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Case Details (Sorted by Age)

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VAERS ID:273115 (history)  Vaccinated:2007-02-14
Age:12.0  Onset:2007-02-15, Days after vaccination: 1
Gender:Female  Submitted:2007-02-20, Days after onset: 5
Location:North Carolina  Entered:2007-02-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR1210F0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1302F SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: redness at site, fever, swollen

VAERS ID:273150 (history)  Vaccinated:2007-02-22
Age:12.0  Onset:2007-02-22, Days after vaccination: 0
Gender:Female  Submitted:2007-02-27, Days after onset: 5
Location:Tennessee  Entered:2007-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: open heart, VSO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1099R1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Joint dislocation, Loss of consciousness, Monoplegia, Pain, Pharyngolaryngeal pain, Pyrexia
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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: all happened from 2/22/07-2/25/07 aches-fever-sore throat and passed out-convulsion-crippled rt leg-rt thumb went out of socket

VAERS ID:273207 (history)  Vaccinated:2006-12-28
Age:12.0  Onset:2006-12-28, Days after vaccination: 0
Gender:Female  Submitted:2007-02-28, Days after onset: 62
Location:Pennsylvania  Entered:2007-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yaz birth control
Current Illness: NONE reported
Preexisting Conditions: NKDA; no birth defects; no medical conditions
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1208F0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 2-27-07 Patient stated "I had redness in my right arm that went down to right hand and knuckles, then it started in left arm and hand it was very itchy. Started 30-45 min after injection given.

VAERS ID:273228 (history)  Vaccinated:2007-02-19
Age:12.0  Onset:2007-02-19, Days after vaccination: 0
Gender:Female  Submitted:2007-03-01, Days after onset: 10
Location:Maryland  Entered:2007-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Subsequently diagnose with sinusitis/bronchitis.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)AVENTIS PASTEURC2340AA0 LA
Administered by: Private     Purchased by: Private
Symptoms: Bronchitis, Pain, Pyrexia, Sinusitis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: After vaccine patient had abrupt onset of fever to 103 with chills, vomiting and achiness.

VAERS ID:273325 (history)  Vaccinated:2007-02-12
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-03-02
Location:Connecticut  Entered:2007-03-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: None
Preexisting Conditions: Asthma, Scoliosis, Adjustment d/o, egg allergy & lactose intolerant
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.927243080SCRA
Administered by: Public     Purchased by: Public
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: mild varicella like rash developed 13 days after vaccine

VAERS ID:273391 (history)  Vaccinated:2006-12-11
Age:12.0  Onset:2006-12-12, Days after vaccination: 1
Gender:Female  Submitted:2006-12-15, Days after onset: 3
Location:Louisiana  Entered:2007-03-05, Days after submission: 80
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: LA0710207
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2456AA5IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0495F0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Pain, Wound drainage
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Received Tdap 12/11/06 - no symptoms until 12/12/06 redness and soreness noted. Mother state she also had small amount of pus-like drainage then symptoms have improved everyday 12/15/06 today redness with soreness - measuring 45 x 45 mm.

VAERS ID:273505 (history)  Vaccinated:2007-02-23
Age:12.0  Onset:2007-02-23, Days after vaccination: 0
Gender:Female  Submitted:2007-03-06, Days after onset: 11
Location:Massachusetts  Entered:2007-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: allergic to strawberries
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1426F1IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Pain
SMQs:
Write-up: Aftershot, patient developed pain on the side of the body (left) that shot was administered, over left arm, left trunk, and left leg. There was no local redness, swelling, or pain at site of vaccine itself. The patient was treated with Motrin and ice and resolved after 24 hours.

VAERS ID:273523 (history)  Vaccinated:2007-02-24
Age:12.0  Onset:2007-02-25, Days after vaccination: 1
Gender:Female  Submitted:2007-02-27, Days after onset: 2
Location:Wisconsin  Entered:2007-03-07, 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: Advair 50/100 inhaler, Albuterol inhaler
Current Illness:
Preexisting Conditions: asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2609AA0IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0905F1SC 
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pruritus, Rash, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 24 hours after immunization given, developed had raised area 3 inches long x 1 inch wide area, warm to touch, itchy, tender to touch. Needle insertion site in the middle of red area

VAERS ID:273535 (history)  Vaccinated:2007-02-20
Age:12.0  Onset:2007-02-21, Days after vaccination: 1
Gender:Female  Submitted:2007-02-28, Days after onset: 7
Location:California  Entered:2007-03-07, 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
Current Illness: well child visit
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 0 RA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2689AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1307F1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling and tenderness left deltoid approx 0.5 cm erythema at each puncture site. Approx 4x4 cm erythema with induration distal to injection sites.

VAERS ID:273680 (history)  Vaccinated:2007-02-12
Age:12.0  Onset:2007-03-05, Days after vaccination: 21
Gender:Female  Submitted:2007-03-08, Days after onset: 3
Location:Pennsylvania  Entered:2007-03-08
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1256F1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective, Varicella
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Vaccine induced eruption (mild) after recommended varicella vaccine. One lesion on left arm, right leg, left neck, 3 mm and minor itch.

VAERS ID:273691 (history)  Vaccinated:2006-12-11
Age:12.0  Onset:2006-12-21, Days after vaccination: 10
Gender:Female  Submitted:2007-03-08, Days after onset: 77
Location:New York  Entered:2007-03-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: seizure~HPV (Gardasil)~2~12~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: Developmental delay. PMH: developmental delay-non progressive. Occasional h/a. Lyme Disease age 5. Allergy to nuts, hives from Amoxicillin.
Diagnostic Lab Data: MRI and EEG.. Labs and Diagnostics: Brain MRI WNL. EEG WNL. Fragile X test with normal karyotype.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2166MA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1163F0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Aphasia, Complex partial seizures, Electroencephalogram, Electroencephalogram normal, Grand mal convulsion, Karyotype analysis normal, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain normal, Throat tightness, Tremor
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad)
Write-up: First seizure 10 days after first gardasil vaccine. Two months later, second seizure episode 16 days after second gardasil. 08/22/2008 MR received from Neuro consult dated 12/22/06 (as well as some past hx.) Assessment: 1st Seizure. Most likely a complex partial seizure with secondary generalization. Pt was trying to speak but unable to do so, then had a 30-40 sec grand mal seizure which may have begun in the legs. Neuro exam WNL. 9/11/2008 2 ER recs received dated 12/21/2006 and 6/16/2007 with DX: 1st seizure and seizure. Pt 1st presented 12/21/06 following 30-40 sec seizure. Seen 6/17/07 after 2 episodes of lip quivering and feeling of throat closing which was a similar aura with last grand mal seizure. C/o headache after.

VAERS ID:273815 (history)  Vaccinated:2007-02-20
Age:12.0  Onset:2007-02-20, Days after vaccination: 0
Gender:Male  Submitted:2007-02-23, Days after onset: 3
Location:Wisconsin  Entered:2007-03-12, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin
Current Illness: acute right Otitis Media, Strep Throat
Preexisting Conditions: 1 yr well child check
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB129AA0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1005R2IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0661F0SCLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIESB08670E3IMRL
Administered by: Private     Purchased by: Other
Symptoms: Incorrect dose administered
SMQs:
Write-up: Adult dose of Hepatitis A given (1440 elu) instead of Pediatric dose of Hepatitis A (720 elu).

VAERS ID:273878 (history)  Vaccinated:2007-03-06
Age:12.0  Onset:2007-03-06, Days after vaccination: 0
Gender:Male  Submitted:2007-03-13, Days after onset: 6
Location:Iowa  Entered:2007-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra daily, Albuterol PRN
Current Illness: NONE
Preexisting Conditions: Lactose intolerant, cats, asthma, kawaski syndrome
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU2061AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Insomnia, Pruritus, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash developed with itching. Started between shoulder blades evening of 3-6-07. Next day gradually spread to cover whole body. Difficulty sleeping 3-7-07 d/t itching. Mom gave Benadryl 3/8/07 am with no relief. Physician gave rx for Hydroxyzine 25 mg 3-4 times daily PRN.

VAERS ID:273922 (history)  Vaccinated:2007-03-05
Age:12.0  Onset:2007-03-05, Days after vaccination: 0
Gender:Female  Submitted:2007-03-07, Days after onset: 2
Location:Michigan  Entered:2007-03-14, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vague RLQ abd pain
Preexisting Conditions: Depression, seasonal allergies
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1424F IMRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1397F SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2720AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Fatigue, Pharyngolaryngeal pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Six hours s/p injections developed fever, rash up right arm, right side of neck and face. Also developed sore throat in 24 hours. Temp = 102. Rash responded to Benadryl except for local injection sites. Is having RLQ pain but that started before injections. Generally feels fatigued as well. No rash on left arm.

VAERS ID:273987 (history)  Vaccinated:2007-03-12
Age:12.0  Onset:2007-03-13, Days after vaccination: 1
Gender:Female  Submitted:2007-03-14, Days after onset: 1
Location:Oregon  Entered:2007-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: recovering from Mono diagnoised 12/12/06
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0804F0IMLA
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2720AA5IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient recieved immunizations 3/12/07 at routine well check. On 3/13/07 in evening per mother noted swelling, red, and hot at site of Varicella immunization. On 3/14 Mom called office to report to RN that lump was size of a small egg. No other swelling noted away from site (left upper arm). Child was at school and acting fine. Advised to give Ibuprophen or Tylenol, alternate ice/heat and to come in if swelling, redness, or pain increases.

VAERS ID:274023 (history)  Vaccinated:2007-03-07
Age:12.0  Onset:2007-03-08, Days after vaccination: 1
Gender:Male  Submitted:2007-03-15, Days after onset: 6
Location:Michigan  Entered:2007-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: No test done Seen in ER on 03/10/2007
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0610F0IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0287R0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1306F1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Facial palsy, Hypoaesthesia, Paraesthesia oral, Paralysis, Paresis
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: 24 hours within recieving HepA, HepB and Varivax developed R sided Numbness/tingling of tongue; within 48 hours could not close R eye lid-paresis/paralysis. Diagnosed Bells Palsy. Right side of neck and face paralyzed.

