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Case Details (Sorted by Vaccination Date)

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VAERS ID:324672 (history)  Vaccinated:2008-09-06
Age:65.0  Onset:2008-09-06, Days after vaccination: 0
Gender:Female  Submitted:2008-09-09, Days after onset: 3
Location:North Carolina  Entered:2008-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: Patient is a Polio survivor and is diagnosed with Post Polio Syndrome. Had similar reaction to pneumonia vaccine 2 years ago, but not for such a prolonged period.
Diagnostic Lab Data: Shingles vaccine
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Feeling hot, Hyperhidrosis, Induration, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness and swelling in arm within several hours; hard lump and feverish type sweating persisting for 3 days. Family physician recommended taking Tylenol or Alleve or something similar to treat symptoms.

VAERS ID:332336 (history)  Vaccinated:2008-09-06
Age:5.0  Onset:2008-09-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 69
Location:Illinois  Entered:2008-11-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: See attached
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2934AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04923UNLA
Administered by: Private     Purchased by: Private
Symptoms: Rash erythematous, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: 9/6/08 within several hours of receiving IPV + DTP, PT developed confluent rash with raised welts incompletely responsive to Benadryl received Epi & ORAPRED lasted 6-7 days + buttock rash.

VAERS ID:324384 (history)  Vaccinated:2008-09-07
Age:43.0  Onset:2008-09-07, Days after vaccination: 0
Gender:Male  Submitted:2008-09-07, Days after onset: 0
Location:Tennessee  Entered:2008-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500551P0IN 
Administered by: Military     Purchased by: Military
Symptoms: Abdominal discomfort, Fatigue, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Head ache, fatigue, GI upset(nausea) onset 15 minutes post Flumist

VAERS ID:325231 (history)  Vaccinated:2008-09-07
Age:4.0  Onset:2008-09-07, Days after vaccination: 0
Gender:Female  Submitted:2008-09-08, Days after onset: 1
Location:Colorado  Entered:2008-09-16, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild sneezing
Preexisting Conditions: Coarctation of aorta
Diagnostic Lab Data: Visit to check in office
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSU2787EA IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB284DA0IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Eye rolling, Staring
SMQs:, Ocular motility disorders (narrow)
Write-up: Rolled eyes for about 60 sec. Stared x 2 at preschool two hours after receiving influenza vaccine and Hep A ped.

VAERS ID:326855 (history)  Vaccinated:2008-09-07
Age:25.0  Onset:2008-09-07, Days after vaccination: 0
Gender:Male  Submitted:2008-10-02, Days after onset: 25
Location:Illinois  Entered:2008-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: morphine allergy, past medical history: lasik eye surgery 2005, ORIF Left ankle 1998
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500551P2IN 
Administered by: Military     Purchased by: Military
Symptoms: Bronchospasm, Chest pain, Dehydration, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Patient reported to and was treated at local ER. Pt complained of shortness of breath and chest pain following Flumist administration. Symptoms started shortly after inhalation of Flumist and continued to progress. Local ER evaluated as dehydration and brochospasm secondary to Flumist. Treated with nebulizers and steroids and released.

VAERS ID:328676 (history)  Vaccinated:2008-09-07
Age:  Onset:2008-09-07, Days after vaccination: 0
Gender:Unknown  Submitted:2008-09-15, Days after onset: 8
Location:Washington  Entered:2008-10-15, Days after submission: 30
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: MEDI0007125
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500479P IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, Medication error, No adverse event
SMQs:
Write-up: A non serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatrician''s office. This case is submitted in accordance with MedImmune''s post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. 10/07/08 Follow-up received 07-Oct-2008: No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.

VAERS ID:333796 (history)  Vaccinated:2008-09-07
Age:0.8  Onset:0000-00-00
Gender:Male  Submitted:2008-11-14
Location:Washington  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA01126
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Rash
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a pharmacist concerning an 8 month old male infant who one month ago on approximately 07-SEP-2008 was vaccinated with a first dose of oral ROTATEQ. Subsequently, the patient developed diarrhea after receiving his first and only dose. The patient was taken to the hospital for hydration but was not admitted. He did not have weight loss. It was unspecified if lab studies were performed. It was noted that after the patient received the vaccination, the patient was prescribed ZITHROMAX for unrelated infection and he developed a rash. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2008. Follow-up information was received from the physician assistant. "It has been determined that the diarrhea experienced by the infant is unrelated to ROTATEQ. Additional information is not expected.

VAERS ID:389467 (history)  Vaccinated:2008-09-07
Age:34.0  Onset:2008-10-01, Days after vaccination: 24
Gender:Male  Submitted:2010-05-25, Days after onset: 601
Location:Unknown  Entered:2010-05-27, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Some PVCs, see full attached summary
Diagnostic Lab Data: see attached
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A IDUN
Administered by: Military     Purchased by: Military
Symptoms: Atrial fibrillation, Chest pain, Dyspnoea, Palpitations, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Chest pain, SOB and palpitations. Condition developed into a chronic Afib condition. see attached full report. Symptoms: Pain, chest NOS(786.50), Palpitations(785.1), Tachycardia NOS (785.0).

VAERS ID:324521 (history)  Vaccinated:2008-09-08
Age:1.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-09-08, Days after onset: 0
Location:Connecticut  Entered:2008-09-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0747U0  
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0172X0  
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Erythema around injection site. MMR and Varicella within less than 10 minutes. No warmth.

VAERS ID:324663 (history)  Vaccinated:2008-09-08
Age:20.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-09, Days after onset: 0
Location:Connecticut  Entered:2008-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: MILD COLD S/S
Preexisting Conditions: NKDA,NO BIRTH DEFECTS,HEMORRHOIDS
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0263U2IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA11880IMRA
Administered by: Military     Purchased by: Military
Symptoms: Chills, Dizziness, Flushing, Nausea, Pain, Palmar erythema, Pruritus, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: 0658 9-9-08 SYNCOPE, BODY ACHES, CHILLS, NAUSEA, LIGHT HEADED, FLUSHED FACIAL CHEEKS, PALMS ERYTHEMIC, PRUITIS PALMS,DIPHENHYDRAMINE 25MG PO TIMES ONE,TYLENOL 975MG PO TIMES ONE GIVEN;

VAERS ID:324669 (history)  Vaccinated:2008-09-08
Age:1.1  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-09, Days after onset: 1
Location:Pennsylvania  Entered:2008-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: well child
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B079BA0IMRA
HIBV: HIB (ACTHIB)SANOFI PASTEURUF369AA0IMLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0542U0SCLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499200IMLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site urticaria, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Several minutes after receiving immunizations (At approx 3 PM) child developed a single hive 10mm in size adjacent to MMRV administration site. No other adverse events or other hives. Color was good. No respiratory problems. Child playing, walking and drinking bottle. Hrt rate 132. Observed child for 50 minutes and no changes in status. Hive fading. ER was notified and child transported by parents to local ER at about 3:52 PM. Per phone call to mom on 9/9 child was ordered benadryl po and tylenol/motrin alternating. Other than mild fever child not experiencing any other problems.

VAERS ID:324682 (history)  Vaccinated:2008-09-08
Age:0.5  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-09-09, Days after onset: 1
Location:Pennsylvania  Entered:2008-09-09
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: have a cough
Preexisting Conditions: n/a
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER    
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER    
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Unknown
Symptoms: Anorexia, Asthenia, Febrile convulsion, Moaning, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: After receiving vaccinations, my son was developing a fever at 102 degree at that night. I treated him tylenol infants'' drop 0.6ML at 8:30pm. After one hour, his fever was not decreased. I called his doctor and was advised to treat him tylenol again after 4 hours. Around 10pm, my son was getting so weak, vomit, moaning and febrile convulsion. He was taking his second tylenol at 12:30am. In the next morning, he had low-grade fever and no appetite.

VAERS ID:324693 (history)  Vaccinated:2008-09-08
Age:5.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-09-09, Days after onset: 1
Location:Nebraska  Entered:2008-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2934AA4IMLL
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500541P  UN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0805 SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0807X SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.A08051SCLL
Administered by: Private     Purchased by: Private
Symptoms: Oedema peripheral, Weight bearing difficulty
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling of left leg from upper thigh to below knee-increasing knot. Inability to bear weight.

VAERS ID:324706 (history)  Vaccinated:2008-09-08
Age:1.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-09, Days after onset: 1
Location:Florida  Entered:2008-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Desonate cream
Current Illness: None
Preexisting Conditions: Atopic dermatitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04912UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0513X0UNLL
Administered by: Private     Purchased by: Private
Symptoms: Crying, Erythema, Pyrexia, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Crying inconsolably greater 1 hour, temperature greater 101. Red, raised, swollen rash top of head down to buttocks (? hives).

VAERS ID:324713 (history)  Vaccinated:2008-09-08
Age:1.3  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-09, Days after onset: 0
Location:North Carolina  Entered:2008-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0315X0SCRL
Administered by: Private     Purchased by: Public
Symptoms: 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)
Write-up: Fever of 104 less than 24 hours if receiving VARIVAX. Had febrile seizure as well. Child had febrile seizure 03/18/08 which was not related to vaccines.

VAERS ID:324776 (history)  Vaccinated:2008-09-08
Age:1.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Male  Submitted:2008-09-10, Days after onset: 1
Location:New Hampshire  Entered:2008-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB234BA0IMRA
PPV: PNEUMO (PNU-IMUNE)PFIZER/WYETHC861403IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0512X0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Child developed fever of 103+ within 24 hours of vaccine administration. No other symptoms occurred.

VAERS ID:324791 (history)  Vaccinated:2008-09-08
Age:15.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-10, Days after onset: 1
Location:Maryland  Entered:2008-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMNICEF 250 MG/5ML
Current Illness: HAD STREP THROAT DIAGNOSED ON 09/05/2008.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB297BA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0973X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: TENNIS BALL SIZE REACTION, SMALL REACTION STARTED ON 09/09/2008 WITH INCREASING SIZE AND REDNESS. RED AND SWOLLEN

VAERS ID:324794 (history)  Vaccinated:2008-09-08
Age:55.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-10, Days after onset: 2
Location:Idaho  Entered:2008-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: Sudden sensorineural hearing loss on the right with tinnitus 2005
Diagnostic Lab Data: CT scan normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2994BA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Computerised tomogram normal, Confusional state, Dizziness, Dyspnoea, Hypertension, Hypoaesthesia, Paraesthesia, Vision blurred
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Reaction began with light-headedness and progressed over next two hours to extremely high blood pressure, difficulty catching a breath, confusion, blurry vision, numbness and tingling of right side of head, face, and arm. Symptoms slowly faded over five hours in the hospital emergency room.

VAERS ID:324801 (history)  Vaccinated:2008-09-08
Age:66.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-09-09, Days after onset: 1
Location:Kentucky  Entered:2008-09-10, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2753AA IMUN
Administered by: Other     Purchased by: Private
Symptoms: Dysuria, Hyperhidrosis, Nausea, Pyrexia, Renal disorder, Stomach discomfort, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Fever, nausea, vomiting, stomach upset - kidney "shut down" - unable to urinate - excessive sweating

VAERS ID:324805 (history)  Vaccinated:2008-09-08
Age:13.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-10, Days after onset: 1
Location:North Carolina  Entered:2008-09-10
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB292AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2661AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0331X1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Indurated, erythematous area 4cm x 6cm over the post. aspect of the right upperarm which is warm and slightly tender. Varicella

VAERS ID:324811 (history)  Vaccinated:2008-09-08
Age:4.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Male  Submitted:2008-09-10, Days after onset: 1
Location:Kansas  Entered:2008-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B103AC7IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB268EA1IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0666X1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0513X1SCLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling of left arm from shoulder to elbow. First noted to be swollen 09/09/08 by maternal grandmother at about 1515. Mother reports arm swollen, red, and hot. Arm iced and Tylenol given. Mother reports child woke up crying a couple of times during night. Mother reports arm is not as red today and skin on arm is not as tight, however arm remains swollen. Left arm at axillary and around deltoid measures 9 1/2 inches and just above, elbow is 7 1/2 inches in circumference, compared to right arm circumference measurements of 8 inches at deltoid and 6 1/2 inches above elbow. Referred to medical provider at family practice center for further evaluation. Child has been afebrile since onset.

VAERS ID:324813 (history)  Vaccinated:2008-09-08
Age:4.0  Onset:2008-09-10, Days after vaccination: 2
Gender:Male  Submitted:2008-09-10, Days after onset: 0
Location:Florida  Entered:2008-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: asthma, reflux (GERD), Allergic rhinitis
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0788X1UNLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site cellulitis, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Cellulitis to left thigh 2 1/4 x 1 1/2 inch area of mild swelling with 1 inch x 1 1/4 inch; Augmentin (600/S) 6 me po BID x 10 days

VAERS ID:324844 (history)  Vaccinated:2008-09-08
Age:22.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-08, Days after onset: 0
Location:Wisconsin  Entered:2008-09-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU2080BA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: 1410 Donor became light headed - layed donor on bed, gave donor H2O. Donor sat 20 minutes. Vital signs at 14:10 117/56, pulse 70, vital signs at 14:30 125/85, pulse 75.

VAERS ID:324875 (history)  Vaccinated:2008-09-08
Age:11.0  Onset:2008-09-11, Days after vaccination: 3
Gender:Male  Submitted:2007-06-06, Days after onset: 463
Location:California  Entered:2008-09-11, Days after submission: 463
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2569AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0155X1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: After giving Varicella,Mcv4 and Tdap mo ther called clinic son had moderate rashes all over body reactions mostlikely with var no fever no other major reations so far

VAERS ID:324894 (history)  Vaccinated:2008-09-08
Age:4.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-11, Days after onset: 2
Location:Maine  Entered:2008-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2800AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA08363IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0413U1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0432X1SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 24-36 hr after fever 99 red swollen hot injection site.

VAERS ID:324981 (history)  Vaccinated:2008-09-08
Age:2.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-09-08, Days after onset: 0
Location:Connecticut  Entered:2008-09-12, 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: No
Preexisting Conditions: Has Trisomy 21, complete AV canal, S/P repair, intraatrial re-entry, tachycardia, S/P radio frequency ablation (May/08)
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0486X1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Generalized hives 20 minutes after Varivax S.C. Vital signs stable, no wheezing heard. Received Epinephrine 0.3ml (1:1000) and sent to hospital ER by 911 for observation.

VAERS ID:324987 (history)  Vaccinated:2008-09-08
Age:9.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:New Jersey  Entered:2008-09-12
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: History of asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0571X1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0514X1UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Varicella and Gardasil vaccine given - on her way to the car, turned pale and was dizzy. BP 105/65, HR 84.

VAERS ID:324997 (history)  Vaccinated:2008-09-08
Age:1.3  Onset:2008-09-09, Days after vaccination: 1
Gender:Unknown  Submitted:2008-09-12, Days after onset: 3
Location:Maryland  Entered:2008-09-12
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR  IMUN
HEPA: HEP A (VAQTA)MERCK & CO. INC.  IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  IMUN
Administered by: Private     Purchased by: Private
Symptoms: Crying, Irritability, Pyrexia, Speech disorder, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: crying, fussy,1h following vaccine, fever 24h later 103, shaking and vomiting, fever continued till day 5 after vaccine. Mother reports "no eye contact" now and not saying words.

VAERS ID:324998 (history)  Vaccinated:2008-09-08
Age:13.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Male  Submitted:2008-09-12, Days after onset: 3
Location:Michigan  Entered:2008-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2687AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2995BA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: PT COMPLAINED OF SHORTNESS OF BREATH AND DIZZINESS APPROX 24 HOURS AFTER RECIEVING INJECTIONS. HE WAS SEEN AT AN URGENT CARE FACILITY AND THEN FOLLOWED UP WITH US ON 09112008. AT THAT TIME THE SYMPTOMS HAD SUBSIDED.

VAERS ID:325031 (history)  Vaccinated:2008-09-08
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2008-09-12
Location:Minnesota  Entered:2008-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Iron
Current Illness: Prematurity, Esophageal atresia
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B149AA0IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0475X0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF399AB0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC45721H0IMLL
Administered by: Public     Purchased by: Unknown
Symptoms: Medication error, No adverse event
SMQs:
Write-up: Patient received RECOMBIVAX B vaccine x 2. Given RECOMBIVAX and PEDIARIX same day. No adverse effects.

VAERS ID:325082 (history)  Vaccinated:2008-09-08
Age:14.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-09, Days after onset: 1
Location:California  Entered:2008-09-15, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None Reported~ ()~~0~In Patient|None Reported~ ()~~0~In Sibling|None Reported~ ()~~0~In Sibling
Other Medications: Doxycycline
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Patient fainted after needle was withdrawn, lost consciousness for 2 seconds. Mother of patient called our office the next day stating that patient collapsed in coffee shop after having left the clinic. Patient was observed in exam room for 15 minutes, and was released without problem.

VAERS ID:325087 (history)  Vaccinated:2008-09-08
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2008-09-08
Location:Michigan  Entered:2008-09-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0492 SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0890X SCRL
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B030AA IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0787X SCLL
Administered by: Private     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: Gave Tdap instead Dtap

VAERS ID:325136 (history)  Vaccinated:2008-09-08
Age:18.0  Onset:2008-09-12, Days after vaccination: 4
Gender:Male  Submitted:2008-09-15, Days after onset: 3
Location:Hawaii  Entered:2008-09-15
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1420SCRA
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500547P0IN 
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04-003A0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Post vaccination autoinoculation, Skin lesion, Vaccinia virus infection
SMQs:
Write-up: Satiellate lesion on left shoulder next to primary.

VAERS ID:325147 (history)  Vaccinated:2008-09-08
Age:18.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-09-10, Days after onset: 2
Location:Washington  Entered:2008-09-15, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2550AA0UNUN
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt. reports symptoms started 9/8/08 at approx 6 pm (HA), 9/9/08-HA cont., weakness, fever (did not take), but felt like fever, redness at site and swollen area 9/10/08- decreased HA, no weakness, no reddness at site, warm to touch and mildly swollen.

VAERS ID:325198 (history)  Vaccinated:2008-09-08
Age:12.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Maine  Entered:2008-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: mild asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2604AA0IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B020AA0IMUN
Administered by: Unknown     Purchased by: Public
Symptoms: Chills, Dizziness, Headache, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: Developed a fever 101 on 9/9 increased 102 feeling dizzy and c/o headache, shaking and chills with fever

VAERS ID:325199 (history)  Vaccinated:2008-09-08
Age:12.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Male  Submitted:2008-09-12, Days after onset: 3
Location:Virginia  Entered:2008-09-16, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B018AA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea and vomiting one day after injection.

VAERS ID:325214 (history)  Vaccinated:2008-09-08
Age:1.6  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-09-09, Days after onset: 1
Location:Montana  Entered:2008-09-16, 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: N/A
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2955BA3IMLL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local reaction, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Severe local reaction - swelling red, hot to touch.

VAERS ID:325226 (history)  Vaccinated:2008-09-08
Age:4.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Utah  Entered:2008-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2950AA3IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04903SCLA
Administered by: Public     Purchased by: Public
Symptoms: Lethargy, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Vaccines administered 9:45am. Mother reported fever in child at 12:30 - 1 am lasting 4 hours and child lethargic in AM with fever of 101 - she gave Tylenol 4, within 20 hours fever at 100. Today, vomiting abated. "Reaction" began approximately 14 hours after vaccine. Child had similar reaction on #2 DTAP but tolerated #3 without problems. F/U call 9/10 - vomiting began between 1 - 1:30 am. Today she has a 99 temperature, feeling better.

VAERS ID:325233 (history)  Vaccinated:2008-09-08
Age:4.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-09-10, Days after onset: 2
Location:New York  Entered:2008-09-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2933AB4IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0422X1SCRA
Administered by: Private     Purchased by: Unknown
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: Rt arm swollen red, warm. Tx Keflex, Benadryl, cool compress.

VAERS ID:325237 (history)  Vaccinated:2008-09-08
Age:0.3  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-16, Days after onset: 7
Location:Wyoming  Entered:2008-09-16
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: head ultrasound
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B150AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF449AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC631160IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fontanelle bulging, Foster care, Ultrasound skull normal
SMQs:, Neonatal disorders (narrow)
Write-up: Pediarix, ActHib and PCV were administered in the afternoon of 9/8/2008. About 4 am the next morning the foster mom noticed the child''s fontanel was protruding about 1/2 inch above her head. The foster mom called the baby''s doctor, but couldn''t get in right away. She then took the baby to the Emergency Room. By this time, the fontanel had reduced in size by about 1/2. The ER doctor did not run any test and sent them home. The next day, Wednesday, the foster mom was still concerned so she took the baby to her doctor. At that time, the foster mom''s doctor, had an ultrasound done on the baby''s head. Everything was reported to be normal. No other findings have been reported.

VAERS ID:325358 (history)  Vaccinated:2008-09-08
Age:17.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-21, Days after onset: 13
Location:Indiana  Entered:2008-09-17, 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: Benadryl Prilosec
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U2IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024BA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Eye rolling, Muscle twitching, Physical examination normal, Pruritus, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow), Hypersensitivity (broad)
Write-up: Pt''s mom reported itching 1 hr after vaccines. Gave Benadryl. Pt''s boyfriend states she started twitching/shaking head & neck & eyes rolled back in her head. 9/22/08-records received-9/9/08-Seen in office day after C/O itching, twitching and shaking head and neck. Eyes rolled. PE grossly WNL.

VAERS ID:325367 (history)  Vaccinated:2008-09-08
Age:1.4  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-16, Days after onset: 7
Location:Pennsylvania  Entered:2008-09-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA 60mg; FLOMAX
Current Illness: None
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2865AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0604X1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, Rash erythematous, Rash papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Seen 9/8 for well check, red, papular pruritic rash developed with 24 hr at time of visit 9/10 50-75 papular rash non vesicular, no crust. (+) pruritus

VAERS ID:325403 (history)  Vaccinated:2008-09-08
Age:0.1  Onset:2008-09-11, Days after vaccination: 3
Gender:Male  Submitted:2008-09-17, Days after onset: 6
Location:California  Entered:2008-09-17
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: N/A
Diagnostic Lab Data: CBC; increase in Eosinophils and plt ct.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B145AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF466AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC940970IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0302X0PO 
Administered by: Private     Purchased by: Public
Symptoms: Eosinophil count increased, Full blood count, Platelet count increased, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Urticaria on both legs 12 - 48 hours after Prevnar administration.

VAERS ID:325405 (history)  Vaccinated:2008-09-08
Age:17.0  Onset:2008-09-14, Days after vaccination: 6
Gender:Female  Submitted:2008-09-17, Days after onset: 3
Location:Georgia  Entered:2008-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Evra
Current Illness: Urticaria
Preexisting Conditions: No known allergies. Patient denies a family history of asthma; familial congenital defects; hay fever
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2638AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Woke up with hives Sunday 9/14/08, covering most of body. immunized 9/8/08

VAERS ID:325500 (history)  Vaccinated:2008-09-08
Age:28.0  Onset:2008-09-11, Days after vaccination: 3
Gender:Female  Submitted:2008-09-12, Days after onset: 1
Location:Iowa  Entered:2008-09-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2077AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling of left upper arm - fever - 100deg - redness 5.0 x 9.00cm; Tx with ice/Tylenol or ibuprofen

VAERS ID:325617 (history)  Vaccinated:2008-09-08
Age:8.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 7
Location:Virginia  Entered:2008-09-19, 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: None
Current Illness: None
Preexisting Conditions: Food allergies and antibodies were low.
Diagnostic Lab Data: Before vaccine - antibodies were low. After vaccine - white blood count was elevated.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0614X0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site swelling, Mobility decreased, Nausea, Oedema peripheral, Pain, Pain in extremity, Pyrexia, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness and swelling down arm and at the injection site, fever (105), nausea, achy body, pain in arm and difficult to move arm - (Flu like symptoms) - Taken to several doctors and given Cephalexin and pain medication (Tylenol & Motrin).

VAERS ID:325641 (history)  Vaccinated:2008-09-08
Age:48.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-19, Days after onset: 10
Location:Oregon  Entered:2008-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Combivent, bisacodyl, budesonide, ergocalciferol, furosemide, lactuose, melatonin, methocarbamol, miralax, neomycin/polymyxin otic susp, omeprazole, oycodone, senna
Current Illness: Residual effects from earlier stroke, fatigue, UTI, allergies
Preexisting Conditions: Allergies: phenobarbital, aspirin, clarithromycin, imipramine, piroxicam, salsate, morphine, baclofen, sulfas, hydromorphone. Hx of stroke, UTI, asthma, cervical cancer, GERD, insomnia, menopausal syndrome, obesity, quadriplegia, depression, sleep apnea, trigeminal neuralgia, urge incontinence
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.06622X1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899AA IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Flatulence, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Nausea, Oedema peripheral, Pain, Pain in jaw, Pruritus generalised, Skin discolouration, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Pt states that her right arm was swollen and ached all the way down to her fingertips, itched all over body, jaw hurt to open/close, no fevers but had a little nausea/bowel issues (after gas bout she had a lot of pus coming out of anus), states her arm is really red at injection site and now it''s hot and swollen about teh size of a quarter then around that about the size of a half dollar. It''s welted with white patches at teh lower border. Pt also states her whole head is itchey but she states that her swelling is more localized.

VAERS ID:325651 (history)  Vaccinated:2008-09-08
Age:2.0  Onset:2008-09-17, Days after vaccination: 9
Gender:Male  Submitted:2008-09-19, Days after onset: 2
Location:Virginia  Entered:2008-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1311U0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499163IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0538X0SCRL
Administered by: Private     Purchased by: Private
Symptoms: Anorexia, Diarrhoea, Rash papular, Rhinorrhoea, Varicella post vaccine
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: mild varicella disease symptoms with rash (papular rash, rhinorrhea, diarrhea, anorexia) with rash appearing 8 days after administration and prodrome 5 days after admin.

VAERS ID:325760 (history)  Vaccinated:2008-09-08
Age:1.4  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-10, Days after onset: 1
Location:Louisiana  Entered:2008-09-22, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Oral candidiasis; URI
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type: LA080902
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURU18087C4UNLL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pallor, Rash papular, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Large, localized red, swollen area left thigh laterally. Blanches with pressure. No tenderness with few tiny papules.

VAERS ID:325791 (history)  Vaccinated:2008-09-08
Age:20.0  Onset:2008-09-21, Days after vaccination: 13
Gender:Male  Submitted:2008-09-22, Days after onset: 1
Location:Unknown  Entered:2008-09-22
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1550IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB108AA2IMRA
JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUREJN236A0SCLA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDRA
Administered by: Military     Purchased by: Military
Symptoms: Eye pain, Headache, Lymph node pain, Mass, Pain in jaw
SMQs:, Glaucoma (broad), Osteonecrosis (broad)
Write-up: 20 Y/O Male presented to a Corpsman with c/c of bump on his left forhead 1 1/2" above his eyebrow. Pt stated that he was experiencing h/a, pain behind the eyes, jaw pain, and lymph node pain in the neck. Pt received the smallpox vaccine 13 days prior, with no reaction when checked on the 12th. An occlusive dressing was placed over the affected site, and the PT was given direction to follow a strict hygiene regimen. Pt was also informed to report to sick call daily for dressing changes, along with a follow up to observe any changes in the lesion.

VAERS ID:325966 (history)  Vaccinated:2008-09-08
Age:18.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-10, Days after onset: 2
Location:North Carolina  Entered:2008-09-24, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: Gallbladder surgery 3 months
Diagnostic Lab Data: N/A
CDC Split Type: NC08099
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0571X2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Fatigue, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Received telephone call from patient''s mother 4:30 pm 9/08/08. Reports patient received #3 HPV injection this am at 8:30 am - since receiving injection, patient with complaints of feeling "light headed, dizzy and tired". Also complaints of pain to arm - Enc M.D. follow up: immediately.

VAERS ID:326306 (history)  Vaccinated:2008-09-08
Age:52.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-26, Days after onset: 18
Location:Colorado  Entered:2008-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Temazepam
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DPP: DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Emotional distress
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Three or so hours after taking the pill I begin to cry uncontrollably. I remain emotional and defensive throughout the two days between pills.

VAERS ID:326348 (history)  Vaccinated:2008-09-08
Age:60.0  Onset:2008-09-12, Days after vaccination: 4
Gender:Female  Submitted:2008-09-26, Days after onset: 14
Location:Pennsylvania  Entered:2008-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0409X0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Headache and site of injection is red and hard.

VAERS ID:326416 (history)  Vaccinated:2008-09-08
Age:1.1  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-09-10, Days after onset: 2
Location:Texas  Entered:2008-09-29, Days after submission: 19
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2757AA0IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSB245AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0931X0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC457243IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0999X0SCLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Varicella vaccine was given in left anterior thigh. Immediately following the vaccine the patients leg appeared very red with welts measuring about 2 inches. no systemic signs. Observed patient for 30 mins in office and applied cold compress for 8 minutes.

