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Case Details (Sorted by Vaccination Date)

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VAERS ID:311075 (history)  Vaccinated:2008-04-28
Age:11.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-28, Days after onset: 0
Location:Arizona  Entered:2008-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2571AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA IMRA
Administered by: Unknown     Purchased by: Unknown
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)
Write-up: After given series of shots, patient was found on the floor outside of bathroom and complaining of dizziness and fainting. Suspect Gardasil.

VAERS ID:311077 (history)  Vaccinated:2008-04-28
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-28
Location:Massachusetts  Entered:2008-04-28
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
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2354AA5IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None. Patient given wrong vaccine, not approved for over age 7 years.

VAERS ID:311078 (history)  Vaccinated:2008-04-28
Age:0.3  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-28, Days after onset: 0
Location:Massachusetts  Entered:2008-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lactulose
Current Illness: None
Preexisting Conditions: Chronic constipation
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B139AA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF345AC1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC575361IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.040801PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Patient given Pediarix/Hib/Prevnar and rotavirus vaccines about 10:30am. Within 1 hr, mother reports inconsolable crying that lasted for a total of 4.5hrs. She was able to sleep for 1 hr, but was crying for 4.5hrs. Not better with Tylenol at home. In office at 5pm; was crying inconsolably. Nl exam otherwise, afebrile. Given Tylenol again and by 5:45p, crying had ceased. Looked well.

VAERS ID:311211 (history)  Vaccinated:2008-04-28
Age:23.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-29, Days after onset: 1
Location:Illinois  Entered:2008-04-29
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
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB096AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSC2632AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Dizziness, Dysgeusia, Musculoskeletal stiffness, Nausea, Somnolence, Unresponsive to stimuli
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: Approx 8-10 min after vaccines administered client c/o nausea and dizziness, body became stiff with "seizure like" activity, was unresponsive but quickly became responsive, c/o "metal like" taste and "felt like she had just awakened from a nap." EMS was called and client was transported to the ED.

VAERS ID:311241 (history)  Vaccinated:2008-04-28
Age:29.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Male  Submitted:2008-04-29, Days after onset: 1
Location:Indiana  Entered:2008-04-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None; Hx of knee surgery
Preexisting Conditions: None
Diagnostic Lab Data: Dr did CBC and complete blood count in ER - all results were normal.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB520AA2UNLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Feeling abnormal, Full blood count normal, Hypoaesthesia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Within 2 minutes of getting shot, pt began to feel funny. Left arm felt numb, became light-headed, dizzy. After 1 hour vomited. No loss of consciousness or airway impairment. Wife picked him up from work and was seen in ER. Given fluids, Benadryl.

VAERS ID:311315 (history)  Vaccinated:2008-04-28
Age:3.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Male  Submitted:2008-04-30, Days after onset: 1
Location:Indiana  Entered:2008-04-30
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
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0874U0IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives on trunk, legs and face within 24 hours of the vaccine. No other known new or concerning exposures.

VAERS ID:311317 (history)  Vaccinated:2008-04-28
Age:11.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-30, Days after onset: 1
Location:North Carolina  Entered:2008-04-30
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA2IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2619AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 2" ROUND CIRCLE AROUND VACCINE AREA. IT IS HARD AND WARM TO THE TOUCH, ITCHING AND SWOLLEN RAISED ABOUT 1/2 INCH.

VAERS ID:311321 (history)  Vaccinated:2008-04-28
Age:6.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-30, Days after onset: 1
Location:California  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 (NO BRAND NAME)UNKNOWN MANUFACTURER1270U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: ON 4/30/2008 PATIENT WAS SEEN BY CLINIC FOR PHYSICIAN AND SCHOOL FORMS. RED SWOLLEN AREA (2 X 2 cm) NOTED ON PT''S LEFT ARM OUTER ASPECT. PT C/O ITCHING. AREA IS HOT TO THE TOUCH. MOTHER INSTRUCTED TO APPLY COLD COMPRESS FOR 10 MIN ON AND 10 MIN OFF FOR 1 HOUR TO RELIEVE SWELLING AND PROVIDE COMFORT TO PT. MOTHER STATED IT WAS FIRST NOTICED ON 4/29/2008.

VAERS ID:311328 (history)  Vaccinated:2008-04-28
Age:4.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-30, Days after onset: 1
Location:Unknown  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: Patient had no fever, no pain, no illness reported.
Preexisting Conditions:
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B049AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04743IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1236F1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1780U1SCLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Local reaction, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient had redness and swelling and warmth to touch of the left upper arm, 8cm x 10cm size. Patient had DTAP and Varicella vaccine on the left arm 2 days ago. Provider examined the arm, and instructed the Father of the patient that it is a local reaction and to treat with home care-Tylenol and cold compress. Patient had no fever, no pain, no complaints.

VAERS ID:311500 (history)  Vaccinated:2008-04-28
Age:4.0  Onset:2008-04-30, Days after vaccination: 2
Gender:Female  Submitted:2008-05-02, Days after onset: 2
Location:Michigan  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2607AA4IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01703SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0215X1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1917U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Mother called On 4/30 stating patient had a ping pong sized lump in area where injection was given. It was warm and red. Mom states she did not notice any reaction on Mondau or Tuesday.

VAERS ID:311539 (history)  Vaccinated:2008-04-28
Age:40.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Male  Submitted:2008-05-02, Days after onset: 4
Location:North Carolina  Entered:2008-05-02
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
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB116AA0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04900SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0147X0SCLA
RAB: RABIES (IMOVAX)SANOFI PASTEURA04831IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2938AA0IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA0446 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Feeling cold, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Severe chills, shaking uncontrollably. Temp spike102 deg, saw PCP: "felt very cold." No dizziness, nausea, headache.

VAERS ID:311558 (history)  Vaccinated:2008-04-28
Age:1.3  Onset:2008-05-03, Days after vaccination: 5
Gender:Male  Submitted:2008-05-04, Days after onset: 1
Location:New Jersey  Entered:2008-05-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI Sx''s
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0411U0SCRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC575433UNRL
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia, Rash maculo-papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Maculopapular rash on face trunk & legs fever 101.3 - 6 days after admin of vaccine.

VAERS ID:311575 (history)  Vaccinated:2008-04-28
Age:16.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-29, Days after onset: 0
Location:Pennsylvania  Entered:2008-05-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U1UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2938AA1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Skin hyperpigmentation
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: Hyperpigmentation with central blistering developed over the course of the day -$g pt was given topical spray anesthetic at time of vaccination - area consistent with area topical was sprayed.

VAERS ID:311586 (history)  Vaccinated:2008-04-28
Age:26.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-29, Days after onset: 0
Location:California  Entered:2008-05-05, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Nausea, Pyrexia, Restlessness
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea; Fever; Restlessness; Headache.

VAERS ID:311587 (history)  Vaccinated:2008-04-28
Age:22.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-30, Days after onset: 1
Location:Iowa  Entered:2008-05-05, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2688AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain upper, Chills, Nausea, Pyrexia, Retching
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 4-29-08 - 1:00 AM - Fever/chills. 4-29-08 - 8:00 AM - Nausea/chills, stomach cramping. Dry heaves - done at 10:00 AM. Fever gone at 8:00 PM on 4-29-08.

VAERS ID:311622 (history)  Vaccinated:2008-04-28
Age:5.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-30, Days after onset: 1
Location:California  Entered:2008-05-05, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2951BA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA11883IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0097X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pallor, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Onset redness and swelling on (R) deltoid at site of DTaP vaccine (#5) about 24 hrs after vaccine. No fever/ V/D/chills/exudate/resp distress. In clinic today, pat with 3 3/4" x 2" area erythema, warm, blanching, nontender, swollen on (R) deltoid. NO purulent fluid, no exudate.

VAERS ID:311623 (history)  Vaccinated:2008-04-28
Age:5.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-30
Location:Florida  Entered:2008-05-05, 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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2950AA4UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04943UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0265X1UNRL
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Mild edema with erythematous base irregular margins, warm slight tenderness no systemic manifestation i.e. no fever, no wheezs-tx''d as a cellulitis with Cephalexin and antipyretics.

VAERS ID:311632 (history)  Vaccinated:2008-04-28
Age:14.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-05-05, Days after onset: 6
Location:Pennsylvania  Entered:2008-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none other than stinging nettle for allergies
Current Illness: none
Preexisting Conditions: seasonal allergies
Diagnostic Lab Data: n/a
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Adnexa uteri pain, Arthralgia, Micturition urgency, Ovulation pain, Pelvic pain, Polyuria, Vaginal discharge
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: beginning on the afternoon after the 2nd Gardasil shot, pelvic and stomach pain, joint pain, vaginal discharge with fishy odor, slight bloody discharge 6/9/08-records received for DOS 4/28-5/08/08-received vaccination #2 on 4/28/08-on 5/3/08 C/O middleschmertz pain few days ago. Extremely bad cervical pain, blood tinged fishy odor. 5/5/08 episodic pain since second vaccination. C/O positive urine urgency, polyuria. Pain intermittent. Pelvic exam normal. Impression likely middleschmertz vs. ovarian cyst.