VAERS ID:274122 (history)  Vaccinated:2007-02-01
Age:12.0  Onset:2007-02-01, Days after vaccination: 0
Gender:Female  Submitted:2007-03-14, Days after onset: 40
Location:Pennsylvania  Entered:2007-03-16, 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: Aortic incompetence, Migraine
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00724
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0013U0IM 
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Body temperature increased, Dizziness, Myalgia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Initial and follow up information has been received from an LPN and the mother of a 12 year old female patient with aortic insufficiency and migraine headaches who on 01-FEB-2007 was vaccinated IM with her first dose of Gardasil, lot #654741/0013U. There was no concomitant medication. Subsequently, the patient experienced dizziness and developed an elevated temperature. It was also reported that the patient felt weak and had muscle aches for several days. The side effects eventually disappeared. However on 21-FEB-2007, the patient woke up with breast rashes. As of 21-FEB-2007 breast rashes persisted. Additional information has been requested.

VAERS ID:274161 (history)  Vaccinated:2007-03-16
Age:12.0  Onset:2007-03-16, Days after vaccination: 0
Gender:Male  Submitted:2007-03-16, Days after onset: 0
Location:Minnesota  Entered:2007-03-16
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
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB346AB0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B011BA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient has hives at the site of the injections and on his upper bodya nd back. Had injections at 8am on 3-16-07 and was reported to the clinic at 4pm the same day.

VAERS ID:274173 (history)  Vaccinated:2007-03-13
Age:12.0  Onset:2007-03-14, Days after vaccination: 1
Gender:Female  Submitted:2007-03-16, Days after onset: 2
Location:California  Entered:2007-03-16
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: Allergy to Motrin
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU1975BA0IM 
Administered by: Private     Purchased by: Unknown
Symptoms: Dyspnoea, Lip swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Swelling of lips, difficulty breathing.

VAERS ID:274189 (history)  Vaccinated:2006-11-06
Age:12.0  Onset:2006-11-06, Days after vaccination: 0
Gender:Female  Submitted:2007-03-14, Days after onset: 127
Location:Virginia  Entered:2007-03-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA01175
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0013U1  
Administered by: Private     Purchased by: Private
Symptoms: Head injury, Inappropriate schedule of drug administration, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Initial and follow up information has been received from a licensed practical nurse via a company representative, concerning a 12 year old white female student, who on 06 Nov 2006 was vaccinated in the right deltoid with 0.5 ml of the first dose of Gardasil. There was no concomitant medication. There was no illness at the time of vaccination. The patient passed out in the physician''s waiting room after receiving the vaccination. The patient stated she did not eat breakfast. Upon awakening, the patient was given crackers and soda, and stated she felt better. On 05 Feb 2007, three months after the first dose, the patient was vaccinated in the left deltoid with the second dose of Gardasil. After the second vaccination, the mother called and reported her daughter had passed out at home and hit her head. The patient did not receive medical attention, but her physician was informed. The patient recovered the same day, 05 Feb 2007. Additional information is not expected.

VAERS ID:274230 (history)  Vaccinated:2007-02-13
Age:12.0  Onset:2007-02-13, Days after vaccination: 0
Gender:Unknown  Submitted:2007-03-14, Days after onset: 28
Location:Unknown  Entered:2007-03-16, 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: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA02913
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0 UN
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Nausea, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Information has been received from registered nurse supervisor, via a company representative, concerning a 12 year old patient who on 13-FEB-2007 was vaccinated IM in the left deltoid a 5:00 pm with the first dose of Gardasil. Three hours later (8:00pm), the patient had developed hives on the face, back and bottom. By 8:30pm, the patient began to experience wheezing, but then "slept fine through the night". Treatment was not specified. The next morning (14-FEB-2007), hives "had subsided," but the patient "felt nauseous and tired." At the time of this report, the patient had not recovered. The nurse also reported that the patient will not be given the second and third dose of the vaccine. Additional information has been requested.

VAERS ID:274285 (history)  Vaccinated:2007-01-01
Age:12.0  Onset:2007-01-01, Days after vaccination: 0
Gender:Female  Submitted:2007-03-14, Days after onset: 71
Location:Massachusetts  Entered:2007-03-16, 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: Sore throat; Hypothyroidism; Growth hormone deficiency
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA03141
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1427F IMUN
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Pain
SMQs:, Arthritis (broad)
Write-up: Information has been received from a nurse practitioner concerning a 13 year old female who in January 2007, was vaccinated with Gardasil. In January 2007, the patient developed arthritic symptoms. The patient had developed achy knees and wrists. There was no redness on the knees and the wrists but were sore. It was reported that ibuprofen was little help in relieving the pain. The nurse practitioner reported that she would ask for lab work to be done for rheumatoid arthritis and a sedimentation rate. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a nurse practitioner concerning a 13 year old, female with a sore throat at the time of vaccination, hypothyroidism and growth hormone deficiency, who on either "02-JAN-2007" was vaccinated IM, with a dose of GARDASIL (Lot #655619/1427F). On 15-FEB-2007, the patient developed arthritic symptoms, including achy knees and wrists. There was no redness on the knees and the wrists but were sore. It was reported that IBUPROFEN was little help in relieving the pain. The nurse practitioner reported that she would ask for lab work for rheumatoid arthritis and a sedimentation rate (results and tests not confirmed). Follow up information indicated that "according to rheumatology" the patient probably did not have a reaction to (GARDASIL)." At the time of this report, it was unknown if the patient had recovered. Additional information has been requested.

VAERS ID:274294 (history)  Vaccinated:2007-02-12
Age:12.0  Onset:2007-02-12, Days after vaccination: 0
Gender:Female  Submitted:2007-03-14, Days after onset: 29
Location:California  Entered:2007-03-16, 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: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA03444
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IM 
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 12 year female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of Gardasil. On approximately 12-FEB-2006 the patient fainted after the administration of Gardasil. Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:274297 (history)  Vaccinated:2007-02-06
Age:12.0  Onset:2007-02-06, Days after vaccination: 0
Gender:Female  Submitted:2007-03-14, Days after onset: 35
Location:Virginia  Entered:2007-03-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood pressure, 02/07/07, 110/7
CDC Split Type: WAES0702USA03468
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0637F1IMLA
Administered by: Military     Purchased by: Military
Symptoms: Balance disorder, Dizziness, Feeling cold, Loss of consciousness, Tunnel vision
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Retinal disorders (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Initial and follow up information has been received from a registered nurse and a health care provider, concerning a 12 year old female patient who on 21-NOV-2006 (previously reported as within the last 3 months) was vaccinated intramuscularly in the right deltoid, with an 0.5 mL dose of GARDASIL vaccine (Lot #653937/0637F), and on 06-FEB-2007, was vaccinated IM in the left deltoid with an additiional 0.5 mL dose of GARDASIl vaccine (Lot # 653937/0637F). After receiving the dose on 06-FEB-2007. Subsequently the patient experienced dizziness to the point of losing consciousness. The event lasted for a matter of seconds. The patient was well enough to leave in a few minutes. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow up information from the health care provider who administered the vaccine, stated that on 06-FEB-2007 after the vaccination, the patient "was really cold, she got tunnel vision and began to lose her balance." The patient rested for 15 minutes, and was sent home after evaluation by the nurse. The patient was considered to have recovered on the same day. No further information is expected.

VAERS ID:274302 (history)  Vaccinated:2007-01-18
Age:12.0  Onset:2007-01-18, Days after vaccination: 0
Gender:Female  Submitted:2007-03-14, Days after onset: 54
Location:Wisconsin  Entered:2007-03-16, 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: UNK
Diagnostic Lab Data: diagnostic microbiology 01/18?/07 - normal strep test, Lyme disease assay 01/18?/07 - normal, serum creatine kinase 01/18?/07 - normal, serum influenza B virus 01/18?/07 - normal, serum rheumatoid factor 01/18?/07 - normal, serum influenza A virus 01/18?/07 - normal, serum ANA 01/18?/07 - normal, complete blood cell 01/18?/07 - normal pelvic x-ray, 02/07/07, normal pelvis and hips; joint x-ray, 02/07/07, normal; joint x-ray, 02/07/07, normal; erythrocyte, 01/18?/07, normal; erythrocyte, 02/07/07, 41 mm/HR high
CDC Split Type: WAES0702USA03560
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1424F0IM 
Administered by: Private     Purchased by: Other
Symptoms: Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, Borrelia test negative, Fatigue, Full blood count normal, Influenza serology negative, Injection site pain, Microbiology test, Musculoskeletal pain, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus serology negative, X-ray limb normal, X-ray of pelvis and hip
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a registered nurse concerning a 12 year old female who on 18-JAN-2007 was vaccinated IM with a first dose of Gardasil. No other vaccinations were administered. On approximately 18-JAN-2007, the patient experienced soreness at injection site, fatigue, musculo-skeletal pain, and joint pain. The following laboratory tests were performed on the patient: complete blood cell (CBC) count; erythrocyte sedimentation rate (sed rate); rheumatoid factor (RF); antinuclear antibodies test (ANA); creatine kinase (CPK); "strep test"; influenza A and B; Lyme disease enzyme-linked immunosorbent assay. All lat test results were reported as normal. The patient was not prescribed any treatment. By 20-FEB-2007, the patient was fully recovered. Additional information is not expected. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Follow-up from a physician indicated that approximately 10-14 days after the patient was vaccinated, she developed shoulder, hip and ankle pains. On 07-FEB-2007, the patient had a shoulder x-ray, right knee x-ray, and hip x-ray. All were normal. On 07-Feb-2007, the patient''s ESR was 41. On 17-FEB-2007 the patient recovered from the shoulder, hip and ankle pain. Additional information is not expected.

