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Found 533873 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

This is page 304 out of 534

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VAERS ID:326506 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-14
Location:North Carolina  Entered:2008-08-18, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA00248
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache
SMQs:
Write-up: Information has been received from a physician concerning a teenage girl believed to be 17 year old who on an unknown date was vaccinated with GARDASIL vaccine (yeast). The physician reported that a patient developed severe headaches after received GARDASIL vaccine (yeast). The patient is currently seeing a neurologist (name unspecified) and taking NEURONTIN for the headaches. There was no product quality complaint. Additional information has been requested.

VAERS ID:322644 (history)  Vaccinated:2008-08-18
Age:17.0  Onset:2008-08-18, Days after vaccination: 0
Gender:Male  Submitted:2008-08-19, Days after onset: 1
Location:Texas  Entered:2008-08-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Pt denied any
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU25710IMLA
Administered by: Public     Purchased by: Public
Symptoms: Fall, Haemorrhage, Skin laceration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hostility/aggression (broad)
Write-up: Patient received MCV-4 in L deltoid 0.5 ml at approx 4pm accompanied by his mother and sister. Pt waiting in hallway for his sister to get her shot. Pt fell to the floor. Pt had cell phone on a chain around his neck it was in back of his head when he hit the floor. Skin laceration noted to back of his head by EMT. Pt awake alert. Pressure applied bleeding stop. Pt stated he has been getting black out spells approx 3 per month. Pt taken to EMT.

VAERS ID:322904 (history)  Vaccinated:2008-08-18
Age:17.0  Onset:2008-08-18, Days after vaccination: 0
Gender:Male  Submitted:2008-08-21, Days after onset: 3
Location:Michigan  Entered:2008-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Drysol 20% topical solution. Prescribed day of visit (prior to rxn).
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2687AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Limb discomfort, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Arm injection given on swollen, redden, warm to touch. Pt states began 1 hr after injection. Waited til next day to report when swelling got bigger, arm tighter. Came in next day for steroid injection, orders for Xyzal, benadryl and oral steriods. Came back next day after treatment for re-assessment. Swelling improved considerably per doctor''s assessment.

VAERS ID:323025 (history)  Vaccinated:2008-08-04
Age:17.0  Onset:2008-08-04, Days after vaccination: 0
Gender:Female  Submitted:2008-08-21, Days after onset: 17
Location:Unknown  Entered:2008-08-22, 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: None
Diagnostic Lab Data: None
CDC Split Type: WAES0808USA02481
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fall, Loss of consciousness, Mydriasis, Respiratory arrest, Skin disorder
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), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow)
Write-up: Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history, drug reactions or allergies who on 04-AUG-2008 was vaccinated with a dose of GARDASIL (Lot #660389/1968U). Concomitant therapy included Hep A (unspecified). On 04-AUG-2008, after receiving GARDASIL, the patient stood up, passed out with eyes open and hit the ground. She did not breathe for 30 seconds, eyes were dilated and still open and skin was terrible. The patient looked like a corpse. The nurse called the patient the next day (05-AUG-2008) and the patient said she was fine. Unspecified medical attention was sought. Upon internal review, "did not breathe for 30 seconds" was determined to be an other important medical event. Additional information has been requested.

VAERS ID:323046 (history)  Vaccinated:2008-08-18
Age:17.0  Onset:2008-08-18, Days after vaccination: 0
Gender:Unknown  Submitted:0000-00-00
Location:Nebraska  Entered:2008-08-22
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2569AA UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021AA UNLA
Administered by: Public     Purchased by: Public
Symptoms: No adverse event
SMQs:
Write-up: No adverse events

VAERS ID:323122 (history)  Vaccinated:2008-08-05
Age:17.0  Onset:2008-08-15, Days after vaccination: 10
Gender:Female  Submitted:2008-08-19, Days after onset: 4
Location:Wisconsin  Entered:2008-08-22, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0847X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Temp 102 8/15 & 8/16/08.

VAERS ID:323141 (history)  Vaccinated:2008-07-07
Age:17.0  Onset:2008-07-07, Days after vaccination: 0
Gender:Female  Submitted:2008-08-22, Days after onset: 46
Location:Unknown  Entered:2008-08-25, 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; XANAX; PROZAC; trazodone hydrochloride
Current Illness: Pregnancy NOS (LMP = 6/18/2008)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA05053
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
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 nurse practitioner for the pregnancy registry for GARDASIL concerning a 17 years old female who on 07-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included PROZAC, XANAX, trazodone HCl and albuterol. The nurse practitioner reported that the patient may have been pregnant when the first dose of GARDASIL. No adverse reactions reported. The last menstrual period was 18-JUN-2008. Her due date is 25-MAR-2009. The patient sought medical attention, she was seen by nurse practitioner. There was no product quality complaint. Additional information has been requested. Follow up information has been received from a nurse practitioner that reported that the patient had an elective termination of her pregnancy last week at approximately 8 weeks estimated gestational age (EGA) (approximately 08-AUG-2008). The nurse practitioner reported that she saw the patient on 13-AUG-2008 and she seemed to be doing well, following the termination of her pregnancy last week at approximately 8 weeks EGA. The nurse practitioner stated that the decision to have the termination was not due to the GARDASIL. The patient was also being treated with PROZAC, XANAX and trazodone HCl, and had concerns related to these medication as well as other concerns. Upon internal review termination of her pregnancy was determined to be an other important medical event. Additional information is not expected.

VAERS ID:323165 (history)  Vaccinated:2008-08-19
Age:17.0  Onset:2008-08-19, Days after vaccination: 0
Gender:Female  Submitted:2008-08-21, Days after onset: 2
Location:Ohio  Entered:2008-08-25, 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: Thyroid, Prevacid, Zoloft, Yaz, Ducolax, clonazepam
Current Illness:
Preexisting Conditions: NKDA, irritable bowel syndrome, scoliosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Immediately after vaccine was given, patient became pale and nauseous. Also, felt dizzy and light-headed. Feeling passed after laying down x few minutes.

VAERS ID:323215 (history)  Vaccinated:2008-08-02
Age:17.0  Onset:2008-08-02, Days after vaccination: 0
Gender:Female  Submitted:2008-08-25, Days after onset: 23
Location:Virginia  Entered:2008-08-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none known
Preexisting Conditions: none known
Diagnostic Lab Data:
CDC Split Type: VA08015
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB452IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB261IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2543AA0IMRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1993BA1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pallor
SMQs:, Hypotonic-hyporesponsive episode (broad)
Write-up: patient given immunizations; became VERY PALE - BP 110/60, P 68. Patient had not eaten since "last night". Ammonia inhalant used and cold compress to face. Juice given to drink. Checked by FNP.

VAERS ID:323241 (history)  Vaccinated:2008-08-19
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-21
Location:Michigan  Entered:2008-08-25, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB213AA0UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2365AA0UNRA
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, Dizziness, Local reaction, Oedema peripheral, Pain in extremity, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: Dizziness, weakness, arms very sore. Left arm tender, mild swelling - local reaction. Rx Benadryl 25 mg QID, cold compresses. RTO if symptoms get worse or if new concerns.

VAERS ID:323309 (history)  Vaccinated:2008-08-11
Age:17.0  Onset:2008-08-11, Days after vaccination: 0
Gender:Male  Submitted:2008-08-13, Days after onset: 2
Location:Illinois  Entered:2008-08-26, Days after submission: 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 at time of reaction, patient stated that he had a sore throat earlier in the day.
Preexisting Conditions: Asthma in past
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVBS17AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0444X0SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Dizziness, Ear disorder, Eye swelling, Fatigue, Muscle twitching, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: 20 minutes after receiving shots the patient noticed that his neck started to itch, pounding sound in his ears, eyes started to twitch and became mildly swollen, and hands and fingers itched. Patient returned to clinic and was roomed within 20 minutes of symptoms onset. Patient reclined, itching subsided substantially, but became dizzy. 2 tsp of Benadryl was given, patient rested, then went home just feeling tired.

VAERS ID:323318 (history)  Vaccinated:2008-08-05
Age:17.0  Onset:2008-08-05, Days after vaccination: 0
Gender:Male  Submitted:2008-08-12, Days after onset: 7
Location:Michigan  Entered:2008-08-26, 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: Ciloxa 30mg 1 q daily; Conarton 36mg q daily
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2418AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, Body temperature increased, Dyspnoea, Fatigue, Feeling hot, Heart rate increased, Pruritus, Speech disorder, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Came in 8/6/08. Complained of feeling hot the night of 8/5/08. Went to sleep, woke up hot, hives over entire body. Came into our office at 11:30AM 8/6/08 vitals: pulse 120, resp 20, temp 101.2. Patient was short of breath, weak, fatigue, itchy hives over entire body. Patient had difficulty speaking and was sent to the E.D.

VAERS ID:323359 (history)  Vaccinated:2008-08-07
Age:17.0  Onset:2008-08-07, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Illinois  Entered:2008-08-26
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: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB291CA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Pharyngeal oedema, Pharyngolaryngeal pain
SMQs:, Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Patient was fine initially after shots. Patients usually get the burning, tingling and numbness after shot. Patient did tell me that after shot (Gardasil) mom looked very concerned on the side effects. So I checked patient after 10 minutes. No reaction at the time. After 15 minutes, I checked patient to see if any reaction - none at time. Advised patient and mother to make next appointment at front desk. Patient then told mother her throat was hurting. Mother told receptionist to see if that was ok. Receptionist got me - then I proceeded to put patient back in room to get the doctor to examine her. Mother told me she started to have a sore throat after vaccines were given. I asked patient how she was feeling regarding her breathing. She said (patient) she was fine. Again I asked to see if maybe her throat felt like it was closing. They all giggled and patient said I think I would know. I interrupted the doctor with her next patient to inform her and mother came out and said her daughter felt like her throat was swollen. The doctor then saw patient while I got the float nurse to do vitals and pulse ox. Float nurse requested to report to room that patient was in. Patient was jovial when arrived, asked how patient felt, stated she felt fine. Took Pulse Ox (99), Pulse (92), Resp (24) and BP (90/60). Asked if she had difficulty breathing. Patient stated "no". Lungs sound clear.

VAERS ID:323474 (history)  Vaccinated:2008-08-12
Age:17.0  Onset:2008-08-12, Days after vaccination: 0
Gender:Male  Submitted:2008-08-18, Days after onset: 6
Location:Kansas  Entered:2008-08-27, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: minocycline. PMH: Allergy to Minocycline
Diagnostic Lab Data: X-ray - pneumonia; Lab - hematuria. Labs and Diagnostics: CXR (+) for worsening bibasilar infiltrates and hypoventilation. CBC with WBC 20.1, 2% lymphs, 87% segs. UA with moderate blood and 3-5 RBCs, rare bacteria. Blood cx (-).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2406AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Bacteria urine, Blood culture negative, Body temperature increased, Chest X-ray abnormal, Cough, Dyspnoea, Fatigue, Full blood count, Haematuria, Heart rate increased, Hypoxia, Lymphocyte percentage decreased, Neutrophil percentage increased, Oxygen saturation decreased, Pneumonia, Red blood cells urine positive, Respiratory rate increased, Tachycardia, Tachypnoea, Throat tightness, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad)
Write-up: Temperature 99.4 degrees, pulse 128, resp. 48 in clinic 8/13/08. Pt stated short of breath and felt like "throat was closing up" around 1800 on 8/12/08. Pt. admitted to hospital 8/13/08. SpO2 93% on RA. 9/15/2008 MR received for DOS 8/14-15/2008 with D/C DX: Bilateral bibasilar pneumonia most likely causing dyspnea and hypoxia. Hematuria. Pt presented with shortness of breath, fatigue and feeling like his trhroat was closing up since the prior evening. Found to be tachypneic, tachycardic and with O2 sat of 93%. Temp 99.4. Dry cough. Temp increased to 101 o/n. Tx with abx, solumedrol and benadryl with some improvement noted.

VAERS ID:323485 (history)  Vaccinated:2008-08-06
Age:17.0  Onset:2008-08-11, Days after vaccination: 5
Gender:Female  Submitted:2008-08-27, Days after onset: 16
Location:Oklahoma  Entered:2008-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
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.0171U1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2573AA1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: fatigue, headache, weakness & fever onset 1 week after vaccine

VAERS ID:323595 (history)  Vaccinated:2007-09-04
Age:17.0  Onset:2007-09-04, Days after vaccination: 0
Gender:Female  Submitted:2008-08-21, Days after onset: 352
Location:Maryland  Entered:2008-08-28, 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: None
Preexisting Conditions: None-She was physically active / healthy.
Diagnostic Lab Data: Neurological screening-impairment; CT Scan, MRI, muscle breakdown, mononucleosis, Lyme, thyroid, pregnancy, see pediatrician for others she ordered. Vision exam-20/20 vision 9/3/08-records received-CT normal.All lab values normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U0 RA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2233CA0 LA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Blood test, Burning sensation, Computerised tomogram, Computerised tomogram normal, Confusional state, Decreased appetite, Diplopia, Disturbance in attention, Dizziness, Fatigue, Head discomfort, Head injury, Headache, Impaired driving ability, Impaired work ability, Laboratory test normal, Lethargy, Loss of consciousness, Memory impairment, Middle ear effusion, Mononucleosis heterophile test, Musculoskeletal stiffness, Myalgia, Neck pain, Nervous system disorder, Neurological examination abnormal, Nuclear magnetic resonance imaging, Pain, Pain in extremity, Paraesthesia, Pharyngolaryngeal pain, Photophobia, Photosensitivity reaction, Pregnancy test, Single functional kidney, Somnolence, Syncope, Thyroid function test, Vision blurred, Visual acuity tests normal, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Four minutes post injection, she fainted on her feet and struck the front of her head on the checkout window frame. A receptionist, nurse and attending physician came to her aid. The next 30 days brought severe debilitating headaches, confusion, decreased consciousness, extreme muscle aches, weakness, eye sensitivity, dizziness, decreased appetite, lack of energy, and weight loss. We returned to the pediatrician''s office four days after injections because she suffered from these symptoms. She was diagnosed with fluid behind her ears. Blood was drawn twice, tests were run; all results were negative. A CT scan showed no abnormal development. Still she was suffering from severe persistent headaches. Two months after shots, she visited a neurologist. A 2 1/2 hour screening was done; showed impairment. A copy of the lab report was sent to pediatrician who called our home with sentiments. The neurologist prescribed two different drugs that didn''t touch her headaches, but rendered her unable to drive, work or do school work. Four months after shots, she begins chiropractic care to ease pain. No success. Six months after shots, she has blurred vision. Eye exam performed; no abnormalities detected (20/20 vision). Nine months later; MRI-all normal. Begins physical therapy; persistent pain. Twelve months later; additional problems. Sudden onset of stiff neck & neck pain, joint stiffness, tingling in fingers, burning in lower back muscles, strong aching in arms, and all body muscles. Exhaustion and headaches, headaches! 9/3/08-records received-9/7/07-9/18/07-presented with C/O fatigue and headaches since 9/4/07 date HPV and meningitis vaccines were administered at which time she passed out but recovered. 9/7/07 C/O weakness and fatigue. Head feels heavy and there is pressure. Lethargic, sleeping. Sore throat. Appetite decreased. 10/29/07-evaluation for possibility of concussion after hitting right side of head on 9/4/07. C/O blurry vision and occasional double vision and sensitivity to light. Difficulty concentrating and

VAERS ID:323677 (history)  Vaccinated:2007-12-21
Age:17.0  Onset:2008-01-25, Days after vaccination: 35
Gender:Female  Submitted:2008-08-28, Days after onset: 215
Location:Massachusetts  Entered:2008-08-29, 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:
Preexisting Conditions: None PMH: periorbital cellulitis age 3. HPV #1 0960F, given 6/28/07, HPV #2 0960F given 8/29/07. Menactra U2107AA, given 6/28/07. Smoker, depression/anger, occasional ETOH, contraception. UTI w/normal renal US, avulsion fibula fx, migraine HA, scoliosis, dysmenorrhea.
Diagnostic Lab Data: diagnostic laboratory, positive SM/RNP antibody; Smith antigen, positive LABS: WBC 12.27(H), ANC 9.77(H). ESR 34(H). CRP 5.30(H). ANA ab IgG 1:5120(H), SSA/RO IgG 118(H), ribonucleic protein IgG .1 Throat c/s neg. IgG 1740(H), RF 50.7(H), C4 13(L). Haptoglobin 190(H).
CDC Split Type: WAES0808USA04680
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0387U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Acne, Antibody test positive, Antinuclear antibody positive, Arthralgia, Asthenia, C-reactive protein increased, Complement factor C4 decreased, Cough, Culture throat negative, Diarrhoea, Dizziness, Ear pain, Exposure to communicable disease, Fatigue, Fibula fracture, Haptoglobin increased, Headache, Hyperhidrosis, Hypersomnia, Hypoaesthesia, Joint stiffness, Joint swelling, Laboratory test abnormal, Lymph node pain, Lymphadenopathy, Mixed connective tissue disease, Nausea, Neutrophil count increased, Oedema peripheral, Pain in extremity, Paraesthesia, Peripheral coldness, Pharyngeal erythema, Pharyngitis, Pharyngolaryngeal pain, Photophobia, Photosensitivity reaction, Raynaud's phenomenon, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor positive, Rhinorrhoea, Skin discolouration, Systemic lupus erythematosus, Viral infection, Vomiting, Weight decreased, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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 (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Vasculitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U). Concomitant therapy included MENACTRA. In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists. The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud''s lupus. Smith antigen antibodies test indicated positive. SM/RNP antibody was positive. The patient''s Raynaud''s lupus persisted. No product quality complaint was involved. Raynaud''s lupus was considered to be disabling due to numbness and joint pain. Additional information has been requested. 10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP. Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement. 9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination. RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before. Also complaining of numbness of hands. Exam revealed tender lymph nodes, reddened throat. Dx w/viral illness. RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA. Boyfriend had mono. RTC 12/21 for final HPV. C/O spotting few days prior to menses for past several cycles. RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms. Dx w/probably Raynaud''s. RTC 2/25 for hands turning purple when cold then white & painful. When warm, hands get red, sweaty & swollen. Also c/o facial acne. RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose. Dx w/pharyngitis, probably viral. RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive. Dx w/probable connective tissue/autoimmune disorder. Encouraged to d/c oral contraceptiives & switch to IUD. Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.

VAERS ID:323687 (history)  Vaccinated:2008-05-06
Age:17.0  Onset:2008-05-06, Days after vaccination: 0
Gender:Female  Submitted:2008-05-20, Days after onset: 14
Location:Georgia  Entered:2008-08-29, Days after submission: 101
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None voiced
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: GA08057
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AAVF IMRA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure decreased, Cold sweat, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Patient here for TDAP, after injection patient began to have decreasing B/P, clammy skin, and complained of nausea. Continued to have decreasing B/P while sitting or standing only. EMS called patient transported to ER.