VAERS ID:326547 (history)  Vaccinated:2008-09-08
Age:2.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-26, Days after onset: 17
Location:Washington  Entered:2008-09-30, 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: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER 3UNRL
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRL
Administered by: Private     Purchased by: Other
Symptoms: Gait disturbance, Injection site swelling, Injection site warmth
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 1 1/2 days after shots, noticed severe swelling in leg that shots were given. Swelling was from top of thigh to below the knee. Difficulty walking due to severe swelling. Gave her tylenol and used ice. Leg was hot at the knee.

VAERS ID:326879 (history)  Vaccinated:2008-09-08
Age:61.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-10-02, Days after onset: 24
Location:Georgia  Entered:2008-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: Anemia 2 diverticular dz., Fibroids Uterus
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2824AA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain upper, Influenza like illness, Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site warmth, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received ADACEL on 9-8-08 in LA - We received a TC from Pt''s husband on 9-11-08 AM. With Pt c/o local Rx at inject site - warm red swollen - also pt with mild fever and stomach hurting. Pt subsequently came in for O.V. on 9-12-08 and was diagnosed with severe reaction to ADACEL 10+ cm of Erythema, central induration, blister, flu like Sx. - Rx Pred-

VAERS ID:327057 (history)  Vaccinated:2008-09-08
Age:1.3  Onset:2008-09-19, Days after vaccination: 11
Gender:Female  Submitted:2008-10-03, Days after onset: 14
Location:Connecticut  Entered:2008-10-03
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC990803UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0135X0UNLL
Administered by: Private     Purchased by: Unknown
Symptoms: Rash morbilliform
SMQs:, Hypersensitivity (narrow)
Write-up: Measles Rash

VAERS ID:327684 (history)  Vaccinated:2008-09-08
Age:4.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-08, Days after onset: 0
Location:Idaho  Entered:2008-10-09, Days after submission: 31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: ID08034
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA092330IMLL
Administered by: Public     Purchased by: Unknown
Symptoms: Dysphagia, Oropharyngeal pain, Pharyngeal erythema, Pharyngeal oedema, Pharyngitis, Throat irritation
SMQs:, Agranulocytosis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow)
Write-up: Possible swelling and redness of pharynx see nurses notes. Approximately 10 minutes after receiving TYPHOID injection, child was in restroom with parent reporting "Fuzzy" Throat and difficulty swallowing; "It hurt a little bit". Child had rec''d a portion of juice after the injection with her sticker. Parent reports child has had a banana allergy when very small girl but she grew out of it. "Examined pharynx with Light in clinic; significant erythema and mild swelling noted. No difficulty swallowing cool water after exam. Child acting normally. Skin warm and dry, no pallor. No SOB. Assessment: Likely has mild pharyngitis which may have been exacerbated by the juice. Will complete VAERS regardless. Left clinic about 30 minutes after injection with parent without incident.

VAERS ID:329729 (history)  Vaccinated:2008-09-08
Age:24.0  Onset:2008-09-15, Days after vaccination: 7
Gender:Female  Submitted:2008-10-14, Days after onset: 29
Location:New York  Entered:2008-10-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOVIA
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA03931
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0152X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 24 year old female who on 08-SEP-2008 was vaccinated with a first dose of GARDASIL (lot # 0152X). Concomitant therapy included ZOVIA. On 15-SEP-2008 the patient experienced a rash on her face. The patient did not seek medical attention but was told to take BENADRYL for the rash. There was no lab test. No further information was provided. Additional information has been requested.

VAERS ID:330659 (history)  Vaccinated:2008-09-08
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-14
Location:Unknown  Entered:2008-10-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA04689
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0573X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Limb discomfort, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a nurse concerning a 25 year old female who on 08-SEP-2008 was vaccinated with her first dose of GARDASIL (LOT#: 0573X) 0.5mL intramuscularly. Subsequently the patient experienced a severe pain and discomfort in the whole arm that the injection was given in. No treatment requirement. The patient''s injection site severe pain and discomfort in the whole arm persisted. The patient sought medical attention in the office on 26-SEP-2008 with continued pain. Additional information has been requested.

VAERS ID:329304 (history)  Vaccinated:2008-09-08
Age:0.5  Onset:2008-10-06, Days after vaccination: 28
Gender:Female  Submitted:2008-10-10, Days after onset: 4
Location:Massachusetts  Entered:2008-10-21, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild congestion
Preexisting Conditions: None. PMH: eczema.
Diagnostic Lab Data: Abdominal ultrasound. Labs and Diagnostics: Abd X-ray abnormal. US (+) for extensive ileocolic IS. Air contrast enema (+) for IS.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B142AA2IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF472AB2IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC504572IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0692X2PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal X-ray, Abdominal pain, Barium double contrast, Barium enema abnormal, Crying, Diarrhoea haemorrhagic, Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: Intussusception with vomiting, abdominal pain and bloody stool. Treated with air-enema. 11/05/2008 MR received for DOS 10/7-8/2008 with D/C DX: Intussusception. Pt presented with 1 day hx of vomiting, bloody diarrhea, and episodic abdominal pain with crying. Ileocolic IS noted on US and tx with Air contrast enema which successfully reduced the IS. Observed o/n and d/c next day.

VAERS ID:329524 (history)  Vaccinated:2008-09-08
Age:26.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 36
Location:Unknown  Entered:2008-10-21, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SEASONALE; CLARITIN
Current Illness: Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA02657
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Head injury, Nuclear magnetic resonance imaging, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a registered nurse concerning a 26 year old female with sulfonamide allergy who on 08-SEP-2008 was vaccinated IM with the second 0.5ml dose of GARDASIL (lot #: 660555/0279X). Concomitant therapy included CLARITIN and SEASONALE. On 08-SEP-2008 the patient fainted and hit her head after she received the second dose of GARDASIL. The patient was still at the physician''s office when she fainted and received unspecified medical attention. The date of administration and the lot number for the first dose was unspecified. Magnetic resonance imaging was performed, the result was not reported. No further information is available.

VAERS ID:330656 (history)  Vaccinated:2008-09-08
Age:25.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 36
Location:New York  Entered:2008-10-30, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dysplasia
Preexisting Conditions: Hernia
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA04665
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0573X0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a registered nurse concerning a female with a history of hernia and no drug allergies reported who on 08-Sep-2008 was vaccinated with the first dose of GARDASIL (lot # 0573X), 0.5 mL, IM. There was no concomitant medication. On 08-Sep-2008, after vaccination, the patient experienced pain at injection site. On around 12-Sep-2008, the patient developed shoulder pain. At the time of the report, on 26-Sep-2008, the patient was having constant pain on right arm. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/14/2008; 1/7/2009. Follow-up information has been received from a registered nurse concerning a 25 year old female with mild dysplasia and a history of hernia and no known allergies who on 08-SEP-2008 at 5:18 p.m. was vaccinated intramuscularly in the right deltoid with a 0.5 ml first dose of GARDASIL . There was no concomitant medication. The nurse reported that the adverse events resolved on their own. No further information is available.

VAERS ID:331613 (history)  Vaccinated:2008-09-08
Age:40.0  Onset:2008-09-12, Days after vaccination: 4
Gender:Female  Submitted:2008-10-28, Days after onset: 46
Location:Illinois  Entered:2008-11-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was not taking any concomitant medication at the time of vaccination with FLULAVAL.
Diagnostic Lab Data: UNK
CDC Split Type: A0748898A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA171AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of arm pain in a female subject aged between 40 and 49 year old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 08 September 2008, the subject received unspecified dose of FLULAVAL (.5 unknown, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced severe arm pain and presented to the emergency room for treatment, where she was prescribed prednisone at 40 mg for five days, vicodin and antibiotics. The subject was seen for follow-up at the physician''s office on 15 September 2008, when she informed the reporting nurse of the event. The subject told the nurse that she did not know why she was prescribed the antibiotics. At the time of reporting, the event was improved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. Follow-up information received on 07 October 2008 indicated that the subject was 40 year old at the time of events. FLULAVAL was administered in an unknown arm. On 12 September 2008, the subject experience arm pain and had swelling. She was treated with Prednisone, Vicodin and Keflex. The events resolved. In the reporter''s opinion, the events were possibly related to treatment with FLULAVAL.

VAERS ID:331385 (history)  Vaccinated:2008-09-08
Age:48.0  Onset:2008-09-20, Days after vaccination: 12
Gender:Male  Submitted:2008-10-23, Days after onset: 33
Location:Pennsylvania  Entered:2008-11-05, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0452X0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia
SMQs:, Arthritis (broad)
Write-up: Patient received MMR vaccine on 9/8/08. 2 weeks later patient began experiencing joint pain in his left ankle and left knee. The pain is intermittent but continues.

VAERS ID:331898 (history)  Vaccinated:2008-09-08
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2008-11-10
Location:Massachusetts  Entered:2008-11-10
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Immunizations given only 1 month after the first dose.

VAERS ID:331899 (history)  Vaccinated:2008-09-08
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2008-11-10
Location:Massachusetts  Entered:2008-11-10
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Vaccine administered only 1 month after the first dose. Contacted the CDC and after realizing and told that 2''nd dose would be invalid.

