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Found 596012 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

This is page 304 out of 597

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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
FLUX: 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), Glaucoma (broad), 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: no~ ()~~0.00~Patient|no~ ()~~0.00~Sibling
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.

VAERS ID:305805 (history)  Vaccinated:2008-02-18
Age:12.0  Onset:2008-02-18, Days after vaccination: 0
Gender:Male  Submitted:2008-02-19, Days after onset: 1
Location:Virginia  Entered:2008-02-26, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: cold-no fever
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: paleness, weakness, nausea, faintness upon leaving dr. office and for 15-20 minutes thereafter; fatigued for rest of day

VAERS ID:305830 (history)  Vaccinated:2005-06-30
Age:12.0  Onset:2008-01-27, Days after vaccination: 941
Gender:Male  Submitted:2008-02-25, Days after onset: 29
Location:Pennsylvania  Entered:2008-02-27, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None. PMH: none. Recent sinus congestion. NKDA.
Diagnostic Lab Data: State Health Department, laboratory testing: Neisseria Meningitidis, Strain Y. Labs and Diagnostics: LP with CSF protein 269, WBCs 1150. Serum WBCs 22K on admission, WNL by d/c. PT12.2 on admission down to 10.9. PTT 36 then down to 26.
CDC Split Type: 200800531
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU1657AA0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase decreased, Arthralgia, Blood alkaline phosphatase, Blood fibrinogen increased, Blood glucose increased, CSF protein increased, CSF white blood cell count increased, Headache, Laboratory test abnormal, Lumbar puncture abnormal, Meningitis meningococcal, Myalgia, Oral intake reduced, Pain, Petechiae, Prothrombin time prolonged, Pyrexia, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: A 15-year-old male patient, with no pre-existing medical conditions, received an injection of Menactra (lot number, route, and site not reported on 30 June 2005. On 27 January 2008, two years and seven months after vaccination, he was diagnosed with Neisseria Meningitidis, Strain Y. Per the patient''s parent, this was confirmed via laboratory testing by the State Health Department. He was hospitalized for four days, and treated with Vancomycin and Rocephin. The patient was subsequently discharged to home, and had recovered with no sequelae. 03/05/2008 MR received for DOS 1/27-30/2008 with D/C DX: Meningococcal Meningitis. Pt had meningitis vax at age 12. Pt presented to local hospital with fevers, headache, vomiting, achiness, and petechial rash which was worsening. LP revealed increased WBCs and protein and pt was transfered for higher level of care. Pt had poor po intake, rhinorrhea, myalgias and arthragias in addition to above on admission. PICC line was inserted for IV abx. Petechial rah was fading and po intake improved upon d/c. To continue IV abx as an outpt.

VAERS ID:305872 (history)  Vaccinated:2008-01-31
Age:12.0  Onset:2008-02-04, Days after vaccination: 4
Gender:Male  Submitted:2008-02-27, Days after onset: 23
Location:Alabama  Entered:2008-02-27
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: Obesity, current fracture of right arm, recent fracture of left arm
Diagnostic Lab Data: None LABS: fasting insulin 29 (H), H/H 11.8/36.3
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2407AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B018BA4IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood insulin increased, Cough, Facial palsy, Facial paresis, Haematocrit normal, Haemoglobin normal, Impaired fasting glucose
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Lipodystrophy (broad), Hypoglycaemia (broad)
Write-up: Left sided Bell''s palsy 3 days after vaccine administration. Was resolving at time of examination 21 days later. No treatment was required at that point in time. 5/23/08 Reviewed PCP medical records & vax records. FINAL DX: left Bell''s palsy. Records reveal patient experienced prior casted arm fracture & was referred to ortho. Also experienced vision deficits & referred to ophthal. Returned to PCP 2/25/08 w/left facial weakness & cough that had started 2/4/08. Family noticed w/talking. No treatment provided as was resolving spontaneously. Labs revealed impaired glucose metabolism & referred for further w/u.

VAERS ID:306303 (history)  Vaccinated:2008-02-18
Age:12.0  Onset:2008-02-21, Days after vaccination: 3
Gender:Male  Submitted:2008-02-29, Days after onset: 8
Location:Pennsylvania  Entered:2008-03-03, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2420AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2631AA5UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1761U1UNLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: (R) upper arm - red, swollen, bumps

VAERS ID:306313 (history)  Vaccinated:1996-07-09
Age:12.0  Onset:2008-02-29, Days after vaccination: 4252
Gender:Male  Submitted:2008-03-03, Days after onset: 3
Location:Massachusetts  Entered:2008-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0393B0UNRL
Administered by: Private     Purchased by: Public
Symptoms: Rash, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient presented in office with approximately 20 lesions. Rash started 2/27, patient presented on 2/29.

VAERS ID:306511 (history)  Vaccinated:2008-03-04
Age:12.0  Onset:2008-03-05, Days after vaccination: 1
Gender:Female  Submitted:2008-03-05, Days after onset: 0
Location:Washington  Entered:2008-03-05
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2359AA0IMLA
Administered by: Unknown     Purchased by: Unknown
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: Syncope and collapse day after. Flu symptoms.

VAERS ID:306598 (history)  Vaccinated:2008-03-01
Age:12.0  Onset:2008-03-01, Days after vaccination: 0
Gender:Female  Submitted:2008-03-04, Days after onset: 3
Location:Maryland  Entered:2008-03-06, 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: Musculoskeletal chest wall pains
Preexisting Conditions:
Diagnostic Lab Data: CBC, CMP unremarkable
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Full blood count, Laboratory test normal
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Dizziness only at night when goes to bed. Is fine during day.

VAERS ID:306734 (history)  Vaccinated:2007-12-31
Age:12.0  Onset:2008-01-08, Days after vaccination: 8
Gender:Male  Submitted:2008-03-05, Days after onset: 57
Location:Idaho  Entered:2008-03-10, Days after submission: 4
Life Threatening? No
Died? Yes
   Date died: 2008-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: sibling w/VSD repair. PE tubes @3yo.
Diagnostic Lab Data: Globulin 2.3 1.8-3.5 g/dl; ALB/Glob ratio 1.4 1.0-2.7 ratio; Bilirubin, TOT 0.2 <2.0 mg/dl; ALT 21 5-50 u/L; ALK Phos 144 103-429 u/L; AST 30 14-40 u/L; CK, TOT 161 25-287 u/L; Myoglobin 147 (high) LT 65 ng/ml; Troponin-T <0.01 0.00-0.10 ng/ml. LABS: in ER, venous pH 6.94 (L), CO2 16 (L), serum myoglobin 147 (H), anion gap 23 (H), glucose 278 (H), total protein 5.7 (L), albumin 3.3 (L).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2382BA UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA UNRA
Administered by: Private     Purchased by: Private
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Anion gap increased, Arthralgia, Aspartate aminotransferase normal, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin, Blood creatine phosphokinase normal, Blood glucose increased, Blood pH decreased, Carbon dioxide decreased, Cardiac arrest, Globulin, Hypertrophic cardiomyopathy, Inappropriate schedule of drug administration, Myoglobin blood increased, Protein total decreased, Sudden death, Troponin, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Medication errors (narrow)
Write-up: Sudden death on school playground. 3/11/08 Reviewed medical records that accompanied autopsy report which reveal patient who appeared large for his age was involved in after school snow ball fight w/friends then ran across street approx 50 yards to parent''s vehicle & collapsed over the car. Parent & other bystanders witnessed event & called 911. Parent told ER patient was gurgling, color drained from face & eyes glassed over. Transported to ER where resuscitation unsuccessful. 3/25/08 Reviewed pcp medical records of 12/31/07. Only complaint was of slight pain right knee s/p bike crash. Pt wt 148 lbs, ht 63.5 in, BMI 25.8. BP 100/60. Vax record supplies lot #. Family hx: parent w/HTN.

VAERS ID:306872 (history)  Vaccinated:2006-12-06
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-11
Location:Montana  Entered:2008-03-11
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: Severe localized reactions to bee & wasp stings, non-anaphylactic.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0 UN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Gaze palsy, Immediate post-injection reaction, Syncope, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: My daughter fainted immediately after administration of the vaccine. Her eyes rolled back, and her body had mild convulsing, followed by fainting. I have just found out about your reporting system, therefore the delay in reporting. My daughter has had 2 shots of the HPV Vaccine, and fainted following both. She has had all other childhood vaccines and many travel vaccines and never fainted. I believe both HPV vaccines were Gardasil, but this should be confirmed with physician. The first HPV vaccine 12/06 was administered with an additional DTap vaccine; HPV Vaccine #2 was administered alone and again produced faintness. Both times injection was given in upper arm-- can''t recall which side.

VAERS ID:307075 (history)  Vaccinated:2008-02-27
Age:12.0  Onset:2008-02-28, Days after vaccination: 1
Gender:Female  Submitted:2008-03-03, Days after onset: 4
Location:Louisiana  Entered:2008-03-14, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: LA080301
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.136241SCRA
Administered by: Other     Purchased by: Public
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: 24-48 hours after Double softball size, red, swollen, hand and hot to touch area. Treated with Benadryl prn.

VAERS ID:307214 (history)  Vaccinated:2008-03-04
Age:12.0  Onset:2008-03-04, Days after vaccination: 0
Gender:Male  Submitted:2008-03-06, Days after onset: 2
Location:Florida  Entered:2008-03-17, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB25880UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2559AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEUR0276AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.17606 UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral, Pyrexia, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Elevated fever, vomiting 24 hours after vaccines for 1 day. Redness 8x6cm, firmness, swelling, hot, tenderness at injection sites. Left deltoid onset that evening with red, warm, swelling.

VAERS ID:307467 (history)  Vaccinated:2007-10-01
Age:12.0  Onset:2007-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 165
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory; magnetic resonance; computed axial
CDC Split Type: WAES0802USA00457
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IJUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Computerised tomogram, Headache, Laboratory test, Nuclear magnetic resonance imaging
SMQs:, Dementia (broad)
Write-up: Information has been received from a mother concerning her 12 year old daughter who sometime in October 2007, was vaccinated with the first dose, in DEC 2007 with her second dose of Gardasil (lot numbers not provided). In October 2007, the patient experienced terrible consistent headaches. The headaches went away for a while but came back after she had the second dose in December 2007. The patient states the headaches have remained constant and she said on a scale of 1-10 they remain a 7 and they last all day and all night. Patient has missed 2 weeks of school because of it. The patient''s mother states that her daughter has been to the physician 13 times regarding her daughter''s headaches. Patient has been to several neurologists and they could not find anything wrong. Patient has been give Tylenol with codeine, Aleve, hydrocodone, Motrin, Advil and Immatrex (manufacturers unknown) and this past week she was given Depakote intravenously. Patient''s mother states that none of the medications have helped but have only made her feel worse. The patient''s terrible consistent headaches persisted. No further information is available. 07/08/08 Follow up was received on 31-MAR-2008. There was not further AE information and the practice does not want to receive any further letters.

VAERS ID:307469 (history)  Vaccinated:2007-07-16
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Unknown  Entered:2008-03-17, 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:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA00472
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.    
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypomenorrhoea, Vaccine positive rechallenge
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a physician concerning a 12 year old female who on 16-JUL-2007 was vaccinated with the first dose (lot number: 657617/0384U), on 20-SEP-2007 with the second dose (lot number: 658282/0929U) and 20-JAN-2008 with the third dose of Gardasil (lot number not provided). Concomitant therapy included VAQTA. It was reported that the patient had "gotten her first period after receiving the vaccine, but it only had lasted for a day." It was also reported that this "also occurred after she had received her second dose of Gardasil, with her period only lasting a day." The patient''s mother was reluctant and didn''t schedule her for her third dose. The patient recovered. On an unspecified date the patient received her third dose. No further information is available. This is in follow up to report(s) previously submitted on 3/14/2008. Informatino has been received from a physician concerning a 12 year old female who on 16-JUL-2007 was vaccinated with the first dose (lot number: 657617/0384U), on 20-SEP-2007 with the second dose: lot number: 658282/0829U) and 20-JAN-2008 with the third dose of GARDASIL (lot number: 058563/1063U). Concomitant therapy included VAQTA. It was reported that the patient had "gotten her first period after receiving the vaccine, but it only had lasted for a day." It was also reported that this "also occurred after she had received her second dose of GARDASIL, with her period only lasting a day." The patient''s mother was reluctant and didn''t schedule her for her third dose. The patient recovered. On an unspecified date the patient received her third dose. Follow-up information was received on 19-Mar-2008 the mom reports that child began first period after dose of 1 of GARDASIL for 1-2 days. Then the second cycle for 1-2 days after 2nd dose of GARDASIL. Mom held off for one month for dose 3 and child had third cycle at time that the third dose was to be received. No further information is available.

