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Case Details (Sorted by Age)

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VAERS ID:297302 (history)  Vaccinated:2007-11-12
Age:12.0  Onset:2007-11-12, Days after vaccination: 0
Gender:Female  Submitted:2007-11-12, Days after onset: 0
Location:Pennsylvania  Entered:2007-11-19, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Exercise induced asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Patient fainted in office hallway after receiving Gardasil #2 and Menactra. BP was taken - and was normal. Patient was observed by doctor 20 min after incident. was sent home when she was feeling well enough to leave.

VAERS ID:297322 (history)  Vaccinated:2007-11-16
Age:12.0  Onset:2007-11-16, Days after vaccination: 0
Gender:Female  Submitted:2007-11-16, Days after onset: 0
Location:Missouri  Entered:2007-11-19, 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: None
Current Illness: None
Preexisting Conditions: None Known
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB377AA0UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB211AA0UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0417U0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1471U0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Immediate post-injection reaction, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 1/2 am - light red circle surrounding varicella vaccination site. reaction was immediate. Advised provider immediately. O TX done (a) this time. (R) Arm subq.

VAERS ID:297343 (history)  Vaccinated:2007-11-09
Age:12.0  Onset:2007-11-10, Days after vaccination: 1
Gender:Female  Submitted:2007-11-12, Days after onset: 2
Location:North Carolina  Entered:2007-11-19, 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: None
Current Illness: None
Preexisting Conditions: none known
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1367U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 24 hours after vaccine. Her left upper Arm And elbow Area had redness, swelling and pain that extended to her upper forearm after 2days. Then the pain and swelling began to subside by day number 3 Also had Fever for 24-48 hours.

VAERS ID:297438 (history)  Vaccinated:2007-11-20
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-11-20
Location:New York  Entered:2007-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA282DA1IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Medication error
SMQs:, Medication errors (narrow)
Write-up: 11-20-07 13 y/o female was given Fluarix 0.5 ml IM in (R) arm lot AFLUA282DA Exp 6/30/08. This vaccine is not approved for children < 19 yrs old. No adverse event reported from parent

VAERS ID:297528 (history)  Vaccinated:2007-09-15
Age:12.0  Onset:2007-10-06, Days after vaccination: 21
Gender:Female  Submitted:2007-11-20, Days after onset: 45
Location:Unknown  Entered:2007-11-23, Days after submission: 3
Life Threatening? Yes
Died? Yes
   Date died: 2007-10-06
   Days after onset: 0
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: WAES0711USA02619
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death
SMQs:
Write-up: Information has been received from a physician''s assistant concerning a 12 year old female with no reported medical history who on approximately 15-SEP-2007 was vaccinated with Gardasil. It was noted that this was not where the vaccine was administered, rather they were the patient''s family physician. On 06-OCT-2007 the patient died in her sleep. No further information was provided. No lot number was given. Additional information has been requested.

VAERS ID:297645 (history)  Vaccinated:2007-11-08
Age:12.0  Onset:2007-11-08, Days after vaccination: 0
Gender:Female  Submitted:2007-11-23, Days after onset: 15
Location:Washington  Entered:2007-11-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: h/o migraines, allergic rhinitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS809590IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0388U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2375BA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015BA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Nausea, dizziness & vomiting during 12-24 hours after vaccines.

VAERS ID:297720 (history)  Vaccinated:2007-11-12
Age:12.0  Onset:2007-11-16, Days after vaccination: 4
Gender:Female  Submitted:2007-11-26, Days after onset: 10
Location:New York  Entered:2007-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: asthma 1/2/08-records received-PMH:asthma.
Diagnostic Lab Data: CT scan head - normal, EKG-normal, screening blood test (CBC, electrolytes) -normal, Video EEG- results pending, MRI- results pending 1/2/08-records received-EKG normal sinus rhythm. CT ventricles normal. VEEG generalized seizures during sleep.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2524AA6IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.126760IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2538AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood electrolytes normal, Computerised tomogram normal, Electrocardiogram normal, Electroencephalogram abnormal, Epilepsy, Full blood count normal, Nuclear magnetic resonance imaging, Posture abnormal, Syncope, Tremor, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: 11/16/2007 7:30 am patient had episode of spinning-head tilted to r-then whole body shaking lasting less than 2 minutes- no fever- EMS called and taken to ER- ?partial complex seizure vs syncopal episode. Transferred to Hospital for further evaluation. Discharged home on 11/18/2007. On 11/20/2007 mom called to say that patient had another seizure. She returned to hospital and was begun on depakote. 1/2/08-records received for DOS 11/16-11/18/07-DC DX: Seizure. One episode of eye twitching. Per parent happened 3 times, collapssed. No post ictal state. 1/2/08-records received for DOS 11/16-11/18/07-DC DX seizure. Morning of ER visit found on floor. Per 60 day follow up: Patient diagnosed with generalized epilepsy by neurologists. MRI brain- normal. She is being treated with DEPAKOTE ER 500 mg qhs. R/C in EEG consistent iwth genralized motor epilepsy.

VAERS ID:297757 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-11-21
Location:Unknown  Entered:2007-11-26, 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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA02903
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anger, Balance disorder, Demyelination, Encephalitis, Gait disturbance, Hypoaesthesia, Sensory loss, Syncope, Walking aid user
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Hostility/aggression (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a company representative concerning a 12 year old female with braces, who was vaccinated with a 0.5 mL dose of Gardasil (lot # not reported). It was reported that the patient experienced acute demyelinating encephalomyelitis after getting the vaccine. The patient''s mother reported that two weeks post vaccination. The patient was walking through the house and collapsed. The patient stated that she could not feel her leg. The patient was taken to the hospital. It was reported that two months later and after hours of physical therapy, the patient still had no feeling in her left leg. It was also reported that it was difficulty for the patient to walk and balance and she often needed a little help. The patient''s mother reported that her daughter was "mad." The patient was also learning how to cope with crutches, and a walker. The patient was diagnosed by her physician to have Acute Demyelinating Encephalomyelitis or ADEM. At the time of the report, the patient''s status was not reported. Acute demyelinating encephalomyelitis was considered to be disabling an other important medical event. No further information is available.

VAERS ID:297924 (history)  Vaccinated:2007-11-16
Age:12.0  Onset:2007-11-17, Days after vaccination: 1
Gender:Female  Submitted:2007-11-20, Days after onset: 3
Location:Texas  Entered:2007-11-27, 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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2842AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1028U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site vesicles
SMQs:
Write-up: Noticed reaction 11-17-07. 1 cm red vesicular patch at injection site (L) upper arm local reaction to Varicella vaccine. To use Eucerin and oral Benadryl.

VAERS ID:298115 (history)  Vaccinated:2007-10-23
Age:12.0  Onset:2007-10-24, Days after vaccination: 1
Gender:Male  Submitted:2007-11-29, Days after onset: 36
Location:South Carolina  Entered:2007-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: SC0719
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2357AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B018BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Back pain, Feeling hot, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Child became ill on 10-24-07 (AM) with backache, pain in legs, arms, and knees. Had feeling of "being hot". Muscle and joint pain severe enough to limit walking and school attendance - out of school until Monday, 10/29 per MD.

VAERS ID:298202 (history)  Vaccinated:2007-09-17
Age:12.0  Onset:2007-09-17, Days after vaccination: 0
Gender:Female  Submitted:2007-11-29, Days after onset: 73
Location:Oklahoma  Entered:2007-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U1UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0777U1UNRL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Erythema, Slight edema, tender, the erythema ranged in size approx radius 5 in to 16 in treated with Benadryl and ice packs

VAERS ID:298230 (history)  Vaccinated:2007-09-27
Age:12.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2007-11-29, Days after onset: 63
Location:Oklahoma  Entered:2007-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.07777U1SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Oedema, Rash vesicular
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 9-27-07 patient came in with reaction to 2nd Varicella; Slight tenderness at site with slight erythema, slight edema, afebrile, with approx 10in radius. Treatment; Benadryl and Ice packs. do apply ice pack directly to skin and RTC or call with any problems. 9-27-07 When Pt''s mom came back into clinic to check immunization site. Pt''s mom now stated that she was not sure if Pt. had had the chicken pox disease or not. Pt''s mom led me to believe that Pt. had some chickenpox bumps a few years ago.

VAERS ID:298607 (history)  Vaccinated:2007-11-07
Age:12.0  Onset:2007-11-07, Days after vaccination: 0
Gender:Female  Submitted:2007-12-03, Days after onset: 26
Location:Alaska  Entered:2007-12-04, 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: None
Current Illness:
Preexisting Conditions: Diarrhoea; Chronic abdominal pain
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA04755
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1425F IMLA
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Dizziness, Injected limb mobility decreased, Injection site pain, Muscular weakness, Musculoskeletal stiffness, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a licensed practical nurse concerning her 12 year old daughter with a history of diarrhea and chronic intermittent abdominal pain who on 07-NOV-2007 was vaccinated IM in the left deltoid with a 0.5 mL dose of Gardasil (lot # 655165/1425F). There was no concomitant medication. On 07-NOV-2007 the patient "developed muscle pain and weakness with some dizziness following vaccination with Gardasil. The nurse reported that her daughter experienced immediate pain at the injection site and the injection site arm was sore for the next couple of days. It was also reported that her daughter experienced muscle weakness and "muscle bruising" below the injection site about one week after vaccination with Gardasil. The nurse reported that her daughter''s elbow was sore and she could not straighten her elbow. The muscle pain then moved to the other arm 2 to 3 days ago and currently both elbows and upper arms are sore. The patient has also experienced occasional dizziness." At the time of the report the patient had not recovered. The patient''s muscle pain, weakness below injection site, dizziness, injection site pain, weakness and injection site arm soreness and sore elbow and upper arms were considered to be disabling. Additional information has been requested.