VAERS ID:274318 (history)  Vaccinated:2007-01-01
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-03-14
Location:Ohio  Entered:2007-03-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA03751
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0 UN
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a pharmacist concerning a 12 year old female with no pertinent medical history who in approximately January 2007, was vaccinated with a first dose of Gardasil. There was no concomitant medication. Subsequently the patient developed a lump at the injection site. It was reported that the lump at the injection site "recently" became painful. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. At the time of the report, the lump and pain at the injection site persisted. Additional information has been requested.

VAERS ID:274594 (history)  Vaccinated:2007-02-16
Age:12.0  Onset:2007-02-16, Days after vaccination: 0
Gender:Female  Submitted:2007-03-14, Days after onset: 25
Location:Unknown  Entered:2007-03-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions: Birth defects; Surgery
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA04212
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1 UN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Inappropriate schedule of drug administration, Lip swelling, Neck pain, Pharyngolaryngeal pain
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a consumer concerning her 12 year old daughter with a history of surgery for birth defects and allergic to erythromycin who on 15-JAN-2007 and 16-FEB-2007 was vaccinated with a first and second dose of Gardasil, respectively. There was no concomitant medication. On 22-FEB-2007 ''last night", the consumer''s daughter experienced headache, sore throat, neck pain and her lips were swollen. No medical attention was sought. No laboratory studies were performed. At the time of this report, the consumer''s daughter had not recovered. It was also reported that she tolerated her first of the vaccine with any events. The consumer plans on having her daughter receive the third dose of the vaccine. No product quality complaint was involved. Additional information is not expected.

VAERS ID:274744 (history)  Vaccinated:2007-02-12
Age:12.0  Onset:2007-02-12, Days after vaccination: 0
Gender:Female  Submitted:2007-03-14, Days after onset: 29
Location:California  Entered:2007-03-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA00940
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IM 
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram, Head injury, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of Gardasil. On approximately 12-FEB-2007 the patient fainted after the administration of Gardasil. It was reported that this patient may have fainted while on the way to the car and hit her head at an unspecified area. Medical attention was sought and the patient''s mother was requesting a computed axial tomography because the patient was experiencing bad headaches. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:274252 (history)  Vaccinated:2007-03-12
Age:12.0  Onset:2007-03-12, Days after vaccination: 0
Gender:Male  Submitted:2007-03-14, Days after onset: 2
Location:New Jersey  Entered:2007-03-19, 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: Albuterol MOI prn, Flovent prn as directed
Current Illness:
Preexisting Conditions: Asthma-mild intermittent
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU1922AB0IMLA
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2689AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Lip swelling, Oedema mouth
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Vaccines administer at approximately 2 pm on 3/12/07. At approx 4pm he noticed his lips and mouth were swollen. Mom noticed at 8pm and administered Benadryl. He had another dose of Benadryl in the morning.

VAERS ID:274450 (history)  Vaccinated:2007-03-06
Age:12.0  Onset:2007-03-06, Days after vaccination: 0
Gender:Male  Submitted:2007-03-19, Days after onset: 12
Location:Kansas  Entered:2007-03-21, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: seizure, fever-hospitalized ICU several days~DTP (unknown mfr)~~2~In Sibling
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Initial visit to Health Department.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURY0575-20SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1053R0SCRA
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2454AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received Tdap IM Left deltoid. Within the hour after vaccine given Left axilla and area began to swell. Unable to use arm much for 1 week and swelling continues 2 weeks post shot. Ran some fever. Parent notified health department on day #12 after shot given. Had not seen physician.

VAERS ID:274469 (history)  Vaccinated:2007-03-09
Age:12.0  Onset:2007-03-10, Days after vaccination: 1
Gender:Male  Submitted:2007-03-12, Days after onset: 1
Location:Louisiana  Entered:2007-03-21, Days after submission: 9
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
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2454AA0IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0913F1SC 
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Arm red, swollen, tender

VAERS ID:274470 (history)  Vaccinated:2007-03-13
Age:12.0  Onset:2007-03-13, Days after vaccination: 0
Gender:Female  Submitted:2007-03-15, Days after onset: 2
Location:New York  Entered:2007-03-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Chest X-ray, 03/13?/07
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0186U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU1967AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2456AA4UNRA
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Chest X-ray, Chest discomfort, Chest pain, Dyspnoea, Neck pain, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Severe arm and neck pain, chest tightness, 2 hour post vaccine. No prior history of asthma, abdominal pain. Seen in the ER and discharged with Albuterol. This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a registered nurse and a licensed practical nurse concerning a 12 year old female student with no pertinent medical history who on 13-MAR-2007, at 16:45 was vaccinated, intramuscularly into the left arm, with a 0.5 mlm first dose of GARDASIL (lot #655618/0186U) concomitantly with a first dose of MENACTRA (lot #0167AA) and a fifth dose of ADACEL (lot #C2456AA) into the right arm. On 13-MAR-2007, at 17:45 (also, reported as 2 hours after vaccination), the patient developed severe arm and neck pain, chest tightness and abdominal pain. At bedtime, the patient had difficulty breathing and pain in her chest. Her mother took her to the emergency room where she had a chest x-ray. It was reported that there was no detection of wheezing, swelling or pulmonary embolism. She was treated with albuterol which "did not seem to help." As of 14-MAR-2007, the patient was improving her arm and chest were "just sore." No further information is available.

VAERS ID:274480 (history)  Vaccinated:2007-03-17
Age:12.0  Onset:2007-03-17, Days after vaccination: 0
Gender:Male  Submitted:2007-03-20, Days after onset: 3
Location:Louisiana  Entered:2007-03-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (MENOMUNE)AVENTIS PASTEURU2058AA0IMLA
TD: TD ADSORBED (NO BRAND NAME)AVENTIS PASTEURU1620BA5IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1156F1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received Varicella vaccine left arm Subq. Before 12 noon on 3-17-07. At bed time- red area as big as a quarter. The next AM 3/18/07-4"x6" area red, hard, hot, swollen, painful and itching. 3-21-07-still red and painful and itching-but getting better.

VAERS ID:274537 (history)  Vaccinated:2006-01-18
Age:12.0  Onset:2006-01-19, Days after vaccination: 1
Gender:Female  Submitted:2006-01-25, Days after onset: 6
Location:North Carolina  Entered:2007-03-22, Days after submission: 420
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: BERNA20060013
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD  PO 
Administered by: Private     Purchased by: Private
Symptoms: Fatigue, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This 12-year old female was vaccinated with Vivotif (typhoid vaccine live oral Ty21a, Batch no. : unknown). She took the first capsule on 18.Jan.2006, the second capsule on 20.Jan.2006 and third capsule on 22.Jan.2006. One day after intake of the first capsule the patient felt fatigue. After intake of 3rd capsule on 22.Jan.2006 the patient developed skin rash on neck and truck. The patient did not take the fourth capsule. Outcome and treatment of reaction was not reported. This case was forwarded by manufacturer reported. The case was reported as non-serious.

VAERS ID:274612 (history)  Vaccinated:2007-01-01
Age:12.0  Onset:2007-01-01, Days after vaccination: 0
Gender:Female  Submitted:2007-03-22, Days after onset: 79
Location:Unknown  Entered:2007-03-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: ultrasound 01/??/07 - results not reported
CDC Split Type: WAES0703USA02141
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0  
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Ovarian cyst, Ovarian cyst ruptured, Ultrasound scan, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from an office receptionist concerning a 12 year old female who in January 2007 was vaccinated with the first dose of Gardasil. Concomitant mediation was not reported. In January 2007, the developed an ovarian cyst that ruptured 10 days after receiving the first dose of Gardasil. Initially, the patient started vomiting for a few days and then there was significant abdominal pain. The patient was examined and diagnosed with ruptured ovarian cyst. The patient''s ovarian cyst and ruptured ovarian cyst persisted and were considered to be disabling. Additional information has been requested.

VAERS ID:274635 (history)  Vaccinated:2007-03-22
Age:12.0  Onset:2007-03-22, Days after vaccination: 0
Gender:Female  Submitted:2007-03-23, Days after onset: 1
Location:Wisconsin  Entered:2007-03-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE per parent~~NULL~~In Patient|NONE per parent~~NULL~~In Sibling1|NONE per parent~~NULL~~In Sibling2
Other Medications: None
Current Illness: No
Preexisting Conditions: None noted on vaccine history form completed by mother before immunizations given
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1426F0IMRA
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2457AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure, Chills, Confusional state, Dizziness, Muscle contracture, Oxygen supplementation, Pallor, Paraesthesia, Paraesthesia oral, Posture abnormal, Sensation of heaviness, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)
Write-up: Adacel given first, appeared fine. HPV then given and within a minute or two, client''s chin fell to chest while arm contracted at elbow up off lap. She did not respond to name or shaking of shoulders for approximately one minute (B/P 100/60, pulse 64). Then became aroused, although very confused and unsure where she was. Called out for her mom and asked where she was and said she felt dizzy. Client then assisted off chair to floor. Became extremely pale, c/o lips tingling, B/P 130/64 at 1800. While resting c/o "heavy head" feeling and paresthia in R arm, R and L hands and feet as well as c/o of chills. At 1805 EMS called and responded by 1810 (B/P 130/66, RR 18 at 1805). Given oxygen per EMS. Client transported to ER. Client discharged from ER within a couple hours. Parent contacted at 2000 and states client was "fine now". Returned to school on 3/23/07 per mother.