VAERS ID:307482 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA00802
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Menstruation delayed
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a certified medical assistant concerning a female, approximately 12 years old, who was vaccinated with Gardasil. Subsequently, the patient experienced a delayed period of one month. The patient''s menstrual cycle returned to normal on it''s own and the patient was reported to be recovered. Additional information has been requested.

VAERS ID:307564 (history)  Vaccinated:2008-01-29
Age:12.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 44
Location:Maryland  Entered:2008-03-17, 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:
Preexisting Conditions: Injection site reaction
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA01920
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a patient''s mother concerning her 12 year old daughter with a history of injection site reactions who on 29-JAN-2008 was vaccinated intramuscularly with her first dose of Gardasil. There was no concomitant medication. On 29-JAN-2008 the patient experienced warmth and swelling at the injection site. The patient''s warmth and swelling at the injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:307565 (history)  Vaccinated:2008-02-06
Age:12.0  Onset:2008-02-06, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 36
Location:Kentucky  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Attention deficit/hyperactivity disorder
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 02/06/08, 94/68; blood pressure, 02/06/08, 88/62; blood glucose, 02/06/08, 88
CDC Split Type: WAES0802USA01934
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 12 year old female with attention deficit/hyperactivity disorder who on 06-FEB-2008 was vaccinated 0.5mL with her first dose of GARDASIL (lot #659655/1486U). On 06-FEB-2008 the patient fainted 2 minutes after receiving her vaccination. Reporter noted they were not sure if it was a seizure because they did not witness the fainting. The patient recovered on the same day and went home. Additional information has been requested. 07/08/08 Follow up information received 24-MAR-2008 stated after the patient received the vaccination (approximately 3:30PM) she stiffened and passed out (approximately 3:40PM). It was reported the patient was taken to an exam room and examined by physician. The patient blood pressure measurement was 94/68 lying down and 88/62 sitting up. The patient''s blood glucose was 88. Subsequently, the patient recovered on the same day. Additional information has been requested.

VAERS ID:307670 (history)  Vaccinated:2008-01-04
Age:12.0  Onset:2008-01-04, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 69
Location:California  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA03713
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health care professional concerning a 12 year old female who on 18-JUN-2007 was vaccinated with the first dose of GARDASIL an don 24-AUG-2007 was vaccinated with the second dose of GARDASIL and on 04-JAN-2008 was vaccinated IM with the third (0.5 ml) dose of GARDASIL. There was no concomitant medication. After receiving the third dose the patient experienced injection site reaction. At the time of reporting the patient still had significant pain on the injection site on her right arm and could not even lift her arm to write. Medical attention was sought. Patient had not recovered at the time of reporting. No product quality complaint was involved. Additional information has been requested.

VAERS ID:307691 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA03180
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse practitioner concerning "around 12 year old" female who on an unspecified date was vaccinated with a first dose of Gardasil 0.5 mL injection. On an unspecified date after receiving the Gardasil the patient experienced a depressed white cell count. Medical attention was sought. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested.

VAERS ID:307694 (history)  Vaccinated:2007-05-15
Age:12.0  Onset:2007-05-15, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 304
Location:Texas  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp 101 Faren
CDC Split Type: WAES0802USA03203
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0961F0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Injection site mass, Pyrexia, Vaccine positive rechallenge
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: Information has been received from a nurse concerning a 13 year old female with no reported medical history who on 15-MAY-2007 was vaccinated with her first dose of GARDASIL (lot number not given) intramuscularly and on 6-DEC-2007 was vaccinated with her second dose of GARDASIL. The nurse reported that on 15-MAY-2007 the patient developed a fever of 101 degrees Fahrenheit and also had a knot in her arm at the injection site after receiving the first and in December 2007 developed a fever of 101 degrees Fahrenheit and also had a knot in her arm at the injection site after receiving the second dose. The patient outcome was unknown at the time of reporting. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/14/2008. Information has been received from a nurse concerning a 11 year old female student with no reported medical history who on 15-MAY-2007 was vaccinated with her first dose of GARDASIL (LOT#654369/0961F) intramuscularly to the right deltoid and on 6-DEC-2007 was vaccinated with her second dose of GARDASIL (LOT# 658556/1050U) intramuscularly to the left deltoid. There were no illnesses reported at the time of vaccination. The nurse reported that on 15-MAY-2007 and 06-DEC-2007, following vaccination with GARDASIL, the patient developed a fever of 101 degrees farenheit and also had a knot in her arm at the injection site. The patients outcome was unknown at the time of reporting. No product quality complaint was involved. Additional information has been requested.

VAERS ID:307743 (history)  Vaccinated:2008-02-18
Age:12.0  Onset:2008-02-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 24
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA04624
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
TDAP: TDAP (ADACEL)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a Nurse Practitioner concerning a 12 year old female on 18-FEB-2008 was vaccinated with the first dose of GARDASIL (lot # not reported). The patient also received MENACTRA (lot # not reported) and ADACEL (lot # not reported) "at the same time." On 18-FEB-2008, "shortly after receiving GARDASIL", the patient "was pale and felt lightheaded." On 19-FEB-2008, "the day after receiving the vaccines, she blacked out while taking a shower and was still very pale. She did not hurt herself when she blacked out." The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:307793 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA05334
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Injection site swelling, Pyrexia, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a healthcare worker concerning a 12 year old female who was vaccinated with her second dose of Gardasil (lot number not provided). Concomitant therapy included MENACTRA. Subsequently the patient experienced swelling at injection site, rash, fever and shortness of breath. The patient was reported to be recovering. No further information is available.

VAERS ID:307796 (history)  Vaccinated:2008-02-16
Age:12.0  Onset:2008-02-17, Days after vaccination: 1
Gender:Female  Submitted:2008-03-14, Days after onset: 25
Location:California  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA05492
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
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: Information has been received from a physician concerning a 12 year old female, who on 16-FEB-2008 was vaccinated with a first dose of Gardasil. Concomitant vaccinations included tetanus toxoid and meningococcal vaccine (unspecified). Over the weekend, within 24 hours post vaccination the patient experienced several episodes of dizziness, and one syncopal episode where she actually fainted. The patient returned to the office and the physician did not see any signs of dizziness at that point. It was reported that the patient did not require any emergency or prolonged health assistance. The patient recovered on an unspecified date. Additional information has been requested.

VAERS ID:307836 (history)  Vaccinated:2008-01-17
Age:12.0  Onset:2008-01-18, Days after vaccination: 1
Gender:Female  Submitted:2008-03-14, Days after onset: 55
Location:Mississippi  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory, unknown; upper GI series X-ray, unknown; urinalysis, unknown
CDC Split Type: WAES0802USA06098
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Laboratory test, Malaise, Nausea, Urine analysis, Vomiting, Weight decreased, X-ray with contrast upper gastrointestinal tract
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a consumer concerning her daughter, a 12 year old female with no medical history reported, who on 17-JAN-2008 was vaccinated with the first 0.5 ml dose of Gardasil. There was no concomitant medication. On 18-JAN-2008 the patient experienced sickness, nausea, vomiting, and weight loss. The patient missed ten days of school. The patient sought unspecified medical attention. Diagnostic laboratory tests included a blood test, upper GI and urinalysis but no results were reported. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:307852 (history)  Vaccinated:2007-08-02
Age:12.0  Onset:2007-08-02, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 225
Location:California  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA05219
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise, 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 02-AUG-2007 was vaccinated with GARDASIL (dose unspecified). On 02-AUG-2007 the patient experienced fever and felt ill. Subsequently, this lasted 48-72 hours. The patient sought unspecified medical treatment. No further information was provided. Additional information has been requested.

VAERS ID:307874 (history)  Vaccinated:2007-08-06
Age:12.0  Onset:2007-08-06, Days after vaccination: 0
Gender:Male  Submitted:2008-03-04, Days after onset: 211
Location:Pennsylvania  Entered:2008-03-17, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fexofenadine hydrochloride
Current Illness: Allergy
Preexisting Conditions: The subject has allergies to nickel and aluminum.
Diagnostic Lab Data: The subject''s blood pressure and glucose were checked and were normal.
CDC Split Type: A0669899A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB184AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0838U1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Blood glucose normal, Blood pressure normal, Dizziness, Hyperhidrosis, Hyperventilation, Muscular weakness, Pallor, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of dizziness in a 12-year-old male subject who was vaccinated with HAVRIX, GlaxoSmithKline. Concurrent vaccination included VARIVAX (Merck) given on 6 August 2007. Concurrent medications included Fexofenadine hydrochloride (Allegra). On 6 August 2007 the subject received 1st dose of HAVRIX at 0.5 ml in the right arm. A short time after vaccination with HAVRIX, as the subject was on his way to the car, he experienced dizziness, sweating, pallor, almost fainting and legs buckling. He returned inside the office and was watched and allowed to recline for two hours. He never lost consciousness. His blood pressure and glucose were normal. He also reported tingling hands most likely from hyperventilating. He was released after two hours. All events were resolved, with the outcomes of tingling hands and hyperventilation not specified. The events of dizziness, sweating and pallor were reported as possibly related to treatment with HAVRIX. Almost fainting and legs buckling was unrelated. Relationship of tingling hands and hyperventilation was not reported. Follow-up received on 20 September 2007 from the healthcare professional indicated that the events resolved.

VAERS ID:307917 (history)  Vaccinated:2007-11-09
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2008-03-04
Location:Minnesota  Entered:2008-03-17, Days after submission: 12
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: The subject had no relevant medical history. The subject had no adverse events following receipt of prior immunizations.
Diagnostic Lab Data: Unknown
CDC Split Type: A0695229A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Public     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of rash in a 12-year-old male subject who was vaccinated with HAVRIX, GlaxoSmithKline. It was assumed that HAVRIX was administered, the reporter was unclear whether the patient received HAVRIX or Hepatitis A vaccine (Merck). On 9 November 2007 at 11:00, the subject received 1st dose of HAVRIX (.5 ml, unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced a rash. The healthcare professional was notified on 14 November 2007 that the patient developed a rash. It was reported that the patient was going to be seen in the clinic for follow-up. The immunization series was delayed. At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was possibly related to vaccination with HAVRIX.

VAERS ID:307358 (history)  Vaccinated:2008-02-05
Age:12.0  Onset:2008-02-05, Days after vaccination: 0
Gender:Male  Submitted:2008-02-28, Days after onset: 23
Location:Mississippi  Entered:2008-03-19, Days after submission: 19
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: EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500500P0IN 
Administered by: Private     Purchased by: Public
Symptoms: Electroencephalogram, Loss of consciousness, Muscle contracture, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Patient was walking on a treadmill as he often does. Patient grabbed left side of chest and said "mama" and collapsed. He was unconscious and constricted. Incident happened on 2-5-08 about 5:30. Mother took to ER at 18:03. Accuv-102 et EEG.