VAERS ID:311633 (history)  Vaccinated:2008-04-28
Age:55.0  Onset:2008-05-01, Days after vaccination: 3
Gender:Female  Submitted:2008-05-05, Days after onset: 4
Location:California  Entered:2008-05-05
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: DM, HTN, Hyperlipidemia, Hypothyriodism, Allergic Rhinitis
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Induration, Pain in extremity, Tenderness
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: 3 days after injection, started with increase of pain to the left upper arm with 8.5 x 11cm circular area of erythema surrounding 3 x 4cm induration, warm and tender to the touch. Treatment: Motrin 600mg BID and apply ice 10-15min intervals BID-TID. Cipro 500mg BID for 7days.

VAERS ID:311635 (history)  Vaccinated:2008-04-28
Age:9.0  Onset:2008-04-30, Days after vaccination: 2
Gender:Male  Submitted:2008-05-05, Days after onset: 5
Location:California  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: no known
Current Illness: none
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0092X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: L arm tender with blister, red, swollen 4x1 cm

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)
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:311762 (history)  Vaccinated:2008-04-28
Age:11.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Male  Submitted:2008-05-06, Days after onset: 8
Location:Colorado  Entered:2008-05-06
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2604AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Nausea, Oedema peripheral, Pain in extremity, Throat irritation, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 3/9/08 told by client that after school he was having a lot of pain in his left arm, it swelled up, he got nauseated and vomited, and his throat felt itchy. His parents took him to the ER. Parents Spanish speaking only. Client reported no treatment.

VAERS ID:311771 (history)  Vaccinated:2008-04-28
Age:72.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 7
Location:Michigan  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: calcium multivit, Evista, ASA, B100
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2294DA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 4/29 & 4/30 injection site warm, painful. 5/1 hives around injection site, itchy. Rx''d Benadryl, Tylenol or Advil.

VAERS ID:311825 (history)  Vaccinated:2008-04-28
Age:21.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-05-07, Days after onset: 8
Location:Maryland  Entered:2008-05-07
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: PCN; peaches
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2937BA IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB208AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U2IMLA
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD7352216 PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Lip swelling, Periorbital oedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Came to facility for travel consult 4/15/08; Went to Travel clinic 4/17 for Yellow Fever, Came to facility 4/29/08 had started Oral Typhoid 4/28/08 c/o right periorbital edema, no hives, no SOB. Advised to continue Oral Typhoid. Came to facility 5/5 c/o of Left peri-orbital edema, hives on right arm and left hip, with lip swelling. Denied SOB,wheezing, difficulty swallowing. Received 50 mg of IM benadryl, Epi-Pen, and started tappering dose of prednisone at 60 mg.Advised not to take last dose of Typhoid. Returned to facility 5/6 symptoms resolved

VAERS ID:311831 (history)  Vaccinated:2008-04-28
Age:5.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-05-07, Days after onset: 8
Location:New York  Entered:2008-05-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: singulair
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2798AA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0147-23SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1363U1SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Cough, Injection site swelling, Nasal congestion
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: cough, mother also stated that patient''s right arm sweeling on 4/29 after the shot on 4/28, didn''t check on 4/30, but worsed today no runy nose, + mild stuffy nose

VAERS ID:312021 (history)  Vaccinated:2008-04-28
Age:45.0  Onset:2008-05-01, Days after vaccination: 3
Gender:Female  Submitted:2008-05-02, Days after onset: 1
Location:Maine  Entered:2008-05-09, 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: Annual PE
Preexisting Conditions:
Diagnostic Lab Data: CBC
CDC 'Split Type': ME00408
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Fatigue, Feeling abnormal, Full blood count, Pain in extremity, Pruritus, Swelling, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Lt arm sore itchy redness 4-28-08 - making her feel weird - disconnected - very tired, felt like vomiting the other day. Redness and swelling now diminished somewhat.

VAERS ID:312138 (history)  Vaccinated:2008-04-28
Age:10.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-28, Days after onset: 0
Location:North Carolina  Entered:2008-05-12, Days after submission: 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: None
Diagnostic Lab Data: None
CDC 'Split Type': NC08055
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: At approximately 8:45 am-pt. brought into health center for Tdap shot- No contraindications and consent form signed and Tdap given. Due to pt''s age NCIR stated not valid.

VAERS ID:312177 (history)  Vaccinated:2008-04-28
Age:16.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-30, Days after onset: 2
Location:South Carolina  Entered:2008-05-13, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: increase temp, crying~Tdap (no brand name)~UN~11~In Sibling
Other Medications: Claritin prn
Current Illness: seasonal allergic rhinitis
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cold sweat, Fatigue, Headache, Injection site pruritus, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: c/o itchy at injection site and itchy all over, since left the office has had HA "between eyes", palms of hands clammy, and tired. Claritin given by mom

VAERS ID:312224 (history)  Vaccinated:2008-04-28
Age:1.3  Onset:2008-05-06, Days after vaccination: 8
Gender:Male  Submitted:2008-05-07, Days after onset: 1
Location:Wisconsin  Entered:2008-05-13, 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: None
Preexisting Conditions:
Diagnostic Lab Data: CBC with diff and lytes (ha 134, kr 3.6).
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B073AA3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1482U0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC547663IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature increased, Cough, Febrile convulsion, Full blood count, Nasal congestion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Elevated temperature 102.2 7 days after MMR. Had 1 febrile seizure, no sequelae. Also had an URI at the time of seizure with cough and nasal congestion.

VAERS ID:312226 (history)  Vaccinated:2008-04-28
Age:15.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-05-06, Days after onset: 8
Location:Florida  Entered:2008-05-13, 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: sinus infection, allergies
Preexisting Conditions:
Diagnostic Lab Data: CBC; CT; EKG
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U1UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Computerised tomogram, Electrocardiogram, Full blood count, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient was seen in office for sinus infection and allergies. Patient was administered GARDASIL and when patient left the office, she vomited and had a syncope episode. Mom took her to ER under direction of office. Vomited again.

VAERS ID:312461 (history)  Vaccinated:2008-04-28
Age:0.4  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-05-12, Days after onset: 14
Location:Tennessee  Entered:2008-05-16, 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: KEPPRA, vigabatrin
Current Illness: otitis media (acute)
Preexisting Conditions: tuberous sclerosis, history of seizures
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC213137AA1UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURDF295AA1UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC451501UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1828U1PO 
Administered by: Private     Purchased by: Other
Symptoms: Staring
SMQs:
Write-up: 4 mo. old female with tuberous sclerosis and history of seizures - had a staring spell approx. one hour after vaccination.

VAERS ID:313314 (history)  Vaccinated:2008-04-28
Age:11.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 16
Location:Arizona  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: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA06414
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning an 11 year old female who on 28-APR-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM in the arm. Concomitant therapy also given at the same office visit on 28-APR-2008 included MENACTRA, and "PTD" (unspecified). GARDASIL and "PTD" was given in the same arm. On 28-APR-2008, immediately after being vaccinated, the patient experienced syncope, nausea, and passed out. The patient was kept in the office for 30 minutes until her "high pressure went down". On an unspecified date, the patient recovered. Additional information has been requested.

VAERS ID:312711 (history)  Vaccinated:2008-04-28
Age:17.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Male  Submitted:2008-05-20, Days after onset: 22
Location:Georga  Entered:2008-05-20
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: Treated at Er Dx as Vasovagal reaction from injection
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0608F0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2416AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Chills, Depressed level of consciousness, Hypoaesthesia oral, Pallor, Syncope vasovagal, Vaccination complication
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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: 10 mins from recieving injection client became pale. ammonia used with minimum improvement, miminum respone to verbal stimuli c/o chilling and numbness to tongue Ems Called

VAERS ID:313003 (history)  Vaccinated:2008-04-28
Age:5.0  Onset:2008-05-03, Days after vaccination: 5
Gender:Male  Submitted:2008-05-06, Days after onset: 3
Location:Pennsylvania  Entered:2008-05-22, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: urticaria
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2935AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04743SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0868U1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1580U1SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 5 days after receiving vaccines, mother noticed hives starting on L thigh around the injection sites - pt was taken to medical center & was treated there.

VAERS ID:313180 (history)  Vaccinated:2008-04-28
Age:4.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-05-23, Days after onset: 24
Location:North Carolina  Entered:2008-05-23
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: Cedax - allergy; Hemangioma left arm
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2356BA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04743SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling, Pallor
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: 4/29/08 - Morning following vaccine, red and swollen at injection site. Decreased swelling with ice. 5/6/08 - Rt lateral upper arm with erythema, blanching, below initial injection site with "knot" at presumed site. Not tender. No warmth. Vertical rectangle 3-4in x 2 in.

VAERS ID:313218 (history)  Vaccinated:2008-04-28
Age:22.0  Onset:2008-05-08, Days after vaccination: 10
Gender:Male  Submitted:2008-05-26, Days after onset: 18
Location:Unknown  Entered:2008-05-26
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: Unknown birth defects - history of diaphragmatic hernia as newborn, tracheal stenosis, possible VSD, possible PDA. Pt had well-healed sternotomy incision. PMH: cardiac surgery as a NB. Congenital tracheomalcia. Diaphragmatic hernia/repair
Diagnostic Lab Data: EKG - anterior fascicular block. CK-MB<1, Myoglobin 39, troponin 0. CXR - staples in area of trachea. Pt had history of cardiac surgery as newborn - possible VSD, possible PDA, possible tracheal stenosis surgery. Labs and Diagnostics: Cardiac enzymes WNL. EKG (+) for anterior fasicular block, otherwise WNL. EKG with ST elevation and sinus arrhythmia. PFTs (+) for expiratory airflow obstruction. Hgb 17.3. Hct 52.4. TEE (+) for dilated coronary sinus. CT chest (+) for inner vessel nodularity in lungs.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A1IDLA
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase MB, Body temperature increased, Breath sounds abnormal, Bundle branch block left, Cardiac enzymes normal, Chest X-ray abnormal, Chest pain, Computerised tomogram abnormal, Dyspnoea exertional, Echocardiogram, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Erythema multiforme, Fatigue, Haematocrit increased, Haemoglobin increased, Malaise, Pericarditis, Polycythaemia, Pulmonary function test abnormal, Pyrexia, Rash, Rash papular, Troponin
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: Pt c/o chest pain and fever 10 days post-vaccination. EKG - anterior fascicular block (no old EKG for comparison. Hospitalized on ward in ship, enzymes remained normal throughout course of treatment. Treated with Motrin for presumed pericarditis. Pain resolved over 4 days, remained afebrile. PE - diffuse, multiformed papular rash, non-pruritic over trunk. 8/18/08 Email received with case summary included. Pt presented with chest pain 12 days s/p smallpox vax. Earlier he had developed an erythema multiforme reaction several days after the vax. 12/8/08 Additional MR received. Pt presented 5/9/08 with c/o substernal chest pressure and pain, dyspnea on exertion and erythma multiform rash. ST elevations noted on EKG. PE (+) for T= 100.3''F. DX: Pericarditis. Chest pain resolved w/in 24 hrs. F/U 6/18/08 with c/o increasing fatigue and SOB with exertion. Unable to complete daily exercises as before. Chest soreness follwing exercise. PE (+) for raspy airway sounds, otherwise WNL. Feeling tired and poorly. Polycythemia noted 7/14/08.

VAERS ID:313375 (history)  Vaccinated:2008-04-28
Age:0.2  Onset:2008-05-01, Days after vaccination: 3
Gender:Male  Submitted:2008-05-23, Days after onset: 22
Location:California  Entered:2008-05-27, 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: Unknown
Diagnostic Lab Data: None
CDC 'Split Type': WAES0805USA03400
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2951BA UNUN
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1622U UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUROF259AA UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0452 UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC63112 UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0209X0PO 
Administered by: Other     Purchased by: Other
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Information has been received from a physician concerning a 58-day-old male who on 28-APR-2008 was vaccinated orally with a first 2 ml dose of ROTATEQ (lot # 660597/0209X). Concomitant vaccines administered on 28-APR-2008 included a dose of ACTHIB (lot # OF259AA), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot # C2951BA), dose of PREVNAR (lot # C63112), a dose of IPOL (lot # A0452-2) and a dose of hepatitis B virus vaccine rHBsAg (yeast) (MSD) (lot # 657898/1622U). On 01-MAY-2008 the patient had a very small amount of blood in his stools one time only. The physician instructed the patient''s mother to observe the patient and to obtain a stool sample. The patient''s mother called the physician the following day and stated that the patient''s bloody stools had resolved. The patient''s mother canceled the patient''s stool sample and reported that the patient''s symptoms had resolved and the patient had recovered. No further symptoms. The patient sought medical attention via a phone call. There was no diagnostic labs performed. A product quality complaint was not involved. Upon internal review "blood in stools" was considered an other medically important event. Additional information has been requested.

VAERS ID:313736 (history)  Vaccinated:2008-04-28
Age:17.0  Onset:2008-05-01, Days after vaccination: 3
Gender:Female  Submitted:2008-05-27, Days after onset: 26
Location:Washington  Entered:2008-05-28, 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: ACCUTANE
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory, 05/01?/08 LABS: 5/1/08 LABS: Hgb 12.7 (L). AST 3(L). CT scan WNL.
CDC 'Split Type': WAES0805USA02970
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B06BAA UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U0UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC52B06BAA UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2604AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Aspartate aminotransferase decreased, Computerised tomogram normal, Dehydration, Haemoglobin decreased, Headache, Inappropriate schedule of drug administration, Laboratory test, Lip dry, Nausea, Pain, Pain in extremity, Pyrexia, Urine output decreased, Vomiting
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad)
Write-up: Initial and follow up information has been received from a physician and by telephone from a registered nurse (R.N.) concerning a 17 year old female patient who on 28-APR-2008 was vaccinated with a first dose of GARDASIL lot # 659180/1758U. Concomitant therapy included DTAP-IPV, MENACTRA and ACCUTANE. On 01-MAY-2008 the patient experienced severe headache and nausea and after getting the first injection and went to the emergency room (ER). The next day, on 02-MAY-2008 she went to her physician''s office and her physician sent her to the hospital. While at the hospital she was given Intravenous (IV) Fluids and narcotics for the pain. Unspecified laboratory blood work was done. In follow up telephone call to the office the nurse reported that there was no documentation regarding patient''s hospitalization. No additional information was provided. The patient was reported as recovered at the time of this report. Additional information has been requested. 8/15/08 Reviewed hospital medical records of 5/2/2008. FINAL DX: acute HA; fever; vomiting; & dehydration Records reveal patient experienced severe vomiting, HA, low grade fever & dehydration. Patient admitted to HA prior to vaccination & was on Accutane. Also had leg pain. Seen in PCP office where she could not stand w/o vomiting. Had been seen in ER on 5/1 as well w/decreased urine output & dry lips. Tx w/IVF & improved. D/C to home on same day.

VAERS ID:314792 (history)  Vaccinated:2008-04-28
Age:5.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-30, Days after onset: 2
Location:California  Entered:2008-06-03, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC 'Split Type': CA080010
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B046AA3IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08733SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1216F2SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1772U2SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red swollen L upper arm. Ice packs/MOTRIN.

VAERS ID:316190 (history)  Vaccinated:2008-04-28
Age:15.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Male  Submitted:2008-04-29, Days after onset: 0
Location:Unknown  Entered:2008-06-13, Days after submission: 45
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 PASTEURU2582AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Body temperature, Headache, No reaction on previous exposure to drug
SMQs:
Write-up: Spoke with mother of 15 yo who states "took child to ER for c/o terrible headache. No nausea/vomiting slight temperature 99.4. Per mom has taken childhood immunizations OK in the past (still has not been seen by MD).

VAERS ID:316345 (history)  Vaccinated:2008-04-28
Age:21.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Male  Submitted:2008-06-17, Days after onset: 49
Location:Unknown  Entered:2008-06-17
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: unknown 7/14/08-records received-Penicillin allergy.
Diagnostic Lab Data: atypical chest pain: work-up completed per memorandum dtd 09 Jun 2003, Subj: Establishment of Case MAnagement Guidelines for Smallpox Vaccine Associated Myopericarditis. 7/14/08-records received-6/6/08-cardiac panel, ESR, EKG, chest x-ray and echo negative for myopericarditis.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERUNK0UNUN
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB195AB0UNUN
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERUNK0OTUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERA052220UNUN
Administered by: Military     Purchased by: Military
Symptoms: Cardiac enzymes normal, Chest X-ray normal, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Palpitations, Red blood cell sedimentation rate normal
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Patient started having chest pain with associated shortness of breath, the day after receivine smallpox vaccination. Symptoms are not dependant on level of activity. 7/14/08-records received-C/O shortness of breath on 4/28/08 started day after smallpox vaccine. Precordium chest pain with palpitations rarely with dyspnea and worse with bending over.Atypical chest pain. 6/20/08-improved with Prilosec. However, during a run felt palpitations and winded.

VAERS ID:316458 (history)  Vaccinated:2008-04-28
Age:69.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Male  Submitted:2008-06-12, Days after onset: 44
Location:Unknown  Entered:2008-06-17, 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: PMH includes- osteoarthritis, diverticulosis, peptic ulcer disease, allergic rhinitis, hyperlipidemia. Medications include- simvastatin 20 mg qhs, flurisolide nasal bid, MVI daily, ASA 326 mg daily, vitamin B/C complex daily
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0161X SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash, Secretion discharge
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient received ZOSTAVAX on 4/28/08 in left arm. On 4/29/08, patient developed rash. Rash first developed in the left inner arm by the elbow bend and later developed on the left abdomen to a lesser degree. The area on the arm was seeping. Patient denied pain, but the rash was seeping. Rash only developed on the left side. Patient was advised to use calamine lotion to the rash. Patient stated the calamine did not seem to help, and that the reaction needed to run its course. States it took several weeks to resolve. Symptoms: 1. SkinRash

VAERS ID:316586 (history)  Vaccinated:2008-04-28
Age:16.0  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 46
Location:Unknown  Entered:2008-06-19, 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: Unknown
Current Illness: Seasonal allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0805USA01442
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U IM 
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 16 year old female patient with seasonal allergies who on 28-APR-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (Lot #660387/1967U). On 28-APR-2008, the patient experienced hives all over. On 30-APR-2008, the patient recovered. Hives were considered to be an other important medical event. No further information is available.

