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Case Details (Sorted by Age)

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VAERS ID:354424 (history)  Vaccinated:2009-08-14
Age:17.0  Onset:2009-08-15, Days after vaccination: 1
Gender:Female  Submitted:2009-08-17, Days after onset: 2
Location:Ohio  Entered:2009-08-17
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB326AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3029AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever of 102 or above and headache x3 days after.

VAERS ID:354455 (history)  Vaccinated:2009-02-19
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-17
Location:Louisiana  Entered:2009-08-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 10/26/2008)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA03594
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1222X0SCUN
Administered by: Public     Purchased by: Other
Symptoms: Caesarean section, Chlamydial infection, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a nurse practitioner, for the Pregnancy Registry for VARIVAX (Merck), concerning a 17 year old female with no pertinent medical history and no reported drug allergies, who on 19-FEB-2009 was vaccinated SC with first 0.5mL dose of VARIVAX (Merck) (Lot number 661856/1222X). There was no concomitant medication. The patient was 16 weeks pregnant at the time of vaccination; the date of last menstrual period was 26-OCT-2008. The patient sought medical attention in office. Laboratory tests performed included urine pregnancy test. Follow up Information has been received from a registered nurse concerning a 17 year old female with a history of 1 pregnancy and 1 live birth and no reported allergies who on 19-FEB-2009 was vaccinated SC with first 0.5mL dose of VARIVAX (Merck) (lot number 661856/1222X). Concomitant therapy included DTaP (unspecified manufacturer). The registered nurse reported that the patient did not experience local reaction of vaccination site neither herpes zoster symptoms after vaccination. The patient was schedule for an ultrasound prenatal testing on 10-MAR-2009. Information has been received from the registered nurse through the Pregnancy Registry for VARIVAX (Merck), concerning the patient who on 17-JUL-2009 (38 weeks) delivered a normal and healthy male baby weighing 6 pounds and 10.9 ounces. No congenital anomalies. There were non concomitant medications during pregnancy. There were complications or abnormalities, the patient delivered per elective c-section (not further specified). There were no complications during the pregnancy and labor/delivery, and no concurrent medical conditions. On 12-DEC-2008, during the pregnancy, the patient experienced Chlamydia infection which was treated on the same day. There were no other medications used during this pregnancy. Upon internal review elective C-Section was considered to be an other important medical event. Additional information has been requested.

VAERS ID:354464 (history)  Vaccinated:2009-08-05
Age:17.0  Onset:2009-08-05, Days after vaccination: 0
Gender:Female  Submitted:2009-08-17, Days after onset: 12
Location:California  Entered:2009-08-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Convulsion in childhood
Diagnostic Lab Data: electrocardiogram, negative; diagnostic laboratory, "CMP" urine analysis; hematology, genetic blood tests negative; complete blood cell, negative
CDC Split Type: WAES0908USA01924
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Electrocardiogram normal, Full blood count normal, Grand mal convulsion, Loss of consciousness, Metabolic function test, Urine analysis
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 physician concerning a 17 year old female with childhood seizures from age 5-11 years old and had been seizure free since 11 years old and with no drug reactions/allergies. On 05-AUG-2009 the patient was vaccinated IM with the first 0.5ml dose of GARDASIL. The patient had been on DEPAKOTE (last dose was at age 13). On 05-AUG-2009 three hours after she received GARDASIL the patient had a grand mal seizure with loss of consciousness. The patient was seen in the emergency room at the hospital. There was no family history of seizure noted. The lab diagnostics studies performed: Genetic blood tests, "CBC", "CMP" urine analysis, "EKG" and all were negative. The patient was scheduled for a 48 hours Electroencephalography (EEG) next week. The physician requested to have WAES form faxed to him and he would provide all needed information. At the time of report the patient''s status was recovering. Upon internal review, grand mal seizure was determined to be an other medical event. Attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.

VAERS ID:354471 (history)  Vaccinated:2009-08-12
Age:17.0  Onset:2009-08-12, Days after vaccination: 0
Gender:Male  Submitted:2009-08-12, Days after onset: 0
Location:New Jersey  Entered:2009-08-18, Days after submission: 6
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; PULMICORT; ZYRTEC; CALCITRATE
Current Illness: None
Preexisting Conditions: Allergic to milk, peanuts, tree nuts, fish, shellfish, mold, dust mites PMH: asthma
Diagnostic Lab Data: Pulse ox. in ER 100%
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0206Y0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURUF551AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Anaphylactic reaction, Cough, Dermatitis exfoliative, Dyspnoea, Erythema, Hypersensitivity, Oxygen saturation normal, Paraesthesia oral
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Shortly after receiving Hepatitis A and Tdap vaccines had dyspnea and coughing along with redness of neck and tingling tongue - used ALBUTEROL inhaler and EPIPEN (administered by mother) and brought to ER where he was given PREDNISONE and observed. 8/19/09 ER records received for DOS 8/12/09 with dx: Allergic reaction. Pt presented with sx of anaphylaxis/coughing after receiving vax at PCP''s office. Given benadryl and epi at office as well as albuterol MDI. PE (+) for erythroderma. Tx with steroids and d/c.

VAERS ID:354639 (history)  Vaccinated:2008-06-03
Age:17.0  Onset:2008-06-21, Days after vaccination: 18
Gender:Female  Submitted:2009-08-01, Days after onset: 406
Location:California  Entered:2009-08-19, Days after submission: 18
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:
Diagnostic Lab Data: Systemic Lupus Erythematosus; Raynaud''s. 9/16/09 Rheumatology records received DOS 4/28/09 to 9/9/09. LABS and DIAGNOSTICS: ANA (+), ds-DNA 38 IU/mL (+), SSA (+), SSB (+). ESR 30 (H). C3 74 (L). Complement C4C 5 mg/dL (L). 24 hr Urine - Protein Total 768 mg/24 hr (H) Protein/Creatinine Ratio 667 mg/g creat (H). CHEM - Glucose 104 mg/dL (H) Potassium 3.6 mmol/L (L) Calcium 8.7 mg/dL (L) Albumin 3.5 g/dL (L) AST 11 U/L (L). Urinalysis - Cloudy, Protein 3+, Squamous Epithelial Cells 20-27 HPF (H), Bacteria many.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X2UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Alopecia, Anaemia, Antibody test abnormal, Antinuclear antibody positive, Arthralgia, Aspartate aminotransferase decreased, Bacteria urine, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Butterfly rash, Complement factor C3 decreased, Complement factor C4 decreased, DNA antibody positive, Dizziness, Dry skin, Dysmenorrhoea, Fatigue, Headache, Joint stiffness, Joint swelling, Leukopenia, Musculoskeletal stiffness, Pain in extremity, Polyarthritis, Protein urine present, Rash, Rash generalised, Raynaud's phenomenon, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Urinary sediment present, Urine abnormality, Urine protein/creatinine ratio increased, Vitiligo, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Vasculitis (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (narrow), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: Fatigue, dry skin, extreme fatigue, light headed, headache, increased menstrual cramps, Raynaud''s disease, weight loss, hair loss, joint pain, facial rash, extreme joint pain, body rash. 9/16/09 Rheumatology records received DOS 4/28/09 to 9/9/09. Assesment: Systemic Lupus Erythematosus. Vitiligo. Patient presented with progressive fatigue and weight loss with impaired functional capacity. Joint pain, swelling, and stiffness at PIPs, MCPs and wristes. Malar rash and Raynauds of feet. Leukopenia, anemia. Inflammatory polyarthropathy.

VAERS ID:354784 (history)  Vaccinated:2009-08-07
Age:17.0  Onset:2009-08-07, Days after vaccination: 0
Gender:Female  Submitted:2009-08-20, Days after onset: 13
Location:Washington  Entered:2009-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Possible dehydration- patient told EMT''s that she had not had anything to eat or drink since the day before her injection.
Preexisting Conditions: No Allergies, Migraine headaches, Smoker.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1130X1IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Hyperhidrosis, Inappropriate schedule of drug administration, Injection site pain, Muscle rigidity, Neck pain, No reaction on previous exposure to drug, Pain in extremity, Pallor, Presyncope, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Patient had first Gardisil injection at her pediatric clinic without complications approximately 1 year ago. Gave 2nd Gardisil 0.5ml injection in L Deltoid on 8/7/09. Patient stated that it hurt then started to lean to the left side. Her body went rigid, hands clenched at chin level. She quickly sat up and opened eyes and became responsive. She was pale, diaphoretic, radial pulse of 58 bp 90/60. Placed her head between knees and did slow deep breathing. Patient stated she felt better. VS more stable...pulse 64, bp 96/62. Aproximately 10 minutes later, patient became pale, diaphoretic, dizzy c/o neck pain. Radial pulse 58, thready, bp 92/58. Staff called 911. Kept patients head down, slow breathing until EMT''s arrived. Gave EMT''s report of sx and vitals. Patient vomited x 2. Patient recovered. EMT''s stated that she vasovagaled from the injection. She had not eaten dinner the night before or breakfast or had anything to drink since the night before which may have contributed to the fainting as well. Patient did not want to go to ER...father signed release, patient left with dad and boyfriend.

VAERS ID:354969 (history)  Vaccinated:2008-08-23
Age:17.0  Onset:2008-08-23, Days after vaccination: 0
Gender:Female  Submitted:2009-08-20, Days after onset: 362
Location:California  Entered:2009-08-22, 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: Moderate pain at injection site
Preexisting Conditions: Asthma, seasonal allergies. 9/1/09 ER records received DOS 3/5/09. Allergy to Augmentin. Asthma.
Diagnostic Lab Data: Upon arriving at the ER at Medical Center, prior to seeing the doctor, the nurse took my vitals and noticed that one of my pupils were slightly dilated. I saw the doctor and he ordered labs and brain scans. After a CT, lumbar puncture, and full labs (blood test, urine screening) on the ER visit on March 5, 2009, all tests came back normal. The ER doctor I was seen by Dr., prescribed me Tylenol 3 with Codeine and recommended that I should go see a neurologist. 9/1/09 ER records received DOS 3/5/09. LABS and DIAGNOSTICS: Lumbar Puncture (-). CAT Scan Brain - WNL. CBC - Anisocytosis 1+.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2622AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Altered visual depth perception, Asthenia, Balance disorder, Blood test normal, Computerised tomogram normal, Condition aggravated, Confusional state, Disability, Disorientation, Dizziness, Drug screen negative, Epistaxis, Fall, Fatigue, Gait disturbance, Headache, Injection site pain, Laboratory test normal, Lumbar puncture normal, Movement disorder, Nausea, Pain, Pain in extremity, Visual impairment
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: From the time of vaccination until about a month after, I experienced moderate pain in my left arm at the injection site and in the entire arm and had pain when trying to move it. By that time, school had started on Sept 26, and over the course of the next few months and to the present I began to (and still) experience weakness, dizziness, and fatigue, sometimes with episodes of confusion or disorientation. No matter how much rest or sleep I get, I still experience those symptoms. Also during this same time period, I began to get chronic headaches that varied in severity and struck suddenly during everyday activities. I know for a fact that the headaches were neither due to dehydration or heat stroke because I drink 2 liters of water daily and it was the winter season. In late 2008, around early December, I began to notice something off in my vision. It seemed that when I looked at straight lines, like edges of a wall or a doorframe, etc, the surfaces seemed to shake. All of my symptoms persisted into the new year and the dizziness and vision problem worsened. During January 2009, I started to become so dizzy that it began to affect my balance. I would start stumbling or have errors in depth perception and walk into walls or other solid objects. The vision problem, after doing some online research, I believe is a condition called nystagmus, started to affect not just straight-line figures in my vision, but all shapes and figures. Soon I was seeing my entire environment seem like it was all vibrating or oscillating from side to side or up and down very rapidly. These symptoms, along with the dizziness continued up until February 27, 2009. On the morning of Feb 27, at 8:00a I had just woken up and started to brush my teeth when blood started streaming out of my nose. I hadn''t irritated my nose by blowing it or picking it and my nose wasn''t too dry either. It was a completely random occurrence. It just started bleeding and it wouldn''t stop. Within five minutes'' time so much blood had flowed out that it was all over my face and my bathroom sink looked like something out of a horror movie. I tried to use tissue to ebb the flow, but I bled right through the tissue in a matter of seconds. My blood wasn''t clotting at all. In a moment of panic and what I thought was a good idea to get the bleeding to stop, I reached under my sink and to grab a Super Plus absorbency tampon and removed the insertion tubes and put the tampon in my nose. My nose continued to bleed for the next two hours before it finally stopped (10:15a). About four to five hours later, I experienced the worst headache I''d ever had. I was completely incapacitated. I couldn''t even lift my head or even try to think because it hurt so much. I just laid on my living room sofa from the onset of the headache, not moving until I had to go to bed at 10:00pm. From 2:15pm until 10:00pm I had been taking 2 Tylenol and 1 ibuprofen for the pain (every 4 hours for the Tylenol, every 8 for the ibuprofen--I followed all dosage directions properly and did not overmedicate), but it was having no effect whatsoever. While I had the headache I felt very dizzy and disoriented even though I was lying down and not moving. I suffered with these incapacitating headaches for the next six days and had to continue to attend school. At school, the headaches came up on me from doing any form of physical exertion, even things as simple as walking or climbing up a couple of stairs on campus. (I have no heart problems nor diabetes nor am I obese. I am at a healthy, normal weight for my age and height and I have a healthy, normal heart.) At school, there were many instances where I became so dizzy I thought I was going to pass out. I never lost consciousness, but when I got home and my head was still pounding, I would eat, finish homework, and then go to sleep--it was the only thing that I could do to stop feeling the pain, if only for a few hours. But even after sleeping, I would wake up with the same hea

VAERS ID:355214 (history)  Vaccinated:2009-08-22
Age:17.0  Onset:2009-08-24, Days after vaccination: 2
Gender:Male  Submitted:2009-08-25, Days after onset: 1
Location:Kansas  Entered:2009-08-25
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: NO
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0778Y0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hyperhidrosis, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 2 days after getting vaccine, arm became swollen, red, very tender, had difficulty raising arm. Had sweats today. Had some mild itching until he took some benadryl on 8/24/09.