VAERS ID:307570 (history)  Vaccinated:2008-03-17
Age:12.0  Onset:2008-03-19, Days after vaccination: 2
Gender:Female  Submitted:2008-03-20, Days after onset: 1
Location:Texas  Entered:2008-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Varicella (no brand name)~1~6~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2825AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1564U2SCLA
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: Red, swollen, hot to touch Augmentin XR one tablet p.o. BID x 7 days

VAERS ID:307709 (history)  Vaccinated:2008-02-27
Age:12.0  Onset:2008-02-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-03, Days after onset: 5
Location:Arizona  Entered:2008-03-21, 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: Hypotension
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Condition aggravated, Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: - Fainting; - Hypotension

VAERS ID:307993 (history)  Vaccinated:2008-02-21
Age:12.0  Onset:2008-02-21, Days after vaccination: 0
Gender:Male  Submitted:2008-03-24, Days after onset: 31
Location:California  Entered:2008-03-24
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
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB300AA IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB210AA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1309U SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2430AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA IMLA
Administered by: Public     Purchased by: Public
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: Patient had vaso-vagal reaction after receiving vaccinations

VAERS ID:308081 (history)  Vaccinated:2008-03-18
Age:12.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-18, Days after onset: 0
Location:Pennsylvania  Entered:2008-03-25, 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: Vitiligo
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253AA0UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.175700UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2568AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1797J0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Hypoaesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Patient got dizzy and felt like legs numb. Eyes closed and patient became syncopal. Patient vs stable. Drank juice and felt ok. Patient ambulated out of office.

VAERS ID:308127 (history)  Vaccinated:2008-03-24
Age:12.0  Onset:2008-03-24, Days after vaccination: 0
Gender:Female  Submitted:2008-03-25, Days after onset: 1
Location:North Carolina  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2354CA3IMLA
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:, Medication errors (narrow)
Write-up: Pt. had no adverse reaction

VAERS ID:308128 (history)  Vaccinated:2007-05-19
Age:12.0  Onset:2007-05-20, Days after vaccination: 1
Gender:Female  Submitted:2008-03-25, Days after onset: 310
Location:Pennsylvania  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN0IMLA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Menorrhagia, Vaccine positive rechallenge
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: My daughter received the Gardisil vaccine on May 19, 2007. The next day her menstrual cycle started and lasted 6 weeks. I called the doctor and they assured me it was just coincidence. She had the second booster on July 19, 2007. The following day, her menstrual cycle started again and lasted 4 weeks this time. Up to this date, she had always had regular cycles. We never went back for the final vaccination. She has had regular cycles since then.

VAERS ID:308158 (history)  Vaccinated:2008-03-24
Age:12.0  Onset:2008-03-24, Days after vaccination: 0
Gender:Male  Submitted:2008-03-25, Days after onset: 1
Location:Alabama  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2550AA UNGM
TDAP: TDAP (ADACEL)SANOFI PASTEURC276AA UNGM
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1916U SCLA
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea, vomiting, abd cramps. Pt given Pepcid OTC instructions.

VAERS ID:308218 (history)  Vaccinated:2008-03-19
Age:12.0  Onset:2008-03-20, Days after vaccination: 1
Gender:Female  Submitted:2008-03-21, Days after onset: 1
Location:Arizona  Entered:2008-03-26, 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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU255AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1568U2SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Edema with redness at Sub Q site.

VAERS ID:308281 (history)  Vaccinated:2008-03-02
Age:12.0  Onset:2008-03-21, Days after vaccination: 19
Gender:Male  Submitted:2008-03-26, Days after onset: 5
Location:Oregon  Entered:2008-03-26
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Local reaction, Pain
SMQs:
Write-up: Large local reaction to vaccine, presume pertussis component. Right armpit is very sore, difficult to move without pain.

VAERS ID:308423 (history)  Vaccinated:2008-03-05
Age:12.0  Onset:2008-03-05, Days after vaccination: 0
Gender:Male  Submitted:2008-03-27, Days after onset: 21
Location:Massachusetts  Entered:2008-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Pesticides- cause hives
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)
Write-up: According to mother on 3/5/08 evening, patient complained of nausea and was "exhausted". The next morning, 3/6/08, he complained about a "very bad" headache and "very sore" arm. Mom administered Ibuprofen on 3/6/06 & 3/7/08 for sypmtoms. All sypmtoms resolved by 3/9/08. No hives, rashes, breathing difficulties, vomiting, loss of consciousness or swelling occured. Mom reported to Health Department on 3/27/08.

VAERS ID:308598 (history)  Vaccinated:2008-02-15
Age:12.0  Onset:2008-02-15, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 41
Location:Idaho  Entered:2008-03-31, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA03696
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 1UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 12 year old female, who on 15-FEB-2008 was vaccinated IM with a third dose of GARDASIL. Concomitant suspect vaccination included the second dose of hepatitis A vaccine (inactive) (manufacturer unknown). On 15-FEB-2008 the patient passed out and had a seizure after administration of the vaccine. The patient was given a cold wash cloth, which was placed on her head. No laboratory diagnostics were performed. It was reported that the patient was fine before she left the office. The patient recovered on 15-FEB-2008. No product quality complaint was involved. Upon internal review the seizure was considered to be an other important medical event. Additional information has been requested.

VAERS ID:308617 (history)  Vaccinated:2008-03-25
Age:12.0  Onset:2008-03-27, Days after vaccination: 2
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:Arizona  Entered:2008-03-31, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1787U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Oedema peripheral, 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: Right arm swelling, erythema, tenderness, 3" diameter. Placed on warm compound for cellulitis.

VAERS ID:308687 (history)  Vaccinated:2008-03-14
Age:12.0  Onset:2008-03-15, Days after vaccination: 1
Gender:Female  Submitted:2008-03-18, Days after onset: 3
Location:Michigan  Entered:2008-04-01, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None - well child visit
Preexisting Conditions: Allergies: PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2565AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Decreased appetite, Headache, 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: Received immunizations on Friday. Menactra and Tdap. Began vomiting at 5 am Saturday morning. Headache and high fever lasting Saturday and Sunday. Decreased appetite, generalized weakness. Has had DTP, DTAP series as infant/ child - slowly getting better.

VAERS ID:308788 (history)  Vaccinated:2005-08-31
Age:12.0  Onset:2005-08-31, Days after vaccination: 0
Gender:Male  Submitted:2008-04-02, Days after onset: 945
Location:Arizona  Entered:2008-04-02
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Severe allergic reaction to Augmentin (see Box #19)~Measles + Mumps + Rubella (Virivac)~UN~1~In Patient
Other Medications: We were instructed to take Tylenol.
Current Illness: None were known at the time of vaccination.
Preexisting Conditions: Allergic to cow''s milk and tree nuts. Just months prior to MMR/Varicella vaccines, he had a severe allergic reaction to Augmentin resulting in severe hives/rash over his entire body. To treat it he was given a steroid injection of Hydroxyzine and given Prednisolone orally. He vomitted with Prednisolone and was then given Orapred.
Diagnostic Lab Data: Lab tests of his urine,stool, and blood reveal: Underlying mitochondrial disorder, severe cellular inflammation, and severe oxidative stress: moderate to High DNA and RNA oxidative damage, along with very high MDA oxidative damage. He also
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC)MERCK & CO. INC.0154R0IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0327R0IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Diarrhoea, Immediate post-injection reaction, Insomnia, Laboratory test abnormal, Mitochondrial cytopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: After his MMR/Varicella, he experienced immediate fever, continual crying episodes, severe, explosive, chronic diarrhea and ever since has NOT had a solid stool. He could not fall asleep unless he was held, in the swing, or driving in the car (required movement).

VAERS ID:308842 (history)  Vaccinated:2008-03-31
Age:12.0  Onset:2008-04-01, Days after vaccination: 1
Gender:Male  Submitted:2008-04-03, Days after onset: 2
Location:North Carolina  Entered:2008-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: same as patient~Varicella (Varivax)~2~11.30~Sibling
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Mild adverse local reaction to Varivax.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1918U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema induratum, Local reaction
SMQs:, Vasculitis (narrow)
Write-up: Inspection for rashes, lesions, ulcers -- Pt is having 1-2 cm erythematous induration on right deltoid area, where he received VARIVAX yesterday. No abscess.

VAERS ID:308885 (history)  Vaccinated:2008-03-31
Age:12.0  Onset:2008-04-01, Days after vaccination: 1
Gender:Male  Submitted:2008-04-02, Days after onset: 1
Location:Illinois  Entered:2008-04-03, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1496U1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Cellulitis
SMQs:
Write-up: Patient diagnosed with cellulitis of left arm - presented Keflex 500mg by PO BID x 10 days and to flu in 2 weeks.

VAERS ID:308945 (history)  Vaccinated:2008-04-01
Age:12.0  Onset:2008-04-01, Days after vaccination: 0
Gender:Female  Submitted:2008-04-04, Days after onset: 3
Location:California  Entered:2008-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U0IMLA
VARCEL: VARICELLA (VARILRIX)GLAXOSMITHKLINE BIOLOGICALS1497U0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Local reaction, Oedema, Pruritus
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: LOCAL REACTION R ARM W/REDNESS, ITCHINESS, ERYTHEMA/EDEMA AROUND SITE PATIENT LOOKS WELL NO FEVER NO CHILLS, DYSPIRGIA.

VAERS ID:308948 (history)  Vaccinated:2008-03-26
Age:12.0  Onset:2008-03-29, Days after vaccination: 3
Gender:Female  Submitted:2008-04-04, Days after onset: 6
Location:California  Entered:2008-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none PMH: cold s/s week before Family Hx: stroke, epilepsy, diabetes
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.C2767AA0IDRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2553AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1793U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Facial palsy, Headache, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)
Write-up: VACCINES GIVEN ON 3/26/2008. (MENACTRA, VARIVAX, ADACEL, GARDASIL. Patient Presented with Bells Palsy to ED on 3-29-08. Treated with Acyclovir and Prednisone. 4/22/08 Reviewed ER medical records from PCP of 3/29/08. FINAL DX: Bell''s Palsy Records reveal patient experienced left facial droop & numbness, HA, & unable to wrinkle forehead x 1 day. Tx w/antiviral, steroids, eye ointment & taping.

VAERS ID:308964 (history)  Vaccinated:2008-03-05
Age:12.0  Onset:2008-03-08, Days after vaccination: 3
Gender:Female  Submitted:2008-03-12, Days after onset: 3
Location:North Carolina  Entered:2008-04-04, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Developed submental lymph node enlargement and pain 72 hours after receipt of Gardasil on 3/18/05~HPV (Gardasil)~1~17.00~Sibling
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA, no food or environmental allergies. Has hx of eczema/patches of dry skin which appear when weather to cold. Denies seasonal allergic rhinitis. Hx of asthma as child - no longer uses any inhalers or meds.
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Military     Purchased by: Military
Symptoms: Rash erythematous, Rash papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 11 y/o WF dependent daughter developed fine erythemic pruritic papular rash on neck, chest and abdomen 72 hours after receipt of primary Gardasil vaccine and Tdap both given in right deltoid on afternoon of 03/05/08. Denies fever or malaise in temporal association with receipt of vaccines.

VAERS ID:309011 (history)  Vaccinated:2008-03-17
Age:12.0  Onset:2008-03-17, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 11
Location:Wisconsin  Entered:2008-04-07, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: ADHD
Diagnostic Lab Data: Nasal Xray Dx: nasal fracture
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Face and mouth X-ray abnormal, Facial bones fracture, Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Pt received imm inj per protocol, bandage was applied + clothing covered arm. Pt was sitting on exam table and talking after injection. Mother was in the room. Pt touched left deltoid approx 1 1/2 minutes, nurse disposing sharps when pt fainted & fell striking nose. Xray revealed nasal Fx, ENT consulted with splint.

VAERS ID:309117 (history)  Vaccinated:2008-03-29
Age:12.0  Onset:2008-03-30, Days after vaccination: 1
Gender:Male  Submitted:2008-04-01, Days after onset: 2
Location:California  Entered:2008-04-08, 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: Aggressive behavior & overweight
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2425AA0IMLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1944AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1578U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness on mid-section of R arm pt. c/o pain.

