|
VAERS ID: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: |
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: Abortion
spontaneous, Drug
exposure during pregnancy |
|
Write-up: Information has been received
from a registered nurse, via a company representative, concerning a 26 year
old female patient, who on 11-DEC-2006, was vaccinated with the first dose of
Gardasil, and on 02-FEB-2007 with the second dose of Gardasil (lot # not
provided). On approximately 06-MAR-2007 ("on or about 06-MAR-2007")
the patient became pregnant. On approximately 26-JUN-2007
("approximately 16 weeks later"), she had a miscarriage. At the
time of this report, the outcome of "had a miscarriage" was
unknown. Upon internal review, "had a miscarriage" was determined
to be serious as an other important medical event. Additional information has
been requested. |
|
VAERS ID: |
Vaccinated: |
2007-05-08 |
|
|
Age: |
16.0 |
Onset: |
2007-06-21,
Days after vaccination: 44 |
|
Gender: |
Female |
Submitted: |
2007-09-17,
Days after onset: 88 |
|
Location: |
California |
Entered: |
2007-09-20,
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=05/20/2007); Anaemia |
|
Diagnostic Lab Data: urine beta-human,
08/16/07, positive; serum alpha-fetoprotein, 09/14/07, abnormal downs
syndrome risk 1:23; urine culture, 09/07/07, WNL; gynecological, Negative for
vaginal bleeding; ultrasound, 10/01/07, for abnormal MSAFP and was within
normal limits |
|
Previous Vaccinations: |
|
Other Medications: CLEOCIN T;
ferrous sulfate 325 mg |
|
Preexisting Conditions: PPD skin
test positive |
|
CDC 'Split Type': WAES0708USA03293 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
AHAVB141AA |
0 |
UN |
UN |
|
HPV4 |
MERCK & CO. INC. |
0011U |
0 |
IM |
UN |
|
VARCEL |
MERCK & CO. INC. |
0115U |
1 |
UN |
UN |
|
Administered by:
Other Purchased by: Other |
|
Symptoms: Alpha
1 foetoprotein increased, Culture
urine, Culture
urine negative, Drug
exposure during pregnancy, Pre-eclampsia,
Pregnancy
test urine positive, Trisomy
21, Ultrasound
scan abnormal, Urinary
tract infection, Urine
human chorionic gonadotropin positive, Vaginal
haemorrhage |
|
Write-up: Information has been
received from the Merck Pregnancy Registry via a nurse practitioner
concerning a 16 year old female with a history of a positive PPD in 2005 who
on 08-MAY-2007 was vaccinated intramuscularly with a 0.5 ml first dose of
Gardasil (654702/0011U). On 10-JUL-2007 the patient was vaccinated with a
second dose of Gardasil (654510/0962F). Concomitant therapy included CLEOCIN
T. Subsequently the patient became pregnant. The patient''s last menstrual
period was on 20-MAY-2007 and the estimated date of delivery will be
24-FEB-2008. On approximately 26-JUN-2007 the patient developed vaginal
spotting for five days. On 16-AUG-2007 a urine pregnancy test was positive.
On an unspecified date the patient was seen for an office visit. At the time
of the report the patient''s outcome was of pregnancy was unknown. Additional
information has been requested. 07/08/08 Initial and follow-up information
has been received from the Merck Pregnancy Registry via a nurse practitioner
concerning a 16 year old female with a history of a positive PPD in 2005 who
on 08-MAY-2007 was vaccinated intramuscularly with a 0.5 ml first dose of
GARDASIL (Lot #654702/0011U). Concomitant vaccinations on the same day
included VARIVAX (Lot #656572/0115U). Other concomitant vaccinations on the
same day included HAVRIX (Lot #AHAVB141AA). On 10-JUL-2007 the patient was
vaccinated with a second dose of GARDASIL (Lot #654510/0962F). Concomitant
therapy included CLEOCIN T. Subsequently the patient became pregnant. The
patient''s last menstrual period was on 20-MAY-2007 and the estimated date of
delivery will be 24-FEB-2008. On approximately 26-JUN-2007 the patient
developed one episode of vaginal spotting for five days. The patient was seen
and treated for a urinary tract infection also. On 16-AUG-2007 a urine
pregnancy test was positive. The patient was seen in the emergency
department, she had a pelvic exam for vaginal bleeding. On an unspecified
date the patient was seen for an office visit. On 07-SEP-2007 a urine c/s was
performed and was found to be within normal limits. The patient recovered
from the urinary tract infection. At the time of the report the patient''s
pregnancy outcome was unknown. Follow-up information was received from the
registered nurse. Concomitant therapy included ferrous sulfate for anemia. On
14-SEP-2007 a maternal serum alpha fetoprotein test was performed and results
was abnormal down''s syndrome risk 1:23. On 01-OCT-2007 an ultrasound was
performed for the abnormal MSAFP and was within normal limits. The patient
had a healthy baby boy weighing 7 pounds 13 ounces, length was 20. The
patient had severe pre-eclampsia during labor/delivery. Additional
information is not expected. 01/07/2008 This is in follow-up to report(s)
previously submitted on 9/17/2007. Initial and follow-up information has been
received from the Merck Pregnancy Registry via a nurse practitioner
concerning a 16 year old female with a history of a positive PPD in 2005 who
on 08-MAY-2007 as vaccinated intramuscularly with a 0.5 ml first dose of
GARDASIL (Lot #654702/0011U). Concomitant vaccinations on the same day
included VARIVAX (Lot #656572/0115U). Other concomitant vaccinations on the
same day included HAVRIX (Lot #AHAVB141AA). On 10-JUL-2007 the patient was
vaccinated with a second dose of GARDASIL (Lot #654510/0962F). Concomitant therapy
included CLEOCIN T. Subsequently the patient became pregnant. The patient''s
last menstrual period was on 20-MAY-2007 and the estimated date of delivery
will be 24-Feb-2008. On approximately 26-JUN-2007 the patient developed one
episode of vaginal spotting for five days. The patient was seen and treated
for a urinary tract infection also. On 16-AUG-2007 a urine pregnancy test was
positive. The patient was seen in the emergency department, she had a pelvic
exam for vaginal bleeding. On an unspecified date the patient was seen for an
office visit. On 07-SEP-2007 a urine c/s was performed and was found to be
within no |
|
VAERS ID: |
Vaccinated: |
0000-00-00 |
|
|
Age: |
|
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2007-09-24 |
|
Location: |
Unknown |
Entered: |
2007-09-25,
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: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0709USA02009 |
|
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
through a Merck Pregnancy registry from an office manager concerning a female
(age not reported) who on an unspecified date was vaccinated with a second
dose of Gardasil. It was reported that the patient had a miscarriage after being
vaccinated with a second dose of Gardasil. Upon internal review, the
patient''s miscarriage was considered an other important medical event.
Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-05-31 |
|
|
Age: |
17.0 |
Onset: |
2007-06-06,
Days after vaccination: 6 |
|
Gender: |
Female |
Submitted: |
2007-09-28,
Days after onset: 114 |
|
Location: |
Wyoming |
Entered: |
2007-10-01,
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: serum beta-human |
|
Previous Vaccinations: |
|
Other Medications: antimicrobial (unspecified);
hormonal contraceptives |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0709USA03460 |
|
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 |
|
Write-up: Information has been received
from Merck Pregnancy Registry for the Gardasil vaccine from a health
professional concerning a 17 year old female patient who on 31-MAY-2007 was
vaccinated with a dose of Gardasil. Concomitant therapy included hormonal
contraceptives (unspecified) and antimicrobial (unspecified). The reporter
reported that patient miscarried on 18-AUG-2007 after receiving the dose of
Gardasil. The estimated date of conception was about 06-JUN-2007. On an
unspecified day laboratory test serum beta-human chorionic gonadotropin test
was done. Unspecified medical attention was sought. The outcome was unknown.
Upon internal review, miscarried was considered an other important medical
event. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-02-20 |
|
|
Age: |
20.0 |
Onset: |
2007-07-24,
Days after vaccination: 154 |
|
Gender: |
Female |
Submitted: |
2007-10-03,
Days after onset: 71 |
|
Location: |
Unknown |
Entered: |
2007-10-04,
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 = 5/16/2007) |
|
Diagnostic Lab Data: None |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0709USA03985 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
induced, Drug
exposure during pregnancy |
|
Write-up: Information has been received
from a nurse practitioner and through a Merck Pregnancy Registry concerning a
20 year old female who on 20-FEB-2007 was vaccinated, intramuscularly with
one dose of Gardasil. The patient discovered she was 9 weeks pregnant on
18-JUL-2007 with an estimated last menstrual period of approximately
16-MAY-2007. The pregnancy was terminated on 24-JUL-2007. It was reported
that the termination was not due to Gardasil. No further information is
available. Upon internal review termination of pregnancy was considered an
other important medical event. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-07-24 |
|
|
Age: |
24.0 |
Onset: |
2007-07-24,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-10-08,
Days after onset: 76 |
|
Location: |
North
Carolina |
Entered: |
2007-10-09,
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=6/24/2007),
Drug hypersensitivity |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0710USA00945 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Uterine
dilation and curettage |
|
Write-up: Information has been received via
the Merck Pregnancy registry, from a registered nurse, a 24 year old female
with a drug hypersensitivity to morphine, who was unknowingly pregnant (LMP
date of 24-JUN-2007) when on 24-JUL-2007 she was vaccinated with the first
dose of Gardasil (lot # not provided). On 17-SEP-2007 the nurse reported that
she "started to miscarry," and consequently underwent an outpatient
dilation & curettage (D & C) procedure. The fetus was at 8 weeks
gestation at the time of the miscarriage. At the time of this report, the
patient had recovered (duration not specified). The nurse considered
miscarriage to be serious as an other important medical event. Additional
information has been requested. |
|
VAERS ID: |
Vaccinated: |
2006-11-30 |
|
|
Age: |
22.0 |
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2007-10-12 |
|
Location: |
Ohio |
Entered: |
2007-10-15,
Days after submission: 3 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? Yes |
|
Hospitalized? Yes, 0 days |
|
Extended
hospital stay? No |
|
Current Illness: |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: Papanicolaou smear abnormal |
|
CDC 'Split Type': WAES0710USA01461 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Drug
exposure during pregnancy, Induced
labour, Intra-uterine
death, Premature
labour |
|
Write-up: Information has been received
from a physician concerning a 22 year old female with a history of abnormal
papanicolaou smears with no treatment who on 30-NOV-2006 was vaccinated with
a first dose of Gardasil. On 07-JAN-2007, the patient tested positive for
pregnancy (type unspecified). The date of her last menstrual period was not
reported. Medical attention was sought. On an unspecified date in 2007, at 19
weeks gestation, the mother''s "water broke", and she was taken to
the hospital where labor was induced. The baby did not live. At the time of
reporting, the status of the mother was unspecified. Additional information
has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-05-30 |
|
|
Age: |
14.0 |
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2007-10-12 |
|
Location: |
Unknown |
Entered: |
2007-10-15,
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: |
|
Previous Vaccinations: |
|
Other Medications: |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0710USA00779 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0960F |
0 |
UN |
UN |
|
MNQ |
SANOFI
PASTEUR |
|
|
UN |
UN |
|
TTOX |
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 physician through the Merck Pregnancy Registry concerning a 14 year
old female who on 30-MAY-2007 was vaccinated IM with a first 0.5 ml dose of
Gardasil (lot # 654535/0960F). Concomitant therapy on 30-MAY-2007 included
Menactra and tetanus toxoid. A second 0.5 ml IM dose of Gardasil (lot # 654535/0960F).
Subsequently the patient had a miscarriage at 9 weeks. Upon internal review,
miscarriage was considered an other important medical event. Additional
information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-07-31 |
|
|
Age: |
17.0 |
Onset: |
2007-08-15,
Days after vaccination: 15 |
|
Gender: |
Female |
Submitted: |
2007-09-17,
Days after onset: 33 |
|
Location: |
Kansas |
Entered: |
2007-09-20,
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 = 6/26/2007);
Acne |
|
Diagnostic Lab Data: |
|
Previous Vaccinations: |
|
Other Medications: BENZACLIN |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0708USA03726 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0243U |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abdominal
pain, Abortion
induced, Drug
exposure during pregnancy, Ultrasound
scan |
|
Write-up: Information has been received
from a nurse concerning a 17 year old female with acne with a history of 0
pregnancies and 0 live births who on 31-JUL-2007 was vaccinated IM with the
first dose of with Gardasil included benzoyl peroxide (+) clindamycin
phosphate (BENZACLIN), gel BID for the treatment of acne. On 15-AUG-2007 the
patient experienced abdominal pain and an ultrasound was performed which
confirmed a pregnancy. it was believed that the patient was 7 weeks pregnant
and that her due date was 01-APR-2008. At the time of this report it was
unknown if the patient had recovered from the abdominal pain. Additional
information has been requested. This is in follow-up to report(s) previously
submitted on 9/17/2007. Follow up information was received from the nurse
which stated that on 24-AUG-2007 the patient had an elective abortion.
