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Found 511680 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:461419 (history)  Vaccinated:2012-08-07
Age:2.0  Onset:2012-08-08, Days after vaccination: 1
Gender:Male  Submitted:2012-08-08, Days after onset: 0
Location:California  Entered:2012-08-08
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
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF189634IMRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Leg of inj had round 2.5cm hard spot.

VAERS ID:461483 (history)  Vaccinated:2012-08-07
Age:5.0  Onset:2012-08-09, Days after vaccination: 2
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:Ohio  Entered:2012-08-09
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4154BA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH14523IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0412AE1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0065371SCLA
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Entire deltoid area is red, warm and hard. Affected site measures 60mm x 55mm in size. Child complains of pain to the touch. Parent first noticed the symptoms on the morning of 8/9/12. Approximately 44 hours post vaccination.

VAERS ID:461529 (history)  Vaccinated:2012-08-07
Age:57.0  Onset:2012-08-09, Days after vaccination: 2
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:Kentucky  Entered:2012-08-09
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0566AE0SCLA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site mass, Rash, Rash erythematous, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: HER ARM HAS A LARGE, HOT, RED RASH AND THERE IS A HARD LUMP AT THE INJECTION SITE. IT IS NOT ITCHING OR BURNING.

VAERS ID:461597 (history)  Vaccinated:2012-08-07
Age:13.0  Onset:2012-08-08, Days after vaccination: 1
Gender:Female  Submitted:2012-08-10, Days after onset: 2
Location:Vermont  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergic reaction to pertussis vaccine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4244AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: General malaise, fever greater than 101.6.

VAERS ID:461607 (history)  Vaccinated:2012-08-07
Age:36.0  Onset:2012-08-08, Days after vaccination: 1
Gender:Female  Submitted:2012-08-10, Days after onset: 2
Location:Kansas  Entered:2012-08-10
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: ALLERGY: CODEINE AND ZMAX
Diagnostic Lab Data: SONO OF ARM
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B087BC IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Chest pain, Injection site pain, Pain in extremity, Ultrasound scan
SMQs:, Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: PAIN RADIATING DOWN LEFT ARM OVER TO CHEST AREA. SORENESS AT INJECTION SITE.

VAERS ID:461710 (history)  Vaccinated:2012-08-07
Age:65.0  Onset:2012-08-08, Days after vaccination: 1
Gender:Female  Submitted:2012-08-09, Days after onset: 1
Location:California  Entered:2012-08-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hx Renal calculi; Freq Fungal infections; Tremors *R Arm; Lung cancer
Diagnostic Lab Data: Blood culture pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0088AE0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4383AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood culture, Cellulitis, Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: See ER notes- treated with 1. Clindamycin 300mg 4xdaily/900mg IV 2. BENADRYL Cap 2 25 mg at Bedtime 3. Prednisone 40mg po.

VAERS ID:461665 (history)  Vaccinated:2012-08-07
Age:54.0  Onset:2012-08-09, Days after vaccination: 2
Gender:Female  Submitted:2012-08-12, Days after onset: 3
Location:New York  Entered:2012-08-12
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: Environmental allergies but none to latex, neomycin, or gelatin.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0257AE0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Cough, Ear pain, Eye pain, Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Respiratory tract congestion, Upper-airway cough syndrome
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad)
Write-up: Started with post-nasal drip and coughing. Turned into a cold. Sore throat. Nasal and chest congestion. Sore eyes. Sore ear.

VAERS ID:461712 (history)  Vaccinated:2012-08-07
Age:69.0  Onset:2012-08-09, Days after vaccination: 2
Gender:Female  Submitted:2012-08-10, Days after onset: 1
Location:Florida  Entered:2012-08-12, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Injection site swelling, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Fever (103). Chilling/shaking. Swelling at injection site.

VAERS ID:461763 (history)  Vaccinated:2012-08-07
Age:6.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Male  Submitted:2012-08-07, Days after onset: 0
Location:Nebraska  Entered:2012-08-13, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Runny nose
Preexisting Conditions: Ex 20 week infant
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193BA IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0682AE1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0610AE1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Pruritus, Rash erythematous, Rash generalised, Rash papular, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Stomach ache with vomiting skin itching, red, papular non urticarial rash all over - confluent.

VAERS ID:461764 (history)  Vaccinated:2012-08-07
Age:18.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Female  Submitted:2012-08-07, Days after onset: 0
Location:Kentucky  Entered:2012-08-13, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None; Dental visit for tooth extraction the week before
Preexisting Conditions: Gets allergy injection. Allergic to bees; seafood & VICODIN. No known life threatening allergies but does have Epi pen
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA110500IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B071BB IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0568AE1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site pruritus, Pruritus, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)
Write-up: C/o itching (R) arm at site of varicella injection. Then began c/o tightening feeling in throat & itching of neck. Diphenhydramine 50 mg given IM (R) deltoid. Called EMD. EMS came to evaluate. She reported feeling better & declined transfer for further evaluation.

VAERS ID:461911 (history)  Vaccinated:2012-08-07
Age:13.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Female  Submitted:2012-08-07, Days after onset: 0
Location:North Carolina  Entered:2012-08-14, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0097461IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Pain in extremity, Pruritus generalised, Vaccination site haematoma
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Please see attached report -. HPV #2 (lot # H009746 with exp. date 11JAN15) vaccine was administered at 10:25 per MD order. There was immediate bleeding lasting less than 5 seconds upon removal of the needle. Bleeding was stopped with compression. A quarter sized hematoma was noted at the vaccine site with redness spreading t half dollar size. Patient complained of soreness and numbness all over her left arm at 10:30am. MD was notified and ordered a cold compression dressing and 400mg of ibuprofen, which was administered orally at 10:35 am. Patient began itching all over left arm at 10:45 am. BENADRYL 25 mg was given orally at 10:47 am per MD order. At 11:32am, a pressure dressing was applied and the cold pack was removed per MD order. The patient was released from our care in good condition. Mother and patient were instructed to continue 400mg of ibuprofen every six hours for the next 48 hours. Mother was advised of the possibility of bruising and swelling. Patient was instructed to follow up with any concerns.

VAERS ID:461944 (history)  Vaccinated:2012-08-07
Age:11.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Female  Submitted:2012-08-10, Days after onset: 3
Location:Georgia  Entered:2012-08-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None stated
Preexisting Conditions: Mother denies any previous allergy/seizure
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B05AA5IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.042AE1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Received 2 immunizations in clinic - walked with parent thru building and out to parking lot before collapsing in parking lot with seizure activity. Evaluated by clinic staff and EMS summoned - transported to ER per EMS. Discharged from ER with instructions to make appt with neurologist.

VAERS ID:461975 (history)  Vaccinated:2012-08-07
Age:14.0  Onset:2012-08-08, Days after vaccination: 1
Gender:Female  Submitted:2012-08-08, Days after onset: 0
Location:Texas  Entered:2012-08-14, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA110520UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pain at injection site. Itching whole body. Injection site size of golf ball. Warm at injection site. Told patient to take BENADRYL, apply cold compress and go to Dr. or call ASAP.

VAERS ID:461976 (history)  Vaccinated:2012-08-07
Age:0.2  Onset:2012-08-08, Days after vaccination: 1
Gender:Female  Submitted:2012-08-08, Days after onset: 0
Location:California  Entered:2012-08-14, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B300AA0UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH258AA0UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF654410UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1671AA0PO 
Administered by: Private     Purchased by: Public
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site pain, Macule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Mom noted redness in (L) thigh, with induration. Minimal pain. Noted the following morning after injection. See in clinic today 2 x 2.5 cm macule with 1 cm induration. Rec: observation and reassurance.

VAERS ID:464339 (history)  Vaccinated:2012-08-07
Age:  Onset:2012-08-07, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-16, Days after onset: 9
Location:Unknown  Entered:2012-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA003317
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a nursing supervisor refers to a patient of unknown age. On 07-AUG-2012, at time of the report the patient was in the office to receive the second dose of GARDASIL (Lot # unspecified) which would be late. The first dose was administered two years ago (in approximately August 2010). No symptoms reported. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.

VAERS ID:463312 (history)  Vaccinated:2012-08-07
Age:67.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-27, Days after onset: 20
Location:Unknown  Entered:2012-08-27
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA008226
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)
Write-up: Information has been received from a physician assistant concerning a 67 years old patient (gender was not provided). In 2009, the patient received a dose of ZOSTAVAX, (dose, route and lot number was not provided). On 07-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route and lot number was not provided) as vaccination. No other co-suspects were reported. No concomitant medications were reported. On 07-AUG-2012, about 10 hours after received ZOSTAVAX, the patient experienced myocardial infarction and was hospitalized. On 10-AUG-2012, the patient was discharged from the hospital. The reporter physician assistant was not the provider that administered ZOSTAVAX (name of provider unspecified). The patient''s outcome was reported as recovering/resolving. The physician assistant considered the event as significant disability and life threatening. Additional information has been requested.

VAERS ID:464222 (history)  Vaccinated:2012-08-07
Age:47.0  Onset:2012-08-08, Days after vaccination: 1
Gender:Female  Submitted:2012-08-08, Days after onset: 0
Location:North Carolina  Entered:2012-09-06, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4335AA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling of the (L) deltoid warmth, no erythema or cellulitis.

VAERS ID:464223 (history)  Vaccinated:2012-08-07
Age:50.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Male  Submitted:2012-09-05, Days after onset: 29
Location:New York  Entered:2012-09-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lyme disease
Preexisting Conditions: Chronic lyme disease
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Balance disorder, Headache, Hypoaesthesia, Nausea, Paraesthesia, Vertigo
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: Vertigo, nausea, weakness, headache, & numbness & tingling in lower extremities, poor balance.

VAERS ID:464682 (history)  Vaccinated:2012-08-07
Age:16.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Female  Submitted:2012-09-07, Days after onset: 31
Location:Arkansas  Entered:2012-09-10, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0624AE0IMGM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3906AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Pt mom called 3 hours post inj stating she had to carry child to ER for trouble breathing.

VAERS ID:468398 (history)  Vaccinated:2012-08-07
Age:14.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Female  Submitted:2012-09-16, Days after onset: 40
Location:Unknown  Entered:2012-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA010631
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1171AA2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This spontaneous pregnancy report as received from a registered nurse, for GARDASIL, Pregnancy Registry product, refers to a 14 years old female patient. The patient''s history of previous pregnancies and live births is not known. The patient was vaccinated with dose 1 GARDASIL on 04-AUG-2011. On 22-DEC-2011, the patient was vaccinated with the second dose of GARDASIL. Subsequently, the patient became pregnant with an LMP of 15-JUN-2012 and an EDD of 22-MAR-2013. Initial exposure to GARDASIL was at 7 weeks. On 07-AUG-2012, the patient was vaccinated with the third dose of GARDASIL (lot # 670049/1171AA). Concomitant medications included: vitamins (unspecified) (vitamins (unspecified)). Additional information has been requested.

VAERS ID:469360 (history)  Vaccinated:2012-08-07
Age:1.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Male  Submitted:2012-09-17, Days after onset: 41
Location:Massachusetts  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Ventricular septal defect
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA012266
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0079AE0SCRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a other health professional refers to a 11 months old male patient. The patient''s medical history was reported as ventricular septal defect (VSD). The patient was vaccinated with the first dose of VARIVAX (lot# was reported as 0079AE) subcutaneous on right thigh on 07-AUG-2012 2:49pm. The patient had no illness at time of vaccination. On 07-AUG-2012 the patient developed redness and swelling at immunization site. On 20-AUG-2012 the patient was seen with several vesicles at immunization site. Spoke with mom on 24-AUG-2012, rash had resolved for the most part. The outcome of patient was reported as recovered on 24-AUG-2012. Additional information is not expected.

VAERS ID:466824 (history)  Vaccinated:2012-08-07
Age:17.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Male  Submitted:2012-09-28, Days after onset: 52
Location:North Dakota  Entered:2012-09-28
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: Asthma
Diagnostic Lab Data:
CDC Split Type: ND1217
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11047 IMLA
Administered by: Private     Purchased by: Private
Symptoms: Fall, Feeling abnormal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt. recieved the HPV in the right deltoid and the MCV4 in the left deltoid. Pt was seated as the vaccinations were given. After about 3 minutes, Pt wanted to stand in the hallway to wait for his father. Pt stated that he felt "good." After about 5 minutes of standing in the hallway, patient fainted and fell to the floor. Patient reported that his head got cloudy and he knew he was going to faint. Patient''s father reported that patient has fainted in the past after shots.

VAERS ID:539490 (history)  Vaccinated:2012-08-07
Age:19.0  Onset:2014-08-07, Days after vaccination: 730
Gender:Female  Submitted:2014-08-11, Days after onset: 4
Location:Texas  Entered:2014-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4445AB0IMUN
Administered by: Public     Purchased by: Public
Symptoms: Chills, Hot flush, Pyrexia, Respiratory tract congestion, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)
Write-up: Fever, chills, congestion, throat felt closed, hot flashes.

VAERS ID:542245 (history)  Vaccinated:2012-08-07
Age:51.0  Onset:2012-08-10, Days after vaccination: 3
Gender:Male  Submitted:2014-08-28, Days after onset: 748
Location:Pennsylvania  Entered:2014-09-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Arthritis
Diagnostic Lab Data: Bone Density Scan; X-Rays; Blood work
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3076UNAR
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Blood test, Bone scan, Joint swelling, Osteoarthritis, X-ray
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: A few days after I received my 7th Anthrax shot. I had swelling and pain in my knees and hip joints. After returning from deployment I seen a orthopedic and had a bone density scan and x-rays. He diagnosed me with osteoarthritis. Symptoms have decreased over this time.

VAERS ID:553224 (history)  Vaccinated:2012-08-07
Age:20.0  Onset:2014-03-01, Days after vaccination: 571
Gender:Male  Submitted:2014-11-12, Days after onset: 256
Location:Florida  Entered:2014-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: No
Preexisting Conditions: N/A
Diagnostic Lab Data: Seen by urologist; Aldara prescribed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0200022IMUN
Administered by: Unknown     Purchased by: Private
Symptoms: Anogenital warts
SMQs:
Write-up: Genital warts.

VAERS ID:574374 (history)  Vaccinated:2012-08-07
Age:55.0  Onset:2013-09-22, Days after vaccination: 411
Gender:Male  Submitted:2015-04-17, Days after onset: 572
Location:Missouri  Entered:2015-04-17
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin (pump); Simvastatin; Lo Dose Aspirin
Current Illness: NONE
Preexisting Conditions: TYPE 1 DIABETES
Diagnostic Lab Data: Three MRIs, two Lumbar Punctures, and a Spinal Angiogram were performed.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERUA393ABA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Angiogram, Balance disorder, Bowel movement irregularity, Fall, Gait disturbance, Lumbar puncture, Micturition disorder, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging, Pain, Sensory loss, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (broad)
Write-up: Diagnosed with Transverse Myelitis. Experienced the following symptoms: Significant reduction in sensation from my lower chest all the way through my legs. Weakness in my legs to the point I can only walk short distances, in the past I have experienced times when I was unable to rise from a chair because my legs would not respond at all.? Loss of balance, I have fallen a number of times and now walk with a walker or forearm crutches. Continued disruption in both urination and bowel movements. Positional pain, when I am lying or setting in a reclined position there is little or no pain, when I stand or set up straight, the pain increases over time until I have to recline to avoid it.

VAERS ID:579741 (history)  Vaccinated:2012-08-07
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2015-05-28
Location:Pennsylvania  Entered:2015-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Nausea, dizziness.
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNAR
Administered by: Public     Purchased by: Other
Symptoms: Palpitations, Pelvic pain
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Write-up: Heart palpitations, possible luteal phase defect, pelvic pain, possible PCOS.

VAERS ID:461848 (history)  Vaccinated:2012-08-07
Age:7.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Female  Submitted:2012-08-13, Days after onset: 6
Location:Foreign  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0821771A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB567DI SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Cold sweat, Hyperhidrosis, Malaise, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of fainting in a 7-year-old female subject who was vaccinated with HAVRIX Junior (GlaxoSmithKline). On 7 August 2012 the subject received unspecified dose of HAVRIX Junior (1 injection, Batch number AHAVB567DI, Expiry May 2014). On 7 August 2012, 5 minutes after vaccination with HAVRIX Junior, the subject experienced fainting. At an unknown time later, the patient experienced pallor, sweating, clamminess and feeling unwell. This case was assessed as medically serious by GSK. Within a few hours, on 7 August 2012, the events resolved.

VAERS ID:462191 (history)  Vaccinated:2012-08-07
Age:5.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Female  Submitted:2012-08-16, Days after onset: 9
Location:Foreign  Entered:2012-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial asthma; Skin eczema
Preexisting Conditions: Neuroborreliosis
Diagnostic Lab Data: UNK
CDC Split Type: B0822988A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B129DB UNLG
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Dyspnoea, Eczema, Injection site erythema, Injection site pallor, Neuroborreliosis, Product quality issue
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of injection site redness in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). The subject''s medical history included neuroborreliosis (a year ago). Concurrent medical conditions included bronchial asthma (since the age of 4 years) and skin eczema (since newborn age). On 7 August 2012, the subject received unspecified dose of INFANRIX (unknown route of administration, unknown thigh). On 7 August 2012, less than one day after vaccination with INFANRIX, the subject experienced difficulty breathing. On 8 August 2012, the subject experienced eczema in both popliteal fossa and injection site redness (8-10 cm). Maximum size of reaction was on 9 August 2012, then erythema was turning pale in the center with red borders, and later was slowly recovering. On 9 August 2012, difficulty breathing was resolved. The physician considered the events were clinically significant (or requring intervention). At the time of reporting, the eczema and injection site redness were improved. The physician considered injection site redness was almost certainly related to vaccination with INFANRIX, whereas the other events were probably related to vaccination with INFANRIX. This case is associated to a product complaint because this is the third subject with similar reaction after INFANRIX vaccination at the reported physician.

