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Found 31944 cases where Vaccine is HPV4

Case Details

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VAERS ID:335403 (history)  Vaccinated:2008-12-01
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-16
Location:Missouri  Entered:2008-12-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB257AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2670AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2998BA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1186X1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Client received vaccines on 12-1-08 and found out on 12-11-08 she is pregnant.

VAERS ID:335410 (history)  Vaccinated:2008-01-28
Age:17.0  Onset:2008-11-24, Days after vaccination: 301
Gender:Female  Submitted:2008-12-16, Days after onset: 22
Location:Georga  Entered:2008-12-16
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Ultrasounds, chest xrays, ct and pet scans showed tumor growth. CBC out of normal range for months. 4/29/09-records received. WBC 30.1, lymph % 12.6, neut % 77. Biopsy of lymph node partial involvement Hodgkin lymphoma nodular sclerosis t
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Axillary mass, Biopsy lymph gland, Chest X-ray abnormal, Computerised tomogram abnormal, Cyst, Full blood count abnormal, Hodgkin's disease, Lymphocyte percentage decreased, Menstruation irregular, Neutrophil percentage decreased, Neutrophil percentage increased, Positron emission tomogram abnormal, Pruritus generalised, Red blood cell sedimentation rate increased, Ultrasound scan abnormal, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Malignant tumours (narrow), Fertility disorders (broad), Hypersensitivity (broad), Malignant lymphomas (narrow)
Write-up: Patient received last of 3 Gardasil vaccinations. Approximately 2 months later was diagnosed with Hodgkins Lymphoma. Symptoms became evident just after the third vaccination. 3/9/09-records received-office visit 1/22/09-C/O tired SOB, Irregular menses which is secondary to chemo. Monitor labs if not better 3-6 mos. 4/29/09-records received-office visit 1/23/08 for C/O possible brachial cleft cyst or neck mass. Past 2 weeks swelling in left axilla. Decreased energy and generalized pruritus.

VAERS ID:335442 (history)  Vaccinated:2008-12-09
Age:11.0  Onset:2008-12-10, Days after vaccination: 1
Gender:Female  Submitted:2008-12-10, Days after onset: 0
Location:Texas  Entered:2008-12-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: dealt step
Preexisting Conditions: ADD
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2742AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Eye pruritus, Fatigue, Malaise, Nausea, Somnolence
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Patient complain of dizziness, eye itchy, nauseated, doesn''t feel well, fatigue and sleeping more.

VAERS ID:335461 (history)  Vaccinated:2008-09-24
Age:11.0  Onset:2008-09-24, Days after vaccination: 0
Gender:Female  Submitted:2008-12-10, Days after onset: 77
Location:Arizona  Entered:2008-12-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2683AA0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSC2998BA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Immediate post-injection reaction
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Within 1 minute of administering 3 immunizations listed above, pt began having seizure. o2 was administered and vitals monitored. Seizure was approx. 5-10 secs. She was observed for more than 30 mins until she was able to leave office safely.

VAERS ID:335484 (history)  Vaccinated:2008-09-10
Age:29.0  Onset:2008-09-10, Days after vaccination: 0
Gender:Female  Submitted:2008-12-16, Days after onset: 97
Location:Massachusetts  Entered:2008-12-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REPLIVA 21/7, tab; FLONASE
Current Illness: Pregnancy NOS (LMP = 2/24/2008); Anaemia; Seasonal allergy; Asthma; Antiallergic therapy
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 07/14/08, normal survey; Beta-human chorionic, positive; Apgar score, 9/9
CDC 'Split Type': WAES0809USA01813
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0573X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Apgar score normal, Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow-up information has been received for the pregnancy registry for GARDASIL from a nurse, a physician and a 29 year old female with a history of anemia, asthma and seasonal allergies, who on 10-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 0573X) 0.5 mL, IM into her deltoid, when she was six and a half months pregnant. Concomitant medication included REPLIVA and FLONASE. The nurse and the physician reported that the patient has an estimated delivery date of 01-DEC-2008. The patient''s condition was not determined to be life threatening, or resulting in significant disability/incapacity, not related to a congenital anomaly, not related to an overdose, not related to cancer, and there was no need for intervention to prevent serious criteria. The patient sought unspecified medical attention. On an unspecified date, there was a pregnancy test performed resulting positive. On 14-JUL-2008, a routine ultrasound test was performed resulting in a normal survey. Follow-up information was received from a physician who reported that the patient delivered a normal baby on 26-NOV-2008. The baby was male and weighed 9 pounds 5.9 ounces, and the APGAR score was 9/9. The infant was born with a congenital small ear tag in his left ear. There were no other complications or abnormalities. The physician reported that during the pregnancy the patient had a normal level II ultrasound/fetal survey at 20 weeks. The patient had no complications during the pregnancy and labor/delivery. There were no infections or illnesses during pregnancy. The patient''s medications used during this pregnancy included REPLIVA 1 tablet daily since 11-SEP-2008 for anaemia, and FLONASE daily since preconception. Additional information has been requested.

VAERS ID:335488 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-16
Location:Unknown  Entered:2008-12-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVAIR; hormonal contraceptives
Current Illness: Pregnancy NOS (LMP = 7/25/2008); Drug hypersensitivity
Preexisting Conditions: Neoplasm; Blood transfusion; Rhinoplasty; Sinus disorder; Tumour excision
Diagnostic Lab Data: ultrasound, baby has club foot
CDC 'Split Type': WAES0812USA01813
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Endometriosis, Foetal disorder, Ovarian cyst, Surgery, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Information has been received from a 25 year old female patient with polytrim eye drops allergy and a history of a tumor taken out of her chest and blood transfusion at age 4, and nose surgery because of a sinus problem in 2005, who received all 3 doses of GARDASIL. In 2007 (last year) was vaccinated with the first dose of GARDASIL (Lot # not reported). On approximately 15-MAY-2008 (mid May 2008), was vaccinated with the third dose of GARDASIL (Lot # not reported). Concomitant therapy included ADVAIR and "birth control". Around July 2008, the patient got pregnant. The patient is feeling fine, however the ultrasound discovered that the baby has a club foot. The patient also mentioned that before receiving the third dose she had a surgery because endometriosis, and had an ovarian cyst drained. The patient sought unspecified medical attention. Normal laboratory tests and first trimester screen were performed (results not provided). Last menstrual period was approximately on 25-JUL-2008 and estimated delivery date is on 01-May-2009. Upon internal review club foot was determined to a congenital anomaly. Additional information has been requested.

VAERS ID:335489 (history)  Vaccinated:2008-06-01
Age:20.0  Onset:2008-07-25, Days after vaccination: 54
Gender:Female  Submitted:2008-12-16, Days after onset: 144
Location:Unknown  Entered:2008-12-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 7/25/2008)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA02338
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a licensed practical nurse concerning a 20 year old female patient who in June 2008, was vaccinated with the first dose of GARDASI, lot # was not reported. It was reported that the patient became pregnant with twins and had a miscarriage about one week ago. Patient was hospitalized. LMP was 25-JUL-2008. Additional information has been requested.

VAERS ID:335511 (history)  Vaccinated:2008-12-12
Age:16.0  Onset:2008-12-14, Days after vaccination: 2
Gender:Female  Submitted:2008-12-17, Days after onset: 3
Location:Oregon  Entered:2008-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Citalopram 40 mg Trazadone 100 mg,Necon 0.5/35, Albuterol inhaler
Current Illness: None
Preexisting Conditions: Concerta, milk Mushrooms
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X2IMRA
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 48 hours after administration of Vaccine the injection site became very red and swollen. With in a few minutes the redness radiated down her arm near her wrist.

VAERS ID:335520 (history)  Vaccinated:2007-12-05
Age:14.0  Onset:2008-02-05, Days after vaccination: 62
Gender:Female  Submitted:2008-12-17, Days after onset: 316
Location:Missouri  Entered:2008-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Was not ill at time of GARDASIL started having nose bleeds, headaches, and fatigue by the meningitis vaccine in July.
Preexisting Conditions: none PMH: constipation HPV#2 Lot # 1267U, given 3/21/08 IM/LA HPV#3 Lot # 1740U, given 6/9/08 IM/LA
Diagnostic Lab Data: pancreatitis,labs - pnemonia, x-ray- cyst,ultrasound- upper and lower scope,gastrointestinal- central line for TPN and Lipids LABS: CT scan suggested RLL pneumonia & bilateral ovarian cysts. CBC, chemistry & UA WNL. KUB revealed ileus. US revealed prominent left ovarian cyst & smaller right ovarian cyst.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0012U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Allodynia, Computerised tomogram abnormal, Condition aggravated, Diarrhoea, Disability, Dizziness, Drug interaction, Endoscopy, Epistaxis, Eructation, Fatigue, Flank pain, Full blood count normal, Galactorrhoea, Gastrointestinal disorder, Headache, Hyperlipasaemia, Hyperprolactinaemia, Hypersensitivity, Ileus, Laparoscopy, Metabolic function test normal, Nausea, Ovarian cyst, Pain, Pancreatitis, Parenteral nutrition, Pneumonia, Retching, Ultrasound scan abnormal, Urinary system X-ray, Urine analysis normal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: nose bleeds, headaches sudden onset after first shot continued after second and third shot third shot 6/9/08 fatigue, end of July received meningits vaccine sept started pain, cyst on ovaries,then nausea,vomiting,pancreatitis,gastrointestinal disorders,dizziness,pnenmonia,lactating,hypersensitivity,8 weeks in hospital still sick 1/27/09 Link with 338052. 2/2/09 Received hospital & clinic medical records for 9/18-12/10/2008. FINAL DX: Pancreatitis Records reveal patient seen in ER 9/18 for RLQ flank/abdominal pain with nausea, fever & cough x 2 days. Improved w/meds & d/c to home. Returned w/severe pain. Hospital admit 9/20-9/22/2008. FINAL DX: right flank pain, resolving; pneumonia, resolving. Records reveal RLQ flank/abdominal pain improved. d/c to home on continued oral antibiotics for pneumonia & w/GYN f/u. OB/GYN records of 10/7 & 10/8 & Operative report of 9/24/2008. FINAL DX: RLQ pain w/bilateral ovarian cysts Patient had laparoscopic aspiration of ovarian cysts as same day surgery. Had continued post op RLQ abdominal pain. US was WNL. referred to PCP for additional GI w/u. Returned to ER 10/23/2008 W/persistent RLQ pain. Labs all WNL & d/c to home. Returned to ER 12/10/2008 w/nausea, vomiting, dry heaves x 1 day, diarrhea x 2 weeks. Had recently been d/c from higher level of care w/dx pancreatitis & was on TPN. Found to have ileus. Tx w/meds & d/c to home. 2/17/09 Received hospital medical records of 11/21-12/3/2008. FINAL DX:allodynia w/abdominal wall pain improving; hyperlipasemia, etiology uncertain; galactorrhea & hyperprolactinemia secondary to Lexapro; marked disability in association w/chronic pain; intermittent, frequent belching/retching related to disability & chronic pain. Records reveal patient experienced RLQ pain. Had been transferred from outlying hospital where she had been admitted 10/15/08 & extensive medical record review of that hospitalization included. Endocrine, pain mgt, psych consult done & meds adjusted. Tx w/TPN. Improved & d/c to home w/continued TPN, pain meds, PT, psych counseling & serial labs.

VAERS ID:335521 (history)  Vaccinated:2008-11-13
Age:23.0  Onset:2008-11-29, Days after vaccination: 16
Gender:Female  Submitted:2008-12-17, Days after onset: 18
Location:Ohio  Entered:2008-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Sprintec
Current Illness: None
Preexisting Conditions: Codeine- reaction is rash
Diagnostic Lab Data: WBC on 12/13 was 12.5 but on 12/16 (day of admission) was 7.0. All other labs are within normal limits. CT of arm on 12/13 was within normal limits but MRI with and without contrast of arm on 12/16 indicated: 1. EVIDENCE OF A FAIRLY DIFFUS
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Chills, Computerised tomogram normal, Fasciitis, Fatigue, Hypophagia, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Laboratory test normal, Lethargy, Myositis, Nuclear magnetic resonance imaging abnormal, Pyrexia, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient received vaccine and initially had soreness at the injection site for about 2 weeks. On 11/29 she noticed redness and warmth in addition to pain in the area. This initally improved without any treatment. Symptoms began to worsen again (redness, pain, warmth in the deltoid area of the arm) and she was seen at an urgent care facility on 12/9 and was given Keflex 250mg TID. Symptoms continued to worsen. She presented to the Emergency Department on 12/13/08 and was given a 1 gram dose of Vancomycin IV and was ultimately discharged home on Keflex 500mg QID and Bactrim DS - 1 tab BID. Patient reports initial improvement after the antibiotic change but then symptoms again worsened and she returned to the ED on 12/16/08 and was admitted to the hospital for IV antibiotics with worsening erythema and pain. She is currently on vancomycin IV and Clindamycin IV was added today because symptoms are not significantly improving. There is no abcess associated with the cellululitis. Patient is still in the hospital- anticipated discharge date unknown. 2/2/09-records received for DOS 12/16-12/19/08 DC DX:Myositis/fascitis.Presented to ER with 6 week history of LUE cellulitis at which time received 3rd gardasil injection in left arm. After injection noticed army sore 1 week later with red ring around injeciton site and treated with oral antibiotics. LUE pain worsing and redness spreading, decreased ROM, fever feeeling lethergic/fatigued. Presented with chills decreased oral intake.

VAERS ID:335546 (history)  Vaccinated:2008-12-13
Age:12.0  Onset:2008-12-13, Days after vaccination: 0
Gender:Female  Submitted:2008-12-13, Days after onset: 0
Location:California  Entered:2008-12-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2833AA UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAL52B029AA UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0790X UNUN
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt. had dizziness and nausea after vaccination. Had pallor and diaphoresis. Vital stable. CNS exam. WNL. Referred to ER for eval.

VAERS ID:335557 (history)  Vaccinated:2007-05-04
Age:16.0  Onset:2007-05-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-17, Days after onset: 593
Location:Maryland  Entered:2008-12-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN; Vitamins (unspecified)
Current Illness: Penicillin allergy
Preexisting Conditions: Erythema multiforme PMH: Had been on Yasmin until 10/1/08 for dysmenorrhea. HA, dizziness, intermittent neck & back pain x 7 yrs. Polyposis of paranasal sinuses w/sinus surgery & repair of deviated septum. Bilateral CTS, intermittent numbness hands, itching. Irregular menses, herpetic rash on face age 6 yr, trauma right eye, migraine HA. Umbilical hernia repair. Sinus surg
Diagnostic Lab Data: Unknown LABS: MRI abnormal & c/w optic neuritis. CSF test WNL.
CDC 'Split Type': WAES0812USA02328
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amnesia, Back pain, Blindness unilateral, CSF test normal, Condition aggravated, Cranial nerve disorder, Diplopia, Dizziness, Epistaxis, Eye pain, Fall, Fatigue, Halo vision, Headache, Hypoaesthesia, Lumbar puncture, Malaise, Micturition urgency, Mood altered, Nausea, Nuclear magnetic resonance imaging brain abnormal, Ophthalmological examination abnormal, Optic neuritis, Pain in extremity, Paraesthesia, Phonophobia, Photophobia, Pollakiuria, Tunnel vision, Urinary incontinence, Vision blurred, Weight increased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (narrow), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Ocular infections (broad), Ocular motility disorders (broad)
Write-up: Information has been received from a patient''s mother concerning her 17 year old daughter with penicillin allergy and a history of erythematous multiforme (about 10 years ago) who was vaccinated with the first dose of GARDASIL on 04-MAY-2007, she received the second dose of GARDASIL on 06-JUL-2007 and then received the third dose of GARDASIL on 06-NOV-2008. Vaccinations also received on 04-MAY-2007 included a first dose of Hep A (manufacturer unknown) and a second dose of Hep A (manufacturer unknown) on 06-NOV-2007. Concomitant therapy included YASMIN and vitamins (unspecified). It was reported that the patient started complaining of extreme back pain that went from the head down to the spine in May-2008 and then on 22-SEP-2008 the patient started to have vision loss in her one eye, which eye was unspecified. The patient was then admitted to the hospital on 06-OCT-2008 because of the vision problem, she could not control her bladder, very moody, tired, extreme head and back pain. At the hospital she had spinal test done. MRI of her brain and spine, and numerous blood work was done. The patient was diagnosed with optic neuritis and is totally blind in the one eye, and was then sent home from the hospital on 11-OCT-2008. It was reported that the patient still was having problems with the back pain, she also had short term memory loss, she falls a lot, and had tingling and numbing of the hands and feet. It was noted that the patient still had most of the symptoms and they were trying to rule out multiple sclerosis. The patient''s mother reported that lot # that she had was 655165/1425F, but she was unsure what dose that lot # was for. At the time of the report the patient had not recovered. Additional information has been requested. 1/06/09 Received hospital medical records of 12/16-12/17/2008. FINAL DX: blurred vision left eye, not optic neuritis; optic neuritis right eye. Records reveal patient seen for loss of vision in right eye beginning 9/08 & tunnel vision left eye beginning 12/16/08. Did not feel well

VAERS ID:335558 (history)  Vaccinated:2008-07-07
Age:15.0  Onset:2008-10-10, Days after vaccination: 95
Gender:Female  Submitted:2008-12-17, Days after onset: 68
Location:Maryland  Entered:2008-12-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Motor vehicle accident; Head injury PMH: headaches, food allergies(carrots, anaphylaxis), bronchitis, pneumonia, tonsillitis. Using contraception. Prior head injuries: 2003, MVA; 2005 sports injury; 2007 struck beam. RAD, migraines, ear tube insertion, adenoidectomy.
Diagnostic Lab Data: computed axial, ?/?/03, normal; electroencephalography, 10/??/08, bilateral seizure activity LABS: CBC,chemistry & UA WNL. TSH 6.93(H). Urine drug screen neg. CT head revealed chronic sinusitis. EEG abnormal.
CDC 'Split Type': WAES0812USA02806
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood thyroid stimulating hormone increased, Computerised tomogram abnormal, Condition aggravated, Drug screen negative, Electroencephalogram abnormal, Epilepsy, Full blood count normal, Grand mal convulsion, Headache, Hypothyroidism, Laboratory test normal, Loss of consciousness, Migraine, Postictal state, Sinusitis, Tongue biting, Urine analysis normal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (narrow), Hyperthyroidism (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a registered nurse concerning a 15 year old female patient with a history of motor vehicle accident in 2003 (CT scan at that time was normal) and minor head injuries due to sports that required stitches who on 03-MAR-2008 was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscularly, lot # 660387/1967U), and on 07-JUL-2008 the second dose of GARDASIL (0.5 ml, intramuscularly, lot # 660553/0070X). On 10-OCT-2008 the patient experienced a petit mal seizure and on 18-OCT-2008 had a second seizure. The nurse stated that each seizure lasted 2 to 3 minutes and it took 30 minutes post seizure for the patient to fully recover. Patient was seen in Emergency Room after the 2nd seizure because she bit her tongue which required treatment. The 3rd GARDASIL dose was delayed pending neurologist''s decision. EEG showed bilateral seizure activity. Patient is now taking TOPAMAX. Upon internal review, petit mal seizure, and seizure were determined to be other important medical events. Additional information has been requested. 12/29/08 Received ER medical records for 10/11/2008. FINAL DX: new onset seizures & hypothyroidism. Records reveal patient experienced HA followed by LOC & parent witnessed generalized seizure lasting approx 2-3 min followed by postictal period of approx 15-20 min. Had 1 prior seizure on 10/10/08 & seen by PCP. Referred to neuro. No further seizure activity while in ER & d/c to home. 2/26/09 Received Neuro consut of 10/16/2008. FINAL DX: solitary seizure & migraines Records reveal patient experienced witnessed seizure activity w/tongue biting & postictal period & preceeded by emesis. Tx w/meds & referred for EEG. No further records available. 3/3/09 Received Neuro consult of 10/22/2008. FINAL DX: Epilepsy Records reveal patient had 2 generalized tonic-clonic events c/w epilepsy but unable to determine if partial onset or primary generlized. Was to continue meds & obtain copy of MRI & EEG done at outlying hospital for review. No further r

VAERS ID:335576 (history)  Vaccinated:2008-08-11
Age:17.0  Onset:2008-08-11, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 123
Location:Florida  Entered:2008-12-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0389U1IMRA
Administered by: Other     Purchased by: Public
Symptoms: Body temperature increased, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Reported 4 month after #2 GARDASIL. Temp. 101. Nausea and fainting episode.

VAERS ID:335577 (history)  Vaccinated:2008-12-10
Age:15.0  Onset:2008-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-12-10, Days after onset: 0
Location:Hawaii  Entered:2008-12-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild cold symptoms, cough, runny nose
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': HI0809
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2806AA0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHA4B246AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1208F0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2538AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B020AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dyskinesia
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad)
Write-up: Client closed eyes, looked like she was going to faint and then she had two jerky movements. She then opened her eyes and asked what happened. Jerky movements lasted three seconds. Involved head and upper body.

VAERS ID:335632 (history)  Vaccinated:2008-10-07
Age:22.0  Onset:2008-10-08, Days after vaccination: 1
Gender:Female  Submitted:2008-12-18, Days after onset: 71
Location:New York  Entered:2008-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu like symptoms~HPV (Gardasil)~1~23~In Patient
Other Medications: Lexapro 10 mg
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Negative/N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Asthenia, Diarrhoea, Headache, Influenza like illness, Pain in extremity
SMQs:, Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Mild Headache, Pain in entire left arm (not at injection site), general weakness, mild diarrhea, mild flu like symptoms. Symptoms began the day after the injection and lasted for 4-7 days.

VAERS ID:335697 (history)  Vaccinated:2008-11-01
Age:17.0  Onset:2008-11-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-18, Days after onset: 47
Location:Wisconsin  Entered:2008-12-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Convulsion disorder
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA03210
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female patient with a history of seizure disorders who in approximately 15-NOV-2008 "about a month ago", was vaccinated with a second 0.5ml dose of GARDASIL. The physician reported that the patient experienced a seizure after receiving the vaccine. The patient sought unspecific medical attention. The patient recovered within a few minutes. Upon internal review seizure disorders were considered as an other important medical event. Additional information has been requested.

VAERS ID:335769 (history)  Vaccinated:2008-12-15
Age:41.0  Onset:2008-12-16, Days after vaccination: 1
Gender:Female  Submitted:2008-12-19, Days after onset: 3
Location:Texas  Entered:2008-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: PMH: uterine fibroids, DDD, insomnia, painful intercourse, anxiety/depression, migraine HA, irritability, elective abortion, . Allergy: pollen.
Diagnostic Lab Data: LABS: CBC, chemistry, PAP smear all WNL. HPV test neg.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Full blood count normal, Human papilloma virus test negative, Laboratory test normal, Nausea, Smear cervix normal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Asthma, Nausea. 1/20/09 Reviewed GYN medical records of 12/15/08. FINAL DX:none provided. Normal GYN exam. Records reveal patient experienced asthma like symptoms reported by phone.

VAERS ID:335777 (history)  Vaccinated:2008-11-21
Age:24.0  Onset:2008-11-21, Days after vaccination: 0
Gender:Female  Submitted:2008-12-19, Days after onset: 28
Location:Florida  Entered:2008-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Aspirin allergy.
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Cold sweat, Dizziness, Injection site erythema, Injection site pruritus, Pallor
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Gardasil administered to left deltoid IM. Client complained of feeling dizzy approx. 15 - 25 seconds later. Slight paleness to skin and hands clammy. 2nd nurse called to assist. Feet were propped up, cold compresses applied, client stated approx 5 - 7 minutes later that she was feeling better. Client left office on own accord, with mother, after approx. 10 minutes of observation. When client presented to another clinic in health department she refused 2nd Gardasil shot with complaints of feeling weak for 2 days post vaccine. Further stated that injection site was itching and red.