VAERS ID:355217 (history)  Vaccinated:2009-08-24
Age:17.0  Onset:2009-08-24, Days after vaccination: 0
Gender:Female  Submitted:2009-08-25, Days after onset: 1
Location:Michigan  Entered:2009-08-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1127Y IM 
HPV4: HPV (GARDASIL)MERCK & CO. INC.1129X IM 
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2826CA IM 
TDAP: TDAP (ADACEL)SANOFI PASTEURC3058AA IM 
Administered by: Public     Purchased by: Private
Symptoms: Hyperhidrosis, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 3 minutes after client received5 vaccinations she became diaphoretic, pale, nauseated, faint, this continued for about 15 minutes, kept for observation with comfort measures for 35 minutes

VAERS ID:355235 (history)  Vaccinated:2009-08-19
Age:17.0  Onset:2009-08-20, Days after vaccination: 1
Gender:Female  Submitted:2009-08-25, Days after onset: 5
Location:California  Entered:2009-08-25
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: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB326AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2929AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3070AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Lethargy, Malaise, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 24 hours post injection, high fever (mom did not check temp) lethargy, abd pain, achy, looked sick for 3 days. sibling with same symptoms but only for 24 hours

VAERS ID:355418 (history)  Vaccinated:2009-08-05
Age:17.0  Onset:2009-08-06, Days after vaccination: 1
Gender:Female  Submitted:2009-08-25, Days after onset: 19
Location:Arizona  Entered:2009-08-26, 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: ADVAIR
Current Illness:
Preexisting Conditions: None 9/3/09 Medical records received w/PMH: right knee surgery. 11/5/09 Medical records received for date 9/18/09 and 10/15/09 PMH: several syncopal episodes till age 8.
Diagnostic Lab Data: computed axial, 08/18/09, negative; laboratory test, 08/18/09, negative 9/3/09 Medical records received w/LABS: CBC, CMP, CT brain WNL. 11/5/09 Medical records received for date 9/18/09 and 10/15/09 Diagnostics: MRI brain(-), EEG(-), bl
CDC Split Type: WAES0908USA03202
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0671Y0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2919440IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0726Y1SCLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Computerised tomogram normal, Dizziness, Fatigue, Full blood count normal, Headache, Heat exhaustion, Hyperhidrosis, Malaise, Metabolic function test normal, Nausea, Nuclear magnetic resonance imaging brain normal, Syncope, Vertigo, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 17 year old female patient who on 05-AUG-2009 was vaccinated intramuscular with the first and only dose of 0.5ml GARDASIL (lot # 663452/0671Y). Secondary suspected therapy included VARIVAX administered on 05-UG-2009. Other concomitant therapy included ADVAIR and MENACTRA administered on 05-AUG-2009. On 06-AUG-2009 the patient developed exertional vertigo and extreme fatigue. The patient was a Division 1 softball player and she had not been able to participate due to these symptoms. On 18-AUG-2009 the patient had syncope and ended up in the emergency room. she was not admitted. She will be seen in the office on 19-AUG-2009. The patient had sought the physician for medical attention on 11-AUG-2009. The patient had not recovered. The patient''s exertional vertigo, extreme fatigue and syncope were considered to be disabling. Follow up information has been received from the physician concerning the 17 year old female patient who on 15-AUG-2009 had concomitantly received the second dose of VARIVAX (LOT# 664701/0726Y) and MENACTRA (LOT # U291944). On 18-AUG-2009, the patient had syncope and was taken to the Emergency room. The patient had a CT scan and laboratory tests. All testing was negative. The patient was not admitted to the hospital. The patient was seen by the physician on 19-aug-2009. The patient complained of nausea, dizzy and light-headedness on exertion. The physician stated that he was going to refer the patient to a cardiologist for evaluation. Additional information has been requested. 9/3/09 Received ER medical records of 8/18-8/19/2009. FINAL DX: dizziness w/evidence of mild heat exhaustion; possible HPV vaccine side effects. Remained stable & d/c to home w/PCP f/u. Records reveal patient experienced dizziness & malaise since vaccines, with nausea & vomiting while playing sports on day of admission. 9/8/09 Received PCP record of 8/19/09 & vaccine records. FINAL DX: syncopy & nausea Records reveal seen in ER w/neg w/u. Recovered. 11/

VAERS ID:355419 (history)  Vaccinated:2007-11-06
Age:17.0  Onset:2009-07-31, Days after vaccination: 633
Gender:Female  Submitted:2009-08-25, Days after onset: 25
Location:Pennsylvania  Entered:2009-08-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: hematology, 11/??/07, normal; platelet count, 10/03/08, 190,0; platelet count, 07/30/09, 21,00
CDC Split Type: WAES0908USA03204
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1210U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood product transfusion, Contusion, Haemorrhage, Idiopathic thrombocytopenic purpura, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a consumer concerning her 19 year old daughter who in Summer 2007 was vaccinated with the first dose of 0.5ml GARDASIL. No information was provided for the second dose of 0.5ml GARDASIL. On 06-NOV-2007 the patient was vaccinated with the third dose of 0.5ml GARDASIL. There was no concomitant medication. On 31-JUL-2009 the patient developed "Idiopathic Thrombocytic Purpura". The consumer stated that "when blood passes through the patient''s spleen the antibodies are killing her platelets causing massive bruising and internal bleeding". The patient was hospitalized on 31-JUL-2009 for 4 days. The patient''s platelet count was back up after hospitalization, but was going back down again. Laboratory included blood work without result. The patient had not recovered. Additional information has also received from a medical assistant reported that the patient was vaccinated with the first, second and third dose of GARDASIL separately on 05-MAR-2007 (lot # 655849/0263U), 06-JUL-2007 (lot# 658100/0525U) and 06-NOV-2007 (lot # 655154/1210U). No other vaccines given concomitantly. In September 2008, the patient was placed on birth control. Information has also been received from a physician reported that in November 2007, the patient''s blood work was normal. On 03-OCT-2008, the patient''s platelet count was 190,000. On 30-JUL-2009, the platelet count decreased to 21,000 and the patient was hospitalized the next day it''s on 31-JUL-2009. The patient was treated with IV immunoglobulin and steroids. Patient was currently on the titrating dose of prednisone. The physician considered the condition to be disabling but not life threatening. The physician dose not know if GARDASIL was the cause of this event. The patient referred to a hematologist. The receptionist of the hematologist reported that their office was not treating the patient so that the patient might have been treated elsewhere. Additional information has been requested.

VAERS ID:355489 (history)  Vaccinated:2009-08-25
Age:17.0  Onset:2009-08-25, Days after vaccination: 0
Gender:Female  Submitted:2009-08-26, Days after onset: 1
Location:Indiana  Entered:2009-08-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: DENIED
Preexisting Conditions: DENIED
Diagnostic Lab Data: 8/26 EEG- pending; CT spine- no fractures; CT head- normal; Hx of back problems/cortisone injections X 1 year
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3249AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Depressed level of consciousness, Disorientation, Electroencephalogram, Electroencephalogram normal, Head injury, Loss of consciousness, Mental status changes, Mutism, Scan brain, Syncope, Tonic clonic movements, X-ray normal
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), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (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 (narrow)
Write-up: After a few minutes patient lost consciousness; hit head on table ; unable to rouse; phoned 9-1-1 for EMS transport to Hospital;patient remains hospitalized on date of this report

VAERS ID:355627 (history)  Vaccinated:2009-07-01
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-26
Location:Unknown  Entered:2009-08-27, 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: WAES0908USA03811
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anogenital warts, Deafness, Deafness unilateral, Tinnitus
SMQs:, Hearing impairment (narrow)
Write-up: Information has been received from a pharmacist concerning a 17 year old female with unspecified drug reactions/allergies and medical history, who was vaccinated with a third dose of GARDASIL in July-2009 ("6 weeks" since vaccination) (route and lot number not reported). The pharmacist mentioned the patient experienced ringing in the ear, 50% hearing loss in the unspecified one ear and genital warts. At the time of the report the outcome of the patient was not recovered. The patient sought medical attention by visit physician''s office. Ringing in the ear, 50% hearing loss in the unspecified one ear and genital warts were considered to be disabling. Additional information has been requested.

VAERS ID:355852 (history)  Vaccinated:2009-08-21
Age:17.0  Onset:2009-08-21, Days after vaccination: 0
Gender:Female  Submitted:2009-08-28, Days after onset: 7
Location:Wisconsin  Entered:2009-08-28
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: Crohn disease-controlled, pt complains of vomiting approx once daily
Diagnostic Lab Data: R Wrist x-ray
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2825AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B039AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crohn's disease, Discomfort, Dizziness, Fall, Immediate post-injection reaction, Joint injury, Syncope, X-ray limb
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal premalignant disorders (narrow), Accidents and injuries (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: 11:30am-Pt was given Tdap, HPV, & Meningococcal Vaccine while sitting on exam table. Pt stated she felt "lightheaded" following injections and was instructed to lie down, but pt declined. Very shortly after the pt received immunizations, she fainted. As she was moving from sitting to lying down, she actually slumped forward. The drawer holding some books on the exam table was open. She apparently landed onto the drawer first and then rolled off the drawer landing on the floor. The pt awakened immediately upon becoming supine, as Dr. rushed into exam room upon hearing the loud noise. Initially pt denied discomfort but then did discover that she had some discomfort on the dorsal aspect of her R wrist. The pt was observed closely for quite some time and then allowed to sit up. Even when standing after 15-20 min., she was a little lightheaded. Further questioning revealed pt had no PO intake for the entire day. She was given a couple of glass of apple juice and was brought to parent vehicle via wheelchair. Pt mother was instructed to push fluids for remainder of the day and continue to monitor.

VAERS ID:355874 (history)  Vaccinated:2009-08-28
Age:17.0  Onset:2009-08-28, Days after vaccination: 0
Gender:Male  Submitted:2009-08-28, Days after onset: 0
Location:Wisconsin  Entered:2009-08-28
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2933AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3029AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Hypokinesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fainting on and off for about 20 minutes. Had difficulty moving hands at one point. Got client on a bed to lay down, applied cold compress, and encouraged deep breathing.

VAERS ID:355887 (history)  Vaccinated:2009-08-26
Age:17.0  Onset:2009-08-26, Days after vaccination: 0
Gender:Female  Submitted:2009-08-28, Days after onset: 2
Location:Missouri  Entered:2009-08-28
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Private     Purchased by: Unknown
Symptoms: Migraine
SMQs:
Write-up: Developed migrane headache

VAERS ID:355914 (history)  Vaccinated:2009-08-21
Age:17.0  Onset:2009-08-23, Days after vaccination: 2
Gender:Female  Submitted:2009-08-27, Days after onset: 4
Location:Michigan  Entered:2009-08-28, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3012AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0856Y1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Joint swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Joint swelling to include digits, knees, elbows.

VAERS ID:355949 (history)  Vaccinated:2009-08-17
Age:17.0  Onset:2009-08-18, Days after vaccination: 1
Gender:Female  Submitted:2009-08-28, Days after onset: 10
Location:Texas  Entered:2009-08-28
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: cyst rem. left clavicle above noted site 3 years ago
Diagnostic Lab Data: X-ray left shoulder & clavicle
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0381X2UNLA
Administered by: Private     Purchased by: Private
Symptoms: Neck mass, Pain, X-ray limb
SMQs:
Write-up: Collar bone sore. Bump on left side of neck. C/o of pain with intensity x 2 days.