VAERS ID:463221 (history)  Vaccinated:2012-08-07
Age:0.8  Onset:2012-08-09, Days after vaccination: 2
Gender:Male  Submitted:2012-08-24, Days after onset: 15
Location:Foreign  Entered:2012-08-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported; F-up received on 15 August 2012: No relevant medical history. No concomitant medications.
Diagnostic Lab Data: Not reported; F-up received on 15 August 2012: Lab tests, performed on 08 August 2012, revealed WBC at 6800/mL, neutrophils at 42%, CRP at 0.2 mg/dL, blood culture was negative, culture throat was negative, stool culture was also negative (only normal bacterial flora). On 09 August 2012, head CT scan did not revealed abnormalities.
CDC Split Type: 201207531
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURG15540SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, C-reactive protein normal, Computerised tomogram head normal, Cough, Culture stool negative, Culture throat negative, Diarrhoea, Exanthema subitum, Febrile convulsion, Intensive care, Neutrophil percentage decreased, Pharyngeal erythema, Pyrexia, Rash generalised, Rhinorrhoea, Status epilepticus, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Initial report received from the health authority on 10 August 2012. Local reference number: A201200222. Authority reference number: HIB-409. A 09-months-old male patient, whose medical history and concomitant medications were not reported, had received a dose of ACTHIB vaccine (batch number- G1554, route and site of administration-not reported) on 07 August 2012. On 08 August 2012, 1 day after the patient received ACTHIB vaccine, the patient developed pyrexia over 39 degree. Corrective treatment and relevant diagnostic tests or laboratory data were not reported. As of 08 August 2012, the patient had not recovered. List of documents held by sender: none. Follow-up information received from Health Authorities through the local affiliate on 15 August 2010 under the local reference number A201200222. The case was upgraded by the Health Authorities due to hospitalization. A 09-month-old male patient, with no relevant medical history and concomitant medications, had received his first subcutaneous dose of ACT-HIB, batch number G1554 in left upper arm, on 07 August 2012. The patient''s body temperature was at 36.4 degrees C before vaccination and his weight at birth was 3.562 kg. The patient had received his third subcutaneous dose of DTP vaccine (unknown manufacturer) batch number not reported, in the right upper arm on 24 July 2012. On 07 August 2012, post vaccination, the patient developed stools watery. On 08 August 2012, he presented with pyrexia (39.5 degrees C) and was seen by a physician. Lab tests, performed on the same day, revealed WBC at 6800/mL, neutrophils at 42%, CRP at 0.2 mg/dL, blood culture was negative, culture throat was negative, stool culture was also negative (only normal bacterial flora). The patient also presented with nasal discharge, cough and redness of pharynx ; consciousness was clear. He ate normally. On 09 August 2012, at night, the patient developed status epilepticus (over 30 minutes) leading to hospitalization. He was treated with DIAPP and status epilepticus subsided. On 09 August 2012, head CT scan did not revealed abnormalities. Fever also subsided but the patient developed rash generalized. The patient was diagnosed with febrile convulsion caused by exanthema subitum. On 10 August 2012, recurrence of status epilepticus was suspected and the patient was transferred in ICU in another hospital. On 12 August 2012, the patient was discharged. The patient was recovering on 14 August 2012. Documents held by sender: none.

VAERS ID:463923 (history)  Vaccinated:2012-08-07
Age:0.3  Onset:2012-08-09, Days after vaccination: 2
Gender:Female  Submitted:2012-08-31, Days after onset: 22
Location:Foreign  Entered:2012-08-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood electrolytes, 09Aug2012, normal; Blood gases, 09Aug2012, normal; Body temperature, 09Aug2012, normal; Body temperature, 09Aug2012, normal; Full blood count, 09Aug2012, normal; Neurological examination, 09Aug2012, see text; Ultrasound abdomen normal, 09Aug2012, normal; )9 August 2012 Neurological examination: no vigilance disorder, symmetrical and sharp reflexes, no compression of fontanelle, Cardiorespiratory examination: unremarkable, no pain, no pharyngitis and no otitis, No inflammatory syndrome
CDC Split Type: B0824444A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA800A0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood electrolytes normal, Blood gases normal, Full blood count normal, Hypotonia, Moaning, Neurological examination normal, Ultrasound abdomen normal
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a foreign regulatory authority (BX20120922) and described the occurrence of hypotonia in a 14-week-old female subject who was vaccinated with INFANRIX QUINTA (GlaxoSmithKline). On 07 August 2012, the subject received a primary course of INFANRIX QUINTA (batch A20CA800A, intramuscular, injection site unknown). ON 09 August 2012, at around 13:00, about two days after vaccination with INFANRIX QUINTA, the subject presented suddenly with hypotonia and moaning at wake-up. There was no vomiting, fever, transit disorder, cough or sign of rhinitis. Neurological examination did not evidence any vigilance disorder, reflexes were symmetrical and sharp and there was no compression of fontanelle. Cardiorespiratory examination was unremarkable without pain, pharyngitis or otitis. Full blood count, blood electrolytes, blood gases were normal. There was inflammatory syndrome. Abdominal ultrasound scan was normal. Events resolved on the same day at around 23:00. The subject was hospitalized. The agency assessed the causal relationship of vaccination with INFANRIX QUINTA with the reported events as unlikely, according to the method of assessment.

VAERS ID:465207 (history)  Vaccinated:2012-08-07
Age:0.2  Onset:2012-08-10, Days after vaccination: 3
Gender:Female  Submitted:2012-09-13, Days after onset: 34
Location:Foreign  Entered:2012-09-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 10-AUG-2012, Oxygen saturation, 74%
CDC Split Type: 2012222805
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad)
Write-up: This is a spontaneous report received from the Regulatory authority report number DE-PEI-PEI2012029766 by a contactable physician. A 12-weeks-old female patient received PREVENAR 13 on 07Aug2012 and INFANRIX HEXA on 07Aug2012. The patient medical history and concomitant medications were not reported. On 10Aug2012, the patient experienced oxygen saturation decreased. The patient underwent lab tests and procedures which included oxygen saturation: 74% on 10Aug2012. The patient was hospitalized at the time that the event occurred for not reported reason. The event resolved after 4 hours.

VAERS ID:467507 (history)  Vaccinated:2012-08-07
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2012-10-03
Location:Foreign  Entered:2012-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210DEU002092
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1166Z0SCRL
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, Fatigue, Local reaction, Pallor
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Case was received from the Health Authorities on 27-Sep-2012 (reference number PEI2012033995). Case is medically confirmed. An 11-month-old male patient received a first dose of M-M-RVAXPRO, lot-no. G005825) SC into the right thigh on 07-Aug-2012. Unspecified time later he developed general reaction with pallor, bradycardia, lassitude and local reaction leading to hospitalisation for an unspecified time. Unspecified corrective treatment was carried out. Duration of general reaction with pallor, bradycardia and lassitude was twice 10 minutes, local reaction lasted 15 minutes. At the time of reporting to HA (20-Aug-2012) the patient had completely recovered.

VAERS ID:473166 (history)  Vaccinated:2012-08-07
Age:18.0  Onset:2012-08-07, Days after vaccination: 0
Gender:Female  Submitted:2012-11-06, Days after onset: 91
Location:Foreign  Entered:2012-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: 08/14/2012, CSF culture; 08/14/2012, CSF lymphocyte count, 110; 08/14/2012, CSF lymphocyte count, 42.7%; 08/14/2012, CSF neutrophil count, 83; 08/14/2012, CSF neutrophil count, 32.3%; 08/14/2012, White blood cell count, 257.0
CDC Split Type: WAES1211DEU001994
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H004195 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Bacterial test positive, CSF culture positive, CSF lymphocyte count increased, CSF neutrophil count, Headache, Lymphocyte percentage, Malaise, Meningism, Neutrophil percentage increased, Pyrexia, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Malignant lymphomas (broad)
Write-up: Case was received from the Health Authorities on 02-Nov-2012 (reference number PEI2012054738). Case is medically confirmed. An 18-year-old female patient received a dose of GARDASIL (lot-no. H004195, injection site not reported) IM on 07-Aug-2012. The same day developed fever up to 39.7 degrees C for six days. On the seventh day p.v., fever resolved and in the evening the patient developed severe headache and slight meningism. On 14-Aug-2012 she developed fever, headache, severe malaise and meningism leading to hospitalisation. On 14-Aug-2012 white blood cell count was 257.0/ul., CSF: neutrophils 83/ul, 32.3%, lymphocytes 110/ul, 42.7% and culture showed growth of Rastonia insidiosa. Diagnosis of meningitis was established. On 04-Sep-2012 the patient had completely recovered. The hospital neurologists contemplated Ralstonia insidios as possible cause.

VAERS ID:473972 (history)  Vaccinated:2012-08-07
Age:0.1  Onset:2012-08-07, Days after vaccination: 0
Gender:Female  Submitted:2012-11-12, Days after onset: 97
Location:Foreign  Entered:2012-11-13, 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: Family and personal medical history: not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201210390
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20911002A IMUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUFA11008 IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG9952 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authorities in a foreign country on 06 November 2012 (HA''s number PL-URPL-N1219/2012). A 01-month-old female patient, with no reported medical history, had received an intramuscular dose of EUVAX B (batch number UFA11008, site of administration not reported), an intramuscular dose of ACTHIB (batch number G9952-1, site of administration not reported), and an intramuscular dose of DTP (other manufacturer, batch number 20911002A, site of administration not reported) on 07 August 2012. On 07 August 2012, the day of the vaccination, the patient experienced unconsolable crying for 4 hours at the evening (one episode). The patient recovered on 07 August 2012. Reporter''s comment: "Child''s crying - expected reaction." The Health Authorities coded unconsolable crying.

VAERS ID:480066 (history)  Vaccinated:2012-08-07
Age:0.2  Onset:2012-08-29, Days after vaccination: 22
Gender:Female  Submitted:2013-01-02, Days after onset: 126
Location:Foreign  Entered:2013-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0843689A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA414AA0PO 
Administered by: Other     Purchased by: Other
Symptoms: Haematochezia, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: This case was reported by a physician and described the occurrence of bloody stools in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received 1st dose of ROTARIX (1.5 ml, oral). On 29 August 2012, less than one year after vaccination with ROTARIX, the subject experienced bloody stools. On 18 September 2012, the event was resolved. After the next vaccination with ROTARIX the event recurred. On an unspecified date, the subject received 2nd dose of ROTARIX (1.5 ml, oral). On 15 October 2012, less than one year after vaccination with ROTARIX, the subject experienced bloody stools again. The physician considered the events were clinically significant (or requiring intervention). On 29 October 2012, the event was resolved. The physician considered the events were related to vaccination with ROTARIX. Follow-up information received on 28 December 2012: On 7 August 2012, the subject received 1st dose of ROTARIX. On 29 August 2012, 22 days after vaccination with ROTARIX, the subject experienced bloody stool (occult blood: 262 ng/mL). On 18 September 2012, the event was resolved. On 9 October 2012, the subject received 2nd dose of ROTARIX. On 16 October 2012, 7 days after vaccination with ROTARIX, the subject experienced bloody stools (occult blood: more than 800 ng/mL). On 25 October 2012, the event was resolved.

VAERS ID:481778 (history)  Vaccinated:2012-08-07
Age:  Onset:2012-08-08, Days after vaccination: 1
Gender:Female  Submitted:2013-01-17, Days after onset: 162
Location:Foreign  Entered:2013-01-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 08Aug2012, 38deg.C
CDC Split Type: B0857926A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA782A SCUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERH007803 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose increased, Body temperature increased, Depressed level of consciousness, Grand mal convulsion, Hyperglycaemia, Salivary hypersecretion, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician via a regulatory authority (PL-URPL-OCR-20121222001) and described the occurrence of tonic clonic convulsion in a female subject of unspecified age who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline) and MMRVAXPRO (non-gsk). On 7 August 2012, the subject received an unspecified dose of INFANRIX-IPV/HIB (subcutaneous, administration site unknown) and an unspecified dose of MMRVAXPRO (subcutaneous, unknown). On 8 August 2012, at 2.45 am, 1 day after vaccination with INFANRIX-IPV/HIB and MMRVAXPRO, the subject experienced tonic clonic convulsion and salivation. Between 3 and 3.15 am, the subject experienced vomiting. At 4 am, body temperature increased. The subject was hospitalised in medium serious general condition. He also experienced obnubilation at the beginning. Tachycardia was observed at physical examination (155/min). In lab test, hyperglycemia was observed. The subject was treated with antipyretics. At the time of reporting, the events were improved.

VAERS ID:482857 (history)  Vaccinated:2012-08-07
Age:42.0  Onset:2012-08-08, Days after vaccination: 1
Gender:Female  Submitted:2013-01-29, Days after onset: 174
Location:Foreign  Entered:2013-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: L-THYROXIN; NEBILET; Formoterol fumarate
Current Illness: Endometriosis; Hypertension; Multiple allergies; Asthma; Immunisation
Preexisting Conditions: Thyroidectomy
Diagnostic Lab Data: 08/13/2012, Autoantibody test, No pathological findings; 08/09/2012, Blood culture, anaerobe and aerob:no growth; 08/10/2012, Blood glucose, 169; Blood glucose, 120/80; 08/09/2012, Blood thyroid stimulating hormone, <0.01; 08/10/2012, Blood thyroid stimulating hormone, <0.01; 08/13/2012, Blood thyroid stimulating, <0.01; 08/09/2012, Blood urine; C-reactive protein, 60; 08/09/2012, C-reactive protein, 188; 08/10/2012, C-reactive protein, 231.4; 08/13/2012, C-reactive protein, 3104; 08/082012, Chest x-ray, inconspicuous; 08/08/2012, Electrocardiogram, sinus tachycardia; 08/09/2012, Gamma-glutamyltransferase, 45; Hear rate, 100; 08/08/2012, Heart rate, 116; 08/09/2012, Thyroxine free, 3.02; 08/10/2012, Thyroxine free, 2.59; 08/09/2012, Tri-idi
CDC Split Type: WAES1209DEU003627
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.E007906 UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autoantibody negative, Blood culture negative, Blood glucose, Blood thyroid stimulating hormone decreased, Blood urine present, C-reactive protein increased, Chest X-ray normal, Electrocardiogram abnormal, Gamma-glutamyltransferase increased, General physical health deterioration, Injection site erythema, Injection site induration, Injection site warmth, Local reaction, Localised infection, Pyrexia, Sinus tachycardia, Staphylococcus test positive, Thyroxine free normal, Tri-iodothyronine free, Ultrasound abdomen normal, Urine analysis abnormal, Vaccination site pain, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad)
Write-up: Case was received from the Health Authorities on 06-Sep-2012 (reference number PEI2012029549). Case is medically confirmed. A 42-year-old female patient received a dose of PNEUMOVAX 23 (lot-no. was reported as E007906 but cannot be attributed to a SPMSD product) on 07-Aug-2012, injection route and site not reported. Later on that date, she developed fever up to 39 degrees C and local reaction. The patient was hospitalised. Laboratory: CRP increased (60, no unit reported) and white blood cell count increased (15.000, no unit reported). At the time of reporting to HA on 09-Aug-2012 symptoms were ongoing. Follow-up information received on 01-Oct-2012: The hospital report was forwarded by the HA. On 08-Aug-2012 the female patient experienced fever up to 39 degrees C and vaccination site pain (left upper arm) leading to hospitalisation on the same day. Four weeks before admission the patient had been starting L-THYROXIN 300 mg daily. Further concomitant medication included NEBILET 2.5 mg/day and FORMOTEROL 12 u. Patient''s medical history included asthma bronchial, multiple allergies (Acetylic salicylic acid, diclofenac, ibuprofen, indomatecin, VIOXX, metamizole, fructose), hypertension arterial, status post thyroidectomy and endometriosis. Physical examination showed slightly reduced general health condition and obese single status. The patient presented with a warm, reddened and indurated site on the left upper arm at the area of deltoid muscle. Blood culture (anaerobic and aerobic) on 09-Aug-2012 showed no growth. On 10-Aug-2012 Staphylococcus haemolyticus was found in urine. Autoimmune anti-bodies on 13-Aug-2012 were without pathological findings. Laboratory parameters were without findings except for the following: C-reactive protein: 09-Aug-2012: 188.0 mg/L/20-Aug-2012: 231.4 mg/L/13-Aug-2012: 31.4 mg/L; TSH: 09-Aug-2012: <0.01 ulU/ml/ 10-Aug-2012: <0.01 ulU/ml / 13-Aug-2012: <0.01 ulU/ml; Free T3: 09-Aug-2012: 4.96 pg/ml / 10-Aug-2012: 4.22 pg/ml; Free T4: 09-Aug-2012: 3.02 ng/dl / 10-Aug-2012: 2.59 ng/dl; Blood in urine: 09-Aug-2012:+++ White blood cell count: 09-Aug-2012: 10-Aug-2012: 10.5 / 13-Aug-2012: 5.9; 08-Aug-2012: ECG: revealed sinus tachycardia, heart rate 116/min and no indication for recent ischemia. 08-Aug-2012: Sonography abdomen revealed no pathological findings; 08-Aug-2012: Chest x-ray revealed no pathological findings; Initially the patient was treated with UNACID IV. Due to increasing infection parameters, treatment was changed to cefuroxime IV leading to significant decrease of infection parameters. Diagnosis of local infection after pneumococcal vaccination was established. The patient was discharged from hospital on 12-Aug-2012 in good condition. At the time of reporting, the outcome was reported as recovered/resolved by the HA. CASE IS CLOSED. Follow-up information received on 10-Jan-2013. Upon review by the manufacturer it was reported that the lot-no. E007906 is not a valid lot number.

VAERS ID:461335 (history)  Vaccinated:2012-08-08
Age:19.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-08-08, Days after onset: 0
Location:Tennessee  Entered:2012-08-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: ALLERGIES TO DOGS, CATS, DUST, BAHIA GRASS, KENTUCKY BLUE GRASS
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC010AB1IMRA
Administered by: Other     Purchased by: Private
Symptoms: Nausea, Pruritus generalised, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: NAUSEA & RASH ON BOTH ARMS, ITCHING ALL OVER BODY.

VAERS ID:461341 (history)  Vaccinated:2012-08-08
Age:11.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-08, Days after onset: 0
Location:Virginia  Entered:2012-08-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild cough
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0097460UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4343AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Patient felt nauseous & lightheaded after vaccines, no loss of consciousness. Had patient lay down with legs elevated, blood pressures normal, felt normal after 10 minutes & walked out of office without difficulty.

VAERS ID:461403 (history)  Vaccinated:2012-08-08
Age:20.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-08, Days after onset: 0
Location:New Jersey  Entered:2012-08-08
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: Sports induced asthma,
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Other
Symptoms: Abdominal discomfort, Chills, Dizziness, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad)
Write-up: Dizzy, achy muscles, upset stomach, headache, fever of 102 at 4:00 PM, chills at 7:00 PM. Advil 600 mg helped a bit.

VAERS ID:461404 (history)  Vaccinated:2012-08-08
Age:12.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-08, Days after onset: 0
Location:North Dakota  Entered:2012-08-08
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: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB550AA IMLL
HPV4: HPV (GARDASIL)MERCK & CO. INC.0022AE IMLL
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3843AA IMRL
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B071BB IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1274AA SCRL
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Head injury, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: WHILE STILL IN IMMUNIZATION ROOM PT STATED SHE FAINTED. SHE WAS STANDING AT THE TIME AND SHE FELL INTO A CHAIR AND HER FATHER TRIED TO CATCH HER GRABBING HER BY THE UPPER ARMS. REDNESS WAS VISIBLE ON HER UPPER ARMS. FATHER WAS UNSUCCESSFUL IN CATCHING HER AND SHE HIT THE BACK OF HER HEAD ON THE DOOR KNOB BEFORE HITTING THE FLOOR. SHE STATES SHE WAS NOT NAUSEATED OR DIZZY BUT THAT SHE SUDDENLY FAINTED. C/O BACK OF HER HEAD HURTING. NO HEALTHCARE PERSONNEL WAS PRESENT TO WITNESS AS STEPPED OUT OF THE ROOM TO OBTAIN IMMUNIZATION RECORD PRINT-OUT FROM PRINTER.