VAERS ID:298951 (history)  Vaccinated:2007-08-28
Age:12.0  Onset:2007-09-25, Days after vaccination: 28
Gender:Female  Submitted:2007-11-28, Days after onset: 64
Location:South Carolina  Entered:2007-12-06, 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: None
Current Illness: Right ankle pain, well child visit 12/18/07-ankle injury 9/4/07-
Preexisting Conditions:
Diagnostic Lab Data: X-rays
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0929U1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2394BA0IM 
TDAP: TDAP (ADACEL)SANOFI PASTEURCZ638AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Contusion, Fall, Gait disturbance, Hypoaesthesia facial, Muscular weakness, Neuralgic amyotrophy, Oedema peripheral, Peroneal nerve injury, Peroneal nerve palsy, Tendonitis, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (narrow), Hypoglycaemia (broad)
Write-up: 9/25/07 - Patient developed falling when walking on left foot. 9/26/07 - Patient saw doctor - diagnosis given foot drop. 9/27/07 - Patient saw doctor - diagnosis Parsonage Turner Syndrome. 10/17/07 - Patient saw doctor, better but not 100% recovered. 12/18/07-records received for DOS 9/4/07-C/O injury to anke and tendinitis of her peroneal tendons on the right. Visit 9/26/07-Day prior to visit felt a pop in her foot and since then inabiity to raise the toes, some swelling and bruising in leg. Numbness down in her foot. DX: Spontaneous peroneal nerve injury left leg. PE: footdrop which is incomplete and partial. Visit 9/28/07-Antalgic gait consistent with footdroop and 3/5 tenderness and weakness. DX: Viral peroneal nerve-parsonage-turner syndrome. Visit 10/17/07-Regaining full strength.

VAERS ID:298960 (history)  Vaccinated:2007-11-21
Age:12.0  Onset:2007-11-21, Days after vaccination: 0
Gender:Female  Submitted:2007-11-27, Days after onset: 6
Location:Ohio  Entered:2007-12-06, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500492P0IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.152241IMLA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Syncope with questionable brief (seconds) seizure that resolved in 10-15 seconds total. Patient rested in office for 15-20 min and drank some water. Had normal vital signs after event. She passed out 15 min after injection.

VAERS ID:298997 (history)  Vaccinated:2007-11-19
Age:12.0  Onset:2007-11-21, Days after vaccination: 2
Gender:Male  Submitted:2007-11-27, Days after onset: 6
Location:Indiana  Entered:2007-12-06, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1096U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 13.5 cm x 10.5 cm area of induration surrounding injection site with smaller 4cm x 5cm more erythematous induration at injection site.

VAERS ID:299050 (history)  Vaccinated:2007-12-05
Age:12.0  Onset:2007-12-06, Days after vaccination: 1
Gender:Male  Submitted:2007-12-07, Days after onset: 1
Location:Texas  Entered:2007-12-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: Zithromax (Hives), Motrin (Hives/Wheezing)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2541AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 12/6/07 Patient observed with right deltoid having 5 x 8 cm. area with significant swelling, redness, nontender, warm to touch. Following injection in the AM 12/05/07 patient went swimming that evening. 12/7/07 patient rechecked and area with less redness but increased swelling. Benadryl given in office 12/6/07 and instructions to continue every 4-6 hours in additon to applications of cold/ice to area. To follow-up if worsens.

VAERS ID:299124 (history)  Vaccinated:2007-12-06
Age:12.0  Onset:2007-12-06, Days after vaccination: 0
Gender:Male  Submitted:2007-12-10, Days after onset: 4
Location:New York  Entered:2007-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None indicated
Preexisting Conditions: None specified
Diagnostic Lab Data: Emergency Room Physician did not order any tests.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2423AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1144F0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Chest pain, Contusion, Dermatitis allergic, Dizziness, Haematoma, Loss of consciousness, Paraesthesia, Syncope vasovagal, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Pt c/o dizziness, lost consciousness and fell, hitting the back of his head on the floor. Loss of consciousness lasted 30-45 seconds. Although he denied s/s of neck/back/head injury (N/V, dizziness, ha, back/neck pain), he complained of chest pain that felt like "pins & needles". No difficulty breathing or respiratory distress noted. This RN did not observe any rash and pt did not c/o pruritis. Approximately 15 minutes after the episode, pt c/o difficultly visually focusing on objects far away. He was sent to the closest emergency room without incident, where he was diagnosed with 1.) vasovagal syncope 2.) single contusion with soft tissue hematoma to the scalp 3.) Probable allergic reaction with skin rash. Pt was discharged to home with instructions to apply ice intermittently, take Benadryl 25mg PO every 6 hours for itching and to observe HEAD INJURY PRECAUTIONS. Pt was also advised not to participate in sports the following day and to follow-up with PCP.

VAERS ID:299193 (history)  Vaccinated:2007-11-20
Age:12.0  Onset:2007-12-04, Days after vaccination: 14
Gender:Female  Submitted:2007-12-06, Days after onset: 2
Location:Iowa  Entered:2007-12-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Normal platelet count Petechiae resolved.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB176AA1UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2331AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Petechiae, Platelet count normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt received Menactra and Hep A #2 on 11/20/07 - developed temp 100.4 on 12/04/07 along with mild petechial rash scattered sparsely over body.

VAERS ID:299216 (history)  Vaccinated:2007-11-26
Age:12.0  Onset:2007-11-28, Days after vaccination: 2
Gender:Female  Submitted:2007-12-10, Days after onset: 12
Location:Massachusetts  Entered:2007-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1247U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: L arm swollen, red, painful. Treated with antibiotic Keflex 500mg tid x10 days.

VAERS ID:299223 (history)  Vaccinated:2007-12-05
Age:12.0  Onset:2007-12-06, Days after vaccination: 1
Gender:Female  Submitted:2007-12-07, Days after onset: 1
Location:Texas  Entered:2007-12-10, 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: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1120U1SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site cellulitis, Local reaction
SMQs:
Write-up: Cellulitis vs Local Rxn at site of Varicella vaccine

VAERS ID:299314 (history)  Vaccinated:2007-11-06
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2007-11-14
Location:Georgia  Entered:2007-12-11, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type: GA07071
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2449AA1IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB163AB IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2137AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURUC2759AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1106U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, Medication error
SMQs:, Medication errors (narrow)
Write-up: Client was in for update of immunizations. Clerk checked 11-14-07 GRITS and failed to see that client had received MCV4 and Tdap 1-9-07. When the billing clerk was inputting data into the computer and checking to be sure data had transferred to GRITS she found that these immunizations were replicated.

VAERS ID:299402 (history)  Vaccinated:2007-12-10
Age:12.0  Onset:2007-12-11, Days after vaccination: 1
Gender:Female  Submitted:2007-12-11, Days after onset: 0
Location:North Dakota  Entered:2007-12-12, 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: No meds
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: ND0718
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2428AA UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B016BA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Exfoliative rash, Headache, Malaise, Pyrexia
SMQs:, Severe cutaneous adverse reactions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Approx. 24 hours post Menactra/Tdap immunizations - temp 101.3, severe H/A, malaise, dizzy, fine scaly rash forehead cheeks, up trunk - improving over course of day. Recommended Tylenol PRN.

VAERS ID:299442 (history)  Vaccinated:2007-12-12
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-13
Location:North Carolina  Entered:2007-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: None reported when vaccine error was reported to mother of the pt.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2290AA5IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2540AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Pt was in clinic with younger sister to obtain vaccines. Nurse obtained vaccines for the four old sister to be administered which included DTaP. Pt only needed HepA. Mother preferred that the four year old sister recieve HepA only. Pt was given DTaP instead of HepA.

VAERS ID:299671 (history)  Vaccinated:2007-12-05
Age:12.0  Onset:2007-12-06, Days after vaccination: 1
Gender:Male  Submitted:2007-12-13, Days after onset: 7
Location:Colorado  Entered:2007-12-13
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: Allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Injection site erythema, Injection site rash, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: ? Received chicken pox vaccine in L upper arm on 12/05/07, seen 2d later for swollen & redness of upper arm, 7cm diameter, mildly erythem circular raised area surrounding injection site. No Rx.

VAERS ID:300089 (history)  Vaccinated:2007-11-09
Age:12.0  Onset:2007-11-09, Days after vaccination: 0
Gender:Male  Submitted:2007-12-01, Days after onset: 22
Location:Hawaii  Entered:2007-12-17, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Labs and Diagnostics: CT scan of head, neck, chest, and abdomen (+) for multiple enalrged lymph nodes. Sed rate 46. CRP 3.2. Monospot (-). Flu A & B (-). Rapid strep (-). Na+ 132. Bicarb 18.
CDC Split Type: HI0708
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2461AA IMUN
Administered by: Public     Purchased by: Unknown
Symptoms: Abdominal pain, Blood bicarbonate decreased, Blood sodium decreased, C-reactive protein increased, Computerised tomogram abnormal, Fatigue, Headache, Hypoaesthesia, Hypoaesthesia facial, Influenza serology negative, Injection site pain, Lymphadenopathy, Malaise, Mononucleosis heterophile test negative, Myalgia, Night sweats, Pain, Pyrexia, Red blood cell sedimentation rate increased, Streptococcus identification test, Vomiting, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Lactic acidosis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, Vomit, Malaise, Headache. 12/28/2007 MR received for DOS 12/78/2007 with Final Dx: Fever of Unknown origin. 2'' Dx: Abdominal pain. Lymphadenopathy. Pt admitted for w/u of FOU x 1 month. Pt developed injection site pain and muscle aches following flu shot. Pt has developed diffuse body aches, abdominal pain, night sweats, malaise, nausea, vomiting and fatigue. Pt has been seen multiple times and txd with multiple abx with persistant sx. 5 lb weight loss. Pt also had 1 week of intermittant L-sided numbness of head, face, neck, chest, arm and fingers. PMH: none. PE (+) for cervical lymph node swelling. Per consultant- "pt may have mononucleosis picture".