VAERS ID:274983 (history)  Vaccinated:2007-03-19
Age:12.0  Onset:2007-03-20, Days after vaccination: 1
Gender:Male  Submitted:2007-03-22, Days after onset: 2
Location:Minnesota  Entered:2007-03-27, 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: Claritin, Benadryl, Singulair, Nasonex, Albuterol, Epipen Jr
Current Illness: No illness
Preexisting Conditions: food induced urticaria
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)AVENTIS PASTEURU1923EA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal pain upper, Dizziness, Injection site erythema, Injection site induration, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Localized erythema and mild induration at vaccine site of left deltoid, pt. c/o fever 100.5 degrees x 1 dy in duration, Also c/o general body ache, stomach ache, and dizziness, sx onset the day after the vaccine and are improved as of 3/22/07

VAERS ID:275111 (history)  Vaccinated:2007-03-14
Age:12.0  Onset:2007-03-14, Days after vaccination: 0
Gender:Female  Submitted:2007-03-28, Days after onset: 14
Location:North Carolina  Entered:2007-03-29, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown PMH: hearing loss since age 3, wears hearing aid left ear. Pyelonephritis, renal cysts. Migraine headaches, multiple episodes of allergies, allergic rhinitis, sinusitis, pharyngitis, recurrent ear infections, gastroenteritis, tonsillitis & tonsillar hypertrophy, cellulitis & viral illness. Patient was home schooled & had hx of ADD, taking Adderall. Family HX: patient''s maternal aunt w/renal failure since age 3, had 3 unsuccessful kidney transplants & died.
Diagnostic Lab Data: Unknown LABS 3/18 admit: urine & blood c/s revealed E.coli. Creatinine peak at 9. Renal US revealed echogenic kidneys w/poor corticomedullary differentiation containing multiple tiny cysts; normal renal artery acceleration times w/slightly elevated resistive indices. Repeat urine c/s neg at d/c. LABS 3/27 admit: HD catheter, urine & blood c/s neg. Rotavirus +. Creatinine 4. C. diff neg. LABS 4/25/07: serum creatinine 3.1 & creatinine clearance of 21.9mL/min 4/27/07 - TEE done which was normal & revealed no LVH. 5/7/07 MRI of brain was WNL.
CDC Split Type: WAES0703USA03783
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0181V0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bacteraemia, Bacteria urine identified, Blood creatinine increased, Blood culture positive, Clostridium difficile toxin test, Congenital cystic kidney disease, Culture urine positive, Dialysis, Diarrhoea, Diarrhoea haemorrhagic, Dizziness postural, Echocardiogram, Gastroenteritis rotavirus, Haematochezia, Hypotension, Nausea, Nuclear magnetic resonance imaging brain normal, Pain, Pyelonephritis, Pyrexia, Renal failure acute, Renal failure chronic, Rotavirus test positive, Ultrasound kidney abnormal, Urinary tract infection, Urosepsis, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad)
Write-up: Information has been received from a physician concerning a 13 year old female who, on an unspecified date, was vaccinated intramuscularly with a second dose of Gardasil. Within 24-48 hours, the patient experienced fever, achiness and diarrhea. The physician reported that 1-2 days later, the patient developed blood in the stool and was admitted to the hospital. The physician reported that the patient was diagnosed with acute kidney failure and was still hospitalized. At the time of this report, the patient''s fever, achiness and acute kidney failure persisted. Fever, achiness and acute kidney failure were considered to be immediately life-threatening and disabling. Additional information has been requested. 5/18/07 Received medical records from hospital which reveal patient seen at hospital 3/18-3/26/07 for nausea, vomiting, bloody diarrhea & fever starting approx 3/11/07. Found to have asymptomatic E.coli UTI that traveled to kidneys. Treated w/IV antibiotics & started on dialysis & placed on kidney transplant list. Progressed well & d/c to home on oral antibiotics. FINAL DX: acute renal failure, urosepsis, polycystic kidney disease, end stage renal failure, hemodialysis. 3/27-4/2/07 - Re-Admitted to pediatric nephrology with fever, dizziness & orthostasis. Treated w/multiple IV antibiotics. Was to continue dialysis but at least 2 sessions cancelled due to hypotension. Outpatient hemodialysis was arranged closer to her home & was to continue IV antibiotics at dialysis center as well as continue on oral antibiotics. Plan was to transition to peritoneal dialysis after off antibiotics for 1 week. FINAL DX: posible partially treated urosepsis; end stage renal disease; polysystic kidney disease; rotavirus gastroenteritis; h/o acute renal failure. 4/25/07 Seen in Dialysis at outlying center. Doing well, last dose of antibiotics on 4/13 & afebrile since then. Labs were much improved & a trial of decreased dialysis was discussed. 5/4/07 - Seen in surgery clinic for evaluation of peritoneal dialysis catheter for acute renal failure superimposed on chronic renal failure. HD site noted to possibly be infected & was started on oral antibiotics. Repeat stool & urine tests ordered & scheduled for PD placement. 5/7/07 MRI of brain was WNL. 6/22/07 Received medical records & vax record from reporter/provider which reveal patient received HPV on 3/14/07 & was 1st dose. VAERS database updated w/same. Medical records of 1994-2004.

VAERS ID:275183 (history)  Vaccinated:2007-03-28
Age:12.0  Onset:2007-03-29, Days after vaccination: 1
Gender:Female  Submitted:2007-03-29, Days after onset: 0
Location:Minnesota  Entered:2007-03-29
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
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0 L
Administered by: Private     Purchased by: Unknown
Symptoms: Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever, Soreness, Aches approximately 16 hours after the shot was administered

VAERS ID:275217 (history)  Vaccinated:2007-03-19
Age:12.0  Onset:2007-03-19, Days after vaccination: 0
Gender:Female  Submitted:2007-03-22, Days after onset: 3
Location:New Jersey  Entered:2007-03-30, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Firm, mobile mass Right upper arm
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU2141AA0 LA
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2644AA0 RA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient presented to office with Right arm red and swollen after vaccination the previous two days-symptoms began the same day as vaccination.

VAERS ID:275310 (history)  Vaccinated:2007-03-13
Age:12.0  Onset:2007-03-14, Days after vaccination: 1
Gender:Female  Submitted:2007-03-30, Days after onset: 16
Location:Florida  Entered:2007-03-30
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: Left Choroidal fissure brain cyst - stable in size
Diagnostic Lab Data: Rapid Strep test (-), rapid influenza test (-)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1427F0  
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURA17714A0  
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Chills, Dizziness, Headache, Influenza serology negative, Pharyngolaryngeal pain, Pyrexia, Streptococcus identification test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Received Gardasil and Menactra on same day 3/13/07 at a routine physician. Approximately 12 hours later, she began with fevers, chills, headache, dizziness, sore throat & abdominal pain, vomited x 1

VAERS ID:275320 (history)  Vaccinated:2007-03-05
Age:12.0  Onset:2007-03-08, Days after vaccination: 3
Gender:Male  Submitted:2007-03-30, Days after onset: 21
Location:Utah  Entered:2007-03-30
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: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Right deltoid swollen/red. Hot pack-reverse if worsens.

VAERS ID:275381 (history)  Vaccinated:2007-03-20
Age:12.0  Onset:2007-03-22, Days after vaccination: 2
Gender:Male  Submitted:2007-03-23, Days after onset: 1
Location:California  Entered:2007-04-02, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Lymph node pain
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURUE966AA0IMLA
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2690AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Localized swelling and redness confounding factor-patient also had generalized hives and was on amoxicillin. Improved with Benadryl.

VAERS ID:275428 (history)  Vaccinated:2007-03-01
Age:12.0  Onset:2007-03-07, Days after vaccination: 6
Gender:Female  Submitted:2007-04-02, Days after onset: 25
Location:New York  Entered:2007-04-02
Life Threatening? No
Died? Yes
   Date died: 2007-03-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: aortic and mitral valve insufficiency, unknown aetiology
Diagnostic Lab Data: ER LABS of 3/8/07: ABG pH 7.23, po2 62. Serum glucose 353, Creat 1.7, albumin 2.6, total protein 4.9, SGPT 62, SGOT 359. Blood c/s was neg. 2005 Cardiology LABS: echocardiogram revealed mild mitral valve & aortic valve insufficiency. Mi
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1280F1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0263U0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0943R1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Acidosis, Alanine aminotransferase increased, Aspartate aminotransferase increased, Autopsy, Blood albumin decreased, Blood creatinine increased, Blood culture negative, Blood gases abnormal, Blood glucose increased, Cardiomegaly, Chest X-ray abnormal, Cough, Echocardiogram abnormal, Gastroenteritis, Mitral valve incompetence, Myocarditis, Nervousness, Oxygen saturation decreased, Palpitations, Protein total decreased, Pyrexia, Rhinorrhoea, Ventricular tachycardia, Viral myocarditis
SMQs:, Torsade de pointes/QT prolongation (narrow), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad)
Write-up: presented to ED with Ventricular tachycardia. Preliminary autopsy finding of myocarditis. 4/3/07 Spoke w/ME who stated prelim COD as acute myocarditis, presumably viral. States patient had PMH of heart murmur which was evaluated by ped cardiologist who found mild aortic & mitral valve insufficiency & regurgitation. ME states did not see evidence of that on autopsy but did find cardiomegaly. Also states patient had been taken to ER on day of death for abdominal pain w/fever & was dx w/gastroenteritis. CXR at that time revealed cardiomegaly. No EKG or cultures were done. Was d/c to home & continued to not feel well. Parent found patient in bathroom unresponsive at approx 2AM & was transported to a second ER where she expired. ME states patient had approx 2 week hx of cough & runny nose prior to death. 6/12/07 Received final Autopsy Report which reveals COD as acute probable viral etiology myocarditis & manner of death as natural. 6/29/07 Received ER records from hospital where patient expired which reveal patient was in respiratory arrest & had been intubated by EMS. ACLS measures were unsuccessful & patient pronounced. 8/24/07 Received cardiology consult which reveals patient evaluated for heart murmur in 2005 which had been diagnosed for long time but never evaluated. Patient admitted to palpitations & nervousness. Patient history did not reveal any evidence of rheumatic fever. Antibiotic endocarditis prophylaxis recommended prior to dental & surgical procedures. Patient was to f/u w/cardiology in 2-3 yearrs to document progress of valvular insufficiency. FINAL Cardiology DX: Aortic & mitral valve insufficiency of unknown etiology.