VAERS ID:309211 (history)  Vaccinated:2008-03-31
Age:12.0  Onset:2008-03-31, Days after vaccination: 0
Gender:Unknown  Submitted:2008-04-09, Days after onset: 9
Location:Michigan  Entered:2008-04-09
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 PASTEURU2402AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: FEVER FOR FOUR DAYS FOLLOWING IMMUNIZATION.

VAERS ID:309233 (history)  Vaccinated:2007-04-27
Age:12.0  Onset:2007-06-22, Days after vaccination: 56
Gender:Female  Submitted:2008-04-09, Days after onset: 292
Location:Unknown  Entered:2008-04-10, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2007-06-29
   Days after onset: 7
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Convulsion; Arrhythmia
Diagnostic Lab Data: electrocardiogram
CDC Split Type: WAES0804USA00429
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0250U1 LA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Arrhythmia, Brain death, Brugada syndrome, Cardio-respiratory arrest, Convulsion, Death, Electrocardiogram, Electrocardiogram QT prolonged, Headache, Life support, Rash
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Congenital and neonatal arrhythmias (narrow), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a consumer concerning her 12 year old daughter with a history of seizures and heart arrhythmias, who on 25-JAN-2007 was vaccinated with a first dose of Gardasil. On 27-APRIL-2007 the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included LAMICTAL, vitamins (unspecified) and KEPPRA. Subsequently, the patient began to have seizures, developed a rash on her arm, and was complaining about headaches. On 22-JUN-2007 the patient experienced a heart arrhythmia and was hospitalized. Due to the arrhythmia the patient was placed on life support and died on 29-JUN-2007. The patient''s mother reported that the patient had an electrocardiogram (EKG) about 5 years ago to test for prolonged QT syndrome. The test came back normal. It was reported that at that time the patient was in and out of the emergency room due to having seizures periodically. The patient had been seeing a neurologist and had not had any seizures for about two years until she received the second dose of Gardasil. The patient''s mother reported after her daughter''s death and burial she had received copies of her daughter''s medical records. Throughout the reports it showed that for the past five years the patient had prolonged QT syndrome, and proguda syndrome "which causes seizures and heart arrythmias." The patient''s cause of death was prolonged QT syndrome, brain death, and proguda syndrome. No product quality complaint was involved. The seizures, rash, headaches, heart arrythmias, prolonged QT syndrome, brain death, and proguda syndrome were considered to be other important medical events. Additional information is not available.

VAERS ID:309254 (history)  Vaccinated:2008-04-03
Age:12.0  Onset:2008-04-04, Days after vaccination: 1
Gender:Male  Submitted:2008-04-04, Days after onset: 0
Location:Ohio  Entered:2008-04-10, 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: Zyrtec, Nasonex
Current Illness:
Preexisting Conditions: Allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR42568AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.191641SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site induration, Injection site pruritus, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt came in for routine care 4/3/08. Was given two vaccines MCV4 and Varicella. Woke in AM w/ severe localized reaction. Checked by Dr in office. No fever, sl. induration, od itching. Benadryl Q4 hrs. Call if increase size or fever. The reaction was to Varivax.

VAERS ID:309379 (history)  Vaccinated:2008-04-08
Age:12.0  Onset:2008-04-09, Days after vaccination: 1
Gender:Male  Submitted:2008-04-12, Days after onset: 3
Location:Texas  Entered:2008-04-12
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: ADHD, Pediatric Overweight
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0797U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2541AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1777U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large local reaction of erythema, induration, and tenderness at varicella site (8 X 11 cm) and at Tdap site (5 X 3 cm).

VAERS ID:309451 (history)  Vaccinated:2008-04-08
Age:12.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Male  Submitted:2008-04-14, Days after onset: 6
Location:Nevada  Entered:2008-04-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None.
Preexisting Conditions: ADHD - evaluation only, not taking meds.
Diagnostic Lab Data: CAT scan and bloodwork at E.R. was unremarkable. Has follow-up appointment with neurologist on 4-22-08.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B016BA2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Familial risk factor
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Patient received his Tdap vaccination and within 5-10 minutes had a seizure. Mother witnessed the seizure and feels it lasted about 1 minute. Patient has no history of seizure activity, but Mother''s sister has a seizure disorder. Patient was examined at the emergency room that evening (CAT scan and bloodwork were unremarkable) and has a follow up appointment with a neurologist on 4-22-08. Patient attended school the following day.

VAERS ID:309466 (history)  Vaccinated:2008-03-26
Age:12.0  Onset:2008-03-28, Days after vaccination: 2
Gender:Male  Submitted:2008-04-10, Days after onset: 13
Location:New York  Entered:2008-04-14, 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: Vigamox started 3-26-08
Current Illness: Mild conjunctivitis vs. allergic conjunctivitis
Preexisting Conditions: Hypercholesterolemia
Diagnostic Lab Data: None performed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2582AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dermatitis allergic, Oedema peripheral, Rash pruritic
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient developed allergic, itchy rash with raised bumps, swollen hands and feet on 3-28-08. Rash did not start around eyes (on Vigamox since 3-26-08). Mother gave Benadryl. Rash gone when seen by Dr on 3-31-08 & then recurred through April 6, 2008.

VAERS ID:309475 (history)  Vaccinated:2008-04-08
Age:12.0  Onset:2008-04-11, Days after vaccination: 3
Gender:Female  Submitted:2008-04-19, Days after onset: 8
Location:Massachusetts  Entered:2008-04-14, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1364U1UNRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema, Skin discolouration, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Right arm quarter size area bright and red surrounded by light pink border. Slightly warm to touch. No streaking noted. Minimal edema.

VAERS ID:309638 (history)  Vaccinated:2008-03-13
Age:12.0  Onset:2008-03-14, Days after vaccination: 1
Gender:Female  Submitted:2008-03-14, Days after onset: 0
Location:Idaho  Entered:2008-04-16, Days after submission: 33
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: ID08015
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA0IMUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA052220IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1514U1SCUN
Administered by: Public     Purchased by: Private
Symptoms: Body temperature increased, Dizziness, Erythema, Oedema peripheral, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Morning after shots, clients R arm started with small redness & rash. Spread with soft swelling. Placed cold at site & gave ibuprofen. Temperature up to 102 degrees F. 48 hours after symptoms started, they resolved. Fever lasted only 24 hours. Dizziness 24 hours.

VAERS ID:309665 (history)  Vaccinated:2008-04-03
Age:12.0  Onset:2008-04-04, Days after vaccination: 1
Gender:Male  Submitted:2008-04-04, Days after onset: 0
Location:Ohio  Entered:2008-04-16, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, Nasonex
Current Illness:
Preexisting Conditions: Allergic Rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2568AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1916U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Induration, Local reaction, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient came in for routine care. 4/3/08 - was given two vaccines MCV4 and Varicella. Woke in AM w/severe localized reaction. Checked by Dr in office. No fever, slight induration, slight itching. Benadryl 1 q4hrs. Call if increase in size or fever.

VAERS ID:310438 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-14
Location:Maryland  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01556
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Hyperhidrosis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 12 year old female who was vaccinated on an unspecified date with her first dose of Gardasil (lot# not reported). Concomitant therapy included Varivax (duration and dose not reported). Other concomitant therapy included MENACTRA and Tdap. Subsequently the patient broke out into hives, became dizzy and started to sweat after receiving Gardasil. The patient was recovering. She sought unspecified medical attention. Additional information has been requested. Additional information was received. The nurse indicated that without a patient''s name she can not fill out the form. She was advised to call the MNSC, but they could not provide the patient''s name.

VAERS ID:310441 (history)  Vaccinated:2007-10-18
Age:12.0  Onset:2007-10-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 179
Location:Arizona  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Drug hypersensitivity
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01615
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from a physician concerning a 13 year old female with an allergy to Amoxil, who was vaccinated intramuscularly in the right arm on 18-Oct-2007 with Gardasil (lot# 658556/1060U). Concomitant medication included the influenza virus vaccine (unspecified) which was administered in her left arm on 18-Oct-2007 (lot Number U2443AA). Subsequently the patient experienced numbness in her arm for one to three months post vaccination. The patient sought unspecified medical attention. Follow up information revealed the pain is still lingering at the time of second dose, which is 2 months later. Additional information has been requested.

VAERS ID:310463 (history)  Vaccinated:2007-08-30
Age:12.0  Onset:2007-08-30, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 228
Location:New York  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01970
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.14267F0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Vaccine positive rechallenge, Vomiting
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 who on 30-AUG-2007 was vaccinated with her first dose of GARDASIL (lot number reported as "14267F"). Concomitant therapy included VARIVAX, VAQTA and MENACTRA. On 30-AUG-2007 the patient experienced nausea and vomiting which lasted for 2 days. On 18-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (lot number 659439/1267U) and she experienced nausea and vomiting which lasted for 2 days. Additional information has been requested.

VAERS ID:310654 (history)  Vaccinated:2008-01-09
Age:12.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 95
Location:Wisconsin  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 12/14/2007) Early sexual debut
Preexisting Conditions: Victim of abuse
Diagnostic Lab Data: Ultrasound - pregnant; ultrasound, 03/11/08, normal for dates: first trimester; beta-human chorionic, 02/??/08, pregnant
CDC Split Type: WAES0803USA03300
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Early sexual debut, Hyperemesis gravidarum, Injection site haemorrhage, Pregnancy with young maternal age, Ultrasound uterus
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a certified medical assistant, via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. The patient''s pregnancy was confirmed by an ultrasound (date not reported). She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, irregular spotting and bleeding was ongoing; the outcome of vomiting was not specified. The patient was seen at the physician''s office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2009. Initial and follow up information has been received from a certified medical assistant and a registered nurse, certified. Via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. There were no previous pregnancies. In February 2008, the pregnancy was confirmed by a pregnancy test, and on 11-MAR-2008, the patient had and ultrasound that was "normal for dates, placenta, amniotic fluid good." She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, the outcome of irregular spotting and bleeding and the outcome of vomiting was not specified. The patient was seen at the physician''s office, and was currently living in a treatment shelter. Additional information has been requested.

VAERS ID:310660 (history)  Vaccinated:2007-03-30
Age:12.0  Onset:2007-03-30, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 381
Location:Louisiana  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: asthma and allergies
Diagnostic Lab Data: Unknown. Labs and Diagnostics: ECG (+) tachycardia. Echo WNL. Holter monitoring (+) for tachycardia. No ectopy. TSH high with normal T4
CDC Split Type: WAES0803USA02848
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0960F1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthma, Blood thyroid stimulating hormone increased, Cardiac murmur, Chest pain, Dizziness, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Heart rate increased, Heart sounds abnormal, Palpitations, Tachycardia, Thyroxine free normal, Tremor, Upper respiratory tract infection, Vaccine positive rechallenge, Viral infection
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Vestibular disorders (broad), Hypersensitivity (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a company representative concerning a female who on 30-MAR-2007 was vaccinated with her first dose of GARDASIL (lot# unspecified) and experienced dizziness and chest pain. On 30-May-2007, the patient was vaccinated with her second dose of GARDASIL (lot# unspecified) and again experienced dizziness and chest pain. It was reported that the patient refused her third dose. At the time of this report the outcome was unknown. No further information was provided. Additional information has been requested. 4/29/2008 MR received from PCP for multiple OVs 3/30/07-3/18/08. First seen in F/u for ER visit 3/28/07 for viral infection. Elevated HR note in ER. DX: URI, ? Heart murmur. HPV#2 given 5/30/07. Seen 1 week later for URI and Tachycardia. ? Hypothyroidism. Seen again 6/13/07 with Tachycardia and palpitations. Refered to cardiology. Dx: Asthma 8/13/07. Seen again 2/15/08 for chest pain. DX: ? Esophagitis, ? Anxiety and 2/21/08 for dizziness and shaking. ? Anxiety. 5/22/08 Cardiac consult of 8/28/2007 recd with DX: Non-specific tachycardia, no evidence of arrhthmia or cardiac disease. Pt presented with c/o intermittent, brief heartrate increases which have occurred every week or 2 for the past few months. PE (+) for S3 at the apex in the supine position, otherwise WNL.