VAERS ID:300515 (history)  Vaccinated:2007-07-11
Age:12.0  Onset:2007-07-13, Days after vaccination: 2
Gender:Unknown  Submitted:2007-08-28, Days after onset: 46
Location:Pennsylvania  Entered:2007-12-17, Days after submission: 111
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 200702625
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2327A0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0674U0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Malaise, Neck pain, Pharyngolaryngeal pain, Pyrexia, Streptococcus identification test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was received from a health professional on 25 July 2007. A 12-year-old patient with no known medical history received an intramuscular right deltoid injection of Menactra (lot number U2327AA) and an intramuscular left deltoid injection of Varivax (Merck, lot number 0674U) on 11 July 2007. On 13 July 2007, two days after vaccination, the patient developed a temperature of 101 degrees Fahrenheit, chills, sore throat, malaise, vomiting, and neck pain. The patient was seen in the doctor''s office on 16 July 2007, at which time a strep test was negative. Treatment included fluids and rest, and the events resolved after 48 hours. Follow-up information received on 20 August 2007 from a health care professional. The case was reviewed, and there was no additional information at this time. The reporter in this case is the same as in case 2007-02626.

VAERS ID:300567 (history)  Vaccinated:2007-07-31
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2007-08-29
Location:Pennsylvania  Entered:2007-12-17, Days after submission: 110
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient has a history of migraines. The patient had no illness at the time of vaccination.
Diagnostic Lab Data:
CDC Split Type: 200702702
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  IMLA
Administered by: Private     Purchased by: Other
Symptoms: Headache, Injection site erythema, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial non-serious report received from the patient''s parent on 01 August 2007. A twelve-year old male with history of migraines had received an intramuscular injection of Menactra (Lot number not reported) to his left arm on 31 July 2007. On 01 August 2007, approximately 16 hours following vaccination, the patient experienced redness at injection site, fever of 100.9 degrees Fahrenheit and headache. The patient had no illness at the time of vaccination and no concomitant medications were reported. Recovery status was reported as "resolving". On 02 August 2007, the patient''s mother called to report an additional symptom of left axillary lymph node swelling (the size of a lemon). The patient went to the Emergency Room and was placed on "steroids". It was reported that Infectious Disease specialist was being consulted. No additional information had been provided at the time of this report.

VAERS ID:300243 (history)  Vaccinated:2007-12-18
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-18
Location:Texas  Entered:2007-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: n/a~ ()~NULL~~In Patient
Other Medications: none
Current Illness: none
Preexisting Conditions: none known
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.M0929U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2407AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Nausea
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Client received mcv and hpv immunizations at approximately 11:20 am-stated did not have breakfast nor anything to eat-during 15 minute waiting period both mother and client returned to vaccination room, stating client was nausaeous and feeling weak. client was laid down to rest for approximately 20 minutes after which she stated she was feeling better-no injuries were noted. Client left ambulating with mother and comfort measures were reinforced,to seek er attention if furthur episode.

VAERS ID:300291 (history)  Vaccinated:2007-08-20
Age:12.0  Onset:2007-08-20, Days after vaccination: 0
Gender:Female  Submitted:2007-11-30, Days after onset: 102
Location:Pennsylvania  Entered:2007-12-18, Days after submission: 18
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: Persistent hyperplastic primary vitreous right eye
Diagnostic Lab Data: Cat scan positive for pseudo tumor.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA IMUN
Administered by: Private     Purchased by: Private
Symptoms: Brain neoplasm, Computerised tomogram abnormal, Headache, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tumours of unspecified malignancy (narrow), Hypoglycaemia (broad)
Write-up: 8/20/07 - very lethargic this continues even now. 9/13/07 - headaches treated with Motrin. 9/23/07 - ER visit, got steroids for pseudo tumor behind right eye, pain was so severe that Motrin couldn''t control them. At this point she was incapacitated.

VAERS ID:300602 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-14
Location:Unknown  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA00910
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Lymphadenopathy, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse practitioner concerning a 12 year old female who in October 2007, was vaccinated with Gardasil (lot # not reported). In October 2007, two days after she was given Gardasil the patient presented with a swollen thigh. The patient then progressed to lymphadenopathy. As of 05-Nov-2007, the patient''s swollen thigh and lymphadenopathy persisted. Unspecified medical attention was sought. Additional information has been requested.

VAERS ID:300692 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-14
Location:Unknown  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA01941
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Influenza like illness, Pain in extremity
SMQs:, Dementia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a consumer concerning her 12 year old daughter who was vaccinated (date not reported) intramuscularly (site not reported) with the 1st dose of 0.5ml Gardasil vaccine (lot # not reported). Post vaccination, the patient developed flu like symptoms and pain in the leg (which leg not specified). Per the mother, the patient was sick in bed approximately 5 days. The patient did see unspecified medical attention and recovered from these events. Mother is unsure if her daughter will continue series of Gardasil. Additional information has been requested. Additional information has been received from a nurse stating that she was not aware of any AE for this patient. No additional informatin is expected.

VAERS ID:300725 (history)  Vaccinated:2007-08-17
Age:12.0  Onset:2007-08-19, Days after vaccination: 2
Gender:Female  Submitted:2007-12-14, Days after onset: 117
Location:Florida  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Perennial allergic rhinitis; Ashtma
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA02905
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2657AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0837U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a registered nurse concerning a 12 year old female who on 17-AUG-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (lot # 65822/0927U). Concomitant vaccination included Menactra. On approximately 19-AUG-2007 "two days after vaccination" the patient developed a rash. The patient presented with little crusty lesions on her knees and buttocks. The rash was localized to the lower area of the body. The patient went back to the doctor''s office a few weeks ago and she still had some lesions. The patient''s status was reported as recovering. There was no product quality complaint. Additional information has been requested. Follow-up received 04/16/2008. Follow up information obtained on 11-DEC-2007. The physician reported that the 12 year old female patient with asthma and a chronic allergic rhinitis weighed 131 pounds and height of 64 inches. It was reported that there were no asthma symptoms at the time of vaccination and that the allergic rhinitis is better with immunotherapy. It was reported that on 17-AUG-2007, the patient was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (lot # 558222/0927U), intramuscularly in the left deltoid with the first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot # C2657AA) and the subcutaneously in the left deltoid with the second dose of varicella virus vaccine (lot # 658058/0837U). On 19-AUG-2007, the patient developed molluscum contagious/multiple lesions in different sites. The patient''s dermatologist was consulted and gave "unspecified" topical treatment. It was reported that the patient status improved after treatment. Additional information has been requested.

VAERS ID:300732 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-14
Location:Florida  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Haemorrhoids
Preexisting Conditions: Haemorrhoids
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA03115
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Information has been received from a certified medical assistant (C.M.A.) concerning a 12 year old female with haemorrhoids and no drug reactions/allergies who on 26-FEB-2007 was vaccinated with her first dose of GARDASIL. In 2007, "sometime in the past couple of months", the patient developed blood in her feces. The C.M.A. believes that it is the result of her hemorrhoids. On 14-NOV-2007 the patient will receive her second dose of GARDASIL. As of 14-NOV-2007 the patient had not recovered. Medical attention was sought in the office. The product quality complaint unit was not involved. Additional information has been requested.

VAERS ID:300736 (history)  Vaccinated:2007-11-13
Age:12.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 31
Location:Unknown  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA03139
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: No reaction on previous exposure to drug, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a mother concerning her 12 year old daughter who on 09-May-2007 was vaccinated into the left arm with a first dose of Gardasil. On 13-Nov-2007, the patient was vaccinated with a third dose of Gardasil. Concomitant suspect vaccination on the same day included Vaqta. On 14-Nov-2007 the patient fainted. She "came out of it shaking or tremoring (whole body) and almost fell off the table". She was given orange juice and was told to lie down. The patient was in the office. On 13-Nov-2007, the patient recovered. The patient had no problems with the first and second dose of Gardasil. Additional information has been requested.

VAERS ID:300849 (history)  Vaccinated:2007-11-10
Age:12.0  Onset:2007-11-10, Days after vaccination: 0
Gender:Female  Submitted:2008-04-07, Days after onset: 148
Location:Unknown  Entered:2007-12-18, Days after submission: 110
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA03619
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2452AA IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthma, Condition aggravated, Cough, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Information has been received from a consumer concerning her 12 year old daughter with asthma who was vaccinated with her first dose of Gardasil via injection. Concomitant therapy included influenza virus vaccine (unspecified). The mother reported that two to three hours after her daughter received the vaccine she developed signs of asthma which included wheezing. The patient was treated with a nebulizer. The wheezing continued for two to three days and then ceased. The mother mentioned that her daughter had a history of asthma, however, she had not had an asthmatic episode in a while. The patient also received a flu vaccine the same day (unspecified). Additional information has been requested. This is in follow-up to report(s) previously on 12/14/2007. Information has been received from a consumer concerning her 12 year old daughter with asthma who was vaccinated with her first dose of GARDASIL (Lot #658222/0827U) intramuscularly in the left arm. Concomitant therapy included influenza virus vaccine (Lot #U2452AA) intramuscularly in the right arm. The mother reported that two to three hours after her daughter received the vaccine she developed signs of asthma which included wheezing and coughing. The patient was treated with a nebulizer, an inhaler, and 2 courses of oral steroids. The wheezing continued for two to three days and then ceased. The patient is now better but she is still coughing. The mother mentioned that her daughter had a history of asthma.However, she had not had an asthmatic episode in over 2 years. The patient also received a flu vaccine the same day (unspecified).