VAERS ID:332131 (history)  Vaccinated:2008-09-08
Age:5.0  Onset:2008-10-06, Days after vaccination: 28
Gender:Female  Submitted:2008-11-12, Days after onset: 37
Location:Louisiana  Entered:2008-11-12
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? Yes
Previous Vaccinations: fever~ ()~~5~In Patient
Other Medications:
Current Illness: None 1/20/09-records received-Presented to ED with C/O vomiting and cough ten days prior. Hospitalized 9/26-9/29/08 with DX of
Preexisting Conditions:
Diagnostic Lab Data: The first doctor/hospitalization was pneumonia. The second doctor/hospitalization was a lung infection. 1/20/09-records received-O2 saturation 88-90%. CBC WNL. Chest x-ray negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B064AA0UNUN
HEP: HEP B (FOREIGN)MERCK & CO. INC.1714U1UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF400AA0UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0836   
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.047X0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bronchial hyperreactivity, Chest X-ray normal, Dehydration, Dyspnoea, Full blood count normal, Hypoxia, Intensive care, Lethargy, Pyrexia, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Patient had an appointment to get immunized by Dr. for the first time. A total of six shots were administered to patient on 09/08/2008. After approximately two weeks patient was taken to her family doctor and diagnosed with pneumonia. She was hospitalized for 4 days. Ater two days of being released she had a relapse. She was taken to back to the Hospital and immediately put into ICU. She stayed in ICU for about 3 days. She was then allowed to move to a private room. She was diagnosed with a bad lung infection by her pediatrician that admitted. She was leased within 2 days after coming out of ICU. On November 4th patient developed a high fever(104) and was taken to her family doctor because i(mom) was out of town at the moment. She was again put on Antibiotics and is still on that medication. She was scheduled to return to her pediatrician on 11/07/08 to follow up on six more shots. The school nurse then put her out of school because she''s not up to date on her shots. She now has an appointment on 11/13/08. i am very concerned about her taking so many shots in so little time. Her immune system is so low that she can''t stay well enough to stay in school for at least a week. Now they want to give her more shots. I don''t feel comfortable with that and i will try to fight it off as much as i can. I don''t want to gamble with my child''s life just so she can catch up with her shots and stay in school. I''ll home school her if i have to. I almost lost her once, i don''t want her to be put in that situation again. 1/20/09-records received for DOS 10/6/10/908-DC DX: Respiratory distress, resolved. Hypoxia, resolved. Reactive airway disease. Vomiting, resolved. Dehydration, resolved. Day prior to admission developed difficulty breathing, shortness of breath, vomiting, lethargy with fever of 104.

VAERS ID:332420 (history)  Vaccinated:2008-09-08
Age:33.0  Onset:2008-09-17, Days after vaccination: 9
Gender:Female  Submitted:2008-11-14, Days after onset: 58
Location:Virginia  Entered:2008-11-14
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0481X0SCLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2078AC0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: On September 8, 2008, client received Td and MMR. Screening question regarding possibility of pregnancy was answered no by client. Prior to administration of vaccine, client was asked if there was any chance she was pregnant, client answered, no. Was explained she should not be pregnant and receive the vaccine nor should she become pregnant for 4 weeks after receiving the vaccine. Client stated agreement to information, and was also provided with MMR and Td VIS statements prior to vaccinating. Client returned to HD for another appointment on Sept. 17, 2008. During that visit, she stated to the nurse she thought she was pregnant. Further inguiry found that clients LMP was 8/9/2008, she states her menses is the following month and two days past previous LMP date. Client states she believes her next menses should have started on 9/6/2008 and she believes she is 11 days past that due date. States uses condoms, but did not use a condom one time. Pregnancy test performed with positive results. Referred client to OB Department with written information regarding receipt of MMR and instructions for client to discuss this with OB physician.

VAERS ID:332432 (history)  Vaccinated:2008-09-08
Age:0.2  Onset:2008-09-19, Days after vaccination: 11
Gender:Female  Submitted:2008-11-14, Days after onset: 56
Location:Georgia  Entered:2008-11-14
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: Sternomastoid hematoma, torticollis
Diagnostic Lab Data: PT,PTT normal.CBC with WBC 20,000, increase in lymphs. In office, WBC repeated- platlets 537.K/uL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2958AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02980IMRL
Administered by: Private     Purchased by: Private
Symptoms: Lymphocyte count increased, Platelet count increased, Prothrombin level normal, Prothrombin time normal, Purpura, White blood cell count increased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad)
Write-up: Non-blanching rash on leg- looks slightly purpuric. Afebrile. CBC,PT,PTT Followed up in office in am. WBC repeated Sustained elevated platlet count requiring hemotology visits- to be rechecked in 3 months

VAERS ID:334961 (history)  Vaccinated:2008-09-08
Age:13.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-11-14, Days after onset: 66
Location:Arizona  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA05139
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Information has been received from physician concerning a 13 year old female patient with asthma who on 08-SEP-2008 was vaccinated with the first dose of GARDASIL vaccine (site and route not reported). No other vaccines were administered at this time. On 9-SEP-2008, the day after she received the vaccine, the patient went to the physician''s office due to was the mother felt was an asthma attack. The patient was treated with levalbuterol and Orapred. The patient was not hospitalized. Additional information has been requested. Follow up information was received from a nurse who reported that they can not find any information about the patient. No further information is available.

VAERS ID:334976 (history)  Vaccinated:2008-09-08
Age:14.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 67
Location:Connecticut  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA05349
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 14 year old female who on 08-SEP-2008 was vaccinated with GARDASIL vaccine 0.5ml. Second suspect therapy included VAQTA vaccine (inactive) (manufacture unknown) which was vaccinated at the same time. On 08-SEP-2008 the patient experienced syncope. The patient sought unspecified medical attention. On the same day, the patient recovered. Additional information has been requested

VAERS ID:333166 (history)  Vaccinated:2008-09-08
Age:0.8  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-11-24, Days after onset: 77
Location:Illinois  Entered:2008-11-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Known
Preexisting Conditions: None Known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B150AA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF472AB1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC504571IMRL
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: According to mother''s report, Navontae ran a fever for 5 days after his second Pediarix. Mom would give Tylenol but the temperature kept going back up until it was 105. At that point Mom took the baby to the ER. Motrin given and fever came down.

VAERS ID:333265 (history)  Vaccinated:2008-09-08
Age:49.0  Onset:2008-09-10, Days after vaccination: 2
Gender:Male  Submitted:2008-11-25, Days after onset: 76
Location:Illinois  Entered:2008-11-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; PREDNISONE, since 9/08; VICODIN, for pain; MVI; ZYRTEC
Current Illness: Injured right finger nail
Preexisting Conditions: Asthma
Diagnostic Lab Data: C reactive protein; CPK; ANA; CMP; ESR; ALDOSE; autoimmune profile, anti smooth muscle, AB; Antimitochondrial AB; component CB, 34; EKG; chest CT; persatine stress test
CDC Split Type:
Vaccination
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2749AA0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Aldolase, Anaphylactic reaction, Antimitochondrial antibody, Antinuclear antibody, Asthenia, Blood creatine phosphokinase, C-reactive protein, Cardiac stress test, Chest pain, Computerised tomogram, Electrocardiogram, Injection site pain, Metabolic function test, Musculoskeletal pain, Pain, Red blood cell sedimentation rate, Smooth muscle antibody
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: 09/10/2008 Pain in injection area, increasing left shoulder pain 09/17/2008, left shoulder/chest pain. 9/26/2008 Anaphactic reaction all over body pain, weakness. 10/08 all over body pain/weakness, chest pain. 11/08 all over body pain/weakness and still has chest pain.

VAERS ID:333926 (history)  Vaccinated:2008-09-08
Age:28.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-12-03, Days after onset: 85
Location:Washington  Entered:2008-12-04, 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: Birth Control Pills
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURUF452AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: Received ADACEL. Injection was given high on L shoulder near joint. Had worsening pain and limited range of motion for a week after the injection before it slowly began to improve. Now, 3 months later there is still residual pain in the L shoulder when certain movements.

VAERS ID:336231 (history)  Vaccinated:2008-09-08
Age:13.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-12-29, Days after onset: 112
Location:Indiana  Entered:2008-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Asthma-does not take medication
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2686AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B029AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Flushing, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Pt described itching ears and had slight flushing of skin on chest area. Benadryl given and symptoms resolved. Symptoms developed 33 mins after vaccine given. Symptoms resolved within 30 minutes.

VAERS ID:336298 (history)  Vaccinated:2008-09-08
Age:66.0  Onset:2008-09-11, Days after vaccination: 3
Gender:Male  Submitted:2008-12-31, Days after onset: 111
Location:California  Entered:2008-12-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Please see/poll Hospitals for periods described above, from 09/08/2008 thorugh November 2008.
CDC Split Type:
Vaccination
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.UNKNOWN0UNRA
Administered by: Military     Purchased by: Military
Symptoms: Abdominal pain, Laboratory test normal, Muscle spasms, Nausea, Renal pain, Ultrasound scan normal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Received Zostavax shingles vax on 09/08/2008 in loose fatty tissue of RIGHT arm under tricep. Within two days onset of spasms in lower back, symmetrically in muscles adjacent to Left and Right side of spine immediately above belt line (waist) and just below rib cage. Spasms increased in pain to 8-10 level (10 pt. max.) over ensuing week. Pain spread throughout RIGHT side of back and throughout right side of abdomen, especially in (R) rear kidney area. 09/18/2008 severe pain plus nausea necessitate visit to ER. Interviews plus tests with personnel result in prescribing some muscle relaxers plus advice to take Ibuprofen. Arrange with PCP to take more lab tests in mid Oct. 2008 and visit in late Oct. 2008. Dr''s examination concludes not shingles. "Try & see" for one month. Lower back spasms ebb away very slowly over period late Oct. to early Nov. 2008, but abdominal and kidney pain persist. Though kidney pain ebbs slowly away, abdominal pain persists at 3-5 level and PCP Dr. orders more lab tests and ultrasound exam in early Nov. Test results normal, but as of this report still have persistent RIGHT front abdominal pain. Conclusion: This is a VERY UNUSUAL first time experience for patient. Patient questions proximity of problems to shingles vax, "RIGHT" sidedness of everything (shot location and ensuing problems). Requests examination of still ongoing episode.

