknown, if the patient recovered. Upon internal review, it was determined that miscarried was an other important medical event. Additional information has been requested.


VAERS ID:

275702  

Vaccinated:

0000-00-00

Age:

  

Onset:

2007-02-01

Gender:

Female  

Submitted:

2007-04-05, Days after onset: 62

Location:

Minnesota  

Entered:

2007-04-06, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP=unknown)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0703USA05521

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

 

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received through the pregnancy registry from a physician concerning a female teenager who was vaccinated with a first dose of Gardasil without the knowledge that she was pregnant. It was found out that the patient was pregnant after the administration of the vaccine. Later the patient had a miscarriage. As per the reporter, the miscarriage happened "last month or so." Medical attention was sought. The patient was recovering. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

275779  

Vaccinated:

2006-11-28

Age:

23.0  

Onset:

2007-01-31, Days after vaccination: 64

Gender:

Female  

Submitted:

2007-04-06, Days after onset: 64

Location:

Illinois  

Entered:

2007-04-09, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 1/31/2007)

Diagnostic Lab Data: Diagnostic laboratory 02/26/07, gynecological 02/26/07, ultrasound 02/26/07

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0704USA00075

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0688F

1

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Gynaecological examination, Laboratory test, Ultrasound scan

Write-up: Information has been received from a consumer and a licensed practical nurse, through the pregnancy registry, concerning a 23 year old female, who was vaccinated on 28-SEP-2006 with the first dose of Gardasil, and on 28-NOV-2006 with the second dose of Gardasil (Lot # 653735/0688F). There was no concomitant medication. The nurse reported that on 26-FEB-2007 (consumer reported as 13-MAR-2007, "some time after"she received the second dose) the patient had a miscarriage. The date of the last LMP was approximately 31-JAN-2007 ("late January"). According to the consumer, lab diagnostic tests included "several blood tests, ultrasounds, vaginal probe" (results not provided). On 29-MAR-2007, the third dose of Gardasil (Lot # 654389/0961F) was administered to the patient, and the nurse reported the patient "was fine" at that visit. The miscarriage was considered to be an other important medical event. Additional information has been requested.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

VAERS ID:

276315  

Vaccinated:

2006-12-20

Age:

26.0  

Onset:

2007-01-01, Days after vaccination: 12

Gender:

Female  

Submitted:

2007-04-13, Days after onset: 101

Location:

Unknown  

Entered:

2007-04-16, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: hormonal contraceptives

Preexisting Conditions:

CDC 'Split Type': WAES0704USA00625

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

1

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a registered nurse for the Pregnancy registry for Gardasil concerning a 26 year old female who on 20-DEC-2006 was vaccinated IM with the second 0.5 mL dose of Gardasil. The patient was vaccinated with the first 0.5 mL dose Gardasil (lot # 653937/0637F) on 27-OCT-2006. Concomitant therapy included hormonal contraceptives (unspecified). In January 2007, the patient became pregnant. In March 2007, the patient had a miscarriage at 8 weeks gestation. The patient sought unspecified medical attention. Subsequently, the patient recovered. Upon internal review, the patient''s miscarriage was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

276902  

Vaccinated:

2007-03-16

Age:

16.0  

Onset:

2007-03-16, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-04-13, Days after onset: 28

Location:

New Mexico  

Entered:

2007-04-16, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP=01/17/2007); Human papilloma virus infection; Anaemia; Cardiac murmur

Diagnostic Lab Data: beta-human chorionic, positive; ultrasound, 5/31/07, normal; ultrasound, 10/21/07, normal; serum alpha-fetoprotein, 05/31/07, normal; Apgar score, 10/23/07, 8/9

Previous Vaccinations:

Other Medications: Iron (unspecified) 325 mg; vitamins (unspecified);

Preexisting Conditions: Cholecystectomy

CDC 'Split Type': WAES0703USA04967

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

1427F

1

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Alpha 1 foetoprotein normal, Anaemia, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan normal, Vaginal haemorrhage

Write-up: Information has been received from a Certified Medical Assistant for the pregnancy registry for GARDASIL concerning a 16 year old female patient with human papilloma virus who on 11-JAN-2007 was vaccinated IM with her first dose of Gardasil, lot#655619/1427F. On 16-MAR-2007 the patient, who was 9 weeks pregnant (positive pregnancy test) received her 2nd dose of Gardasil. The patient reported vaginal spotting during this pregnancy. Her outcome was unknown. Additional information has been requested. Follow-up information received 4/16/08 from the Certified nurse manager indicated that the now 17 year old patient delivered the baby on 10/23/07. The baby was a female weighing 7 lbs and 14 oz and length was 20 1/2 inches. Medications used during the pregnancy were prental vitamins once daily and iron (unspecified) 325 mg twice daily for anemia. Laboratory diagnostic tests included ultrasounds on 05/31/07 and 10/21/07 which were normal. A maternal serum alpha-fetoprotein screening (MSAFP) was performed on 05/31/2007 which was within normal limits. 07/08/2008 Initial and follow up information has been received from a Certified nurse manager for the pregnancy registry for GARDASIL concerning a 16 year old female patient with human papilloma virus and a heart murmur and a history of gallbladder removal and 0 pregnancies who on 11-JAN-2007 was vaccinated IM with her first dose of GARDASIL, lot #655619/1427F. On 16-MAR-2007 the patient, who was 9 weeks pregnant (positive pregnancy test) received her 2nd dose of GARDASIL. Her LMP was 17-JAN-2007 (estimated date of delivery 24-OCT-2007). The patient reported vaginal spotting during this pregnancy. Her outcome was unknown. Follow-up information received from the Certified nurse manager indicated that the now 17 year old patient delivered the baby on 23-Oct-2007. The baby was a female weighing 7 lbs and 14 oz and length was 20 1/2 inches. Her apgar score was 8/9. Medications used during pregnancy were prenatal vitamins once daily and iron (unspecified) 325 mg twice daily for anemia. Laboratory diagnostic tests included ultrasounds on 31-May-2007 and 21-Oct-2007 which were normal. A maternal serum alpha-fetoprotein screening was performed on 31-May-2007 which was within normal limits.


VAERS ID:

276911  

Vaccinated:

2007-02-26

Age:

19.0  

Onset:

2007-02-27, Days after vaccination: 1

Gender:

Female  

Submitted:

2007-04-13, Days after onset: 44

Location:

Florida  

Entered:

2007-04-16, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Asthma; Morbid obesity; Peanut allergy

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions: Injury

CDC 'Split Type': WAES0703USA05176

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0263U

2

IM

LA

 

Administered by: Other     Purchased by: Military

Symptoms: Hypoaesthesia, Vaginal haemorrhage

Write-up: Information has been received from a physician concerning a 19 year old female who was vaccinated with an IM, third dose with Gardasil. Subsequently the patient experienced numbness in legs. Subsequently, the patient recovered from numbness in legs. It was reported the patient had no problems following the first 2 doses. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician concerning a 19 year old female with asthma, morbid obesity and peanut allergy and a history of orthopedic injuries from previous falls who on 26-FEB-2007 was vaccinated in her left arm with a third dose of GARDASIL (lot# 655849/0263U) at 11:00. On 27-FEB-2007 at 10:00 the patient experienced light vaginal bleeding that was between her menstrual cycles and numbness in both legs. Subsequently, the patient in one week recovered from light vaginal bleeding and numbness in both legs after 7 days. The patient did not seek medical attention until several weeks after these symptoms. No further information is available.


VAERS ID:

277166  

Vaccinated:

2007-03-27

Age:

26.0  

Onset:

2007-03-27, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-04-20, Days after onset: 24

Location:

Unknown  

Entered:

2007-04-23, Days after submission: 3

 

Life Threatening Illness? Yes

Died? No

Disability? Yes

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? Yes, days

    Extended hospital stay? No

Current Illness:

Diagnostic Lab Data: pelvic ultrasound 04/09/07 spontaneous abortion; complete blood cell Result not reported; total serum human 03/28/07 positive

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions: Miscarriage

CDC 'Split Type': WAES0704USA02270

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

1

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Full blood count, Pregnancy test positive, Ultrasound scan, Uterine dilation and curettage, Vaginal haemorrhage, Vaginitis bacterial

Write-up: Information has been received from a physician for the Pregnancy registry for GARDASIL, concerning a 26 year old female patient with a history of first trimester miscarriage in 2006 who on 25-JAN-2007 was vaccinated IM with a first dose of HPV. The physician reported that on 27-MAR-2007 the patient was vaccinated with second dose of HPV and had a positive pregnancy test the next day. The patient presented to the physician''s office on 09-APR-2007 with vaginal bleeding and a pelvic ultrasound determined that she was suffering a spontaneous abortion. She was at 6 weeks gestation. The patient was admitted to the hospital on the night of 09-APR-2007 with severe vaginal hemorrhaging and underwent an emergency dilation and curettage procedure. The patient was recovering without complication. The physician added that, on 27-MAR-2007, the patient was diagnosed with bacterial vaginosis but she did not take the prescribed treatment. The physician considered spontaneous abortion to be significantly disabling and life threatening. Additional information has been requested.