VAERS ID:300851 (history)  Vaccinated:2007-11-10
Age:12.0  Onset:2007-11-10, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 34
Location:Unknown  Entered:2007-12-18, Days after submission: 4
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: WAES0711USA03632
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IM 
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Feeling hot, Mass, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 12 year old female who on 10-Nov-2007 was vaccinated intramuscularly in the upper thigh with the third dose of Gardasil (lot number not provided). On 10-Nov-2007 the patient developed a knot that was hot, red, tender to the touch, and about the size of a half dollar. No further information is available.

VAERS ID:301300 (history)  Vaccinated:2007-11-26
Age:12.0  Onset:2007-11-27, Days after vaccination: 1
Gender:Female  Submitted:2007-12-14, Days after onset: 17
Location:North Carolina  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA05333
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU23948A1IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52018AB1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1503F1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Anorexia, Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 12 year old female who on 26-NOV-2007 was vaccinated with a first dose of Gardasil vaccine injection. Concomitant therapy on the same day included varicella virus vaccine live (unspecified) and Menactra. On 27-NOV-2007, the patient came back into the office with a fever, no appetite and a headache. Medical attention was sought. Subsequently, on an unspecified date the patient recovered from the events with therapy unspecified. There was no further AE information. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a physician and an other health professional concerning a 12 year old white female who on 26-NOV-2007 at 5:00PM, was vaccinated intramuscularly into the left arm with a second dose of GARDASIL (Lot# 659055/1522U). Concomitant therapy also given on 26-NOV-2007 included intramuscular vaccinations with second doses of VARIVAX (Lot# 656279/1503F: right arm), MENACTRA (Lot# U2390BA: right arm) and BOOSTRIX (Lot# AC528018AB: left arm). There was no illness at the time of vaccination. The physician reported that on 27-NOV-2007 the patient came back into the office with a fever, no apppetite and a headache. Additional information reported by a health professional indicated that on the morning of 27-NOV-2007, the patient had developed fatigue and fever. The physician reported that on an unspecified date the patient recovered. Additional informationm is not expected.

VAERS ID:300433 (history)  Vaccinated:2007-12-19
Age:12.0  Onset:2007-12-19, Days after vaccination: 0
Gender:Female  Submitted:2007-12-19, Days after onset: 0
Location:California  Entered:2007-12-19
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: NOT APPLICABLE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2506AA IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.1258U IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0755U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2383BA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2690AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1054F1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: VASOVAGAL SYNCOPE EPISODE LASTED FOR AT LEAST 5 SECONDS. PATIENT TRANSPORTED VIA WHEELCHAIR IN THE TREATMENT WITH MOM. VITAL SIGNS TAKEN (BP80/50;PR 82;RR12;T 97.1;O2SAT 94%. APPLIED ICE PACK ON BACK OF NECK AND FOREHEAD. NO DIZZINESS, N/V,SOB/DYSPNEA, CHEST PAIN, DENIES WEAKNESS, NO COLD CLAMMY SKIN, NO LABORED BREATHING. NO HIVES. NO OTHER SXS NOTED/REPORTED. OFFERED SIPS OF WATER WHICH PATIENT TOLERATED. STAYED WITH PATIENT FOR 20 MINUTES RECHECKED VITAL SIGNS STABLE ( BP 90/56;PR86;RR16;O2SAT 100%). SKIN LOOKS NORMAL AND PATIENT STATES FEELS MUCH BETTER. ASKED TO SIT UP PATIENT TOLERATED AND ABLE TO AMBULATE WITH MOM. REVIEWED WITH MOM THE VISs AND TO SEEK ER CARE/CALL CLINIC IMMEDIATELY IF PATIENT HAVING SERIOUS ALLERGIC REACTION.

VAERS ID:300487 (history)  Vaccinated:2007-12-03
Age:12.0  Onset:2007-12-03, Days after vaccination: 0
Gender:Male  Submitted:2007-12-20, Days after onset: 17
Location:Pennsylvania  Entered:2007-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2157BA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B011AA5IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Student was given the Tdap and MCV vaccines and kept for observation. After about 10 minutes, he began itching on his chest. A rash appeared and began to spread on his chest, abdomen, shoulders and back. His Grandfather came and took him to emergency room. It was reported the next day that he became worse in the ER & had to be given medication. When he returned to school he brought Benadryl & an Epi-pen with him. However, we have not been able to get the ER report from the family yet to get specific information.

VAERS ID:300616 (history)  Vaccinated:2007-11-30
Age:12.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-20, Days after onset: 20
Location:Massachusetts  Entered:2007-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: cONCERTA 36MG PO QD
Current Illness: recovered from a viral infection earlier that week
Preexisting Conditions: ADD
Diagnostic Lab Data: Pelvic x-ray, Lab work (see above)MRI of right hip 2/7/08-records received-WBC elevated 16.6 with 78% polys. Blood cultures no growth. LFTs, Chem 7, ESR and CRP WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Blood culture negative, Body temperature increased, C-reactive protein increased, C-reactive protein normal, Juvenile arthritis, Laboratory test, Laboratory test normal, Liver function test normal, Nuclear magnetic resonance imaging, Pyrexia, Red blood cell sedimentation rate normal, Red man syndrome, Tendonitis, White blood cell count increased, X-ray of pelvis and hip
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient had a viral infection earlier that week. Received her HPV Vaccine on Friday 11/30/07 at 4:25 p.m. Pt was feeling fine ,until 8:30p.m.. Complained of hip pain. By 9:30, pt was in horrible bilateral hip pain over the greater trochanters. Given motrin 400mg by mother and a warm bath, no relief. Called pediatrian, no noted side effects. Wnt to the emergency department. Temperature 102, WBC 17 sed rate 5 & C-reactive protein 1.5. Pt. also developed bilteral knee pain. Pt was given torodolwhich brought the pain down from 10/10 to 5/10. Pt the was given a percocet for the pain bring the pain down to a 2/10. Sent home. Called back for + blood culture on Sunday . Back to the emergency department for I.V. antibiotics. WBC 9,C- reactive protein was 41.5. Pt. was admitted to the hospital. Diagnosis: acute tendonitis of the hips & knees. 2/7/08-records received for DOS 12/2-12/5/07-DC DX: Polyarticular arthritis. Presented with bilateral knee and hip pain times 3 days after symptoms of viral syndrome. Six days prior to admission developed sore throat, headache, vomiting and abdominal pain that lasted 3 days. On 11/30/07 febrile to 102, Post infectious arthritis. Developed red man syndrome to vancomycin.

VAERS ID:300801 (history)  Vaccinated:2007-12-18
Age:12.0  Onset:2007-12-19, Days after vaccination: 1
Gender:Male  Submitted:2007-12-20, Days after onset: 1
Location:California  Entered:2007-12-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2734AA5IMRA
Administered by: Public     Purchased by: Public
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Complained of severely sore arm and "unable to go to school"

VAERS ID:300882 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-19
Location:New York  Entered:2007-12-26, 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: Reportedly, the patient had no illnesses, pre-existing medical conditions, or use of other medications at the time of the vaccination with Adacel (date unknown). It was reported that neither the patient nor the brother has experienced any adverse events following prior vaccinations. No vaccinations were given within four weeks of the vaccination with Adacel.
Diagnostic Lab Data:
CDC Split Type: 200704280
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  UNLA
Administered by: Private     Purchased by: Other
Symptoms: Hypotension, Nausea, Syncope, Visual disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Initial report received on 14 December 2007 from the patient''s parent. A 12-year old female, with no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a dose of Adacel (lot number "unknown") in the left deltoid on an "unknown" date. Minutes after receiving the vaccination, the patient became nauseated, saw spots and fainted to the floor. The patient spontaneously awoke within a minute; and the nurse stated the patient''s blood pressure was low (blood pressure reading not reported). Blood pressure reading prior to the vaccination was not reported. No treatment for the adverse event was required. At the time of this report, the patient had recovered with "no sequelae."

VAERS ID:300972 (history)  Vaccinated:2007-12-17
Age:12.0  Onset:2007-12-17, Days after vaccination: 0
Gender:Female  Submitted:2007-12-20, Days after onset: 3
Location:Pennsylvania  Entered:2007-12-26, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic to Codeine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2531AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U2IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: At site of immunization (R deltoid), 5 cm area induration, no erythema. (Examined 12/19/2007, reaction began evening of immunization 12/17/07).

VAERS ID:301063 (history)  Vaccinated:2007-10-16
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-06
Location:Utah  Entered:2007-12-26, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU1985AB5IMLA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:, Medication errors (narrow)
Write-up: DTaP given to 12-year-old should have been Tdap. No adverse event reported.