VAERS ID:318012 (history)  Vaccinated:2008-04-28
Age:18.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-06-10, Days after onset: 42
Location:South Carolina  Entered:2008-07-01, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: V 20.2, Sinusitis
Preexisting Conditions: Nasal allergy only
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB264AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0387U0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Local reaction
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Local erythema less than 2 cm in diameter.

VAERS ID:318562 (history)  Vaccinated:2008-04-28
Age:0.2  Onset:2008-04-28, Days after vaccination: 0
Gender:Female  Submitted:2008-07-08, Days after onset: 71
Location:Kentucky  Entered:2008-07-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2355CA0UNRL
HEP: HEP B (FOREIGN)MERCK & CO. INC.1610U0UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF256AB0UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03010UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC547620UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1828U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Cried for 6 hours straight inconsolably at 2 months of age.

VAERS ID:319444 (history)  Vaccinated:2008-04-28
Age:65.0  Onset:2008-04-30, Days after vaccination: 2
Gender:Female  Submitted:2008-06-24, Days after onset: 55
Location:Unknown  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy, Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0805USA00313
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, 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 65 year old female with penicillin allergy and hypersensitivity to benzocaine, thimerosal, and quinine who on 28-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 ml subcutaneous (SC) (Lot # was not provided). Concomitant therapy included fexofenadine hydrochloride (ALLEGRA), spironolactone (ALEXAN (spironolactone), hydrochlorothiazide (HYDRAZIDE (hydrochlorothiazide)), atorvastatin calcium (LIPITOR) and potassium (unspecified). On 30-APR-2008 the patient experienced "an injection site after receiving Zostavax. The site was red, hard, swollen, three or four inches across, and itches". At the time of this report, the patient had not recovered. No further information is available. This is in follow-up to report (s) previously submitted on 6/24/2008. Additional information is not expected. The patient is not interested in pursuing this case.

VAERS ID:319472 (history)  Vaccinated:2008-04-28
Age:62.0  Onset:2008-05-01, Days after vaccination: 3
Gender:Male  Submitted:2008-06-24, Days after onset: 54
Location:New Jersey  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyroidism, Hypertension, Hypercholesterolaemia, Glaucoma; Thyroid cancer; Impaired fasting glucose
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0805USA00830
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0161X0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 62 year old male patient with hypothyroidism, hypertension, hypercholesterolaemia, glaucoma and no allergies who on 28-APR-2008 was vaccinated SC in the left arm with a dose of zoster vaccine live (Oka/Merck) (Lot # 659614/0161X). Concomitant therapy included hydrochlorothiazide, unspecified glaucoma drops and levothyroxine Na (SYNTHROID). On 01-MAY-2008 the patient experienced itching, redness, warmth and pain at the injection site. The patient was examined and prescribed cephalexin (KEFLEX), ice, ibuprofen (MOTRIN), and diphenhydramine hydrochloride (BENADRYL). The patient was instructed to call the physician if the symptoms persisted. The patient had not contacted the provider as of 05-MAY-2008. No additional symptoms or treatment were provided. No diagnostic laboratory tests were performed. As of this report, the patient was recovering. No product quality complaints were involved. Additional information has been requested. Follow up information was received from the physician concerning a 62 years old male patient, with thyroid cancer, hypertension, increased cholesterol, glaucoma and impaired fasting glucose, who on 28-APR-2008 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 659614/0161X). The patient developed a large area of erythema, induration, warmth and pain. The patient was placed on antibiotics because it resembled a severe cellulitis. At the time of the report, the patient recovered from the AEs. No diagnostic tests were performed. There was no illness at the time of vaccination. No further information is available.

VAERS ID:319107 (history)  Vaccinated:2008-04-28
Age:1.2  Onset:2008-07-03, Days after vaccination: 66
Gender:Male  Submitted:2008-07-15, Days after onset: 12
Location:Massachusetts  Entered:2008-07-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2354CA3IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0526U0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Varicella
SMQs:
Write-up: + chickenpox.

VAERS ID:319885 (history)  Vaccinated:2008-04-28
Age:14.0  Onset:2008-05-28, Days after vaccination: 30
Gender:Female  Submitted:2008-07-15, Days after onset: 48
Location:Unknown  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Papilloma viral infection
Preexisting Conditions: Genital wart
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA02876
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1424F0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Ataxia, Chemical poisoning, Gait disturbance, Intentional drug misuse, Musculoskeletal stiffness, Speech disorder, Trismus
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (narrow), Parkinson-like events (broad), Drug abuse and dependence (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad)
Write-up: Information has been received from a nurse practitioner concerning a 14 year old female with "high risk human papillomavirus", and a history of genital warts who on 28-APR-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot # 654885/1424F, site and route not reported). Concomitant therapy included "DOXY" (not otherwise specified). On 28-MAY-2008, also reported as "2 weeks before 11-JUN-2008", "the patient had trouble walking because of stiff legs and had trouble opening her jaw". When the patient relaxed on her bed, the symptoms went away, but when she started to walk again, the symptoms came back. The patient went to the emergency room and was released (not further specified). The patient outcome was not reported. No further information was provided. Additional information has been requested. Follow-up information. On an unspecified date, the patient presented to the clinic with ataxis and difficulty speaking. The patient was sent to the emergency room. The nurse practitioner stated the reaction "wasnt related to the vaccine". "The patient had taken her mother''s psychiatric medication, ABILIFY and drank some bleach." The patient received activated charcoal, recovered and discharged. When asked if this was a suicide attempt, the nurse practitioner stated "It was just a bunch of kids being kids." The patient took the medication and drank bleach with "a bunch of friends". There was "no adverse reaction to the vaccine". No additional information was provided. Additional information is not available.

VAERS ID:331379 (history)  Vaccinated:2008-04-28
Age:5.0  Onset:2008-10-31, Days after vaccination: 186
Gender:Female  Submitted:2008-10-31, Days after onset: 0
Location:Ohio  Entered:2008-11-05, 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: BENADRYL
Current Illness: varicella
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1659U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Varicella post vaccine
SMQs:
Write-up: Breakthrough varicella - has had 2 vaccines.

VAERS ID:334418 (history)  Vaccinated:2008-04-28
Age:0.3  Onset:0000-00-00
Gender:Male  Submitted:2008-11-21
Location:Michigan  Entered:2008-12-09, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Eczema; Spitting up
Preexisting Conditions: GERD; Bronchitis
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURUF105AB1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04741IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC391861IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1665U1PO 
Administered by: Other     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Dtap - HIB combo given before 15 months of age no side effects reported.

VAERS ID:336453 (history)  Vaccinated:2008-04-28
Age:11  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2009-01-05, Days after onset: 251
Location:Massachusetts  Entered:2009-01-05
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: MOLLUSCUM CONTAGIOSUM
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1512U SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Site of varicella vaccine swollen to the size of a half dollar, red and hot. Tender to the touch. No Shortness of Breath

VAERS ID:336938 (history)  Vaccinated:2008-04-28
Age:4  Onset:2008-04-30, Days after vaccination: 2
Gender:Female  Submitted:2009-01-09, Days after onset: 254
Location:Massachusetts  Entered:2009-01-09
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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2291BA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08723IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left arm where dtap and polio was given is red and warm to touch. Not painful. Moving fine, no fever, no other s/s illness

VAERS ID:337711 (history)  Vaccinated:2008-04-28
Age:11  Onset:2008-05-15, Days after vaccination: 17
Gender:Female  Submitted:2009-01-20, Days after onset: 250
Location:Louisiana  Entered:2009-01-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Her pediatrician has checked her vital signs, sent her for blood work, did an ultrasound on her heart, and a CT scan. All came back normal. Labs and Diagnostics: ECG WNL. Creatinine (L) 0.7. Head CT (-).
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2551AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B020AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1584U SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Balance disorder, Blood creatinine decreased, Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Loss of consciousness, Syncope, Ultrasound scan normal, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: I believe the symptoms started after the second dose. Patient has been having fainting spells where she gets dizzy and sees black with white spots and she loses her balance. It only lasts a few seconds. It has happened at least 25 times or more. 2/23/09 PCP rec received for OV 12/15/08 with c/o black-out episodes x several months. Sees "spots" then blacks out. Reported loses vision x 4-5 seconds with slow return. PE WNL. Sent for labs and testing.