VAERS ID:

277666  

Vaccinated:

0000-00-00

Age:

19.0  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-04-30

Location:

Unknown  

Entered:

2007-05-01, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = unknown)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0704USA05597

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

1

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Drug exposure during pregnancy

Write-up: Information has been received via the Merck pregnancy registry, from a licensed practical nurse, concerning a 19 year old female patient who was vaccinated with a first and second dose of Gardasil (dates unspecified), and during the vaccination series discovered she was pregnant (date of the LMP and estimated date of delivery were unspecified). The nurse reported that the patient elected to undergo an abortion for personal reasons, and clarified that this decision was "totally unrelated to receiving Gardasil." Upon internal review, elected to undergo an abortion was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

277668  

Vaccinated:

2007-02-09

Age:

16.0  

Onset:

2007-02-09, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-04-30, Days after onset: 79

Location:

Indiana  

Entered:

2007-05-01, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 1/5/2007)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0704USA04977

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Benign hydatidiform mole, Blighted ovum, Drug exposure during pregnancy

Write-up: Information has been received via the pregnancy registry, from a consumer concerning her 16 year old daughter, who was pregnant with an estimated date of conception on 05-JAN-2007, and on 09-FEB-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. On 29-MAR-2007, the mother reported that her daughter, who was then "12 weeks pregnant," experienced a miscarriage; the mother added that the pregnancy was considered to be a blighted ovum, which she also referred to as a "mole pregnancy." The mother added that in April 2007, her daughter received the second dose of Gardasil. At the time of this report, it was unknown if the patient had recovered from the events. Upon internal review, blighted ovum, "mole pregnancy" and miscarriage were determined to be an other important medical event. Additional information has been requested.


VAERS ID:

278130  

Vaccinated:

2006-11-29

Age:

17.0  

Onset:

2006-11-29, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-05-07, Days after onset: 158

Location:

Unknown  

Entered:

2007-05-08, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown) Pregnancy

Diagnostic Lab Data: None

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0705USA00039

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0955F

0

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Drug exposure during pregnancy, Inappropriate schedule of drug administration

Write-up: Information has been received from a registered nurse concerning a 17 year old female who was 18 weeks pregnant and was vaccinated with her first dose of GARDASIL (lot 653978/0955F) on 29-Nov-2006. There was no concomitant medication. In March 2007, the patient experienced an abortion. The nurse believes that the patient terminated the pregnancy for reasons other than the vaccine. The first dose of the vaccine was given at her pediatrician''s office. Subsequently the patient experienced an inappropriate schedule of the vaccine when she received the 2nd dose on 24-Apr-2007. Upon internal review, abortion was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

278380  

Vaccinated:

2006-10-31

Age:

25.0  

Onset:

2006-11-11, Days after vaccination: 11

Gender:

Female  

Submitted:

2007-05-10, Days after onset: 179

Location:

Tennessee  

Entered:

2007-05-11, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 11/11/2006)

Diagnostic Lab Data: beta-human chorionic 12/18/06 - Positive

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0705USA00787

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0800F

1

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive

Write-up: Information has been received via the manufacturer pregnancy registry, from a certified medical assistant (CMA) concerning a 25 year old female patient, who on 31-OCT-2006 was vaccinated IM, with the first dose of Gardasil (Lot #654540/0800F). On 18-DEC-2006, the patient had a positive pregnancy test; the date of the LMP was 11-NOV-2006, with an estimated date of delivery of 18-AUG-2007. The CMA confirmed that on 22-DEC-2006, the patient had a spontaneous miscarriage, through hospitalization was not reported and testing of the miscarried fetus was unavailable. It was not specified if the patient sought medical attention, nor if the patient had recovered from the spontaneous abortion. On 27-DEC-2006, the patient was vaccinated IM, with the second dose of Gardasil (Lot #654540/0800F). Upon internal review, spontaneous miscarriage was determined to be an other important medical event. This patient also experienced a pregnancy following vaccination with the second dose of Gardasil (WAES #0705USA01062). Additional information has been requested.


VAERS ID:

278785  

Vaccinated:

2006-12-08

Age:

23.0  

Onset:

2006-12-14, Days after vaccination: 6

Gender:

Female  

Submitted:

2007-05-16, Days after onset: 152

Location:

Wisconsin  

Entered:

2007-05-17, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: beta-human chorionic 12/14/06 - positive

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions: Pregnancy NOS (LMP = 11/16/2006)

CDC 'Split Type': WAES0612USA02963

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

 

UN

UN

 

Administered by: Unknown     Purchased by: Unknown

Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive

Write-up: Initial and follow up information has been received from a nurse and manufacturer pregnancy registry concerning a 23 year old black female patient with one previous pregnancy who on 08-DEC-2006 was vaccinated with a dose of Gardasil. On 14-DEC-2006 a pregnancy test was positive. The patient''s LMP was late November 2006. On 07-MAY-2007 the nurse reported that the patient had not been to the office since the original prenatal appointment on 12-FEB-2007. She had cancelled 3 appointments on 05-March-2007, 12-MAR-2007 and 19-MAR-2007. Follow up information from the nurse indicated that on 16-NOV-2006 patient had her last menstrual period and her estimated delivery date 20-AUG-2007. She called back on 07-MAY-2007 but did not give any information about the miscarriage. On 24-APR-2007 patient reported that she had miscarried. No date was identified when the patient miscarried. Unspecified medical attention was sought. The outcome was unknown. Upon internal review, miscarriage was considered an other important medical event. Additional information has been requested.


VAERS ID:

279196  

Vaccinated:

0000-00-00

Age:

23.0  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-05-14

Location:

Unknown  

Entered:

2007-05-17, 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: Unknown

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions: Unknown

CDC 'Split Type': WAES0704USA02230

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

 

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Dizziness, Vaginal haemorrhage

Write-up: Information has been received from a physician office manager, via a company representative, concerning the office manager''s 23 year old daughter, who was vaccinated with a dose, 0.5ml, of Gardasil (date unspecified). Subsequently the patient experienced dizziness and menstrual bleeding. At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. No further information is expected.



VAERS ID:

279251  

Vaccinated:

2006-09-13

Age:

26.0  

Onset:

2007-05-11, Days after vaccination: 240

Gender:

Female  

Submitted:

2007-05-21, Days after onset: 10

Location:

Unknown  

Entered:

2007-05-22, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown); Drug hypersensitivity; Factor V Leiden mutation; 5-alpha reductase deficiency; Prothrombin level

Diagnostic Lab Data: ultrasound 04/16/07 - + pregnancy confirmed, ultrasound 05/11/07 - positive miscarriage, beta-human chorionic 04/16/07 - + pregnancy confirmed

Previous Vaccinations:

Other Medications: Clonazepam, Topamax, Coumadin

Preexisting Conditions: Pulmonary embolism; Deep vein thrombosis; Herpes virus infection

CDC 'Split Type': WAES0705USA02904

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0688F

0

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Ultrasound abdomen

Write-up: Information has been received from a registered nurse for the pregnancy registry for Gardasil, concerning a 26 year old female with a drug reaction/allergy to Wellbutrin, factor v laiden mutation/clotting disorder, prothrombin mutation, bipolar disorder, seizure disorder and Mthfr and a history of pulmonary embolism and multiple deep vein thrombosis and herpes virus infection who on 13-SEP-2006 was vaccinated with her first Gardasil 0.5 ml IM (lot # 653735/0688F). Concomitant therapy included Coumadin, Topamax and clonazepam. The nurse stated that the patient was very non-complaint and never returned for the second or third dose of the vaccine. On 16-APR-2007, the patient was found to be pregnant which was confirmed by ultrasound and a pregnancy test. The patient''s last menstrual period, gestational age or due date were not reported. On 11-MAY-2007 the patient experienced spontaneous miscarriage which was confirmed by ultrasound. The patient sought unspecified medical attention. The patient was not hospitalized. Upon internal review, spontaneous miscarriage was determined to be an other important medical event. Additional information has been requested.