VAERS ID:356033 (history)  Vaccinated:2009-07-10
Age:17.0  Onset:2009-07-24, Days after vaccination: 14
Gender:Female  Submitted:2009-08-20, Days after onset: 27
Location:Louisiana  Entered:2009-08-31, Days after submission: 11
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 60 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No known allergies; No med. condition
Diagnostic Lab Data:
CDC Split Type: LA090807
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X2IM 
Administered by: Public     Purchased by: Public
Symptoms: Blood culture negative, C-reactive protein increased, CSF cell count abnormal, CSF culture negative, Confusional state, Culture urine positive, Dizziness, Electroencephalogram abnormal, Encephalitis viral, Full blood count abnormal, Headache, Lumbar puncture, Metabolic function test normal, Musculoskeletal stiffness, Nausea, Neck pain, Nuclear magnetic resonance imaging brain abnormal, Photophobia, Red blood cell sedimentation rate increased, Similar reaction on previous exposure to drug, Staphylococcal infection, Streptococcus identification test negative, Tenderness, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: See copies of pt''s record 7/31/09. 8/20/09 Spoke by phone to mother of patient says that patient received #1 HPV on 9-19-08. On Oct/2008 patient was hospitalized for 2 mos with S/S like the S/S she had on 7/31/09 but much worse. According to mom, patient was seen at ER on 7/31/09 but not admitted. According to mom, they were told that the episode of what happened to pt. were not for sure if it was related to HPV vaccine. 17 y/o presents with c/o headache which started on Monday and increased in severity to a 7 out of 10 on pain scale. Pt. reports no blurry vision with headache. Pt. reports the headache is on the (L) side of her head and is dull in description. Pt had one episode of N/V yesterday. Pt. reports headache is about 1 out of ten now. Pt. reports neck stiffness since Monday and has increased. Pt. reports tenderness to touch of her upper neck and pain when putting chin to chest. Pt. has had similar episode in Oct. 2008 and was hospitalized for about 1 1/2-2 months with IV antibiotics (ROCEPHIN) & Acyclovir for what appeared to be HSV-1 encephalitis. Pt had CT scans & MRIs which showed some edema & focal enlargement of the right media temporal lobe. Herpes encephalitis was a consideration. Pt. also had started taking ORTHO-TRICYCLEN & GARDASIL 2 wks prior to incident. Pt also reports taking both drugs again for about 2 wks. Pt has recently returned from band camp.

VAERS ID:356038 (history)  Vaccinated:2009-08-26
Age:17.0  Onset:2009-08-26, Days after vaccination: 0
Gender:Male  Submitted:2009-08-26, Days after onset: 0
Location:Wisconsin  Entered:2009-08-31, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2735AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2768BA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Musculoskeletal stiffness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Client received MCV4 and TDAP. Approx. 1-2 minutes after became pale - had client sit down - had syncopal episode that lasted < 1 min. Client did stiffen up and attempted to stand. Had to be caught by nurse. Denies injury. Observed 20 min. until symptoms resolved.

VAERS ID:356112 (history)  Vaccinated:2009-08-24
Age:17.0  Onset:2009-08-24, Days after vaccination: 0
Gender:Female  Submitted:2009-08-24, Days after onset: 0
Location:Oregon  Entered:2009-08-31, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB312AA IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0864Y IMLA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Hot flush, Nausea, Paraesthesia, Vision blurred
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Pt had HPV, Hep A, & Verasella. Symptoms were dizzyness, nausea, hot flash, blurry eyes & tingling ears, pt layed down for 15 min w/ ice pack.

VAERS ID:356191 (history)  Vaccinated:2009-08-19
Age:17.0  Onset:2009-08-19, Days after vaccination: 0
Gender:Male  Submitted:2009-08-28, Days after onset: 9
Location:Arizona  Entered:2009-09-01, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 15 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: None Known. 9/22/09 Hospital records received DOS 8/20/09 to 9/4/09. Clubfoot.
Diagnostic Lab Data: MRI has revealed a small clot in his medulla. 9/22/09 Hospital records received DOS 8/20/09 to 9/4/09. LABS and DIAGNOSTICS: MRI Cervical Spine - Abnormal. MRI Brain - Abnormal. Chest X-ray - Abnormal. DX Swallowing Function (Barium flour
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0804Y1UNUN
Administered by: Public     Purchased by: Public
Symptoms: Activities of daily living impaired, Ataxia, Barium swallow abnormal, Blepharospasm, Brain stem infarction, Chest X-ray abnormal, Cognitive disorder, Dysphagia, Dysphonia, Face injury, Gait disturbance, Gastrointestinal tube insertion, Hypoaesthesia facial, Hypoaesthesia oral, Muscle spasticity, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Paraesthesia oral, Pneumonia aspiration, Sports injury, Swollen tongue, Thrombosis, Wallenberg syndrome
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic cerebrovascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow)
Write-up: Patient had Varicella vaccination about 3:30 pm. His mother drove him to football practice. About 5:00 PM he took a very hard hit. 15-30 minutes later he started to experience tongue swelling, tingling and numbness of the tongue and one side of his face. One eyelid twitching and closing. Air evacted to hospital. Later transferred to another hospital. Still hospitalized, can''t swallow, has had aspiration pneumonia. 9/22/09 Hospital records received DOS 8/20/09 to 9/4/09. Assessment: Lateral medullary infarct/Wallenberg Syndrome. Patient admitted after football injury, hit on left side of face. Later developed numbness on left side of face and tongue. Problems with swallowing and ataxia. Aspiration pneumonia, dysphonic voice. Scissoring and steppage gait. Deficits of ADLs. NG tube feeding. Impairment of cognition. ICD-9 Codes: 959.01, 434.91, 507.0, 781.2, 787.20, 754.70, 351.0, E886.0 E849.4, V57.89, 438.11, 438.84

VAERS ID:356226 (history)  Vaccinated:2009-08-18
Age:17.0  Onset:2009-08-18, Days after vaccination: 0
Gender:Female  Submitted:2009-08-27, Days after onset: 9
Location:Massachusetts  Entered:2009-09-01, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No 9/3/09-records received- Mom has history of panic attacks.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0381X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR43016AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chest pain, Dizziness, Fatigue, Heart rate increased, Nausea, Presyncope
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), Hypotonic-hyporesponsive episode (broad)
Write-up: Near syncope - some chest pain & dizziness nausea. 2nd episode 19th/8/09 (same SX). 9/3/09-records recived-date of service 8/25/09-2 episodes of basically near syncope, chest pain and nausea associated with it-dizziness and lightheadedness. First occurred on 8/19/09. Heart beat felt rapid. Second episode on same day. General sense of fatigue which is longstanding.C/O back pain in office day vaccines administered.

VAERS ID:356236 (history)  Vaccinated:2009-07-16
Age:17.0  Onset:2009-07-22, Days after vaccination: 6
Gender:Female  Submitted:2009-07-23, Days after onset: 1
Location:Mississippi  Entered:2009-09-01, Days after submission: 40
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.1968U0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Severe headache with fever 100 degrees F on 7/23/09.

VAERS ID:356328 (history)  Vaccinated:2008-06-03
Age:17.0  Onset:2008-11-10, Days after vaccination: 160
Gender:Female  Submitted:2009-08-25, Days after onset: 287
Location:Indiana  Entered:2009-09-02, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None. Caffeine beverages. PMH: none Allergies: NKDA
Diagnostic Lab Data: EKG; Echocardiogram; Tilt table test; EEG; Bloodwork. LABS and DIAGNOSTICS: EKG - Abnormal, sinus bradycardia with A-V dissociation and junctional rhythm. Chest X-ray - Minimal scoliosis, otherwise normal. CT Head - Sphenoid sinusitis, oth
CDC Split Type:
Vaccination
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U UNRA
Administered by: Private     Purchased by: Other
Symptoms: Arrhythmia, Atrioventricular block, Atrioventricular dissociation, Blood cortisol decreased, Blood glucose increased, Blood test, Blood urine present, Bradycardia, Cardiac murmur, Chest X-ray abnormal, Chest pain, Computerised tomogram abnormal, Contusion, Dizziness, Echocardiogram, Echocardiogram normal, Electrocardiogram, Electroencephalogram, Electroencephalogram normal, Fatigue, Head injury, Loss of consciousness, Menstruation irregular, Nasal congestion, Nodal rhythm, Red blood cell count decreased, Red blood cells urine positive, Sinus arrhythmia, Sinus bradycardia, Sinusitis, Somnolence, Syncope, Thyroid function test normal, Tilt table test, Urine analysis abnormal, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic erythropenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Conduction defects (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tubulointerstitial diseases (broad)
Write-up: Bradycardia, arrythmias, heart block, syncope, chest pains. Taking 3 kinds of medicine daily. Has plenty of follow ups with cardiologists, possibly put in a pacemaker. 9/25/09 ER records reeived DOS 11/10/08 and 11/22/08. Assessment: syncopal episodes, sinusitis, sinus arrhythmia. Patient felt dizzy, passed out, hit side of head. Presents at ER awake and alert saying she feels tired. Lost 40 lbs during the past year. Irregular periods. Nose stuffy. Drowsy. Bump on side of head. Systolic murmur left sternal border. 11/2/2009 records from 6/4-6/7/2009 and ED visit 8/5/2009. Patient was seen for c/o''s syncope on both occasions. Tx: telemetry, lab and echo normal, Ekg noted bradycardia. Patient discharged with Holter monitor. Dx: vasovagal syncope

VAERS ID:356357 (history)  Vaccinated:2009-08-31
Age:17.0  Onset:2009-09-01, Days after vaccination: 1
Gender:Female  Submitted:2009-09-02, Days after onset: 1
Location:Nevada  Entered:2009-09-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y2IMLA
Administered by: Military     Purchased by: Military
Symptoms: Chills, Pain in extremity, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Sore arm evening of vaccination. Woke up 4am, vomiting, chills, fever. Lasted 12 hours and symptoms subsided. No treatment neccessary

VAERS ID:356391 (history)  Vaccinated:2009-08-31
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-02
Location:New Mexico  Entered:2009-09-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nausea & vomiting
Preexisting Conditions: Was already having nausea & vomiting.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X2UNLA
Administered by: Private     Purchased by: Public
Symptoms: Condition aggravated, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt had nausea & vomiting after GARDASIL vaccine.

VAERS ID:356394 (history)  Vaccinated:2009-09-01
Age:17.0  Onset:2009-09-01, Days after vaccination: 0
Gender:Female  Submitted:2009-09-01, Days after onset: 0
Location:Ohio  Entered:2009-09-02, 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: On birth control (TRI-PHASIL)
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt got GARDASIL # 3 given as injection; approximately 5 mins later stood up; was walking out of room and fainted. Pt also had blood drawn as well and hadn''t eaten much that day.

VAERS ID:356442 (history)  Vaccinated:2009-06-24
Age:17.0  Onset:2009-06-24, Days after vaccination: 0
Gender:Female  Submitted:2009-09-03, Days after onset: 71
Location:Kentucky  Entered:2009-09-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: blood work cat scan and is scheduled for mri and eeg on september 18, 2009.
CDC Split Type:
Vaccination
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURNOT SURE0UNLA
Administered by: Public     Purchased by: Other
Symptoms: Blood test, Computerised tomogram, Convulsion, Grand mal convulsion, Tongue biting
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Recieved menactra on june 24 2009. She had seizure during the night bit tongue severely. Went to doctor next day, said to watch her. She had another seizure on September 1, 2009 during class at college. Was sent to emergency room.They are tonic clonic seizures. No family history of seizures and she was fine up until menactra vaccine.She has seen neurologist who has now put her on seizure medicine.