VAERS ID:301139 (history)  Vaccinated:2007-12-07
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-20
Location:Massachusetts  Entered:2007-12-27, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Dysphonia, Fatigue, Headache, Pain, Pyrexia, Respiratory tract congestion, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 100 deg F Feever, Vomiting, Headache, Tiredness, Hoarseness, Heavy Congestion, Body Aches. 12-07-07 had a yearly physical also T-dao shot and Meningococcal Vaccine at 4:30 by 8:00 Symptoms started to occur seen by doctor Sunday. Also called Doctor Saturday. Somewhat Still Congested

VAERS ID:301169 (history)  Vaccinated:2007-11-29
Age:12.0  Onset:2007-11-29, Days after vaccination: 0
Gender:Male  Submitted:2007-12-28, Days after onset: 29
Location:Ohio  Entered:2007-12-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NON
Preexisting Conditions: ASTHMA, ENVIRONMENTAL ALLERGIES
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2507AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure increased, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad)
Write-up: dizziness,nausea, elevated blood pressure in the 24 hours after the vaccine was given

VAERS ID:301714 (history)  Vaccinated:2007-09-05
Age:12.0  Onset:2007-09-05, Days after vaccination: 0
Gender:Male  Submitted:2007-12-21, Days after onset: 107
Location:New Jersey  Entered:2007-12-28, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA00564
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0884U SCUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse concerning a 12 year old male who on 05-SEP-2007 was vaccinated SC with a 0.65 ml of Zostavax (Oka/Merck) (Lot # 658211/0884U) instead of a dose of Varivax (Oka/Merck) (MSD). It was reported that the vials looks alike. No adverse event was reported. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated the product confusion occurred because both the vaccine''s vials looked alike and both were stored in the same freezer. There were no adverse symptoms. Additional information has been requested.

VAERS ID:301791 (history)  Vaccinated:2008-01-03
Age:12.0  Onset:2008-01-04, Days after vaccination: 1
Gender:Female  Submitted:2008-01-07, Days after onset: 3
Location:Washington  Entered:2008-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: decreased consciousness~HPV (Gardasil)~5~12.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U4IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Depressed level of consciousness, Dizziness, Pain in extremity, Pallor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: After 1st dose HPV had episode lasting about 40 min of decreased consciousness, also excessive pain in arm. After 3rd dose HPV had episode following day when felt faint, lasted about 40 min. 2 days after HPV3 had episode per mom''s description: Was in shower, Yelled ''mom'' and turned white, slumped down in shower, turned pale, took 40 min to return to normal awareness. Is fine now.

VAERS ID:301810 (history)  Vaccinated:2008-01-04
Age:12.0  Onset:2008-01-04, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 3
Location:California  Entered:2008-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0IM 
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U1IM 
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2209AA0IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1354U0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Patient stated feeling dizzy, then fainted 5-10 minutes after vaccinations were complete. Doctor performed complete assessment on patient. Condition stable. Patient released to parents, advised to go to ER if any complications occur.

VAERS ID:301873 (history)  Vaccinated:2007-12-19
Age:12.0  Onset:2007-12-20, Days after vaccination: 1
Gender:Male  Submitted:2008-01-08, Days after onset: 19
Location:Pennsylvania  Entered:2008-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RHINOCORT, CONCERTA, SINGULAIR, ALLEGRA, ASMANEX
Current Illness: NONE
Preexisting Conditions: ADHD, ASTHMA
Diagnostic Lab Data: NOT APPLICABLE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Chills, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: APPROXIMATELY 12 HOURS AFTER IMMUNIZATIONS WERE ADMINISTERED CHILD DEVELOPED VIOLENT VOMITING, ACHINESS, WEAKNESS & CHILLS. DEVELOPED FEVER OF 103PO LATER DURING EVENING OF 12/20. GIVEN TYLENOL/MOTRIN FOR FEVER. SXS SPONTANEOUSLY RESOLVED 24 HOURS AFTER ADMINISTRATION OF VACCINES.

VAERS ID:301963 (history)  Vaccinated:2007-10-10
Age:12.0  Onset:2007-10-10, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Washington  Entered:2008-01-08
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2405AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, Discomfort, Hypotonia, Injected limb mobility decreased, Local swelling, Myalgia, Skin nodule
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad)
Write-up: Menactra was given in (L) deltoid 10/10/07. Pt had a lot of swelling locally that evening, lasting about 10 days. was left with a residual nodule a few weeks. Since then, 2 1/2 months later, still c/o muscle ache and weakness in deltoid. My sense is that she avoided using the arm due to discomfort and now has lost muscle tone/bulk. Needs to start exercising.

VAERS ID:302324 (history)  Vaccinated:2007-10-30
Age:12.0  Onset:2007-11-23, Days after vaccination: 24
Gender:Female  Submitted:2008-01-10, Days after onset: 48
Location:Pennsylvania  Entered:2008-01-10
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: We were instructed to log symptoms for 1 month. When examined her regular Dr. was unavailable so she was seen by another doctor, who insisted that the symptoms had no relation to the injection and stated that she probably hit her head when she fainted (which was denied by the teacher that witnessed the syncopal episode). Because patient was having abdominal pain the day of the exam on 1/3/08, Dr. ordered an abdominal sonogram and told her to drink more water for the headaches.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURERGARDASIL ??0UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Convulsion, Dizziness, Headache, Nausea, Syncope, Ultrasound abdomen, Visual disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: 24 days after having the flu shot and Gardasil vaccine simultaneously, experienced an episode of nausea, dizziness, severe headache, seeing black spots, fainted and seizure activity (her teacher reported that she was shaking). She continues to have frequent headaches, nausea and occassional dizziness, & anxiety over the above.

VAERS ID:302480 (history)  Vaccinated:2008-01-08
Age:12.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:2008-01-11, Days after onset: 3
Location:Massachusetts  Entered:2008-01-11
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal pain upper, Dizziness
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Pt. received Gardasil. C/O dizziness, stomach cramps. Advised to treat as viral. Increased fluids, sm. am''ts bland food. Call if change of sx.

VAERS ID:302488 (history)  Vaccinated:2008-01-03
Age:12.0  Onset:2008-01-03, Days after vaccination: 0
Gender:Female  Submitted:2008-01-08, Days after onset: 5
Location:Massachusetts  Entered:2008-01-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure decreased, Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Pt. C/O feeling lightheaded after getting Gardasil. Fainted in waiting room. BP 80/50. BP taken after 10 mins-100/40, 98/65 awake & alert.

VAERS ID:302524 (history)  Vaccinated:2008-01-08
Age:12.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Male  Submitted:2008-01-11, Days after onset: 3
Location:Pennsylvania  Entered:2008-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: fever~Vaccine not specified (no brand name)~2~0~In Patient
Other Medications:
Current Illness: No
Preexisting Conditions: Celiac disease, asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Chills, Headache, Injection site cellulitis, Injection site erythema, Injection site pain, Pain, Pallor, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient developed soreness, fever approx. 6 hours after Tdap. Was OK during night. Developed fever to 102 degrees with headache, chills, paleness. Redness & tenderness at site. Seen today in office. Dx with cellulitis at injection site. Put on Keflex 250 TID x10d, Advil 200 mg 1 6-8 hrs & Benadryl 125 q 6 hr. Fever resolved today (1/11/08).

VAERS ID:302613 (history)  Vaccinated:2008-01-08
Age:12.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Male  Submitted:2008-01-14, Days after onset: 6
Location:New Mexico  Entered:2008-01-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Peanut allergy when a young child, not had any reaction to peanuts in several years. Seasonal allergies, eczema.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B016BA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Syncope, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: The evening after receiving the shot the patient developed hives not relieved with Benadryl, lasting 24 hrs, and he also fainted the evening after receiving the shot. He was not taken to the ER.

VAERS ID:302727 (history)  Vaccinated:2008-01-09
Age:12.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Male  Submitted:2008-01-10, Days after onset: 0
Location:Florida  Entered:2008-01-15, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2383BA0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B011AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1473U1UNLL
Administered by: Private     Purchased by: Private
Symptoms: Headache, Injection site pain, Nausea, Photophobia, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt. feels nauseated, headache is ongoing, sensitive to light, fever of 102.0, pain in arm & leg (injection sites).

VAERS ID:303114 (history)  Vaccinated:1999-02-02
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-08
Location:New Jersey  Entered:2008-01-16, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Hepatitis B antibody Nov2006 Negative
CDC Split Type: A0652203A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis B antibody negative, No adverse reaction
SMQs:
Write-up: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 13-year-old female subject who was vaccinated with Engerix B for prophylaxis. On 02 February 1999, 05 March 1999 and 10 September 1999 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (10 mcg). In November 2006, 7 years after vaccination with Engerix B, the subject did not have antibodies to Hepatitis B. At the time of reporting the event was unresolved. Follow-up information was received from the reporting healthcare professional on 07 June 2007. The reporter indicated that she had not reported the event to a regulatory agency. There was no other additional information reported.

VAERS ID:303118 (history)  Vaccinated:2007-12-06
Age:12.0  Onset:2007-12-06, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 32
Location:California  Entered:2008-01-16, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0712USA02199
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 12 year old female who on 06-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil. On 06-DEC-2007 the patient experienced "blurred vision and felt faint." No further information was provided and no lot number was given. The reporter felt that blurred vision and felt faint were not related to therapy with Gardasil. Additional information has been requested.

VAERS ID:303154 (history)  Vaccinated:2003-08-19
Age:12.0  Onset:2003-08-19, Days after vaccination: 0
Gender:Female  Submitted:2008-01-08, Days after onset: 1603
Location:Ohio  Entered:2008-01-16, 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: No concurrent medication
Current Illness: Unknown
Preexisting Conditions: The subject had no relevant medical history. The subject had not experienced any adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0649146A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSENG5374A20UNUN
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU0526AA UNUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Mobility decreased, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of injection site pain in a 12-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. The subject had no adverse events following receipt of prior immunizations and no relevant medical history. There were no concurrent medications. On 19 August 2003 the subject received unspecified dose of Engerix B (.5 ml, unknown) in the right arm. On 19 August 2003, the subject also received a booster dose of Td adsorbed (Aventis Pasteur) in the left arm. On 19 August 2003, less than one day after vaccination with Engerix B, the subject experienced injection site pain and arm weakness of the right arm. The physician reported that the subject, "had to use her left arm to raise her right arm." The physician reported that the "symptoms occurred intermittently and resolved after one year without treatment." The vaccination course with Engerix B was discontinued. The physician considered the events were probably related to vaccination with Engerix B. Follow up information was received on 09 May 2007 via the physician, who reported that the subject had not previously received Engerix-B prior to the first administration on 19 August 2003. The immunization series was discontinued, and the events resolved. Upon follow-up, the physician indicated that the events were possibly related to vaccination with Engerix B.

VAERS ID:303093 (history)  Vaccinated:2007-12-27
Age:12.0  Onset:2007-12-29, Days after vaccination: 2
Gender:Female  Submitted:2008-01-18, Days after onset: 20
Location:North Carolina  Entered:2008-01-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB213AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA0UNLA
Administered by: Public     Purchased by: Public
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: (L) deltoid site of injection red, hot, swelling also at site, knot developed at site also.

VAERS ID:303720 (history)  Vaccinated:2007-12-17
Age:12.0  Onset:2007-12-17, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 29
Location:Texas  Entered:2008-01-21, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA08079
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on 17-DEC-2007 was vaccinated with the first dose of GARDASIL. Concomitant vaccine therapy included diphtheria toxoid (-) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer not specified). A few seconds after the vaccination with GARDASIL, the patient fainted. She recovered after 15 minutes. Additional information has been requested.

VAERS ID:304015 (history)  Vaccinated:2007-10-18
Age:12.0  Onset:2007-10-18, Days after vaccination: 0
Gender:Unknown  Submitted:2008-01-15, Days after onset: 89
Location:Maine  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA01904
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Medication error, No adverse reaction
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse concerning a 12 year old female who on 18-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#''s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.

VAERS ID:303199 (history)  Vaccinated:2007-07-10
Age:12.0  Onset:2007-07-10, Days after vaccination: 0
Gender:Female  Submitted:2008-01-17, Days after onset: 191
Location:Ohio  Entered:2008-01-22, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy to Amoxil, Left anomolous carotoid Artery in middle ear. 2/4/08-records received-Allergy:Penicillin.
Diagnostic Lab Data: Head Ct 2/4/08-records received-CT scan left front contusion. Subsequent CT scan 7/37/07-resolution of left frontal parenchymal contusion. Normal CT.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2224AA0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B018AB0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0715U1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram, Computerised tomogram abnormal, Confusional state, Contusion, Feeling abnormal, Head injury, Headache, Loss of consciousness, Nausea, Neck pain, Syncope vasovagal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: Received vaccines, passed out while checking out and hit head on floor about 15 minutes later. Ice applied and observed x 20min. Did have brief LOC immediately after fall. Released to home, where began to experience episodes of vomiting and seemed "out of it" per dad about 1 1/2 after vaccine given. Sent per squad to MC-ER. Was evaluated and admitted. 2/4/08-records received for DOS 7/10-7/11/07-DC DX: Left frontal contusions secondary to fall. Experienced a vasovagal event after receiving vaccinations producing a fall to floor. Momentary loss of consciousness then recurrent emesis and confusion. C/O headache and waning nausea. Left-sided neck pain.

VAERS ID:303241 (history)  Vaccinated:2008-01-15
Age:12.0  Onset:2008-01-18, Days after vaccination: 3
Gender:Female  Submitted:2008-01-18, Days after onset: 0
Location:Pennsylvania  Entered:2008-01-22, Days after submission: 4
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: Noonan''s Syndrome
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2502AA0IMRA
HEPA: HEP A (VAQTA)MERCK & CO. INC.4495U0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0601F0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2609AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Erythema, Injected limb mobility decreased, Oedema, Pruritus, Skin exfoliation, Skin warm
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: (R) arm, edema, red, warm, peeling - 2" from site of injection down to elbow. Could not straighten arm out. T 99, was itchy. Was put on antibiotic, was to call/come back PRN.

VAERS ID:303338 (history)  Vaccinated:2007-02-19
Age:12.0  Onset:2007-02-19, Days after vaccination: 0
Gender:Female  Submitted:2008-01-23, Days after onset: 338
Location:Virginia  Entered:2008-01-23
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: Tested for SLE, RA, arthritis, thyroid deficiency & Lyme disease all negative results. Allergy testing done and presently referred to allergist for more testing but they want her off any medication and she can''t do that because of symptoms.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy test, Borrelia burgdorferi serology negative, Dizziness, Eye swelling, Lip swelling, Petechiae, Rash generalised, Rheumatoid factor negative, Swelling face, Thyroid function test normal
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: HPV series completed on 8/20/07. Had dizziness same day 1st dose on 2/19/2007. Has progressed with body rashes and continues to have petechiae on her face, swelling of her eyes, cheeks, and lips and rashes, has been treated with Benadryl, ZYRTEC and has an epi pen at school and at home. She ended in the ER on 1/22/2008 and was give prednisone. All this has been going on since she first started with the HPV vaccine.

VAERS ID:303361 (history)  Vaccinated:2008-01-11
Age:12.0  Onset:2008-01-12, Days after vaccination: 1
Gender:Female  Submitted:2008-01-14, Days after onset: 2
Location:Unknown  Entered:2008-01-23, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2609AA0UNLA
Administered by: Other     Purchased by: Public
Symptoms: Cough, Erythema, Induration, Malaise, Oedema, Pyrexia, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 6 cm diameter area or edema induration and erythema with tenderness. Had accompanying low grade fever, malaise and cough.

VAERS ID:303612 (history)  Vaccinated:2008-01-02
Age:12.0  Onset:2008-01-18, Days after vaccination: 16
Gender:Female  Submitted:2008-01-22, Days after onset: 4
Location:Florida  Entered:2008-01-25, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: allergy shots; Singular; Asmanex; Nasonex; Human growth hormone (Humatrope)
Current Illness: None
Preexisting Conditions: Unknown PMH: asthma; growth hormone deficiency; T&A.
Diagnostic Lab Data: spinal tap LABS: Brain & spine MRI WNL. CSF: WBC 8 (H), protein 335 (H), glucose 60 (N). Blood, urine & CSF c/s neg. Echocardiogram WNL. CBC showed WBC 13.9 (H), segs 88% (H), lymphs 9% (L). ESR 40 (H). Chemistry essentially WNL w/to
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2545AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Back pain, Blood culture negative, C-reactive protein increased, CSF culture negative, CSF glucose normal, CSF protein increased, CSF test abnormal, CSF white blood cell count increased, Chest X-ray normal, Culture urine negative, Decreased activity, Decreased appetite, Echocardiogram normal, Facial palsy, Fatigue, Guillain-Barre syndrome, Immunoglobulins, Influenza serology negative, Intensive care, Laboratory test normal, Lumbar puncture, Lymphocyte percentage decreased, Musculoskeletal stiffness, Nausea, Neck pain, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Protein total increased, Red blood cell sedimentation rate increased, Somnolence, Ultrasound scan normal, Urine analysis abnormal, Urine ketone body present, Vomiting, Weight decreased, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Hearing impairment (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Child received vaccine (Menactra and Boostrix) On 1/2/08-diagnosed with Guillain-Barre. On 1/18/08 at med ctr child is in PICU presently. 2/5/08 Reviewed hospital medical records which reveal patient experienced over prior 6 days back neck & leg pain, stiffness, nausea, intermittent abdominal pain, emesis, decreased appetite, decreased activity, fatigue, excess sleepiness, 5# wt loss. Admitted1/18-1/26/2008. Neuro, ICU, ID consult done. Developed left facial paralysis. LP done. Transferred to PICU. IVIG x 5 days. Improved dramatically & facial paralysis resolved w/IVIG & PT. D/C to home w/ outpatient PT & neuro f/u. FINAL DX: Guillain-Barre.

VAERS ID:303748 (history)  Vaccinated:2008-01-09
Age:12.0  Onset:2008-01-11, Days after vaccination: 2
Gender:Female  Submitted:2008-01-11, Days after onset: 0
Location:California  Entered:2008-01-28, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.049541UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR42428AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: (L) arm swelling with redness, pain.

VAERS ID:303786 (history)  Vaccinated:2007-12-13
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2008-01-26
Location:Michigan  Entered:2008-01-28, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERAC14B046AA IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Medication error
SMQs:, Medication errors (narrow)
Write-up: Vaccines given in error.

VAERS ID:303817 (history)  Vaccinated:2008-01-18
Age:12.0  Onset:2008-01-18, Days after vaccination: 0
Gender:Female  Submitted:2008-01-29, Days after onset: 11
Location:Alabama  Entered:2008-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: runny nose
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Feeling abnormal, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Pt. received 2nd HPV dose, vomited after leaving facility, felt pain in side and felt "cloudy headed". Returned to Health dept. for observation. Pulse was 88, BP was 120/60, O2 was 98%. Pt. did not vomit anymore but felt faint for 5 minutes. Pt. left health dept. walking, talking o.k. Pt. was at store when she vomited.