VAERS ID:

279328  

Vaccinated:

2007-02-13

Age:

32.0  

Onset:

2007-02-13, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-05-22, Days after onset: 97

Location:

Unknown  

Entered:

2007-05-23, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data: ultrasound 11/13/06 - fetal leiometry for size and dates, ultrasound 01/13/07 - adequate fetal growth since last ultrasound, fetal anatomy appears to be normal, ultrasound 04/13/07 - decreased fetal movements, threatened preterm labor, biophysical profile 8/8, AFI 20.5 cm, S/D 2.71, ultrasound 04/23/07 - adequate fetal growth since ultrasound AFI 12.1 cm, serum alpha-fetoprotein 12/04/06 negat

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions: Intra-uterine death

CDC 'Split Type': WAES0702USA02398

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

1427F

0

 

 

 

Administered by: Other     Purchased by: Other

Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Foetal movements decreased, Inappropriate schedule of drug administration, Intra-uterine death, Medication error, Ultrasound scan abnormal, Ultrasound scan normal, Umbilical cord abnormality

Write-up: Information has been received from a physician through a manufacturer pregnancy registry concerning a 32 year old female with a history of 5 pregnancies and 4 live births (one fetal loss at 16-20 weeks) who on 13-FEB-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F). Concomitant medication was not reported. On 13-NOV-2006, an ultrasound was performed results reported were fetal leiometry which corresponds the size and dates. On 04-DEC-2006, serum alpha-fetoprotein test was performed results were negative. On 13-FEB-2007, after the patient was vaccinated with Gardasil, the physician found out that the patient was pregnant. The physician reported that the pregnancy was normal to date. Follow-up information has been received from a physician. On 13-JAN-2007, an ultrasound performed showed adequate fetal growth since last sonography and fetal anatomy appears to be normal. On 13-APR-2007, an ultrasound performed showed biophysical profile 8/8, AFI 20.5 cm, S/D ratio 2.71, cervical length 4.44cm. On 23-APR-2007, an ultrasound performed showed adequate fetal growth since last ultrasound AFI 12.1 cm. On 24-APR-2007, the patient was diagnosed with intrauterine fetal demise and a female infant was delivered on 26-APR-2007 at 06:40, 3.235 kg. The placenta and cord were sent to pathology with no pathological diagnosis. Autopsy was refused. Clinically fetal death was due to cord accident, long umbilical cord, around body once and legs twice. Upon internal review, intrauterine fetal demise and umbilical cord complication were considered to be other important medical events. Additional ifnormation is not expected.


VAERS ID:

279424  

Vaccinated:

2006-11-30

Age:

26.0  

Onset:

2006-12-26, Days after vaccination: 26

Gender:

Female  

Submitted:

2007-05-23, Days after onset: 147

Location:

Unknown  

Entered:

2007-05-23, Days after submission: 0

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: beta-human chorionic 01/30/07 5 weeks pregnant

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions: Asthma

CDC 'Split Type': WAES0702USA04650

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

 

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Pregnancy, Surgery, Uterine dilation and curettage

Write-up: Information has been received from a registered nurse through the manufacturer pregnancy registry concerning a 26 year old female patient, with a "history of asthma in 1999," who on 30-NOV-2006 was vaccinated with the first dose, 0.5ml, of Gardasil. The nurse stated that the patient reported she was "5 weeks pregnant" on 30-JAN-2007. Pregnancy was confirmed via pregnancy test (not specified). The approximate date of conception was 26-DEC-2006, with an estimated due date of 02-OCT-2007. On 22-FEB-2007, at approximately 8 weeks of pregnancy, the patient "had a miscarriage." The patient went to the emergency room (ER) on 22-FEB-2007 due to the miscarriage, but she was not admitted. On 23-FEB-2007, the patient had a dilatation & curettage (D & C) performed. The nurse reported that the patient "was not seen in the physician office for her pregnancy," and added that she "had recovered from the events" (date not specified). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.


VAERS ID:

280234  

Vaccinated:

0000-00-00

Age:

  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-06-01

Location:

Tennessee  

Entered:

2007-06-04, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0705USA05018

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

 

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a physician for the pregnancy registry for Gardasil concerning a female who was vaccinated with an unknown number of 0.5 mL doses of Gardasil. "A few weeks ago," the patient developed a miscarriage in the first trimester. The patient''s outcome was unknown. Upon internal review, the patient''s spontaneous abortion was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

281537  

Vaccinated:

2007-04-25

Age:

17.0  

Onset:

2007-04-25, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-06-12, Days after onset: 48

Location:

Michigan  

Entered:

2007-06-13, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 3/28/2007); Allergic reaction to antibiotics

Diagnostic Lab Data: total serum human -

Previous Vaccinations:

Other Medications: none

Preexisting Conditions:

CDC 'Split Type': WAES0706USA00513

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

1

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test

Write-up: Information has been received from a registered nurse concerning a 17 year old female patient with a drug allergy to erythromycin and no medical history, who on 21-FEB-2007 was vaccinated IM with a 0.5ml first dose of Gardasil (Lot# 655324/0089U). There was no concomitant medication. On 25-APR-2007 the patient received her second dose of the vaccine while pregnant (LMP 28-MAR-2007). On 16-MAY-2007, the patient experienced an uncomplicated spontaneous miscarriage. Unspecified medical attention was sought. It was reported that the patient has not required any treatment and has not experienced any further problems. Laboratory diagnostic studies included a quantitative HCG. At the time of this report, the patient was recovering. No product complaint was involved. Upon internal review, uncomplicated spontaneous miscarriage was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

282215  

Vaccinated:

2007-01-22

Age:

19.0  

Onset:

2007-05-22, Days after vaccination: 120

Gender:

Female  

Submitted:

2007-06-18, Days after onset: 27

Location:

Unknown  

Entered:

2007-06-19, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: Pap test-abnormal-ASCUS, LGSIL, HPV; beta-human chorionic 05/22/07 positive

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions: Papilloma viral infection; Atypical squamous cells of undetermined significance; Low grade squamous intraepithelial lesion

CDC 'Split Type': WAES0705USA04050

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

1161F

1

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion induced, Drug exposure during pregnancy, Papilloma viral infection, Pregnancy test positive, Smear cervix abnormal

Write-up: Initial and follow up information has been received, from a physician and a healthcare professional, concerning a 19 year old white female patient, with no previous pregnancies and a history of an abnormal pap (indicating human papilloma virus, atypical squamous cell of undetermined significance and a low grade squamous intraepithelial lesion; date unspecified), who on 21-NOV-2006, was vaccinated with the first dose of Gardasil (Lot #653650/0702F), and on 22-JAN-2007 with the second dose of Gardasil (Lot #654540/1161F). On 22-MAY-2007, the patient took a pregnancy test in the doctor''s office which was positive. The patient was unsure of the date of her LMP. No problems were reported. Follow up information from the healthcare professional indicated the patient "had decided to terminate the pregnancy," although the reason for the decision was not specified, and the date for the procedure was left blank; it was not confirmed that the procedure had actually been completed. Upon internal review, decided to terminate the pregnancy was determined to be serious as an other important medical event. Additional information has been requested.


VAERS ID:

282370  

Vaccinated:

2007-02-19

Age:

20.0  

Onset:

2007-04-04, Days after vaccination: 44

Gender:

Female  

Submitted:

2007-06-19, Days after onset: 76

Location:

Texas  

Entered:

2007-06-20, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 4/4/2007)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: ORTHO TRI-CYCLEN LO

Preexisting Conditions:

CDC 'Split Type': WAES0706USA01990

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0688F

0

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a registered nurse concerning a 20 year old female with no relevant medical history who on 19-FEB-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (lot 653735/0688F). Concomitant therapy included Ortho Tri-Cyclen Lo. Subsequently, she became pregnant. Date of LMP was 04-APR-2007. The patient subsequently miscarried. The patient was seen in the emergency room on 14-MAY-2007 for the miscarriage. She was not admitted to the hospital. The patient called the office on 17-MAY-2007 to notify the physician of the miscarriage, but had not returned to the office for follow-up visits. Upon internal review, the patient''s spontaneous abortion was considered an other important medical event. Additional information has been requested.