Additional information was not provided. At the time of the report the
patient had recovered from the event. Upon internal medical review the elective
abortion was considered to be an other medical event. Additional information
has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-03-29 |
|
|
Age: |
33.0 |
Onset: |
2007-04-01,
Days after vaccination: 3 |
|
Gender: |
Female |
Submitted: |
2007-10-15,
Days after onset: 197 |
|
Location: |
Unknown |
Entered: |
2007-10-16,
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: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0710USA02359 |
|
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, Inappropriate
schedule of drug administration, Uterine
dilation and curettage |
|
Write-up: Information has been received for
pregnancy Registry for Gardasil from a Certified Medical Assistant (C.M.A)
concerning a 33 year old female patient who on 29-MAR-2007 was vaccinated
with a first dose of Gardasil and on 26-APR-2007, received her second dose of
Gardasil. The patient was discovered to be pregnant in July (date
unspecified). In August there was no fetal heartbeat detected (date
unspecified). The patient had a Dialation and curettage (D & C) on
18-SEP-2007 and post D & C visit on 04-OCT-2007. It was unclear if any
fetal tissue was recovered and what the cause of the termination of
pregnancy. No other information to report. On 04-OCT-2007 patient recovered.
Upon internal review, miscarriage was determined other medical event (OME)
category. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-08-14 |
|
|
Age: |
|
Onset: |
2007-08-14,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-10-17,
Days after onset: 64 |
|
Location: |
Unknown |
Entered: |
2007-10-18,
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: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0710USA02985 |
|
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 via
the Merck Pregnancy registry from a consumer, concerning her daughter (age
not specified) who was pregnant when vaccinated on 14-AUG-2007, with a dose
of Gardasil (lot # not specified). The mother stated that "the fetus had
no heartbeat," and indicated that her daughter had a miscarriage (date
not provided). At the time of this report, the outcome of miscarriage was
unknown. The consumer''s daughter sought unspecified medical attention from
her physician. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-04-01 |
|
|
Age: |
25.0 |
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2007-10-18 |
|
Location: |
Unknown |
Entered: |
2007-10-19,
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 = 7/9/2007) |
|
Diagnostic Lab Data: None |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0708USA04042 |
|
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: Initial and follow-up information
has been received through the Merck pregnancy registry from a 25 year old
female, who in approximately April 2007, was vaccinated with a second dose of
Gardasil. There was no concomitant medication. Subsequently the patient
became pregnant. The patient''s last menstrual period was 09-Jul-2007, with
an estimated date of delivery was 14-Apr-2008. Subsequently, on an
unspecified date, the patient had a miscarriage at 10 weeks. Upon internal
review, miscarriage was considered to be an other important medical event.
Additional information is not expected. |
|
VAERS ID: |
Vaccinated: |
2007-04-24 |
|
|
Age: |
25.0 |
Onset: |
2007-09-20,
Days after vaccination: 149 |
|
Gender: |
Female |
Submitted: |
2007-10-18,
Days after onset: 28 |
|
Location: |
Delaware |
Entered: |
2007-10-19,
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 = 7/7/2007)
Headache; Depression |
|
Diagnostic Lab Data: ultrasound 09/17/07 -
bleeding-fetal demise |
|
Previous Vaccinations: |
|
Other Medications: CELEXA; FLEXERIL |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0708USA01727 |
|
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, Haemorrhage,
Ultrasound
scan abnormal |
|
Write-up: Initial and follow-up information
has been received from a 25 year old female with headaches, depression, and
no drug allergies, who on 23-FEB-2007 and 24-APR-2007 was vaccinated with a
first dose and second dose of Gardasil, respectively. Concomitant medication
included citalopram hydrobromide (CELEXA) and cyclobenzaprine hydrochloride
(MSD). Subsequently, after receiving the first two vaccinations the patient
reported she was 5 weeks pregnant. It was noted that the patient discontinued
the dosing schedule. The patient''s last menstrual period was 07-JUL-2007,
the estimated conception date was approximately 21-JUL-2007, and the
estimated delivery date was approximately 14-APR-2007. On 17-SEP-2007 the
patient had an ultrasound due to bleeding and the results of the test were
reported as fetal demise. On 20-SEP-2007 the patient had a spontaneous
abortion at 10 weeks. The products of conception were examined and reported
as immature chorionic villi with decidua. It was unknown if the fetus was
normal. The patient did not have any previous pregnancies. 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: |
Vaccinated: |
2007-04-25 |
|
|
Age: |
17.0 |
Onset: |
2007-04-25,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-10-22,
Days after onset: 180 |
|
Location: |
Michigan |
Entered: |
2007-10-23,
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 = 3/27/2007) |
|
Diagnostic Lab Data: |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0705USA00693 |
|
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
through the Merck pregnancy registry and from a mother of a 17 year old
female patient who on 25-APR-2007 was vaccinated IM with a second 0.5ml dose
of Gardasil (date unknown of first injection). On 25-APR-2007, the patient
discovered she was pregnant. (date of LMP = 27-MAr-2007). Follow up
information stated that on approximately 13-MAY-2007, the patient had a
spontaneous abortion. She was approximately 7 weeks from her LMP. It was
unknown if the products of conception were examined or if the fetus was
normal. At the time of this report, the patient''s outcome was unknown. Upon
internal review spontaneous abortion was considered to be an other important
medical event. Additional information is not expected. |
|
VAERS ID: |
Vaccinated: |
2007-09-14 |
|
|
Age: |
18.0 |
Onset: |
2007-06-11,
Days after vaccination: -95 |
|
Gender: |
Female |
Submitted: |
2007-10-24,
Days after onset: 135 |
|
Location: |
Texas |
Entered: |
2007-10-25,
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 = 8/14/2007);
Drug hypersensitivity |
|
Diagnostic Lab Data: ultrasound 09/17/07 - 4w/6d sac;
beta-human chorionic 09/14/07 - positive |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0709USA02456 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
1447f |
2 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Inappropriate
schedule of drug administration, Pregnancy
test positive, Ultrasound
scan |
|
Write-up: Information has been received
from the Merck Pregnancy Registry via a physician concerning an 18 year old
female with no previous pregnancies and a drug hypersensitivity to codeine
who 28-FEB-2007 was vaccinated with a first dose of Gardasil (lot
#655617/1447F). On 11-JUN-2007, the patient was vaccinated with a second dose
of Gardasil (lot #655617/1447F). On 14-SEP-2007, the patient was vaccinated
IM with a third 0.5 ml dose of Gardasil (lot #655617/1447F). There was no
concomitant medication. On 14-SEP-2007, the patient had a positive pregnancy
test. The patient''s last menstrual period was 14-AUG-2007 and the estimated
date of delivery was 20-MAY-2008. On 17-SEP-2007 and ultrasound revealed the
patient was 4 weeks and 6 days with sac. On 03-OCT-2007, the patient had a
spontaneous abortion. Upon internal review, spontaneous abortion was
considered to be an other important medical event. Additional information has
been requested. |
|
VAERS ID: |
Vaccinated: |
2007-05-29 |
|
|
Age: |
|
Onset: |
2007-06-01,
Days after vaccination: 3 |
|
Gender: |
Female |
Submitted: |
2007-10-24,
Days after onset: 145 |
|
Location: |
Colorado |
Entered: |
2007-10-25,
Days after submission: 1 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? Yes |
|
ER or Doctor Visit? Yes |
|
Hospitalized? Yes, 0 days |
|
Extended
hospital stay? No |
|
Current Illness: Pregnancy NOS (LMP = Unknown) |
|
Diagnostic Lab Data: beta-human chorionic 06/01/07
posit |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0710USA03992 |
|
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, Pregnancy
test positive |
|
Write-up: Information has been received
from a Merck pregnancy registry from a nurse concerning herself. She reported
that on 21-APR-2007 she was vaccinated IM with the first dose of Gardasil
(Lot#0641B). On 29-MAY-2007 she received the second dose of Gardasil (Lot#
not provided). On 01-JUN-2007 she learned she was four weeks pregnant and
experienced viral vaccine exposure during pregnancy. On 28-JUN-2007 the
patient experienced a miscarriage and was hospitalized. Unspecified medical
attention was sought. Subsequently, the patient recovered from the
miscarriage. Upon internal medical review the spontaneous abortion was
considered an other medical event. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-08-06 |
|
|
Age: |
19.0 |
Onset: |
2007-08-06,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-10-25,
Days after onset: 80 |
|
Location: |
Unknown |
Entered: |
2007-10-27,
Days after submission: 2 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? No |
|
Hospitalized? No |
|
Current Illness: Pregnancy NOS (LMP = 7/14/2007)
Contraception |
|
Diagnostic Lab Data: Ultrasound 09/04/07 - fetus less
than five weeks; urine beta-human 09/04/07 +; Pap test ?/?/05 - abnormal;
serum alpha-human 09/10/07 4379; Pap test ?/?/06 - abnormal; Pap test ?/?/07
- abnormal |
|
Previous Vaccinations: |
|
Other Medications: NUVARING |
|
Preexisting Conditions: Cervical intraepithelial
neoplasia; Loop electrosurgical excision procedure |
|
CDC 'Split Type': WAES0709USA00258 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0212U |
2 |
IM |
UN |
|
Administered by: Unknown Purchased by: Unknown |
|
Symptoms: Abortion
spontaneous, Blood
human chorionic gonadotropin positive, Drug
exposure during pregnancy, Smear
cervix abnormal, Ultrasound
scan abnormal, Urine
human chorionic gonadotropin positive |
|
Write-up: Initial and follow-up information
has been received from a health professional concerning a 19 year old female
with no known allergies and a history of cervical intraepithelial neoplasia
and loop electrosurgical excision procedures in May 2005, April 2006, and
April 2007, who on 03-APR-2007 was vaccinated with the second dose of
Gardasil (Lot #0212U). On 06-AUG-2007, the patient was vaccinated with the
third dose of Gardasil (Lot #0212U). Concomitant therapy included ethinyl estradiol
(+) etonogestrel (NUVARING). Prior to the third vaccination, the patient''s
method of birth control, ethinyl estradiol (+) etonogestrel had been
discontinued and the patient was going to change to drospirenone (+) ethinyl
estradiol (YAZ). The patient was instructed to take precautionary measures
until that was started. On 04-SEP-2007, the patient was seen in the clinic
and tested positive for pregnancy. An internal exam was performed and a urine
pregnancy test was positive. An ultrasound showed that that fetus was less
than five weeks. On 10-SEP-2007, a serum HCG was 4379. The patient''s
estimated was approximately 14-JUL-2007 (previously reported as 23-JUL-2007);
estimated EDC 28-APR-2008. Follow-up information indicated that the patient
had a spontaneous abortion (miscarriage) on 13-OCT-2007. Additional
information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-05-25 |
|
|
Age: |
24.0 |
Onset: |
2007-05-25,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-10-26,
Days after onset: 154 |
|
Location: |
Pennsylvania |
Entered: |
2007-10-29,
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 = 5/20/2007);
Seasonal allergy; Penicillin allergy; Drug hypersensitivity |
|
Diagnostic Lab Data: ultrasound 07/13/03 - within
normal limits |
|
Previous Vaccinations: |
|
Other Medications: vitamins (unspecified) |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0707USA02337 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0388U |
1 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
induced, Drug
exposure during pregnancy, Ultrasound
scan normal |
|
Write-up: Initial and follow-up information
has been received through the Merck pregnancy registry from two Licensed
Practical Nurses concerning a 24 year old female with seasonal allergies and
allergies to penicillin, codeine, z pak, and ceftan who on 27-MAR-2007 was
vaccinated IM with 0.5 mL of the first dose of Gardasil (Lot #655503/0012U).
On 25-MAY-2007 the patient received the second dose of Gardasil (lot
#657622/0388U). Concomitant medication included prenatal vitamins. The
patient reported that she is now pregnant. Unspecified medical attention was
sought. On 13-JUL-2007 the patient had an ultrasound reported as within
normal limits. The patient''s last menstrual period was 20-MAY-2007. The
estimated date of delivery was 24-FEB-2008. Follow-up information indicated
that in October 2007 the patient had an elective termination 20 weeks from
her last menstrual period. The products of conception were underprocess of
being examined. The fetus was not normal due to anencephaly with a heart
defect. At the time of the report, the patient''s outcome was unknown.