VAERS ID:335795 (history)  Vaccinated:2008-11-11
Age:12.0  Onset:2008-11-12, Days after vaccination: 1
Gender:Female  Submitted:2008-12-12, Days after onset: 30
Location:Ohio  Entered:2008-12-19, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Psychosocial issues in school PMH: eczema, constipation, head trauma 1 yr ago, fall, umbilical hernia repair. Family hx: SLE & mental health issues.
Diagnostic Lab Data: LABS: CBC, CRP, CK, CMP all WNL.
CDC 'Split Type': MEDI0007625
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500553P IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U2UNUN
Administered by: Private     Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Blood creatine phosphokinase normal, C-reactive protein normal, Chest pain, Conversion disorder, Facial paresis, Full blood count normal, Gait disturbance, Headache, Hypoaesthesia, Metabolic function test normal, Mood altered, Oropharyngeal pain, Pain in extremity, Pharyngitis, Physiotherapy, Viral infection, Weight decreased
SMQs:, Agranulocytosis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad)
Write-up: A serious, spontaneous report of conversion disorder reaction, facial muscles have not moved and numbness in toes and fingers was received from a consumer concerning a 12 year old female subsequent to FLUMIST. The patient has a history of psychosocial issues. The patient received GARDASIL the same day as FLUMIST. The patient received FLUMIST intranasal for Flu vaccination on 11-Nov-2008. On 11-Nov-2008 the patient was seen in the pediatricians office for chest pains and during the visit received FLUMIST and GARDASIL. Since 24 hours after administration the patients facial muscles have not moved and she has numbness in her toes and fingers. The patient subsequently was seen by a neurologist, cardiologist and the pediatrician for the events and an MRI was taken. Results are not available. The events are on going and the patient is scheduled to begin physical therapy. The responsible physician assessed the events as not related to vaccine administration and instead considered the event a conversion disorder reaction. The event is considered a serious important medical event. 1/2/09 Received PCP, ER & Neuro medical records of 11/24-12/3/08 FINAL DX: none provided; possible conversion reaction Records reveal patient experienced HA, weakness, difficulty walking, pain in all extremities x approx 3 wks. Missed several days of school. Had been seen in Urgent care 11/24 & 11/27 for sore throat, HA & body aches. W/u WNL. Dx w/viral illness & pharyngitis. Flat affect, weight loss. Required follow-up attempts have been performed, requested information unable to be obtained.

VAERS ID:335798 (history)  Vaccinated:2008-12-05
Age:21.0  Onset:2008-12-16, Days after vaccination: 11
Gender:Female  Submitted:2008-12-17, Days after onset: 1
Location:Pennsylvania  Entered:2008-12-19, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0650X2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: (L) arm muscle soreness for 1 week duration.

VAERS ID:335799 (history)  Vaccinated:2008-07-17
Age:27.0  Onset:2008-07-18, Days after vaccination: 1
Gender:Female  Submitted:2008-08-19, Days after onset: 32
Location:Florida  Entered:2008-12-19, Days after submission: 122
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Splenectomy from ITP
Diagnostic Lab Data: Blood work run. Very high enzymes (3 of 4) LABS: PAP smear of 7/17/08 HPV(+). Repeat PAP 11/26/08 LSIL. Vaginal c/s 1/26/09 (+) Gardnerella vaginalis & HPV.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X UNUN
Administered by: Private     Purchased by: Private
Symptoms: Abdominal distension, Blood culture, Body temperature increased, Cervical dysplasia, Colposcopy, Culture positive, Enzyme abnormality, Headache, Human papilloma virus test positive, Inappropriate schedule of drug administration, Papilloma viral infection, Smear cervix abnormal, Vaginal discharge, Vaginitis gardnerella, Viral infection
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Reproductive premalignant disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Headache about 24hrs later, no pain killers helped. Temperature about 48hrs later. Both got worse. Went to Dr 6 days later. Said viral must fight off. Continued a full 2 wks after vaccination. Then a wk of severe stomach bloating. 3/9/09 Received PCP medical recods of 07/17/08-1/26/2009. FINAL DX: Low grade squamous intraepithelial lesion, HPV infection Records reveal patient experienced good health on 7/17/08. RTC 11/10/08 & 11/26/08 w/vaginal discharge. Colposcopy done 1/12/09. RTC 1/26/09 & tx w/meds.

VAERS ID:335801 (history)  Vaccinated:2008-12-19
Age:21.0  Onset:2008-12-19, Days after vaccination: 0
Gender:Female  Submitted:2008-12-19, Days after onset: 0
Location:Maryland  Entered:2008-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0947X1IMLA
Administered by: Private     Purchased by: Other
Symptoms: Excoriation, Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 2nd dose of GARDASIL administered on 12/19/08. Pt experienced syncope, fell to the floor, experienced abrasion on (L) side of face. After 30 mins. pt "felt better",given water for hydration. Driven home by mother

VAERS ID:335807 (history)  Vaccinated:2008-11-21
Age:27.0  Onset:2008-12-15, Days after vaccination: 24
Gender:Female  Submitted:2008-12-19, Days after onset: 4
Location:Illinois  Entered:2008-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR, 40mg; CLOBETASOL, 0.05
Current Illness:
Preexisting Conditions: KNA or medical conditions
Diagnostic Lab Data: Neurology exam, negative per patient
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0737U1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Laboratory test, Neurological examination normal, Pain in extremity
SMQs:
Write-up: Her whole arm hurts. Hurts most on her deltoid and travels down her arm. Has seen MD to get labs done and neurology exam.

VAERS ID:335844 (history)  Vaccinated:2008-11-01
Age:24.0  Onset:2008-11-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-19, Days after onset: 48
Location:Unknown  Entered:2008-12-22, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA03375
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Coma, Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
SMQs:, Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow)
Write-up: Information has been received from Company representative who was told by a friend of the patient''s family. The patient was a 24 year old female patient who was vaccinated in approximately November-2008 with the third dose of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified). In approximately November-2008, the patient reported tingling in her fingers and toes shortly after the vaccinations. It got worse over night and she went to the Hospital the next day. The hospital did test for persistent numbness and the patient was sent home. The patient''s mother found her crawling on the floor a few days later and she was taken by ambulance to the hospital where she was admitted, intubated and in coma. The patient was diagnosed with Guillain-Barre. As of 16-DEC-2008, the patient was still in coma. Guillain-Barre syndrome and coma were considered to be immediately life-threatening and disabling and other important medical event. No further information is available.

VAERS ID:335852 (history)  Vaccinated:2008-11-26
Age:15.0  Onset:2008-11-26, Days after vaccination: 0
Gender:Female  Submitted:2008-12-22, Days after onset: 26
Location:New Mexico  Entered:2008-12-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CT head, CBC, CMP, T4, TSH
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500552P0IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA1UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X2UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Blood thyroid stimulating hormone, Computerised tomogram, Dizziness, Full blood count, Headache, Hypoaesthesia, Metabolic function test, Paraesthesia, Thyroxine, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Headache, occasional blurring vision, tingling numbness, dizziness.

VAERS ID:335864 (history)  Vaccinated:2008-09-18
Age:16.0  Onset:2008-09-22, Days after vaccination: 4
Gender:Female  Submitted:2008-12-16, Days after onset: 85
Location:North Carolina  Entered:2008-12-22, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: asthma. Family hx: stroke, PD, migraines, HTN.
Diagnostic Lab Data:
CDC 'Split Type': NC09004
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2582AA0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Fatigue, Flushing, Gait disturbance, Headache, Hyperhidrosis, Hypersensitivity, Nausea, Neurological examination normal, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Four days after vaccine administration, Pt became unable to walk. Was evaluated by neurologist who advised pt to never again take the GARDASIL vaccine. 3/13/09 Received Neuro medical records of 9/24/08. FINAL DX:generalized weakness, fatigue, N/V s/p HPV vaccine Records reveal patient experienced weakness. States patient developed weakness, N/V/D, fatigue, HA, abdominal pain, flushing, diaphoresis within 2 days of HPV #1. Seen in ER & referred to Neuro. Examination WNL & referred back to PCP. 3/16/09 Received ER medical records of 9/24/2008. FINAL DX: medication reaction; r/o GBS Records reveal patient experienced weakness, N/V/D, difficulty walking.

VAERS ID:335869 (history)  Vaccinated:2008-09-29
Age:25.0  Onset:2008-09-30, Days after vaccination: 1
Gender:Female  Submitted:2008-12-18, Days after onset: 79
Location:Connecticut  Entered:2008-12-22, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oral contractive; Benadryl PRN
Current Illness:
Preexisting Conditions: "Soy"
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.001140IMUN
Administered by: Other     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Client returned to office for #2 GARDASIL states ''after last shot broke out in Hives''.

VAERS ID:335916 (history)  Vaccinated:2008-07-07
Age:15.0  Onset:2008-09-30, Days after vaccination: 85
Gender:Female  Submitted:2008-12-22, Days after onset: 83
Location:Ohio  Entered:2008-12-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVAIR
Current Illness: None
Preexisting Conditions: asthma
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Alopecia
SMQs:
Write-up: Hair loss/thining at 2 mos after administration of 2nd GARDASIL shot on 7/7/08

VAERS ID:335919 (history)  Vaccinated:2008-12-22
Age:13.0  Onset:2008-12-22, Days after vaccination: 0
Gender:Female  Submitted:2008-12-22, Days after onset: 0
Location:Utah  Entered:2008-12-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 3UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Migraine
SMQs:, Hypersensitivity (narrow)
Write-up: Migraine immediately after GARDASIL injection

VAERS ID:335946 (history)  Vaccinated:2008-12-11
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-18
Location:Idaho  Entered:2008-12-23, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X1SCRA
Administered by: Private     Purchased by: Other
Symptoms: Hypersensitivity, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Had episode of emesis and hypersensitivity after vaccine. Resolved with breathing in paper bag.

VAERS ID:335951 (history)  Vaccinated:2008-12-16
Age:14.0  Onset:2008-12-16, Days after vaccination: 0
Gender:Female  Submitted:2008-12-17, Days after onset: 1
Location:Pennsylvania  Entered:2008-12-23, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIFFERIN GEL; BENZODIAZEPINE
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB320AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2823AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: After 10 minutes - stood up in hallway - collapsed - to floor - got up with help - assisted back to room - gave O2 2 - took vitals every 5 minutes - gave water - after 20 minutes - could walk without help - referred to ER. Was taken by mother.

VAERS ID:335960 (history)  Vaccinated:2008-12-10
Age:25.0  Onset:2008-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-12-16, Days after onset: 6
Location:Virginia  Entered:2008-12-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LESSINA
Current Illness: None
Preexisting Conditions: Reports allergy to Sulfanamides
Diagnostic Lab Data: O2 Sat 97
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X1IMRA
Administered by: Private     Purchased by: Private
Symptoms: No reaction on previous exposure to drug, Oxygen saturation normal, Pallor, Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Approximately ten minutes following administration of GARDASIL #2, patient experienced erythematous blanchable macules on both arms. Denied SOB, nausea, itching and/or pain. No reaction following GARDASIL #1. Rash began to resolve with no treatment except BENADRYL, 25 mg.

VAERS ID:336031 (history)  Vaccinated:2008-12-22
Age:11.0  Onset:2008-12-22, Days after vaccination: 0
Gender:Female  Submitted:2008-12-23, Days after onset: 1
Location:California  Entered:2008-12-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS899850IMLA
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1884U2IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2617AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1143X1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Pallor
SMQs:, Hypotonic-hyporesponsive episode (broad)
Write-up: Client received vaccines listed below-Advised to remain seated while paper work was being filled in and signed. I noticed patient sliding down in her chair she became very pale. I assisted her to sit up in the chair advised her to lower her head and she did-I applied ice pack advising her to take slow deep breaths which she did client agreed to lie down. Take to clinic area per co-worker where checked by physician.

VAERS ID:336047 (history)  Vaccinated:2008-12-10
Age:24.0  Onset:2008-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-12-19, Days after onset: 9
Location:New York  Entered:2008-12-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2803AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0650X0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR0650X0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient fainted after receiving vaccines

VAERS ID:336049 (history)  Vaccinated:2008-01-31
Age:16.0  Onset:2008-02-03, Days after vaccination: 3
Gender:Female  Submitted:2008-12-22, Days after onset: 323
Location:Tennessee  Entered:2008-12-24, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic Antihistamines septra PMH: BCP. allergic: sulfa. 37 wk preemie w/NICU x 1 week.
Diagnostic Lab Data: Per non blood work was done - reports are not available
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB215AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.144660IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Asthenia, Blood test, Cellulitis, Chills, Decreased appetite, Ear pain, Erythema multiforme, Malaise, Nausea, Otitis externa, Pseudomonas infection, Rash erythematous, Rash generalised, Rash papular, Rash pruritic, Weight decreased
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: On 10-02-2008 the patients mother was in the health department for services and reported that patient became very ill 3 days after getting vaccine here 1/2008. She began with rash and itching on 1 leg that spread in patches all over her body. She did not have a fever. She chilled, had nausea , and was unable to eat. she had no energy. Over the course of her illness (3mo) she lost 20lbs. Shortly after onset of illness, she saw a doctor and was sent to a Dermatologist. According to the patients mother diagnosis was pseudomonas. After 3 months the patient began to have relief from symptoms and is now feeling recovered. Any treatment/ Medications is unknown to me. 12/31/08 Reviewed PCP medical records of 4/08. FINAL DX: erythema multiforme Records reveal patient experienced papular red itchy rash all over x 1 week, decreased appetite, fever & chills x 2 days. Seen in ER on 4/12 & dx w/cellulitis. Tx w/antibiotics. PCP dx w/EM & tx w/steroids. RTC 4/29 w/o improvement, now w/left ear pain & 9# wt loss. Dx w/otitis externa, treated w/ear drops & referred to Derm. No other records available.

VAERS ID:336077 (history)  Vaccinated:2008-09-02
Age:13.0  Onset:2008-09-03, Days after vaccination: 1
Gender:Female  Submitted:2008-12-26, Days after onset: 114
Location:Massachusetts  Entered:2008-12-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.175242UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0537X1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt pruented in office 2 days post VARIVAX vaccine with swelling and itching around injection site, starting 1 day prior.

VAERS ID:336089 (history)  Vaccinated:2008-12-22
Age:16.0  Onset:2008-12-23, Days after vaccination: 1
Gender:Female  Submitted:2008-12-27, Days after onset: 4
Location:Alabama  Entered:2008-12-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bladder infection and yeast infection
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0650X1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Burning sensation, Candidiasis, Chlamydial infection, Dizziness, Fatigue, Headache, Injection site pain, Muscle spasms, Trichomoniasis, Urinary tract infection, Vaginal infection
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad)
Write-up: Severe dizziness and unable to function. Severe headache. Fatigue and pain in arm at injection site. Burning on the front of the forehead. This is her second injection. 1/14/09 Reviewed GYN medical records of 12/22/2008. FINAL DX: candida vaginitis; uti; (+) Chlamydia & trichomonas 10/08, resolved. Records reveal patient tx for UTI on day of vaccination. Parent stated previously via voicemail message that patient not seen by PCP or ER for treatment & has fully recovered from HA following HPV vaccination of 12/22/08. Has back spasms couple of times/wk only & treats w/OTC meds.

VAERS ID:336102 (history)  Vaccinated:2008-12-01
Age:14.0  Onset:2008-12-02, Days after vaccination: 1
Gender:Female  Submitted:2008-12-24, Days after onset: 22
Location:Michigan  Entered:2008-12-26, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Concerta, Benzaclin
Current Illness: None
Preexisting Conditions: Acne, ADHD
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB436AA IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2568AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1154X SCRA
Administered by: Private     Purchased by: Private
Symptoms: Local reaction
SMQs:
Write-up: Local injection reaction - treatment ice, NSAIDS

VAERS ID:336130 (history)  Vaccinated:2008-12-11
Age:17.0  Onset:2008-12-11, Days after vaccination: 0
Gender:Female  Submitted:2008-12-15, Days after onset: 4
Location:Oregon  Entered:2008-12-29, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tacrolimus; Mycophenolate; Prednisone
Current Illness: Nasal/Sinus congestion; general ache; sore throat; fever; chronic HA
Preexisting Conditions: Kidney transplant 2004. PMH: Renal translants x 2, on immunosupressives. Chronic h/a.
Diagnostic Lab Data: Respiratory viral panel; CBC; Vacts; Blood culture; CXR. Labs and Diagnostics: Creatinine 1.13. UC (+) for 10K mixed flora. CMV PCR, EBV PCR (-).
CDC 'Split Type': OR200849
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSUB259AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0381X1IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0890X1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Blood creatinine normal, Blood culture, Chest X-ray, Chest pain, Condition aggravated, Culture urine, Culture urine positive, Cytomegalovirus test negative, Dehydration, Epstein-Barr virus test negative, Full blood count, Headache, Immunisation reaction, Immunosuppression, Malaise, Myalgia, Oropharyngeal pain, Polymerase chain reaction, Pyrexia, Respiratory tract infection viral, Viral test
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Admit ER 12/11/08 with fever, chest pain transfer to hospital, infectious disease consent, tested for viruses. Discharge diagnosis likely acute viral respiratory tract disease. 12/29/08 VAERS report submitted with medical records attached. Pt received 3 vax on 12/11/08. Had been feeling poorly at time of vax, but felt progressively worse afterward with headache, myalgias, fever and sore throat. Dehydrated on admission. Tx with IVF. Sx likely due to vaccine side effect and/or virus. DX: Fever. Immunosupression.

VAERS ID:336145 (history)  Vaccinated:2008-03-28
Age:24.0  Onset:2008-06-09, Days after vaccination: 73
Gender:Female  Submitted:2008-12-22, Days after onset: 196
Location:Unknown  Entered:2008-12-29, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No known drug allergy.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.3446U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hyperaesthesia, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received her second GARDASIL vaccine in June on her left arm. Patient states that her arm is stills swollen and feel very tender. She is sensitive to touch.

VAERS ID:336146 (history)  Vaccinated:2008-12-13
Age:14.0  Onset:2008-12-13, Days after vaccination: 0
Gender:Female  Submitted:2008-12-21, Days after onset: 8
Location:Unknown  Entered:2008-12-29, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Disorientation, Fatigue, Headache, Immediate post-injection reaction, Sensation of heaviness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Patient was given the GARDASIL shot at county health dept. She had two other shots done in her right arm, before the GARDASIL shot was given on the left side. Patient immediately fainted. When the nurse and I got her back up onto the table, she seized for about 30-60 seconds. It scared the nurse and I both. When she finally "came to" she was extremely disoriented. She said that her legs felt really "heavy" and that her head hurt. It took her about 30 minutes to be able to just stand up. She was then really tired and exhausted all day the rest of that day. This really scared both of us. She really doesn''t want to take the next 2 series of the shots because she is scared to death the same thing will happen again. Frankly, so am I. Is this going to be a possibility? Or do we not take the shots now? Please let us know as we are both really concerned.

VAERS ID:336152 (history)  Vaccinated:2008-12-19
Age:13.0  Onset:2008-12-20, Days after vaccination: 1
Gender:Female  Submitted:2008-12-22, Days after onset: 2
Location:New Hampshire  Entered:2008-12-29, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Healthy
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500584P3IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X2IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1012X1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Within 24 hrs arm itchy and red-swollen-size of tennis ball. 2nd day redness and swelling doubled in size. 3rd day still red and swollen size - 15X16 cm at office.

VAERS ID:336153 (history)  Vaccinated:2008-12-23
Age:15.0  Onset:2008-12-23, Days after vaccination: 0
Gender:Female  Submitted:2008-12-23, Days after onset: 0
Location:New York  Entered:2008-12-29, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE 150mg po
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0650X0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURUF456CA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Pt reported dizziness, blurry vision 15 min after injection. Pt laying down X 15 min. Pt stated "feeling better".

VAERS ID:336154 (history)  Vaccinated:2008-11-07
Age:22.0  Onset:2008-11-07, Days after vaccination: 0
Gender:Female  Submitted:2008-11-10, Days after onset: 3
Location:New Jersey  Entered:2008-12-29, Days after submission: 49
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X2IMRA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Lip swelling, Pruritus, Swollen tongue, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Approx. 20 minutes following the vaccination, pt began experiencing hives across both shoulders and neck. Hives were red and "itchy." Pt began experiencing swelling of the tongue and eventually of the lips as well. Treatment was administered by ER.

VAERS ID:336157 (history)  Vaccinated:2008-12-09
Age:16.0  Onset:2008-12-09, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Florida  Entered:2008-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB319AA0UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X2UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Hypoaesthesia, Nausea, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Dizziness and nausea. Numbness of arms, legs and head, shaking, fainting.

VAERS ID:336161 (history)  Vaccinated:2008-09-11
Age:14.0  Onset:2008-09-18, Days after vaccination: 7
Gender:Female  Submitted:2008-12-24, Days after onset: 97
Location:Connecticut  Entered:2008-12-29, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergic Rhinitis, LKDA
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0572X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Condition aggravated, Dizziness, Rhinitis allergic
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Intermittent dizziness and elevated temps (98.9-99.9) starting one week after injection and lasting one week. Simultaneously experienced exacerbation of allergic rhinitis.

VAERS ID:336164 (history)  Vaccinated:2008-12-17
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-17
Location:Maryland  Entered:2008-12-29, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Urine HCG
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500558P IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2818AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Patient given FLUMIST and GARDASIL and subsequently noted urine HCG was positive.

VAERS ID:336198 (history)  Vaccinated:2008-12-22
Age:15.0  Onset:2008-12-22, Days after vaccination: 0
Gender:Female  Submitted:2008-12-29, Days after onset: 7
Location:Texas  Entered:2008-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U2IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2816AA1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Client fainted immediately post vaccine administration and regained consciousness within moments. Her last meal was breakfast & vaccine administration occured in the mid PM. Mother called me today (12/29/08)reporting the client ate upon returning home the day of vaccine administration, slept the rest of the day, and had no further problems. Mother verbalizes the client had never experienced this problem post vaccine administration in the past.

VAERS ID:336205 (history)  Vaccinated:2008-12-29
Age:14.0  Onset:2008-12-29, Days after vaccination: 0
Gender:Female  Submitted:2008-12-29, Days after onset: 0
Location:Ohio  Entered:2008-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fainting~HPV (Gardasil)~1~14~In Patient
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0546X2IMRA
Administered by: Public     Purchased by: Private
Symptoms: Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient received an injection while in the supine position. Following 12 minutes lying down, patient sat up for about 5 minutes on the exam table. Public Health Nurses then went on to assist her to a chair and allowed her to sit for an additional 5 minutes. The patient then fainted and fell off the chair. The entire time the patient never complained of feeling faint, she had little warning it was going to happen. After the patient fainted, nurses assisted her to a supine position and kept her that way for about a half hour when she felt much better. Patient was only out for about 30 seconds. She came back to and an ice pack was placed behind the patients neck. She was pale throughout the course until she started felling better at which time she began to get her pink color back. She was assisted to the car by wheelchair and transported home per parent.