VAERS ID:303837 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-28
Location:Unknown  Entered:2008-01-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA03891
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cerebral haemorrhage, Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a business manager for a physician concerning a 12 year old female who on an unknown date was vaccinated with her first dose of Gardasil. It was reported that the patient received four injections (therapy unspecified) at that time. Subsequently on an unknown date the patient experienced syncope, hit her head and cerebral bleeding and was hospitalized. It was reported that subsequently, on an unknown date, the patient had full recovery. This is one of several reports received from the same source. No further information is expected.

VAERS ID:303860 (history)  Vaccinated:2008-01-10
Age:12.0  Onset:2008-01-11, Days after vaccination: 1
Gender:Female  Submitted:2008-01-23, Days after onset: 12
Location:North Carolina  Entered:2008-01-29, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sinusitis
Preexisting Conditions: NKDA; asthma
Diagnostic Lab Data: C-RP; sed rate; CBC; ASO titer; parvovirus; strep test
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, C-reactive protein, Eye oedema, Full blood count, Parvovirus B19 serology, Rash, Red blood cell sedimentation rate, Streptococcus identification test, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vomiting x1; urticaria all over body; eye edema; positive large wheal eruptions abs, feet, arms, hand; joint pain.

VAERS ID:303871 (history)  Vaccinated:2008-01-21
Age:12.0  Onset:2008-01-21, Days after vaccination: 0
Gender:Female  Submitted:2008-01-23, Days after onset: 2
Location:Florida  Entered:2008-01-29, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2479AA1UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB200BA1UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U20UNRA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Pt received 2nd Gardasil; Tdap, Hep A on 3/29/07 and 3rd HPV on 1/21/08, 2nd Hep A, and flu vaccine. Pt had syncope spell in office after vaccines given. On 1/21/08 - went to dance class x 3 hours after left office. Pt has not had dizzy spells and sore throat since 1/21/08.

VAERS ID:304155 (history)  Vaccinated:2008-01-21
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-21
Location:Missouri  Entered:2008-02-01, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2524AA2IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA2IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U3IMRA
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: None reported. No adverse events.

VAERS ID:304156 (history)  Vaccinated:2008-01-21
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-30
Location:Missouri  Entered:2008-02-01, 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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0800U1 RA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1210U1 LL
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2403AA1 RA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA1 LA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1493U2 LA
Administered by: Private     Purchased by: Private
Symptoms: No adverse reaction
SMQs:
Write-up: None reported. No adverse events.

VAERS ID:304244 (history)  Vaccinated:2008-01-21
Age:12.0  Onset:2008-01-23, Days after vaccination: 2
Gender:Male  Submitted:2008-01-29, Days after onset: 6
Location:Delaware  Entered:2008-02-04, 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:
Preexisting Conditions: Allergic Rhinitis only
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051A0UNRA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0800U0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2545AA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Pain in extremity, Pyrexia, Skin reaction
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: fevers 102, arm pain, adverse skin reaction both arms

VAERS ID:304376 (history)  Vaccinated:2008-01-29
Age:12.0  Onset:2008-01-31, Days after vaccination: 2
Gender:Female  Submitted:2008-02-01, Days after onset: 1
Location:New Jersey  Entered:2008-02-05, Days after submission: 4
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: Hypothyroidism
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.144800UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2222A0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1515U1UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Pain, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Orange size circle, raised and red, painful. No fever, positive welting.

VAERS ID:304511 (history)  Vaccinated:2008-01-29
Age:12.0  Onset:2008-01-30, Days after vaccination: 1
Gender:Male  Submitted:2008-01-31, Days after onset: 1
Location:North Carolina  Entered:2008-02-07, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Ceclor Allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB217BA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2550AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1473U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site cellulitis, Injection site erythema, Injection site haemorrhage, Injection site vesicles
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Cellulitis of left upper arm at vaccine site, centered darker erythema, + vesicles, + ecchymotic areas. 2-2-08 per mother, area fading and getting better. Improving without medication.

VAERS ID:304691 (history)  Vaccinated:2008-02-04
Age:12.0  Onset:2008-02-05, Days after vaccination: 1
Gender:Male  Submitted:2008-02-11, Days after onset: 6
Location:Pennsylvania  Entered:2008-02-11
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: Allergic Rhinitis, hypothyroidism, ADD, Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.102501SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Dizziness, Headache, Injection site erythema, Injection site induration, Injection site 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red painful swollen indurated area R arm at site of injection, low grade fever (99 F) began 2/5/2008, 1 day after administration, 2/4/2008; Keflex called in 2/5/08; OV 2/6/2008 prescribed Septra and changed Keflex to Augmentin; 2/7/2008 afebrile, reaction fading but spreading distally in response to gravity; 2/8/08 phone call patient lightheaded, headache, stomach pain; advised to change Augmentin back to Keflex and make OV. Did not show for follow up OV.

VAERS ID:304753 (history)  Vaccinated:2008-02-05
Age:12.0  Onset:2008-02-06, Days after vaccination: 1
Gender:Female  Submitted:2008-02-08, Days after onset: 2
Location:Massachusetts  Entered:2008-02-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Induration, Inflammation, Local reaction, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: local reaction right shoulder red; swollen mild tender nonfluctuant; Mild induration; local inflammatory reaction. Follow up 2-8-08 mom states decreased swelling no redness

VAERS ID:304861 (history)  Vaccinated:2008-02-07
Age:12.0  Onset:2008-02-07, Days after vaccination: 0
Gender:Female  Submitted:2008-02-11, Days after onset: 4
Location:Connecticut  Entered:2008-02-13, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: CT200802
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U0IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0827U1SCUN
Administered by: Private     Purchased by: Public
Symptoms: Blister, Malaise, Skin lesion, Urticaria, Varicella
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Within 48 hours of administration of VZV #2 (booster), pt erupted with both vesicles and hives, along with mild malaise. Vesicles continued to erupt over next 48 hours with older lesions leaving crater. Many lesions in scalp, axillary groin & intertrigenous areas. Dx varicella.

VAERS ID:304934 (history)  Vaccinated:2008-02-06
Age:12.0  Onset:2008-02-07, Days after vaccination: 1
Gender:Male  Submitted:2008-02-08, Days after onset: 1
Location:Texas  Entered:2008-02-14, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR02543AA IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1513U SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Had adverse reaction to Varivax. Red/tender at injection site

VAERS ID:305030 (history)  Vaccinated:2008-02-13
Age:12.0  Onset:2008-02-14, Days after vaccination: 1
Gender:Female  Submitted:2008-02-15, Days after onset: 1
Location:Florida  Entered:2008-02-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no known
Preexisting Conditions: no known
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU254AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient developed redness on her ear the evening of 2/14/08 around 800pm, then redness at the back of her neck. She then developed a red welt like rash on both arms from shoulder to mid arms, large welts on her back. No rash on her face, but did have a few spots on both feet. Parent gave 25mg of Benadryl, the rash continued to spread, but completely resolved by morning.

VAERS ID:305183 (history)  Vaccinated:2008-02-18
Age:12.0  Onset:2008-02-19, Days after vaccination: 1
Gender:Female  Submitted:2008-02-19, Days after onset: 0
Location:Texas  Entered:2008-02-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol or Motrin prn
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1655U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 6 cm erythema with induration to R tricep.

VAERS ID:305621 (history)  Vaccinated:2008-01-07
Age:12.0  Onset:2008-01-08, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 37
Location:Unknown  Entered:2008-02-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02020
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a nurse practitioner (NP), via a company representative, concerning a 12 year old female patient, who on 28-OCT-2007 was vaccinated IM with the first dose and on 08-JAN-2008 with the second dose of Gardasil (lot # invalid dose 1; lot #658556/1060U dose 2). On 08-JAN-2008, "within 24 hours" of receiving the second vaccination, the patient experienced nausea and a possible fever. On 09-JAN-2008, she returned to the NP''s office for evaluation, though she did not have a fever at that time. Subsequently, the patient also recovered from nausea (duration not specified). Additional information has been requested.

VAERS ID:305951 (history)  Vaccinated:2007-06-22
Age:12.0  Onset:2007-07-18, Days after vaccination: 26
Gender:Female  Submitted:2008-02-14, Days after onset: 211
Location:Connecticut  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac murmur; Drug hypersensitivity;
Preexisting Conditions:
Diagnostic Lab Data: electrocardiogram 06?/??/07 - elongated QTC 494, potential for arrhythmia; electrocardiogram 08?/??/07 - "LQTC" 502; electrocardiogram, 07/18/07, QT between 0.46 and 0.54;
CDC Split Type: WAES0801USA04447
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B006BA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cardiac murmur, Electrocardiogram QT prolonged
SMQs:, Torsade de pointes/QT prolongation (narrow), Conduction defects (narrow), Torsade de pointes, shock-associated conditions (narrow), Pulmonary hypertension (broad)
Write-up: Information has been received from a consumer, concerning his 12 year old daughter with no known allergies, who in June 2007, was vaccinated with the first dose of Gardasil (lot # not reported). Concomitant therapy included an unspecified beta blocker (indication not reported). Following the vaccination (date not specified), his daughter saw a cardiologist and had an electrocardiogram (EKG) result of an elongated QTC level of 494 (units not specified), with the potential for arrhythmia. In August 2007, his daughter was vaccinated with the second dose of Gardasil (lot # not reported). Following the second vaccination, her "LQTC" level was higher at 502 (date and units not specified). At the time of this report, the patient had not recovered. Additional information has been requested. Follow up information from the physician indicated that on 22-JUN-2007, the patient (a caucasian student), with a heart murmur and a possible allergy to CEFZIL but otherwise well, was vaccinated IM in the right arm with the first dose of GARDASIL (lot # 658094/0524U). Concomitant vaccine therapy, administered IM in the left arm at the visit, included the first dose of BOOSTRIX (lot #AC52B006BA). There was no illness at the time of vaccination. The physician stated that, "we noted a murmur at that visit which lead to a cardiac eval which lead to diagnosis for elongated QT." There was no immediate reaction noted. The diagnosis was confirmed on 18-JUL-2007, when the patient''s QT, on a holter monitor, was between 0.46 and 0.54. The findings were reported to the physician by cardiology. Additional information has been requsted.