VAERS ID:339975 (history)  Vaccinated:2008-09-08
Age:0.5  Onset:2008-11-20, Days after vaccination: 73
Gender:Female  Submitted:2009-02-12, Days after onset: 84
Location:Texas  Entered:2009-02-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Sun
Diagnostic Lab Data: Rotazyme
CDC Split Type:
Vaccination
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RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1231F2PO 
Administered by: Private     Purchased by: Other
Symptoms: Rotavirus infection, Rotavirus test
SMQs:
Write-up: Patient was diagnosed with rotavirus after receiving vaccination series.

VAERS ID:345393 (history)  Vaccinated:2008-09-08
Age:0.2  Onset:2008-09-12, Days after vaccination: 4
Gender:Male  Submitted:2009-04-10, Days after onset: 210
Location:Unknown  Entered:2009-04-24, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: None Provided.
CDC Split Type: USWYEH06035908
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH0940970IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who experienced urticaria on both legs. At 2 months of age, the patient received the first dose on 08-Sep-2008. The patient also received a dose of DTaP on 08-Sep-2008. Additional suspect medication included ROTATEQ, IPOL, and Hib. The patient experienced urticaria on both legs on 12-Sep-2008. Prednisone was prescribed but the mother did not use the drug. The patient recovered. No additional information was available at the time of this report.

VAERS ID:344938 (history)  Vaccinated:2008-09-08
Age:22.0  Onset:2008-12-01, Days after vaccination: 84
Gender:Female  Submitted:2009-04-27, Days after onset: 146
Location:Michigan  Entered:2009-04-27
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: pentoxifllyne,
Current Illness:
Preexisting Conditions: PMH: scoliosis. tonsillectomy
Diagnostic Lab Data: positive anti nuclear antibody blood test. Labs: ANA 1:640. RF (-). Anti-DNA (-). Echo WNL. CXR WNL. US R LE (-) for DVT.
CDC Split Type:
Vaccination
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0546X1UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Activities of daily living impaired, Alopecia, Amnesia, Anti-cyclic citrullinated peptide antibody, Antinuclear antibody positive, Anxiety, Aphthous stomatitis, Arthralgia, Arthritis reactive, Asthenia, Autoimmune disorder, Balance disorder, Chest X-ray normal, Cognitive disorder, Cyanosis, DNA antibody negative, Disturbance in attention, Dizziness, Dyspnoea, Echocardiogram normal, Fatigue, Fibromyalgia, Flushing, Headache, Hyperhidrosis, Hypoaesthesia, Insomnia, Musculoskeletal chest pain, Musculoskeletal stiffness, Myalgia, Pain, Peripheral coldness, Presyncope, Raynaud's phenomenon, Scab, Somnolence, Ultrasound scan normal, Vision blurred, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (narrow)
Write-up: autoimmune disease fibromyalgia, raynods, numbness, flushing/sweats, anxiety,headaches, exhaustion to the point where its impossible to work, total body pain constantly,hair loss, vision problems,stiff and sore muscles,insomnia, trouble focusing and concentrating, memory loss, weakness, trouble breathing,and dizziness near syncope. All the side effects happened and intensified during December through January so I had an anti nuclear antibody blood test that was positive revealing the autoimmune disease fibromyalgia and raynods. My ANA blood test has come back positive several times. The doctors put me through a ridiculous amount of tests to try to figure out a diagnosis and why this had come out of nowhere. They thought I had at one point every different type of autoimmune disease including lupus but settled on FIbromyalgia with raynods and the possible beginnings of Lupus. I have to frequent a rheumatologist, neurologist,and primary care doctor several times a month. The side effects have made me very weak and unable to live my life normally, its hard for me to work. I teach children which take a lot of energy when I have none what so ever. I used to be strong and able to work out and ride horses and live a healthy active lifestyle, now I cannot enjoy any of it. My body is in such pain all the time that its impossible for me to have a normal life. I wanted this vaccine to help prevent problems, when all it did was destroy my life. 5/18/09 Vax info received. HPV#1 7/7/08 0847X. HPV#2 9/8/08 0546X. HPV#3 1/7/09 0546X. 7/15/09 Rheumatology consult rec''d dated 1/29/09 to 6/8/09 with final dx: Inflammatory arthritis, arthralgias. Pt presented with c/o numbness and bluish discoloration of the feet. Pt also has a blackish scab on the R 3rd toe. Pt reports feeling achy all over. PE (+) for cold fingers and toes and bluish discoloration of toes. (+) fibromyalgia tender points. Assess: Raynaud''s. ANA (+). Scoliosis. Possible fibromyalgia. F/U 3/5/09 with dx: fibromyalgia. Pt reporting poor sleep

VAERS ID:347126 (history)  Vaccinated:2008-09-08
Age:4.0  Onset:2009-02-04, Days after vaccination: 149
Gender:Female  Submitted:2009-05-15, Days after onset: 99
Location:Pennsylvania  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0902USA01026
Vaccination
Manufacturer
Lot
Dose
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Exposure to communicable disease, Pyrexia, Skin lesion, Varicella
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Information has been received from a registered nurse concerning a 4 year old female with no known medical history and drugs allergies, who on 08-SEP-2005 was vaccinated with a dose of VARIVAX (Merck), subcutaneous. There was no concomitant medication. The patient was exposed to a person who had shingles two weeks ago. On 04-FEB-2009 the patient developed chicken pox. The patient had a fever from 04-FEB-2009 to 05-FEB-2009. The patient was seen on 05-FEB-2009 and it was reported that the patient had about 30 chicken pox lesions scattered on her face and upper torso. The patient was seen again on 06-FEB-2009 for follow up and the nurse mentioned that the patient had more lesions. No laboratories studies performed. The patient sought medical attention through an office visit. At the time of this report that patient had not recovered. Additional information has been requested. Follow up information received on 26-MAR-2009 from the registered nurse stated that it was a student patient with no known medical history and illness at the time of vaccination. The patient received a second dose of VARIVAX (lot # 647958/0068R), subcutaneoulsy into the left arm on 08-SEP-2005. On 04-FEB-2009 at 09:00 the patient developed more than 30 viscles and fever but the reporter stated that this was not an adverse event since the patient was exposed to shingles 2 weeks priot the vaccination. No laboratorties studies performed. The patient required emergency room visit/doctor visit. The patient recovered on 09-FEB-2009. No further information is available.

VAERS ID:347405 (history)  Vaccinated:2008-09-08
Age:12.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2009-05-15, Days after onset: 248
Location:New Jersey  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA02115
Vaccination
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0996X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a license practical nurse concerning a 12 year old female who on 08-SEP-2008 received the second dose of VARIVAX (Merck) (Lot#661562/0996X) SQ in left arm and the first dose of MENACTRA (Lot#U2726AA) IM in right arm. On 09-SEP-2008 the patient experienced redness and swelling at injection site of VARIVAX (Merck). At the time of report on 13-OCT-2008, the patient had recovered. Additional information has been requested.

VAERS ID:347697 (history)  Vaccinated:2008-09-08
Age:5.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Male  Submitted:2009-05-15, Days after onset: 248
Location:Florida  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA01575
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA049143SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0430X1SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Initial and follow-up information has been received from a physician concerning a 5 year old male patient (birth weight was 7 pounds, 11 ounces) with allergy to AMOXIL who was previously vaccinated on 05-AUG-2008 with the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), Lot number 659704/0667, intramuscularly into the right thigh and fifth dose of DAPTACEL, Lot number C29343A, intramuscularly into the left thigh. On 08-SEP-2008, was vaccinated with the second dose of VARIVAX vaccine (Oka/Merck), Lot # 660671/0403X, 0.5 mL, subcutaneously into the right thigh and a fourth dose of IPOL (previously reported as poliovirus vaccine, unspecified), Lot number A04914, subcutaneously into the left thigh. On 08-SEP-2008 the patient experienced hives and redness after receiving the second dose of VARIVAX vaccine (Oka/Merck). The patient experienced the hives shortly after receiving the dose followed by redness in the area as the hives resolved. The lot number for the first dose was not available. In follow-up information the physician reported that the patient had no hives and the patient recovered from redness at site of VARIVAX vaccine (Oka/Merck) injection. Additional information is not expected.

VAERS ID:347702 (history)  Vaccinated:2008-09-08
Age:15.0  Onset:2008-09-10, Days after vaccination: 2
Gender:Male  Submitted:2009-05-15, Days after onset: 247
Location:Pennsylvania  Entered:2009-05-21, 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: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA01745
Vaccination
Manufacturer
Lot
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1903U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a pharmacist concerning a 15 year old male patient with AMOXICILLIN allergy who on 08-SEP-2008 was vaccinated with VARIVAX (Oka/Merck) (lot number 659603/1903U, site and route not reported) at a clinic associated with the hospital. Subsequently, two days after the vaccination, the patient''s parent called to report the injection site reaction which was described as swelling and warmth at the injection site that involved the whole upper arm. The area was warm to touch, but the patient did not have a fever. There was no other information. The patient sought medical attention. The patient sought medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Further information has been requested.

VAERS ID:353675 (history)  Vaccinated:2008-09-08
Age:65.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Male  Submitted:2009-07-30, Days after onset: 324
Location:Florida  Entered:2009-08-06, 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: Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA01945
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1960U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a consumer concerning her 65 year old husband with an allergic reaction to sulfa drugs and no pertinent medical history who on 08-SEP-2008 was vaccinated IM with PNEUMOVAX (lot # 659487/1960U) 0.5mL/single dose. Concomitant therapy included influenza virus vaccine (unspecified). On 09-SEP-2008 the patient developed a "streaking rash" that went around both arms and on the skin of his testicles after receiving PNEUMOVAX. The patient sought unspecified medical attention. The reporter had no additional information. At the time of the report the patient had not recovered from "streaking rash" that went around both arms and on the skin of his testicles. Additional information has been requested.