VAERS ID:323738 (history)  Vaccinated:2008-08-19
Age:17.0  Onset:2008-08-19, Days after vaccination: 0
Gender:Female  Submitted:2008-08-25, Days after onset: 6
Location:Wisconsin  Entered:2008-08-29, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2636AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024DB0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0103X1SCLA
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 in exam room after receiving vaccinations. No trauma occurred. Had not eaten anything or had anything to drink prior to vaccinations. Patient responsive almost immediately after fainting. Given watermelon to eat. Kept patient in clinic for about 15 minutes.

VAERS ID:323779 (history)  Vaccinated:2008-08-26
Age:17.0  Onset:2008-08-27, Days after vaccination: 1
Gender:Male  Submitted:2008-08-29, Days after onset: 2
Location:Texas  Entered:2008-08-29
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: Attention deficit-hyperactivity disorder, allergic rhinitis
Diagnostic Lab Data: ESR 10, Mono spot negative, CBC pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2582AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0271X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Axillary pain, Full blood count, Injection site erythema, Injection site induration, Lymph node pain, Lymphadenopathy, Mononucleosis heterophile test negative, Red blood cell sedimentation rate normal
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Right axillary lymph node swelling and tenderness with normal injection site right deltoit; redness and induration at injection site left arm.

VAERS ID:323789 (history)  Vaccinated:2008-08-28
Age:17.0  Onset:2008-08-29, Days after vaccination: 1
Gender:Female  Submitted:2008-08-29, Days after onset: 0
Location:Oklahoma  Entered:2008-08-29
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2622AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1911U0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: TELEPHONE CALL FROM A FAMILY FRIEND REPORTING CLIENT HAD RECEIVED A MENINGITIS SHOT YESTERDAY AND TODAY SHE WAS FAINTING AND HAVING PROBLEMS BREATHING.THE MOTHER WAS ALSO THERE AT THE RESIDENCE.INSTRUCTED CALLER TO CALL 911 NOW AND NOTIFY R.N. OF OUTCOME. Client seen Dr on 8-29-08 and was told she may have had a reaction to the HYDROCODONE she had been taking so he discountinued HYDROCODONE. The father of the client also states the breathing problems resolved after she stated using her asthma inhaler all symptoms now resolved.

VAERS ID:323854 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-29
Location:Oklahoma  Entered:2008-09-02, 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: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA04715
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
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 physician, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female who was vaccinated with GARDASIL. It was reported that the patient was pregnant when she was given GARDASIL. The patient had a miscarriage 1 week after the third dose of GARDASIL was given (date unspecified). It was unspecified if the patient sought medical attention or not. Upon internal review miscarriage was considered to be other important medical event. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:323882 (history)  Vaccinated:2008-08-11
Age:17.0  Onset:2008-08-11, Days after vaccination: 0
Gender:Female  Submitted:2008-09-02, Days after onset: 22
Location:Pennsylvania  Entered:2008-09-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Migraine headaches, Asthma, Seasonal allergies, PCOS, Morbid obesity
Diagnostic Lab Data: U/A negative, CMP normal, LFTs normal, CK normal CBC and didd normal. Urine pregnancy normal, rapid strep Neg. CT Brain without contrast negative. on 8-26-08
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood creatine phosphokinase normal, Chest pain, Computerised tomogram normal, Differential white blood cell count normal, Dizziness, Full blood count normal, Gait disturbance, Headache, Hypoaesthesia, Laboratory test normal, Liver function test normal, Nausea, Neck pain, Paraesthesia, Pregnancy test negative, Scan brain, Streptococcus identification test, Streptococcus identification test negative, Urine analysis normal, Vision blurred
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: headache, chestpain, nausea and dizziness immediately following receiving the 2nd HPV vaccine on 8/11/08 in the left deltoid muscle.Seen in emergency room on 8/26/08 with persistent symptoms and new symptoms: numbness and tingling on the left arm, unstady gait, neck pain, blurry vision and chest pain.In ER given ketolac and IV fluids. U/A negative, CMP normal, LFTs normal, CK normal CBC and didd normal. Urine pregnancy normal, rapid strep Neg. CT Brain without contrast negative. Symptoms resolved by 9-2-08

VAERS ID:324047 (history)  Vaccinated:2008-08-27
Age:17.0  Onset:2008-08-27, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Alaska  Entered:2008-09-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.144860IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1311U1SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2658AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2966AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: The client was very anxious before the injections. She was seated on the exam table. Immediately after the injections, she stated she felt dizzy and she became pale. She had an episode of syncope. She reclined on the exam table and was awake/alert within minutes. No injuries.

VAERS ID:324139 (history)  Vaccinated:2008-09-03
Age:17.0  Onset:2008-09-03, Days after vaccination: 0
Gender:Female  Submitted:2008-09-04, Days after onset: 1
Location:Tennessee  Entered:2008-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OTC MULTIVITAMIN
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X IM 
Administered by: Private     Purchased by: Private
Symptoms: Erythema of eyelid, Eyelid oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: BILATERAL UPPER EYELIDS ERYTHEMA AND SWELLING FIRST NOTED AT 10:30 PM 09/03/08, WORSENED UPON WAKING THE AM OF 09/04/08. PATIENT EXAMINED BY DOCTOR AND ADVISED TO USE OTC BENADRYL 25 MG Q 6 HOURS PO AND COLD COMPRESSES TO EYES.

VAERS ID:324300 (history)  Vaccinated:2008-04-21
Age:17.0  Onset:2008-04-28, Days after vaccination: 7
Gender:Unknown  Submitted:0000-00-00
Location:North Carolina  Entered:2008-09-05
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:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA6IMRA
Administered by: Private     Purchased by: Public
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Per phone call - sx appeared 7d after injection - mom describes. Rash that looked like large whelps resembling "ring-worm" - faded away after 5-7d with meds - rash was on back arms - hips.

VAERS ID:324465 (history)  Vaccinated:2008-08-25
Age:17.0  Onset:2008-08-25, Days after vaccination: 0
Gender:Female  Submitted:2008-08-25, Days after onset: 0
Location:Maryland  Entered:2008-09-08, 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:
Current Illness: No
Preexisting Conditions: To food coloring and dye
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB238AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2375BA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Convulsion, Pain in extremity, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (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), Tendinopathies and ligament disorders (broad)
Write-up: Client fainted. Client''s mother stated client had a seizure not witnessed by staff. Client stated after hepatitis A, she felt pain in Lt arm. After MENACTRA she felt like she had to sleep.

VAERS ID:324506 (history)  Vaccinated:2008-05-13
Age:17.0  Onset:2008-05-13, Days after vaccination: 0
Gender:Female  Submitted:2008-09-08, Days after onset: 118
Location:South Carolina  Entered:2008-09-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; Levsin; Anaprox; Desogen
Current Illness: None
Preexisting Conditions: Asthma; GERD; Depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Has 1/2 cm raised area where GARDASIL vaccine was given on 5-13-08. Extreme itching still.

VAERS ID:326261 (history)  Vaccinated:2008-08-14
Age:17.0  Onset:2008-08-14, Days after vaccination: 0
Gender:Male  Submitted:2008-08-25, Days after onset: 11
Location:New Jersey  Entered:2008-09-09, Days after submission: 15
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: The patient had allergies to augmentin, penicillin, strawberries, cashews, and pitted fruits.
Diagnostic Lab Data: None reported.
CDC Split Type: 200802645
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2422A0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Headache, Muscle spasms, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)
Write-up: Initial information was received from a health care professional on 18 August 2008. A 17 year old female with allergies to augmentin, penicillin, strawberries, cashews, and pitted fruits received a first dose injection of MENACTRA (U2422AA) intramuscularly in the left deltoid on 14 August 2008. On 14 August 2008 she complained of "pins and needles" in the hands, fingers, and feet. A few hours after vaccination she developed cramping in her knees and elbows. She had a temperature of 101.9 the evening after vaccination. The following day she complained of a headache. She was seen by a doctor and her temperature was 98.9. The patient''s recovery status was unknown at the time of the report. 10/31/08 Reviewed PCP office records & vaccination records. Records reveal patient felt dull ping sensation in hands, feet, fingers, toes, cramping feeling in knees & elbows starting evening of vaccination 8/14/08. Developed HA & fever 8/15/when seen in office & arms/feet/hands were feeling normal. Was encouraged to rest & increase fluids, monitor condition. No further medical records available.

VAERS ID:324719 (history)  Vaccinated:2008-08-06
Age:17.0  Onset:2008-08-06, Days after vaccination: 0
Gender:Male  Submitted:2008-09-08, Days after onset: 33
Location:New York  Entered:2008-09-10, 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: Strep A negative, T/C negative, mild pharyngitis
Preexisting Conditions: Acne
Diagnostic Lab Data: Orthopedic evaluation including x-rays both shoulders which are negative, PT, EMG done - verbal results = + right axillary nerve palsy.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2685AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2994AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Electromyogram abnormal, Injected limb mobility decreased, Musculoskeletal pain, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: Received call 8/7/08, child in severe left shoulder pain. Patient seen - injection site not warm/tender/erythemateous. Patient complained of severe left shoulder pain - strength WNL, ROM WNL. Given Vicodan/ice. 8/13/08 received call from dad, pain now $g right arm and decreased mobility of left = ortho consult suggested ASAP. 8/13/08 received call from ER. 8/14/08 again sugg ortho, our office made appt for 8/15/08.

VAERS ID:324730 (history)  Vaccinated:2008-08-19
Age:17.0  Onset:2008-08-19, Days after vaccination: 0
Gender:Female  Submitted:2008-09-03, Days after onset: 15
Location:Michigan  Entered:2008-09-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergies - eyes watery
Preexisting Conditions: Allergies (? Asthma). Environmental allergies.
Diagnostic Lab Data: Wound culture. Follow-up Information 05-SEP-2008: On 9/3/08 physician at health center took samples to culture from scabbed spots on clients head. 9/29/08 RDI to be sent to med. clinic for det.
CDC Split Type: MI2008023
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2623AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B027AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0513X1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Acne, Culture wound, Erythema, Oedema peripheral, Pain in extremity, Rash pustular, Scab
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Multiple red pustules with surrounding erythema starting 13-14 days after receiving multiple vaccines. Follow-up Information 05-SEP-2008: Client states approx. 1 hour after receiving imms on 8/19/08 both arms became swollen and painful. Client states this lasted 4 days then resolved. Then on 9/1/08 client reports she had swelling and black and blue marks in her upper arms with approx 20-30 "pimples" on her arms, face, and head. She states they were painful to the touch. Client visited the health center 9/3/08 for evaluation. PP gave client a prescription for Bactrim, took culture of her "pimples" that are now scabbed over and made a follow-up appt for next week.

VAERS ID:324744 (history)  Vaccinated:2008-09-03
Age:17.0  Onset:2008-09-03, Days after vaccination: 0
Gender:Female  Submitted:2008-09-03, Days after onset: 0
Location:Massachusetts  Entered:2008-09-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~~0~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B027AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Depressed level of consciousness, Dyskinesia, Fall, Urinary incontinence
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Found fallen in exam room, decreased consciousness, jerky movements of right forearm and had urinary incontinence, vital signs stable, water found, came quickly to alertness; Sent to ER.

VAERS ID:324795 (history)  Vaccinated:2008-07-09
Age:17.0  Onset:2008-07-17, Days after vaccination: 8
Gender:Female  Submitted:2008-09-10, Days after onset: 55
Location:Michigan  Entered:2008-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Preexisting condition at right. Not ill at that time.
Preexisting Conditions: Syncope-vasovagel/postural orthostatic/ tachycardia syndrome. ICD-9 780.2
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0270X1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysphonia, Pain, Pharyngeal oedema, Swollen tongue, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Patient recevied both varicella and HPV on 7/9/08. The mother called our clinic on 7/18/08 with the note documented below.Nurse Comments: Placed call back to mom. Mom states patient had reported to mom last night that her throat felt swollen. Mom gave Benadryl. Mom states today she has her voice back. Questioned if patient had hives yesterday or just itching. Mom states patient did have hives and she gave Benadryl yesterday. States right now patient is reporting that her tongue feels thick and her throat feels swollen. Mom states patient says she aches all over. Patient recently just went off of her Florinef that she had been on x 2 years and wondered if that could be contributing. Recommended mom give Benadryl again now. Discussed with Dr. here in the office who states patient should go to ER at this time. Mom informed of this and states understanding. Completed by Nurse: July 18, 2008 11:52 AM Patient was taken to clinic by mother. The physician form there called and discussed the case with Dr. She ordered a referral to an allergist. The patient has an appointment with an allergist on 9/17/08 for this and other past allergic reactions.

VAERS ID:325063 (history)  Vaccinated:2008-07-24
Age:17.0  Onset:2008-08-01, Days after vaccination: 8
Gender:Female  Submitted:2008-09-12, Days after onset: 42
Location:Kansas  Entered:2008-09-15, Days after submission: 3
Life Threatening? No
Died? Yes
   Date died: 2008-08-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Acne
Preexisting Conditions:
Diagnostic Lab Data: Unknown LABS: WBC 10.3(H). Troponin greater than 100(H) & CPK 5492(H), CKMB 313.1(H) c/w infectious myocarditis, possibly viral. TSH 0.09(L). CRP 38.3(H). BNP 533(H). ANA neg. ASO 200(+). CXR abnormal w/water bottle appearing heart. Sodium 132(L), potassium 3.7(L), bicard 18(L), BUN 29(H), creatinine 1.3(H). AST 832(H), ALT 211(H). Urine drug screen neg. Blood c/s neg. MRSA screen neg.
CDC Split Type: WAES0809USA00837
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Alanine aminotransferase increased, Antinuclear antibody negative, Aspartate aminotransferase increased, Asthenia, Azotaemia, Blood bicarbonate decreased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood culture negative, Blood potassium decreased, Blood sodium decreased, Blood thyroid stimulating hormone decreased, Blood urea increased, Brain natriuretic peptide increased, C-reactive protein increased, Cardiac enzymes increased, Cardiac failure congestive, Cardiomyopathy, Catheterisation cardiac abnormal, Chest X-ray abnormal, Chest pain, Chills, Death, Dizziness, Drug screen negative, Dyspnoea, Ejection fraction decreased, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Hypotension, Hypoxia, Intensive care, Intra-aortic balloon placement, Malaise, Methicillin-resistant Staphylococcus aureus test negative, Myocardial infarction, Myocarditis infectious, Pain, Pyrexia, Respiratory distress, Shock, Streptococcus identification test positive, Tachycardia, Troponin increased, Ventricular tachycardia, Viral cardiomyopathy, Viral myocarditis, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (narrow), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow)
Write-up: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included erythromycin, solution, topical. On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized. On 05-AUG-2008, the patient experienced myocarditis and died. Diagnosis was myocarditis but the doctor said it was not related to GARDASIL. The last time she was seen in this office was 2005. No additional information at this time. Additional information has been requested. 10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor. 9/22/08 Reviewed PCP medical records. Reveals patient experienced abdominal pain, chest pain & aching everywhere. Expired 8/5/08 w/viral infection of the heart. Concomitant med was erythomycin topical solution for acne. Patient noted to be in good health on day of vaccination. 4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days. Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB, respiratory distress w/hypoxemia, azotemia, shocklike symptoms. EKG w/diffuse ST changes & ST elevations. Dx w/acute anteroseptal MI Emergent cardiac cath revealed EF 23% & balloon pump placed. Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.

VAERS ID:325120 (history)  Vaccinated:2008-08-28
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-12
Location:Wisconsin  Entered:2008-09-15, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC2900AA IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2616AA SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0103X SCUN
Administered by: Private     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:
Write-up: Pt received DTAP and POLIO combo and should have received Tdap as ordered by physician.

VAERS ID:325254 (history)  Vaccinated:2008-08-12
Age:17.0  Onset:2008-09-07, Days after vaccination: 26
Gender:Female  Submitted:2008-09-16, Days after onset: 9
Location:Wisconsin  Entered:2008-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Oral contraceptive, albuterol inhaler as needed
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: CT Scan, EEG, spinal tap and other labs
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2580AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Laboratory test, Lumbar puncture, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Received Menactra vaccine on 8/12/2008. The next day had fever (103 degrees F) and generalized body aches for three days. On 09/07/2008 she had another fever and had two generalized convulsive seizures. She was taken to the Emergency Room by ambulance. Fever of unknown etilogy at that time.

VAERS ID:325329 (history)  Vaccinated:2008-06-03
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-16
Location:New York  Entered:2008-09-17, 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: Unknown
Current Illness:
Preexisting Conditions: Atypical squamous cells of undetermined significance; Papilloma viral infection; Low grade squamous intraepithelial lesion
Diagnostic Lab Data: ultrasound, 06/11/08, pregnant: SIUP 20w 3d; cervix HPV DNA assay, 06/26/08, negative; serum Toxoplasma IgG Ab, 06/26/08, positive; serum Toxoplasma IgM Ab, 06/26/08, positive
CDC Split Type: WAES0807USA00383
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alkalosis, Drug exposure during pregnancy, Human papilloma virus test negative, Premature labour, Renal failure, Toxoplasma serology positive, Toxoplasmosis, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad)
Write-up: Information has been received through the Merck pregnancy registry from a physician concerning a 17 year old female with a history of a pap smear on 01-DEC-2006 that was positive for HPV and showed ASCUS, and a colposcopy on 11-JAN-2007 which showed LGSIL, who on approximately 03-JUN-2008 was vaccinated with a first dose of GARDASIL (route and administrating site not reported) at her primary care provider''s office. The patient found out she was pregnant about 3 or 4 weeks after receiving the GARDASIL. The patient has a follow up exam scheduled with the physician. The patient sought medical attention by calling the office. The patient''s last menstrual period was approximately 21-JAN-2008. The estimated due date is 24-OCT-2008. An ultrasound test perform on 11-JUN-2008 indicated a SIUP at 20 weeks and 3 days. On 26-JUN-2008 a pap smear was negative for HPV. Follow-up information was received from a registered nurse indicating that on 26-JUN-2008 a toxoplasma IgG and IgM was performed with a positive result. Spiramycin was used from 18-JUL-2008 to 11-AUG-2008 for the treatment of toxoplasmosis. The patient''s complications during pregnancy included renal failure and alkalosis. On 26-AUG-2008 the patient gave birth prematurely at 31 weeks. The birth weight of the female infant was 1630 gm. Upon internal review the premature birth and the mother''s renal failure were determined to be other important medical events. Additional information has been requested.

VAERS ID:325358 (history)  Vaccinated:2008-09-08
Age:17.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-21, Days after onset: 13
Location:Indiana  Entered:2008-09-17, 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: Benadryl Prilosec
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U2IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024BA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Eye rolling, Muscle twitching, Physical examination normal, Pruritus, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow), Hypersensitivity (broad)
Write-up: Pt''s mom reported itching 1 hr after vaccines. Gave Benadryl. Pt''s boyfriend states she started twitching/shaking head & neck & eyes rolled back in her head. 9/22/08-records received-9/9/08-Seen in office day after C/O itching, twitching and shaking head and neck. Eyes rolled. PE grossly WNL.