VAERS ID:356630 (history)  Vaccinated:2009-09-03
Age:17.0  Onset:2009-09-03, Days after vaccination: 0
Gender:Female  Submitted:2009-09-04, Days after onset: 1
Location:Wisconsin  Entered:2009-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BCP
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: E Room gave IV BENADRYL - no rash present
CDC Split Type:
Vaccination
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HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB287AB0UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0940X0UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Cold sweat, Dizziness, Dry skin, Dysarthria, Dyspnoea, Fatigue, Feeling abnormal, Feeling hot, Hyperhidrosis, Muscle spasms, Nausea, Paraesthesia oral, Pulse abnormal, Skin warm
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad)
Write-up: 10:05A - received vaccines shortly after got nauseated, warm. Dizzy - laid in supine position. Ice to back of neck. BP (L) arm sitting 104/60 pulse 60 slightly thready. Skin warm & dry palms sweaty/clammy. After 15-20 min c/o trouble getting breath, tongue feeling funny, general feeling "feeling funny", unable to describe. Mid chest became red in color - lacy looking at this time. Client c/o again of not being able to get breath, speech somewhat slurry & thick sounding - E vehicle called. B/P 106/68 Pulse continues to be slightly thready but 60-60 in number. Feeder were evaluated. Skin dry, palms of hands sweaty. Rash after approx 5 min decreased in intensity. Continues to c/o of feeling weird, but unable to describe feelings. Throughout this event client continued to have "spasms of legs, arms & lips - denied being cold. Transported by E-vehicle to hospital. 9-4-09 9AM TC to parent. Patient is tired, but has been taking BENADRYL. No rash at this time. Eating & drinking. Slept most of yesterday. Taking ibuprofen also for c/o HA & sore arm.

VAERS ID:356632 (history)  Vaccinated:2009-08-31
Age:17.0  Onset:2009-09-01, Days after vaccination: 1
Gender:Male  Submitted:2009-09-03, Days after onset: 2
Location:New York  Entered:2009-09-04, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500675P0IN 
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Eye swelling, Ocular hyperaemia, Sneezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Glaucoma (broad), Hypersensitivity (narrow)
Write-up: Red face & eyes after vaccine - sneezed for hrs. eye swollen. No wheezing.

VAERS ID:356735 (history)  Vaccinated:2009-08-18
Age:17.0  Onset:2009-08-19, Days after vaccination: 1
Gender:Female  Submitted:2009-08-25, Days after onset: 6
Location:Florida  Entered:2009-09-08, Days after submission: 14
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: CBC and sed rate was to be performed
CDC Split Type: 200903616
Vaccination
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0IDLA
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature increased, Cough, Full blood count, Headache, Hypoaesthesia, Hypoaesthesia oral, Red blood cell sedimentation rate
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: Initial report was received 20 August 2009 from a health care professional, who is also the patient''s parent. A 17-year-old female patient with no concurrent illness and no pre-existing medical conditions had received a first dose intramuscular injection of MENACTRA (lot number unknown) on 18 August 2009, and one day later, she experienced a frontal and temporal headache with numbness of the forehead, upper palate and upper dental area, a dry cough and an axillary temperature of 100 degrees. MOTRIN and TYLENOL were administered every six hours as corrective treatment. The patient was scheduled for a physical evaluation on 20 August 2009 and per the reporter, laboratory testing (CBS and sed rate) was to be performed. The patient''s recovery status was not reported. Document held by sender: None

VAERS ID:356909 (history)  Vaccinated:2009-06-03
Age:17.0  Onset:2009-06-12, Days after vaccination: 9
Gender:Female  Submitted:2009-09-08, Days after onset: 88
Location:Maryland  Entered:2009-09-10, 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: None
Preexisting Conditions: Autism
Diagnostic Lab Data: MRI being done, results pending
CDC Split Type:
Vaccination
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2917AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3058AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Cyanosis, Gaze palsy, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Unresponsive to stimuli, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: Received MENACTRA & Tdap on 6/3/09. Had a seizure on 6/12/09. Eyes rolled back, she stiffened and turned blue around the lips. Vomited & unresp. for 10 min. 2nd seizure on 8/3/09.

VAERS ID:356918 (history)  Vaccinated:2009-09-02
Age:17.0  Onset:2009-09-03, Days after vaccination: 1
Gender:Female  Submitted:2009-09-04, Days after onset: 1
Location:Massachusetts  Entered:2009-09-10, 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: TRISPRINTEC
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3209AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Patient reports feeling nauseated approx 2-3 hrs after flu vaccine. Vomited from 3AM 9/3 - 6AM. Also complained of headache. Self resolved no further vomiting or nausea; headaches continued.

VAERS ID:356939 (history)  Vaccinated:2009-05-27
Age:17.0  Onset:2009-06-04, Days after vaccination: 8
Gender:Female  Submitted:2009-09-10, Days after onset: 98
Location:Louisiana  Entered:2009-09-10
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 12/23/2009 PMH: Eczema, Allergy to PanMist DM Syrp. PMH: pneumonia, chronic sinusitis, chicken pox.
Diagnostic Lab Data: MRI of head and spine +/- contrast with small areas of intensity. LP with CSF normal, including evaluation for oligoclonal bands negative. 12/23/2009 Diagnostics: WBC-Elevated, Blood cultures-Negative, Lumbar puncture-Negative, MRI of cervical spine (Oct 09): Normal, MRI (Oct 09): 2 perventricular white matter lesions on the occipital horr. The lesions do not enhance. No other lesions. MRI brain (Nov 09): Normal enhanced study with nothing to indicate focal or diffuse intracranial demyelinating process vasogenic edema or space occupying process. 01/06/2010 LABS and DIAGNOSTICS: Thyroid01 function tests-Normal, Monospot test-Neg, Sepsis workup-unremarkable, MRI brain- central signal hyperintensity on T2, clear imaging on the left parietal
CDC Split Type:
Vaccination
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0652X  RA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2869AA   
TDAP: TDAP (ADACEL)SANOFI PASTEURC3068AA   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Acute disseminated encephalomyelitis, Asthenia, Autonomic nervous system imbalance, Blood culture negative, Blood test normal, C-reactive protein increased, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Chest X-ray normal, Clonus, Convulsion, Coordination abnormal, Dyspnoea, Electrocardiogram abnormal, Encephalomyelitis, Fatigue, Gait disturbance, Headache, Hyperreflexia, Lethargy, Lumbar puncture normal, Mental status changes, Muscle twitching, Neck pain, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging normal, Pain in extremity, Palpitations, Pyrexia, Spinal X-ray normal, Tachycardia, Thyroid function test normal, Tremor, Urinary tract infection, Urine analysis abnormal, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Demyelination (narrow), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: Mental status changes starting 7 days after immunization with fever, headache, lethargy, inability to walk, discoordination, signs of autonomic instability (BP/pulse). Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 month following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She has diffuse, symmetric hyperreflexia in all extremities with 1-beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment given. 12/23/2009 Clinic note received for DOS 11/18/2009. DX: Post Vaccine ADEEM Patient presented complaint of tachycardia lasting 3 to 4 days, pain in leg, episode of right hand shaking for a few minutes, episode of rapid trembling, shortness of breath and increased headache and fatigue. Assessment: No evidence of recurrence of demyelinating lesion, re-current symptoms are residual from first attack. 12/23/2009 Neurology consult, clinic note and MRI report received for DOS 07/14/2009-11/18/2009. DX: ADEM One week after receiving Gardasil vaccine, patient developed high fever, tachycardia and unsteady gait. Patient was hospitalized (2 days) for headache and tachycardia and was treated with antibiotics. Due to persistent fatigue, patient was re-admitted and diagnostic tests were performed. All symptoms improved. Patient still has fatigue and notes twitching on arms, legs and face. Gait has returned to normal. 01/06/2010 Hospital H&P, consults and diagnostic tests received for DOS 07/13/09- 07/14/09 and laboratory tests received for DOS 06/05/09. DX: Lethargy, Headache, Weakness. Poss. Acute Demyelinating Encephalomyelitis. Patient c/o increasing weakness, pressure in the head when moving, passed out two days earlier, headach. Neurologic examinaton noted hyperreflexia with sustained clonus.

VAERS ID:356942 (history)  Vaccinated:2009-09-09
Age:17.0  Onset:2009-09-09, Days after vaccination: 0
Gender:Male  Submitted:2009-09-10, Days after onset: 1
Location:Texas  Entered:2009-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Friedreich''s Ataxia Diagnosed March 2009
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97838P20IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Gait disturbance, Muscular weakness, Paraesthesia, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: Approximately 4 hours after vaccine administered patient reported:Visual changes including letters appearing in different sizes, unsteady gait, muscle weakness and unusual sensation in hands while typing. Patient went to emergency room for evaluation. Patient was contacted on 9/10/09 and symptoms resolved.

VAERS ID:356962 (history)  Vaccinated:2009-09-08
Age:17.0  Onset:2009-09-10, Days after vaccination: 2
Gender:Female  Submitted:2009-09-10, Days after onset: 0
Location:Arizona  Entered:2009-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Sever fever and seisure~Measles + Mumps + Rubella (MMR II)~1~1.50~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0249Y90UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURV3021AA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Arthralgia, Erythema, Headache, Malaise, Neck pain, Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Severe pain 2 days after injection- neck & left side of upper body down arm into elbow, symptoms/pain are continuing to increase & travel down arm. Face showing redness/rash on cheeks & chin. Day of vaccine: headache, sick, slept.

VAERS ID:357032 (history)  Vaccinated:2009-08-24
Age:17.0  Onset:2009-08-26, Days after vaccination: 2
Gender:Female  Submitted:2009-09-03, Days after onset: 8
Location:Georgia  Entered:2009-09-11, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Well Child Check
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
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VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0856Y1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Localized swelling (quarter size), redness warm to the touch fever x 2days 101 increase.

VAERS ID:357098 (history)  Vaccinated:2009-07-23
Age:17.0  Onset:2009-09-03, Days after vaccination: 42
Gender:Female  Submitted:2009-09-11, Days after onset: 8
Location:Illinois  Entered:2009-09-11
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: was not aware she was pregnant
Diagnostic Lab Data:
CDC Split Type:
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2661AA0IMRA
Administered by: Other     Purchased by: Public
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: Miscarriage Pt was not aware she was pregnant at time of vaccine Pt was 5-6 wks pregnant at time of vaccine. H/o prior miscarriage about 1 yr ago.

VAERS ID:357164 (history)  Vaccinated:2009-06-10
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-25
Location:Missouri  Entered:2009-09-14, Days after submission: 20
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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HPV4: HPV (GARDASIL)MERCK & CO. INC.1130X0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: Gardisil vaccine was stored at temperature that was out of normal range.

VAERS ID:357184 (history)  Vaccinated:2009-09-11
Age:17.0  Onset:2009-09-14, Days after vaccination: 3
Gender:Female  Submitted:2009-09-14, Days after onset: 0
Location:Virginia  Entered:2009-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENADRYL;ALLEGRA
Current Illness: SEASONAL ALLERGIES
Preexisting Conditions: EXERCISED INDUCED ASTHMA
Diagnostic Lab Data: NONE
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3204AA4IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0982X0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local reaction, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: LEFT SHOULDER AND DELTOID 3" IRREGULAR TENDER FROM MIDDLE RED. LOCAL REACTION TO VACCINE

VAERS ID:357200 (history)  Vaccinated:2009-09-02
Age:17.0  Onset:2009-09-03, Days after vaccination: 1
Gender:Female  Submitted:2009-09-14, Days after onset: 11
Location:Missouri  Entered:2009-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: zicam taken 9/6/09
Current Illness: Denies
Preexisting Conditions: allergy to peanuts
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1584X0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1497X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3018AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3246BA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Abdominal pain upper, Headache, Hypoaesthesia, Mobility decreased, Pain in extremity, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: On 9/4/09@ 1400 client called me and notified me of the following information...9/3/09 @0630 client states woke up with tingling pain in bilateral lower extremities. States was able to attend school but also had tummy ache, head ache but no temp. Denies having taken any other meds to help aleve some of the discomfort. On 9/4/09@0630 client stated when getting out of bed that morning she was unable to walk due to pain in both legs. Client describes pain as feeling like your legs are asleep but they''re tingling so bad it hurts to move them. States pain is bilateral lower extremities and nowhere else. Client denies having taken anything for the pain. I was taking the report on 9/4/09 at approx. 2pm and asked if she had taken any meds to help alleviate pain and client denies at this time, but does state that symptoms have subsided. I instructed her to see a pcp at the local walk in clinic immediately to evaluate symptoms. Client voices that she will do so as soon as we hang up. 9/7/09@0815 Phone call made to client to check on progress. Aunt state''s she is better and is at school @ this time but will have patient call when she''s back from school today. 9/8/09@1600 patient returns call and states that all the s/sx have disappeared. She worked an 8 hour shift on that Saturday 9/5/09 following onset of her s/sx and did fine. Denies having seen a doctor for any follow up care states that she feels fine and didn''t feel like she needed further care.