VAERS ID:338586 (history)  Vaccinated:2008-04-28
Age:20  Onset:0000-00-00
Gender:Female  Submitted:2009-01-16
Location:Florida  Entered:2009-01-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA02593
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0052X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Information has been received from a healthcare worker concerning a 20 year old female patient with no pertinent medical history and with allergic reaction to CECLOR who on 28APR-2008 was vaccinated with the first dose of GARDASIL (lot# 655604/0052X), on 30-JUN-2008 was vaccinated with the second dose of GARDASIL (lot# 0152X) and on 10-Nov-2008 she received third dose of GARDASIL (lot# 0250X). Concomitant therapy included YAZ. It was reported that the patient was diagnosed with Bell''s palsy after receiving the third dose of GARDASIL. It was reported that the patient had not recovered at the time of the report. The patient sought medical attention with a different physician. Follow up information was received on 15-DEC-2008 from a medical assistant who stated that the patient went to the emergency room. Follow up information was received on 15-DEC-2008 from the medical assistant who stated that on 10-DEC-2008 went to the emergency room and diagnosed Bell''s palsy by the physician. Additional information has been requested.

VAERS ID:339270 (history)  Vaccinated:2008-04-28
Age:5  Onset:2009-01-22, Days after vaccination: 269
Gender:Male  Submitted:2009-02-04, Days after onset: 13
Location:West Virginia  Entered:2009-02-09, 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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB5401603UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0093X0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Varicella
SMQs:
Write-up: Chicken pox

VAERS ID:339771 (history)  Vaccinated:2008-04-28
Age:13  Onset:2008-10-26, Days after vaccination: 181
Gender:Female  Submitted:2009-02-09, Days after onset: 106
Location:Illinois  Entered:2009-02-18, Days after submission: 9
Life Threatening? No
Died? Yes
   Date died: 2008-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Bloodclot~HPV (Gardasil)~3~13~Patient
Other Medications:
Current Illness:
Preexisting Conditions: 5/7/09-records received-5/7/09-records received-office visit 4/21/00-evaluation for dehydration, vomiting, sore throat and febrile. Impression strep pharyngitis. 9/2/05-routine physical. Assessment:overweight. Office visit 1/4/08-C/O lump in neck noticed in 9/07. Intermittently hurts. Assessment:mild lymphadenopathy.
Diagnostic Lab Data: 3/9/09-records received-WBC 17.3.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U2UNUN
Administered by: Private     Purchased by: Private
Symptoms: Cardiac arrest, Cardiomegaly, Cough, Pulmonary embolism, Upper respiratory tract congestion, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad)
Write-up: She developed a pulmonary embolism after having 3 rounds of vaccine GARDASIL. She was a healthy, active teenager. 2/23/09-autopsy report received immediate cause:Massive pulmonary embolism. Mild cardiomegaly. Last several days C/O cough and congestion. 3/9/09-ED records received for DOS 10/26/08-presented in full cardiac arrest after suffering a full and prolonged cardiac arrest, aystole. Expired.

VAERS ID:342614 (history)  Vaccinated:2008-04-28
Age:17  Onset:2008-12-01, Days after vaccination: 217
Gender:Female  Submitted:2009-03-13, Days after onset: 101
Location:Michigan  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN 1.5/30
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic laboratory; "hormones" normal; Thyroid function test, normal; Serum prolactin test, normal.
CDC 'Split Type': WAES0902USA01507
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood prolactin normal, Headache, Laboratory test normal, Thyroid function test normal
SMQs:
Write-up: Information has been received from a certified medical assistant concerning a 17 year old female with asthma and no known drug allergies who on 06-AUG-2007, 15-OCT-2007 and 28-APR-2008 was vaccinated respectively with the first, second and third dose of GARDASIL, 0.5 mL, intramuscularly (dose 1 lot # 0927U, dose 2 lot # 658558/1061U, and dose 3 lot # 660387/1967U). Concomitant therapy included LOESTRIN (1.5/30). The medical assistant stated that the patient''s mother called the office on 27-JAN-2009 because her daughter had had a headache for 7 weeks. It was reported that the patient was evaluated by an unspecified neurologist who could not find anything wrong. Laboratory tests including "hormones", prolactin, and thyroid were normal. At the time of reporting, the patient had not recovered. Additional information has been requested.

VAERS ID:347808 (history)  Vaccinated:2008-04-28
Age:14  Onset:2008-04-29, Days after vaccination: 1
Gender:Male  Submitted:2009-05-15, Days after onset: 381
Location:California  Entered:2009-05-21, 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: mercaptopurine
Current Illness: Crohn''s disease; Immunosuppression
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0805USA05122
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1973U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Injection site pain, Injection site swelling, Nausea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a registered nurse concerning a 14 year old male with no allergies and with Crohn''s disease and who is immunocompromised as a result of taking 6 MP who on 15-MAR-1996 was vaccinated subcutaneous with a first dose of VARIVAX (Merck) and on 28-APR-2008 at 8:45AM was vaccinated subcutaneous in left triceps with the second dose of VARIVAX (Merck) (LOT# 660323/1973U) when the patient came in for routine physical examination. Concomitant therapy included 6 MP. On 29-APR-2008 the patient''s father called the physician and stated that the patient became nauseated with abdominal pain and had swelling and tenderness at the injection site. The responsible physician called and spoke with another physician in infectious disease department who stated that the second dose of vaccine administration was fine. On 30-APR-2008 the patient felt better and less abdominal pain. His feeding was much improved. On 21-MAY-2008 the patient recovered from the symptoms. There was no product quality complaint. Additional information is not expected.

VAERS ID:353170 (history)  Vaccinated:2008-04-28
Age:21  Onset:2008-06-05, Days after vaccination: 38
Gender:Female  Submitted:2009-08-04, Days after onset: 425
Location:New Jersey  Entered:2009-08-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 6/15/2008)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 09/03/08, results were normal and 12 weeks gestation; serum alpha-fetoprotein, 10/13/08, normal
CDC 'Split Type': WAES0810USA04728
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0151X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Drug exposure during pregnancy, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (broad)
Write-up: Information has been received from a registered nurse (R.N.), for the Pregnancy Registry for GARDASIL, concerning a 22 year old female who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL (first lot #0151X, second lot #0250X) on 28-APR-2008 and 30-JUN-2008, respectively. The patient had 3 previous pregnancies and 2 elective terminations. Subsequently, the patient discovered that she was pregnant. Her LMP was 15-JUN-2008. On 03-SEP-2008, she had ultrasound and "the results were normal and she was 12 weeks gestation at that time". On 13-OCT-2008, she had serum alpha-fetoprotein test and the result was normal. No adverse effects reported. The patient sought medical attention via office visit. Additional information was received from a physician via Initial Pregnancy Questionnaire. The physician reported the patient had 3 previous pregnancies and 2 elective terminations. The patient''s LMP was 15-JUN-2008 and estimated delivery date was 02-MAR-2009. The result of patient''s serum alpha-fetoprotein test was normal on 13-OCT-2008. Follow up information was received via pregnancy questionnaire indicated that the patient delivered a normal male baby on 05-MAR-2009, 38-39 weeks from the patient''s LMP, weighting 9.1, length 21 inches. There was no congenital anomalies, complication, infections or illnesses during pregnancy and no complication during labor/delivery. It was also noted that the patient took VITAFOL during this pregnancy. Follow up information was received which reported the patient with G3P0 on 05-MAR-2009 underwent C-section. The baby was well health. Upon internal review, the C-section was determined to be an other important medical event. Additional information is not expected.

VAERS ID:382228 (history)  Vaccinated:2008-04-28
Age:0.1  Onset:2009-01-29, Days after vaccination: 276
Gender:Female  Submitted:2010-03-08, Days after onset: 403
Location:Unknown  Entered:2010-03-09, 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: Unknown
Diagnostic Lab Data: Apgar score, 9&9 at 1 and 5 minutes respectively
CDC 'Split Type': WAES0805USA00511B1
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Ankyloglossia congenital, Apgar score normal, Drug exposure during pregnancy, Tongue tie operation
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a nurse for the Pregnancy Registry for GARDASIL and pediatric medical records concerning a female infant whose mother in approximately November or December 2007, was vaccinated with her first dose of GARDASIL (lot# not reported). In February 2008, her mother was vaccinated with her second dose of GARDASIL (lot# not reported). On 28-APR-2008 her mother was vaccinated with her third dose of GARDASIL (lot# not reported) and found out that she was pregnant. The mother''s LMP was 28-MAR-2008. The pregnancy was confirmed on an unspecified date by a positive pregnancy test and complete bloodwork. Concomitant therapy included allergenic extract (allergy shot once a month). On 26-DEC-2008, the female infant was delivered via cesarean section with Apgars of 9 & 9 at 1 and 5 minutes respectively. On 29-JAN-2009, at 4 weeks well check, it was noted the infant was tongue tied. The infant was vaccinated with a second dose of hepatitis B vaccine (manufacturer unknown). The mother returned in February 2009 for her postpartum visit and she was breastfeeding the baby and there were "no problems" for her or the baby. She added the notes from the hospital and the office after the birth had no indication there were any problems. On 04-MAR-2009, at 4 month well check, the infant was vaccinated with a first dose of DT, ACTHIB, IPOL, PREVNAR (MSD). On 06-MAY-2009, at 2 month well check, the infant was vaccinated with the second dose of DT, ACTHIB, IPOL, PREVNAR and ROTATEQ (MSD) and tongue clip was performed. The infant''s ankyloglossia was considered a congenital anomaly. The mother''s experience has been captured in WAES # 0805USA00511. No further information is available. All medical records will be provided upon request.

VAERS ID:311239 (history)  Vaccinated:2008-04-29
Age:6.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Male  Submitted:2008-04-29, Days after onset: 0
Location:California  Entered:2008-04-29
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: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF214AA4IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC631121IMUN
Administered by: Private     Purchased by: Private
Symptoms: Hypokinesia, Wrong drug administered
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient unable to lift right arm where HIB inj. was given. Pt received wrong immunizations. Pt is a 6 y/o male.

VAERS ID:311505 (history)  Vaccinated:2008-04-29
Age:65.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Female  Submitted:2008-05-02, Days after onset: 2
Location:Montana  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Colace, Calcium, Claritan, Nasonex, Cranberry Extract
Current Illness: MS, Mental Disorder, Cataract
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2765AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None - given Daptacel instead of Adacel

VAERS ID:311506 (history)  Vaccinated:2008-04-29
Age:52.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Male  Submitted:2008-05-02, Days after onset: 2
Location:Montana  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D, Nexum, Carafate, Calcium Citrate, Celexa, Reglan, Flomax
Current Illness: MR, Infantile cerebral palsy, ileostomy, DPH, GERD, Depression, Osteoporosis
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2765AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None - given Daptacel instead of Adacel

VAERS ID:311507 (history)  Vaccinated:2008-04-29
Age:48.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Female  Submitted:2008-05-02, Days after onset: 2
Location:Montana  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Baclofen, Pepcid, Oxyfast, Senna, Reglan
Current Illness: Persistant Vegetative State, Depressive Disorder, Fall resulting in striking against other object
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2765AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None - given Daptacel instead of Adacel

VAERS ID:311508 (history)  Vaccinated:2008-04-29
Age:4.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Male  Submitted:2008-05-02, Days after onset: 2
Location:California  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No~ ()~NULL~~In Patient|No~ ()~NULL~~In Sibling1
Other Medications: None
Current Illness: No illnesses
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC532853IMRA
Administered by: Public     Purchased by: Public
Symptoms: Blister, Injection site erythema, Injection site induration
SMQs:, Severe cutaneous adverse reactions (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Child presented @ clinic 48 hours post vaccination with red, indurated R deltoid with 4 cm area of coalescing bulli on skin surface, per MD chart note. Hydrocortisone cream 1% BID, PRN prescribed.

VAERS ID:311509 (history)  Vaccinated:2008-04-29
Age:53.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Male  Submitted:2008-05-02, Days after onset: 2
Location:Montana  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nexium, Baclofen, Klonopin, Ferrous Sulfate, Robaxin, Norco, Zoloft
Current Illness: MS, Depressive Disorder, Bipolar Disorder, Cellulitis, Gastritis, Hyperlipidemia, Epilepsy
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2765AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None - given Daptacel instead of Adacel

VAERS ID:311510 (history)  Vaccinated:2008-04-29
Age:65.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Female  Submitted:2008-05-02, Days after onset: 2
Location:Montana  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Neurontin, Prilosec, Morphine Sulfate, Reglan, Metoprolol, MSContin, Calcium Carbonate, Glipizide, Celexa, Ativan
Current Illness: Diabetes, Cerebral Artery Occulusion, Osteomyelitis, Digestive Disease
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2765AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None - given Daptacel instead of Adacel

VAERS ID:311511 (history)  Vaccinated:2008-04-29
Age:53.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Female  Submitted:2008-05-02, Days after onset: 2
Location:Montana  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Senna, Zyprexa, Lexapro, Valium
Current Illness: MS, Tachycardia, Dementia w/delusions
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2765AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None - given Daptacel instead of Adacel

VAERS ID:311513 (history)  Vaccinated:2008-04-29
Age:55.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Female  Submitted:2008-05-02, Days after onset: 2
Location:Montana  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Keppra, Senna, Valium
Current Illness: Hypothyroidism, Downs Syndrome, Convulsions, Senile Dementia
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2765AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None - given Daptacel instead of Adacel

VAERS ID:311514 (history)  Vaccinated:2008-04-29
Age:59.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Male  Submitted:2008-05-02, Days after onset: 2
Location:Montana  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Senokot, Calm-Forte, Mebara
Current Illness: Infantile Cerebral Palsy, Convulsions
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2765AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None - given Daptacel instead of Adacel

VAERS ID:311579 (history)  Vaccinated:2008-04-29
Age:11.0  Onset:2008-05-01, Days after vaccination: 2
Gender:Female  Submitted:2008-05-05, Days after onset: 4
Location:Indiana  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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Musculoskeletal pain, Skin warm, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: (L) shoulder pain, warm to touch, firm and tender to palp, "knot" to (L) delt

VAERS ID:311582 (history)  Vaccinated:2008-04-29
Age:11.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Male  Submitted:2008-04-30, Days after onset: 0
Location:Massachusetts  Entered:2008-05-05, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU255VAA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1346U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: (L) upper arm 4cm x 2 cm raised tender area from Varivax.

VAERS ID:311589 (history)  Vaccinated:2008-04-29
Age:75.0  Onset:2008-05-01, Days after vaccination: 2
Gender:Male  Submitted:2008-05-01, Days after onset: 0
Location:Virginia  Entered:2008-05-05, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Private
Symptoms: Dizziness postural
SMQs:
Write-up: Extreme dizziness upon waking (could not stand up). Recovery: <4 hrs.

VAERS ID:311758 (history)  Vaccinated:2008-04-29
Age:27.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Female  Submitted:2008-05-06, Days after onset: 7
Location:Guam  Entered:2008-05-06
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: codeine
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUREJN 234A0SCLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA09231IMRA
Administered by: Military     Purchased by: Military
Symptoms: Chills, Oedema peripheral, Pyrexia, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Fever, hives, chills and swelling of hands 5 hrs after the shot and lasted for approx 8 hrs. Resovled with Benadryl.

VAERS ID:311773 (history)  Vaccinated:2008-04-29
Age:10.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Female  Submitted:2008-05-02, Days after onset: 3
Location:Alaska  Entered:2008-05-06, 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 known
Preexisting Conditions:
Diagnostic Lab Data: None; Patient given Septra and ceftrioxone via injection
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1561U1SCRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red swelling 6-8 hrs post vaccination 4" x 2" at injection site R upper arm. Developed to 8x8" flaming red swollen area with red streaks to R forearm as described by attending health aid in village and picture via AFHCAN.

VAERS ID:311866 (history)  Vaccinated:2008-04-29
Age:63.0  Onset:2008-05-01, Days after vaccination: 2
Gender:Female  Submitted:2008-05-02, Days after onset: 1
Location:Washington  Entered:2008-05-08, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.6320F0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2689AA0IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.P88740SCLA
Administered by: Military     Purchased by: Unknown
Symptoms: Erythema, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Lt arm-back (SC) Zostavax vaccine injected. 2 days later has reddened area 25 mm in circumf. Swelling slightly today with itching noted.

VAERS ID:311940 (history)  Vaccinated:2008-04-29
Age:5.0  Onset:0000-00-00
Gender:Male  Submitted:2008-05-05
Location:Louisiana  Entered:2008-05-09, 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: Adderall
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2950AA4UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03013UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: R arm, red, feverish and swelling front side of arm down to elbow

VAERS ID:311944 (history)  Vaccinated:2008-04-29
Age:3.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Female  Submitted:2008-05-02, Days after onset: 3
Location:Louisiana  Entered:2008-05-09, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2657AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA034223SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0039X1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1798U1SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt. received immunizations at 1:30pm on 4/29/08. Within 2 hours she had area at one injection sites that red and the size of a half dollar. The next AM the area was softball sized, red & warm to touch.

VAERS ID:311963 (history)  Vaccinated:2008-04-29
Age:39.0  Onset:2008-05-05, Days after vaccination: 6
Gender:Female  Submitted:2008-05-06, Days after onset: 1
Location:Kentucky  Entered:2008-05-09, 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: KFlex
Current Illness: none
Preexisting Conditions: DM
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2067AA UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Arthralgia, Back pain, Neck pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (broad)
Write-up: Complained of soreness in back, hips, arms and neck.