VAERS ID:275443 (history)  Vaccinated:2007-03-22
Age:12.0  Onset:2007-03-22, Days after vaccination: 0
Gender:Female  Submitted:2007-03-28, Days after onset: 6
Location:Wisconsin  Entered:2007-04-02, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU2181AA0IMRA
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2572AA5IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0442F1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Sore R arm after vaccine received on 3/22/07. It has continued and not changed in intensity.

VAERS ID:275466 (history)  Vaccinated:2007-03-27
Age:12.0  Onset:2007-03-27, Days after vaccination: 0
Gender:Male  Submitted:2007-03-30, Days after onset: 3
Location:New Mexico  Entered:2007-04-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol, Flovent
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B014BA4IMRA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Severe headache, dizziness, fever of 104 deg (decreasing after 2 days) Given at ER: Ibuprofen 500MG Q 3-4 HRS.

VAERS ID:275470 (history)  Vaccinated:2007-03-06
Age:12.0  Onset:2007-03-07, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Pennsylvania  Entered:2007-04-03
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
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2720AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling and erythema right upper arm

VAERS ID:275559 (history)  Vaccinated:2007-03-26
Age:12.0  Onset:2007-03-27, Days after vaccination: 1
Gender:Female  Submitted:2007-04-03, Days after onset: 7
Location:Pennsylvania  Entered:2007-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: nickel and lactose allergies
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0186U0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B009AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Rash papular
SMQs:
Write-up: patient developed a skin collored papular nonpruritic rash on arms and face 5 days after receiving hpv and tdap vaccines. came to the doctors to be evalauted for the rash. no other symptoms or sequelae

VAERS ID:275618 (history)  Vaccinated:2007-04-04
Age:12.0  Onset:2007-04-04, Days after vaccination: 0
Gender:Female  Submitted:2007-04-04, Days after onset: 0
Location:Wisconsin  Entered:2007-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.024001 LA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site pain, Neck pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Pain from injection site extending into neck. Paresthesia in hand.

VAERS ID:275951 (history)  Vaccinated:2007-04-03
Age:12.0  Onset:2007-04-07, Days after vaccination: 4
Gender:Female  Submitted:2007-04-10, Days after onset: 3
Location:Ohio  Entered:2007-04-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Med allergy to Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.000140 LA
HPV4: HPV (GARDASIL)MERCK & CO. INC.038440 RA
Administered by: Private     Purchased by: Private
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Broke out with rash and hives 4-7-07 x 3 days.

VAERS ID:276026 (history)  Vaccinated:2007-03-29
Age:12.0  Onset:2007-04-01, Days after vaccination: 3
Gender:Male  Submitted:2007-04-04, Days after onset: 3
Location:Pennsylvania  Entered:2007-04-11, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: EEG (P)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1508F1 LA
Administered by: Private     Purchased by: Private
Symptoms: Electroencephalogram, Partial seizures
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: Focal seizure 4/1/07

VAERS ID:276062 (history)  Vaccinated:2007-04-10
Age:12.0  Onset:2007-04-10, Days after vaccination: 0
Gender:Male  Submitted:2007-04-11, Days after onset: 1
Location:Ohio  Entered:2007-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.   LA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEUR   LA
TDAP: TDAP (ADACEL)AVENTIS PASTEURA26899AA  RA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Dizziness, Hallucination, Nausea, Retching, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (narrow), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: Received shots at 10:30 am-ok until 6:30pm- He was dizzy, nauseous, and had joint pains. 8:30 pm vomiting and then dry heaves. Vision was blurry and he was dizzy. 11 pm he had hallucations, seen in office 4-4-07.

VAERS ID:276177 (history)  Vaccinated:2007-04-10
Age:12.0  Onset:2007-04-11, Days after vaccination: 1
Gender:Female  Submitted:2007-04-12, Days after onset: 1
Location:Ohio  Entered:2007-04-12
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: AMOXIL ALLERGY
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0244U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU1968AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B011AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0113U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: area of erythema and induration at site of second varicella immunization. 9 by 4 cm. no fever

VAERS ID:276259 (history)  Vaccinated:2007-03-23
Age:12.0  Onset:2007-03-25, Days after vaccination: 2
Gender:Female  Submitted:2007-04-02, Days after onset: 8
Location:New Hampshire  Entered:2007-04-13, Days after submission: 11
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: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB141AA1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU2003AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1258F1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Fatigue, Headache, Hypoaesthesia, Injection site pain, Neck pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: 3-27-07: Parent called dr''s office to report patient had the following symptoms for 2 days: "wakign with really, bad headache", "numbness and tingling down one arm, then the other arm, intermittently", "neck hurts, constantly tired, sometimes dizzy", soreness at injection site

VAERS ID:276343 (history)  Vaccinated:2007-03-26
Age:12.0  Onset:2007-03-26, Days after vaccination: 0
Gender:Female  Submitted:2007-03-26, Days after onset: 0
Location:Louisiana  Entered:2007-04-16, Days after submission: 21
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: LA070401
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0960F0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2061AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2556AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Expired drug administered
SMQs:
Write-up: #2 MMR administered expired lot # MSD 0377R (3/24/07) couldn''t update in LINKS

VAERS ID:276421 (history)  Vaccinated:2007-04-13
Age:12.0  Onset:2007-04-13, Days after vaccination: 0
Gender:Male  Submitted:2007-04-16, Days after onset: 3
Location:Utah  Entered:2007-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS8550IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS804 IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.8521SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: PT RECIEVED VARICELLA VACCINTATION IN LLA. UPON RECIEVING INJECTION PT STARTED TO C/O ITCHING AT THE SITE. UPON INSPECTION THE PT APPEARED TO HAVE A SIGNIFICANT OF REDNESS AND SWELLING. PT STATED HE WAS NOT HAVING ANY DIFFICULTIES BREATHING OF AGITATION JUST ITCHING. PT WAS ASKED TO STAY AT CLINIC FOR OBSERVATION. AFTER PERIODIC EVALUATION OF PT REDNESS AND SWELLING WERE SUBSIDING, PT HAD NO C/O OF DIFFICULTY BREATHING. PT FATHER WAS ADVISED TO GIVE THE PT SOME BENADRYL AND WATCH IT CLOSELY, HE WAS ALSO GIVEN A PHONE NUMBER IF HE NEEDED ANYTHING. BEFOR LEAVING THE CLINIC THE PT REDNESS HAD DECREASED TO A QUARTER SIZE SPOT AT THE INJECTION SITE WITH NO FURTHER SWELLING OR C/O ITHCING. PT FATHER WS PHONED AFTER RETURNING TO CLINIC AT 5:30 PM, HE STATED THAT THE PT WAS NO LONGER HAVING ANY PROBLEMS WITH THE SITE OF DIFFICULTY BREATHING.

VAERS ID:276659 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-04-13
Location:Unknown  Entered:2007-04-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unk
Diagnostic Lab Data: Unk
CDC Split Type: WAES0703USA02192
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Acne, Eye swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse concerning her 12 year old daughter who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil. On the same day, the patient was concomitantly vaccinated with a dose of Varivax (MSD). Subsequently, the patient developed a swollen eye and acne. The patient sought unspecified medical attention. Subsequently, the patient recovered from swollen eye and acne. Additional information has been requested.

VAERS ID:276663 (history)  Vaccinated:2007-01-12
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-04-13
Location:Unknown  Entered:2007-04-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0703USA02332
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Menstruation delayed
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a licensed practical nurse concerning a 12 year old female who on 12-JAN-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM. On 12-MAR-2007, the patient was vaccinated with the second dose of Gardasil. Subsequently, on an unspecified date, the patient missed her menstrual cycle after receiving her first dose of Gardasil. Subsequently in February, the patient''s menstrual cycle returned to normal and the patient recovered from the event. Additional information has been requested.

VAERS ID:276694 (history)  Vaccinated:2007-01-12
Age:12.0  Onset:2007-01-12, Days after vaccination: 0
Gender:Female  Submitted:2007-04-13, Days after onset: 90
Location:Unknown  Entered:2007-04-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA03292
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amenorrhoea
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a licensed practical nurse concerning a 12 year old female who on 12-JAN-2007 was vaccinated with a first dose of Gardasil and a second dose on 12-MAR-2007. The patient''s mother reported to the nurse her daughter did not get a period in January 2007 but she in February 2007 and she is not pregnant. Additional information has been requested.

VAERS ID:276881 (history)  Vaccinated:2007-03-22
Age:12.0  Onset:2007-03-22, Days after vaccination: 0
Gender:Female  Submitted:2007-04-13, Days after onset: 22
Location:Tennessee  Entered:2007-04-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA04477
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Presyncope
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on 22-MAR-2007 was vaccinated with a dose, 0.5ml, of Gardasil. The physician reported that on 22-MAR-2007, after the vaccination was administered, the patient "experienced dizziness and almost passed out." At the time of the report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:276541 (history)  Vaccinated:2007-03-29
Age:12.0  Onset:2007-03-29, Days after vaccination: 0
Gender:Female  Submitted:2007-04-13, Days after onset: 15
Location:Louisiana  Entered:2007-04-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Hx headaches / depression / systolic murmur records received 6/20/07-PMH: Migraines, depression and aggressive behavior.
Diagnostic Lab Data: CBC with diff, LMP, BHCG, EKG, Echocardiogram, head CT scan, Chest X-ray, EEG records received 6/20/07-CT head negative. Doppler echocardiogram normal. Sinus tachycardia with sinus arrhythmia. EEG normal. EKG sinus rhythm with 1st degree A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0960F0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2061AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Atrioventricular block first degree, Blood glucose increased, Chest X-ray, Computerised tomogram, Echocardiogram, Electrocardiogram, Electroencephalogram, Full blood count, Head injury, Headache, Loss of consciousness, Pregnancy test, Sinus arrhythmia, Sinus tachycardia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), 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: patient collapsed 15 to 20 minutes after receiving MCV4 and Gardasil vaccines. 06/20/07-records received from facility for DOS 3/29-3/30/07-DC DX: Syncope. Head Trauma. After injection positive loss of consciousness for about 2-3 minutes. No nausea, vomiting fever or chills but headache for about 2 days. No visual changes.