VAERS ID:310672 (history)  Vaccinated:2008-02-21
Age:12.0  Onset:2008-02-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 52
Location:Florida  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA03057
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Erythema, Familial risk factor, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 12 year old female who on 21-FEB-2008 was vaccinated intramuscularly in her left arm with a first dose of GARDASIL (Lot # unknown) and vaccinated subcutaneously in her left arm with a second dose of VARIVAX (Lot # unknown). Less than 24 hours later, on approximately 21-FEB-2008, the patient''s bicep became very painful and very red. She also experienced syncope and dizziness. It was also reported that the patient''s brother (WAES No. 0803USA03075) experienced similar symptoms with a 2nd dose of Varicella virus vaccine live. Outcome unknown. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:310687 (history)  Vaccinated:2008-03-12
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-14
Location:Unknown  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA02072
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Fall, Head injury, Nervousness, Syncope, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health professional concerning a 12 year old female who on 12-MAR-2008 was IM vaccinated with her first dose of Gardasil (lot number unspecified) in her deltoid of an unknown arm. Report states a 175 pound female client was vaccinated and felt weak post vaccination. Nurse observed client acted nervous during vaccination. When client arrived at her home, she fainted, broke out into hives and fainted again. When client fainted the second time she fell and hit her jaw. Client went to the Emergency room for unspecified medical attention. Additional information has been requested. Follow up information received from the physician indicated the patient also had shortness of breath. The emergency room ruled out reaction to the shot. Patient has history of hives when she gets excited. Additional information has been requested.

VAERS ID:310776 (history)  Vaccinated:2007-08-22
Age:12.0  Onset:2007-08-27, Days after vaccination: 5
Gender:Female  Submitted:2008-04-14, Days after onset: 231
Location:Texas  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhinitis allergic
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA02317
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a consumer concerning her 13 years old daughter who on approximately 30-AUG-2007 was vaccinated with her first dose of Gardasil (lot# unspecified). There was no concomitant medication. Approximately one week later the patient began experiencing dizziness and vomiting. It was reported that initially she experienced the dizziness and vomiting at least once a week and then once every couple of months. Unspecified medical attention was sought. At the time of this report, the patient was still recovering from her experience. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a physician and a consumer concerning her 12 years old daughter with allergic rhinitis and no known drugs allergies who on 22-AUG-2007 was vaccinated in the left deltoid with her first dose of GARDASIL (lot# 658222/0927U). Unspecified medical attention was sought when patient''s mother called the physician''s office on 27-Aug-2007 regarding the patient''s complaint of headache, nausea and dizziness. No additional information was provided. Additional information has been requested.

VAERS ID:310786 (history)  Vaccinated:2008-02-27
Age:12.0  Onset:2008-02-29, Days after vaccination: 2
Gender:Female  Submitted:2008-04-14, Days after onset: 44
Location:Illinois  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA02486
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.12661IMUN
Administered by: Other     Purchased by: Other
Symptoms: Vulvovaginal human papilloma virus infection
SMQs:
Write-up: Information has been received from a health professional concerning a female who on 27-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (lot # reported as "1266"). On 27-FEB-2008 the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil (lot # reported as "1266"). There was no concomitant medication. On approximately 29-FEB-2008, "about two weeks ago", the patient noticed that she developed vaginal warts. No other symptoms and treatment were reported. The patient sought unspecified medical attention during an office visit. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a certified medical assistant and a physician concerning a female who on 27-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # reported as "1266"). On 27-FEB-2008 the patient was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL (lot # reported as "1266"). There was no concomitant medication. On approximately 29-FEB-2008, "about two weeks ago", the patient noticed that she developed vaginal warts. No other symptoms and treatment were reported. The patient sought unspecified medical attention during an office visit. Additional information has been requested.

VAERS ID:310789 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-14
Location:New York  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA02753
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, No reaction on previous exposure to drug
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning an approximately 12 year old female who on unspecified date was vaccinated intramuscularly with the second dose of Gardasil (lot # unspecified). Date of 1st dose of Gardasil was not reported. Post vaccination the patient experienced pain at the injection site for approximately one month. The physician reported that the patient did not have this experience after the first dose. Subsequently, on unspecified date the patient recovered from the pain at the injection site. No further information was provided. Additional information has been requested.

VAERS ID:310969 (history)  Vaccinated:2007-09-05
Age:12.0  Onset:2007-09-05, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 222
Location:Kansas  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA04150
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0242U0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Nausea, Vaccine positive rechallenge
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a health professional concerning a female who on 05 SEP-2007 was IM vaccinated with her first dose of GARDASIL (654539/0242U). On 21-Nov-2007 the patient was IM vaccinated with her second dose of GARDASIL (lot number 654519/0742U). Subsequently the patient experienced nausea and dizziness after both doses. The patient sought unspecified medical treatment which included the patient''s mother calling the physician. Subsequently, the patient recovered from nausea and dizziness. Additional information has been requested. This is in follow-up to rep(s) previously submitted on 4/14/2008. On 01-Apr-2008 the patient reported receiving her third dose of GARDASIL (lot number 654540/1290U). Concomitant medication included vaccination with meningococcal ACYW conj vaccine (dip toxoid) on 05-Sep-2007. Follow up information clarified the initial discrepancy of the third dose date. It was also reported that when the patient received her third dose, she was placed in a supine position and the patient did not feel as if she were going to pass out.

VAERS ID:310974 (history)  Vaccinated:2008-01-17
Age:12.0  Onset:2008-01-17, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 87
Location:Texas  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Budesonide (+) Levalbuterol; Meningococcal Polysaccharide; Asmanex; Singulair
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA04164
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.2405AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a health professional concerning a 12 year old female with a history of asthma who on 17-JAN-2008 was IM vaccinated with her first dose of GARDASIL (lot number reported as "2405AA"). Concomitant therapy included SINGULAIR, MENINGOCOCCAL POLYSACCHARIDE VACCINE GROUPS A AND C COMBINED and ASMANEX. On 17-JAN-2008 the patient experienced numbness in lower extremities and myalgia in lower extremities. Subsequently, the patient recovered from numbness in lower extremities and myalgia in lower extremities at an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:309865 (history)  Vaccinated:2008-04-01
Age:12.0  Onset:2008-04-02, Days after vaccination: 1
Gender:Male  Submitted:2008-04-04, Days after onset: 2
Location:Massachusetts  Entered:2008-04-17, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pulmicort; Singulair
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1490U UNLA
Administered by: Private     Purchased by: Public
Symptoms: Local reaction, Oedema peripheral, Pyrexia, Rash pustular
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Had Varivax on 4-1 Now with fever and swelling; left arm swollen trice P 1cm pink approximately central red pustule - Local immunization reaction

VAERS ID:309899 (history)  Vaccinated:2008-04-16
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-16
Location:Wisconsin  Entered:2008-04-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB346AB2UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2543AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA0UNRA
Administered by: Private     Purchased by: Public
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: Patient fainted briefly recovered immediately, did not suffer injuries.

VAERS ID:310082 (history)  Vaccinated:2008-03-25
Age:12.0  Onset:2008-03-27, Days after vaccination: 2
Gender:Male  Submitted:2008-04-18, Days after onset: 22
Location:Ohio  Entered:2008-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clarinex, Nasonex and Albuterol IH
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2416AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.2746F1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient came in for follow-up for an 8cm x 11 cm 2 days after being vaccined with 4 vaccines. The area of redness was at the site where he had received a Varivax. Pt was advised by Dr. to use Tylenol/Motrin for pain and come back if no better.

VAERS ID:310334 (history)  Vaccinated:2008-04-18
Age:12.0  Onset:2008-04-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-21, Days after onset: 3
Location:Pennsylvania  Entered:2008-04-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: n/a
Preexisting Conditions: n/a
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain, Rash, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received vaccine on Friday, April 18, 2008 at around 1pm. By Friday evening, was a round, raised, hot bug-bite looking area. By Saturday, it was about the size of a 50 cent piece, painful, and very hot to the touch. We applied Cortisone cream and used ice on and off, but is still getting bigger. Doctor said to use Benedryl. Her sister had a similar yet more severe reaction to this vaccine on the same date.

VAERS ID:310385 (history)  Vaccinated:2008-04-11
Age:12.0  Onset:2008-04-12, Days after vaccination: 1
Gender:Female  Submitted:2008-04-14, Days after onset: 2
Location:Ohio  Entered:2008-04-21, 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: Benadryl/Ibuprofen (after reaction)
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.14480IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2563AA0IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.17861SCUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Approximately 4 1/2 cm diameter, redness/painful and tender area/edematous site of Varicella/Gardasil. ? if immunization reaction or cellulitis. Treatment - Clindanokin x 10 days. Return if worsen.

VAERS ID:310529 (history)  Vaccinated:2008-04-15
Age:12.0  Onset:2008-04-16, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Connecticut  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Seasonal allergies
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021CB0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Fatigue, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: H/A, fatigue, nausea, T 100.8 <24 after adm

VAERS ID:310584 (history)  Vaccinated:2008-04-17
Age:12.0  Onset:2008-04-18, Days after vaccination: 1
Gender:Male  Submitted:2008-04-22, Days after onset: 4
Location:Washington  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Left hand injury
Preexisting Conditions: Penicillin- Rash
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2562AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral
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: Patient was in office on 4/17 for visit and was noted to need Menactra vaccine. Patient given vaccine 4/17 and per parent report on Friday the 18th she noted swelling to the left arm. Saturday the 19th of April parent took child to ER to be evaluated for swelling. Swelling approx 2 inches and redness from elbow to shoulder of left arm. Seemed to improve after Benadryl given. Then given Benadryl Q 4 hours X 24+ hours. Was seen for follow up appointment on 4/22 and was recovered.

VAERS ID:310600 (history)  Vaccinated:2008-04-16
Age:12.0  Onset:2008-04-17, Days after vaccination: 1
Gender:Female  Submitted:2008-04-16, Days after onset: 1
Location:New Jersey  Entered:2008-04-22, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data:
CDC Split Type: NJ200801
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U2IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash, Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hive-like lesions developed after the patient''s 3rd Gardasil injection. She states that the lesions began around her injection site on her (R) arm and spread out throughout her body

VAERS ID:310697 (history)  Vaccinated:2008-03-26
Age:12.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 19
Location:Unknown  Entered:2008-04-23, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA04651
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IJUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
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 concerning a "12 year old" female with no known drug allergies and known drug allergies and no past medical history who on 26-MAR-2008 was vaccinated with her first of three doses of GARDASIL (lot# unspecified, sit not reported.). Concomitant therapy included MENACTRA. The physician reported that the patient fainted after receiving the vaccination. Subsequently, the patient recovered. No additional information was provided. Additional information has been requested. Follow-up information received from the office worker on 12-May-2008 indicated that she was unable to identify the patient who had this event. No additional information is expected.

VAERS ID:310824 (history)  Vaccinated:2008-04-15
Age:12.0  Onset:2008-04-16, Days after vaccination: 1
Gender:Male  Submitted:2008-04-21, Days after onset: 5
Location:Ohio  Entered:2008-04-24, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: ADHD
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2569AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Headache, Injection site erythema, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Menactra and Adacel given 4/1508. Slight T-100 on 4/16. Slight headache. 4/17/08 Redness injection site - pain with movement of arm. Redness about 10cm in diameter. No fluctuance at site

VAERS ID:311016 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-23
Location:Pennsylvania  Entered:2008-04-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD
Current Illness: Well child exam
Preexisting Conditions: Asthma, ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2565AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2730AA0IMLA
Administered by: Public     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: Left arm red, swollen, painful size of a silver dollar, denies SOB, or itching-per nurse at home

VAERS ID:311079 (history)  Vaccinated:2008-01-16
Age:12.0  Onset:2008-04-25, Days after vaccination: 100
Gender:Female  Submitted:2008-04-28, Days after onset: 3
Location:Wyoming  Entered:2008-04-28
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: 5/5/08-records received-Accucheck 386-4/28/08-A1C $g14. krk
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U2UNUN
Administered by: Private     Purchased by: Public
Symptoms: Blood glucose increased, Diabetes mellitus, Glucose urine present, Glycosylated haemoglobin increased, Otitis media, Visual disturbance
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)
Write-up: 4/28/08 random BS 386, urine $g 1000 mg/dl glucose 05/05/08-records received-seen in office 3/5/08-C/O LOM. Next visit 4/25/08-feels well however C/O vision problems, 20/40. DX: Diabetes

VAERS ID:311235 (history)  Vaccinated:2008-04-24
Age:12.0  Onset:2008-04-24, Days after vaccination: 0
Gender:Male  Submitted:2008-04-29, Days after onset: 5
Location:Utah  Entered:2008-04-29
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: Possible Aspergers and ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB221UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2571AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Abnormal dreams, Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient complained of dizziness, vivid dreams, and headache.