Additional information is not expected. |
|
VAERS ID: |
Vaccinated: |
2007-01-05 |
|
|
Age: |
20.0 |
Onset: |
2007-01-05,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-10-30,
Days after onset: 297 |
|
Location: |
Massachusetts |
Entered: |
2007-10-31,
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 = 12/5/2006);
Ovarian cyst |
|
Diagnostic Lab Data: ultrasound 01/17/07 - 6 weeks, 1
day intrauterine pregnancy; urine beta-human 01/16/07 - positive |
|
Previous Vaccinations: |
|
Other Medications: Necon 1/35 |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0701USA03047 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0868F |
0 |
UN |
RA |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
induced, Drug
exposure during pregnancy, Ultrasound
scan abnormal, Urine
human chorionic gonadotropin positive |
|
Write-up: Information has been received
from a registered nurse through the Merck pregnancy registry concerning a 20
year old female with an ovarian cyst of left ovary (28-NOV-2006) who on
05-JAN-2007 was vaccinated in the right upper arm with a first dose of
Gardasil (lot 653736/0868F). Concomitant therapy included ethinyl
estradiol/norethidrone (NECON 1/35). On the day the patient was vaccinated
with Gardasil she was being seen at the clinic for follow up for a cyst of
her left ovary. At that time, the patient though she was beginning her period
cycle. The patient also had a prescription for birth control, but it was
found out that she stopped taking them on an unspecified date. The patient
called the clinic on 16-JAN-2007 stating that she performed a urine home
pregnancy test which was positive. On 17-JAN-2006, she was seen at the
clinic. An ultrasound was performed and results revealed patient was 6 weeks,
1 day intrauterine pregnancy. The patient told the resident physician that
this was an unplanned and undesired pregnancy, and she would be terminating
the pregnancy. On 12-FEB-2007, at 8 weeks gestation, the patient terminated
the pregnancy. The patient continued with the Gardasil series having received
3 doses. Upon internal review, the patient''s induced abortion was considered
an other important medical event. No additional information is expected. |
|
VAERS ID: |
Vaccinated: |
2007-04-18 |
|
|
Age: |
16.0 |
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2007-10-30 |
|
Location: |
California |
Entered: |
2007-10-31,
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 = 3/7/2007) |
|
Diagnostic Lab Data: None |
|
Previous Vaccinations: |
|
Other Medications: |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0704USA04145 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0181U |
|
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion,
Drug
exposure during pregnancy |
|
Write-up: Information has been received
from a physician concerning a 16 year old female with no known medical
history or drug allergies who on 18-APR-2007 was vaccinated intramuscularly
with a dose of Gardasil (Lot # 656371/0181U) while pregnant. Concomitant
vaccinations included Menactra and DTaP. The patient''s last menstrual period
was "6 weeks ago" and her estimated date of delivery is 12-DEC-2007.
No symptoms had been reported. No laboratory diagnostic tests were performed.
Subsequently, on an unspecified date, the patient had an abortion. At the
time of this report, the patient''s outcome was unknown. No product quality
complaint was involved. No further information is available. |
|
VAERS ID: |
Vaccinated: |
2007-07-05 |
|
|
Age: |
|
Onset: |
2007-10-23,
Days after vaccination: 110 |
|
Gender: |
Female |
Submitted: |
2007-10-30,
Days after onset: 7 |
|
Location: |
Washington |
Entered: |
2007-10-31,
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: total serum human ?/?/07 -
pregnant; complete blood cell ?/?/07; erythrocyte ABO antigen ?/?/07;
erythrocyte Rh antigen ?/?/07 |
|
Previous Vaccinations: |
|
Other Medications: Ortho Tri-Cyclen Lo |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0710USA05709 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
|
IM |
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, Red
blood cell scan |
|
Write-up: Information has been received via
the Merck Pregnancy registry, from a registered nurse, concerning a female
patient (age not specified) who on 05-JUL-2007 was vaccinated with a dose of
Gardasil (lot # not provided). Concomitant therapy included ethinyl
estradiol/noregestimate (ORTHO TRI-CYCLEN LO). On an unknown date, the
patient became pregnant (gestation details not provided), and on 23-OCT-2007
she had miscarriage. She was treated in the physician''s office (details not
provided). At the time of this report, the patient was recovering from the
miscarriage. Upon internal review, the event of miscarriage was considered to
be an other important medical event. Additional information has been
requested. |
|
VAERS ID: |
Vaccinated: |
2007-09-10 |
|
|
Age: |
22.0 |
Onset: |
2007-10-08,
Days after vaccination: 28 |
|
Gender: |
Female |
Submitted: |
2007-10-31,
Days after onset: 23 |
|
Location: |
Kansas |
Entered: |
2007-11-01,
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 = 08/27/2007);
Papilloma viral infection; Depression |
|
Diagnostic Lab Data: beta-human chorionic 10/08/07 -
positive |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0710USA04863 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
1060U |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Blood
human chorionic gonadotropin positive, Drug
exposure during pregnancy |
|
Write-up: Information has been received
from a registered nurse concerning a 22 year old female with papilloma viral
infection, depression, and no drug allergies, who on 10-SEP-2007 was
vaccinated intramuscularly with a first dose of Gardasil (Lot# 658556/1060U).
There was no concomitant medication. Subsequently, the patient believed that
she had become pregnant on the same day as the vaccination. On 08-OCT-2007 a
pregnancy test was performed and was positive. The patient''s last menstrual
period was 27-AUG-2007 and her estimated delivery date was 02-JUN-2008. On
20-OCT-2007 the patient had a miscarriage. No other symptoms were noted. The
patient had an office visit. At the time of the report, the patient''s
outcome was unknown. No product quality complaint was involved. Upon internal
review miscarriage was considered to be an other important medical event.
Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2006-12-18 |
|
|
Age: |
25.0 |
Onset: |
2006-12-18,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-10-31,
Days after onset: 316 |
|
Location: |
Florida |
Entered: |
2007-11-01,
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 = 12/9/2006);
Drug hypersensitivity |
|
Diagnostic Lab Data: urine beta-human - positive;
serum beta-human - waiting for results |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0701USA01391 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
|
UN |
UN |
|
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 physician and a
nurse concerning a 25 year old female with drug hypersensitivity to aspirin
with a history of 3 pregnancies and 1 live birth (2 terminations of pregnancy)
who on 18-DEC-2006 was vaccinated with a first 0.5 ml dose of Gardasil (lot
reported as "1101F"). There was no concomitant medication. On an
unspecified date, the patient took a home pregnancy test and it was positive.
On 09-JAN-2007 the patient was seen in the physician''s office and blood test
was drawn for pregnancy (results not reported). The patient''s last menstrual
period was 09-DEC-2006 and estimated date of delivery is 15-SEP-2007. The
physician reported that he was going to tell the patient to terminate the
pregnancy. Follow-up reported that on an unspecified date the patient
terminated the pregnancy. Upon internal review, terminated pregnancy was
considered to be an other important medical event. Additional information has
been requested. |
|
VAERS ID: |
Vaccinated: |
2007-01-30 |
|
|
Age: |
22.0 |
Onset: |
2007-01-30,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-11-05,
Days after onset: 279 |
|
Location: |
Wyoming |
Entered: |
2007-11-06,
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 = 1/8/2007);
Hypothyroidism; Depression |
|
Diagnostic Lab Data: ultrasound 02/19/07 - NL;
diagnostic laboratory; beta-human chorionic; Chlamydia trachomatis; thyroid
function test |
|
Previous Vaccinations: |
|
Other Medications: Wellbutrin 150 mg; Synthroid 0.2
mg |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0703USA01556 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
1427F |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
induced, Blood
human chorionic gonadotropin positive, Chlamydia
serology, Drug
exposure during pregnancy, Laboratory
test, Thyroid
function test, Ultrasound
scan normal |
|
Write-up: Information has been received
through the Merck pregnancy registry from a registered nurse concerning a 22
year old female with no drug reactions/allergies, hypothyroidism, depression
and a history of 3 pregnancies and 3 live birth who on 30-JAN-2007 was
vaccinated with the first dose of Gardasil IM in right deltoid (Lot #
65519/1427F). Concomitant therapy included levothyroxine Na (SYNTHROID) and
bupropion HCl (WELLBUTRIN). The patient was found to be pregnant (LMP
08-JAN-2007). The estimated delivery date was reported as 16-OCT-2007. A
pregnancy test, chlamydia culture, thyroid level and wellness screening panel
were done (results not reported). An ultrasound done on 19-FEB-2007 for
prenatal care and was noted to be normal. Additional information indicated
that in April, 2007, week from LMP 12, the patient had an elective
termination of pregnancy. It was unknown whether the fetus was normal and the
products of conception examined. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-08-01 |
|
|
Age: |
19.0 |
Onset: |
2007-09-01,
Days after vaccination: 31 |
|
Gender: |
Female |
Submitted: |
2007-11-09,
Days after onset: 69 |
|
Location: |
Unknown |
Entered: |
2007-11-12,
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: None |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0711USA01374 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Drug
exposure during pregnancy, Foetal
disorder, Intra-uterine
death |
|
Write-up: Information has been received for
the Merck Pregnancy Registry for Gardasil from a 20 year old female with no
pertinent medical history or drug reactions/allergies who in August 2007, was
vaccinated with a first dose of Gardasil (lot# unknown) 0.5 mL injection.
There was no concomitant medication. On an unspecified date, the beginning of
September 2007, the patient became pregnant. Seven weeks into the pregnancy
the development of the baby had stopped and the baby was pronounced dead. The
patient can not miscarriage until 12 weeks into the pregnancy which she had
an appointment not do so the week of 12-NOV-2007 but the day of the week was
unknown. The patient was supposed to receive her second dose of Gardasil on
09-OCT-2007, around the same time 06-OCT-2007 "4 weeks ago" the
baby was pronounced dead, which makes her think Gardasil and the baby''s
death is a coincidence. No further information was provided. The patient''s
last menstrual period was unknown but the patient is 11 weeks pregnant. Upon
internal review intra-uterine death and fetal disorder was considered to be
an other medical event (OME) Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
0000-00-00 |
|
|
Age: |
16.0 |
Onset: |
2007-05-25 |
|
Gender: |
Female |
Submitted: |
2007-11-09,
Days after onset: 168 |
|
Location: |
Arkansas |
Entered: |
2007-11-12,
Days after submission: 3 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? Yes |
|
ER or Doctor Visit? No |
|
Hospitalized? No |
|
Current Illness: Penicillin allergy |
|
Diagnostic Lab Data: None |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0711USA00909 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy |
|
Write-up: Information has been received
from a 16 year old female consumer with no previous medical history, and an
allergy to penicillin, who was vaccinated at an unknown date, with the first
dose of Gardasil. There was no concomitant medication. The patient reported
that she did not know that she was one week pregnant at the time of
vaccination. On 25-May-2007 she found out that she was pregnant. It was
reported that on 25-Jul-2007 the patient had a miscarriage. Unknown medical
attention was sought. The patient was recovered. No product quality complaint
was involved. Upon internal review miscarriage considered to be an other
important medical event. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
0000-00-00 |
|
|
Age: |
17.0 |
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2007-11-13 |
|
Location: |
Unknown |
Entered: |
2007-11-14,
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) |
|
Diagnostic Lab Data: |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0711USA01459 |
|
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''s assistant concerning a 17 year old female who, on an
unspecified date, was vaccinated with Gardasil. Three weeks after the vaccination,
the patient experienced a miscarriage. The patient was not known to be
pregnant at the time the vaccine was administered. The patient was examined
in a local emergency room, but no details are available. The patient was
examined in the office as follow-up, but no details were provided. Upon
internal review, miscarriage was determined to be an other important medical
event. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-02-01 |
|
|
Age: |
19.0 |
Onset: |
2007-04-01,
Days after vaccination: 59 |
|
Gender: |
Female |
Submitted: |
2007-11-20,
Days after onset: 233 |
|
Location: |
New
Jersey |
Entered: |
2007-11-23,
Days after submission: 3 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? Yes |
|
Hospitalized? Yes, days |
|
Extended
hospital stay? No |
|
Current Illness: Pregnancy NOS (LMP = Unknown) |
|
Diagnostic Lab Data: diagnostic laboratory |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0706USA02481 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
2 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abdominal
pain, Abortion
spontaneous, Drug
exposure during pregnancy, Intra-uterine
death, Laboratory
test |
|
Write-up: Information has been received
through the Merck pregnancy registry, from a physician, concerning a 19 year
old female who in March 2007, was vaccinated with a second dose of Gardasil.
Subsequently the patient received her two doses of the vaccine and then
became pregnant. Unspecified medical attention was sought. Follow up
information received from the mother of the patient, indicated that in
September 2006, her daughter received the first dose of Gardasil, on an
unknown date the second dose, and in February 2007 the third dose of Gardasil
(lot #''s not provided). She reported her daughter became pregnant in April
2007. In November, when 7 months pregnant, her daughter was admitted to the
hospital for abdominal pain, and on 04-NOV-2007, she "lost her
baby." The child "had no heartbeat and was dead for a week in her
womb. The child was not fully formed." She added that the fetus''s eyes,
ears and nose were not fully developed. Her daughter remained in the hospital
for "about a week." At the time of this report, she was recovering
from the event. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-05-14 |
|
|
Age: |
20.0 |
Onset: |
2007-09-22,
Days after vaccination: 131 |
|
Gender: |
Female |
Submitted: |
2007-11-30,
Days after onset: 69 |
|
Location: |
California |
Entered: |
2007-11-30,
Days after submission: 0 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? Yes |
|
Hospitalized? No |
|
Current Illness: Pregnancy NOS (LMP=6/26/2007) |
|
Diagnostic Lab Data: ultrasound 09/19/07 results-8
weeks and 4 days pregnancy, beta-human chorionic 09/05/07 positive, serum
beta-human 09/06/07 positive |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0710USA03414 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0089U |
1 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
induced, Blood
human chorionic gonadotropin positive, Drug
exposure during pregnancy, Ultrasound
uterus, Urine
human chorionic gonadotropin positive |
|
Write-up: Information has been received
from a physician concerning a female (age not reported) with no known medical
history and/or drug reactions/allergies who on 02-MAR-2007 was vaccinated
intramuscularly with the first 0.5 mL dose of Gardasil (lot # 653736/0868F).