VAERS ID:325391 (history)  Vaccinated:2008-09-17
Age:17.0  Onset:2008-09-17, Days after vaccination: 0
Gender:Female  Submitted:2008-09-17, Days after onset: 0
Location:Nebraska  Entered:2008-09-17
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.0843X1IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B028AA2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Muscle twitching, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Approx 3-4 minutes after receiving a HPV #2 and Tdap she fainted and twitching of facial muscles and extention of arms and legs for less than 5 seconds. After episode was over and she set up she was oriented x 4, pale, Vital Signs within Normal limits. Observed for 30 minutes with V.S. done every 10 minutes. V.S. remained WNL. Mom was presented and escorted daughter home with instructions to take to ER if condition changed.

VAERS ID:325405 (history)  Vaccinated:2008-09-08
Age:17.0  Onset:2008-09-14, Days after vaccination: 6
Gender:Female  Submitted:2008-09-17, Days after onset: 3
Location:Georgia  Entered:2008-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Evra
Current Illness: Urticaria
Preexisting Conditions: No known allergies. Patient denies a family history of asthma; familial congenital defects; hay fever
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2638AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Woke up with hives Sunday 9/14/08, covering most of body. immunized 9/8/08

VAERS ID:326734 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-15
Location:Texas  Entered:2008-09-17, 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: Iron (unspecified); ZOFRAN ODT 8 mg; PHENERGAN TABLETS/SUPPOSITORIES 20 mg; vitamins (Unspecified)
Current Illness: Pregnancy NOS (LMP - 11/17/2007; sulfonamide allergy; bacterial infection due to streptococcus, group B; Iron deficiency.
Preexisting Conditions: Papilloma viral infection; termination of pregnancy - elective; cervical dysplasia; ankle fracture.
Diagnostic Lab Data: Ultrasound 01/23/08 - within normal limits confirmational; ultrasound 01/14/08 - 9 wks; ultrasound 02/20/08 - 13 6/7 wk: NI NTL; diagnostic laboratory 02/20/08 - normal. Serum human - positive; serum alpha-fetoprotein 03/19/08 - within nor
CDC Split Type: WAES0801USA02556
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
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 health professional concerning a 17 year old female with papilloma viral infection diagnosed in December 2007 history of 2 pregnancies, 1 live birth and a history of an elective termination who on an unspecified date was vaccinated with a first dose of GARDASIL. On 14-MAR-2007 the patient was vaccinated with a second dose of GARDASIL (lot#657006/0188U). Concomitant therapy included prenatal vitamins (CB Complete), iron (unspecified), PHENERGAN and ZOFRAN ODT. The patient''s (last menstrual period) LMP date was 17-NOV-2007 and the (estimated date of delivery) EDD date is 23AUG-2008. The estimated date of conception was 30-NOV-2007. On 23-JAN-2008 a confirmation ultrasound was performed and was within normal limits. On 19-MAR-2008 a maternal serum alpha-fetoprotein test was performed for sequential screening and was within normal limits. There was no adverse experience was related to this event. Medical attention was sought in the office. The product quality complaint unit was not involved. Follow up information was received which indicated that the patient had one previous pregnancy and on elective termination (6-8 weeks from LMP). The patient had allergy to sulfa and iron deficiency anemia and a history of Papilloma viral infection (biopsies revealed mild to moderate (cervical) dysplasia) and ankle fracture in motor vehicle accident (in MAY of 2007). It was also reported that the patient was group B Strep carrier during pregnancy. On 20-Feb-2008, the patient underwent sequential screen and the result indicated normal. On 19-AUG-2008 (39 3/7 weeks from LMP) the patient delivered a normal male baby who was 8 LB 1oz with an Apgar score 9/9. Additional information is not expected.

VAERS ID:326755 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-15
Location:Unknown  Entered:2008-09-17, 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: Unknown
Current Illness: Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA01134
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Headache
SMQs:
Write-up: Information has been received from a physician assistant (also reported as nurse practitioner) concerning a 17 year old female with "allergies" who on an unknown date was vaccinated IM with the second dose of GARDASIL vaccine (yeast) 0.5 ml. The physician assistant reported that a patient was experienced headache and fatigue after received GARDASIL vaccine (yeast) vaccine. The patient did not seek medical attention. There was no product quality complaint. No further information is available.

VAERS ID:326772 (history)  Vaccinated:2008-08-05
Age:17.0  Onset:2008-08-05, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 41
Location:Texas  Entered:2008-09-17, 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: None
Current Illness: Asthma, Chest pain
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA01205
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chest pain, Electrocardiogram, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a medical assistant concerning a 17 year old female with no known drug allergies and who had childhood asthma, and positive family history of hypertension, stoke and cardiac disorder, who on 05-AUG-2008 was vaccinated with the first and only dose of GARDASIL vaccine (yeast), 0.5 ml. There was no concomitant medication. The medical assistant reported that on 05-AUG-2008, shortly after received GARDASIL vaccine (yeast), the patient experienced for 20 minutes racing heartbeat and chest pain. The medical assistant reporter that prior the vaccination, the patient had occasional chest pain for the six past months. On unspecified date an "EKG" was performed (results not provided). The patient saw the physician. At the time of the report the patient had not recovered. Additional information has been requested.

VAERS ID:326775 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-15
Location:Unknown  Entered:2008-09-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA01275
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: General physical health deterioration, Lethargy, Rash
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow)
Write-up: Information has been received from the news media concerning a 17 year old female who was vaccinated with a dose of GARDASIL vaccine (yeast) (Batch #, Lot #, route and site of administration not reported). Subsequently the patient developed rash and then experienced progressive decline (what sounds like lethargy) months after vaccination with GARDASIL vaccine (yeast). The patient and her parents believe GARDASIL vaccine (yeast) is the cause. No additional information is expected.

VAERS ID:326777 (history)  Vaccinated:2008-01-08
Age:17.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 250
Location:Illinois  Entered:2008-09-17, 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: Unknown
Current Illness: Pregnancy NOS, Allergic reaction to antibiotics
Preexisting Conditions: Abortion, LMP = 12/15/2007
Diagnostic Lab Data: ultrasound - 03/12/08 - 13 weeks - Establish due date WNL, biopsy - 04/30/08 - CINI on Bx, ultrasound - 07/07/08 - EFW 3# measures 28-30 wks, Pap test - 03/04/08 - Abnormal and was positive for HPV type 16
CDC Split Type: WAES0808USA01307
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy cervix, Cervical dysplasia, Drug exposure during pregnancy, Human papilloma virus test positive, Pregnancy, Smear cervix abnormal, Ultrasound antenatal screen normal
SMQs:, Reproductive premalignant disorders (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)
Write-up: Initial and follow-up information have been received from a nurse for the Pregnancy Registry for GARDASIL vaccine (yeast) concerning a 17 year old white female with allergic reaction to CECLOR and a history of one previous pregnancy, one elective termination and no full-term deliveries who on 08-JAN-2008 was vaccinated with GARDASIL vaccine (yeast) (Lot # 659439/1267U) and is pregnant. The patient had a pap test on 04-MAR-2008 that revealed atypical squamous cell of undetermined significance (ASCUS). An ultrasound test was performed on 12-MAR-2008 to established pregnancy due date of 15-SEP-2008. A colposcopy was performed on 18-APR-2008 and a biopsy from 30-APR-2008 provided a diagnosis of cervical intraepithelial neoplasia 1 (CIN 1). An ultrasound test was performed on 07-JUL-2008 and revealed an estimated fetal weight of 3 pounds and a fetal measurement of 28-30 weeks. A repeat pap test was performed on 21-JUL-2008 that revealed ASCUS. Pregnancy was reported as normal to date. Additional information has been requested.

VAERS ID:326778 (history)  Vaccinated:2008-08-01
Age:17.0  Onset:2008-08-02, Days after vaccination: 1
Gender:Female  Submitted:2008-09-15, Days after onset: 44
Location:Unknown  Entered:2008-09-17, Days after submission: 2
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: WAES0808USA01331
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0229X IMUN
Administered by: Other     Purchased by: Other
Symptoms: Myalgia, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician assistant concerning a 17 year old female who on 01-AUG-2008 was vaccinated with GARDASIL vaccine (yeast) intramuscularly (site unspecified) (Lot #: 660612/0229X). On 02-AUG-2008, after receiving a dose of GARDASIL vaccine (yeast), the patient experienced fever, vomiting and muscle aches. Fever, vomiting and muscle aches lasted 24 to 48 hours. Subsequently, on 07-AUG-2008, the patient recovered from fever, vomiting and muscle aches. It was not specified whether the patient sought medical attention. Additional information has been requested.

VAERS ID:326800 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-15
Location:Pennsylvania  Entered:2008-09-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA01658
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 17 year old female who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient developed pre-syncopal episodes were unspecified. The patient was referred to a neurologist. Additional information has been requested.

VAERS ID:326907 (history)  Vaccinated:2008-08-06
Age:17.0  Onset:2008-08-09, Days after vaccination: 3
Gender:Female  Submitted:2008-09-15, Days after onset: 37
Location:New Jersey  Entered:2008-09-17, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA01903
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Local swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Information has been received from a certified medical assistant concerning a 17 year old female with no pertinent medical history and no known drug reactions/allergies who on 06-AUG-2008 was vaccinated with a dose of GARDASIL and a dose of VARIVAX (Merck). there was no concomitant medication. On 09-AUG-2008 the patient experienced a swollen feeling in her neck and difficulty breathing. Subsequently the patient recovered from swollen feeling in her neck and difficulty breathing. At the time of the nurse report. The patient''s medical chart was not available. The patient sought medical attention at the emergency room. Additional information has been requested.

VAERS ID:326909 (history)  Vaccinated:2008-08-11
Age:17.0  Onset:2008-08-11, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 35
Location:Unknown  Entered:2008-09-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA01949
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Device leakage, Pain in extremity, Underdose
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from registered nurse (R.N.) concerning a 17 year old female who on 11-AUG-2008 was vaccinated with a dose of GARDASIL. On 11-AUG-2008, when administering GARDASIL, a small account of GARDASIL leaked out from the hub. The nurse reported that the patient had no problems other than reporting a "sore arm". The outcome of the patient was not reported. additional information has been requested.

VAERS ID:326924 (history)  Vaccinated:2008-07-16
Age:17.0  Onset:2008-07-16, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 61
Location:Washington  Entered:2008-09-17, 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: DEPO-PROVERA
Current Illness:
Preexisting Conditions: Convulsion
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA02159
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.660557/0072X0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Head injury, 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: Information has been received from a physician, concerning a 17 year old female patient with a history of seizures up until 8 years old, who on 16-JUL-2008 was vaccinate with the first dose of GARDASIL (lot # 660557/0072X). Concomitant therapy included DEPO-PROVERA two days before GARDASIL. On 16-JUL-2008, the patient experienced fainting 15 minutes later after vaccination. The patient hit her head when she fainted. The patient recovered on an unspecified date. Th patient sought medical attention. There was no product quality complaint. Additional information is expected.

VAERS ID:327064 (history)  Vaccinated:2008-04-07
Age:17.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 161
Location:California  Entered:2008-09-17, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0808USA02854
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Dizziness, Nausea, Palpitations, Pyrexia, Vaccine positive rechallenge
SMQs:, 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)
Write-up: Information has been received from a physician concerning a 17 year old female, who on 06-FEB-2008 was vaccinated with the first dose of GARDASIL (lot# 654488/1264U). On 07-APR-2008, the patient was vaccinated with the second dose of GARDASIL (lot# 659655/1486U). After receiving the first and second dose of GARDASIL, the patient experienced dizziness, nausea and heart palpitations. The patient also experienced fever after the second dose. The patient''s symptoms started the same vaccination days. The AE symptoms began in the physician''s office and unspecified medical attention was sought. Follow-up information was received which reported that the patient recovered from dizziness, nausea, heart palpitations, chills and fever the same date that the adverse events started. The patient also experienced a Fever on 06-FEB-2008. Also, chills and fever were reported in one occasion all day long. No further information is available.

VAERS ID:327077 (history)  Vaccinated:2007-09-20
Age:17.0  Onset:2007-09-20, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 361
Location:Indiana  Entered:2008-09-17, 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: BENZACLIN; SUMYCIN
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0808USA03594
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.657868/0523U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Syncope, Vertigo
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), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received form a licensed practical nurse (L.P.N.) concerning a 17 year old female with no pertinent medical history or no known drug allergies who on 20-SEP-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 657868/0523U), on 04-JAN-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot # 659439/1267U) and on 20-JUN-2008 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL ( lot # 660393/0067X). Concomitant therapy included BENZACLIN, SUMYCIN, MENACTRA (20-JUN-2008). On 20-SEP-2007 the patient experienced syncope. The patient had also experienced intermittent vertigo and nausea since May 2008. The patient''s syncope and intermittent vertigo and nausea persisted. Medical attention was sought via office visit. No product quality complaint was involved. Additional information has been requested.

VAERS ID:327081 (history)  Vaccinated:2008-06-06
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-15
Location:Ohio  Entered:2008-09-17, 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: None
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic laboratory, STD panel; serum prostatic acid
CDC Split Type: WAES0808USA02785
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Laboratory test, Myalgia, Pyrexia, Smear cervix
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 17 year old female with PENICILLIN allergy and no other pertinent medical history who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM (lot# 660389/1968U). There was no concomitant medication. Subsequently the patient experienced myalgas and fever that lasted for three days after receiving the first dose. STD panel routine PAP were performed. On an unspecified date, the patient recovered from myalgas and fever. The patient sought medical attention seen by the practice. Additional information has been requested.

VAERS ID:327082 (history)  Vaccinated:2008-08-14
Age:17.0  Onset:2008-08-14, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 32
Location:Unknown  Entered:2008-09-17, 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: SEASONIQUE
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0808USA02789
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 17 year old female with asthma and no known drug allergies/reactions who on an unspecified date was vaccinated with the first dose GARADSIL and on 14-AUG-2008 was vaccinated with the second dose of GARDASIL (Lot No. 659184/0843X). Concomitant therapy included SEASONIQUE. On 14-AUG-2008 the patient developed dizziness and nausea immediately after administration and throughout the evening. Patient has not responded back to the office''s attempt to follow-up. Patient sought medical attention, at the office. Additional information has been requested.

VAERS ID:327087 (history)  Vaccinated:2008-04-01
Age:17.0  Onset:2008-04-01, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 167
Location:Kentucky  Entered:2008-09-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: colposcopy, 07/??/08; Pap test, 07/??/08, abnormal
CDC Split Type: WAES0808USA02805
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cervical dysplasia, Colposcopy, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from two medical assistants concerning a 17 year old female who in July 2007, was vaccinated with the first dose of GARDASIL. In November 2007, the patient was vaccinated with the second dose of GARDASIL. In April 2008, the patient was vaccinated with the third dose of GARDASIL. The medical assistants reported that the patient came back to the office in July 2008 for her annual checkup and had "abnormal pap atypical squamous cells of undetermined significance". The patient also had a colposcopy. The outcome was unknown. The patient saw the physician to seek unspecified medical attention. Additional information has been requested.

VAERS ID:327090 (history)  Vaccinated:2008-08-15
Age:17.0  Onset:2008-08-15, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 31
Location:Connecticut  Entered:2008-09-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA02821
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose, 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: Information has been received from a health professional, concerning a 17 year old female patient who on 15-AUG-2008 was vaccinated with 0.5 mL dose of GARDISIL IM. On 15-AUG-2008, the patient "passed out as she was walking out of the room". On the same date, the patient recovered. Glucose test was performed and the result was not provided. The patient did seek medical attention. There was no product quality complaint. Additional information is expected.

VAERS ID:327151 (history)  Vaccinated:2008-04-16
Age:17.0  Onset:2008-04-16, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 152
Location:Michigan  Entered:2008-09-17, 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: Unknown
Current Illness: Infectious mononucleosis; Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: free serum thyroxine, 07/31/08, 1.1 ng/dL; serum TSH, 07/31/08, 0.30 uIU/m, abnormal: low; WBC count, 07/31/08, 4.8 bil/L; red blood cell count, 07/31/08, 5.30 tril/, abnormal: high; hemoglobin, 07/31/08, 13.5 g/dL; hematocrit, 07/31/08, 42
CDC Split Type: WAES0808USA03998
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Alanine aminotransferase increased, Alopecia, Aphthous stomatitis, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood thyroid stimulating hormone decreased, Contusion, Globulins increased, Granulocyte count increased, Hyperhidrosis, Liver function test abnormal, Malaise, Mean cell volume decreased, Neutrophil count decreased, Pain, Protein total increased, Red blood cell count increased, Red cell distribution width increased, Syncope, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (narrow), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a office manager, concerning an 17 year old female patient with mononucleosis diagnosed in the beginning of April 2008. On 14-APR-2008, the patient had a recheck for the mononucleosis. On 16-APR-2008, the patient was vaccinated with the first dose of GARDASIL (Lot #14870) and MENACTRA. The patient experienced feeling sick and fainted immediately after the vaccinations. The patient also experienced a lot of bruising on an unspecified arm within 24 hours of the vaccinations and her hair was falling out (unspecified date). The patient recovered on an unknown date. The patient sought medical attention in the office and called the office. There was no product quality complaint. Follow up information was received from the physician''s office and laboratory records concerning a 17 year old white female with infectious mononucleosis (recovering; last day re-checked on 14-APR-2008 and "she was ok") and an allergy to sulfa who on 16-APR-2008 was vaccinated with a first dose of GARDASIL into the right arm and with a first dose of MENACTRA (Lot # U2542AA) into the left arm. In between 16-APR-2008 and 31-JUL-2008, the patient complained about sweating, shaking, vomiting and being extremely sore all over. On 14-APR-2008 the patient underwent a hepatic panel and complete blood count which revealed an elevated liver enzymes which were noted to be "improving." (refer to lab data field). On 31-JUL-2008 the patient had a thyroid stimulating hormone and free thyroxine level and CBC. The TSH was low at 0.30 uIU/mL (nl 0.50 - 5.20) and the FT4 was normal 1.1 ng/dL (nl 0.8 - 1.8). The MCH and MCHC were low. (refer to lab fields). On 08-MAY-2008 patient developed canker sores treated with FAMVIR. On 31-JUL-2008 the patient developed hair loss (checked with Blood work) and was bruising easily. The patient had recovered on an unknown date. Additional information is expected.

VAERS ID:327152 (history)  Vaccinated:2008-08-11
Age:17.0  Onset:2008-08-15, Days after vaccination: 4
Gender:Female  Submitted:2008-09-15, Days after onset: 31
Location:Maryland  Entered:2008-09-17, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: throat culture, 08/19/08, negative
CDC Split Type: WAES0808USA04000
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Culture throat negative, Lip swelling, Lymphadenopathy, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history and no allergies who on 11-AUG-2008 was vaccinated with the first dose of GARDASIL IM 0.5 ml (lot # not reported). There was no concomitant medication. On 15-AUG-2008 the patient experienced swelling of her lips, unilateral facial swelling and swollen glands after administration of her first dose. On 19-AUG-2008 the throat culture result indicated negative. The patient''s swelling of her lips and unilateral facial swelling and swollen glands persisted. The patient sought medical attention in the office visit. Additional information has been requested.