VAERS ID:354171 (history)  Vaccinated:2008-09-08
Age:53.0  Onset:0000-00-00
Gender:Female  Submitted:2009-07-30
Location:Maryland  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Diabetes; Convulsion disorder; Chronic fatigue syndrome; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0812USA01763
Vaccination
Manufacturer
Lot
Dose
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0224X IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site reaction, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a certified medical assistant concerning a 53 year old female patient with diabetes, seizure disorder, chronic fatigue syndrome, DEPAKOTE, DILANTIN and PROVIGIL; who on 08-SEP-2008 was vaccinated intramuscularly with one dose of PNEUMOVAX (Lot # 660717/0224X). Subsequently, the patient experienced an injection site reaction. The area was swollen, red and painful. The patient sought medical attention. On an unspecified date, the patient had recovered. This is one of two cases from the same source. Additional information has been requested.

VAERS ID:355153 (history)  Vaccinated:2008-09-08
Age:9.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Male  Submitted:2008-11-06, Days after onset: 58
Location:Pennsylvania  Entered:2009-08-13, Days after submission: 279
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOCALIN XR
Current Illness: ADD; 2) Constipation
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, ??/??/08, normal; Stool analysis, ??/??/08
CDC Split Type: MEDI0007168
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500544P IN 
Administered by: Private     Purchased by: Private
Symptoms: Abdominal X-ray, Abdominal pain, Diarrhoea, Stool analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: A serious report of vomiting, diarrhea, and abdominal pain has been received from a physician and a consumer (patient''s mother) concerning a nine-year-old male subsequent to FLUMIST. Concomitant medications included dexmethylphenidate hydrochloride for attention deficit disorder. The patient had a history of constipation. The patient was an otherwise healthy child and had no known allergies to food or medications. The patient received FLUMIST on 08-Sep-2008 for health maintenance. On 09-Sep-2008, the patient experienced vomiting, diarrhea, and abdominal pain. His symptoms were intermittent. The second episode occurred when he awoke on 13-Sep-2008 and the patient went to the physician''s office. The patient''s symptoms continued at least daily to every other day. He went to the doctor twice for treatment. An abdominal X-ray was normal. The physician reported stool testing was ordered but no results were available and questioned if the patient did not go for the testing. On 17-Oct-2008, the patient had another episode of vomiting, diarrhea, and abdominal pain. Three or four days after that, the patient had another episode of vomiting, diarrhea, and abdominal pain. Both times the patient had eaten something "that had egg proteins in it like a muffin" during the day and experienced the episodes in the middle of that night. The patient did not have an egg allergy. In between episodes, the patient was "fine". On 05-Nov-2008, the patient was seen by a general pediatrician in a different medical center. The pediatrician did not perform any testing because he indicated that patient previously had a normal abdominal X-ray. He also reported that the patient had a history of constipation and thought his symptoms might be related to constipation. As of 05-Nov-2008 when he saw the general pediatrician, the patient''s episodes were occurring "far less frequently". The physician indicated the vomiting, diarrhea, and abdominal pain were considered serious (important medical event) due to frequent school absences. Additional informat

VAERS ID:357569 (history)  Vaccinated:2008-09-08
Age:1.1  Onset:2008-09-10, Days after vaccination: 2
Gender:Unknown  Submitted:2009-09-17, Days after onset: 372
Location:Michigan  Entered:2009-09-17
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: none
CDC Split Type:
Vaccination
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Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0620Y4SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHD871853IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0997Y0SCRL
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: slight rash and low fever.

VAERS ID:380259 (history)  Vaccinated:2008-09-08
Age:32.0  Onset:2009-03-10, Days after vaccination: 183
Gender:Female  Submitted:2010-01-07, Days after onset: 303
Location:North Carolina  Entered:2010-01-27, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had no relevant medical history.
Diagnostic Lab Data: Hepatitis B surface antibody, 10Oct2008, 7.8; Hepatitis B surface antibody, 10Mar2009, 8.9
CDC Split Type: A0778220A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB584AA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Hepatitis B antibody positive, Inappropriate schedule of drug administration, Product quality issue, Therapeutic response decreased
SMQs:, Liver infections (narrow), Lack of efficacy/effect (narrow)
Write-up: This case was reported by a health care professional and described the occurrence of decreases therapeutic response in a 32-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. The subject had received two historical HEPATITIS vaccinations on 25 March 1997 and 13 May 1997 prior to coming to the reporter''s clinic. On 8 September 2008, 16 October 2008 and 12 February 2009 the subject received 1st dose, 2nd dose and 3rd of ENGERIX B (20 mcg/mL, left deltoid, left deltoid and right deltoid, respectively). On 10 October 2008, a titer was drawn which was negative at 7.8. On 12 February 2009, the subject experienced drug dose administration interval too short. On 10 March 2009, 26 days after vaccination which the third dose of ENGERIX B, the subject experienced decreased therapeutic response. On 10 March 2009, HEPATITIS B surface antibody was low at 8.9 mIU/mL. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot, and dose 3 from the same lot experienced this adverse event. The subjects received the doses on a 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but ws questioning the quality and content of the vaccines. This reporter felt strongly that that there was something potentially wrong with one of these vaccine lots because sc many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Please see A0778211A, A0778216A, A0778217A, and A0778218A. Follow-up information was received on 14 May 2009 from Quality Assurance. Per the Quality Assurance. Per the Quality Statement: ENGERIX vaccine lot numbers AHBVB703AA, AHBVB584AA and AHBVB670AA met the requirements of Quality Assurance''s specifications and the batches were suitable for vaccination purposes.

VAERS ID:388092 (history)  Vaccinated:2008-09-08
Age:28.0  Onset:0000-00-00
Gender:Female  Submitted:2010-05-14
Location:Unknown  Entered:2010-05-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0908USA03502
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Breast feeding, Drug exposure during pregnancy, Injection site haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from Merck Pregnancy Registry for VARIVAX (Merck) from a nurse practitioner concerning a 29 year old nursing mother with pertinent medical history reported as none and drug reactions or allergies reported as none who on 08-SEP-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously. On 18-AUG-2009 she received second dose of VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously. There was no concomitant medication. On 31-MAY-2009 the patient had a healthy infant. The patient was examined in the office on 20-AUG-2009 and was found to have a small Hematoma at the injection site of the left upper arm. There were no laboratories diagnostics studies performed. Additional information has been requested.

VAERS ID:325333 (history)  Vaccinated:2008-09-08
Age:  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-16, Days after onset: 8
Location:Foreign  Entered:2008-09-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Asthma; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809AUS00035
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0055X2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Anxiety, Feeling hot, Headache, Pharyngolaryngeal pain, Pruritus, Rash, Viral infection
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from the NSW via the agency concerning a school girl with asthma and penicillin allergy who on 08-SEP-2008 was vaccinated with the third dose of GARDASIL (Lot # 659659/0055x, Batch # K3031, Expiry date 06-AUG-2010). On 08-SEP-2008 the patient experienced anaphylactic reaction described as pruritus, feeling hot, rash, feeling of impending doom. It was reported that the student was treated at the school, then by the paramedics and was treated with 0.5 mL 1:1000 adrenaline. The patient recovered en route to the emergency room where she was also treated with prednisone but not admitted overnight. The patient was followed up around 09-SEP-2008 or 10-SEP-2008 and was still recovered however she had a sore throat and head. The patient''s physician considered that her subsequent sore throat and head were the result of a coincidental virus. The agency considered that anaphylactic reaction was related to therapy with GARDASIL. Upon internal medical review (epinephrine) adrenaline administration in the emergency room within 24 hours of vaccination was considered an other important medical event. Additional information is not expected.

VAERS ID:325334 (history)  Vaccinated:2008-09-08
Age:  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-16, Days after onset: 8
Location:Foreign  Entered:2008-09-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809AUS00038
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0055X2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Chest discomfort, Mass, Pain, Rash
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from the NSW Department of Health via the agency concerning a school girl who on 08-SEP-2008 was vaccinated with the third dose of GARDASIL (Lot # 659659/0055X, Batch # K3031, Expiry date 06-AUG-2010). On 08-SEP-2008 the patient experienced anaphylactic reaction described as rash, chest tightness, painful lump on chest. It was reported that the student was treated at the school, then by the paramedics and was treated with 0.5 mL 1:1000 adrenaline. Subsequently, the patient recovered from anaphylactic reaction en route to the emergency room but was not admitted overnight. The patient was followed up around 09-SEP-2008 or 10-SEP-2008 and had a rash and chest tightness. The patient was returned to the hospital emergency room and was treated with VENTOLIN, phenergan and TELFAST. The agency considered that anaphylactic reaction was related to therapy with GARDASIL. Upon internal medical review (epinephrine) adrenaline administration in the emergency room within 24 hours of vaccination was considered an other important medical event. Additional information is not expected.

VAERS ID:325335 (history)  Vaccinated:2008-09-08
Age:  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-16, Days after onset: 8
Location:Foreign  Entered:2008-09-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809AUS00039
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0055X2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Pharyngeal oedema, Swollen tongue, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Information has been received from the NSW Department of Health via the agency concerning a school girl who on 08-SEP-2008 was vaccinated with the third dose of GARDASIL (Lot # 659659/0055X, Batch # K3031, Expiry date 06-AUG-2010). On 08-SEP-2008 the patient experienced anaphylactic reaction described as felt faint, vomiting, throat swelling, tongue swelling and breathing difficulty. It was reported that the student was treated at the school, then by the paramedics and was treated with 0.5 mL 1:1000 adrenaline en route to the emergency room where she was also treated with prednisone but not admitted overnight. The patient was followed up around 09-SEP-2008 or 10-SEP-2008 and had recovered. The agency considered that anaphylactic reaction was related to therapy with GARDASIL. Upon internal medical review (epinephrine) adrenaline administration in the emergency room within 24 hours of vaccination was considered an other important medical event. Additional information is not expected.