VAERS ID:461410 (history)  Vaccinated:2012-08-08
Age:16.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 1
Location:New Hampshire  Entered:2012-08-09
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
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis, Presyncope
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Sudden lightheaded, profuse sweating, nearly fainted. Sat with head down and ice on forehead and back of neck, given ice water. Symptoms passed within 5 minutes but came with no warning. Barely made it 3 steps to a chair; hate to think if she was driving when this occurred.

VAERS ID:461425 (history)  Vaccinated:2012-08-08
Age:15.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-08, Days after onset: 0
Location:Pennsylvania  Entered:2012-08-09, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.H0101450IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0104280IMRA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Feeling hot, Pallor, Presyncope
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 5-10 minutes after receiving vaccines, she became pale, felt warm & weak. She was given a cool cloth, water & a lollipop. She did not actually have syncope, only near-syncope. Observed longer.

VAERS ID:461440 (history)  Vaccinated:2012-08-08
Age:11.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-08-08, Days after onset: 0
Location:New York  Entered:2012-08-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU434AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU438AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: 15 minutes post immunization the patient experienced dizziness & nausea that was not relieved. He was sent to the ER for further evaluation.

VAERS ID:461469 (history)  Vaccinated:2012-08-08
Age:26.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 1
Location:Michigan  Entered:2012-08-09
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: none
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB533AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Pt was given the pediatric/adolescent dose of the Hepatitis A vaccine, instead of the adult dose. This was discovered about 5 minutes after pt was given the dose, by another medical assistant. Pt was told what happened, and tolerated the injection fine without complications.

VAERS ID:461477 (history)  Vaccinated:2012-08-08
Age:0.2  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 1
Location:California  Entered:2012-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B29BA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH6099A0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451350IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB217A0IMLL
Administered by: Military     Purchased by: Military
Symptoms: Incorrect route of drug administration
SMQs:
Write-up: Infant was given Rotarix by injection instead of by oral route.

VAERS ID:461481 (history)  Vaccinated:2012-08-08
Age:0.2  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 1
Location:California  Entered:2012-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS  IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEUR  IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  IMRL
Administered by: Military     Purchased by: Military
Symptoms: Incorrect route of drug administration
SMQs:
Write-up: Patient was given Rotarix injection instead of oral.

VAERS ID:461486 (history)  Vaccinated:2012-08-08
Age:10.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Male  Submitted:2012-08-09, Days after onset: 0
Location:Virginia  Entered:2012-08-09
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: Patient has seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC103AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1792AA SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Slight fever of 99. Redness at the injection site. Some itching at the injection site.

VAERS ID:461506 (history)  Vaccinated:2012-08-08
Age:10.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 1
Location:Pennsylvania  Entered:2012-08-09
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: Per parent-patient has a history of fainting
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Nausea, Unresponsive to stimuli
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt given HPV dose 1. Approximately 2-3 minutes later she became unresponsive sitting in chair. Ammonia capsule snapped and patient awoke, c/o nausea. Applied ice pack to neck and administered juice. Pt became more responsive, then moved to mat on the floor until she felt that she could sit in chair.

VAERS ID:461509 (history)  Vaccinated:2012-08-08
Age:18.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:New York  Entered:2012-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness reported by patients or patients parent at time of vaccination.
Preexisting Conditions: No Known Allergies or medical conditions per pediatrician, patient did have a right knee arthroscopy with a medial meniscus repair on 05/09/2012 or 05/10/2012
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4244AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Back pain, Chills, Headache, Neck pain, Oropharyngeal pain, Pain, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Arthritis (broad)
Write-up: Sudden onset of fever, chills, headache, neck and back pain, shaking, sorethroat, and body aches.

VAERS ID:461522 (history)  Vaccinated:2012-08-08
Age:4.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 1
Location:Oklahoma  Entered:2012-08-09
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
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALS 1  
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1  
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1  
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: Varicella and MMR where given within 10 days of a previous MMR, no adverse reactions seen as of this time.

VAERS ID:461523 (history)  Vaccinated:2012-08-08
Age:17.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-08-09, Days after onset: 1
Location:Michigan  Entered:2012-08-09
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: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB523AA IM 
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURG15001 SC 
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU4136AA IM 
Administered by: Public     Purchased by: Public
Symptoms: Immediate post-injection reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Client passed out seconds after receiving 3rd vaccination. He was passed out for about 20 seconds.

VAERS ID:461525 (history)  Vaccinated:2012-08-08
Age:5.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 1
Location:Florida  Entered:2012-08-09
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: Zero
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B213AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0660AE SCRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient had topical reaction to right arm. Patient also had hives around her mouth. Hives have disappeared, arm is still very swollen and red.

VAERS ID:461543 (history)  Vaccinated:2012-08-08
Age:10.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:New Mexico  Entered:2012-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1795AA1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: At 7:00 am patient''s mother notice a red, raised, itchy area at site of injection. Applied BENADRYL gel at 9:00 am. Will give BENADRYL orally this pm, cont. CLARITIN tomorrow.

VAERS ID:461554 (history)  Vaccinated:2012-08-08
Age:32.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:California  Entered:2012-08-09
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
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076DA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: H/A, chills, stomach ache, fever 103.6, nausea no vomiting. Received call from patient reporting symptoms above. Called at 415 pm. Has started taking ibuprofen q 6 hrs.

VAERS ID:461556 (history)  Vaccinated:2012-08-08
Age:11.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-08-08, Days after onset: 0
Location:Georgia  Entered:2012-08-10, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB586CA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1860AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3999AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3898BA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient received 4 vaccines at apprx 11:40 AM. At apprx 11:50 AM patient had a syncopal episode in the office, complaining just prior to that he began seeing gray spots.

VAERS ID:461601 (history)  Vaccinated:2012-08-08
Age:17.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Male  Submitted:2012-08-10, Days after onset: 1
Location:Texas  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA110521SYRRA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Feeling cold, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Felt dizzy, cold, had calicus on both hands, and had fever. Took Tylenol. Went to the emergency room to get checked out. Doctor stated adverse reaction to the meningitis immunization. The doctor gave Motrin.

VAERS ID:461635 (history)  Vaccinated:2012-08-08
Age:1.1  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-10, Days after onset: 1
Location:California  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0325AE IM 
HIBV: HIB (ACTHIB)SANOFI PASTEURUH573AA IM 
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC)MERCK & CO. INC.1884AA SC 
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH918246 IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H006852 SC 
Administered by: Public     Purchased by: Public
Symptoms: Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: REDNESS, SWELLING, AND ITCHY ON VACCINE ADMINISTRATION SITE.

VAERS ID:461688 (history)  Vaccinated:2012-08-08
Age:4.0  Onset:2012-08-10, Days after vaccination: 2
Gender:Female  Submitted:2012-08-10, Days after onset: 0
Location:Arizona  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Earache
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193BA4UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1404AA1SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF272904UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0611AE1SCUN
Administered by: Public     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: (L) arm redness 10+cm round patch w/ mild erythema minimal swelling no warmth, tenderness no fever.

VAERS ID:461689 (history)  Vaccinated:2012-08-08
Age:65.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-10
Location:D.C.  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Sulfa; Penicillin; Amoxicillin; Ampicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1601AA0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Inflammation, Injection site inflammation, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Multifocal rash with inflammation at inoculation site and contralateral arm and chest without fever/chills.

VAERS ID:461706 (history)  Vaccinated:2012-08-08
Age:4.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Male  Submitted:2012-08-10, Days after onset: 1
Location:Oregon  Entered:2012-08-10
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: Herpes; Gingivostomatitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4022AA4IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVBB522BA1IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0078AE1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0609AE1SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, 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: Some swelling at the site of injection, and since then it''s been growing increasing erythematous. It itches a little. Area, red, raised and hot and hard. No treatment (L) thigh.

VAERS ID:461707 (history)  Vaccinated:2012-08-08
Age:13.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-10, Days after onset: 2
Location:Alaska  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1291AA2SYRLA
Administered by: Public     Purchased by: Unknown
Symptoms: Gaze palsy, Immediate post-injection reaction, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Immediately after injection, patient eyes rolls, fainted, unresponsive for a short while. Attempted by caller her name, help her to exam table, head raised - observed x 30 minutes.

VAERS ID:461647 (history)  Vaccinated:2012-08-08
Age:51.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-11, Days after onset: 2
Location:Virginia  Entered:2012-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses
Preexisting Conditions: NKDA @ the time Patient has a diagnosis of Hypertension
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.HOO9779 SCRA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness and warmth to site of the injection.

VAERS ID:461648 (history)  Vaccinated:2012-08-08
Age:17.0  Onset:2012-08-10, Days after vaccination: 2
Gender:Female  Submitted:2012-08-11, Days after onset: 1
Location:Maryland  Entered:2012-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, pain and swelling at site of injection. Diameter of swelling approx. 1.5 inches. Following day, swelling increased to 2.5 inches.

VAERS ID:461659 (history)  Vaccinated:2012-08-08
Age:4.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-11, Days after onset: 2
Location:Texas  Entered:2012-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLL
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCLL
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCRL
Administered by: Private     Purchased by: Unknown
Symptoms: Decreased appetite, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: PATIENT COMPLAINED OF SEVERE ITCHING ON FACE, NECK, TORSO, ARMS. SHE HAD SMALL TO VERY LARGE (JOINED) HIVES FROM HER HIPS TO HER CHEEKS. SHE WAS QUIET AND DID NOT HAVE AN APPETITE. ITCHING AND HIVES HAVE REAPPEARED DAILY.

VAERS ID:461703 (history)  Vaccinated:2012-08-08
Age:0.4  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-11, Days after onset: 3
Location:New Hampshire  Entered:2012-08-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4268AA1IMLG
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9182421IMLG
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0055AE1PO 
Administered by: Private     Purchased by: Public
Symptoms: Injection site reaction, Irritability, Local reaction, Pyrexia, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: Prolonged, excessive irritability & screaming spells, fever & local reaction injection site lasting greater than 72 hrs. Similar reaction after initial vaccine series lasting 1-2 weeks (by parental history).

VAERS ID:461682 (history)  Vaccinated:2012-08-08
Age:0.0  Onset:2012-08-11, Days after vaccination: 3
Gender:Male  Submitted:2012-08-13, Days after onset: 2
Location:Unknown  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Complete rule out sepsis work up to include: CBC, LP, LFT, Chem 7, UA, Urine culture, blood culture, Chest XR, HSV PCR.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1047AA0IMLL
Administered by: Military     Purchased by: Military
Symptoms: Blood culture, Body temperature increased, Chest X-ray, Culture urine, Full blood count, Herpes simplex serology, Laboratory test, Liver function test, Lumbar puncture, Polymerase chain reaction, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Patient admitted to hospital for rule out sepsis after presenting to the E.D. with temperature of 102.5F.

VAERS ID:461699 (history)  Vaccinated:2012-08-08
Age:5.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-10, Days after onset: 1
Location:Ohio  Entered:2012-08-13, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4211AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13543SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0184AE1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0612AE1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site induration, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large local reaction to IPV (L) thigh 9 cm of induration BENADRYL 25 mg qid prn apply ice prn.

VAERS ID:461716 (history)  Vaccinated:2012-08-08
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2012-08-09
Location:Minnesota  Entered:2012-08-13, 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: Multivitamin
Current Illness: None
Preexisting Conditions: Heart murmur 8/18/08; VSD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4022AA UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR942440 UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1438AA UNUN
Administered by: Private     Purchased by: Private
Symptoms: Incorrect dose administered
SMQs:
Write-up: None other than adult dose given to pediatric patient.

VAERS ID:461772 (history)  Vaccinated:2012-08-08
Age:13.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Male  Submitted:2012-08-13, Days after onset: 4
Location:Minnesota  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No known illness.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)SANOFI PASTEURU3868AE IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0413AE SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 2-3 inch area around site of injection red and sore. Benadryl cream applied.

VAERS ID:461814 (history)  Vaccinated:2012-08-08
Age:83.0  Onset:2012-08-11, Days after vaccination: 3
Gender:Male  Submitted:2012-08-13, Days after onset: 2
Location:Pennsylvania  Entered:2012-08-13
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0364AE0SCLA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: PT CAME IN TO REPORT INJECTION SITE RXN - DID OBSERVE LOCALIZED REDNESS, NO WARMTH OR SWELLING, NO PAIN OR TENDERNESS REPORTED BY PT.

VAERS ID:461829 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-13, Days after onset: 5
Location:Kentucky  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0786Z0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEUR1U4304BA0UNRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1652AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Muscle twitching, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Mother brought pt back into office (pt walking) because in parking lot which mother states pt twitched & did not answer her for 2 minutes. Spontaneously recovered & in office was behaving normally, VSS left in stable condition.

VAERS ID:461873 (history)  Vaccinated:2012-08-08
Age:18.0  Onset:2012-08-10, Days after vaccination: 2
Gender:Female  Submitted:2012-08-10, Days after onset: 0
Location:Unknown  Entered:2012-08-13, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKA; No significant history.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal pain lower, Headache, Hypoaesthesia, Nasal congestion
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Called s/o with headache, lower abdominal pain, nasal stuffiness, (R) arm numbness. Pt. advised further evaluation in an urgent care.

VAERS ID:461862 (history)  Vaccinated:2012-08-08
Age:54.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-14, Days after onset: 6
Location:Pennsylvania  Entered:2012-08-14
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: allergy to bee stings
Diagnostic Lab Data: stable exam
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0294AE IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Paraesthesia oral, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad)
Write-up: Pt. reported throat tightening and lip tingling. No lip/tongue swelling/dysphonia/wheezing or vital sign instability, including stable oxygen saturation measured.

VAERS ID:461947 (history)  Vaccinated:2012-08-08
Age:63.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-11, Days after onset: 2
Location:Ohio  Entered:2012-08-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergy to doxycycline; PERCOCET; No unusual healthy conditions
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0097790SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: At injection site, itchy, red, warm to touch, 3 1/2" x 2" patch. Not resolving after 3 days - counseled to take TYLENOL/MOTRIN and ice. If gets worse, seek medical attention.

VAERS ID:461959 (history)  Vaccinated:2012-08-08
Age:61.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-14, Days after onset: 5
Location:California  Entered:2012-08-14
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: Patient report physician confirmed allergies and sensitivities to several substances including latex and cortisone. No reported sensitivity to vaccine components.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4325AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Oropharyngeal pain, Paraesthesia, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain, redness, swelling and small blister at injection site. This was followed by generalized symptoms of stomach ache, mild fever, headache, sore throat and tingling in leg. Symptoms continued to worsenand on advice of PMD went to ER where she received Benadryl and other medication on 8/13/12. As advised by ER, reported to us on 8/14/12. Patients states she is "ok" following treatment.

VAERS ID:461990 (history)  Vaccinated:2012-08-08
Age:0.2  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-13, Days after onset: 5
Location:Pennsylvania  Entered:2012-08-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Apparent life threatening event
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B329AB0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH526AB0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF636660IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1808AA0PO 
Administered by: Private     Purchased by: Private
Symptoms: Apparent life threatening event, Cyanosis, Erythema, Hypotonia, Pyrexia, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Taken to ER by ambulance after episode of facial cyanosis, turning limp, and not breathing for about 30sec. When tilted up had emesis and turned pink. When arrived at ER was found to have fever 38.9 degrees C.

VAERS ID:464069 (history)  Vaccinated:2012-08-08
Age:15.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-08-14, Days after onset: 6
Location:Pennsylvania  Entered:2012-08-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA005874
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a office administrator refers to a 15 years old male patient. The patient was vaccinated with dose 1 GARDASIL (lot #, dose and route not reported) on 17-JUL-2012. On 08-AUG-2012 the patient was vaccinated with dose 2 GARDASIL (lot #, dose and route not reported). No adverse experience had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:464076 (history)  Vaccinated:2012-08-08
Age:5.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-14, Days after onset: 6
Location:Unknown  Entered:2012-08-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004012
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report was received from a registered nurse refers to a 5 years old female patient who on 08-AUG-2012, was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (lot number not reported) instead of VARIVAX (Merck). No other co-suspects were reported. Concomitant vaccines included KINRIX and MMR II administered during the same office visit on 08-AUG-2012. The registered nurse reported that on 08-AUG-2012, the patient demonstrated injection site pain, as evidence by"I could hear her screaming down the hall". No treatment was given for the experience. At the time of the report, the registered nurse stated that the patient was stable. It was unspecified if the patient sought medical attention. The relatedness for the patient demonstrated injection pain was unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:462005 (history)  Vaccinated:2012-08-08
Age:5.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-15, Days after onset: 6
Location:Pennsylvania  Entered:2012-08-15
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
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193BA0UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0184AE1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0065381UNLA
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: Round red warm to touch 3cm slightly elevated "mark" around injection site both arms.

VAERS ID:462053 (history)  Vaccinated:2012-08-08
Age:11.0  Onset:2012-08-11, Days after vaccination: 3
Gender:Female  Submitted:2012-08-15, Days after onset: 4
Location:Wisconsin  Entered:2012-08-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU38570IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B0750IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: RASH AND "LUMP" AT INJECTION SITE. RED/PAINFUL.

VAERS ID:462089 (history)  Vaccinated:2012-08-08
Age:56.0  Onset:0000-00-00
Gender:Male  Submitted:2012-08-15
Location:New Jersey  Entered:2012-08-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins
Current Illness: None
Preexisting Conditions: Arthritis; Spinal stenosis; Allergic sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH350AA0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Developed nickel size hive on forearms 5 days after YF shot. Denies any other symptoms. Taking Thuja Occidentalis from accupuncturist.

VAERS ID:462090 (history)  Vaccinated:2012-08-08
Age:67.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-08-14, Days after onset: 6
Location:Florida  Entered:2012-08-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0240AE0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Erythema, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Few hours after receiving vaccine patient started experiencing shoulder/arm pain. Got so bad he went to ER, came to office 8/14, had developed linear array of microvessicles & redness 2.5" long.

VAERS ID:462108 (history)  Vaccinated:2012-08-08
Age:16.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-08-15, Days after onset: 7
Location:Virginia  Entered:2012-08-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA005406
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This spontaneous report as received from a physician via a field employee refers to a male patients of 16-18 age. The patient was vaccinated intramuscularly with 0.5 ml GARDASIL (lot# was unknown) on 08-AUG-2012 and passed out after vaccinated. The patient sought medical attention. The doctor doesn''t believe that it was due to the vaccine, he believed it was because the patient were nervous about getting shot in general. The outcome of passed out was unknown. The doctor didn''t want to be contacted regarding this AE. Upon internal review, the pass out was considered as medically significant. This is one of the same report received from the same source. Additional information is not expected.

VAERS ID:462132 (history)  Vaccinated:2012-08-08
Age:76.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-15, Days after onset: 6
Location:Washington  Entered:2012-08-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic asthma
Preexisting Conditions: Sulfa; PCN; Echinacea; Nystatin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0693AA SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site mass, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 24 hours post vaccination site with redness & elongated lump. Temp to 101 degrees. Upper arm swollen from shoulder to elbow. On 8/15/12 (in Dr''s office for a different issue) no redness. Afebrile but palpable elongated lump remains.