On 14-MAY-2007 the patient was vaccinated with the second dose of Gardasil
(lot # 655324/0089U). The physician reported that the patient had intercourse
in early August 2007. On 05-SEP-2007 the patient took a home pregnancy test
which was positive. She contacted her doctor. On 06-SEP-2007 a serum
pregnancy test was performed with positive results. On 19-SEP-2007 the
patient had an ultrasound done which showed that she was 8 weeks and 4 days
pregnant. On 22-SEP-2007 the pregnancy was terminated. The patient''s status
was not reported. There was no product quality complaint. Additional
information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-09-20 |
|
|
Age: |
14.0 |
Onset: |
2007-10-02,
Days after vaccination: 12 |
|
Gender: |
Female |
Submitted: |
2007-11-30,
Days after onset: 59 |
|
Location: |
North
Carolina |
Entered: |
2007-12-03,
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: beta-human chorionic 09/25/07 -
Positive |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0711USA03166 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0384U |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion,
Blood
human chorionic gonadotropin positive, Drug
exposure during pregnancy |
|
Write-up: Initial and follow-up information
has been received from the Merck Pregnancy Registry via a licensed practical
nurse concerning a 14 year old female with no pertinent medical history who
on 20-SEP-2007 was vaccinated intramuscularly with a first dose of Gardasil
(lot #657617/0384U). There was no concomitant medication. On 25-SEP-2007, the
patient was found to be pregnant with a positive Pregnancy test at the
office. Follow-up information received from the licensed practical nurse
reported that the patient had an abortion at approximately 5 weeks gestation.
The licensed practical nurse reported that the abortion was for reasons other
than therapy with Gardasil, including that the patient was only 14 years old.
Upon internal review, abortion was considered to be an other important
medical event. Additional information is not expected. |
|
VAERS ID: |
Vaccinated: |
0000-00-00 |
|
|
Age: |
|
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2007-11-30 |
|
Location: |
New
York |
Entered: |
2007-12-03,
Days after submission: 3 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
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': WAES0711USA04825 |
|
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 as
part of a pregnancy registry from a physician concerning a female who was
vaccinated with Gardasil. As of 26-NOV-2007, the patient "recently"
miscarried. Upon interval review, spontaneous abortion was determined to be
an other important medical event. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-10-20 |
|
|
Age: |
22.0 |
Onset: |
2007-10-20,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-11-30,
Days after onset: 41 |
|
Location: |
Unknown |
Entered: |
2007-12-03,
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: None |
|
Previous Vaccinations: |
|
Other Medications: Zoloft, Ambien |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0711USA04956 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
||||
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy |
||||
|
Write-up: Information has been received
through the pregnancy registry through a 22 year old female who on
20-OCT-2007 was vaccinated with her first dose of Gardasil. Concomitant
therapy included sertraline HCl (ZOLOFT) and zolpidem tartrate (AMBIEN). On
approximately 27-OCT-2007 the patient found out she was pregnant (not further
specified). On approximately 24-NOV-2007 the patient experienced a
miscarriage. The patient sought unspecified medical attention with a
physician. Upon internal review, miscarriage was determined to be an other
important medical event. No additional information is expected. |
||||
|
VAERS ID: |
Vaccinated: |
2007-07-24 |
|
|
|
Age: |
17.0 |
Onset: |
2007-09-20,
Days after vaccination: 58 |
|
|
Gender: |
Female |
Submitted: |
2007-12-04,
Days after onset: 75 |
|
|
Location: |
Unknown |
Entered: |
2007-12-05,
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)
Anaemia; Vaginitis trichomonal |
|
Diagnostic Lab Data: ultrasound 09/24/07
reason-bleeding result-empty gestational sac vs. an embryonic pregnancy
implying early spontanoeus, urine beta-human |
|
Previous Vaccinations: |
|
Other Medications: ferrous sulfate 325 mg;
metronidazole 500 mg; metronidazole 500 mg; vitamins (unspecified) |
|
Preexisting Conditions: Termination of pregnancy-elective |
|
CDC 'Split Type': WAES0709USA03260 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0525U |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Anaemia,
Blighted
ovum, Drug
exposure during pregnancy, Haemorrhage,
Ultrasound
uterus, Urine
human chorionic gonadotropin positive |
|
Write-up: Initial and follow-up information
has been received from a nurse practitioner through the pregnancy registry
concerning a 17 year old female with a history of an elective termination of
a previous pregnancy, and with borderline anaemia, Trichomonas, and no drug
allergies, who on 24-JUL-2007 was vaccinated intramuscularly with a 0.5mL
first dose of Gardasil. Concomitant therapy included vitamins (unspecified),
ferrous sulfate, and metronidazole. Subsequently, the patient was determined
to be pregnant. No problems were reported. The patient''s last menstrual
period was reported as the end of June 2007. The patient was examined in the
office. On 20-SEP-2007 the patient had a spontaneous abortion approximately
"10 to 12 weeks" from the last menstrual period. The methods of
conception were not examined. During the pregnancy the patient had
Trichomonas which was treated with metronidazole 500mg, two times a day for 7
days. The treatment was started on 24-JUL-2007 and 20-SEP-2007. On
24-SEP-2007 an ultrasound was performed due to bleeding and the results
showed empty gestational sac versus an embryonic pregnancy implying that an
early spontaneous abortion was in progress. The patient had one previous
pregnancy that resulted in an elective termination. At the time of the
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: |
Vaccinated: |
2007-07-23 |
|
|
Age: |
|
Onset: |
2007-07-23,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-12-06,
Days after onset: 136 |
|
Location: |
Unknown |
Entered: |
2007-12-07,
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 = 6/19/2007);
Drug hypersensitivity; Contraception; Rhesus antibodies negative |
|
Diagnostic Lab Data: urine beta-human - pregnant |
|
Previous Vaccinations: |
|
Other Medications: Ortho tri-cyclen |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0709USA00106 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
1424F |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Drug
exposure during pregnancy, Pregnancy
test positive, Stillbirth
|
|
Write-up: Initial and follow up information
has been received via the Merck pregnancy registry, from a physician''s
assistant (PA), concerning a female patient (birthdate invalid; age
previously reported as age 11), with a drug hypersensitivity to DEPAKOTE and
no previous pregnancies, who had her LMP on 19-JUN-2007, and on 23-JUL-2007
was vaccinated IM with the first dose, 0.5 ml, of Gardasil (Lot #
654885/1424F). Concomitant therapy included ORTHO TRI-CYCLEN. Following the
vaccination (date not specified) the patient had a positive urine pregnancy
test confirming that she was pregnant (estimated date of delivery was
25-MAR-2008). Follow up information received from the PA reported that on
approximately 13-NOV-2007 ("21 weeks from LMP"), the patient
experienced the death/stillbirth of her fetus (details not provided). It was
unknown if the fetus was normal, or if the products of conception were
examined. The sex of the fetus was not reported. The PA noted that the
patient had a blood type of Rh negative (type A-), and the paternal blood
type was Rh positive. No further details were provided. The PA added that the
patient had married and moved (address not provided). The patient sought
unspecified medical attention. Additional information is not expected. |
|
VAERS ID: |
Vaccinated: |
0000-00-00 |
|
|
Age: |
|
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2007-12-06 |
|
Location: |
Unknown |
Entered: |
2007-12-07,
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 = Unknown) |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0712USA01357 |
|
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 |
|
Write-up: Information has been received
from a registered nurse (RN) concerning a female patient (age not reported),
who in approximately 2006 ("about one year ago") was vaccinated
with the first dose of Gardasil (lot # not reported). On the same day, the
patient found out she was pregnant. Subsequently the patient terminated her
pregnancy (date not reported). The nurse stated that the pregnancy was not
intended, and the "termination had nothing to do with the Gardasil
vaccine." At the time of this report, the outcome of the event was
unknown. No additional details were available. Upon internal review, the
event of "terminated her pregnancy" was considered to be serious,
as an other significant medical event. No further information is expected. |
|
VAERS ID: |
Vaccinated: |
2007-03-27 |
|
|
Age: |
18.0 |
Onset: |
2007-05-01,
Days after vaccination: 35 |
|
Gender: |
Female |
Submitted: |
2007-12-10,
Days after onset: 223 |
|
Location: |
Nebraska |
Entered: |
2007-12-11,
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: urine beta-human 05/25/07 posit;
serum beta-human posit |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: Sulfonamide allergy |
|
CDC 'Split Type': WAES0712USA01216 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0188U |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Urine
human chorionic gonadotropin positive |
|
Write-up: Information has been received
through the Merck pregnancy registry through a laboratory technician
concerning a 19 year old female with a history of sulfonamide allergy
(BACTRIM) who on 27-MAR-2007 was vaccinated with the first 0.5 ml dose of
Gardasil (Lot # 657006/0188U). There was no concomitant medication. It was
reported that on 25-MAY-2007 the patient got a positive pregnancy test
through urine HCG test and had a miscarriage on 31-MAY-2007. The patient
recovered around the end of May from the miscarriage. The patient did not
report any adverse reaction. The patient completed the Gardasil series and
received the second dose on 19-Jul-2007 and the third dose on 09-Nov-2007.
Unknown medical attention was sought. No product quality complaint was
involved. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-10-04 |
|
|
Age: |
16.0 |
Onset: |
2007-11-07,
Days after vaccination: 34 |
|
Gender: |
Female |
Submitted: |
2007-12-18,
Days after onset: 41 |
|
Location: |
Michigan |
Entered: |
2007-12-19,
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 = 09/15/5007);
Asthma |
|
Diagnostic Lab Data: beta-human chorionic 10/11/07 -
positive |
|
Previous Vaccinations: |
|
Other Medications: Ventilan (albuterol) |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0710USA06218 |
|
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, Pregnancy
test positive, Urine
human chorionic gonadotropin positive |
|
Write-up: Information has been received
from a physician concerning a 16 year old female with asthma who on
02-AUG-2007 was vaccinated intramuscularly with her first dose of Gardasil.
On 04-OCT-2007 she received her second dose of Gardasil intramuscularly.
Concomitant therapy included VENTILAN. The patient was determined to be
pregnant on 11-Oct-2007 with a pregnancy test. The patient sought unspecified
medical attention in the office. Subsequently the patient experienced vaccine
exposure during pregnancy. No problems reported. No further details
available. Additional information has been requested. Follow up information
received on 11-Dec-2007 from the physician stated that the patient had a
spontaneous abortion on 07-Nov-2007, approximately 8 weeks from LMP. The
products of conception were examined and described as hemorrhagic necrotic
dicidua few syncytiotrophoblastic cells involutengehorioric villi. |
|
VAERS ID: |
Vaccinated: |
2007-06-13 |
|
|
Age: |
15.0 |
Onset: |
2007-06-13,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2010-06-08,
Days after onset: 1091 |
|
Location: |
Washington |
Entered: |
2007-12-18,
Days after submission: 902 |
|
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: None |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0706USA05171 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0171U |
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Cystitis,
Drug
exposure during pregnancy, Premature
baby, Premature
labour, Small
for dates baby |
|
Write-up: Information has been received via
the Merck pregnancy registry, from a physician concerning a 15 year old
female patient, who on 13-JUN-2007 was vaccinated with the first dose of
Gardasil (Lot #655620/0171U). There was no concomitant medication. After
receiving the vaccination (date not reported), the patient learned that she
was pregnant (date of LMP and estimated date of delivery not reported).
Follow up information received from the physician, via a company representative,
indicated that the pregnancy resulted in a premature birth (date and
gestational week not provided). The infant (gender not specified), also was
"a low birth weight baby" (weight not specified). At the time of
this report, the outcome and details of premature birth and low birth weight
baby were unknown. No further details were provided. Additional information
has been requested. This is in follow-up to report (s) previously submitted
on 12/14/2007. Initial and follow-up information has been received via the
Merck pregnancy registry, from a physician concerning a 15 year old female
patient with an allergy to Penicillin, who on 13-JUN-2007 (also reported as
March 2007) was vaccinated with the 0.5mL first dose of GARDASIL (Lot
#655620/0171U). There was no concomitant medication. After receiving the
vaccination (date not reported), the patient learned that she was pregnant
(date of LMP and estimated date of delivery not reported) (also reported that
the patient became pregnant in January 2007). Follow up information received
from the physician, via a company representative, indicated that the
pregnancy resulted in a premautre birth (date and gestational week not
provided). The infant (gender not specified), also was "a low birth
weight baby" (weight not specified). At the time of this report, the
outcome and details of premature birth and low birth weight baby were
unknown. It was reported that "everything is ok." The patient was
hospitalized when she had the baby for a little over one day. No further details
were provided. Follow-up information was received on 24-MAR-2008 and on
07-APR-2008 from a physician and a woman from the physician''s office. It was
reported that in July or August 2007, the patient was vaccinated
intramuscularly with one 0.5 ml dose of GARDASIL (previously reported as
13-JUN-2007). In October 2007, the patient became pregnant (previously
reported as January 2007). During her pregnancy, the patient had a bladder
infection and was restricted to bedrest because of preterm labor. The outcome
of the patient was not reported. This is a consolidation of two reports.