VAERS ID:

282645  

Vaccinated:

0000-00-00

Age:

  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-06-21

Location:

Unknown  

Entered:

2007-06-22, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: (therapy unspecified)

Preexisting Conditions:

CDC 'Split Type': WAES0706USA02595

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

 

UN

UN

MMR

MERCK & CO. INC.

 

 

UN

UN

UNK

UNKNOWN MANUFACTURER

 

 

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a health professional, for the Pregnancy Registry for Gardasil, concerning a female patient who was vaccinated with a dose of Gardasil. Concomitant suspect therapy included a dose of M-M-R II. Other concomitant therapy included "other unspecified vaccines". The reporter mentioned that the patient was pregnant but miscarried after receiving Gardasil. Unspecified medical attention was sought. No additional information was available. Upon internal review, miscarriage was determined to be an other Important Medical Event. Additional information has been requested.


VAERS ID:

282909  

Vaccinated:

2007-01-16

Age:

15.0  

Onset:

2007-01-16, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-06-26, Days after onset: 160

Location:

Arizona  

Entered:

2007-06-27, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 1/1/2007) asthma

Diagnostic Lab Data: Ultrasound 05/20/07 - unknown results, ultrasound 05/22/07 - unknown results

Previous Vaccinations:

Other Medications: albuterol

Preexisting Conditions:

CDC 'Split Type': waes0705usa03252

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

1447F

0

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion induced, Drug exposure during pregnancy, No adverse effect, Ultrasound scan

Write-up: Information has been received from a physician''s assistant through the Merck Pregnancy registry concerning a 15 year old female patient with asthma who on 16-JAN-2007, was vaccinated IM with a second dose of Gardasil (Lot# 655617/1447F). Concomitant therapy included albuterol MDI. After the second dose, it was discovered that she was pregnant. No adverse events were noted. On 24-MAY-2007, the patient elected to terminate the pregnancy. The patient was 21 weeks from last menstrual period. On 20-MAY-2007 and 22-MAY-2007, an ultrasound was performed and the results were unknown. At the time of this report, the patient''s outcome was unknown. It was also reported on 16-NOV-2006, the patient was vaccinated with a first dose of Gardasil (Lot# 653736/0868F). No product quality complaint was involved. Upon internal review, elective termination was considered to be an other important medical event. Additional information is not to be expected.


VAERS ID:

283520  

Vaccinated:

2007-03-06

Age:

17.0  

Onset:

2007-03-06, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-06-29, Days after onset: 114

Location:

Michigan  

Entered:

2007-07-02, Days after submission: 3

 

Life Threatening Illness? Yes

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? Yes, 3 days

    Extended hospital stay? No

Current Illness: Pregnancy NOS (LMP = 1/28/2007)

Diagnostic Lab Data: diagnostic laboratory - results not provided 7/11/07-records received Labs: Sticky platelet syndrome epinephrine response mildly increased ADP response normal amplitutde. PTT 25.3, PT 12.6. INR 1.1. D-Dimer 8706 high. Antithrombin III low

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0706USA04112

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0187U

0

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Antithrombin III decreased, Deep vein thrombosis, Drug exposure during pregnancy, Dyspnoea, Fall, Injury, Laboratory test, Thrombosis, Ultrasound Doppler abnormal, X-ray normal

Write-up: Information has been received from the Merck Pregnancy Registry from a physician concerning a 17 year old female with no pertinent medical history who on 06-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot # 656049/0187U). The patient was prescribed ethinyl estradiol (+) norgestimate (ORTHO TRI-CYCLEN) on the day she received the vaccination, but the reporter did not have any information regarding whether the patient was taking them or not. It was later learned that the patient was pregnancy when she received the vaccination. On 07-APR-2007, the patient experienced shortness of breath. On 14-APR-2007, she was hospitalized due to shortness of breath. It was later determined that the patient was experiencing a blood clot in her left leg, deep vein thrombosis (DVT). On 16-APR-2007, the hospital determined that the patient was 11 weeks and 1 day pregnant. The estimated date of delivery was 04-NOV-2007. Subsequently, the patient had an abortion performed for personal reasons not related to the vaccine. On 14-JUN-2007, the patient had not recovered from the blood clot and the reporter indicated that an unspecified blood thinner was recommended as treatment. At the time of the report, the blood clot persisted. The physician considered shortness of breath, abortion and blood clot in left leg to be other important medical events. The physician considered shortness of breath and blood clot in left leg to be immediately life threatening events. Additional information has been requested. 7/11/07-ER records received for DOS 4/14/07-DX: Recently diagnosed deep venous thrombosis. Possible pulmonary embolism. DX of blood clot 2 weeks prior. 4/14/07-attempted to terminate pregnancy, 12 weeks pregnant. Procedure not performed. C/O dyspnes on exertion. RX with Lovenox. No chest pain. Left let swelling and tenderness especially in popliteal fossa this has been ongoing for 2-3 weeks. 8/24/07-records received for DOS 04/07-04/10/07- DC DX: Deep venous thrombosis, left lower extremity. Intrauterine pregna


VAERS ID:

283644  

Vaccinated:

2007-05-10

Age:

31.0  

Onset:

2007-03-26, Days after vaccination: -45

Gender:

Female  

Submitted:

2007-07-02, Days after onset: 98

Location:

Unknown  

Entered:

2007-07-03, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 3/26/2007)

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0705USA02762

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0389U

1

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration

Write-up: Initial and follow up information has been received through the Merck pregnancy registry, from a 31 year old female healthcare professional, who on 10-MAY-2007 (previously reported as 30-APR-2007), was vaccinated intramuscularly with the second dose of Gardasil (Lot #657736/0389U), and recently found out she was pregnant. The date of the LMP was reported as 26-MAR-2007, with an estimated delivery date on 31-DEC-2007. Unspecified medical attention was sought. It was not known if the patient had been seen by OB/GYN. Follow up information from the healthcare professional, stated that she "had a miscarriage." No further information or details were provided. Upon internal review, "had a miscarriage" was considered to be serious as an other significant medical event. Additional information has been requested.


VAERS ID:

283826  

Vaccinated:

2007-05-03

Age:

17.0  

Onset:

2007-05-21, Days after vaccination: 18

Gender:

Female  

Submitted:

2007-07-03, Days after onset: 43

Location:

Kansas  

Entered:

2007-07-05, Days after submission: 2

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 4/15/2007) Folliculitis; Genital wart

Diagnostic Lab Data: Ultrasound 05/21/07 - 5 week gestational sac Reason for test was clotting/spotting, total serum human 05/25/07 - 2231, total serum human 05/30/07 - 118

Previous Vaccinations:

Other Medications: AUGMENTIN mg, trichloroacetic acid

Preexisting Conditions:

CDC 'Split Type': WAES0705USA04344

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0387U

1

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Metrorrhagia, Pregnancy test positive, Thrombosis, Ultrasound scan normal

Write-up: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 17 year old female patient with folliculitis, genital condyloma and no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 655618/0186U). On 03-MAY-2007 the patient received a second dose of Gardasil (Lot# 657621/0387U). Concomitant therapy included, AUGMENTIN and trichloroacetic acid. The patient stated her last menstrual period was 15-APR-2007. The nurse reported that the patient kept changing the date at each visit. The patient was sent to an OB/GYN and it was determined that she was 4 weeks pregnant as of 21-MAY-2007. Diagnostic laboratory studies performed were an ultrasound on 21-MAY-2007 due to clotting/spotting which resulted as 5 week gestational sac. On 25-MAY-2007 and 30-MAY-2007, HCG quantitative test were performed which resulted as 2231 and 118, respectively. The nurse mentioned that the patient has not experienced any difficulties with the pregnancy as this time. On 27-MAY-2007, it was reported that the patient had a spontaneous abortion. She was 6 weeks from LMP. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information is not expected.