VAERS ID:311973 (history)  Vaccinated:2008-04-29
Age:60.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Alaska  Entered:2008-05-09
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0803U UNLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1085U UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red rash on chest wall

VAERS ID:312205 (history)  Vaccinated:2008-04-29
Age:4.0  Onset:2008-05-01, Days after vaccination: 2
Gender:Female  Submitted:2008-05-06, Days after onset: 5
Location:California  Entered:2008-05-13, 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: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU1343AA UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0126 SCUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1484U SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1995U SCUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swollen with redness left arm. 400 mm ind. Per Dr, advised to ice area and Tylenol prn

VAERS ID:312210 (history)  Vaccinated:2008-04-29
Age:1.5  Onset:2008-05-01, Days after vaccination: 2
Gender:Female  Submitted:2008-05-01, Days after onset: 0
Location:New Jersey  Entered:2008-05-13, 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: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2935AA3IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The patient had DTaP administered in left arm/deltoid on 4/29/08. Today 5/1/08 she developed redness and swelling along lateral border of her left arm. No fever or pain.

VAERS ID:313053 (history)  Vaccinated:2008-04-29
Age:23.0  Onset:2008-05-04, Days after vaccination: 5
Gender:Male  Submitted:2008-05-24, Days after onset: 20
Location:Illinois  Entered:2008-05-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: UNK
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU2019AB0IMUN
Administered by: Other     Purchased by: Private
Symptoms: Injection site induration, Injection site pain, Rash macular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Pt received a tetanus injection on 4-29-08, he stated he developed pain and hard nodule in the same arm approx 4 days later then he developed a blotchy rash down both arms and across his chest no itching or irritation noted.

VAERS ID:313846 (history)  Vaccinated:2008-04-29
Age:54.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 6
Location:Tennessee  Entered:2008-05-28, Days after submission: 22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: antihypertensive
Current Illness: none
Preexisting Conditions: allergy to tuberculin skin test
Diagnostic Lab Data:
CDC 'Split Type': TN08017
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1954CD0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Induration, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient received Td vaccine L deltoid 04/29/05 at 8:05 AM. 04/30/08 pt. had fever 101 degrees at 5pm took aspirin. 05/01/08 arm red & swollen from armpit to midsection of arm with "knot" below armpit. Treated by Priv. Dr. 05/02/08.

VAERS ID:314365 (history)  Vaccinated:2008-04-29
Age:4.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Male  Submitted:2008-04-30, Days after onset: 1
Location:Arkansas  Entered:2008-05-30, Days after submission: 30
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': AR0821
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2354BA4IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253BA0IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02733SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1311U1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.008641SCRA
Administered by: Private     Purchased by: Private
Symptoms: Eye swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Phone call from states (L) eye swollen since he received his vaccines this morning. Denies any respiratory distress. Brought to clinic at 10:45 to be evaluated. Assessment: (L) eye swollen and puffy, no distress, V/S 110/70 - 100 - 12 even, no swollen tongue. Sent to ER for evaluation.

VAERS ID:314397 (history)  Vaccinated:2008-04-29
Age:0.6  Onset:2008-05-01, Days after vaccination: 2
Gender:Female  Submitted:2008-05-30, Days after onset: 29
Location:Illinois  Entered:2008-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: None Known
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B137AA2IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC575372IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1243U2PO 
Administered by: Public     Purchased by: Public
Symptoms: Body temperature, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mother noticed rash on the infants back, chest and face on 5/1/08 in the AM. Mother called to report the symptoms questioning if due to vaccines given on 4/29/08. Instructed to observe for changes or worsening of symptoms and instruction given to follow-up in the ER if worse or here at Child Health Clinic on 5/2/08. Questioned if infant had been given any medication and Mother states gave Tylenol every 5 hours after vaccines given. Mother did not show for appointment on 5/2/08 and when telephone call made to her she said she remebered that she had given rice cereal and cow''s milk to the infant on the evening of 4/29/08, so maybe that was the cause of the rash. Mother states rash did not get any worse and no other symptoms. Infants temp 98.1. Instructed to call if rash continues.

VAERS ID:316052 (history)  Vaccinated:2008-04-29
Age:11.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Male  Submitted:2008-05-06, Days after onset: 7
Location:Missouri  Entered:2008-06-11, Days after submission: 36
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: Medical history, concurrent medication and illness at time of vaccination were unknown
Diagnostic Lab Data:
CDC 'Split Type': 200801390
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Headache, Injection site inflammation

VAERS ID:317434 (history)  Vaccinated:2008-04-29
Age:7.0  Onset:2008-05-01, Days after vaccination: 2
Gender:Male  Submitted:2008-05-07, Days after onset: 6
Location:Idaho  Entered:2008-06-25, Days after submission: 49
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC 'Split Type': ID08025
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0085X1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Rt thigh red raised warm to the touch, itchy, 1 1/2-1 1/2 inches.

VAERS ID:317435 (history)  Vaccinated:2008-04-29
Age:9.0  Onset:2008-04-30, Days after vaccination: 1
Gender:Female  Submitted:2008-05-07, Days after onset: 7
Location:Idaho  Entered:2008-06-25, Days after submission: 49
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC 'Split Type': ID08024
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0085X1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 1 1/2" x 1 1/2" erythematous indurated raised area surrounding vaccine site. No vesicles, increased warmth.

VAERS ID:320361 (history)  Vaccinated:2008-04-29
Age:0.3  Onset:0000-00-00
Gender:Female  Submitted:2008-07-09
Location:Arkansas  Entered:2008-07-24, Days after submission: 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: None
Diagnostic Lab Data:
CDC 'Split Type': AR0827
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSPOXB133B0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF238AB0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499230IMLL
Administered by: Public     Purchased by: Public
Symptoms: Lethargy, Posture abnormal
SMQs:, Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: After receiving 1st vaccine series (04-29-08) at age 3 mo x 3 day infant lethargic. Poor or no neck control, improved by 3rd days. No further problem without these signs and symptoms.

VAERS ID:326927 (history)  Vaccinated:2008-04-29
Age:23.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 139
Location:Washington  Entered:2008-09-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0808USA02169
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.657622/0388U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 23 year old female who on 29-APR-2008 was vaccinated with the first dose of GARDASIL (lot # 557622/0388U). On 29-APR-2008 the patient developed a localized rash at the injection site. As of 06-MAY-2008, the rash spread over the body and still persisted. The patient sought unspecified medical attention. Additional information has been requested

VAERS ID:333838 (history)  Vaccinated:2008-04-29
Age:0.2  Onset:2008-05-05, Days after vaccination: 6
Gender:Male  Submitted:2008-11-26, Days after onset: 205
Location:Louisiana  Entered:2008-12-04, Days after submission: 8
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: None known
Diagnostic Lab Data: Doctor''s office did not review with parent. Labs drawn however (cultures, etc.) Labs: Stool cx (-).
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B141BA0UNLL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUF255AP0UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC575430UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1829U0PO 
Administered by: Private     Purchased by: Other
Symptoms: Culture stool negative, Decreased appetite, Diarrhoea, Gastroenteritis viral, Laboratory test, Poor quality sleep, Rash, Vomiting projectile
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Days post medication administered, baby exhibited moderate vomiting & diarrhea for 2 1/2 weeks; 1 episode in doctor''s office. 12/15/2008 Office notes and vax rec received from PCP. Seen for 2 mon well visit and vax 4/29/08. Imp: Well infant ? GER. Returned 5/7/08 with c/o projectile vomiting, diarrhea, decreased appetite, not resting well, rash on face and extremities. DX: Viral GE. Seen 5/13/08 still projectile vomiting. Stool cx sent and (-). 3 month checkup 5/23/08-noted to be well.

VAERS ID:336380 (history)  Vaccinated:2008-04-29
Age:0.5  Onset:2008-04-30, Days after vaccination: 1
Gender:Male  Submitted:2009-01-02, Days after onset: 247
Location:Massachusetts  Entered:2009-01-02
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: POLYDACTYLY, extra thumb
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B138BA IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF209AA IMLL
PPV: PNEUMO (PNU-IMUNE)PFIZER/WYETHB97283C IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0019X PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever of 101 beginning within 24 hours of imm.

VAERS ID:339220 (history)  Vaccinated:2008-04-29
Age:0.7  Onset:2008-04-29, Days after vaccination: 0
Gender:Male  Submitted:2009-01-29, Days after onset: 275
Location:New York  Entered:2009-02-05, 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: Vaccination adverse reaction; Fever
Diagnostic Lab Data: Body temp, 04/29?/08, fever
CDC 'Split Type': WAES0805USA00246
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.  UNUN
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.  UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  UNUN
MEA: MEASLES (ATTENUVAX)MERCK & CO. INC.  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been recieved from a consumer concerning her 8 month old son who on 29-APR-2008 was vaccinated with a dose of MMR II. Suspect vaccination on the same day included a dose of COMAX (OMPC) (MSD), a dose of PEDVAXHIB (OMPC) (manufacturer unknown), and a dose of PNEUMOVAX (MSD). Other concomitant vaccinations on the same day included a dose of PREVENAR, dose of DTaP (unspecified) (+) IPOL. The reporter noted that the vaccines were mixed together in on vial. On approximately 29-APR-2008, the patient experienced a fever and other side effects (not further specified). The reporter stated the patient experienced fever and other side effects (not further specified). The reporter stated her son "always gets fever and other side effects after getting any vaccines." Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:342647 (history)  Vaccinated:2008-04-29
Age:20  Onset:2008-04-29, Days after vaccination: 0
Gender:Female  Submitted:2009-03-13, Days after onset: 318
Location:Unknown  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Minocycline
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0902USA00628
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anxiety, Dyspnoea, Herpes simplex, Hypoaesthesia, Insomnia, Irritability, Lymphadenopathy, Palpitations, Paraesthesia, Tension, Tremor
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no known allergies/drug reactions who on 25-Jan-2008 was vaccinated with the first dose of GARDASIL (lot#659962/17400) 0.5ml intramuscularly. The patient received the second dose of GARDASIL (lot# 660389 / 1968U) 0.5ml intramuscularly on 29-Apr-200. Concomitant therapy included ~~~~ 4/8/09 GYN records received. OV 1/28/08 with HPV#1 given-1740U. HPV#2 given-1968U. Report states no prior rxn to vaccine. 4/21/09 Office notes received from PCP for 2 OVs 3/4/09 with dx: Anxiety and 3/24/09 with DX: Herpes simplex oral-resolving. First seen for c/o 1-2 month hx of anxiety, tenseness, tremoulousness, palpitations, dyspnea, irritability, insomnia and difficulty relaxing r/t heavy school load. PE WNL. Returned 3/24/09 with R sided oral cold sore and swollen gland under the neck, now resolving. Pt reports no other c/o.

VAERS ID:342762 (history)  Vaccinated:2008-04-29
Age:26  Onset:2008-04-29, Days after vaccination: 0
Gender:Female  Submitted:2009-03-13, Days after onset: 318
Location:Massachusetts  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZITHROMAX, vitamins (unspecified)
Current Illness:
Preexisting Conditions: Papanicolacu smear abnormal; Smoker
Diagnostic Lab Data: ultrasound, 7/15/08, 12W 4D; serum alpha-fetoprotein, 08/13/08, negative;
CDC 'Split Type': WAES0805USA05935
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Beta haemolytic streptococcal infection, Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (broad)
Write-up: Information has been received from a consumer and a nurse practitioner for the Pregnancy Registry for GARDASIL concerning herself, a 26 year old female with no medical history, and no drug reactions/allergies, who on 29-APR-2008 was vaccinated with her first dose of GARDASIL (lot # unspecified). On 02-May-2008 (three days later), the patient became pregnant (LMP estimated as 15-Apr-2008). Concomitant therapy included azithromycin (ZITHROMAX). The patient sought unspecified medical attention. At the time of this report the outcome was unknown. No further information available. Follow-up information received on 17-FEB-2009 from a nurse practitioner who reported the patient is Hispanic and has a history of smoking 2-5 cigarettes a day which she stopped with pregnancy, and an abnormal PAP s/p LEEP. Patient has had a previous pregnancy, no previous full term deliveries and a miscarriage. On 15-Jul-2008 patient had an ultrasound, which showed 12 weeks and 4 days pregnant ERA normal. On 13-AUG-2008 patient had a MSAFP testing with normal results. The lot # of the first dosage of GARDASIL received is 659180/1758U. Concomitant medications during pregnancy included prenatal vitamins (unspecified) which patient started taking on 18-JUN-08 (27 mg of Iron and folate 1mg daily) and on 08-JAN-2009 penicillin (unspecified) 3000000 international units every 4 hours for the treatment of bacterial infection due to streptococcus, group B. Date of last menstrual period on 18-APR-2008 (previously reported as 15-APR-2008) and estimated delivery date on 23-JAN-2009. Patient had a normal baby on 09-JAN-2009, male, who weighed 2975 grams, length 49 cm, Apgar score 9/9, head circumference 33.5 cm. No congenital anomalies or other complications or abnormalities. No complications during pregnancy, or during labor and/or delivery. No further information is available.

VAERS ID:343198 (history)  Vaccinated:2008-04-29
Age:0.1  Onset:2008-05-19, Days after vaccination: 20
Gender:Male  Submitted:2009-03-06, Days after onset: 291
Location:Unknown  Entered:2009-03-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cleft lip
Preexisting Conditions: Jaundice; Blood bilirubin abnormal; Infantile spitting up
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0809USA01661
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Infantile spitting up, Plagiocephaly
SMQs:, Congenital, familial and genetic disorders (narrow), Neonatal disorders (narrow)
Write-up: Pediatric medical records were received and received concerning an 6 week old male with cleft lip and a history of jaundice, spitting up and blood bilirubin abnormal (WAES # 0708USA01488) who on 29-APR-2008 was vaccinated with ROCOMBIVAX HB. On 09-APR-2008 a 2 weeks male infant with no with no known allergies was examined. The weight was 7 pounds 9 ounces, the length 20 3/4 inches, head circumference 14 1/4 inch, temperature 98.4 degrees F, pulse 158, respiratory frequency 40. The infant was well. It was noted that the patient spit up when nursing assessment: well child. On 29-APR-2008 the 4 weeks male infant with no with no known allergies was examined. The weight was 9 pounds 6 ounces, the length 21 inches, head circumference 14 3/4 inch, temperature 99.2 degrees F, pulse 120, respiratory frequency 32. The baby was vaccinated with RECOMBIVAX HB IM in left thigh. The infant was well. On 19-MAY-2008 plagiocephaly was noted. On 27-MAY-2008 an 8 weeks male infant with no known allergies was examined. The weight was 11 pounds 4.5 ounces, the length 22 1/2 inches, head circumference 15 1/2 inch, temperature 99 degrees F, pulse 128, respiratory frequency 30. Feeding problems reported as "spit up". The infant was well. The baby was vaccinated on this same day with: PREVNAR (C80901) IM in right thigh. ROTAVIRUS (660596/0211X) PO. ACTHIB (UF352AA) IM in left thigh. On 26-JUN-2008 the patient was vaccinated with: TRIPEDIA (C2934AA) IM in left thigh. IPOL (A0492) SC/IM in right thigh. On 27-AUG-2008, the patient had an upper respiratory infection. (WAES # 0809USA02064) No additional information is expected.

VAERS ID:343681 (history)  Vaccinated:2008-04-29
Age:24  Onset:2008-05-13, Days after vaccination: 14
Gender:Female  Submitted:2009-04-07, Days after onset: 329
Location:Unknown  Entered:2009-04-07
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: unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  ID 
Administered by: Military     Purchased by: Military
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Vaccinated with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery.

VAERS ID:346780 (history)  Vaccinated:2008-04-29
Age:16  Onset:2008-05-05, Days after vaccination: 6
Gender:Female  Submitted:2009-05-14, Days after onset: 374
Location:Unknown  Entered:2009-05-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown PMH: Von Willebrand''s Disease, OCs
Diagnostic Lab Data: Unknown . Labs and Diagnostics: EKG 5/26/09 abnormal (5/2008 WNL, 6/7/08 EKG borderline abnormal but may represent normal variant). Echo WNL. Holter 5/2008 WNL with several perceived episodes by pt.
CDC 'Split Type': WAES0904USA00606
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arrhythmia, Arthralgia, Cardiac ablation, Cardiac murmur, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory normal, Fatigue, Heart rate decreased, Heart rate irregular, Malaise, Myalgia, Palpitations, Supraventricular tachycardia, Syncope, Vomiting, Wolff-Parkinson-White syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Information has been received from a registered pharmacist concerning her 17 year old daughter with no pertinent medical history, who on an unspecified date was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On an unknown date, the patient developed heart arrhythmia after getting the third dose of GARDASIL lot # was not provided. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Additional information has been requested. 7/10/09 Cardiology consult rec''d for DOS 5/12/08-6/5/09 with final dx: Wolff-Parkinson-White syndrome with supraventricular tachycardia. Pt initially presented 5//12/08 with ~ 1wk hx of episodes of palpitations which begin and end suddenly. Also reporting joint pain in the wrists, knees and ankles. Syncope with vomiting 7/2008. Episode of palpitations 5/26/09 at school and RN noted HR between 200-300. Sent to ER where the WPW dx was made. Cardiac ablation scheduled. 7/14/09 MR recd from PCP with vax info. Several OVs 4/2008-6/2008 r/t c/o fatigue and irregular heart rate. One episode ~2/2008. Referred to cardiologist (above). Dx: Fatigue, malaise, arthralgia, palpitation, irregular heartbeat, heart murmur..Seen 7/5/08 in f/u to sycopal episode on 7/4/08. Several month hx of fatigue, muscle aches, palpitations. Wearing a heart monitor which registered HR 32 during event. Dx: fainting. 7/15/09 ER record rec''d for 2 ER visits 6/7/08 and 5/26/09 as well as a heme/onc consult from 11/2008. Initially presented on 6/7/08 with c/o sudden onset of palpitations lasting~5 minutes. Resolved on arrival. .. To f/u with peds cardiology (above). Heme/onc consult 11/20/08 in f/u for von Willebrand. Reports sensation of heart racing and fatigue, but vW in good control. ER visit 5/26/09 with dx: Wolff Parkinson-White syndrome. SVT. EKG abnormal-see above.

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