VAERS ID:311309 (history)  Vaccinated:2008-04-15
Age:12.0  Onset:2008-04-15, Days after vaccination: 0
Gender:Male  Submitted:2008-04-23, Days after onset: 8
Location:Delaware  Entered:2008-04-30, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB264BA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1797U1SCRA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Eye irritation, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Corneal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Burning, itching, swelling, redness

VAERS ID:311319 (history)  Vaccinated:2008-03-12
Age:12.0  Onset:2008-03-13, Days after vaccination: 1
Gender:Female  Submitted:2008-04-30, Days after onset: 48
Location:Indiana  Entered:2008-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1791U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2 inch red and swollen area of right arm. Hot to touch. No immobility noted or voiced.

VAERS ID:311481 (history)  Vaccinated:2008-04-16
Age:12.0  Onset:2008-04-16, Days after vaccination: 0
Gender:Female  Submitted:2008-04-24, Days after onset: 8
Location:New Jersey  Entered:2008-05-02, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No; Mother states patient has had 3 episodes of similar incident occurring with medical procedures over the period of her life.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1586U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Gaze palsy, Headache, Opisthotonus, Posturing, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: As per MD who administered vaccines, pt fainted ~1 minute after 3 vaccines had been administered. MD called for me and I saw the patient who was in a chair. Her back arched back. Eyes open & rolled back was unresponsive & noted tonic posturing of her left hand. PT became awake & oriented after being assisted to floor. Episode lasted <1 minute. Pt was given soda (had no breakfast) and released to mother''s care upon becoming fully awake/alert/oriented. Mom reported patient had headache x24H following the incident (follow-up phone call x 9 days after).

VAERS ID:311637 (history)  Vaccinated:2008-04-24
Age:12.0  Onset:2008-04-24, Days after vaccination: 0
Gender:Male  Submitted:2008-05-05, Days after onset: 11
Location:Texas  Entered:2008-05-05
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: HIV, asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient complained of headache and dizziness for approximately 14 hours after receiving the vaccine. Patient was observed for 4 hours in the emergency department that evening, but no intervention except ibuprofen was given. Symptoms resolved subsequently.

VAERS ID:311641 (history)  Vaccinated:2008-04-10
Age:12.0  Onset:2008-04-11, Days after vaccination: 1
Gender:Female  Submitted:2008-05-05, Days after onset: 24
Location:California  Entered:2008-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Denies any
Preexisting Conditions: Denies any
Diagnostic Lab Data: On 4/25 she went to her PMD. On 4/29 she had an xray and ultrasound. These test were negative. On 5/6/08 she is getting a bone scan. Labs and Diagnostics: Venous duplex studies (-). X-ray of hip, knee, and ankle (-). Arterial duplex
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0930U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody increased, Arthralgia, Bone scan normal, Femoral pulse abnormal, Full blood count normal, Gait disturbance, Groin pain, Laboratory test normal, Oedema peripheral, Pain in extremity, Pallor, Peripheral coldness, Skin discolouration, Tenderness, Ultrasound Doppler normal, Ultrasound scan normal, Weight bearing difficulty, X-ray normal
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: The morning after her injection she woke up complaining of upper right leg pain, near the groin area where the leg bends. No fever or reddness.Two days later the pain extended down to the knee, and by a week and a half later the pain extended down to the foot. She was also experiencing swelling of the leg and blanching of the skin accompanied by her leg getting cold to touch. Her right leg is painful to touch and she can not tolerate weight bearing. After a day at school the leg is very painful and swollen.So far nothing seems to help, heat, ice, elavating the leg,or vicodin. So she takes extra strength tylenol for the pain. 5/28/2008 MR received from PCP for 2 OVs dated 4/29/08 and 5/02/08 with DX: R leg pain and R leg pain now with absent femoral pulse. Pt presented with c/o of R leg pain which began 1 day s/p HPV vax. Initially started in the groin, then moved distally to the thigh and knee, and now to the ankle over the course of several weeks. Pt was unable to walk for several days but is ambulating with crutches. Pt reports occasional swelling and purplish skin discoloration. PE (+) for pain and tenderness to touch and with hip and ankle flexion and. extension. RTO 3 days later with worsening pain and now coldness of the R lower extremity as well as the purple color. PE (+) for purple discoloration and cool to touch especially in the calf area. No palpable femoral pulse. Concern for acute arterial obstruction. DDx spinal nerve impingement, bony abnormality, RSD.

VAERS ID:311646 (history)  Vaccinated:2008-05-01
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-05
Location:Unknown  Entered:2008-05-05
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.0384U0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: After receiving injection pt. walked out of room and started feeling dizzy and passed out on the floor. Pt. eyes were open and pt. was alert. Pt states felt very lightheaded. Went into room and laid on the table s/p check. Pt. remained on table x 30 min. Discharged in stable condition.

VAERS ID:311689 (history)  Vaccinated:2007-10-08
Age:12.0  Onset:2008-02-04, Days after vaccination: 119
Gender:Female  Submitted:2008-05-05, Days after onset: 90
Location:Iowa  Entered:2008-05-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory, results unknown; diagnostic laboratory, 02/18/08, head, ears, eyes, nose, throat (HEENT)-within normal limits; blood pressure, 02/18/08, 106/6; serum Epstein-Barr, 02/18/08, negative; body weight measurement, lost 6-10 pounds; throat culture, 02/04/08, strep ID-negative; complete blood cell, 02/18/08, normal
CDC Split Type: WAES0804USA02241
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Acute sinusitis, Balance disorder, Blood pressure, Culture throat negative, Dizziness, Ear, nose and throat examination normal, Epstein-Barr virus test negative, Fatigue, Full blood count normal, Headache, Hypotension, Laboratory test, Lethargy, Nasal congestion, Oral intake reduced, Pharyngitis, Pharyngolaryngeal pain, Sinus headache, Somnolence, Streptococcus identification test negative, Vertigo, Viral infection, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Initial and follow-up information has been received from a physician concerning a 12 year old female, who on 23-JUL-2007 was vaccinated with her first dose of Gardasil (lot# 658094/0524U). Concomitant vaccination included Tdap (Lot# AC5213018A13). On 08-OCT-2007 the patient was vaccinated with her second dose of Gardasil (lot# 658558/1061U). On 04-FEB-2008 the patient was seen in the office and complained of a sore throat, headache, and stomach ache. The patient was diagnosed with acute pharyngitis. The physician believed the pharyngitis to probably be viral, but would follow culture to 48hours. The strep ID was negative. The patient was given information on how to treat and what to watch for. On 18-FEB-2008 the patient was seen at the office with complaints of dizziness/vertigo, severe headache, and felt "off balance." The patient was diagnosed with fatigue, lethargy, and a headache. The patient also experienced weight loss. The patient''s head, ears, eyes, nose, and throat (HEENT) was within normal limits, complete blood count (CBC) was normal, serum Epstein-Barr virus antibody test was negative, and blood pressure was 106/60. The patient appeared to be recovering from viral illness. The physician discussed low blood pressure with the patient. The patient was reminded to stand up slow, eat a healthy diet and to call if signs and symptoms worsened or did not improve. On 25-FEB-2008 the patient was seen in the office with complaints of headache, dizziness, and a decrease in oral intake with a 6-10 pound weight loss over the week. The patient''s mother reported that the patient has been sleepy during the week. The patient experienced nasal congestion, and mild pain over frontal sinuses. The patient was diagnosed with headache and acute sinusitis. The patient was prescribed ZITHROMAX TRI-PAK. It was reported that the headache was gone. The patient was advised to take antibiotic with chocolate milk or a meal to help with the upset stomach and to continue the ZITHROMAX TRI-PAK and call with any other problems. On 29-FEB-2008 it was reported that the patient''s sinuses were not better. The patient was prescribed amoxicillin 500mg by mouth for 10 days. On 10-MAR-2008 the patient''s mother reported to the office that the patient''s headache continued. The patient was told to come to the office the next day. On 11-MAR-2008 the patient was seen at the office with continued headache. The patient also experienced a sore throat in the AM, congestion, upset stomach, was very tired, and was losing weight. The patient was currently being treated with amoxicillin and the sinusitis was not any better. The patient was prescribed CEFTIN 250mg 2x daily for 10 days and to continue another 10 days if better. She had unspecified lab tests and the results were unknown. It was reported that the patient''s mother has been researching on the internet and feels that there is a relationship between the symptoms and the possible side effects of the vaccine. She was last seen by the office on 11-MAR-2008 and the patient''s outcome was not recovered (previously reported as was believed to be recovered). The acute pharyngitis, fatigue, headache, lethargy, and sinusitis were considered to be disabling and other important medical events. This is one of two reports from the same source. Additional information has been requested. Medical records are available upon request.

VAERS ID:311710 (history)  Vaccinated:2008-04-29
Age:12.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Male  Submitted:2008-05-02, Days after onset: 2
Location:Missouri  Entered:2008-05-06, 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: Singulair, ranitidine, Claritin
Current Illness: no
Preexisting Conditions: none known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2541AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Red rash, warm, slight swelling at injection site R deltoid meas-5 1/2cm x 7cm, oval. No wheeze. Tx: Medrol dose pack & Vistaril po.

VAERS ID:311753 (history)  Vaccinated:2008-04-28
Age:12.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-05-06, Days after onset: 8
Location:California  Entered:2008-05-06
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 (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Injection site warmth, Oedema peripheral
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: Returned to clinic four days post vaccination with right upper arm swollen and erythematous. Site warm to touch. Onset was evening of vaccination. Denies other symptoms: no fever, other rashes,no shortness of breath. States feels feel. Treated with Ice to site and benadryl.

VAERS ID:311757 (history)  Vaccinated:2008-05-05
Age:12.0  Onset:2008-05-06, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 0
Location:Washington  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: na
Current Illness: na
Preexisting Conditions: na
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0133X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2546AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 4 inch area of induration appeared in r arm. Skin or arm was not affected (no redness, warmth or drainage).

VAERS ID:311801 (history)  Vaccinated:2008-04-30
Age:12.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Male  Submitted:2008-05-01, Days after onset: 0
Location:New Mexico  Entered:2008-05-07, 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 known
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B023AA0 RA
Administered by: Other     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 05/01/2008 10:30 AM student c/o "high fever", took temp 101 degrees. Called mother and she came to get him.

VAERS ID:311904 (history)  Vaccinated:2008-05-06
Age:12.0  Onset:2008-05-07, Days after vaccination: 1
Gender:Male  Submitted:2008-05-08, Days after onset: 1
Location:Virginia  Entered:2008-05-08
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: PCN (allergic)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB233AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1997U1SCRL
Administered by: Public     Purchased by: Public
Symptoms: Pain, Skin disorder, Skin warm
SMQs:
Write-up: Right arm has large dark red area approximately 3 1/2 inches, very hot, & sore. Developed on 5-07-08

VAERS ID:311910 (history)  Vaccinated:2008-05-01
Age:12.0  Onset:2008-05-02, Days after vaccination: 1
Gender:Female  Submitted:2008-05-09, Days after onset: 7
Location:Unknown  Entered:2008-05-09
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U IM 
Administered by: Military     Purchased by: Unknown
Symptoms: Herpes zoster
SMQs:
Write-up: RASH ACROSS CHEST DIAGNOSED AS SHINGLES; ONSET OF RASH ONE DAY AFTER HPV #2.