VAERS ID:

284195  

Vaccinated:

2007-02-26

Age:

22.0  

Onset:

2007-06-18, Days after vaccination: 112

Gender:

Female  

Submitted:

2007-07-09, Days after onset: 21

Location:

Unknown  

Entered:

2007-07-10, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 5/14/2007)

Diagnostic Lab Data: Ultrasound - results not provided, Beta-human chorionic - results not provided

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0706USA05115

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0800F

0

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy, Ultrasound scan

Write-up: Information has been received for the Merck Pregnancy Registry from a licensed practical nurse concerning a 22 year old female with no pertinent medical history who on 26-FEB-2007 was vaccinated with 0.5 ml of the first dose of Gardasil (Lot # 654540/0800F). There was no concomitant medication. On 02-MAY-2007, the patient was vaccinated with 0.5 ml of the second dose of the Gardasil (Lot # 656050/0245U). It was reported that the patient was pregnant. Unspecified medical attention was sought. Her last menstrual period was approximately 14-MAY-2007. The estimated date of delivery was 18-FEB-2008. Two ultrasounds were performed (results not provided), and "hormone levels for pregnancy levels dropping was monitored by beta-human chorionic gonadotropin test (bHCG)", On 18-JUN-2007, the patient went to the emergency room and experienced a miscarriage at 5 weeks gestation. It was reported that the patient was recovering. Upon internal review, the miscarriage was determined to be an other important medical event. Additional information has been requested.


VAERS ID:

284352  

Vaccinated:

2007-06-04

Age:

18.0  

Onset:

2007-06-04, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-07-10, Days after onset: 36

Location:

Pennsylvania  

Entered:

2007-07-11, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0706USA01796

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

 

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion induced, Drug exposure during pregnancy

Write-up: Information has been received from an 18 year old female who in 2007 was vaccinated IM with a dose of Gardasil. The patient reported that she is 8 weeks pregnant and received the vaccine. No adverse reaction reported. Follow up information has been received from a physician concerning the 18 year old female with 0 previous pregnancies and no medical history who on 04-JUN-2007 was vaccinated IM with a dose of Gardasil. The patient received an elective abortion at 8 weeks. The elective termination occurred the week of 04-JUN-2007. Upon internal review, elective abortion was considered to be an other important medical event. No further information is available.


VAERS ID:

284390  

Vaccinated:

2007-04-13

Age:

16.0  

Onset:

2007-05-01, Days after vaccination: 18

Gender:

Female  

Submitted:

2007-07-11, Days after onset: 71

Location:

Florida  

Entered:

2007-07-12, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: beta-human chorionic 05/01/07 29576 - positive, beta-human chorionic 05/16/07 74136

Previous Vaccinations:

Other Medications: vitamins (unspecified)

Preexisting Conditions:

CDC 'Split Type': WAES0705USA00509

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0137U

0

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Amenorrhoea, Blood human chorionic gonadotropin increased, Drug exposure during pregnancy, Pregnancy test positive

Write-up: Initial and follow-up information has been received from a physician for the Pregnancy Registry for Gardasil concerning a 16 year old female with no medical history or previous pregnancies who on 13-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil (lot # 655165/0137U). Concomitant therapy included pre-natal vitamins. On 01-MAY-2007 a pregnancy test was performed because of amenorrhea and found to be positive with an HCG results of 29576. The estimated conception date was 7 weeks and the estimated delivery date was 22-DEC-2007 (LMP was not known). On 16-MAY-2007, an additional HCG test was performed with a result of 74136. The patient sought unspecified medical attention. In May 2007, the patient experienced a spontaneous abortion. It was noted that the patient was currently under a physician''s care and that she was permitted to return to normal activities without limitations. At the time of this report, the outcome was unknown. No further information is available.


VAERS ID:

284706  

Vaccinated:

2007-05-29

Age:

  

Onset:

2007-06-29, Days after vaccination: 31

Gender:

Female  

Submitted:

2007-07-13, Days after onset: 14

Location:

Unknown  

Entered:

2007-07-16, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 5/6/2007), Latex allergy

Diagnostic Lab Data: beta-human chorionic - positive

Previous Vaccinations:

Other Medications: Abilify, ascorbic acid, calcium (unspecified), Optimum Omega, Lamictal, pyridoxine, Valtrex, vitamins (unspecified)

Preexisting Conditions: Bipolar disorder

CDC 'Split Type': WAES0706USA02076

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0089U

0

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion induced, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy

Write-up: Information has been received from a licensed practical nurse through the Merck pregnancy concerning a female patient with latex allergy and a history of bipolar disorder who on 29-MAY-2007, was vaccinated IM with a first 0.5 ml dose of Gardasil (Lot# 655324/0089U). Concomitant therapy included lamotrigine (LAMICTAL), valacyclovir HCl (VALTREX), aripiprazole (ABILIFY), vitamins (unspecified), garlic extract (+) omega-3 marine triglycerides (+) vitamin E (OPTIMUM OMEGA), calcium (unspecified), ascorbic acid and pyridoxine. Subsequently, the nurse reported that the patient had a positive pregnancy test and will be terminating her pregnancy. Follow up information stated that the patient terminated her pregnancy on 29-JUN-2007. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Upon internal review, terminated her pregnancy was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

284856  

Vaccinated:

2007-04-03

Age:

26.0  

Onset:

2007-06-04, Days after vaccination: 62

Gender:

Female  

Submitted:

2007-07-16, Days after onset: 42

Location:

Unknown  

Entered:

2007-07-17, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: urine beta-human 06/04/07 positive

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0707USA01083

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ectopic pregnancy, Urine human chorionic gonadotropin positive

Write-up: Information has been received from a registered nurse concerning a 26 year old female with no relevant medical history reported who on 03-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. There was no concomitant medication. on 04-JUN-2007, the patient returned to the office for her second dose of Gardasil. Dose 2 was not given because she tested positive for pregnancy on that day. In June 2007, the patient had a miscarriage. It was determined that the patient experienced an ectopic pregnancy. The patient returned to the office on 06-JUL-2007 to receive dose 2 of Gardasil. The nurse reported that the patient was "fine now". Upon internal review, ectopic pregnancy and miscarriage were determined to be other important medical events. Additional information has been requested.


VAERS ID:

285291  

Vaccinated:

2006-11-01

Age:

15.0  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-07-19

Location:

Colorado  

Entered:

2007-07-20, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Pregnancy NOS (LMP=Unknown)

Diagnostic Lab Data: None

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0707USA01041

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a medical assistant through the Merck pregnancy registry concerning an approximately 15 year old female patient with no pertinent medical history or drug reactions/allergies, who in November 2006, was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml). There was no concomitant medication. It was reported that the patient did not receive her second vaccination due to pregnancy. The patient subsequently had a miscarriage. The date of miscarriage was not known. Upon internal review, the miscarriage was felt to be an other important medical event. Additional information has been requested.


VAERS ID:

285363  

Vaccinated:

2006-10-26

Age:

16.0  

Onset:

2007-05-07, Days after vaccination: 193

Gender:

Female  

Submitted:

2007-07-16, Days after onset: 70

Location:

Missouri  

Entered:

2007-07-18, Days after submission: 2

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy (LMP = 8/24/2006); Attention deficit/hyperactivity disorder

Diagnostic Lab Data: ultrasound 11/09/06 - 11 weeks 3 days

Previous Vaccinations:

Other Medications: CONCERTA

Preexisting Conditions:

CDC 'Split Type': WAES0611USA01347

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0954F

1

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Drug exposure during pregnancy, Pregnancy, Premature labour, Ultrasound scan

Write-up: Information has been received from the Merck pregnancy registry via a physician concerning a 16 year old female with attention deficit/hyperactivity disorder with a history of 0 pregnancies and 0 live births who on 17-AUG-2006 was vaccinated with a first dose of Gardasil (lot # 653937/0637F). On 26-OCT-2006, the patient was vaccination with a second dose of Gardasil (lot #653938/0954F). Concomitant therapy included CONCERTA. Subsequently, she became pregnant. Last menstrual period was 24-AUG-2006 and estimated date of delivery was 29-MAY-2007. On 09-NOV-2006 and ultrasound reported that the patient was 11 weeks and 3 days. On approximately 07-MAY-2007 the patient developed pre-term labor and chorioamnionitis. On 07-MAY-2007, the patient gave birth to a normal male. Other medications used during this pregnancy included KEFLEX. On 18-JUN-2007, the patient was vaccinated with a third dose of Gardasil (lot #657736/0389U). No further information is available.


VAERS ID:

285712  

Vaccinated:

2007-04-09

Age:

17.0  

Onset:

2007-07-13, Days after vaccination: 95

Gender:

Female  

Submitted:

2007-07-17, Days after onset: 4

Location:

Michigan  

Entered:

2007-07-24, Days after submission: 7

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type':

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0188U

1

IM

LA

 

Administered by: Private     Purchased by: Private

Symptoms: Drug exposure during pregnancy, Intra-uterine death

Write-up: Patient was pregnant - which she did not inform and then had fetal demise - the cord was wrapped around fetus arm and shoulder 4 times.