VAERS ID:327161 (history)  Vaccinated:2007-12-07
Age:17.0  Onset:2008-08-18, Days after vaccination: 255
Gender:Female  Submitted:2008-09-15, Days after onset: 28
Location:New York  Entered:2008-09-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory, several other tests; complete blood cell;
CDC Split Type: WAES0808USA04085
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Full blood count, Hypoaesthesia, Laboratory test, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Information has been received from a nurse practitioner concerning a 17 year old female who in June 2008 (date discrepant), was vaccinated with the first dose of GARDASIL. On 07-DEC-2007 the patient vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL. On 10-AUG-2008 the patient returned to the physician''s office with numbness, tingling and weakness in her arms and fingers after receiving her third dose of GARDASIL. At the time of this report, the patient''s symptoms persisted. The physician felt that the patient''s condition was not a result of GARDASIL. Additional information has been requested.

VAERS ID:327233 (history)  Vaccinated:2008-08-18
Age:17.0  Onset:2008-08-18, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 28
Location:Indiana  Entered:2008-09-17, Days after submission: 2
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: Fear of needles
Diagnostic Lab Data: Unknown; blood pressure, 120/7
CDC Split Type: WAES0808USA04147
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U2IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IMLA
Administered by: Private     Purchased by: Public
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Syncope
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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a registered nurse concerning a 17 year old female with a fear of needles who on 20-AUG-2008 was vaccinated with the third dose of GARDASIL 0.5mg, IM. Subsequently on 20-AUG-2008 the patient fainted and fell on her head. Subsequently, the patient recovered. The patient didn''t seek medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/15/2008. Follow up information was received from the registered nurse on 23-DEC-2008: the patient was vaccinated with the third dose GARDASIL (Lot # 657617/0384U) intramuscularly in her right deltoid on 18-AUG-2008 at 10:50, and in the same day she received a dose of ADACEL (Lot # C2730AA) intramuscularly in her left deltoid at 10:46. It was reported that the patient was seated on exam table, talking post injection, did not complain, suddenly at 11:00 fell off left side of table, and landed on head, unconscious for approximately 3 to 4 minutes. No warning before fainting. At 11:10, the patient''s blood pressure was 120/72 and she also had complaint of headache. The patient was examined by the physician. She was found to have full range of motion and had no parathesia. The patient had recovered at the time of this report. No further information is available.

VAERS ID:327234 (history)  Vaccinated:2007-12-01
Age:17.0  Onset:2007-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 288
Location:California  Entered:2008-09-17, 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: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA04154
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 17 year old female patient who toward the end of 2007 was vaccinated with the first dose of GARDASIL (Lot#not reported). There were no concomitant medication. The patient fainted within few minutes after her first dose. No injuries were sustained. Additional information has been requested.

VAERS ID:327244 (history)  Vaccinated:2008-08-19
Age:17.0  Onset:2008-08-20, Days after vaccination: 1
Gender:Female  Submitted:2008-09-15, Days after onset: 26
Location:Alabama  Entered:2008-09-17, 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: Sulfonamide allergy
Diagnostic Lab Data: None
CDC Split Type: WAES0808USA04203
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a healthcare worker from a physician''s office concerning a 17 year old female with no medical history and allergic to SULFAMETHOXAZOLE (+) TRIMETHOPRIM (BACTRIM) who on 28-MAR-1996 was vaccinated with a first dose of VARICELLA (Lot# 660495/0431X) and experienced no adverse side effects. On 19-AUG-2008 the patient was vaccinated with a second dose of GARDASIL on the left arm and with a dose of FLUMIST. On 20-AUG-2008, an angioedema developed on her upper right arm where the VARICELLA was administered. At the time of reporting, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.

VAERS ID:327289 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-15
Location:Texas  Entered:2008-09-17, Days after submission: 2
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA04364
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
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 17 year old female patient who had unspecified "issues with injections" and no known allergies, who on an unknown date was vaccinated with 0.5 mL GARDASIL IM. The patient experienced fainted after receiving the dose of GARDASIL. The patient recovered on an unknown date. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is expected.

VAERS ID:327438 (history)  Vaccinated:2008-07-24
Age:17.0  Onset:2008-07-24, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 53
Location:Pennsylvania  Entered:2008-09-17, 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: ALLEGRA
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: she is anemic
CDC Split Type: WAES0808USA04985
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Fatigue, Hyperhidrosis, Malaise, Pallor
SMQs:, Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 17 year old female with no pertinent medical history or drug allergies who on 24-JUL-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 660553/0070X). Concomitant therapy included ALLEGRA. It was reported that the patient was not feeling well, looked pale, and complained of fatigue and diaphoresis when she came in to get her GARDASIL. Labs done that day after she got GARDASIL came back that she is anemic and the mom was blaming the GARDASIL. On an unspecified date, the patient recovered. The patient was seen by doctor. No product quality complaint was involved. Additional information has been requested.

VAERS ID:327457 (history)  Vaccinated:2008-08-28
Age:17.0  Onset:2008-08-28, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 18
Location:Unknown  Entered:2008-09-17, 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: LOESTRIN 24 FE
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: urine beta-human, 08/28/08, negative
CDC Split Type: WAES0808USA05351
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Urine human chorionic gonadotropin negative
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: Information has been received from a nurse concerning a 17 year old female with no pertinent medical history or drug reactions or allergies who on 28-AUG-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 659184/0843X). Concomitant therapy included LOESTRIN 24 FE. Subsequently the patient passed out when she was signing out at the front desk to leave. The patient was observed and recovered and went home. On the same day, urine pregnancy test was performed and the result was negative. Additional information has been requested.

VAERS ID:327466 (history)  Vaccinated:2008-08-12
Age:17.0  Onset:2008-08-14, Days after vaccination: 2
Gender:Female  Submitted:2008-09-15, Days after onset: 32
Location:Unknown  Entered:2008-09-17, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA00040
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Stomach discomfort
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from patient''s mother who reported that her 17 year old daughter on 12-AUG-2008 was vaccinated with GARDASIL. There was no concomitant medication. On 14-AUG-2008, two days after her daughter was vaccinated she began to have an upset stomach which has been ongoing up until now. The patient''s mother said that the stomach discomfort has been occurring approximately 15 minutes after she eats or drinks something. At the time of the report, the patient had not recovered from her upset stomach. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:327513 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-15
Location:Wisconsin  Entered:2008-09-17, Days after submission: 2
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA00064
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0  
Administered by: Other     Purchased by: Other
Symptoms: Influenza like illness, Pyrexia, Vaccine positive rechallenge
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a medical assistant concerning her 17 year old daughter who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 18 VLP vaccine (yeast). In November 2007 the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient experienced fever and flu like symptoms after both of the doses were given. The third dose has not yet given to the patient. Subsequently, the patient recovered from fever and flu like symptoms.

VAERS ID:325555 (history)  Vaccinated:2008-09-16
Age:17.0  Onset:2008-09-17, Days after vaccination: 1
Gender:Female  Submitted:2008-09-18, Days after onset: 1
Location:Colorado  Entered:2008-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin 800 mg
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB243AA1IMLL
TDAP: TDAP (ADACEL)SANOFI PASTEURC2774AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0097X1SCLA
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient called clinic to describe reaction to injection site to back of left arm. Patient describes adverse reaction began 24 hours after injection which included back of arm swelling to a golf ball size, warm to touch, painful; describes site as a "knott". R arm injction site was also swollen, but to a lesser degree. Patient states she has no fever. She state she is on a 6-day course of Augmentin 800 mg dailey for a throat cyst and started antibiotic on day of injection. Discussed monitoring for a fever, worsening symptoms, continuing antibiotic course to completion and taking tylenol or motrin for pain. Patient will call if symtpoms do not improve.

VAERS ID:325563 (history)  Vaccinated:2008-08-25
Age:17.0  Onset:2008-08-25, Days after vaccination: 0
Gender:Female  Submitted:2008-08-27, Days after onset: 2
Location:Tennessee  Entered:2008-09-18, Days after submission: 22
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: Healthy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2643AA0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Asthenia, Chills, Headache, Musculoskeletal stiffness, Pain in extremity
SMQs:, Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Started with HA & chills about 10PM after being out in weather. Had gotten home about 6PM did homework. Weak decreased HA at school next day no N/V neck stiff but not on exam. Arm sore. Mom p/u from school 10AM slept until came in to be seen 3PM.

VAERS ID:325584 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-18
Location:Unknown  Entered:2008-09-19, 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: WAES0809USA02083
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Autism
SMQs:
Write-up: Information has been received from a nurse midwife which reported that "a mother of one of her patients said she read somewhere" concerning a 17 year old female who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently the patient developed autism. It was unknown if the patient sought any medical attention. The outcome of the patient was unknown. Upon internal review, autism was determined to be an other important medical events. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information has been requested.

VAERS ID:325585 (history)  Vaccinated:2007-12-01
Age:17.0  Onset:2008-01-01, Days after vaccination: 31
Gender:Female  Submitted:2008-09-18, Days after onset: 260
Location:New York  Entered:2008-09-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA01973
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Autoimmune disorder, Headache, Malaise, Myalgia, Systemic lupus erythematosus
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (narrow), Dementia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a consumer concerning her daughter a 17 year old female who on an unspecified dates was vaccinated with the first and second doses of GARDASIL. In December 2008, the patient was vaccinated with a third dose of GARDASIL. Around January 2008, the patient developed headaches and muscle aches. She has a pending diagnosis of lupus. The patient has been in and out school due to sickness and autoimmune systems issues. Upon internal review, lupus was determined to be an other important medical event. Additional information has been requested.

VAERS ID:325590 (history)  Vaccinated:2008-03-01
Age:17.0  Onset:2008-03-01, Days after vaccination: 0
Gender:Female  Submitted:2008-09-18, Days after onset: 200
Location:Kentucky  Entered:2008-09-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory, numerous tests 1/7/09-records received-Workups for arthritis negative. Complement levels normal, rheumatoid factor normal, CRP increased.
CDC Split Type: WAES0809USA01791
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia, Arthralgia, Atrioventricular block, C-reactive protein increased, Chills, Complement factor normal, Laboratory test, Malaise, Nausea, Pyrexia, Rheumatoid factor negative, Urticaria, Weight increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Conduction defects (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history or drug reactions/allergies, who about six months ago (approximately in March 2008) was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Reporter''s daughter developed a fever, chills, nausea, hives, and became seriously ill after getting the first dose of GARDASIL. Patient has been hospitalized 4 times since then. Lab diagnostics studies performed included numerous tests. Therapy with GARDASIL was discontinued. At time of report, the patient had not recovered. Additional information has been requested. 1/7/09-records received for DOS 5/23-5/26/08-Admitted with C/O pain unable to get out of bed without any discomfort. History of polyarthralgia admitted for increased symptoms. first degree heart block. 11/2/08 C/O hair loss, weight gain.

VAERS ID:325657 (history)  Vaccinated:2008-08-07
Age:17.0  Onset:2008-08-07, Days after vaccination: 0
Gender:Male  Submitted:2008-08-12, Days after onset: 5
Location:Texas  Entered:2008-09-19, Days after submission: 38
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB431BA3IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA1IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0480X2IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2624AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B016BA5IMLA
Administered by: Public     Purchased by: Public
Symptoms: Eating disorder, Headache, Heart rate normal, Nausea, Pain, Pallor, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: 08/07/08 Client recieved vaccines, client turned pale, c/o nausea, tingling felling in fingers t 98.2, P62, B/p 98/66 called EMT monitored client 30 min. 08/12/08 called follow-up mother states pt. c/o headaches, body aches, not eating well, no fever, refer to ER.

VAERS ID:325661 (history)  Vaccinated:2008-09-04
Age:17.0  Onset:2008-09-13, Days after vaccination: 9
Gender:Female  Submitted:2008-09-19, Days after onset: 6
Location:Illinois  Entered:2008-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0245U1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Blister, Erythema, Headache, Induration, Myalgia, Rash pustular
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Erythema, Induration-approx 12mm in diameter, vesical/pustule approx 2mm in diameter, arthralgia,myalgia, headache.

VAERS ID:325685 (history)  Vaccinated:2008-09-16
Age:17.0  Onset:2008-09-16, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Massachusetts  Entered:2008-09-19
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Choking sensation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (broad)
Write-up: Received Gardasil 9/16/08 at gyn office. Reports sensation of obstruction in throat 1/2 hour after vaccine given. Seen in this office 9/18. By history, breathing and eating fine. Exam negative.

VAERS ID:325840 (history)  Vaccinated:2008-09-22
Age:17.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2008-09-23, Days after onset: 1
Location:Florida  Entered:2008-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cindamycin 300mg oral capsule 1 tab PO QID; Analapril 5mg PO daily; Vitamin D; Flovent 2 puffs inhaled; Laclulose 30ml PO BID; Asacol 800mg PO BID; Non-formula continuous infusion; Prednisone 20mg PO daily; Alampin 150mg PO daily; Alampin 3
Current Illness:
Preexisting Conditions: Primary sclerosing cholangitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791AA0UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0619X0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient received PNEUMOVAX vaccine. Arm became swollen, warm to touch, down into chest few hours after receiving injection. Went to ER around 11:00 PM.

VAERS ID:326001 (history)  Vaccinated:2007-09-08
Age:17.0  Onset:2007-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-24, Days after onset: 382
Location:Alabama  Entered:2008-09-24
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: AL0824
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB529AA1IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2567AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Chills, Feeling hot, Neck pain, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt. o.k. at Family planning appt. Immunizations below given with problems. Patient called 9/10/08 c/o joints hurting, rt.elbow, lt.knee, rt. foot & neck. Advised try advil and better that pm to 9/11/08 am. Pt. states thinks had fever night of 9/08/08 some shivers but none since. Better today 9/11/08

VAERS ID:326404 (history)  Vaccinated:2008-09-20
Age:17.0  Onset:2008-09-20, Days after vaccination: 0
Gender:Male  Submitted:2008-09-22, Days after onset: 2
Location:California  Entered:2008-09-29, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2662AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA6IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0443X1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient complained of swelling in area afternoon after shot. Some itching. Pink area 7 cm x 5.5 x cm with dark, red area in center 3 cm x 3 cm.

VAERS ID:326519 (history)  Vaccinated:2007-01-24
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-29
Location:Louisiana  Entered:2008-09-30, 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: vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = unknown)
Preexisting Conditions:
Diagnostic Lab Data: Beta-human chorionic
CDC Split Type: WAES0708USA03487
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Cephalo-pelvic disproportion, Culture negative, Delayed delivery, Drug exposure during pregnancy, Laboratory test normal, Pregnancy test, Umbilical cord around neck
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Information has been received for Pregnancy Registry for GARDASIL from a consumer''s mother concerning her 18 year old daughter with no medical history who on 24-JAN-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included HEP B (unspecified) and Vitamins (Prenatal DHA). The reporter mentioned that "her daughter received her first injection and found out that she was pregnant 2-3 weeks later." No adverse event reported. It was reported that she had a pregnancy test done. On 27-SEP-2007, the patient delivered a normal, healthy female baby weighing 7 lbs and 6 oz, length 20, apgar score 8/9, head circumference not reported. No congenital anomalies. Complications during pregnancy or labor/delivery included Nuchal cord x 1 and cephalopelvis disproportion (1 CTC/S) failure to progress. Diagnostic test during pregnancy included routine Quad screen, routine labs, culture and biophysical all within normal limits. Upon internal review cephalopelvis disproportion and failure to progress were considered to be an other important medical event. No further information is available.

VAERS ID:326532 (history)  Vaccinated:2008-09-17
Age:17.0  Onset:2008-09-19, Days after vaccination: 2
Gender:Female  Submitted:2008-09-23, Days after onset: 4
Location:Indiana  Entered:2008-09-30, 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: Ortho-cept
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.0955F0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2620AA0UNRA
Administered by: Public     Purchased by: Public
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Marked pain involving entire upper arm where injection was given, swelling and warmth. Patient unable to lift her arm due to pain. Subjective fevers. All occurred within 1-2 hours after vaccines and worsened over 36 hours. Managed with acetaminophen and Ibuprofen.

VAERS ID:326536 (history)  Vaccinated:2008-07-31
Age:17.0  Onset:2008-07-31, Days after vaccination: 0
Gender:Female  Submitted:2008-08-14, Days after onset: 14
Location:California  Entered:2008-09-30, Days after submission: 47
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: pregnancy dx after immunizations.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.U928U IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2571AA IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Fall, Head injury, Lip swelling, Syncope, Tooth fracture
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Pt fainted after receiving 3 vaccines, TDAP MENACTRA and HPV #1. Pt. refused to lay down or to hold moms hand. She fainted after 5-8 seconds after vaccines were given. Fell hit her forehead, lip was swollen and chipped her tooth was discharged and reviewed by dr at office.

VAERS ID:326660 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-30
Location:Unknown  Entered:2008-10-01, 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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA04359
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cardiac monitoring, Convulsion, Electroencephalogram, Loss of consciousness, Postural orthostatic tachycardia syndrome
SMQs:, Torsade de pointes/QT prolongation (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a registered nurse concerning her niece, a 17 year old female who about 2 years ago, in approximately 2006 was vaccinated with GARDASIL. It was reported that the patient had had seizure activity and had passed out since vaccination with GARDASIL. The niece had completed the GARDASIL series. The niece had been to the Emergency Room and may had been admitted to the hospital. She have been diagnosed with POTS syndrome (Postural Orthostatic Tachycardia Syndrome) . On unspecified dates, numerous tests including EEG and heart monitoring had been performed (no results reported). The patient had been seen by many doctors. At the time of the report, the patient had not recovered. Upon internal review, seizure activity was considered to be an other important medical event. Additional information has been requested.

VAERS ID:326661 (history)  Vaccinated:2008-02-20
Age:17.0  Onset:2008-09-04, Days after vaccination: 197
Gender:Female  Submitted:2008-09-30, Days after onset: 26
Location:Ohio  Entered:2008-10-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown 9/9/08-records received-Oral contraception. Xanax for stress and anxiety.
Current Illness:
Preexisting Conditions: Unknown 9/9/08-records received-PMH: some congenital heart valve anomaly.
Diagnostic Lab Data: Unknown 10/9/08-records received-Echo unremarkable. CT scan of head and neck negative. Toxicology screen positive for bezos. Prolactin level elevated. EEG showed presence of generalized potentially epileptogenic discharges some associated
CDC Split Type: WAES0809USA04227
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1427F2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood prolactin increased, Computerised tomogram normal, Convulsion, Depression, Drug dependence, Echocardiogram normal, Electroencephalogram abnormal, Fall, Hallucination, Myoclonic epilepsy, Myoclonus, Physical examination normal, Postictal state, Skin laceration, Suture insertion, Syncope, Tachycardia, Toxicologic test abnormal
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), Drug abuse and dependence (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a female who was vaccinated with the third dose of GARDASIL 0.5 mL, IM. About one month after that vaccination, the patient developed syncope and had a seizure. The patient sought unspecified medical attention. Upon internal review, seizure was considered to be other important medical event. Additional information has been requested. 10/09/08-records received for DOS 9/2-9/4/08-DC DX: Seizure and or syncope. Laceration and suture repair to forehead. Tachycardia. Drug dependence. Presented to ED status post syncopal episode followed by seizure activity on 9/2/08. Noted to have bit tongue and was postictal after event. Orthostatics negative. 10/14/08-records received-date of 1st HPV4 vaccine 3/15/07-lot#1427F left arm, 2nd HPV4 6/1/07-Lot#0702F left arm. 2/20/08-C/O back problems and shoulder pain. HPV4 #3 lot#1427F right arm. Seen on 5/9/08-C/O depressed tried using parent''s Prozac. Hallucinating in school. 9/10/08-new seizure meds making her sick, no appetite, nausea. 9/13/08-S/P seizure activity, injury to head. Stress. Neuro consult 9/22/08-uncertain as to whether the seizure caused the incident or the fall. PE: normal.