VAERS ID:357350 (history)  Vaccinated:2007-08-21
Age:17.0  Onset:2009-04-12, Days after vaccination: 600
Gender:Female  Submitted:2009-09-15, Days after onset: 156
Location:Michigan  Entered:2009-09-15
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Was in Hospital for 5 days, they ran all the relevant test for blood clots. Then went to clinic, and they ran numerous tests related to blood clots and she does not have any risk factors associated with blood clotting.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1208F3IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Chest pain, Dyspnoea, Laboratory test normal, Prothrombin time prolonged, Pulmonary embolism, Pulmonary thrombosis, Ultrasound Doppler, White blood cell count increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Blood Clot in lung on 4-12-2009 and will have to be on blood thinners rest of her life. She is currently on 15mg of warifin daily to keep her blood thinned between 2-3 INR.

VAERS ID:357418 (history)  Vaccinated:2009-09-08
Age:17.0  Onset:2009-09-08, Days after vaccination: 0
Gender:Female  Submitted:2009-09-09, Days after onset: 1
Location:Iowa  Entered:2009-09-15, 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: Prenatal Vits, Tylenol
Current Illness:
Preexisting Conditions: Pregnant, gallstones
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3187AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Back pain, Breast pain, Chest discomfort, Erythema, Eye pain, Ocular hyperaemia, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Retroperitoneal fibrosis (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Hypersensitivity (broad)
Write-up: Eyes became red & sore, face red, breast sore (L). Wheezing, tightness in chest, pain inside & upper back. 2 hours after receiving flu vaccine. Pt took Tylenol, 9/8 went to ER & left without being seen. Called clinic 9/9 @ 9:00am.

VAERS ID:357531 (history)  Vaccinated:2009-09-14
Age:17.0  Onset:2009-09-14, Days after vaccination: 0
Gender:Female  Submitted:2009-09-17, Days after onset: 3
Location:South Carolina  Entered:2009-09-17
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: none
CDC Split Type: SC0927
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2933AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0734Y0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: PATIENT STATES THAT ON 9-14-09 AT ABOUT 8PM HER RIGHT ARM BECAME SORE AT INJECTION SITE, THE FOLLOWING DAY SHE STATES SHE WAS UNABLE TO LIFT HER RIGHT ARM ABOVE HER HEAD WITHOUT IT HURTING SIGNIFICANTLY, SHE ALSO STARTED HAVING SOME TINGLING IN HER RIGHT ARM THAT WENT FROM HER SHOULDER TO HER HAND, THIS SYMPTOM WOULD COME AND GO, THE FOLLOWING DAY (9-16-09) THE TINGLING CONTINUED ALONG WITH THE OTHER SYMPTOMS, PATIENT TOOK SOME BENADRYL, HER ARM BECAME NUMB AROUND 10AM AND REGAINED FEELING AT 11 AM, SHE ALSO HAD PAIN THAT RADIATES FROM HER RIGHT ARM ACROSS HER SHOULDERS TO HER LEFT SHOULDER, SHE TOOK SOME IBUPROFEN THIS AFTERNOON. ENCOURAGED PATIENT TO GO TO HER PRIMARY DOCTOR OR URGENT CARE IF SYMPTOMS CONTINUED

VAERS ID:357537 (history)  Vaccinated:2009-09-17
Age:17.0  Onset:2009-09-17, Days after vaccination: 0
Gender:Male  Submitted:2009-09-17, Days after onset: 0
Location:Florida  Entered:2009-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: mom denies
Preexisting Conditions: mom reports history of downs syndrome
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB707AA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0618Y0SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3355AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: 30-45 min after vaccines given child felt light-headed, sat down on front steps.When I was notified child was in back seat of cab and back to normal condition for child

VAERS ID:357618 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-08
Location:Minnesota  Entered:2009-09-17, 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: No
Preexisting Conditions: Duricef
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3200AA IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Oedema peripheral, Pruritus, Pyrexia, Respiratory tract congestion, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Itchy, swelling, lungs filling up, swollen feet, fever within 5 mins. Within 24 hours.

VAERS ID:357808 (history)  Vaccinated:2009-09-21
Age:17.0  Onset:2009-09-21, Days after vaccination: 0
Gender:Male  Submitted:2009-09-21, Days after onset: 0
Location:California  Entered:2009-09-21
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 STATED
Preexisting Conditions: NONE STATED
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0649Y0IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB312AA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0553Y1SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3013AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B036A0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0866Y0SCLA
Administered by: Unknown     Purchased by: Public
Symptoms: Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: CHILD FAINTED AND ASSISTED TO RESTING POSITION. LEGS ELEVATED. RESTED FOR 1/2 HOUR. FELT TINGLING IN FINGERS WHICH RESOLVED. JUICE ADMINISTERED. BP 140/80 AP 62 AND REGULAR, RESPIRATIONS EVEN AND UNLABORED. MOTHER FED CHILD BREAD. CHILD HAD NOT EATEN ALL DAY. ALERT, ORIENTED, STATES HE IS FEELING BETTER. HOME WITH MOTHER AND AUNT.

VAERS ID:357908 (history)  Vaccinated:2009-09-15
Age:17.0  Onset:2009-09-15, Days after vaccination: 0
Gender:Female  Submitted:2009-09-21, Days after onset: 6
Location:California  Entered:2009-09-22, Days after submission: 1
Life Threatening? Yes
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: WAES0909USA02188
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0381X2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Immunisation reaction, Lymphadenopathy, Nausea, No reaction on previous exposure to drug, Throat tightness, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a medical assistant concerning a 17 year old female with no medical history or drugs allergies, who on 02-JUL-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 660555/0279X), intramuscularly. The patient received a second dose of GARDASIL vaccine (lot 660612/0229X) on 03-SEP-2008 and a third dose of GARDASIL vaccine (lot # 661046/0381X) on 15-SEP-2009. There was no concomitant medication. The patient experienced reactions after her third dose of GARDASIL vaccine. The patient had vomiting, nauseas, and swollen glands. Her throat tightened also. The patient did not have any reactions from the first and the second doses of GARDASIL vaccine. No laboratories studies performed. The patient went to an emergency room but recovered within 10 minutes. A lot check has been initiated. Throat tightened was considered to be immediately life-threatening. Additional information has been requested.

VAERS ID:357956 (history)  Vaccinated:2009-09-14
Age:17.0  Onset:2009-09-14, Days after vaccination: 0
Gender:Female  Submitted:2009-09-16, Days after onset: 2
Location:California  Entered:2009-09-22, 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:
Diagnostic Lab Data: Influenza A swab sent
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B046AA IMUN
Administered by: Private     Purchased by: Private
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Influenza serology, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Received tetanus shot 9-14-09. That night had chills, dizziness, shortness of breath and chest tightness. Had fever 101 in am. No caryza, cough, sore throat. Symptoms lasted about 24 hours.

VAERS ID:358275 (history)  Vaccinated:2009-05-13
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-24
Location:Kansas  Entered:2009-09-24
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: Primary care and emergency department records received for dates of service 8/7/09 to 9/22/09. PMH: None.
Diagnostic Lab Data: saw neurologist Dr He told mother and pt that it was a reaction from Gardasil. LABS and DIAGNOSTICS: MRI Brain - Arachnoid cyst an incidental finding. CT Scan Head - Normal. X-ray Abdominal Series - Abnormal. 10/19/09 Primary care and emergency department records received for dates of service 8/7/09 to 9/22/09. Labs and diagnostics: Mono screen negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0558X0IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal X-ray, Abdominal pain, Acute sinusitis, Adverse drug reaction, Arachnoid cyst, Arthralgia, Asthenia, Computerised tomogram normal, Confusional state, Decreased appetite, Dehydration, Depression, Diarrhoea, Eye disorder, Faecaloma, Headache, Hypoaesthesia, Hypoaesthesia oral, Labyrinthitis, Malaise, Mononucleosis heterophile test negative, Neurological examination normal, Nuclear magnetic resonance imaging abnormal, Panic attack, Paraesthesia, Pharyngeal erythema, Pharyngitis, Rash, Rash erythematous, Rash papular, Rash pruritic, Streptococcal infection, Tonsillitis, Vomiting, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (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 (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: since 8/6/09 pt has had headaches, eye problems, confusion, numbeness in hands and feet. Had MRI that was negative, bones are achey. Pt had Strep at the end of July, vomiting with amoxicillin then inner ear infection in august.10/19/09. 10/05/09 Neurology consult received DOS 9/22/09. Assessment: Panic attacks. Patient was first noted to have red itchy bumps on arms and abdomen. The bumps eventually went away. Throat was red, placed on amoxicillin and started to vomit. Found to have urinary tract infection, placed on antibiotic and vomited again. Inner ear infection, placed on antibiotics, vomited, could not eat. Became confused and was seen at an ER where she had a panic attack followed by perioral numbness along with numbness and tingling of hands and feet. Fecal retention, ER visit, panic attacks. Patient now to be evaluated for c/o paresthesias over hands / feet , malaise, arthralgia. Neurological exam normal.Primary care and emergency department records received for dates of service 8/7/09 to 9/22/09. Dx: Streptococcal pharyngitis on 8/7/09. Vomiting, diarrhea, dehydration, tonsillitis 8/11/09. Acute sinusitus 9/4/09. Abdominal pain, vomiting in ED 9/6/09. Weakness, constipation, chills, numbness 9/8/09. Weakness, depression with anxiety, numbness and abdominal pain 9/9/09. Anxiety, vomiting in ED 9/10/09.

VAERS ID:358381 (history)  Vaccinated:2009-09-14
Age:17.0  Onset:2009-09-14, Days after vaccination: 0
Gender:Female  Submitted:2009-09-25, Days after onset: 11
Location:Iowa  Entered:2009-09-25
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 BIOLOGICALSAHAVB244AD0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0672Y0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2670AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B036BA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: immediate syncope event folling all shots

VAERS ID:358386 (history)  Vaccinated:2009-02-09
Age:17.0  Onset:2009-02-10, Days after vaccination: 1
Gender:Male  Submitted:2009-09-25, Days after onset: 226
Location:Michigan  Entered:2009-09-25
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
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0726X1IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04921SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1255X1SCLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2078AC1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1384X1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site discolouration, Injection site pruritus
SMQs:
Write-up: Discoloration of skin where vaccine given and itching at site for appox. 6 weeks after vaccination

VAERS ID:358516 (history)  Vaccinated:2009-08-17
Age:17.0  Onset:2009-09-13, Days after vaccination: 27
Gender:Female  Submitted:2009-09-15, Days after onset: 2
Location:Unknown  Entered:2009-09-28, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0008876
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  IN 
Administered by: Other     Purchased by: Other
Symptoms: Depression
SMQs:, Depression (excl suicide and self injury) (narrow)
Write-up: A serious clinical trial report of Grade 3 depression was received from an Investigator concerning a 17 year-old female, subject number (2018007) who is enrolled in a study. The subject''s past medical history and concomitant medications were not reported. The subject received one dose of MEDI3414 or placebo on 17-Aug-2009 intranasally. On 13-Sep-2009 the subject was hospitalized for depression. The event of depression was reported as ongoing. The Study Investigator reported the causality of the depression to MEDI3414 or placebo as none.

VAERS ID:358563 (history)  Vaccinated:2009-09-21
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-28
Location:Massachusetts  Entered:2009-09-28
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
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA474CA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: pt given adult vaccine pt is 17 y.o.

VAERS ID:358746 (history)  Vaccinated:2009-09-29
Age:17.0  Onset:2009-09-29, Days after vaccination: 0
Gender:Female  Submitted:2009-09-29, Days after onset: 0
Location:Louisiana  Entered:2009-09-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DepoProvera
Current Illness: denies
Preexisting Conditions: denies
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y2IMRA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Dyskinesia, Posture abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: Approximately 3 minutes after Gardasil injection, patient began slumping forward in her chair, and then began slight jerking movements. Patient exhibited these movements for only 5-10 seconds. After sitting for about 15 minutes, patient began feeling better. Patient denies losing consciousness; however, reports "feeling dizzy". Patient has not eaten anything today, but has had a soda. (it is 1:42 p.m. now) DepoProvera was administered immediately after Gardasil in the opposite arm.

VAERS ID:358810 (history)  Vaccinated:2009-09-14
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-29
Location:Oregon  Entered:2009-09-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fainting post vaccination
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED05749111A0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Non noted. Adult flu vaccine given, ALFLURIA for over 18ys.

VAERS ID:358859 (history)  Vaccinated:2009-09-24
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-24
Location:Michigan  Entered:2009-09-29, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED05849111A IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Gave patient the AFLURIA vaccine instead of FLUVIRIN. No adverse events reported.