VAERS ID:276588 (history)  Vaccinated:2007-04-09
Age:12.0  Onset:2007-04-09, Days after vaccination: 0
Gender:Female  Submitted:2007-04-09, Days after onset: 0
Location:Texas  Entered:2007-04-17, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: UTI
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0511F  LA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0110U  RA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Administered varicella in R deltoid at 1626 immediately pt states "itching at 1630, pt deltoid muscle swollen and redness around site.

VAERS ID:276624 (history)  Vaccinated:2007-03-06
Age:12.0  Onset:2007-03-06, Days after vaccination: 0
Gender:Female  Submitted:2007-04-17, Days after onset: 41
Location:California  Entered:2007-04-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOPENEX
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0962F0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU2082AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B007AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1085F1SCLA
Administered by: Public     Purchased by: Private
Symptoms: Hypoaesthesia, Malaise, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pain and numbeness in arm for 2 days after vaccine administered. Malaise and intermittant nausea since day of vaccination.

VAERS ID:276626 (history)  Vaccinated:2006-09-13
Age:12.0  Onset:2007-04-10, Days after vaccination: 209
Gender:Female  Submitted:2007-04-17, Days after onset: 7
Location:Washington  Entered:2007-04-17
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1033B0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Herpes zoster, Varicella post vaccine
SMQs:
Write-up: Shingles r arm, vaccine related, no prior h/o chickenpox

VAERS ID:276629 (history)  Vaccinated:2007-01-17
Age:12.0  Onset:2007-02-12, Days after vaccination: 26
Gender:Female  Submitted:2007-04-17, Days after onset: 63
Location:Maine  Entered:2007-04-17
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Migraine Records received 4/24/07-PMH: meconium aspiration ventilated for 10 days, full term. Several episodes of dehydration as a toddler required ER visits and IV hydration.
Diagnostic Lab Data: Available Records received 4/24/07-hemoglobin 5.4 and hematocrit 17. WBC 3.6. Platelets 211,000. LDH 493. Total Bilirubin 3.8. DAT Coombs found to have IgG anti-e antibody. Retic count elevated.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0954F1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Anaemia haemolytic autoimmune, Blood bilirubin increased, Blood immunoglobulin G, Blood lactate dehydrogenase increased, Coombs direct test positive, Fatigue, Haematocrit decreased, Haemoglobin decreased, Pallor, Reticulocyte count increased, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Biliary system related investigations, signs and symptoms (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Acute onset Autoimmune hemolytic anemia requiring IV steroids and hospitalization.Records received 4/24/07-from facility for DOS 02/13-02/15/07- DC DX: warm agglutinin autoimmune hemolytic anemia. Found at routine visit to be anemic by PCP. RX with high dose steroids. Two week HX of fatigue pallor, nauseated. 4-6 weeks prior had URI .

VAERS ID:276756 (history)  Vaccinated:2007-02-28
Age:12.0  Onset:2007-02-28, Days after vaccination: 0
Gender:Female  Submitted:2007-04-18, Days after onset: 48
Location:California  Entered:2007-04-18
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: Penicillin Allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.024EU0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria on lower arm after HPV immunization

VAERS ID:276763 (history)  Vaccinated:2007-04-12
Age:12.0  Onset:2007-04-13, Days after vaccination: 1
Gender:Male  Submitted:2007-04-18, Days after onset: 5
Location:North Carolina  Entered:2007-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: WBC - WNL, Ultrasound (-) fn abscess at ER 4/14/07
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABTD1640IMLA
Administered by: Private     Purchased by: Public
Symptoms: Chills, Dizziness, Erythema, Fatigue, Headache, Oedema peripheral, Pain in extremity, Pyrexia, White blood cell disorder
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient''s mother states he had reaction to Td given Thursday 4/12/07, started Friday - fever, dizziness, localized swelling and redness in left deltoid, fatigue. Seen in ER 4/14 - ultrasound (-) fn abscess. S/S include chills, fever. WBC WNL. 4/16 Mild residual occipital HA, left deltoid mildly sore "like a bruise", and erythema. Rec''d Tylenol, Amoxicillin at ER.

VAERS ID:276977 (history)  Vaccinated:2007-04-17
Age:12.0  Onset:2007-04-18, Days after vaccination: 1
Gender:Female  Submitted:2007-04-19, Days after onset: 1
Location:Minnesota  Entered:2007-04-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1393F0SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEUR41875AA0 RA
Administered by: Private     Purchased by: Public
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient had extremely sore inferior deltoid area with 6cm diameter of redness and swelling with 8cm area of subcutaneous induration. No drainage for shot site. Patient had chills nut no fever. No other infections signs/ symptoms at time of complaint.

VAERS ID:276993 (history)  Vaccinated:2007-04-18
Age:12.0  Onset:2007-04-19, Days after vaccination: 1
Gender:Male  Submitted:2007-04-19, Days after onset: 0
Location:Florida  Entered:2007-04-19
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU1995AA0IMRA
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2456AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Headache
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Began with a headache around 10:00am 4/19/07. Presented to health room at school with Temp. 101 and headache at approx 2:30pm.

VAERS ID:277188 (history)  Vaccinated:2007-03-30
Age:12.0  Onset:2007-03-30, Days after vaccination: 0
Gender:Female  Submitted:2007-03-30, Days after onset: 0
Location:Texas  Entered:2007-04-23, Days after submission: 24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Type II Diabetes
Preexisting Conditions: No known drug allergies, just diagnosed with Type II Diabetes
Diagnostic Lab Data: No test performed at the office on 3-30-07.
CDC Split Type: TX07027
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1424F0IMUN
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: 3/30/07 10:00 AM HPV vaccine was administered on her left upper arm sitting on an exam table. 2-3 minutes after administering vaccine, pt. c/o a headache and dizziness. Pt. was placed on exam table in a laying position.

VAERS ID:277195 (history)  Vaccinated:2007-04-17
Age:12.0  Onset:2007-04-17, Days after vaccination: 0
Gender:Female  Submitted:2007-04-18, Days after onset: 1
Location:Alaska  Entered:2007-04-23, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paroxetine, Nasonex
Current Illness: Allergic Rhinitis
Preexisting Conditions: Allergic Rhinitis, Anxiety NOS, ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1427F1 LA
Administered by: Public     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient developed hives on her arm and then on trunk approximately 3 hours after administration of 2nd HPV vaccine.

VAERS ID:277319 (history)  Vaccinated:2007-04-13
Age:12.0  Onset:2007-04-13, Days after vaccination: 0
Gender:Female  Submitted:2007-04-24, Days after onset: 11
Location:New Mexico  Entered:2007-04-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was reported to be "otherwise healthy". The subject experienced no adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0647898A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB148AA0IJLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0187U0IJUN
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, 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), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of unconscious in a 12-year-old female subject who was vaccinated with Havrix, Gardasil for prophylaxis. The subject was reported to be "otherwise healthy". The subject experienced on adverse events following previous vaccinations. There were no concurrent medications. On 13 April 2007 at 11:00, the subject received the 1st dose of Havrix (.5 ml, unknown, left arm). On 13 April 2007 at an unspecified time, the subject received the 1st dose of Gardasil. On 13 April 2007, 2 minutes after vaccination with Havrix and an unspecified time after vaccination with Gardasil, the subject experienced two episodes of dizziness and fainting within five minutes of dosing. The subject was unconscious for a minute or less with each episode. This case was assessed as medically serious by manufacturer. On 13 April 2007, the events were resolved. 06/17/10 Follow-up information was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that on 13-Apr-2007 a 12 year old female was vaccinated with the first dose of GARDASIL (lot# 656049/0187U) 0.5 mL, injection. Concomitant therapy included HAVRIX, (Lot # AHAVB148AA). On 13-APR-2007, the patient fainted and had pseudo seizure like symptoms. The patient had dreams about receiving the shot and the physician felt that the reaction was anxiety related. The patient had the following laboratory diagnostic tests performed after the incident: glucose 85, blood pressure 135/75 mm Hg, pulse 85 and one hour later, after the incident the blood pressure was 97/63 mm Hg, pulse 73, oxygen saturation (pulse oximetry) was 99% and serum glucose was 85. No BENADRYL was given to the patient. Subseqeuntly the patient recovered from the events that same day. Conversion disorder, Nightmare and syncope were considered non-serious. VAERS # 277319. This is a consolidation of two reports concerning the same patient. Additional information has been requested.

VAERS ID:277331 (history)  Vaccinated:2007-04-16
Age:12.0  Onset:2007-04-17, Days after vaccination: 1
Gender:Female  Submitted:2007-04-24, Days after onset: 7
Location:Virginia  Entered:2007-04-24
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|NONE~~NULL~~In Sibling2
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 (VAQTA)MERCK & CO. INC.0001U0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1498F1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 2X3 RASH RED RAISED REACTION AROUND SHOT INJECTION SITE ON POSTERIOR ASPECT OF RIGHT UPPER ARM WITH TENDERNESS. TREATMENT: MONITOR SITE, RETURN TO PROVIDER IF WORSENS.