VAERS ID:326681 (history)  Vaccinated:2008-09-29
Age:17.0  Onset:2008-09-30, Days after vaccination: 1
Gender:Female  Submitted:2008-10-01, Days after onset: 1
Location:Georgia  Entered:2008-10-01
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: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.MSD0571X1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURPMCU2689AA1IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.MER0975L2SCRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: SCHOOL NURSE CALLED CLINIC THIS AM, 10-01-08. NURSE STATES PT C/O TENDERNESS IN RA. SCHOOL NURSE DESCRIBES REDNESS AND SWELLING NOTED. SCHOOL NURSE STATES SHE HAS ADMINISTERED ACETAMINOPHEN AND HAS APPLIED AN ICE PACK.

VAERS ID:326692 (history)  Vaccinated:2008-10-01
Age:17.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-01, Days after onset: 0
Location:California  Entered:2008-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URINARY TRACT INFECTION
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB519AA1IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB247AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U1IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: WITHIN 2 MINS OF INJECTIONS ADMINISTERED PT FELT FAINT, AND VOMITTED B/P WAS CHECKED 80/40. 10 MINS LATER B/P WAS CHECKED 91/71 PATIENT WALKED OUT, NO PROBLEMS

VAERS ID:326694 (history)  Vaccinated:2008-09-30
Age:17.0  Onset:2008-09-30, Days after vaccination: 0
Gender:Female  Submitted:2008-10-01, Days after onset: 1
Location:California  Entered:2008-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling2|none~ ()~NULL~~In Sibling1
Other Medications: none
Current Illness: none
Preexisting Conditions: Seasonal allergies to cats, dust. No other medical history
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.Q650X IM 
Administered by: Private     Purchased by: Private
Symptoms: Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: 2 hours after vaccine administered, patient turned "ghostly white" per her mother and started vomiting. She had multiple episodes of vomiting for the next 6 hours. No diarrhea or fevers to suggest a viral illness.

VAERS ID:326888 (history)  Vaccinated:2008-09-25
Age:17.0  Onset:2008-09-26, Days after vaccination: 1
Gender:Female  Submitted:2008-10-02, Days after onset: 6
Location:Illinois  Entered:2008-10-02
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1000X0IMRA
Administered by: Private     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: Swelling and redness at injection site - right arm for 4 days, No treatment given

VAERS ID:326953 (history)  Vaccinated:2008-07-07
Age:17.0  Onset:2008-07-07, Days after vaccination: 0
Gender:Female  Submitted:2008-09-28, Days after onset: 83
Location:Unknown  Entered:2008-10-03, Days after submission: 5
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: My daughter never had any health problems before the GARDASIL shot. I took her to the OB/GYN to get her on birth control pills hoping it would shorten her period. The doctor put her on YAZ and that seem to work just fine until we decided a few months later to get this shot. PMH: none. on Yaz
Diagnostic Lab Data: EKG, 9/15/08; Urine test, 7/7/08, 8/11/08, 9/15/08; Doctor exam, 7/7/08, 8/11/08, & 9/15/08; Ultrasound, 9/15/08
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal pain lower, Abdominal pain upper, Activities of daily living impaired, Anorexia, Anxiety, Arthralgia, Arthropathy, Chest pain, Chills, Depression, Dyspepsia, Ear pain, Electrocardiogram, Erythema, Eye pain, Fatigue, Gastrooesophageal reflux disease, Headache, Immunisation reaction, Influenza like illness, Joint stiffness, Joint swelling, Leukoplakia oesophageal, Malaise, Menstruation irregular, Myalgia, Nasal congestion, Nausea, Oral intake reduced, Oropharyngeal pain, Ovarian cyst, Pain in extremity, Pelvic pain, Pyrexia, Rhinorrhoea, Sinusitis, Sleep disorder, Ultrasound scan, Urine analysis, Vomiting, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal premalignant disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Fertility disorders (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: My daughter had the first GARDASIL shot on 7/7/08. 7 to 10 days later she began having severe pains and cramping in her pelvic area along with redness, fever, vomiting, and joint pains. Her doctor said it was just a reaction to the shot and after examining her told her to go home and take TYLENOL for headaches, pains, etc because she was the first case he had seen this severe and didn''t know what to do other than to examine her once a month. Every week she has experienced severe joint pains, cramps, not feeling well enough to eat, etc. She lost 10 lbs. Since she is 17 years old and only weighed 105 lbs that didn''t set well with me. She is naturally skinny. The gynecologist still doesn''t know what to do with my daughter''s pains. He did an EKG, ultrasound, urine test and they all came back ok. The ultrasound showed an enlarged cyst on one of her ovaries. This is getting ridiculous in the fact that she can no longer lead a normal life due to weekly pains and not feeling well. Isn''t there anything she can take to reverse the medicine''s side effects as I see this as being a lifetime adventure for her. PLEASE ADVISE on what I as a parent can do next. I feel this is all the medicine''s fault because my daughter Never had anything wrong with her until after having this shot. I don''t like reading all the articles about this shot and seeing that the company tries to blame every day life events or happenings for causing the bad things to happen to these girls. It is definitely the GARDASIL Shot that has caused the adverse health of these young girls having problems. 12/29/2008 PCP records received for several OVs between 9/29/08 and 11/10/2008. Pt initially presented with c/o painful joints, cramping chest pain. ROS (+) for fever, chills, fatigue, 10 lb weight loss, abdominal pain, nausea, vomiting, H/A, eye pain, ear pain, sore throat, congestion, runny nose and Flu-like sx since Gardasil vax in July. Pt also reports sleep disturbance, joint pain and swelling, morning stiffness, myalgias, anxiety and depres

VAERS ID:326964 (history)  Vaccinated:2008-09-19
Age:17.0  Onset:2008-09-19, Days after vaccination: 0
Gender:Female  Submitted:2008-09-27, Days after onset: 8
Location:Indiana  Entered:2008-10-03, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0571X2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Rash, Swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Pt was dizzy and nauseous on 9-19 after receiving shot on 9-19. On 9-20 Pt woke with a swollen face and body with a rash on her arms and legs. Pt was given an IV with steroids, BENADRYL and PEPCID to counteract the reaction. PREDNISONE was prescribed for home use.

VAERS ID:326989 (history)  Vaccinated:2008-10-01
Age:17.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-10-03, Days after onset: 1
Location:North Carolina  Entered:2008-10-03
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.0279X1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURUF452CA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Right arm swollen, hot to touch, erythema and itching starting 22 hours after injection.

VAERS ID:327101 (history)  Vaccinated:2008-08-25
Age:17.0  Onset:2008-08-25, Days after vaccination: 0
Gender:Female  Submitted:2008-10-02, Days after onset: 38
Location:California  Entered:2008-10-06, 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: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA04534
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Drug exposure during pregnancy, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received through the Merck pregnancy registry for GARDASIL from staff member at a physician''s office (not the office that vaccinated) concerning her close friend a 17 year old female patient who on approximately 25-AUG-2008, one month ago, was vaccinated with the first dose of GARDASIL. On approximately 25-AUG-2008, after receiving the vaccine, the patient fainted, had a seizure and had headaches. The patient is pregnant. Date of last menstrual period was not reported. On an unknown date, the patient recovered from fainted and seizure. The patient sought medical attention at physician''s office. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.

VAERS ID:327343 (history)  Vaccinated:2008-09-22
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-22
Location:Alaska  Entered:2008-10-07, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2658AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0789X0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Large, swollen, red area on left posterior upper arm. 8 x 6.5cm. First day after vaccine was swollen. Next day was larger after being seen and taking Benadryl area was not swollen anymore. Swelling resolved on 3rd day.

VAERS ID:327406 (history)  Vaccinated:2008-09-30
Age:17.0  Onset:2008-10-01, Days after vaccination: 1
Gender:Male  Submitted:2008-10-02, Days after onset: 1
Location:Oregon  Entered:2008-10-07, 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: Trazodane 50mg
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB238AA1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2617AA0IMRA
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site swelling, Skin warm
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right upper arm with increased warmth and approximately 5 inches of swelling surrounding injection site. Denies pain. Advised to apply warm packs and take Ibuprofen.

VAERS ID:327578 (history)  Vaccinated:2008-10-06
Age:17.0  Onset:2008-10-07, Days after vaccination: 1
Gender:Male  Submitted:2008-10-08, Days after onset: 1
Location:Ohio  Entered:2008-10-08
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
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0570U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2621AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Flushing, Headache, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Severe headache/pressure, facial flushing, pain to (R) arm-resolved gradually over 24 hrs.

VAERS ID:328470 (history)  Vaccinated:2008-10-14
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-14
Location:Minnesota  Entered:2008-10-14
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: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2811AA4IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB294BA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Pt. received two 0.5cc FLUZONE lot#U2811AA

VAERS ID:328740 (history)  Vaccinated:2008-08-19
Age:17.0  Onset:2008-08-19, Days after vaccination: 0
Gender:Female  Submitted:2008-10-08, Days after onset: 50
Location:California  Entered:2008-10-15, 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: Unknown
Current Illness: Nervousness
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA00234
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from other health professional concerning a 17 year old Hispanic female with no known medical condition or illness at time of vaccination, who on 19-AUG-2008, at 10:30, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot #659655/1486U) via intramuscular on her right deltoid and varicella virus vaccine live (Oka/Merck) (MSD) via subcutaneous on her left deltoid. On 19-AUG-2008, at 10:30 the patient felt light headed, looked pale and fainted right after shots given. The patient recovered a few seconds after. The patient was monitored for half an hour. The patient stated that she was nervous prior vaccine administration and did not eat in the morning. Laboratory test were not performed. No further information is available.

VAERS ID:328848 (history)  Vaccinated:2008-07-29
Age:17.0  Onset:2008-08-12, Days after vaccination: 14
Gender:Female  Submitted:2008-10-08, Days after onset: 57
Location:Unknown  Entered:2008-10-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGEN
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: chest x-ray, negative; pulmonary function tests, normal; Lyme disease assay, negative
CDC Split Type: WAES0809USA00487
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Borrelia burgdorferi serology negative, Chest X-ray normal, Cough, Dyspnoea, Lip swelling, Oedema peripheral, Pulmonary function test normal, Rash pruritic
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 17 year old white female who at 9 am on 29-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 660557/0072X) 0.5 ml IM in her left deltoid. Concomitant therapy included (DESOGEN). At 8 am on 12-AUG-2008 (also reported as 13 to 14th August) the patient noted a pruritic rash beginning on her trunk and extending down her legs and arms. Within 24 hours, her plantar surfaces were swollen and she developed a pruritic rash. Then the patient developed swollen lips and a dry cough with shortness of breath within 48 hours. The patient was prescribed 3 weeks course of Prednisone oral, an unspecified "antihistamine" and an Albuterol inhaler. The patient had a chest x-ray on an unspecified date which was negative. A pulmonary function test was performed on an unspecified date with a normal result. A Lyme disease enzyme-linked immunosorbent assay for "pulmonary edema" and her events were confirmed as an allergic reaction. The patient was recovered from the allergic reaction. The patient sought medical attention in the office. Additional information is not expected.

VAERS ID:328897 (history)  Vaccinated:2008-08-04
Age:17.0  Onset:2008-08-04, Days after vaccination: 0
Gender:Female  Submitted:2008-10-08, Days after onset: 65
Location:Indiana  Entered:2008-10-15, 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:
Current Illness: allergic reaction to antibiotics
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA01204
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL. Subsequently, the patient experienced vomiting and nausea. Subsequently, the patient recovered from vomiting and nausea. No product quality complaint was involved. Additional information has been requested. This is in follow-up information to report (s) previously submitted on 10/8/2008. Follow-up information on 23-DEC-2008 was received from an other health professional who reported that on 04-AUG-2008, the 17 year old student with allergic reaction to CECLOR and no illness at the time of vaccination was vaccinated with the first dose of GARDASIL vaccine into the left deltoid (lot # 659962/1740U). Immediately after injection, the patient became pale, clammy and nauseated. The patient did have small anti of emesis. The patient''s grandmother took her in and had her lay down. When the patient awoke, symptoms resolved. The patient was very anxious about having vaccine. Additional information is not expected.

VAERS ID:328617 (history)  Vaccinated:2008-09-02
Age:17.0  Onset:2008-09-03, Days after vaccination: 1
Gender:Female  Submitted:2008-10-16, Days after onset: 43
Location:California  Entered:2008-10-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Normal: CT abdomen/pelvis, abdominal ultrasound, esophagogastroduodenoscopy, serum amylase, CBC, H. pylori antibody, pregnancy test, comprehensive metabolic panel (except for low potassium due to the vomiting) 10/27/08-records received-Uri
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB238AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2658AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Blood amylase, Blood potassium decreased, Computerised tomogram normal, Dehydration, Dysuria, Full blood count normal, Helicobacter pylori identification test negative, Hypertension, Hypokalaemia, Metabolic function test, Nausea, Oesophagogastroduodenoscopy, Pollakiuria, Pregnancy test negative, Protein urine present, Pyelonephritis, Red blood cells urine positive, Ultrasound abdomen normal, Urine analysis abnormal, Urine bilirubin increased, Urine ketone body present, Urine leukocyte esterase positive, Vomiting, White blood cells urine positive
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: Patient developed intractable vomiting within 72 hours of vaccine administration resulting in dehydration and hypokalemia. Patient also developed hypertension. Symptoms lasted approximately 3-1/2 weeks. 10/27/08-records received for DOS 9/6/08-presented to ED with C/O vomiting times 3 days with abdominal pain (LUQ) and persistent nausea. Slight dysuria and frequency. DX: left pyelonephritis with abdominal pain and vomiting.

VAERS ID:328938 (history)  Vaccinated:2008-09-17
Age:17.0  Onset:2008-09-22, Days after vaccination: 5
Gender:Female  Submitted:2008-10-08, Days after onset: 16
Location:Pennsylvania  Entered:2008-10-17, Days after submission: 9
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.0843X0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR2685AA0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: All over hive type body rash 5 days after vaccinations. Benadryl OTC prn.

VAERS ID:328955 (history)  Vaccinated:2008-10-06
Age:17.0  Onset:2008-10-06, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:North Carolina  Entered:2008-10-17
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB140AA0IMUN
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: gave patient TWINRIX before age 18

VAERS ID:329273 (history)  Vaccinated:2008-01-07
Age:17.0  Onset:2008-01-07, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 280
Location:Unknown  Entered:2008-10-17, 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 = unknown)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 05/29/08, normal; beta-human chorionic, positive; serum alpha-fetoprotein, 03/05/08, negative
CDC Split Type: WAES0801USA04540
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Chlamydial infection, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan normal
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 from a mother and a licensed practical nurse for the Merck Pregnancy Registry for GARDASIL concerning her 17 year old daughter with no previous pregnancies who on approximately 07-JAN-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL. The mother was calling to report that her daughter was pregnant after receiving the vaccine. Therapy was discontinued. The patient''s mother reported that "they had no physician information because they have not found an OB/GYN in their area." The patient''s mother advised that "once a doctor has been found they would call with the information." Medical attention was not sought. The patient''s mother requested prescribing information. No product quality complaint was involved. On 29-JAN-2008 the patient was placed on therapy with ZITHROMAX (250mg once) for the treatment of chlamydia. Other medications taken during pregnancy included ZOFRAN and pre-natal vitamins. On 29-MAY-2008, the ultrasound was performed for rule out abruption and the result was normal. On 05-MAR-2008 the serum alpha fetoprotein test was performed as routine screen with negative result. On 09-AUG-2008 the patient delivered a normal female baby weighing 7 pounds 6 ounces at 38.5 weeks. There were no complications during pregnancy and labor/delivery. There were no congenital anomalies, other complications or abnormalities. Additional information has been requested.

VAERS ID:329511 (history)  Vaccinated:2008-05-13
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-14
Location:Florida  Entered:2008-10-17, 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: blood work and ruled out mononucleosis
CDC Split Type: WAES0809USA02400
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Infectious mononucleosis, Lymphadenopathy
SMQs:
Write-up: Information has been received from a physician concerning an 18 year old female who in May 2008, was vaccinated with her first dose of GARDASIL 0.5 mL, IM. In approximately May 2008, after receiving the vaccination, the patient experienced lymphadenopathy. The patient called the physician in August 2008, about 10 days before her schedule appointment to say her lymph nodes were swollen. The physician said to wait the 10 days and then come in for her second dose. She come in 10 days after her call but was still sick so the second dose was not given. The physician "ran a bunch of testing, including bloodwork, and ruled out mononucleosis." Patient came on 02-SEP-2008 for a follow-up, but the physician still has to send her for a biopsy. Additional information has been requested. On 03-Nov-2008, Dr reported that the patient was seen by Infectious Disease specialist, and was diagnosed with mononucleosis. The patient''s status was reported as recovered.

VAERS ID:329577 (history)  Vaccinated:2008-09-02
Age:17.0  Onset:2008-09-02, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 42
Location:Pennsylvania  Entered:2008-10-17, 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: WAES0809USA01660
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Urinary tract infection
SMQs:
Write-up: Information has been received from a physician concerning a 17 year old female patient, who one week ago (approximately 02-SEP-2008) was vaccinated with the second dose of 0.5 mL GARDASIL (Lot # not reported). One week ago (approximately 02-SEP-2008), the patient experienced urinary tract infection after receiving the second dose of GARDASIL. The patient sought medical attention, seen by the physician. There was no product quality complaint. Additional information is expected.

VAERS ID:329601 (history)  Vaccinated:2008-02-13
Age:17.0  Onset:2008-02-13, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 243
Location:Pennsylvania  Entered:2008-10-17, 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: MENACTRA
Current Illness: Drug Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA01827
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injection site nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a emergency medical technician and a patient''s mother concerning an 18 year old female with KEFLEX allergy who on 24-SEP-2007 (previously reported as "6 months ago") was vaccinated with the first dose of GARDASIL (lot# 658558/1061U). On 13-FEB-2008, she was vaccinated with a second dose of GARDASIL (lot # 659439/1267U). On 19-AUG-2008 (previously reported as "week of 11-AUG-2008") the patient was vaccinated with a third dose of GARDASIL (lot #660612/0229X), 0.5, I.M. Shortly, after receiving her third dose, on 19-AUG-2008, the patient experienced a 30 mm nodule at the injection site (previously reported as a lump at the injection site, the size of a "half dollar"). The patient sought medical attention calling the practice. The nodule persisted for 7-10 days, then resolved. The nodule returned at the same area in September 2008. At the time of reporting, the patient had not recovered from the nodule at the injection site. Additional information has been requested.

