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Found 557344 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:449167 (history)  Vaccinated:2012-01-31
Age:29.0  Onset:2012-02-01, Days after vaccination: 1
Gender:Female  Submitted:2012-02-08, Days after onset: 7
Location:Texas  Entered:2012-02-08
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: Allergic to erythromycin; AUGMENTIN; sulfa
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS10126A0IMLA
Administered by: Public     Purchased by: Public
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: Pt received MCV 4 immunization on 1/31/12, on the next morning 2/1/12 she had a 1-2" red, swollen area at site of injection & pain; she treated area with a cool compress & TYLENOL as instructed, she also took BENADRYL. The next morning 2/21/12, the redness, swelling & pain had enlarged to the entire upper (L) arm. She went to the dr. on 2/4/12 & dr felt it was a reaction to one of the proteins in the immunization (clinic). She was instructed to continue TYLENOL and BENADRYL but to use a warm compress instead of a cool one. She began to feel some relief by Sunday 2/5/12 & has continued to get better since & problem is now resolved.

VAERS ID:448553 (history)  Vaccinated:2012-02-01
Age:31.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-01, Days after onset: 0
Location:Massachusetts  Entered:2012-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH273AA SCLA
Administered by: Military     Purchased by: Military
Symptoms: Incorrect drug dosage form administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Patient had no adverse reaction. Reporting concentrated dose.

VAERS ID:448563 (history)  Vaccinated:2012-02-01
Age:70.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-01, Days after onset: 0
Location:Washington  Entered:2012-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Treated with steroid injection for neck pain two days prior to Hep B injection.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC010AB IMUN
Administered by: Unknown     Purchased by: Other
Symptoms: Flushing
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Patient RTC complaining of facial flushing ten minutes after administration of Hep B. Patient presents with mild facial flush but no rash, no hives, no respiratory distress. Given one Claritin 10mg. Patient requested and was given ice pack for face, and reclined on exam table. Patient states facial warmth has "almost gone away." Still no respiratory distress, no hives and no rash. Patient checked out by PAC. Patient discharged home with instructions to call 911 if symptoms return. Patient understands and agrees with plan.

VAERS ID:448568 (history)  Vaccinated:2012-02-01
Age:0.2  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-01, Days after onset: 0
Location:California  Entered:2012-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1543AA0PO 
Administered by: Private     Purchased by: Other
Symptoms: Rash erythematous, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Per Dr. office note - pt developed red patches all over body, not raised, no swelling, no change in mouth or eye mucosa. Rash went away within 10 minutes.

VAERS ID:448612 (history)  Vaccinated:2012-02-01
Age:0.5  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-02, Days after onset: 1
Location:Washington  Entered:2012-02-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL at 6pm.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Guiac (+) stool
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC39981AA2UNRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4230AA0UNRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1259AA2UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1303AA2PO 
Administered by: Private     Purchased by: Public
Symptoms: Faecal volume increased, Haematochezia, Occult blood positive, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Since immunizations: Fever 102 yesterday, 100.5 this AM (no meds this AM). Increase in stool output. Blood in stool - flecks on day of vaccines, approximately 1 tsp today. Stool Guiac (+) in office. Feeding well, acting well. Nl PE (no s/s intussusception).

VAERS ID:448620 (history)  Vaccinated:2012-02-01
Age:27.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-02-02, Days after onset: 0
Location:New York  Entered:2012-02-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL, BUSPIRONE, CLONAZEPAM
Current Illness: INITIAL REASON FOR PHYSICIAN VISIT WAS FOR A GENERAL EXAM. THE FOLLOWING ISSUES WERE DISCUSSED DURING THE VISIT WITH PHYSICIAN: PELVIC PAIN FATIGUE INNER EAR DISCOMFORT FOR I RECEIVED A PRESCRIPTION
Preexisting Conditions: FIBROIDS, ANXIETY
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Dysarthria, Hyperhidrosis, Nausea, Pain, Swelling face, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: AWOKE WITH SEVERE GENERALIZED BODY PAIN, DIZZINESS, NAUSEA, TREMORS AND SLURRED SPEECH, SWOLLEN FACE, DIAPHORESIS.

VAERS ID:448624 (history)  Vaccinated:2012-02-01
Age:3.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-02, Days after onset: 1
Location:New Jersey  Entered:2012-02-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: When asked at time of appt, mother states "none"
Current Illness: No illness; Temp = 96.2 F; PE conducted by physician = WNL
Preexisting Conditions: Mother states: NKA; NKDA; Denies illnesses, injuries, problems, concerns; Denies pt taking medication currently. Pt arrived from another country September 2011. Mother registered pt on 1.26.12 and presented original vaccination hx. Noted on "Screening Questionnaire for Child and Teen Immunization" = parent underlined "asthma" to the question: "Has the child had a health problem with asthma, lung, heart, kidney, or metabolic disease (diabetes) or a blood disorder?" The answer "yes" was checked off on this question.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT426AA IM 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB492AA IM 
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0059AA IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0573AA SC 
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Febrile convulsion
SMQs:, Neuroleptic malignant syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rec''d phone call on 2.2.12 at 10 am from pediatrician from Medical Center. States pt brought to Medical Center at 11 pm on 2.1.12 with c/o temp of $g104 and febrile seizures. Dr. treated pt. Pt had ID consult with another Dr. Dr. notified our clinic physician. Dr. stated she will refer pt for neuro consult. Pt recovered and is doing well.

VAERS ID:448664 (history)  Vaccinated:2012-02-01
Age:34.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-02-02, Days after onset: 0
Location:Rhode Island  Entered:2012-02-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: b/l ankle and foot swelling of as yet undetermined etiology
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B078AA0IMAR
Administered by: Private     Purchased by: Private
Symptoms: Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Tongue swelling. Time of onset approximate.

VAERS ID:448695 (history)  Vaccinated:2012-02-01
Age:61.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-02-02, Days after onset: 0
Location:Georgia  Entered:2012-02-02
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: Codeine, ACTIFED allergy; Meniere''s dz
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1158AA IMLA
Administered by: Military     Purchased by: Military
Symptoms: Unevaluable event
SMQs:
Write-up: Patient had PNEUMOVAX 1 Feb 2012 at 1300 in immunization hallway by administrator.

VAERS ID:448718 (history)  Vaccinated:2012-02-01
Age:9.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Male  Submitted:2012-02-03, Days after onset: 1
Location:Wisconsin  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Dairy allergy per mother
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3922AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pain, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Moderate pruritus, warm to the touch, moderately painful. Treatment: symptomatic measures, OTC analgesics if needed and BENADRYL as needed 10cc/25mg of liquid BENADRYL given in the office.

VAERS ID:448735 (history)  Vaccinated:2012-02-01
Age:23.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 2
Location:Kentucky  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: multivitamins
Current Illness: none noted
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0664Z1IMLA
Administered by: Public     Purchased by: Other
Symptoms: Pharyngeal oedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt states that she broke out with hives all over body and it feels like her throat was swelling, pt took Benadryl for symptoms.

VAERS ID:448743 (history)  Vaccinated:2012-02-01
Age:10.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 2
Location:West Virginia  Entered:2012-02-03
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0949AA1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site cellulitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Cellulitis of (L) arm at injection site and fever. Symptoms started night after injection. BACTRIM prescribed.

VAERS ID:448755 (history)  Vaccinated:2012-02-01
Age:5.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-03, Days after onset: 2
Location:Massachusetts  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PULMICORT; SINGULAIR; Albuterol; LURIDE
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0512AA1SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0411AA1SCUN
Administered by: Private     Purchased by: Public
Symptoms: Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Several hours after vaccines given, developed hives on face and began to wheeze. No rash at vaccine site. Given PO BENADRYL & Albuterol -$g did well and all symptoms relieved in several hrs.

VAERS ID:448802 (history)  Vaccinated:2012-02-01
Age:64.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 2
Location:Vermont  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: Patient was diagnosed with possible cellulitis or exorbitant immune reaction to vaccine. Patient was started on 500mg of Keflex qid for 7 days.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1270AA0SCLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, 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: Patient reported, erythema, prurtitis, swelling, and warmth around injection site with a 3in radius.

VAERS ID:448808 (history)  Vaccinated:2012-02-01
Age:35.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-02-04, Days after onset: 2
Location:New York  Entered:2012-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, fenugreek, multivitamin
Current Illness: None
Preexisting Conditions: Hashimotos Disease, Irritable Bowel Syndrome
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3927BA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Headache, Lymphadenopathy, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Headache began at noon. By evening, developed fever, aches, chills and swollen glands.

VAERS ID:448812 (history)  Vaccinated:2012-02-01
Age:11.0  Onset:2012-02-04, Days after vaccination: 3
Gender:Female  Submitted:2012-02-04, Days after onset: 0
Location:Georgia  Entered:2012-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Oedema peripheral, Pallor, Petechiae
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Blanching petechial rash and swelling to left arm (arm of injection) and to right hand.

VAERS ID:448868 (history)  Vaccinated:2012-02-01
Age:7.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-03, Days after onset: 2
Location:Maryland  Entered:2012-02-06, 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: No
Current Illness: Cough; Otitis media
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YL20691IN 
Administered by: Private     Purchased by: Unknown
Symptoms: Oedema peripheral, Rash generalised, Rash pruritic, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Itchy rash all over body, facial swelling & swelling of feet.

VAERS ID:448872 (history)  Vaccinated:2012-02-01
Age:71.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-01, Days after onset: 0
Location:New York  Entered:2012-02-06, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: HBP; acid reflux; Allergies: iodine, DEMEROL, tetracycline, cephalexin, novocaine
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1603AA0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Blood pressure increased, Chest discomfort, Condition aggravated, Dizziness, Gastrooesophageal reflux disease
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Hypertension (narrow), Vestibular disorders (broad)
Write-up: Pt felt lightheaded & dizzy - increased BP - chest tightness, acid reflux like symptoms/ RN assessed/ family was called - son called MD - MD advised ER.

VAERS ID:448882 (history)  Vaccinated:2012-02-01
Age:1.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-02-06, Days after onset: 4
Location:Ohio  Entered:2012-02-06
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: Recent fever - none at DOS
Preexisting Conditions: None
Diagnostic Lab Data: MRI of brain with & without contrast; EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB550AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1118AA0SCRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF654423IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0780AA0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging brain, Scan with contrast
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Seizure at home - called on-call physician and was instructed to call 911. Child was fever free at time of seizure per hospital report. Seizure/febrile 1-5-12 and 1-22-12 history.

VAERS ID:448887 (history)  Vaccinated:2012-02-01
Age:31.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Male  Submitted:2012-02-06, Days after onset: 4
Location:New York  Entered:2012-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ibuprofen 400mg q 6 hrs po Aleve 1 tab one time only po Cymbalta 30mg qd po simvastatin 20 mg qd po bc pill 1 pill qd po fish oil 1 cap. qd po
Current Illness: No
Preexisting Conditions: Multiple allergies: grass, mold, dog dander, tree pollen
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1157Z0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Injection site swelling, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Localized pain/swelling @ injection site; chills, body and muscles aches, fever of 103.5 orally at highest 02/03/2012 @ 1am. Warm pack applied intially, then cold pack applies x 2 days (on 02/03 - 02/04/2012).

VAERS ID:448917 (history)  Vaccinated:2012-02-01
Age:46.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-06, Days after onset: 5
Location:Alaska  Entered:2012-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient was taking vitamin B supplement. No other Rx or OTC medications.
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: laboratory tests pending, patient still being treated as of 2/6/2012- still symptomatic
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH463AB0IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBV765AA2IMRA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Chills, Erythema, Injection site erythema, Injection site pain, Pyrexia, Tremor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.

VAERS ID:448924 (history)  Vaccinated:2012-02-01
Age:61.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-02-06, Days after onset: 4
Location:North Carolina  Entered:2012-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B060BA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Lymphadenopathy, Nausea, Oedema peripheral, Pain, Pain in extremity
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: TDAP vaccine received on 2/1/12, 2/2/12 evening (Rt) arm sore, underneath sore. 2/3/12 - 2/4/12 (Rt) arm swollen painful, lymph node swollen under (Rt) axilla. Took ADVIL q 4-6 hours. 2/4/11 - aching ax over nausea & swelling decrease.

VAERS ID:448927 (history)  Vaccinated:2012-02-01
Age:5.0  Onset:2012-02-03, Days after vaccination: 2
Gender:Male  Submitted:2012-02-06, Days after onset: 3
Location:North Carolina  Entered:2012-02-06
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: ALLERGY TO EGGS. QUESTIONABLE ALLERGY TO OATMEAL.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184CA0IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AD IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1026AA1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: MARKED WARMTH/EDEMA MID-WAY TO BACK OF LEFT LEG. MILD PINK ERYTHEMA DIFFUSELY OVER ENTIRE LEFT ANTERIOR THIGH. FULL ROM OF LEFT HIP.

VAERS ID:448930 (history)  Vaccinated:2012-02-01
Age:27.0  Onset:2012-02-03, Days after vaccination: 2
Gender:Female  Submitted:2012-02-06, Days after onset: 3
Location:Colorado  Entered:2012-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: BP 119/77 mmHg Temp 98.4 deg F
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.115020IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Rash macular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient had area of blotchy redness, pain, and sensation of heat on skin. This area was about 5 inches in diameter on the upper arm at the location of the injection.

VAERS ID:448938 (history)  Vaccinated:2012-02-01
Age:4.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Male  Submitted:2012-02-03, Days after onset: 1
Location:California  Entered:2012-02-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B171BA IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1090AA1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Presented to office with 2 1/2 in x 2 in erythema raised lesion at the injection site Rt leg, warm to touch. Ice pack/compress every 4 hrs KEFLEX prescribed for early cellulitis.

VAERS ID:449007 (history)  Vaccinated:2012-02-01
Age:47.0  Onset:2012-02-05, Days after vaccination: 4
Gender:Male  Submitted:2012-02-07, Days after onset: 2
Location:New Jersey  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4073BA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4009AA0UNLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11240UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Pain, Rash, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt received MENACTRA & typhoid in (R) deltoid and Tdap in (L) deltoid 2/1/12. On Sunday 2/5 started with redness & "small little bumps" & tenderness. Then on 2/6 bumping was gone & area was just tender, reddened with 3" diameter. Pt concerned very sore.

VAERS ID:449119 (history)  Vaccinated:2012-02-01
Age:1.4  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-01, Days after onset: 0
Location:California  Entered:2012-02-08, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Upper respiratory infection
Preexisting Conditions: Prior hx jaundice at birth; past hx anemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4230AA2IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB533AA0IMLL
Administered by: Private     Purchased by: Public
Symptoms: Immediate post-injection reaction, Injection site reaction, Rash papular, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Immediately after pt got hep A and INFLUENZA vaccine, he developed hives at his face, neck, trunk, and a papular rash at injection site.

VAERS ID:449142 (history)  Vaccinated:2012-02-01
Age:31.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-01, Days after onset: 0
Location:Michigan  Entered:2012-02-08, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TB; No other meds
Current Illness: None
Preexisting Conditions: Allergic; shellfish; cats
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSUFLAU658AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3844AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site urticaria, Oropharyngeal discomfort, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt c/o hives (L) upper arm, then (R) lower arm, (L) lower arm, face & then "funny feeling in throat," First BENADRYL 25 mg PO then BENADRYL 50 mg IM -$g called 911 - $g to hospital.

VAERS ID:449184 (history)  Vaccinated:2012-02-01
Age:21.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-08, Days after onset: 7
Location:Minnesota  Entered:2012-02-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH456AA IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURE01232IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4007AA0IMRA
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)SANOFI PASTEURU3421BA1IMLA
Administered by: Other     Purchased by: Public
Symptoms: Headache, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Developed redness and swelling on Left deltoid. Developed a headache on the morning of 02/02/12.

VAERS ID:449228 (history)  Vaccinated:2012-02-01
Age:58.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Male  Submitted:2012-02-03, Days after onset: 1
Location:California  Entered:2012-02-09, 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: Pruritis & lower back pain
Preexisting Conditions: Allergic to oxycodone - itching; HTN; Sleep apnea; Obesity
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1124AA0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature increased, Erythema, Pain, Rash papular, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt received a ZOSTAVAX vaccine on 2/1/12 SQ in his (L) arm. Next day noted pain, swelling and papular/vesicular rash within an approximately 7 cm diameter area of erythema. Pain scale 5/10. Temp on 2/3/12 99.2.

VAERS ID:449231 (history)  Vaccinated:2012-02-01
Age:55.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-02-06, Days after onset: 4
Location:Pennsylvania  Entered:2012-02-09, 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: SINGULAIR; XYZAL; ADVAIR; albuterol
Current Illness: No
Preexisting Conditions: Asthma; allergic rhinitis; pre HTN; borderline hyperlipidemia
Diagnostic Lab Data: None - observe left arm
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1489AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site rash, Pain in extremity, Skin plaque, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient called 2/3/12 has rash (L) deltoid left arm bicep anterior and axillary irregular shaped erythematous plaque of varying sizes non blanching (+) tender - no adenopathy & painful arm.

VAERS ID:449277 (history)  Vaccinated:2012-02-01
Age:0.3  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-09, Days after onset: 8
Location:Kansas  Entered:2012-02-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Chem 14, UA 2/2/2012 - WNL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4047AB1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF200021IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1347AA1PO 
Administered by: Public     Purchased by: Private
Symptoms: Convulsion, Laboratory test normal, Urine analysis normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: 2/1/12 11pm seizure #1 no fever lasted approx 2 min, to medical center exam WNL, DC home. 2/2/12 5am seizure #2 temp 99.7 Ax lasted approx 2 min, to medical center exam WNL. Admitted for observation Chem 14, UA WNL. 2/8/12 seizure #3 1210pm unsure how many min, to medical center exam WNL. Referred to neurologist for evaluation.

VAERS ID:449284 (history)  Vaccinated:2012-02-01
Age:63.0  Onset:2012-02-06, Days after vaccination: 5
Gender:Female  Submitted:2012-02-09, Days after onset: 3
Location:Nevada  Entered:2012-02-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRILOSEC; Vitamin D; PREMARIN; CELEXA; Lovastatin; NORCO
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1268AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt states she has a ''hive'' 1" x 2", 1.5" below injection site. The hive appeared 4-5 days post injection. It is sore. No fever, dizziness, SOB reported.

VAERS ID:449295 (history)  Vaccinated:2012-02-01
Age:30.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-09, Days after onset: 8
Location:Massachusetts  Entered:2012-02-10, 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: Kariva 28-day birth control
Current Illness: No
Preexisting Conditions: Sulfa medication- Allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN559060IMRA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Fatigue, Malaise, Pain
SMQs:
Write-up: Extreme Fatigue/Malaise (24 hours). Full body aches (24 hours). Chills (5-6 hours).

VAERS ID:449356 (history)  Vaccinated:2012-02-01
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-10
Location:North Carolina  Entered:2012-02-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin; Omeprazole; Lisinopril/HCTZ
Current Illness: Obesity; Urinary incontinence
Preexisting Conditions: Obesity & HTN
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0985AA0SCLA
Administered by: Public     Purchased by: Private
Symptoms: Cellulitis, Dizziness, Fatigue, Injection site erythema, Injection site pain
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad)
Write-up: 12 x 8 cm area of redness at injection site (L) upper arm. Reports fatigue & dizziness & moderate pain at site. Adverse event reported 2-3-12 at ER visit & Dx. with cellulitis.

VAERS ID:449414 (history)  Vaccinated:2012-02-01
Age:11.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Male  Submitted:2012-02-03, Days after onset: 1
Location:Louisiana  Entered:2012-02-13, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4072BA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4103AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1208AA1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Vaccination complication
SMQs:
Write-up: 1 cm x 2 cm vaccine reaction.

VAERS ID:449510 (history)  Vaccinated:2012-02-01
Age:3.0  Onset:2012-02-03, Days after vaccination: 2
Gender:Male  Submitted:0000-00-00
Location:Virgin Islands  Entered:2012-02-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU3749AA IMRA
Administered by: Other     Purchased by: Public
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: Swelling, redness, and pain to injection site.

VAERS ID:449550 (history)  Vaccinated:2012-02-01
Age:42.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-02-03, Days after onset: 1
Location:Georgia  Entered:2012-02-14, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA684AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Dyspnoea, Erythema, Oedema peripheral, Skin warm, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 24 hrs after receiving INFLUENZA vaccine, around 7 pm, (L) arm was swollen, red, hives, hot to touch. Dizziness and SOB.

VAERS ID:449575 (history)  Vaccinated:2012-02-01
Age:21.0  Onset:2012-02-14, Days after vaccination: 13
Gender:Male  Submitted:2012-02-14, Days after onset: 0
Location:Colorado  Entered:2012-02-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: None
Diagnostic Lab Data: Smallpox vaccine 01FEB2012
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDRA
Administered by: Military     Purchased by: Military
Symptoms: Influenza like illness, Rash pustular, Scab
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Two crusted pustules on face both <5mm size. Flu like symptoms.

VAERS ID:449615 (history)  Vaccinated:2012-02-01
Age:5.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-02-03, Days after onset: 1
Location:Minnesota  Entered:2012-02-15, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None.
Preexisting Conditions: Atopic dermatitis
Diagnostic Lab Data: None.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1508Z0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0946AA0SCLL
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, 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: Redness, swelling, warmth, & pruritus at the site of injection. The area was larger the day after vaccine, than today, so improving w/o treatment. Recommended warm compress, cetirizine.

VAERS ID:449821 (history)  Vaccinated:2012-02-01
Age:60.0  Onset:2012-02-04, Days after vaccination: 3
Gender:Female  Submitted:2012-02-18, Days after onset: 14
Location:South Carolina  Entered:2012-02-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0761AA0UNUN
Administered by: Other     Purchased by: Unknown
Symptoms: Herpes zoster, Pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient reports getting shingles within 3 days of vaccine. Severe pain, fever, rash.

VAERS ID:450013 (history)  Vaccinated:2012-02-01
Age:75.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Colorado  Entered:2012-02-21
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Injected limb mobility decreased, Injection site rash, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swollen, red from underarm to shoulder. Rash surrounding shot site - left arm was sore for 4-5 days. Trouble lifting arm.

VAERS ID:450024 (history)  Vaccinated:2012-02-01
Age:1.1  Onset:2012-02-08, Days after vaccination: 7
Gender:Female  Submitted:2012-02-16, Days after onset: 8
Location:Idaho  Entered:2012-02-21, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Examined by Dr. & given medication.
CDC Split Type: ID12004
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1228AA0UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0516AA0UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169773UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0816AA0UNLL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red circle & warm with thickness. Started cephalexin liquid 3 times a day for 10 days.

VAERS ID:450258 (history)  Vaccinated:2012-02-01
Age:63.0  Onset:2012-02-04, Days after vaccination: 3
Gender:Female  Submitted:2012-02-16, Days after onset: 12
Location:New Jersey  Entered:2012-02-24, 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: See attached
Current Illness:
Preexisting Conditions: Codeine; HALDOL & drug reaction to LEVAQUIN; DX: Profound MR
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1605AA SCLA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Erythema
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/4/12 - Red, raised blisters scattered over torso & back & on face. No drainage. 2/6/12 - MD Rx: Silvadene cream to blisters on chest & back at 9A & 9p x 14 days.

VAERS ID:450880 (history)  Vaccinated:2012-02-01
Age:0.4  Onset:2012-02-11, Days after vaccination: 10
Gender:Male  Submitted:2012-03-01, Days after onset: 19
Location:Georgia  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Abdominal ultrasound was suspicious for intussusception, diagonsis was confirmed with air enema - the procedure was diagnostic as well as therapeutic.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4080AA IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF65442 IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0922AA PO 
Administered by: Private     Purchased by: Private
Symptoms: Enema administration, Infrequent bowel movements, Intestinal obstruction, Intussusception, Ultrasound abdomen abnormal, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: SX: Bowel Obstruction - no bowel movements for one day, projectile vomiting. DX: Intussusception. TX: Air Enema Reduction.

VAERS ID:451331 (history)  Vaccinated:2012-02-01
Age:28.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-09
Location:Florida  Entered:2012-03-09
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.083AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash macular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Employee reported to us on 3-6-12 that she had a "red blotched area $g 4 inches" on arm after 2-1-12 vaccine administration.

VAERS ID:451345 (history)  Vaccinated:2012-02-01
Age:60.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-03-09, Days after onset: 36
Location:Mississippi  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair, Zyrtec, Symbicort, Asterpro, Procardia XL,
Current Illness: no
Preexisting Conditions: allergies, asthma
Diagnostic Lab Data: No tests were done due to receiving a Decadron Injection prior to ppsv.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
Administered by: Unknown     Purchased by: Military
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling of injection site with raised red places, low grade fever (100 degrees), general unwell feeling.

VAERS ID:451835 (history)  Vaccinated:2012-02-01
Age:  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-03-13, Days after onset: 40
Location:Unknown  Entered:2012-03-15, Days after submission: 2
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: No other medications
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: 02/--/2012, body temperature, 108 centigrade
CDC Split Type: 2012063585
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 3IMUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Public
Symptoms: Aspiration, Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is an initial spontaneous report by a contactable physician. A Pfizer sales representative reported on behalf of a physician for a currently 13-month-old female patient who received a fourth dose (0.5 ml) of PREVNAR 13, intramuscularly on an unspecified day in Feb2012 as immunization for prevention of streptococcus pneumoniae and a dose of VARICELLA VACCINE administered on the same (unspecified) day in Feb2011. Past product history was unknown. The patient had no relevant medical history or concomitant medications. In Feb2012, post-vaccination, the patient experienced a 108 degree Celsius fever and febrile seizure for which she was hospitalized. Therapeutic measures taken in response to febrile seizure included ATIVAN. On an unspecified date in 2012 the patient also aspirated for which she was transferred to a hospital. It was unknown if the patient had any siblings. Relevant laboratory data was unknown. At the time of the report she had not recovered from the above mentioned events.

VAERS ID:451898 (history)  Vaccinated:2012-02-01
Age:7.0  Onset:2012-02-25, Days after vaccination: 24
Gender:Female  Submitted:2012-03-15, Days after onset: 18
Location:Michigan  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SC 
Administered by: Private     Purchased by: Private
Symptoms: Rash, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: VESICULAR RASH NOTICED BY MOTHER ON CHILD''S TRUNK. 5 VESICLES.

VAERS ID:451951 (history)  Vaccinated:2012-02-01
Age:70.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-03-15, Days after onset: 42
Location:Unknown  Entered:2012-03-16, Days after submission: 1
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: Unknown
Current Illness: Anxiety
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1203USA01426
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Dizziness
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a registered pharmacist concerning a female patient in her "70s" who in approximately February 2012, was vaccinated with a dose of 0.65 mL ZOSTAVAX (Merck) (Lot# not reported) subcutaneously. In approximately February 2012, the patient experienced dizziness and chest-tightening after being vaccinated with ZOSTAVAX (Merck) and was hospitalized in an unspecified hospital (duration and location unspecified). The patient was anxious before getting the vaccination. The AE was improved on therapy. Subsequently, the patient recovered from dizziness and chest-tightening on an unspecified date. Additional information has been requested.

VAERS ID:452611 (history)  Vaccinated:2012-02-01
Age:33.0  Onset:2012-02-04, Days after vaccination: 3
Gender:Female  Submitted:2012-03-28, Days after onset: 52
Location:Texas  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Humira
Current Illness:
Preexisting Conditions: Ulcerative Colitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Induration, Joint swelling, Mass, 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), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large, red, hard lumps covering both legs on shins and calves with a few on upper thighs and forearm. Swelling of shins, calves, and ankles.

VAERS ID:453342 (history)  Vaccinated:2012-02-01
Age:46.0  Onset:2012-03-24, Days after vaccination: 52
Gender:Female  Submitted:2012-04-11, Days after onset: 18
Location:Tennessee  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: RA
Preexisting Conditions: RA; Hypothyroid; Cholesterol
Diagnostic Lab Data: ER performed X-ray to rule-out other causes of pain. Rash developed later that day
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1266AA0UNUN
Administered by: Other     Purchased by: Unknown
Symptoms: Accidental exposure, Herpes zoster, Pain, Rash, X-ray
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vaccine was not received. I am vaccinating pharmacist and also immunosuppressed (REMICADE, IMURAN, Prednisone). Developed shingles within 6 weeks of starting to handle the ZOSTAVAX vaccine.

VAERS ID:453948 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:0000-00-00
Location:Unknown  Entered:2012-04-18
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.VNR1LO1P IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect route of drug administration
SMQs:, Medication errors (narrow)
Write-up: I am a staff pharmacist at a retail pharmacy. Recently when cleaning up consultation room where we administer vaccines, I noticed supplies had been left on counter from a previous ZOSTAVAX appointment. The ZOSTAVAX vaccine had been given by a colleague earlier that day. I noticed the syringe wrapper that was left out was for a 1 inch syringe. We usually use 1 inch for IM vaccines and 5/8 inch for SC vaccines. I checked the patient documentation form, and noted my colleague had documented that she''s given that dose in the deltoid. Next day, I asked my colleague and she said yes she''d given the ZOSTAVAX IM, I advised her that SC is the correct route of administration for ZOSTAVAX. She thought it could be given either way, she tried to find information/research to support that belief, but could not. ZOSTAVAX should be administered subcutaneously as a single dose. The vaccine should not be injection intramuscularly. However, it is not necessary to repeat vaccination if the shingles vaccine is administered intramuscularly. My colleague said of the error: "If your ok with it, then I''m ok with it", and no further discussion or documentation of error took place. I felt like the error should''ve been reported to our supervisor and our authorizing prescriber and documented per our quality assurance program that we use for dispensing near missed and/or errors. Our written protocol should also be reviewed with clear instructions on what to do in case of error. I reviewed all our patient vaccine documentation forms for ZOSTAVAX and was able to find 8 more times previously (over a 2 year period) where the same colleague documented that she gave the shingles vaccine IM/deltoid. Obviously, I think she will give correctly from now on. But these errors highlight, in my opinion, for the need for ongoing training for vaccine administration. As a pharmacist, I am able to take a very detailed educational program once and be certified to administer vaccines. I am required in my state to keep records for healthcare providers (CPR and AED) and Bloodborne Pathogen training up to date. Which required annual or biannual renewal/review. But I am not required to take additional CE credit in vaccine topics. I took approved class/training in 2009 and the colleague took approved training in 2001.

VAERS ID:455547 (history)  Vaccinated:2012-02-01
Age:60.0  Onset:2012-04-18, Days after vaccination: 77
Gender:Female  Submitted:2012-05-14, Days after onset: 26
Location:Georgia  Entered:2012-05-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA00611
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Herpes zoster
SMQs:, Dementia (broad)
Write-up: Information has been received from a Doctor of Pharmacy concerning a female patient in her 60''s who in approximately February 2012 "about 3 months ago", was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not provided). On approximately 18-APR-2012 "about 2 weeks ago", the patient developed shingles. The pharmacist stated the patient had not been able to go to work for 2 weeks, it was unknown if there was any permanent disability. At the time of the report, the patient''s outcome was unknown. It was unknown if the patient sought medical attention. Shingles was considered to be disabling by the reporting Doctor of Pharmacy. Additional information has been requested.

VAERS ID:456011 (history)  Vaccinated:2012-02-01
Age:39.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Female  Submitted:2012-05-22, Days after onset: 109
Location:Hawaii  Entered:2012-05-22
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
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Fatigue
SMQs:
Write-up: Next day had severe fatigue which lasted several weeks.

VAERS ID:462306 (history)  Vaccinated:2012-02-01
Age:  Onset:2012-02-01, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-06, Days after onset: 186
Location:Unknown  Entered:2012-08-06
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: WAES1207USA002841
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 2 of GARDASIL (Lot number, dose and route not reported) in January 2012. In February 2012, a month later, the patient received dose 3 of GARDASIL (Lot number, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received the third dose outside of the recommended dosing schedule. No adverse reaction reported. Additional information has been requested.

VAERS ID:464303 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Male  Submitted:2012-08-15
Location:Unknown  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: WAES1208USA003331
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  IMGM
Administered by: Other     Purchased by: Other
Symptoms: Drug administered at inappropriate site, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report as received from a physician refers to himself. The patient was vaccinated IM with single dose of ZOSTAVAX (lot# not reported) intramuscularly in the gluteus muscle in either February or March of 2012. No other co-suspects were reported. No adverse effects reported. No concomitant medications were reported. No treatment information was reported. Additional information has been requested.

VAERS ID:462581 (history)  Vaccinated:2012-02-01
Age:4.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-08, Days after onset: 7
Location:Illinois  Entered:2012-08-17, Days after submission: 190
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: MEDI0014856
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Jan-2012. The patient received expired product on either 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune''s FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.

VAERS ID:462626 (history)  Vaccinated:2012-02-01
Age:9.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-08, Days after onset: 7
Location:Illinois  Entered:2012-08-17, Days after submission: 190
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: MEDI0014852
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of administration of expired product was received from a health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received FLUMIST either on 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this mediation error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.

VAERS ID:462725 (history)  Vaccinated:2012-02-01
Age:11.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-08, Days after onset: 7
Location:Illinois  Entered:2012-08-17, Days after submission: 190
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: MEDI0014837
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 11-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 05-Feb-2012. The patient received expired FLUMIST either on 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.

VAERS ID:462745 (history)  Vaccinated:2012-02-01
Age:7.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-08, Days after onset: 7
Location:Illinois  Entered:2012-08-17, Days after submission: 190
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: MEDI0014854
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a seven-year-old male. Neither relevant medical nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received expired FLUMIST on either 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.

VAERS ID:462799 (history)  Vaccinated:2012-02-01
Age:5.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-02-08, Days after onset: 7
Location:Illinois  Entered:2012-08-17, Days after submission: 190
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: MEDI0014853
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.   UN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a healthcare professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received expired FLUMIST on either 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.

VAERS ID:462812 (history)  Vaccinated:2012-02-01
Age:7.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-08, Days after onset: 7
Location:Illinois  Entered:2012-08-17, Days after submission: 190
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: MEDI0014857
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received expired product on either 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.

VAERS ID:463307 (history)  Vaccinated:2012-02-01
Age:2.0  Onset:2012-02-04, Days after vaccination: 3
Gender:Female  Submitted:2012-06-04, Days after onset: 120
Location:New York  Entered:2012-08-27, Days after submission: 84
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: The patient had no known allergies (NKA) and a medical history of
Diagnostic Lab Data: Not reported
CDC Split Type: 201201434
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3944AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG15001IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial report was received from a health care professional on 06 February 2012. A 23-month-old female patient had received a dose 1 intramuscular injection in the left thigh of DAPTACEL, sanofi pasteur Ltd. lot number C3944AA on 01 February 2012 and a dose 2 intramuscular injection in the right thigh of IPOL, sanofi pasteur SA lot number 94244-0 (not a valid sanofi pasteur lot number) on 01 February 2012 with a 5/8 inch needle. On 04 February 2012, the patient experienced a flat red rash at the injection site on the left thigh and "all down the thigh" with a temperature of 101, vomiting, pain and swelling at the injection site. The patient was seen in the physician''s office on 06 February 2012 and no treatment was prescribed. The patient had no known allergies (NKA) and a medical history of kidney reflux. The patient was concomitantly taking BACTRIM. No further information was available at the time of the report. The patient''s outcome was not recovered. Follow-up information was received from a health care professional on 12 March 2012. The lot number of IPOL was reported as G1500. The patient''s birth weight was 7 pounds 15 ounces and the patient had one brother or sister. The patient''s outcome remained not recovered. Follow-up information was received on 21 May 2012: It was reported that the patient recovered on 18 Feb 2012. The patient had no illness at the time of vaccination.

VAERS ID:468425 (history)  Vaccinated:2012-02-01
Age:  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 228
Location:Washington  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: 11/--/2011, Dermatomyositis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1206USA05130
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Condition aggravated, Dermatomyositis
SMQs:
Write-up: Information has been received from a female patient with dermatomyositis which was symptomatic since November of 2011 who in February 2012, was vaccinated with a dose of GARDASIL (lot # not reported). In February 2012, the patient''s dermatomyositis got worse since the vaccination. The patient had sought unspecified medical attention. Prednisone and PLAQUENIL were given to the patient as treatments. At the time of this report, the patient had not recovered. Follow-up information has been received from nurse practitioner. It was reported that the patient was currently being treated for a recent "diagnosis of dermatomyositis". It was reported that she was taking steroid and an immunosuppressants. It was reported that the patient did not feel that she had a reaction but that it was coincident. Additional information is not expected.

VAERS ID:473033 (history)  Vaccinated:2012-02-01
Age:1.3  Onset:2012-09-23, Days after vaccination: 235
Gender:Female  Submitted:2012-10-11, Days after onset: 18
Location:Maryland  Entered:2012-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis; Premature baby
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA000056
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1296AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Pruritus, Rash, Varicella post vaccine
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a registered nurse concerning a 23 months old female patient with no drug reactions/allergies, who was preemie baby born at 36 weeks. On 01-FEB-2012 the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml subcutaneously (lot # reported as 1206AA - in validation process). Other secondary suspect therapies included: M-M-R II (lot #, route and dose not reported) given on the same date. Concomitant therapy included FLUZONE administered on the same day. The nurse reported that the patient developed chickenpox which presented with rash and itchiness on 23-SEP-2012. The patient received treatment for the events: BENADRYL, calamine lotion and AVEENO bath. The outcome of chickenpox was reported as recovering/resolving. No laboratory diagnostic studies were performed. The patient sought medical attention - contacted physician. The relatedness for chickenpox was unknown for VARIVAX (Merck) and M-M-R II. Additional information has been requested.

VAERS ID:474693 (history)  Vaccinated:2012-02-01
Age:30.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-09-21, Days after onset: 232
Location:California  Entered:2012-10-17, Days after submission: 26
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: A0967067A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNAR
Administered by: Private     Purchased by: Private
Symptoms: Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a healthcare professional via a sales representative and described the occurrence of low grade fever in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In February 2012 the subject received a dose of BOOSTRIX at 0.5 ml in an unknown deltoid. Less than one month after vaccination with BOOSTRIX, the subject experienced low grade fever and body pain. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.

VAERS ID:474699 (history)  Vaccinated:2012-02-01
Age:66.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-09-21, Days after onset: 232
Location:North Carolina  Entered:2012-10-17, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject''s concomitant vaccines, concomitant medications and relevant medical history were all unknown. It was unknown if the subject had experienced any adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0968259A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNAR
Administered by: Private     Purchased by: Private
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of lymph node swelling in a 66-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In February 2012 the subject received a dose of BOOSTRIX (unknown route, unknown arm). In February 2012, less than one month after vaccination with BOOSTRIX, the subject experienced lymph node swelling. The subject sought medical attention at a physician''s office. At the time of reporting the event was resolved.

VAERS ID:475622 (history)  Vaccinated:2012-02-01
Age:50.0  Onset:0000-00-00
Gender:Male  Submitted:2012-10-19
Location:Unknown  Entered:2012-10-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: --/--/2012, Hepatitis B surface antibody, Negative for surface antibody
CDC Split Type: WAES1210USA006251
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1106AA1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This spontaneous report as received from a nurse refers to a male patient of age in his 50''s. No medical history and no known drug reactions or allergies was reported. The patient was vaccinated with a dose of 1 ml of RECOMBIVAX HB (lot number reported as 1106AA and expiry date unspecified) given intramuscularly with first dose on 28-DEC-2011, second dose on 01-FEB-2012 and the third dose on 28-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. Subsequently, on an unknown date in 2012, the patient experienced negative hepatitis B surface antibody titers. No treatment was given. The patient sought medical attention and visited the physician''s office. The outcome of negative hepatitis B surface antibody titers was not recovered at the time of report. The relatedness for the event was unknown for RECOMBIVAX HB. The patient was in the process of repeating the 3 dose series of RECOMBIVAX HB. The case is linked to # 1209USA005863 and # 1210USA006250. Additional information is not expected.

VAERS ID:475485 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2012-11-01
Location:Unknown  Entered:2012-11-01
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: WAES1210USA001171
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:, Medication errors (narrow)
Write-up: This spontaneous report as received from a consumer refers to a her daughter, a female patient of unknown age. The patient was vaccinated (route not reported) with dose 1 GARDASIL in December 2011 and she received her second dose in February 2012, but she has not received her third dose yet. No other co-suspects were reported. No concomitant medications were reported. No adverse event involved. Additional information has been requested.

VAERS ID:476434 (history)  Vaccinated:2012-02-01
Age:54.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-09-28, Days after onset: 239
Location:West Virginia  Entered:2012-11-07, Days after submission: 40
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole 20mg EC cap active 180 02/01/2012 09/27/2012 take two capsules by mouth every morning before breakfast for stomach; Lorazepam 0.5mg tab active 04/03/2012 09/20/2012 1 Fluoxetine HCL 20 mg cap; Prednisone 5 mg tab; Albuterol 90 mc
Current Illness:
Preexisting Conditions: Depressive disorder Nos 04/03/2012; Anxiety 02/01/2012; Spondylosis 02/01/2012; Asthma 05/07/2004; Ankylising spondylitis and other inflammatory spondylopathies 05/01/1995; Iron Deficiency Anemia 05/07/2004; Hyperlipidemia 01/20/2004; GERD 02/01/2012; Chronic bronchitis NOS 01/12/2007
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0895AA1IMLA
Administered by: Other     Purchased by: Other
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: Local title: Physician, Clinic note date of note: FEB 01, 2012 at 10:43 02/01/2012 Addendum Status: Complete. Patient return stating the arm where she had the pneumonia shot this morning is swollen. Patient said the swelling has stopped worsening the last 1-2 hrs. Slightly red and warm. No fever, no shortness of breath or wheezing. No swelling of her lips. PE: Lt deltoid area slightly swollen and warm to touch. No erythema. No limitation of movement. MEDROL dose pack ordered. BENADRL qid prn (patient has at home). Return if symptom worsens, arm turns red, sob, wheezing or swelling starts. Patient acknowledged understanding. Local title: Nursing Primary Care Note Date of Note: FEB 01, 2012 at 08:55 This is the patient''s initial visit to establish care and receive medication. The following screening options were offered: *PNEUMOVAX: Patient received 0.5ml of pneumococcal vaccine IM at this encounter. Site: Lt deltoid. Manufacturer: Merck Lot #: 0895AA Exp. date: 11/12/2012

VAERS ID:479662 (history)  Vaccinated:2012-02-01
Age:54.0  Onset:0000-00-00
Gender:Male  Submitted:2012-11-05
Location:Iowa  Entered:2012-12-03, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sulfa Allergy
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0993519A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB227BA1UNRA
Administered by: Public     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a healthcare professional (nurse) and described the occurrence of rash in a 54-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included sulfa allergy. Concurrent vaccination included seasonal influenza vaccine (non-gsk); non-GSK manufacturer; intradermal; unknown given in January 2012. On February 2012 and January 2012 the subject received 2nd dose and 1st dose of TWINRIX (1 ml, unknown route, right arm). Less than one month after vaccination with dose 1 of TWINRIX, less than one year after vaccination with dose 2 of TWINRIX, the subject experienced rash. According to the nurse, the subject reported that he experienced a rash after his first two doses of TWINRIX. At the time of reporting the outcome of the events was unspecified.

VAERS ID:484305 (history)  Vaccinated:2012-02-01
Age:3.0  Onset:2012-02-02, Days after vaccination: 1
Gender:Male  Submitted:2012-02-04, Days after onset: 2
Location:Idaho  Entered:2013-02-13, Days after submission: 375
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Had diarrhea 2 nights before
Preexisting Conditions: Neuroblastoma dx at 6 mo. off chemo since 10/30/09
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B213BA0UNRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.H0156240UNLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Large hard welt on thigh 6 in x 3 in. Mom using warm soaks & compresses. Noticed welt on Sat, increased by Sunday & decreasing now. No other sxs.

VAERS ID:485424 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2013-02-22
Location:Unknown  Entered:2013-02-22
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1302USA009565
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure increased, Injection site erythema
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot# unspecified) one year ago in approximately February 2012. The patient developed redness at the injection site after receiving the dose. She also complained of increased blood pressure after receiving the dose. The onset date of the events was not reported. The outcome of increased blood pressure and redness at the injection site was reported as recovered. Additional information has been requested.

VAERS ID:495093 (history)  Vaccinated:2012-02-01
Age:78.0  Onset:2012-06-01, Days after vaccination: 121
Gender:Female  Submitted:2013-06-25, Days after onset: 389
Location:Unknown  Entered:2013-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; Lisinopril
Current Illness: Rheumatic fever
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1306USA008702
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Mass, Pain, Rheumatoid arthritis
SMQs:, Arthritis (narrow)
Write-up: This spontaneous report as received from a patient''s sister refers to a 79 year old female patient with no drug reactions/allergies and a pertinent medical history of "rheumatic fever". Sometime in February 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # was not reported), subcutaneous. Concomitant therapies included LIPITOR and lisinopril (manufacturer unknown). The reporter stated the patient developed the following adverse reactions "four to six months" after ZOSTAVAX was administered: a lump on her collarbone that created pain, and rheumatoid arthritis. The patient sought medical attention by an office visit on an unspecified date. The patient was prescribed prednisone (unspecified dose, frequency and manufacturer) and methotrexate (unspecified dose, frequency and manufacturer). The patient also underwent "blood work". At the time of reporting, the patient was not recovered. Additional information is not expected.

VAERS ID:501434 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2013-09-03
Location:Unknown  Entered:2013-09-03
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: WAES1308USA009052
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
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unknown date of February 2012 (a year a half ago) the patient was vaccinated with the first dose of GARDASIL (dose and lot # were not provided). On an unknown date the patient was vaccinated with the second dose of GARDASIL (dose and lot # were not provided) as recommended. However the patient did not received the third dose for a year. Additional information has been requested.

VAERS ID:501924 (history)  Vaccinated:2012-02-01
Age:  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Unknown  Entered:2013-09-10
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:
Diagnostic Lab Data:
CDC Split Type: 429642USA
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0231AA UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4259AA UNUN
Administered by: Military     Purchased by: Unknown
Symptoms: Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years, experienced other anaphylactic shock, NEC (confirmed) (serious, since 01-Feb-2012, until 01-Feb-2012) while enrolled in the study. The patient was hospitalized for IV treatment which included: epinephrine (injection) started on 01-Feb-2012, stopped on 01-Feb-2012 (dose, unit, frequency and indication unknown); SOLU-MEDROL (IV) started on 01-Feb-2012, stopped on 01-Feb-2012 (dose, unit, frequency and indication unknown); BENADRYL (IV) started on 01-Feb-2012, stopped on 01-Feb-2012 (dose, unit, frequency and indication unknown). The patient also received MCV4P on 01-Feb-2012 (lot#U4259AA manufacture PCM), Tdap on 27-Jan-2012 (lot#AC52B075AA manufacture SKB), and influenza on 27-Jan-2012 (lot#UT423AA, manufacture PMC); PEDVAX on 01-Feb-2012 (lot#0231AA, manufacture MSD). At the time of the report the outcome of the AEs were: other anaphylactic shock, NEC: recovered/resolved. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. Concomitant medications within 42 days of vaccination: calamine lotion (topical) started on 14-Feb-2012, stopped on 10-Mar-2012 (dose, unit, frequency and indication unknown), Influenza Vaccine, DTP vaccine, IPV, Meningococcal Vaccine, PEDVAX-HIB. The patient''s past medication were unspecified. Action taken with suspect drugs: Adenovirus Vaccine - not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Hospitalization Required, Other Serious (Important Medical Events)). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not related to the Adenovirus Vaccine.

VAERS ID:502248 (history)  Vaccinated:2012-02-01
Age:72.0  Onset:2013-08-28, Days after vaccination: 574
Gender:Male  Submitted:2013-09-09, Days after onset: 12
Location:Nevada  Entered:2013-09-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Allergy-PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1268AA0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Herpes zoster
SMQs:
Write-up: 8/28/2013 Moderate Other. Patient has had increased cases of shingles since receiving vaccine (3 outbreaks in the last year). He has also had shingles lesions in 2 new locations since receiving the vaccine.

VAERS ID:509102 (history)  Vaccinated:2012-02-01
Age:  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2013-10-23
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Age in years - 19-24
Diagnostic Lab Data:
CDC Split Type: 437829USA
Vaccination
Manufacturer
Lot
Dose
Route
Site
ADEN_4_7: ADENOVIRUS TYPES 4 & 7, LIVE, ORAL (NO BRAND NAME)TEVA PHARMACEUTICALS34600018 PO 
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4259AA UNUN
Administered by: Military     Purchased by: Unknown
Symptoms: Chlamydial infection, Dizziness, Drug hypersensitivity, Nausea, Paraesthesia, Toxicity to various agents, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353459USA. A female patient between the ages of 19-24 years, who experienced poisoning by unspecified drug or medicinal substance (Serious, since 01-Feb-2012, until 01-Feb-2012); tingling - follow up reaction to PCN (Serious, since 03-Feb-2012, until 03-Feb-2012); nausea with vomiting, follow up lightheadedness (Serious, since 25-Feb-2012, until 25-Feb-2012) while enrolled in a Teva study. The patient was an active recruit. Adenovirus vaccine was administered on 01-Feb-2012. At the time of the report the outcome of the AEs were: poisoning by unspecified drug or medicinal substance: unknown, tingling - follow up reaction to PCN: recovered/resolved, nausea with vomiting, follow up lightheadedness: recovered/resolved. Adverse events within 42 days of vaccination: Observation for susp condition follow-up (since 01-Feb-2012, until 01-Feb-2012), (outpatient visit, treated with treatment medication included prescription and OTC) outcome not resolved, severity and seriousness not assessed; Chlamydia infection (since 14-Feb-2012, until 14-Feb-2012), (outpatient visit, treated with treatment medication included prescription and OTC), outcome not resolved, severity and seriousness not assessed; patient education action plan (since 23-Feb-2012, until 23-Feb-2012), (outpatient visit, treated with non drug treatment, outcome, severity and seriousness not assessed; nausea with vomiting (since 25-Feb-2012, until 25-Feb-2012), (outpatient visit, treated with treatment medication included prescription and OTC) outcome not resolved, severity and seriousness not assessed. Concomitant medications within 42 days of vaccination: Azithromycin (since 14-Feb-2012, until 15-Feb-2012), (1g, as directed, PO) unknown indication; penicillin G (since 14-Feb-2012, until 14-Feb-2012), (2mL, 1x, IM) unknown indication; ondansetron (since 24-Feb-2012, until 27-Feb-2012), (4mg, Q6H, PO) unknown indication; acetaminophen (since 24-Feb-2012, until 05-Mar-2012), (325mg, Q6H, PO) unknown indication; pseudoephedrine and codeine and guaifenesin (since 25-Feb-2012, until 06-Mar-2012), (6/2/20mg/mL, QHS, PO) unknown indication; naproxen (since 25-Feb-2012, until 06-Mar-2012), (500mg, BID, PO) unknown indication; promethazine (since 25-Feb-2012, until 28-Feb-2012), (25mg, Q 4-6H, PO) unknown indication. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient''s concomitant medication included DTP (since 26-Jan-2012); Meningococcal Vaccine (since 01-Feb-2012); IPV (since 26-Jan-2012); Influenza Vaccine (since 26-Jan-2012). The patient''s past medication were unspecified. Action taken with suspect drugs: Adenovirus vaccine - Not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Disability or Permanent Damage, Other Serious (Important Medical Events)). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not assessable to the Adenovirus Vaccine.

VAERS ID:522931 (history)  Vaccinated:2012-02-01
Age:  Onset:2014-01-24, Days after vaccination: 723
Gender:Female  Submitted:2014-02-18, Days after onset: 25
Location:Nevada  Entered:2014-02-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA005531
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: This spontaneous report as received from a physician via company representative refers to a female patient in her "Mid" 60 years old. In approximately February 2012 ("1-2 years prior"), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry date, dose, strength and route not reported). Concomitant therapies included TYLENOL. The physician reported that the patient developed a shingles outbreak in the "last two weeks" (on approximately 24-JAN-2014). The physician stated that the patient developed dermatomes on her "right side mid line to mid line from T5-T8 or 9". The patient was seen by the physician on an unspecified date. At the time of reporting, the outcome of the event was recovering. Additional information is not expected.

VAERS ID:526519 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2014-03-24
Location:Unknown  Entered:2014-03-24
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: WAES1402USA013500
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incomplete course of vaccination, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. About two years ago (approximately February 2012) the patient was vaccinated with the first two doses of GARDASIL (dosing information not provided). The reporter stated that the patient still has not yet received the 3rd shot of GARDASIL. No adverse events were reported. Additional information has been requested.

VAERS ID:530136 (history)  Vaccinated:2012-02-01
Age:5.0  Onset:2014-04-26, Days after vaccination: 815
Gender:Male  Submitted:2014-04-29, Days after onset: 3
Location:Virginia  Entered:2014-05-05, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0873AA1UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0785AA2UNUN
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash generalised, Varicella post vaccine
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash consistent with chicken pox over entire body starting 4/26/14, low grade fever.

VAERS ID:565570 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2015-02-16
Location:Alabama  Entered:2015-02-16
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: Unknown
Preexisting Conditions: Emphysema; Tobacco user
Diagnostic Lab Data:
CDC Split Type: A1076118A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Public     Purchased by: Public
Symptoms: Abdominal pain upper, Diarrhoea, Hyperhidrosis, Influenza like illness, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a consumer (subject''s son) and described the occurrence of flu like symptoms in an adult female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject''s medical history included emphysema and smoker. The subject had none concomitant medications. In February 2012, the subject received unspecified dose of Influenza vaccine (unknown route and injection site; lot number not provided). In February 2012, less than 1 month after vaccination with Influenza vaccine, the subject experienced flu like symptoms, diarrhea, sweating, stomach pain and fever. At the time of reporting the events were resolved. Limited information was provided; during the report the subject''s son did not feel comfortable answering any further questions regarding his mother and the report stopped.

VAERS ID:450931 (history)  Vaccinated:2012-02-01
Age:13.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-03-01, Days after onset: 29
Location:Foreign  Entered:2012-03-01
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: UNK
CDC Split Type: B0782855A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Paraesthesia oral, Tongue oedema, Vaccination site pain
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by another health professional via a regulatory authority (ES-AGEMED-024811441) and described the occurrence of red face in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 1 February 2012, the subject received an unspecified dose of CERVARIX (administration site and route unknown). On 1 February 2012, within hours of vaccination with CERVARIX, the subject experienced red face, tongue edema and vaccination site tenderness. She went to the Emergency Room approximately 8 hours after vaccination. 4 hours after admission, the saturation level was 100%. On 2 February 2011, 1 day after vaccination with CERVARIX, the subject experienced tongue tingling and vaccination site pain. She returned back to the Emergency Room. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with SOLUMODERIN and cool compress. At the time of reporting, red face, tongue edema and vaccination site tenderness were unresolved. The outcome of tingling tongue was unspecified. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX.

VAERS ID:451128 (history)  Vaccinated:2012-02-01
Age:25.0  Onset:2012-02-26, Days after vaccination: 25
Gender:Female  Submitted:2012-03-05, Days after onset: 8
Location:Foreign  Entered:2012-03-05
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: Alanine aminotransferase incre, Feb2012, above 2000U/l; Aspartate aminotransferase inc, Feb2012, above 2000U/l; Lactate dehydrogenase increase, Feb2012, 918U/l; Quick''s value decreased, Feb2012, 38%
CDC Split Type: D0074664A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood lactate dehydrogenase increased, Nausea, Prothrombin time shortened, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a hospital physician and described the occurrence of severe increase of alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) in a 25-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). On an unknown date early in February 2012 the subject received the third dose of TWINRIX adult (1 ml, unknown). Approximately two weeks post vaccination with TWINRIX adult, on 26 February 2012, the subject experienced nausea and vomiting. On 27 February 2011 the subject was hospitalised for an unknown period of time. Laboratory examinations, performed on an unknown date in February 2012, showed severely increased alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) to more than 2000 U/l both, increased lactate dehydrogenase (LDH) to 918 U/l and decreased Quick''s value to 38%. No cause for these events has been found up to 01 March 2012. At the time of reporting, on 01 March 2012, the outcome of the events was unspecified. Follow-up information has been requested.

VAERS ID:451677 (history)  Vaccinated:2012-02-01
Age:0.2  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-03-13, Days after onset: 40
Location:Foreign  Entered:2012-03-13
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: B0787713A
Vaccination
Manufacturer
Lot
Dose
Route
Site
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Decreased activity, Somnolence, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional (nurse) and described the occurrence of unresponsive to stimuli in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included live attenuated oral poliomyelitis vaccine (manufacturer unspecified) given in February 2012. No symptom occurred after this vaccination. In February 2012, the subject received 1st dose of ROTARIX (oral, batch number not provided). In February 2012, less than one day after vaccination with ROTARIX, the subject experienced drowsiness and hypoactivity. The subject didn''t respond to physical stimulation and was observed for 1 hour. After ROTARIX, the subject received unspecified dose of SYNFLORIX and of pentavalent vaccine, without any event. This case was assessed as medically serious by GSK. After 1 hour, the events were resolved. Feeding was normal, activity and physical evaluation was negative. The healthcare professional considered the events were almost certainly related to vaccination with ROTARIX.

VAERS ID:452276 (history)  Vaccinated:2012-02-01
Age:2.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-03-14, Days after onset: 41
Location:Foreign  Entered:2012-03-22, Days after submission: 8
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, 1st dose of PREVENAR; Unknown, 2nd dose of PREVENAR
Diagnostic Lab Data:
CDC Split Type: 2012064052
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Blood test normal, Intermittent claudication, Synovitis, X-ray of pelvis and hip abnormal
SMQs:, Osteonecrosis (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This is a spontaneous report from a contactable physician. The pediatrician reported that a 25-month-old female patient of an unspecified ethnicity received a single dose of PREVENAR 13 intramuscular on Feb2012 for active immunisation. Relevant medical history and concomitant medication (s) were not provided. Past product history noted a therapy regimen change as the child had received in the past (unknown dates) 4 doses of PREVENAR without experiencing any adverse event. 15 days after immunisation with PREVENAR the child developed claudication and pain at the hip (the pediatrician could not remember if it was the right or the left hip). On Feb2012, the child was hospitalised. On Feb2012 The patient underwent hip X-ray which revealed hip synovitis and a little synovial fluid. Unspecified blood tests performed on Feb2012, showed normal values. The child was administered painkillers and was discharged two days after her admission. The patient had recovered from the event at the time of the report and treatment with painkillers was discontinued. No more information was available.

VAERS ID:452568 (history)  Vaccinated:2012-02-01
Age:0.2  Onset:2012-02-05, Days after vaccination: 4
Gender:Unknown  Submitted:2012-03-28, Days after onset: 51
Location:Foreign  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastroenteritis
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, 05Feb2012, 45IU/L; Albumin, 05Feb2012, 4.4%; Alkaline phosphatase, 05Feb2012, 1241IU/L; Aspartate aminotransferase, 05Feb2012, 57IU/L; Bilirubin total, 05Feb2012, 0.8MG/DL; Blood urea nitrogen, 05Feb2012, 5MG/DL; Body temperature, 05Feb2012, 38deg.C; Body temperature, 05Feb2012, 38.5deg.C; C-reactive protein, 05Feb2012, 0.06mg/dL; Chloride, 05Feb2012, 105mEq/L; Creatine phosphokinase, 05Feb2012, 91IU/L; Creatinine, 05Feb2012, 0.16mg/dL; Hematocrit, 05Feb2012, 32.3%; Hemoglobin, 05Feb2012, 10.7g/dL; Influenza virus test, NEGATIVE; Lactate dehydrogenase, 05Feb2012, 220IU/L; Mean cell hemoglobin, 05Feb2012, 29.2pg; Mean cell hemoglobin concentra, 05Feb2012, 33.1g/dL; Mean cell volume, 05Feb2012, 88.3gL; Neisseria test
CDC Split Type: B0780759A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Alanine aminotransferase increased, Aspartate aminotransferase normal, Blood albumin, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine decreased, Blood culture negative, Blood glucose normal, Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein normal, CSF culture negative, Chest X-ray normal, Culture stool negative, Culture urine negative, Diarrhoea, Eye discharge, Gastroenteritis rotavirus, Haematocrit decreased, Haemoglobin normal, Icterus index, Influenza virus test negative, Laboratory test normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Neisseria test positive, Pharyngeal erythema, Platelet count, Protein total normal, Pyrexia, Red blood cell count normal, Respiratory syncytial virus test negative, Rotavirus test positive, Streptococcus test positive, X-ray normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of rotavirus diarrhea in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received the 1st dose of ROTARIX (1.5 ml, oral, lot number not provided). Two to three days after vaccination with ROTARIX, the subject was admitted to the hospital for pyrexia. Because the subject also had loose stools, he received an antigen test, which showed positive for rotavirus. The subject was hospitalised. At the time of reporting the outcome of the event rotavirus diarrhea was unspecified, the events fever and loose stools were unresolved. Additional information received on 15 February 2012: The subject''s medical condition included gastroenteritis. On 02 February 2012, the subject received 1st dose of ROTARIX (1.5 ml, oral). On 07 February 2012, 5 days after vaccination with ROTARIX, the subject was admitted for pyrexia. On 09 February 2012, the event fever resolved. Additional information received on 20 February 2012: ON an unspecified date, the events loose stools and rotavirus diarrhea resolved. Additional information received on 21 March 2012. On 01 February 2012, the subject was vaccinated with ROTARIX. On 05 February 2012, early in the morning, pyrexia developed at 38 degrees Centigrade. The subject visited the emergency outpatient department of the reporting physician''s hospital and was admitted to the hospital on the same day. The subject''s grandmother and mother had common cold symptoms. On admission, her body weight was 5.5 kg and body temperature was 38.5 degrees Centigrade. Left eye discharge and a mild redness of pharynx were observed. No abnormal finding was observed on the anterior fontanelle or thoracoabdominal region. On 1st day of hospitalisation, the subject presented with gastroenteritis symptoms. The subject was placed under observation with a treatment with fluid replacement only. On 2nd days of hospitalisation, the pyrexia resolved. The symptoms gradually improved. On 3rd day of hospitalisation, the general condition was good. The subject drank milk well and was discharged from the hospital with improvement of the symptoms. On discharge, the subject was prescribed MIYA BM (1 g/pack) at 0.5 pack x3/day for 4 days and Zinc Oxide Ointment (10%) 50 g, one tube.