VAERS ID:

286246  

Vaccinated:

2007-06-08

Age:

17.0  

Onset:

2007-07-17, Days after vaccination: 39

Gender:

Female  

Submitted:

2007-07-23, Days after onset: 6

Location:

Florida  

Entered:

2007-07-30, Days after submission: 7

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness: None

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: None

Preexisting Conditions: None

CDC 'Split Type':

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

14290

0

IJ

LA

 

Administered by: Private     Purchased by: Private

Symptoms: Abortion spontaneous, Endocervical curettage, Pregnancy test positive, Ultrasound uterus, Uterine dilation and curettage

Write-up: Pt was give Gardasil shot June 8-Had positive preg. test June 21. U/S 2 months baby heart beating 2nd U/S no heart beat (7/17 d/c to remove deceased baby) at medical center


VAERS ID:

286273  

Vaccinated:

2007-05-29

Age:

17.0  

Onset:

2007-06-15, Days after vaccination: 17

Gender:

Female  

Submitted:

2007-07-30, Days after onset: 45

Location:

Unknown  

Entered:

2007-07-31, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: ultrasound 06/15?/07 - 6 weeks 4 days pregnant, diagnostic laboratory - + HPV, ultrasound 07/19/07 - heart beat had stopped

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0707USA02094

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0211U

0

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion, Drug exposure during pregnancy, Foetal heart rate abnormal, Papilloma viral infection, Ultrasound scan

Write-up: Initial and follow-up information has been received via the Merck pregnancy registry, from a nurse practitioner (NP) and a mother concerning her daughter, a 17 year old female, who on 29-MAY-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #0211U). On approximately 15-JUN-2007 ("2 1/2 weeks later"), the patient became pregnant. An ultrasound test (date not reported), confirmed the pregnancy duration as 6 weeks and 4 days, and provided an estimated date of delivery of 01-MAR-2008. On 19-JUL-2007 the patient went for an ultrasound that reported the baby''s heart beat had stopped. On an unspecified date the patient tested for positive for human papilloma virus. Upon internal review, abortion was considered to be other important medical event. Conflicting information has been received from the patients mother. In was reported that the patient was vaccinated with the first dose of Gardasil on 18-JUN-2007 and the patient was two and a half months pregnant at the time of the vaccination. Additional information has been requested.


VAERS ID:

286707  

Vaccinated:

0000-00-00

Age:

17.0  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-08-02

Location:

Michigan  

Entered:

2007-08-03, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 9/26/2006)

Diagnostic Lab Data: ultrasound 07/13/07 - 37 weeks gestation; cervical smear - unknown; beta-human chorionic - positive

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0707USA03886

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0188U

1

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Intra-uterine death, Smear cervix, Ultrasound scan

Write-up: Information has been received from the Merck Pregnancy Registry via a medical assistant concerning a 17 Year old female with no pertinent past medical history who on 18-JAN-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot #655619/1427F). On an unspecified date the patient was vaccinated intramuscularly with the second dose of Gardasil (657005/0188U). There were no concomitant therapies. It was reported by the medical assistant that the patient did not let the staff know she was pregnant and the first and second doses of Gardasil were administered respectively. The patient''s last menstrual period was 26-SEP-2006. Estimated the patient''s pregnancy to be at least 37 weeks gestation. Subsequently the patient''s pregnancy ended in a fetal demise. Unspecified medical attention was sought. At the time of the report the patient''s outcome was unknown. Additional information has been requested.


VAERS ID:

286708  

Vaccinated:

2007-06-07

Age:

26.0  

Onset:

2007-06-07, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-08-02, Days after onset: 56

Location:

Connecticut  

Entered:

2007-08-03, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 5/18/2007)

Diagnostic Lab Data: diagnostic laboratory - "prenatal labs": all normal , ultrasound - "MAB"

Previous Vaccinations:

Other Medications: PERCOCET

Preexisting Conditions:

CDC 'Split Type': WAES0707USA01570

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0522U

2

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion missed, Drug exposure during pregnancy, Laboratory test normal, Ultrasound scan abnormal, Uterine dilation and curettage

Write-up: Initial and follow-up information has been received for the Merck Pregnancy Registry from a nurse and a certified nurse midwife concerning a 26 year old female who on 12-DEC-2006 was vaccinated with a first dose of Gardasil (Lot # 654389/0961F). On 07-FEB-2007, the patient vaccinated with a second dose of Gardasil (Lot #653736/0014U). Subsequently the patient became pregnant. The estimated date of conception was 02-JUN-2007. On 07-JUN-2007 the patient was vaccinated IM with a third dose of Gardasil (Lot #657737/0522U). Concomitant therapy included Percocet. Unspecified medical attention was sought. All "prenatal labs" were normal. The date of the patient''s last menstrual period was 18-MAY-2007. The estimated date of delivery was 22-FEB-2008. On 23-JUL-2007 the patient underwent an ultrasound for viability which revealed missed abortion. On 24-JUL-2007, the patient underwent a uterine dilation and curettage. Other medications used during this pregnancy included prenatal vitamins. Upon internal review, the missed abortion was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

286711  

Vaccinated:

2007-05-01

Age:

24.0  

Onset:

2007-05-01, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-08-02, Days after onset: 93

Location:

South Carolina  

Entered:

2007-08-03, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 6/27/2007)

Diagnostic Lab Data: Serum alpha-human - Quantitative HCG

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0707usa04531

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

1

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ectopic pregnancy

Write-up: Information has been received from a Registered Nurse, through the Merck pregnancy registry, concerning a 24 year old female patient who in March 2007, was vaccinated with a first dose of Gardasil and in May 2007 received the second dose of Gardasil. On 25-JUN-2007 Methotrexate was given for treatment of the ectopic pregnancy. Pregnancy was confirmed 1 week before 25-JUN-2007. No further information was available. Upon internal review, ectopic pregnancy, spontaneous abortion was determined to be an other Important Medical Event. Additional information has been requested.


VAERS ID:

287759  

Vaccinated:

2007-03-19

Age:

25.0  

Onset:

2007-06-24, Days after vaccination: 97

Gender:

Female  

Submitted:

2007-08-09, Days after onset: 46

Location:

Pennsylvania  

Entered:

2007-08-10, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 6/24/2007)

Diagnostic Lab Data: ultrasound 07/29/07 - no fetus/pregnancy; beta-human chorionic 07/23/07 - positive

Previous Vaccinations:

Other Medications: ZYRTEC; PREVACID

Preexisting Conditions:

CDC 'Split Type': WAES0708USA00038

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0243U

1

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Muscle spasms, Ultrasound scan abnormal, Vaginal haemorrhage

Write-up: Information has been received from a registered nurse concerning a 25 year old female with no pertinent medical history or drug reactions/allergies who on 29-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655617/1447F) injection 0.5mL IM left deltoid. On 19-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # 656372/0243U) injection 0.5mL IM left deltoid. Concomitant medication included ZYRTEC and PREVACID. The date of the patient''s last menstrual period was 24-JUN-2007. On 23-JUL-2007, the patient reported that she tested positive for pregnancy. On 29-JUL-2007, the patient sought medical attention for a miscarriage (the estimated date of delivery was 30-MAR-2008). On 29-JUL-2007, the patient arrived at the emergency room with complaints of bleeding and cramping. An ultrasound performed showed no fetus/pregnancy. Additional information was received from the registered nurse via telephone. It was originally reported that the miscarriage was life-threatening. The nurse clarified that it was not life-threatening to the mother but was unknown to the fetus as it was very early on in the pregnancy. The relationship of the miscarriage to Gardasil was unknown. Upon internal review, spontaneous abortion was considered to be an Other Important Medical Event. No additional information is expected.


VAERS ID:

287889  

Vaccinated:

2007-03-09

Age:

24.0  

Onset:

2007-04-09, Days after vaccination: 31

Gender:

Female  

Submitted:

2007-08-10, Days after onset: 123

Location:

Unknown  

Entered:

2007-08-13, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? Yes, 2 days

    Extended hospital stay? No

Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidi

Diagnostic Lab Data: beta-human chorionic 04/09/07 posit

Previous Vaccinations:

Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride

Preexisting Conditions: Early onset of delivery

CDC 'Split Type': WAES0708USA00308

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Uterine dilation and curettage

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.