Additional information has been requsted. |
|
VAERS ID: |
Vaccinated: |
2007-08-01 |
|
|
Age: |
19.0 |
Onset: |
2007-08-13,
Days after vaccination: 12 |
|
Gender: |
Female |
Submitted: |
2007-12-19,
Days after onset: 128 |
|
Location: |
New
Jersey |
Entered: |
2007-12-20,
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 = 8/13/2007);
Penicillin allergy; Smoker |
|
Diagnostic Lab Data: ultrasound 10/23/07 empty sac;
elevated beta; ultrasound 10/30/07 elevated beta;empty sac; serum beta-human
positive |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0709USA04214 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0469U |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Blood
human chorionic gonadotropin increased, Drug
exposure during pregnancy, Pregnancy
test positive, Ultrasound
scan abnormal |
|
Write-up: Information has been received
through the pregnancy registry through a nurse concerning a 19 year old
female with a history of social smoking, penicillin allergy, and with two
previous pregnancies (two elective abortions) who on 01-AUG-2007 was
vaccinated intramuscularly with her first dose of Gardasil (Lot # 0469U).
There was no concomitant medication. The patient had a blood pregnancy test
(date unspecified) which was positive (LMP=13-AUG-2007). The patient sought
unspecified medical attention in the office. No symptoms were reported. On
23-OCT-2007 and 30-OCT-2007, the patient had an ultrasound due to elevated
beta levels. The ultrasounds showed an empty sac. The reporter indicated that
there was a question as to whether there was missed antibodies vs. an ectopic
pregnancy, but it was probably missed antibodies. On an unspecified date, the
patient had a spontaneous abortion, no further details were provided. Additional
information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-10-18 |
|
|
Age: |
13.0 |
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2007-12-26 |
|
Location: |
Illinois |
Entered: |
2007-12-26,
Days after submission: 0 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? Yes |
|
ER or Doctor Visit? No |
|
Hospitalized? No |
|
Current Illness: NA |
|
Diagnostic Lab Data: Not Any |
|
Previous Vaccinations: |
|
Other Medications: NA |
|
Preexisting Conditions: NA |
|
CDC 'Split Type': |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0245U |
0 |
IM |
RA |
|
MNQ |
SANOFI
PASTEUR |
U2226AA |
0 |
IM |
RA |
|
TDAP |
GLAXOSMITHKLINE
BIOLOGICALS |
AC52B016BA |
0 |
IM |
LA |
|
Administered by: Public Purchased by: Unknown |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Pregnancy
test positive |
|
Write-up: Pt stated that she was pregnant
at the time of her last set of immunizations but had not realized it at the
time. She stated after receiving the vaccines, she took a pregnancy test and
learned she was "a few weeks pregnant." She reported that she had
then miscarried at 9 weeks. |
|
VAERS ID: |
Vaccinated: |
2007-07-18 |
|
|
Age: |
18.0 |
Onset: |
2007-07-18,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2007-12-27,
Days after onset: 162 |
|
Location: |
Michigan |
Entered: |
2007-12-28,
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=6/26/2007);
Asthma |
|
Diagnostic Lab Data: ultrasound 09/12/07 11 week and 7
day Intrauterine pregnancy; amniocentesis 09/27/07 results not reported;
beta-human chorionic Positive |
|
Previous Vaccinations: |
|
Other Medications: Depo-Provera 150 mg |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0709USA02085 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0523U |
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
induced, Amniocentesis,
Drug
exposure during pregnancy, Pregnancy,
Pregnancy
test positive, Ultrasound
scan |
|
Write-up: Initial and follow-up information
has been received from the Pregnancy Registry via a health professional
concerning an 18 year old female with asthma who on 18-JUL-2007 was
vaccinated with a first dose of Gardasil (Lot #657868/0523U). Concomitant
therapy included medroxyprogesterone acetate (DEPO-PROVERA). Subsequently, it
was discovered that the patient was pregnant. The patient''s last menstrual
period was on 26-JUN-2007 and the estimated date of delivery was 04-APR-2007.
A pregnancy test was performed, results positive. On 12-SEP-2007 an
ultrasound was performed revealing an 11 week and 7 day intrauterine
pregnancy. On 27-SEP-2007 an amniocentesis was scheduled, results not
reported. On 23-OCT-2007, an elective termination of Pregnancy was performed.
At the time of the report the patient''s outcome was unknown. Upon internal
review, elective termination was considered an other important medical event.
Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-08-22 |
|
|
Age: |
24.0 |
Onset: |
2007-11-05,
Days after vaccination: 75 |
|
Gender: |
Female |
Submitted: |
2007-12-28,
Days after onset: 53 |
|
Location: |
Unknown |
Entered: |
2007-12-31,
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=7/7/2007)
Asthma; Hypoglycaemia |
|
Diagnostic Lab Data: beta-human chorionic |
|
Previous Vaccinations: |
|
Other Medications: albuterol |
|
Preexisting Conditions: Cervical cancer; Smoker |
|
CDC 'Split Type': WAES0709USA04280 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0384U |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Blood
human chorionic gonadotropin, Drug
exposure during pregnancy |
|
Write-up: Initial and follow-up information
has been received from a registered nurse through the Pregnancy registry
concerning a 24 year old female smoker of 1/2 pack per day who quit on
25-SEP-2007, with a history of cervical cancer in 2001, and with asthma,
hypoglycemia diagnosed in April 2005, and no drug allergies, who on
22-AUG-2007 was vaccinated intramuscularly with a 0.5 mL first dose of
Gardasil (Lot# 657617/0384U). Concomitant therapy included albuterol inhaler.
Subsequently, the patient was pregnant. The patient''s last menstrual period
was 04-JUL-2007 and her estimated delivery date was 23-APR-2008. The patient
had an office visit. A pregnancy test was performed (no results provided). At
the time of the report, the patient''s outcome was unknown. No product
quality complaint was involved. Follow-up indicated that on 05-NOV-2007 the
patient had a spontaneous abortion 16 weeks from her last menstrual period.
It was unknown if the products of conception were examined. It was reported
that the patient had not seen a doctor for this pregnancy. The patient was
seen in the emergency room on 05-NOV-2007 when she learned of the
miscarriage. The patient had 3 previous pregnancies with 1 full term
delivery, 1 spontaneous abortion, and 1 elective termination. Upon internal
review spontaneous abortion was considered to be an other important medical
event. Additional information is not expected. |
|
VAERS ID: |
Vaccinated: |
2007-10-20 |
|
|
Age: |
18.0 |
Onset: |
2007-10-20,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-03,
Days after onset: 75 |
|
Location: |
Unknown |
Entered: |
2008-01-04,
Days after submission: 1 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? Yes |
|
ER or Doctor Visit? Yes |
|
Hospitalized? No |
|
Current Illness: Pregnancy NOS (LMP = 10/5/2007) |
|
Diagnostic Lab Data: ultrasound, 12/14/07, did not
detect a fetal heartbeat; ultrasound, 12/17/07, did not detect a fetal
heartbeat; beta-human chorionic, 10?/??/07, positive |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0712USA08672 |
|
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, Foetal
heart rate abnormal, Pregnancy
test positive, Ultrasound
scan abnormal |
|
Write-up: Information has been received
from an RN concerning an 18 year old female patient who had delivered her
first child in January 2007 who on 20-OCT-2007 was vaccinated IM with a a
first dose of Gardasil. Within 2 weeks she had a positive pregnancy test at
another facility. Her LMP was 05-OCT-2007. Sonagrams on 14-DEC-2007 and
17-DEC-2007 did not detect a fetal heartbeat. It was reported that she
"later" miscarried. Medical attention was sought in the office. Her
outcome was not reported. Upon internal review, miscarriage was considered to
be an other important medical event. Additional information has been
requested. |
|
VAERS ID: |
Vaccinated: |
2007-01-02 |
|
|
Age: |
17.0 |
Onset: |
2007-01-02,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-04,
Days after onset: 367 |
|
Location: |
Iowa |
Entered: |
2008-01-07,
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 = 12/24/2006) |
|
Diagnostic Lab Data: amniocentesis 07/26/07 - mature
fetal lungs; ultrasound 03/20/07 - results not reported; beta-human chorionic
positive |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: Unknown |
|
CDC 'Split Type': WAES0702USA00526 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0961F |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Acute
respiratory distress syndrome, Amniocentesis
normal, Blood
human chorionic gonadotropin, Caesarean
section, Cervical
incompetence, Drug
exposure during pregnancy, Gastrooesophageal
reflux disease, Premature
labour, Thrombocytopenia,
Ultrasound
scan |
|
Write-up: Initial and follow up information
has been received from a physician''s assistant for the Merck Pregnancy
registry, concerning a 17 year old white female with no medical history and a
history of 0 previous pregnancies who on 30-OCT-2006 was vaccinated with the
first dose of Gardasil (lot #653650/0697F) 0.5 ml intramuscularly. On
2-JAN-2007 the patient received her second dose of Gardasil (lot
#654389/0961F) 0.5 ml intramuscularly. Subsequently, the patient presented
with a pregnancy (pregnancy test found positive). The patient''s LMP was
24-DEC-2006. The patient sought unspecified medical attention. Additional
follow up information has been received: From 13-FEB-2007 to 29-JUL-2007 the
patient received prenatal vitamins. On 20-MAR-2007 an ultrasound was
performed, results were not reported. From 25-APR-2007 to 29-JUL-2007 the
patient received nifedipine 20 mg PO Q 4 hours for preterm labor. On
03-MAY-2007 and 04-MAY-2007 she received 12 mg bethamethasone for prevention
of respiratory distress syndrome. On 02-MAY-2007 she received general
anesthesia for circlagic placement due to incompetent cervix. From
20-JUN-2007 to 29-JUL-2007 the patient received PREVACID 30 mg daily for
gastroesophageal reflux disease (GERD). On 29-JUL-2007 the patient underwent
amniocentesis for fetal lung maturity. The result indicated mature fetal
lungs. On 30-JUL-2007 2 liveborn female infants were delivered at 31 weeks
from LMP. Weight of twin A was 2425 g; APGAR score was 9/9. Weight of twin B
was 2405 g; APGAR score was 8/9. The infants were normal; there were no
congenital anomalies. However both twins had other
complications/abnormalities: placentas. Twin A massive chronic villitis. Twin
B focal chronic villitis. It was noted that the mother had a complication
during pregnancy: gestational thrombocytopenia. She also had a complication
during labor/delivery, specifically arrest of dilation resulting in
c-section. Upon internal review, premature infant births at 31 weeks and
arrest of dilation resulting in c-section were considered othe |
|
VAERS ID: |
Vaccinated: |
2007-06-11 |
|
|
Age: |
25.0 |
Onset: |
2007-06-11,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-07,
Days after onset: 210 |
|
Location: |
Unknown |
Entered: |
2008-01-08,
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 = 6/18/2007),
endometriosis |
|
Diagnostic Lab Data: ultrasound, 08/09/07, within
normal limits; ultrasound, 10/22/07, within normal limits |
|
Previous Vaccinations: |
|
Other Medications: folic acid, vitamins
(unspecified) |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0708USA01059 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0522U |
1 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Drug
exposure during pregnancy, Intra-uterine
death, Stillbirth,
Ultrasound
scan normal |
|
Write-up: Information has been received
from a nurse through a Merck pregnancy registry concerning a 25 year old
caucasian female with endometriosis who on 26-Mar-2007 was vaccinated IM in
the right deltoid with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast)
(lot #655503/0012U). Concomitant therapy included folic acid and unspecified prenatal
vitamins. On 11-Jun-2007 the patient was vaccinated IM in the left deltoid
with a second dose (lot #657737/0522U). The patient now is pregnant. The
patient''s LMP was 18-Jun-2007. Her estimated delivery date is 25-Mar-2008.
The patient will be in the office on 07-Aug-2007. Follow-up information
received indicates that the patient had ultrasound testing on 09-Aug-2007 and
22-Oct-2007, results of both were reported to be within normal limits. Follow
up information received on 02-Jan-2008, indicated that on 28-Dec-2007, the
patient had a fetal death/stillbirth, weeks from LMP 27. Autopsy being done.