VAERS ID:329679 (history)  Vaccinated:2008-07-28
Age:17.0  Onset:2008-09-07, Days after vaccination: 41
Gender:Female  Submitted:2008-10-14, Days after onset: 37
Location:Pennsylvania  Entered:2008-10-17, 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: Penicillin allergy; Drug hypersensitivity
Preexisting Conditions: PMH: anorexia/bulimia, weight loss, irregular periods, nephrolithiasis, pyelonephritis, allergic rhinitis, eczema, rhinoplasty for nasal septal deviation s/p fracture, MVA w/back & hip pain. Allergy: PCN, ceclor, amoxicillin(rash). Family hx: migraine HAs.
Diagnostic Lab Data: Chest X-ray; blood tests LABS: CBC & CMP WNL.
CDC Split Type: WAES0809USA02113
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2657AA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Arthralgia, Blood test, Chest X-ray, Condition aggravated, Cough, Eczema, Fatigue, Full blood count normal, Joint swelling, Malaise, Metabolic function test normal, Migraine, Nausea, Phonophobia, Photophobia, Pyrexia, Rash, Urinary tract infection, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a licensed practical nurse concerning a 17 year old female with penicillin allergy and drug hypersensitivity to CECLOR who on 28-JUL-2008 was vaccinated with the first dose of GARDASIL (lot # 660553/0070X). Concomitant therapy included MENACTRA. "A couple weeks ago" the patient developed swollen ankles, rash on her legs and arms and night time fevers after her first dose of GARDASIL. Her ankles were swollen to the size of grapefruit. She also had an unproductive cough for 2 weeks and general malaise. The patient was seen in the office. At the time of reporting a chest X-ray and a blood tests were performed but results were pending. At the time of reporting the patient had not recovered from swollen ankles, rash on her legs and arms and night time fevers. Additional information has been requested. 3/27/09 Received PCP vaccine & medical records of 12/21/2006-2/26/2009. FINAL DX: none provided Records reveal paitent experienced general good health on 7/28/08 & also received MCV4 same day. Ongoing psych counseling for eating disorder. RTC 9/11/08 for rash, fever, cough x 2 wk, bilateral ankle swelling w/pain x 4 days, eczema flareup & fatigue. RTC 1/12/09 w/intermittent abdominal pain. Dx w/UTI & tx w/antibiotics. RTC 2/26/09 w/migraine HA x 4 days w/phonophobia, photophobia, N/V & had missed school. Tx w/meds. This is in follow-up to report (s) previously submitted on 10/14/2008. Follow up information was received on 23-Dec-2008, patient weights 141 pounds and is 5 feet 11 inches tall. GARDASIL (lot # 660551/0070X) was received on the left deltoid at 3:00 pm. On 07-Sep-2008 patietn experienced fatigue, ankle pain, swelling and joint arthralgias. Follow-up information received on 18-Feb-2009 from a liscensed practical nurse who reported that it was determined by the doctor that the patient''s symptoms were not related to GARDASIL but rather were a result of other medical condition. GARDASIL is not considered to be suspect. No futher information is available.

VAERS ID:329690 (history)  Vaccinated:2008-05-15
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-14
Location:Ohio  Entered:2008-10-17, 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: Penicillin allergy
Preexisting Conditions: Tonsillectomy
Diagnostic Lab Data: Vaginal specimen, negative for vaginitis Blood pressure, 09/11/08, 105/6, left arm sitting
CDC Split Type: WAES0809USA02127
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Back pain, Diagnostic procedure, Dysmenorrhoea, Faeces discoloured, Headache, Muscular weakness, Nausea, Pain in extremity, Premenstrual syndrome, Somnolence, Vaginal discharge, Vulvovaginal burning sensation, Vulvovaginal pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from an office manager concerning a 17 year old female with penicillin allergy and a history of tonsillectomy (1994) who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml, IM and on 15-MAY-2008 was vaccinated with the second dose of GARDASIL vaccine 0.5 mL, IM. The patient had not yet received the third dose. Concomitant therapy included DEPO-PROVERA. The office manager reported that in 2008, the patient experienced stomach pain, leg pain, back pain and her leg had been "sore" and limp. The patient also had sleepy feeling. The patient was also experienced increased incidence of headaches and she also had a thin white discharged in the vagina. On 11-SEP-2008 the patient experienced green pink stool. The patient felt nauseated after eating, she had no diarrhea and constipation. As of 15-SEP-2008 the patient experienced green pink stool. She had no diarrhea and constipation. As of 15-SEP-2008 the patient had not recovered from the symptoms. A vaginal specimen analysis was performed that were negative for vaginitis. The patient sought medical attention by seeing the physician. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/14/2008. Follow-up information was received from a physician via medical record who reported that on 11-SEP-2008, the patient went to doctor''s office complianing of vaginal discharge that she describe as burning, itchy, white, foul, smelling and thin. The doctor stated the patient had premenstrual dysmenorrhea. The duration in 5 days and was interfering with work and normal activities. It was reported that the patient was not going to take DEPRO-PROVERA anymore because she didn''t like the way it makes her feel. It was also reported that the patient had an adenoidectomy in 1994. The patient had never had a PAP smear or a mammogram, she had no history of significant medical diseases. At the physical exam patient height: 64 inches, weight 105 pounds and blood pressure 103/60. The patient''s pelvic exam was normal and she had no history of obstetrical or gynecological surgery. The patient denied previous exposure to STD. On 14-SEP-2008 the patient was having a lot of symptomatology. She was concerned it is for GARDASIL vaccine. On 16-SEP-2008 the patient''s mother called the physician and stated that the primary care physician put the patient on prednisone and that did not work. The patient still had tingling in her legs. The patient was send to a Neurologist. Additional information has been requested.

VAERS ID:329695 (history)  Vaccinated:2008-03-11
Age:17.0  Onset:2008-03-11, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 217
Location:Pennsylvania  Entered:2008-10-17, 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: Low blood pressure
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA02173
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Road traffic accident
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), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician concerning a 17 year old female with low blood pressure who on 11-MAR-2008, 12-MAY-2008 and 13-SEP-2008 was vaccinated with a first, second and third dose of GARDASIL. Respectively, no concomitant medication was reported. The physician mentioned that after the first dose on 11-MAR-2008 the patient passed out in the office. No injuries were sustained and the patient was discharged home. The physician reported that three hours after receiving the second dose on 12-MAY-2008 the patient passed out while driving and hit another vehicle. No injuries were sustained. The physician reported that there were no adverse effects after the third dose. The outcome of the patient was not reported. The patient sought medical attention: in the office. There was no product quality complaint. Additional information has been requested.

VAERS ID:329714 (history)  Vaccinated:2008-01-17
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-14
Location:Ohio  Entered:2008-10-17, 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: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: lower extremity x-ray, 02/08/08, essentially normal
CDC Split Type: WAES0809USA03739
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1258U0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, X-ray limb normal
SMQs:, Arthritis (broad)
Write-up: Information has been received from a registered nurse concerning a 17 year old white female with allergic reaction to CECLOR and clindamycin who on 17-Jan-2008 was vaccinated with a first dose of GARDASIL (lot# 659439/1267U) IM in her left deltoid. Other suspect therapy received on the same date included a first dose of VAQTA (lot# 569186/1258U) IM in her right deltoid. In January 2008, the patient experienced right knee pain, mostly anterior. On 25-Jul-2008 the patient was vaccinated with a second dose of GARDASIL (lot# 660553/0070X) IM in her left deltoid. Other suspect therapy received on the same date included a second dose of VAQTA (lot# 659186/1258U) IM in her right deltoid. Approximately 2 weeks after the vaccinations the patient experienced right knee pain, mostly anterior. On 08-Feb-2008 the patient was seen by an orthopedic and performed an X-ray with essentially normal result. As of 16-Sep-2008, the patient''s right knee pain persisted without obtained knee injury. Additional information has been requested.

VAERS ID:329722 (history)  Vaccinated:2008-08-12
Age:17.0  Onset:2008-09-01, Days after vaccination: 20
Gender:Female  Submitted:2008-10-14, Days after onset: 43
Location:Texas  Entered:2008-10-17, 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: None
CDC Split Type: WAES0809USA03873
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Information has been received from a physician, concerning a 17 year old female patient who on 12-AUG-2008 was vaccinated with her first dose of GARDASIL from her school. Lot number not available at this time. A few days ago, she experienced symptoms of Bell''s palsy with paralysis of her face. She phoned the doctor and will be seen in the office this week. As of 22-SEP-2008, the patient had not recovered. There was no product quality complaint. Additional information is expected.

VAERS ID:330483 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:2008-08-18
Gender:Female  Submitted:2008-10-14, Days after onset: 57
Location:Unknown  Entered:2008-10-17, 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:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA04347
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 3IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a consumer concerning her daughter a 17 year old female with no known drug allergies/reactions and no pertinent medical history reported who on unspecified dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). On 18-AUG-2008, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) and experienced soreness at the injection site after receiving the vaccine. On 23-SEP-2008 the patient was vaccinated with a fourth dose of GARDASIL vaccine (yeast) 0.5 mL intramuscularly, and the patient''s mother stated that the doctor''s nurse accidentally administered the fourth dose. On 23-SEP-2008, soreness at the injection site reappeared after the 4th dose of GARDASIL vaccine (yeast). The patient sought unspecified medical attention. The patient recovered from soreness at the injection site on 23-SEP-2008. Additional information is not expected.

VAERS ID:330503 (history)  Vaccinated:2008-07-23
Age:17.0  Onset:2008-07-23, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 83
Location:Florida  Entered:2008-10-17, 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: hormonal contraceptives
Current Illness: Contraception
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA04607
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Mass, Oedema peripheral, Pain, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a nurse concerning a 17 year old female who on 23-JUL-2008 was vaccinated with the first dose of GARDASIL (lot # 659964/1978U) via IM. Concomitant therapy included unspecified birth control pill. Later the same day, she experienced pain in her whole arm lasting for 2 weeks and swelling, a big throbbing lump, at site for a few days. She sought medical attention in office. No treatment required. Additional information has been requested.

VAERS ID:330671 (history)  Vaccinated:2008-04-23
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-14
Location:Arkansas  Entered:2008-10-17, 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. 7/20/09 Consultant records received DOS 7/26/06 to 1/31/07. Assessment: Warts. Warts on legs, feet, arms, hands, face; treated by laser, intralesional injection, topical ointments. Dry peeling skin on face. History of tonsillectomy, myringotomy. Endometriosis. Multiple nevi.
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA04924
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Therapeutic response unexpected
SMQs:
Write-up: Information has been received from a physician concerning a 17 year old female who on 23-APR-2008 was vaccinated with the third dose of GARDASIL. The physician reported that after the patient''s last dose of GARDASIL the patient experienced skin warts that were all over her body cleared up. Biopsy of skin warts were performed. The patient sought unspecified medical attention. Additional information has been requested. 6/24/09 CDC spoke with Provider who stated that all warts started PRIOR TO HPV4 vaccine. Pt was treated with interferon, freezing and drugs and none of these cured the warts that were all over the body. Then given HPV4 vaccine on the following dates: Oct. 2007, Jan 2008 and 4/23/08. All warts had cleared up after receipt of # 3 dose of HPV4. 7/20/09 Consultant records received DOS 7/26/06 to 1/31/07. Assessment: Warts. Warts on legs, feet, arms, hands, face; treated by laser, intralesional injection, topical ointments. Dry peeling skin on face. History of tonsillectomy, myringotomy. Endometriosis. Multiple nevi. /ksk 9/29/09 PCP records received. Warts cleared up by 9/2008.

VAERS ID:329214 (history)  Vaccinated:2008-08-26
Age:17.0  Onset:2008-10-19, Days after vaccination: 54
Gender:Female  Submitted:2008-10-20, Days after onset: 1
Location:Iowa  Entered:2008-10-20
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Birth Control Pills
Current Illness:
Preexisting Conditions: 12/4/08-records received-Family history notable for upper extremity deep venous thrombosis.
Diagnostic Lab Data: CT chest on 10/19/08 showed several small pulmonary emboli. Ultrasound of left upper extremity, 10/19/08, showed extensive DVT. 12/4/08-records received-Ultrasound showed extensive deep venous thrombosis. WBC 13.4 84% neutrophils 11% lymp
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0053X0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram abnormal, Deep vein thrombosis, Dysmenorrhoea, Liver function test normal, Lymphocyte percentage decreased, Neutrophil percentage increased, Oedema peripheral, Oral contraception, Orthostatic hypotension, Pain in extremity, Pulmonary embolism, Thoracic outlet syndrome, Ultrasound scan abnormal, White blood cell count increased
SMQs:, Cardiac failure (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient received Gardasil around 8/1/08 in left arm. While attending a forum for high school students, she presented to ER on 10/19/08 with left arm swelling and pain. Ultrasound demonstrated LUE DVT, and CT of chest showed small pulmonary emoboli. Only other risk factor for DVT is birth control pills. 12/04/08-records received for DOS 10/19-10/23/08-DC DX:Left upper extremity deep venous thrombosis with a few very small pulmonary emboli identified in right lung as well on chest computerized tomography. Transient orthostatic hypotension. Thoracic outlet syndrome on left likely contributing to deep venous thrombosis. Oral birth control pills started within last 4-6 months-now discontinued. Presented to ED with acute swelling of left upper extremity. 2/26/09-office visit note for DOS 8/26/08 received follow-up visit for dysmenorrhea now improved.

VAERS ID:329237 (history)  Vaccinated:2008-09-26
Age:17.0  Onset:2008-09-29, Days after vaccination: 3
Gender:Female  Submitted:2008-10-20, Days after onset: 21
Location:Massachusetts  Entered:2008-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair, Advair 500/50, albuterol, anaprox
Current Illness: None
Preexisting Conditions: Asthma, allergies,NKDA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2766AA9IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Injection site rash, Oedema peripheral, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient received flu shot on 9/26/08, 3 days later right arm was swollen, red, warm to touch, itchy and had a rash at the site of injection. She came to clinic on 10/20/08 and was treated with benadryl and prednisone 60mg po daily x 3 days.

VAERS ID:329242 (history)  Vaccinated:2008-09-05
Age:17.0  Onset:2008-09-06, Days after vaccination: 1
Gender:Female  Submitted:2008-10-20, Days after onset: 44
Location:Connecticut  Entered:2008-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: none noted
Diagnostic Lab Data: MRI (brain), CAT scan (spine and neck), numerous blood tests, opthalmic testing, lumbar puncture Labs and Diagnostics: Cervical and Thoracic MRI WNL. CT brain scan WNL. CBC WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2371AA0  
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B029AA   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Axillary pain, Blood test normal, CSF test normal, Computerised tomogram normal, Full blood count normal, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Ophthalmological examination, Pain, Papilloedema, Paraesthesia, Scan brain, Sensory loss, Vision blurred, Visual disturbance, Visual field defect
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Lens disorders (broad), Retinal disorders (broad)
Write-up: 5 days after injection, one arm went completely numb. The day after that, the other arm went numb. The day after that, she lost partial vision in one eye. Went to local emergency, then to Hospital for 2 days. Underwent MRI (brain) CAT scan (neck & spine), multiple blood tests, testing by an opthalmogogist, attempted lumbar puncture but it was unsuccessful. All testing came back negative. Symptoms lasted about a week, then slowly subsided, although she still had problems. Four weeks later, one leg went numb. Had lumbar puncture, - testing came back negative. 10/31/2008 MR received for DOS 9/12-14/2008 with D/C DX: Paresthesias. Pt presented with several day hx of numbness and tingling which 1st presented in R arm, then L. Sudden onset of loss of peripheral vision in L eye, L eye heaviness and blurred vision. Papilledema with blurred disc margins, decreased sensation of upper extremities and 4/5 strength noted on PE. (+) visual field defect. Pain noted in bilateral axillary area with active ROM and mastoid area intermittently. Ophth consult with Impression: Decreased visual field OS-no cause found. No papilledema. Tingling of extremities. Must r/o Lymes, MS etc.

VAERS ID:329351 (history)  Vaccinated:2008-10-04
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-15
Location:Wisconsin  Entered:2008-10-21, 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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR42765AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2637AA0SC 
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027BA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Incorrect route of drug administration
SMQs:
Write-up: Patient was given MENACTRA SQ instead of IM on 10-14-08

VAERS ID:329354 (history)  Vaccinated:2008-09-26
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-13
Location:California  Entered:2008-10-21, Days after submission: 8
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: dysmenorrhea & irregular periods.
Diagnostic Lab Data: Optic Neuritis LABS: CBC WNL. MRI brain abnormal w/focal inflammatory changes in posterior right optic nerve & right maxillary sinusitis.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2637AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024DB0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Eye pain, Full blood count normal, Headache, Inflammation, Nuclear magnetic resonance imaging brain abnormal, Optic nerve disorder, Optic neuritis, Sinusitis, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad), Arthritis (broad)
Write-up: Optic Neuritis - referred to ophthalmology for work-up. Symptoms started after vaccination. Unclear specific day/time. 1/30/09 Received PCP medical records of 9/26-11/3/2008. FINAL DX: Optic neuritis Records reveal patient in usual state of good health on 9/26/08 when received vaccinations & depoprovera. RTC 10/13 w/eye pain w/movement x 1.5 wk, peripheral blurry vision, seeing white spots, frontal HA, bilateral knee pain. Referred to Ophtho but no report available.

VAERS ID:329587 (history)  Vaccinated:2007-09-21
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-21
Location:Illinois  Entered:2008-10-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA02781
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Complication of pregnancy, Drug exposure during pregnancy, Premature labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a consumer for the pregnancy registry for GARDASIL, concerning her 17 year old daughter with no medical history and no drug allergies reported, who on 09-JUL-2007 was vaccinated with the first dose of GARDASIL and on 21-SEP-2007 was vaccinated with the second dose of GARDASIL while she was pregnant. The patient did not know at the time of vaccination that she was pregnant. The patient gave birth two months early on 14-DEC-2007. The patient was hospitalized twice during the pregnancy due to unspecified complications. The patient received the third dose of GARDASIL after giving birth but it was unknown if the vaccine was given late. There was no concomitant medication. The patient''s LMP was unknown. Additional information has been requested.

VAERS ID:329656 (history)  Vaccinated:2008-09-15
Age:17.0  Onset:2008-09-22, Days after vaccination: 7
Gender:Female  Submitted:2008-10-22, Days after onset: 30
Location:California  Entered:2008-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: 17 year well check visit
Preexisting Conditions: Augmentin, Cefzil, Nuts, Zyrtec allergies. Spastic CP, Migraines, had Grp B Strep Meningitis as newborn 11/14/08-records received-PMH: anxiety, cerebral palsy, developmental delay secondary to neonatal group B streptococcal meningitis with seiuzres up to 6 monthg of age and no seizure from that point forward.
Diagnostic Lab Data: EEG, MRI, bloodwork 11/14/08-records received-CBC, CMP LFTs normal. UA negative, CK 53. EEG abnormal-generalized slowing of background.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2787EA IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0229X0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Blood test normal, Crying, Delusion, Depression, Electroencephalogram abnormal, Full blood count normal, Irritability, Laboratory test normal, Major depression, Mental status changes, Muscle twitching, Neurological examination, Nuclear magnetic resonance imaging normal, Psychotic disorder, Staring, Urine analysis normal
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow)
Write-up: Pt had Gardasil and Fluzone vaccines on 9/15/08. 9/22/08 presented to the office crying with delusions about family members with lethal disease. Pt sent to Hospital to the ER for Neuro consult. EEG and labwork negative. 3 admits to Hospital and neuro work up. Inconclusive and unknown etiology. 11/14/08-records received for DOS 9/22-9/24/08-DC DX: Major deprssive disorder with psychotic features. Admitted due to changes in behavior and altered mental status. Increased irritability, staring with right sided twitching. Follow-up: Continues with psychiatric problems.