VAERS ID:453748 (history)  Vaccinated:2012-02-01
Age:0.2  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 70
Location:Foreign  Entered:2012-04-16, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012089943
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMUN
MNC: MENINGOCOCCAL (MENINGITEC)PFIZER/WYETH  IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cyanosis, Hypotonia, Pallor
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This is a spontaneous report from a physician, contactable only through the Drug Agency. Regulatory authority number ES-AGEMED-514477338. A 2-month-old female patient received a dose of PREVENAR 13 intramuscularly along with a dose of MENINGITEC intramuscularly and a dose of INFANRIX HEXA intramuscularly on 01Feb2012 for routine vaccination. Relevant medical history and concomitant medications were not reported. On 01Feb2012, a few minutes after vaccination, the patient developed perioral cyanosis, hypotonia and pallor. The events were considered medically significant. The patient was transferred to the hospital. Therapeutic measures taken as a result of the event included treatment with adrenaline and oxygen therapy. The patient recovered after treatment on 01Feb2012. In the past, the patient''s brother experienced the same reaction when he was administered the same vaccines. No follow-up attempts possible. No further information expected.

VAERS ID:454262 (history)  Vaccinated:2012-02-01
Age:0.3  Onset:2012-02-01, Days after vaccination: 0
Gender:Unknown  Submitted:2012-04-20, Days after onset: 78
Location:Foreign  Entered:2012-04-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201203849
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B122JA IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG9558 IMUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURE5983 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Emotional distress, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from the Health Authorities in a foreign country on 11 April 2012 under the reference number 2012/0093 (HA''s number PLURPLOCR20120320003). A 03-month-old patient, with no reported medical history and concomitant therapy, had received an intramuscular dose of IMOVAX POLIO (batch number E5983, site of administration not reported), an intramuscular dose of ACTHIB (batch number G9558-1, site of administration not reported) and an intramuscular dose of INFANRIX (other manufacturer, batch number AC14B122JA, site of administration not reported) on 01 February 2012. On 01 February 2012, about 4 hours post-vaccination, the patient experienced crying lasting for 2 days. The patient could not calm down and did not want to be touched. He had fever at 39 degrees C. The patient was referred to the vaccine consulting center where the individual immunization program and recommendations were done. The patient recovered on an unspecified date and was in good general condition. The case was assessed as serious due to other medical important condition. The Health Authorities coded crying uncontrollable and fever.

VAERS ID:455173 (history)  Vaccinated:2012-02-01
Age:0.2  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-05-08, Days after onset: 96
Location:Foreign  Entered:2012-05-08
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: Bronchopulmonary dysplasia
Preexisting Conditions: Prematurity
Diagnostic Lab Data: Blood culture, 2012, negative; C-reactive protein, 01Feb2012, 8mg/L; Echocardiography, 2012, see text; Oxygen saturation, 2012, improved
CDC Split Type: B0799677A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA745A UNUN
UNK: PNEUMO (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSASPNA063AJ UNUN
Administered by: Other     Purchased by: Other
Symptoms: Apnoea, Blood culture negative, C-reactive protein increased, Continuous positive airway pressure, Echocardiogram abnormal, Heart rate decreased, Mechanical ventilation, Oxygen saturation abnormal, Right ventricular hypertrophy, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (# 121318) and described the occurrence of apnea in a 2-month-old female subject who was vaccinated with SYNFLORIX (GlaxoSmithKline), INFANRIX-POLIO-HIB. The subject''s medical history included prematurity (born on week 24 of gestation). Concurrent medical conditions included bronchopulmonary dysplasia. On 1 February 2012, the subject received unspecified dose of SYNFLORIX (.5 ml, unknown route and injection site), unspecified dose of INFANRIX-POLIO-HIB (.5 ml, unknown route and injection site) as it was planned she''ll be sent home. On 1 February 2012 in the evening, less than one day after vaccination with INFANRIX-POLIO-HIB and SYNFLORIX, the subject experienced apnea, repeated decreased heart rate and positive c-reactive protein (8 mg/L). The subject got better after stimuli with enhanced dose of oxygen. The subject was also treated with Antibiotic. During the night of vaccination with INFANRIX-POLIO-HIB and SYNFLORIX, the subject experienced a lot of apnea episodes. At some occasions, less than 1 week after vaccination with INFANRIX-POLIO-HIB and SYNFLORIX, the subject was unresponsive to stimuli and had to be ventilated one more time. The subject was hospitalised. A blood culture (negative) and an echocardiography were performed (nothing new, relief on the left and right ventricle hyper atrophy). The subject was treated with BETAMETASONE, FUROSEMIDE, caffeine citrate, GLUCOSE and mechanical ventilation (CPAP) with 60% oxygen. Two days after vaccination CRP decreased and oxygen saturation improved. CPAP was removed. At the time of reporting the outcome of decreased heart rate and unresponsive to stimuli was unspecified. The regulatory authority reported that the events were possibly related to vaccination with SYNFLORIX and INFANRIX-POLIO-HIB.

VAERS ID:455474 (history)  Vaccinated:2012-02-01
Age:0.1  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-05-08, Days after onset: 96
Location:Foreign  Entered:2012-05-14, Days after submission: 6
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: Premature baby 26 to 32 weeks
Diagnostic Lab Data:
CDC Split Type: 2012108328
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fatigue, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)
Write-up: This is a spontaneous report from a contactable physician. This is a report received from the Foreign Medical Product Agency. Regulatory authority report number 121376. A 1-month-old male patient of an unspecified ethnicity received PREVENAR, via an intramuscular route of administration on an unknown date in Feb2012 at 0.5 ml single dose and SYNFLORIX the next day in Feb2012 as 1 single dose: both for vaccination. Medical history included premature birth at week 26 plus 4 days and hospitalization at age 12 days for respiratory distress syndrome. At birth, the patient had respiratory distress syndrome and was treated with a respirator. He was stable per circulation with no remarks regarding nutrition. After a week of continuous respirator, it was replaced by intermittent use (not further specified) until week 32; and then oxygen treatment for an additional two weeks. The patient''s concomitant medications were not reported. During the hospitalization in Feb2012, the patient received PREVENAR and became very fatigued and was affected with increased requirements of oxygen during that day. The hospitalization was thus extended. The following day in Feb2012, the patient received SYNFLORIX and received the same reaction with saturation dips and tiredness. Unspecified lab tests were taken the same day and the following days but showed no signs of infection. The clinical outcome of the events, very fatigued/tiredness and increased requirements of oxygen/saturation dips, was recovered on an unknown date. The Foreign Medical Products Agency classified the causalities as possible for the vaccines, PREVENAR vaccine and SYNFLORIX, and the events, very fatigued/tiredness and increased requirements of oxygen/saturation dips. No follow-up attempts possible. No further information expected.

VAERS ID:457354 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2012-06-13
Location:Foreign  Entered:2012-06-13
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: Travel to foreign country
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0075535A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatic enzyme increased, Hepatitis A, Hepatitis A antibody negative, Hepatitis B antibody negative
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of hepatitis A in an approximately 67-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). Concurrent medical conditions included travel to foreign country. In February 2012 and March 2012 the subject received unspecified doses of TWINRIX adult (unknown route and application site). It was unknown, if the basic immunisation was complete. The last dose was administered seven days before departure. At an unspecified time after vaccination with TWINRIX adult, four weeks after returning home the subject experienced hepatitis A. The subject was hospitalised. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 04 June 2012 from the physician. At an unspecified time after vaccination with TWINRIX adult, a test was negative for hepatitis A antibody and hepatitis B antibody. After her travel, the patient had increased liver values. The values had improved at the time of follow-up. No further information will be available.

VAERS ID:457825 (history)  Vaccinated:2012-02-01
Age:15.0  Onset:2012-04-01, Days after vaccination: 60
Gender:Female  Submitted:2012-06-20, Days after onset: 80
Location:Foreign  Entered:2012-06-21, Days after submission: 1
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:
Preexisting Conditions: Peripheral vascular disorder; Stomach discomfort
Diagnostic Lab Data: Diagnostic laboratory test, inconspicuous
CDC Split Type: WAES1206USA02753
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Condition aggravated, Gastric disorder, Laboratory test, Peripheral vascular disorder, Vaccine positive rechallenge
SMQs:
Write-up: This case was received from a physician on 12-JUN-2012. The case is medically confirmed. A 15-year-old female patient received dose 2 of GARDASIL April 2012-lot number, route and site of administration were not reported. Shortly after the vaccination the patient presented with peripheral circulatory problems and stomach problems. At an unspecified date she was hospitalized, unspecified diagnostic tests were inconspicuous. The physician stated that the problems were worse when the patient was attending school. At the time of the report the events were persisting. In February 2012 the patient had received the first dose of GARDASIL (lot-number not reported) and developed peripheral circulatory disorder and stomach problems. At this time an oral contraceptive (start of intake at the same time) was suspected to have triggered the events. However, due to the positive rechallenge the events were attributed to the vaccination with vaccine. Other business partner numbers include E2012-03800. No further information expected.

VAERS ID:474436 (history)  Vaccinated:2012-02-01
Age:5.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Male  Submitted:2012-11-16, Days after onset: 289
Location:Foreign  Entered:2012-11-16
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: UNK
CDC Split Type: B0844517A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hallucination, auditory, Pyrexia, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via a regulatory authority (# CZ-CZSUKL-12001900) and described the occurrence of viral infection in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). In February 2012, the subject received an unspecified dose of INFANRIX (administration site and route unknown, batch number not provided). In February 2012, less than one day after vaccination with INFANRIX, the subject experienced auditory hallucinations at night and high fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). The hallucinations reoccurred approximately once a month and persisted for 5 days. At the time of reporting, auditory hallucination was unresolved. The outcome of high fever was unspecified. The paediatrician qualified the adverse events as viral infection.

VAERS ID:476804 (history)  Vaccinated:2012-02-01
Age:0.5  Onset:2012-02-02, Days after vaccination: 1
Gender:Male  Submitted:2012-12-04, Days after onset: 306
Location:Foreign  Entered:2012-12-06, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: USG of his brain and two EEG examinations (date unknown): revealed no brain harm; Neurological and laboratory examination (date unknown): without pathological findings
CDC Split Type: 2012300201
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF34602 IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Application site erythema, Application site induration, Electroencephalogram normal, Eye movement disorder, Laboratory test normal, Neurological examination normal, Staring, Ultrasound scan normal, Ultrasound skull
SMQs:, Ocular motility disorders (narrow)
Write-up: This is a spontaneous case received from a Regulatory Authority as E2B report with a number SK-SUKLSK-20120836. This case was reported by a physician. A 6-month-old male subject who was vaccinated with PREVENAR 13. On 01Feb2012, the subject received the intramuscular dose 1x0.5ml of PREVENAR 13 in his right thigh. Autoimmune thyroiditis, atopic dermatitis in his mother''s medical history and polinosis in his father''s medical history. Within 1 day after vaccination the subject developed application site erythema, application site induration and a transient turning of the eye bulb. The physician described the event as "the patient''s look was freeze and then he turned his eye bulbs for a few seconds of". The subject underwent neurological examination in a paediatric hospital. USG of his brain and two EEG examinations revealed no brain damage, neurological and laboratory examination was without pathological findings. The patient recovered. Additional details not reported.

VAERS ID:489555 (history)  Vaccinated:2012-02-01
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-18
Location:Foreign  Entered:2013-04-18
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: B0883293A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Grip strength decreased, Injected limb mobility decreased, Joint range of motion decreased, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a consumer and described the occurrence of arm swollen in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In February 2012, the subject received unspecified dose of CERVARIX (intramuscular, left arm; lot number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced arm swollen in the left arm, injected limb mobility decreased and pain. The subject was referred to a orthopaedic surgery department and was currently still receiving rehabilitation. The subject''s joint range of motion decreased and she had grip strength decreased in the left hand (she was unable to even hold an object). The subject was treated with LYRICA after which the pain slightly subsided but did not improve the symptom. At the time of reporting the outcome of the events was unspecified.

VAERS ID:490079 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2013-04-25
Location:Foreign  Entered:2013-04-25
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: 2011, GARDASIL, Dose 1, No adverse event
Diagnostic Lab Data:
CDC Split Type: WAES1304DNK013945
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Acupuncture, Asthenia, Confusional state, Dizziness, Dysstasia, Feeling abnormal, Headache, Scan, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Case received from a consumer in a foreign newspaper via company representative on 16-Apr-2013. Case medically confirmed. A adolescent (13 year old at the time of reporting) female patient had received an injection of GARDASIL (Dose 2, batch number, administration route and site not reported) on unspecified date in 2011 and later on post vaccination she developed dizziness and confusion she had also headache often. The symptoms started suddenly and increased. On unspecified date in February 2012 she received the third dose of GARDASIL (batch number, administration route and site not reported). After the third dose the headache became chronic and the dizziness increased. She often had to support against the walls. She fainted 5 times the week before the school break in the autumn 2012. She described that one day she started to feel like a foggy bubble around her head that made her weak and drowsy and thereafter she fainted. She had received physical therapy, back exercises, hospitalisation, scans and medical checks but nothing helped. Her condition improved significantly after acupuncture treatment. The patient had previously received an injection of GARDASIL (Dose 1, batch number, administration route and site not reported) on unspecified date in 2011. No adverse event reported after this vaccination. At the time of reporting, the outcome was not recovered. According to the patient''s parents the reaction was related to vaccination.

VAERS ID:490541 (history)  Vaccinated:2012-02-01
Age:91.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-01
Location:Foreign  Entered:2013-05-01
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: Hypertension; Diabetes mellitus
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1304CAN017727
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Blister, Pemphigoid, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report as received from a consumer refers to a 91 year old female patient (her mother) with high blood pressure and diabetes. In FEB-2012, the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. Following the vaccination the patient got a rash which she did not tell anyone and the rash got worse. The rash was on her trunk and no one noticed until she went to the cardiologist for a routine visit. She had blisters all over her body. After several doctors (general practitioners and dermatologists) could not diagnose it, she was sent to a specialist who diagnosed bullous pemphigoid. The patient was hospitalized and is on cortisone plus anti-rejection drugs. According to the reporter this has debilitated her greatly. She can no longer live at home due to the effects of the medications she is on. She is now in a nursing home. The outcome of bullous pemphigoid, rash and debilitated was reported as not recovered/not resolved. The event relatedness was not provided. Additional information is not expected.

VAERS ID:500182 (history)  Vaccinated:2012-02-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2013-08-21
Location:Foreign  Entered:2013-08-21
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:
Diagnostic Lab Data: UNK
CDC Split Type: B0916363A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site calcification, Injection site erythema, Injection site induration, Injection site swelling, Surgery
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site calcification in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) 1st dose and 2nd dose given on August 2011 and September 2011. In February 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). At an unspecified time after vaccination with CERVARIX, the subject experienced redness, swelling and induration at injection site, which became calcified. The pharmacist considered the events were clinically significant (or requiring intervention). The subject was treated with surgery. At the time of reporting, the outcome of the events was unspecified.

VAERS ID:500956 (history)  Vaccinated:2012-02-01
Age:12.0  Onset:2012-03-01, Days after vaccination: 29
Gender:Female  Submitted:2013-08-28, Days after onset: 544
Location:Foreign  Entered:2013-08-28
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: Nuclear magnetic resonance ima, 2012, unknown
CDC Split Type: B0918086A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149CA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dysmenorrhoea, Headache, Hypoaesthesia, Nuclear magnetic resonance imaging
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This case was reported by a physician via a regulatory authority (V13000584) and described the occurrence of headache in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included human papilloma type 16 + 18 vaccine; GlaxoSmithKline; intramuscular; unknown given on August 2011 and September 2011. Before vaccination, body temperature was between 36.4 and 36.5 deg.C. In February 2012, the subject received 3rd dose of CERVARIX (intramuscular, administration site unknown). In March 2012, 1 month after vaccination with CERVARIX, the subject experienced headache and painful periods. At an unspecified time after vaccination with CERVARIX, the subject experienced also numbness of upper extremities. The regulatory authority reported that the events were clinically significant (or requiring intervention). She underwent examinations including magnetic resonance imaging and was prescribed various drugs but the symptoms persisted without improvement. At the time of reporting, headache and painful periods were unresolved. Numbness of upper extremities was resolved.

VAERS ID:448665 (history)  Vaccinated:2012-02-02
Age:67.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-02, Days after onset: 0
Location:Georgia  Entered:2012-02-02
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: Azithromycin, Sulfa, Codeine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1477AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt describes swelling with pain at injection site last night at 5:00 PM, then 2/2/12 at 2:00 PM pt began to develop a red rash on the upper portion of her body.

VAERS ID:448666 (history)  Vaccinated:2012-02-02
Age:23.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-02, Days after onset: 0
Location:South Carolina  Entered:2012-02-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair, Singulair, Claritin, Camrese
Current Illness: no
Preexisting Conditions: asthma, seasonal allergies
Diagnostic Lab Data: received an antihistamine and steroid via IV
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH276AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Throat tightness, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Wheezing, tightness in throat, hives.

VAERS ID:448753 (history)  Vaccinated:2012-02-02
Age:0.4  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 1
Location:Florida  Entered:2012-02-03
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: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4024AA1UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169751UNRL
Administered by: Private     Purchased by: Private
Symptoms: Crying, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Baby was crying non stop for several hours. Also vomiting non stop.

VAERS ID:448794 (history)  Vaccinated:2012-02-02
Age:51.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 1
Location:Minnesota  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair Pro Air Ibuprofen Lyrica Cymbalta cholesterol med
Current Illness: No
Preexisting Conditions: Reflex Sympathetic Dystrophy Fibromyalgia Asthma Depression
Diagnostic Lab Data: Woke up feeling better However, am still off "kilter"; shallow breathing; shaky feeling inside and on hands; pounding "sound" in ears. Another doc appt at facility today at 315.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   RA
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER   RA
Administered by: Public     Purchased by: Other
Symptoms: Blood glucose decreased, Blood pressure increased, Chest discomfort, Dizziness, Dry mouth, Headache, Hyperhidrosis, Hypopnoea, Nausea, Nervousness, Tinnitus, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Respiratory failure (narrow), Hypoglycaemia (narrow)
Write-up: 15 Minutes later walking to next appt started sweating profusely; nauseated; shallow breathing; dizzy; headache; chest pressure; dry mouth; shaky legs and arms. Blood sugars dropped/Blood pressure went up to 212/134? Taken by ambulance to Hospital for observation.

VAERS ID:448799 (history)  Vaccinated:2012-02-02
Age:4.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Male  Submitted:2012-02-03, Days after onset: 1
Location:Kentucky  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol liquid
Current Illness: no illness noted
Preexisting Conditions: chronic cough
Diagnostic Lab Data: CT scan urinalysis spinal tap
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196BA0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1250Z0SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9177350IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1147AA0SCLL
Administered by: Military     Purchased by: Military
Symptoms: Body temperature increased, Computerised tomogram, Convulsion, Lumbar puncture, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Child''s temp at 103, child went into a seizure that lasted 2 and a half minutes. Child taken to ER Motrin was given temp decreased and child had a 2nd seizure lasting just a couple of mins.

VAERS ID:448804 (history)  Vaccinated:2012-02-02
Age:0.5  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 1
Location:Hawaii  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: local swelling~DTaP + IPV + Hib (Pentacel)~1~0.17~Patient
Other Medications: None
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4143AA2IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4149CA0IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC070AA2IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9177352IMRL
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Local redness at site of injection. Later developed swelling. Fever to 101.7 later that evening. Fussy.

VAERS ID:448821 (history)  Vaccinated:2012-02-02
Age:10.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Male  Submitted:2012-02-03, Days after onset: 0
Location:New York  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Negative strep.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH486AD4IMLA
Administered by: Private     Purchased by: Private
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever & sore throat started the day after receiving vaccine. Strep test negative. Exam otherwise unremarkable.