VAERS ID:464307 (history)  Vaccinated:2012-08-08
Age:20.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Male  Submitted:2012-08-15, Days after onset: 6
Location:New York  Entered:2012-08-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004437
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Chest pain
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This spontaneous report as received from a pharmacist refers to his son a 20 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated with 0.5 ml GARDASIL (Lot # and duration were unspecified) on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were used. The father of the patient reported that his son was experiencing chest pain and back pain on 09-AUG-2012, "the day after receiving GARDASIL". The patient had sought medical attention via contacting his father who was also a pharmacist. No lab diagnostics studies performed. Treatment of ADVIL was given for the AE. The outcome was reported as not recovered/not resolved. Additional information has been requested.

VAERS ID:464325 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-16, Days after onset: 8
Location:Texas  Entered:2012-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004082
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated IM with the first dose of GARDASIL in approximately 2011 ("about 1 year ago") and would be vaccinated with the second dose of GARDASIL on 08-AUG-2012. No known adverse effects. Additional information has been requested.

VAERS ID:464500 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-16, Days after onset: 8
Location:Georgia  Entered:2012-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004612
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: This spontaneous report as received from a doctor of pharmacist refers to a newborn patient. The patient was inadvertently vaccinated IM with a dose of PNEUMOVAX23 (0.5 ml, lot# not reported) instead of RECOMBIVAX HB Pediatric dose on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information is not expected.

VAERS ID:465003 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-17, Days after onset: 9
Location:Unknown  Entered:2012-08-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004184
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with VARIVAX (Lot#, route, dosage unspecified) instead of ZOSTAVAX on 08-AUG-2012. No symptoms reported. Additional information has been requested.

VAERS ID:462330 (history)  Vaccinated:2012-08-08
Age:55.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-18, Days after onset: 10
Location:Massachusetts  Entered:2012-08-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRA
Administered by: Unknown     Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Had dizziness after injection. Felt better that night.

VAERS ID:465808 (history)  Vaccinated:2012-08-08
Age:21.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-19, Days after onset: 11
Location:New York  Entered:2012-08-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA005356
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: This spontaneous report as received from a mother refers to a 21 year old patient. The patient was vaccinated respectively with first and second dose of GARDASIL in August-2011 (reported as "a year ago") and on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. Additional information has been requested. This is one of several reports received from same source.

VAERS ID:465826 (history)  Vaccinated:2012-08-08
Age:16.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-19, Days after onset: 11
Location:New York  Entered:2012-08-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004513
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: This spontaneous report as received from a mother refers to a 16 year old patient. The patient was vaccinated respectively with first and second dose of GARDASIL in August-2011 (reported as one year ago) and on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was unknown of the patient had sought medical attention. Additional information has been requested. This is one of several reported received from same source.

VAERS ID:465908 (history)  Vaccinated:2012-08-08
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-19
Location:Unknown  Entered:2012-08-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions: Penicillin (unspecified); Antimicrobial (unspecified)
Diagnostic Lab Data:
CDC Split Type: WAES1208USA006138
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a healthcare student refers to a 54 years old female patient with allergic to penicillin and allergic to cephalosporins. The patient had no pertinent medical history. The patient was vaccinated with ZOSTAVAX (lot umber 0562AE, expired date was unknown) (dose and injection site were not reported) subcutaneously on 08-AUG-2012. No other co-suspects were reported. There were no concomitant medications. At some unspecified time point after this vaccination in August 2012, the patient experienced a "red, golf ball sized swollen area at the site of injection". No treatment information was reported. The patient current status was unknown. There was no laboratory diagnostics performed. The patient''s family had called the pharmacy for medical attention. Additional information is not expected.

VAERS ID:462393 (history)  Vaccinated:2012-08-08
Age:17.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-08-14, Days after onset: 6
Location:Oklahoma  Entered:2012-08-20, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1745AA2SYRLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13052SCRA
Administered by: Public     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Client in room 10 min after injections left & fainted in lobby in chair. Did not have breakfast or anything to eat prior to coming to health department was given food & drink before leaving health department.

VAERS ID:462446 (history)  Vaccinated:2012-08-08
Age:45.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-08-20, Days after onset: 12
Location:Wisconsin  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None stated
Preexisting Conditions: No allergy to MMR or Neomycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0009AE SC 
Administered by: Private     Purchased by: Private
Symptoms: Cough, Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Hives difficulty breathing including cough within about 30 min. of the MMR vaccine. Treated in Emergency Room with epinephrine and "breathing treatment". Resolved.

VAERS ID:462531 (history)  Vaccinated:2012-08-08
Age:70.0  Onset:2012-08-10, Days after vaccination: 2
Gender:Female  Submitted:2012-08-11, Days after onset: 1
Location:Minnesota  Entered:2012-08-20, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0423AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Injection site rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 2 white bumps around where vaccine was administered. Pt also has a red area about 2x4. She says it doesn''t itch & is not painful. Pt will start to use Hydrocortisone cream.

VAERS ID:466324 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-20, Days after onset: 12
Location:Unknown  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004195
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
SMQs:
Write-up: This spontaneous report has been received from a Bachelor of Science in Nursing refers to a patient who was vaccinated with the third dose of VAQTA on 08-AUG-2012 in the morning. The patient received the first dose of VAQTA in 2003 and the second in 2006. No symptoms were reported. It was unknown if the patient sought medical attention. At the time of report, the patient''s status was unknown. Additional information has been requested.

VAERS ID:462664 (history)  Vaccinated:2012-08-08
Age:72.0  Onset:2012-08-11, Days after vaccination: 3
Gender:Unknown  Submitted:0000-00-00
Location:North Carolina  Entered:2012-08-21
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
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC046CA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B087CB0UNRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received Tdap per Dr request on 8-8-12 Pt in on 8/13/12 stating (R) upper arm swelling with redness at injection site and towards inside of arm.

VAERS ID:462696 (history)  Vaccinated:2012-08-08
Age:4.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-10, Days after onset: 2
Location:Washington  Entered:2012-08-21, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1014AA1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0609AE1SCRL
Administered by: Public     Purchased by: Public
Symptoms: Injection site induration, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Sub Q injection (R) lateral thigh developed 4-5 cm area of induration, pruritic.

VAERS ID:462740 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-19, Days after vaccination: 11
Gender:Male  Submitted:2012-08-18, Days after onset: 1
Location:Unknown  Entered:2012-08-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Other
Symptoms: Blister, Injection site reaction, Papule, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow)
Write-up: Injection site reaction, blisters-vesicles. Skin reaction of papules and vesicles. Mild varicella form eruption. 1 week duration.

VAERS ID:466489 (history)  Vaccinated:2012-08-08
Age:64.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-22, Days after onset: 14
Location:Unknown  Entered:2012-08-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions: COMPAZINE; Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1206USA004702
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report as received from a 64 years old female consumer with COMPAZINE allergy and no other pertinent medical history refers to herself. The patient was vaccinated with a dose of ZOSTAVAX on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-AUG-2012, a few hours after vaccination, the patient experienced headache and injection site soreness. The patient had been taking TYLENOL. But it was not relieving her headache. The patient had not sought any medical attention. No lab diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information is not expected.

VAERS ID:463012 (history)  Vaccinated:2012-08-08
Age:4.0  Onset:2012-08-14, Days after vaccination: 6
Gender:Male  Submitted:2012-08-23, Days after onset: 9
Location:Arizona  Entered:2012-08-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193CA4IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0325AE1IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0233AE1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0610AE1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Patient began vomiting and also endured fever after 1 week of having injections.

VAERS ID:466706 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-19, Days after onset: 11
Location:Michigan  Entered:2012-08-23, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004697
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a consumer refers to her daughter. The patient was vaccinated IM with the first and second dose of 0.5 ml GARDASIL in June 2011 and on 08-AUG-2012 separately. Now, she did not known if she would get the third dose or if she must start the series of shots all over again. It was unknown if the patient sought medical attention or not. No adverse reactions reported. Additional information has been requested.

VAERS ID:463315 (history)  Vaccinated:2012-08-08
Age:23.0  Onset:2012-08-15, Days after vaccination: 7
Gender:Female  Submitted:2012-08-27, Days after onset: 12
Location:Unknown  Entered:2012-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sexually transmitted disease; Drug hypersensitivity
Preexisting Conditions: Penicillin (unspecified), Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1208USA008859
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report as received from a medical assistant refers to a 23 years old female patient with penicillin allergy and unspecified sexually transmitted disease. The patient was intramuscularly vaccinated at left deltoid with first dose of 0.5 ml GARDASIL (Lot# reported as 0636AE, Exp date 09-JAN-2015) on 08-AUG-2012. No other co-suspects were reported. Concomitant medications included NUVARING, flaxseed oil, biotin, Vitamin B-12, fiber (unspecified) and doxycycline (to treat sexually transmitted disease). The medical assistant reported that the patient experienced pain at the injection site on 08-AUG-2012 when she received the vaccine. The medical assistant then spoke to the patient on 10-AUG-2012 and the patient said she was experiencing less pain. On 13-AUG-2012 the patient said her arm was "hurting more". The medical assistant spoke with the patient again on 15-AUG-2012 and the patient said she was experiencing severe pain of her arm and she cannot move her arm. There was no redness and no warmth. The patient had sought medical attention via calling office. No lab diagnostics studies performed and no treatment was given for the adverse event. The outcome was reported as not recovered/not resolved. Pain at the injection site, severe pain of her arm and she cannot move her arm were considered to be significant disability or incapacity by reporter. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:463354 (history)  Vaccinated:2012-08-08
Age:65.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:New York  Entered:2012-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0073AE0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site reaction, Rash vesicular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Approx 1" vesicular eruption around injection site surround by 5-6" bordered red zone. Recommended ice, MOTRIN 600 BID & BACTRIM DS BID x 1 week.

VAERS ID:463380 (history)  Vaccinated:2012-08-08
Age:17.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 20
Location:Florida  Entered:2012-08-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No.
Preexisting Conditions: Allergy to eggs. Reaction stomach ache, purple circles in the skin under the eyes.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4238AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Dizziness, Hypoaesthesia, Vision blurred
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Client just had the HPV vaccine, and after 5 minutes approximately, she had a seizure of about 20 seconds. She was sweating, and had blurry eyes. She was sitted and Nurse was holding her. She complained of numbness in the left hand, the same arm where HPV was given. At 13:13 she complained again of dizziness.

VAERS ID:463803 (history)  Vaccinated:2012-08-08
Age:3.0  Onset:2012-08-25, Days after vaccination: 17
Gender:Male  Submitted:2012-08-31, Days after onset: 6
Location:Texas  Entered:2012-08-31
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: Examination of rash
CDC Split Type: TX120044PR
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0065371SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema multiforme, Rash pruritic
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Erythema multiforme on 8/25/12. Treatment included Benadryl 12.5 mg/5ml oral liquid 1.5 tsp q 6h prn itching/rash and orapred ODT, 2 tabs dissolved by mouth qd x 3 days then 1 tab qd for 2 days.

VAERS ID:463855 (history)  Vaccinated:2012-08-08
Age:63.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-08-31, Days after onset: 23
Location:Florida  Entered:2012-08-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.11001070SCRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site discolouration, Injection site erythema, Injection site haematoma, Injection site scar
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Red scar at the site where the needle penetrated the skin. Around the area is discolored, it looks like a bruise. It appeared after (the same days as the) vaccine was administered.

VAERS ID:468591 (history)  Vaccinated:2012-08-08
Age:67.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-09-04, Days after onset: 26
Location:Illinois  Entered:2012-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1208USA005958
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0421AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report as received from a Doctor of pharmacy refers to a 67 years old female patient with a history of allergies and no known drug reactions. On 08-AUG-2012, the patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX. The pharmacist reported that on 09-AUG-2012 the patient experienced redness and itchiness at injection site after receiving ZOSTAVAX the patient sought medical attention by calling the pharmacist. No treatment for the adverse event was given. Laboratory and diagnostics were not performed. The outcome of itchiness at injection site and redness at injection site was reported as not recovered. Additional information is not expected.

VAERS ID:464144 (history)  Vaccinated:2012-08-08
Age:54.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-09-05, Days after onset: 28
Location:Pennsylvania  Entered:2012-09-05
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0365AE0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Axillary mass, Erythema, Injection site discomfort, Injection site swelling, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Pruritus, Rash papular, Swelling face
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: 8/8/12 patient received vaccination subcutaneously in Right upper posterior arm. 8/21/12 patient phoned to report that she believes she may have had a reaction to the Zostavax. Relates the following events: 8/8/12 - several hours after the vaccination experienced injection site swelling and discomfort. 8/9/12 noted lumps under her Right arm. 8/13/12 noted throbbing pain in Right scapula area and down Right arm, she also noted red swollen papule type lumps approx. 5mm in diameter that were surrounded by a dark red area. These were not vesicles. 8/22/12 referred to company physician noted she did not exhibit classic vesicles or crusting of HSV, prescribed Lyrica, Atarax, and Tylenol #3. Referred to her PCP for fup on 8/27/12. 8/27/12 saw PCP in fup. Experienced swelling in face, legs, and feet which the Dr. related to the Lyrica, Lyrica was discontinued and a course of Prednisone was started and pt is using hydrocortisone cream under her arm for the itch. 8/31/12 fup appt with PCP, no further treatment.

VAERS ID:464151 (history)  Vaccinated:2012-08-08
Age:24.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Male  Submitted:2012-09-05, Days after onset: 28
Location:New York  Entered:2012-09-05
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: Blood pressure and Blood glucose
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB554AA0IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG15410IMRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH349AA0SCRA
Administered by: Unknown     Purchased by: Private
Symptoms: Blood glucose normal, Depressed level of consciousness, Disorientation, Dyspnoea, Immediate post-injection reaction, Pallor, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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), Hypersensitivity (narrow)
Write-up: Patient and his wife stated that he has had a history of fainting when recieving shots and requested to lay down on the floor. He laid down on the floor prior to recieving vaccines. He recieved 3 vaccines at this time and was speaking while he recived the first 2 (Typhoid and yellow fever). During the administration of the 3rd vaccine (Hep A) pt turned pale and stopped speaking. Pt was breifly unresponsive, but was having labored breathing. Ammonia tablet used to help pt become alert. 911 was called for help. Pt became alert and oriented after being unresponsive for about 30 seconds. Pt was alert and oriented to person place and time. BP was 117/60 and pt''s breathing was normal at this time. EMS arrived and monitored pt''s BP for about 30 minutes. Blood glucose leverl was taken and was stable. PT was stable and was not complaining of any syncope at this time. Pt declined to be taken to the Emergency department for evaluation. Pt was driven home by his wife. A follow up call was made several hours after the incident and pt stated that he was feeling fine.

VAERS ID:464340 (history)  Vaccinated:2012-08-08
Age:8.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 20
Location:Illinois  Entered:2012-09-06, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM1441AA0SYRRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0675AA1SYRLA
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: Red raised patch at the injection site on the (R).

VAERS ID:464458 (history)  Vaccinated:2012-08-08
Age:17.0  Onset:2012-08-10, Days after vaccination: 2
Gender:Male  Submitted:2012-09-07, Days after onset: 28
Location:Colorado  Entered:2012-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: UA 08/16/12 --$g clear
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4237AA1IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Oliguria, Urine analysis normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Tumour lysis syndrome (broad)
Write-up: On Friday 08/10/12, patient started to experience oliguria told mom 8/15/12. Visited PA on 08/16/12. UA came back clear. Started on Antibiotic & Tamsulosin 8/17/12. By 8/19/12, symptoms subsided & medication stopped.

VAERS ID:466834 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-28, Days after vaccination: 20
Gender:Unknown  Submitted:2012-09-07, Days after onset: 10
Location:Unknown  Entered:2012-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA001840
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a physician assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of VAQTA (lot number, dose and injection site were not known) intramuscularly on 09-APR-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced patient received VAQTA on 09-APR-2012 and on 28-AUG-2012. No known adverse effects. It was unspecified if the patient had sought medical attention. Additional information has been requested.

VAERS ID:464525 (history)  Vaccinated:2012-08-08
Age:13.0  Onset:2012-08-14, Days after vaccination: 6
Gender:Male  Submitted:2012-08-28, Days after onset: 14
Location:Montana  Entered:2012-09-10, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Did all types of viral testing all were negative - treated for Herpes and West nile both came by negative - dia was meningitis probably viral
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1508AA1UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4287AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4008AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0610AE1UNRA
Administered by: Public     Purchased by: Private
Symptoms: Convulsion, Headache, Herpes simplex serology negative, Loss of consciousness, Meningitis viral, Pyrexia, Viral test negative, West Nile virus test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Headache Tues 8/14/12 & fever. 5:30 Seizure Wed (went uncon.) 8/15/12 was ambulance / air to hospital then to hospital in another city by air.

VAERS ID:464582 (history)  Vaccinated:2012-08-08
Age:26.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Male  Submitted:2012-09-09, Days after onset: 31
Location:Wisconsin  Entered:2012-09-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Diabetes
Diagnostic Lab Data: Inflamation of the Synovium tissue
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AA20IMRA
Administered by: Other     Purchased by: Other
Symptoms: Immobile, Musculoskeletal pain, Musculoskeletal stiffness, Pain, Soft tissue inflammation
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Shoulder Pain, Stiffness, Soreness, Immobility, Treated with Ibuprofen 800mg with no effect.

VAERS ID:464866 (history)  Vaccinated:2012-08-08
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2012-09-11
Location:California  Entered:2012-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRIVIT drops; Acetaminophen elix.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196CA0IMLL
Administered by: Private     Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: None - A/E. Pt given vaccine for children 4+ yrs old at 2 mos.

VAERS ID:464938 (history)  Vaccinated:2012-08-08
Age:58.0  Onset:2012-08-12, Days after vaccination: 4
Gender:Female  Submitted:2012-09-11, Days after onset: 30
Location:New Jersey  Entered:2012-09-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: High blood pressure
Preexisting Conditions: Hypertension
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0705AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4188AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.170620UNRA
Administered by: Private     Purchased by: Private
Symptoms: Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)
Write-up: Loss of sensation in 1st & 2nd lt finger.

VAERS ID:464976 (history)  Vaccinated:2012-08-08
Age:13.0  Onset:2012-08-14, Days after vaccination: 6
Gender:Male  Submitted:2012-08-28, Days after onset: 14
Location:Montana  Entered:2012-09-13, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Did all types of viral testing all were negative - treated for Herpes and West Nile both came by negative - dia was meningitis probably viral
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1508AA1UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4287AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4008AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0610AE1UNLA
Administered by: Public     Purchased by: Private
Symptoms: Convulsion, Headache, Herpes simplex serology negative, Loss of consciousness, Meningitis viral, Pyrexia, Viral test negative, West Nile virus test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Headache Tues 8/14/12 & fever. 5:30 seizure Wed (went uncon.) 8/15/12. Was ambulance / air to another location then to hospital in another city by air.