VAERS ID:329887 (history)  Vaccinated:2007-10-11
Age:17.0  Onset:2007-10-22, Days after vaccination: 11
Gender:Female  Submitted:2008-10-23, Days after onset: 367
Location:Pennsylvania  Entered:2008-10-24, 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 = 10/22/2007); Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: physical examination, a skeletaljoint exam, the baby had pes adductus; serum beta-human, 11/19/07, positive
CDC Split Type: WAES0711USA04440
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Foetal disorder
SMQs:, 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 through the pregnancy registry for GARDASIL concerning a 17 year old female with penicillin allergy who on 11-OCT-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (Lot # 655620/0171U). There was no concomitant medication. On 19-NOV-2007, the patient had a blood work drawn in the office for a pregnancy test which was positive (LMP approximately 22-OCT-2007). It was reported that the patient was 3 to 4 weeks pregnant. The patient sought unspecified medical attention in the office. Follow-up information received indicated that on 25-JUN-2008 the patient vaginally delivered a "normal" infant. Upon a skeletal joint exam in the hospital the baby was found to have pes adductus (club feet). The baby''s club feet were considered a congenital anomaly. No further information is available.

VAERS ID:329893 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-23
Location:Unknown  Entered:2008-10-24, 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)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA03362
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal disorder
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female patient who was vaccinated with three 0.5 ml doses of GARDASIL on an unspecified date (lot number not provided). The patient became pregnant after getting all three doses of GARDASIL and delivered a baby on an unspecified date. Two months later, the baby died from "DNA trim". No additional information was provided. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:329908 (history)  Vaccinated:2008-10-20
Age:17.0  Onset:2008-10-20, Days after vaccination: 0
Gender:Female  Submitted:2008-10-20, Days after onset: 0
Location:Arizona  Entered:2008-10-24, 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 PASTEURU2746AA0UNLA
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: Pt fainted and was advised to go to Emergency Room.

VAERS ID:329975 (history)  Vaccinated:2008-10-21
Age:17.0  Onset:2008-10-21, Days after vaccination: 0
Gender:Female  Submitted:2008-10-24, Days after onset: 3
Location:Arizona  Entered:2008-10-24
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: B/P 158/88 then lowered to 138/70
CDC Split Type: AZ0816
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAB234BA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2659AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B027AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure increased, Dizziness, Dyskinesia, 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), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Had immunizations. Immediately after last one given (MCV4). Complained of dizziness and passed out. Lowered to floor regained consciousness, but did make a few jerky movements and snorting sound before regaining consciousness.

VAERS ID:330026 (history)  Vaccinated:2008-09-23
Age:17.0  Onset:2008-09-28, Days after vaccination: 5
Gender:Female  Submitted:2008-10-15, Days after onset: 17
Location:Indiana  Entered:2008-10-24, Days after submission: 9
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: has never had any sickness
Diagnostic Lab Data: Labs and Diagnostics: CBC & Chem WNL. Monospot (-).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal tenderness, Activities of daily living impaired, Back pain, Epigastric discomfort, Fatigue, Feeling cold, Full blood count normal, Headache, Laboratory test normal, Malaise, Mononucleosis heterophile test negative, Nausea, Night sweats
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: my daughter had GARDASIL. The next day became very sick with headache and nausea and very tired. This is going on 3 weeks she is still sick from this. has seen two doctors and can''t find anything causing this. They won''t say it was the shot. but she was very healthy when I took her for her yearly check up. She has missed 3 weeks of school so far.11/5/2008 PCP records received OV 10/3/08 with c/o low back pain, abdominal pain, nausea, tiredness and feeling cold x 1 week. Abd pain is epigastric-(+) tenderness. Bland diet suggested. TC from parent re: nausea-phnergan prescribed. Pt extremely tired unable to attend school x 2 days. OV 10/10/08 F/U for stomach pain, queezy, night sweats. Assessment: Nausea, H/A, fatigue-possible viral etiology, doubts 2'' to Gardasil. ER visit 10/15/08 for above sx-prescribed Nexium.

VAERS ID:330165 (history)  Vaccinated:2008-10-27
Age:17.0  Onset:2008-10-27, Days after vaccination: 0
Gender:Female  Submitted:2008-10-27, Days after onset: 0
Location:Kentucky  Entered:2008-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Orthotricyclen, allegra
Current Illness: none
Preexisting Conditions: seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR42749AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Eyelid oedema, Headache, Petechiae, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: 30 minutes following administration patient suffered vomiting. Vomiting was severe and she had swelling of eyelids and peticheae surrounding eyes. She also reported HA.

VAERS ID:330174 (history)  Vaccinated:2005-11-02
Age:17.0  Onset:2006-04-04, Days after vaccination: 153
Gender:Female  Submitted:2008-10-27, Days after onset: 937
Location:Arkansas  Entered:2008-10-27
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none at all PMH: hypokalemia. Mild MVP w/mild mitral regurgitation. Non-smoker, non-drinker.
Diagnostic Lab Data: LABS: UA w/3(+)glucose, tr. ketones. Blood sugar 250(H). EKG & holter monitor WNL. Lymphs 44.5%(H), TSH 0.1(L). Thyroid ab 153(H). Glucose 278(H). HgbA1C 7.4(H). US of abdomen w/small amount of sludge in gallbladder
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB170IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURY0496-20SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0300R0SCRA
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURERU1620BA1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Anti-thyroid antibody positive, Anxiety, Asthenia, Blood glucose increased, Blood thyroid stimulating hormone decreased, Bradycardia, Cholelithiasis, Dizziness, Echocardiogram, Electrocardiogram abnormal, Electrocardiogram ambulatory normal, Electroencephalogram normal, Glucose urine, Glycosylated haemoglobin increased, Headache, Heart rate increased, Heart rate irregular, Hyperglycaemia, Hypoaesthesia, Lethargy, Loss of consciousness, Lymphocyte percentage increased, Muscle spasms, Nausea, Pain in extremity, Polydipsia, Polyuria, Renal impairment, Salivary hypersecretion, Tachycardia, Type 1 diabetes mellitus, Type 2 diabetes mellitus, Ultrasound abdomen abnormal, Urine analysis abnormal, Urine ketone body absent, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad)
Write-up: Approximately 3 months after immunizations, irregular heartbeat,pain down left arm with high salava being produced, blackouts, and severe stomach cramps began. This only accured about once a month. Didn''t know what was going on and it didn''t seem frequent enough to have checked out. These signs started to appear more often until 9 months later, an EEG was done by family doctor. Nothing was found, but signs continued. 1 year after the EEG, legs cramped up and was taken to emergency room where high sugar levels were found. Family doctor tried for 6 weeks to get sugar levels under control by oral meds. Was diagnosted as type 2 diabetic. By end of the 6 weeks, sugar levels were over 900 and was diagnosted as type 1 diabetic. Was told that the pancreas not producing insulin could have caused all of the signs above, which could have been caused by the immunizations given. No family history of diabetes on either side of family, and patient is not over weight. Is very active. 11/7/08 Reviewed hospital medical records of 11/27-11/30/2007. FINAL DX: no d/c summary dictated. Admitted for hyperglycemia & new onset type 1 diabetes. Records reveal patient experienced new onset DM approx 3 weeks prior when developed severe leg cramps while playing sports & seen in outlying ER w/very high blood sugar. Unable to control BS at home on oral agent, ranging from 400-600mg/dl along w/blurry vision, HA, lethargy, weakness, nausea polyuria. BS in current ER was 600, tx w/IVF & decreased only to 386, neg ketones. Tx w/sliding scale insulin, oral agent d/c, additional IVF & meds. Referred to Endocrine clinic & started on routine insulin. 11/14/08 Reviewed PCP medical records of 4/24/06-11/01/2007. FINAL DX: new type II DM Records reveal patient experienced facial poison ivy 4/06. Seen in ER & treated w/steroid taper. RTC 9/06 w/rapid heart beat, nausea, left arm numbness, dizziness. EKG at that time revealed HR 58. Referred for echocardiogram & Holter monitor. RTC 10/2007 s/p ER visit for severe leg cramps while playing sport, polyuria, polydipsia. BS in ER was 250 & tx w/insulin. Started on oral agent & additional labs ordered. RTC 11/2007 w/consistently high but improving blood sugars. Meds were adjusted. 11/18/08 Reviewed ER medical records of 10/17/2007. FINAL DX: leg cramps, hyperglycemia. Records reveal patient experienced leg cramps lasting approx 2 hours s/p physical activity. Reported occ visual blurring, excessive thirstiness & excessive voiding. Exam revealed anxiety, tachycardia, calf cramps. Tx w/meds, improved & d/c to home to f/u w/PCP re diabetic control. 1/28/2010 Patient still has type 1 Diabetes-having to give insulin 5 times a day is having some kidney problems right now.

VAERS ID:330230 (history)  Vaccinated:2008-10-15
Age:17.0  Onset:2008-10-15, Days after vaccination: 0
Gender:Female  Submitted:2008-10-27, Days after onset: 12
Location:New York  Entered:2008-10-27
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.0548X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2817AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Patient feeling dizzy and nauseous - doctor spoke to mom 1st day close observation. Day 2 advised rest/push fluids/use Motrin for HA, if worsening to call back. Telephone call received from mother with the following information: 10/15 7 pm: feeling dizzy and nauseous a few hours after getting GARDASIL. Advised close observation and fluids tonight. Call in am to speak with PCP if persists. 10/16 9 am: spoke with mom this am to check on patient and she was not so great last night - woke up in middle of the night and vomited. This am had headache and went to school. Advised to follow up with PCP re future shots. Discussed that this is likely an intercurrent illness, not related to GARDASIL, but no way to know.

VAERS ID:330285 (history)  Vaccinated:2008-10-15
Age:17.0  Onset:2008-10-15, Days after vaccination: 0
Gender:Female  Submitted:2008-10-15, Days after onset: 0
Location:Wisconsin  Entered:2008-10-28, Days after submission: 13
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 BIOLOGICALSAHAVB285AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U2IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2638AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Immediate post-injection reaction, 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), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: After receiving all three vaccine pt felt lightheaded and passed out while sitting in the upright position on the exam table for under ten seconds. After incident vitals were wnl. BP was 94/58

VAERS ID:330365 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Unknown  Submitted:0000-00-00
Location:Washington  Entered:2008-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Faint~Measles + Mumps + Rubella (no brand name)~1~12~In Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.042441SCLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2077BA1UNLA
Administered by: Private     Purchased by: Other
Symptoms: Gaze palsy, Immediate post-injection reaction, Musculoskeletal stiffness, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Immediately s/p MMR SQ injection, pt fainted; unresponsive, eyes rolled and extremities stiffened during approx. 2 minute time lapse. Pt awoke oriented x 3, pulse regular at 56 beats, per minute. Pt supine for 25 minutes, semi-fowlers 10 minute. Pt dc''d approx. one s/p ADR - LPN.

VAERS ID:330432 (history)  Vaccinated:2008-10-17
Age:17.0  Onset:2008-10-21, Days after vaccination: 4
Gender:Male  Submitted:2008-10-27, Days after onset: 6
Location:California  Entered:2008-10-28, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Seasonal coughing/allergies 1 per yr. 11/12/08-records received-PMH: tear, anterior cruciate ligament (ACL).
Diagnostic Lab Data: Everything Was Normal! 11/12/08-records received-CO2 decreased 19, BUN increased 23, anion gap increased 23, creatinine increased 1.48, CK increased 378. CT head normal brain. Chest x-ray normal. CSF normal. 12/11/08-records received-LP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500540P0IN 
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2637AA1UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Agitation, Anion gap increased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood urea increased, CSF cell count normal, Carbon dioxide decreased, Cardiac arrest, Chest X-ray normal, Computerised tomogram normal, Confusional state, Electrocardiogram QT prolonged, Implantable defibrillator insertion, Respiratory arrest, Syncope, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (narrow), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow)
Write-up: Cardiac arrest! Stopped breathing, collapsed! CPR w/in 5 mins, AED w/in 10 mins Paramedics. ER - implanted w/ ICD. 11/12/08-records received for ED visit 10/21/08-presented after a witnessed collapse while in basketball practice. AED was connected and a single shock given. At ED awake confused and agitated. Transferred to another facility.12/1108-records received for DOS DC 10/21-10/26/08-DX ventricular fibrillation status post implantation of cardiac defibrillator.

VAERS ID:330434 (history)  Vaccinated:2008-09-16
Age:17.0  Onset:2008-10-20, Days after vaccination: 34
Gender:Female  Submitted:0000-00-00
Location:Florida  Entered:2008-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Cyclical anaemia. PMH: Iron deficiency anemia, asthma, (H/A, dizziness , weakness-2 yrs ago)
Diagnostic Lab Data: MRI; Cardiology workup; Neurology workup (neg). Labs and Diagnostics: MRI brain (-) except for sinus disease. CBC with WBC 6.5, Hgb 9.9, Hct 31. Retic 148. CSF WNL with (+) RBCs. CXR WNL. EEG showed flattening of the occipital rhythm du
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0052X IMLA
Administered by: Private     Purchased by: Public
Symptoms: Activated partial thromboplastin time prolonged, Activities of daily living impaired, Asthenia, Blood iron increased, CSF test normal, Cardiac murmur, Cardiovascular evaluation, Chest X-ray normal, Dizziness, Echocardiogram normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Electroencephalogram abnormal, Full blood count, Haematocrit decreased, Haemoglobin decreased, Headache, Intracranial hypotension, Loss of consciousness, Microcytic anaemia, Nausea, Neurological examination, Nuclear magnetic resonance imaging brain abnormal, Occult blood negative, Orthostatic hypotension, Parvovirus B19 serology positive, Red blood cells CSF positive, Reticulocyte count increased, Reticulocyte percentage increased, Serum ferritin increased, Syncope, Syncope vasovagal, Ultrasound Doppler, Ultrasound Doppler normal, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Haemolytic disorders (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Severe dizziness, headache x1 wk. D/ch from hosp 10/27/08. 11/3/2008 MR received for DOS 10/20-22/2008 with D/C DX; Syncope. Iron deficiency anemia. Pt presented to ER for the 2nd time in several days with c/o of H/A, dizziness, weakness and most recently passing out. Microcytic anemia noted on 1st ER visit. On the day of admission pt unable to get out of bed 2'' to dizziness and H/A, mild nausea. Cardiology consult impression was presyncopal neurocardiogenic syncope. Transfered to higher level of care for further diagnostics. 11/12/2008 MR received from transfer hospital with DOS 10/22-25/2008 and d/C DX: Dizziness. Headaches. Iron deficiency anemia. Murmur. Orthostatic hypotension. Neurocardiogenic presyncope. Neuro consult with impression intracranial hypotension. Recommend increasing salt and fluids. Cardiac consult with impression orthostatic hypotension/dizziness/ pre-syncope/ H/A.

VAERS ID:330590 (history)  Vaccinated:2008-10-21
Age:17.0  Onset:2008-10-21, Days after vaccination: 0
Gender:Male  Submitted:2008-10-29, Days after onset: 8
Location:Texas  Entered:2008-10-29
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2789CA IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAB259AA IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2636AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Fall, Hyperhidrosis, 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), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: client screened,nocontraindications,vaccines given,client stood up,moved to stand behind parents who took turns getting flu shots, client momentarily lost consciousness,slid to carpeted floor,immediately opened eyes,skin sweaty, BP 116/58,P60,R20,PERRLA,had not eaten all day.no tx. parents declined medical tx.No injuries.

VAERS ID:330688 (history)  Vaccinated:2008-10-22
Age:17.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-29, Days after onset: 7
Location:Unknown  Entered:2008-10-30, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA04308
Vaccination
Manufacturer
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HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Consciousness fluctuating, Feeling cold, Heart rate decreased, Hypersensitivity, Immediate post-injection reaction, Inappropriate schedule of drug administration, Unresponsive to stimuli
SMQs:, Angioedema (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), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 17 year old female patient with no previous medical history and allergies reported, who on 06-JUN-2007 was vaccinated with the first dose of GARDASIL 0.5 mL. On 22-OCT-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # not provided) 0.5 mL. On 22-OCT-2008, the patient developed severe allergic reactions like unresponsiveness, in and out consciousness, heart rate down to 62 and cold immediately. On an unknown date, the patient recovered. The patient sought unspecified medical attention. The patient''s adverse events were considered to be immediately life-threatening by the physician. Additional information is expected.

VAERS ID:330805 (history)  Vaccinated:2008-10-28
Age:17.0  Onset:2008-10-30, Days after vaccination: 2
Gender:Female  Submitted:2008-10-30, Days after onset: 0
Location:Ohio  Entered:2008-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heartburn; GERD
Preexisting Conditions: Headache; glucose impairment; Acanthosis nigricans; Amenorrhea; sleep apnea; Hyperlipidemia; Metabolic Syndrome
Diagnostic Lab Data: CBC with diff, ordered 10/30/08
CDC Split Type:
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HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Fatigue, Full blood count, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Headache, mild nausea and fatigue. Since evening of vaccine - 10/28/08.

VAERS ID:331164 (history)  Vaccinated:2008-10-29
Age:17.0  Onset:2008-10-29, Days after vaccination: 0
Gender:Male  Submitted:2008-11-03, Days after onset: 5
Location:Kansas  Entered:2008-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Enalapril 15 mg, Metoprolol 50 mg, COUMADIN 10 mg
Current Illness: seasonal allergies/rhinitis
Preexisting Conditions: Mechanical aortic valve; HTN
Diagnostic Lab Data: None
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLAA167AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash bilateral arms, chest, back, face within 10 min. of injection. Gave 25 mg BENADRYL IM and 80 mg DEPO MEDROL IM. Within 5 minutes of BENADRYL rash beginning to resolve; within 15 minutes of BENADRYL rash completely cleared. No edema of face, throat, lips.

VAERS ID:331200 (history)  Vaccinated:2008-10-28
Age:17.0  Onset:2008-10-28, Days after vaccination: 0
Gender:Female  Submitted:2008-11-03, Days after onset: 6
Location:California  Entered:2008-11-04, 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: antimicrobial (unspecified); NUVARING; Influenza virus vaccine
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA05135
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Hypotonia, Presyncope
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a consumer concerning her 17 year old grand-daughter with allergy to penicillin and no pertinent medical history reported who on 28-OCT-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included NUVARING, flu vaccine (unspecified) (also given on 28-OCT-2008) and unspecified antibiotic. After receiving her first dose of GARDASIL, on 28-OCT-2008, in the physician''s office, the patient almost fainted and her head was flopping around. The consumer stated that she thought it looked like a seizure. At the time of reporting, the patient was recovering. Upon internal review, seizure was considered to be other important medical event. Additional information has been requested.

