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Case Details (Sorted by Age)

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VAERS ID:356266 (history)  Vaccinated:2009-08-12
Age:18.0  Onset:2009-08-12, Days after vaccination: 0
Gender:Female  Submitted:2009-09-01, Days after onset: 20
Location:Kansas  Entered:2009-09-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2875AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain, Dyskinesia, Fall, Head injury, Loss of consciousness, Skin laceration, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient fainted and fell to floor hitting head on exam stool. LOC was approximatedly 10 seconds, BP 90/60, P 56, arms jerking, laceration on left side of forehead, c/o blurry vision and abd pain. EMS called and was transported to hospital via ambulance.

VAERS ID:356410 (history)  Vaccinated:2009-08-27
Age:18.0  Onset:2009-08-27, Days after vaccination: 0
Gender:Male  Submitted:2009-08-28, Days after onset: 1
Location:Oregon  Entered:2009-09-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.50067AP IN 
Administered by: Other     Purchased by: Public
Symptoms: Chest discomfort, Lip oedema, Ocular hyperaemia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Glaucoma (broad), Hypersensitivity (narrow)
Write-up: Edema of lips, red eyes, hives on arms, back of head, chest tightness. Patient took BENADRYL. Rx for prednisone taper.

VAERS ID:356422 (history)  Vaccinated:2009-03-03
Age:18.0  Onset:2009-03-22, Days after vaccination: 19
Gender:Female  Submitted:2009-09-02, Days after onset: 164
Location:Unknown  Entered:2009-09-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control Pills
Current Illness: Focal seizures
Preexisting Conditions: Acne
Diagnostic Lab Data:
CDC 'Split Type': 200903660
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2669A0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0270X2IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Arthralgia, Blood test normal, Hypersensitivity, Mechanical urticaria, Serum sickness, White blood cell count increased
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was received from a health care professional, via another manufacturer (reference number WAES 0906USA00846), on 25 August 2009. The following is verbatim from that report: "Initial and follow-up information has been received from a nurse practitioner concerning her daughter, a 18 year old female student who on 06-MAR-2009 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscularly into her right deltoid (LOT# 661703/0651X) at 10:40 am." "On 03-MAR-2009, the patient was vaccinated with her third dose of VARIVAX (Lot: 659845/0270X) intramuscularly into her right deltoid at 15:00 pm and with her first dose of MENACTRA (lot # U2669AA) intramuscularly into her left deltoid at 15:00 pm. Concomitant therapy included an unspecified birth control pill." "Subsequently the patient had an "allergic reaction, where you could write on her skin with a pen and still see it 3 hours later". However it was not specified if she meant that she could still saw ink on her skin 3 hours later or if she could still saw the indentation on her skin 3 hours later. The reporter''s daughter also experienced joint pain. The nurse practitioner said that her daughter''s allergist thought that it was an allergic reaction to MENACTRA (manufacturer unspecified). At the time of reporting the patient''s present status was unknown." "Additional information has been received from the medical assistant and provided the following additional details:" "The patient has a past medical history of acne, no known drug allergies." "The exact AE onset date is unknown, but the chart notes show an ER visit on approximately 22-MAR-2009. The patient went into the office on 23-MAR-2009 for blood work (values mostly within normal limits; WBC slightly elevated). The patient was treated with a MEDROL dose pack and BENADRYL. The medical assistant couldn''t say if the events were disabling or life threatening. The patient''s status was unknown." "The health care professional contacted during telephone follow up could not supply the following information: d

VAERS ID:356452 (history)  Vaccinated:2009-09-01
Age:18.0  Onset:2009-09-03, Days after vaccination: 2
Gender:Female  Submitted:2009-09-03, Days after onset: 0
Location:North Carolina  Entered:2009-09-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0975Y1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: A 3 cm round erythromatous indurated area around injection site.