VAERS ID:277366 (history)  Vaccinated:2007-04-17
Age:12.0  Onset:2007-04-17, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Colorado  Entered:2007-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CF
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB162CB IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1496F SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: localized area of redness and induration, ? low grade fever

VAERS ID:277378 (history)  Vaccinated:2007-04-23
Age:12.0  Onset:2007-04-23, Days after vaccination: 0
Gender:Female  Submitted:2007-04-25, Days after onset: 2
Location:Pennsylvania  Entered:2007-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair 5mg tablet qhs, Flovent 110 mcq-2 puffs BID, Albuterol prn, Benadryl prn
Current Illness: none
Preexisting Conditions: Asthma, Dairy Allergy, Mold Allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEUR 0IMLA
TDAP: TDAP (ADACEL)AVENTIS PASTEUR  IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chest discomfort, Cough, Erythema, Eye pruritus, Rash generalised, Rhinorrhoea, Throat irritation, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow)
Write-up: 15 minutes after injection: c/o itching throat, chest tightness. 20 minutes: cough, itching eyes,nasal discharge. 25 minutes: bright red rash over entire body and shaking. Medications given at onset of reaction: Benadryl 50mg po, Prednisone 40mg po(1 tablet chewed other swallowed), Zantac 150mg po, Albuterol Inhaler-2 puffs. Symptoms relieved with above meds.

VAERS ID:277391 (history)  Vaccinated:2007-03-29
Age:12.0  Onset:2007-04-12, Days after vaccination: 14
Gender:Female  Submitted:2007-04-25, Days after onset: 13
Location:Maryland  Entered:2007-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Sulfa allergy, causes rash
Diagnostic Lab Data: MRI theraco lumbar spine/brain WNL LABS: CT of brain was WNL. CBC, chem & UA all WNL EMG done 4/20/07 was WNL. Referred for MRI to r/ocentral demyelinating disease. head computed axial - 04/12/07 - normal. neurological - 04/20/07 - normal. nerve conduction study - 04/20/07 - normal. magnetic resonance - 04/20/07 - lumbar - negat. magnetic resonance - 04/20/07 - thoracic - negat.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0186U   
Administered by: Private     Purchased by: Private
Symptoms: Abasia, Computerised tomogram normal, Electromyogram normal, Fall, Full blood count normal, Gait disturbance, Hypoaesthesia, Laboratory test normal, Muscular weakness, Neurological examination normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Scan brain, Tremor, Urinary incontinence, Urine analysis normal, Weight bearing difficulty
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Lower extremity weakness, frequent falls, lower extremity paraesthesia 5/1/07 Received medical records from 1st hospital where pt seen in ER & then transferred to higher level of care. Pt experienced bilateral LE weaness & numbness of both legs while at school. She tried to brace herself up against a wall but was unable to remain upright. Exam revealed she was unable to bear weight secondary to weakness FINAL DX: paresthesia & motor weakness of bilateral legs, etiology unknown. 5/22/07 Received hospital Neuro clinic medical records which reveal patient evaluated 4/20/07 by MD who had seen her in ER week before for legs shaking w/weakness & numbness since 4/12/07. Seen at outlying hospital ER & d/c. On approx 4/10 had an episode of urinary incontinence. Neuro exam was WNL except for slightly antalgic gait. 06/11/2009: This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow-up information has been received from a immunization coordinator and a physician concerning a 12 year old female student with a sulfa allergy with a rash many years ago and no other medical history who on 27-MAR-2007 at 11:30 was vaccinated intramuscularly in the left arm with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot #655618/0186U). There was no concomitant medication. ON 12-APR-2007, the patient presented with progressive weakness of her lower extremities, one episode of incontinence and paraesthesias of both legs. On 12-APR-2007, at school, the patient noted that her legs started to shake and that she could not feel her legs well. She went to the nurse and was transferred to the hospital emergency room because of numbness in her legs and associated weakness. These events were also reported as "about two months post vaccination, sometime in May 2007, the patient could not walk and was complaining of leg pain." Over the course of that day, the patient was aware of numbness along both of her shins and persistence of that numbness over the following week though it spread to the anterior distal aspect of both thighs. It was largely symmetric. She still had some problem with the shaking of her legs when she went up or down the stairs and had been using crutches to help her walk. It was also noted that a couple of nights before this event occurred, the patient had a urinary accident at night which was very unusual for her. On 12-APR-2007, a CT of the brain was performed and was normal. On 20-APR-2007, the patient presented to the reporting physician for a visit. Nerve conduction studies and neurologic exam were performed and were all normal. ON 20-APR-2007, an MRI of the lumbar and thoracic spine was performed and was negative. About 2 to 3 weeks after the onset of progressive weakness of her lower extremities, incontinence and paraesthesias of both legs, the patient recovered. At the time of this report, the outcome of the leg pain, inability to walk, numbness along both shins/could not feel legs and shaking of legs was unknown. No product quality complaint was involved. According to the reporting physician, there was a concern about possible myelopathy and neuropathy such as Guillan-Barre syndrome. However, the reporting physician stated that "this has clearly not developed in the interval." Upon internal review, the patient''s experience of "could not walk" was considered disabling. Additional information is not expected.

VAERS ID:277450 (history)  Vaccinated:2006-08-14
Age:12.0  Onset:2006-09-01, Days after vaccination: 18
Gender:Female  Submitted:2007-04-26, Days after onset: 237
Location:Pennsylvania  Entered:2007-04-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: neurology consult
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B0711AA  RA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B004AA  LA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Medication error, Neurological examination
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient was ordered the Hep A vaccine and the Boostrix. The Pediarix and Boostrix was given in error. c/o dizziness one month later

VAERS ID:277453 (history)  Vaccinated:2007-04-26
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-04-26
Location:New Hampshire  Entered:2007-04-26
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: NH0719
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1425F0IMLL
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, Medication error, Unevaluable event
SMQs:
Write-up: Sisters in same exam room; both due to receive HPV vaccine and Menactra. 12 y/o patient received 1 dose of HPV vaccine in each arm, I''m simultaneously, instead of 1 dose HPV and 1 dose Menactra.

VAERS ID:277494 (history)  Vaccinated:2007-04-06
Age:12.0  Onset:2007-04-06, Days after vaccination: 0
Gender:Female  Submitted:2007-04-26, Days after onset: 20
Location:Florida  Entered:2007-04-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Atarax
Current Illness: None
Preexisting Conditions: H/O Multiple Food Allergies, RAD, Eczema, Anaphylaxis (not to vaccines)
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.024960IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU1968AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2644AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Angioedema, Dizziness, Hypersensitivity, Hypotension, Urticaria, Vaccination complication, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Rapid onset wheezing, hypotension and urticaria within 15 minutes of vaccines. 5/15/07 Received hospital medical records which reveal patient experienced wheezing, dizziness & itching. Admitted for observation 4/6-4/8/07. Kept on steroids & antihistamines as well as IVF. Progressed well & d/c home on steroids & antihistamine & local skin care. FINAL DX: allergic reaction to vaccines & angioedema, both resolved.

VAERS ID:277495 (history)  Vaccinated:2007-04-23
Age:12.0  Onset:2007-04-24, Days after vaccination: 1
Gender:Male  Submitted:2007-04-26, Days after onset: 2
Location:Washington  Entered:2007-04-27, 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: Zithromax 250 mg, Concerta 36 mg
Current Illness: Sinusitis
Preexisting Conditions: NKDA
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU2183AA IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B013AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: patch L deltoid swelling pruritic

VAERS ID:277536 (history)  Vaccinated:2007-04-25
Age:12.0  Onset:2007-04-26, Days after vaccination: 1
Gender:Female  Submitted:2007-04-27, Days after onset: 1
Location:Oklahoma  Entered:2007-04-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU2181AA0 LA
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2572AA0 LA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0173U1 RA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Red, firm area approx 2 cm x 4 cm to right arm that is warm to touch

VAERS ID:277596 (history)  Vaccinated:2007-03-27
Age:12.0  Onset:2007-03-27, Days after vaccination: 0
Gender:Female  Submitted:2007-03-29, Days after onset: 2
Location:California  Entered:2007-04-30, Days after submission: 32
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: ADD
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2689AA6IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Excoriation, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Muscle spasms, Paraesthesia, Pyrexia, Viral upper respiratory tract infection
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: After receiving Tdap 3-27-07 for knee abrasion that occurred 2d. prior, pt. developed red, swollen induration at injection site which became sensitive and painful resulting in muscle spasm and tingling. Also had concomitant Id. Hx fever to 105 w/viral URI.

VAERS ID:277639 (history)  Vaccinated:2007-04-24
Age:12.0  Onset:2007-04-25, Days after vaccination: 1
Gender:Female  Submitted:2007-04-30, Days after onset: 5
Location:Pennsylvania  Entered:2007-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Apparently healthy
Preexisting Conditions: None -- she does have a bit of hayfever
Diagnostic Lab Data: Strep test was negative. Afternoon temperature tests by Dr. office on 4/27 and 4/30 showed no fever. AM temperature at home on 4/30 showed no fever.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURERHPV0 RA
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature, Cough, Dizziness, Headache, Pharyngolaryngeal pain, Pyrexia, Streptococcus identification test negative, Viral infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Within 12 hours of vaccine, patient had 102 degree fever. First day symptoms were also headache, dizzy, sore throat. Morning fever last multiple days. Today, 6 days later, fever is gone, throat is raw with cough, strep test is negative, patient is ill. Dr. believes it is a viral infection, but cannot determine if related to vaccine or independent cause.

VAERS ID:277735 (history)  Vaccinated:2007-04-23
Age:12.0  Onset:2007-04-24, Days after vaccination: 1
Gender:Male  Submitted:2007-04-25, Days after onset: 1
Location:Minnesota  Entered:2007-05-01, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Hx of severe allergies and asthma
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0126U1SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Asthma, Injection site reaction, Multiple allergies, Skin lesion
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: 1x4cm red round lesion right over her injection site - 5x5cm.