VAERS ID:

288456  

Vaccinated:

2007-08-01

Age:

17.0  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-08-17

Location:

Texas  

Entered:

2007-08-20, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0708USA01821

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

1

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a health professional concerning a 17 year old female, who on 12-JUL-2007 was vaccinated with a first 0.5mL dose of Gardasil. At the time of the first vaccination the patient was unaware that she was three weeks pregnant. In August 2007 the patient was vaccinated with a second dose of Gardasil. The patient miscarried sometime between the first dose and the second dose. The patient sought unspecified medical attention. At the time of the report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID:

288708  

Vaccinated:

2007-06-04

Age:

34.0  

Onset:

2007-06-04, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-08-14, Days after onset: 71

Location:

South Carolina  

Entered:

2007-08-16, Days after submission: 2

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 5/31/2007); Drug hypersensitivity

Diagnostic Lab Data: diagnostic laboratory 07/05/07; diagnostic procedure - baby''s heart tunnels are present; beta-human chorionic 06/25/07 - positive; diagnostic laboratory 07/09/07 - 4-5 weeks pregnant; beta-human chorionic 06/26/07 - positive

Previous Vaccinations:

Other Medications: antimicrobial (unspecified); ASTELIN; KLONOPIN; NEXIUM; NASONEX; hormonal contraceptives

Preexisting Conditions: Surgical intervention

CDC 'Split Type': WAES0706USA04965

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

1424F

1

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Laboratory test, Pregnancy test positive, Uterine dilation and curettage, Vaginal haemorrhage

Write-up: Initial and follow-up information has been received from the Merck pregnancy registry from a registered nurse and a physician concerning a 34 year old female with drug hypersensitivity to codeine with a history of dilation and curettage procedure done in February, who on 29-MAR-2007 was vaccinated IM with a first dose of Gardasil (lot # 654885/1424F). On 04-Jun-2007 was vaccinated IM with a second dose of Gardasil (lot # 654885/1424F). Concomitant therapy included NEXIUM, ASTELIN, NASONEX, KLONOPIN, "FECON", and antimicrobial (unspecified). ON 25-JUN-2007 and 26-JUN-2007 the patient reported that the beta-human chorionic gonadotropin test (unspecified) were positive. On 05-JUL-2007 and 09-JUL-2007 the patient came into the office for blood work. The 09-JUL-2007 blood work reported that the patient was four to five week pregnant. The patient''s last menstrual period was approximately 31-MAY-2007 and the delivery date was 06-MAR-2008. The physician reported that the baby''s heart tunnels are present. Subsequently the patient experienced some bleeding during pregnancy. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from the Merck pregnancy registry form a registered nurse and a physician concerning a 34 year old female with drug hypersensitivty to codeine with a history of dilation and curettage procedure done in Febraury who on 29-MAR-2007 was vaccinated IM with a first dose of GARDASIL (lot # 654885/1424F). On 04-Jun-2007 was vaccinated IM with a second dose of GARDASIL (lot # 654889/1424F). Concomitant therapy inclued NEXIUM, ASTELIN, NASONEX, KLONOPIN, FECOM, and antimicrobial (unspecified). On 25-JUN-2007 and 26-JUN-2007 the patient reported that the beta-human chorionic gonadotropin test (unspecified) were positive. On 05-JUL-2007 and 09-JUL-2007 the patient came into the office for blood work. The 09-JUL-2007 blood work reported that the patient was four to five weeks pregnant. The patient''s last menstural period was approximately 31-MAY-2007 and the delivery date was 06-MAR-2008. The physician reported that the baby''s heart tunnels are present. Subsequently the patient experienced some bleeding during pregnancy. Follow up information was received from the nurse on 27-MAR-2008. The patient did not receive her prenatal care at their office. The name of the provider was not available. No additional information was provided.


VAERS ID:

289665  

Vaccinated:

2007-05-01

Age:

20.0  

Onset:

2007-05-01, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-08-14, Days after onset: 105

Location:

Arizona  

Entered:

2007-08-16, Days after submission: 2

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions: Unknown

CDC 'Split Type': WAES0707USA04429

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0389U

0

UN

LA

 

Administered by: Private     Purchased by: Private

Symptoms: Vaginal haemorrhage

Write-up: Information has been received from a certified medical assistant concerning a 20 year old female, who in May-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed vaginal bleeding for about a month. On 23-JUL-2007 the patient was vaccinated intramuscularly with a 0.5mL second dose of Gardasil. Subsequently, the patient developed vaginal bleeding again. The patient was not due for menses. At the time of the report, the patient''s outcome was unknown. The physician felt that the vaginal bleeding was unrelated. Additional information has been requested. 01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a certified medical assistant concerning a 21 year old female, who on 16-MAY-2007 at 11:20 was vaccinated in the left deltoid with a first dose of GARDASIL (Lot# 657736/0389U). On 16-MAY-2007 at 11:20 the patient developed vaginal bleeding for about a month. On 23-JUL-2007 at 11:15 the patient was vaccinated intramuscularly in the left deltoid with a 0.5mL second dose of GARDASIL (Lot# 658222/0927U). On 23-JUL-2007 at 11:15 the patient developed some spotting for 1 week that was not related to her cycle (also reported as vaginal bleeding). The patient was not due for menses. The physician felt that the vaginal bleeding was unrelated. Additional information is not expected.


VAERS ID:

288459  

Vaccinated:

2007-07-02

Age:

17.0  

Onset:

2007-07-02, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-08-17, Days after onset: 46

Location:

West Virginia  

Entered:

2007-08-20, Days after submission: 3

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 5/24/2007); Bipolar disorder; Headache

Diagnostic Lab Data: urine beta-human 07/02/07 posit

Previous Vaccinations:

Other Medications: XANAX

Preexisting Conditions:

CDC 'Split Type': WAES0707USA00550

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

1447F

0

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive

Write-up: Initial and follow-up information has been received through the Merck Pregnancy registry from a registered nurse a 17 year old white female with bipolar disorder, headache, and no previous pregnancies, who on 02-JUL-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 655617/1447F). Concomitant therapy included XANAX. On 02-JUL-2007, after the vaccination, a urine beta-human chorionic gonadotropin test was reported positive for pregnancy. The patients last menstrual period was 24-MAY-2007. The estimated date of delivery was 02-MAR-2008. On 19-JUL-2007, at 8 weeks from the last menstrual period, the patient had an elective termination of the pregnancy. The patient was scheduled to return for her second dose of Gardasil on 10-SEP-2007. Upon internal review, elective termination was considered to be an other important medical event. Additional information is not expected.


VAERS ID:

288528  

Vaccinated:

0000-00-00

Age:

  

Onset:

0000-00-00

Gender:

Female  

Submitted:

2007-08-20

Location:

Louisiana  

Entered:

2007-08-21, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP=Unknown)

Diagnostic Lab Data: urine beta-human positive

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0707USA04078

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy, Urine human chorionic gonadotropin positive

Write-up: Information has been received from the Pregnancy Registry for Gardasil from a physician concerning a female who was vaccinated with the first dose of Gardasil (lot # unknown) 0.5 mL. The physician recently found out the patient was pregnant. The physician did not know if the patient would terminate the pregnancy. No adverse experience was reported. Medical attention was sought. Follow-up information was received from the physician. The physician reported that the patient had an elective termination of her pregnancy not due to the use of Gardasil. Upon internal review elective abortion is considered to be an other medical event. Additional information has been requested.