VAERS ID:448824 (history)  Vaccinated:2012-02-02
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2012-02-03
Location:New Mexico  Entered:2012-02-03
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 BIOLOGICALSAHAVB513AA2IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4039AA1IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B070BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.09242AA2SCLA
Administered by: Private     Purchased by: Other
Symptoms: Accidental exposure, Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This young man received, Varicella, Meningococcal and Hepatitis A vaccines on Aug 9, 2011. He was re-administered the same vaccines on 02/02/12 inadvertently. He has not had an adverse reaction.

VAERS ID:448809 (history)  Vaccinated:2012-02-02
Age:33.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-04, Days after onset: 2
Location:Texas  Entered:2012-02-04
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
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER 2 RA
Administered by: Unknown     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain in extremity
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Severe pain at injection site, stiffness, sharp pain, cannot lift my arm. It has been two days and still have very bad pain in that arm.

VAERS ID:448894 (history)  Vaccinated:2012-02-02
Age:52.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-06, Days after onset: 4
Location:North Carolina  Entered:2012-02-06
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: Latex
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABA041A0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/2/12 Given Td (L) deltoid IM. Started to get red, itchy, swollen arm 30-60 minutes after injection. Had called clinic 2/6/12 10am to inform of this event. Stated she forgot to tell nurse of latex allergy. Told to alternate hot/cold compresses to site. Use BENADRYL or hydrocortisone as needed for itching.

VAERS ID:448897 (history)  Vaccinated:2012-02-02
Age:26.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-02-07, Days after onset: 4
Location:Ohio  Entered:2012-02-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: SINGULAIR; PROAIR HFA; Albuterol sulfate; FLOVENT HFA; Fluticasone; AVIANE
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data: In hospital - tests being done but not available
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1706AA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness, swelling, pain left arm inj. site. Fever of 103 degrees since 2/3/12 - pt. is still hospitalized.

VAERS ID:448916 (history)  Vaccinated:2012-02-02
Age:4.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-06, Days after onset: 4
Location:Arkansas  Entered:2012-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Has doctor''s appt on 2/10/12.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B167FA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1001AA SCRA
Administered by: Public     Purchased by: Public
Symptoms: Decreased appetite, Diarrhoea, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Began vomiting that night, has had continued loss of appetite. Diarrhea and rash also reported. Mom reported 4-inch rash 2 inches below Kinrix site.

VAERS ID:449010 (history)  Vaccinated:2012-02-02
Age:68.0  Onset:2012-02-04, Days after vaccination: 2
Gender:Female  Submitted:2012-02-07, Days after onset: 3
Location:Pennsylvania  Entered:2012-02-07
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0358AA0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Neck pain
SMQs:, Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Inj site rxn: red, itchy, grew to size of hand. Pain in upper back & neck (ok of previous shingles infxn in late 30''s). Developed headache. Rec''d to use ice on inj & APAP for HA. BENADRYL rec''d but pt didn''t want to use b/c drowsy feeling assoc''d with & seen by PCP on 2-6-12. No tx prescribed - just set APAP.

VAERS ID:449059 (history)  Vaccinated:2012-02-02
Age:3.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Male  Submitted:2012-02-07, Days after onset: 4
Location:Ohio  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none reported.
Current Illness: none reported.
Preexisting Conditions: none reported.
Diagnostic Lab Data: none reported.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AD4IMRL
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Decreased appetite, Hypotonia, Loss of consciousness, Pyrexia, Staring, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Pt did not eat much for supper. It was bath time for the patient and pt was very, weak, limp and starry eyed during this. Pt kept complaining of her one arm, a limp feeling. Pt was going to have a snack afer bath time and pt wet herself and then passed out. Pt did have a fever and was given a fever reducer for that. Pt was taken to ER for evaluation and pt "snapped out of it and was fine for her ER visit." Pt did carry a fever through out the weekend and was kept home from preschool one day just to make sure she was still doing ok.

VAERS ID:449062 (history)  Vaccinated:2012-02-02
Age:35.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-07, Days after onset: 5
Location:Pennsylvania  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: partial thickness burn of left thumb
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4304AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Dizziness, Skin discolouration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Within 2 minutes of receiving IM TDAP in left deltoid, patient complained of feeling faint, was eased to the floor experiencing a very brief syncopal episode. She responde to verbal stimuli immediately and once her color returned she was hepled to an examining table, given po fluids, vital signs monitored (stable at 90/70 p-90) and observed for 30 minutes. She left ambulatory in no distress with her husband who drove her home. On follow up the next day she reported feeling fine.

VAERS ID:449066 (history)  Vaccinated:2012-02-02
Age:16.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-07, Days after onset: 5
Location:Texas  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none noted
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1524AA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0953AA SCLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC53B070BA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash papular
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Papular rash.

VAERS ID:449147 (history)  Vaccinated:2012-02-02
Age:10.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 1
Location:Vermont  Entered:2012-02-08, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB481BB0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: About 30 min after vaccine given pt developed some tingling and numbness in hand on same side. Pt examined and does have sensation to hand but decreased ability to tell one vs two point contact. Symptoms consistent with small nerve being affected, should recover on its own will monitor. Motor intact.

VAERS ID:449181 (history)  Vaccinated:2012-02-02
Age:19.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-02-08, Days after onset: 5
Location:Wisconsin  Entered:2012-02-08
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.1317AA IM 
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B072FA IM 
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Nauseated, dizzy.

VAERS ID:449226 (history)  Vaccinated:2012-02-02
Age:2.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Male  Submitted:2012-02-03, Days after onset: 1
Location:Nebraska  Entered:2012-02-09, 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: Hx of pneumococcal meningitis
Diagnostic Lab Data: None - monitoring
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.14778A IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Weight bearing difficulty
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt was given vaccine by Dr. nurse 2-2-12 was seen in our clinic 2-3-12 with (R) leg swollen, red, hot, fever and unable to bear weight.

VAERS ID:449272 (history)  Vaccinated:2012-02-02
Age:1.3  Onset:2012-02-06, Days after vaccination: 4
Gender:Male  Submitted:2012-02-09, Days after onset: 3
Location:Virginia  Entered:2012-02-09
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: STREP A ANTIGEN (THROAT)-NEGATIVE INFLUENZA A/B ANTIGEN-NEGATIVE RSV ANTIGEN-NEGATIVE NONCONTRAST CT OF HEAD-NORMAL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B136BB0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB534CA0IMLA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1785AA0IMRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172443IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Computerised tomogram head, Computerised tomogram normal, Febrile convulsion, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Respiratory syncytial virus test negative, Streptococcus test negative
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: FEBRILE SEIZURE.

VAERS ID:449278 (history)  Vaccinated:2012-02-02
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2012-02-09
Location:Arkansas  Entered:2012-02-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B171DA0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0666AA1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0814AA1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Vaccination site erythema, Vaccination site oedema
SMQs:
Write-up: Erythema & edema at site of vaccination 3 x 4 cm.

VAERS ID:449392 (history)  Vaccinated:2012-02-02
Age:0.2  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-02-12, Days after onset: 9
Location:Maryland  Entered:2012-02-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Polyvisol vitamins
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Test completed at doctor''s office to confirm blood in stools.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     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: Bloody stools.

VAERS ID:449636 (history)  Vaccinated:2012-02-02
Age:0.2  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-08, Days after onset: 6
Location:Tennessee  Entered:2012-02-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: URI - viral & occasional emesis
Preexisting Conditions: Preterm Birth - (32 wk EGA); Neonatal feeding problems
Diagnostic Lab Data: Abnormal Abd. Xray; Showing gastric outlet obstruction
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B315AA0IMUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1515AA0IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169210IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1312AA0PO 
Administered by: Private     Purchased by: Public
Symptoms: Abdominal X-ray, Dehydration, Haematemesis, Obstruction gastric, Pyloric stenosis, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Congenital, familial and genetic disorders (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Vomiting & dehydration with hematemesis onset 2/2/12 diagnosed with pyloric stenosis on 2/4/12 had surgery & has improved.

VAERS ID:449681 (history)  Vaccinated:2012-02-02
Age:1.4  Onset:2012-02-13, Days after vaccination: 11
Gender:Male  Submitted:2012-02-16, Days after onset: 3
Location:Indiana  Entered:2012-02-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1118AAA0SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0945AA0SCUN
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash, Rash papular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash 20-30 mild papules arms legs, face, trunk. Low grade fever, 2 wks after vaccine given.

VAERS ID:449713 (history)  Vaccinated:2012-02-02
Age:1.1  Onset:2012-02-14, Days after vaccination: 12
Gender:Male  Submitted:2012-02-16, Days after onset: 2
Location:Texas  Entered:2012-02-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol prn
Current Illness: None noted.
Preexisting Conditions: None noted
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4024AA0IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4230AA0IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.1068AA0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0400AA0SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9166183IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0672AA0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Irritability, Rash maculo-papular, Skin warm
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Grandmother noted that patient has been fussy since Valentines day, felt a little warm but temperature not taken. Patient given Tylenol. Child woke up this morning with a maculopapular rash noted by nurse from hairline to waistline. Family treated skin with Aveeno lotion from first sign of rash. Instructed to continue to monitor and treat symptoms, report any changes to the health department staff. Explained that a rash can occur up to 12 days post vaccination in a small percentage of vaccinated and virus cannot reproduce so no precautions are needed. Grandmother voiced understanding and will report any further concerns.

VAERS ID:449760 (history)  Vaccinated:2012-02-02
Age:27.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Male  Submitted:2012-02-10, Days after onset: 8
Location:California  Entered:2012-02-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: Below knee amputation at birth; Deformed (L) hand at birth
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLA637AA UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB459BB0UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10835UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B071BB UNLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH138AA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: (L) hand swelling, redness and itching since 7:00pm on 2/2/12. No fever, chills, SOB, tongue swelling or throat swelling. No apparent reaction at injection site either (L) or (R) arm. Per pt swelling and redness subsided within 48 hours. (2/9/12 back to normal).

VAERS ID:449765 (history)  Vaccinated:2012-02-02
Age:52.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Male  Submitted:2012-02-10, Days after onset: 7
Location:Minnesota  Entered:2012-02-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURAC52BUNEAA0IMAR
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSUH486AE0IMAR
Administered by: Other     Purchased by: Public
Symptoms: Chills, Decreased appetite, Diarrhoea, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Patient called complaining of fever, severe chills and several bouts of diarrhea. He also complains of lethargy and loss of appetite.

VAERS ID:450171 (history)  Vaccinated:2012-02-02
Age:0.4  Onset:2012-02-02, Days after vaccination: 0
Gender:Male  Submitted:2012-02-14, Days after onset: 12
Location:Alabama  Entered:2012-02-23, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Screamed~DTaP + IPV + Hib (Pentacel)~1~0.20~Patient|Screamed~Pneumo (Prevnar13)~1~0.20~Patient|Screamed~Rotavirus (Rotateq)~1~0.
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3943AA1IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH654421IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0919AA1PO 
Administered by: Private     Purchased by: Public
Symptoms: Screaming
SMQs:, Hostility/aggression (broad)
Write-up: Infant screamed for 9 hours starting 1 1/2 hrs. after receiving 4 mo. immunizations.

VAERS ID:450588 (history)  Vaccinated:2012-02-02
Age:14.0  Onset:2012-02-05, Days after vaccination: 3
Gender:Female  Submitted:2012-02-22, Days after onset: 17
Location:California  Entered:2012-02-27, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: MRI (head) with and without contrast; lyme antibody titer
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AC7IMLA
Administered by: Private     Purchased by: Private
Symptoms: Antibody test, Dyskinesia, Eyelid function disorder, Eyelid ptosis, Hypoaesthesia, Nuclear magnetic resonance imaging brain, Scan with contrast, VIIth nerve paralysis
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: On 2/5/12 (L) eye started to droop & will not completely close. (L) side of face numbness. When raises eyebrows only (R) eyebrow raises. (L) facial droop. When smiles only (R) side of lip turns up.

VAERS ID:450731 (history)  Vaccinated:2012-02-02
Age:18.0  Onset:2012-02-05, Days after vaccination: 3
Gender:Female  Submitted:2012-02-13, Days after onset: 8
Location:North Carolina  Entered:2012-02-28, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None stated
Current Illness: None stated
Preexisting Conditions: None stated; Pt is bipolar, mother concerned re: known connection to bipolar & GARDASIL
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1317AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM100590IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3518AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Abnormal behaviour, Aggression, Agitation, Fatigue, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Hypoglycaemia (broad)
Write-up: 3d after vaccine was was fatigued & sleepy & agitated. On 4th or 5th day, she became aggressive with raising voice to her parents, abrupt & didn''t want to be around her family members. This was a sudden change.

VAERS ID:450751 (history)  Vaccinated:2012-02-02
Age:58.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-28, Days after onset: 26
Location:South Carolina  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zocar
Current Illness: none
Preexisting Conditions: tendonitis right arm
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3110CA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Periarthritis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (narrow)
Write-up: Complained of severe pain (without movement and unable to raise arm due to pain) upper left arm following Tdap injection. Denied redness, swelling or warmth at site. After 48 hours, pain improved some, then has persisted to present. Pain is slowly resolving. Client described as "frozen shoulder" with feeling of joint pain. Client called to report event 12 days afterwards, and advised to seek medical evaluation. Seen per Dr the next week. No diagnosis given. Only treatment Ibuprofen as needed.

VAERS ID:450773 (history)  Vaccinated:2012-02-02
Age:60.0  Onset:2012-02-26, Days after vaccination: 24
Gender:Female  Submitted:2012-02-28, Days after onset: 2
Location:California  Entered:2012-02-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Unsure~Influenza (Seasonal) (no brand name)~UN~0.00~Patient
Other Medications: Estradiol
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1160AA0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Herpes zoster, Infection, Musculoskeletal pain, Pain in extremity, Rash vesicular
SMQs:, Rhabdomyolysis/myopathy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt developed pain in right arm/shoulder on 2/26/12. Within 24 hours developed blister like rash (R) arm c/w shingles area of mid forearm with secondary infection.

VAERS ID:451015 (history)  Vaccinated:2012-02-02
Age:69.0  Onset:2012-02-09, Days after vaccination: 7
Gender:Male  Submitted:2012-03-02, Days after onset: 22
Location:New York  Entered:2012-03-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Stubbed right hand 3 weeks ago - has slight swelling of middle finger, 5th finger
Preexisting Conditions: Hypertension; Bipolar; GERD; Hyperlipidemia; DJD; No known allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT474AB1SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Induration, Neck pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Vet indicated he went to the Emergency room where injection site was assessed and was given MOTRIN 600mg to take for pain every 6 hours as needed for pain and was instructed to use warm compress 20 minutes on and off. Vet denies any fevers, skin irritation or redness (although he is very dark skin color). He indicated that since he had the flu shot injection area became indurated and the pain started spreading up to his neck and back. Pain is not at injection site but at left supraclavicular area more on upper trapezius muscle.

VAERS ID:451551 (history)  Vaccinated:2012-02-02
Age:1.5  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-03-12, Days after onset: 37
Location:California  Entered:2012-03-12
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: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Otitis media acute, Productive cough, Pyrexia
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Developed a fever, then had a seizure and was taken by ambulence to the emergency room. When I evaluated her again on 2/8/12, she had complaints of 1 week of a productive cough and evidence of acute otitis media on exam.

VAERS ID:453158 (history)  Vaccinated:2012-02-02
Age:32.0  Onset:2012-02-05, Days after vaccination: 3
Gender:Female  Submitted:2012-04-08, Days after onset: 62
Location:Mississippi  Entered:2012-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Valacyclovir/Valtrex
Current Illness: None
Preexisting Conditions: Shellfish allergies, Erythema Multiforme.
Diagnostic Lab Data: Skin Biopsies revealed - Cytotoxic Dermatitis Complete Blood Count - normal findings
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH140AA0SCRA
Administered by: Public     Purchased by: Other
Symptoms: Biopsy skin abnormal, Dermatitis, Full blood count normal, Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Papule, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/5/2012 - Burning, redness and swelling at injection site. 2/6/2012 - development of itchy rash near injection site (posterior right arm). 2/7/2012 - rash, itching, inflammation spreading from injection site. Appearance of burns to physician. Physician treated rash for burn with Silvadene ointment. 2/8/2012 - itching on chest and neck. Began self treatment with Benadryl and Hydrocortisone cream (OTC). 2/9/2012 - small, itching papules emerged on chest, spreading to neck. 2/10/2012 - intense itching, rash spread from chest and neck to both arms, face, stomach, back and legs. 2/11/2012 - Dr. visit. Physical examination. Encouraged to continue Benadryl and hydrocortisone treatment. 2/16/2012 - two physician visits. CBC performed with physician visit #2. Referred to dermatologist. Doctor order two skin biopsies. Began treatment with Zantac, Zyrtec and Claritin and Clobetasol cream. Itching and rash resolved within a week.

VAERS ID:453617 (history)  Vaccinated:2012-02-02
Age:  Onset:2012-02-02, Days after vaccination: 0
Gender:Unknown  Submitted:2012-03-29, Days after onset: 55
Location:Unknown  Entered:2012-04-10, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1202USA00665
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Infantile spitting up, Oral administration complication
SMQs:, Neonatal disorders (narrow)
Write-up: Information has been received from a nurse concerning a patient who on 02-FEB-2012, was vaccinated with a dose of ROTATEQ (lot# and dose not reported) and spit up the ROTATEQ after it was administered. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:457800 (history)  Vaccinated:2012-02-02
Age:0.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Male  Submitted:2012-06-20, Days after onset: 137
Location:Connecticut  Entered:2012-06-20
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
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0UNUN
Administered by: Public     Purchased by: Unknown
Symptoms: Eczema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives head to toe hours after vaccine given. Vaccine was also given against parents will. Child''s hives got increasingly worse over 24 hours after injection. Child started with severe eczema within weeks that was felt to be related to vaccine by all doctors.

VAERS ID:460546 (history)  Vaccinated:2012-02-02
Age:0.5  Onset:2012-06-30, Days after vaccination: 149
Gender:Female  Submitted:2012-07-26, Days after onset: 26
Location:Wisconsin  Entered:2012-07-30, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject had previously received PENTACEL dose one on 21 September 2011 and dose two on 22 November 2011.
Diagnostic Lab Data:
CDC Split Type: 201207042
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Chest X-ray normal, Cough, Culture negative, Laboratory test abnormal, Nasopharyngitis, Polymerase chain reaction
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow)
Write-up: Initial report received on 19 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; dose one on 21 September 2011, dose two on 22 November 2011 and dose three on 02 February 2012 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 30 June 2012, approximately 4 months after the last dose. On 02 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea. Laboratory testing included positive PCR on 02 July 2012. Culture date 02 July 2012 with negative results. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 16 July 2012, the subject''s cough had resolved. The duration of the cough was reported at that time as 17 days. No investigator causality assessment as per protocol. Documents held by sender: None.

VAERS ID:486735 (history)  Vaccinated:2012-02-02
Age:57.0  Onset:2012-07-01, Days after vaccination: 150
Gender:Female  Submitted:2013-03-12, Days after onset: 254
Location:Florida  Entered:2013-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: verapamil; triamterene; hydrochlorothiazide; levothyroxine sodium; calcium (unspecified); vitamin D (unspecified), vitamins (unspecified)
Current Illness: Drug hypersensitivity; Hypothyroidism
Preexisting Conditions: Hypotension; Cataract; Mitral valve disease; NASONEX, Drug hypersensitivity; Penicillin, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1303USA004303
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1265AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood bilirubin increased, Hepatic enzyme increased, Rash
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report as received from a licensed practical nurse refers to a 57 years old female patient with hypothyroidism, allergy to penicillin and allergy to NASONEX. The patients medical history included mitral valve disorder, bilateral cataracts and hypotension. On 02-FEB-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # 671139/1265AA, expiry date 05-NOV-2012 and dose was not reported) subcutaneously. Concomitant therapies included verapamil, triamterene, hydrochlorothiazide, levothyroxine sodium, calcium (unspecified) vitamin d and vitamins (unspecified) (reported as multivitamin). Approximately on 16-FEB-2012 (reported as 2 weeks after vaccination) the patient experienced rash all over the face. Following vaccination approximately on an unknown date in July 2012, the patient developed elevated hepatic enzymes (ast and alt) and elevated bilirubin levels. The nurse reported that the patient went to an unspecified eye doctor for the treatment of the rash (treatment details were unspecified). The duration and the type of the rash was not specified. The patient had reported about the rash on 07-MAR-2013 during the routine office visit. On an unknown date, unspecified blood test was performed. On an unknown date, the patient recovered from rash all over the face. on an unknown date in September 2012, the event elevated hepatic enzymes (ast and alt) was reported as recovered/resolved. The outcome of elevated bilirubin levels was reported as not recovered/not resolved at the time of this report. Additional information has been requested.

VAERS ID:507253 (history)  Vaccinated:2012-02-02
Age:78.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Male  Submitted:2013-10-07, Days after onset: 612
Location:Arizona  Entered:2013-10-15, Days after submission: 8
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Terazosin; Citalopram; Oxybutynin; Omeprazole; Meclizine; Aspirin; Loratadine
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1255AA0SYRLA
Administered by: Military     Purchased by: Military
Symptoms: Amnesia, Computerised tomogram head normal, Confusional state, Disorientation, Electroencephalogram normal, Headache, Impaired driving ability, Impaired work ability, Musculoskeletal chest pain, Neck pain, Nuclear magnetic resonance imaging brain normal, Ultrasound Doppler, Ultrasound scan normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: Shingles vaccine 2/2/2012, 3:20pm at the clinic. Left there 15mins later. Patient had to stop driving said he did not know the way home. I drove him back to the clinic, they did a CT, found nothing wrong with is brain no stroke. He had episodes of confusion, disoriented not making any since not known what he had to do. After the initial episode he lost a great deal of his memory there were no symptoms and no warnings. On 3/4/12 the clinic did an MRI on his head and found nothing that would cause these problems. On 4/23/12 the clinic did another CT and again found nothing wrong. On 9/27/12 another episode I took him to a hospital they ordered an EEG the findings were again nothing wrong. On 9/14/13 patient was having severe stabbing pain on the rt. side of his head down his neck. Pain was so bad he was yelling and his body stiffened in his recliner. I took him back to hospital emergency. The doctor ordered carotid ultrasound on both sides. Those were ok also. 10/7/13 patient had stabbing pains again, this time on his left lower side rib cage very painful. Lasted a short time. I have all the reports if you need to see them. All this started happening about 15mins. after that Shingles Vaccine was given to him. Because of this, he has not regained his memory, had his driving privileges taken from him, which lost him his job. This was a serious and detrimental event for him.

VAERS ID:509830 (history)  Vaccinated:2012-02-02
Age:11.0  Onset:2012-04-17, Days after vaccination: 75
Gender:Female  Submitted:2013-10-28, Days after onset: 559
Location:Tennessee  Entered:2013-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No illnesses
Preexisting Conditions: None
Diagnostic Lab Data: MRI, X-rays, Multiple Blood Tests
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1288AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1495AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110330IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4015AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abasia, Activities of daily living impaired, Arthralgia, Blood test, C-reactive protein increased, Epistaxis, Headache, Infection, Livedo reticularis, Loss of consciousness, Nuclear magnetic resonance imaging abnormal, Ovarian cyst, Pain in extremity, Pelvic pain, Rash, Spinal pain, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Patient received the first Gardasil HPV shot on 2/2/12 and severe nosebleeds and headaches followed the next few weeks. Patient developed a "rash" although not raised (Livedo Reticularis) on her thighs in mid-March. Patient received the second dose of the Gardasil HPV shot on 4/03/2013 - she passed out at the check out counter at the dr office and started having pain in her hips, tailbone, legs, and pelvic region on 4/17/2012. Patient was hospitalized on 4/20/2012 for excruciating pain in her hips. She did not walk for 6 of those days in the hospital. Her CRP level when she entered the hospital was 166. She was administered Clindamycin and then Vancomycin via IV as well as morphine and Toradol, oxycodone for pain and what was believed to be an infection deep in her hip muscles and tissues. She was released with only a follow-up to her pediatrician. Now 18 months later, patient is still having debilitating pain in her hips. She was forced to stop playing soccer with her school team as the pain was too great. She is in physical therapy 2x week. Orthopedic doctor recently did an MRI of her pelvic region which did not show any infection, however, did show that patient has 3 ovarian cysts.

VAERS ID:563294 (history)  Vaccinated:2012-02-02
Age:0.2  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2015-01-31, Days after onset: 1094
Location:Pennsylvania  Entered:2015-01-31
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: No known issues at time of vaccines.
Diagnostic Lab Data: MRI on 02/14/2012, no tumor found, continued treatment with ophthalmology who, after 1 year of treatment decided glasses wouldn''t fix her vision and surgery wouldn''t help it as it was a "wiring" problem.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4083AA0IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1259AA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF227210IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0530AA0PO 
Administered by: Public     Purchased by: Other
Symptoms: Blindness, Childhood disintegrative disorder, Eye movement disorder, Nuclear magnetic resonance imaging normal, Visual tracking test abnormal
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow)
Write-up: Eyes tracking like ping pong balls, complete loss of vision, loss of ability to babble.

VAERS ID:639918 (history)  Vaccinated:2012-02-02
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2012-05-23
Location:Unknown  Entered:2016-06-17, Days after submission: 1486
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: Scoliosis; Hypersensitivity, to BACTRIM, AUGMENTIN and CT contrast
Preexisting Conditions: Hernia
Diagnostic Lab Data:
CDC Split Type: PHEH2012US003161
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10053 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2012US003161, is an initial spontaneous report received from a nurse on 02 Feb 2012 and with a follow up received on 27 Feb 2012. This case refers to 22-years-old male patient. The patient''s medical history included of scoliosis and hernia, allergic to BACTRIM, AUGMENTIN and CT contrast. The patient was received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: M10035), that was reconstituted with a sterile water instead of Men C, Y, W-135 liquid conjugate, intramuscularly into his left deltoid on 02 Feb 2012. No adverse reaction had occurred following this administration error. Later the patient was vaccinated with full product. Follow up information received from a nurse on 27 Feb 2012: Updated date of vaccination, medical history and description of the event.

VAERS ID:449557 (history)  Vaccinated:2012-02-02
Age:14.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-02-14, Days after onset: 11
Location:Foreign  Entered:2012-02-14
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: Body temperature, 04Feb2012, 37.2deg. C.; White blood cell, 04Feb2012, 11200
CDC Split Type: B0780750A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Enterocolitis, Nausea, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of enterocolitis in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 2 February 2012, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). On 3 February 2012, at night, 1 day after vaccination with CERVARIX, the subject experienced enterocolitis with abdominal pain and diarrhea. On 4 February 2012, in the morning, 2 days after vaccination with CERVARIX, the subject experienced queasy feeling, vomiting and diarrhea. The subject''s body temperature was 37.2 degrees centigrade. The subject''s white blood cell count was 11200. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.

VAERS ID:449706 (history)  Vaccinated:2012-02-02
Age:20.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-02-14, Days after onset: 12
Location:Foreign  Entered:2012-02-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2012DE009466
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED20549411A0SYRLA
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER3001804090SYRRA
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS492011A0SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Deafness unilateral, Dyspnoea, Feeling cold, Hypoaesthesia, Loss of consciousness, Nausea, Peripheral coldness, Respiration abnormal, Tinnitus, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)
Write-up: Case number PHHY2012DE009466, is a combined initial and follow-up spontaneous report received from physician and license partner (BERNA-2012-0098) on 03 Feb 2012 respectively. This case refers to 20-years-old female patient. She was vaccinated with first dose of RABIPUR (batch 492011A), at dose of 1 ml, into the left upper arm, first dose of HAVPUR (batch number: 3001804/09), at dose of 0.5 ml, into right upper arm and AFLURIA (batch number: 20549411A, other manufacturer) into the left upper arm on 02 Feb 2012 at about 8:30 a.m. On the same day, at 6:15 p.m. she developed feeling of numbness in the neck, deafness right ear, whistling left ear, then blackout with visual disturbances, nausea and cold hands. Subsequently she placed herself on the floor for 15-minutes. Subsequently she was weak and was unable to lift things. The following two hours she felt cold and she claimed that she had interruptions of breathing which lasted for 2 hours. The outcome reported as completely recovered. The physician did not report the serious criterion. The causality of the events was not reported.

VAERS ID:450165 (history)  Vaccinated:2012-02-02
Age:14.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-02-23, Days after onset: 20
Location:Foreign  Entered:2012-02-23
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: B0782850A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)SANOFI PASTEUR   UN
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS   UN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.   UN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Headache, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a regulatory authority (ES-AGEMED-829117344) and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline), VARIVAX (non-gsk) and DTP (a or w not known) vaccine (non-gsk). On 2 February 2012, the subject received an unspecified dose of CERVARIX (intramuscular, administration site unknown, batch number not provided), an unspecified dose of VARIVAX (unknown) and an unspecified dose of TRIAXIS, DTP (a or w not known) vaccine (non-GSK) (unknown). On 3 February 2012, 1 day after vaccination with CERVARIX, DTP (a or w not known) vaccine (non-GSK0 and VARIVAX, the subject experienced syncope followed by dizziness during all the day, headache and malaise. The regulatory authority reported that the events were clinically significant (or requiring intervention). On the same day, she had taken ibuprofen. Therefore, the subject was treated with codeine. On 3 February 2012, syncope and dizziness were resolved. On 6 February 2012, headache and malaise were resolved.

VAERS ID:450626 (history)  Vaccinated:2012-02-02
Age:5.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Male  Submitted:2012-02-24, Days after onset: 21
Location:Foreign  Entered:2012-02-27, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHFR2012GB001155
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10146 SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case number PHFR2012GB001155 is an initial spontaneous report received from a nurse on 13 Feb 2012. This case refers to 5 years and 10 months old male child. He was vaccinated with MENVEO (batch number: M10146 and expiration date: Jul 2013) on 02 Feb 2012. He complained of having a red arm the next day. Two days later he had facial swelling and was admitted to the accident and emergency department. He was given PIRITON and steroids (not specified) as treatment. At the time of this report he was fine.

VAERS ID:450852 (history)  Vaccinated:2012-02-02
Age:14.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-02-29, Days after onset: 26
Location:Foreign  Entered:2012-03-01, 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: None reported.
Diagnostic Lab Data:
CDC Split Type: E201201333
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
TDAP: TDAP (ADACEL)SANOFI PASTEUR  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Headache, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Case received from the Health Authorities (reported to them by a physician) in a foreign country on 22-FEB-2012 under the reference number: ES-AGEMED-829117344. Case medically confirmed. A 14 year-old female patient had received a VARIVAX (batch number not reported, route unknown) on 02-FEB-2012 afternoon, a dose of a TRIAXIS (batch number not reported, route unknown), a dose of CERVARIX (manufactured by GSK, batch number not reported) via intramuscularly and an allergy vaccine (tradename not reported, batch number, route and site of administration not reported) on the afternoon on 02-FEB-2012. The same day of the vaccines administration, the patient had been taken ibuprofen (stop date: 03-FEB-2012, dose not reported). VARIVAX, TRIAXIS and CERVARIX were coded by the HAs as suspect drugs. One day later, on 03-FEB-2012 in the morning, at school, the patient presented with syncope, malaise, headache and dizziness. The patient received corrective treatment with paracetamol/codeine (start and stop dates not reported, dose not reported). The patient recovered from syncope and dizziness on 03-FEB-2012 and she recovered from malaise and headache on 06-FEB-2012. Case reported as serious by the Health Authorities with other medically important condition as criteria. No further information reported.

VAERS ID:451139 (history)  Vaccinated:2012-02-02
Age:59.0  Onset:2012-02-17, Days after vaccination: 15
Gender:Female  Submitted:2012-03-05, Days after onset: 17
Location:Foreign  Entered:2012-03-06, Days after submission: 1
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:
Preexisting Conditions: The patient had a medical history of hypertension treated with nifedipine. The patient was not allergic to any medication.
Diagnostic Lab Data: Results of lab tests performed on 21 February 2012 showed platelets 8000; leucocytes 10800; neutrophils 9.3; lymphocytes 0.8; hemoglobin 12.9; hematocrit 37.1; glucose 213; urea 372; creatinine 0.60; TGO 79; TGP 104; lactate deshydrgenase 7.20; amylase 79; total bilirubin 1.4; direct bilirubin 0.10 and indirect bilirubin 1.3. Results of lab tests performed on 24 February 2012 showed leucocytes 8400; neutrophils 92.7%; hemoglobin of 11.5 GR; hematocrit 32.5%; platelets 4000.
CDC Split Type: 201202423
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH461AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Amylase normal, Apheresis, Aspartate aminotransferase increased, Bilirubin conjugated, Blood bilirubin increased, Blood bilirubin unconjugated increased, Blood creatinine normal, Blood glucose increased, Blood lactate dehydrogenase decreased, Blood urea increased, Condition aggravated, Ecchymosis, Haematocrit decreased, Haemoglobin decreased, Hypertension, Local reaction, Lymphocyte count decreased, Neutrophil count increased, Neutrophil percentage increased, Petechiae, Platelet count decreased, Thrombocytopenia, White blood cell count increased
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (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), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Hypertension (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from a Healthcare Professional on 23 February 2012 under the reference number MX-2012-002. A 59-year-old female patient, with a medical history of hypertension treated with nifedipine, had received her primary dose of FLUZONE (batch number UH461AA, expired date 30 June 2012) intramuscularly in the left deltoid on 02 February 2012. The patient was not allergic to any medication. On 17 February 2012, the patient presented to hospital with thrombocytopenia, multiple ecchymosis (various sizes) on the abdomen and on the rest of the body, petechiae and hypertension. On an unknown date she also developed disseminated ecchymosis (reported as local reaction). The patient was admitted to hospital on 18 February 2012. On 18 February 2012, the initial diagnosis was thrombocytopenia not specified. Results of lab tests performed on 21 February 2012 showed platelets 8000, leucocytes 10800, neutrophils 9.3, lymphocytes 0.8, hemoglobin 12.9, hematocrit 37.1, glucose 213, urea 37.2, creatinine 0.60, TGO 79, TGP 104, lactate dehydrogenase 7.20, amylase 79, total bilirubin 1.4, direct bilirubin 0.10 and indirect bilirubin 1.3. On 22 February 2012, the second diagnosis was thrombocytopenia secondary of the vaccine. Results of lab tests performed of 24 February 2012 showed leucocytes 8400, neutrophils 92.7%, hemoglobin of 11/5 GR, hematocrit 32.5%, platelets 4000. The patient was treated with steroids high dose and clonazepam 2.5mg/mL 6 drops/ 24 hours. Apheresis platelets was done. The patient had not recovered at the time of reporting.

VAERS ID:451148 (history)  Vaccinated:2012-02-02
Age:14.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-03-05, Days after onset: 31
Location:Foreign  Entered:2012-03-06, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1202USA04353
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Headache, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Case received from the Health Authorities (reported to them by a physician) on 22-FEB-2012 under the reference number: ES-AGEMED-829117344. Case medically confirmed. A 14 year old female patient had received a dose of VARIVAX (Merck) (lot number, batch number not reported, route unknown) on 02-FEB-2012 afternoon, a dose of TRAVXIS (batch number not reported, route unknown), a dose of CERVARIX (batch number not reported) via intramuscular and an allergy vaccine (trade name not reported, batch number, route and site of administration not reported) on the afternoon of 02-FEB-2012. The same day of the vaccines administration, the patient had been taken ibuprofen (stop date: 03-FEB-2012, dose not reported). VARIVAX (Merck), TRIAXIS and CERVARIX were coded by the Health Authorities as suspect drugs. One day later, on 03-FEB-2012 in the morning, at school, the patient presented by syncope, malaise, headache and dizziness. The patient received corrective treatment with paracetamol/codeine (start and stop dates not reported, dose not reported). The patient recovered from syncope and dizziness on 03-FEB-2012 and she recovered from malaise and headache on 06-FEB-2012. Case was reported as serious by the Health Authorities with other medically important condition as criteria. Other business partner numbers include E2012-01333. No further information is reported.

VAERS ID:451276 (history)  Vaccinated:2012-02-02
Age:14.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-03-07, Days after onset: 33
Location:Foreign  Entered:2012-03-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Neurological examination, 06Feb12, revealed an incomplete right eye lid closure, frowning on the right side and whistling were not poss; Diagnostic laboratory test, 07Feb12, Borrelia serology: negative; Cerebrospinal fluid analysis, no pathological findings especially no evidence for herpes simplex, herpes zoster of enterovirus.
CDC Split Type: WAES1203USA00159
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSG0089 UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.G0042170UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood glucose normal, Borrelia test negative, C-reactive protein normal, CSF test normal, Differential white blood cell count normal, Eyelid function disorder, Facial paresis, Headache, Neurological examination abnormal, Post lumbar puncture syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Case was received from the Health Authorities on 22-FEB-2012 (reference number PEI2012005079). Case was medically confirmed. A 14-year-old female patient concomitantly received a dose of REPEVAX (lot no. G0089-2) into the left upper arm/deltoid muscle and a first dose of GARDASIL (lot no. G004217) into the right upper arm on 02-FEB-2012. About 24 hours later, on 03-FEB-2012, she noticed a missing right eye lid closure and an asymmetry of her mouth. On 06-FEB-2012 she was hospitalized. Neurological examination on admission revealed an incomplete right eye lid closure, frowning on the right side and whistling were not possible and the right corner of the mouth was hanging. The patient did not remember a tick bite. On 07-FEB-2012 cerebrospinal fluid showed no pathological findings especially no evidence for herpes simplex, herpes zoster or enterovirus. Borrelia serology was negative. The patient developed a post dural puncture syndrome with headache and vomiting. Further laboratory parameters including differential blood count. CRP and blood glucose revealed normal results. The patient was diagnosed with "facial paresis caused by vaccination". Treatment with cortisone and physiotherapy was started. On 11-FEB-2012 she was discharged in good general condition and free of complaints. Facial paresis had slightly improved. The final outcome was not reported. FILE CLOSED. Other business partner numbers included E2012-01259. No further information is available.

VAERS ID:451602 (history)  Vaccinated:2012-02-02
Age:41.0  Onset:2012-02-09, Days after vaccination: 7
Gender:Female  Submitted:2012-03-09, Days after onset: 29
Location:Foreign  Entered:2012-03-12, Days after submission: 2
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: Uterine dilation and curettage
Diagnostic Lab Data:
CDC Split Type: PHHY2012CH019697
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICS1124011C IMAR
Administered by: Other     Purchased by: Other
Symptoms: Abortion missed, Maternal exposure during pregnancy, Uterine dilation and curettage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Case number PHHY2012CH019697 is an initial spontaneous report received from a physician via Health Authority (2012-00749) on 07 Mar 2012. This report refers to a 41-year-old female patient. Her medical history and concomitant medication were not reported. On 31 Jan 2012 it was discovered that the patient was pregnant. The last menstruation cycle was on 25 Nov 2011 and sono-graphically the age was determined as six-weeks and three-days on 31 Jan 2011. She was vaccinated with AGRIPPAL (batch number: 1124011C), at a dose of 0.5 ml intramuscularly for immunization against influenza on 02 Feb 2012. On 09 Feb 2012, missed abortion was diagnosed and the length of the embryo corresponded to age of seven-weeks reflecting that the embryo died around 04 Feb 2012. On 14 Feb 2012 curettage was conducted. Histo-morphological results were compatible with missed abortion. The analyzed material did not provide causes for abortion. There were no signs for chromosomal aberrations, molar pregnancy, anomalies or malignancies. Health authority assessed this case as serious requiring hospitalization and the outcome was reported as completely recovered. Missed abortion was assessed as unlikely due to treatment with AGRIPPAL.

VAERS ID:451587 (history)  Vaccinated:2012-02-02
Age:33.0  Onset:2012-02-28, Days after vaccination: 26
Gender:Female  Submitted:2012-03-12, Days after onset: 12
Location:Foreign  Entered:2012-03-13, 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: Pregnancy NOS (LMP = 08Jan12)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic gonadotropin (unsp), patient used over-the counter pregnancy test by self check
CDC Split Type: WAES1202USA02301
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abortion spontaneous, Haemorrhage, Pregnancy test positive
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: A study in healthy young adults to assess the safety, tolerability, and immunogenicity of HEPAVAXTM-II manufactured using a modified process. Information has been received from an investigator concerning a 33 year old female with a history of 3 pregnancies including 1 live birth 1 full term birth, 1 ectopic pregnancy, 1 spontaneous abortion, (no late fetal deaths, no elective abortion) who entered a study. On 02-FEB-2012 the patient was randomized and vaccinated subcutaneously injection with a 0.5 ml dose of 1XP hepatitis B virus vaccine or 2XP hepatitis B virus vaccine. It was reported that the patient became pregnant. On 14-FEB-2012, the pregnancy test was done at home, and the result was a positivity. On 16-FEB-2012, she consulted obstetrics and the pregnancy was confirmed (gestational sac was confirmed, but fetal heart movement wasn''t confirmed). The last menstrual period was on 08-JAN-2012. The estimated delivery date would be 14-OCTZ-2012. On 27-FEB-2012, patient had abdominal pain and a small amount of hemorrhage. On 28-FEB-2012, she consulted the physician, and spontaneous abortion was found. The hemostatic preparation and womb shrinkage medication was prescribed. The reporting investigator felt that pregnancy was not related to study therapy. Spontaneous abortion was considered to be an other important medical event by the investigator and was considered related to study therapy. The record for this patient was unblinded on 09-MAR-2012. Additional information has been requested. The patient was vaccinated with HEPTAVAX-II 2XP SC modified process.

VAERS ID:451676 (history)  Vaccinated:2012-02-02
Age:74.0  Onset:0000-00-00
Gender:Male  Submitted:2012-03-13
Location:Foreign  Entered:2012-03-13
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: A0968468A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB243AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Neck pain, Pain in extremity, Product quality issue, Transmission of an infectious agent via a medicinal product
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a healthcare professional (nurse) and by the healthcare professional via a sale representative and described the occurrence of transmission of an infectious agent via a medicinal product in a 74-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 2 February 2012 the subject received 1st dose of TWINRIX (intramuscular, left deltoid). In February 2012, less than one month after vaccination with TWINRIX, the subject experienced arm pain at injection site and radiating neck pain ("pain at site of injection and radiating to his neck"). On follow up information from the healthcare professional, the subject experienced "pain radiating in arm and neck" (radiating pain in arm and radiating neck pain). The healthcare professional reported that the pain radiating in arm and neck was a result of transmission of an infectious agent via a medicinal product. No additional information was provided to support the claim that vaccination was contaminated. This case was associated with a pharmaceutical product complaint due to the injection site pain with TWINRIX and the ongoing Product Incident Review Committee with TWINRI. This case was assessed as medically serious by GSK. The subject was treated with physical therapy (7 Physiotherapy treatments). At the time of reporting the radiating neck pain and radiating pain in arm were improved and the outcome of the other events was unspecified. The healthcare professional considered the events were possibly related to vaccination with TWINRIX. This healthcare professional reported two subjects experiencing events with TWINRIX. See case A0968467A for details regarding the other case.

VAERS ID:451750 (history)  Vaccinated:2012-02-02
Age:45.0  Onset:2012-02-08, Days after vaccination: 6
Gender:Male  Submitted:2012-03-13, Days after onset: 33
Location:Foreign  Entered:2012-03-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Smoking; Alcohol; The patient is a smoker and occasionally drinks alcohol. The patient has no underlying disease and takes no concomitant medication. The patient had received dose 1 of rabies vaccine (manufacturer and lot-no. were not reported) on 26-Jan-2012- toleration was not reported. Previous unspecified vaccinations were tolerated well.
Diagnostic Lab Data: Lab tests showed CK = 240 U/l, all other tests were within normal ranges. CSF- examination showed normal protein count, cell count and blood brain barrier, liquor and serum tests were negative for HSV, VZV, MRZ test (measles/rubella/zoster), Borrelia and lues. A cranial MRI showed unspecified cerebral medulla lesions but suspicion of an inflammatory CNS-disease was not raised. A spinal MRI was unremarkable. Electrophysiology tests were unremarkable and no paresis or absent muscle reflexes were noted.
CDC Split Type: E201201510
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Ataxia, Blood creatine phosphokinase increased, Borrelia test negative, CSF cell count normal, CSF protein normal, Cardiac electrophysiologic study normal, Central nervous system lesion, Gait disturbance, Herpes simplex serology negative, Illusion, Laboratory test normal, Myelitis, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord normal, Paraesthesia, Positive Rombergism, Sensory level abnormal, Treponema test negative, Varicella virus test negative, Viral test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)
Write-up: This case was received from the Health Authorities on 02-Mar-2012 (reference number PEI2012006582). The case is medically confirmed. A 45-year-old male patient who is a smoker and occasionally drinks alcohol, received dose 2 of rabies vaccine (manufacturer not reported) on 02-Feb-2012-lot-no., route and site of administration were not reported. One week prior, on 26-Jan-2012, he had received dose 1 of rabies vaccine (manufacturer and lot-no. were not reported) and a dose of INFLUVAC (Solvay Arzneimittel, lot-no. not reported). On 08-Feb-2012 the patient noticed paraesthesia of the lower extremities during exercise. Later the same evening the paraesthesia spread to the hip and his right arm. He also developed mild perception disorder, and he had an unsteady gait. On 09-Feb-2012 on admission to the neurological department a slight atactic unsteady gait was found. Romberg test showed gait instability, he was very unsteady when walking with one foot in front of the other, and he had reduced sensory levels on both legs and the right arm. The patient stated that he had no recent infections. Lab tests showed CK = 240 U/l, all other tests were within normal ranges. CSF- examination showed normal protein count, cell count and blood brain barrier, liquor and serum tests were negative for HSV, VZV, MRZ test (measles/rubella/zoster), Borrelia and lues. A cranial MRI showed unspecified cerebral medulla lesions but suspicion of an inflammatory CNS-disease was not raised. A spinal MRI was unremarkable. Electrophysiology tests were unremarkable and no paresis or absent muscle reflexes were noted. The results and clinical examination raised the suspicion of a mild myelitic affection and therapy with intravenous URBASON 1 g daily over five days was administered whereupon the symptoms improved. On 14-Feb-2012 the patient had recovered and was discharged. The hospital report stated that a drug event relationship between the events and the vaccinations seems possible. The patient has no underlying disease and takes no concomitant medication. Previous unspecified vaccinations were tolerated well. CASE IS CLOSED.

VAERS ID:452296 (history)  Vaccinated:2012-02-02
Age:32.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-03-22, Days after onset: 47
Location:Foreign  Entered:2012-03-22
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: Body temperature, 03Feb2012, 37.8deg. C
CDC Split Type: B0790183A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB197AU0UNUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER0541BIA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Pyrexia, Rash, Rash erythematous, Somnolence, Yellow skin
SMQs:, Cholestasis and jaundice of hepatic origin (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of yellow skin on feet in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), TD PUR (non-GSK). On 2 February 2012 the subject received 1st dose of TWINRIX (unknown route, unknown injection site), unspecified dose of TD PUR (unknown route, unknown injection site). On 3 February 2012, 1 day after vaccination with TD PUR and TWINRIX, the subject experienced tiredness, sleepiness and fever (37.8 deg C) which lasted for 5-6 hours. On 4 February 2012, the subject developed yellow skin on feet and red spots on abdomen and legs (similar to herpes). This case was assessed as medically serious by GSK. On 3 February 2012, fever, tiredness, and sleepiness were resolved. At the time of reporting, the outcome of the other events was unspecified.

VAERS ID:452521 (history)  Vaccinated:2012-02-02
Age:38.0  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 53
Location:Foreign  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Allergic to Mosquito Bites; The subject had no history of migraines.
Diagnostic Lab Data: UNK
CDC Split Type: A0969026A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB902DD0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Decreased activity, Headache, Migraine
SMQs:, Dementia (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of migraine in a 38-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 2 February 2012 at 11:00 the subject received 1st dose of ENGERIX B (unknown). On the evening of 2 February 2012, less than one day after vaccination with ENGERIX B, the subject experienced an enormous migraine. The subject went tot he emergency room that evening, but was not hospitalized. At the hospital, the subject received MAXALT. She continued to have a migraine for 1 week. Then, the subject continued having a headache. Twenty days after administration with ENGERIX B, 22 February 2012, the subject received VIVOTIF (non-gsk) and DUKORAL (non-gsk). The headache resolved by 07 March 2012. Follow up received from the healthcare professional on 21 March 2012. Historic medical condition included allergy to mosquito bite "venom". On 02 February 2012, the subject received 1st dose of ENGERIX B (1 ml, intramuscular route, left arm). On 02 February, hours after vaccination with ENGERIX B, the subject experienced migraine. According to the healthcare professional, the subject was vaccinated at 11:30 (previously reported at 11:00) and the migraine started after supper. That night the subject was treated with MEXAL from a nurse. The subject had a severe migraine for 1 week. The subject had "very little daily activity" (decreased ability to perform daily activities). The second week, the subject still had headaches daily that decreased and on 07 March 2012, the subject had no more headaches. According to the healthcare professional, the subject had never had a migraine in the past. The healthcare professional considered the events as possibly or probably related to the ENGERIX B vaccination and considered the events as jeopardizing the subject or requiring intervention. At the time of reporting, the events were resolved (noted by healthcare professional as improved then resolved).

VAERS ID:454492 (history)  Vaccinated:2012-02-02
Age:0.6  Onset:2012-02-03, Days after vaccination: 1
Gender:Male  Submitted:2012-04-26, Days after onset: 82
Location:Foreign  Entered:2012-04-27, Days after submission: 1
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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1204USA02834
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 2IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Febrile convulsion, Pyrexia, Rhinitis, Urine analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 28 week old male patient who on 02-FEB-2012, was vaccinated with a third dose of ROTATEQ, oral (dose, lot number not reported). Secondary suspect vaccines included a third dose of: INFANRIX HEXA, intramuscular and PREVNAR 13, intramuscular. On 03-FEB-2012, a day after vaccination the patient presented to emergency following a 5 minute typical febrile convulsion, with 1 vomit and mild coryza. The patient was hospitalized. Urine (SPA) test was performed (results not provided). The patient was observed in Emergency Department (ED) and discharged on an unknown date, with advice of management of febrile convulsions and given ibuprofen for fever. At the time of the report the patient''s outcome was recovered from vomiting, febrile convulsion and mild coryza. The reporter felt that vomiting, febrile convulsion and mild coryza were possibly related to therapy with ROTATEQ. The original reporting source was not provided. Additional information is not expected.

VAERS ID:457840 (history)  Vaccinated:2012-02-02
Age:0.6  Onset:2012-02-08, Days after vaccination: 6
Gender:Female  Submitted:2012-06-21, Days after onset: 133
Location:Foreign  Entered:2012-06-21
Life Threatening? Yes
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: UNK
CDC Split Type: D0076025A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA752C0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Petechiae, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2012017894) and described the occurrence of thrombocytopenia in a 6-month-old female subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline). On 2 February 2012 and 18 April 2012 the subject received 1st dose and 2nd dose of INFANRIX-IPV/HIB (intramuscular, application site). On 8 February 2012, 6 days after vaccination with INFANRIX-IPV/HIB the subject experienced petechiae. On 13 February 2012 petechiae was resolved. On 22 May 2012, 34 days after vaccination with INFANRIX-IPV/HIB, the subject experienced thrombocytopenia. The subject was hospitalised and the reporter reported that the events were life threatening. On 25 May 2012 thrombocytopenia was resolved. No further information will be available.

VAERS ID:459995 (history)  Vaccinated:2012-02-02
Age:0.2  Onset:2012-02-02, Days after vaccination: 0
Gender:Male  Submitted:2012-07-24, Days after onset: 172
Location:Foreign  Entered:2012-07-24
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: B0815794A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Apnoea, Eye swelling, Foaming at mouth, Hypotonia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via a regulatory authority (DHH-N2012-59982) and described the occurrence of apnea in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or family history. The subject had no affections or known allergies. Prior vaccinations went uncomplicated. On 2 February 2012, the subject received 2nd dose of ROTARIX (unknown route). On 2 February 2012, less than one day after vaccination with ROTARIX, the subject experienced apnea, eye swelling, atonia, foam in mouth and swelling of face. This case was assessed as medically serious by GSK. On 2 February 2012, tonus recovery after 5 minutes and all the events were resolved without sequelae. It was unknown if the subject received a treatment. The regulatory authority reported that the events were almost certainly related to vaccination with ROTARIX.

VAERS ID:460959 (history)  Vaccinated:2012-02-02
Age:0.4  Onset:2012-02-02, Days after vaccination: 0
Gender:Male  Submitted:2012-08-02, Days after onset: 181
Location:Foreign  Entered:2012-08-03, Days after submission: 1
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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012183795
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB173A1IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF431141IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 172272. A physician (contactable through Regulatory Authority only) reported that a 4-months-old male patient received second dose of PREVENAR 13 Lot # F43114 intramuscular on 02Feb2012 and second dose of INFANRIX HEXA Lot # A21CB173A intramuscular on 02Feb2012, both for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced convulsions and loss of consciousness on 02Feb2012. The patient was hospitalized until 03Feb2012 at 03 AM. The patient recovered on 03Feb2012.

VAERS ID:475367 (history)  Vaccinated:2012-02-02
Age:1.2  Onset:2012-02-02, Days after vaccination: 0
Gender:Male  Submitted:2012-11-26, Days after onset: 298
Location:Foreign  Entered:2012-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0846654A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB567CL UNUN
Administered by: Other     Purchased by: Other
Symptoms: Conjunctivitis, Kawasaki's disease, Pyrexia, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vasculitis (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of kawasaki syndrome in a 14-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 2 February 2012, the subject received unspecified dose of HAVRIX (unknown route of administration, unknown site of injection). On 2 February 2012, less than one day after vaccination with HAVRIX, the subject experienced high fever, followed by exanthema and conjunctivitis. The subject was hospitalised for 8 days at Pediatric Department. He was admitted on 08 February 2012 and discharged on 15 February 2012 with diagnosis of Kawasaki syndrome. At the time of reporting, the events were improved. The physician considered the events were possibly related to vaccination with HAVRIX.

VAERS ID:480987 (history)  Vaccinated:2012-02-02
Age:1.2  Onset:2012-02-02, Days after vaccination: 0
Gender:Male  Submitted:2013-01-11, Days after onset: 344
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: C-reactive protein, 2012, 9.82; Echocardiography, 09Feb2012, Hyperechoic left; Echocardiography, 15Feb2012, Coronary improve; Erythrocyte sedimentation rate, 2012, 120; Physical examination, 2012, see text; White blood cell count, 2012, Unspecified high
CDC Split Type: B0857266A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB567CL IMRL
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein, Conjunctival hyperaemia, Echocardiogram abnormal, Hyperaemia, Immunoglobulin therapy, Kawasaki's disease, Pyrexia, Rash generalised, Red blood cell sedimentation rate increased, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Vasculitis (narrow), Conjunctival disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# 186654) and described the occurrence of Kawasaki Syndrome in a 14-month-old male subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline). The subject''s medical history was negative. On 2 February 2012, the subject received unspecified dose of HAVRIX pediatric (intramuscular, unknown injection site). On 2 February 2012, less than one day after vaccination with HAVRIX pediatric, the subject experienced Kawasaki Syndrome and fever. The subject was hospitalised between 04 February 2012 and 19 February 2012. On admission the physical examination showed: conjunctival redness, pharyngeal hyperemia and generalized exanthema. The subject was treated with normal immunoglobulin and aspirin. On 15 February 2012, the Kawasaki Syndrome and fever resolved. At the time of reporting the outcome of conjunctival redness, pharyngeal hyperemia and generalized exanthema was unspecified. The regulatory authority reported that the Kawasaki Syndrome and fever were possibly related to vaccination with HAVRIX pediatric.

VAERS ID:483955 (history)  Vaccinated:2012-02-02
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2013-02-08
Location:Foreign  Entered:2013-02-08
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
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, < 39.5deg. C
CDC Split Type: B0865632A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER10PVZF031Z0UNUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURERG53640PO 
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSQROLA371BA0PO 
UNK: PNEUMO (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSASPNA095BA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Death, Hypersensitivity, Pyrexia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by other health professional (National Immunization Program) and described the occurrence of death due to unknown causes in a 3-month-old female subject who was vaccinated with live attenuated ROTARIX (GlaxoSmithKline), SYNFLORIX, poliomyelitis vaccine live oral (non-gsk) and dtpa-hib (non-gsk). On 2 February 2012, the subject received 1st dose of ROTARIX (oral), 1st dose of SYNFLORIX (unknown), 1st dose of poliomyelitis live oral (Non-GSK), 1st dose of DTPa-Hib (Non-GSK) (unknown). In 2012, less than one year after vaccination with DTPa-Hib (Non-GSK), poliomyelitis vaccine live oral (Non-GSK), ROTARIX and SYNFLORIX, the subject experienced fever (less than 39.5 deg. C) and hypersensitivity (systemic syndrome of premature reaction). The subject was hospitalised. The subject died due to unknown causes. It was unknown whether an autopsy was performed. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.

VAERS ID:496293 (history)  Vaccinated:2012-02-02
Age:12.0  Onset:2012-06-01, Days after vaccination: 120
Gender:Male  Submitted:2013-07-09, Days after onset: 403
Location:Foreign  Entered:2013-07-09
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: UNK
CDC Split Type: B0904770A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Crohn's disease
SMQs:, Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad)
Write-up: This case was reported by a consumer via a regulatory authority (SE_KRMPAWWW-1371105210853) and described the occurrence of morbus chron disease in a 14-year-old male subject who was vaccinated with TWINRIX pediatric (GlaxoSmithKline). At approximately the same time, his cousin experienced also Crohn''s disease but did not receive any vaccine. In February 2012, the subject received an unspecified dose of TWINRIX pediatric (administration site and route unknown, batch number not provided). In June 2012, 4 months after vaccination with TWINRIX pediatric, the subject experienced Crohn''s disease. The subject was hospitalised and the regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with prednisolone and ASACOL. At the time reporting, the event was resolved with the following sequelae (unspeciifed).

VAERS ID:500110 (history)  Vaccinated:2012-02-02
Age:1.6  Onset:2012-02-02, Days after vaccination: 0
Gender:Female  Submitted:2013-08-22, Days after onset: 566
Location:Foreign  Entered:2013-08-22
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1308NLD009135
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Diabetes mellitus, Malaise, Thirst
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad)
Write-up: Case received from the Health Authority in a foreign country on 15-Aug-2013 under the reference number NL-LRB-158021. The agency reported this case as "medically confirmed". Initial source was a physician from a community health service. Case reported as serious by the agency (criterion: Hospitalisation). A 31-month-old female patient (date of birth 14-Jun-2010) had received the first dose of MMRVAXPRO (batch number unknown, vaccination route subcutaneous) and the first dose of NEISVAC-C (Baxter, batch number unknown, vaccination route intramuscular) on 02-Feb-2012 in the Childhood Immunisation Programme. Concomitant medication was not reported. The patient experienced diabetes mellitus on 02-Feb-2012 with a latency of hours. The patient began to drink a lot and had malaise appearing less than 24 hours after the vaccination. 10-12 days after this the parents went to the general practitioner with her and the patient was sent to the pediatrician. She was hospitalised for 2-3 weeks and diabetes mellitus was diagnosed. Medical history: the patient had no known medical history and no known past drug therapy but both grandfathers of the patient were diagnosed with diabetes mellitus type 2 and a son of the mothers sister had been diagnosed with diabetes mellitus type 1 when he was 15 years old. Physical findings and investigations: Unknown. Treatment and clinical course: the patient was treated with insuline given by a pump at the moment of reporting. Causality for the diabetes mellitus and vaccination against meningococci C and MMR was considered unlikely. Theoretically it could be possible that a vaccination has an influence on the immune system that could cause diabetes mellitus, but with this short interval (less than 24 hours) after the vaccination, it can not be imagined. The following MedDRA LLT was coded by the agency: diabetes mellitus. Upon internal review the company judged relevant to code the following adverse event: "malaise" which was mentioned by the CA in the narrative but not coded. Outcome reported by the agency: not recovered. Noteworthy: the agency reported that the brand names of the reported measles, mumps and rubella dn the meningococci C vaccines were not specified, but MMRVAXPRO and NEISVAC-C were the most plausible vaccines used in the childhood vaccine program at the reported date of administration. No further information expected.

VAERS ID:506957 (history)  Vaccinated:2012-02-02
Age:14.0  Onset:2012-05-01, Days after vaccination: 89
Gender:Female  Submitted:2013-10-10, Days after onset: 527
Location:Foreign  Entered:2013-10-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 17 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation, Dose 1. Lot number G005824.
Diagnostic Lab Data: Ultrasound joint: slight synovitis of both wrist. Ultrasound abdomen: expanded liver veins. CT scan: subpleural interstitial changes of lung tissue. ANA: positive. Autoantibody test: Anti-PM-Scl positive; 06/06/2013, Alanine aminotransferase, 55 U/L; 06/21/2013, Alanine aminotransferase, 48 U/L; Antinuclear antibody, Positive; 06/06/2013, Aspartate aminotransferase, 79 U/L; 06/21/2013, Aspartate aminotransferase, 84 U/L; Autoantibody test, Anti-PM/Scl positive; 06/06/2013, Blood 25-hydroxycholecalciferol, 9.9 ng/mL; 06/06/2013, Blood creatine phosphokinase, 1352 U/L; 06/06/2013, Blood creatine phosphokinase, 1763 U/L; 06/06/2013, Blood lactase dehydroginase, 393 U/L; Blood lactase dehydroginase, 415 U/L; Body temperature increased, 37.5 to
CDC Split Type: WAES1310DEU002902
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN126100UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Antinuclear antibody, Antinuclear antibody positive, Arthralgia, Aspartate aminotransferase increased, Autoantibody positive, Blood 25-hydroxycholecalciferol decreased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Body temperature increased, Cell marker increased, Chest pain, Complement factor C3, Complement factor normal, Computerised tomogram thorax abnormal, Constipation, Depressed mood, Dysphagia, Fatigue, Frequent bowel movements, Gastrointestinal hypomotility, Haematochezia, Headache, Interstitial lung disease, Lipase normal, Local swelling, Muscle enzyme increased, Musculoskeletal pain, Myalgia, Myositis, Night sweats, Oesophageal disorder, Overlap syndrome, Pain in extremity, Peripheral coldness, Polymyositis, Raynaud's phenomenon, Respiratory distress, Scleroderma, Synovitis, Ultrasound abdomen abnormal, Ultrasound joint, Ultrasound scan abnormal, Vitamin D decreased, Vitamin D deficiency
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from a health care professional on 30-Sep-2013. Case is medically confirmed. Case is linked to non-serious case E2013-5989 (same reporter, same vaccine, different reaction, different patient). A 15-year-old female patient (weight 59.9 kg, height 167 cm) received the second dose of GARDASIL (batch-no G017722, lot number NP00860) on 29-May-2012. On an unspecified date in May-2012, the patient developed polymyositis/scleroderma-overlap-syndrome including Raynaud''s pnenomenon, swollen fingers, changes to the capillary arteries, dysfunction of the oesophagus, suspicion of intestinal pseudoobstruction, intestinal lung disease, myositis with increased muscle enzymes. In the lab test ANA was positive with a nuclear pattern and anti-PM/Scl was positive. Since this time she was hospitalised frequently. The patient was hospitalised in May-2013. During this hospital stay a high-definition CT of the lung revealed subpleural interstitial changes of the lung tissue. Therapy with URBASONE was continued, azathioprine was replaced by MYFORTIC. Additionally, the patient started therapy with QUENSYL and rituximab. Furthermore, a therapy with amlodipine was started as well as MOVICOL. The patient received regular physiotherapy, massage and ergotherapy. Despite all this, there was no significant improvement of the symptoms. Since end of that hospitalization the patient experienced progressive health problems with continuing pronounced bifrontal headache, stomach ache, muscle and joint pain. The patient described periods of pronounced fatigue and persistent pain in both knees. Her temperature was slightly increased (37.5 to 37.8 degree C) and she experienced night sweat. All fingers were painful and cold. The patient experienced nightly respiratory distress with left-sided precordial chest pain. The patient was hospitalised from 05-Jun-2013 to 22-Jun-2013 with persisting symptoms including daily chronic headache, chronic cramp-like epigastric stomach pain, dysphagia, frequent defecation with hematochezia, arthralgia of the knees, myalgia of the right calf and pronounced swelling of the fingers with Raynaud''s phenomenon. Examination of joints showed pronounced constriction of active movement; passively a complete fist could be formed under pain. Both knees could be moved freely under pain. Ultrasound of the joints of both wrists showed a slight synovitis. Ultrasound of the abdomen revealed expanded liver veins with a diameter of 1.5 cm. Lab tests on 06-Jun-2013 revealed GOT 79/l, GPT 55 U/l, LDH 393 U/l, CK 1352 U/l, C3 96 mg/dl, Neopterin 17.4 nmol/l and 25-OH vitamin D 9.9 ng/ml. Lab tests on 21-Jun-2013 revealed GOT 84 U/l, GPT 48 U/l, LDH 415 U/l, CK 1763 U/l and Lipase 51 U/l. A secondary pain syndrome with daily chronic headaches and arthromyalgia was suspected. Vitamin-D deficiency was diagnosed and treated with Vigantoletten. After rituximab therapy methylprednisolone could be reduced and the patient''s depressive mood improved. For the persistent myositis with pronounced increased muscle enzymes and neopterin (as a marker for interferon-activated macrophages) an additional therapy with GAMUNEX IV was started. Further medication included: MYFORTIC, QUENSYL, MOVICO and SORBITOL due to chronic obstipation. At the time of reporting, the patient had not recovered. According to the reporter, the reactions were definitely related to the vaccination. Previous dose of GARDASIL (D1, batch-no. G005824, lot number NN12610, Exp. Date: 20-SEP-2013) was given on 02-Feb-2012. Toleration was not reported.

VAERS ID:521312 (history)  Vaccinated:2012-02-02
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2014-01-29
Location:Foreign  Entered:2014-01-29
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: B0963135A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149CA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Dizziness, Headache, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of malaise in a female subject aged between 10 and 19 years old who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included CERVARIX; GlaxoSmithKline; intramuscular; unknown given on 2 August 2011 and 30 August 2011. On 2 February 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown). Approximately, 1 year after vaccination with CERVARIX, the subject experienced malaise, headache, arthralgia, giddiness and feeling queasy. The subject was absent from school. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the events were unresolved. The physician considered malaise, headache and arthralgia were related to vaccination with CERVARIX.

VAERS ID:448797 (history)  Vaccinated:2012-02-03
Age:21.0  Onset:2012-02-03, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 0
Location:Pennsylvania  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: no
Preexisting Conditions: penicillin
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1333Y1IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Dizziness, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Shortly after patient received vaccine, she became pale, said she felt dizzy and nauseous. She requested an ice pack while sitting down. After 5-10 minutes she was feeling better and looked less pale. She then left office.

VAERS ID:448800 (history)  Vaccinated:2012-02-03
Age:0.8  Onset:2012-02-03, Days after vaccination: 0
Gender:Male  Submitted:2012-02-03, Days after onset: 0
Location:North Carolina  Entered:2012-02-03
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: No Known Drug Allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3745AA IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4184BC IMRL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB991BA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF17155 IMLL
Administered by: Public     Purchased by: Public
Symptoms: Blister
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: After patient received vaccines, mother and patient went to the check-out area and when mother was putting patient''s socks back on she noticed blisters on the patient's toes. Patient had blisters on the bottom of both great toes and underneath all other toes. Patient did not have any signs of difficulty breathing, no wheezing, no swelling of mouth/throat and no blisters were noted anywhere else on the patient''s body. Patient was scheduled to see a local pediatrician this afternoon to be evaluated. Mother was instructed to take patient to emergency room if she noticed patient having difficulty breathing or if blisters started to occur more. Mother verbalized understanding of instructions.

VAERS ID:448810 (history)  Vaccinated:2012-02-03
Age:4.0  Onset:2012-02-03, Days after vaccination: 0
Gender:Female  Submitted:2012-02-04, Days after onset: 1
Location:Georgia  Entered:2012-02-04
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: born with one kidney, but functions normally
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRL
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRL
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever of 102.3, alternated Tylenol and Motrin every 4 hours. At 3:30 AM patient started throwing up. She threw up one time. 24 hours after vaccinations still has 101 fever and very tender and red at injection site.

VAERS ID:448918 (history)  Vaccinated:2012-02-03
Age:75.0  Onset:2012-02-03, Days after vaccination: 0
Gender:Female  Submitted:2012-02-06, Days after onset: 3
Location:New Mexico  Entered:2012-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: None
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1268AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Vertigo
SMQs:, Vestibular disorders (narrow)
Write-up: Vertigo.

VAERS ID:448926 (history)  Vaccinated:2012-02-03
Age:2.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-06
Location:Virginia  Entered:2012-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4003AA3IMLL
Administered by: Private     Purchased by: Private
Symptoms: Crying, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Mom reports intense crying for 24 hrs and swelling at site.

VAERS ID:448936 (history)  Vaccinated:2012-02-03
Age:0.5  Onset:2012-02-03, Days after vaccination: 0
Gender:Male  Submitted:2012-02-03, Days after onset: 0
Location:Alabama  Entered:2012-02-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4142AA2IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4197BA IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1156AA2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF561772IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1457AA2PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Legs became very red. Cold compresses given in office. 435pm Dad said legs still a little red, but seemed fine.

VAERS ID:448949 (history)  Vaccinated:2012-02-03
Age:60.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Female  Submitted:2012-02-06, Days after onset: 2
Location:Iowa  Entered:2012-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin 500mg BID; Diltiazem SA 120mg QD; Triam/HCTZ 37.5/25 QD
Current Illness: None
Preexisting Conditions: Diabetes; Hypertension
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1603AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient called immunizing pharmacist on 2/6/12 to report rash/hot/swollen reaction at injection site. Reaction was noted on 2/4/12 and still evident at time of phone call. Injection site: Deltoid/Rt. arm.

VAERS ID:448933 (history)  Vaccinated:2012-02-03
Age:1.5  Onset:2012-02-04, Days after vaccination: 1
Gender:Male  Submitted:2012-02-07, Days after onset: 3
Location:Washington  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: My son was at the end of a 10-day course of Amoxicillin. He was being treated for an ear infection. He was a healthy, happy kid on the day of his shot.
Preexisting Conditions:
Diagnostic Lab Data: A CBS, chest x-ray, and urine analysis was administered at the ER. All tests were negative. However, the doctors indicated to us that our son was reacting to the DTAP shot.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 3SYRLL
Administered by: Private     Purchased by: Private
Symptoms: Abasia, Body temperature fluctuation, Body temperature increased, Chest X-ray normal, Cyanosis, Diet refusal, Full blood count normal, Hypersomnia, Hypophagia, Injection site swelling, Skin discolouration, Tremor, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: His symptoms started with a swollen leg (site of the injection). His left leg was the size of a grape fruit and my son was unable to walk. His temperature on the morning of Feb 4, 2012 was 103. Throughout the day, my son refused to eat and drank very little. He slept all day. When we put him down for bed we noticed he was hot -- very hot. His temperature registered 104. We were advised from the on-call pediatrician to give him Tylenol and push the fluids. We did. By 11:30 PM on Feb 12, 2012, my son''s temperature was 105. He was blue in the lips, the hands, and the toes. His body was shaking. The color of his skin turned into a lace like pattern of white and purple. We took him to the ER where he was immediately put into the Code room. The doctors wrapped his body in warmers, while trying to find a vein for an IV. By the time he got to the ER his temperature of "off the charts," according to the doctor. This meant, his temperature was higher than 105.5 We spent the entire evening and early morning of Feb 5 in the ER. My son''s temperature continued to spike to 104 and then fall. This pattern repeated all night. We were sent home and the same pattern of previous shaking, high temperature, and lack of interest in food continued until Monday, Feb at 1:30 PM.

VAERS ID:449017 (history)  Vaccinated:2012-02-03
Age:4.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Female  Submitted:2012-02-07, Days after onset: 3
Location:Kansas  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness: None
Preexisting Conditions: Congenital hypothyroidism
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4003AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG11453SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0705AA1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1091AA1SCLL
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: Swelling, redness, pain, warm to touch 8 cm Rt thigh.

VAERS ID:449050 (history)  Vaccinated:2012-02-03
Age:41.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Female  Submitted:2012-02-07, Days after onset: 3
Location:Texas  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN55105 IMLA
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1259AA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.12502 SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4030AA IMLA
Administered by: Military     Purchased by: Private
Symptoms: Auricular swelling, Headache, Lymphadenopathy, Pain
SMQs:, Angioedema (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling to glands in right neck, right ear canal swollen. Pain and headache.

VAERS ID:449055 (history)  Vaccinated:2012-02-03
Age:29.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Male  Submitted:2012-02-07, Days after onset: 3
Location:Pennsylvania  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Occasional intermittent asthma (required albuterol once in past 12 months).
Diagnostic Lab Data: None to date - will seek medical advice tomorrow if diarrhea is not improved.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMRA
Administered by: Public     Purchased by: Private
Symptoms: Decreased appetite, Diarrhoea, Faecal incontinence, Fatigue, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Started with slight nausea, proceeded to anorexia and diffuse myalgias as well as severe fatigue in the next 2 hours. No vomiting. One episode of subjective fever late in evening 2/5, pt awoke on bathroom floor (syncopal episode?) and was afebrile. Fatigue and anorexia continue til now (2/7 pm) though myalgias are better. Watery diarrhea (no blood or mucus) began 2/5 PM. $g10 episodes per day continued until now. 2 episodes of fecal incontinence. Pt is continuing conservative treatment at current time with hydration and rest. If diarrhea continues tomorrow will seek medical advice.

VAERS ID:449060 (history)  Vaccinated:2012-02-03
Age:54.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Female  Submitted:2012-02-07, Days after onset: 3
Location:Washington  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bupropion calcium carbonate Glucosamine chondroitin MVI Synthroid
Current Illness:
Preexisting Conditions: NKA Hypothyroid
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1193AA0SCLA
Administered by: Unknown     Purchased by: Other
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Injection site, red, swollen, pain at injection site and surrounding area, even into arm pit. Also felt feverish.

VAERS ID:449068 (history)  Vaccinated:2012-02-03
Age:62.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Male  Submitted:2012-02-07, Days after onset: 3
Location:Texas  Entered:2012-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR, CYMBALTA, HYDROCODONE, VERAPAMIL, XANAX, PROTONICS, UROXATRAL, NO OTHER VACCINES WERE GIVEN DURING THAT DAY
Current Illness: GI BLEEDING DUE TO STOMACH ULCER
Preexisting Conditions: TREATED FOR GI BLEEDING, RECEIVED 5 PINTS OF BLOOD TRANSFUSION, WEAK, LOW HEMOGLOBIN LEVEL
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLA
Administered by: Public     Purchased by: Other
Symptoms: Arthralgia, Asthenia, Heart rate increased, Joint swelling, Myalgia, Oedema peripheral, Oropharyngeal pain, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: DEVELOPED RASH IN ARMS, BACK AREA AND EXTREMITIES, SWELLING OF WRIST AND BOTH HANDS, KNEE PAIN, MUSCLE PAIN, SORE THROAT, WEAKNESS, FAST HEART BEAT FOR 3 DAYS AFTER VACCINE ADMINISTRATION.

VAERS ID:449114 (history)  Vaccinated:2012-02-03
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-07
Location:California  Entered:2012-02-08, 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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AB SYRLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swollen at site (L) (D) - warm to touch. FLUZONE injection given on 2/3/12.

VAERS ID:449151 (history)  Vaccinated:2012-02-03
Age:15.0  Onset:2012-02-03, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 0
Location:New York  Entered:2012-02-08, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0477AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Syncope episode after administration of vaccine.

VAERS ID:449262 (history)  Vaccinated:2012-02-03
Age:4.0  Onset:2012-02-03, Days after vaccination: 0
Gender:Male  Submitted:2012-02-09, Days after onset: 6
Location:California  Entered:2012-02-09
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 other than eczema
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B171CA4IMLA
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA604BA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0447AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0779AA1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Pruritus, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Diffuse macular papular rash over axilla (left). Persisted for 5 days. No vesicles. (+) pruritus. No respiratory distress or stridor.

VAERS ID:449299 (history)  Vaccinated:2012-02-03
Age:41.0  Onset:2012-02-03, Days after vaccination: 0
Gender:Female  Submitted:2012-02-10, Days after onset: 7
Location:Pennsylvania  Entered:2012-02-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NASONEX; Vitamin B12; Vitamin D; Fish oil
Current Illness: Minor nasal congestion; Runny nose; No fever
Preexisting Conditions: Allergy to mold, dust, grass; Hypercalcemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH140AA0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Nausea, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: In the afternoon after receiving yellow fever injection, patient developed redness, swelling, & itching at site in left arm. Reports feeling tired & nauseous last weekend. 1 week later, reports soreness & mild itching. Did not apply ice or heat or take any analgesic.

VAERS ID:449309 (history)  Vaccinated:2012-02-03
Age:15.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Male  Submitted:2012-02-06, Days after onset: 2
Location:Ohio  Entered:2012-02-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AB0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0692AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4008AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0768AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, Pruritus, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/4/12. 8:30 am Red blistery area noted next to (R) deltoid upper injection site - c/o itching 2:30 pm. Rash noted from injection site across chest toward neck area 2/5/12- Rash darker red, itching continues 2/6/12 - rash remains with itching - 8:30 am - BENADRYL given 10:30 am - Rash fading, itching subsiding.

VAERS ID:449359 (history)  Vaccinated:2012-02-03
Age:0.6  Onset:2012-02-03, Days after vaccination: 0
Gender:Male  Submitted:2012-02-10, Days after onset: 7
Location:Texas  Entered:2012-02-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: My son was not taking any medications when vaccinations were given. He only began taking pedia care oral elixir acetamenophin when he developed fever, as ordered by his doctor.
Current Illness: None, perfectly healthy
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 2 LL
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 2 RL
Administered by: Unknown     Purchased by: Private
Symptoms: Diarrhoea, Pyrexia, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: My son developed a fever ranging from 99 degrees Fahrenheit to 102.7 degrees Fahrenheit on the same evening after receiving the hib, IPV, Dtap vaccines. The fever continued in that way for exactly six (6) days. On the fourth day, I took him to his pediatrician who examined him, and determined that he could not conclude what exactly was wrong with my son, and to return if the fever was 106 degrees Fahrenheit or more, or if the problem persisted past 14 days. On the fifth day, my son developed diarrhea, which still persists to date. Exactly seven (7) days after his vaccination, my sons fever subsided only to be replaced with a red raised rash that covered his face, neck, back, chest, pubic area, and buttocks. I have made another appointment for my son to see his pediatrician this afternoon.

VAERS ID:449401 (history)  Vaccinated:2012-02-03
Age:17.0  Onset:2012-02-06, Days after vaccination: 3
Gender:Female  Submitted:2012-02-10, Days after onset: 4
Location:Ohio  Entered:2012-02-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AC0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3712AA1UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness & swelling, and pain.

VAERS ID:449412 (history)  Vaccinated:2012-02-03
Age:13.0  Onset:2012-02-03, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Ohio  Entered:2012-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Headache
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1104050IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.E0087581SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Seen 2/3/12 for headache & delayed immunizations. Received flu vaccine ((L) upper arm), HPV vaccine ((R) upper arm superior aspect) & varicella vaccine ((R) upper middle area). Within 10 - 20 minutes felt itching by varicella vaccine & swelling. Swelling has slightly decreased & itchiness has decreased. Area is not painful except for with palpation. Has not used any meds except for topical hydrocortisone, slightly helpful.

VAERS ID:449484 (history)  Vaccinated:2012-02-03
Age:42.0  Onset:2012-02-03, Days after vaccination: 0
Gender:Female  Submitted:2012-02-13, Days after onset: 10
Location:Vermont  Entered:2012-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multivitamin, fish oil, folate
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 7IMLA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 12IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site pain, Oedema, Pruritus, Skin discolouration
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Soreness at injection site; edema (size of a palm/hand); itchy; skin discoloration.

VAERS ID:449508 (history)  Vaccinated:2012-02-03
Age:5.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Male  Submitted:2012-02-06, Days after onset: 2
Location:Wisconsin  Entered:2012-02-14, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Yes.~Pneumo (Prevnar13)~3~3.00~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B118CA3UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG150013UNLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/4/12 redness at site, swelling. 2/4/12 E.R. visit Rx Cephalexin Dx cellulitis. 2/5/12 E.R. visit 2 shots antibiotic & Rx another antibiotic. Dx - Cellulitis. Fu with PMD today 2/6 seems "a little better" & hydrocortisone cream for itchiness.

VAERS ID:449577 (history)  Vaccinated:2012-02-03
Age:11.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Male  Submitted:2012-02-09, Days after onset: 5
Location:Texas  Entered:2012-02-14, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0477AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA100510IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B069FA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0448AA2SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Local swelling, Skin warm
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red swollen area noticed by pt on Sat on (R) arm. Warm to touch. Instructed by NP to take ibuprofen & may take antihistamines as well. RTC if sx does not resolved in next 1-2 days.

VAERS ID:449639 (history)  Vaccinated:2012-02-03
Age:5.0  Onset:2012-02-12, Days after vaccination: 9
Gender:Male  Submitted:2012-02-15, Days after onset: 3
Location:Illinois  Entered:2012-02-15
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: NKDA None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4006AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13053IMRA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus, Rash macular, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Few blotchy, raised, itchy lesions over extremeties and trunk. Treating with Benadryl- up to 3 teaspoons every 8 hours as needed.

VAERS ID:449645 (history)  Vaccinated:2012-02-03
Age:65.0  Onset:2012-02-04, Days after vaccination: 1
Gender:Female  Submitted:2012-02-07, Days after onset: 3
Location:Michigan  Entered:2012-02-15, 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: Simvastatin; COZAAR; Metformin; RELAFEN; Thyroid; Citalopram; ASA - 81 mg; Fexofenadine
Current Illness: None
Preexisting Conditions: DM2; Osteoarthritis; Depression; HTN; hyperchol; Allergies: SEPTOCAINE with Epinephrine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Contusion, Erythema,