VAERS ID:358893 (history)  Vaccinated:1976-05-01
Age:17.0  Onset:1976-09-01, Days after vaccination: 123
Gender:Male  Submitted:2009-09-24, Days after onset: 12076
Location:Florida  Entered:2009-09-30, Days after submission: 6
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 21 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: PMH: DM type I since 01/80, eye surgery.
Diagnostic Lab Data: Glucose over 1,250 DX studies: CT in 07/89: normal, Glucose varies 400-20.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Military     Purchased by: Private
Symptoms: Autoimmune disorder, Blood glucose increased, Computerised tomogram normal, Convulsion, Diabetes insipidus, Hypoglycaemia, Neuropathy peripheral, Polyuria, Sensory loss, Type 1 diabetes mellitus
SMQs:, Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Tubulointerstitial diseases (broad)
Write-up: Swine Flu shot that resulted in type I diabetes - Autoimmune disease in 1976-77 when diagnosed. 12/21/09 MR received for multiple service dates 03/20/86. DX Pt followed up on diabetes. Pt did not have any complaints with no signs of motor or sensory deficits. Pt insulin dependent diabetes. MR for DOS 08/15/88-16/16/88. Pt admitted to r/o diabetes insipidus. Pt had 12 L urine output. DX studies: BUN and creatinine. MR for DOS 11/01/97. DX: peripheral neuropathy and sz disorder. Pt c/o peripheral neuropathy and sz. Pt had a seizure due to hypoglycemia. Pt reported several episodes of sz in 96 and 97. Neurological exam: decreased sensation. MR for DOS Pt occasional poliuria. Neurological exam: decreased pin prick. Peripheral neuropathy.

VAERS ID:358895 (history)  Vaccinated:2009-09-17
Age:17.0  Onset:2009-09-17, Days after vaccination: 0
Gender:Male  Submitted:2009-09-29, Days after onset: 12
Location:Oregon  Entered:2009-09-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED05749111A0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: Gave pt AFLURIA instead of FLUZONE.

VAERS ID:358904 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-10
Location:New York  Entered:2009-09-30, Days after submission: 20
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3199AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Erythema at vaccine site - increased pain & heat.

VAERS ID:358917 (history)  Vaccinated:2009-09-29
Age:17.0  Onset:2009-09-30, Days after vaccination: 1
Gender:Female  Submitted:2009-09-30, Days after onset: 0
Location:Michigan  Entered:2009-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: buspar, ortho tricyclen
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3209AA IMRA
Administered by: Private     Purchased by: Public
Symptoms: Anxiety, Disturbance in attention, Dizziness, Flushing
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: dizziness, flushing, anxiety, difficulty concentrating

VAERS ID:358994 (history)  Vaccinated:2009-09-30
Age:17.0  Onset:2009-09-30, Days after vaccination: 0
Gender:Male  Submitted:2009-09-30, Days after onset: 0
Location:Texas  Entered:2009-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97838P2 IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Gaze palsy, Loss of consciousness, Tremor
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), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Administered vaccine and got up to leave and within 3 minutes patient passed out. Patient also, demonstrated tremors with eyes rolling back. The patient''s mother was there and is a physician''s assistant. The patient then snapped out of it and was talking to mom. Patient tried to stand up after laying for a while and then passed out again.. 911 was called and an ambulance took patient to hospital for observation.

VAERS ID:359243 (history)  Vaccinated:2009-10-02
Age:17.0  Onset:2009-10-03, Days after vaccination: 1
Gender:Male  Submitted:2009-10-04, Days after onset: 1
Location:Wisconsin  Entered:2009-10-04
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
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Inflammation, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: pain, redness, inflammation, applied cold compresses, ingested oral tylenol 1000mg

VAERS ID:359446 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-10-02
Location:Unknown  Entered:2009-10-05, Days after submission: 3
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: WAES0909USA03644
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blindness transient
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad)
Write-up: Information has been received from a physician, that was informed by a patient, that someone else experienced temporary blindness within one or two days after receiving the second 0.5 ml dose of GARDASIL. The pt was reported to be female between 16 and 18 years old. No further information was provided. The physician was not the treating physician of this patient and does not wish to be contacted regarding this case. The reporting physician considered temporary blindness to be disabling. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.

VAERS ID:359537 (history)  Vaccinated:2009-09-20
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:New York  Entered:2009-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control pills. Had just completed course of Abx.
Current Illness: No illness
Preexisting Conditions: Dust mite allergy.
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site induration, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Right arm swelled twice it size, but red, area tender to touch. After words "hard ball" where she recd the vaccine.

VAERS ID:359553 (history)  Vaccinated:2009-08-31
Age:17.0  Onset:2009-09-07, Days after vaccination: 7
Gender:Female  Submitted:2009-10-05, Days after onset: 28
Location:Massachusetts  Entered:2009-10-06, 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: ADVIL
Current Illness: None
Preexisting Conditions: None + Amoxicillin allergy PMH: none
Diagnostic Lab Data: None yet Lab: none Dx studies: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0216Y0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Compartment syndrome, Exercise tolerance decreased, Intervertebral disc protrusion, Muscular weakness, Myositis, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: 1 week after GARDASIL vaccine 8/31/09, pt started feeling migratory pain in her legs and weakness. Her running stamina has decreased, and she ever feels weak when she climbs stairs. Exam nl. Temp 97.6. NL DTRs, sensation, strength in legs.10/9/2009 MR from PCP received office visit 10/2/2009. Presenting c/o''s of pain and weakness in legs, sx x 4 weeks. PE was normal. DX: compartment syndrome, myositis, herniated disc syndrome. Referred to Orthopedic MD. 10/12/09 Per parent pt has not been to see any consult. Still having some weakness.

VAERS ID:359683 (history)  Vaccinated:2009-09-24
Age:17.0  Onset:2009-09-26, Days after vaccination: 2
Gender:Female  Submitted:2009-09-30, Days after onset: 4
Location:Missouri  Entered:2009-10-06, 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: Migraines PMH: migraines Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0940X2UNLA
Administered by: Public     Purchased by: Other
Symptoms: Convulsion, Headache
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Seizure on 09-26-09. 10/15/2009 received hospital records for date 9/27/2009. Patient left hospital approx 2 hours later without seeing MD or getting any Tx. 10/15/09: Hospital records receiced for date of service 9/27/09 Assessment: Pt. presented with HA pain 4/10. VSS, left before seeing MD. No mention of seizure in records. 10/16/2009 received Immunization Records.

VAERS ID:359858 (history)  Vaccinated:2009-07-02
Age:17.0  Onset:2009-07-07, Days after vaccination: 5
Gender:Female  Submitted:2009-10-06, Days after onset: 91
Location:Ohio  Entered:2009-10-07, 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: Drug hypersensitivity
Preexisting Conditions: PMH: Migraines, Asthma Allergies: Amoxicillin, Augmentin, Omnicef, Sulfa
Diagnostic Lab Data: oral T, 102.3 Lab: CBC, Lipid profile, CMP, LDH, ESR, CMV titer, IgM titer, Toxoplasmosis serology WNL, TSH 5.1 high, Cat scratch panel. Mono-test, PPD, EBV, ANA negative, ACE normal, Monocyte ct 15.6 high, Basophil ct high at 2.05, Thyroglobulin antibody test high at 127.8, Strep Test positive, Serum Cortisol, Thyroid studies WNL Dx studies/Xrays: CXR mild rt hilar lymphadenoapthy is suspected, CT neck bilateral cervical lymphadenopathy with enlarged tonsils, Pelvic US normal Labs: FSH and LH high, HCG neg
CDC Split Type: WAES0907USA00374
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1131X0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Amenorrhoea, Angiotensin converting enzyme, Anti-thyroid antibody positive, Antinuclear antibody negative, Autoimmune thyroiditis, Basophil count increased, Blood cortisol normal, Blood follicle stimulating hormone increased, Blood lactate dehydrogenase, Blood luteinising hormone increased, Blood thyroid stimulating hormone increased, Body temperature increased, Chest X-ray abnormal, Computerised tomogram abnormal, Cytomegalovirus antibody negative, Decreased appetite, Diarrhoea, Dizziness, Epstein-Barr virus antibody negative, Fatigue, Full blood count normal, Haematuria, Headache, Influenza like illness, Laboratory test normal, Lipids normal, Local swelling, Lymphadenitis, Lymphadenopathy, Malaise, Monocyte count increased, Mononucleosis heterophile test negative, Nausea, Oropharyngeal pain, Pollakiuria, Pregnancy test negative, Pyrexia, Red blood cell sedimentation rate normal, Streptococcus identification test positive, Thyroid function test normal, Tonsillar hypertrophy, Toxoplasma serology negative, Tuberculin test negative, Ultrasound pelvis normal, Urinary tract infection, Urticaria, Viral infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tubulointerstitial diseases (broad)
Write-up: Information has been received from a physician concerning a female who on 02-JUL-2009 was vaccinated intramuscularly with a dose of GARDASIL (lot no. not reported). After vaccination, on an unknown date, the patient started experiencing flu like symptoms and had swelling in her groin area. Subsequently, the patient recovered. Follow up information has been received from a licensed practical nurse who regarding a 17 year old female at 134 pounds weight and 52 inches with drug allergies to AUGMENTIN, OMNICEF, BACTRIM who on 02-JUL-2009 was vaccinated intramuscularly in the right deltoid with her first dose of GARDASIL (Lot#661954/1131X) at 11:50 am. It was reported that 5 - 7 days following GARDASIL first injection on 07-JUL-2009, the patient experienced cervical lymphadenopathy, sore throat, headache, dizziness, fever (TM 102.3), hives, nausea, diarrhea and loss of appetite. On an unknown date some symptoms dissipated but the patient had prolonged (10 weeks) of out cervical lymphadenopathy, fatigue and dizziness. Extensive work-up by a hematologist, ENT (ears, nose, and throat), infectious disease and endocrinology. At the time of the report the patient was improving. the liscensed practical nurse considered the patient''s experience to be disabling. Additional information has been requested. 10/19/2009 records from PCP, ENT, Hematologist and Endocrinologist visits. Patient 5 days post vaccine had sx of: cervical lymphadenopathy, headache, sore throat, fever, urticaria, nausea, diarrhea, dizziness , malaise, fatigue and anorexia. Initially dx''d with strep pharyngitis and was on ABX x 2 and Medrol dose pak, lymph node size decreased at first but then rebounded and have continued to enlarge since then. PE notes tender , mobile bilateral enlarged cervical lymph nodes appox 2-3 cm. ED visit 9/10/2009: sx frequent urination, hematuria. DC Dx UTI, Tx''d with ABX/Pyridium. Final Dx: Hashimoto''s Thyroiditis, Viral lymphadenitis with mono-like illness. Tx: modify activities/rest. 11/5/2009 records from OB-GYN MD 5-8/2009, with c/o''s amenorrhea

VAERS ID:359859 (history)  Vaccinated:2009-01-22
Age:17.0  Onset:2009-01-22, Days after vaccination: 0
Gender:Female  Submitted:2009-10-06, Days after onset: 256
Location:Massachusetts  Entered:2009-10-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 1/2/2009); Asthma; Smoker
Preexisting Conditions: PMH: Asthma. Previous normal full-term vaginal birth in 2007. Family h/o hydrocephalus, diabetes and hypertension. Allergies: NKDA
Diagnostic Lab Data: Beta-human chorionic, positive; Beta-human chorionic, 01/22/09, negative . Labs & Diags: Fetal U/S- 19 wks, significant hydrocephalus and dilated lateral ventricles, thin cortical mantles, and dangling choroids. fetal U/S 22wks- moderate to severe ventricular dilation (brain). MRI pelvis abnormal for fetal anomalies.
CDC Split Type: WAES0909USA04933
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS9000 IJRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Asthma, Back pain, Drug exposure during pregnancy, Foetal disorder, Nuclear magnetic resonance imaging abnormal, Pregnancy test positive, Premature labour, Ultrasound antenatal screen abnormal, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a registered nurse concerning a 17 year old female with no known drug reactions/allergies and severe asthma who on 15-APR-2008 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 659964/1978U) and on 22-JAN-2009, was vaccinated intramuscularly with the second dose of GARDASIL (Lot # 661531/1311X). Concomitant therapy included ADVAIR, FLOVENT, Prednisone, Albuterol and Influenza virus vaccine (unspecified) (given on 22-JAN-2009). The registered nurse reported that the patient became pregnant after receiving the second dose of GARDASIL. She also stated the patient delivered the baby on 11-SEP-2009; however, the baby was born with hydrocephalus. The patient sought unspecified medical attention. On 01-OCT-2009, through a telephone call, the registered nurse reported that the mother and baby were being treated by the same physician. The mother was seen in the office on 22-JAN-2009 for an appointment. She was a severe asthmatic who had been on ADVAIR for years (exact therapy dates not provided) and ADVAIR was not controlling her asthmas as well as the physician would have liked. The patient was also noted to be a smoker. On 22-JAN-2009, the patient was switched to FLOVENT, Prednisone and Albuterol for asthma management. The patient was also given a flu vaccine (manufacturer not specified) and her second dose of GARDASIL. The registered nurse further noted that on that date (22-JAN-2009) the patient had a negative urine HCG test. It was estimated that the patient was actually 3 weeks, pregnant at the time of the urine pregnancy screen because she soon found out she was pregnant and her last menstrual period was estimated to have been around 02-JAN-2009. The reporter did not have the mother OB/Gyn contact information or any specific information surrounding her labor and delivery. She reported that she thought that the baby''s hydrocephalus was diagnosed by ultrasound prior to his birth, but she did not have the baby''s chart available at the moment to consult. She did report that the baby was 36 weeks gestation at birth on 11-SEP-2009. She did not have any more details to provide. She reported that she thinks he spent time in the hospital and thought he had a stent placed to treat the hydrocephalus. The health care professional contacted during telephone follow-up could not supply the following information: healthcare provider name and contact information for mother''s OB/Gyn care or specific information about the baby. Additional information has been requested. 11/06/09 Medical records recieved for DOS range 1/22/09-10/14/09. Pt seen for asthma check 1/22/09 with vax given. ED visit for fall on ice and lower back pain mid Feb 2009. Subsequently found (+) pregnant. LMP (1/28/09). EDD 10/7/09. Return to ED 2/15/09 with abd pain and persistent back pain. UTI (+). Several ER visits for asthma exacerbations. Prenatal consults note fetus with moderate to severe hydrocephalus and club feet seen on U/S. Amnio notes normal chromosomal, male fetus. Subsequent PCP visit for exacerbation of asthma. Poor air movement. Neb and MDI tx. Improved. Live male infant born at 36wks. Apgars8/9 .Severe hydrocephalus.