VAERS ID:356504 (history)  Vaccinated:2009-04-14
Age:18.0  Onset:2009-04-14, Days after vaccination: 0
Gender:Female  Submitted:2009-04-14, Days after onset: 0
Location:Georgia  Entered:2009-09-03, Days after submission: 142
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None Known
Current Illness:
Preexisting Conditions: None Known
Diagnostic Lab Data:
CDC 'Split Type': GA09029
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR    
Administered by: Public     Purchased by: Public
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: MCV given in left deltoid at approximately 11:30 am. Client left with no complaint after shot & went to restaurant. Mom then states child complained of difficulty breathing & was taken to the hospital by EMS.

VAERS ID:356645 (history)  Vaccinated:2008-10-07
Age:18.0  Onset:2008-10-07, Days after vaccination: 0
Gender:Female  Submitted:2009-09-04, Days after onset: 332
Location:Unknown  Entered:2009-09-08, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 9/15/2008)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0810USA04754
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Labour complication
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from an 18 year old healthy female who on 13-OCT-2008 was vaccinated with the first dose of GARDASIL (Lot # 660393/0067X) and was about 4 weeks pregnant at the time (LMP approximately 15-SEP-2008). Estimated delivery date: 22-Jun-2009. No adverse event reported. The patient did not seek medical attention. Follow-up information was received from the registered nurse indicating that the outcome pregnancy questionnaire was forwarded to the OB/GYN who is currently seeing the patient. Follow up information was received from the registered nurse for the pregnancy registry for GARDASIL who reported that on 10-JUN-2009, the patient gave birth to a normal male infant weighing 6 pounds and 6 ounces, length 19 and head circumference 12 3/4. There were no other complications or abnormalities. It was reported that during pregnancy there were no complications. Other medication used during pregnancy included prenatal vitamins (everyday). No diagnostic tests were performed during pregnancy. During labor/delivery, the patient did not dilate and required a c-section. Upon internal review, did not dilate and required a c-section was determined to be an other important medical event. Additional information has been requested.

VAERS ID:356653 (history)  Vaccinated:2009-01-01
Age:18.0  Onset:2009-04-01, Days after vaccination: 90
Gender:Female  Submitted:2009-09-04, Days after onset: 156
Location:Unknown  Entered:2009-09-08, Days after submission: 4
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. 9/18/09 Hospital/medical records received DOS 4/16/09 to 8/24/09. Obesity. Insulin resistance syndrome. Diabetes mellitus. Hypothyroid.
Diagnostic Lab Data: Unknown. 9/18/09 Hospital/medical records received DOS 4/16/09 to 8/24/09. LABS and DIAGNOSTICS: CBC - WBC 11.6 K/MM3 (H) Lymph 25.4% (L). Urinalysis - Blood 2+ (H) RBC (+) Bacteria (+) Urobilinogen 2.0 EU/DL (H). CHEM - K 3.4 MEQ/L (L) Glu
CDC 'Split Type': WAES0909USA00324
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain upper, Activated partial thromboplastin time prolonged, Angiogram, Angiogram pulmonary abnormal, Bacteria urine, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood urine present, Carbon dioxide decreased, Chest X-ray, Chest discomfort, Chest pain, Lymphocyte percentage decreased, Metabolic syndrome, Prothrombin time prolonged, Pulmonary embolism, Red blood cells urine, Urobilin urine, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: Information has been received from a health professional concerning an 18 year old female patient who in January 2009, was vaccinated with a dose of GARDASIL (the patient was not vaccinated at the reporter''s clinic). The consumer became their patient because of the pulmonary embolism diagnosed shortly after getting GARDASIL in April 2009. The patient was treated with COUMADIN for 3 months, but then she was on aspirin daily. She has been hospitalized on several occasions due to her pulmonary embolism (one reported hospitalization lasting 10 days). It was reported that there were no other risks identified for the pulmonary embolism. At the time of the report, the patient status was unknown. The reporter considered the pulmonary embolism to be immediately life-threatening. Additional information has been requested. 9/18/09 Hospital/medical records received DOS inpatient 4/16/09 to 4/17/09 and outpatient visits to 8/24/09. Assessment: Pulmonary embolism and infarction. Dysmetabolic syndrome X. Patient presents with upper abdominal pain and lower chest type symptoms. Pulmonary emboli. Chest pain. ICD-9 Codes: 415.19 Pulmonary embolism and infarction. 277.7 Dysmetabolic syndrome X.

VAERS ID:356675 (history)  Vaccinated:2009-08-31
Age:18.0  Onset:2009-09-01, Days after vaccination: 1
Gender:Female  Submitted:2009-09-14, Days after onset: 13
Location:Virginia  Entered:2009-09-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB327AA0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR62729AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B029AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site cellulitis
SMQs:
Write-up: (L) Deltoid Cellulitis after MENACTRA vaccine administration (at injection site).

VAERS ID:356690 (history)  Vaccinated:2008-01-31
Age:18.0  Onset:2008-02-07, Days after vaccination: 7
Gender:Female  Submitted:2009-09-03, Days after onset: 573
Location:Puerto Rico  Entered:2009-09-08, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Unknown
Symptoms: Eye swelling, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Swelling eyes and lips, and all over the body. And can walk. And it come and go. On this day is starting.

VAERS ID:356798 (history)  Vaccinated:2009-07-27
Age:18.0  Onset:2009-07-27, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Illinois  Entered:2009-09-09
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 LIMITEDAFLLA192AA0UNRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB245AB0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2992AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B046AA0UNRA
Administered by: Military     Purchased by: Military
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: See attached.

VAERS ID:356950 (history)  Vaccinated:2006-10-10
Age:18.0  Onset:2006-12-01, Days after vaccination: 52
Gender:Female  Submitted:2009-09-10, Days after onset: 1013
Location:North Dakota  Entered:2009-09-10
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. Ortho Tri-Cyclen
Current Illness: None. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. Metrorrhagia
Preexisting Conditions: None. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. Septal rhinoplasty with tonsillectomy.
Diagnostic Lab Data: Doctors performed many tests and we came back with no answers. Other than positive results for numerous yeast infections and bladder infections. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. LABS and DIAGNOSTICS: Urinalysi
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0955F1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal pain lower, Abdominal pain upper, Alopecia, Anxiety, Bacteria urine, Bowel movement irregularity, Candidiasis, Cervical dysplasia, Colitis, Colonoscopy abnormal, Constipation, Cystitis, Depression, Diarrhoea, Disturbance in attention, Dizziness, Dyspepsia, Dysplastic naevus syndrome, Dysuria, Fatigue, Feeling abnormal, Fungal infection, Gastric disorder, Gastrooesophageal reflux disease, Headache, Irritable bowel syndrome, Joint injury, Laboratory test abnormal, Melanocytic naevus, Memory impairment, Menstruation irregular, Micturition urgency, Mucous stools, Myalgia, Nitrite urine present, Oropharyngeal pain, Pelvic pain, Pollakiuria, Premenstrual syndrome, Red blood cells urine positive, Sinusitis, Smear cervix abnormal, Systemic candida, Urinary tract infection, Vision blurred, White blood cells urine positive, X-ray limb normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Reproductive premalignant disorders (narrow), Skin premalignant disorders (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Tumours of unspecified malignancy (narrow), Uterine and fallopian tube malignant tumours (broad), Fertility disorders (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow)
Write-up: Symptoms began with hair loss two months after first shot, progressed to stomach problems, indigestion, bloating, menstrual irregularities, PMS Symtoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. We are currently treating her for Systemic Candidias. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. Assessment: Cystitis. Irritable bowel syndrome alternating type. GERD. Patient presents with urinary urgency, dysuria, and frequency. Hypogastric tenderness. Nevus on shoulder. Dysplastic Nevus. Multiple benign nevi. Sinus infection, stomach ache, constipation, feeling run down, sore throat. UTI. Diarrhea. Ankle injury. Bloating. Dizziness, ''spacy'', hair loss. Mucous in stool. Pelvic pain. LGSIL. Abnormal bowel movement pattern. Inflammation of colon.

VAERS ID:356980 (history)  Vaccinated:2008-04-01
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-10
Location:South Carolina  Entered:2009-09-11, 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: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: cervical smear, abnormal
CDC 'Split Type': WAES0909USA00783
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Smear cervix abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a nurse for GARDASIL, a pregnancy registry product, concerning an 18 year old female patient who in April 2008 was vaccinated with the second dose of GARDASIL. After receiving her second dose the patient became pregnant and miscarried. the last menstruation period was unspecified. She reported this to office after the event and they followed up with a Pap smear which came back normal. No lot number provided. At the time of report the patient''s status was unknown. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.

VAERS ID:356981 (history)  Vaccinated:2008-12-22
Age:18.0  Onset:2009-05-01, Days after vaccination: 130
Gender:Female  Submitted:2009-09-10, Days after onset: 132
Location:Michigan  Entered:2009-09-11, 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:
Preexisting Conditions: 9/18/09 Hospital records received DOS 5/27/09 to 6/4/09. Birth Control Pills. Anemia.
Diagnostic Lab Data: Unknown. 9/18/09 Hospital records received DOS 5/27/09 to 6/4/09. LABS and DIAGNOSTICS: CT - Abnormal. Venous Doppler lower extremity - Abnormal. EKG - NSR. Chest X-ray - Abnormal. Iron 43 ug/dL (L) Iron saturation 13% (L) Ferritin 448 ng/mL (H). Prothrombin time 25.6 sec (H) INR 2.57 (H). PTT 127 sec (H). CBC - RBC 3.43 M/uL (L) Hemoglobin 8.1 g/dL (L) Hematocrit 28.5% (L) MCH 23.6 pg (L) MCHC 28.4 RDW 20.3% (H). CHEM - BUN 3 mg/dL (L) Albumin 2.6 g/dL (L) Anion Gap 3 (L) Haptoglobin Serum 250.00 mg/dL (H). Lupus Anticoagulant 168 sec (H) Dilute Russel Viper Venom 51 Sec (H) dRVVT 50 sec (H).
CDC 'Split Type': WAES0909USA00762
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0546X1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Activated partial thromboplastin time prolonged, Anion gap decreased, Antiphospholipid antibodies positive, Anxiety, Aspiration pleural cavity, Blood albumin decreased, Blood iron decreased, Blood urea decreased, Breath sounds abnormal, Chest X-ray abnormal, Chest pain, Computerised tomogram abnormal, Cough, Deep vein thrombosis, Dyspnoea, Electrocardiogram normal, Haematocrit decreased, Haemoglobin decreased, Haptoglobin increased, International normalised ratio increased, Iron deficiency anaemia, Lobar pneumonia, Mean cell haemoglobin concentration, Mean cell haemoglobin decreased, Pleural effusion, Prothrombin time prolonged, Pulmonary embolism, Red blood cell count decreased, Red cell distribution width increased, Renal failure acute, Respiratory distress, Respiratory rate increased, Russell's viper venom time abnormal, Serum ferritin increased, Tachycardia, Thrombosis, Transferrin saturation decreased, Ultrasound Doppler abnormal, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad)
Write-up: Information has been received from a physician concerning a 19 year old female patient with no pertinent medical history and no known drug allergy who in August 2008 was vaccinated with the first dose of GARDASIL. In January or February 2009 the patient was vaccinated with the second dose of GARDASIL. Concomitant therapy included birth control pills (unspecified) for years. In May 2009, the patient developed a blood clot in the leg that resulted in a pulmonary embolism. She was hospitalized for several days. She was currently considered to be recovered but still taking COUMADIN. Her initial and second dose of GARDASIL were given at another office so no administration information available. The physician could not give any other details and said he was not consulted on this case. He learned of the incident through the patient''s mother. He did not have the name of the physician who administered the GARDASIL, and did not know the name of the hematologist who followed the patient. The physician did not offer to contact the patient''s mother to gain this information. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination/therapy, lot numbers, healthcare provider name and contact information. Additional information has been requested. 9/18/09 Hospital records received DOS 5/27/09 to 6/4/09. Assessment: Right lower lobe pulmonary embolism acute. Left leg DVT. Iron deficiency anemia. Pleural effusion. Viral syndrome 3 weeks prior followed by difficulty breathing. Patient now c/o increasing chest pain and shortness of breath last 7 days. Could not breath. Respiratory distress. Nonproductive cough. Decreased breath sounds right side. Anxiety. Tachycardia. Increased respiratory rate. Thoracocentesis. Acute mild renal failure. Right lower lobe pneumonia. ICD-9 Codes: 415.19 Oth Pulm embolism/Infrac, 486 Pneumonia Organism NOS, 453.41 DVT Proximal Leg, 511.9 Pleural Effusion NOS, E932.2 ADV EFF Ovarian Hormones, 280.9 Iron Defic Anemia NOS, 564.00 Constipation NOS, 477.9 Allergic Rhinitis NOS

VAERS ID:357105 (history)  Vaccinated:2009-09-09
Age:18.0  Onset:2009-09-09, Days after vaccination: 0
Gender:Female  Submitted:2009-09-10, Days after onset: 1
Location:Pennsylvania  Entered:2009-09-11, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB296AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Hyperhidrosis, Nausea, Tinnitus, Vision blurred, Visual impairment
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad)
Write-up: 10 mins after vaccine admin. pt c/o dizzy --$g sat down c/o ears ringing, blurred vision & seeing spots, nauseous & diaphoretic --$g lasted approx 10 mins. BP 96/60.

VAERS ID:357120 (history)  Vaccinated:2009-07-01
Age:18.0  Onset:2009-07-20, Days after vaccination: 19
Gender:Male  Submitted:2009-09-14, Days after onset: 56
Location:South Carolina  Entered:2009-09-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Environmental allergies (self diagnosed); migraine headaches (self diagnosed) PMH: none Allergies: NKDA 1210/09 PHM: Environmental allergies, panic attack.
Diagnostic Lab Data: 7/20/09, CRP, 11.0 H; CMP wnl except 105 H, AST 50 H; CBC wnl except WBC 11.8 H; 7/20/09, CT Lumbar Spine (without contrast): Unremarkable exam; 7/20/09, CT Head (without contrast): No acute intracranial abnormalities. Chronic sinusitis; 7/21/09, NCS: Normal motor NCS and F-wave latencies of the left median and peroneal nerves without evidence for conduction block of other findings to indicate GBS at this time. Labs: CBC: wbc high, CRP and ESR high, CSF norm, serum electrolytes wnl, UA wnl, urine drug screen (results pending) Dx studies: CT head noted chronic sinusitis, CT LS spine norm, NCV studies norm, EMG abnormal
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB160AA UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2927AA UNUN
TDAP: TDAP (ADACEL)SANOFI PASTEURAC5213041 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Aspartate aminotransferase increased, Blood electrolytes normal, C-reactive protein increased, Computerised tomogram head, Computerised tomogram normal, Cough, Drug screen, Dysphagia, Dysstasia, Electromyogram abnormal, Exercise tolerance decreased, Fall, Full blood count normal, Gait disturbance, Guillain-Barre syndrome, Headache, Hypoaesthesia, Hyporeflexia, Joint injury, Mastication disorder, Metabolic function test, Mobility decreased, Muscular weakness, Musculoskeletal discomfort, Nerve conduction studies normal, Neurological examination abnormal, Occupational therapy, Oropharyngeal pain, Pain, Pain in extremity, Physiotherapy, Pyrexia, Red blood cell sedimentation rate increased, Respiratory tract congestion, Speech rehabilitation, Urine analysis normal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Demyelination (narrow)
Write-up: Pt received immunizations (FLUMIST, HepA/B, Meningococcal, MMR, and Pneumococcal) on 7/1/09. He denied any local reaction. The pt was seen in medical on 8July09--the pt had fallen while running and injured his right knee. In reflection the pt remembered a feeling of weakness in both of his thighs. He was treated with naproxen and states that he felt ok on the 9th of July. The pt reported to medical on 20July09 with complaints of fever, sore throat, headache, cough and chest congestion for approximately 10 days. The pt remembers that several members of his platoon were sick with the same symptoms. The pt also complained of sharp, shooting pain in both of his legs and weakness in both of his arms. He denied having bowel or bladder incontinence at any time. The pt states that he experienced about 4 falls prior to this medical appt (he had intermittent numbness/weakness in his legs which seemed better after a night''s sleep). The pt was released but he returned at 1030 stating that his legs were numb, his legs were weal (R$gL). The pt was taken to a civilian ER. He had a CT scan of his head and spine (see below). The pt was discharged to full duty. On 21 July 09 the pt had difficulty walking--he fell and he required assistance to ambulate, he could not hold up his head--he felt a constant, throbbing, pressure in his neck and back, and he was having difficulty swallowing. The pt was seen by a civilian neurologist who performed an NCS (see results below). The pt was admitted to hospital with GBS. At his worst he needed assistance with getting out of bed, standing transferring; he had difficulty chewing and swallowing; and difficulty lifting his arms to feed himself. The pt received a 3 day course of IV IG .8mg/kg with improvement in his symptoms. After 4 days he was transferred to acute rehab. Prior to discharge the pt was able to swallow, he was able to walk short distances with support, his arms were weak. As of 8/27/09 the pt had no issues with swallowing or chewing. His fatigue was 60% better. He was able to feed himself and had adequate arm strength and movement to performs ADLs. He was unable to perform any pushups (prior 44), no pull ups (prior 4-5), no sit-ups (prior 88). Previously he could curl 25-30lbs and now he can curl 9 lbs for 10 reps. He fatigued within 2-3 minutes of performing on the arm bike. He was able to ambulate short distances without assistance otherwise he used a cane; he could walk on the treadmill for about 1/2 mile before he fatigued. According to the pt he had made no progress in the last 7-10 days. He is currently a pt on the "light care" unit at the hospital. 11/20/2009 ED and MR for 7/21-7/24/2009.Dx GBS Patient with c/o''s progressive extremity weakness and dysphagia. Neuro exam noted hyporeflexia. Tx: IVIG, LP, evaluated for PT, OT and ST , dc''d to inpatient rehab for continuing care 12/10/09 Medical records received for DOS 07/24/09- 07/31/09 (Rehab Inpatient Unit) and 07/20/09-9/09/09 (PCP records) Following discharge on 07/31/09, Pt. reports fatigue improving; Physical therapy reports increased muscle strength and improved balance.

VAERS ID:357167 (history)  Vaccinated:2009-06-08
Age:18.0  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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1130X0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: GARDASIL vaccine was stored at temperature that was out of range

VAERS ID:357290 (history)  Vaccinated:2009-09-09
Age:18.0  Onset:2009-09-09, Days after vaccination: 0
Gender:Female  Submitted:2009-09-09, Days after onset: 0
Location:Pennsylvania  Entered:2009-09-15, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3195AA0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: The student received the flu shot R deltoid, became pale, emesis x1, no loss of consciousness. Able to ambulate.

VAERS ID:357292 (history)  Vaccinated:2009-09-09
Age:18.0  Onset:2009-09-09, Days after vaccination: 0
Gender:Female  Submitted:2009-09-09, Days after onset: 0
Location:Pennsylvania  Entered:2009-09-15, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Denies
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3195AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: The student received a flu vaccination walked back to chair in the waiting area and fainted in her chair. Immediately arrousable with spirits of ammonia. Able to ambulate.

VAERS ID:357353 (history)  Vaccinated:2009-09-14
Age:18.0  Onset:2009-09-14, Days after vaccination: 0
Gender:Female  Submitted:2009-09-15, Days after onset: 1
Location:Oklahoma  Entered:2009-09-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB737BA0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB343BA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.01000IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0424Y0SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2990AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B039BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0860Y0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt. stated that she didn''t feel well after vaccines were given. Nurse had her lay her head down on desk. She then said she was feeling worse, she did lose consousness briefly(10-15sec.) Her father helped move her to the floor, where cold pack was placed on her neck and feet were elevated. When she was able, she also was given a juice drink.

VAERS ID:357357 (history)  Vaccinated:2007-09-07
Age:18.0  Onset:2007-10-01, Days after vaccination: 24
Gender:Female  Submitted:2009-09-15, Days after onset: 715
Location:Hawaii  Entered:2009-09-15
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: 10/26/09: Outpatient medical records received for dates of service 2/6/08 to 10/5/09. PMH: Eye surgery for esophoria, wisdom teeth removal, Allergic to Amoxicillin.
Diagnostic Lab Data: Vaccine dates: Feb 27/07, Apr 27/07, Sept 07/07 10/26/09: Outpatient medical records received for dates of service 2/6/08 to 10/5/09. Labs and diagnostics: ANA-Positive, anti-CCP ab.-Positive, anti RNP ab.-Positive, CRP-Negative, Lupus
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0469U3UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acne, Activated partial thromboplastin time prolonged, Agoraphobia, Angiogram, Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody positive, Antiphospholipid antibodies, Anxiety, Arthralgia, Cardiac stress test, Chest pain, Confusional state, Dizziness, Dyspnoea, Electrocardiogram, Electrocardiogram ambulatory, Electrocardiogram ambulatory normal, Electroencephalogram abnormal, Exercise electrocardiogram, Fatigue, Haematemesis, Lymphocyte count decreased, Major depression, Mass, Melaena, Mixed connective tissue disease, Musculoskeletal discomfort, Neutrophil count increased, Nuclear magnetic resonance imaging brain normal, Oxygen saturation decreased, Panic disorder, Raynaud's phenomenon, Respiratory disorder, Rheumatoid arthritis, Skin papilloma, Smear cervix abnormal, Systemic lupus erythematosus, Thrombosis, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Arthritis (narrow)
Write-up: The first two vaccines were no extreme signs,...just some minor ones like light headed, but after the 3rd vaccine the problems started within the following month. Reactions likes: shaking, anxiety, chest pain, trouble breathing, confusion, wart outbreak, blood issues (clotting and low oxygen levels) and later Dr''s believe she has lupus and Rhuematoid arthritis. She also just had a fibroma tumor removed from the same foot that had the large wart develop although different area. 10/26/09: Outpatient medical records received for dates of service 2/6/08 to 10/5/09. Dx: Mixed connective tissue disease, Major depressive disorder, Panic disorder with agoraphobia, Pap smear abnormal + HPV, Respiratory abnormality NEC, Anxiety state NOS, Raynaud''s syndrome. Assessment: Presents with persistent arthralgias of the hands and wrists, fatigue and achiness in neck without swelling. Had positive ANA, placed on Plaquenil. Also had positive lupus anticoagulant, but a subsequent test was negative. Started on Methotrexate weekly with positive results. Left forefoot soft tissue mass excision performed, pt. healing well at 4 weeks post op. Also had episode of hematemesis, and melena, endoscopy was normal. C/o body shakes, EEG-Abnormal. Also c/o dyspnea at times, 24 hour Holter monitoring was normal with no correlation between rhythm changes and reported dyspnea. Tendancy to desat. to 92% with exertion, though treadmill stress test was WNL; started on Advair and albuterol. Pt. has acne vulgaris and peringual warts. Additional meds.: Buspirone, Lexapro.

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