VAERS ID:305976 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Virginia  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory unspecified
CDC Split Type: WAES0801USA04664
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cyanosis, Dizziness, Laboratory test, Oedema peripheral, Rash generalised, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a registered nurse concerning her 12 year old granddaughter who in February 2007, was vaccinated with a first dose of Gardasil (lot# unknown) injection. In April 2007, the patient was vaccinated with a second dose of Gardasil injection and experienced dizziness. Medical attention was sought. The patient recovered from dizziness. In August 2007 the patient was vaccinated with a third dose of Gardasil injection. Approximately one week after receiving the third dose of Gardasil the patient had broken out in hives all over the body and since then the patient had developed rashes all over her body, hands were turning blue and swelling had occurred. The patient was given (diphenhydramine hc1) BENADRYL and (montelukast sodium) SINGULAIR (MSD) to help with these symptoms, but they have not subsided. The nurse reported that the patient had gone to the emergency room on 22-JAN-2008 and was placed on prednisone (manufacturer unspecified). The nurse was not sure if the patient was admitted to the hospital. The nurse reported that the patient had many unspecified diagnostic tests. There was no further AE experience. At the time of reporting the patient had not recovered. Additional information has been requested.

VAERS ID:306014 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:California  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05739
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a physician concerning a 12 year old female with no known allergies or medical history who in November 2007, was vaccinated with her first dose of Gardasil. Soon after receiving Gardasil, the patient experienced nausea and did not feel well for about one day following her first dose. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from nausea. Additional information has been requested.

VAERS ID:306030 (history)  Vaccinated:2008-01-07
Age:12.0  Onset:2008-01-07, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 38
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ROCEPHIN
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05074
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Anxiety, Dyspnoea, Hyperventilation, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician assistant concerning a 12 year old female who on 07-JAN-2008 was vaccinated with her third dose of 0.5 ml Gardasil via injection. Concomitant therapy included ROCEPHIN. The physician assistant reports the patient received the third dose of Gardasil and after a couple of hours the patient developed urticaria, anaphylactic reaction, had difficulty breathing, had hives with anxiety and hyperventilating. The physician assistant reported that the mother of the patient wanted to give the patient the third dose of Gardasil and the ROCEPHIN all at the same time before school started, even if the physician assistant wanted to wait to provide the Gardasil. Per the physician assistant, after the patient was given the Gardasil the patient was still fine. The mother of the patient then brought the patient to the dentist on the same day and the patient was given fluoride. The patient went home after the dental appointment and developed the symptoms. The physician assistant noted that the patient was brought back to their office and was given BENADRYL and they called an ambulance to take the patient to the hospital. The patient was brought to the emergency room. The physician assistant was not aware of the present status of the patient and whether the patient was admitted to the hospital. The lot number was not provided and no further information was provided. Additional information has been requested.

VAERS ID:306033 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05090
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a consumer concerning her 12 year old female granddaughter with no known allergies and no reported medical history who was vaccinated with a series of three shots of Gardasil. The reporter stated that her granddaughter told when she got her sot it was really painful and stung alot. No additional information was provided. The onset date was ''after each shot". Additional information has been requested.

VAERS ID:306089 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05962
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Clonus, Convulsion, Gaze palsy, Immediate post-injection reaction, Musculoskeletal stiffness, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a newspaper article concerning a 12 year old female who on an unspecified date was vaccinated with a first dose of Gardasil. A few minutes post vaccination, the patient walked about 50 steps then went into what the patient''s mother believed to be a seizure. The patient''s eyes rolled back in her head, she stiffened up and had clonic jerks. The patient was placed on a stretcher and rushed to the emergency room. The physician''s at the emergency room told the patient''s mother that the patient experienced vasovagal syncope because "the patient was scared from the shot." Additional information is not expected.

VAERS ID:305237 (history)  Vaccinated:2008-01-28
Age:12.0  Onset:2008-01-30, Days after vaccination: 2
Gender:Female  Submitted:2008-02-20, Days after onset: 21
Location:South Dakota  Entered:2008-02-20
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: Ibuprofen
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Left arm became red, swollen and tender to the touch and warm 50-54 hours after administration. Tylenol administered, no fever. Went away after 8-10 hours.

VAERS ID:305239 (history)  Vaccinated:2008-02-14
Age:12.0  Onset:2008-02-16, Days after vaccination: 2
Gender:Male  Submitted:2008-02-20, Days after onset: 4
Location:New York  Entered:2008-02-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2430AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Anorexia, Pain, Pyrexia, Upper respiratory tract infection, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/16 at midnight started with fever 103 and body ache. Progressively worsened, was unable to walk by Monday that family took to ER. Has also had vomiting and poor appetite since onset. Mother reported ER stated child had URI or less likely vaccine reaction. Fever ceased Wed 2/20/08.

VAERS ID:305240 (history)  Vaccinated:2008-02-19
Age:12.0  Onset:2008-02-19, Days after vaccination: 0
Gender:Female  Submitted:2008-02-19, Days after onset: 0
Location:Georgia  Entered:2008-02-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0494U IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2417AA IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B049AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: PATIENT FELT SLIGHT DIZZY LESS THAN A MINUTE PATIENT RECOVERED IMMEDIATELY AND WENT HOME. THIS PATIENT ALSO DID NOT HAD ANY FOOD OR LIQUIDS BEFORE VACCINATION. DOCTOR FELT THIS ALSO A VERY MILD VASO VAGAL REACTION.

VAERS ID:305367 (history)  Vaccinated:2008-02-13
Age:12.0  Onset:2008-02-13, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 1
Location:Kentucky  Entered:2008-02-21, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU25480IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus, Type III immune complex mediated reaction
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Several hours after the shot pt developed a pruritic Arthus type reaction of the upper arm. No fever, no difficulty breathing, just itchiness. I discussed the pt with Dr., an allergist, and I''m giving Clarinex 5 mg daily till clear.

VAERS ID:305693 (history)  Vaccinated:2007-08-13
Age:12.0  Onset:2007-09-02, Days after vaccination: 20
Gender:Female  Submitted:2008-02-26, Days after onset: 177
Location:Florida  Entered:2008-02-26
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 13 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None. PMH: none. Allergic to PCN and Septra.
Diagnostic Lab Data: Tests confirmed acute disseminated encephalomyelitis (ADEM). Labs and Diagnostics: Spinal Arteriogram revealed no AV malformations. MR of spine c/w inflammatory process /demyelination. UC (+) for E. coli and Enterobacter. CSF WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0245U0UNLA
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B016BA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Anterior spinal artery syndrome, Arteriogram normal, Asthenia, Back pain, CSF test normal, Culture urine positive, Dysuria, Hyporeflexia, Laboratory test abnormal, Leukoencephalomyelitis, Monoplegia, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Urinary incontinence, Urinary tract infection, Walking aid user, Weight bearing difficulty
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: On September 2, 2007, patient''s left leg became paralyzed. She was taken to the emergency room and hospitalized for 13 days. The doctors at hospital diagnosed her with non-infectious A.D.E.M. 04/11/2008 MR received from hospital for DOS 9/6-10/2008 where pt was sent for diagnostic testing to r/o AVM. D/C DX: was Spinal cord anterior spinal artery infarct. Pt was transfered to another facility where Final DX was made. Pt initially had presented to local facility with sudden onset L lower extremity plegia. 04/28/2008 MR received for DOS 9/10-15/2007 with D/C DX: Acute Demyelinating Encephalomyelitis (ADEM). Urinary Tract infection. Pt admitted after transfer from above admission. Pt initially presented with Left leg weakness/paralysis and upper back pain. Upon admission pt was unable to void and later had urinary incontinence. Tx with solumedrol and abx for UTI. At D/C pt still with decreased strength of LLE, depressed reflexes and unable to bear weight independantly. Using a walker. Will continue with Outpt rehab. 1/20/2010 Patient stil has not been able to walk or run normal. She is still receiving physical therapy 2x a week. Follow-up Information 06-MAY-2008:

VAERS ID:305725 (history)  Vaccinated:2008-01-04
Age:12.0  Onset:2008-01-05, Days after vaccination: 1
Gender:Female  Submitted:2008-02-15, Days after onset: 41
Location:California  Entered:2008-02-26, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U2UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Oedema peripheral, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Right arm pain from elbow to shoulder, unable to elevate arm above shoulder with minimal swelling. Treatment 400mg Ibuprofen Tid after food for 1 week.

VAERS ID:305745 (history)  Vaccinated:2008-02-26
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-26
Location:Oklahoma  Entered:2008-02-26
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: nkda, pregnant
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Pt received a Gardasil injection before her pregnancy results came back from the lab. The lab results showed she was pregnant.

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