VAERS ID:325482 (history)  Vaccinated:2008-09-08
Age:1.7  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-09-16, Days after onset: 7
Location:Foreign  Entered:2008-09-18, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Base excess, 09-Sep-2008, -2.4 mmol/L; Blood bicarbonate, 09-Sep-2008, 20.9 mmol/L; Blood pressure, 09-Sep-2008, 115/58 mmHg; Body height, 09-Sep-2008, 0.82 mm; Body temperature, 09-Sep-2008, rectal: 39.1 degrees C; C-reactive protein, 09-S
CDC Split Type: DEWYEG02152508
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21CA414A IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSA21CA414A IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA21CA414A IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA21CA414A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH323232IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Base excess decreased, Blood bicarbonate decreased, Blood electrolytes normal, Blood glucose normal, Body height, Body temperature increased, C-reactive protein normal, Culture throat, Differential white blood cell count, Ear, nose and throat examination abnormal, Eosinophil percentage, Fall, General physical health deterioration, Grand mal convulsion, Haemoglobin normal, Heart rate increased, Leukocytosis, Lymphocyte percentage, Microbiology test, Monocyte percentage decreased, Neutrophil percentage, Oxygen saturation normal, PCO2 increased, Platelet count increased, Pupil fixed, Pyrexia, Renal function test normal, Tremor, Unresponsive to stimuli, Urine analysis normal, Viral infection, Weight, White blood cell count increased, pH body fluid
SMQs:, Haematopoietic leukopenia (broad), Lactic acidosis (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), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 20-month-old female patient who experienced viral, shaking, fell over, fever, unresponsive to verbal stimuli, reduced general condition, fixed pupils, leukocytosis and tonic-clonic seizures. The patient received the third dose on 08-Sep-2008. The patient has no past history of seizure and no family history of epilepsy. Additional suspect medication included INFANRIX HEXA which was administered on the same day. Concomitant medications were not reported. On 09-Sep-2008, one day after vaccination the patient fell over while sitting and drinking the bottle. The patient had a fixed view and was unresponsive to verbal stimuli but she was not twitching and was neither stiff nor limp. Therefore the patient was hospitalized. The patient arrived at hospital with a reduced general condition, the patient was shaking and still unresponsive to verbal stimuli, reacted on manipulation with aimed defense and suffered from fever. The patient did not show any typical symptoms of meningococci infection or encephalitis. At hospital a tonic-clonic seizure with view deviation to top left was diagnosed. After receiving DIAZEPAM 5 mg (rectal) the patient recovered from grand-mal convulsion. Afterwards the patient was still shaking and the body temperature rectal was 39.1 degrees C. The patient did not show any neurological findings in the past and there was no family history of epilepsy. The patient also experienced leukocytosis. At hospital the patient did not experience another seizure and did not show any neurological complications. No focus was found, so that the reason for the seizure was a viral infection. The patient received an antipyretic treatment and was discharged from hospital on 11-Sep-2008 with a good general condition. On 09-Sep-2008 test results were: body temperature (results: rectal: 39.1 degrees C); microbiology test (results: smear of pharynx: results pending); weight (results: 13 kg); body height (results: 0.82 mm); heart rate (re

VAERS ID:326625 (history)  Vaccinated:2008-09-08
Age:0.2  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-30, Days after onset: 22
Location:Foreign  Entered:2008-10-01, 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: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG02237708
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR  IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Crying, Cyanosis, Hypotonia, Hypotonic-hyporesponsive episode, Injection site pain, Pallor, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 2-month-old female patient who experienced crying abnormal, pain injection site, cyanosis peripheral, apnoea and hypotonic-hyporesponsive episode. The patient received the second dose on 08-Sep-2008. Relevant medical history was not provided. Additional suspect medication included PEDIACEL. Concomitant medications were not reported. The patient experienced crying abnormal and pain injection site on 08-Sep-2008, about 18 hours after the vaccinations, the child experienced apnoea, cyanosis peripheral and hypotonic-hyporesponsive episode. She was pale, floppy and unresponsive. After being picked up, she regained some color and the hypotonia resolved. The child was hospitalised for 1 night for observation. The child has recovered. No additional information was available at the time of this report.

VAERS ID:328918 (history)  Vaccinated:2008-09-08
Age:3.0  Onset:2008-09-11, Days after vaccination: 3
Gender:Female  Submitted:2008-10-16, Days after onset: 35
Location:Foreign  Entered:2008-10-17, 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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA02396
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema multiforme, Musculoskeletal stiffness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from the health authority (ADR 20322501) concerning a 36 month old female with no medical history reported who on 08-SEP-2008 was vaccinated IM with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (manufacturer and batch number not reported). On 11-SEP-2008, three days post-vaccination, the patient experienced erythema multiforme rash over the torso, back, face, arms and thighs. The patient was also pyrexic, with neck stiffness and myalgia. At the time of reporting the patient was recovering. The reporter considered erythema multiforme, neck stiffness, myalgia and pyrexia to be other important medical events. Other business partner numbers include: E2008-09512. Additional information has been requested.

VAERS ID:333609 (history)  Vaccinated:2008-09-08
Age:5.0  Onset:2008-09-09, Days after vaccination: 1
Gender:Female  Submitted:2008-11-25, Days after onset: 77
Location:Foreign  Entered:2008-12-02, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Electroencephalogram, see text unit; Nuclear magnetic resonance imaging, normal unit
CDC Split Type: B0538377A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B063DH IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Electroencephalogram abnormal, Nuclear magnetic resonance imaging normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of convulsion in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMR (strain not specified; Sanofi Pasteur MSD; intramuscular) given on 8 September 2008. On 8 September 2008 the subject received unspecified dose of INFANRIX (intramuscular). ON 9 September 2008, 1 day after vaccination with INFANRIX, the subject experienced convulsion. The regulatory authority reported that the event was clinically significant (or requiring intervention). Relevant test results included normal nuclear magnetic resonance imaging and the electroencephalogram showed left posterior epileptic anomalies (very likely only functional). The subject was treated with DIAZEPAM. At the time of reporting the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with INFANRIX. After several attempts no further information could be obtained. Therefore on 24 November 2008 this case has been closed.

VAERS ID:342678 (history)  Vaccinated:2008-09-08
Age:35.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2009-03-25, Days after onset: 198
Location:Foreign  Entered:2009-03-25
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: ALLERGIES
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0565747A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB106AA2UNLA
Administered by: Other     Purchased by: Other
Symptoms: Hypersensitivity, Paraesthesia oral, Pharyngeal oedema, Pruritus, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (Medical Product Agency # 090712) and described the occurrence of allergic reaction in a 35-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). Subject with previously known allergies against animals with fur, grass, mugwort and stone-fruits. On 8 September 2008, the subject received 3rd dose of TWINRIX adult (unknown route of administration). On 8 September 2008, 5-10 minutes after vaccination with 3rd dose of TWINRIX adult, the subject experienced allergic reaction. She experienced feeling of swelling in the throat, tongue getting larger and also a tingling sensation in the lips. The subject experienced pruritus in face and back of the neck. Stable circulation. The subject was given 1ml adrenaline s.c during 5 minutes, Betametasone p.o and Cetirizine. The pruritus was decreased, tongue was more normal. Ambulance was called and the subject was transported to hospital for surveillance. The subject was hospitalised. At the time of reporting the events were resolved. The regulatory authority reported that the events were probably related to vaccination with TWINRIX adult.

VAERS ID:347212 (history)  Vaccinated:2008-09-08
Age:  Onset:0000-00-00
Gender:Male  Submitted:2009-05-22
Location:Foreign  Entered:2009-05-26, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Cow''s milk allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA02121
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Failure to thrive
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Information was obtained on request by the company from the agency via public case details form concerning a male patient with a possible cow''s milk protein allergy, who on 08-SEP-2008 and 05-NOV-2008 was vaccinated with a dose of ROTATEQ. Subsequently, the patient experienced diarrhoea and failure to thrive and was admitted to hospital. On an unspecified date, the patient recovered. The agency considered that the patient''s diarrhoea and failure to thrive were possibly related to therapy with ROTATEQ. The original reporting source was not provided. No further information is available.

VAERS ID:380750 (history)  Vaccinated:2008-09-08
Age:16.0  Onset:2008-09-08, Days after vaccination: 0
Gender:Female  Submitted:2010-02-17, Days after onset: 527
Location:Foreign  Entered:2010-02-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1002USA01872
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0583U1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Activities of daily living impaired, Amenorrhoea, Asthenia, Bedridden, Decreased activity, Fatigue, Gait disturbance, Headache, Hyperhidrosis, Malaise, Muscle fatigue, Muscular weakness, Myalgia, Post viral fatigue syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Fertility disorders (broad)
Write-up: Information was obtained on a request by the company from the agency via a Public Case Details form concerning a 16 year old female who on 08-SEP-2008 was vaccinated with a dose of GARDASIL (batch number J2896, lot number 657872/0583U). On 08-SEP-2008, after second dose of GARDASIL the patient experienced generalized muscular weakness, severe headache-could not participate in sports at school. The next 5-6 weeks the patient experienced severe and continual headaches, muscle pain and weakness to the extent that the patient had to be carried to the toilet and was bed-bound. The mother also reported that student did not menstruate at all in between her first and second dose of GARDASIL. The mother also commented that the student had noticed "that she was sweating a lot" between dose 1 and dose 2 of GARDASIL. On 03-JUN-2009 the patient was still unwell and was experiencing the same symptoms, (severe headaches, muscle fatigue, has difficulty walking due to weakness) and extreme fatigue. The patient had not been able to return to school as too unwell. The patient was hospitalized for 1 week under the care of immunologist who diagnosed the patient with "post viral fatigue". The patient had been referred to a clinic for ongoing reaction with a physiologist and psychologist. At the time of reporting on 21-SEP-2009, the patient had not recovered. The agency considered that muscular weakness, amenorrhoea, fatigue, headache and hyperhidrosis were possibly related to therapy with GARDASIL. The original reporting source was not provided. No further information is available.

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