VAERS ID:312194 (history)  Vaccinated:2008-05-06
Age:12.0  Onset:2008-05-07, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Massachusetts  Entered:2008-05-13
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1120U1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: L arm at site 4 cm2 red/warm. Local reaction.

VAERS ID:312222 (history)  Vaccinated:2008-04-30
Age:12.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Male  Submitted:2008-05-05, Days after onset: 4
Location:Illinois  Entered:2008-05-13, 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: Adderall, Melatonin; HGH; Strattera
Current Illness: None
Preexisting Conditions: ADHD; ASD Has had DTAP/DPT w/HIB w/o incident
Diagnostic Lab Data: Just did quick system review - WNL except c/o HA.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR 0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Activities of daily living impaired, Balance disorder, Dizziness, Gastrooesophageal reflux disease, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: C/O dizziness, nausea, reflux, severe HA, can''t stabilize self, had to be sent home from school, gave TYLENOL and laid down.

VAERS ID:312259 (history)  Vaccinated:2008-05-06
Age:12.0  Onset:2008-05-08, Days after vaccination: 2
Gender:Male  Submitted:2008-05-13, Days after onset: 5
Location:Pennsylvania  Entered:2008-05-13
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: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1917U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: swollen red pruritic area at the site of vaccine

VAERS ID:312376 (history)  Vaccinated:2007-08-20
Age:12.0  Onset:2007-08-20, Days after vaccination: 0
Gender:Female  Submitted:2008-05-15, Days after onset: 269
Location:Ohio  Entered:2008-05-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: ALLERGY TO CITRIC ACID
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB163AB0IMRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0227U0SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2338AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B007AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: DEVELOPED 2 SMALL HIVES AT PROQUAD INJECTION SITE. ICE PACK APPLIED. MOTHER SPOKE WITH PCP AND CHOSE NOT TO TAKE CHILD TO OFFICE OR ER.

VAERS ID:312409 (history)  Vaccinated:2008-05-07
Age:12.0  Onset:2008-05-09, Days after vaccination: 2
Gender:Female  Submitted:2008-05-09, Days after onset: 0
Location:Minnesota  Entered:2008-05-15, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: ADHD; Asthma; Seasonal allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1710U1IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1518U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Oedema peripheral, Skin warm, Swelling, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Severe swelling and tenderness (R) upper at tender arm and swollen.

VAERS ID:312855 (history)  Vaccinated:2007-08-02
Age:12.0  Onset:2007-08-02, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 286
Location:New Mexico  Entered:2008-05-19, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0804USA01706
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Private     Purchased by: Other
Symptoms: Amenorrhoea
SMQs:, Fertility disorders (broad)
Write-up: This is in follow-up to report (s) previously submitted on 5/14/2008. Information has been received from a physician concerning a 12 year old female with concomitant medications and pertinent medical history reported as unspecified, who on approximately 02-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot:634535/0960F). 0.5 ml IM. The second dose of GARDASIL was given on 02-APR-2008 (Lot # not reported). Following the first dose she did not get a period for 5 months (she has had her period since age 11). She sought the medical attention of a physician and her mother refused to allow her to take a pregnancy test. The outcome was unspecified. No product quality complaint was involved. Additional information has been requested. Followup information was received from the physician who reported that the patient had no mentrual cycle for 5 months from AUG-2007 until approximately JAN-2008. It was reported that she recovered in approximately JAN-2008.

VAERS ID:312862 (history)  Vaccinated:2007-01-30
Age:12.0  Onset:2007-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 469
Location:Massachusetts  Entered:2008-05-19, 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: WAES0804USA01787
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1447F0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Inappropriate schedule of drug administration, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a nurse concerning a 13 year old female student who on 30-JAN-2007 was vaccinated IM in the left arm with the first dose of GARDASIL (Lot # 655617/1447F). On 06-Apr-2007, the patient was vaccinated IM in the left arm with the second dose of GARDASIL (Lot # 656051/0244U) and on 18-MAR-2008, the patient was vaccinated IM in the left arm with the third dose of GARDASIL (Lot # 659964/1978U). On 30-JAN-2007 the patient passed out in the hallway after the first dose of the vaccine and was monitored until feeling better then allowed to leave. After the second dose the patient felt a little dizzy and sat in the office for 20 minutes. The patient was fine after the third dose and sat in the office for 20 minutes. Patient outcome was recovered. Additional information has been requested.

VAERS ID:312875 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Texas  Entered:2008-05-19, 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: WAES0804USA02103
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site oedema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 12 year old female who was vaccinated IM with the first 0.5 ml dose of GARDASIL. The patient developed pain, swelling, and edema at the injection site. Unknown medical attention was sought in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.

VAERS ID:312895 (history)  Vaccinated:2008-04-03
Age:12.0  Onset:2008-04-03, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 41
Location:Nevada  Entered:2008-05-19, 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:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Blood pressure, 04/03/08, 70/60; Blood presure, 04/03/08
CDC Split Type: WAES0804USA02473
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Immediate post-injection reaction, 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), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 12 year old female who on 03-APR-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (lot # not reported). Concomitant therapy included Tdap and MENACTRA administered "at the same visit" on 03-APR-2008. It was reported that as the patient started to leave the office she felt lightheaded. She sat down and fainted and shortly "came around". The physician reported that this occurred around 3:00 in the afternoon and the only thing the patient had consumed that day was a soda and a glass of milk. The patient recovered and left the office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/10/2008. Initial and follow up information has been received from a physician and an unspecified reporter concerning a 12 year old female who on 03-APR-2008 was vaccinated intramuscularly in the upper left arm with a 0.5 mL first dose of GARDASIL (lot # 660389/1968U). Concomitant therapy included MENACTRA administered "at the same visit" on 03-APR-2008. Initially it was reported that as the patient started to leave the office she felt lightheaded. She sat down and fainted and shortly "came around". The physician reported that this occurred around 3:00 in the afternoon. In follow up it was reported that the patient fainted for a few seconds, had no loss of consciousness, 10 minutes after the shots were given. In follow up it was also reported that the shots were given at 5:10 pm and the adverse event onset was 5:15 pm. The patient''s blood pressure was 70/60 and the only thing the patient had consumed that day was a soda and a glass of milk. The patient was given MEDIALYTE SOLUTION) and her blood pressure went up. The patient recovered and left the office.

VAERS ID:313084 (history)  Vaccinated:2008-04-14
Age:12.0  Onset:2008-04-15, Days after vaccination: 1
Gender:Female  Submitted:2008-05-14, Days after onset: 29
Location:New Jersey  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA03581
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 12 year old female who on 14-APR-2008 was vaccinated with a third dose of GARDSIL (lot 3 not reported). Dates and lots of the previous two vaccinations were not reported. The physician reported that the patient''s "parent phoned the office on 15 or 16- APR-2008 to state the patient had experienced a rash at injection site." The patient sought unspecified medical attention during the phone call. A the of this report the patient had not recovered from the rash. Additional information has been requested. 1/5/10 follow up - injection site rash: Urticaria initial and follow up information has been received from a physician concerning a 12 yr old female student with seasonal allergies who on 16-apr-2008 (previously reported on 14-apr-2008) was vaccinated intramuscularly inton the right arm with a third dose of HPV 6 11 16 18 VLP vaccine. dates and lots of the previous two vaccinations were not reported. the physician reported that the patient''s parent phoned the office on 15 or 16 apr 2008 to state that the patient had experienced a rash at the injection site. the patient sought unspecified medical attention.

VAERS ID:313092 (history)  Vaccinated:2008-04-15
Age:12.0  Onset:2008-04-15, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 29
Location:Unknown  Entered:2008-05-19, 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: ORTHO EVRA; ALLEGRA
Current Illness:
Preexisting Conditions: Pollen allergy
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA03669
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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: Information has been received from a physician concerning a 22 year old female with history of pollen allergy who on 15-APR-2008 was vaccinated IM in the right upper arm with a 0.5 mL dose of GARDASIL (lot # 655327/1287U). Concomitant therapy included ALLEGRA and ORTHO EVRA. On 15-APR-2008 the patient experienced generalized hives and itching, as well as redness, tenderness and swelling at the injection site of the right arm, several hours after receiving the vaccine on 15-APR-2008. The patient called the office on 16-APR-2008 and reported that the hives had resolved but she still had generalized itchiness. No treatment was recommended. There was no laboratory test performed. The patient was reported to be recovering. Additional information has been requested.

VAERS ID:313240 (history)  Vaccinated:2008-02-22
Age:12.0  Onset:2008-02-22, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 81
Location:Illinois  Entered:2008-05-19, 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: None
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: allergy test, for yeast-results not reported
CDC Split Type: WAES00804USA04849
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a consumer concerning her 12 year old daughter with a penicillin allergy, who on 22-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot # 654272/0073x). There was no concomitant medication. On 22-FEB-2008, approximately one hour post vaccination, the patient developed hives or her legs. The patient sought unspecified medical attention. Diagnostic testing included testing for yeast allergy with no results reported. On 22-FEB-2008 the patient recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:313291 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Unknown  Entered:2008-05-19, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA06060
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Migraine
SMQs:
Write-up: Information has been received from a registered nurse concerning a 12 year old female with no medical history and no drug allergies, who "one month ago" was vaccinated with a first dose of GARDASIL. There was no concomitant medication. Subsequently, the patient experienced prolonged migraine headaches. The patient was seen by her physician. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:313320 (history)  Vaccinated:2007-10-04
Age:12.0  Onset:2008-01-01, Days after vaccination: 89
Gender:Female  Submitted:2008-05-14, Days after onset: 133
Location:Unknown  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0805USA00025
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Amenorrhoea
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from the agency (#2008023-2478662) from a nurse concerning an 11 year old female, who had reached menarche 8 months prior (approximately Nov-2006), who on 31-JUL-2007 was vaccinated with the first dose of GARDASIL, IM, (Lot # and dose not specified). On 04-OCT-2007 the second dose of GARDASIL, IM, (Lot # and dose not specified) was administered. On 07-FEB-2008 the third dose of GARDASIL (Lot #, dose and route not specified) was administered. The patient''s mother reports that the GARDASIL vaccinations caused her daughter to stop menstruating. It was unknown if the daughters periods were regular. The outcome of the event was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. Information has been received from the agency (#2008023-2478662) froma a nurse concerning a 13 year old female (weight 117 1/2, height 62"), who had reached menarche 8 months prior (approximately Nov-2006), who on 31-JUL-2007 was vaccinated with the first dose of GARDASIL vaccine (Lot # 658094/0924U), 0.5 mL, IM in the right arm. On 04-Oct-2007, the patient received the second dose of GARDASIL vaccine (Lot #658563/1063U), 0.5 mL, IM in the left arm. On 07-FEB-2008, the patient received the third dose of GARDASIL vaccine (Lot #658488/1264U), 0.5 mL, IM in the left arm. Concomitant medication was not reported. On 17-MAR-2008, the patient''s mother visited the physician''s office and discussed her concerns regarding GARDASIL vaccine going to cause long term problems according to "research" she had conducted on the internet. On 27-MAR-2008, the patient''s mother reported that her daughter has not had her period since January 2008 and this being caused by GARDASIL vaccine. On 21-APR-2008, the patient''s mother called again to report the patient still had not had her period. It was unknown if the daughter''s periods were regular. The patient was advised to be evaluated by an Ob-Gyn which she had and appointment for on 27-MAY-2008. At the time of the report amenorrhea persisted. Additional information is not expected.