VAERS ID:360084 (history)  Vaccinated:2009-10-06
Age:17.0  Onset:2009-10-08, Days after vaccination: 2
Gender:Female  Submitted:2009-10-08, Days after onset: 0
Location:Georgia  Entered:2009-10-08
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: n/a
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3174FA IMRL
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B047BA IMRL
Administered by: Private     Purchased by: Private
Symptoms: Local reaction
SMQs:
Write-up: local reaction

VAERS ID:360086 (history)  Vaccinated:2009-08-13
Age:17.0  Onset:2009-08-15, Days after vaccination: 2
Gender:Female  Submitted:2009-10-08, Days after onset: 54
Location:Oklahoma  Entered:2009-10-08
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: None Allergies: NKDA
Diagnostic Lab Data: Labs: CRP, Amylase, ESR, C3, C4, CH50, ANA, Anti-DNA, SSa, SSb, Jo1 AB all wnl/neg, TSH low, CBC wnl, UA + bacteria but urine culture negative, CMP , iron, iron sat and TIBC wnl, Antiphospholipid AB neg
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.067140IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alopecia, Antinuclear antibody negative, Antiphospholipid antibodies negative, Blood amylase, Blood iron normal, Blood thyroid stimulating hormone decreased, C-reactive protein normal, Complement factor C3, Complement factor C4, Complement factor normal, Culture urine negative, DNA antibody negative, Fatigue, Flushing, Full blood count normal, Laboratory test, Metabolic function test, Myalgia, Red blood cell sedimentation rate normal, Urine analysis abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypersensitivity (broad)
Write-up: Hair loss began within a few days of Gardasil. This continued at a dramatic rate so that she has lost what mom believes to be up to 50% of her hair volume. Has also had extreme fatigue and muscle soreness. 1/4/2010 PCP records for 8-11/2009, on 11/9/2009 patient with c/o''s hair loss, fatigue, facial flushing

VAERS ID:360421 (history)  Vaccinated:2009-10-05
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2009-10-05
Location:Ohio  Entered:2009-10-12, 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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED01549211A IMRA
Administered by: Public     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: No adverse event. Administered CSL AFLURIA Lot #1549211A to a 17 yr. old patient. Vaccine is intended for use on 18 yr. old and older. Patient waited 20 minutes and reported no side effects.

VAERS ID:360564 (history)  Vaccinated:2009-09-24
Age:17.0  Onset:2009-10-03, Days after vaccination: 9
Gender:Female  Submitted:2009-10-13, Days after onset: 10
Location:Virginia  Entered:2009-10-13
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. PMH: Asthma. ALLERGIES: none.
Diagnostic Lab Data: MRI negative; EEG pending. LABS & DIAGS: chloride 108 (H), anion gap 16 (H), MRI brain- no evidence of acute infarct, non-specific white matter changes may be seen in setting of migraine HAs, gliosis, vasculitis, demyelination or Lyme''s, L
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X1UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3158AA6UNLA
Administered by: Private     Purchased by: Private
Symptoms: Anion gap increased, Blood chloride increased, Convulsion, Electroencephalogram, Fatigue, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia, Postictal state, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Lactic acidosis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad)
Write-up: 10-309 Sz- 1st episode seizure - MRI negative - 10am. 10-12-09 Left hand weakness $g given phenytoin - 7pm. 10/23/09 Medical records received for ER visits DOS 10/03 and 10/09. FINAL DIAGNOSES: Seizure disorder, left arm parasthesia. On 10/3 first time seizure w/prolonged postictal period. Witnessed by parents. Hard to awaken. H/O extremity shaking, numbness and tingling, dropping things w/o LOC. Usually in the am. PE wnl, (+) fatigue only. Discharged to home. Planned neuro follow-up. 10/9 patient returned to ER with c/o L hand, coldness, tingling and numbness. Subtle pain 1/3 up to elbow. Equal grasp. Developed weakness bilat legs in ER. Phenytoin tx. Resolved. Discharged to home. EEG and Neuro follow-up as planned.

VAERS ID:360612 (history)  Vaccinated:2009-09-24
Age:17.0  Onset:2009-09-24, Days after vaccination: 0
Gender:Female  Submitted:2009-10-12, Days after onset: 18
Location:Virginia  Entered:2009-10-13, 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:
Current Illness: 12/30/09 laryngitis, cough
Preexisting Conditions: Unknown 12/30/09 PMH: laryngitis, cough 01/04/10 PMH: finger injury, syncope
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA04821
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0671Y0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram, Concussion, Convulsion, Dizziness, Fall, Hyperhidrosis, Immediate post-injection reaction, Joint injury, Loss of consciousness, Nausea, Neck pain, Somnolence, Syncope, Tooth injury, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a physician concerning a 16 year old female with no known drug allergies, no pertinent medical history or concurrent conditions, who on 24-SEP-2009 was vaccinated with the 0.5 mL first dose of GARDASIL (lot # 663452/0671Y). No other vaccines or concomitant medications administered. The nurse administered the injection and the patient had immediate syncope with no warning and loss of consciousness for 15 seconds. The patient fell forward off the exam table, chip a tooth, scraped her knee, had a seizure and a concussion. The whole incident was 15 seconds. The physician stabilized her neck to open her airway, turned her on her back and patient came around. The patient was transported to emergency room and got a CT scan of head and neck performed (result not reported). Subsequently the patient recovered from the events. The physician''s receptionist contacted during telephone follow-up, stated that the patient was not hospitalized and could not comment on disability or whether the event was life threatening, as there was no mention of this in the patient''s chart. Seizure, syncope with no warning, fell forward off the exam table, chip a tooth, scraped her knee and concussion were determined to be an other important medical event by the physician. No further information is available. 12/30/09 PCP record received for DOS 09/28/07- 10/15/09. Patient had syncopal episode after receiving 1st dose of Gardasil on 09/24/09. Fell forward and hit head. Pt. was diaphoretic and unresponsive for 10-15 seconds with 3 second seizure. Transferred to ED. On 09/25/09 Pt. presents for ER followup with neck pain. Tx. with Advil. Phone call from mother on 9/28/09 reports pt. having dizziness, sleepiness and nausea. Pt. went to school on 9/29/09 with headache and persistent sensitivity to left side of face. 01/04/10 ED records received DOS 02/21/06

VAERS ID:360613 (history)  Vaccinated:2009-05-11
Age:17.0  Onset:2009-05-11, Days after vaccination: 0
Gender:Female  Submitted:2009-10-12, Days after onset: 154
Location:Tennessee  Entered:2009-10-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO
Current Illness: Pregnancy NOS (LMP = 6/1/2009); Depressive disorder; Bipolar disorder
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, fetus has a misshapen skull with anterior and posterior bulging at the forehead; Pap test, Positive
CDC Split Type: WAES0910USA00171
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal disorder, Papilloma viral infection, Rash generalised, Smear cervix abnormal, Ultrasound scan abnormal
SMQs:, Anaphylactic reaction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with depressive disorder and no known drug allergies who on 17-AUG-2007 and 11-MAY-2009 was vaccinated with first dose (lot number 656051/0244U) and second dose (659184/0843X), respectively of GARDASIL. Concomitant therapy included LEXAPRO. On an unspecified date after the patient received the second dose of GARDASIL, a PAP test was positive for HPV. The registered nurse reported that the patient is now pregnant. The patient''s LMP was on 01-JUN-2009 and the EDT was 08-MAR-2010. The registered nurse reported that there was an abnormality in fetus. An initial ultrasound by their office found an abnormality and the patient was referred to an unspecified perinatologist who did another ultrasound which also showed the abnormality. There were additional work ups being done followed by perinatologist and by their office. Follow up information was received from a Licensed Practical Nurse. She reported the patient was being seen for her Ob/Gyn care. The patient received 2 doses of GARDASIL at her Pediatrician''s office: the first dose was administered on 17-AUG-2007 (Lot number 656051/0244U, route not reported) and the second dose was given on 11-MAY-2009 (Lot # 659184/0843X). The patient has a history of Bipolar disorder for which she was being treated with LEXAPRO (start date not reported). The patient''s LMP was reported as 01-JUN-2009 and her EDD is 08-MAR-2010. The licensed practical nurse further added that the maternal great uncle of the baby''s father had a history of mental retardation. The patient was on no other concomitant medications and had no other vaccinations at the same time as her GARDASIL injections. After the patient discovered she was pregnant, she stopped taking LEXAPRO (stop date not reported). The patient had a body rash during her first trimester (no further details were provided). The patient underwent a pregnancy ultrasound, the following was noted: The fetus has a misshap

VAERS ID:360714 (history)  Vaccinated:2009-10-13
Age:17.0  Onset:2009-10-13, Days after vaccination: 0
Gender:Female  Submitted:2009-10-17, Days after onset: 4
Location:California  Entered:2009-10-13, 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:
Current Illness:
Preexisting Conditions: Pt known to pass out after getting injections.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.50071AP IN 
Administered by: Other     Purchased by: Private
Symptoms: Convulsion, Loss of consciousness, Pallor
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: Pt had a mild seizure according to mother and passed out while still sitting in pharmacy. Pt was pale. Mom was able to take her to urgent care.

VAERS ID:360909 (history)  Vaccinated:2009-10-05
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Michigan  Entered:2009-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED08549111A0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
SMQs:
Write-up: Patient 17 yrs old. AFLURIA indicated for 18 and above.

VAERS ID:360918 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2009-10-14
Location:New Hampshire  Entered:2009-10-14
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 PASTEURUT3172AA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Mom stated that pt had diarrhea the next day. Dad said he also had diarrhea, but didn''t get the flu vaccine.

VAERS ID:361004 (history)  Vaccinated:2009-10-15
Age:17.0  Onset:2009-10-15, Days after vaccination: 0
Gender:Female  Submitted:2009-10-15, Days after onset: 0
Location:Pennsylvania  Entered:2009-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: n/a
Preexisting Conditions: Hx of headaches and anemia
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEUR500756P0IN 
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3210AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0819Y2IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B045CA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Child c/o itchiness of b/l arms. No rash present. Child was otherwise well. VSS. Lungs CTA. MD was notified. Benadryl given. CHild stayed in office x 30 min. Itching resolved. No further intervention required.

VAERS ID:361149 (history)  Vaccinated:2009-10-09
Age:17.0  Onset:2009-10-09, Days after vaccination: 0
Gender:Male  Submitted:2009-10-09, Days after onset: 0
Location:Washington  Entered:2009-10-16, 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: None per profile
Current Illness: None
Preexisting Conditions: None or not specified
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICSP8447P10IMRA
Administered by: Other     Purchased by: Private
Symptoms: Convulsion, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Pt had seizure minor episode, dizzieness, nauseaus sensation within 5 minutes of FLUVIRIN shot. It lasted fo 15 min and was taken to St. Peters ER. Pt. was administered 0.3 mg Epipen injection at 4:25 pm on 10/9/09, after the reaction. Patient is in stable condition now per Dr.

VAERS ID:361318 (history)  Vaccinated:2007-10-20
Age:17.0  Onset:2007-10-20, Days after vaccination: 0
Gender:Female  Submitted:2009-10-17, Days after onset: 728
Location:Florida  Entered:2009-10-17
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: allergic codeine, pcn
Diagnostic Lab Data: MRI, MRV, CAT SCANS, numerous blood work studies, EEG, EKG, Holt monitor, tilt table testing.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angiogram normal, Antibody test negative, Anxiety, Autonomic nervous system imbalance, Blindness, Blood test, Chest pain, Computerised tomogram, Convulsion, Deafness, Depression, Dizziness, Ear pain, Echocardiogram, Echocardiogram normal, Electrocardiogram, Electrocardiogram ambulatory normal, Electroencephalogram normal, Faecal incontinence, Fatigue, Headache, Hyperhidrosis, Hypertension, Injection site pain, Insomnia, Loss of consciousness, Menstruation irregular, Migraine, Muscular weakness, Myalgia, Nausea, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Orthostatic hypotension, Pain in extremity, Palpitations, Panic reaction, Papilloedema, Paraesthesia, Postural orthostatic tachycardia syndrome, Quality of life decreased, Sinusitis, Syncope, Tachycardia, Tilt table test, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (broad)
Write-up: severe pain at injection site, since that time has started blacking out, seizures, migraines, heart palpitations, blood pressure control problems, nausea, severe pain in extremities, tingling in arms and legs,severe tiredness, low quality of life. 11/4/09 Medical records received for date 6/5/08 to 10/28/09. 6/5/08 Pt established care at PCP with initial c/o multiple syncopal episodes in past few wks. Mostly when changing positions lying/sitting. DX: syncope, irreg. menses, sinusitis, insomnia. Multiple OV for c/o syncope, body aches, dizziness, chest pain, ear pain, DX: syncopal episodes, orthostatic HTN, muscle pain, chest pain, tachycardia, depression/anxiety, autonomic dysfunction.

VAERS ID:361742 (history)  Vaccinated:2009-10-06
Age:17.0  Onset:2009-10-07, Days after vaccination: 1
Gender:Female  Submitted:2009-10-12, Days after onset: 5
Location:Florida  Entered:2009-10-20, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0819Y0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2874BA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain and swelling of hands and feet - mild but uncomfortable - no 1 or at injection site inflammation swelling or discomfort no rash, fever or other symptoms.

VAERS ID:361803 (history)  Vaccinated:2009-10-13
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-10-13
Location:Ohio  Entered:2009-10-20, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB632AA2IMRA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
SMQs:
Write-up: None. Pt given Adult Hep B instead of pediatric Hep B. There was no adverse event: This was a 17 year old getting an adult dose of Hep B. No adverse event noted.

VAERS ID:361804 (history)  Vaccinated:2009-10-14
Age:17.0  Onset:2009-10-15, Days after vaccination: 1
Gender:Female  Submitted:2009-10-15, Days after onset: 0
Location:New York  Entered:2009-10-20, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROVENTIL, LEXAPRO 10 mg gd.
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3265JA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Lip swelling, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Flu vaccine 10-14-09 evening. LEXAPRO taken 10-15-09 for first time *swollen upper lip; body itchiness since am 10-15-09 **given PREDISONE 10 mg

VAERS ID:361879 (history)  Vaccinated:2009-10-17
Age:17.0  Onset:2009-10-18, Days after vaccination: 1
Gender:Female  Submitted:2009-10-20, Days after onset: 2
Location:Iowa  Entered:2009-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TEGRTOL 4cc 3x day
Current Illness:
Preexisting Conditions: Seizure disorder 1997
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUP001AA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Cough, Fatigue, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Parent called me at the office on Oct 19, 2009 stating that her daughter was having symptoms. Fever, cough, body aches, chills and fatigue. Daughter was have these symptoms on Oct 18, 2009. Mom checking temp frequently and giving her TYLENOL for fever. Pt is responding to medication. Mom keeping her home from school.

VAERS ID:361996 (history)  Vaccinated:2009-10-16
Age:17.0  Onset:2009-10-17, Days after vaccination: 1
Gender:Female  Submitted:2009-10-21, Days after onset: 4
Location:West Virginia  Entered:2009-10-21
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: WV0910
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS98446P1A IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0627Y IMRA
Administered by: Private     Purchased by: Public
Symptoms: Hyperaesthesia, Injection site movement impairment, Injection site pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Pt started with pain in arm early AM day prior to shot. Small area (about pencil eraser size) at site of injection. Pain increased throughout day & was unable to touch/move arm. Area at site increased in size to thumbnail by 600 pm. By 730 was upper arm & welting & tracking down & around arm given Prednisone 60 mg & Lortab ER.

VAERS ID:362124 (history)  Vaccinated:2009-10-05
Age:17.0  Onset:2009-10-06, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Oregon  Entered:2009-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD; Allesse
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3047AA UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0727Y UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, 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)
Write-up: Patient felt dizzy the day after her immunizations, and had 1 episode of syncope, no injuries.

VAERS ID:362299 (history)  Vaccinated:2009-10-12
Age:17.0  Onset:2009-10-16, Days after vaccination: 4
Gender:Male  Submitted:2009-10-22, Days after onset: 6
Location:New York  Entered:2009-10-22
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: Asthma, seasonal allergies, previous seizure disorder now resolved, nut allergy, red green color blind, lactose intolerant. 10/26/09: Primary Care Records received for date of service 10/17/09 to 10/21/09. PMH: None.
Diagnostic Lab Data: 10/26/09: Primary Care Records received for date of service 10/17/09 to 10.21.09. Labs and diagnostics: None.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3200AA12IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysgeusia, Facial palsy, Lacrimation increased, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Lacrimal disorders (narrow)
Write-up: left sided Bell''s palsy. 10/26/09: Primary Care Records received for date of service 10/17/09 to 10.21.09. Dx: Bell''s Palsy. Assessment: Presented with L side of face paralysis. Sensation of tingling in cheek. L eye watery. Had mild pain behind L ear that lasted half an hour. Feeling of weakness. Slight improvement noted with sense of taste. No nystagmus, decreased movement and L eye only closes about 90%, normal Romberg, normal heel walk and toe walk on exam. No antecedent for infection. Case discussed with neurology. Prescribed prednisone and Valtrex. Discharged to home. Bell''s Palsy was resolving by appt. on 10/21/09.

VAERS ID:362333 (history)  Vaccinated:2009-10-13
Age:17.0  Onset:2009-10-14, Days after vaccination: 1
Gender:Female  Submitted:2009-10-22, Days after onset: 8
Location:California  Entered:2009-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)MEDIMMUNE VACCINES, INC.500759P0IN 
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Cough, Fatigue, Oropharyngeal pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Patient had acute cough, fever, sore throat,chills, and fatigue.

VAERS ID:362481 (history)  Vaccinated:2009-09-16
Age:17.0  Onset:2009-09-16, Days after vaccination: 0
Gender:Male  Submitted:2009-10-16, Days after onset: 30
Location:Michigan  Entered:2009-10-23, 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: Well visit
Preexisting Conditions: NKA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3194AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3077AA0IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Depressed level of consciousness, Dizziness, Feeling abnormal, Feeling hot, Hypokinesia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Received MCV4 and seasonal TIV 9-16-09. Mom reported incident 10-15-09. Approximately 2 hours after receiving vaccines mom found him with with a blank look on face. 1/2 hour later felt "fuzzy", "dizzy" and hot, laid down on floor and could not move. Answered questions slowly with effort with mono syllables, PEARL. Mom took to ER, waited 2 hours without being seen and left in normal condition without further problem.

VAERS ID:362521 (history)  Vaccinated:2009-10-10
Age:17.0  Onset:2009-10-12, Days after vaccination: 2
Gender:Female  Submitted:2009-10-23, Days after onset: 11
Location:Washington  Entered:2009-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: History of migraine headaches
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3204AA3IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB320IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0653X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3021AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B038CA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0973Y1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Phone report from mother. Left arm swollen, red, hot to touch, itchy. Swollen area is full circumference of arm and extends approximately 6 inches from top of deltoid to mid upper arm. No fever. Mother giving Tylenol and topical hydrocortisone. Advised mother to contact pediatrician. Mother called back on 10/14/2009 and stated patient had seen Dr. and was given an antibiotic. Redness and swelling is resolving.

VAERS ID:362700 (history)  Vaccinated:2009-10-22
Age:17.0  Onset:2009-10-23, Days after vaccination: 1
Gender:Female  Submitted:2009-10-25, Days after onset: 2
Location:Maryland  Entered:2009-10-25
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: Asthma Allergy to Amoxicillin- rash
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUP009AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to vaccine, Headache, Rash generalised, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Diffuse hives. 10/27/09 ED records records received service date 10/25/09. Assessment: Allergic reaction to H1N1 Vaccine. Patient presents with generalized, diffuse, itching rash. Mild headache. Urticaria.

VAERS ID:362777 (history)  Vaccinated:2009-10-20
Age:17.0  Onset:2009-10-21, Days after vaccination: 1
Gender:Female  Submitted:2009-10-26, Days after onset: 5
Location:Minnesota  Entered:2009-10-26
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB327AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0864Y1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 10/20/09 - Mild erythema + swelling - Reaction occurred morning after vaccine was administered per pt. 10/21/09 - Treatment: Ice, BENADRYL ointment, RTC if symptoms persist.

VAERS ID:362849 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-10-23
Location:Unknown  Entered:2009-10-26, 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: WAES0910USA02373
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Chronic fatigue syndrome, Dyspepsia, Hypoaesthesia, Muscle spasms, Myalgia, Nausea, Pain, Paralysis, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow)
Write-up: It was reported in a newspaper article that a 17 year old female who on 09 February (year unknown) was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported) and a dose of MENACTRA. Subsequently the patient experienced digestive problems, rashes, severe muscle pain. The patient''s mother reported that the patient was in pain every day. The patient had to drop out of a major skating competition because she can no longer land jumps or handle a four-minute routine. The patient was seen by several physicians. The patient agreed that something catastrophic must have happened to cause the extreme nausea that put the patient on acid blockers, the muscle pain that at one time required morphine, and that "roaming paralysis" that sometimes cramped her hands into claws and numbed her feet. Finally, in April, a rheumatologist wrote that the patient most likely was suffering from positive fatigue syndrome. Without explaining, the rheumatologist wrote that "it was possible" but "not very likely" that the patient''s Feb, 9 GARDASIL and MENACTRA immunizations triggered the symptoms. The patient''s mother was convinced that GARDASIL caused her daughter''s symptoms. Upon internal review, paralysis was determined to be an other important medical event. This is one of several reports from the same source. No further information is available.

VAERS ID:363260 (history)  Vaccinated:2009-10-26
Age:17.0  Onset:2009-10-27, Days after vaccination: 1
Gender:Female  Submitted:2009-10-27, Days after onset: 0
Location:Georgia  Entered:2009-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ocella Birth Control Pills
Current Illness: No
Preexisting Conditions: Menorrhagia, Herpetic Vulvitis, Depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)MEDIMMUNE VACCINES, INC.500757P0IN 
Administered by: Private     Purchased by: Public
Symptoms: Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticarial rash with facial swelling

VAERS ID:363397 (history)  Vaccinated:2009-02-19
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2009-10-28
Location:Texas  Entered:2009-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: TX090011PU
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB260AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X2IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2816AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: TODAY PATIENT''S MOTHER INFORMED ME THAT PATIENT HAS DISCOVERED THAT SHE IS PREGNANT. SHE THINKS HER LAST MENSTRAL PERIOD WAS IN DECEMBER 2008.

VAERS ID:363446 (history)  Vaccinated:2009-10-27
Age:17.0  Onset:2009-10-27, Days after vaccination: 0
Gender:Female  Submitted:2009-10-28, Days after onset: 1
Location:Missouri  Entered:2009-10-28
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 Allergies Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUP005AA1IJRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest pain, Cyanosis, Dyspnoea, Fatigue, Headache, Nausea, Neck pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Labored breathing, blue fingers, headache, chest pains, very tired.

VAERS ID:363456 (history)  Vaccinated:2009-10-21
Age:17.0  Onset:2009-10-21, Days after vaccination: 0
Gender:Female  Submitted:2009-10-21, Days after onset: 0
Location:North Carolina  Entered:2009-10-28, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0216Y1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, Hypoaesthesia, Injected limb mobility decreased, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Shot @ around 9am L arm, @ 10:45am, tingling sensation from shoulder to fingers, then decreased strength then numb unable to use. L leg tingles. @ 2:45, numbness resolves, tingling starts @ 4:00pm - painful L humenous forarm . still present x 4 - 6 hours then resolved.

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