VAERS ID:331243 (history)  Vaccinated:2007-10-24
Age:17.0  Onset:2007-10-25, Days after vaccination: 1
Gender:Female  Submitted:2008-11-04, Days after onset: 376
Location:Pennsylvania  Entered:2008-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: NA
Current Illness: NA
Preexisting Conditions: NA PMH: depression.
Diagnostic Lab Data: LABS: EKG, CBC, drug screen all neg.
CDC Split Type:
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HPV4: HPV (GARDASIL)MERCK & CO. INC.1265U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Asthenia, Condition aggravated, Crying, Disturbance in attention, Drug screen negative, Electrocardiogram normal, Feeling abnormal, Full blood count normal, Major depression, Overdose, Pharyngitis, Suicidal ideation, Suicide attempt, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Agranulocytosis (broad), Suicide/self-injury (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Drug abuse and dependence (broad), Oropharyngeal infections (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient was a perfectly healthy young woman prior to these events. The day after receiving the first shot of Gardasil on 10/24/2007, patient experienced frequent fainting and crying spells. The possible connection to the vaccine shot was not considered. Her pediatrician recommended a psychiatrist for an evaluation. The psychiatrist diagnosed severe depression and prescribed Lexapro. 17 days later, patient overdoses and is transported to the hospital. She is hospitalized for 4 days. She continues to be seen over the next 9 months for depression. Meds are frequently changed. She was plagued by various side effects. Her life ruined. 01/19/09 Reviewed hospital medical recods of 11/25-11/29/2007. FINAL DX: major depression, recurrent, severe, w/o psychotic features; pharyngitis on antibiotics; GAF on admit 25, on d/c 60. Records reveal patient had suicide attempt by overdose after worsening depression, decreased energy, decreased concentration, feelings of hopeless & worthless. No history of prior suicide attempts or prior psych hospitalizaations although had long history of depression. Had been started on Lexapro approx 2 wks prior to suicide attempt. Slowly improved & d/c to home with continued outpatient psych program. 1/19/09 Reviewed ER medical records of 11/25/2007. FINAL DX: overdose suicide attempt Records reveal patient took multiple drugs in suicide attempt. Had increased depression & suicidal thoughts lately. Under psych treatment & transferred to inpatient psych hospital. 02/01/2010 Following Gardasil shot-experienced freq. fainting/crying spells. Prescribed Lexapro. 20 days later-overdosed. A year and a half later, and after being prescribed many, many variations of anxiety/depression meds-a new psychiatrist believed she was misdiagnosed and wrongly medicated. She is off meds now and doing so much better. Almost pre-GARDASIL/pre-LEXAPRO. Still suffers feelings of anxiety as a result of losing 2 prime years of her life.

VAERS ID:331270 (history)  Vaccinated:2008-11-01
Age:17.0  Onset:2008-11-03, Days after vaccination: 2
Gender:Male  Submitted:2008-11-04, Days after onset: 1
Location:Colorado  Entered:2008-11-04
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: Allergic to dogs and horses
Diagnostic Lab Data: Taken to PCP then to emergency room at hospital. Given shot of penicillan, xrays,
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Unknown
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Headache, Local swelling, Myalgia, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Swollen neck (left gland), fever, shivers,severe headache, difficulty breathing, sroe throat, muscle aches, cough and felt tired

VAERS ID:331344 (history)  Vaccinated:2008-10-28
Age:17.0  Onset:2008-10-29, Days after vaccination: 1
Gender:Female  Submitted:2008-10-29, Days after onset: 0
Location:Nebraska  Entered:2008-11-05, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: Urogram- large amount of blood; UA with micro and calcium kreatonine peding
CDC Split Type:
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Haematuria, Urine analysis, Urogram abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Tubulointerstitial diseases (broad)
Write-up: Hematuria noted at 2:30 am on 10/29/2008. Patient had received 1st GARDASIL shot on 10-28-08 at 09:05am

VAERS ID:331351 (history)  Vaccinated:2008-10-28
Age:17.0  Onset:2008-10-30, Days after vaccination: 2
Gender:Female  Submitted:2008-10-30, Days after onset: 0
Location:Florida  Entered:2008-11-05, 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:
Preexisting Conditions: Depression
Diagnostic Lab Data: MRI
CDC Split Type:
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0702X2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: GARDASIL given 10/28/08 in (L) arm. Gradual onset of numbness, tingling and pain in (L) arm beginning on the morning of 10/30/08.

VAERS ID:331354 (history)  Vaccinated:2008-07-02
Age:17.0  Onset:2008-07-03, Days after vaccination: 1
Gender:Female  Submitted:2008-10-21, Days after onset: 110
Location:Maryland  Entered:2008-11-05, Days after submission: 15
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: Turners Syndrome NFI
Diagnostic Lab Data: Multiple lab tests on 7/4/2008. CBC, lytes, BUN, UA all WNL except platelets 447
CDC Split Type:
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0250X0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Adverse reaction, Blood urea normal, Full blood count normal, Hypoaesthesia, Laboratory test, Muscle spasms, Myalgia, Pain in extremity, Paraesthesia, Platelet count increased, Urine analysis normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Tingling/numbness in legs. Started in lower legs & moved higher in both legs. Called dr 7/4/08 am and was told to go to urgent care. Urgent care on 7/4/08 with exam and lab work with follow-up on 7/6/08. Symptoms slowly diminished. 11/20/08 MR received for OV 7/4/2008 with DX: Adverse rxn to Gardasil. Pt presented with c/o 3 day hx of leg cramps which began 1 day after HPV vax. PE (+) for calf tenderness, otherwise WNL. Does not think GBS. F/U 7/6/08 with 80% resolution of muscle tenderness. No further c/o.

VAERS ID:331503 (history)  Vaccinated:2008-10-29
Age:17.0  Onset:2008-10-29, Days after vaccination: 0
Gender:Female  Submitted:2008-10-31, Days after onset: 2
Location:Colorado  Entered:2008-11-06, Days after submission: 6
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:
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DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3199AA0IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB555AA0IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC734460IMUN
Administered by: Private     Purchased by: Public
Symptoms: Accidental needle stick, Erythema, Inappropriate schedule of drug administration, Oedema, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Mother of patient, DOS 7-25-08, who is a patient at our clinic, she was holding patient on her lap when immz were being given. After giving immz in thigh, nurse stuck patient with the needle on 5th knuckle R hand. Went to where patient is staying on 10/30/08 cleaned area with 1/2 Str H2O, applied NEOSPORIN and a bandaid. Site has approximately 1 cm area of erythema with edema & tender to palpation. Full ROM of hand (unsure which immz had been given prior to needle stick.)

VAERS ID:331710 (history)  Vaccinated:2008-10-22
Age:17.0  Onset:2008-10-29, Days after vaccination: 7
Gender:Female  Submitted:2008-11-07, Days after onset: 9
Location:Florida  Entered:2008-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: NONE
Preexisting Conditions: N/A PMH: intermittent epigastric pain x 6 yrs. Allergy: bee sting, shrimp, drug allergies to antibiotics & hydrocodone.
Diagnostic Lab Data: LABS: CT of abdomen/pelvis, gastric emptying study, EGD all WNL. X-ray of c-spine slightly abnormal. (+)proteinuria. Sodium 133(L). EBV antibody (+).
CDC Split Type:
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0650X2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal pain upper, Activities of daily living impaired, Blood sodium decreased, Computerised tomogram normal, Drug intolerance, Epstein-Barr virus antibody positive, Fatigue, Gastric emptying study, Haematochezia, Headache, Nausea, Oesophagogastroduodenoscopy, Proteinuria, Sleep disorder, Spinal X-ray abnormal
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: NAUSEA, HEADACHE, STOMACH PAIN, AND FATIGUE START A WEEK AFTER INJECTION MOTHER STATE SHE TOOK CHILD FOR LAB WORK AND CT SCAN. MOTHER NOTIFY ME ON FRIDAY 11/07/2008 IN AM. 12/23/08 Reviewed PCP medical records from 6/08-11/08. FINAL DX: none provided Records reveal patient experienced intermittent nausea, epigastric abdominal pain, HA, fatigue, tiredness & hematochezia(NSAID induced) while out of country. No weight loss. Sleep disturbance w/pain. Missed several days of school. GI consult done.

VAERS ID:331851 (history)  Vaccinated:2008-11-10
Age:17.0  Onset:2008-11-10, Days after vaccination: 0
Gender:Female  Submitted:2008-11-10, Days after onset: 0
Location:Kansas  Entered:2008-11-10
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:
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0546X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2637AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Unresponsive to stimuli
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt became pale and diaphoretic about 5 mins after injection given. Pt passed out and became unresponsive but was breathing for 5 mins-after given cool cloth and cool water and placed on exam bed Pt became responsive - color improved and was released with Mom in 10 mins.

VAERS ID:332035 (history)  Vaccinated:2008-10-22
Age:17.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-04, Days after onset: 13
Location:Oklahoma  Entered:2008-11-12, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2811AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: 10/31/08 by 5:30 L Deltoid red, swollen, tender, hot to touch from elbow to shoulder. Pain increase to point, client unable to use L arm rest of the evening/night. For next 2 days, deltoid warm, red, tender. 11-01-08 - Resolved. Client used TYLENOL for pain.

VAERS ID:332061 (history)  Vaccinated:2008-08-08
Age:17.0  Onset:2008-08-08, Days after vaccination: 0
Gender:Female  Submitted:2008-11-05, Days after onset: 89
Location:Texas  Entered:2008-11-12, 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: Dermatitis to face
Preexisting Conditions: PMH: Facial rash-dermatitis. Asthma. Tonsillectomy. Ear tubes. Allergy to Ceclor. Env allergies.
Diagnostic Lab Data: Paresthesia. Labs and Diagnostics: X-ray L knee WNL.
CDC Split Type:
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HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB235BA1UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Arthralgia, Breast pain, Headache, Hypoaesthesia, Meralgia paraesthetica, Migraine, Muscular weakness, Musculoskeletal pain, Neuropathy peripheral, Pain in extremity, Paraesthesia, X-ray limb normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Lipodystrophy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: c/o weakness to left arm since GARDASIL vaccine given on 8/8/08. 11/24/2008 Office records received from PCP. WCC 8/8/08 with vax given. PE WNL except papular lesions on the face. Seen agin 9/15/08 with c/o L arm pain which radiates to L hand since receiving HPV vax. Assessment: Paresthesia. X-ray 9/16/08 for knee pain. Seen again 9/29/08 with pain sx now also to the shoulder and breast. Awaiting neuro appt. 1/7/09 Neuro consult received from PCP dated 11/11/2008 with DX: Left Ulnar Neuropathy Symptoms. Left thigh Meralgia Paresthetica. Tendency to Migraine. Pt presented with 3 month hx of L sided head pain, L hand numbness and L thigh numbness which began after receiving HPV vaccine. PE (+) for altered sensation in ulnar distribution of L hand and no sensitivity of the nerve at the elbow. Unable to see association to immunization.

VAERS ID:332094 (history)  Vaccinated:2008-07-01
Age:17.0  Onset:2008-08-28, Days after vaccination: 58
Gender:Female  Submitted:2008-11-12, Days after onset: 76
Location:Michigan  Entered:2008-11-12
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: NKA
Diagnostic Lab Data: CAT Scan, PET Scan, Lymph Node Biopsy, Bone Marrow Biopsy, Blood Work 11/13/08-records received- Labs WNL. Chest x-ray PA & Lateral demonstrated soft tissue density at right heart border not seen on previous exam of 10/4/07. Also soft tiss
CDC Split Type:
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HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U2UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Biopsy bone marrow, Biopsy lymph gland, Biopsy skin, Blood test, Chest X-ray abnormal, Chest pain, Computerised tomogram abnormal, Cough, Dizziness, Dyspnoea, Hepatomegaly, Hodgkin's disease stage II, Melanocytic naevus, Myalgia, Positron emission tomogram
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Malignant tumours (narrow), Malignant lymphomas (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Garadsil vaccine given on 12/4/2007, 2/29/2008 and 7/1/2008. On 8/28/2008 chest pain, shortness of breath, lightheadedness and dizziness occured. OSF saw her in the ER. Chest X-ray should a "fullness" by the heart. On 8/30/2008 a CAT scan was performed and early Stage II A Hodgkin''s Lymphoma was the official diagnosis received on 9/24/2008. Patient is currently undergoing treatment at the clinic. Prior to the beginning of the 3 shot series of Gardasil vaccine, patient had a chest X-ray, and the cheset X-ray showed no signs of Hodgkin''s Lymphoma. 11/13/08-records received for ED DOS 8/28/08-presented with C/O shortness of breath, difficulty taking a deep breath symptoms began 5 hours ago.ED visit 9/14/08-presented with sternal pain, shortness of breath onset with attending a competition. C/O cough, arthralgia, myalgia. DX: chest pain, lymphoma. 3/3/09-seen in clinic on 1/23/09-with stage II nodular sclerosing Hodgkin''s disease status post radiation and chemotherapy. Presents with C/O change in nerves in right armpit.

VAERS ID:332109 (history)  Vaccinated:2008-09-11
Age:17.0  Onset:2008-09-19, Days after vaccination: 8
Gender:Female  Submitted:2008-11-12, Days after onset: 54
Location:California  Entered:2008-11-12
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: ALLERY TO SULFA. PMH: ear infections, stomach aches. allergic to sulfa.
Diagnostic Lab Data: BIOPSY, BLOOD TESTS, CHEST XRAY. Labs and Diagnostics: Skin bx c/w pityriasis rubra pilaris.
CDC Split Type:
Vaccination
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HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Biopsy, Blood test, Chest X-ray, Contusion, Erythema, Pain in extremity, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: NO APPETITE, HEADACHE, HANDS HURT WHILE EXPOSED TO HOT WATER, DARK PURPLE OVAL BRUISE-LIKE MARKS ON BOTH ELBOWS, REDNESS AROUND BOTH FEET, PAIN IN LEFT ARM AND IN FEET WHEN STANDING UP. I TOOK MY DAUGHTER TO URGENT CARE AND PRIMARY DOCTOR WITHIN DAYS OF EACH OTHER. REFERRED TO DERMATOLOGY AND AWAITED BLOOD TEST RESULTS. A WEEK OR TWO AFTER THESE SYSTEMS, THE SKIN ON HANDS AND ELBOWS BEGAN TO PEEL OFF JUST SHREDD OFF AND ABOUT TWO WEEKS LATER THE SKIN ON THE FEET BEGAN TO PEEL OFF, JUST SHREDDING OFF AND PURPLE BRUISE-LIKE MARKS APPEARED ON BACK, ANKLES, BUTTOCK AREA. DERMOTOLOGIST TOOK BLOOD TESTS AND A BIOPSY. A STERIOD OINTMENT WAS GIVEN AND USED ON PEELING/PURPLE AREAS OF SKIN FOR 14 DAYS. MANY BLOOD TESTS WERE DONE, CHEST X-RAY, BIOPSY OF ELBOW AND FOOT AREA. REFERRED TO HOSPITAL. ANOTHER OINTMENT WAS ISSUED. 11/14/08 MR received for dematology consult dated 10/15/2008. Pt presented for eval of rash which began on the elbows, gluteal cleft, hands and feet. Itchy at first, now improved. Burning sensation noted in hot water. Tx with steroids with some improvement. Pt also reports elbow pain. PE (+) for diffuse, slighly waxy exfoliation on the bilateral plantar surfaces of the feet, mild erythema w/o scale on elbows, hyperpigmented scaly plaques on the posterior and medial ankles, scaling and exfoliation on palms, follicular hyperkeratosis on knees and pustule and papules (acne) on the face. Assessment: Localized variant of pityriasis rubra pilaris vs psoriasis.

VAERS ID:332159 (history)  Vaccinated:2008-10-25
Age:17.0  Onset:2008-10-27, Days after vaccination: 2
Gender:Male  Submitted:2008-11-12, Days after onset: 16
Location:Virginia  Entered:2008-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: X-rays; CT scans 5/11/09-Medical records received for DOS 11/3/08 to 11/7/09. LABS and DIAGNOSTICS: CBC - Mildly elevated white count. CHEST PA/LAT - small right apical pneumothorax. Small pleural effusion. CT PE DVT PROTOCOL - Tiny apical pneumothorax, bubbles around chest tube within pleural space. Basilar pneumothorax resolved. Right pleural effusion. No evidence of deep vein thromobosis.
CDC Split Type:
Vaccination
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500563P2IN 
Administered by: Military     Purchased by: Military
Symptoms: Breath sounds, Breath sounds abnormal, Chest X-ray abnormal, Chest pain, Chest tube insertion, Collapse of lung, Computerised tomogram abnormal, Pleural effusion, Pneumothorax, Pyrexia, Tachycardia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (narrow)
Write-up: 45 hours after receiving the vaccine, my son had a lung collapse while sitting in class. He was sent by ambulance to hospital where he was diagnosed with a spontaneous pneumothorax. He had a chest tube inserted. After 7 days, without healing, he was sent to another hospital. 5/11/09-Medical records received for DOS 11/3/08 to 11/7/09. FINAL DIAGNOSIS: Resolved Pneumothorax Transferred to this hospital, after stepping on chest tube, for definitive management of persistant pneumothorax. Air leak. Decreased breath sounds on right, chest pain. Fever, tachycardia.

VAERS ID:332183 (history)  Vaccinated:2008-11-11
Age:17.0  Onset:2008-11-11, Days after vaccination: 0
Gender:Male  Submitted:2008-11-12, Days after onset: 1
Location:New York  Entered:2008-11-12
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: Amox allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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Lot
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2853AB2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cyanosis, Rash, Tremor, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Mom states- last night subject was shaking turned blue, alert oriented, vomited and felt better, no fever- Had flu shot rashes in the day? if it was from the shot.

VAERS ID:332477 (history)  Vaccinated:2007-08-29
Age:17.0  Onset:2008-08-14, Days after vaccination: 351
Gender:Female  Submitted:2008-11-14, Days after onset: 92
Location:Washington  Entered:2008-11-14
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
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0IMUN
Administered by: Private     Purchased by: Other
Symptoms: Smear cervix abnormal
SMQs:
Write-up: Patient was HPV neg. Was given series of 3 GARDISIL vaccines summer of 2008. Aug 2008 PAP ASCUS and positive for high risk HPV PAPs previously were normal HPV neg.

VAERS ID:332491 (history)  Vaccinated:2008-11-10
Age:17.0  Onset:2008-11-10, Days after vaccination: 0
Gender:Male  Submitted:2008-11-13, Days after onset: 3
Location:Montana  Entered:2008-11-14, 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: ZOLOFT; Tetracycline
Current Illness: None
Preexisting Conditions: No known disease or allergies; No seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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TDAP: TDAP (ADACEL)SANOFI PASTEURC2996AA5IMLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Local reaction, Lymphadenopathy, Nausea, Pain,