VAERS ID:336226 (history)  Vaccinated:2007-11-28
Age:20.0  Onset:2008-08-12, Days after vaccination: 258
Gender:Female  Submitted:2008-12-29, Days after onset: 139
Location:Texas  Entered:2008-12-29
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Allergy to Penicillin PMH: oral contraception, TB 2005, ex-smoker, social drinker. Allergy: PCN, morphine. Family hx: high cholesterol; depression; Cushings syndrome.
Diagnostic Lab Data: ANA Panel results were higher then normal. I had a blood test for acetylcholine receptor antibodies. Normal is .05 and below. My results were 64.o. 5/13/09 hospital records received DOS 11/25/08 to 11/27/08. LABS and DIAGNOSTICS: CT lack of sulci small ventricles otherwise WNL. LP hazy, cell count 795 mm3 (H), neutrophils 76%, Gram stain (-) other than WBCs, protein 70 mg/dL (H). CBC WNL other than WBC 15000, Segs 90%. CHEM: sodium 132 mmol/L (L) otherwise WNL. 5/19/09 Received HSV titre (-) & MRI head (-). FARR DNA DS ab 21.6(H). ANA titer 1:320(+), speckled homogeneous. Abnormal PAP smear w/atypical squamous cells. WBC 28.6(H), segs 86%(H), lymphs 7%(L), ANC 25.7(H).CMP, hepatitis panel, CRP, RA factor, ASO all WNL. Acetylcholine bi
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amblyopia, Antiacetylcholine receptor antibody positive, Antinuclear antibody increased, Asthenia, Autoimmune disorder, Balance disorder, Blood product transfusion, Blood sodium decreased, C-reactive protein normal, CSF cell count increased, CSF culture negative, CSF neutrophil count increased, CSF protein increased, CSF test abnormal, Diplopia, Disturbance in attention, Dizziness, Double stranded DNA antibody, Dysarthria, Dyskinesia, Dyspepsia, Dysphagia, Dyspnoea exertional, Dysstasia, Eyelid ptosis, Facial palsy, Fatigue, Grip strength decreased, Headache, Herpes simplex serology negative, Jaw disorder, Lumbar puncture, Lymphocyte percentage decreased, Mastication disorder, Memory impairment, Meningitis viral, Musculoskeletal stiffness, Myasthenia gravis, Nausea, Neutrophil count increased, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain normal, Pollakiuria, Rheumatoid factor negative, Rhinorrhoea, Scan brain, Sensation of heaviness, Smear cervix abnormal, Streptococcus identification test, Streptococcus identification test negative, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Optic nerve disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Chronic kidney disease (broad), Arthritis (broad)
Write-up: Diagnosed with Myasthenia Gravis (autoimmune disease) 5/13/09 hospital records received DOS 11/25/08 to 11/27/08. FINAL DIAGNOSIS: Myasthenia gravis, viral meningitis Post vaccination droopy left eyelid, difficulty running, weak grip, mouth and jaw fatigue, diplopia, dizziness. Admitted for IVIG treatment. Headache, increased ptosis, upper and lower extremity weakness. Nausea, vomiting 5/14/09 Received Neuro medical records of 11/24/2008. FINAL DX: myasthenia gravis Records reveal patient experienced weakness x 2 mo starting w/left eyelid droop, then mouth weakness, arm heaviness, grip strength decreased, leg stiffness, difficulty arising from sitting position, diplopia, intermittent left lazy eye, mouth/jaw fatigue, tiredness, slurred speech, DOE, heartburn, difficulty chewing & swallowing, loss of balance, loss of memory, urinary frequency esp at night. Sent to hospital for CT, IVIG x 2 days, steroids. 5/18/09 Received PCP medical records of 10/21/08-2/25/2009. Records reveal patient experienced fatigue, dizziness, blurred vision, gen weakness, difficulty concentrating & memory retention difficulties x approx 1 mo when seen 10/21. Referred to Rheum. No further visits until 2/25/09 s/p myasthenia gravis. 5/18/09 Received medical records from Rheum but was only labs of 11/19/2008.

VAERS ID:336238 (history)  Vaccinated:2008-04-08
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-29
Location:Unknown  Entered:2008-12-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA04566
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Breast cancer, Chemotherapy, Lymphadenectomy, Mastectomy, Radiotherapy
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Malignant tumours (narrow), Breast malignant tumours (narrow)
Write-up: Information has been received from a Nurse practitioner concerning a 25 year old female patient who on 18-APR-2008 was vaccinated with the first dose of GARDASIL. After receiving the first dose of GARDASIL the patient was diagnosed with right breast cancer (2008). In November 2008, the patient had a right segmental mastectomy and lymph node dissection. As per the oncologist the breast cancer is not related to the GARDASIL. The patient was continuing on HERCEPTIN chemotherapy treatments until May 2009. She was also currently receiving radiation therapy. Upon internal review, breast cancer was considered to be an Other Important Medical Event. Additional information has been requested. 1/19/09 Reviewed PCP medical records of 11/14/2008. FINAL DX: right breast cancer, clinical stage T1C N0 M0; ER-positive, HER-2-positive; neoadjuvant chemotherapy; BRCA1 & 2 gene negative; right segmental mastectomy & sentinel lymph node biopsy 11/5/08.

VAERS ID:336246 (history)  Vaccinated:2008-02-27
Age:22.0  Onset:2008-02-27, Days after vaccination: 0
Gender:Female  Submitted:2008-12-26, Days after onset: 303
Location:Pennsylvania  Entered:2008-12-30, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 2/16/2008); Cardiac murmur; Smoker
Preexisting Conditions: Hypothyroidism
Diagnostic Lab Data: Ultrasound, 06/10/08, due date is 24-NOV-2008; ultrasound, 07/02/08, within normal limits; urine beta-human, 06/10/08, positive; Apgar score, 11/12/08, 8/9
CDC 'Split Type': WAES0807USA00806
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U0IMUN
Administered by: Public     Purchased by: Other
Symptoms: Anaemia, Drug exposure during pregnancy, Foetal disorder, Gestational diabetes, Ultrasound scan normal, Urine human chorionic gonadotropin positive
SMQs:, Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a licensed practical nurse (L.P.N) through the Merck pregnancy registry concerning a 22 year old female with cardiac murmur with a history of 2 pregnancies and 2 live births and a history of hypothyroidism who on 27-FEB-2008 was vaccinated with the first dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included FLINTSTONES Multivitamin. The patient was pregnant. The reporter stated that the patient''s last menstrual period was 16-FEB-2008. The estimated conception date was 02-MAR-2008. The patient was in for first obstetrics (OB) visit on 10-JUN-2008 and urine pregnancy test was positive and ultrasound due date was 24-NOV-2008. On 02-JUL-2008 ultrasound was performed for size and dating. The result was within normal limits (MNL) and the estimated delivery date was 23-NOV-2008. No product quality complaint was involved. Follow-up information on 19-DEC-2008 was received from a licensed practical nurse (L.P.N) concerning a 23 year old patient who was a smoker, on 27-FEB-2008 at 1535 was vaccinated intramuscularly into left deltoid with the first dose of GARDASIL (lot # 659653/1448U). Ferrous sulfate, FLINTSTONES Multivitamin and omeprazole were used during pregnancy. On 12-NOV-2008, the patient delivered a female baby with congenital anomaly weighing 3103gm (weeks from LMP: 38). Length: 20 inch. Apgar score: 8/9. The baby had a cleft palate. There were no other complications or abnormalities. The complications during pregnancy included gestational diabetes and anemia. Ferrous sulfate was taken for the treatment of anemia. At the time of reporting, the outcomes for cleft palate, gestational diabetes and anemia were unknown. Additional information has been requested.

VAERS ID:336247 (history)  Vaccinated:2007-12-12
Age:25.0  Onset:2008-01-16, Days after vaccination: 35
Gender:Female  Submitted:2008-12-26, Days after onset: 345
Location:New Jersey  Entered:2008-12-30, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREVACID
Current Illness: Pregnancy NOS (LMP = 1/16/2008); Pollen allergy; Mycotic allergy
Preexisting Conditions:
Diagnostic Lab Data: Urine beta-human, positive
CDC 'Split Type': WAES0802USA06370
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 25 year old female with environmental allergies to pollen and mold who on 12-DEC-2007 was vaccinated 0.5mL, IM with a 1st dose of GARDASIL (lot# 659439/1267U). Concomitant therapy included PREVACID. It was reported that the patient had a positive urine pregnancy test (LMP 16-JAN-2008). The patient sought unspecified medical attention in her doctor''s office. Follow-up information was received from the registered nurse to report that the patient went to another facility and had elective termination on 19-APR-2008. The patient''s outcome was unknown. Upon internal review, elective termination was determined to be an other important medical event. Additional information is not expected.

VAERS ID:336283 (history)  Vaccinated:2008-12-30
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-30
Location:Pennsylvania  Entered:2008-12-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NKDA,H/O HEART MURMUR AS INFANT
Diagnostic Lab Data: SYNCOPAL EPISODE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Bradycardia, Dizziness, Fall, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: ALERT INITIALLY. SOON C/O FEELING LIKE SHE WAS GOING TO PASS OUT (PHYSICIAN CAUGHT PATIENT AS SHE WAS FALLING FACE FIRST OFF EXAM TABLE). WAS PALE X 1 MIN, BRADYCARDIC X 2 MIN. PT WAS LAID ON EXAM TABLE WITH KNEES ELEVATED. COMPLETE SET OF VITALS OBTAINED BY PHYSICIAN AND THOROUGH EXAM PERFORMED WITH NEGATIVE OUTCOME. PT GIVEN POPSICLE AND WAS ABLE TO LEAVE IN 15 MINUTES.

VAERS ID:336294 (history)  Vaccinated:2008-12-12
Age:17.0  Onset:2008-12-20, Days after vaccination: 8
Gender:Female  Submitted:2008-12-30, Days after onset: 10
Location:California  Entered:2008-12-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zovia, ranitidine, Trazodone
Current Illness: abdominal pain
Preexisting Conditions:
Diagnostic Lab Data: varicella IgG neg. IgM pending.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMRA
MEN: MENINGOCOCCAL (MENOMUNE)SANOFI PASTEUR 0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Erythema, Rash papular, Rash pruritic, Skin lesion, Varicella zoster serology negative
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 10 days after Varivax pt developed generalized pruritic rash of clear vesicles and erythematous papules which progressed to open lesions. Treatment was symptomatic only w/ topical Calamine lotion, Aveeno baths, and oral Benadryl.

VAERS ID:336303 (history)  Vaccinated:2008-10-30
Age:15.0  Onset:2008-10-30, Days after vaccination: 0
Gender:Female  Submitted:2008-10-30, Days after onset: 0
Location:California  Entered:2008-12-30, Days after submission: 61
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma, mild
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0495U0UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1782U1UNLA
Administered by: Private     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: None Stated

VAERS ID:336327 (history)  Vaccinated:2008-12-04
Age:20.0  Onset:2008-12-11, Days after vaccination: 7
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2008-12-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.06050X0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt had onset of pain at (R) shoulder vaccination site @ 12/11 of PM -exam c/w localized reaction at lateral aspect of deltoid no sign of infection or isotonic reaction.

VAERS ID:336335 (history)  Vaccinated:2008-08-20
Age:22.0  Onset:2008-08-21, Days after vaccination: 1
Gender:Female  Submitted:2008-12-23, Days after onset: 124
Location:Wisconsin  Entered:2008-12-31, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: History of depression
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0834X0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injected limb mobility decreased, Pain in extremity
SMQs:
Write-up: Patient had injection on 8/20/08. Patient called on 10/7/08 stating her arm still hurt with certain movements. Felt that her arm was "restricted". Stated ibuprofen was helping. Patient called 12/23/08 and says her arm much improved but not 100% yet.

VAERS ID:336339 (history)  Vaccinated:2008-12-31
Age:14.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-12-31, Days after onset: 0
Location:New Jersey  Entered:2008-12-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.O575X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2735AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC26768BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Hypotension, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Nausea, lightheadedness, hypotension, syncope

VAERS ID:336340 (history)  Vaccinated:2008-09-02
Age:15.0  Onset:2008-09-11, Days after vaccination: 9
Gender:Female  Submitted:2008-12-31, Days after onset: 111
Location:Arizona  Entered:2008-12-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bactrim DS, Flonase 50mcg, Loratidine 10mg
Current Illness: None
Preexisting Conditions: Allergy to Amoxicillin- rash documented 5/01/2000 PMH:allergic conjunctivitis, allergic rhinitis.
Diagnostic Lab Data: physical exam
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X2IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain, Pain in extremity, Radiculitis brachial
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Initial administration of the HPV vaccine on 9/2/08 was in the right deltoid and was administered without incident. On 9/11/08 the patient was seen in the express care clinic by Dr. At this time the patient had compaints of sharp and throbbing arm pain, as well as arm weakness (brachial neuritis). This pain is worse at night. The patient was given Ibuprofen 400mg #30 and Desipramine 25mg #20. Patient was to return to the clinic in 2 weeks for follow up. 2/19/09 Received PCP & ER medical records of FINAL DX: right arm brachial neuritis Records reveal patient experienced constant sharp throbbing pain right arm x 1 week w/decreased ROM when seen in ER on 9/11/08. Tx w/meds & referred to PT.

VAERS ID:336352 (history)  Vaccinated:2007-10-15
Age:14.0  Onset:2008-02-18, Days after vaccination: 126
Gender:Female  Submitted:2008-12-31, Days after onset: 317
Location:Illinois  Entered:2009-01-02, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Current Illness:
Preexisting Conditions: Atypical squamous cells of undetermined significance
Diagnostic Lab Data: Ultrasound, 07/14/08, with normal limits; Serum alpha-fetoprotein, 06/23/08, negative
CDC 'Split Type': WAES0808USA02610
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Drug exposure during pregnancy, Failed trial of labour, Pre-eclampsia, Threatened labour, Ultrasound scan normal
SMQs:, Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (broad)
Write-up: Information has been received from a certified medical assistant (C.M.A.), for the Pregnancy Registry for GARDASIL, concerning a 14 year old female with Ascus positive HR HPV, late care who on 14-AUG-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot #657617/0384U), on 15-OCT-2007 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (Lot #657617/0384U) and on 13-MAR-2008 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (Lot #758222/0927U). Concomitant therapy included prenatal vitamins (PVN). There was no concomitant medication. The patient was pregnant, and her last menstrual period was 18-FEB-2008 and the estimated delivery date will be on 17-NOV-2008 (previously reported as 24-NOV-2008). No adverse event was reported. Medical attention was sought via office visit. Follow up information was received which reported that on 02-NOV-2008, the patient delivered a normal and healthy male baby. The patient had complications, she had mild preclampsia and she was scheduled for induction on 31-OCT-2008. The patient underwent CERVIDIL and PITOCIN, the patient failed to dilate past 4 cm. The patient and partner elected for C/section. There was no infections or illness during pregnancy reported. During the pregnancy was used PROCARDIA, 10 mg, every four hours for threatened pre term labor. Upon internal review failed to dilate was considered an other important medical event because the patient required a C-section. Additional information has been requested.

VAERS ID:336382 (history)  Vaccinated:2009-01-02
Age:15.0  Onset:2009-01-02, Days after vaccination: 0
Gender:Female  Submitted:2009-01-02, Days after onset: 0
Location:Illinois  Entered:2009-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Taking Birth Contol Pills
Current Illness: None
Preexisting Conditions: NKA; anemia when younger
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dry skin, Dyskinesia, Erythema, Fall, Immediate post-injection reaction, Muscle twitching, Pain, Pallor, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Was in reception area immediately after injection of Gardasil and fell to floor and had full body twitching for 5 to 10 seconds. Was not observed falling. Mother had back to her while paying receptionist. No complete loss of consciousness noted. Has redness on right side of face and c/o of pain in right temple area. PERL. Pale. Skin warm and dry. Not involuntary of bodily functions. Full ROM and good grasp and answers commands appropriately. No prior Hx of medical conditions except anemia when younger. BP130/90. Pulse 88reg. Happened at 9:50am and ambulance arrived to take her to ER at 9:57am. Phone call from mother stating she was discharged to go home at 11:20am.

VAERS ID:336390 (history)  Vaccinated:2008-05-01
Age:18.0  Onset:2008-06-24, Days after vaccination: 54
Gender:Female  Submitted:2009-01-02, Days after onset: 192
Location:California  Entered:2009-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none PMH: frontal H/A. Low back pain x 1 yr.
Diagnostic Lab Data: ekg, eeg, cat scan, mri, blood tests. Labs and Diagnostics: EKG WNL. EEG WNL. Normal imaging studies. Brain MRI WNL.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB281IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Amenorrhoea, Back pain, Blood test, Chills, Computerised tomogram, Dizziness, Ear pain, Electrocardiogram normal, Electroencephalogram normal, Headache, Immobile, Loss of consciousness, Malaise, Menstruation irregular, Migraine, Nausea, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Paraesthesia, Photophobia, Presyncope, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: syncope or seizure still being determined,events started in june of 08, she has experienced over 100 syncope episodes since that time, a month or so after inoculation, co administered with Hep A, episodes began in june, again in august, september, weekly in november, december, has experienced immobility, nausea, irregular and missed periods, migraine like headaches, left ear pain, leg pain and tingling in hands and feet, lower back pain, to date she has been to the ER 7 times and had two hospital stays for issues of passing out from 3 minutes to over 30 minutes as she passes out repeatedly, no medical treatment other than rest up until this point, she is being admitted for further neurological understanding and a three day hospital evaluation. 2/4/09 Neurology consult received dated 12/22/08 for eval of episodic LOC. Pt initially began having lapses of consciousness in 6/2008 on vacation. Seen in ER and found to be dehydrated, possibly r/t alcohol consumption. Repeat attacks however were with good hydration status. 1 week after 1st episode pt was feeling ill and unable to walk/stand w/o having an episode. W/U (-). Pt may have weeks w/o episodes, but then begin with teeth chattering, then a "head rush", dizziness and the feeling of going to pass out. Holter monitor did not register any abnormalities during episodes. Episode in 8/2008, pt was unable to roused x 30 minutes. W/U (-). In 12/08 episode did not involve complete LOC but had bifrontal H/A with photophobia after. Some events involve hand shaking or whole body shaking. Pt to be admitted for further eval.D/C Summary received for DOS 1/5-8/2009 with D/C DX: Unexplained LOC. PE WNL. One mild event noted during admission with teeth chattering and tremulous movements of the upper extremities, L$gR. No LOC. No further events during admission.

VAERS ID:336393 (history)  Vaccinated:2008-12-30
Age:17.0  Onset:2008-12-31, Days after vaccination: 1
Gender:Female  Submitted:2009-01-02, Days after onset: 2
Location:Washington  Entered:2009-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Induration, Skin warm, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Marked local swelling, induration, erythema, warmth, and tenderness resulting in a physician office visit.

VAERS ID:336436 (history)  Vaccinated:2008-12-29
Age:17.0  Onset:2008-12-30, Days after vaccination: 1
Gender:Female  Submitted:2008-12-30, Days after onset: 0
Location:Arkansas  Entered:2009-01-02, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.057SX0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2637AA0SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURUF455AA5SCRA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Influenza like illness, Pain, Pain in extremity
SMQs:, Arthritis (broad)
Write-up: Mom reports child with "severe" hip and joint pain. Complains of severe pain in legs, feels like she has the flu, mom feels this is more than an average reaction, achy all over 12/31/08 feeling a little better, mom did not want daughter to receive anymore HPV vaccines.

VAERS ID:336457 (history)  Vaccinated:2008-01-23
Age:15.0  Onset:2008-03-25, Days after vaccination: 62
Gender:Female  Submitted:2009-01-05, Days after onset: 286
Location:Massachusetts  Entered:2009-01-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None HPV #2 given 3/24/08, lot # 1446U, LA.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0522U0IDLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Discomfort, Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Extreme Hives, trouble breathing / problems have continued since first injection / she breaks out in hives when there is a change of temperature (outside to inside / inside to outside) / has trouble breathing when exerting (cross country runner / basketball player) / has continued with sports but pushes through discomfort / very frustrating 1/23/09 Received PCP medical records of 3/24/08 FINAL DX: hives Records reveal patient w/daily hives since 2/15/08. Referred to specialist & declined further in series. No further records available.

VAERS ID:336473 (history)  Vaccinated:2007-08-07
Age:18.0  Onset:2007-09-01, Days after vaccination: 25
Gender:Female  Submitted:2008-12-23, Days after onset: 479
Location:Tennessee  Entered:2009-01-05, Days after submission: 13
Life Threatening? Yes
Died? Yes
   Date died: 2009-03-23
   Days after onset: 569
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Iron-deficiency anemia
Diagnostic Lab Data: muscle biopsy; MRI separate. Dx clinical myositis
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0804F0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2207AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2457AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Activities of daily living impaired, Asthenia, Ataxia, Biopsy muscle, Budd-Chiari syndrome, Cardio-respiratory arrest, Death, Dermatomyositis, Dysphagia, Fatigue, Headache, Immunoglobulin therapy, Muscle atrophy, Muscular weakness, Myalgia, Neuropathy peripheral, Nuclear magnetic resonance imaging, Osteomalacia, Pain in extremity, Paraesthesia, Pernicious anaemia, Polymyositis, Tachycardia, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad)
Write-up: Onset increased muscle pain, fatigue, weakness, dysphagia, weight loss. Pt requiring Prednisone IVIG every q monthly. Methotrexate headache, muscle atrophy. 2/6/09 Received PCP medical records of 11/11/08-1/20/09. FINAL DX: polymyositis, likely MCV4 vaccine related; osteomalacia; neuropathy; pernicious anemia; tachycardia; ataxia; Budd-Chiari syndrome; dermatomyositis. Records reveal patient experienced muscle weakness, paresthesias, leg pain. Referred to Neuro & Rheum. Tx w/PT & meds including methotrexate, imuran, steroids, enbrel, bicillin, IVGG. Had to drop out of college due to illness. 04/6/2010 Patient''s condition never improved and she died on 3/23/2009.

VAERS ID:336474 (history)  Vaccinated:2008-03-12
Age:13.0  Onset:2008-03-12, Days after vaccination: 0
Gender:Female  Submitted:2008-12-18, Days after onset: 281
Location:Ohio  Entered:2009-01-05, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Seasonal allergies; Patient was very healthy before this shot and the only conditions that she had or has is seasonal allergies.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Arthralgia, Depression, Dizziness, Dry skin, Fatigue, Headache, Irritability, Menstrual disorder, Muscle spasms, Rash, Syncope, Vision blurred, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: After my daughter received her 1st shot of 3 (to complete full dose) she started having problems soon after.- light headed, dizziness, fainting, fatigue, loss of appetite, change in menstrual cycle, blurred vision, headaches, joint hip pain, irritability, depression, throwing up and bad cramps. FYI- we opted out of the last two shots. Took patient to regular Dr. appt. We were than told that she should get the HPV shot I was reluctant because I don''t have or never had cervical cancer and neither had my mother. They said she would need 3 series of shots all together. After the 1st shot (3/12/08) we started to notice all the symptoms that are describe on page 1. She was a tract runner for her school and very good at that. But after the shot anytime she would run she would throw up and cramp right after. Once she was able to make it half way when she was running 100 yard dash. 1/22/09 Received PCP clinic medical records of 3/12/08 FINAL DX: none provided Records reveal patient experienced rash on abdomen waxing & waning since 12/07. Only dry skin found on exam & tx w/lotion. No other records available. 02/01/2010 Still has side/hip pain whenever she over erats herself insports.

VAERS ID:336496 (history)  Vaccinated:2008-12-29
Age:13.0  Onset:2008-12-29, Days after vaccination: 0
Gender:Female  Submitted:2008-12-30, Days after onset: 1
Location:North Carolina  Entered:2009-01-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXITINE
Current Illness: None
Preexisting Conditions: Anxiety Disorder
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Drooling, Loss of consciousness, Posture abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Immunization was administered in left arm. Patient then passed out & was laid down. Pt was drooling, then her legs & arms extended outward (straight) with contracted flexed fingers. Total episode last approx. 5-10 seconds. Patient was dizzy afterwards & could not recall the incident.

VAERS ID:336497 (history)  Vaccinated:2008-12-22
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-30
Location:North Carolina  Entered:2009-01-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHAVB516BA2UNGM
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X1UNGM
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA106024UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1084X2SCLA
Administered by: Public     Purchased by: Public
Symptoms: Wrong technique in drug usage process
SMQs:
Write-up: None. Hep B injection in gluteal region.

VAERS ID:336556 (history)  Vaccinated:2008-12-31
Age:17.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-12-31, Days after onset: 0
Location:Missouri  Entered:2009-01-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: BPS, 8:10 92/54 P60, 8:15 98/72 P64, 8:18 96/64 sitting P72, 8:20 112/68 P64
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.148660IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure decreased, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient blacked out after receiving HPV vaccine.

VAERS ID:336578 (history)  Vaccinated:2008-06-30
Age:19.0  Onset:2008-06-30, Days after vaccination: 0
Gender:Female  Submitted:2009-01-05, Days after onset: 189
Location:New Jersey  Entered:2009-01-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 9/19/2008); Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA03496
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0250X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a Certified Medical Assistant for the Pregnancy Registry for GARDASIL concerning a 19 year old female with penicillin allergy who on 30-JUN-2008 was vaccinated with a 0.5 ml first dose of GARDASIL (LOT # 0250X) and on 29-AUG-2008 received a second dose of GARDASIL (LOT # 0573X). The reporter stated that the patient who had received the GARDASIL vaccine "is pregnant". Her LMP was 19-SEP-2008. Expected date of delivery is 26-JUN-2009. There was no concomitant medication. No adverse effect was reported. The patient was seen in the office for medical attention. Follow up information was received on 30-DEC-2008 from a certified medical assistant who stated that there was a elective termination of the pregnancy. It was unknown if the products of conception were examined or if the fetus was normal. Upon internal review, elective termination was considered to be an other important medical event. Additional information has been requested.

VAERS ID:336580 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2009-01-05
Location:Florida  Entered:2009-01-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown) Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown 11/13/09 Medical records received for date 11/10/09 Diagnostics/Labs: Eosinophils% 12.3(H), potassium 2.6(L), WBC 14.1(H), HCT 35(L), Pregnancy test(-), UA WNL.
CDC 'Split Type': WAES0812USA05190
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abortion spontaneous, Blood potassium decreased, Drug exposure during pregnancy, Dysmenorrhoea, Eosinophil percentage increased, Haematocrit decreased, Pelvic inflammatory disease, Pelvic pain, Pregnancy test negative, Urinary tract infection, Urine analysis normal, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a consumer, for the Pregnancy Registry for GARDASIL vaccine, concerning his 25 year old wife general anesthesia allergy who was vaccinated 3 doses of GARDASIL vaccine (Lot # not reported) prior to becoming pregnant. Concomitant therapy included heart medication. Consumer''s wife is the patient in this case. Consumer reported that his wife had completed the GARDASIL vaccine series approximately six months to becoming pregnant with their first child. Consumer reported that they learned at 17 weeks gestation that his wife had lost their baby around 12 weeks of gestation. Laboratory test was performed previous to pregnancy and during pregnancy. Consumer reported that his wife will call back with more specific dates and information. Upon internal review, abortion spontaneous was determined to be an other important medical event. Additional information has been requested. 11/13/09 Medical records received for date 11/10/09. DX: PID, UTI, dysmenorrheal. Presented with pelvic pain x1 month abrupt onset. Pt states intermittent cramps. Assessment: WNL, cervical/uterus exam WNL, pt signed out before external genitalia exam. Pt signed out AMA.

VAERS ID:336581 (history)  Vaccinated:2008-05-27
Age:18.0  Onset:2008-08-30, Days after vaccination: 95
Gender:Female  Submitted:2009-01-05, Days after onset: 128
Location:Unknown  Entered:2009-01-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Termination of pregnancy - elective
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA05011
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a physician, for the pregnancy registry for GARDASIL, concerning an 18 year old female with a history of 2 pregnancies, 2 elective terminations, 0 live births and no other medical history who on 27-May-2008 was vaccinated with the second dose of GARDASIL (lot#659964/1978U). There was no concomitant medication. Subsequently, she became pregnant and her LMP was 26-Jul-2008. On 30-Aug-2008, about 5 weeks from her LMP, the patient underwent elective termination. Upon internal review, elective termination was determined to be an other important medical event. Additional information has been requested.

VAERS ID:336610 (history)  Vaccinated:2008-03-19
Age:9.0  Onset:2008-03-20, Days after vaccination: 1
Gender:Female  Submitted:2009-01-06, Days after onset: 292
Location:Massachusetts  Entered:2009-01-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE 20 MG CAP, DELAYED RELEASE SOLIA 0.15 MG-30 MCG TAB (DESOGESTREL-ETHINYL ESTRADIOL) FLUCONAZOLE 150 MG TAB LORATADINE 10 MG TAB
Current Illness: Chronic vomiting assoc with history of esophageal dilatation.
Preexisting Conditions: Allergic to pollen, chronic vomiting.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2501AA0IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURAC52B016BA0IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA044620IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1759U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Skin warm, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt presented with approx 5 cm area of redness, sl warmth but minimal swelling. Mildly tender. No streaking. Rx''d Tylenol or Motrin for discomfort.

VAERS ID:336705 (history)  Vaccinated:2009-01-07
Age:12.0  Onset:2009-01-07, Days after vaccination: 0
Gender:Female  Submitted:2009-01-07, Days after onset: 0
Location:Pennsylvania  Entered:2009-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0 RA
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Nausea, Pallor, Tinnitus
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Dizziness, nauseous, ringing in the ears, paleness for about 10 minutes after the vaccine.

VAERS ID:336707 (history)  Vaccinated:2008-08-19
Age:13.0  Onset:2008-08-19, Days after vaccination: 0
Gender:Female  Submitted:2009-01-07, Days after onset: 141
Location:New York  Entered:2009-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity, Tenderness
SMQs:
Write-up: Patient presented to Immunization clinic on 01/06/09 for the second dose of HPV vaccine, having received the first dose on 08/19/08. During screening, patient stated that she has experienced pain in the upper 3/4 of the upper left arm since the 08/19/08 immunization. She reports that the affected area has been tender to firm touch since then, and that it is painful if she lies on it. She has full use of the arm, with normal strength and ROM. She reports that she experienced no unusual redness, swelling, or excessive pain immediately after the 08/19/08 vaccination. Her account of SX is confirmed by her mother.

VAERS ID:336714 (history)  Vaccinated:2008-11-15
Age:14.0  Onset:2009-01-02, Days after vaccination: 48
Gender:Female  Submitted:2009-01-07, Days after onset: 5
Location:Georga  Entered:2009-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Muscle spasms, Pain, Vaginal discharge
SMQs:, Dystonia (broad)
Write-up: Patient had Gardasil shot and then Depo-Provera about 1 week later. 2 months later, this past Friday she passed a mass of tissue vaginally that was approximately 5" X 2" and was in pain similar to labor. This child is not sexually active, has experience severe cramping. Concerned may have caused permanent damage to her uterus. Ultrasound today, gyn in the next few.

VAERS ID:336726 (history)  Vaccinated:2008-12-22
Age:9.0  Onset:2008-12-31, Days after vaccination: 9
Gender:Female  Submitted:2009-01-05, Days after onset: 5
Location:Unknown  Entered:2009-01-07, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 4/14/09-records received- Allergies:amoxicillin. Obstructive sleep apnea. Tonsillectomy adenoidectomy.
Diagnostic Lab Data: 4/14/09-records received-CT scan brain normal. 4/28/09-records received- Rapid strep negative. Assessment: Acute pharyngitis. WBC 13.0, Antinuclear antibodies direct 95, adenovirus negative. CT head normal.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0650X1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody negative, Asthenia, Axillary pain, Back pain, Blood urine present, Burning sensation, Chest pain, Computerised tomogram normal, Erythema, Myalgia, Neck pain, Oral pain, Oropharyngeal pain, Pain, Pain in extremity, Pain in jaw, Photophobia, Pruritus, Pyrexia, Rash pruritic, Scan brain, Streptococcus identification test, Swelling, Urticaria, Viral infection, Virus serology test, Vision blurred, Visual impairment, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: My daughter received her second injection of GARDASIL on December 22, 2008. On December 31, 2008 she had a sudden and severe hives reaction- inner thighs of both legs and feet, blood red, swelled, very painful and itchy. We went to the emergency room where she was treated unsuccessfully with BENADRYL and then was given steroids, which after 12 hours reduced the horrific hives. Then on Friday, January 2, 2009 she started to complain about severe pain in her armpits. By Sunday night the pain spread up her chest, neck, jaw and lips. We have an appointment at our Dr. this afternoon, but felt that since there was NO other reason - sickness, strange meal, etc. I should report this event immediately.4/14/09-records received-presented to ED 12/30/08- C/O rash on legs began morning of visit to ED. Pruritic. Has had similar rash in past. DX: urticaria. Subsequently developed aches in neck and axillae, legs. Assessment: viral syndrome. 1/12/09 C/O body aches and generalized weakness and low back pain and buring of hands. Now severe headache with photophobia and neck stiffness, slight nausea. 4/28/09-office visit 15/09-C/O musculoskeletal symptoms and rash. Previously seen in ED for allergice reaction. Now have aches in neck, axillae, legs. Impression: Viral syndrome. 1/7/09 continues to C/O leg pain and hand and arm pain. Impression: Myalgia. 1/12/09-second opinion for C/O jaw pain, muscle pain and headache. Light sensitive. Spots in eyes. Impression: Parent child concerns. 1/13/09-seen in ED for worst headache of her life. Parent refuses LP. Impression: headache. headache maybe migranoid with photophobia. Myalgia. 1/19/09-C/O blood in urine, fever and sore throat. 3 week history of evolving UTI and strep throat per parent.

VAERS ID:336730 (history)  Vaccinated:2008-06-19
Age:21.0  Onset:0000-00-00
Gender:Female  Submitted:2009-01-07
Location:Michigan  Entered:2009-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: AMOXICILLIN
Diagnostic Lab Data: + USN ON 7-31-08 with 10W4d on 8-11-08-patient had increased risk downs/on ULTRACET, patient chose termination of pregnancy.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Patient received first dose of GARDASIL and may have been pregnant 7/31/08-LMP-5/15/08 received GARDASIL 16-1608

VAERS ID:336731 (history)  Vaccinated:2008-12-23
Age:14.0  Onset:2008-12-23, Days after vaccination: 0
Gender:Female  Submitted:2009-01-07, Days after onset: 15
Location:Vermont  Entered:2009-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Syncope within minutes of administration of vaccines.

VAERS ID:336732 (history)  Vaccinated:2008-12-22
Age:14.0  Onset:2008-12-22, Days after vaccination: 0
Gender:Female  Submitted:2009-01-06, Days after onset: 15
Location:Illinois  Entered:2009-01-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0650X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: GARDASIL administered 12/22/08, within hours patient noticed "tremors" (looks like she is having chills). Family and friends noticed episodes too. Episodes are less frequent but still occurring. 1/12/09 Receied PCP medical records of 10/16/08-1/6/2009. FINAL DX: tremors Records reveal patient experienced intermittent bilateral tremors of arms, hands & fingers since 12/22 w/decreasing intensity & duration. No tx rendered & patient was to RTC if worsened.

VAERS ID:336743 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2008-12-12
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA01122
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Migraine
SMQs:
Write-up: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL vaccine. The patient experienced migraines after vaccination. Patient went to emergency room but it was not known if the patient was admitted. Additional information has been requested.

VAERS ID:336744 (history)  Vaccinated:2008-07-07
Age:11.0  Onset:2008-10-18, Days after vaccination: 103
Gender:Female  Submitted:2008-12-12, Days after onset: 55
Location:Kentucky  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified)
Current Illness: Environmental allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA01109
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a 11 year old female with environmental allergies who on 06-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (lot # 658282/0929U). The physician reported than on 07-JUL-2008 the patient received her second dose of GARDASIL vaccine (lot # 659441/1446U) and on 18-OCT-2008 the patient experienced peeling on the palms of her hands and between her fingers and the soles of her feet. The patient was seen at an office visit. At the time of the report the patient''s peeling on the palms of her hands and between her fingers and the soles of her feet persisted. No lab diagnostic studies were performed. Additional information has been requested.

VAERS ID:336745 (history)  Vaccinated:2008-11-07
Age:14.0  Onset:2008-11-07, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 35
Location:Maryland  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN
Current Illness:
Preexisting Conditions: Syncope
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA01106
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a nurse concerning a 14 year old female patient with a medical history of fainting and no known drug reaction/allergies, who on 18-AUG-2008, was vaccinated with the first dose GARDASIL, 0.5ml, intramuscularly, and on 07-NOV-2008 was vaccinated with the second dose of GARDASIL vaccine (Lot # 660557/0072X), 0.5ml, intramuscularly. Concomitant therapy included ORTHO TRI-CYCLEN. The nurse reported that on 07-NOV-2008, the patient received the second of GARDASIL, and fainted twice while laying in the supine position. Additionally, the patient became nauseous and vomited once. The nurse reported that the patient was observed in the office and then discharged home. The patient recovered from the symptoms on the same day of the vaccination. The nurse reported that the patient did not experience any difficulties with the first dose of the GARDASIL. Additional information has been requested.

VAERS ID:336746 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 72
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA01098
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a medical assistant concerning a female patient who in approximately October 2008, was vaccinated with GARDASIL vaccine. The patient experienced rash from waist up after receiving GARDASIL vaccine. On an unknown date in 2008, the patient recovered from the rash. Additional information has been requested.

VAERS ID:336747 (history)  Vaccinated:0000-00-00
Age:21.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': WAES0811USA00993
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Papilloma viral infection
SMQs:
Write-up: Information has been received from a 21 year old female who in approximately November 2007, was vaccinated with the first dose of GARDASIL (route and site not reported). Subsequently on an unknown date, the patient was diagnosed with human papilloma virus (HPV). The patient stated she had been unable to get second and third dose of GARDASIL. At the time of report, the patient''s outcome was unknown. No further information available.

VAERS ID:336748 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:California  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00930
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a female who "2 months ago" in September 2008 was vaccinated with her first dose of GARDASIL. The physician reported that the patient called the clinic to inform that she developed redness and pigmentation on the injection site after receiving the vaccine. Follow up information from the physician also indicated that the patient had pain at the injection site, and "crescent shaped hypo-pigmented area" at the injection site. The patient sought medical attention from the physician. At the time reporting, the outcome was unknown. Additional information has been requested.

VAERS ID:336749 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Washington  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00922
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Feeling hot, Lymph node pain, Lymphadenopathy
SMQs:
Write-up: Information has been received from a physician concerning a female patient with no known drug reactions/allergies and medical history, who was vaccinated with the first dose of GARDASIL by an unspecified route in the deltoid area. There was no concomitant medication. The physician reported that the patient developed a swollen lymph node one week after vaccination. The swollen lymph node was warm and tender and about 4 inches from the injections site. The lymph node is still swollen but much less. The patient sought medical attention. At the time of the report it was reported that the patient was not recovered. Additional information has been requested.

VAERS ID:336751 (history)  Vaccinated:2008-06-02
Age:21.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Texas  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Loestrin
Current Illness:
Preexisting Conditions: Allergic reaction to antibiotics
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA00915
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 21 year old female with allergic reaction to CECLOR who on 26-Mar-2008 was vaccinated with the first dose of GARDASIL (lot#659655/1486U). Concomitant therapy included LOESTRIN. On 02-Jun-2008. the patient was vaccinated with a second dose of GARDASIL(lot#660387/1967U. It was reported that after the patient''s second dose (date not provided), the patient developed severe and prolonged diarrhea after each meal, with no abdominal pain. Subsequently, the patient recovered on Sep-2008. It was reported that the event was mentioned at the patient''s next office visit. The reporter also indicate that the patient "may have experienced diarrhea after her first dose" of GARDASIL . No laboratory diagnostic studies were preformed. Additional information has been requested.

VAERS ID:336752 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 72
Location:Washington  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00912
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a female patient who was vaccinated with the first dose of GARDASIL (lot number was not provided) within the last week (in October 2008). The patient fainted in the waiting room of the physician''s office after receiving her first dose of GARDASIL. She was taken to the emergency room for x-rays of her neck, but results were not provided. It was not known if she was admitted to the hospital. The patient recovered on an unspecified date. Additional information has been requested.

VAERS ID:336754 (history)  Vaccinated:2008-10-23
Age:13.0  Onset:2008-10-23, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 50
Location:New York  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00904
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0560X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Information has been received from a nurse concerning a 13 year old female patient female patient who on approximately 23-Oct-2008 was vaccinated with the first dose of GARDASIL. The nurse reported that on approximately 23-Oct-2008 the patient began swelling up and ended up going to the emergency room. It is unknown whether the patient was admitted to the hospital. Follow-up information has been received from a licensed practical nurse concerning a 13 year old female patient with no known allergies and no relevant medical history who on 22-OCT-2008 at 4:02 pm was vaccianted intramuscularly in her left deltoid with GARDASIL (659055/0560X) at her doctor''s office. It was reported that the patient experienced dizziness less than 5 minutes after receiving the injection which progressed to complaints of shortness of breath. The patient stated "not feeling like I can catch a full breath:". An emergency room visit wa required but the patient was not hospitalized. On 22-OCT-2008 the patient recovered. No further information is available.

VAERS ID:336755 (history)  Vaccinated:2008-08-26
Age:23.0  Onset:2008-09-02, Days after vaccination: 7
Gender:Female  Submitted:2008-12-12, Days after onset: 101
Location:Georga  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory - cysto test
CDC 'Split Type': WAES0811USA00889
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cystoscopy, Pollakiuria
SMQs:
Write-up: Information has been received from a 23 year old female medical assistant with sulfonamide allergy, who on 26-AUG-2008 was vaccinated with the first dose of GARDASIL, HAVRIX, and meningococcal vaccine (unspecified). On 02-SEP-2008 she started to have frequent urination. The medical assistant reported that she did see an urologist who did a "cysto test" in which they stretched her urethra, which relieved some of the pressure, but on 03-NOV-2008 the frequent urination started again. The medical assistant stated that she is not sure is the HPV vaccine has caused this, but she is due to receive the second dose on 11-NOV-2008. At the time of the reporting, the patient had not recovered. Additional information has been requested.

VAERS ID:336756 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Michigan  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA00876
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Skin papilloma
SMQs:
Write-up: Information has been received from a physician concerning a female patient, with no pertinent medical history and no known drug allergies/drug reactions, who was vaccinated with the first dose of GARDASIL intramuscularly. There was no concomitant medication. The physician reported that a couple of weeks after vaccination. The patient developed "a couple of warts" on the extremity. None laboratories diagnostics studies performed. The patient was seen by the physician. The patient''s outcome was not recovered. Additional information has been requested.

VAERS ID:336757 (history)  Vaccinated:2008-10-29
Age:21.0  Onset:2008-10-29, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 44
Location:New Mexico  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SEASONALE
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00872
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Feeling hot, Injection site erythema, Injection site nodule, Injection site swelling, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 21 year old female who on 29-OCT-2008 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X), IM, left deltoid. Concomitant therapy included SEASONALE-BARR. On 29-OCT-2008 within 12 hours post vaccination, the patient experienced swelling and redness at the injection site, a rash that was painful to the touch, the area felt hot and felt like a little ball or nodule at the injection site. At time of the reporting, the patient had not recovered. No medical attention was sought. Additional information has been requested.

VAERS ID:336758 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00771
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pain in extremity
SMQs:
Write-up: Information has been received from a female who on an unspecified date was vaccinated with a dose GARDASIL. After receiving GARDASIL, the patient "got a pain" in her arm. The outcome of the patient was not reported. The patient did not seek medical attention. No further information is available.

VAERS ID:336759 (history)  Vaccinated:2008-10-20
Age:15.0  Onset:2008-10-20, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 53
Location:California  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown; blood pressure, 10/20/08, 116/7; blood pressure, 118/6; blood pressure, 10/20/08, 116/7; total heartbeat count, 10/20/2008, 70; pulse oximetry, 97%; pulse oximetry, 10/20/08, 100%; serum glucose, 10/20/08, 99; total heartbeat count, 60
CDC 'Split Type': WAES0811USA00758
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERU2804AA UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X1UNUN
Administered by: Private     Purchased by: Private
Symptoms: Blood glucose normal, Blood pressure increased, Dizziness, Heart rate normal, Muscle rigidity, Nausea, Nervousness, Oxygen saturation, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician. The physician who reported this did not administer the dose of GARDASIL vaccine to this patient and therefore does not know if this was reported already by the physician who did administer it. It was reported that a female patient was very nervous about receiving their second dose of GARDASIL and told the physician several times that she was going to faint. After receiving the vaccine she became very pale, fainted and became very rigid. The physician noted that it was not a seizure. The patient was sent to the emergency room but it is not known if she was admitted to the hospital. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow up information has been received from a Nurse Practitioner and medical records reporting that the patient, a 15 year old non-smoker with no known allergies, was vaccinated with the first dose of GARDASIL at 11:35 on 12-AUG-2008. The patient was vaccinated with the second dose of GARDASIL at 18:10 on 20-OCT-2008 (lot no. 661530/0575X). Concomitant therapy included the flu vaccine (lot no. u2804AA) on 20-OCT-2008. Concomitant medication included an unspecified acne medication. Just after receiving vaccination for GARDASIL and flu shot, the patient suffered a syncopal episode in the doctor''s office. The patient fainted. She suffered no trauma with this episode. When recovered she became nauseated and dizzy. Just after the episode nurses took her vital signs and found her with a blood pressure 116/70, pulse rate 70 and oxygen saturation 100%. The patient was feeling a little queasy and now she felt better. The patient had no headache or chest pain or abdominal pain. She was currently menstruating. There had been no history of heavy bleeding or anemia, the patient has had no history of hypoglycemia or metabolic disturbance. There had been no recent history of vomiting or diarrhea. The patient was otherwise healthy. The patient was sent to the emergency room for further evaluation. It was reported on the medical records that "Constitutional symptoms: no fever, no chills. Past medical history: Unremarkable. Medications: Medication for acne. Allergies: No Known drug allergies. FH: Noncontributory. Social history: No smoking, no drinking, no illicit drug use. Physical exam: Thin female teenager in no acute distress. Vital Signal: temperature 98.7, pulse rate 60, respirations 19, blood pressure 118/67, oxygen saturation 97% on room air. Neuro: intact and non-focal motor, DTR and cranial nerve examination. Light touch sensation intact throughout. Normal gait. Accu-Chek reveals a serum glucose of 98. Intervention: The patient was placed on cardiac monitor. No ectopy or arrhythmia were seen. Vital signs at 2005 revealed blood pressure 111/61, pulse rate 70, oxygen saturation 100%. Discussion: Risk of complications and morbidity if untreated are potentially moderate. Differential diagnosis was considered for syncope from noxious stimuli i.e, vaccination injection. Diagnosis: Syncopal episode. Disposition: The patient is discharged in stable condition. Parents were given printed ACI. She should follow up within 1 to 2 days if symptoms recur." No further information is available.

VAERS ID:336760 (history)  Vaccinated:2008-10-29
Age:14.0  Onset:2008-10-29, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 44
Location:New Hampshire  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Sulfonamide Allergy, Penicillin Allergy; Asthma
Diagnostic Lab Data: Peak expiratory flow 10/30/08 350 usual, body temp 10/29/2008 101 degr - fever,
CDC 'Split Type': WAES0811USA00742
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0652X IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Body temperature increased, Dyspnoea, Ear pain, Erythema, Fatigue, Injection site reaction, Oral dysaesthesia, Pain, Peak expiratory flow rate decreased, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 14 year old female with sulfonamide allergy, Penicillin allergy, and asthma who on 29-Oct-2008 was vaccinated at another office with GARDASIL (661766/0652X) intramuscularly in her left arm. Secondary suspected therapy included MENACTRA in her left arm and an unspecified influenza virus in her right arm. All 3 vaccines were received on the same day. The nurse stated that the patient developed a reaction after receiving the 3 vaccines. On 29-Oct-2008 the patient experienced pain bilaterally in her upper and lower back. The patient said her "mouth felt funny" but had no problem swallowing. The patient had ear pain on her right side and ear turned red. The patient also reported mild aches in thighs and knees and a fever of 101f with generalized body aches and fatigue. The patient was seen in the office of the reporter for these symptoms on 30-Oct-2008 and had a transient "hive like" rash on the underside of her left upper arm. The patient also had mild difficulty breathing (her peak flow rate was usually 500 and it dropped to 350). Subsequently, the patient recovered. Additional information has been requested.

VAERS ID:336761 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:North Carolina  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUMIST
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic Laboratory, tests for autoimmune disease
CDC 'Split Type': WAES0811USA00737
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Laboratory test, Raynaud's phenomenon
SMQs:
Write-up: Information has been received from a physician concerning a 15 year old female with no drug reactions or allergies, who in September 2008 was vaccinated with a first and only dose of GARDASIL. Concomitant therapy included hepatitis A virus vaccine (manufacturer unknown) and influenza virus 3v reassortant vaccine live intranasal (cold adapted Ann Arbor master strain) FLUMIST. Within 2 weeks after the vaccination, the patient developed Raynaud''s Phenomenon. The physician saw the patient. "Tests for autoimmune disease" were performed. At the time of reporting, the patient''s Raynaud''s Phenomenon persisted. Additional information has been requested.

VAERS ID:336762 (history)  Vaccinated:0000-00-00
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00733
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 14 year old female who in approximately September 2008, was vaccinated with a second dose GARDASIL. After received the second dose of GARDASIL the patient experienced "bumps" right next to the injection site. The patient sought medical attention and was given Benadryl, and the "bumps" went away. Additional information has been requested.

VAERS ID:336763 (history)  Vaccinated:2008-05-05
Age:23.0  Onset:2008-08-05, Days after vaccination: 92
Gender:Female  Submitted:2008-12-12, Days after onset: 129
Location:Pennsylvania  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES0811USA00732
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia
SMQs:, Arthritis (broad)
Write-up: Information has been received from a registered nurse concerning her 24 year old daughter with allergies to cephalosporins and no pertinent medical history who approximately 05-MAY-208 was vaccinated IM with the third dose of GARDASIL. There was no concomitant medication. On approximately 05-AUG-2008, "three month ago", the patient experienced joint pain three months after receiving the third dose. At the time of this report, the patient''s joint pain persisted. No lab tests were performed. The patient did not seek medical attention. Follow-up call was made and the office confirmed that the patient reported was not the patient with the practice. Additional information has been requested.

VAERS ID:336764 (history)  Vaccinated:2008-11-04
Age:19.0  Onset:2008-11-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-12, Days after onset: 37
Location:Georga  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Attention deficit/hyperactivity disorder
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA00712
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a physician concerning a 19 year old female with no drug reactions or allergies and a history of attention deficit/hyperactivity disorder (ADHD) who on 04-NOV-2008 was vaccinated with the first 0.5 ml dose of GARDASIL. Concomitant therapy included Concerta and Buspar. On 05-NOV-2008 the patient experienced vomiting. At the time of this report, the patient''s vomiting persisted. No lab test were performed. The patient was seen by the physician and sought unspecified medical attention. Additional information has been requested. Follow up information was received which reported that the physician was no longer in the practice. Additional information is not expected.

VAERS ID:336765 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Tennessee  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA00692
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia
SMQs:
Write-up: Information has been received from a physician concerning a 12-year-old female patient who on an unknown date was vaccinated with the second dose of GARDASIL (lot number, route and injection site unknown). Concomitant vaccinations included the first dose of MENACTRA and HAVRIX. Subsequently, in October 2008 ("sometime last month"), the patient was experiencing hair loss. She didn''t sought any medical attention and her outcome was not reported. Additional information has been requested.

VAERS ID:336768 (history)  Vaccinated:2008-10-23
Age:23.0  Onset:2008-10-26, Days after vaccination: 3
Gender:Female  Submitted:2008-12-12, Days after onset: 47
Location:New Mexico  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00690
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0572X1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Local swelling, Lymphadenopathy
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial and follow-up information has been received from a nurse and a physician concerning a 23-year-old female patient. According to the physician, on 23-OCT-2008 the patient was vaccinated IM with a first dose of 0.5 ml GARDASIL (lot # 660618/0572X) in the left deltoid. Concomitant medication included YASMIN. About three days post vaccination, the patient experienced "swelling in the neck-top of the shoulder area". The nurse reported that the patient received a dose of GARDASIL on 15-AUG-2008; also reported that she developed hardening of lymph nodes in her arm 3 days after receiving her second dose of GARDASIL. The patient sought unspecified medical attention and recovered on an unspecified date. Additional information has been requested.

VAERS ID:336770 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Pennsylvania  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00577
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Mood altered, Personality change
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Information has been received from a physician concerning a female who "about a year ago" in approximately 2007 was vaccinated with a dose of GARDASIL, lot number was not provided. The physician reported that the patient''s mother reported that her daughter experienced severe mood/personality changes "about a week post vaccination" after receiving GARDASIL. At the time of the report, the patient''s outcome was unknown. This is one of two patients concerning the same source. Additional information has been requested.

VAERS ID:336804 (history)  Vaccinated:2008-10-22
Age:14.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 51
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00541
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site reaction, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a medical assistant concerning a 14 year old female patient who on 23-APR-2008 was vaccinated with the first dose of GARDASIL, on 23-JUN-2008 she received the second dose of GARDASIL and on 22-OCT-2008 the patient received the third dose of GARDASIL 0.5 ml, I.M. in right deltoid. The medical assistant reported that after the third dose of HPV vaccine, the patient developed an injection site reaction. The patient experienced pain at the injection site and massaged the area that evening. The patient still had what was described as "BB size hard knot" at the injection site with discomfort. At the time of the report, the patient had no recovered. The patient sought medical attention at the office. Additional information has been requested. Follow up information has been received on 12-FEB-2009 from a health care professional who reported that the patient is a 14 year old female student who no known allergies or pertinent medical history (Weight 125 lb and heighth 62 in). On 22-OCT-2008 was vaccinated intramuscularly into her left deltoid with 0.5 ml of the third dose of GARDASIL (Lot# 660359/1968U). There was no concomitant medication. On 04-NOV-2008 the patient developed a small bb size hard knot at the injectio site. Sore to touch. On an unspecified date the patient recovered. There was no illness at the time of vaccination. In further follow-up received from the health care professional and medical records, it was reported that on 04-NOV-2008, the patient complained of a knot still on the arm. No further information is available. All available medical records will be provided upon request.

VAERS ID:336805 (history)  Vaccinated:2008-10-22
Age:  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 51
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00535
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a nurse practitioner concerning a female patient who on 22-OCT-2008, was vaccinated with the third dose of GARDASIL. The nurse practitioner reported that the patient experienced small knot at the injection site after getting the third dose of GARDASIL. The nurse stated that the patient did not experienced any AE on the first and second dose of GARDASIL. At the time of the report the outcome was

VAERS ID:336806 (history)  Vaccinated:2008-10-23
Age:14.0  Onset:2008-10-23, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 50
Location:California  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA00526
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0381X0UNUN
Administered by: Private     Purchased by: Public
Symptoms: Fall, Hemiparesis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician and a nurse concerning a 14 year old female patient with no drug reactions/allergies, who on 23-OCT-2008 was vaccinated with the first dose of GARDASIL. The physician reported that the patient fainted after receiving the GARDASIL. The nurse reported that "the patient upon feeling weak on one side of her body, the patient did fall". The patient recovered 15 minutes later after having the symptom. The patient sought unspecified medical attention. Follow up information has been received from a medical assistant on 12-JAN-2009. It was reported that the patient felt faint and unable to stand on her own. The GARDASIL site of administration was the left deltoid (lot number 661046/0381X) and was given on 23-OCT-2008 at 15:42. Additional information is not expected.

VAERS ID:336807 (history)  Vaccinated:2008-10-24
Age:16.0  Onset:2008-10-27, Days after vaccination: 3
Gender:Female  Submitted:2008-12-12, Days after onset: 46
Location:California  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00512
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB245AA UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2378BA0UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B012AA UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1192X UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site swelling, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female who on 24-OCT-2008 was vaccinated with the first dose of GARDASIL. The same day she received additional vaccines VARIVAX (Oka/Merck), (duration and dose not reported), DTAP (manufacturer unknown), MENACTRA and HEP A (manufacturer unknown). The physician reported that the patient experienced throwing up for a week, after receiving GARDASIL and VARIVAX (Oka/Merck). The patient outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested. 1/22/08 MR received from PCP. WCC with multiple vax 10/24/08. TC from parent 10/29/08 with report of injection site swelling and 2 days of nausea. Not seen in the office for c/o.

VAERS ID:336808 (history)  Vaccinated:2008-09-30
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives; CLARITIN
Current Illness: Irritable bowel syndrome
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA00509
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a nurse practitioner concerning a 25 year old female with irritable bowel syndrome as concurrent condition and no known drug allergies who on 30-SEP-2008 was vaccinated intramuscularly in her left arm with 0.5 mL of the first dose of GARDASIL (Lot # 660387-1967U). Concomitant therapy included hormonal contraceptives (unspecified) and CLARITIN. On an unspecified date the patient developed a lump at the site of injection. The patient sought medical attention via telephone. At the time of the report the patient had not recovered. Additional information has been requested.

VAERS ID:336809 (history)  Vaccinated:2008-09-04
Age:13.0  Onset:2008-09-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 99
Location:Arizona  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00500
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Hypoaesthesia, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a physician and a health care worker concerning a 13 year old female patient who on 04-SEP-2008, was vaccinated with her first dose of GARDASIL (lot # 660555/0279X). The physician reported that after receiving GARDASIL, the patient waited for 15 minutes and then went home. When the patient got home, she felt numbness in her legs, severe nausea, dizziness and vomiting (also reported by the office manager as occurring 15 minutes after being vaccinated). The physician and office manager reported that the numbness in her legs resolved in 30 minutes and the physician stated that the the severe nausea, vomiting and dizziness resolved sometime in September, 2008. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:336810 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Texas  Entered:2009-01-08, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: cervix HPV DNA assay - positive
CDC 'Split Type': WAES0811USA00270
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Human papilloma virus test positive, Papilloma viral infection
SMQs:
Write-up: Information has been received from a physician concerning an 18 year old female with no relevant medical history or allergies who in approximately 2007, also reported as last year was vaccinated intramuscularly with a first, second and third 0.5 ml dose of GARDASIL (lot number and injection site not reported). There was no concomitant medication. The physician reported that the patient tested positive for GARDASIL. The patient called the physician''s office and unspecified medical attention was sought. At time of this report, the patient''s event persisted. Additional information has been requested.

VAERS ID:336811 (history)  Vaccinated:2008-10-17
Age:15.0  Onset:2008-10-24, Days after vaccination: 7
Gender:Female  Submitted:2008-12-12, Days after onset: 49
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00257
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Local swelling, Skin nodule
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a consumer concerning her daughter with no medical with no medical medical history and no known allergies who on approximately 17-Oct-2008 was vaccinated with the third dose of GARDASIL given on the right a cause but believe that it could be the HPV vaccine" The consumer did not want to provide any or demographics or further information until she speaks with her daughter''s physician. At the time of the report the patient had not recovered. Follow-up information was received which reported that the patient received the shot on 17-Oct-2008. The "bumps" started on " the weekend of October 24th" and she saw the doctor on 31-October-2008 and again on 07-Nov-2008. The bumps "stopped getting lager" on 05-Nov-2008 and now "they are getting smaller again". When the AE started, "you could not see them but you could feel them because they were under her skin. At their largest , "her neck looked swollen on that side and you could see them. "Presently, they are not visible but they can be felt". She did not have the lot# and the doctor did not do any tests when he saw the patient about this AE. No further information is available.

VAERS ID:336812 (history)  Vaccinated:2008-08-21
Age:18.0  Onset:2008-08-21, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 113
Location:Missouri  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA00233
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Nausea, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a registered nurse concerning a 19 year old female patient who on 21-AUG-2008 was vaccinated intramuscularly with the first 0.5 dose of GARDASIL (Lot # 660555/0279X) and on 27-OCT-2008 was vaccinated intramuscularly with the second 0.5 dose of GARDASIL (Lot # 660555/0279X). Concomitant therapy included birth control pills (unspecified). The nurse reported that after the first and second dose of GARDASIL, the patient experienced headache, vomiting and general body aches. The patient recovered 24 hours after the symptoms started. At the time of the report the nurse was thinking of premedicating her before her third dose of GARDASIL, with ibuprofen and PHENERGAN suppositories. The patient did not seek medical attention. Additional information has been requested. Follow up information has been recieved from a registered nurse on 12-JAN-2008. On 21-AUG-2008 at 15:30, the patient was vaccinated, into the right deltoid with a first dose of GARDASIL. On 21-AUG-2008, at 10:30, the patient experienced headache, nausea, vomiting and "achiness all over." The patient recovered after 24 hours. On 27-OCT-2008, at 14:00, the patient was vaccinated, into the left deltoid with a second dose of GARDASIL. On 27-OCT-2008, at 15:00, the patient experienced headache, nausea, vomiting and "achiness all over." The patient recovered after 24 hours. Additional information is not expected.

VAERS ID:336813 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2008-12-12
Location:New Jersey  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00222
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Adverse event
SMQs:
Write-up: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with GARDASIL. The physician reported that the patient experienced an adverse event. The physician is not sure whether or not the adverse event is related to the vaccine. No further information was provided. Additional information has been requested.

VAERS ID:336814 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Pennsylvania  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00218
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Mood altered, Personality change
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Information has been received from a physician concerning a female who "about a year ago" in approximately 2007 was vaccinated with a dose of GARDASIL, Lot number was not provided. The physician reported that the patient''s mother reported that her daughter experienced severe mood/personality changes "about a week post vaccination" after receiving GARDASIL. At the time of the report, the patient''s outcome was unknown. This is one of two patients concerning the same source. Additional information has been requested.

VAERS ID:336815 (history)  Vaccinated:2008-02-27
Age:18.0  Onset:2008-02-27, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 289
Location:New York  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 1/15/2008)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound - negative results.; hematology - (prenatal) no abnormal results.
CDC 'Split Type': WAES0808USA05335
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Haematology test normal, Nausea, Ultrasound scan normal, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial and follow-up information has been received from a registered nurse for the pregnancy registry of GARDASIL, concerning an 18 year old female who on 27-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (Lot # 658556/1060U) (Expiration date 13-APR-2010), 0.5 mL, I.M. It was noted that on 27-FEB-2008, the patient received MENACTRA. After vaccination the patient discovered that she was pregnant. On an unknown date was performed a prenatal blood work with no abnormal results and an ultrasound with negative results. In follow-up, on 21-NOV-2008, a registered nurse was reporting that the patient experienced nausea and vomiting shortly after receiving the first vaccination on 27-FEB-2008. At the time of the initial report, the time of gestation was 32 weeks. Estimated date of delivery was 23-OCT-2008. In follow-up was also noted that the patient had competed her pregnancy. The date of delivery was not available. The patient sought medical attention at the office. Additional information has been requested.

VAERS ID:336816 (history)  Vaccinated:2007-12-05
Age:17.0  Onset:2007-12-22, Days after vaccination: 17
Gender:Female  Submitted:2008-12-12, Days after onset: 356
Location:New York  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 12/22/2007); Asthma; Peanut allergy
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 09/09/08, small gest age; Beta-human chorionic, positive; Serum alpha-fetoprotein, 04/23/08, negative; Complete blood cell, anemia; Apgar score, 09/22?/08, 9/9
CDC 'Split Type': WAES0808USA04895
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Apgar score normal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Full blood count abnormal, Small for dates baby, Ultrasound scan abnormal
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a licensed practical nurse for the pregnancy registry for GARDASIL concerning an 18 year old female with asthma, peanut allergy and 1 previous pregnancies and 1 full term delivery (no birth defects or infant complications noted) who on 05-DEC-2007 was vaccinated with the first dose of GARDASIL IM 0.5 ml. On 05-FEB-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5 ml. Concomitant therapy included albuterol inhaler as needed. Other medications used during pregnancy included ferrousSO4 and biotin (+) carbonyl iron (+) docusate sodium (+) folic acid (+) minerals (unspecified) (+) vitamins (unspecified) (PRENATE ELITE) and iron supplement for anemia (begin on 12-JUN-2008 until delivery). The patient was pregnant with an estimated date of confinement of 30-SEP-2008. Fetal ultrasounds and positive pregnancy test were performed. On 09-SEP-2008 the ultrasound was performed with the result of "small gestational age". On 23-APR-2008 serum alpha fetoprotein was performed with negative results. The complete blood cell count was performed with the result of anemia. On 22-SEP-2008 the patient delivered a normal male baby weighing 6 pounds 2 ounces at 38 weeks with apgar scores 9/9. There were no congenital anomalies and no other complications or abnormalities. There was no complication during labor/delivery. The patient sought medical attention in the office visit. Additional information is not expected.

VAERS ID:336817 (history)  Vaccinated:2006-10-08
Age:14.0  Onset:2007-05-28, Days after vaccination: 232
Gender:Female  Submitted:2008-12-12, Days after onset: 564
Location:New Jersey  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Minocycline
Current Illness: Pregnancy NOS (LMP = 5/28/2007)
Preexisting Conditions:
Diagnostic Lab Data: Apgar score, 9/9
CDC 'Split Type': WAES0807USA03876
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0962F1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Apgar score normal, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a physician, for Pregnancy Registry for GARDASIL, concerning a 15 year old female with a history of 0 pregnancies and 0 live births and no other medical history or drug allergies who on 08-OCT-2006 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL in the deltoid and on 10-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL in the deltoid (lot # 654510/0962F). Concomitant therapy included minocycline. The patient delivered a healthy baby on 27-FEB-2008. Weight: 6 pounds 14 ounces, Length: 50.0cm, Apgar score: 9/9, Head circumference: 20 inches. No adverse symptoms. Medical attention was sought via office visit. No product quality complaint was involved. There were no congenital anomalies or other complication or abnormalities. Pediatric medical records were received and reviewed and the following experiences were identified: A 06-MAR-2008 office visit noted that the male child had eye discharge and required special formula due to lactose intolerance. The healthy male, was born on 27-FEB-2008 via normal spontaneous vaginal delivery. On 27-FEB-2008, poly vitamin with fluoride with Iron multiple vitamins with Iron and Fluoride 0.25 50, 1 dropperful, PO, once a day and erythromycin ophthalmic ointment 0.5%, QID, were prescribed. On 15-MAY-2008 the male child was vaccinated with PEDIARIX, PNEUMOVAX, ROTATEQ (manufacturer unknown) and HIB (manufacturer unknown). On 25-AUG-2008 the child was vaccinated with PEDIARIX, PNEUMOVAX (manufacturer unknown) and HIB (manufacturer unknown). Additional information is not expected.

VAERS ID:336818 (history)  Vaccinated:2008-07-10
Age:57.0  Onset:2008-07-10, Days after vaccination: 0
Gender:Unknown  Submitted:2008-12-12, Days after onset: 155
Location:Maryland  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0807USA01871
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:
Write-up: Information has been received from an office manager concerning a 57 year old patient who inadvertently was vaccinated with a dose of GARDASIL by human error. No adverse effect reported. Follow-up information was received from a physician who reported that on 10-JUL-2008 the patient was given GARDASIL, IM, in the left arm instead of ADACEL inadvertently. No further information is available.

VAERS ID:336823 (history)  Vaccinated:2007-05-31
Age:18.0  Onset:2007-05-31, Days after vaccination: 0
Gender:Female  Submitted:2009-01-08, Days after onset: 588
Location:Missouri  Entered:2009-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN0 LA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Within about one minute of receiving Gardasil I immediately started throwing up, became dizzy, covered in sweat, shaking, and felt faint. I was required to lay down for about 45 minutes and then was allowed to leave when these symptoms went away. I did not continue with the other two shots in the series.

VAERS ID:336825 (history)  Vaccinated:2009-01-07
Age:16.0  Onset:2009-01-07, Days after vaccination: 0
Gender:Female  Submitted:2009-01-08, Days after onset: 1
Location:New York  Entered:2009-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89623 IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U2IMRA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Hyperhidrosis, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: after the vacc,pt c/o dizzyness,when seen pt looked pale and sweaty,pulse 55,bp 88/54,pt put on table at trendlenberg position felt better ,bp 99/69,pulse 82

VAERS ID:336834 (history)  Vaccinated:2008-07-25
Age:44.0  Onset:2008-07-26, Days after vaccination: 1
Gender:Female  Submitted:2009-01-08, Days after onset: 166
Location:California  Entered:2009-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Penicillin allergy PMH: head trauma, hypercholesterolemia, chronic migraines, constipation, depression. Allergies: codeine. Family hx: Parkinson''s & Alzheimers.
Diagnostic Lab Data: LABS: MRI c-spine c/w disc protrusion, spinal stenosis, neural foraminal narrowing, facet arthrosis.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0530U1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Balance disorder, Cervicobrachial syndrome, Facet joint syndrome, Grip strength decreased, Headache, Hypoaesthesia, Injected limb mobility decreased, Intervertebral disc protrusion, Muscular weakness, Musculoskeletal pain, Myalgia, Neck pain, Neuropathy peripheral, Nuclear magnetic resonance imaging abnormal, Osteoarthritis, Paraesthesia, Spinal column stenosis, Tremor, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (narrow)
Write-up: Pt reports tingling and numbness/neuropathy-type symptoms in arm vaccine was administered (right). She also states some motor symptoms, mainly difficulty at times with gripping in the arm vaccine was given. There are some symptoms on the left as well, but less pronounced. 1/23/09 Received PCP medical records which consisted of Neuro consult. FINAL DX: cervical radiculopathy Neuro Records of 10/21/08 reveal patient experienced numbness & weakness of right arm x 3 mos, right hand trmor, neck & shoulder pain, difficulty lifting arm, disequilibrium, muscle aches, blurry vision & HA.

VAERS ID:336848 (history)  Vaccinated:2009-01-06
Age:13.0  Onset:2009-01-06, Days after vaccination: 0
Gender:Female  Submitted:2009-01-07, Days after onset: 1
Location:Pennsylvania  Entered:2009-01-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Loss of consciousness approximately ten minutes after GARDASIL, episode lasting less than 30 seconds.

VAERS ID:336852 (history)  Vaccinated:2008-01-23
Age:26.0  Onset:2008-03-08, Days after vaccination: 45
Gender:Female  Submitted:2009-01-07, Days after onset: 305
Location:Minnesota  Entered:2009-01-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: folic acid; vitamins (unspecified)
Current Illness:
Preexisting Conditions: Drug hypersensitivity
Diagnostic Lab Data: Beta-human chorionic, positive
CDC 'Split Type': WAES0805USA00247
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Failed induction of labour, Gestational diabetes, Nausea, Pregnancy test positive
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow up information has been received from a licensed practical nurse (L.P.N.) for the Pregnancy Registry for GARDASIL concerning a 26 year old female with a history of drug hypersensitivity to TYLENOL #3, DEMEROL, and CODEINE, who on 23-JAN-2008 was IM vaccinated with her first dose of GARDASIL (lot number 659439/1267U). On 24-MAR-2008 the patient was IM vaccinated with her second dose of GARDASIL (lot number 659964/1978U). The patient became pregnant after receiving two doses. She has not received her third dose yet. The patient''s LMP is 08-Mar-2008. The patient sought unspecified medical treatment with an office visit. The patient has had one previous pregnancy and one previous live birth, with no birth defects and no infant complications reported. Patient outcome was not reported. Follow-up information was received 05-JAN-2009 from the L.P.N. indicating that the patient''s estimated conception date was approximately 22-MAR-2008. Ultrasounds were performed on 07-JUL-2008, 19-AUG-2008, 15-SEP-2008, 22-OCT-2008 and 04-NOV-2008, respectively (results not provided). Other medication used during this pregnancy included HUMALOG daily for the treatment of gestational diabetes, LANTUS daily for the treatment of gestational diabetes, "gummi vitamin/folic acid" daily and ZOFRAN), as needed for the treatment of nausea. On 03-DEC-2008, the patient had a C-section due to failure to progress and delivered a normal female baby, weighing 6 pounds, 12 ounces. The baby''s length was 18 inches, head circumference was 13 inches and apgar score was 9/9. There were no congenital anomalies or other complications. The patient had no concurrent medical conditions. The outcome of the patient was not reported. Upon internal review, "C-section due to failure to progress" was determined to be an other important medical event. Additional information has been requested.

VAERS ID:336853 (history)  Vaccinated:2007-08-18
Age:15.0  Onset:2007-08-18, Days after vaccination: 0
Gender:Female  Submitted:2009-01-07, Days after onset: 508
Location:Colorado  Entered:2009-01-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vulval ulceration; West Nile viral infection
Preexisting Conditions: Mouth ulceration; Canker sores oral; Viral infection PMH: PCOS, ? DMII on oral meds. Allergy: sulfa.
Diagnostic Lab Data: Diagnostic laboratory, STD testing LABS: pathergy test neg. ESR 32(H), CRP 10.5(H). CBC, chemistry, LFTs WNL. HSV/PCR neg. HSV I (+), HSV II(-). Biopsy vulvar lesion.
CDC 'Split Type': WAES0812USA02633
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Private     Purchased by: Other
Symptoms: Acne, Aphthous stomatitis, Behcet's syndrome, Biopsy skin, Blindness transient, C-reactive protein increased, Catheter placement, Cellulitis, Depression, Dysuria, Flushing, Full blood count normal, Herpes simplex serology negative, Hirsutism, Hypoaesthesia, Inflammation, Influenza like illness, Laboratory test normal, Liver function test normal, Lymphadenopathy, Oropharyngeal pain, Pain, Paraesthesia, Polymerase chain reaction, Pyrexia, Rash erythematous, Rash pruritic, Red blood cell sedimentation rate increased, Suicidal ideation, Vulval ulceration, West Nile viral infection
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Depression (excl suicide and self injury) (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a female patient with a history of mouth ulcers who on an unknown date was vaccinated with a dose of GARDASIL, lot # unspecified. The patient came back to the physician''s office 4 hours after getting GARDASIL with "vulvar ulcers" diagnosed as "bipolar aphthosis". The physician stated that the patient had gotten the shot when she was experiencing symptoms of West Nile virus; however it was not diagnosed after she had been given GARDASIL. The patient became sexually active "shortly before" she got GARDASIL. At the time of reporting, the outcome of the event was unknown. Follow-up information was received from the physician who reported that the patient had a history of canker sores. The physician also reported that the patient had a viral illness (not specified) prior to receiving the third dose of GARDASIL. The physician stated that the patient had experienced bipolar aphthosis every month for over one year. Follow-up information was received from the physician, who reported that the patient was vaccinated with the third dose of GARDASIL IM, on 18-AUG-2007. The physician reported that within 4 hours of vaccination, the patient had the first outcome of nonherpetic vulvar ulcers. Major work up negative. Presumed to be bipolar aphthosis. At the time of reporting, the patient had not recovered. The patient had numerous cultures and laboratories (unspecified) and a presumptive positive West Nile virus test. The physician considered the event to be disabling. This is one of two reports from the same source. No further information is available. 2/17/09 Received Immunology Clinic records of 7/15-9/26/2008. FINAL DX: Bechet''s disease Records reveal patient did not have symptoms when initially evaluated. Valtrex d/c. Had bout of depression w/suicidal ideation. Being seen by counselor & tx w/meds. Developed oral canker sores that waxed & waned & by 9/18 had over 40+ vulvar ulcers w/exudate & bilateral lymph node adenopathy. Depression aggravated by eruption, fever 100.5, flu like s/s of aches/pain all over. Developed fine erythematous rash over face & skin next day that waxed & waned. Continues to self cath. Tx w/steroid burst & antibiotics. Improved w/steroids 2/18/09 Received ID clinic records of 4/12-5/21/2008 which revealed no new information. 1/20/09 Received PCP office records 4/8-12/3/2008. FINAL DX: suspect bipolar aphthosis Records reveal patient had cleaned out pond 8/2007. Dx w/WNV & had recurring symptoms since then of: 7-14 day menses, facial warmth, painful oral & vaginal lesions, dysuria requiring self catheterization. Lesions are blisters that ooz yellow fluid & also red bumpy itchy rash on trunk & arms. Skin painful during these episodes. Fevers up to 101,(+) inguinal nodes, axillary nodes. Not sexually active. Tx w/antivirals, pain meds & antigout med. Referred to ID 2/5/09 Received GYN medical records of 8/28/2007-11/25/2008. FINAL DX: Bechet''s syndrome records reveal patient seen 8/28/07 in f/u on vulvar operations that were felt to be response to viral illness. Patient was feeling better, lesions were resolving w/o pain. RTC 10/15/07 w/vaginal lesions; numbness & tingling of LEs; intermittent recurrent vision loss; and mouth lesions x 3 days. Referred to Neuro. RTC 12/10/07 & record states pt w/known West Nile virus x approx 5 mo. RTC 2/28/08 w/hirsutism & acne. Added yaz to glucophage & valtrex already on. Labs ordered. RTC 3/17/08 w/recurrent vaginal lesions x 2 days & sore throat x 2 weeks. Records state HSV IgM (+) 12/2007. Patient had self d/c valtrex due to increased depression. Dx w/HSV outbreak w/superimposed cellulitis. RTC 7/08 & referred to university specialist. RTC 10/29 & given trial of colchicine as recommended by specialist. RTC 11/25/08 w/recurrent outbreak of vulvar ulcers most c/w Bechets. Tx w/meds.

VAERS ID:336854 (history)  Vaccinated:2008-12-06
Age:16.0  Onset:2008-12-07, Days after vaccination: 1
Gender:Female  Submitted:2009-01-07, Days after onset: 31
Location:New York  Entered:2009-01-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None PMH: Foreign travel 7/08. Family hx: IBS.
Diagnostic Lab Data: Diagnostic laboratory, 12/12/08, enzyme levels over 800 LABS: CT scan & US abdomen abnormal w/pancreatic & common bile duct dilation & calcification of pancreatic head. MRI/MRCP abnormal w/dorsal duct syndrome, pancreatic stones & stric
CDC 'Split Type': WAES0901USA00056
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2853AB UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0652X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Abdominal rigidity, Activities of daily living impaired, Blood amylase increased, C-reactive protein increased, Computerised tomogram abnormal, Cough, Diarrhoea, Endoscopic retrograde cholangiopancreatography abnormal, Enzyme abnormality, Gait disturbance, Gastrointestinal sounds abnormal, Lipase increased, Muscle strain, Nasopharyngitis, Nausea, Nuclear magnetic resonance imaging abnormal, Oesophagogastroduodenoscopy, Pallor, Pancreatic calcification, Pancreatic disorder, Pancreatic duct dilatation, Pancreatitis acute, Pancreatitis chronic, Pancreatolithiasis, Red blood cell sedimentation rate increased, Sick relative, Stent placement, Ultrasound abdomen abnormal, Upper respiratory tract infection, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a consumer concerning her 16 year old daughter with no medical history or drug allergies who on 06-DEC-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Within 24 hours after vaccination the patient started experiencing pain and within 2 days she started vomiting. She was admitted to a hospital on 12-DEC-2008 (enzyme levels were over 800) and released on the 16th. The hospital determined it was pancreatitis. Multiple tests were performed in the hospital including CAT scan and ultrasound but the results were not provided. The patient was not fully recovered yet, however her mother stated that she was better and her enzyme levels were coming back to normal. Additional information has been requested. 3/16/09 Received PCP medical records of 7/31/08-2/13/2009. FINAL DX: acute on chronic pancreatitis w/strictures & pancreatic stones s/p stent placement; pancreas divisum; asymptomatic until 12/10/08. Records reveal patient experienced good health on 12/6/08 when received HPV #1 & flu shot. RTC 12/10/08 w/cough, cold s/s & chest/upper abdomen pain near diaphragm. Dx w/muscle strain & URI. RTC 12/12 w/continued upper abdominal pain w/vomiting, watery diarrhea, pale w/decreased bowel sounds, guarding & rebound. Sent to hospital for acute abdomen. RTC 12/17 s/p hospitalization w/resolving pancreatitis. 4/16/09 Received hospital medical records of 12/12-12/15/2008. FINAL DX: pancreatitis, etiology unknown Records reveal patient experienced progressively worsening epigastric pain x 5 days, N/V x 1 day. Seen by PCP & dx w/musculoskeletal pain. Continued to worsen &unable to walk or attend school. ALso had cold s/s during the week & multiple sick contacts. Surgery & GI consult done. Labs & PE improved & able to tolerate diet. D/C to home W/PCP & GI f/u.

VAERS ID:336858 (history)  Vaccinated:2008-01-21
Age:16.0  Onset:2008-01-21, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 326
Location:Indiana  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALESSE, dose
Current Illness: Pregnancy NOS (LMP = 12/25/2007); Allergic reactions to antibiotics
Preexisting Conditions: Early onset of delivery
Diagnostic Lab Data: Ultrasound, 06/09/08, confirmed the pregnancy: 23 + 6 weeks, normal anatomy; Ultrasound, 08/26/08, normal size/fluid; Serum beta-human, 06/09/08, confirmed the pregnancy; Apgar score, 6/9; Urine beta-human, 06/09/08, confirmed the pregnancy
CDC 'Split Type': WAES0806USA03426
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0515U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Apgar score abnormal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Premature labour, Ultrasound scan normal, Urinary tract infection, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a 16 year old female with allergic reaction to cephlosporins and a history of 1 pre-term delivery at 36 weeks with complication of apnea of prematurity and no birth defects who on 21-JAN-2008, was vaccinated with the first dose of GARDASIL (lot#657872/0515U). Concomitant medication included ALESSE for birth control. The physician reported that on 24-MAR-2008, the patient was vaccinated with the second dose of GARDASIL (lot # 657872/0515U) at her primary care office. On 09-JUN-2008, the patient had a blood test and urine test for pregnancy, and an ultrasound that confirmed the pregnancy and showed the patient was 23 weeks and 6 days pregnant and the fetus had a normal anatomy. The patient''s LMP was 25-DEC-2007 and EDD 30-SEP-2008 and her date of conception was approximately 05 to 10-JAN-2008. The patient sought medical attention at the physician''s office. In further follow up, the physician reported that the baby delivered on 31-AUG-2008 was male and weighed 5 pounds, 2 ounces, was 18 1/2 inches, and the APGAR score was 6/9. The infant was normal, with no congenital anomalies and there were no other complications. The patient had complications during the pregnancy and labor/delivery because was a precipitous delivery. She was on bed rest at 31 weeks. On 26-AUG-2008, the patient had an ultrasound which was normal size/fluid. Other medications were used during this pregnancy, was terbutaline 5 mg every 4 hours for pre term labor from 06-AUG-2008 to 07-AUG-2008 and MACROBID, bid, for treatment of a urinary tract infection from 06-AUG-2008 to 13-AUG-2008. No further information is available.

VAERS ID:336859 (history)  Vaccinated:2007-08-14
Age:14.0  Onset:2007-10-10, Days after vaccination: 57
Gender:Female  Submitted:2008-12-12, Days after onset: 429
Location:Arkansas  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: Pregnancy NOS (LMP = 10/10/2007)
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 05/05/08, normal; Urine beta-human, positive
CDC 'Split Type': WAES0806USA00085
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Infection, Medication error, Ultrasound scan normal, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a registered nurse (R.N.) for the Pregnancy Registry for GARDASIL regarding a 15 year old female who on 14-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot #, and site not reported). Concomitant therapy included a first dose of MENACTRA. On 27-SEP-2007, the patient was vaccinated with a second dose of MENACTRA was received in error. On 16-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot #, and site not reported). On 22-FEB-2008, the patient was vaccinated with her third dose of GARDASIL (Lot # 655165/1425F, site not reported). ON 10-APR-2008, the patient was vaccinated intramuscularly with her fourth dose of GARDASIL (Lot #655165/1425F, site not reported). The patient received the fourth dose of GARDASIL in error. Concomitant therapy included Tylenol. On an unspecified date the patient took a urine pregnancy test which was positive. The patient "thinks she became pregnant in the first week of November 2007" (LMP approximately 10-OCT-2007). On an unspecified date, the patient had an ultrasound (not further specified). The patient had no symptoms. The patient sough unspecified medical attention by seeing the nurse. No further information is available. Follow-up information was received on 03-NOV-2008 from the R.N. and a physician indicating that the patient is with ) previous pregnancies. The patient had no significant past medical history or concurrent medical conditions. It was reported that the third dose of GARDASIL (Lot #655165/1425F) was under bad storage and the dose was therefore repeated on 10-APR-2008. Other medication used during this pregnancy included occasional prenatal vitamins for nutrition and Zithromax (initialized on 05-MAY-2008), 250 mg, daily for an unknown infection (it was also reported that the patient had no infections or illness during pregnancy). The outcome of the infection was not reported. An ultrasound performed on 05-MAY-2008 was normal. On 11-AUG-2008, 40 weeks from her LMP, the

VAERS ID:336860 (history)  Vaccinated:2008-02-27
Age:20.0  Onset:2008-02-27, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 289
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMICTAL, RITALIN
Current Illness:
Preexisting Conditions: Pregnancy NOS (LMP=Unknown) Drug hypersensitivity; Attention deficit/hyperactivity disorder; Bipolar disorder; Depression; Smoker; Bipolar disorder; Depression
Diagnostic Lab Data: Ultrasound 04/17/08 - normal 24.5 weeks, due to dating, erythrocyte Rhesus - A positive , Rapid plasma reagin - NR, serum hepatitis B - Negative, Apgar score 08/02/08 - After one minute: 8 (infant), Apgar score 08/02/08 - After five minutes
CDC 'Split Type': WAES0805USA00373
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Gastrooesophageal reflux disease, Hepatitis B antibody negative, Perineal laceration, Placental disorder, Syphilis test negative, Ultrasound scan normal
SMQs:, Accidents and injuries (narrow), Gastrointestinal nonspecific dysfunction (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 20 year old white female with allergies to PROZAC, attention deficit /hyperactivity disorder, bipolar disorder and depression with a history of 1 pregnancy and 1 live birth who on 28-Aug-2007 was vaccinated intramuscularly with the 0.5ml first dose of GARDASIL (lot#658282/0929U). On 27-Feb-2008, the patient was vaccinated with the second dose of GARDASIL (lot#659437/1266U). Concomitant therapy included LAMICTAL and RITALIN. Subsequently, she became pregnant. The estimated delivery date was 02-Aug-2008. The patient sought medical attention at the office. On 17-Apr-2008, an ultrasound was performed for dating and that result showed 24.5 weeks. During the pregnancy, other medications included PREVACID 15mg daily for Gastroesophageal reflux disease. On 02-Aug-2008 the patient delivered a normal, healthy female baby weighing 5 pounds 14 ounces. The apgar scores were 8/9. There were no congential anomalies and no other complications/abnormalities. Additional information has been received from a physician concerning a 20 year old female smoker who had a precipitous spontaneous delivery of a healthy female infant on 02-Aug-2008. On 02-Aug-2008, it was reported that the mother had a calcified placenta and 2nd degree lacerations on her left labial and peri clitoral. On approximately 19-Sep-2008, the patient reported having upper respiratory symptoms. On 02-Aug-2008, the patient''s infant had cord around her neck x2. The patient''s infant was born without abnormalities. The infant''s length was 19 3/4 inches. On 02-Aug-2008, the newborn had a hearing screening test and passed. On 12-Aug-2008, the mother took her infant to a well child visit. She had concerns for some bleeding from the umbilicus. The mother also reported that her infant was spitting up and requested to switch formula to Isomil. Overall, newborn screen and PKU status were normal. On 27-Aug-2008, the mother brought her infant to the physician''s office in

VAERS ID:336861 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:2008-02-25
Gender:Female  Submitted:2008-12-12, Days after onset: 291
Location:Wyoming  Entered:2009-01-09, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 2/25/2008); Epilepsy
Preexisting Conditions: Loop electrosurgical excision procedure; Gastroesophageal reflux disease
Diagnostic Lab Data: Urine beta-human, 04/02?/08, positive; Erythrocyte ABO antigen, AB positive; Serum hepatitis B, Negative; Rapid plasma reagin, Non-reactive; Serum HIV-1 and/or 2, non-reactive.
CDC 'Split Type': WAES0804USA02244
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood grouping, Drug exposure during pregnancy, HIV antibody negative, Hepatitis B antibody negative, Pre-eclampsia, Pregnancy test positive, Syphilis test negative
SMQs:, Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a consumer, who is the mother of the patient, for the pregnancy registry for GARDASIL concerning an 18 year old female who sometime last year (2007) was vaccinated with the first dose of GARDASIL (lot# not reported). Per the reporter, the patient received the second dose of GARDASIL (lot # not reported) either in November or December 2007. About a week ago, the patient found out that she was pregnant (gestation = "patient is 3 months pregnant") and her due date is on 27-OCT-2008 (LMP is approximately 19-JAN-2008). The patient sought unspecified medical attention. About a week ago the patient had a positive urine pregnancy test. No further AE information was provided. Follow-up information was received from a physician concerning the patient with no known allergies and a history of epilepsy, loop electrosurgical excision procedure in Aug 2007 and gastroesophageal reflux disease who at 06:06 on 05-NOV-2008, delivered a normal male infant with no congenital anomalies. It was reported that patient''s prenatal testing included ultrasound which was performed on 30-MAY_2008, 05-AUG-2008 and 25-SEP-2008, and her estimated delivery date was 01-DEC-2008. The patient''s medication used during pregnancy included prenatal vitamins, prilosec, 20 mg for gastroesophageal reflux disease and Zetran 4 mg for nausea. It was reported that the patient experienced mild pre-eclampsia since 14:23 28-OCT-2008, and severe pre-eclampsia since 13:46 30-OCT-2008. Vacuum assisted delivery was done for problematic fetal heart rate pattern (deep recurrent variables to 100 returning to baseline with overshoots. Minimal progress with pushing from +2 station). Apgar scores included: apgar 1 min: 6; apgar 5 min: 7. The outcome of birth infant included: weight: 2845 gm (6lbs + 4.354 oz) length: 49.50 cm (19.5 inches), head circumference: 34.50 cm (13.6 inches), chest circumference: 32.50 cm (12.8 inches). Additional information has been requested.

VAERS ID:336862 (history)  Vaccinated:2008-03-27
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 3/3/2008); Group B betahaemolytic streptococcal positive; Drug exposure before pregnancy
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 07/21/08, normal survey; Beta-human chorionic, 04/02/08, pregnant; Serum alpha-fetoprotein, 04/18/08, within normal limit (negative)
CDC 'Split Type': WAES0804USA01350
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Hepatic enzyme increased, Pregnancy induced hypertension, Premature baby, Proteinuria, Ultrasound scan normal
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Systemic lupus erythematosus (broad), Tumour markers (narrow), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Chronic kidney disease (broad)
Write-up: Information has been received from a 22 year old female consumer with no pertinent medical history or drug allergies, for the Pregnancy Registry for GARDASIL, concerning the consumer who on 27-MAR-2008 was vaccinated with the first 0.5 ml dose of GARDASIL. Concomitant therapy included "petrocyclin." On 02-APR-2008 the consumer took a pregnancy test, and discovered that she was pregnant. The date of LMP was 03-MAR-2008, the estimated date of delivery was 08-DEC-2008. The patient would discontinue the rest of the series until the pregnancy was over. No further information was provided. The patient sought unspecified medical attention. Follow-up information was received from the patient who reported that she saw certified nurse midwife and she was well, not having any problems and her EDD was 08-DEC-2008. Follow-up information on 24-NOV-2008 from a Certified Nurse Midwife who reported that on 27-MAR-2008, the patient who was a positive Group B streptococcus carrier and with no previous pregnancies was vaccinated with the first dose of GARDASIL. Concomitant therapy included unspecified therapy. On 18-APR-2008, the patient underwent serum alpha-fetoprotein test and result was within normal limit (negative). On 21-JUL-2008, the patient underwent ultrasound for tetracycline exposure and family history of Meckel and result was normal. On 03-NOV-2008, the patient delivered a normal infant (Weeks from LMP: 35). There were no congenital anomalies. The patient experienced pre term dilation, pregnancy induced hypertension, elevated liver enzymes, and positive proteinuria during the pregnancy. Tetracycline was used for dermatologic reason during the pregnancy prior to knowledge. At the time of reporting, the outcomes were unknown. Additional information was requested.

VAERS ID:336863 (history)  Vaccinated:2007-08-09
Age:17.0  Onset:2007-08-09, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 491
Location:Iowa  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 7/1/2007)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA01117
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Infection
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received through the pregnancy registry and a nurse concerning a 17 year old female who on 09-AUG-2007 and 11-OCT-2007 was vaccinated with a first and second dose of GARDASIL, respectively. Subsequently, she became pregnant. Her last menstrual period (LMP) was reported as July 2007. She received late prenatal care. On 30-MAR-2008, the patient was hospitalized "for delivery" and delivered a healthy baby. Her pregnancy was reported as normal. At the time of this report, the patient had recovered. No product quality complaint was involved. In follow up medical record it was reported that patient developed an infection two days after delivery. The outcome was not reported. Pediatric medical records were received and reviewed. The following experience with the baby were identified. On 08-APR-2008 the baby was brought to the clinic and thick white patch was present on her tongue. She was prescribed nystatin 4 cc on a swab. The mother was instructed to boil blttle nipples. She was instructed to call the clinic if it dose not clear within two weeks. On 11-APR-2008 the baby came to the clinic again. The mother thought she was fussy with bowel movement and felt that she had constipation. Mother reported that the baby was very irritable and screamed with bowel movement. She was advised to use 1-2 teaspoons of dark Karo syrup in every other bottle to see if it helps with the irritability and difficulty stooling. On 01-MAY-2008 baby had a visit to the clinic. On this visit mother reported that baby had watery left eye. It was reported that the baby recovered from constipation (date not reported). Her diaper area was reddened with multiple papules. No excess tearing from the eye noted in this visit. On 01-JUN-2008 the baby reported to have diaper candidiasis. She was called in clotrimazole cream to apply three times per day for ten days to the diaper area. It was discussed with mom other methods of improving diaper rash. Mom was concerned about a bump on baby''s right hand. She wanted it to be checked. The

VAERS ID:336864 (history)  Vaccinated:2007-11-14
Age:19.0  Onset:2007-11-25, Days after vaccination: 11
Gender:Female  Submitted:2008-12-12, Days after onset: 383
Location:Pennsylvania  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Urinary tract infection; Kidney infection; Papanicolaou smear abnormal; Termination of pregnancy - elective
Diagnostic Lab Data: Ultrasound, 03/19/08, normal limit 12 wk 7 days; Ultrasound, 04/26/08, anatomy - 18 wk 1 day with echogenic fetal kidneys; Ultrasound, 05/06/08, Echogenic fetal kidney-anatomy screen: 0 problems; Diagnostic laboratory, ?/?/08, everything wa
CDC 'Split Type': WAES0803USA03041
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Constipation, Diagnostic procedure, Drug exposure during pregnancy, Premature labour, Ultrasound scan abnormal, Ultrasound scan normal, Urine human chorionic gonadotropin positive, Vaginitis bacterial
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow-up information has been received from a registered nurse and a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with a history of urinary tract infections, kidney infections, a previous pregnancy with an elective abortion, and an "abnormal pap with cryo" in December 2006, who on 14-NOV-2007 was vaccinated with her first dose of GARDASIL. On 21-JAN-2008, the patient was vaccinated with her second dose of GARDASIL. There was no concomitant medication. Subsequently, the patient became pregnant. No adverse symptoms were reported. The registered nurse stated that the patient was 12 weeks pregnant as of 18-Mar-2008. On an unspecified date, the patient took a urine pregnancy test which was positive. The date of last menstrual period was 23-DEC-2007 and the estimated delivery date was 28-SEP-2008. On 19-MAR-2008, the patient had a pelvic ultrasound with the normal result. On 25-MAR-2008 the patient had a maternal serum alpha-fetoprotein test for first trimester screening which was negative. On 26-APR-2008, the patient had an ultrasound for "anatomy" with "Echogenic Fetal Kidneys", results not provided. The dose of GARDASIL were administered at another site while the patient attended college. The patient sought unspecified medical attention in the office. On 10-OCT-2008, the nurse practitioner reported that the patient had her baby at the end of September or beginning of October. She did not have the patient''s chart available at the moment so she wasn''t sure of the exact date. She also reported that "nothing ever came of that" about the echogenic fetal kidneys that were seen during the 18 week 1 day anatomy scan on 26-APR-2008. The patient had undergone some genetic counseling/testing but everything was normal with the baby. There were no congenital anomalies and the baby was healthy when it was born. Follow-up information has been received from a completed questionnaire from a Certified Registered Nurse Practitioner. Other medication used d

VAERS ID:336872 (history)  Vaccinated:2008-12-15
Age:15.0  Onset:2008-12-18, Days after vaccination: 3
Gender:Female  Submitted:2008-12-19, Days after onset: 1
Location:Wisconsin  Entered:2009-01-09, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2848AA3IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0652X0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0177X1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Rec''d varicella and FLUZONE R arm 12/15/2008. Mother reports today an area " 3"x4", that is warm, red, hard and rashy" at the injection site R arm.

VAERS ID:336873 (history)  Vaccinated:2008-10-10
Age:25.0  Onset:2008-10-10, Days after vaccination: 0
Gender:Female  Submitted:2009-01-06, Days after onset: 88
Location:Maryland  Entered:2009-01-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Loss of consciousness, Respiratory arrest, Syncope, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Pt passed and approximately 15-30 sec after injection. Was assisted to prone position. No respiratory effort for approximately 30 seconds. Color remained pink. Pulse present , Chin - lift position to open airways and pt regained consciousness. Monitored x 30 min. Parents came to take pt home. Incontinent of urine during syncope episode.

VAERS ID:336887 (history)  Vaccinated:2008-02-07
Age:16.0  Onset:2008-02-07, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 309
Location:Pennsylvania  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 1/25/2008); Depression
Preexisting Conditions:
Diagnostic Lab Data: Beta-human chorionic, 02/19/08, positive
CDC 'Split Type': WAES0803USA01873
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bronchiolitis, Drug exposure during pregnancy, Pregnancy test positive, Urinary tract infection
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician for the Pregnancy Registry of GARDASIL concerning a 16 year old female who on 07-FEB-2008 was vaccinated with her first dose of GARDASIL (lot # not reported). Concomitant therapy included a dose of VARIVAX (lot number unknown). Other concomitant therapy included MENACTRA. On 19-FEB-2008 the patient had a positive pregnancy test. Her LMP was 25-JAN-2008. Follow-up information was received from the physician. The patient had medical history of depression. Concomitant medication during her pregnancy included KEFLEX for UTI (started on 11-JUN-2008) and ZITHROMAX for bronchiolitis (started on 08-SEP-2008). On 29-OCT-2008, the patient delivered a normal, health male baby (no congenital anomalies), weighing 7 pounds 14 ounces, 20 inch in length, with Apgar score 9/9 and head circumference 50.5 cm. There were no complication during labor or delivery. Additional information is not expected.

VAERS ID:336888 (history)  Vaccinated:2007-10-11
Age:18.0  Onset:2008-01-16, Days after vaccination: 97
Gender:Female  Submitted:2008-12-12, Days after onset: 331
Location:Michigan  Entered:2009-01-09, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 1/16/2008)
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 06/02/08, within normal limits; Colposcopy, 03/13/08, cervicitis, focal HPV changes; Cervical smear, 02/04/08, ASCUS s/o HPV; Beta-human chorionic, positive
CDC 'Split Type': WAES0803USA00533
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cervical dysplasia, Cervicitis, Colposcopy abnormal, Papilloma viral infection, Pregnancy test positive, Smear cervix abnormal, Urinary tract infection
SMQs:, Reproductive premalignant disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from a Registered Nurse for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 11-OCT-2007 was vaccinated with the first dose of GARDASIL (lot number not provided) and on 06-FEB-2008 was vaccinated with the second 0.5 ml dose of GARDASIL (lot number not provided) and is now pregnant. There was no concomitant medications. The patient was not experiencing any known symptoms. Medical attention was sought in the practice. Patient outcome was unknown. No product quality complaint was involved. Follow-up information was received from another health professional who reported that on 06-FEB-2008 a PAP test showed atypical squamous cell of undetermined significance s/o HPV. She had the second dose of GARDASIL the same day. On 13-MAR-2008 the patient underwent colposcopy and was diagnosed with cervicitis, focal HPV changes. The patient received MACROBID 100 mg, twice a day for the treatment of urinary tract infection from 07-MAY-2008 to 14-MAY-2008. On 02-JUN-2008 an ultrasound was performed which was within normal limits and showed a fetal anatomy scan at 19 weeks. An MSAFP was declined. Patient declined genetic screening. This was the patient''s first pregnancy. On 15-AUG-2008 (at 28 weeks) because she was Rh negative the patient received globulin, RHOGAM intramuscularly. The outcome of cervicitis and urinary tract infection was unknown. On 08-NOV-2008, at 40.5 weeks from LMP, the patient gave birth to a liveborn female infant weighing 5 pounds, 5 ounces, length was 18 inches, head circumference was 12 inches. Apgar score was 8. There were no complications during delivery. The infant was normal. There were no congenital anomalies or other complications or abnormalities. No further information is available.

VAERS ID:336889 (history)  Vaccinated:2008-01-02
Age:18.0  Onset:2008-01-02, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Michigan  Entered:2008-12-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins (unspecified), mg
Current Illness:
Preexisting Conditions: Attention deficit/hyperactivity disorder
Diagnostic Lab Data: cervix biopsy, 05/20/08, LSIL; beta-human chorionic, 02/27/08, positive; Pap test, 06/12/08, possible HPV changes; Pap test, 11/13/08, results pending; Pap test, 05/20/2008, LSIL
CDC 'Split Type': WAES0802USA04707
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy cervix abnormal, Blood human chorionic gonadotropin positive, Cervical dysplasia, Drug exposure during pregnancy, Fungal infection, Infection, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Uterine and fallopian tube malignant tumours (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad)
Write-up: Information has been received from a health professional through the Pregnancy Registry for GARDASIL concerning an 18 year old female, with a history of ADHD as a child, who on 18-OCT-2007 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 658563/1063U). On 02-JAN-2008, the patient was vaccinated intramuscularly with her second 0.5 ml dose of GARADASIL (Lot # 659437/1266U). On 27-FEB-2008, the patient had a pregnancy test, in the doctor''s office, which was positive (LMP = "mid-December 2007"). the patient sought unspecified medical attention in the office. Follow-up information received from a nurse practitioner concerning the patient. During the patient''s pregnancy, on 02-JAN-2008 she developed yeast infection and was treated with TERAZOL on 2-JAN-2008, 1 mg, QHS for 7 days. On 20-FEB-2008, she was treated with prental vitamin, 1 mg, daily. An ultrasound was performed (results not provided). On 20-MAY-2008 cervix biopsy and papanicolaou test (PAP) were performed which revealed low-grade intraepithelial lesion (LSIL). On 12-JUN-2008, a PAP test revealed possible HPV changes. On 24-SEP-2008 the patient developed a paronychia infection and was treated with KEFLEX, tablet, oral, and 250mg twice daily for 14 days. On 04-OCT-2008, at 38 weeks gestation, delivered a normal, healthy female baby weighing 6.1 pounds. Length of the baby was 18 and head circumference was 12.25. On 13-NOV-2008, the patient underwent a repeat PAP test (results pending). No further information is available.

VAERS ID:336890 (history)  Vaccinated:2007-08-15
Age:16.0  Onset:2008-09-16, Days after vaccination: 398
Gender:Female  Submitted:2008-12-12, Days after onset: 87
Location:Oklahoma  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TANDEM DHA
Current Illness: Pregnancy NOS (LMP = 11/8/2007); Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 03/06/08, for size and date
CDC 'Split Type': WAES0802USA04438
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0388U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a Registered Nurse for the pregnancy registry for human papillommavirus vaccine concerning a female with a penicillin allergy who on 12-FEB-2007 was vaccinated with the first dose of GARDASIL (Lot #654741/1208F). The patient received the second dose on 01-MAY-2007 (Lot #655205/1426F) and the third dose on 15-AUG-2007 (Lot #657622/0388U). The patient became pregnant after her last menstrual period of 08-NOV-2007. No adverse effects were reported. Follow up information was received from a licensed practical nurse concerning a Caucasian female with no history of previous pregnancies, who on 12-FEB-2007, 01-MAY-2007 and 15-AUG-2007 was vaccinated with the first, second and third dose of GARDASIL respectively. Concomitant medication included TANDEM DHA. The LPN reported that on 06-MAR-2008 an ultrasound was performed for size and date. On 26-AUG-2008 the female patient gave birth to a normal male (weight 8 pounds 11 ounces and length 20.5 cm). It was reported that there were no complications during pregnancy and none during labor/delivery. The baby presented sleep apnea noted at 3 weeks. Last menstrual period was 08-NOV-2007. Estimated delivery date was 14-AUG-2008. No further information is available.

VAERS ID:336891 (history)  Vaccinated:2007-10-01
Age:17.0  Onset:2007-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 438
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 9/24/2007) Thalassaemia minor; Diabetes; Papilloma viral infection; Smoker
Preexisting Conditions: Depression
Diagnostic Lab Data: ultrasound 02/04/08 - OB within normal limits; ultrasound 05/09/08 - OB within normal limits; ultrasound 05/27/08 - BPP 8/10; Apgar score 06/11/08 - 8/10; vaginal Streptococcus - screen positive
CDC 'Split Type': WAES0802USA00417
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Drug exposure during pregnancy, Gestational diabetes, Streptococcus identification test positive, Ultrasound antenatal screen normal, Vaginitis bacterial
SMQs:, Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a certified nurse midwife for the pregnancy registry for GARDASIL, concerning an approximately 19 year old female with diabetes, papilloma viral infection, successful smoking cessation at 27 weeks of gestation and thalassaemia minor and a history of depression, who in October 2007, was vaccinated with the first dose of GARDASIL and subsequently was determined to be pregnant. It was reported the patient has no previous pregnancies. On 31-Jan-2008, the patient was placed on therapy with prenatal vitamins (unspecified), PRN for the pregnancy and the treatment of anemia. Other therapies used in pregnancy included as follows: On 31-JAN-2008, the patient was placed on therapy with metronidazole, 500 mg twice a day for the treatment of bacterial vaginosis. On 04-FEB-2008, the patient was placed on ferrous sulfate, 325 mg twice a day for the treatment of anemia. On 04-FEB-2008, an ultrasound was performed and was found within normal limits. On 07-FEB-2008, therapy with metronidazole was discontinued. On 28-APR-2008, the patient was placed on therapy with glyburide, 2.5 mg twice a day for the treatment of gestational diabetes. On 09-MAY-2008, an ultrasound was performed and was found within normal limits. On 27-MAY-2008, an ultrasound was performed and a biophysical profile of 8/10 was found. Diagnostic laboratory tests during pregnancy also included a blood work for iron studies and a group B strep screen found positive. The patient''s LMP was on 24-SEP-2007. On 11-JUN-2008, the patient delivered a 39 weeks healthy baby girl with an apgar score of 8 at one minute and 10 at 5 minutes. The estimated date of delivery was 18-JUN-2008. On 14-NOV-2008, the patient had a 5 month old visit and well child examination was found. Baby''s growth and developed was considered normal. The baby was recommended for flu vaccine and scheduled for follow-up in two months. No further information is available.

VAERS ID:336892 (history)  Vaccinated:0000-00-00
Age:23.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo-Provera; Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 11/22/2007); Smoker
Preexisting Conditions: Abortion
Diagnostic Lab Data: Ultrasound, 04/17/08, dates, survey, bleeding; Ultrasound, 07/23/08, dates, survey , bleeding; Ultrasound, 01/01/08, dates, survey; Ultrasound, 08/08/08, dates, survey, bleeding; Beta-human chorionic, 12/17/07, negative; Beta-human chorioni
CDC 'Split Type': WAES0801USA05865
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Unknown
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Apgar score normal, Blood human chorionic gonadotropin negative, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Fungal infection, Ultrasound scan abnormal, Vaginal haemorrhage
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow up information has been received from a nurse and a certified medical midwife for the Pregnancy Registry for GARDASIL, concerning a 23 year old female patient who smokes cigarettes, who in 17-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot No 658563/1063U). In approximately 2008, the patient was vaccinated with the second dose of GARDASIL, 0.5 mL. Concomitant therapy included Depo-Provera on 17-DEC-2007 for contraception. On 17-DEC-2007, the patient took a pregnancy test which came back negative. Patient came back approximately a week later and was pregnant. The last date of menstrual period was on 22-NOV-2008 and the estimated delivery date was on 02-SEP-2008. On 11-JAN-2008, 17-APR-2008, 23-JUL-2008, 08-AUG-2008 some ultrasounds were performed to check the dates, survey and bleeding was found it. On 04-APR-2008 a serum alpha-fetoprotein test performed with negative results. The certified medical midwife reported that on 04-SEP-2008 the patient delivered a normal male baby, with no congenital anomalies, and with no known complication during labor/delivery. The patient had an obstetric history of one previous pregnancy with an spontaneous abortion and history of yeast during pregnancy. There was a complication during the patient''s pregnancy with a vaginal bleeding at 36 weeks. Other medication used during pregnancy were prenatal vitamins (PVN), ferrous sulfate for anaemia, and Diflucan for yeast. The baby''s weight was 6 pounds with 8 onz, with length of 18 1/2 cm a head circumference of 32 cm and an Apgar score of 9/9. No further information is expected.

VAERS ID:336893 (history)  Vaccinated:2007-09-15
Age:18.0  Onset:2007-11-12, Days after vaccination: 58
Gender:Female  Submitted:2008-12-12, Days after onset: 396
Location:Pennsylvania  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 11/12/2007); Asthma
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 04/04/2008, within normal limits; Ultrasound, 06/23/08, within normal limits; Ultrasound, 07/22/08, within normal limits; Urine beta-human, positive; Apgar score, 8/9; Serum glucose, 05/29/2008, within normal limits
CDC 'Split Type': WAES0810USA05569
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose normal, Drug exposure during pregnancy, Staphylococcal infection, Ultrasound scan normal, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician through the Pregnancy Registry for GARDASIL concerning an 18 year old female with a history of deep vein thrombosis at the age of 15 and no drug allergies, who in the middle of September 2007 was vaccinated intramuscularly in the left arm with the first dose of GARDASIL. The patient was vaccinated with a second dose of GARDASIL approximately from the middle to the end of November 2007. There was no concomitant medication. Subsequently, the patient was pregnant. The patient sought medical attention from her primary care physician. A urine pregnancy test was performed and was positive. The patient''s last menstrual period was 12-NOV-2007 and her estimated delivery date was 18-AUG-2008. The patient contacted the physician for OB/GYN care. No problems were reported. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow-up information was received from a nurse practitioner and patient who reported that the patient delivered a normal healthy baby on 12-AUG-2008. The nurse practitioner reported that during the pregnancy the patient had a routine pregnancy ultrasound on 04-APR-2008, 23-JUN-2008 and 22-JUL-2008 and the results were normal. On 29-MAY-2008, the patient had a glucose screen and was normal. In further follow up, the patient reported that the baby was female and weighed 7 pounds, was 20 inches, the APGAR score was 8/9 and head circumference was 32. The infant was normal, with no congenital anomalies and there were no other complications. The patient had no complications during the pregnancy and labor/delivery. Infection during the pregnancy included a "staff" infection. The medications used during her pregnancy were LOVENOX, 40mg, daily (January to July 2008) and HEPARIN, 20mg, twice daily (July to August 2008) for the treatment of deep vein thrombosis. No further information is available.

VAERS ID:336894 (history)  Vaccinated:2008-01-04
Age:24.0  Onset:2008-01-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 343
Location:Michigan  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Gestational diabetes; Pre-eclamsia
Diagnostic Lab Data: beta-human chorionic - positive
CDC 'Split Type': WAES0801USA04765
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Drug exposure during pregnancy, Gestational diabetes, Pregnancy test positive
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received, for the Pregnancy Registry for GARDASIL, from a 24 year old female with a history of gestational diabetes who on 04-JAN-2008 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. The patient reported that after receiving GARDASIL, she found out that she was 5 weeks pregnant. Her LMP was approximately 15-Dec-2007. A pregnancy test was performed. The patient did not seek medical attention. Follow-up information was received on 01-FEB-2008 via phone call from a person of a doctor''s office indicating that they did not have any record of the patient ever receiving GARDASIL or any indication that she was pregnant. The patient was last seen in their office in November 2007. Follow-up information was received from a person of a doctor''s office indicating that the Hispanic patient had 2 previous pregnancies and 2 pre-term deliveries. No birth defects occurred in previous pregnancies. The patient had pre-eclampsia and gestational diabetes in previous pregnancies. On 26-FEB-2008 an ultrasound was performed and the results were with normal limits. The patient was also placed on prenatal vitamins. Follow-up information was received on 03-NOV-2008 which confirmed that the patient had a past medical history of gestational diabetes. The patient developed insulin dependent diabetes during this pregnancy. She was treated with insulin human NOVOLIN (from 110JUL-2008 till EDC), 24 units, twice a day and insulin aspart NOVOLOG (from 11-JUL-2008 till EDC), 20/16 units, 20, every morning and 16, after supper. Other medication used during this pregnancy included prenatal vitamin (initialized on 20-MAY-2008), 1 mg, daily. On 02-SEP-2008, 37.3 weeks from her LMP, the patient delivered a normal male baby, weighing 7 pounds, 8 ounces. The baby''s length was 19.5, head circumference was 13.5 and apgar score was 7/10. There were no congenital anomalies. There were no other complications or abnormalities. The patient had no complication during labor/delivery. Th

VAERS ID:336895 (history)  Vaccinated:2007-08-28
Age:22.0  Onset:2007-09-04, Days after vaccination: 7
Gender:Female  Submitted:2008-12-12, Days after onset: 465
Location:California  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 7/4/2007)
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 10/30/07, confirmation of pregnancy; Ultrasound, 12/14/07, within normal limits; Beta-human chorionic, positive; Serum alpha-fetoprotein, positive; Hemoglobin, 10.9
CDC 'Split Type': WAES0712USA03771
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0245U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein, Anaemia, Drug exposure during pregnancy, Foetal disorder, Haemoglobin decreased, Postpartum depression, Pregnancy test positive, Ultrasound scan normal
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Depression (excl suicide and self injury) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow-up information has been received through Pregnancy Registry for a 22 year old female consumer with 2 previous full term deliveries who on 28-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (lot # 656050/0245U). There was no concomitant medication. On approximately 04-Sep-2007, the patient had a pregnancy test which was positive (LMP approximately 04-JUL-2007). The patient reported having an ultrasound; however, no additional information was provided. The patient sought unspecified medical attention. On 30-OCT-2007, the patient had a positive pregnancy test. The estimated conception date is 27-JUL-2007. The estimated date of delivery is 09-APR-2008. In further follow up, a nurse practitioner reported that the patient delivered a female baby on 23-MAY-2008. The baby weighed 10 pounds 2 ounces, was 20 inches, and the APGAR score was unknown. The infant was macrosomic and had no other abnormalities or complications. During pregnancy, the patient experienced anemia (HgE 10.9). The patient experienced failure to progress because of the large baby during the labor/delivery. On 14-DEC-2007, the patient had an ultrasound which was within normal limits. On an unspecified date, the patient had a positive alpha-fetoprotein test. There were no infections or illnesses during pregnancy. Follow-up information was received from a nursing supervisor who stated that the patient went to their offices on 11-JUN-2008 suffering post-partum depression and was referred to "psych". Additional information has been requested.

VAERS ID:336896 (history)  Vaccinated:2007-10-11
Age:25.0  Onset:2007-10-11, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 428
Location:Arizona  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Tubal ligation; Normal delivery
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0710USA04313
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Military     Purchased by: Other
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial and follow up information has been received as part of a Pregnancy registry for GARDASIL. A nurse practitioner and a certified medical assistant reported that a 25 year old female patient with no allergies and two previous pregnancies with full term deliveries and a bilateral tubal ligation (2006), on 11-OCT-2007 was vaccinated with GARDASIL. There was no concomitant medication. Subsequently the patient had a positive home pregnancy test. On 18-OCT-2007 the patient was seen in the office and underwent an ultrasound of the pelvis to confirm pregnancy. The patient''s LMP was 01-SEP-2007 (EDD 29-MAY-2007). Follow-up information was received from a nurse who reported that the patient was scheduled at 39 weeks EGA for a repeat Cesarean section and delivered a healthy and normal male, weighing 7 lbs 3 oz. According to the nurse, the patient recovered postoperatively without problems. Additional information is not expected.

VAERS ID:336897 (history)  Vaccinated:2007-09-14
Age:17.0  Onset:2007-09-14, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 455
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP=9/7/2007
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic, positive.
CDC 'Split Type': WAES0710USA03730
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Vulvovaginal candidiasis
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from a registered nurse concerning a 17 year old female with no known significant past medical history or no known concurrent medical condition, who on 14-SEP-2007 was vaccinated with the first dose of GARDASIL (Lot# 6585558/1061U), and was pregnant. On 14_SEP-2007, the patient experienced vaginal candida. Other medications used during the pregnancy was DIFLUCAN for vaginal candida. The patient''s estimated LMP was 07-SEP-2007 and had a EDD of 14-JUN-2008. On an unknown date, the pregnancy was confirmed by a pregnancy test. The registered nurse wanted to have the patient added to the pregnancy registry. No further information is available.

VAERS ID:336928 (history)  Vaccinated:2009-01-07
Age:18.0  Onset:2009-01-07, Days after vaccination: 0
Gender:Female  Submitted:2009-01-09, Days after onset: 2
Location:Texas  Entered:2009-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Old med: "birth control pills" New Meds: "generic Prozac and Ambien for 6 weeks now"
Current Illness: none
Preexisting Conditions: depression
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0381X2IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Arthralgia, Injection site haematoma, Injection site induration, Injection site pain, Musculoskeletal pain, Nausea, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: pain from left elbow to left shoulder with pain/deep ache all around the left shoulder, and Nausea. She states the nausea started just shortly after receiving the injection, and the pain started two hours after receiving the injection. She states she hates shots and gets nervous; however, the nausea continued until the next day. the injection site is hard, sore to touch with mild bruising noted. No redness or heat noted. However, this time the band-aid did produce a local rash (in the shape of the Band-aid) it''s the same type of band-aids i''ve applied to her skin with previous vaccinations.

VAERS ID:336933 (history)  Vaccinated:2007-08-02
Age:26.0  Onset:2007-09-02, Days after vaccination: 31
Gender:Female  Submitted:2009-01-09, Days after onset: 495
Location:Virginia  Entered:2009-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE. PMH: 30 lb wt loss 2'' to stress
Diagnostic Lab Data: BLOOD WORK, XRAYS AT UVA, FONTAINE RESEARCH CENTER. Labs and Diagnostics: Anti-CCP (+), CRP 1.0. X-rays (+) for osteophytosis of the R foot, otherwise WNL. Complement CH 50 (H) at 386. UA (+) for 14 WBCs and few bacteria. ANA (+) at 1:640
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Antinuclear antibody positive, Aphthous stomatitis, Arthralgia, Blood test, C-reactive protein, Complement factor abnormal, Exostosis, Lymphadenopathy, Oedema peripheral, Oral herpes, Pain in extremity, Polyarthritis, Rheumatoid arthritis, Synovitis, Urine analysis abnormal, X-ray, X-ray abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Systemic lupus erythematosus (narrow), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: HAD THE SERIES OF 3 GARDISIL VACCINES, HAVE BEEN EXPERIENCING PAIN IN FEET, HANDS, THEN OTHER JOINTS, BEEN TO DOCTORS, JUST BEEN TOLD MAY HAVE RHEUMATOID ARTHRITIS!! AT AGE 28. THESE SYMPTOMS STARTED AFTER THE VACCINE,BUT HAVE WORSENED OVER LAS 9-12 MONTHS!! I THNIK IT IS FROM THIS VACCINE! WHAT CAN WE DO? DON''T WANT MY DAUGHTER TAKING RA MEDS IF SOMETHING ELSE CAN HELP!! 2/2/09 Rheumatology consult received for eval of joint pain dated 12/19/08. Pt initially c/o sore feet, particularly in MTP joints x 2 yrs. Hand pain x 1 yr. Recent hand swelling jaw pain, and R shoulder, elbow and wrist pain with morning stiffness x 30 minutes. (+) canker sores and fever blisters. PE (+) for L posterior cervical lymph node, decreased thumb flexion, joint tenderness, synovitis, and swelling. Presntation c/w inflammatory arthritis such as RA.

VAERS ID:336937 (history)  Vaccinated:2007-12-31
Age:17.0  Onset:2008-02-25, Days after vaccination: 56
Gender:Female  Submitted:2009-01-09, Days after onset: 319
Location:Massachusetts  Entered:2009-01-09
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: PMH: BCP since 10/07. Preemie w/NICU & intubation. ITP at 2-3 yo. Sibling w/intrauterine CVA, cerebral palsy & protein s def; aunt w/DVT; parent & grandparent w/protein s deficiency; parent w/no hx of thrombosis & not on coumadin; grandparent w/recurrent thrombosis.
Diagnostic Lab Data: LABS: EKG abnormal w/biatrial enlargement w/RV strain. Troponin 2.13(H). Chest CT scan c/w large bilateral PEs. Echocardiogram abnormal w/RV enlargement, tricuospid regurg, pulmonary HTN.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest discomfort, Computerised tomogram abnormal, Deep vein thrombosis, Dilatation atrial, Dilatation ventricular, Dizziness, Dyspnoea, Dyspnoea exertional, Echocardiogram abnormal, Electrocardiogram abnormal, Familial risk factor, Headache, Hypercoagulation, Intensive care, Orthostatic hypotension, Pulmonary embolism, Pulmonary hypertension, Pyrexia, Tachycardia, Tachypnoea, Tricuspid valve incompetence, Troponin increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad)
Write-up: Patient received HPV vaccine on 10/23/07 and 12/31/07. On 2/25/08 patient presented with breathing difficulty and was diagnosed with pulmonary embolism. Sibling and mother subsequently diagnosed with Protein S deficiency and patient presumed to have this as well. Patient began OCPs 10/07. Pulmonary embolism likely related to underlying hypercoagualability and use of OCPs, but we are reporting just in case HPV could also have been a factor. 01/26/09 Reviewed hospital medical records of 2/25-3/4/2008. FINAL DX: bilateral pulmonary emboli w/left common iliac DVT. Records reveal patient experienced DOE x 3 weeks & acute SOB w/chest pressure on 2/25. Fever & dizziness 2 weeks prior. Frontal HA 1 week prior. Seen by PCP 2/25 & found to have tachycardia, tachypnea, orthostatic BP. Admitted to PICU. Cardio, vascular surgery, Heme, Pulm consults done. Tx w/anticoagulant meds. D/C to home on continued anticoagulant meds w/thrombotic w/u to continue as outpatient in Hematology clinic. 4/24/09 Received Heme clinic med recs of 3/4/08-1/13/09. FINAL DX: PE assoc w/OCP Records reveal coumadin d/c 7/14/08 & covered w/lovenox to permit protein s testing. Patient self d/c coumadin as of 1/13/09 & no further medical records available.

VAERS ID:336939 (history)  Vaccinated:2009-01-08
Age:17.0  Onset:2009-01-09, Days after vaccination: 1
Gender:Female  Submitted:2009-01-09, Days after onset: 0
Location:Texas  Entered:2009-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: NKA, Last Menstrual Cycle :"12/22/2008" per mom and client statement.
Diagnostic Lab Data: Unknown
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2566AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1391X1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Diarrhoea, Emotional distress, Fear of death, Injection site pain, Injection site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: Mother of patient called immunization clinic at 1:15pm today 01/09/2009 asking for nurse who administered vaccination to her daughter. Mother claims daughter came home from high school today (01/09/2009) sick, having vomiting and diarrhea, with pain to the right upper arm and looked swollen. Mother believes child will die from the HPV ("the girls shot") due to information she gathered from her internet search. Mother stated "What should I do?". I expressed concern and needed more data from mother and crossed-check clients immunization consent form from 01/08/2009. It indicates that I was the administrator of the immunizations and that the HPV #1 dose was given on the Left Upper Deltoid (IM) and the Meningococcal Conjugate (MCV) on the Right Upper Deltoid (IM) with the Varicella #2 dose to Right lower arm Tricep (SQ). I strongly recommended Ice Pack or Ice Cubes inside a zip-lock bag as tolerated by client to Right Arm and/or what mother has previously given child for muscle discomfort, like Tylenol or Mortrin. If S/S continued next 24hours, mom would need to take daughter to ER of choice for follow-up. Mom agreed. 1/12/09 T/C to Mom states pt is no longer ill but mentally scared & will not go to school. Has not seen MD or gone to ER. Only researched on internet & is now afraid she is going to die. Not physically ill. Strongly encouraged Mom to have patient seen by MD or go to ER for reassurance & medical testing. Refuses. Gave Mom CDC NIP info phone # for additional info.

VAERS ID:336940 (history)  Vaccinated:2009-01-06
Age:21.0  Onset:2009-01-07, Days after vaccination: 1
Gender:Female  Submitted:2009-01-08, Days after onset: 1
Location:Missouri  Entered:2009-01-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: none...did not seek clinical evaluation by primary care physician
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Erythema, Oedema peripheral, Pruritus, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: 1/7/09@1000-Patient calls this office and speaks to this nurse. States that @ approx. 0630 today she woke up to itchy red bumps all over her (R) arm and (R) arm was swollen, when itched the rash left a greasy residue on her fingers and stated "it felt like my arm was on fire". Patient states @ this time the (L) arm that she got the gardasil injection in was not bothering her at all. Patient stated that she took benedryl (1)p.o. at approx 1100 and itching stopped shortly there after, but rash remained. Patient denies any S.O.B. scratchy throat, or any difficulty breathing. Instructed patient to take benedryl as directed on box and if symptoms worsened to contact Primary physician or Emergency room if needed. I requested at this time for her to come to the clinic for evaluation. 1/7/09@1300 Patient states that rash started on (L) forearm and started to itch and spread up to (L)deltoid. 1/7/09@1620 Patient is here at clinic raised red bumps are seen to (R) & (L) arm that cover the forearm and extend to the deltoid. Patient raised her shirt and no bumps are noted to her back, abdomen, or breast area. Does state that the back of lower (R) leg is itchy but I did not visually see this part and patient states that it is not bothering her like the arms are. Encouraged at this time to follow up with a primary care provider and to continue taking the benedryl as directed on the box. Also encouraged either calamine lotion or over the counter benedryl cream/spray to help with itching. Patient denies anything else new being introduced to her that could cause a reaction at this time. 1/8/09 Was contacted by RN, on this day. Patient states that there is no more itching and the red areas are almost gone.

VAERS ID:336945 (history)  Vaccinated:2008-08-18
Age:18.0  Onset:2008-08-31, Days after vaccination: 13
Gender:Female  Submitted:2009-01-09, Days after onset: 131
Location:Ohio  Entered:2009-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuvaring
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.P0072X1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Fatigue, Feeling cold, Gait disturbance, Headache, Hypersomnia, Hypoaesthesia, Paraesthesia, Sensation of heaviness
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: Woke up that Sunday a.m. feeling very tired. Complained of arms feeling heavy and a headache. Later that day complained of numbness and tingling which progressed bilaterally up both her arms throughout that day and into the next several days. Complained of being cold. She slept up to 16 hours/day. Contacted the physician on-call on Monday (Labor Day) who suggested that we wait a week to see what course the symptoms took. Symptoms continued and progressed to complaints of difficulty walking due to heaviness of legs. Numbness and tingling progressed above elbows, but no further. No difficulty breathing. On Wednesday we went to see her primary care physician who felt she had mono, and that it was not related to the HPV vaccine. (patient had NO sore throat) Her doctor ran blood tests, but these returned negative for mono. Patient began to get less tired and less weak beginning on Friday, September 5th, during the day, but then returned to the weakened state on Saturday through Tuesday. And then rapidly recovered to her usual self by Saturday, September 13th. She has had no recurrence of the symptoms since. (NOTE: Her maternal grandfather was diagnosed with Myasthenia Gravis at age 70, and a cousin on her mother''s side has Juvenile Rheumatoid Arthritis that first surfaced after a tetanus vaccine when she was 10 years old).

VAERS ID:336947 (history)  Vaccinated:2009-01-08
Age:31.0  Onset:2009-01-09, Days after vaccination: 1
Gender:Female  Submitted:2009-01-10, Days after onset: 1
Location:Texas  Entered:2009-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Seasonale, zoloft 50mg
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pyrexia, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad)
Write-up: Low grade fever, sore throat, swollen neck lymph nodes, runny nose, muscle aches and fatigue. Taking ibuprofen.

VAERS ID:336975 (history)  Vaccinated:2009-01-08
Age:18.0  Onset:2009-01-08, Days after vaccination: 0
Gender:Female  Submitted:2009-01-09, Days after onset: 1
Location:New York  Entered:2009-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROZAC; NUVARING
Current Illness: None
Preexisting Conditions: AMOXICILLIN
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Headache, Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Patient given GARDASIL- fainted after getting it, patient complained of headache prior to fainting.

VAERS ID:336977 (history)  Vaccinated:2008-03-18
Age:20.0  Onset:2008-04-22, Days after vaccination: 35
Gender:Female  Submitted:2009-01-05, Days after onset: 258
Location:Hawaii  Entered:2009-01-09, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0572X0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA UNRA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Mood swings, Muscle spasms, Smear cervix abnormal, Tachycardia, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad)
Write-up: Dizzy, lightheaded, tachycardia, intermittent tinnitus. Cramps not related to monthly cycle. Mood swings, abnormal pap smear.

VAERS ID:337031 (history)  Vaccinated:2008-11-24
Age:18.0  Onset:2008-11-24, Days after vaccination: 0
Gender:Female  Submitted:2009-01-09, Days after onset: 46
Location:Unknown  Entered:2009-01-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 10/21/2008)
Preexisting Conditions: PMH: none
Diagnostic Lab Data: Blood pressure, 54/30. Labs and Diagnostics: CBC, Chem and EKG all WNL. Serum B-HCG (-).
CDC 'Split Type': WAES0901USA00339
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin negative, Blood pressure decreased, Electrocardiogram normal, Full blood count normal, Hypotension, Laboratory test normal, Syncope vasovagal, Unresponsive to stimuli, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 24-NOV-2008 was vaccinated with her initial dose of GARDASIL (lot # 661530/0575X) 0.5 mL intramuscularly in deltoid. On unknown date the patient had a severe reaction to the vaccination and went unresponsive. Her blood pressure was recorded at 54/30. The patient was sent to the local Emergency Room via ambulance. She was not admitted to the hospital and recovered from unresponsive. The last menstrual period was 21-OCT-2008 and estimated delivery date was 28-JUL-2009 (reported as "27-JUL-2009"). Upon internal review, went unresponsive was considered to be an important medical event. Additional information has been requested. 2/2/09 ER record received for DOS 11/24/08 with DX: Vasovagal episode. Pt was receiving immunizations when had a single episode of syncope. PE WNL in ER. D/C to f/u up with PCP.

VAERS ID:337032 (history)  Vaccinated:2008-05-01
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2009-01-09
Location:Tennessee  Entered:2009-01-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0901USA00354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNRA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Computerised tomogram, Nerve injury, Nuclear magnetic resonance imaging, Pain in extremity
SMQs:, Dementia (broad), Accidents and injuries (narrow)
Write-up: Information has been received from a physician concerning an 18 year old female who in May 2008 was vaccinated with the third dose of GARDASIL and within 1 week experienced right arm pain (2008). The patient saw an unspecified neurologist who said there of the vaccine was nerve damage. Lab diagnostics performed included MRI and CAT scan. All 3 doses were given in the right arm. Unknown if the patient had any problems with the first or second dose. The patient sought medical attention by visiting the physician''s office. Nerve damage was considered to be disabling by the physician because the patient was on the golf team and was unable to participate. Additional information has been requested.

VAERS ID:337040 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Connecticut  Entered:2009-01-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Solodyne
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500583D0IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X2IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B028AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Fluctuating total body urticaria. Treated with antihistamine/steroids.

VAERS ID:337051 (history)  Vaccinated:2008-12-15
Age:11.0  Onset:2008-12-16, Days after vaccination: 1
Gender:Female  Submitted:2008-12-17, Days after onset: 1
Location:Hawaii  Entered:2009-01-12, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TB Test PPD JHP Pharm. 85857 ID/L Forearm
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2806AA IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Pruritus, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Right arm redness 7.5cm x 3.5cm, tender and itchy for 2 days. Rx''d Benadryl.

VAERS ID:337062 (history)  Vaccinated:2009-01-09
Age:23.0  Onset:2009-01-09, Days after vaccination: 0
Gender:Female  Submitted:2009-01-12, Days after onset: 3
Location:Minnesota  Entered:2009-01-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hyperglycemia, depression, allergies
Diagnostic Lab Data: BP: 130/84 P:80
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Cold sweat, Dizziness, Feeling hot, Paraesthesia, Respiratory rate increased
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: Patient felt hot, dizzy, lightheaded, hands were clammy, tight fisted, tingly and patient was breathing hard and fast

VAERS ID:337133 (history)  Vaccinated:2008-12-29
Age:16.0  Onset:2008-12-29, Days after vaccination: 0
Gender:Female  Submitted:2008-12-30, Days after onset: 1
Location:Washington  Entered:2009-01-13, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2829AA IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X2IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Pallor, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Within 5 mins of receiving HPV injection pt became pale, lightheaded, vision became black, diaphoretic. Had pt wheeled to obs. room- monitored pt for 20 min - full recovery - discharged to Mom care.

VAERS ID:337144 (history)  Vaccinated:2008-12-22
Age:18.0  Onset:2008-12-26, Days after vaccination: 4
Gender:Female  Submitted:2009-01-06, Days after onset: 11
Location:Illinois  Entered:2009-01-13, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fainting~HPV (no brand name)~2~18~In Patient
Other Medications: FEXOFENADINE 180 mg daily
Current Illness: None
Preexisting Conditions: Recurrent urinary tract infections.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0346X2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient fainted 4 days after vaccination per mom''s report: with HPV vaccine patient was getting up from sitting down on couch when she fainted. Mom was in other room and heard her. Patient got up right away and has been acting fine. No fever, no cold symptoms.

VAERS ID:337155 (history)  Vaccinated:2008-10-23
Age:15.0  Onset:2008-10-23, Days after vaccination: 0
Gender:Female  Submitted:2009-01-12, Days after onset: 81
Location:Florida  Entered:2009-01-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 8/1/2008)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 12/08/08, Pregnant. 22 weeks, 1 day
CDC 'Split Type': WAES0901USA00452
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received for the pregnancy registry for GARDASIL from a physician concerning a 15 year old female who on 23-OCT-2008 was vaccinated with a third dose of GARDASIL (lot # 659184/0843X). It was reported that the patient was pregnant since August 2008 (LMP: August 2008). An ultrasound test was performed on 08-DEC-2008, which showed gestation of 22 weeks and 1 day. The physician reported that the patient had an elective termination of her pregnancy. The patient had no previous pregnancies. Upon internal review, elective termination of pregnancy was considered to be an other important medical event. Additional information has been requested.

VAERS ID:337158 (history)  Vaccinated:2009-01-06
Age:22.0  Onset:2009-01-07, Days after vaccination: 1
Gender:Female  Submitted:2009-01-13, Days after onset: 6
Location:Minnesota  Entered:2009-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Allergies to Fish and Shellfish
Diagnostic Lab Data: Mild elevation of CK to 257.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Blood creatine phosphokinase increased, Musculoskeletal stiffness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: after first two HPV shots had muscle soreness and slight fever. After Shot #3 had severe whole body myalgias and stiffness "I can hardly move". Tender in all major trigger points. This report made by treating physician, vaccinating physician is patient''s OBGYN, so I do not have vaccine lot number information

VAERS ID:337160 (history)  Vaccinated:2009-01-12
Age:16.0  Onset:2009-01-12, Days after vaccination: 0
Gender:Female  Submitted:2009-01-13, Days after onset: 1
Location:Oklahoma  Entered:2009-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA~ ()~~0~In Patient|NA~ ()~~0~In Sibling|NA~ ()~~0~In Sibling
Other Medications: BENADRYL
Current Illness: PT PRESENTED TO OFFICE FOR A PHYSICAL. PT C/O BEING "TIRED MORE SINCE CHRISTMAS" WTH INCREASED SLEEPING DURING CHRISTMAS BREAK
Preexisting Conditions: ALLERGIC RHINITIS, ALLERGY-INDUCED ASTHMA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0702X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2660BA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2997AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Dyskinesia, Hypoxia, Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope vasovagal, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: PT RECEIVED GARDASIL, MENACTRA AND ADACEL IMMUNIZATIONS ON 01-12-09. AFTER INJECTIONS, PT GOT DIZZY AND PALE WHILE SITTING UPRIGHT IN CHAIR IN EXAM ROOM. PT SLUMPED DOWN, HAD A BRIEF LOC WITH MILD IRREGULAR JERKING OF EXTREMITIES THAT LASTED APPROX 10 SECONDS. + URINARY INCONTINENCE. PT WOKE STARTLED AND SURPRISED ASKING "WHAT HAPPENED?" THE EPISODE WAS WITNESSED BY DR. DR. DOCUMENTED "THIS SEEMS TO HAVE BEEN A VASOVAGAL SPELL WITH A SUPERIMPOSED HYPOXIC SEIZURE."

VAERS ID:337168 (history)  Vaccinated:2008-09-16
Age:11.0  Onset:2008-09-17, Days after vaccination: 1
Gender:Female  Submitted:2009-01-13, Days after onset: 118
Location:Florida  Entered:2009-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Allergic to many things so much that the tests continue to come back inconclusive for which allergans. Has mild asma. Was born without left hand amniotic banding. Stopped breating in middle of MRI 15 seconds after dye gadoliom was administered last year. PMH: L hand absent 2'' to amniotic banding
Diagnostic Lab Data: contact me in a week and I''ll let you know Labs and Diagnostics: Insulin (H) 35.3. C-peptide 4.5. otherwise WNL.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0571X0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Asthenia, Back pain, Blood insulin increased, Cough, Dermatitis contact, Dizziness, Eczema, Headache, Immunisation reaction, Insulin C-peptide increased, Musculoskeletal discomfort, Myalgia, Neck pain, Otitis media, Pain in extremity, Rash, Rash maculo-papular, Sinusitis, Upper respiratory tract infection, Vaccine positive rechallenge, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Lipodystrophy (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: My daughter recived the first HPV guardasil shot on 9-16-2008. She received meningococcal vaccine at the same time. After the first shot she had a very unusual rash breaking out lasting for about 2 weeks. I did not make the connection until after the 2nd HPV shot on 11-19-2008 when it happened again. In addition this time she had severe neck and back pains severe stomach cramping dizey spells,and feeling weak. It has been 2 months since the 2nd shot. Her doctor has seen her still rash talked to her about her other symptoms that have for the most part cleared up. My daughter will be getting a barage of blood work tomorrow. She is a highly allergic child and had the CDC done a better job of educating parents on their pamplets I would have never never ever let my daughter get this shot. I do not believe children that are chemically sensitive dyes excetra should ever have this shot. To this day the CDC in their pamplet still says there are NO seriouse side effects. 2/24/09 MR received from PCP from 10/8/08 to 2/05/09. WCC 10/8/08 with normal exam. HPV#2 11/19/08. Returned 12/5/08 with c/o neck and back pain and URI sx. PE (+) for discomfort when palpating musculature of posterior neck along T-spine. Impression: URI. BSOM. Neck and Back pain-suspect muscular. Returned 1/9/09 with facial rash and intermittent R hip and leg pain, abdominal cramps on and off. PE (+) for mauculopapular rash face, chest & extremities. Impression: Contact dermatitis. R leg pain now resolved. Vaccination reaction per hx. Returned 2/5/09 with c/o H/A, joint pain, neck soreness and cough. Imp: viral syndrome. sinusitis. 8/18/09 TC from parent to report pt now has dx: ezcema.

VAERS ID:337180 (history)  Vaccinated:2009-01-06
Age:17.0  Onset:2009-01-08, Days after vaccination: 2
Gender:Female  Submitted:2009-01-13, Days after onset: 5
Location:Nevada  Entered:2009-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache
SMQs:
Write-up: Pt developed strong daily headaches. She reports a history of sever headaches in her past history. She noticed daily headaches after 1st Gardasil vaccine. The headaches subsequently subsided. She reports recurrence of headaches within days of 2nd Gardasil vaccine

VAERS ID:337182 (history)  Vaccinated:2007-07-12
Age:15.0  Onset:2008-12-16, Days after vaccination: 523
Gender:Female  Submitted:2009-01-08, Days after onset: 23
Location:Illinois  Entered:2009-01-13, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: fainted~Tdap (no brand name)~6~14~In Patient
Other Medications: Cephalexin;
Current Illness: None
Preexisting Conditions: Allergy Augmentin
Diagnostic Lab Data: 12/16/08, Positive HSV culture genitalia
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0961F2UNLA
Administered by: Private     Purchased by: Public
Symptoms: Genital herpes, Herpes simplex serology positive
SMQs:
Write-up: Patient developed genital herpes primary episode 12/16/08. Treated with hydrontisone prior to culture result. Resolved on own. Pt and her mother reported patient had never been sexually active or nude with a partner. Brother has hx cold sores.

VAERS ID:337184 (history)  Vaccinated:2008-05-20
Age:20.0  Onset:2008-05-23, Days after vaccination: 3
Gender:Female  Submitted:0000-00-00
Location:Hawaii  Entered:2009-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PMH: none
Diagnostic Lab Data: CBC; Hytes; Glucose; TSH; Calcium, normal; CT head 6/08; EKG, 8/08; Holter 10/08 Labs and Diagnostics: PAP smear (+) for ASCUS and HPV. CT brain scan WNL. Pelvic US . ECG reported as normal with interpretation incomplete AV block.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U1IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal pain lower, Anxiety, Atrioventricular block, Blood calcium normal, Blood glucose normal, Blood thyroid stimulating hormone normal, Cervical dysplasia, Colposcopy, Computerised tomogram normal, Dizziness, Dyspnoea, Electrocardiogram abnormal, Electrocardiogram ambulatory, Full blood count normal, Human papilloma virus test positive, Laboratory test normal, Scan brain, Smear cervix abnormal, Suprapubic pain, Tachycardia, Tinnitus, Ultrasound pelvis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Retroperitoneal fibrosis (broad), Reproductive premalignant disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (broad), Uterine and fallopian tube malignant tumours (broad)
Write-up: Dizziness, lightheaded, tachycardia tumoritis persisting since May! Patient c/o sf since May 23 (initially seen 5/28/08 for complaints). 2/24/09 MR received from PCP from 3/2008 to 1/2009 for multiple visits with multiple c/o. PE 3/18/08 with normal exam except wrist tenderness from waitressing. HPV and TDaP given. HPV#2 5/120/08. First seen 5/28/08 with c/o dizziness and lightheadedness x 4 days. Dx: Dizziness-no clear etiology. F/U 6/6/08, 9/18/08 with continued sx and now with lower abd pain and suprapubic discomfort. Neuro consult 7/9/08 with normal exam. DX: Transient lightheadedness of unclear etiology. Encouraged increased H2O and vitamins. 8/18/08 presented with SOB and dizziness. anxiety attack noted 9/18/08. Abnormal PAP with colposcopy 11/2008.Sx continue through 1/09. W/u (-). DX: dizziness.

VAERS ID:337185 (history)  Vaccinated:2008-05-20
Age:20.0  Onset:2008-05-23, Days after vaccination: 3
Gender:Female  Submitted:0000-00-00
Location:Hawaii  Entered:2009-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: none
Diagnostic Lab Data: Labs and Diagnostics: PAP smear (+) for ASCUS and HPV. CT brain scan WNL. Pelvic US . ECG reported as normal with interpretation incomplete AV block.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain lower, Anxiety, Atrioventricular block, Cervical dysplasia, Colposcopy, Computerised tomogram normal,