No other information available. Upon internal review fetal death/stillbirth
considered to be an other important medical event. |
|
VAERS ID: |
Vaccinated: |
2007-12-02 |
|
|
Age: |
21.0 |
Onset: |
2007-12-07,
Days after vaccination: 5 |
|
Gender: |
Female |
Submitted: |
2008-01-07,
Days after onset: 31 |
|
Location: |
Texas |
Entered: |
2008-01-08,
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);
Migraine |
|
Diagnostic Lab Data: Beta-human chorionic - positive |
|
Previous Vaccinations: |
|
Other Medications: |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0712USA07866 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HEPA |
UNKNOWN
MANUFACTURER |
|
|
UN |
UN |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
TTOX |
UNKNOWN
MANUFACTURER |
|
|
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Blood
human chorionic gonadotropin positive, Drug
exposure during pregnancy |
|
Write-up: Information has been received
from a 21 year old female with a history of severe migraines, who on
02-DEC-2007 was vaccinated with the first dose of Gardasil. Concomitant
therapy included hepatitis A virus vaccine (unspecified) and tetanus toxoid.
On 07-DEC-2007, five days after the vaccination the patient found out that
she was pregnant. Medical attention was sought. The patient''s outcome was
not recovered. No product quality complaint was involved. Follow up
information received on 31-DEC-2007 from the patient indicated that she had a
miscarriage on 22-Dec-2007. No additional information provided. Upon internal
review miscarriage considered to be an other important medical event.
Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-08-02 |
|
|
Age: |
18.0 |
Onset: |
2007-08-02,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-14,
Days after onset: 165 |
|
Location: |
Washington |
Entered: |
2008-01-15,
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);
Penicillin allergy; Hypersensitivity; Seasonal allergy |
|
Diagnostic Lab Data: beta-human chorionic 10/01/07
posit |
|
Previous Vaccinations: |
|
Other Medications: |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0801USA00401 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
DTAP |
UNKNOWN
MANUFACTURER |
|
|
UN |
UN |
|
HPV4 |
MERCK
& CO. INC. |
0171U |
0 |
IM |
UN |
|
VARCEL |
MERCK
& CO. INC. |
|
|
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Blood
gonadotrophin decreased, Drug
exposure during pregnancy, Pregnancy
test positive, Vaginal
haemorrhage |
|
Write-up: Information has been received
from a nurse concerning an 18 year old female with no pertinent medical
history, seasonal allergies and allergies to nickel and penicillin who on
02-AUG-2007 was vaccinated intramuscularly (site not reported) with the 1st
dose of the 0.5 ml Gardasil (lot#655620/0171U). The patient was concomitantly
vaccinated with Varivax (MSD) and DTaP (manufacturer unknown). On
15-AUG-2007, the patient was seen in the emergency room with lowering hcg
levels and some vaginal bleeding. On 16-AUG-2007 and 17-AUG-2007, the patient
returned to the emergency room with continuing decreasing hcg levels and
later had a spontaneous abortion (exact date not reported). On 01-OCT-2007,
the patient was vaccinated intramuscularly (site not reported) with the 2nd
dose of the 0.5 ml Gardasil (lot#658094/0524U) while pregnant (WAES#0801USA01237).
Follow-up information was received from the nurse stating that the exact date
of the spontaneous abortion and LMP after the 2nd dose of the Gardasil
vaccine is unknown. Upon internal review spontaneous abortion was considered
to be an other important medical events. Additional information has been
requested. |
|
VAERS ID: |
Vaccinated: |
2007-10-01 |
|
|
Age: |
17.0 |
Onset: |
2007-10-01,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-17,
Days after onset: 108 |
|
Location: |
California |
Entered: |
2008-01-18,
Days after submission: 1 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? Yes |
|
Recovered? Yes |
|
ER or Doctor Visit? Yes |
|
Hospitalized? Yes, 0 days |
|
Extended
hospital stay?
Yes |
|
Current Illness: Pregnancy NOS (LMP=Unknown) |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0801USA02992 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Emotional
distress |
|
Write-up: Information has been received via
the Merck pregnancy registry, from a physician, concerning a 17 year old
female patient who was 2-3 weeks pregnant in October 2007, when she was
vaccinated with the first dose of Gardasil (lot # not reported). On
13-JAN-2008, the patient had a miscarriage and was hospitalized (details and
dates not provided). The physician stated that the patient was
"traumatized." At the time of this report, the outcome of
miscarriage and patient traumatized was unknown. The physician considered the
miscarriage to be disabling/incapacitating due to the patient being
traumatized. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-07-01 |
|
|
Age: |
26.0 |
Onset: |
2007-07-01,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-18,
Days after onset: 201 |
|
Location: |
North
Dakota |
Entered: |
2008-01-22,
Days after submission: 4 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? Yes |
|
Hospitalized? No |
|
Current Illness: Pregnancy NOS (LMP=8/12/2007) |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0709USA04666 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
Administered by: Military Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Uterine
dilation and curettage |
|
Write-up: Information has been received
from a 26 year old female with no pertinent medical history who in
approximately July 2007, was vaccinated with her first dose of Gardasil.
There was no concomitant medication. The patient called to join the Merck
pregnancy registry. It was reported that the patient became pregnant around
the same time she received her first vaccination. The patient last menstrual
period was approximately 10-JUN-2007 and estimated delivery was 16-MAR-2008.
In Jul-2007, the patient experienced no adverse effect. Unspecified medical
attention was sought. Information was received on 04-JAN-2008 indicating the
patient had a spontaneous abortion on 09-NOV-2007 (approximately 12 weeks
from LMP, reported in follow up as 12-AUG-2007). The patient had a D&C on
09-NOV-2007. The pathology result was "consistent with product of
conception." The spontaneous abortion was considered to be an other
important medical event. No further information available. |
|
VAERS ID: |
Vaccinated: |
2007-09-07 |
|
|
Age: |
17.0 |
Onset: |
2007-09-28,
Days after vaccination: 21 |
|
Gender: |
Female |
Submitted: |
2008-01-22,
Days after onset: 116 |
|
Location: |
Unknown |
Entered: |
2008-01-23,
Days after submission: 1 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? Yes |
|
Hospitalized? No |
|
Current Illness: Penicillin allergy |
|
Diagnostic Lab Data: computed axial - results not
reported; magnetic resonance - results not reported; diagnostic laboratory -
unspecified blood work - no results reported; electroencephalography - no
results reported; computed axial - orbit and sinus - results |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: Fractured nose |
|
CDC 'Split Type': WAES0801USA02870 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0930U |
2 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Blood
test, Computerised
tomogram, Drug
exposure during pregnancy, Electroencephalogram,
Haemorrhage,
Headache,
Laboratory
test, Nuclear
magnetic resonance imaging, Vertigo
|
|
Write-up: Information has been received
from a nurse practitioner concerning an 18 female with a penicillin allergy
and a history of a fractured nose. The nurse practitioner reported that the
patient completed the Gardasil series and then miscarried. The patient
received her first dose of Gardasil (Lot #655503/0012U) on 05-MAR-2007, her
second dose on 05-MAY-2007 (Lot #657621/0387U) and her third dose on
07-SEP-2007 (Lot #658488/0930U). The patient miscarried 3-4 weeks after
receiving the last dose approximately 28-SEP-2007. The mother of the patient
said the miscarried fetus had developed for about 3 months. The patient went
to the emergency room for the miscarriage and was treated there for bleeding
post-miscarriage. The patient had also been treated at an unspecified OBGYN
post-miscarriage for bleeding and presently vertigo and headaches. The
patient has been to the emergency room twice for treatment post-miscarriage
and an unspecified neurologist. It was unclear if the patient was ever hospitalized.
There was no testing on the miscarried fetus, because it was
"flushed" and not recovered. There was no other information to
report. Upon internal review a miscarriage was considered an other important
medical event. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-02-09 |
|
|
Age: |
19.0 |
Onset: |
2007-02-09,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-15,
Days after onset: 340 |
|
Location: |
Pennsylvania |
Entered: |
2008-01-21,
Days after submission: 6 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? Yes |
|
Hospitalized? No |
|
Current Illness: Pregnancy NOS (LMP - 1/14/2007);
Penicillin allergy |
|
Diagnostic Lab Data: Ultrasound 06/07/07 within normal
level; Diagnostic procedure 07/18/07 cervical length |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0702USA03568 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
1427F |
0 |
|
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Diagnostic
procedure, Drug
exposure during pregnancy, Premature
baby, Premature
labour, Ultrasound
scan |
|
Write-up: Information has been received
from an other health professional from the pregnancy registry concerning a 19
year old female patient with an amoxicillin allergy and no pertinent medical
history who on 09-Feb-2007, was vaccinated with a 0.5ml dose of Gardasil (lot
#655619/1427F). There was no concomitant medication. It was reported that the
patient was pregnant when she received the vaccine. Unspecified medical
attention was sought. The patient''s last menstrual period was reported to be
14-Jan-2007 and her estimated date of delivery was 21-Oct-2007. Method of
pregnancy confirmation was not reported. Follow-up information received from
the Pregnancy registry indicated that the patient was a smoker. It was
reported that she had pre-term labor, and delivered the baby at 33 weeks on
07-Sep-2007. The infant was a male weighing 5 lbs and 20 oz. There were no
congenital anomalies. The baby was in RICN for 2 weeks and had an apnea
monitor. Medications used during this pregnancy for pre-term labor were
Brethinc injection and bethamethasone 12 mg intramuscularly on 05-Sep-2007.
Laboratory diagnostic tests included an ultrasound on 07-Jun-2007 which was
within normal limits and examination of cervical length on 18-Jul-2007. On
14-Aug-2007 a diagnostic test for fetal fibronectin was performed. On
05-Sep-2007, an ultrasound was performed for the preterm labor. On
27-Dec-2007, a follow up phone call was made and it was reported that the
infant is doing well and no longer required the apnea monitor. |
|
VAERS ID: |
Vaccinated: |
2007-02-14 |
|
|
Age: |
18.0 |
Onset: |
2007-03-14, Days after
vaccination: 28 |
|
Gender: |
Female |
Submitted: |
2008-01-15, Days after onset: 307 |
|
Location: |
Kentucky |
Entered: |
2008-01-21, Days after submission:
6 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? Yes |
|
Hospitalized? No |
|
Current Illness: Pregnancy NOS
(LMP = 2/28/2007); asthma; penicillin allergy |
|
Diagnostic Lab Data: total serum
human, 02/13/07, negative; complete blood cell, ?/?/07; serum rheumatoid
factor, ?/?/07; erythrocyte ABO antigen, ?/?/07; serum hepatitis B Ab,
?/?/07; serum rubella IgG, ?/?/07; HIV antibody screen, ?/?/07; rapid plasma
reagin, |
|
Previous Vaccinations: |
|
Other Medications: albuterol |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0705USA00917 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK & CO. INC. |
1427F |
1 |
IM |
UN |
|
Administered by:
Other Purchased by: Other |
|
Symptoms: Blood
test, Delivery,
Drug
exposure during pregnancy, Full
blood count, HIV
test, Hepatitis
B antibody, Pregnancy
test negative, Premature
labour, Rheumatoid
factor, Rubella
antibody test, Syphilis
test |
|
Write-up: Information has been
received from a registered nurse through the Merck Pregnancy registry
concerning an 18 year old white female with asthma and a penicillin allergy
with a history of 0 pregnancies and 0 live births who on 29-NOV-2006 was
vaccinated with a dose of Gardasil (Lot 654540/0800F). On 13-FEB-2007, an HCG
level was performed and was negative. On 14-FEB-2007, she received her second
vaccination (Lot 655619/1427F). Concomitant therapy included albuterol. On
approximately 14-MAR-2007 the patient became pregnant (LMP 23-FEB-2007).
Laboratory diagnostic studies performed included CBC, prenatal antibody
screen, RPR, blood type and screen, hepatitis B screening, rubella status and
HIV screening. Results were not provided for these tests. On 11-APR-2007, the
patient started taking prenatal vitamins daily. As of 03-MAY-2007, the
patient had not reported any difficulties with her pregnancy. On 05-OCT-2007,
the patient was given BRETHINE 5 mg and PROCARDIA 10 mg every 4 hours for
pre-term labor to stop her contractions. There were reported to have
discontinued on 14-NOV-2007. On 20-NOV-2007, the patient gave birth to a
liveborn female weighing 7 lbs. 11 oz. She was 38 weeks from her last
menstrual period. The infant was reported to be normal and there were no
congenital anomalies. The infant was reported to have jaundice but no other
symptoms. At the time of this report the infant''s and the patient''s outcome
was unknown. No product quality complaint was involved. Additional
information is not expected. |
|
VAERS ID: |
Vaccinated: |
2007-06-04 |
|
|
Age: |
26.0 |
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2008-01-24 |
|
Location: |
Maryland |
Entered: |
2008-01-25,
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=5/22/2007);
Tobacco user |
|
Diagnostic Lab Data: ultrasound 07/20/07 normal;
ultrasound 12/10/07 severe intrauterine growth retardation; beta-human
chorionic 06/07 pregnant; whole blood 12/10/07 MTHFR homozygous; cardiolipin
antibody 12/10/07; lupus anticoagulant 12/10/07 |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0706USA03282 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
1 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Antiphospholipid
antibodies, Antiphospholipid
syndrome, Caesarean
section, Cardiolipin
antibody, Drug
exposure during pregnancy, Foetal
disorder, Foetal
growth retardation, Gout,
Intra-uterine
death, Placental
disorder, Pregnancy
test positive, Ultrasound
scan abnormal |
|
Write-up: Information has been received
from a 26 year old female consumer, who was vaccinated with the first dose,
0.5ml, IM, of Gardasil (Lot # not provided, date unspecified), and had
unknowingly become pregnant, estimated date of conception, 22-MAY-2007 (on
19-JUN-2007, she was "4 weeks pregnant"). On 04-JUN-2007, she was
vaccinated with the second dose, 0.5ml, of Gardasil (Lot # not provided).