VAERS ID:

288630  

Vaccinated:

2007-01-30

Age:

17.0  

Onset:

2006-11-27, Days after vaccination: -64

Gender:

Female  

Submitted:

2007-08-21, Days after onset: 266

Location:

Unknown  

Entered:

2007-08-22, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 11/27/2006); Asthma

Diagnostic Lab Data: ultrasound 05/02/07 - negative; beta-human chorionic 05/23/07 - positive; serum alpha-fetoprotein 04/11/07 - negative

Previous Vaccinations:

Other Medications: albuterol, QVAR 80 microgm

Preexisting Conditions: Termination of Pregnancy - elective

CDC 'Split Type': WAES0705USA05442

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0954F

 

IM

 

 

Administered by: Other     Purchased by: Other

Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Caesarean section, Drug exposure during pregnancy, Pre-eclampsia, Pregnancy, Pregnancy test positive, Premature labour, Ultrasound scan normal

Write-up: Initial and follow up information has been received as part of a pregnancy registry from a nurse practitioner concerning a 17 year old female with asthma, who in January 2007, was vaccinated with a 0.5mL dose of Gardasil (Lot# 653938/0954F). Concomitant medications included albuterol inhaler ("last used winter during allergy season") and Qvar. On 27-NOV-2006 the patient became pregnant. On 23-MAY-2007, the patient underwent a lab test that was positive and revealed that she was 23 weeks and 5 days pregnant. The patient''s last menstrual period was 27-NOV-2006 and her estimated date of delivery was 03-SEP-2007. The patient had two previous births resulting in elective abortions. On 11-APR-2007 an alpha-fetalprotein test was taken and the results were negative. On 02-MAY-2007 an ultrasound was taken and the results were negative. The patient experienced pre-eclampsia resulting in a premature delivery by caeserian section on 12-JUL-2007. The infant was born normal and no congenital anomalies. The infant was a male with a low birthweight of 1510 grams, a length of 43.5cm, a head circumference of 31cm and an Apgar score of 8/9. At the time of the report, the patient''s outcome was unknown. The pre-eclampsia and premature delivery were considered to be other important medical events. Additional information has been requested.


VAERS ID:

288686  

Vaccinated:

2007-06-20

Age:

17.0  

Onset:

2007-08-06, Days after vaccination: 47

Gender:

Female  

Submitted:

2007-08-22, Days after onset: 16

Location:

North Carolina  

Entered:

2007-08-22, Days after submission: 0

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type':

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HEPA

MERCK & CO. INC.

0018U

0

IM

LA

HPV4

MERCK & CO. INC.

0243U

0

IM

RA

 

Administered by: Private     Purchased by: Public

Symptoms: Abortion spontaneous

Write-up: 8-6-07 Miscarriage


VAERS ID:

288907  

Vaccinated:

2007-07-07

Age:

18.0  

Onset:

2007-08-08, Days after vaccination: 32

Gender:

Female  

Submitted:

2007-08-23, Days after onset: 15

Location:

Tennessee  

Entered:

2007-08-24, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 7/11/2007); Penicillin allergy

Diagnostic Lab Data: None

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0708USA03011

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

1

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Information has been received from a licensed practical nurse concerning an 18 year old female with an allergy to penicillin and no medical history, who in June 2007, was vaccinated intramuscularly with a first dose of Gardasil and a second dose in July 2007. There was no concomitant medication. The patient had become pregnant sometime between the two doses. Her last menstrual period was 11-JUL-2007 and her estimated delivery date was 16-APR-2008. On approximately 08-AUG-2007 the patient had a miscarriage. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review spontaneous abortion was considered an other important medical event. Additional information has been requested.


VAERS ID:

289940  

Vaccinated:

2006-12-07

Age:

15.0  

Onset:

2006-12-08, Days after vaccination: 1

Gender:

Female  

Submitted:

2007-09-05, Days after onset: 270

Location:

Unknown  

Entered:

2007-09-06, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = Unknown)

Diagnostic Lab Data: beta-human chorionic 12/08/06 - positive

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0612USA01370

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

0

IM

UN

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion spontaneous, Abortion spontaneous complete, Drug exposure during pregnancy, Pregnancy test positive

Write-up: Information has been received from a nurse practitioner through a Merck pregnancy registry regarding a 16 year old female who on 07-DEC-2006 was vaccinated IM with the first dose of Gardasil (Lot# not reported). On 08-DEC-2006 the patient had a positive pregnancy test result (test not specified). Unspecified medical attention was sought. At the time of this report no symptoms were reported and the outcome of the event was unknown. Follow up information was received from the nurse practitioner which stated that on an unspecified date the patient experienced a miscarriage at 13 weeks. Upon internal medical review the spontaneous abortion was considered to be an other important medical event. Additional information has been requested.


VAERS ID:

290108  

Vaccinated:

2007-06-15

Age:

16.0  

Onset:

2007-06-15, Days after vaccination: 0

Gender:

Female  

Submitted:

2007-09-06, Days after onset: 83

Location:

Florida  

Entered:

2007-09-07, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 6/1/2007)

Diagnostic Lab Data: urine beta-human 08/10/07 - positive

Previous Vaccinations:

Other Medications: None

Preexisting Conditions:

CDC 'Split Type': WAES0708USA02241

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

0384U

 

IM

LA

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy, Urine human chorionic gonadotropin positive

Write-up: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and drug reactions/allergies who on 15-JUN-2007 was vaccinated with Gardasil (lot# 657617/0384U) "single dose" in the left arm IM. There was no concomitant medication. The patient is currently pregnant. The date of the last menstrual period was in "early June 2007". Medical attention was sought. On an unspecified date the patient had a urine beta-human chorionic gonadotropin test performed and the results were positive. No symptoms have been reported. No further information was available. The estimated date of delivery is 07-MAR-2008. Follow-up information was received from the physician via telephone. The physician reported that the patient was going to be terminating her pregnancy. No further information was provided. Follow up information was received from a registered nurse via telephone. The patient was a white female who was seen in the office on 15-JUN-2007 at which time she was menstruating. The patient reported that she was not sexually active. The patient was vaccinated with Gardasil. On 10-AUG-2007 the patient returned to the office at which time she reported that she had become sexually active. A urine beta-human chorionic gonadotropin test sample was taken which was positive for pregnancy. The patient did not receive the vaccination. On 24-AUG-2007 a telephone call was placed to the patient and the physician''s office was told that the pregnancy had been terminated electively. The patient was reported to be doing well. The nurse reported that the series of vaccinations will be continued when the patient returns to the office. Upon internal review elective abortion is considered to be an other important medical event. Additional information has been requested.


VAERS ID:

290265  

Vaccinated:

2007-05-08

Age:

17.0  

Onset:

2007-05-21, Days after vaccination: 13

Gender:

Female  

Submitted:

2007-09-10, Days after onset: 112

Location:

Unknown  

Entered:

2007-09-11, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data: urine beta-human 05/21/07 posit

Previous Vaccinations:

Other Medications:

Preexisting Conditions: Pregnancy

CDC 'Split Type': WAES0705USA05455

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

DTAP

UNKNOWN MANUFACTURER

 

 

 

RA

HEPA

GLAXOSMITHKLINE BIOLOGICALS

 

 

 

RA

HPV4

MERCK & CO. INC.

0243U

0

IM

LA

VARCEL

MERCK & CO. INC.

 

 

 

RA

 

Administered by: Other     Purchased by: Other

Symptoms: Abortion induced, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Urine human chorionic gonadotropin positive

Write-up: Information has been received from a Merck pregnancy registry for Gardasil via a nurse practitioner concerning a 17 year old female with a history of 1 pregnancy and 1 live birth with drug reactions/allergies reported as none known who on 08-MAY-2007 was vaccinated with the first dose of Gardasil (lot #656372/0243U), 0.5 ml, IM in the left deltoid. On the same day, the patient received concomitant therapy which included HAVRIX in the right deltoid, Dtap in the right arm and Varivax in the right tricep. On 21-MAY-2007, the patient came to the office since she missed her period. A urine pregnancy test was performed with results positive for pregnancy. The patient''s last menstrual period (LMP) was 17-APR-2007 and expected delivery date was 22-JAN-2008. The nurse practitioner stated that the patient initially thought that she may want to obtain an abortion, but she changed her mind. This was the second pregnancy for the patient who had a 9 month old daughter. Follow-up information has been received from the nurse practitioner who reported that the patient elected to terminate the pregnancy at 12 weeks gestation. The patient''s decision was not related to any medical reason. Elected to terminate the pregnancy was considered to be an other important medical event. Additional information is not expected.


VAERS ID:

290872  

Vaccinated:

2007-02-02

Age:

26.0  

Onset:

2007-03-06, Days after vaccination: 32

Gender:

Female  

Submitted:

2007-09-18, Days after onset: 195

Location:

Unknown  

Entered:

2007-09-19, Days after submission: 1

 

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 3/6/2007)

Diagnostic Lab Data: Unknown

Previous Vaccinations:

Other Medications: Unknown

Preexisting Conditions:

CDC 'Split Type': WAES0709USA01893

 

Vaccination

Manufacturer

Lot

Dose

Route

Site

HPV4

MERCK & CO. INC.

 

1

UN

UN

 

Administered by: Other     Purchased by: Other

Symptoms: