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Case Details (Sorted by Age)

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VAERS ID:319010 (history)  Vaccinated:2008-04-21
Age:15.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-07-08, Days after onset: 77
Location:Iowa  Entered:2008-07-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOCALEN XR 20mg
Current Illness: cold/sinus infection
Preexisting Conditions: ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2551AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cough, Dyspnoea, Eye swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Swelling in eyes, coughing, trouble breathing.

VAERS ID:319017 (history)  Vaccinated:2008-06-09
Age:15.0  Onset:2008-06-30, Days after vaccination: 21
Gender:Female  Submitted:2008-07-09, Days after onset: 9
Location:Missouri  Entered:2008-07-15, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Severe hives began 6/30/08. Received Gardasil #2 6/9/08. Hives several days = at office with hives, chills and headache 7/9/08 = 10 days.

VAERS ID:319021 (history)  Vaccinated:2008-07-01
Age:15.0  Onset:2008-07-04, Days after vaccination: 3
Gender:Female  Submitted:2008-07-11, Days after onset: 7
Location:Wisconsin  Entered:2008-07-15, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Syncope~HPV (Gardasil)~2~15~In Patient
Other Medications:
Current Illness: No
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Bronchitis, Dyskinesia, Eye rolling, Fatigue, Loss of consciousness, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: 3 days after 2nd HPV (2/28/08), she had a syncopal episode. She was also ill at time, seen in clinic and diagnosed with bronchitis. 3 days after 3rd HPV (7/1/08), she was sitting in a chair, said "I don''t feel well", then mom saw her eyes roll back. She had LOC. Mom noted brief jerking of arms and legs. Within 1 minute she was alert and coherent. Felt tired rest of day. No illness. Felt was prior two days.

VAERS ID:319072 (history)  Vaccinated:2008-07-14
Age:15.0  Onset:2008-07-14, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 1
Location:Maryland  Entered:2008-07-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253BA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0955F0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0273-24IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2329AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2826AA0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Loss of consciousness, Paraesthesia, Syncope, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: PT FAINTED AFTER RECEIVING 5 VACCINES: (HPV#1; HAV#2 - RT DELTOID) AND (IPV, MENACTRA, AND TDAP - LT DELTOID). PT SAID RT ARM WAS TINGLING PRIOR TO HER PASSING OUT. PT WAS UNRESPONSIVE FOR APPROX. ONE MINUTE AND ONE EPISODE OF VOMITING AFTER REGAINING CONSCIOUSNESS.

VAERS ID:319292 (history)  Vaccinated:2008-03-01
Age:15.0  Onset:2008-03-01, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 135
Location:California  Entered:2008-07-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 11/25/2007)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic, 07/01/08, pregnancy
CDC Split Type: WAES0807USA01664
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Premature baby, Premature labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician, for the pregnancy registry for GARDASIL concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (route and administrating site not reported). In March 2008, the patient was vaccinated with a second dose of GARDASIL (route and administrating site not reported). The patient became pregnant during the GARDASIL series. On approximately 01-JUL-2008 the patient was attempting to get clearance from her physician for a sport physical. The physician insisted on a pregnancy test which was positive. On approximately 07-JUL-2008 the patient delivered and the infant was born at 32 weeks gestation. The infant was placed on a respirator in the Neonatal Intensive Care Unit. Additional information has been requested.

VAERS ID:319386 (history)  Vaccinated:2008-07-14
Age:15.0  Onset:2008-07-14, Days after vaccination: 0
Gender:Female  Submitted:2008-07-16, Days after onset: 2
Location:California  Entered:2008-07-16
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2572AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1889U1SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Had swelling, redness, warmth to right arm after varicella injection

VAERS ID:319399 (history)  Vaccinated:2008-07-15
Age:15.0  Onset:2008-07-15, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 0
Location:Florida  Entered:2008-07-16, 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: YAZ
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X1IMRA
Administered by: Private     Purchased by: Other
Symptoms: Blood pressure, Disorientation, Dizziness, Hyperhidrosis, Pallor, Skin discolouration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Sweating/perspiration, discoloration (pallor), dizziness, disorientation. BP 100/62 patient laid down ammonia capsule administered.

VAERS ID:319470 (history)  Vaccinated:2008-07-07
Age:15.0  Onset:2008-07-07, Days after vaccination: 0
Gender:Male  Submitted:2008-07-15, Days after onset: 8
Location:New York  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no illnesses, pre-existing medical conditions, or use of other medications at the time of the vaccination on 07 July 2008. It was "unknown" if the patient had received any other vaccinations within four weeks of 07 July 2008, or with prior vaccinations.
Diagnostic Lab Data: Not reported
CDC Split Type: 200802225
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2562A UNRA
Administered by: Private     Purchased by: Private
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Initial report received on 09 July 2008 from a health care professional. A 15-year-old male patient, who had no concurrent illnesses, pre-existing medical conditions or use of other medications, had received on 07 July 2008 in the morning a right arm dose of MENACTRA (Lot # U2562AA, route not provided), and a dose of DTAP (trade name, manufacturer name, lot #, route and site of administration not provided). Overnight, the patient developed "facial symptoms" and was subsequently evaluated by a physician two days later and was diagnosed with facial Bell''s Palsy. It was not reported whether the patient received any treatment, or if any diagnostic tests were performed. At the time of this report, the patient had not recovered.

VAERS ID:319783 (history)  Vaccinated:2007-05-15
Age:15.0  Onset:2007-05-17, Days after vaccination: 2
Gender:Female  Submitted:2008-07-15, Days after onset: 425
Location:Iowa  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROZAC; magnesium (unspecified); PROTONIX; SEROQUEL; ZONEGRAN
Current Illness: Pregnancy NOS (LMP = 5/17/2007)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 06/15?/07 - patient was 4.5 to 6.5 weeks pregnant; beta-human chorionic, 05/15/07 - negative; beta-human chorionic, 05/31/07 - positive;
CDC Split Type: WAES0706USA03778
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0244U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan normal
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 for the Merck Pregnancy Registry for the GARDASIL via a medical assistant concerning a 15 year old female with no pertinent medical history who on 15-MAY-2007 was vaccinated intramuscularly with the first 0.5 ml dose of the GARDASIL (Lot # 656051/0244U). Concomitant therapy included PROTONIX, PROZAC, magnesium supplement (unspecified), SEROQUEL and ZONEGRAN. A blood HCG test was performed on 15-MAY-2007 and was negative. The blood HCG test was repeated on 31-MAY-2007 and was positive. An ultrasound was performed on approximately 15-JUN-2007 which showed that the patient is approximately 4.5 to 6.5 weeks pregnant. The patient''s last menstrual period was approximately 17-May-2007 and the estimated due date was 21-Feb-2008. The reporter stated that "the patient will not be having a therapeutic abortion." Follow up information has been received from a health professional at the pediatrician''s office and from a registered nurse at the obstetrician''s office, concerning the outcome of the pregnancy. There were no complications or illnesses during the patient''s pregnancy. The health professional and the nurse reported that on 27-JAN-2008, the patient gave birth to a healthy and normal male infant, apgar: 8/1; weight: (3668gms), 8lbs 1oz; length 21; and head circumference: 14. The health professional noted that the infant had no congenital anomalies. The baby however experienced respiratory distress and fever during delivery. No further information was provided. Additional information was provided. Additional information is not expected.

VAERS ID:319792 (history)  Vaccinated:2007-08-03
Age:15.0  Onset:2007-08-03, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 347
Location:Unknown  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 4/15/2007)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 11/25/07 - polyhydramnios; serum beta-human - positive
CDC Split Type: WAES0710USA03974
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Polyhydramnios, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow up information has been received from a nurse and a certified nurse midwife for the Pregnancy Registry for GARDASIL concerning a 15 year old female who on 03-AUG-007 was vaccinated with the first dose of GARDASIL (Lot #, site and route not reported). Concomitant therapy included vaccination with the meningococcal vaccine (unspecified). Subsequently, it was determined that the patient was pregnant (LMP 15-Apr-2007). The patient sought unspecified medical attention. On 25-NOV-2007, ''(also reported as 32 weeks gestation), the patient was sent for a amniotic fluid index (AFI) and the prenatal sonogram found that the patient had polyhydramnios. No numeric AFI was reported. On 20-JAN-2008, the patient delivered vaginally at term with "massive polyhydramnios". She delivered a healthy, and normal baby weighing 7 lbs, 6 oz. Both the mother and baby are doing well. Additional information is not expected.

VAERS ID:319841 (history)  Vaccinated:2008-03-15
Age:15.0  Onset:2008-03-15, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 122
Location:Maryland  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acne
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA02211
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Myalgia, Pyrexia, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Initial and follow up information has been received from a registered nurse concerning a 15 female with acne who on 15-MAR-2008 was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot#659182/175U). Concomitant therapy BENZACLIN and RETIN-A. The patient developed widespread muscle aching and a low grade fever within hours of receiving her first dose which resolved in 1-2 days with out requiring treatment. On 10-JUN-2008 the patient was vaccinated IM with a second 0.5ml dose of GARDASIL (Lot#660391/0063X). After the second dose, the patient''s mother contacted the office by phone to report her daughter''s symptoms of muscle aching, low grade fever, as well as left knee pain that occurred within a few hours of the dose. Rest and ibuprofen were prescribed. At the time of the report, the patient had not recovered. The nurse did not known if the patient was scheduled to receive the third dose. Additional information has been requested.

VAERS ID:319875 (history)  Vaccinated:2008-06-02
Age:15.0  Onset:2008-06-02, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 43
Location:California  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA02562
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
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: Information has been received from a physician concerning a 15 year old female who on 02-JUN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently, the patient fainted after the administration. The patient did not sustain any injuries. The patient sought medical attention in the office. At the time of the report the patient had recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008 Inital and follow up information has been received from a physician and a health professional concerning a 15 year old femaile who on 02-JUN-2008 at 4:50 PM was vaccinated IM with scond dose of GARDASIL (Lot #660553/0070X) in the left deltoid. There was no concomitant medication.After vaccination at 5:10PM, the patient left the office and had a syncopal event at a pharmacy. The patient required medical attention in the office. On 02-JUN-2008, the patient had recovered. Additional information is not expected.

VAERS ID:319995 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-15
Location:Ohio  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Pap test - 05/27/08 - abnor, cervix HPV DNA assay - 05/27/08 - posit - high risk HPV DNA
CDC Split Type: WAES0806USA07749
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: DNA antibody positive, Human papilloma virus test positive, Smear cervix abnormal
SMQs:, Systemic lupus erythematosus (broad)
Write-up: Information has been received from a medical assistant concerning a 15 year old female with no known drug reactions or allergies who was vaccinated with a dose of GARDASIL vaccine (yeast) and now has tested positive for high risk HPV DNA and has an abnormal Pap test. The patient received at least one and possibly two vaccinations with GARDASIL vaccine (yeast) prior to the abnormal Pap and HPV DNA test on 27-MAY-2008. The vaccination with GARDASIL vaccine (yeast) were not administered at the office in the case. The patient had never had an abnormal Pap or positive HPV DNA test in the past. It was unknown whether the patient sought medical attention. Patient outcome was not reported. Additional information has been requested.

VAERS ID:320006 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:2008-04-01
Gender:Female  Submitted:2008-07-15, Days after onset: 105
Location:Illinois  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: Splenomegaly
Diagnostic Lab Data: Serum albumin, 06/20/2008, 3.3; Serum albumin, 06/23/2008, 3.1; Total serum protein, 06/23/08, 5.6; Total serum protein, 06/20/08, 6.5
CDC Split Type: WAES0806USA08058
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0152X1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood albumin decreased, Computerised tomogram, Oedema peripheral, Protein total decreased, Protein total normal, Ultrasound Doppler
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a third dose of GARDASIL vaccine (yeast) 0.5 ml (lot# 0152X). Concomitant therapy included albuterol sulfate (VENTOLIN (albuterol sulfate)), "topical acne medicine" dermatologic (unspecified) and fluticasone propionate (FLOVENT). On 19-JUN-2008 the patient experienced leg edema. The patient was brought to emergency room on 20-JUN-2008 but was not admitted to the hospital. The patient''s leg edema persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008. Follow-up information was received from a physician concerning the patient developed edema of both lower legs/feet beginning on 19-JUN-2008. The patient had had a 10-12 pound weight gain since April, 2008. The physician mentioned in follow up that the patient was still having swelling in the legs and feet. The patient had seen a cardiologist, gastroenterologist and had had a doppler study and CT of the abdomen. Additional information has been requested.

VAERS ID:320007 (history)  Vaccinated:2008-05-10
Age:15.0  Onset:2008-05-10, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 66
Location:Illinois  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08095
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 16 year old female patient who on 10-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 10-MAY-2008 the patient had an injection site reaction (local reaction with erythema) for a few days. Subsequently, the patient recovered from local reaction with erythema for a few days. Additional information has been requested.

VAERS ID:320010 (history)  Vaccinated:2008-06-18
Age:15.0  Onset:2008-06-18, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 27
Location:New York  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiety, Overweight
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08142
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Inappropriate schedule of drug administration, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning an overweight 15 year old female with anxiety and no drug reactions/allergies history reported who on 18-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml IM (lot# 660555/0279X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 18-JUN-2008 the patient became lightheaded, diaphoretic and hypotensive after her first dose of GARDASIL vaccine (yeast). The patient had a consult with a cardiologist due to these adverse experiences and was diagnosed with a vasovagal response to the immunizations. Additional information has been requested.

VAERS ID:320014 (history)  Vaccinated:2008-06-13
Age:15.0  Onset:2008-06-14, Days after vaccination: 1
Gender:Female  Submitted:2008-07-15, Days after onset: 31
Location:New Jersey  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA08226
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthma, Axillary pain, Lymphadenopathy
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a 15 year old white female student with asthma who on 13-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 660391/0063X) intramuscularly into left deltoid. Suspect therapy given the same day included a first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot #0063X) IM into left deltoid. On 14-JUN-2008 the patient developed left axillary adenopathy, left axillary pain and also asthma exacerbation. There was no illness at the time of vaccination. It was unknown by the reporter if the patient had recovered. Additional information has been requested.

VAERS ID:320030 (history)  Vaccinated:2008-06-10
Age:15.0  Onset:2008-06-10, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 35
Location:Unknown  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NASONEX
Current Illness: Rhinitis allergic
Preexisting Conditions: Headache, Meningitis
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA08390
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Dizziness postural, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a licensed visiting nurse (LVN) concerning a 15 year old female with allergic rhinitis and a history of headache and meningitis (at 7 years of age) who on 25-MAR-2008 (Lot 659657/1487U), 10-JUN-2008 and 24-JUN-2008 (Lot #660391/0063X) was vaccinated IM with 0.5 mL doses of GARDASIL vaccine (yeast). Concomitant therapy included mometasone furoate (NASONEX). On 24-JUN-2008, after vaccination, the patient became dizzy/lightheaded upon standing and also developed a headache. The patient was treated with ibuprofen (MOTRIN) 800 mg for the headache. The patient did not require hospitalization, but was seen in the office. At the time of this report, the patient''s dizziness/lightheadedness and headache persisted. Additional information has been requested.

VAERS ID:320059 (history)  Vaccinated:2008-05-23
Age:15.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 53
Location:Unknown  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08649
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician assistant concerning a 15 year old female who on 23-MAY-2008 was vaccinated with a first dose of GARDASIL vaccine and included hepatitis A virus vaccine (manufacturer unknown). The physician assistant reported that the patient received the first vaccination with GARDASIL VACCINE on 23-MAY-2008 and passed out. The patient became pale in color and passed out while sitting on the examination table. The patient was treated with cold compresses and recovered after an unspecified time frame. The patient was asked to wait in the office after recovery, but mother needed to leave. There was no product quality complaint. Additional information has been requested.

VAERS ID:320096 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-15
Location:Arizona  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Headache~HPV (no brand name)~1~12~In Sibling|Local reaction~HPV (no brand name)~1~12~In Sibling
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08872
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Headache, Local reaction, Pain in extremity
SMQs:, Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 15 year old female who was vaccinated with a first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced arm pain, weakness, headache and local reaction. At the time of report, no outcomes were reported. The physician also reported that the patient''s sister experienced the same symptoms after received GARDASIL vaccine (yeast) (WAES# 0806USA08863). Additional information has been requested.

VAERS ID:320097 (history)  Vaccinated:2008-06-19
Age:15.0  Onset:2008-06-19, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 26
Location:Ohio  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08925
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Private     Purchased by: Other
Symptoms: Loss of consciousness, Nausea, Syncope
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a certified medical assistant concerning a female who in June 2008 was vaccinated with the second dose of GARDASIL vaccine. The patient had "trouble getting shots or giving blood." The patient laid down for 15 minutes post vaccination and was monitored. When the patient walked down the hall way the patient fainted, and it took the patient about 30 second to revive. Smelly salts were place under the patient''s nose. Subsequently, the patient recovered from faint. The patient sought medical attention at the office. This is one of several reports from the same source. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a certified medical assistant concerning a 15 year old female who on 10-APR-2008 was vaccinated with the first dose of GARDASIL (lot# 659182/1757U) at 1900. On 19-JUN-2008 the patient was vaccinated with the second dose of GARDASIL at 10:00. The patient attempted to leave and started to feel nauseated after the second dose at 10:00 on 19-JUN-2008. The patient ran into the wall and passed out. The patient was put on floor and it took the patient about 30 second to revive. Smelly salts were placed under the patient''s nose. Subsequently, the patient recovered from faint but still nauseated. The patient did not eat anything prior to shot. The patient was advised to eat prior to the last shot. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:319637 (history)  Vaccinated:2007-08-20
Age:15.0  Onset:2007-09-22, Days after vaccination: 33
Gender:Female  Submitted:2008-07-17, Days after onset: 299
Location:New York  Entered:2008-07-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: folic acid; MINOCIN
Current Illness:
Preexisting Conditions: Wheezing. PMH: ADD. Asthma. NKDA. Mom had seizures ages 13-15, cousin w/ seizures, sibling with Chiari malformation
Diagnostic Lab Data: None. Labs and Diagnostics: Head CT WNL. Tox screen (-). Video EEGs abnormal.
CDC Split Type: WAES0807USA02471
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Disturbance in attention, Electroencephalogram abnormal, Epilepsy, Excessive eye blinking, Fall, Grand mal convulsion, Loss of consciousness, Postictal state, Scan brain, Staring, Toxicologic test normal, Tremor
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), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female with a history of wheezing who on 20-AUG-2007 was vaccinated with her first dose of GARDASIL. On 22-SEP-2007 the patient experienced tonic clonic seizure and was hospitalized. On 15-NOV-2007, the patient received the second dose of GARDASIL. The patient was admitted to the hospital for an unspecified period of time on three separate occasions since the onset of the first seizure. The patient has a positive familial history of seizures. The patient''s last seizure occurred on an unspecified date in January 2008. Concomitant therapy included folic acid and MINOCIN. No other symptoms and no other treatment reported. Additional information has been requested. 8/11/2008 MR received for multiple DOS 9/22-25/2007, 10/29-11/01/2007, 11/7-12/2007 and ER 1/18/2008 with DX: Epilepsy. Pt presented with 1st seizure 9/22/07. Pt lost consciouness, fell and had generalized convulsion with shaking of upper and lower extremities. Sleepy after. Started on Keppra following EEG. Staring episodes noted with adventitial movements during video. D/C for outpt f/u. Returned again 10/29/07 with 2 episodes of seizure on meds. Recent increase in blinking and decreased attention. Keppra increased. Returned again due to allergic rxn to Keppra. Med changed to Zonegran. ER visit for seizure in school. Dose increased.

VAERS ID:319643 (history)  Vaccinated:2008-06-12
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-17
Location:Unknown  Entered:2008-07-18, 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: LAMICTAL
Current Illness: Convulsion
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0807USA01526
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a consumer concerning her 15 year old daughter with seizures and no drug allergies, who on 12-JUN-2008 was vaccinated with a 0.5mL dose of GARDASIL. Concomitant therapy included LAMICTAL. Subsequently, the patient experienced an increase in seizures. No laboratory diagnostics were performed. At the time of the report the patient had not recovered. Upon internal review the seizures were considered to be an other important medical event. Additional information has been requested.

VAERS ID:319697 (history)  Vaccinated:2008-06-24
Age:15.0  Onset:2008-06-24, Days after vaccination: 0
Gender:Female  Submitted:2008-07-18, Days after onset: 24
Location:North Carolina  Entered:2008-07-18
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: nka, no defects or medical condition
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt received HPV and pt. and mother remained in office and during the stay she fainted. Pt. c/o nausea. Dr. and clinical assistant remained with and reassessed pt''s stauts. Staff offered sips of liquid and she refainted 3 - 5 minutes later and remained with c/o nauesa. Pt. remained assessed at office. Once discard pt went home and remained with c/o nausea throughout the day.

VAERS ID:319733 (history)  Vaccinated:2008-07-18
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-18
Location:Arizona  Entered:2008-07-18
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.1758U2IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None Stated

VAERS ID:319810 (history)  Vaccinated:2007-08-06
Age:15.0  Onset:2007-09-20, Days after vaccination: 45
Gender:Female  Submitted:2008-07-18, Days after onset: 302
Location:Illinois  Entered:2008-07-21, Days after submission: 3
Life Threatening? Yes
Died? Yes
   Date died: 2007-09-20
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: 1 prior seizure 8/2007. 4/28/09 Additional records received from PCP at CDC''s request. Pt in for OV 1/30/07 with c/o allergy sx and requesting HPV#1-given 0012U. Returned 3/22/07 for HPV#2-given 1427F with Boostrix AC52B012AA. Mild URI 4/25/07. OV 6/12/07 in F/U to ER visit for seizure on 6/11/07. Syncope noted. Sent for tests. OV 6/28/07 Echo and blood work repor
Diagnostic Lab Data: Unknown. Labs and Diagnostics: Tox screen (-).
CDC Split Type: WAES0807USA02139
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0012U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cardiac arrest, Convulsion, Death, Fall, Mydriasis, Pulmonary congestion, Pulmonary oedema, Pulse absent, Pupil fixed, Respiration abnormal, Syncope, Toxicologic test normal, Unresponsive to stimuli, Ventricular fibrillation, Visceral congestion
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (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), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad)
Write-up: Information has been received from a certified medical assistant concerning a 14 year old female who was vaccinated with a first dose of GARDASIL and experienced syncope. She was taken to an emergency room and released. The patient was vaccinated with a second dose of GARDASIL (unspecified time). Subsequently, the patient experienced her first seizure (unspecified time) and was taken to the emergency room (no further details provided). The patient was vaccinated with a third dose of GARDASIL at 15 years old. Approximately 27-JUN-2008, two weeks after the third dose, the patient developed a complication. She was taken to the hospital by ambulance but passed away during the transport from an unknown cause. The physician has asked the mother for the autopsy report. The reporting medical assistant considered the syncope, seizure and "a complication" were considered to be immediately life-threatening and disabling. Additional information has been requested. 2/13/09 Autopsy report received. COD: Seizure Disorder. Summary Diagnoses: Clinical history of seizure disorder. Pulmonary congestion and edema. Passive visceral congestion. 2/20/2009 ER received from CDC. Pt presented to ER via EMS following witnessed seizure activity with fall from standing. Upon EMS arrival pt had agonal respirations and was pulseless in V-fib at 650. Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and pt expired.

VAERS ID:319914 (history)  Vaccinated:2008-07-11
Age:15.0  Onset:2008-07-12, Days after vaccination: 1
Gender:Female  Submitted:2008-07-21, Days after onset: 9
Location:Alabama  Entered:2008-07-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: topamax,glodon
Current Illness:
Preexisting Conditions: NKDA,no birth defects,bipolar,psychotic
Diagnostic Lab Data:
CDC Split Type: AL0817
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Hypoaesthesia, Hypoaesthesia facial
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pt. called and said she received her 2nd HPV here on 7/11/08 the next morning she began having numbness in her hands and face-lasting from 5-20 minutes, occurs almost daily, denies other symptoms.

VAERS ID:319957 (history)  Vaccinated:2007-04-20
Age:15.0  Onset:2007-11-28, Days after vaccination: 222
Gender:Female  Submitted:2007-11-28, Days after onset: 0
Location:Pennsylvania  Entered:2008-07-21, Days after submission: 235
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia
SMQs:, Arthritis (broad)
Write-up: Arthralgias involving collar bone/wrist, no pain at injection site.

VAERS ID:320155 (history)  Vaccinated:2008-07-15
Age:15.0  Onset:2008-07-15, Days after vaccination: 0
Gender:Female  Submitted:2008-07-22, Days after onset: 7
Location:Kansas  Entered:2008-07-22
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: Allergy to Suprax
Diagnostic Lab Data: Received CT Scan, Blood Work at hospital
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0 LA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0 LA
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER   RA
Administered by: Private     Purchased by: Private
Symptoms: Blindness, Blood test, Computerised tomogram, Convulsion, Dizziness, Headache, Incontinence, Visual field defect, Vomiting
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), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Approximately 10 minutes after the shot, while still in the doctors office, patient experienced a seizure, incontinence, headache, temporary peripheral vision loss in right eye, vomiting, dizziness. Required emergency room visit via ambulance. Received anti-nausea drugs via IV to end vomiting. Released from the hospital later that night.

VAERS ID:320164 (history)  Vaccinated:2008-07-22
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2008-07-22
Location:New Hampshire  Entered:2008-07-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TUBERSOL
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2641AA1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: Pt''s mother called and notified. No adverse reaction noted. She will monitor for any.

VAERS ID:320167 (history)  Vaccinated:2008-07-22
Age:15.0  Onset:2008-07-22, Days after vaccination: 0
Gender:Male  Submitted:2008-07-22, Days after onset: 0
Location:California  Entered:2008-07-22
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: Unknown
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0869U SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2428AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Pt received PPD, MENACTRA and MMR. Non-english speaking. Indicates with hand "spinning". Via translator nauseated. no emesis. Rested in clinic x 20 min. Given water and juice.

VAERS ID:320282 (history)  Vaccinated:2008-07-07
Age:15.0  Onset:2008-07-17, Days after vaccination: 10
Gender:Female  Submitted:2008-07-23, Days after onset: 6
Location:Pennsylvania  Entered:2008-07-23
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: Seizure disorder; asthma
Diagnostic Lab Data: None done at time of event. Will have EEG 7-28-08 and see neurologist.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Condition aggravated, Convulsion, Electroencephalogram, Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had a known seizure disorder in past. Had been seizure-free for over a year and was discharged from her neurologist. She received her first HPV on 7-7-08. She had a seizure on 7-17-08. It was her typical tonic-clonic seizure.

VAERS ID:320396 (history)  Vaccinated:2008-03-07
Age:15.0  Onset:2008-04-15, Days after vaccination: 39
Gender:Female  Submitted:2008-07-24, Days after onset: 100
Location:Pennsylvania  Entered:2008-07-24
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:
Diagnostic Lab Data: CT scan. EEG, and others 8/15/08-records received-CT scan showed mild asymmetry of ventricles, left frontal lobe single punctate lesion in white-gray matter junction in front area. EEG abnormal tracing due to generalized epileptiform disch
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U2IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1657U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram abnormal, Convulsion, Electroencephalogram abnormal, Epilepsy, Eye rolling, Grand mal convulsion, Somnolence
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: 4/15/08 Seizure occured at bedtime. Taken to E.D., CT scan done. 5/15/08 Seizure occured at bedtime. Taken to another Hosp. EEG showed mildly abnormal brain activity. Possibly hormonal trigger. Prescribed seizure medication, Kepra. Continues to be followed medically. 8/15/08-records received-4/21/08-The EEG was performed after one episode of generalized tonic-clonic seizure on 4/8/08. Presented to ED on 5/17/08-after seizure at home, eyes rolled back, sleepy afterward. Similar episode last month during her period. 5/22/08-neurology consult exam essentially normal. Impression: generalized epilepsy.

VAERS ID:320400 (history)  Vaccinated:2008-07-03
Age:15.0  Onset:2008-07-03, Days after vaccination: 0
Gender:Female  Submitted:2008-07-24, Days after onset: 21
Location:Maryland  Entered:2008-07-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB265AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1804U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Fall, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Approximately 5 minutes after HPV, VZV, Hep A administered patient had syncopal episode, fell back, brief loss of consciousness, recovered fully

VAERS ID:320527 (history)  Vaccinated:2008-06-25
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-25
Location:Wisconsin  Entered:2008-07-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Dose 3 was given too soon. It will be repeated per CDC guidelines.

VAERS ID:320510 (history)  Vaccinated:2008-07-26
Age:15.0  Onset:2008-07-26, Days after vaccination: 0
Gender:Female  Submitted:2008-07-26, Days after onset: 0
Location:Illinois  Entered:2008-07-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient fainted. At first felt like she was going to vomit then fainted. Gave Pt water and assisted to chair.

VAERS ID:320571 (history)  Vaccinated:2008-07-24
Age:15.0  Onset:2008-07-24, Days after vaccination: 0
Gender:Female  Submitted:2008-07-28, Days after onset: 4
Location:Florida  Entered:2008-07-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: headache
Preexisting Conditions: Amoxil
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Headache, Hypotension, Nausea, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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: h/a, nausea, hypotension,vasovagal syncope

VAERS ID:320578 (history)  Vaccinated:2008-07-14
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2008-07-28
Location:New York  Entered:2008-07-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2421AA1IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: None. Patient received 1 dose on 7/25/07 and a second dose on 7/14/08.

VAERS ID:320626 (history)  Vaccinated:2008-07-23
Age:15.0  Onset:2008-07-23, Days after vaccination: 0
Gender:Female  Submitted:2008-07-23, Days after onset: 0
Location:Mississippi  Entered:2008-07-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1263U1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure decreased, Dizziness, Gaze palsy, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt received 2nd dose of GARDASIL and TB skin test became pale, eyes rolled upwards and was briefly unconscious but responded quickly, BP decreased 42/10 but gradually became WNL. Last BP 100/58. She also c/o dizziness. Color gradually returned and pt remained responsive.

VAERS ID:320694 (history)  Vaccinated:2008-07-07
Age:15.0  Onset:2008-07-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-28, Days after onset: 21
Location:Unknown  Entered:2008-07-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA04072
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a nurse concerning a 15 year old female with no past history of seizures and no history of drug reactions or allergies who on approximately 07-JUL-2008 was vaccinated with the first dose of GARDASIL. Right after the vaccination the patient experienced convulsions. The patient "improved" the same day. subsequently, the patient recovered from convulsion. The patient sought unspecified medical attention. Upon internal review, convulsion was considered to be an other important medical event. Additional information has been requested.

VAERS ID:320700 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-28
Location:Oregon  Entered:2008-07-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown 8/8/08-records received-PMH: GERD. Migraines. Asthma. Premature 1 month early. Family history of pseudoseizures.
Diagnostic Lab Data: Unknown 8/8/08-records received-EEG:Partial seizure disorder. Labs:microcytic anemia. MRI brain normal.
CDC Split Type: WAES0807USA03800
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1426F2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Depression, Electroencephalogram abnormal, Grand mal convulsion, Microcytic anaemia, Nuclear magnetic resonance imaging normal, Staring
SMQs:, Haematopoietic erythropenia (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 12 year old female with family history of seizure who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL. The patient did not have any problems after the first and second dose of GARDASIL. The patient had a seizure 30 days after receiving the third dose of GARDASIL. The patient sought unspecified medical attention. On an unspecified date, the patient recovered. The physician did not feel the seizure was related to GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. 8/8/08-records received- ED report 1/4/08-presented to ED first seizure 12/26/07-C/O feeling tired. Seizure generalized tonic-clonic lasting 5 minutes. Postictal. Abrasion to tongue. Headache after seizure. Confusion lasting half hour. Neurology consult 1/10/08-the two seizures occurred while playing karaoke. Subsequent seizure with forced eye closure while on the computer. Impression-cryptogenic generalized seizure disorder with multifocal and generalized discharges on EEG. Indeterminate staring spells probably atypical absence seizures. Depression.

VAERS ID:320719 (history)  Vaccinated:2008-07-15
Age:15.0  Onset:2008-07-15, Days after vaccination: 0
Gender:Female  Submitted:2008-07-23, Days after onset: 8
Location:Texas  Entered:2008-07-29, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: seizures prior to 3 years ago
Diagnostic Lab Data: Parents had MRI, EEG week of 7/15. Dr. ruled out seizure. Diagnosed event as post vaccine reaction. Advised to not received HPV doses #2 and 3.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB233AA1UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2624AA0UNRA
Administered by: Public     Purchased by: Public
Symptoms: Condition aggravated, Convulsion, Electroencephalogram, Immediate post-injection reaction, Muscle contractions involuntary, Nuclear magnetic resonance imaging, Syncope, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Receiving immunizations, stood up and collapsed in syncopal episode. Did not loose consciousness but appeared to have muscular contractions/seizure in (R) arm for 15 seconds. Had seizures in the past but not connected w/immunization. No seizures or medication in several years. Mother called PCP during episode and was to take client to PCP when they left health dept.

VAERS ID:320733 (history)  Vaccinated:2008-07-29
Age:15.0  Onset:2008-07-29, Days after vaccination: 0
Gender:Male  Submitted:2008-07-29, Days after onset: 0
Location:New Mexico  Entered:2008-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B027AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Heart rate decreased, Hyperhidrosis, Lethargy, Oxygen saturation normal, Pallor, Respiratory rate
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient tolerated Tdap well, IM L deltoid. Discharged with mother. Mother returned, patient lethargic and diaphoretic and pale, but responsive, patent airway. After placing patient supine he stated he felt much better. VS taken every 2-3 minutes, air way clear, no respiratory distress, O2 sat 100 %. Initail B/P 118-60 p. 58, rr 18. Discharged with stable B/P 94-60, p. 64, rr 19. Patient did not eat prior to injection. Mother states one of his brothers also faints with injection, but patient never has. Patient given Gatorade, tolerated sitting and standing. Color pink, skin warm and dry, alert and oriented. Parametics also evaluated and discharged patient to mother. Patient discharged in stable condititon

VAERS ID:320742 (history)  Vaccinated:2008-07-28
Age:15.0  Onset:2008-07-29, Days after vaccination: 1
Gender:Male  Submitted:2008-07-29, Days after onset: 0
Location:Illinois  Entered:2008-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2
Other Medications: none
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Public
Symptoms: Chills, Dizziness, Fatigue, Headache, Heart rate increased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad)
Write-up: Fever of 101.1, chills, headache, dizziness, tiredness,and fast heartrate all day 07/29/2008. Advil given twice once a.m. once p.m.

VAERS ID:320762 (history)  Vaccinated:2008-07-15
Age:15.0  Onset:2008-07-17, Days after vaccination: 2
Gender:Female  Submitted:2008-07-18, Days after onset: 1
Location:New Jersey  Entered:2008-07-29, Days after submission: 11
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2655AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Child c/o (R) numbness of leg and foot x 12 hrs 7-17-08 pm then foot leg-but much less today 7-18-08 am total 18 hrs

VAERS ID:320788 (history)  Vaccinated:2008-07-17
Age:15.0  Onset:2008-07-18, Days after vaccination: 1
Gender:Male  Submitted:2008-07-23, Days after onset: 5
Location:Wisconsin  Entered:2008-07-29, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2566AA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Chest discomfort, Dizziness, Headache
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: He was in a basketball tournament. After the first game, he had a "stinger feeling in his chest." During the second game, he felt dizzy and complained of headache. His physician followed up with a phone call. I spoke to mom today (7/23). He is fine.

VAERS ID:320833 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-29
Location:Unknown  Entered:2008-07-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA04948
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a registered nurse (R.N.) concerning a 15 year old female who on an unspecified date was vaccinated with her third dose of GARDASIL. Subsequently the patient experienced a seizure. At the time of the report, it was unknown if the patient had recovered from the seizure. Upon internal review, seizure was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:320835 (history)  Vaccinated:2008-07-16
Age:15.0  Onset:2008-07-20, Days after vaccination: 4
Gender:Female  Submitted:2008-07-29, Days after onset: 9
Location:New York  Entered:2008-07-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Syncope PMH: vasovagal responses: one several years prior after head injury & one approx 1 year prior when was overheated. Family hx: brain aneurysm, muscular dystrophy, thyroid disease.
Diagnostic Lab Data: LABS: CBC & chemistry WNL. CT of head WNL. Drug screen & UA neg.
CDC Split Type: WAES0807USA04519
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Conjunctivitis, Convulsion, Cyanosis, Drug screen negative, Foaming at mouth, Full blood count normal, Grand mal convulsion, Laboratory test normal, Loss of consciousness, Paralysis, Tachycardia, Tongue biting, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a registered nurse concerning a 15 year old female with history of syncope who on 16-JUL-2008 was vaccinated with the first dose of GARDASIL (Lot No. 659962/1740U) IM. After the first dose of GARDASIL, on 20-JUL-2008, the patient experienced a seizure. The seizure lasted 3 minutes. The patient went to the emergency room for an evaluation but was not admitted. Subsequently, the patient recovered. Upon internal review, seizure was considered as an other important medical event. Additional information has been requested. 8/26/08 Reviewed ER medical records of 7/20/08. FINAL DX: seizure, conjunctivitis Records reveal patient experienced grand mal seizure lasting approx 3 min & had transient inability to move arms & legs. Tachycardic in ER otherwise stable. D/C to home & referred to neuro for outpatient w/u. 9/2/08 Reviewed neurological consult records of 7/21/2008. FINAL DX: none provided Records reveal patient exprienced witnessed passing out at a friends house after a sleep over. Had generalized tonic-clonic seizure w/foaming at the mouth, cyanosis, bit her tongue & lasting approx 3 minutes. CT scan reviewed & concurred WNL. Suggested MRI/MRA of brain & EEG.

VAERS ID:320849 (history)  Vaccinated:2007-08-08
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-29
Location:Pennsylvania  Entered:2008-07-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0522U IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2386BA IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0437X SCUN
Administered by: Unknown     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: was given MENACTRA 8/8/07 but was not noted in medical record. Pt seen 7/28/08 given MENACTRA again. No adverse event reported by patient or parents

VAERS ID:320896 (history)  Vaccinated:2008-02-18
Age:15.0  Onset:2008-02-19, Days after vaccination: 1
Gender:Female  Submitted:2008-07-30, Days after onset: 161
Location:Delaware  Entered:2008-07-30
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: Mild interm. asthma, recurrent urticaria 8/5/08-records received-Family history of multiple sclerosis.
Diagnostic Lab Data: CBC, CMP, Lyme titres, EMG, MRI of spine - all tests negative 8/4/08 records received-Electrodiagnostic studies normal. CBC WNL, Lyme titer negative. MRI lumbar spine normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Borrelia burgdorferi serology negative, Electromyogram normal, Full blood count normal, Hypoaesthesia, Metabolic function test normal, Nuclear magnetic resonance imaging normal, Paraesthesia, Syncope, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient fainted after receiving GARDASIL #2. Patient complained of tingling & numbness of both legs below the knees ~1 day after GARDASIL #2. 8/4/08-records received -7/2/07-C/O chronic shoulder pain. 4/9/08-C/O tingling in legs from knees down. Exercising with 16 pound weight loss, possible reduced potassium intake. 4/30/08-continues with C/O tingling in both legs. 6/25/08-neurology consult-C/O pins and needles in bilateral lower extremities. Swims and runs competitively. C/O developed in March 2008. PE WNL except for minimally decreased pinprick sensation in lateral aspect of both feet.

VAERS ID:320916 (history)  Vaccinated:2008-07-25
Age:15.0  Onset:2008-07-26, Days after vaccination: 1
Gender:Female  Submitted:2008-07-28, Days after onset: 2
Location:Vermont  Entered:2008-07-31, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U1IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Oedema peripheral, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Rash on various parts of body right thumb swollen.

VAERS ID:320917 (history)  Vaccinated:2008-04-25
Age:15.0  Onset:2008-05-09, Days after vaccination: 14
Gender:Female  Submitted:2008-07-30, Days after onset: 82
Location:Oregon  Entered:2008-07-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Chickenpox
Diagnostic Lab Data: beta-human chorionic
CDC Split Type: WAES0807USA05097
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
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 registered nurse for the pregnancy registry for GARDASIL concerning an 18 year old female with a history of chickenpox disease at age 5 and no allergies who on 25-APR-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM. The patient at the time of vaccination of the first dose indicated she was not pregnant. On approximately 09-MAY-2008, the patient found out she was pregnant. The patient started at an unspecified date and went to the hospital. The hospital informed her on 01-JUN-2008 the patient had a miscarriage. On 25-JUL-2008 the patient was vaccinated with the second dose of GARDASIL 0.5 ml IM. The patient sought medical attention and told the nurse at an office visit. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested

VAERS ID:320920 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-30
Location:Unknown  Entered:2008-07-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA04763
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a registered nurse (R.N.) concerning a 15 year old female who on an unspecified date was vaccinated intramuscularly with her third 0.5 ml dose of GARDASIL. Subsequently the patient experienced seizures. At the time of the report, the patient''s seizures persisted. Unspecified medical attention was sought. Upon internal review, seizure was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:320930 (history)  Vaccinated:2008-07-23
Age:15.0  Onset:2008-07-23, Days after vaccination: 0
Gender:Female  Submitted:2008-07-25, Days after onset: 2
Location:Maryland  Entered:2008-07-31, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Syncopal episode~Tdap (no brand name)~~0~In Sibling|Syncopal episode~Meningococcal (Menactra)~~0~In Sibling
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.0067X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2994BA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2994BA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Syncopal episode 3-5 minutes after administration of TDap, Menactra and Gardasil, which lasted about 30 seconds. After episode she was fine.

VAERS ID:320940 (history)  Vaccinated:2008-07-24
Age:15.0  Onset:2008-07-24, Days after vaccination: 0
Gender:Female  Submitted:2008-07-31, Days after onset: 7
Location:Minnesota  Entered:2008-07-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dyspnoea, Injection site pain, Injection site swelling, Oxygen saturation, Pallor, Presyncope
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: About 17 minutes after the HPV vaccine administered, patient felt uncomfortable in the arm beneath her injection. She then said her arm mildly hurt and thought it looked swollen. Patient then felt it was hard to breathe. She became pale. She was close to fainting. After about 5 minutes she stated it felt better. Initial O2 sats were 99-100 d. She rested for 20 minutes and drank some mountain dew and was able to go home without difficulty.

VAERS ID:320961 (history)  Vaccinated:2008-07-29
Age:15.0  Onset:2008-07-30, Days after vaccination: 1
Gender:Female  Submitted:2008-07-31, Days after onset: 1
Location:Wisconsin  Entered:2008-07-31
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 PASTEURU2543AA1IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1805U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right arm below injection site one day after receiving vaccine had a red raised area about pea size. 2nd day after vaccine area enlarged to 1" x 2". 3rd day area has flattened out but has spread a little larger.

VAERS ID:320995 (history)  Vaccinated:2008-07-22
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-31
Location:Alabama  Entered:2008-07-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2570AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Palmar erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Redness on palm of hands and bottom of feet.

VAERS ID:321047 (history)  Vaccinated:2008-04-07
Age:15.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-23, Days after onset: 107
Location:Indiana  Entered:2008-08-01, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to honey
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt returned for 3rd dose of GARDASIL (HPV) vaccine and reported on questionnaire that she broke out in hives around injection site after 2nd dose on 4.07.08, relieved with ice pack. Denied any difficulty breathing. Indicated allergy to honey on 4.07.08. This writer decided not to give 3rd dose.

VAERS ID:321086 (history)  Vaccinated:2008-05-29
Age:15.0  Onset:2008-05-30, Days after vaccination: 1
Gender:Female  Submitted:2008-08-01, Days after onset: 63
Location:Iowa  Entered:2008-08-01
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Abdominal pain upper, Cold sweat, Dizziness, Hyperhidrosis, Peripheral coldness, Retching, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: The vaccine was given at approximately 5:00pm without incident. At 6:00am the next morning, the patient awakened with what she described as the worst stomach ache she''d ever had. She quickly became cold, clammy, diaphoretic, light-headed, faint and began retching. After about 15 minutes, this all passed and she felt OK.

VAERS ID:321147 (history)  Vaccinated:2008-08-01
Age:15.0  Onset:2008-08-01, Days after vaccination: 0
Gender:Female  Submitted:2008-08-01, Days after onset: 0
Location:Washington  Entered:2008-08-01
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: H/O mild asthma
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1905U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Angioedema, Lip swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Angioedema of upper lip.

VAERS ID:321188 (history)  Vaccinated:2008-07-29
Age:15.0  Onset:2008-07-29, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 1
Location:Massachusetts  Entered:2008-08-04, 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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure normal, Dyskinesia, Heart rate normal, Hyperhidrosis, Oxygen saturation normal, Pain, Postictal state, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: After HPV, pt. had fainting episode with brief jerking generalized lasted for a few seconds. Laid down. Diaphoretic. Responded to voice, flat voice, but sleepy. O2 sat OK. P 66, BP WNL, +c/o pain with light touch. Postictal x10 min. Then alert to date, day events.

VAERS ID:321225 (history)  Vaccinated:2008-07-24
Age:15.0  Onset:2008-07-25, Days after vaccination: 1
Gender:Male  Submitted:2008-08-04, Days after onset: 10
Location:Delaware  Entered:2008-08-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no meds
Current Illness: NO
Preexisting Conditions: No PMH: allergy to cephalexin. Chicken pox, allergic rhinitis. Family hx of DM, CAD & HTN.
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2632AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Decreased appetite, Dyspnoea, Erythema multiforme, Feeling cold, Myalgia, Oedema peripheral, Pruritus, Rash, Rash erythematous, Stevens-Johnson syndrome, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Generalized urticaria and arthralgias, Swelling and itching to all extremities, Dx Stevens Johnson Syndrome 695.1 8/15/08 Reviewed PCP office records of 7/29/08. FINAL DX: erythema multiforme Records reveal patient experienced progressive rash x 4 days. Rash raised & red, initially on arms then spreading to back & legs w/itching. Started 2 days s/p vaccination. Appetite decreased, felt chilled, itchy, difficulty breathing, joint & muscle pain. Exam at that time revealed generalized wheals w/edema of both legs. Tx w/steroids & close f/u.

VAERS ID:321247 (history)  Vaccinated:2008-08-01
Age:15.0  Onset:2008-08-02, Days after vaccination: 1
Gender:Male  Submitted:2008-08-04, Days after onset: 2
Location:New York  Entered:2008-08-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: CHEST WALL PAIN WITH NEGATIVE CXR
Preexisting Conditions: HIVES WITH LAWN MOWING
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1905U3SCLA
Administered by: Private     Purchased by: Private
Symptoms: Chest X-ray normal, Lip swelling, Swollen tongue, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: RECIEVED VARIVAX VACCINE ON 8/01/2008. REPORTED TO HAVE HIVES ALL OVER ON 8/02/2008. REPORTED THAT TONGUE AND LIPS SWOLLEN ON 8/03/2008. MOTHER GIVING BENEDRYL PO Q6HRS PRN. NO REPORT OF RESPIRATORY DIFFICULTY

VAERS ID:321260 (history)  Vaccinated:2008-08-02
Age:15.0  Onset:2008-08-02, Days after vaccination: 0
Gender:Female  Submitted:2008-08-04, Days after onset: 2
Location:New York  Entered:2008-08-04
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 PASTEURU2620AA UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0393X UNUN
Administered by: Public     Purchased by: Public
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow)
Write-up: After leaving clinic at 12:05 PM patient''s mom called clinic at 12:45 PM stating that her daughter may be having an allergic reaction to the vaccine.

VAERS ID:321286 (history)  Vaccinated:2008-07-01
Age:15.0  Onset:2008-07-01, Days after vaccination: 0
Gender:Female  Submitted:2008-08-04, Days after onset: 34
Location:Unknown  Entered:2008-08-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA04601
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Blindness, Convulsion, Disorientation, Fatigue, Headache, Immediate post-injection reaction, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from an unspecified source ("someone who is not part of the clinic") concerning a 15 year old (reported by the source as a 16 year old) female who was vaccinated at the clinic with GARDASIL. The unspecified source told the Company representative that it was reported on television that the patient experienced "fainting and seizure like movements" after receiving GARDASIL. The unspecified source recounted the news report stating the patient was supervised in the office after the vaccine was given for about an hour and was released to home. The patient had "splitting headache" and "fatigue" that persisted for about one week after the fainting incident. According to the archived television program, the patient was a healthy, athletic 15 year old who in approximately July 2008 was taken to the clinic by her mother for a routine physical. As part of her exam, she was offered GARDASIL. When the mother asked about the side effects, she was told only about possible redness and soreness. Almost immediately after getting the vaccination, something went very wrong. The patient stood up and couldn''t see anything. She fainted and began having seizure like motions. For several moments, the patient was thrashing on the examining room floor. When she woke up, the patient didn''t know where and who she was. She was very pale. At first the clinic staff had her sit on the ground, and then eventually had her sit on the table. The patient then became nauseous. After more than two hours, the patient was sent home. Her parents were afraid to let her sleep. It took five days for the patient to get over the migraine-like headaches and debilitating loss of energy. The Company representative attempted to contact the clinic for follow up, but was unable to get anyone to verify the incident. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.

VAERS ID:321318 (history)  Vaccinated:2008-07-31
Age:15.0  Onset:2008-07-31, Days after vaccination: 0
Gender:Female  Submitted:2008-08-01, Days after onset: 1
Location:New York  Entered:2008-08-05, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0271X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Syncope ~2 minutes after receiving vaccine (VARIVAX). Pt drowsy & c/o headache ~20 minutes after vaccine.

VAERS ID:321329 (history)  Vaccinated:2008-07-31
Age:15.0  Onset:2008-07-31, Days after vaccination: 0
Gender:Female  Submitted:2008-07-31, Days after onset: 0
Location:Arizona  Entered:2008-08-05, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PRN albuterol
Current Illness: No
Preexisting Conditions: Asthma
Diagnostic Lab Data: None. Returned for exam - no unusual findings.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB243AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2658AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt. stated that the epigastric pain started after shots given. Epigastric pain continued after pt. ate lunch.

VAERS ID:321357 (history)  Vaccinated:2008-07-23
Age:15.0  Onset:2008-07-24, Days after vaccination: 1
Gender:Male  Submitted:2008-07-28, Days after onset: 4
Location:Vermont  Entered:2008-08-05, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2638AA0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1380U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Leukocytosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Leukocytosis, fever, injection site swelling + erythema.

VAERS ID:321408 (history)  Vaccinated:2008-07-16
Age:15.0  Onset:2008-07-20, Days after vaccination: 4
Gender:Female  Submitted:2008-08-05, Days after onset: 16
Location:Unknown  Entered:2008-08-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: tuberculin purified protein
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: tuberculin skin test, unknown
CDC Split Type: WAES0808USA00052
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Tuberculin test
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a nurse concerning a 15 year old female who on 16-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included Tdap. The patient was also administered a TB test. On 20-JUL-2008 the patient experienced seizure. The patient was rushed to the Emergency Room. On an unspecified date, the patient recovered from seizure. No product quality was involved. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. This was reported to VAERS by the healthcare facility on 23-JUL-2008.

VAERS ID:321425 (history)  Vaccinated:2007-02-19
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-28
Location:Kansas  Entered:2008-08-06, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: migraines. Family hx epilepsy
Diagnostic Lab Data: LABS: SGOT 88(H), SGPT 178(H), CPK 53(N). MRI WNL. CBC w/Hct 36.5(L), segs 31%(L), lymphs 47%(H), Mono test neg. Globulin 3.8(H), ALT 68(H). CBC WNL. ALT 73(H), AGR 1.1(L). CXR WNL. EKG abnormal. Flu A&B neg.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB319AA2UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0263U2UNLA
Administered by: Private     Purchased by: Private
Symptoms: Activities of daily living impaired, Alanine aminotransferase increased, Anorexia, Arthralgia, Aspartate aminotransferase increased, Asthenia, Blood creatine phosphokinase normal, Chest X-ray normal, Chest pain, Computerised tomogram normal, Contraception, Conversion disorder, Cough, Depression, Dizziness, Dysmenorrhoea, Dyspepsia, Electrocardiogram normal, Electroencephalogram normal, Familial periodic paralysis, Fatigue, Globulins increased, Haematocrit decreased, Hypersomnia, Hypoaesthesia, Hypotonia, Infectious mononucleosis, Influenza serology negative, Intensive care, Lethargy, Lymphocyte percentage increased, Malaise, Menstruation irregular, Migraine, Muscle spasms, Myalgia, Nausea, Neuralgia, Neutrophil percentage decreased, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: 15 yo GO WF LMP October 2005 presents with her mother to discuss her infrequent menstrual cycles. The pt had her first menstrual cycle in August of 2005. She then had a cycle in September and then October 2005. She has not had a menstrual cycle since that time. She has never been sexually active. She has severe cramping with her menstrual cycles. She denies any weight changes, temperature instability or breast discharge. D/w pt and her mother issues regarding menarche and cycle irregularity. Also d/w the potential for PCOS. Explained to them the reason that cycle regulation is important long term. They agree to OBCP for cycle regulation. Plan to do some lab evaluation and induce menstrual flow w/ course of progestin. D/w pt information regarding HPV and hepatitis B vaccine. Entire patient history reviewed by MD. 9/23/08 Reviewed neuro 2nd opinion of 3/1/07 & subsequent visits. FINAL DX: periodic paralysis Records reveal patient experienced episodic limpness, constant HA. Tx w/meds. Developed numbness/tingling in fingers/toes & depression, severe heartburn, pinched nerve, leg/muscle pain & cramping on meds. 10/7/08 Reviewed hospital medical records of 2/14-2/15/2007. FINAL DX: conversion disorder Records reveal patient experienced 4 episodes of sudden unexplained paralysis within a 2 week period starting around 12/25/06 w/migraine HA. Then developed a cough & sore throat & dx w/mono. Had decreased energy & increased sleep. Divides time between parent''s homes. Outpatient CT of head & EEG WNL. Had been transferred from outlying ER to PICU. Work up completely WNL. Parent refused psychiatric eval & referred instead for second neuro opinion at outpatient clinic where was seen 3/1/07. 8/26/08 Reviewed OB/GYN medical records for 10/3/2006-2/19/2007. FINAL DX: Records reveal patient experienced good health on 10/3/2006 date of 2nd vaccinations. Returned to clinic 2/5/2007 for f/u after d/cing contraception which she had been on for cycle regulation. Stopped due to severe HAs. HAs did not improve

VAERS ID:321427 (history)  Vaccinated:2008-08-04
Age:15.0  Onset:2008-08-04, Days after vaccination: 0
Gender:Male  Submitted:2008-08-05, Days after onset: 1
Location:Massachusetts  Entered:2008-08-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: allergy: Ibuprofen/has asthma decreased visual disturbances
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB530AA3UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSC29270UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0335X1UNLA
Administered by: Private     Purchased by: Public
Symptoms: No adverse event
SMQs:
Write-up: No adverse events occurred.

VAERS ID:321432 (history)  Vaccinated:2008-08-05
Age:15.0  Onset:2008-08-05, Days after vaccination: 0
Gender:Female  Submitted:2008-08-06, Days after onset: 1
Location:Michigan  Entered:2008-08-06
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: No allergies, hx of exercised induced asthma
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0018U0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2418AA0IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Blood pressure, Blood pressure decreased, Crying, Dizziness, Heart rate normal, Oxygen saturation normal, Pain in extremity, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)
Write-up: NP called into room at 2:50 pm after receiving Hep A and MCV4 in left arm. Patient felt lightheaded & crying that arms hurt. Alert & Ox3, appeared pale, HR-88, BP 116/62, pulse ox 98%. About 3pm pt sat up and Gardasil given in right arm. Had pt lie flat til 3:08pm. Verbalized feeling better & sat up. Pt felt dizzy again HR-96, BP 88/60. Had pt lie flat again & BP 98/56. At 3:20 pm pt felt better and sat up BP 110/70, HR-84. Had pt sit for a few minutes and then stand for a few minutes before walking. Steady on feet. Only complaint of arms sore.

VAERS ID:321508 (history)  Vaccinated:2008-06-06
Age:15.0  Onset:2008-06-06, Days after vaccination: 0
Gender:Female  Submitted:2008-08-06, Days after onset: 61
Location:Unknown  Entered:2008-08-07, 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: Unknown
CDC Split Type: WAES0807USA05581
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received for the pregnancy registry for GARDASIL from a nurse practitioner concerning a 15 year old female patient who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL IM. The day after receiving the first dose of GARDASIL, the patient found out she was pregnant (gestation or last menstrual period of "1 month"). On 11-JUN-2008 the patient started bleeding and went to the emergency room on 17-JUN-2008, where it was determined she had a miscarriage. Upon internal review, miscarriage was considered to be other important medical event. Additional information has been requested.

VAERS ID:321539 (history)  Vaccinated:2008-07-31
Age:15.0  Onset:2008-07-31, Days after vaccination: 0
Gender:Female  Submitted:2008-07-31, Days after onset: 0
Location:New York  Entered:2008-08-07, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported
Current Illness: Denied
Preexisting Conditions: Denied
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2561AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B018CA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Hyperhidrosis, Pallor, Visual disturbance
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Client became pale, diaphoretic, and weak. Client states she was seeing "purple spots". Client was moved to supine position with feet elevated. Vital signs were monitored every 3-5 minutes. Symptoms resolved in 10 minutes from onset.

VAERS ID:321553 (history)  Vaccinated:2008-08-07
Age:15.0  Onset:2008-08-07, Days after vaccination: 0
Gender:Female  Submitted:2008-08-07, Days after onset: 0
Location:Arizona  Entered:2008-08-07
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: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB28OAA1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2666AA1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2997AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.190202SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swoolen and burning sensation at injection site

VAERS ID:321562 (history)  Vaccinated:2008-08-07
Age:15.0  Onset:2008-08-07, Days after vaccination: 0
Gender:Female  Submitted:2008-08-07, Days after onset: 0
Location:Pennsylvania  Entered:2008-08-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vyvanase; Risperdal; Prozac
Current Illness: None
Preexisting Conditions: ADHD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Pallor, 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: Immediately after receiving GARDASIL - fainted - went pale - last less than one minute. Had her elevate feet and rest til no longer faint.

VAERS ID:321626 (history)  Vaccinated:2008-07-29
Age:15.0  Onset:2008-07-29, Days after vaccination: 0
Gender:Female  Submitted:2008-08-04, Days after onset: 6
Location:Florida  Entered:2008-08-08, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB238AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2663AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: "Tingling/numbness" (B) legs. Mostly in pinkie toe.

VAERS ID:321643 (history)  Vaccinated:2008-07-31
Age:15.0  Onset:2008-08-01, Days after vaccination: 1
Gender:Female  Submitted:2008-08-01, Days after onset: 0
Location:Virginia  Entered:2008-08-08, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2655AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 8 x 11 cm of induration in area of injection.

VAERS ID:321654 (history)  Vaccinated:2008-07-31
Age:15.0  Onset:2008-07-31, Days after vaccination: 0
Gender:Female  Submitted:2008-07-31, Days after onset: 0
Location:Texas  Entered:2008-08-08, 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: no
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB284CA1IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR0393X1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.U2580AA0IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 7-31-08 at 1146. Patient fainted leaving office; lasting few seconds, pale, dizzy. States didn''t eat breakfast. Alert, awake, answering questions apppopriately. WNL vital signs.

VAERS ID:321664 (history)  Vaccinated:2008-04-17
Age:15.0  Onset:2008-06-06, Days after vaccination: 50
Gender:Female  Submitted:2008-08-08, Days after onset: 63
Location:New York  Entered:2008-08-08
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: None - healthy 15 year old with NO HISTORY of seizure until after the Gardasil shot was given
Preexisting Conditions: NONE. PMH: none 5/22/09 Medical records (neurology consult) received DOS 6/6/09 to 6/12/09. Headaches, motion sickness, vomiting, somnambulism, kidney stone. painful menstrual periods.
Diagnostic Lab Data: MRI/Brain, CaT SCAN, EEG done after the seizure. Labs and Diagnostics: Head CT (-). CBC, CMP unremarkable. Drug screen (-). Coags WNL$g 5/22/09 Medical records (neurology consult) received DOS 6/6/09 to 6/12/09. LABS and DIAGNOSTICS:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0152X0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Coagulation test normal, Computerised tomogram normal, Contusion, Drug screen negative, Electroencephalogram abnormal, Grand mal convulsion, Head injury, Loss of consciousness, Metabolic function test, Nuclear magnetic resonance imaging brain normal, Tongue biting, Tonic clonic movements, Urine analysis normal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had a grand mal seizure 2 mos. after receiving the Gardasil shot received at Dr''s Office. The seizure last a full 5 minutes with tonic clonic episode and unconsciousness. The episode happened at the high school and taken to Hospital on June 6, 2008. 8/11/2008 MR received for ER visit 06/06/2008 with DX: Closed head injury, loss of consciousness <1 hour. Seizure, generalized. Pt presented to ER after witnessed tonic-clonic seizure at school. (+) vomiting. PE WNL except 2 cm L forehead contusion. D/c to f/u as out pt. 5/22/09 Medical records (neurology consult) received DOS 6/6/08 to 6/12/08. FINAL DIAGNOSIS: Single major convulsive seizure without aura. Presented with major convulsive seizure, tenderness over left eyebrow, bit tongue - small hemorrhagic area.

VAERS ID:321686 (history)  Vaccinated:2008-06-05
Age:15.0  Onset:2008-06-23, Days after vaccination: 18
Gender:Female  Submitted:2008-08-08, Days after onset: 46
Location:New York  Entered:2008-08-08
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: Salt Fish Allergy
Diagnostic Lab Data: Urine dip in ER was reported negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2623AA0IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Chest pain, Erythema, Gait disturbance, Headache, Joint swelling, Lymphadenopathy, Rash generalised, Rash maculo-papular, Serum sickness, Sleep disorder, Urine analysis normal, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt was treated in the ER for Serum Sickness Reaction. She presented with swelling and pain of ankles and rash over body 11/7/08 Reviewed ER medical records of 6/20/2008. FINAL DX: Serum sickness secondary to menactra Records reveal patient experienced HA, generalized maculopapular rash, painful ankle swelling w/erythema & limping x 4 days, chest pain on palpation x 1 day w/cervical lymphadenopathy & sleep disturbed due to pain. Tx w/meds. D/C to home w/PCP f/u.

VAERS ID:321698 (history)  Vaccinated:2008-08-06
Age:15.0  Onset:2008-08-06, Days after vaccination: 0
Gender:Female  Submitted:2008-08-06, Days after onset: 0
Location:Arizona  Entered:2008-08-08, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Heart murmur (mitral valve regurgitation)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB284DA1UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U1UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2573AA0UNRA
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness
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), Hypersensitivity (narrow)
Write-up: Patient passed out immediately following receiving the vaccine and then she had 2 30 second generalized seizure.

VAERS ID:321739 (history)  Vaccinated:2008-08-05
Age:15.0  Onset:2008-08-05, Days after vaccination: 0
Gender:Female  Submitted:2008-08-05, Days after onset: 0
Location:Pennsylvania  Entered:2008-08-11, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fainting~Vaccine not specified (no brand name)~UN~0~In Sibling
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2640AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2774AA0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Gaze palsy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: pt. fainted after administering vaccine I proceed to assist the pt in lying on the table. The pt''s eyes rolled back in her head so I got a doctor to assist me. After stabling pl. check BP 108/76 is ok.

VAERS ID:321759 (history)  Vaccinated:2008-08-08
Age:15.0  Onset:2008-08-08, Days after vaccination: 0
Gender:Female  Submitted:2008-08-11, Days after onset: 3
Location:New York  Entered:2008-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Nasal and ear congestion.
Preexisting Conditions: None
Diagnostic Lab Data: Initial VS after fainting were BP 91/49 and P 60. Was given juice and crackers, layed down.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2564AA0SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1854U0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Ear congestion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient received Tdap, VVX, MCV4 and HPV vaccines. Fainted soon after vaccines were given.

VAERS ID:321871 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-11
Location:Tennessee  Entered:2008-08-12, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0808USA01016
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported). There was no concomitant medication. Within 10 minutes after the vaccination, the patient developed a seizure. The patient stayed in the office and recovered prior to leaving the office. The duration of the seizure was unspecified. The physician reported that no hospitalization or laboratory work up was required for the patient. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.

VAERS ID:321985 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Arizona  Entered:2008-08-13
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB243AA UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B027AA UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1892U SCLA
Administered by: Public     Purchased by: Public
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt felt nausea after 3 vaccines administered. No loss of consciousness. No emesis. Kool-Aid given. Seek medical attention PNU. BP 100/62.

VAERS ID:321994 (history)  Vaccinated:2008-08-06
Age:15.0  Onset:2008-08-06, Days after vaccination: 0
Gender:Female  Submitted:2008-08-07, Days after onset: 1
Location:New Hampshire  Entered:2008-08-13, 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: mild cold sx
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2614AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Eye rolling, Hyperventilation, Immediate post-injection reaction, Loss of consciousness, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (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), Eosinophilic pneumonia (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Vaccine adm. at 1020am. Immediately after injection of this immunization, pt began hyperventilating and limbs began to shake, eyes rolled back in her head & she lost consciousness. Pt revived immediately with 0.3mm ammonia inhalant & once alert helped to supine position, given apple juice & crackers. Ice pack applied to neck & head. BP 114/76 & pulse 60 & RR 18. 15 min after injection pt was sitting at time of injection & no injury occurred.

VAERS ID:322019 (history)  Vaccinated:2008-08-08
Age:15.0  Onset:2008-08-08, Days after vaccination: 0
Gender:Female  Submitted:2008-08-08, Days after onset: 0
Location:New York  Entered:2008-08-13, 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: Uses albuterol inhaler PRN
Current Illness: None
Preexisting Conditions: Exercise induced asthma
Diagnostic Lab Data: Transported to ED via ambulance.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB268EA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0540X1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt received 2 vaccines and was waiting the required 20 min before leaving. Child suddenly fainted and fell from exam table to the floor. Child was not anxious about receiving the vaccines. Child had been fed prior to vaccines.

VAERS ID:322029 (history)  Vaccinated:2008-08-05
Age:15.0  Onset:2008-08-05, Days after vaccination: 0
Gender:Female  Submitted:2008-08-08, Days after onset: 3
Location:Colorado  Entered:2008-08-13, 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: None
Current Illness: Mild URI but appears well
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1893U1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient received Tdap and Varivax in left arm on 8-5-08. On 8-8-08 patient returned with post left upper arm 10cm x 9cm erythema, warm to touch, plus 2cm nodule under skin.

VAERS ID:322034 (history)  Vaccinated:2008-08-04
Age:15.0  Onset:2008-08-04, Days after vaccination: 0
Gender:Female  Submitted:2008-08-13, Days after onset: 9
Location:Florida  Entered:2008-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1
Other Medications:
Current Illness: none
Preexisting Conditions: gluten sensitivity
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0  
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 1  
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Diarrhoea, Dizziness, Nausea, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Patient received simultaneous Gardasil and Varivax vaccines and immediately felt faint, weak, shaky, nauseated and experienced subsequent diahrrea for 24 hours

VAERS ID:322053 (history)  Vaccinated:2008-07-29
Age:15.0  Onset:2008-07-29, Days after vaccination: 0
Gender:Female  Submitted:2008-08-13, Days after onset: 15
Location:North Carolina  Entered:2008-08-13
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 illness at time of vaccination
Preexisting Conditions: Patient had a duodenal atresia at birth that was surgically repaired 1 day after she was born. No other medical conditions.
Diagnostic Lab Data: none done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blindness transient, Dizziness, Faecal incontinence, Immediate post-injection reaction, Visual disturbance
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad)
Write-up: Patient received her 3rd Gardasil vaccine in her left arm and then immediately following, her Hep A vaccine in her right arm. Within seconds following the vaccinations patient became lightheaded and dizzy, and said she could not see. She stated she thought she was blacking out. She did not lose consciousness. She had been standing up and was immediately assisted to the exam table to sit down. Upon sitting down her dizziness and blindness subsided. She was instructed to lie down. But, patient insisted she had to go to the bathroom right away. As she was escorted to the BR, she became dizzy again and was unable to see. She became incontinent of stool as well. She was assisted to the bathroom and after sitting on the toilet she said she felt better. She was cleaned up and sat in the bathroom for approx. 10 minutes. Upon trying to stand, she again became dizzy, so she sat back down. We stayed in the bathroom approx. 45 minutes until patient felt able to walk with assistance to the car. During the walk to the car, she continued to feel lightheaded and dizzy, but did not lose consciousness or vision. Upon arriving home she layed on the sofa for 2-4 hours. There were no more adverse symptoms.

VAERS ID:322059 (history)  Vaccinated:2008-08-11
Age:15.0  Onset:2008-08-11, Days after vaccination: 0
Gender:Female  Submitted:2008-08-13, Days after onset: 2
Location:Oregon  Entered:2008-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Headache
SMQs:
Write-up: Patient complained of headaches after receiving vaccine. Mild headache was still present the following morning when she was seen by me. Normal physical examination.

VAERS ID:322110 (history)  Vaccinated:2008-06-17
Age:15.0  Onset:2008-06-18, Days after vaccination: 1
Gender:Female  Submitted:2008-06-19, Days after onset: 1
Location:Washington  Entered:2008-08-13, Days after submission: 55
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U1IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.148442SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2562AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2688AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1585U1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Decreased appetite, Fatigue, Headache, Muscular weakness, Nausea, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt c/o fatigue, decreased appetite on the evening of 6/17/08. Woke up at 5:15am on 6/18/08 c/o headache, nausea, weakness in arms, "shocking" sensation on arms & trunk (from neck down to abdomen) - this sensation would come in "waves". T 98.3 axillary. All s/s resolved except fatigue.

VAERS ID:322166 (history)  Vaccinated:2008-08-05
Age:15.0  Onset:2008-08-06, Days after vaccination: 1
Gender:Female  Submitted:2008-08-07, Days after onset: 1
Location:Massachusetts  Entered:2008-08-14, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Localized reaction~Varicella (Varivax)~2~0~In Sibling
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B020AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0093X1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site swelling, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Injection site with 2x3 inch localized reaction, warmth, swelling.

VAERS ID:322171 (history)  Vaccinated:2008-08-11
Age:15.0  Onset:2008-08-11, Days after vaccination: 0
Gender:Male  Submitted:2008-08-11, Days after onset: 0
Location:Pennsylvania  Entered:2008-08-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2685AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR2995BA5UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Asthenia, Hyperhidrosis, Malaise, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient became pale, diaphoretic, weak. Patient never lost consciousness and was able to verbalize not feeling well. Symptoms came on after given vaccine within 4-6min and passed after approx 4-6min. *Patient had nothing to eat prior to injections

VAERS ID:322204 (history)  Vaccinated:2008-08-12
Age:15.0  Onset:2008-08-12, Days after vaccination: 0
Gender:Female  Submitted:2008-08-14, Days after onset: 2
Location:Georgia  Entered:2008-08-14
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: ASTHMA
Diagnostic Lab Data: NO LABS
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: PT WAS GIVEN HPV IN L-ARM ON 8/12/2008 PT THEN RETURNED TO OUR OFFICE ON 8/13/2008 C/O BEING DIZZY, VOMITING, HEADACHE, AND DIARRHEA. C/O FEELING TIRED SINCE THE SHOT. ADVISED PT TO MODIFY DIET AS TOLERATED AND TO CALL IF PT STARTS HAVING SEIZURES OR SEVERE WEAKNESS

VAERS ID:322209 (history)  Vaccinated:2008-08-07
Age:15.0  Onset:2008-08-08, Days after vaccination: 1
Gender:Female  Submitted:2008-08-14, Days after onset: 6
Location:Arizona  Entered:2008-08-14
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Dizziness for several days, onset the day after the vaccine was given. No syncope.

VAERS ID:322239 (history)  Vaccinated:2008-08-04
Age:15.0  Onset:2008-08-05, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Unknown  Entered:2008-08-14
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: WBC 7300, Hgb 14.4, plt 182000; glucometer 108
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2581AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Asthenia, Blood glucose normal, Body temperature increased, Crying, Haemoglobin normal, Mood altered, Personality change, Platelet count normal, Pyrexia, White blood cell count normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: temp 101.1; HR - 78; BP 120/74; feeling weak; fever; personality change - weepy; moody

VAERS ID:322244 (history)  Vaccinated:2008-08-01
Age:15.0  Onset:2008-08-08, Days after vaccination: 7
Gender:Male  Submitted:0000-00-00
Location:Virginia  Entered:2008-08-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; albuterol
Current Illness: None
Preexisting Conditions: None Known
Diagnostic Lab Data: Viral CX Positive V. Zoster
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DECAVAC)SANOFI PASTEURU22940A  RA
Administered by: Private     Purchased by: Private
Symptoms: Culture positive, Herpes zoster, Musculoskeletal pain, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Increased pain in right shoulder 8/8/08. Rash in same area 8/09/08. Seen in clinic 8/10/08, rash in C5 distribution. Viral CX done. Got routine booster DT lot # U22940A 08/01/08.

VAERS ID:322319 (history)  Vaccinated:2008-04-24
Age:15.0  Onset:2008-05-03, Days after vaccination: 9
Gender:Female  Submitted:2008-08-15, Days after onset: 104
Location:Georgia  Entered:2008-08-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: eczema, rashes PMH: URI, sinusitis, gastritis secondary to NSAID use, allergic rhinitis, pharyngitis, wrist sprain, viral syndrome, bronchitis, febrile illness, diarrhea, influenza, UTI, vaginitis, LBP. Family hx: HTN, hyperlipidemia. Recently had cousin dx w/RA. Allergic PCN.
Diagnostic Lab Data: LABS: ESR of 5/21/08 5 (N).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1966U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agitation, Anxiety, Arthralgia, Blister, Depression, Dermatitis, Ear pain, Emotional distress, Ephelides, Erythema, Fatigue, Hypersensitivity, Joint swelling, Keratosis pilaris, Melanocytic naevus, Mood swings, Oedema peripheral, Pharyngitis, Pharyngolaryngeal pain, Pruritus, Rash, Rash macular, Rash papular, Rash pruritic, Red blood cell sedimentation rate normal, Seborrhoea, Sinus headache, Skin irritation
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Mysterious rash began 9 days after receiving the initial injection with water blister type manifestion and systemic reaction like symptoms with agitation and anxiety (would come and go with no apparent provocation). Sore throat and ear pain. Swelling of right foot intermittent. Joint pain. Rash continued for months. Increasing fatigue, depression, mood swings, and emotional distress. Has seen general practitioner with no findings, dermatologist can not identify skin irritations and has prescribed lotions which have no effect. 9/26/08 Reviewed dermatologist medical records of 6/17/2008. FINAL DX: perioral dermatitis vs seborrheic dermatitis; nevi, freckling; keratosis pilaris, asymptomatic. Records reveal patient experienced rash on face, back & arms 2 days s/p initial HPV vaccine. Rash noted as recurrent water blisters & facial redness that would dry up w/minimal itching. Exam revealed rough patches over nose, cheeks, perioral area & chin area. No vesicles noted on exam. There was rough eczema appearing rash of antecubital & proximal aspects of bilateral forearms. Keratosis pilaris was noted on bilateral upper arms. Numerous macular freckles were noted on face & shoulders. Tx w/lotion/cream. Was to return should re-excerbation ocur. No further visits on record. 9/30/08 Reviewed urgent care medical records of 6/2004-6/17/2008. FINAL DX: none provided Records reveal patient exprienced pruitic rash of face & arms, sore throat, sinus HA, swollen feet on 5/8/08 dx w/allergic reaction/rash, pharyngitis. Tx w/antibiotics. RTC 5/21/08 w/intermittent pruitic rash & swollen hands/knees. Light pink papular itchy rash noted on cheek, scalp & upper arm but no joint swelling on exam. Tx w/antihistamine & steroids. Seen by dermatologist 6/17/08, records previously reviewed.

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