VAERS ID:465268 (history)  Vaccinated:2012-08-08
Age:47.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 40
Location:Vermont  Entered:2012-09-17
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: Asthma; Crohn''s; Granuloma annulare; Allergies to penicillin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema nodosum, Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pain, Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Arm was sore immediately. The next morning, developed painful red, large, raised irregular lumps around injection site. Lumps were approximately 1cmx2cm, and were scattered around and below the injection point in an area that was 10cm x 10cm. There were approximately 5-6 lumps. No fever, no itching, no breaks in the skin, no shortness or breath, otherwise felt ok. Saw Occupational medicine MD who thought that the condition looked like erythema nodusum. Saw dermatologist (curbside consult) who agreed. Appt schedule for 4 days later, rash had resolved by then.

VAERS ID:465464 (history)  Vaccinated:2012-08-08
Age:6.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Male  Submitted:2012-08-13, Days after onset: 4
Location:Tennessee  Entered:2012-09-18, Days after submission: 36
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: TN1210
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B136BB3IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB522BA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10831SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1768AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0700AE1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Nausea
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: On 8/9/12 child complained of nausea & headache - TYLENOL given & felt better & went to school. Night of 8/9/12 area around the injection site had swelling, redness, hardness, & hot to touch - gave BENADRYL & MOTRIN. 8/10/12 - swelling, redness, & hot to touch was down front of (L) arm - taken to walk in clinic & prescribed prednisolone 15 mg x 10 days. Mother states injection site was "upper (L) arm below the shoulder."

VAERS ID:465765 (history)  Vaccinated:2012-08-08
Age:28.0  Onset:2012-08-10, Days after vaccination: 2
Gender:Female  Submitted:2012-09-20, Days after onset: 41
Location:Georgia  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB225AA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1576AA SCRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080CA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H007609 SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left arm swollen in area where Varicella vaccine was administered. Pt used cool compresses to area.

VAERS ID:471085 (history)  Vaccinated:2012-08-08
Age:91.0  Onset:2012-08-20, Days after vaccination: 12
Gender:Male  Submitted:2012-09-28, Days after onset: 39
Location:Florida  Entered:2012-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA010519
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Herpes zoster ophthalmic, Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Ocular infections (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a physician (then the physician handed to the phone to the healthcare worker for additional reporting) refers to a 91 years old male patient with none pertinent medical history and none drug reactions/allergies, who was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 08-AUG-2012. On 20-AUG-2012 the patient developed shingles following vaccination. The physician described the rash as a red, macular rash in the right trigeminal area of the face, right eye and temple are. The physician reported that the rash was migrating over to the left side. The patient sought medical attention, by office visit on 22-AUG-2012. Antivirals (unspecified) and corticosteroids (unspecified) were given as a treatment. None lab diagnostics studies were performed. At the time of report the patient''s status was not recovered. The relatedness for shingles was not reported for ZOSTAVAX by reporting physician. Additional information has been requested.

VAERS ID:468705 (history)  Vaccinated:2012-08-08
Age:18.0  Onset:2012-08-17, Days after vaccination: 9
Gender:Male  Submitted:2012-10-10, Days after onset: 54
Location:South Carolina  Entered:2012-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: LABS: 8/2012: CBC w/diff: wnl except: Monocytes: 1.1H, Basophils 0.0L, Neutrophils 5.44H; Heat Stroke Panel: wnl except: CK 354H, LDH 228H. 8/23/12: CBC w/diff: wnl except Lymphocytes 16.1L, Basophiles 0.0L; CMP wnl. 8/24/12: CBC w/diff: wnl except Lymphocytes 10.1L, Basophiles 0.0L; CMP wnl. 8/23/12: NCS/EMG: Sensory-motor polyneuropathy with demyelinating features-may represent acute inflammatory demyelinating polyneuropathy (Guillain-Barre syndrome). Additional slowing is seen over (at least) right carpal tunnel, left retroepicondylar groove and left anterior tarsal tunnel. 8/24/12 Modified speech/swallow test: abnormal examination with audible aspiration drinking thin and honey consistencies. The thicker consistencies resulted in a larg
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ADEN_4_7: ADENOVIRUS TYPES 4 & 7, LIVE, ORAL (NO BRAND NAME)TEVA PHARMACEUTICALS  PO 
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB251AA UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4284AA UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B085AA UNRA
Administered by: Military     Purchased by: Military
Symptoms: Asthenia, Back pain, Balance disorder, Barium swallow abnormal, Basophil count decreased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Chest discomfort, Coordination abnormal, Cough, Differential white blood cell count abnormal, Dysphagia, Dyspnoea, Electromyogram abnormal, Fatigue, Full blood count abnormal, Gait disturbance, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia, Immunoglobulin therapy, Inflammation, Injection site pain, Intensive care, Lymphocyte count increased, Metabolic function test normal, Monocyte count increased, Musculoskeletal pain, Nasal congestion, Neck pain, Nerve conduction studies abnormal, Neurological examination normal, Neutrophil count normal, Organic erectile dysfunction, Paraesthesia, Productive cough
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Arthritis (broad), Myelodysplastic syndrome (broad)
Write-up: The pt arrived on 8/7/12. He received multiple vaccinations on 8/8/12 at which time he was in his normal state of good health. He reported that he had no local reactions (erythema, pain, swelling or tenderness). Additionally he denied any systemic reactions (headache, body aches, fever, chills, N, V, diarrhea). The pt noted a "pins and needles" sensation in his toes and fingers on 8/17/12 which progressed to his hands and feet the same day. He reported to medical on 8/20/12. At that time he was afebrile and his neurological exam was normal. The pt was started on Prednisone 60mg/day for inflammation. On 8/21/12 the pt noted "chest tightness" which he described as "difficulty taking an adequate breath" and no change in the tingling in his hands and feet--his neuro exam was normal and the pt was placed on 48 hours SIQ. On 8/23/12 the pt complained of left shoulder pain (6/10) with numbness and tingling in his arms and legs and difficulty walking due to "weakness". On PE grip weakness (L$gR), left shoulder weakness, an abnormal wide gait and decreased reflexes of L4 were noted. The pt was referred to Neurology and was subsequently admitted to Hospital with the diagnosis of Guillain-Barre Syndrome. On admission to the hospital the pt reported new onset of: difficulty swallowing; pain in his left deltoid, mid back and neck; and a mild cough and nasal congestion. He was noted to have decreased BUE/BLE reflexes and motor strength, bilateral weak grip strength and impaired coordination on exam. A NCS and Swallow test were performed (both were abnormal: see results below); the pt was admitted to ICU and started on IVIG 500mg/kg/day for 4 days. He denied incontinence (bowel or bladder) but he did state that he was no longer experiencing morning or night time erections. The pt also reports that his cough worsened and from 8/24-8/26 his cough was productive with thick yellow secretions. He denied rhinorrhea, sneezing, fever, chills, N, V, diarrhea. The pt was NPO and self suctioned to manage his secretions (he was able to move his right forearm). When the pt was transferred to the acute rehab center on 8/28/12 he was able to move all four extremities although with difficulty. His strength was 4/5 in all four extremities and he was areflexic. A repeat swallow test showed improvement. Intensive speech, physical and occupational therapy were initiated. A review of medical records of 9/26/12 indicate that the pt is able to ambulate without assistance; his strength and endurance continue to improve although the pt requires rest breaks during therapy secondary to fatigue; the pt performed lower than expected on standard balance testing. The pt remains at the acute rehab center.

VAERS ID:474741 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-10-17, Days after onset: 70
Location:Unknown  Entered:2012-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA006069
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1733AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.

VAERS ID:471381 (history)  Vaccinated:2012-08-08
Age:17.0  Onset:2012-09-07, Days after vaccination: 30
Gender:Male  Submitted:2012-10-19, Days after onset: 42
Location:Maryland  Entered:2012-10-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA007955
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare worker refers to a 17 years old male patient. The patient was vaccinated intramuscularly in the left arm with the first 0.5 ml dose of GARDASIL on 20-DEC-2011. The second dose was administered on 08-AUG-2012 and the third dose (Lot # 0636AE, in validation, expiration date 09-JAN-2015) was given too early on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.

VAERS ID:475995 (history)  Vaccinated:2012-08-08
Age:61.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-22
Location:Unknown  Entered:2012-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA008827
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0018AE SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site rash, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a 61 years old female patient. The patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneous on 08-AUG-2012 "it was recommended due to her age". Lot# was reported as 0018AE, exp date September 2013 (lot verification result pending). It was reported that after getting ZOSTAVAX, the patient experienced itchiness all over her body and erythema and a rash at the injection site. On 14-SEP-2012 she was prescribed hydroxyzine and a topical steroid cream. The pharmacist hadn''t see her since she picked up the prescription so he didn''t have additional information on her current status. Additional information has been requested.

VAERS ID:479730 (history)  Vaccinated:2012-08-08
Age:3.0  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-12-04, Days after onset: 117
Location:Unknown  Entered:2012-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Immunisation
CDC Split Type: WAES1211USA012590
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Pyrexia, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a nurse refers to a 3 years old female patient. The patient was vaccinated with, .5 ml VARIVAX on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 the patient experienced fever of 104.5 degrees fahrhenheit, 2 days after onset of therapy and small red dots on back. The patient received ADVIL as treatment. The outcome of fever of 104.5 degrees fahrenheit and small red dots on back was reported as recovered/resolved. The relatedness for fever of 104.5 degrees fahrenheit and small red dots on back is unknown for VARIVAX (Merck). Additional information has been requested.

VAERS ID:477837 (history)  Vaccinated:2012-08-08
Age:12.0  Onset:2012-08-22, Days after vaccination: 14
Gender:Female  Submitted:2012-12-06, Days after onset: 106
Location:Iowa  Entered:2012-12-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA009610
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAAARB549UA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0097460IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR44243AA0IMUN
VARCEL: VARICELLA (VARILRIX)GLAXOSMITHKLINE BIOLOGICALS0410AE1SCLA
Administered by: Other     Purchased by: Other
Symptoms: Skin papilloma
SMQs:
Write-up: This spontaneous report as received from a licensed practical nurse refers to an approximately 12-year old female patient with no pertinent medical history and drug reactions/allergies. On 08-AUG-2012, the patient was vaccinated with dose 1 of 0.5 milliliter (ml) GARDASIL (lot number and expiry date were not reported) intramuscularly. No concomitant medications were reported. Approximately on 22-AUG-2012 (reported as 2 weeks after vaccination) the patient developed plantar warts. Warts were not cultured and no lab diagnostic studies were performed. The patient sought medical attention for the events by calling the physician. No treatment was given. The outcome of the event was unknown at the time of this report. Additional information has been requested.

VAERS ID:477386 (history)  Vaccinated:2012-08-08
Age:1.3  Onset:2012-08-09, Days after vaccination: 1
Gender:Female  Submitted:2012-12-10, Days after onset: 123
Location:Montana  Entered:2012-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B149BA IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1785AA IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF63667 IMRL
Administered by: Public     Purchased by: Public
Symptoms: Blister, Injection site vesicles
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: Mother reports that the evening that child received varicella injection that child developed a few fluid filled lesions at site of injection. The following morning the child had fluid filled lesions over her legs, back and to a lesser extent her arms. PMD called, who said that the symptoms were similar to chickenpox and said to stay home since child was not otherwise ill. Dr. advised client to not have #2 varicella. Child attends daycare and had no known exposure to anyone with chickenpox.

VAERS ID:478915 (history)  Vaccinated:2012-08-08
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2012-12-18
Location:Wisconsin  Entered:2012-12-20, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Mass, Oropharyngeal pain, Pyrexia, Streptococcus test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Vaccine given 8/8/2012, 11/21/2012. 1st shot - had a fever and sore throat - negative for strep. Noticed lump on side of neck below ear in the same spot approx 2-4 weeks following vaccine. Plans to see doctor to assess the lump.

VAERS ID:482815 (history)  Vaccinated:2012-08-08
Age:12.0  Onset:2012-08-22, Days after vaccination: 14
Gender:Female  Submitted:2013-01-29, Days after onset: 160
Location:Unknown  Entered:2013-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: In the paediatrics of other hospital the patient had a test (blood and so on), but there was no abnormal finding. In the neurology of other hospital the patient''s cerebrospinal fluid was examined, but there was no abnormal finding.
CDC Split Type: WAES1212JPN009919
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.9QN05R1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Blood test normal, CSF test normal, Gait disturbance, Laboratory test normal, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This spontaneous report as received from an other health professional refers to a 13 years old female. On an unknown date, the patient was vaccinated with a dose of GARDASIL (manufacturer unknown) IM (dose and lot # not reported). No concomitant medications were reported. On an unknown date, the patient experienced low back pain and weakness of limbs. No treatment information was reported. The outcome of low back pain and weakness of limbs was not reported. The reporter felt that low back pain and weakness of limbs were related to GARDASIL (manufacturer unknown). Follow-up information has been received from a physician concerning a 12 year old female patient with no concurrent disease or medical history, who on 08-AUG-2012 was intramuscularly vaccinated with the second injection of GARDASIL, 0.5 ml once a day for prophylaxis of HPV (uterine cervical cancer). No concomitant medication information was provided. On 08-JUN-2012, the patient was vaccinated with the first injection of HPV vaccine. On 08-AUG-2012, the patient was vaccinated with the second injection of GARDASIL. On 22-AUG-2012, the patient developed low back pain. As it was difficult to walk, the patient went to other hospital for an examination. In the paediatrics the patient had a test (blood and so on), and there was no abnormal finding. On 25-AUG-2012, the patient went to orthopedic surgery of other hospital, and the patient developed muscle weakness upper limb and muscle weakness lower limb. The patient''s brain and spine were examined, but there was no abnormal finding. The patient was also introduced to mental health department. On an unspecified date, the patient went to neurology of the other hospital and her cerebrospinal fluid was examined. But, there was no abnormal finding. On 11-DEC-2012, the patient recovered from low back pain, and the patient was recovering from muscle weakness upper limb and muscle weakness lower limb. There was an improvement trend of the symptoms, but there was still the symptom of weakness. Reporting physician''s comment: Before the adverse events occurred the patient was vaccinated with the injection of GARDASIL only, so the relationship between the adverse events and GARDASIL couldn''t be denied. The reporting physician considered that the low back pain, muscle weakness upper limb and muscle weakness lower limb were serious due to other important medical event. The reporting physician felt that the low back pain, muscle weakness upper limb and muscle weakness lower limb were definitely related to GARDASIL. Other reason besides the suspected drug was unknown. Additional information is not expected.

VAERS ID:495418 (history)  Vaccinated:2012-08-08
Age:77.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2013-06-27, Days after onset: 323
Location:Unknown  Entered:2013-06-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1306USA007572
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site scab, Skin disorder
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a 77 year old female patient. The patient had no drug reactions/allergies. On 08-AUG-2012 the patient was vaccinated with ZOSTAVAX (dose and lot# were unknown) by the intramuscular route. The patient had an indented area with small scab at the injection site. The outcome of events was unknown. No treatment was given for adverse event. The patient had sought medical attention via contact pharmacist. Additional information has been requested.

VAERS ID:498045 (history)  Vaccinated:2012-08-08
Age:  Onset:0000-00-00
Gender:Female  Submitted:2013-07-30
Location:Unknown  Entered:2013-07-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Cardiac disorder
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1307USA015456
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cardiac pacemaker insertion
SMQs:
Write-up: This spontaneous report was received from a registered pharmacist via a company representative concerning a female patient of unknown age with heart problems (unspecified). Around 08-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Since an unknown date, the patient was experiencing heart problems (unspecified) prior to receiving ZOSTAVAX. Approximately on 08-SEP-2012 (about a month after ZOSTAVAX was administered), the patient was admitted into an unspecified hospital for an unspecified amount of time and needed to have a pace maker implanted. It was unspecified if any lab tests were performed. On an unknown date, the patient recovered and the patient was doing well at the time of report. The causality was unknown. Additional information has been requested.

VAERS ID:500644 (history)  Vaccinated:2012-08-08
Age:0.1  Onset:2013-08-19, Days after vaccination: 376
Gender:Female  Submitted:2013-08-27, Days after onset: 8
Location:Virginia  Entered:2013-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin at injection
Current Illness: Finger infection
Preexisting Conditions: Milk protein
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.J0023060SCLL
Administered by: Private     Purchased by: Private
Symptoms: Irritability, Pain, Pyrexia, Rash morbilliform
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: Severe measles type rash 11 days post vaccine - fever, fussy and painful.

VAERS ID:512065 (history)  Vaccinated:2012-08-08
Age:5.0  Onset:2012-08-10, Days after vaccination: 2
Gender:Female  Submitted:2013-11-08, Days after onset: 455
Location:New Mexico  Entered:2013-11-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Chest X-rays. Blood test for tumor markers. Rectal exam. Ultrasound of neck mass. Surgical biopsy under general anesthesia with intubation.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1732AA0SCRA
Administered by: Unknown     Purchased by: Other
Symptoms: Biopsy, Chest X-ray, Endotracheal intubation, Feeling hot, Lymph node pain, Lymphadenopathy, Rectal examination, Tumour marker test, Ultrasound scan
SMQs:, Angioedema (broad)
Write-up: In neck same side as arm injection site two lymph nodes became hot, painful, and then massively swollen.

VAERS ID:520764 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-08, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-27, Days after onset: 537
Location:Unknown  Entered:2014-01-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA009227
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0435AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-AUG-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0435AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.

VAERS ID:532214 (history)  Vaccinated:2012-08-08
Age:13.0  Onset:2012-11-18, Days after vaccination: 102
Gender:Male  Submitted:2014-05-28, Days after onset: 555
Location:Texas  Entered:2014-05-29, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: MRI- normal; EEG- abnormal; Sleep test EEG - normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0629AE0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Nuclear magnetic resonance imaging normal, Sleep study normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Tonic-clonic seizures.