There was no concomitant medication, and no other pertinent medical history.
On 19-JUN-2007, she reported a pregnancy test had confirmed her pregnancy.
The estimated date of delivery was 28-FEB-2008. The consumer confirmed that
she has had no ill effects. Follow up information received from a
physician''s office, indicated that this was the patient''s first pregnancy,
and added that she was a tobacco user. On 03-JUL-2007 through 08-JUL-2007,
she was treated for gout, with prednisone, 5mg (no other details provided). On
10-JUL-2007, a pregnancy ultrasound was normal. The were no other illnesses
or infections during pregnancy. On 10-DEC-2007, the patient underwent an
ultrasound due to decreased fetal movement, and it was determined that the
infant had severe intrauterine growth retardation (IUGR). It was also
determined that the patient had placental insufficiency. Lab testing revealed
the mother was positive for methylene-tetra-hydro-folate reductase (MTHFR)
mutation homozygous and included cardiolipin ob and lupus anticoagulant
testing (results not provided). The patient was diagnosed with
antiphospholipid syndrome. An "emergent classical" caesarean
section was performed, resulting in the live birth of a male infant, weight
700 gm, Apgar score 4/8. On 12-DEC-2007, the infant died, due to
complications from prematurity. An autopsy on the infant was pending. The
outcome of gout. MTHFR homozgous and antiphopholipid syndrome was unknown.
Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-12-07 |
|
|
Age: |
17.0 |
Onset: |
2007-12-07,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-24,
Days after onset: 48 |
|
Location: |
New
York |
Entered: |
2008-01-25,
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 = 11/15/2007) |
|
Diagnostic Lab Data: |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0801USA03327 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
induced, Drug
exposure during pregnancy |
|
Write-up: Information has been received
through the Merck pregnancy registry from a health professional concerning a
female who on 07-DEC-2007 was vaccinated intramuscularly with the first dose
of Gardasil. Per the reporter, the patient was 3 weeks pregnant at the time
of vaccination and subsequently experienced vaccine exposure during
pregnancy. On approximately 05-JAN-2008 the patient experienced elective
termination of pregnancy (gestation = 7 weeks). No other information was
available. Elective termination of pregnancy was considered to be an other
important medical event. Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-11-20 |
|
|
Age: |
17.0 |
Onset: |
2007-11-20,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-25,
Days after onset: 66 |
|
Location: |
Virginia |
Entered: |
2008-01-28,
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 = 11/9/2007) |
|
Diagnostic Lab Data: Beta-human chorionic - positive (value) |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0712USA08230 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
1210U |
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
induced, Drug
exposure during pregnancy, Pregnancy,
Urine
human chorionic gonadotropin positive |
|
Write-up: Initial and follow-up information
has been received from a certified medical assistant concerning a 17 year old
female with no medical history, and no drug reactions/allergies, who on
20-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of
Gardasil (Lot#655154/1210U). There was no concomitant medications.
Subsequently, the patient was determined to be pregnant. No adverse
experience was related to this event. A urine pregnancy test was positive.
The patients last menstrual period was 9-Nov-2007 and her estimated delivery
date was 15-AUG-2007. The patient''s mother contacted the office by phone. At
the time of the report, the outcome of the patient was unknown. No product
quality complaint was involved. Follow-up information indicated that the
patient had an elective termination on an unspecified date. It was reported
that the termination was not due to exposure to the vaccine. It was reported
to be unknown if the products of conception were examined. Upon internal
review elective termination was considered to be an other important medical
event. Additional information is not expected. |
|
VAERS ID: |
Vaccinated: |
0000-00-00 |
|
|
Age: |
|
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2008-01-28 |
|
Location: |
Ohio |
Entered: |
2008-01-29,
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': WAES0801USA00934 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
|
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
induced, Drug
exposure during pregnancy |
|
Write-up: Information has been received for
the Merck Pregnancy Registry from a nurse concerning a female (age not
reported) who on an unspecified date was vaccinated with Gardasil (lot#
unknown). "The patient came in on 24-DEC-2007 to receive a dose of
Gardasil, but when she arrived at the office they found out the patient was
pregnant, but the date of gestation was unspecified by the reporter. The
nurse reported that they did not give the dose of Gardasil the patient was
supposed to receive another dose of Gardasil, but what dose was unspecified
by the reporter. No further AE information was given. Medical attention was
sought. The estimated date of delivery was unknown. Follow-up information was
received. The patient''s name was updated. It was reported that the patient
had a miscarriage. The physician does not think it was caused by Gardasil.
Upon internal review miscarriage is considered to be an other medical event
(OME). Follow-up information was received on from a registered nurse on
22-JAN-2008. It was reported that the patient did not have a miscarriage it
was planned termination of the fetus by the patient. Upon internal review
abortion induced is considered to be an other medical event. Additional
information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-05-01 |
|
|
Age: |
17.0 |
Onset: |
2007-05-01,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-01-28,
Days after onset: 272 |
|
Location: |
Unknown |
Entered: |
2008-01-29,
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 = 10/22/2007) |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0801USA04453 |
|
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 consumer concerning her 17 year old daughter with no pertinent medical
history and no drug reactions/allergies who in March 2007, was vaccinated
with Gardasil (lot# unknown). There was no concomitant medication. In May
2007, the patient received her second dose of Gardasil (lot# unknown). The
caller reported that on 30-JUL-2007 the patient experienced a miscarriage
when she was 2 and 1/2 months pregnant. Caller was not aware as to when the
patient learned about her pregnancy. Caller reported that the patient missed
the third dose of Gardasil vaccine which was supposed to be given to her in
"October 2007". The patient''s LMP was approximately 22-OCT-2007
and is now 3 months pregnant again. The patient''s estimated date of delivery
is "July 2008". No further information was provided. Upon internal
review miscarriage is considered to be an other medical event (OME). No
further information is available. |
|
VAERS ID: |
Vaccinated: |
0000-00-00 |
|
|
Age: |
26.0 |
Onset: |
2007-06-06 |
|
Gender: |
Female |
Submitted: |
2008-01-29,
Days after onset: 237 |
|
Location: |
New
York |
Entered: |
2008-01-30,
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) |
|
Diagnostic Lab Data: beta-human chorionic 06/06/07 -
positive |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0706USA05104 |
|
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 positive |
|
|
Write-up: Information has been received
from a health professional, for the Pregnancy Registry for Gardasil,
concerning a 26 year old female who on 03-APR-2007 was vaccinated with a
first dose of Gardasil (lot number unknown) IM. On 06-JUN-2007 the patient
returned for a second dose of Gardasil and a beta-human chorionic
gonadotropin test (unspecified) was conducted and the results were positive.
The patient received her second dose of Gardasil. Patient returned on
26-JUN-2007 and received a second dose of Gardasil at that time and the
patient was no longer pregnant. No further information was available. The
date of the last menstrual period and the estimated time of delivery is
unknown. Follow-up information was received. The patient had no pertinent
medical history or drug reactions/allergies. The patient had a spontaneous
abortion "4/07" from LMP. It was unknown if the products of
conception were examined. The fetus was not normal. In May 2007 a diagnostic
laboratory test was performed during pregnancy. No further information was
available. Upon internal review spontaneous abortion was considered to be an
other important medical event (OME). Additional information is not expected. |
|
|
VAERS ID: |
Vaccinated: |
2007-09-25 |
|
|
Age: |
24.0 |
Onset: |
2007-10-12,
Days after vaccination: 17 |
|
Gender: |
Female |
Submitted: |
2008-02-04,
Days after onset: 115 |
|
Location: |
Unknown |
Entered: |
2008-02-05,
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 = 10/12/2007) |
|
Diagnostic Lab Data: diagnostic laboratory |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0801USA05321 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
1267U |
2 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Laboratory
test |
|
Write-up: Information has been received
from a 24 year old female consumer who on 25-JUL-2007 was vaccinated with her
first dose of Gardasil (Lot # 658490/0802U). On 25-SEP-2007, the patient was
vaccinated with her second dose of Gardasil (Lot # 656050/0245U). On
25-Jan-2008, the patient was vaccinated with her third dose of Gardasil (Lot
# 659439/1267U). There was no concomitant medication. On an unspecified date,
the patient found out she was pregnant (LMP approximately 12-OCT-2007). The
patient had unspecified blood work performed. On an unspecified date, the
patient had to go to the emergency room where she was informed that she had a
miscarriage. No additional information was provided. Upon internal review,
miscarriage was considered to be an other important medical event. Additional
information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-04-26 |
|
|
Age: |
16.0 |
Onset: |
2007-05-01,
Days after vaccination: 5 |
|
Gender: |
Female |
Submitted: |
2008-02-07,
Days after onset: 282 |
|
Location: |
Unknown |
Entered: |
2008-02-08,
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; Penicillin allergy |
|
Diagnostic Lab Data: Beta-Human Chorionic 05/01/07
positive |
|
Previous Vaccinations: |
|
Other Medications: Advair, Menactra |
|
Preexisting Conditions: Asthma |
|
CDC 'Split Type': WAES0705USA01148 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
1426F |
|
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Pregnancy
test positive |
|
Write-up: Information has been received
from a nurse, for the Pregnancy Registry for Gardasil, concerning a 17 year
old female with drug hypersensitivity and penicillin allergy and a history of
asthma. on 26-APR-2007 the patient was vaccinated with Gardasil
(Lot#655205/1426F). Concomitant therapy included ADVAIR and MENACTRA. On
01-MAY-2007 the patient''s mother notified the office that her daughter
tested positive to a home pregnancy test. It was reported that the patient
sought unspecified medical attention. No further information is available at
this time. Follow up information received from the pediatrician, indicated
that the patient had a spontaneous abortion, on/or at less than 20 weeks of
gestation (date not specified). The outcome of spontaneous abortion was not
specified. No further details were provided. Upon internal review, spontaneous
abortion was considered to be serious as an other important medical event.
Additional information is not expected. |
|
VAERS ID: |
Vaccinated: |
2007-08-01 |
|
|
Age: |
21.0 |
Onset: |
2007-08-01,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-02-11,
Days after onset: 194 |
|
Location: |
New
Jersey |
Entered: |
2008-02-12,
Days after submission: 1 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? Yes |
|
ER or Doctor Visit? Yes |
|
Hospitalized? Yes, 0 days |
|
Extended
hospital stay? No |
|
Current Illness: Pregnancy NOS (LMP = 8/25/2007);
penicillin allergy |
|
Diagnostic Lab Data: ultrasound - see narrative;
beta-human chorionic 10/07/07 - positive |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0802USA00286 |
|
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, Foetal
disorder, Pregnancy
test positive, Ultrasound
scan abnormal |
|
Write-up: Information has been received
from a consumer concerning her 21 year old daughter with a history of
penicillin allergy who in "the beginning of" August 2007, was
vaccinated intramuscularly with her first dose of Gardasil. At "the end
of" September 2007, the patient was vaccinated intramuscularly with her
second dose of Gardasil. There was no concomitant medication. On 07-OCT-2007,
the patient had a pregnancy test which was positive, and showed that she was
6 weeks pregnant. An ultrasound showed that the baby had no kidneys (not
further specified). On 22-JAN-2008 the patient experienced a miscarriage and
was hospitalized. The reporter also stated there may have been "fluid on
the brain". Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-03-12 |
|
|
Age: |
17.0 |
Onset: |
2007-03-12,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-02-13,
Days after onset: 338 |
|
Location: |
Unknown |
Entered: |
2008-02-14,
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 = 2/1/2007);
Ovarian cyst |
|
Diagnostic Lab Data: ultrasound 02/28/07 - revealed
complex ovarian cyst; ultrasound 03/30/07 - determined that pt was 6 wks
& 4 days pregnant; ultrasound 02/28/07 - confirmed pt not pregnant; urine
beta-human 02/28/07 - confirmed pt not pregnant |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: Abortion spontaneous; Pelvic
inflammatory disease |
|
CDC 'Split Type': WAES0802USA00792 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0014U |
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Ultrasound
abdomen abnormal, Urinary
tract infection, Urine
human chorionic gonadotropin negative, Uterine
dilation and curettage |
|
Write-up: Information has been received
from a physician''s assistant concerning a 17 year old female who has had
"multiple sexual partners and engages in high risk behavior". Her
first pregnancy resulted in a spontaneous abortion in March 2006. On
06-FEB-2007, the patient had pelvic inflammatory disease from which she
recovered. On 28-FEB-2007, the patient had an ultrasound which revealed a
complex ovarian cyst. Also on 28-FEB-2007, urine and ultrasound tests
confirmed that the patient was not pregnant. She was referred to a
gynecologist for evaluation of her ovarian cyst. On 12-MAR-2007, the patient
was vaccinated with the first dose of GARDASIL (lot #653736/0014U), 0.5 ml.