VAERS ID:313334 (history)  Vaccinated:0000-00-00
Age:12.0  Onset:2008-04-01
Gender:Female  Submitted:2008-05-14, Days after onset: 43
Location:Unknown  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA00255
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hirsutism
SMQs:
Write-up: Information has been received from a physician concerning a 12 year old female who was vaccinated with all three 0.5 mL doses of GARDASIL (lot # not reported). After the third dose was administered a small growth of facial hair was noted under her chin within a month. The patient''s status was not reported. No laboratory diagnostic test was performed. No additional information is expected.

VAERS ID:313336 (history)  Vaccinated:2007-07-10
Age:12.0  Onset:2007-07-10, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 309
Location:Minnesota  Entered:2008-05-19, 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:
Current Illness:
Preexisting Conditions: Penicillin allergy
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA00263
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2455AA IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0360U0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0987F SCLA
Administered by: Public     Purchased by: Public
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 concerning a female (age not reported) who was vaccinated with the first 0.5 mL dose of GARDASIL (lot # not reported). On approximately 23-APR-2008 "last week" the patient fainted after getting the first dose of GARDASIL (lot # not reported). The patient recovered. Additional information has been requested. 10/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Follow up information was received on 19-JUN-2008. The registered nurse reported that the patient was vaccinated IM in the right deltoid with the first dose of GARDASIL (lot # 657617/0384U) on 10-JUL-2007. On the same day the patient was vaccinated SQ in the left arm with a dose of MMR II (lot # 654685/0987F), IM in the right deltoid with the first dose of VAQTA (lot # 657306/0360U) and IM in the left deltoid with a dose of DTAP (lot # C2455AA). It was reported that the patient fainted after given the first dose of GARDASIL. It was reported that it was the last shot given out of 4 shots. The registered nurse had the patient lie on her back on the exam bed. She fainted while sitting up and she came to right after. The patient recovered on 10-JUL-2007. The patient is allergic to amoxicillin. Additional information has been requested.

VAERS ID:312829 (history)  Vaccinated:2008-05-19
Age:12.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Male  Submitted:2008-05-19, Days after onset: 0
Location:Minnesota  Entered:2008-05-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Headaches 6/6/08-records received-PMH:headaches, seasonal allergies. Allergies cephalosporins cause hives.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2078BA  RL
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Dizziness, Feeling of body temperature change, Hypersensitivity
SMQs:, Angioedema (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Complained of dizziness, BG 103, states legs felt weak. Treatment: BENADRYL 50 mg PO. 6/6/08-records received for ER DOS 5/19/08-Assessment:Allergic reaction. C/O weakness all over, dizzy, felt hot and cold. Same symptoms that 10 other kids felt from same school.

VAERS ID:312832 (history)  Vaccinated:2008-05-19
Age:12.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Male  Submitted:2008-05-19, Days after onset: 0
Location:Minnesota  Entered:2008-05-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2078BA UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Chills, Dizziness, Feeling hot, Headache, Hyperhidrosis, Hypersensitivity
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: C/O dizziness, HA, weakness, hot - 30 min after immz. Trtmt. BENADRYL 50 mg po. 6/6/08-records received for ER visit DOS 5/19/08-Assessment:allergic reaction. C/O feeling weak all over, dizzy, chills and sweats. One of several children seen in ED from same school.

VAERS ID:312833 (history)  Vaccinated:2008-05-19
Age:12.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Female  Submitted:2008-05-19, Days after onset: 0
Location:Minnesota  Entered:2008-05-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU159BB UNRL
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Chills, Dizziness, Feeling of body temperature change, Hypersensitivity, Nausea, Stomach discomfort
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Complained of dizziness and chills and complained of upset stomach. Treatment BENADRYL 50mg PO. 6/6/08-records received-ER report for DOS 5/19/08-Assessment:Allergic reaction. C/O feeling hot and cold, dizzy, weakness all over, some nausea. Other kids in school started feeling same symptoms. Stable during entire ER visit.

VAERS ID:312834 (history)  Vaccinated:2008-05-19
Age:12.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Female  Submitted:2008-05-19, Days after onset: 0
Location:Minnesota  Entered:2008-05-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Exercise induced asthma 6/6/08-records received-PMH:asthma exercise induced.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2078BA UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Dizziness, Feeling of body temperature change, Hypersensitivity
SMQs:, Angioedema (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt c/o dizziness with hot & cold flashes at about 1015. Trtmt: BENADRYL 50 mg PO 3/4 hr. after injection. 6/6/08-records received for ER visit DOS 5/19/08-Assessment:allergic reaction. C/O dizzy, felt hot and cold flashes. Weak all over. One of several children from same school.

VAERS ID:312906 (history)  Vaccinated:2008-05-19
Age:12.0  Onset:2008-05-20, Days after vaccination: 1
Gender:Male  Submitted:2008-05-21, Days after onset: 1
Location:Massachusetts  Entered:2008-05-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1567U1UNLA
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain upper, Dizziness, Headache, Injection site erythema, Injection site swelling, Injection site warmth, 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), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: L upper arm redness, swelling warm to touch 2 days after receiving BOOSTRIX + VARIVAX to same arm. Swelling, redness started several hours after receiving vaccine. Last noc h/a, sa dizziness, fever yesterday - feeling fine today. Came in 5-21-08.

VAERS ID:313029 (history)  Vaccinated:2008-05-21
Age:12.0  Onset:2008-05-21, Days after vaccination: 0
Gender:Male  Submitted:2008-05-22, Days after onset: 1
Location:Wisconsin  Entered:2008-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted
Preexisting Conditions: none noted
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB256BA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1766U2SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Fall, Hypoaesthesia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Client received three vaccinations, minutes later fell to the floor and was observed to be having possible seizure activity. Monitored by staff for safety and breathing. pLaced in rescue position and 911 called. Continued to monitor client until EMS arrived. Cool cloth to forehead. Client c/o numbness to nose area after consciousness returned. Swelling to right cheek also noted.

VAERS ID:313157 (history)  Vaccinated:2008-05-19
Age:12.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Female  Submitted:2008-05-19, Days after onset: 0
Location:Minnesota  Entered:2008-05-23, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU159BA0UNUN
Administered by: Public     Purchased by: Public
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: crying

VAERS ID:313158 (history)  Vaccinated:2008-05-19
Age:12.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Female  Submitted:2008-05-19, Days after onset: 0
Location:Minnesota  Entered:2008-05-23, 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: None
Current Illness: See No 7
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1959BB0UNRL
Administered by: Other     Purchased by: Public
Symptoms: Chills, Dizziness, Feeling hot, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pale, felt faint, very warm, chills, symptoms lasting 30 minutes. Occurred 1/2 hour after injection.

VAERS ID:313161 (history)  Vaccinated:2008-05-19
Age:12.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Male  Submitted:2008-05-19, Days after onset: 0
Location:Minnesota  Entered:2008-05-23, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU159BA0UNUN
Administered by: Other     Purchased by: Private
Symptoms: Hyperventilation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad)
Write-up: hyperventilated-he stated "he was fine".

VAERS ID:313188 (history)  Vaccinated:2008-05-14
Age:12.0  Onset:2008-05-16, Days after vaccination: 2
Gender:Male  Submitted:2008-05-19, Days after onset: 3
Location:Indiana  Entered:2008-05-23, 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: Aspergers Disorder, ADHD, Depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB268EA0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0175X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Tender erythematous lesion posterior Rt upper arm. Deeply erythematous central area 4x5cm; Outer fainter erythema 7x10cm. No fluctuance noted.

VAERS ID:313231 (history)  Vaccinated:2008-05-21
Age:12.0  Onset:2008-05-22, Days after vaccination: 1
Gender:Male  Submitted:2008-05-23, Days after onset: 1
Location:Texas  Entered:2008-05-23
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1365U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Upper L arm with 12x12 cm area induration, warm, erythema. Tx: clindamycin.

VAERS ID:313570 (history)  Vaccinated:2008-03-05
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2008-05-16
Location:California  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: injection site rash~Varicella (Varivax)~2~10.00~Sibling|injection site rash~Varicella (Varivax)~2~7.00~Sibling
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA01974
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.659113/1360U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injection site rash
SMQs:, Hypersensitivity (narrow), Medication errors (narrow)
Write-up: This is in follow-up to report(s) previously submitted on 5/16/2008. Information has been received from a health professional concerning an approximately 12 year old male patient who on 25-APR-2000 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot number, dose, route unknown). On 05-MAR-2008, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U, dose, route unknown). Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown). On an unspecified date, the patient developed a localized rash at the injection site. The physician''s office was contacted regarding this experience. This is the third of three reports of rash with the same varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U). The patient recovered from injection site rash on an unspecified date. The caller requested a lot check for this lot number. There was no product quality complaint reported. A lot check has been requested. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.

VAERS ID:313661 (history)  Vaccinated:2007-07-25
Age:12.0  Onset:2007-08-15, Days after vaccination: 21
Gender:Male  Submitted:2008-05-16, Days after onset: 275
Location:Ohio  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA03943
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.657195/0366U0SC 
Administered by: Other     Purchased by: Other
Symptoms: Varicella, Varicella post vaccine
SMQs:
Write-up: Information has been received from a certified medical assistant concerning a who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Some time after receiving the vaccine the patient developed chicken pox. It was unknown whether medical attention was sought, the patient''s outcome was unknown. No product quality complaint was involved. This is one of two patients of same source. Additional information has been requested.

VAERS ID:313668 (history)  Vaccinated:2007-10-09
Age:12.0  Onset:2007-10-12, Days after vaccination: 3
Gender:Male  Submitted:2008-05-16, Days after onset: 217
Location:Oregon  Entered:2008-05-23, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA00591
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2443AA0IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.558432/1245U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a medical assistant concerning a 12 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658432/1246U). Subsequently the patient developed an injection site reaction described as in. There was no product quality complaint. Follow-up information was received which reported that on 09-OCT-2007 the 12 year old whThis report is one of several fite male patient with no pre-existing allergies, birth defects, medical conditions was vaccinated subsquently in in the left arm with the second dose of Varivax (lot #658432/1246U). On the same day the patient was also vaccinated with the first dose of FLUZONE (lot #U2443AA) intramuscularly in the right arm. On 12-OCT-2007 the patient rom the same sourc experienced injection site itch. This is one of several reports received from the same source.

VAERS ID:313677 (history)  Vaccinated:2007-08-23
Age:12.0  Onset:2007-08-24, Days after vaccination: 1
Gender:Male  Submitted:2008-05-16, Days after onset: 266
Location:Unknown  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0709USA04222
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site cellulitis, Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 12 year old male who on 23-AUG-2007 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck). On 24-AUG-2007 the patient developed a localized cellulitis rash at injection site. The patient sought unspecified medical attention. Subsequently, after therapy was stopped, the patient recovered. Therapy was not reintroduced. Additional information has been requested. The same physician also reported on the experience of the patient''s brother WAES# 0703USA04942.

VAERS ID:313687 (history)  Vaccinated:2008-02-22
Age:12.0  Onset:2008-02-22, Days after vaccination: 0
Gender:Male  Submitted:2008-05-16, Days after onset: 83
Location:Maryland  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA00364
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1781U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a health professional concerning a 12 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 659730/1781U). On 22-FEB-2008, the patient experienced injection site redness and swelling. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. Follow up information for the health professional indicated that on 22-FEB2008, the patient has developed a 2% inch hard red bump and swelling. Treatment was not reported.

VAERS ID:313703 (history)  Vaccinated:2007-05-25
Age:12.0  Onset:2007-05-25, Days after vaccination: 0
Gender:Female  Submitted:2008-05-16, Days after onset: 357
Location:Minnesota  Entered:2008-05-23, 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: Allergic reaction to antibiotics, Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: TEST - body temp - 06/??/07 - Low grade fever
CDC Split Type: WAES0710USA00403
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.654811/1260F1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Anorexia, Body temperature increased, Fatigue, Inappropriate schedule of drug administration, Influenza like illness, Malaise, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a licensed practical nurse concerning her 13-year-old white daughter with an allergy to amoxicillin and clavulanic Acid (AUGMENTIN) and azithromycin (ZITHROMAX) who in June 1995, was vaccinated subcutaneous with a first 0.5 ml do