VAERS ID:465866 (history)  Vaccinated:2012-08-08
Age:0.3  Onset:2012-08-12, Days after vaccination: 4
Gender:Unknown  Submitted:2012-09-21, Days after onset: 40
Location:Foreign  Entered:2012-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Echography, 13Aug2012, suspected intuss; Irrigoscopy, 13Aug2012, intussusception
CDC Split Type: B0825104A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROL429BA PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Crying, Echography abnormal, Enema administration, Haematochezia, Intussusception, Mood altered, Ultrasound abdomen abnormal, Vomiting, X-ray normal, X-ray with contrast lower gastrointestinal tract abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 18-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of ROTARIX (oral, batch number not provided). Several days after vaccination with ROTARIX, the subject experienced intussusception. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting, the event was resolved. The physician considered the event was related to vaccination with ROTARIX. Follow-up information received on 24 August 2012: This case was also reported by a regulatory authority (# IL2101344). On 8 August 2012, the subject received an unspecified dose of ROTARIX. On 12 August 2012, 4 days after vaccination with ROTARIX, the subject experienced crying every 10 minutes. On 13 August 2012, early in the morning, 5 days after vaccination with ROTARIX, the subject experienced vomiting 4 times. Bloody stool was observed. An echography was performed which showed suspected intussusception. The irrigoscopy confirmed the diagnosis of intussusception. The subject was hospitalised. On 14 August 2012, intussusception was improved. At the time of reporting, the outcome of crying, vomiting and bloody stool was unspecified. Follow-up information received on 30 August 2012: The batch number was provided. Concurrent vaccination included pneumococcal vaccine (non-gsk); non-GSK manufacturer; subcutaneous; unknown given on 3 August 2012. On 13 August 2012, in the midnight, the subject got into a bad mood and had vomiting. The subject was treated with unknown (Infusion fluid) and was placed under observation. However, intermittent whining was gradually aggravated. A contrast enema showed crab-claw-like shadow based on which the subject was diagnosed with intussusception. Although a reduction was attempted by high pressure enema, the intussusception didn''t improve. The subject moved to the department of surgery of a pediatric medical center on referral. A reduction of invagination of intestine was attempted and accomplished somehow. On 14 August 2012, the subject was discharged. Follow-up information received on 13 September 2012: No family history of intussusception or intestinal abnormality, no history of any intra-abdominal surgery, congenital intestinal malformation, intestinal polyp, Meckel''s diverticulum, intestinal vascular malformation, cystic fibrosis, Hirschsprung''s disease, other gastrointestinal malformation and dysfunction or Intussusception. A visible intussusception or soft tissue mass on plain abdominal X-ray was not confirmed. The niveau and distended intestinal loops on plain abdominal X-ray was not confirmed. Intussusception findings with enema of air or contrast medium was confirmed. Nonspecific abnormalities on plain abdominal X-ray was not confirmed (Abdominal ultrasonography). Visible intussusception or soft tissue mass on abdominal ultrasound was confirmed. Findings of intra-abdominal mass accompanied by specific characteristics (specific characteristics which were confirmed by echography after the intestinal regulation to have been reduced by water enema: The target sign or donut sign on the cross-section image, and the pseudokidney sign or sandwich sign on the transverse section) were confirmed. An abdominal CT scanning was not performed. No treatment was given. The symptom disappeared by contrast media/water/air enema. No surgery was required. The subject didn''t experience any complication associated with X-ray procedure.

VAERS ID:466863 (history)  Vaccinated:2012-08-08
Age:32.0  Onset:2012-09-01, Days after vaccination: 24
Gender:Male  Submitted:2012-09-28, Days after onset: 27
Location:Foreign  Entered:2012-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0831937A
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAC39B038BA IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC39B038BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Amnesia, Daydreaming, Diarrhoea, Headache, Myalgia, Paraesthesia, Poor quality sleep, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by the regulatory authority (reference RE20120497) and described the occurrence of headache in a 32-year-old male subject who was vaccinated with BOOSTRIX-POLIO (GlaxoSmithKline), HAVRIX 1440 (GlaxoSmithKline) and STAMARIL (Non-GSK). This case was reported by the patient. A physician or other health care professional has not verified this report. On 08 August 2012 the subject received an unspecified dose of BOOSTRIX-POLIO (batch AC39B038BA, intramuscular, injection site unknown). On 13 August 2012, the subject received an unspecified dose of HAVRIX 1440 (intramuscular, batch and injection site unknown) and an unspecified dose of STAMARIL (batch, route and injection site unknown). The subject returned from a trip on 27 August 2012 without clinical signs. On 12 September 2012, the patient reported one episode of diarrhea on his return and since one week, the occurrence of headache, sleep disorder with wake up at night and daydreaming sensations, memory loss, myalgia and tingling. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the events were unresolved. The agency assessed the causal relationship of vaccination with BOOSTRIX-POLIO, HAVRIX 1440 and STAMARIL with the reported events as unlikely, according to the method of assessment.

VAERS ID:469752 (history)  Vaccinated:2012-08-08
Age:61.0  Onset:2012-08-13, Days after vaccination: 5
Gender:Female  Submitted:2012-10-15, Days after onset: 63
Location:Foreign  Entered:2012-10-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: HORMONE; LIPITO; COZA XQ
Current Illness:
Preexisting Conditions: Hypertension; Hypercholesterolemia
Diagnostic Lab Data: Not reported
CDC Split Type: 201209462
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site cellulitis
SMQs:
Write-up: Medically confirmed case received from a healthcare professional through a distributor and the local affiliate on 08 October 2012. A 61-year-old female patient, with a reported medical history of hypertension and hypercholesterolemia, had received her intramuscular dose of ADACEL, batch number not reported, in the left arm (deltoid muscle), on 08 August 2012. The patient had had concomitant therapies with "HORMONE", LIPITO per os for hypercholesterolemia and "COZA XQ" per os for hypertension. On 13 August 2012, i.e. 5 days post-vaccination, the patient experienced "serious" injection site cellulitis. She was seen by a physician who prescribed ciprofloxacin. However, the patient''s symptom did not resolve and her family judged that the event was really serious. The patient was therefore hospitalized from 14 August 2012 to 16 August 2012. She was discharged with being recovered. Documents held by sender: none.

VAERS ID:470001 (history)  Vaccinated:2012-08-08
Age:24.0  Onset:2012-08-11, Days after vaccination: 3
Gender:Male  Submitted:2012-10-16, Days after onset: 66
Location:Foreign  Entered:2012-10-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No information regarding the patient''s medical history was provided.
Diagnostic Lab Data:
CDC Split Type: E201206673
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, Cardiomegaly, Chest X-ray abnormal, Culture urine negative, Cytomegalovirus test negative, Dizziness, Echocardiogram normal, Electrocardiogram normal, Epstein-Barr virus antibody positive, Hepatic enzyme increased, Hypotension, Intensive care, Orchitis, Peripheral vascular disorder, Pharyngitis, Phlebitis, Pulmonary congestion, Pyrexia, Smear site unspecified normal, Tachycardia, Ultrasound abdomen normal, Vomiting
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal infections (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Case was received from the Health Authorities on 08-Oct-2012 (reference number PEI2012046589). Case is medically confirmed. A 24-year-old male patient (weight, height not reported) (MFR unknown, lot number, administration site not reported) IM on 08-Aug-2012. 3 days later, on 11-Aug-2012, he developed vomiting, circulatory disorder peripheral, dizziness and high fever. The patient was hospitalised on the same day due to fever of unknown origin. Physical examination on admission was without further findings, blood pressure was 100/65, heart rate 120/min, body temperature 39.8 degrees C and oxygen saturation 97%. ECG was normal, mid-stream urine was sterile. Blood culture of 13-Aug-2012 and 14-Aug-2012 showed sterile aerobic and anaerobic fluid medium. CMV serology was negative, EBV serology only positive for IgG. Abdominal sonography on 14-Aug-2012 was normal. Chest X-ray in standing position on 11-Aug-2012 was normal, on 14-Aug-2012 in lying position it showed cardiomegaly with hilus and pulmonary congestion. Chest X-ray in standing position on 22-Aug-2012 was normal again. Transesophageal echocardiography on 15-Aug-2012 revealed normal findings. Throat smear test on 24-Aug-2012 revealed no pathological findings. The patient was initially treated with infusions of sterofundin and sodium chloride, and PERFALGAN. On 14-Aug-2012, the patient was transferred to the intensive care unit for one day due to tachycardia, hypotension and persisting fever of 40 degrees C. (It was pointed out that the outside temperature was clearly $g 30 degrees C). The patient received MERONEM and gentamycin until 24-Aug-2012 leading to an increase of his lever values. On discharge liver values were normalising. Side effects of antibiotics could not be excluded. During the further course, the patient developed left-sided orchitis which was regressing after local cooling and most likely related to the application of a urine catheter on ICU. He additionally showed a pharyngitis, which was resolving under symptomatic therapy with HEXORAL. Phlebitis which occurred on forearms due to indwelling cannulae was treated locally with ice applications. Origin of fever could not be identified, a vaccination reaction was considered as a possible cause. The patient was discharged on 24-Aug-2012. According to the information from HA the patient had recovered "within 14 days". According to the reporter, the events were possibly related to the typhoid vaccine. Upon medical review the company added the following AEs, which were mentioned in the hospital report but not coded by HA: vomiting, pharyngitis. FILE CLOSED.

VAERS ID:473907 (history)  Vaccinated:2012-08-08
Age:15.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-11-12, Days after onset: 96
Location:Foreign  Entered:2012-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No relevant medical history, previous vaccinations including tetanus vaccine and PRIORIX without excessive pain.
Diagnostic Lab Data: UNK
CDC Split Type: B0842159A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA093BH1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Hyperaesthesia
SMQs:
Write-up: This case was reported by a physician and described the occurrence of hyperalgia in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). This case was linked to case B0836388A (same reporter). The subject had no relevant medical history. She weighed 46 kg and measured 155 cm. Previous vaccines, including tetanus vaccine and PRIORIX, were administered without excessive pain. On 08 August 2012 (batch AHPVA093BH intramuscular, left deltoid) and 28 September 2012 (batch AHPVA135CB intramuscular, left deltoid), the subject received a 1st dose and a 2nd dose of CERVARIX. Immediately after both administration of CERVARIX (positive rechallenge), the subject experienced moderate hyperalgia. The subject was treated with ice and rest. Hyperalgia resolved in unspecified times. The subject refused the administration of the third dose of CERVARIX. The physician considered the event was clinically significant (or requiring intervention). The physician considered hyperalgia as almost certainly related to vaccination with CERVARIX.

VAERS ID:475227 (history)  Vaccinated:2012-08-08
Age:0.3  Onset:2012-08-10, Days after vaccination: 2
Gender:Male  Submitted:2012-11-21, Days after onset: 103
Location:Foreign  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Hematochezia
Diagnostic Lab Data: Alanine aminotransferase, 10Aug2012, 78IU/L; Allergy test, Aug2012, negative; Aspartate aminotransferase, 10Aug2012, 36IU/L; Basophils, 10Aug2012, 0.5%; Bilirubin, 10Aug2012, 0.6mg/dL; Blood urea nitrogen, 10Aug2012, 7.2mg/dL; Body temperature, 10Aug2012, 37.2deg C; C-reactive protein, 10Aug2012, 0.56mg/dL; Eosinophils, 10Aug2012, 4%; Hematocrit, 10Aug2012, 31.3%; Hemoglobin, 10Aug2012, 11.1g/dL; Lactate dehydrogenase, 10Aug2012, 272IU/L; Lymphocytes, 10Aug2012, 43%; Monocytes, 10Aug2012, 9.5%; Neutrophils, 10Aug2012, 42.5%; Platelet count, 10Aug2012, 67.610E4 /mm3; Red blood cell count, 10Aug2012, 4.1810E4 /mm3; Serum creatine, 10Aug2012, 0.23mg/dL; White blood cell count, 10Aug2012, 18800cells/mm3
CDC Split Type: B0824054A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA428CA PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal mass, Alanine aminotransferase increased, Allergy test negative, Aspartate aminotransferase normal, Basophil percentage, Blood bilirubin normal, Blood creatinine normal, Blood lactate dehydrogenase increased, Blood urea normal, C-reactive protein normal, Echography abnormal, Enema administration, Enterocolitis, Eosinophil percentage, Haematochezia, Haematocrit decreased, Haemoglobin normal, Lymphocyte percentage increased, Monocyte percentage increased, Neutrophil percentage decreased, Platelet count decreased, Red blood cell count normal, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of bloody stools in a 3-month-old male subject who was vaccinated with ROTARIX liquid formulation (GlaxoSmithKline). Concurrent vaccination included live attenuated human rotavirus vaccine (GlaxoSmithKline; oral) given on 4 July 2012. On 8 August 2012, the subject received 2nd dose of ROTARIX liquid formulation (1.5 ml, oral). In August 2012, less than one month after vaccination with ROTARIX liquid formulation, the subject experienced bloody stools. The subject was hospitalised. At the time of reporting, the event was resolved and the subject was discharged from the hospital. Follow-up information received on 22 October 2012: On 10 August 2012, 2 days after vaccination with ROTARIX, the subject presented with blood stools, and visited the reporter''s hospital. His mood the sucked amount remained unchanged. On 10 August 2012, relevant test results included: Alanine aminotransferase: 78 IU/L; Aspartate aminotransferase: 36 IU/L; Basophils : 0.5%; Bilirubin: 0.6 mg/dL; Blood urea nitrogen: 7.2 mg/dL; Body temperature: 37.2 deg C; C-reactive protein: 0.56 mg/dL; Eosinophils: 4.0%; Hematocrit: 31.3%; Hemoglobin: 11.1 g/dL; Lactate dehydrogenase: 272 IU/L; Lymphocytes: 43%; Monocytes: 9.5%; Neutrophils: 42.5%; Platelet count: 67.6 x1^4/mm3; Red blood cell count: 4.18 x10^4/mm3; Serum creatine: 0.23 mg/dL; White blood cells: 18800 cells/mm3. On 11 August 2012, the event improved while being observed without treatment, and the subject was discharged from the hospital. The reporter considered the event bloody stool was related to ROTARIX. Suspected causative factors other than ROTARIX: Allergy and invagination of intestine. Although no problems were observed with his birth and developmental history, the subject experienced a course in which bloody stool was noted after birth. Therefore, he might have some kind of possible underlying disease. There was a possibility that oral administration of ROTARIX had caused symptoms of gastroenteritis which led to the occurrence of the bloody stool. All allergy tests were negative. Follow-up information received on 13 November 2012: No family history of invagination of intestine or intestinal abnormality. No history of any intra-abdominal surgery, no congenital intestinal malformation, no intestinal polyp, no Meckel''s diverticulum, no intestinal vascular malformation, no cystic fibrosis, no Hirschsprung''s disease, no other gastrointestinal malformation and dysfunction, no invagination of intestine. On 10 August 2012, 2 days after vaccination with ROTARIX liquid formulation, the subject experienced enterocolitis (instead of gastroenteritis). The subject didn''t experience invagation of intestine. Visible invagination of intestine or soft tissue mass on plain abdominal X-ray or on abdominal CT scanning or on abdominal ultrasound was not confirmed. Niveau and distended intestinal loops on plain abdominal X-ray was not confirmed. Findings of invagination of intestine with enema of air or contrast media were not confirmed. Nonspecific abnormalities on plain abdominal X-ray were not confirmed. Findings of abdominal mass accompanied by specific characteristics (specific characteristics which were confirmed by echography after the intestinal regulation to have been reduced by water enema: The target sign or donut sign on the cross-section image, and the pseudokidney sign or sandwich sign on the transverse section) were not confirmed. The symptoms disappeared spontaneously. On 11 August 2012, the events were improved. As no additional information could be obtained, the case has been closed.

VAERS ID:478115 (history)  Vaccinated:2012-08-08
Age:0.4  Onset:2012-09-19, Days after vaccination: 42
Gender:Female  Submitted:2012-12-14, Days after onset: 86
Location:Foreign  Entered:2012-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: 09/19/2012, Ultrasound scan, Showed intussusception
CDC Split Type: WAES1212AUS004104
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 1UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail form via state/territory health department (local reference number: AUS/12/2693, Agency # OPR307281) concerning a 5 months old female patient who on 08-AUG-2012 received the second dose of ROTATEQ, 1 dose unspecified, 1 time, (batch # not reported) orally. Concomitant vaccination received on the same day included INFANRIX HEXA and PREVNAR 13 both second dose. On 19-SEP-2012, 6 weeks post vaccination the patient began vomiting, abdominal pain and blood in stool. An ultrasound found to have intussusception. The patient was seen by a general practitioner and was admitted to the hospital on 20-SEP-2012. The intussusception was reduced by using gas enema. The reporter considered that intussusception was possibly related to ROTATEQ, Oral vaccination. The child will not be given a further ROTATEQ, Oral dose. Additional Information is not expected.

VAERS ID:480981 (history)  Vaccinated:2012-08-08
Age:1.7  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2013-01-11, Days after onset: 156
Location:Foreign  Entered:2013-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 08Aug2012, 39.2deg.C
CDC Split Type: B0856899A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSYHAVB483AA UNUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSYHIBC593BA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Febrile convulsion, Upper respiratory tract infection
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of febrile convulsion in a 20-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline) and HIBERIX. On 8 August 2012, the subject received an unspecified dose of HAVRIX (administration site and route unknown) and an unspecified dose of HIBERIX (administration site and route unknown). On 8 August 2012, less than one day after vaccination with HAVRIX and HIBERIX, the subject experienced febrile convulsion (39.2 deg.C) and acute upper respiratory infection. The subject was hospitalised. On 9 August 2012, febrile convulsion was resolved. At the time of reporting, the outcome of acute upper respiratory infection was unspecified.

VAERS ID:480996 (history)  Vaccinated:2012-08-08
Age:19.0  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2013-01-11, Days after onset: 156
Location:Foreign  Entered:2013-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness: Frequent Infection
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 09Aug2012, 39.5Deg. C; Body temperature, 10Aug2012, 38.4Deg. C; Body temperature, 11Aug2012, 37Deg. C; Body temperature, 11Aug2012, 41.4Deg. C; C-reactive protein, 11Aug2012, 89; C-reactive protein, 12Aug2012, 7; Culture throat, 11Aug2012, Negative; Mononucleosis heterophile test, 11Aug2012, Negative
CDC Split Type: B0858048A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133BE0UNAR
Administered by: Other     Purchased by: Other
Symptoms: Bronchitis, C-reactive protein increased, Culture throat negative, Injection site pain, Lymphadenopathy, Mononucleosis heterophile test negative, Oropharyngeal pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a healthcare professional (Nurse) via a GSK clinical associate and described the occurrence of swollen lymph node in the neck in a 19-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included frequent infections. Concurrent medications included YASMIN. On 8 August 2012, the subject received 1st dose of CERVARIX (unknown route, unknown arm) as a cross vaccination in a study. On 8 August 2012, in the evening, within hours of vaccination with CERVARIX, the subject experienced severe pain in injected upper arm and foot pain. On 9 August 2012, in the evening, 1 day after vaccination with CERVARIX, the subject experienced fever at 39.5 Deg. C. On 10 August 2012, in the morning, 2 days after vaccination with CERVARIX, the subject experienced sore throat. Lymph nodes on the neck were painful and swollen. Subject''s body temperature was at 38.4 Deg. C. On 11 August 2012, 3 days after vaccination with CERVARIX, the subject''s body temperature was 37 Deg. C. In the evening, the subject''s body temperature rose again up to 41.4 Deg. C. The throat culture was negative, the C-reactive protein was 89. Test of mononucleosis was negative. The subject was hospitalised. On 12 August 2012, 4 days after vaccination with CERVARIX, the C-reactive protein was 7. The throat sore was resolved but the subject still had swollen lymph nodes in the neck. On 19 December 2012, the nurse contacted the subject who informed she also experienced bronchitis and that she would not receive the second dose of CERVARIX. At the time of reporting, the events were resolved.