On 30-MAR-2007, the patient presented to the gynecologist for evaluation of
her existing ovarian cyst. It was determined via ultrasound that the patient
was 6 weeks and 4 days pregnant. Her last menstrual period (LMP) was
estimated to be late January/early February (estimated delivery date
08-NOV-2007). In the end of April 2007, the patient had a spontaneous
abortion followed by a dilation & curettage (D & C). Subsequently
(date unknown), the patient was diagnosed at the ER with a urinary tract
infection (UTI) status post spontaneous abortion and D & C. On
08-MAY-2007, the patient was vaccinated with the second dose of GARDASIL (lot
#657005/0314U). She was fully recovered from the spontaneous abortion at that
time. On 07-SEP-2007, the patient was vaccinated with the third dose of
GARDASIL (lot #657872/0515U). Subsequently, the patient recovered from the
UTI. In the follow-up phone call of 07-FEB-2008, the PA reported that she did
not consider the spontaneous abortion or UTI as disabling or life
threatening. She was unsure if the patient had been hospitalized at all. Upon
internal review, spontaneous abortion was considered to be an other important
medical event. No further information is available. |
|
VAERS ID: |
Vaccinated: |
2008-01-31 |
|
|
Age: |
18.0 |
Onset: |
2008-01-31,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-02-13,
Days after onset: 13 |
|
Location: |
Unknown |
Entered: |
2008-02-14,
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: None |
|
Previous Vaccinations: |
|
Other Medications: None |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0802USA01815 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Ovarian
enlargement, Pain
|
|
Write-up: Information has been received for
the Merck Pregnancy Registry for Gardasil from an 18 year old female with no
pertinent medical history or drug reactions/allergies who on 31-JAN-2008 was
vaccinated with a first dose of Gardasil injection. There was no concomitant
medication. On 03-FEB-2008 or 04-FEB-2008 (3 to 4 days) after receiving the
first dose of Gardasil the patient miscarried. The patient was approximately
2 weeks pregnant. The patient was unaware she was pregnant until she
miscarried. The physician stated to the patient that her left ovary was
swollen. The patient was in alot of pain. The patient was scheduled for a CT
scan next week. At the time of reporting the patient has not recovered. On
approximately 20-JAN-2008 was the patient''s date of last menstrual period.
The patient''s estimated date of delivery was 26-OCT-2008. No additional
information was provided. Upon internal review miscarriage was considered to
be an other medical event. Additional information is not expected. |
|
VAERS ID: |
Vaccinated: |
2007-11-01 |
|
|
Age: |
16.0 |
Onset: |
2007-11-01,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-02-18,
Days after onset: 109 |
|
Location: |
Pennsylvania |
Entered: |
2008-02-19,
Days after submission: 1 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? Yes |
|
Hospitalized? Yes, 3 days |
|
Extended
hospital stay?
Yes |
|
Current Illness: |
|
Diagnostic Lab Data: None |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: None |
|
CDC 'Split Type': WAES0802USA02114 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HEP |
MERCK
& CO. INC. |
|
|
UN |
UN |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy |
|
Write-up: Information has been received
from a consumer concerning her 16 year old daughter with no medical history
and no drug allergies, who in November 2007, was vaccinated IM with a 0.5 mL
first dose of Gardasil. Concomitant vaccination included Recombivax.
Subsequently, the patient was pregnant. In November 2007, the patient had a
miscarriage at approximately 16 weeks. The gestation period at the time of
the first dose was unknown. The patient was hospitalized for approximately
2-3 days. No laboratory diagnostics were performed. The patient did not
discontinue her dosing schedule. The patient was vaccinated with a second
dose of Gardasil on 08-FEB-2008. At the time of the report, the outcome of
the patient was unknown. No product quality complaint was involved. Upon internal
review miscarriage was determined to be an other important medical event.
Additional information has been requested. |
|
VAERS ID: |
Vaccinated: |
0000-00-00 |
|
|
Age: |
16.0 |
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2008-02-14 |
|
Location: |
California |
Entered: |
2008-02-19,
Days after submission: 5 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? Yes |
|
ER or Doctor Visit? Yes |
|
Hospitalized? No |
|
Current Illness: |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: Unknown |
|
CDC 'Split Type': WAES0801USA01026 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Vaginal
haemorrhage |
|
Write-up: Information has been received
from a physician concerning a 16 year old female who on an unspecified date
was vaccinated with Gardasil (lot# unknown) injection. Subsequently the
patient experienced heavy vaginal bleeding after the first dose of Gardasil.
Medical attention was sought. The patient experienced this for 10 to 12 days
and it only stopped when (estrogens, conjugated) PREMARIN (manufacturer
unknown) was administered. Therapy with human papillomavirus vaccine was
discontinued. Subsequently, the patient recovered from heavy vaginal bleeding
on an unspecified date. No further information was available. Additional
information has been requested. |
|
VAERS ID: |
Vaccinated: |
2008-01-04 |
|
|
Age: |
9.0 |
Onset: |
2008-01-10,
Days after vaccination: 6 |
|
Gender: |
Female |
Submitted: |
2008-02-14,
Days after onset: 35 |
|
Location: |
Unknown |
Entered: |
2008-02-19,
Days after submission: 5 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? No |
|
ER or Doctor Visit? No |
|
Hospitalized? No |
|
Current Illness: |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: Unknown |
|
CDC 'Split Type': WAES0801USA03650 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0523U |
|
IM |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Muscle
spasms, Vaginal
haemorrhage |
|
Write-up: Information has been received
from a medical assistant concerning a 9 year old female who on 26-OCT-2007
was vaccinated with her first dose of Gardasil (lot number: 658488/0930U). On
04-JAN-2008 she was vaccinated with her second dose of Gardasil (lot number:
657868/0523U). On approximately 10-JAN-2008, "1 week ago" the
patient experienced cramps and vaginal bleeding. The patient''s cramps and
vaginal bleeding persisted. No further information is available. |
|
VAERS ID: |
Vaccinated: |
0000-00-00 |
|
|
Age: |
18.0 |
Onset: |
2007-12-24 |
|
Gender: |
Female |
Submitted: |
2008-03-03,
Days after onset: 70 |
|
Location: |
New
Jersey |
Entered: |
2008-03-04,
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 = 12/24/2007) |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0802USA01240 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
|
2 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion,
Drug
exposure during pregnancy |
|
Write-up: Initial and follow up information
has been received through the Merck pregnancy registry from a licensed
practical nurse concerning an 18 year old female who was vaccinated with
GARDASIL. The patient became pregnant after receiving all 3 doses of GARDASIL
(dates not specified). The patient''s last menstrual period (LMP) was
24-DEC-2007. The estimated date of delivery was 29-SEP-2008. The patient
sought medical attention. Follow up information indicated that in February,
at 6 or 7 weeks gestation, the patient''s pregnancy was aborted. No further
was provided. Upon internal review, abortion at "weeks from LMP 6 or
7" was considered to be serious as an other important medical event.
This is one several reports from the same source. Additional information has
been requested. |
|
VAERS ID: |
Vaccinated: |
2007-04-24 |
|
|
Age: |
22.0 |
Onset: |
0000-00-00 |
|
Gender: |
Female |
Submitted: |
2008-03-03 |
|
Location: |
Pennsylvania |
Entered: |
2008-03-04,
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 = 7/9/2007) |
|
Diagnostic Lab Data: Unknown |
|
Previous Vaccinations: |
|
Other Medications: |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0802USA04668 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HEPA |
MERCK
& CO. INC. |
|
|
UN |
UN |
|
HPV4 |
MERCK
& CO. INC. |
0960F |
0 |
IM |
UN |
|
MNQ |
SANOFI
PASTEUR |
|
|
UN |
UN |
|
VARCEL |
MERCK
& CO. INC. |
|
|
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy |
|
Write-up: Information has been received
through the Merck pregnancy registry from a Registered Nurse concerning a 23
year old female who on 24-APR-2007 was vaccinated with GARDASIL (Lot
#654535/0960F). Concomitant vaccinations on 24-APR-2007 included MENACTRA,
(manufacturer unspecified) and hepatitis A virus vaccine (manufacturer
unspecified). The patient received the second dose of GARDASIL (Lot
#657006/0188U) on 18-SEP-2007 and then experienced a miscarriage on
06-JAN-2008. The patient received the third dose of GARDASIL on 06-FEB-2008.
The patient received the third dose of GARDASIL on 06-FEB-2008. The
patient''s estimated delivery date was 16-APR-2008. The patient became
pregnant prior to receiving the second dose. Upon internal review,
miscarriage is considered to be an other important medical event. Additional
information has been requested. |
|
VAERS ID: |
Vaccinated: |
2007-09-21 |
|
|
Age: |
16.0 |
Onset: |
2007-09-21,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-03-07,
Days after onset: 168 |
|
Location: |
Unknown |
Entered: |
2008-03-10,
Days after submission: 2 |
|
Life Threatening Illness? No |
|
Died? No |
|
Disability? No |
|
Recovered? Yes |
|
ER or Doctor Visit? No |
|
Hospitalized? Yes, 0 days |
|
Extended
hospital stay? No |
|
Current Illness: Pregnancy NOS (LMP=Unknown) |
|
Diagnostic Lab Data: |
|
Previous Vaccinations: |
|
Other Medications: |
|
Preexisting Conditions: |
|
CDC 'Split Type': WAES0803USA00160 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
0927U |
0 |
IM |
LA |
|
Administered by: Private Purchased by: Other |
|
Symptoms: Drug
exposure during pregnancy, Premature
labour |
|
Write-up: Information has been received
from a physician''s assistant concerning a 16 year old female with pertinent
medical history and drug reaction/allergies reported as none who on
21-SEP-2007 was vaccinated with the first dose of Gardasil
(lot#658222/0927U), 0.5 ml, IM in the left deltoid. Concomitant medication
was not reported. On 08-OCT-2007, the patient told the physician''s assistant
that she was 7 1/2 months pregnant. In approximately October 2007 (date
unspecified), the patient was hospitalized and delivered the baby. The
patient reported that the delivery was preterm, but no problems were
reported. The physician''s assistant reported that there were no known
problems with the baby or mother. On 04-DEC-2007 (about 6 to 8 weeks) after
the patient delivered the baby, the patient received the second dose of
Gardasil (lot#657868/0523U) and a dose of MENACTRA. The physician''s
assistant was not following the pregnancy, only providing the vaccinations.
Subsequently on an unspecified date, the patient recovered from the events.
No product quality complaint was involved. Additional information has been
requested. |
|
VAERS ID: |
Vaccinated: |
2007-12-18 |
|
|
Age: |
20.0 |
Onset: |
2007-12-18,
Days after vaccination: 0 |
|
Gender: |
Female |
Submitted: |
2008-03-07,
Days after onset: 80 |
|
Location: |
Unknown |
Entered: |
2008-03-10,
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: diagnostic laboratory 02/04/08 -
pregnancy quantitative test was < 5.0 |
|
Previous Vaccinations: |
|
Other Medications: Unknown |
|
Preexisting Conditions: Abortion spontaneous |
|
CDC 'Split Type': WAES0802USA06211 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
|
HPV4 |
MERCK
& CO. INC. |
1209U |
0 |
UN |
UN |
|
Administered by: Other Purchased by: Other |
|
Symptoms: Abortion
spontaneous, Drug
exposure during pregnancy, Laboratory
test, Pregnancy
test positive |
|
Write-up: Information has been received for
the Merck Pregnancy Registry for Gardasil from a licensed practical nurse
concerning a 20 year old female with a history of 2 pregnancies and 0 live
births (2 miscarriages) who on 18-DEC-2007 was vaccinated with Gardasil (lot#
654540/1209U). The patient''s date of last menstrual period was 18-DEC-2007.
Subsequently the patient became pregnant. On 04-FEB-2008 the patient
experienced a spontaneous abortion. On 04-FEB-2008, a pregnancy quantitative
was < 5.0. On 21-FEB-2008 the patient was vaccinated with a second dose of
Gardasil (lot# 0530U). Upon internal review spontaneous abortion is
considered to be an other medical event. Additional information is not
expected. |
|
VAERS ID: |
Vaccinated: |
2007-01-01 |
|
|
Age: |
|
Onset: |
0000-00-00 |
|
Gender: |