VAERS ID:277739 (history)  Vaccinated:2007-04-10
Age:12.0  Onset:2007-04-12, Days after vaccination: 2
Gender:Male  Submitted:2007-04-26, Days after onset: 14
Location:Michigan  Entered:2007-05-01, 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: PPD
Current Illness: generalized weakness; rt upper arm painful
Preexisting Conditions: None
Diagnostic Lab Data: 2 week antibiotic treatment, and required urgent care MD exam
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER   RA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Gross swelling, redness, pain and soreness at site (rt deltoid)

VAERS ID:277747 (history)  Vaccinated:2007-03-30
Age:12.0  Onset:2007-03-31, Days after vaccination: 1
Gender:Male  Submitted:2007-05-01, Days after onset: 31
Location:Maryland  Entered:2007-05-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sore throat and cold symptoms for 2 days. No fever.
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU2141AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B018BR0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Hallucination, Mental status changes, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad)
Write-up: Patient developed fever, hallucinations, and mental status changes about 20 hours after receiving Menactra and Tdap.

VAERS ID:277778 (history)  Vaccinated:2007-04-17
Age:12.0  Onset:2007-04-19, Days after vaccination: 2
Gender:Male  Submitted:2007-05-02, Days after onset: 13
Location:Florida  Entered:2007-05-02
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
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2730AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: LEFT ARM SWOLLEN AND RED

VAERS ID:277804 (history)  Vaccinated:2007-04-30
Age:12.0  Onset:2007-05-01, Days after vaccination: 1
Gender:Male  Submitted:2007-05-02, Days after onset: 1
Location:Texas  Entered:2007-05-02
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0109U1 RA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, swelling, warm to touch

VAERS ID:277858 (history)  Vaccinated:2007-05-02
Age:12.0  Onset:2007-05-02, Days after vaccination: 0
Gender:Female  Submitted:2007-05-03, Days after onset: 1
Location:Florida  Entered:2007-05-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)AVENTIS PASTEURU1997AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pain and swelling right deltoid.

VAERS ID:277871 (history)  Vaccinated:2007-04-05
Age:12.0  Onset:2007-04-05, Days after vaccination: 0
Gender:Male  Submitted:2007-05-03, Days after onset: 28
Location:Pennsylvania  Entered:2007-05-03
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: Recieved some tests in ER, but I don''t know which ones
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)AVENTIS PASTEURUE890AA/UE913AA1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Laboratory test, Pruritus genital, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash, itching penis

VAERS ID:278020 (history)  Vaccinated:2007-01-15
Age:12.0  Onset:2007-01-15, Days after vaccination: 0
Gender:Female  Submitted:2007-04-23, Days after onset: 97
Location:New Hampshire  Entered:2007-05-07, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Eval by ENT. No otologic cause. ANA titer 1:1280 (speckled pattern) to berev
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURAC52B012AA UNRL
Administered by: Private     Purchased by: Public
Symptoms: Antinuclear antibody positive, Asthenia, Dizziness
SMQs:, Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: Dizzy and weak - "Feels flimsy" Everything Spinning. Still with symptoms 3 mo after vaccine.

VAERS ID:278025 (history)  Vaccinated:2007-02-15
Age:12.0  Onset:2007-04-16, Days after vaccination: 60
Gender:Male  Submitted:2007-04-30, Days after onset: 14
Location:Texas  Entered:2007-05-07, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of no know allergies. He has the influenza vaccine annually.
Diagnostic Lab Data:
CDC Split Type: 200701399
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  IM 
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU1922A1IM 
TDAP: TDAP (ADACEL)SANOFI PASTEURC2631A IM 
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives, Cluster of 2 patients (patient identification provided) with generalized hives throughout the entire body, after receiving Adacel (lot number C2631AA); Fluzone (lot number unknown) and Menactra (lot number U1922AB); received from a health care professional in the USA on 24 April 2007. Case 1: A 12 year old, male patient (with a history of no known allergies) developed generalized hives throughout the entire body, 2 months after she received Adacel (lot number C2631AA), Fluzone (lot number unknown) and Menactra (lot number U1922AB) on 15 February 2007. He has the influenza vaccine annually. The patient denies any illness or medications at the time of the vaccinations. He was treated with Cortisone, Singular and Atarax. It was reported the hives resolved and the patient recovered. The second case ( the patient''s sister) is detailed in Case 2007-01400.

VAERS ID:278152 (history)  Vaccinated:2007-04-27
Age:12.0  Onset:2007-04-27, Days after vaccination: 0
Gender:Female  Submitted:2007-05-04, Days after onset: 7
Location:North Carolina  Entered:2007-05-08, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen 650 mg 11:00am, Benadryl 50mg 1:12 pm
Current Illness: None known
Preexisting Conditions: allergy testing and injection (weekly) Tree, grass, and + allergy injection
Diagnostic Lab Data: Temp 97.5, BP 102/58, AHR 90 Resp. 24 Schedule for allergy tests with allergist in approximately one month
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1282F0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0960F0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B002AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Heart rate, Heart rate normal, Rash pruritic, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Student came to Student Health Center at 105 pm complaining of a pruritic rash on arms, back stomach and neck - denies any additional symptoms of concern. Have appt. today already scheduled with allergist (state first noted itching at about 11:45 am) rash eased within 15 minutes of Benadryl.

VAERS ID:278268 (history)  Vaccinated:2007-04-24
Age:12.0  Onset:2007-04-25, Days after vaccination: 1
Gender:Female  Submitted:2007-05-08, Days after onset: 13
Location:Texas  Entered:2007-05-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown PMH: hemolytic uremic syndrome requiring hospitalization & blood transfusions out of country, shingles 4/24/07. right wrist tendon injury & fracture of growth plate.
Diagnostic Lab Data: diagnostic laboratory 04/25/07 - negative LABS: WBC 4.4, AST 43, Mag 2.5. CK 292, MBs neg. CSF WBC 55, RBC 10, lymphs 86, monos 14, protein 28, glucose 44, pleocytosis of CSF. CSF herpes & VZ was neg. Blood & urine c/s neg. CT of head
CDC Split Type: WAES0705USA00797
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood culture negative, CSF culture negative, CSF test normal, Computerised tomogram normal, Culture urine negative, Groin pain, Headache, Herpes zoster, Laboratory test normal, Meningitis viral, Nausea, Photosensitivity reaction, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician''s office; the patient was diagnosed with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered from the events. Additional information has been requested. 5/18/2007 Received medical records from hospital which reveal patient experienced shingles, severe HA which continued to worsen, photosensitivity, nausea. Opthal exam prior to admit was WNL. Admitted 5/3-5/6/07. ID consult obtained. Treated w/IV antibiotics & antivirals. Symptoms resolved day after treatment started & patient continued to progress well. D/C home on no meds w/close outpatient PCP f/u. FINAL DX: meninigitis, presumed viral (aseptic), final c/s pending; HA, resolved; herpes zoster right leg suspected. 6/8/07 Received note from PCP stating CSF PCRs for HSV & entervirus were neg. Also included name of admitting physician at hospital where PCP does not have privileges.

VAERS ID:278325 (history)  Vaccinated:2007-05-09
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Massachusetts  Entered:2007-05-10
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
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B012AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0117U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain; Swelling; Right Arm

VAERS ID:278328 (history)  Vaccinated:2007-05-03
Age:12.0  Onset:2007-05-03, Days after vaccination: 0
Gender:Male  Submitted:2007-05-04, Days after onset: 1
Location:Michigan  Entered:2007-05-10, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: allergic rhinitis
Preexisting Conditions: mild asthma, allergic rhinitis
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU1853880IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Asthenia, Neck pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: 60-75 hours after Menactra, elevated fever and weakness. Progressed to high fever 103 and neck pain. Fever resolved after 24 hours. Other child in family got fevers after immunizations.

VAERS ID:278331 (history)  Vaccinated:2007-05-01
Age:12.0  Onset:2007-05-03, Days after vaccination: 2
Gender:Male  Submitted:2007-05-03, Days after onset: 0
Location:Michigan  Entered:2007-05-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2226AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2632AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1300F1SCLA
Administered by: Public     Purchased by: Other
Symptoms: Injection site rash, Migraine, Rash erythematous, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 5/3/07 developed rash 4 1/2 x 5 1/2 cm at site of varicella vaccination (booster dose), erythematous sl rash and diffuse sl raised vesicular rash on ant chest, bilat arms not itchy (+) F/C on 5/2 had recurrent migraine on 5/2 and received ibuprofen

VAERS ID:278333 (history)  Vaccinated:2007-05-07
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-05-08
Location:Pennsylvania  Entered:2007-05-10, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0654F1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0960F1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: pt given Hep A 0.5 ml injection too early from initial injection. Only 2 months apart instead of 6

VAERS ID:278511 (history)  Vaccinated:2007-04-26
Age:12.0  Onset:2007-04-27, Days after vaccination: 1
Gender:Female  Submitted:2007-05-01, Days after onset: 4
Location:Maryland  Entered:2007-05-14, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2610AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 10 x 7 1/2 cm erythema with central raised area tender to touch

VAERS ID:278594 (history)  Vaccinated:2007-05-02
Age:12.0  Onset:2007-05-03, Days after vaccination: 1
Gender:Male  Submitted:2007-05-06, Days after onset: 3
Location:Kansas  Entered:2007-05-15, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Insulin
Current Illness: none
Preexisting Conditions: Diabetes Mellitus-under good control, hypothyroidism
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0017U0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B008AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0117U1SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site rash, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Arm started getting sore within 24 hrs. then ran temp up to 103 for the next 2 days. He developed a rash at the site of the injection. He was seen in the ER 5-4-07 and given Benadryl. It is almost gone, except for at the sorearm 1,5627

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