VAERS ID:482108 (history)  Vaccinated:2012-08-08
Age:  Onset:2012-08-08, Days after vaccination: 0
Gender:Female  Submitted:2013-01-22, Days after onset: 167
Location:Foreign  Entered:2013-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: 08-AUG-2012, at 4:00 body temperature test showed fever (38 Celsius degrees), body temperature increased. On 08-AUG-2012, tachycardia in medical examination (155/min). Hyperglycaemia in laboratory test. 08/08/2012, Body temperature, 38, Increased; 08/08/2012, Heart rate, 155; 08/08/2012, Laboratory test, Hyperglycaemia
CDC Split Type: WAES1301POL004011
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose increased, Depressed level of consciousness, Grand mal convulsion, Hyperglycaemia, Pyrexia, Salivary hypersecretion, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: The information has been received from Health Authority (Agency# PL-URPL-OCR-20121222001) refers to a female child. The information originated from physician. On 07-AUG-2012 patient was vaccinated with subcutaneously with a dose of M-M-RVAXPRO (Batch# reported as H007803). On 08-AUG-2012 patient was vaccinated subcutaneously with a dose of INFANRIX IPV+HIB (Batch A20CA782A). On 08-AUG-2012 at 2:45 a.m. patient experienced tonic/clonic convulsions with salivation. At 3:00 and 3:15 a.m., vomiting occurred. At 4:00 body temperature test showed fever (38 Celsius degrees) which resolved after antipyretic drugs (in report from HA the event "Body temperature increased" was coded as recovering/resolving). The patient was admitted to hospital in medium-heavy condition, initially with obnubilation. It showed tachycardia in medical examination (155/min), and hyperglycaemia in laboratory test. At the time of this report patient was recovering from Tonic/ clonic convulsions with salivation, vomiting, body temperature increased, obnubilation, tachycardia, and hyperglycaemia. All of these events were related to both M-M-RVAXPRO and INFANRIX IPV+HIB. Additional information is not expected.

VAERS ID:492354 (history)  Vaccinated:2012-08-08
Age:1.3  Onset:2012-08-13, Days after vaccination: 5
Gender:Male  Submitted:2013-05-22, Days after onset: 282
Location:Foreign  Entered:2013-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1305ESP010641
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Lymphadenopathy, Pyrexia, Rash papular, Rash vesicular, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Case received from the Health Authorities (reported to them by pharmacist) on 13-MAY-2013 under the reference number ES-AGEMED-218753343. Case medically confirmed. A 15 months-old male patient with no medical history reported had received a dose of VARIVAX (batch number not reported), via unknown, site of administration not reported, on 08-AUG-2012 and 5 days later (according to the narratives the latency was 96 hours), on 13-AUG-2013, the patient presented with fever and with papulo-vesicular rash in lower extremities and hands. On 4-MAR-2013 (6 months p-v) the patient presented with convulsions. According to the narratives written in the HA report the patient presented with papulo-vesicular lesions in lower extremities and hands 96 hours after vaccination. Later (latency not reported in the narratives), the patient presented with fever and convulsion. In the physical exploration is was palpated bilateral laterocervical and inguinal lymphadenopathy. Varicelliform reaction secondary to vaccination was suspected. Upon medical review, the company judged relevant to code the following adverse events: "bilateral laterocervical and inguinal lymphadenopathy" and "varicelliform reaction secondary to vaccine" which were mentioned in the narratives of the HA''s report but not coded by the HA. The outcome from these not coded adverse events was not reported. The patient recovered from fever and papulo-vesicular rash on 20-AUG-2012 and the patient recovered from convulsions on 11-APR-2013. Case reported as serious by the Health Authorities with hospitalization as criteria (admission and discharge dates were not reported). No further information was reported. Upon internal review, a corrective version was created on 16-MAY-2013 in order to complete the dechallenge-rechallenge fields.

VAERS ID:492355 (history)  Vaccinated:2012-08-08
Age:1.3  Onset:2012-08-13, Days after vaccination: 5
Gender:Male  Submitted:2013-05-22, Days after onset: 282
Location:Foreign  Entered:2013-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1305ESP011762
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Lymphadenopathy, Pyrexia, Rash papular, Rash vesicular, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Case received from the Health Authorities (reported to them by a pharmacist) on 13-MAY-2013 under the reference number ES-AGEMED-218753343. Case medically confirmed. A 15 months-old male patient with no medical history reported had received a dose of a VARIVAX (batch number not reported), via unknown, site of administration not reported, on 08-AUG-2012 and 5 days later (according to the narratives the latency was 96 hours), on 13-AUG-2013, the patient presented with fever and with papulo-vesicular rash in lower extremities and hands. On 4-MAR-2013 (6 months p-v) the patient presented with convulsions. According to the narratives written in the HA report the patient presented with papulo-vesicular lesions in lower extremities and hands 96 hours after vaccination. Later (latency not reported in the narratives), the patient presented with fever and convulsion. In the physical exploration it was palpated bilateral laterocervical and inguinal lymphadenopathy. Varicelliform reaction secondary to vaccination was suspected. Upon medical review, the company judged relevant to code the following adverse events: "bilateral laterocervical and inguinal lymphadenopathy and "varicelliform reaction secondary to vaccine" which were mentioned in the narratives of the HA''s report but not coded by the HA. The outcome from these not coded adverse events was not reported. The patient recovered from fever and papulo-vesicular rash on 20-AUG-2012 and the patient recovered from convulsions on 11-APR-2013. Case reported as serious by the Health Authorities with hospitalization as criteria (admission and discharge dates were not reported). No further information was reported.

VAERS ID:510257 (history)  Vaccinated:2012-08-08
Age:0.2  Onset:2012-08-10, Days after vaccination: 2
Gender:Male  Submitted:2013-10-28, Days after onset: 444
Location:Foreign  Entered:2013-10-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: WBC, 13AUG2012, UNK; Neutrophils, 13AUG2012, 17.5%; Lymphocytes, 13AUG2012, 68.6%; Monocytes, 13AUG2012, 8%; Neutrophils, 13AUG2012, UNK; Hemoglobin, 13AUG2012, 111g/L; Hematocrit, 13AUG2012, 30.7%; MCV, 13AUG2012, 77.3fL; Platelet count, 13AUG2012, UNK; WBC, 14AUG2012, UNK; Lymphocytes, 14AUG2012, 43.8%; Hemoglobin, 14AUG2012, 111g/L; Hematocrit, 14AUG2012, 23.4%; MCV, 14AUG2012, 81.8fL; Platelet count, 14AUG2012, UNK; WBC, 14AUG2012, UNK; WBC, 15AUG2012, UNK; Neutrophils, 15AUG2012, 52.34%; Lymphocytes, 15AUG2012, 36.34%; Monocytes, 15AUG2012, 10.44%; Hemoglobin, 15AUG2012, 59g/L; Hematocrit, 15AUG2012 18.1%; Platelet count, 15AUG2012, UNK; WBC, 16AUG2012, UNK; Neutrophil count, 16AUG2012, 62.21%; Platelet count, 16AUG2012, UNK; WBC, 10SE
CDC Split Type: 2013SA107324
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURG15960IMUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURH01160IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Aspartate aminotransferase normal, Autoimmune thrombocytopenia, Bilirubin conjugated normal, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood bilirubin unconjugated normal, Blood creatinine, Blood glucose increased, Blood group B, Blood immunoglobulin A normal, Blood immunoglobulin M normal, Blood thyroid stimulating hormone decreased, Blood urea normal, Carbon dioxide decreased, Complement factor C3, Complement factor C4 decreased, Complement factor normal, Computerised tomogram head normal, Cytomegalovirus test negative, Cytomegalovirus test positive, Eosinophil percentage increased, Globulins decreased, HIV antibody negative, Haematocrit decreased, Haemoglobin decreased, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Immunoglobulin therapy, International normalised ratio normal, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume normal, Monocyte percentage increased, Mycoplasma test, Neutrophil percentage decreased, Platelet count decreased, Platelet distribution width, Platelet transfusion, Plateletcrit, Protein total decreased, Prothrombin time prolonged, Reticulocyte count, Rhesus antibodies positive, Scan bone marrow abnormal, Thyroxine increased, Total bile acids, Treponema test, Tri-iodothyronine increased, Urine analysis normal, White blood cell count decreased, White blood cell morphology abnormal
SMQs:, Liver related investigations, signs and symptoms (broad), Liver-related coagulation and bleeding disturbances (narrow), Haemolytic disorders (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypersensitivity (narrow), Malignant lymphomas (broad)
Write-up: Initial information received from a healthcare professional on 21 October 2013. A 02-month-old male patient whose medical history and concomitant medications were not reported had received 0.5 ml first dose of ACTHIB, batch number: G1596-1 intramuscularly (anatomical site of administration was not reported) and 0.5 ml first dose of IMOVAX POLIO, batch number: H0116-1 intramuscularly (anatomical site of administration was not reported) on 08 August 2012. On 10 August 2012, the patient developed petechia all over the body on his skin. On 13 August 2012, the patient was hospitalised and underwent following investigations: blood: WBC (White Blood cells) 6.24x10^9/L, Neut (Neutrophils) 17.5%, Lym (Lymphocytes) 68.6%, Mono (Monocytes) 8%, EOS (Eosinophils) 5.1%, Neut 1.09x10^9/L, HGB (Hemoglobin) 111g/L, HCT (Hemoconcentration) 30.7%, MCV (Mean Corpuscular volume) 77.3fL, PLT (Platelet) 25x10^9/L, MPV 10.1fL, PDW, 16.5, PCT, 0.025%, ALY% 3.9%, LIC% 3.7%, ALY 0.24x10^9/L, LIC 0.23x10^9/L. Blood: PCT 0.06 ng/ml, TNIU <0.01ug/L, BUN (Blood Urea Nitrogen) 1.04 mmol/L, CREA (Creatinine) 9.7umol/L, CO2 21.1, glucose 9.8mmol/L, PT (prothrombin time) 12.6s, INR 1.050, APTT 33, FIB 1.86, TT 16.7, and Blood type: B, RH (+). The patient was diagnosed to have immunologic thrombocytopenic purpura. The patient received unspecified treatment. On 14 August 2012, Blood test showed: WBC 5.21x10^9/L, Neut 50.4%, Lym 43.8%, Mono 5%, EOS 0.2%, Neut 2.63x10^9/L, HGB 79g/L, HCT 23.4%, MCV 81.8fL, PLT 4x10^9/L, MPV --fL, PDW --fL, PCT --%. Blood: WBC 3.25x10^9/L, Neut 57.64%, Lym 37.8%, Mono 4%, EOS 0.34%, Neut 1.87x10^9/L, Lym 1.23x10^9/L, HGB 66g/L, HCT 19.8%, MCV 82.8fL, PLT 2x10^9/L, MPV --fL, PDW --fL, PCT --%. Blood: WBC 5.05x10^9/L, Neut 58%, Lym 39.3%, Mono 1.4%, EOS 0.7%, Neut 2.93x10^9/L, Lym 1.99x10^9/L, HGB, 69g/L, HCT 21%, MCV 82.8fL, PLT 181x10^9/L, PCT 0.145, ALY% 0.9%, LIC 0.0%, ALY 0.04x10^9/L, LIC 0.23x10^9/L. Blood: HBsAg <0.01, HCV-Ab (-), HIV-Ab (-), TP-Ab (-), Peripheral blood cells morphology: WBC toxic change. Cranial CT: (-). Blood: reticulocyte 0.047. Blood: T3 4.2pmol/L, T4 16.96pmol/L, TSH 0.24uIU/ml. Blood: total protein 57.1g/L, albumin 37.3g/L, globulin 19.8g/L, A/G 1.9, TBIL 13.74umol/L, DBIL 4.87umol/L, IBIL 8.87umol/L, ALT 30.4U/L, AST 36.8U/L, total bile acid 5umol/L, ALP 286.6U/L, C3 102.8mg/dl, C4 19.2mg/dl, IgG 1079.9mg/dl, IgA, 15.3mg/dl, IgM 32.4mg/dl. On 15 August 2012, Blood test showed: Mycoplasma pneumoniae Ab (-), Urine: (-), Blood: WBC 4.63x10^9/L, Neut 52.34%, Lym 36.34%, Mono 10.44%, EOS 0.44%, Neut 2.42x10^9/L, HGB 59g/L, HCT 18.1%, MCV 84.2fL, PLT 156x10^9/L, PCT 0.18%. On 16 August 2012, Blood test showed WBC 4.07x10^9/L, Neut 62.21%, Lym 32.71%, Mono 4.44%, EOS 0.2%. Neut 2.53x10^9/L, Lym 1.33x10^9/L, PLT 172x10^9/L. Bone marrow cells morphology: ITP bone marrow picture. Blood: WBC 5.89x10^9/L, Neut 21.5%, Lym 64.6%, Mono 12.2%, EOS 0.8%, Neut 1.27x10^9/L, HGB 111g/L, HCT 35.3%, MCV 86.2fL, MCH 26.9pg, MCHC 312g/L, PLT 353x10^9/L, PCT 0.258%, PDW 16.2, MPV 7.3fL, ALY% 1.1%, LIC% 1.6%, ALY 0.06x10^9/L, LIC 0.09x10^9/L. On 20 August 2012, the patient had recovered from immunologic thrombocytopenic purpura. On 03 September 2012, Blood test showed: WBC 4.59x10^9/L, Neut 22.9%, Lym 64.1%, Mono 6.5%, EOS 5.7%, Neut 1.05x10^9/L, HGB 113g/L, HCT 35.6%, MCV 85.3fL, MCH 27.1pg, MCHC 318g/L, PLT 196x10^9/L, PCT 0.176%, PDW 17.2, MPV 9fL, ALY% 7.1%, LIC% 1.2%, ALY 0.33x10^9/L, LIC 0.05x10^9/L. On 10 September 2012, Blood test showed: WBC 6.69x10^9/L, Neut 19.2%, Lym 68.1%, Mono 7.1%, EOS 5.1%, Neut 1.29x10^9/L, Lym 4.56x10^9/L, HGB 135g/L, HCT 41.2%, MCV 81.4fL, MCH 26.7pg, MCHC 328g/L, PLT 438x10^9/L, PCT 0.307%, PDW 15.8, MPV 7fL, ALY% 4.2%, LIC% 0%, ALY 0.28x10^9/L, LIC 0x10^9/L. On 26 September 2012, Blood test showed: CMV-IgM (-), CMV DNA 658.2. The patient was treated with gamma globulin IV drip and methylprednisolone (15 mg/kg, BID x3 days) and platelet 0.5 IU. List of documents held by the sender none.

VAERS ID:510720 (history)  Vaccinated:2012-08-08
Age:7.0  Onset:0000-00-00
Gender:Male  Submitted:2013-10-30
Location:Foreign  Entered:2013-10-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0935976A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSYHBVC065AA SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Autism, Gait disturbance, Guillain-Barre syndrome, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of Guillain-Barre in a 7-years-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). On 8 August 2012, the subject received unspecified dose of ENGERIX B pediatric (10 mcg, unknown route, injection site). In early September 2012, 1 month after vaccination with ENGERIX B pediatric, the subject experienced lower limb weakness and walking instability. He was diagnosed with Guillain-Barre syndrome and autism. The subject was hospitalised on 15 January 2013 and the physician considered the events were clinically significant (or requiring intervention). On 28 January 2013, the subject was released from the hospital. The subject also received systemic rehabilitative care from 10 May 2013. The subject was treated with symptomatic therapy. At the time of reporting, the events were improved but unstable walking still persisted.

VAERS ID:461520 (history)  Vaccinated:2012-08-09
Age:11.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:Arizona  Entered:2012-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None Reported
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4288AA IM 
TDAP: TDAP (ADACEL)SANOFI PASTEURC4247AA IM 
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient walked to waiting room after vaccines administered, began to feel lightheaded, then fainted. Child unconscious for less than one minute. Patients vitals monitored, then moved to exam room, and continued to be monitored for more than 20 minutes. Child steadily improved from time of incident. Child released to mothers care.

VAERS ID:461527 (history)  Vaccinated:2012-08-09
Age:19.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:Arizona  Entered:2012-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Employee had no complaints at the time vaccine was adminstered, no known illnesses.
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC010AB1IMRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Dyspnoea, Feeling hot, Hyperhidrosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Recipient felt light headed, hot, sweaty, dizzy, short of breath.

VAERS ID:461528 (history)  Vaccinated:2012-08-09
Age:30.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Male  Submitted:2012-08-09, Days after onset: 0
Location:Arizona  Entered:2012-08-09
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: Denies any - NONE
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)SANOFI PASTEURU3919BA0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Dizziness w/sx started after injection 8/9/12 and slight headache w/ice pack applied, legs, elevated, VS taken, and 20 oz of water.

VAERS ID:461532 (history)  Vaccinated:2012-08-09
Age:10.0  Onset:0000-00-00
Gender:Male  Submitted:2012-08-09
Location:Alaska  Entered:2012-08-09
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB586BA1IMLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451300IMRA
Administered by: Military     Purchased by: Military
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Pt received a PCV 13 when he shouldn''t have. No adverse events to report!

VAERS ID:461533 (history)  Vaccinated:2012-08-09
Age:18.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:Wisconsin  Entered:2012-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMRA
Administered by: Public     Purchased by: Other
Symptoms: Abdominal pain, Chills, Dizziness, Hypoacusis, Nausea, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad)
Write-up: Dizziness, chills, abdominal cramping, felt like i was going to throw up, temporary blurry vision, couldn''t hear correctly temporarily.

VAERS ID:461552 (history)  Vaccinated:2012-08-09
Age:11.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:New York  Entered:2012-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA; ADD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4292AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4023AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 3 hours following receipt of Tdap and MENACTRA vaccines the patient developed a severe bifrontal headache and several episodes of vomiting. No prior history of migraine headaches. No fever. Improving several hours following above episode.

VAERS ID:461611 (history)  Vaccinated:2012-08-09
Age:1.9  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-10, Days after onset: 1
Location:Georgia  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Tamiflu caused rash/vomiting
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0535AE0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0412AE0SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9182453IMLL
Administered by: Unknown     Purchased by: Public
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Developed rash/urticaria. Went to ER. ER treated with steroids and Benadryl. Patient improved significantly after treatment was initiated. Still had mild urticaria this a.m. at office visit.

VAERS ID:461614 (history)  Vaccinated:2012-08-09
Age:14.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-10, Days after onset: 1
Location:Florida  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.H0101450IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0101230IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4056BA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4393BA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: On 8-9-12 pt had blackout spell while getting GARDASIL. Pt stayed in office for 30 min after shot lying down. BP was WNL.

VAERS ID:461633 (history)  Vaccinated:2012-08-09
Age:5.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-10, Days after onset: 0
Location:Minnesota  Entered:2012-08-10
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: All blood work and tests came back fine.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA   
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSH010145   
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0682AE   
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Blood test normal, Choking, Confusional state, Cyanosis, Laboratory test normal, Pyrexia, Respiratory arrest, Somnolence, Staring, Unresponsive to stimuli, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Started throwing up, then choking. Stopped breathing completely, lips turning blue, eyes glassy, could not hold self up. After breathing resumed, was unresponsive and couldn''t stay awake until she received oxygen in the ambulance. Remained unresponsive and confused for about an hour. Tylenol was administered, fever came down and symptoms subsided.

VAERS ID:461637 (history)  Vaccinated:2012-08-09
Age:29.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-10, Days after onset: 0
Location:Louisiana  Entered:2012-08-10
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: Anemia
Diagnostic Lab Data: N/A at this time.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0184AE2SCRA
Administered by: Military     Purchased by: Military
Symptoms: Burning sensation, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction, Lymphadenopathy, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Burning sensation at injection site at approximately 1:30pm. Raised, red, 2inch by 2inch itchy and painful bump at injection site noticed about 3:30pm. Fine red rash covering injected arm noticed at 5:15pm. Swollen glands noted on neck and throat at 5:15pm.

VAERS ID:461639 (history)  Vaccinated:2012-08-09
Age:78.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-10, Days after onset: 0
Location:Missouri  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none reported
Preexisting Conditions: none reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0225AE IMRA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient reported signs of erythema, and swelling in right arm upon waking the morning following injection. She had been monitoring throughout the day and reports the swelling and redness has reduced throughout the day and arm is still tender. She reports not having had any rash, itching, or swelling in or around her throat, face, and trunk area. She had not had any difficulity in breathing.

VAERS ID:461643 (history)  Vaccinated:2012-08-09
Age:12.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-10, Days after onset: 1
Location:California  Entered:2012-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Emergency room personnel tested urine and blood. Results came out negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  SYR 
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0SYR 
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0SYR 
Administered by: Unknown     Purchased by: Other
Symptoms: Abnormal behaviour, Altered state of consciousness, Blood test normal, Crying, Speech disorder, Staring, Urine analysis normal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: During soccer practice exhibited erratic behavior. Crying, unaware of surrounding or people, saying random statements, wide eyes and staring, also closed eyes and motionless.

VAERS ID:461653 (history)  Vaccinated:2012-08-09
Age:18.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-11, Days after onset: 1
Location:California  Entered:2012-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
Administered by: Private     Purchased by: Other
Symptoms: Dysphonia, Headache, Injection site pain, Malaise, Oropharyngeal pain, Pain, Pharyngeal oedema, Pyrexia, Swollen tongue, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: @10:30am-onset of headache, body aches, mild fever. Lasted all day. 9:30pm began to have scratchy throat, mild body aches and mild headache. Next morning- 08/11/2012- Woke up at 7:00am with swelled tongue, throat and uvula. Throat felt covered with mucus/film. Throat felt sore, voice sounded like throat was swelled. Body aches were more severe with feeling of fever. Called advice nurse and instructed to take 50mg Benadryl..Swelling went away after taking it. 12:30 feeling a little better. Injection site still sore and still not feeling well, but no swelling in throat.

VAERS ID:461656 (history)  Vaccinated:2012-08-09
Age:25.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-11, Days after onset: 1
Location:Oregon  Entered:2012-08-11
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: None.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0SYRRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad)
Write-up: EXTREME muscle pain and soreness at injection site. Fever and aches the day after injection.

VAERS ID:461715 (history)  Vaccinated:2012-08-09
Age:34.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-11, Days after onset: 1
Location:Illinois  Entered:2012-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4384AA1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling, redness, flu-like, fever (at inj. site).

VAERS ID:461667 (history)  Vaccinated:2012-08-09
Age:14.0  Onset:2012-08-11, Days after vaccination: 2
Gender:Female  Submitted:2012-08-12, Days after onset: 1
Location:Illinois  Entered:2012-08-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRRA
Administered by: Unknown     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Soreness in arm, couldn''t straighten, hot, red area, about the size on an adult hand on underside of arm, a few inches from injection site.

VAERS ID:461698 (history)  Vaccinated:2012-08-09
Age:11.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Male  Submitted:2012-08-10, Days after onset: 1
Location:North Carolina  Entered:2012-08-13, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Muscle twitching, Sensation of pressure
SMQs:, Dyskinesia (broad), Dystonia (broad)
Write-up: Within 5 minutes of receiving GARDASIL the pt described a pressure sensation in the center of his back which made him want to move his arms for relief - he got the most relief by arching his back downward or putting pressure against his back. He was moving (twitching). Monitored BP & respiration and observed for 1 hr. Called Mom she stated he was back to normal by around 6:30 PM.

VAERS ID:461765 (history)  Vaccinated:2012-08-09
Age:10.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Male  Submitted:2012-08-13, Days after onset: 3
Location:North Carolina  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: (L) arm at deltoid edema with redness.

VAERS ID:461774 (history)  Vaccinated:2012-08-09
Age:1.8  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-13, Days after onset: 4
Location:Missouri  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: IGM DEFICIENCY
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0491AE0IMRL
Administered by: Public     Purchased by: Unknown
Symptoms: Epistaxis, Fatigue, Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Pallor
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Large amount of swelling in right thigh, this is injection site. Not wanting to use leg, severely limping. Pain, redness & swelling at injection site. Enlarged lymph nodes at right groin, previously not enlarged prior to injection. Nosebleed Friday 8/10/12. Noticeable paleness & tiredness noticed to date.

VAERS ID:461777 (history)  Vaccinated:2012-08-09
Age:69.0  Onset:2012-08-12, Days after vaccination: 3
Gender:Male  Submitted:2012-08-13, Days after onset: 1
Location:North Carolina  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Reported
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0242AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Patient received vaccine on 8/09/2012. Patient reported the site "flared up" on 8/12/2012 in the afternoon. Patient reported site is pink and itching, but not bumpy. Patient reports that pain is "sporadic" but seems to be relieved when he takes Benadryl. He reports redness is 4 inches wide at injection site and tapers down as the area goes down his arm. Redness stretches from injection site to 3 inches below the elbow. Itching relieved by Benadryl. Patient to continue to monitor and use Benadryl for itching and Tylenol if needed for pain and if does not improve in 2-3 days, will follow up with PCP.

VAERS ID:461784 (history)  Vaccinated:2012-08-09
Age:55.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-13, Days after onset: 4
Location:California  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR4928100125017IMLA
Administered by: Other     Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever started at about 6PM at about 100.6. Took aspirin and then ibuprofen. Fever peaked at 103.2F at approximately 9PM and lasted until about 8AM on 8/10/2012. From then until 8/11/2012 I was able to keep fever under 100.8. Fever gone on 8/11/2012.

VAERS ID:461812 (history)  Vaccinated:2012-08-09
Age:30.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-13, Days after onset: 4
Location:Minnesota  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Aspirin; High Blood Pressure
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204701A0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0098260IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, injection site swelling, hot to touch, spread around arm radius. Lasted for four days. Treated with Ice, BENADRYL, and Ibuprofen.

VAERS ID:461813 (history)  Vaccinated:2012-08-09
Age:73.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Male  Submitted:2012-08-13, Days after onset: 4
Location:Missouri  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0169AE0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: PATIENT''S WIFE REPORTED PATIENT HAD A SEIZURE FOR WHICH PATIENT DID NOT SEEK ANY ADDITIONAL MEDICAL HELP.

VAERS ID:461816 (history)  Vaccinated:2012-08-09
Age:1.6  Onset:2012-08-09, Days after vaccination: 0
Gender:Male  Submitted:2012-08-13, Days after onset: 4
Location:Illinois  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B3298BA3IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB527CA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH527AA0IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1275AA1IMLL
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: Right thigh erythema and swelling. Site where Pediarix and Hep A given.

VAERS ID:461823 (history)  Vaccinated:2012-08-09
Age:  Onset:0000-00-00
Gender:Male  Submitted:2012-08-14
Location:New York  Entered:2012-08-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abrasion to knee
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURC4114BA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Palpitations, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Fever up to 101.2 the day after the vaccine - resolved after several hours. Also nausea & racing heart.

VAERS ID:461907 (history)  Vaccinated:2012-08-09
Age:12.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Male  Submitted:2012-08-09, Days after onset: 0
Location:California  Entered:2012-08-14, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3979CA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Disorientation, Dizziness, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt received ADACEL injection, after 7 minutes felt sick to his stomach. Nauseated, light-headed and collapsed to floor. Was conscious, but slightly disoriented Pt was given H2O & chair to sit on until EMR team came, took pt to ER - given IV''s to stabilized BP, pt is doing well now.

VAERS ID:461937 (history)  Vaccinated:2012-08-09
Age:4.0  Onset:2012-08-11, Days after vaccination: 2
Gender:Male  Submitted:2012-08-14, Days after onset: 3
Location:Illinois  Entered:2012-08-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Patient seen by doctor on 8/11/12. Antibiotic given for infection per mom.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1123AA SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1376AA SCRA
Administered by: Public     Purchased by: Public
Symptoms: Infection, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling of upper right arm at injection site per parent.

VAERS ID:461953 (history)  Vaccinated:2012-08-09
Age:66.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-14, Days after onset: 5
Location:Washington  Entered:2012-08-14
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0653AE UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4149AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Body aches, headaches, chills and fever.

VAERS ID:462003 (history)  Vaccinated:2012-08-09
Age:61.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-13
Location:Alabama  Entered:2012-08-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM; Cetirizine; NASONEX; Metoprolol; HCTZ; Fexofenadine; CITRICAL D
Current Illness: None
Preexisting Conditions: PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0422AC0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Left arm is red, swollen & hard to touch no fever noted.

VAERS ID:462017 (history)  Vaccinated:2012-08-09
Age:64.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-10, Days after onset: 1
Location:Kentucky  Entered:2012-08-15, 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: No
Preexisting Conditions: No
Diagnostic Lab Data: Patient received PNEUMOVAX at Dr. office just prior to ZOSTAVAX
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1656AA SCRA
Administered by: Other     Purchased by: Other
Symptoms: Headache, Injection site swelling, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling at injection site, headache, body aches.

VAERS ID:462073 (history)  Vaccinated:2012-08-09
Age:13.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-15, Days after onset: 5
Location:South Carolina  Entered:2012-08-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4393BA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling, redness, soreness.

VAERS ID:462135 (history)  Vaccinated:2012-08-09
Age:9.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Male  Submitted:2012-08-09, Days after onset: 0
Location:Wisconsin  Entered:2012-08-15, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergy pollen micronized; Varicella virus vaccine live; Chronic problem; Seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0664AA0SCUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B075BA IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0412AA0SCUN
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Had localized erythema and induration.

VAERS ID:462117 (history)  Vaccinated:2012-08-09
Age:12.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-16, Days after onset: 7
Location:Oklahoma  Entered:2012-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0690AA0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4241AA0UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080CA0UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0360AE0UNUN
Administered by: Unknown     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fainted for few seconds. Laid back on exam table & applied cool cloths to forehead & neck B/P 110/70/5 min later 96/60; feeling fine within 5 min & left clinic ambulatory.

VAERS ID:462121 (history)  Vaccinated:2012-08-09
Age:2.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-13, Days after onset: 3
Location:Georgia  Entered:2012-08-16, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4022AA0UNLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHAVC077CA1UNRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB518CA UNRL
Administered by: Private     Purchased by: Public
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: (L) thigh, red, hot, and swollen very painful size of softball. Pt very guarded. Onset 1 day after vaccine worse 2 days. Treated with ice, massage, BENADRYL, and TYLENOL.

VAERS ID:462154 (history)  Vaccinated:2012-08-09
Age:53.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-16, Days after onset: 7
Location:Washington  Entered:2012-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cancer: PCN; Lidocaine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AA IMLA
Administered by: Other     Purchased by: Public
Symptoms: Chills, Injection site swelling, Pruritus, Pyrexia, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Fever/chills, itching/hives, swollen arm, around injection site, vomiting.

VAERS ID:462175 (history)  Vaccinated:2012-08-09
Age:5.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-16
Location:New York  Entered:2012-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: Pt given Pediarix instead of Dtap, therefore had TWO doses of IPOL on same day (at 2 sites). No report to date from parents re any adverse reaction.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B323BA3IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG108314IMRA
Administered by: Private     Purchased by: Private
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: MEDICATION ERROR - PT GIVEN PEDIARIX (dTAP, IPOL, HEPB) and IPOL.

VAERS ID:464354 (history)  Vaccinated:2012-08-09
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2012-08-16
Location:Unknown  Entered:2012-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004591
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was in the office now (on 09-AUG-2012) to receive the second dose of GARDASIL (dose, route and lot # not reported), which would be late. The first dose was administered a year ago (unspecified date). No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient sought medical attention. Additional information has been requested.

VAERS ID:462223 (history)  Vaccinated:2012-08-09
Age:54.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-16, Days after onset: 6
Location:North Carolina  Entered:2012-08-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1197AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site vesicles, Injection site warmth
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Redness, whelps/blisters, warmth swelling at inj site.

VAERS ID:462285 (history)  Vaccinated:2012-08-09
Age:45.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-17, Days after onset: 8
Location:Massachusetts  Entered:2012-08-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: amoxicillin: rash
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4383AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Feeling hot, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, pain, warmth and swelling.

VAERS ID:462365 (history)  Vaccinated:2012-08-09
Age:18.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:Arizona  Entered:2012-08-17, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: CT scan of head due to fall
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.U555AE0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Computerised tomogram head normal, Fall, Head injury, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt passed out - pt feel off exam table hit head on wall. She was observed and then sent for a CT of the head which was normal.

VAERS ID:464999 (history)  Vaccinated:2012-08-09
Age:  Onset:2012-08-09, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-17, Days after onset: 8
Location:Unknown  Entered:2012-08-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004467
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot#, dose number, dose/frequency, route and duration were unspecified) on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient inadvertently received ZOSTAVAX instead of VARIVAX on 09-AUG-2012. No symptoms reported. It was unspecified whether the patient had sought medical attention. No treatment information was reported. At the time of reporting the outcome was unknown. Additional information has been requested.

VAERS ID:465062 (history)  Vaccinated:2012-08-09
Age:  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-17, Days after onset: 8
Location:Unknown  Entered:2012-08-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004671
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose GARDASIL on 17-AUG-2007, the second dose on 19-DEC-2007, and would receive 3rd dose on 09-AUG-2012. Vaccine lot # and route were unspecified. No adverse effect was reported. Additional information has been requested.

VAERS ID:465063 (history)  Vaccinated:2012-08-09
Age:  Onset:2012-08-09, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-17, Days after onset: 8
Location:Unknown  Entered:2012-08-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA004676
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) in 2009. The patient had not received doses and was in the office on 09-AUG-2012 to receive the second dose of GARDASIL (Lot #, dose and route not reported). It was not known if the patient sought for medical attention. No adverse effect reported. Additional information has been requested.

VAERS ID:462324 (history)  Vaccinated:2012-08-09
Age:24.0  Onset:2012-08-10, Days after vaccination: 1
Gender:Female  Submitted:2012-08-17, Days after onset: 7
Location:Montana  Entered:2012-08-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None--Pt had been attacked by a hawk when she got out of her car across the street where the hawk was nesting in a tree with her baby birds. Pt sustained penetrating claw marks and scratches on her scalp as well as a egg size bump on right parietal area where the hawk had hit her head. Pt''s last Td vaccination had been done on 4/12/2007. Because of her injury pt. needed to be immunized again but with Tdap because she had not yet recieved her booster dose per ACIP standards.
Preexisting Conditions: Morphine allergy
Diagnostic Lab Data: Pt was seen by her provider and placed on Benadryl 50 mgm po every 6 hours for 6 days and was given a referral to allergist to see what component of the Tdap immunization she might be allergic to. Pt was given instructions by her provider on what to do if her symptoms worsened.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4188AA0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Rash erythematous, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt states she awakened in the morning at approximately 7:00 am on 8/10/12 itching with a fine flat red rash over chest, abd, thighs and arms. She noticed slight hives on abdomen as the day wore on. She denied Dyspnea, dysphagia, or edema around face. She called Immunizations and was told to call her medical provider immediately and come to the clinic.

VAERS ID:462331 (history)  Vaccinated:2012-08-09
Age:71.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-18, Days after onset: 9
Location:Washington  Entered:2012-08-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses reported or seen
Preexisting Conditions: No known allergies
Diagnostic Lab Data: NONE THAT WAS REPORTED TO THE PHARMACIST
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4046AB1IMRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0169AE1SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The patient complained of swelling at the injection site and had seen a doctor who prescribed Augmentin.

VAERS ID:462332 (history)  Vaccinated:2012-08-09
Age:24.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-18, Days after onset: 9
Location:New York  Entered:2012-08-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Possible undiagnosed allergies to cats and nickel
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood glucose normal, Blood test, Cerebral disorder, Computerised tomogram head abnormal, Dizziness, Electrocardiogram, Feeling cold, Headache, Immediate post-injection reaction, Loss of consciousness, Palpitations, Seizure like phenomena, Tremor, Vomiting
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), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: I was sitting when the Gardasil vaccine was administered IM in the left shoulder. Immediately after the vaccine was injected, I felt like I might pass out so I put my head down on my lap. The nurse then woke me up. She said that it had looked like I was having a seizure. She said I was shaking for 10-15 seconds and would have fallen out of the chair if she hadn''t caught me. After the event I felt cold and wanted to lie down. I also felt like I was having weak heart palpitations. After I lay down vital signs were taken and they were stable. My blood sugar level was 120 non-fasting (I am not diabetic). I went to the ER and got a glucose reading, blood tests, EKG and CT scan (without contrast). The ER doctor thought I didn''t have a seizure because I was aware of feeling faint before losing consciousness, didn''t bite my tongue, didn''t urinate on myself, and because it didn''t take very long after I woke up for me to know where I was. The only abnormal results on the CT scan were mild prominence of the lateral ventricles and 3mm of cerebellar tonsillar ectopia. After I went home I had a headache and vomited twice. Since the day of vaccination I have had no further side effects. No history of seizures. I have never fainted in the past after an injection or blood draw.

VAERS ID:462341 (history)  Vaccinated:2012-08-09
Age:3.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-19, Days after onset: 10
Location:D.C.  Entered:2012-08-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: NKDA, No medical conditions at this time
Diagnostic Lab Data: Sent to the ER
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4192AA1IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1741AA2IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB591A0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1768AA0SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF636661IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0700AE0SCLL
Administered by: Public     Purchased by: Public
Symptoms: Abasia, Crying, Injection site haemorrhage, Injection site pain, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Mother states that the child was crying all evening since she received the shot, and was complaining that her leg hurt and she couldn''t walk, the mother noticed that it was still bleeding a little and was swollen.

VAERS ID:462389 (history)  Vaccinated:2012-08-09
Age:10.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:Virginia  Entered:2012-08-20, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None, being seen for normal WCC
Preexisting Conditions: Allergic to Amoxicillin - hives
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0754AE0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash maculo-papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Maculopapular itchy rash arms and legs.

VAERS ID:462420 (history)  Vaccinated:2012-08-09
Age:11.0  Onset:2012-08-09, Days after vaccination: 0
Gender:Female  Submitted:2012-08-09, Days after onset: 0
Location:Indiana  Entered:2012-08-20, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered