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Case Details (Sorted by Vaccination Date)

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VAERS ID:298263 (history)  Vaccinated:2007-11-30
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-11-30
Location:Texas  Entered:2007-11-30
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.152240IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Patient given the HPV vaccine unaware at the time the patient was pregnant. No adverse reaction noted.

VAERS ID:298297 (history)  Vaccinated:2007-11-30
Age:20.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-11-30, Days after onset: 0
Location:Colorado  Entered:2007-12-01, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Dizziness, Fall, Headache, Hyperhidrosis, Hypoaesthesia, Immediate post-injection reaction, Loss of consciousness, Muscular weakness, Mydriasis, Nausea, Pain in extremity, Pallor, Sinus headache, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Vaccine given to me around 9:30 AM this morning, I felt a never-before-experienced strong sensation of the fluid entering and flowing down my arm. The nurse left room, within 30 seconds after shot there were strong pains throughout my arm followed by extreme dizziness and faintness. I struggled in the room for around five minutes to not pass out and fell on the floor once. I was experiencing extreme blacking out of vision and loss of consciousness. When I stumbled my way down the hall to the waiting room I collapsed in a chair and two nurses placed me in a wheelchair. I was sweating intensely, was very pale, and my pupils were completely dilated. The remainder of the day I experienced bad sinus pain that only occurred after the vaccine, a sharp headache, shakes and nausea. This evening I feel pressure in my head, am dizzy whenever I stand, my arm is still painful, weak and numb.

VAERS ID:298300 (history)  Vaccinated:2007-11-30
Age:14.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2007-12-01, Days after onset: 1
Location:Missouri  Entered:2007-12-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VICKS 44
Current Illness:
Preexisting Conditions: ASTHMA
Diagnostic Lab Data: asthma attack
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Asthma, Cough, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: difficulty breathing, wheezing, shortness of breath, coughing, asthma attack

VAERS ID:298306 (history)  Vaccinated:2007-11-30
Age:8.0  Onset:2007-12-02, Days after vaccination: 2
Gender:Male  Submitted:2007-12-02, Days after onset: 0
Location:California  Entered:2007-12-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: High fever (106)~Measles + Mumps + Rubella (no brand name)~2~5~In Patient
Other Medications: Nasonex, Pulmicort, Claritin
Current Illness: None
Preexisting Conditions: Asthma, frequent infections, previous meningitis at 5 days old.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Headache, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: High fever (103.6), headache, stomach ache.

VAERS ID:298480 (history)  Vaccinated:2007-11-30
Age:11.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2007-12-03, Days after onset: 3
Location:California  Entered:2007-12-03
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: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1258U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2409AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2690AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1474U1 RA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Gaze palsy, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Approximately 15 minutes after patient received 4 vaccines, patient had a 5 second "seizure-like" episode, eyes rolling back, head extremities shaking. Patient observed in office for 3 hours - recovered well at intervention. On 12/3/07, mom reported patient did well over the weekend at home.

VAERS ID:298505 (history)  Vaccinated:2007-11-30
Age:44.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-03, Days after onset: 3
Location:Connecticut  Entered:2007-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no - ill several weeks before vaccination, well at time of administration
Preexisting Conditions: Reports allergy to Hepatitis B Vaccine - severe systemic reaction in the past
Diagnostic Lab Data: none indicated
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS792413IMLA
Administered by: Military     Purchased by: Private
Symptoms: Immediate post-injection reaction, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hospital RN administered influenza vaccination Fluvirin o.5ml - states that she almost immediately developed hives which progressed, with pruritis - reported to Employee Health approx 1 hour later - escorted to Emergency Dept, received epinephrine, steroids, and pepcid - responded well, discharged several hours later to home.

VAERS ID:298678 (history)  Vaccinated:2007-11-30
Age:30.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-04, Days after onset: 4
Location:Texas  Entered:2007-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Orthotricycline Lo
Current Illness: None
Preexisting Conditions: AV node rentry Tachycardia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0723F0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC282CAA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: That evening around 9 or 10 Left arm started to get sore. Saturday morning from sorness to pain. Saturday evening "big, red whelp developed." Sunday morning at its worst, warm to the touch, limited ROM, could not raise arm above shoulder, red mark 6in by 4 in down arm from injection site down arm. Sunday evening not warm to the touch, limited ROM. Monday morning getting better. Red mark continuously fading until Tuesday. Full ROM on Tuesday. On Tuesday no paid only soreness can more arm fully.

VAERS ID:298685 (history)  Vaccinated:2007-11-30
Age:0.3  Onset:2007-12-02, Days after vaccination: 2
Gender:Male  Submitted:2007-12-04, Days after onset: 2
Location:South Carolina  Entered:2007-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: diarrheal illness followed by ear infection in right ear~Rotavirus (Rotateq)~NULL~0~In Patient
Other Medications: amoxicillin
Current Illness: left otitis media
Preexisting Conditions: none
Diagnostic Lab Data: Seen in the pediatricians office after first vaccination and related ear infection.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR    
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR    
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR    
PNC: PNEUMO (PREVNAR)PFIZER/WYETH    
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.    
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Ear infection, Injection site erythema, Injection site induration, Tympanic membrane perforation, Vaccine positive rechallenge, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Noninfectious diarrhoea (narrow)
Write-up: 1)Local reaction at injection site (redness, induration) measuring 2x1cm on right thigh, initially evident 24 hours post injection, increased size by 48 hours and then began to resolve (less red, still significant induration). The Dtap and Pneumococcal vaccine was given in this leg. No additional treatment was required. 2) Diarrheal illness following administration of second dose of rotatec (rotavirus vaccine). Symptoms began 48 hours post vaccination and were accompanied by severe vomiting x 12 hours. The vomiting required adjusting the volume and frequency of feedings to avoid dehydration. Diarrhea continues presently and we are 3 days into the symptoms; vaccine given 11/30/07 3) Diarrheal illness following the first administration of rota virus vaccine- occurred 5 days post administration and lasted 5 days; my son then developed an ear infection and perforated his tympanic membrane requiring 10 days of ciprodex drops and 10 days of amoxicillin

VAERS ID:298699 (history)  Vaccinated:2007-11-30
Age:34.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Female  Submitted:2007-12-04, Days after onset: 3
Location:Texas  Entered:2007-12-04
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
HEP: HEP B (FOREIGN)MERCK & CO. INC.0711U1IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB173AA1IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1030F1SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2770AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: LEFT ARM AROUND INJECTION SITE RED, SWOLLEN, WARM, PAINFUL.SHE HAD A PHYSICAL YESTERDAY AND THE DOCTOR ADVISED COOL COMPRESSES. I ADVISED HER TO DO THE SAME AND IF THE ARM SWELLS TO ELEVATE IT ON A PILLOW AND TAKE TYLENOL FOR PAIN ONE OR TWO TABLETS. IF SYMPTOMS BECOME WORSEN TO SEE HER PRIMARY CARE DOCTOR SUCH AS INCREASING PAIN,SWELLING,HEAT, WARMTH,REDNESS, DRAINAGE AND PUS AND A FOUL ODOR.

VAERS ID:298700 (history)  Vaccinated:2007-11-30
Age:43.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-04, Days after onset: 4
Location:Illinois  Entered:2007-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuva Ring
Current Illness: No
Preexisting Conditions: NKDA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0489U0IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0939U1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bradycardia, Dizziness, Hyperhidrosis, Injection site discomfort, Injection site erythema, Injection site nodule, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad)
Write-up: 11/30/07- At approx 1:16 pm- Hepatitis B vaccine was given in Left deltoid, within 1 minute a firm nodule was palpated at the injection site, the pt noted mild discomfort,and there was erythema noted at the location of the left deltoid. At approx 1:20 pm the Hepatitis A vaccine was given in the Right deltoid without discomfort, nodule noted, or erythema. At approx 1:21 pm the patient reported that she did not feel good and felt like she was going to pass out. The patient then leaned to the side in her chair. Pt did not loose consciousness, but became diaphoretic, hypotensive, and bradycardic. Epinephrine 0.3 mg was given and 911 was called. Pt responded to epinephrine within 5 min. Pt was taken to ER via ambulance for evaluation.

VAERS ID:298706 (history)  Vaccinated:2007-11-30
Age:19.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Female  Submitted:2007-12-04, Days after onset: 3
Location:Rhode Island  Entered:2007-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORAL CONTRACEPTIVE AND MULTIVITAMIN
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: CBC, ESR, BLOOD CULTURE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0388U2IMRA
Administered by: Private     Purchased by: Public
Symptoms: Blood culture, Discomfort, Erythema, Full blood count, Oedema peripheral, Red blood cell sedimentation rate
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: PATIENT DEVELOPED DIFFUSE SWELLING OF THE DELTOID WITH ONLY MINIMAL DISCOMFORT AND ERRYTHEMA.

VAERS ID:298778 (history)  Vaccinated:2007-11-30
Age:74.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-05, Days after onset: 5
Location:Maryland  Entered:2007-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Phenobarbitol and dilantin
Current Illness: none
Preexisting Conditions: pcn allergy and seizure disorder PMH: macular degeneration.
Diagnostic Lab Data: LABS: WBC 14.2 (H). Sed rate 44 (H). CRP 6.4 (H). Sodium 133 (L). UA WNL. Blood & urine c/s neg. CT brain WNL. MRI brain revealed advanced small vessel ischemic change or periventricular white matter. MRA WNL. CXR WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2448AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0964U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Ataxia, Blood culture negative, Blood sodium decreased, Bronchitis, C-reactive protein increased, Chest X-ray normal, Chills, Computerised tomogram normal, Cough, Culture urine negative, Dizziness, Dyspnoea, Erythema, Nuclear magnetic resonance imaging brain abnormal, Oedema peripheral, Pulmonary congestion, Pyrexia, Red blood cell sedimentation rate increased, Scan brain, Urine analysis normal, Vaccination complication, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Hypersensitivity (broad)
Write-up: pt immunized at 12 noon and that same evening developed sweeling of left extremity and c/o chills and inability to walk. Pt to the ED and admitted to Hospital. Fever was a one point up to 103.9. Pt was discharge from hospital with diagnosis of bronchitis and a prescription for an antibiotic. Unknown reason for neurological symptoms. 12/18/07 Reviewed hospital medical records which reveal patient experienced cough, congestion, dizziness, chills/fever, SOB, ataxia, swelling & redness of left arm. Admitted 12/1-12/4/2007. Tx w/IV antibiotics & nebs. Improved & swelling/redness also improved. D/C to home w/continued oral antibiotics. FINAL DX: Acute bronchitis, query reaction to pneumo shot.

VAERS ID:298818 (history)  Vaccinated:2007-11-30
Age:68.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-05, Days after onset: 5
Location:Michigan  Entered:2007-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1089U0SCLL
Administered by: Other     Purchased by: Private
Symptoms: Injection site discolouration, Injection site induration, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Black & blue from area of shot to elbow. Hard where shot was given. Pain but bearable.

VAERS ID:298823 (history)  Vaccinated:2007-11-30
Age:  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-05, Days after onset: 5
Location:Florida  Entered:2007-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergies to bee stings and insects.
Diagnostic Lab Data: Throat culture
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2371AA0IM 
Administered by: Public     Purchased by: Public
Symptoms: Culture throat, Pruritus, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Body, throat and arms itching.

VAERS ID:298875 (history)  Vaccinated:2007-11-30
Age:68.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Female  Submitted:2007-12-06, Days after onset: 5
Location:North Carolina  Entered:2007-12-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVAIR
Current Illness: NONE
Preexisting Conditions: ALLERGIES: BEE STINGS, PCN, CODEINE -- MEDICAL CONDITIONS: COPD
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1411U0SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: THE PATIENT EXPERIENCED HEADACHE ALL DAY ON THE DAY AFTER THE VACCINE WAS ADMINISTERED. THEN SHE EXPERIENCED NAUSEA AND LOCALIZED HOT, RAISED, BRIGHT RED AREA AT INJECTION SITE, APPROX. 4" IN LENGTH. PATIENT NOTICED IT 2 DAYS AFTER VACCINE ADMINISTERED. NO FEVER. WENT TO E.R. WHERE SHE WAS TOLD BY 2 DIFFERENT MD''S TO APPLY WARM AND COLD COMPRESSES AND DID NEITHER SINCE INFORMATION WAS CONTRADICTORY. DID TAKE TYLENOL.

VAERS ID:298907 (history)  Vaccinated:2007-11-30
Age:22.0  Onset:2007-12-02, Days after vaccination: 2
Gender:Male  Submitted:2007-12-06, Days after onset: 4
Location:Texas  Entered:2007-12-06
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: patellofemoral syndrome; myalgia, myositis, congenital scoliosis, disc degeneration, stress fracture, OA, cervicalgia, overweight, back strain, anxiety.
Diagnostic Lab Data: Elevated S-T segments; EKG chest leads. LABS: 12/4/07 CBC & chemistry WNL. CK-MB neg. CRP 5 (H). ESR 4 (N). CXR WNL. Echocardiogram WNL. EKG revealed ST elevations.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500502P IN 
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase MB, C-reactive protein increased, Chest X-ray normal, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Full blood count normal, Laboratory test normal, Pericarditis, Red blood cell sedimentation rate normal
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad)
Write-up: Pericarditis diagnosed with EKG changes. 12/7/07 Reviewed clinic medical records which reveal patient experienced dussen onset diffusechest pain, inability to lie down or tke deep breaths. Went to ER & admitted 12/2-12/3/2007 for cardiac w/u. Seen in cardiology clinic 12/4/07 FINAL DX: acute pericarditis. 12/18/07 Received v/m from reporter w/vax lot #. VAERS database updated w/same.

VAERS ID:298922 (history)  Vaccinated:2007-11-30
Age:11.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Male  Submitted:2007-12-05, Days after onset: 4
Location:California  Entered:2007-12-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2403AA UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2631AA UNRA
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1363U UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Excoriation, Fall, Immediate post-injection reaction, Injection site pain, Malaise, Neck injury, Pyrexia, Skin laceration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Injection site very sore. Malaise, fever, dizziness, immediately following injections. 24-25 hrs later, he fainted, fell and hit his chin and neck on stairs. 3 inch laceration (lower rt jawline) and 2 multiple abrasions on neck (lower rt jawline) and left side of face.

VAERS ID:298978 (history)  Vaccinated:2007-11-30
Age:21.0  Onset:2007-12-02, Days after vaccination: 2
Gender:Female  Submitted:2007-12-03, Days after onset: 1
Location:Unknown  Entered:2007-12-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hx of smoking, mild social alcohol use, no liver problems, one pregnancy, no children, no known allergies.
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Headache, Oedema peripheral, Pyrexia, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient is a 21 yr old hispanic female was given the Gardasil vaccine on Right arm on Friday Nov 30, 2007 at 2:30 p.m. She reports mild fever was given Two Advils P.O. On Sat Dec 1, 2007, she reports mild headache and mild coughing no meds taken at this point. On Sunday Dec 2, 2007 she reports mild ongoing coughing with mild rash on body she reports no meds taken. On Monday Dec 3, 2007 she reports swollen hands with lid edema on right leg and a moderate rash on body. At this point she took Benadryl 2 tablets P.O. every 4 hours, with plenty of liquids.

VAERS ID:298986 (history)  Vaccinated:2007-11-30
Age:16.0  Onset:2007-12-03, Days after vaccination: 3
Gender:Female  Submitted:2007-12-04, Days after onset: 1
Location:New Jersey  Entered:2007-12-06, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1259U0UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.150641UNLA
Administered by: Private     Purchased by: Private
Symptoms: Induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 4 cm by 2 cm induration on left upper arm

VAERS ID:299061 (history)  Vaccinated:2007-11-30
Age:1.0  Onset:2007-12-04, Days after vaccination: 4
Gender:Female  Submitted:2007-12-07, Days after onset: 3
Location:South Carolina  Entered:2007-12-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF220AA2IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0288U0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB701434H3IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1515U0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Gait disturbance, Irritability, Pain, Weight bearing difficulty
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: Patient developed left leg limping several days after vaccine administration. No ambulation for 1 - 2 days. Remained afebrile. She was somewhat fussy and appeared in pain whenever she was put down to walk. On follow-up examination, she ambulated well, but with a mild limped gait favoring the left leg. Vital signs were stable. Naproxen 100 mg every 8 hours was prescribed for 1 week duration. A follow up appointment was recommended when her Naproxen medication course was complete, or sooner if fever develops and/or no symptomatic improvement results.

VAERS ID:299096 (history)  Vaccinated:2007-11-30
Age:16.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Male  Submitted:2007-12-03, Days after onset: 2
Location:Pennsylvania  Entered:2007-12-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: blindness, deafness
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2538AA0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989U0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC274913A IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Fatigue, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Fatigue, fever 103 degrees, redness, swelling of arm.

VAERS ID:299099 (history)  Vaccinated:2007-11-30
Age:15.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-03, Days after onset: 3
Location:West Virginia  Entered:2007-12-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2540AA0IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.146541SCRA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Varivax given in right post. arm 11/30/07. Began with redness and swelling later that continued to progress. Was seen 12/3/07, area measured 14cm x 15cm, was red & hot. Suspected cellulitis. Started on Duricef 1gm twice daily.

VAERS ID:299110 (history)  Vaccinated:2007-11-30
Age:4.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2007-12-07, Days after onset: 7
Location:New Hampshire  Entered:2007-12-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Zithromax
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14049AA4UNRA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2457DA3UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08723UNLA
Administered by: Private     Purchased by: Public
Symptoms: Oedema peripheral, Rash, Swelling face, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: pt developed rash-Hives approximately 5 hours following vaccination. Approx. 36 hours following vaccination rash progressed and pt developed swelling of face and hands. Rash resolved day 5 following vaccination. Tx w/Benadryl

VAERS ID:299118 (history)  Vaccinated:2007-11-30
Age:1.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2007-12-10, Days after onset: 10
Location:California  Entered:2007-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild febrile illness with diarrhea for 7 days reported by mother. Evaluated at our clinic 11-30-07, noted to be afebrile, playf
Preexisting Conditions: Mild diarrheal illness X 7 days, <5 percentile body weight under evaluation.
Diagnostic Lab Data: Uine, serum electrolytes, glucose, CBC all reassuring.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERAVPU2490AA1IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA0IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.MSD0676U2IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.MSD0289U0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHWYE870143H3IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.MSD0731U0SCRL
Administered by: Unknown     Purchased by: Public
Symptoms: Blood electrolytes normal, Blood glucose normal, Febrile convulsion, Full blood count normal, Urine analysis normal
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: 7 hours after receiving 6 immunizations, patient had 3 minute generalized seizure witnessed by mother. Transported by ambulance to ED where evaluation ensued and was negative after exam and blood work up. Diagnosis: Presumed febrile seizure.

VAERS ID:299188 (history)  Vaccinated:2007-11-30
Age:10.0  Onset:2007-12-02, Days after vaccination: 2
Gender:Female  Submitted:2007-12-08, Days after onset: 6
Location:Florida  Entered:2007-12-10, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 1) Allergies 2) ADD 3) OCD 4) TICP 5)
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2487AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Eye pain, Eye swelling, Myalgia, Pyrexia, Sinus congestion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Sunday 12/1/07-Started with myalgia, chills, fever 101-left eye swelling. Then 12/5/07 left eye pain and sinus congestion Tx-Zithromax x 5 days, Tobranex eye ointment 12/6/07

VAERS ID:299195 (history)  Vaccinated:2007-11-30
Age:66.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-10
Location:Washington  Entered:2007-12-10
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 reported
Diagnostic Lab Data: Wound culture
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2525AA0UNLA
Administered by: Other     Purchased by: Public
Symptoms: Culture wound, Injection site discharge, Injection site reaction
SMQs:
Write-up: Pt had an injection site reaction to his flu vaccine. Pt presented 3 days post flu shot with small lesion, slight amount of exudate. Pt was advised to be seen at physicians office. Culture was done. Flu 1 week later, CK was negative and lesion was healing.

VAERS ID:299259 (history)  Vaccinated:2007-11-30
Age:28.0  Onset:2007-12-03, Days after vaccination: 3
Gender:Male  Submitted:2007-12-11, Days after onset: 8
Location:Colorado  Entered:2007-12-11
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 BIOSOLUTIONSFAV1580SCRA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB431AA1IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ06630IMRA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Local reaction, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Smallpox vaccine given 30Nov07. Patient states his Left arm began swelling a few days after injection date. When he came in to have us view his localized reaction, the swelling and redness in the area was encompassing his entire deltoid. His swelling/redness was radiating to near his elbow area. Tricep area not affected.

VAERS ID:299268 (history)  Vaccinated:2007-11-30
Age:66.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-06, Days after onset: 6
Location:Washington  Entered:2007-12-11, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cholecalciferol (Vitamin D3), Calcium Citrate, Flaxseed Oil Cap, Glucosamine-MSM-Chondroitin, Multivitamin, Prevacid Cap EC, Amitriptyline, Albuterol
Current Illness: None
Preexisting Conditions: Hydrocode allergy, tubular adenoma, colon, multiple recurrent, helicobacter pylori infection, functional bowel disease, gastroesophageal reflux disease, non erosive, morbid obesity, arthritis of knee, bilateral, asthma, diarrhea, dysphagia, meniscus tear, both knees
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA307BA   
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0804U1  
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Left arm redness, tenderness and swelling.

VAERS ID:299286 (history)  Vaccinated:2007-11-30
Age:32.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-04, Days after onset: 4
Location:California  Entered:2007-12-11, 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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2513AA  LA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0200U  RA
Administered by: Private     Purchased by: Public
Symptoms: Headache, Injection site erythema, Injection site swelling, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Fever to 103. Local redness and swelling at site of injection with pneuovax. Malaise, headache started within 6 hours on injection.

VAERS ID:299304 (history)  Vaccinated:2007-11-30
Age:17.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-04, Days after onset: 4
Location:Oregon  Entered:2007-12-11, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1259U1IM 
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U2IM 
Administered by: Private     Purchased by: Private
Symptoms: Oedema peripheral, Pain, Rash, Swelling face, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Vaccines given Friday at 2:00 pm, that evening feet started swelling, rash on feet and chest, hands - given Benedryl. Seen in office Sunday, 12/2/07 - Hives, continue antihistamine. Recheck 12/4 as fingers, toes painful, throbbing, face puffy but no shortness of breath, no fever or other illness. Continue antihistamine. Improved, still recovering.

VAERS ID:299305 (history)  Vaccinated:2007-11-30
Age:4.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Male  Submitted:2007-12-04, Days after onset: 3
Location:California  Entered:2007-12-11, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Speech delay
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B0514IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU24784IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ09243SCLL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0911U2SCRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pyrexia, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: localized erythema, swelling, tenderness and fever that developed over approx 36 hours. Seen in ER and treated with Benadryl

VAERS ID:299329 (history)  Vaccinated:2007-11-30
Age:18.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2007-12-07, Days after onset: 7
Location:Texas  Entered:2007-12-11, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: obesity
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2115AA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: Vaccine administered 15 days post expiration date of 11/15/07 on 11/30/07. Discovered by charge nurse on monthly inventory of VFC vaccines. Info reported to the health dept and manufacturer as well as physician.

VAERS ID:299413 (history)  Vaccinated:2007-11-30
Age:0.3  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2007-12-11, Days after onset: 11
Location:Ohio  Entered:2007-12-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever 103 which started within 24 hours and continued for 4 days. No other symptoms, no focus for infection.

VAERS ID:299540 (history)  Vaccinated:2007-11-30
Age:  Onset:0000-00-00
Gender:Female  Submitted:2007-12-12
Location:Unknown  Entered:2007-12-13, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: general symptom
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01742
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)
Write-up: Information has been received from a physician concerning a female with "some health troubles" who on 30-NOV-2007 was vaccinated with Zostavax single dose of the series. The patient had a heart attack and died. The physician mention that she does not think it was due to Zostavax as the patient had "some health trouble before." Additional information is not expected.

VAERS ID:299635 (history)  Vaccinated:2007-11-30
Age:66.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-10, Days after onset: 10
Location:Indiana  Entered:2007-12-13, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Heart medications-type unknown Physician consulted prior to accepting Hep B
Current Illness:
Preexisting Conditions: Diabetes
Diagnostic Lab Data: Client did not seek medical treatment
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB443BA0IMRA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Client reported feeling diaphoretic, nauseous, and lightheaded 2-3 hours after receiving vaccine. She did not seek medical treatment. She reported the event on 12-10-07

VAERS ID:299815 (history)  Vaccinated:2007-11-30
Age:50.0  Onset:2007-12-07, Days after vaccination: 7
Gender:Male  Submitted:2007-12-14, Days after onset: 7
Location:California  Entered:2007-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none, other than oral typhoid
Current Illness: none
Preexisting Conditions: no known allergies except maybe pollen. Otherwise, nothing to report
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2454AA IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURU1031-2 SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0283U SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2825AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Fatigue, Musculoskeletal stiffness
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Please note: Pt states given birthdate is false. He says his birthday is give or take 3 years. Pt states that one week after his vaccinations, he began to feel fatigued and had a stiff back. States slept 11 hours and felt better except for stiff hamstrings. The following evening he noted that his chest was covered in small red spots. Patient states during this episode he continued to work and do his normal everyday activities. As of 12/13/07, pt states the spots have almost disappeared. Pt states he only reported symptoms because he was worried about having potentially exposed his dentist and dental staff, including a pregnant dental hygenist, to measles or something else contagious. Pt received no treatment for his symptoms. Pt was also taking oral typhoid during this time but we have no information on manufacturer or lot since it was prescribed by his physician.

VAERS ID:299889 (history)  Vaccinated:2007-11-30
Age:67.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Male  Submitted:2007-12-14, Days after onset: 13
Location:New Hampshire  Entered:2007-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Pt had Pneumovax in 1997 with no problem.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1225U IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Erythema, Pain, Pruritus, Skin warm, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: Pneumovax given 11/30/07. Next AM arm red, hot, swollen, sore to touch. Pt had vomiting with hot and cold chills. Pt to ER 12/11/07. Called ER 12/2 area still sore was told to take Claritin and Ibuprofen. Phoned office 12/10 - still sore and itching. Pt taking Claritin - improving now.

VAERS ID:299895 (history)  Vaccinated:2007-11-30
Age:70.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Female  Submitted:2007-12-13, Days after onset: 12
Location:Ohio  Entered:2007-12-14, 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: dysuria, UTI
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0990U0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Ecchymosis, Erythema, Excoriation, Injection site bruising
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (broad), Hypersensitivity (broad)
Write-up: 12/3/07 Redness of upper arm, just above elbow, not at site of injection. Some areas of excoriation. 12/4/07 Recheck Rt upper extremity, redness decreased, ecchymotic areas, bruising at injection site. Dx. 682.3. Rx Cipro 500 BID #14.

VAERS ID:299902 (history)  Vaccinated:2007-11-30
Age:36.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2007-12-14, Days after onset: 14
Location:Wisconsin  Entered:2007-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: diabetic medications
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0723F0IMRA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0645F0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: The client had hives after an injection of hep A and Hep B. He was taken to the local hospital and discharged with and order for benadryl.

VAERS ID:300103 (history)  Vaccinated:2007-11-30
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2007-12-05
Location:Texas  Entered:2007-12-17, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: N/A
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2289CA0IMRL
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B129AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845E0IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0408U0PO 
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
SMQs:
Write-up: None. Pt was given a DTaP and Pediarix in error; should have received only Pediarix.

VAERS ID:300331 (history)  Vaccinated:2007-11-30
Age:25.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2007-12-12, Days after onset: 12
Location:New York  Entered:2007-12-18, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAU1580 LA
Administered by: Military     Purchased by: Military
Symptoms: Abdominal discomfort, Chest pain, Dyspepsia, Erythema, Nausea, Skin warm, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: 1 hour after vaccination of Anthrax with presented burning chest/abdomen with nausea, skin red, warm, shaking. "Severe" epigastric pain which changed to burning in abdomen. Transported via ambulance to hospital.

VAERS ID:300475 (history)  Vaccinated:2007-11-30
Age:29.0  Onset:2007-12-02, Days after vaccination: 2
Gender:Female  Submitted:2007-12-18, Days after onset: 16
Location:North Carolina  Entered:2007-12-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA; No medical conditions or birth defects
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Military     Purchased by: Military
Symptoms: Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 29 y/o female receives AVA # 2 on 30 Nov 2007 in preparation for upcoming deployment in Jan 2008. Member reports the developed of increased soreness in the right arm 2 days after vaccination receipt. The rash appears on day 3 after AVA vaccine receipt.

VAERS ID:300616 (history)  Vaccinated:2007-11-30
Age:12.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-20, Days after onset: 20
Location:Massachusetts  Entered:2007-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: cONCERTA 36MG PO QD
Current Illness: recovered from a viral infection earlier that week
Preexisting Conditions: ADD
Diagnostic Lab Data: Pelvic x-ray, Lab work (see above)MRI of right hip 2/7/08-records received-WBC elevated 16.6 with 78% polys. Blood cultures no growth. LFTs, Chem 7, ESR and CRP WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Blood culture negative, Body temperature increased, C-reactive protein increased, C-reactive protein normal, Juvenile arthritis, Laboratory test, Laboratory test normal, Liver function test normal, Nuclear magnetic resonance imaging, Pyrexia, Red blood cell sedimentation rate normal, Red man syndrome, Tendonitis, White blood cell count increased, X-ray of pelvis and hip
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: Patient had a viral infection earlier that week. Received her HPV Vaccine on Friday 11/30/07 at 4:25 p.m. Pt was feeling fine ,until 8:30p.m.. Complained of hip pain. By 9:30, pt was in horrible bilateral hip pain over the greater trochanters. Given motrin 400mg by mother and a warm bath, no relief. Called pediatrian, no noted side effects. Wnt to the emergency department. Temperature 102, WBC 17 sed rate 5 & C-reactive protein 1.5. Pt. also developed bilteral knee pain. Pt was given torodolwhich brought the pain down from 10/10 to 5/10. Pt the was given a percocet for the pain bring the pain down to a 2/10. Sent home. Called back for + blood culture on Sunday . Back to the emergency department for I.V. antibiotics. WBC 9,C- reactive protein was 41.5. Pt. was admitted to the hospital. Diagnosis: acute tendonitis of the hips & knees. 2/7/08-records received for DOS 12/2-12/5/07-DC DX: Polyarticular arthritis. Presented with bilateral knee and hip pain times 3 days after symptoms of viral syndrome. Six days prior to admission developed sore throat, headache, vomiting and abdominal pain that lasted 3 days. On 11/30/07 febrile to 102, Post infectious arthritis. Developed red man syndrome to vancomycin.

VAERS ID:300707 (history)  Vaccinated:2007-11-30
Age:1.9  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-13, Days after onset: 13
Location:Missouri  Entered:2007-12-21, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR
Current Illness: NONE
Preexisting Conditions: SPINAL DEFORMITIES AND MISSING RIBS, PRONT TO ASPIRATION AND ALLERGIES
Diagnostic Lab Data: NONE
CDC Split Type: MO200746
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2477DA1IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: AT HOME STARTED HAVING HIGH FEVER - 104F GAVE HER TYLENOL THEN HAD SEIZURE AND VOMITING. WENT TO ER SEING DOCTOR TODAY FOR CHECKUP 12-13-07

VAERS ID:300743 (history)  Vaccinated:2007-11-30
Age:0.3  Onset:2007-12-01, Days after vaccination: 1
Gender:Female  Submitted:2007-12-20, Days after onset: 19
Location:Unknown  Entered:2007-12-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory 12/03/07; body temp 12/03/07 103 degr
CDC Split Type: WAES0712USA06456
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0257U UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Diarrhoea, Laboratory test, Local swelling, Lymphadenopathy, Pyrexia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a consumer concerning her 16 week old daughter, who in September 2007, was vaccinated with the first dose of PEDIARIX and PREVNAR, which were well tolerated. On 30-NOV-2007, her daughter was administered the second dose of Hib conj vaccine (lot #656517/0257U), of PEDIARIX and of PREVNAR. On 01-DEC-2007 the infant developed a low grade fever. Within 48 hours, (approximately on 03-DEC-2007), her temperature had spiked to 103 degrees, and her neck was swollen, with the lymph nodes swollen "almost to the size of a golf ball," and she was hospitalized. Blood tests were performed (tests not specified, and results not provided). She reported her daughter was hospitalized for 6 days, and currently was recovering, but had also developed diarrhea. No further details were provided. No further information is expected.

VAERS ID:300747 (history)  Vaccinated:2007-11-30
Age:0.4  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-20, Days after onset: 20
Location:Unknown  Entered:2007-12-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA07277
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0257U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Lymphadenitis, Neck mass
SMQs:
Write-up: Information has been received from a nurse concerning an 18 week old female who on 30-NOV-2007 was vaccinated with Hib conj vaccine (OMPC) (Lot #656517/0257U). On approximately 30-NOV-2007 the patient developed a lump on her neck. She was seen by an ENT for lymphadenitis. On 06-DEC-2007 the patient was admitted to the hospital. On 11-DEC-2007 she was discharged. At the time of this report, the patient was recovering. It was unknown which dose in the series this was for the patient. Additional information has been requested.

VAERS ID:300974 (history)  Vaccinated:2007-11-30
Age:67.0  Onset:2007-12-02, Days after vaccination: 2
Gender:Female  Submitted:2007-12-18, Days after onset: 16
Location:North Carolina  Entered:2007-12-26, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: No tests done. Doctor palpated area.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.109U0 RA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 12-03-07 patient came to health department 1:00 pm and complained of severe itching at site of injection. 5x5cm circular area of erythema present. Advised it appeared to be norma reaction. On 12-11-07 patient called health department and said the area had gotten larger, intense itching and burning and felt hot to touch. Was given Keflex and stopped due to nausea. Was then given Amoxicillin 500mg for 10 days. Started improving in 2-3 days. Totally normal now.

VAERS ID:300998 (history)  Vaccinated:2007-11-30
Age:42.0  Onset:2007-12-03, Days after vaccination: 3
Gender:Male  Submitted:2007-12-05, Days after onset: 2
Location:Unknown  Entered:2007-12-26, Days after submission: 21
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: CBC, RPR, UA drawn 04Dec07. No FluMist shot only.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500501P0IN 
Administered by: Other     Purchased by: Military
Symptoms: Chills, Dysphagia, Erythema, Facial pain, Full blood count, Headache, Lymphadenopathy, Neutrophil count increased, Night sweats, Pyrexia, Syphilis test, Urine analysis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Hypersensitivity (broad)
Write-up: Pain in left side of head, hard to swallow, fever (99.0-101.9), chills, night sweats, lymphadenopathy, facial pain (left temple), L EOC erythemic, increased neutrophils.

VAERS ID:301011 (history)  Vaccinated:2007-11-30
Age:4.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Maine  Entered:2007-12-26
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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2607AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01693IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0414U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1333U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large red area on L arm. Apply cool compress.

VAERS ID:301437 (history)  Vaccinated:2007-11-30
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-19
Location:California  Entered:2008-01-02, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fever~Hib + Hep B (Comvax)~1~0~In Patient
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B125BB1IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2456DA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF160AA1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB53981E IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0768U2PO 
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Irritability, Lacrimation increased, Medication error, Skin warm, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Lacrimal disorders (narrow)
Write-up: Pt is a 6 m male with irritability early this morning, had non-rhythmic shaking movements of upper and lower extremities without organization, seemed chilled to mother though body was hot; a pool of spittle nearby, but that is not abnl for him, as he is teething; Mother states eyes appeared somewhat glazed, period lasted about 2 minutes, and when ended, he seemed more placid and restful; he fell asleep shortly after and awakened his usual time of 6 AM and has seemed normal since, though felt a bit warm on awakening and given infant advil; he fed well at 6 AM; Pt seen yesterday for WB visit and was no ill; he was given flu, Pediarix, HIB and Prevnar, Rotateq, he had had all of these x2 prior, with exception of flu; At 3 months, prior to coming to this area, he had 103 documented temp within 24 hrs of 1st immunizations, consisting of Combivax, DTaP, Prevnar and Rotateq; no intervention required and no sequelae; Pt without perinatal or dev concerns and no fam hx of epilepsy or neurological problems

VAERS ID:301935 (history)  Vaccinated:2007-11-30
Age:1.0  Onset:2007-12-17, Days after vaccination: 17
Gender:Female  Submitted:2008-01-07, Days after onset: 21
Location:Alabama  Entered:2008-01-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Bronchiolitis
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA09293
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bronchitis, Convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 1 year old female with bronchiolitis who on 30-NOV-2007 was vaccinated with a dose of MMR (no lot number was provided). "On 17-DEC-2007 the patient experienced bronchitis and was sent to the hospital with high fever and seizures. Length of time at the hospital was unknown." Subsequently, the patient recovered. There was no product quality complaint. The physician noted that he "believed that this adverse reaction did have any relation to MMR and was due to patient having bronchiolitis." Upon internal review, seizures were determined to be an other important medical event. Additional information has been requested.

VAERS ID:302207 (history)  Vaccinated:2007-11-30
Age:79.0  Onset:2007-12-14, Days after vaccination: 14
Gender:Female  Submitted:2008-01-10, Days after onset: 27
Location:Iowa  Entered:2008-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: baby aspirin
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0744U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blister, Hearing impaired, Pain, Rash pruritic
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hearing impairment (narrow), Hypersensitivity (narrow)
Write-up: Patient reports developing itchy rash two weeks post vaccination administration, rash developed into "pimple like blisters" which also became painful. Over the next 2 weeks pain continued to spread, patient reports pain started underneath her breast, down her abdomen, and down her legs. The pain she described as sharp burning pain when she touched her skin. Pain symptoms improved, although patient still has dull pain. January 5th, patient attended church at which time she noticied she was unable to hear music or speakers, which time she thought was "bad speakers or sound system" However symptoms continues as her hearing seams to be coming in and out and sound is like it is being produced by a speaker which is cutting in and out.

VAERS ID:302805 (history)  Vaccinated:2007-11-30
Age:1.0  Onset:2007-12-28, Days after vaccination: 28
Gender:Male  Submitted:2008-01-08, Days after onset: 11
Location:Michigan  Entered:2008-01-16, Days after submission: 8
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: cold symptoms approx 1 mos
Preexisting Conditions: PMH: full term, c-section, jaundice at birth tx w/phototx. Mother GBS (+). Family hx of diabetes. Had roseola in past.
Diagnostic Lab Data: Platelet count decreased to 8,000 LABS: WBC 7.8, plts 9,000 on admit, 58,000 at d/c, differential WNL. BUN/creat ratio 62 (H), alk phos 3518 (H), LD/LDH 445 (H). UA w/RBC & WBC, pH 8.0 (H), c/s neg.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2480AA0IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB207BA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0527U0SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1473U0SCRL
Administered by: Private     Purchased by: Private
Symptoms: Anaemia, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Contusion, Culture urine negative, Dermatitis diaper, Diarrhoea, Differential white blood cell count normal, Haematuria, Idiopathic thrombocytopenic purpura, Irritability, Petechiae, Platelet count decreased, Rash, Red blood cells urine positive, Somnolence, Urine analysis abnormal, White blood cells urine positive, pH urine increased
SMQs:, Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tubulointerstitial diseases (broad)
Write-up: Idiopathic Thrombocytopenia Purpura platelet count 8,000. Following WinRho platelet count recovered to 234,000. 1/22/08 Reviewed pcp medical records which reveal patient experienced rash x 3 days when seen 12/31/07 w/o fever or other signs of illness. Exam revealed petechia on extremities, trunk & back & multiple purple bruises on shins & left forehead. Labs done revealed decreased plts. Hospitalized 12/31/07-1/1/08 & received WinRo. Plts increased from 8,000 to 58,000 & microscopic hematuria improved. Consult by peds heme/onc while hospitalized. Plts count repeated on visit 1/4 & were 234,000. Having mild diarrhea & diaper rash. Petechia & bruises were resolving. Was to continue serial labs & heme/onc f/u. FINAL PCP DX: ITP, resolving; anemia secondary to WinRo. 1/22/08 Reviewed hospital medical records which reveal patient experienced rash, bruising, irritability & sleepiness x 3 days. Transient diarrheal illness in pt & parents 1-2 wks & URI 1 mo prior to admit. Both parents w/viral URI. Admitted 12/31/07-1/1/08. Responded well to WinRo & d/c to home w/heme & lab f/u. FINAL DX: Immune thrombocytopenic purpura & benign hyperalkaline phosphotase (qcquired vx familial), microscopic hematuria, resolving.

VAERS ID:304065 (history)  Vaccinated:2007-11-30
Age:0.4  Onset:2007-12-01, Days after vaccination: 1
Gender:Male  Submitted:2008-01-29, Days after onset: 59
Location:New York  Entered:2008-02-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B129AA1IMLL
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Per mom after immunizations on 11/30/07 child had diarrhea and on/off fever up to 103 for 3 days. Mom reported this to our office on 12/07/07.

VAERS ID:304112 (history)  Vaccinated:2007-11-30
Age:46.0  Onset:2007-12-03, Days after vaccination: 3
Gender:Female  Submitted:2008-01-28, Days after onset: 56
Location:North Carolina  Entered:2008-02-01, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu like~Smallpox (no brand name)~UN~7~In Patient
Other Medications: birth control pills
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.0288U SCRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1982AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Pain in extremity
SMQs:
Write-up: Intermittent pain shoulder to wrist, left side, 2-3 times per day.

VAERS ID:304693 (history)  Vaccinated:2007-11-30
Age:51.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-11, Days after onset: 73
Location:Kansas  Entered:2008-02-11
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: Mold, cat and dog dander, penicillin, Dilantin. Have spots in my brain which show up on MRI''s but they are of unknown cause.
Diagnostic Lab Data: neurological examination
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS808220UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Dizziness, Facial pain, Hypoaesthesia, Hypoaesthesia facial, Hypoaesthesia oral, Muscle tightness, Neurological examination, Oral pain, Paraesthesia, Paraesthesia oral, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Vestibular disorders (broad)
Write-up: Within ten minutes of receiving the shot, I felt a sensation travel up my arm, shoulder and neck until it stopped in my right jaw area, and felt like novocaine kicking in. I have since had roving tingling, numb-ish sensation, and pain on both sides of my face and throughout my mouth, tingling in my legs, severe muscle tension in my neck, chills and fever, and dizziness. I have seen several doctors but no one has been of any help. I am trying alternative therapies and have have some improvement of symptoms.

VAERS ID:306334 (history)  Vaccinated:2007-11-30
Age:1.0  Onset:2007-12-13, Days after vaccination: 13
Gender:Female  Submitted:2008-02-18, Days after onset: 67
Location:Virginia  Entered:2008-02-20, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA06503
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2460BA0IMUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0437U3IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54015D3IMUN
Administered by: Private     Purchased by: Public
Symptoms: Nausea, Stomach discomfort, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a consumer and follow up from a medical assistant concerning a 12 month old white female with no pertinent medical history, drug reactions/allergies or illness at time of vaccination, who on 30-NOV-2007 was vaccinated intramuscularly (site not reported) with the third (also reported as fourth dose) 0.5ml dose of PEDVAXHIB (OMPC) (lot #656522/0437U). On the same day the patient was concomitantly vaccinated intramuscularly with a fourth dose of PREVNAR (lot # B54015D) and FLUZONE (influenza virus split virion 3v vaccine inactivated) (lot #UT2460BA). Subsequently starting on 13-Dec-2007 at 11:30am, the patient experienced 4 incidents of vomiting (previously reported as 3). The patient was very sick to the stomach and had nausea during the following week. The patient did not receive medical attention and no diagnostic lab test were performed. On 20-Dec-2007, the patient recovered. No additional information is expected.

VAERS ID:306349 (history)  Vaccinated:2007-11-30
Age:1.3  Onset:2007-12-11, Days after vaccination: 11
Gender:Male  Submitted:2008-02-18, Days after onset: 69
Location:Virginia  Entered:2008-02-20, 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: Singulair
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA07211
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0377U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Local reaction
SMQs:
Write-up: Information has been received from a registered nurse concerning a 15 month old male who on 30-NOV-2007 was vaccinated with a dose of PEDVAXHIB (OMPC) (Lot #657380/0377U). Concomitant therapy included montelukast sodium (MSD). On 11-DEC-2007 the patient experienced a localized reaction. The nurse described the reaction as a "strawberry" size and reaction. Unspecified medical attention was sought. At the time of the report the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:307801 (history)  Vaccinated:2007-11-30
Age:18.0  Onset:2008-01-01, Days after vaccination: 32
Gender:Female  Submitted:2008-03-14, Days after onset: 72
Location:Massachusetts  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Fruit allergy
Preexisting Conditions:
Diagnostic Lab Data: allergy test
CDC Split Type: WAES0802USA05578
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy test, Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a consumer concerning her 18 year old daughter with a fruit allergy who on approximately 30-NOV-2007 was vaccinated with her first dose of Gardasil (lot# not reported). There was no concomitant medication. On approximately 01-JAN-2008 the patient experienced a soy allergy (can be anaphylactic and the patient has an epi pen). The patient''s soy allergy persisted. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:308679 (history)  Vaccinated:2007-11-30
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2007-12-10
Location:Unknown  Entered:2008-04-01, Days after submission: 112
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.   UN
Administered by: Military     Purchased by: Unknown
Symptoms: Headache, Pharyngolaryngeal pain, Postnasal drip
SMQs:
Write-up: Had flu mist x 9 days ago. Was seen in UCC on 09 Dec with HA, no temperature, sore throat, any + post nasal drip. Given Atarak + qtr 2 yo.

VAERS ID:309755 (history)  Vaccinated:2007-11-30
Age:68.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 116
Location:Unknown  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0712USA01080
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a consumer concerning his 68-year-old wife on on Friday, 30-NOV-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck). On approximately 30-NOV-2007 the patient developed pain and redness at the injection site. No outcome was reported. Additional information is not expected.

VAERS ID:309768 (history)  Vaccinated:2007-11-30
Age:74.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 116
Location:California  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSAMAX; NORVASC; atenolol; HYZAAR
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA01454
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, Injection site erythema, Injection site rash, Rash vesicular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a certified medical assistant concerning a 74 year old female with no pertinent medical history, drug reactions or allergies who on 30-NOV-2007 was vaccinated into the left tricep with 0.5ml of Zostavax (Oka/Merck). Concomitant therapy included alendronate sodium (MSD), atenolol, losartan potassium-HCTZ (MSD) and NORVASC. On 30-NOV-2007 the patient developed an erythematous, zoster like rash at the injection site. Medical attention was sought. At the time of reporting the patient was recovering. There were no diagnostic studies performed. There was no product quality complaint. Additional information has been requested.

VAERS ID:309936 (history)  Vaccinated:2007-11-30
Age:67.0  Onset:2007-12-11, Days after vaccination: 11
Gender:Male  Submitted:2008-03-26, Days after onset: 105
Location:California  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA08454
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1413U SCUN
Administered by: Other     Purchased by: Other
Symptoms: Discomfort, Herpes zoster, Pain
SMQs:
Write-up: Information has been received from a health professional concerning a 67 year old male with no known allergies or medical history who on 30-NOV-2007, was vaccinated with a 0.65 ml subcutaneous dose of Zostavax (Oka/Merck) (lot# /658867/1413U). There was no concomitant medication. On 14-DEC-2007, the patient was seen by a physician. It was reported that the patient developed a mild case of shingles beginning on 11-DEC-2007, and presented with five lesions with pain and discomfort on his right rib cage. The patient was prescribed VALTREX, one gram every 8 hours for 7 days. On 20-DEC-2007, the patient via phone reported to the nurse that he had been taking 2 ibuprofens (strength unspecified) with meals for pain. As of this report, the patient was reported to have been recovering. A product quality complaint was not reported. Additional information has been requested.

VAERS ID:312244 (history)  Vaccinated:2007-11-30
Age:68.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2008-05-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Dr. ordered an Ultrasound to check for possible cysts or? An MRI was done February 1 and 5, 2008. Nerve conduction study and muscle testing, results inconclusive, no damage noted. The immunologist had extensive blood work done, titer etc. nothing showed any abnormality.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0070U UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to vaccine, Arthralgia, Back pain, Blood test normal, Body temperature increased, Bone pain, Burning sensation, Cellulitis, Chills, Diagnostic procedure, Disturbance in attention, Erythema, Fatigue, Hyperaesthesia, Induration, Injection site discolouration, Injection site erythema, Injection site pain, Injection site warmth, Lethargy, Malaise, Myalgia, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain, Pain in extremity, Sensation of pressure, Skin warm, Swelling, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: November 30, 2007 received pneumonia vaccine: Co. Merck, Lot; 0070u/2/15-09. Within a few hours noted a hard area sensitive to touch and some pain. December 1, 2007 muscle pain began in arm, by evening the pain was very severe (8) particular at the biceps. Upon inspection large red raised areas were noted. The injection site was bright red, surrounded by a white halo which was surrounding by a red halo. The two large reddened areas extended from injection site medially to inner aspect of arm, hot to touch and very painful, in particular the medial one. I experienced chills, elevated temperature. Applied ice, 20 min. about every 1.5 hrs. and took BENADRYL. This gave some temp relieve. December 2, spoke with the nurse, who recommended ADVIL, took ADVIL throughout the day, in all 3 tablets for pain. December 3, saw physician. She diagnosed cellulitis. Prescribed antibiotic LEVAQUIN, qd for 10 days. December 5, redness decreased, however pain began to radiate down the arm, particularly along the biceps, triceps to the medial aspect of the elbow and under the scapula to the spine. December 6, I awoke with severe pain radiating all over the shoulder down to the hand. Called MD and informed RN about changes in pain. The arm felt as if it was a foreign appendage. December 8, evening, suddenly extreme chills for over an hr. no temp. took 1 ADVIL and slowly began feeling a little better. December 10 returned to MD, prescribed prednisone 60 mg, for 5 days. Within an hour there was no more pain. December 15 took last dose of prednisone. December 16 pain returned, almost as severe as before, particularly over scapula and arm, at times very sharp stabbing pain in arm. December 17 called MD informed RN of pain returning within in 25 hrs. after last dose of prednisone. In pm joint pain and muscle pain began. December 18, experienced elbow, knee, hip joint pain, muscles of legs, arms, back ached, I felt terrible, as if body was "disintegrating", extremely lethargic, unusually tired, and great difficulty concentrating at tasks. December 19, felt somewhat better in am but continued to have muscle and joint pain, however less severe tired throughout day, no energy. December 19 saw my regular Dr. who had conferred with the partner who had seen me during the last two visits. Dr. ordered an Ultrasound to check for possible cysts or? Prescribed prednisone 15 mg. for 3 days, followed by 10 mg. for 3 days, 5 mg. for 3 days, 2.5 mg. for 3 days. Currently I am taking 5 mg. The same pain has returned in the biceps since the decrease of the prednisone there is still a small reddened area of sensitive to mild pressure. Dr. suggests that I developed a reaction to one of the additive in the vaccine. As children we were immunized with live bacteria against TB. I had a bad reaction resulting in fistulas at the injection site, took weeks to resolve. February 13-08- Very little has changed concerning the pain since I wrote the above. There may be one or two days a week when I have not much pain, and then there are days when I wake up with pain in the left arm and it is already a 4 or 5. It can involved the total arm, beginning from the lateral aspect of the scapula. Sharp, burning and stabbing pain is often present. The burning like pain is the most unpleasant. At times it feels as if the muscle like muscle cramps, particularly in the biceps, brachialis. Slight pressure on the arm can cause great discomfort, pain. There are days when the left hand feels warmer than the right. The only time I ever had total sustained relief (no pain) happened when I was taken the prednisone. An MRI was done February 1 and 5, 2008. Since February 08, there has been little change in the pain, except I had a few days last week (March 1-5 less pain) but now it has returned and is more severe, ranging between 4-8. The last three days I have had consistent pain between 5-8 or nine at times. March 11-08 pain continues much as before. Nerve co

VAERS ID:312868 (history)  Vaccinated:2007-11-30
Age:18.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 165
Location:Oklahoma  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA01913
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Haemorrhage, Immediate post-injection reaction, Skin laceration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 18 year old female patient with no medical history and no drug allergies who, on 30-Nov-2007 at 13:40 was vaccinated IM in the left deltoid with a 0.5 mL third dose of GARDASIL (Lot # 658490/0820U). There were no illnesses at the time of the vacination. On 30-Nov-2007, 20 minutes post vaccination at 14:05 the patient felt dizzy while standing at the check out window and immediatley fainted and hit her head against the hallway wall. The patient was bleeding profusely from a head laceration. First aid was performed and the patient was sent to the emergency room via emergency medical service "EMS." The patient recovered on an unspecified date.No further information was provided. Outcome was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008.

VAERS ID:313169 (history)  Vaccinated:2007-11-30
Age:14.0  Onset:2008-01-30, Days after vaccination: 61
Gender:Female  Submitted:2008-05-14, Days after onset: 104
Location:California  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory - negative; beta-human chorionic - negative
CDC Split Type: WAES0804USA04603
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Laboratory test normal, Menstruation delayed, Pregnancy test negative
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a physician concerning a 15 year old female who on 30-Nov-2007 was vaccinated IM in the right arm with the first dose (lot# 658490/0802U) and on 30-Jan- 2008, vaccinated IM in the left arm with the second dose of GARDASIL (lot# 658490/0802U). Concomitant therapy included MENACTRA (lot# 42375BA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot# AC52B019AA). After the first dose the patient did not get her period for four months. She was on no medication at that time. Negative labs and negative pregnancy test. On 14-Apr-2008 she had her period. The patient recovered. Additional information has been requested.

VAERS ID:312929 (history)  Vaccinated:2007-11-30
Age:0.2  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2008-05-21, Days after onset: 172
Location:Tennessee  Entered:2008-05-21
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: laryngomyalgia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF22AA0IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURA02730IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54013F0IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0970U0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Anorexia, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: Stopped babbling for approx 5 weeks, extreme sleepiness, temporary loss of appetite, would not make eye contact as she had before. Vax''s given: Rota, Hib, PCV, and IPV/OPV.

VAERS ID:313909 (history)  Vaccinated:2007-11-30
Age:11.0  Onset:2007-12-01, Days after vaccination: 1
Gender:Male  Submitted:2008-05-16, Days after onset: 166
Location:Ohio  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~Varicella (no brand name)~1~1~In Sibling
Other Medications: acetaminophen (+) codeine mg/mL; Zyrtec 10 mg; Zyrtec 7.5 mL; Flonase 50 microgm; Flonase 50 microgm
Current Illness: Seasonal allergic rhinitis
Preexisting Conditions: Closed fracture of unspecified part of forearm
Diagnostic Lab Data: physical examination 12/03/07 - right thigh swelling; physical examination 12/03/07 - cellulitis s/p vaccination
CDC Split Type: WAES0712USA03900
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1355U1SCRL
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Physical examination, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning an 11 year old male who on 30-NOV-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658965/1355U). Suspect vaccination administered on that same day included a dose of Menactra in the left leg. Other concomitant drug therapy included Zyrtec and Flonase. On 01-DEC-2007 the patient was diagnosed with cellulitis characterized by pain in his leg (limped the entire day), a rash on the knee and into the groin and swelling in the interior thigh of his right leg. The patient sought unspecified medical attention. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information from the reporting physician and medical records indicated that an 11 year old male with seasonal allergic rhinitis since 02-OCT-2006, a history of closed fracture of distal forearm (not specified) 09-NOV-2006 and no other medical conditions or allergies who on 30-NOV-2007 at 15:30 was vaccinated SC with his second dose of varicella virus vaccine live (Oka/Merck) (lot# 658965/1355U) in the right leg. There was no illness at the time of vaccination. Concomitant vaccination administered on that day at 15:30 included a dose of Menactra in the left leg. Other concomitant drug therapy initiated on 16-OCT-2007 included Zyrtec 10 mg chewables 1 tablet PO once daily and Flonase 50 mcg 2 sprays each nostril BID. PM 26-OCT-2007 the patient was started on acetaminophen (+) codeine 120-12 mg/5 mL solution 10 mL PO every 3 to 4 times per day. On 01-DEC-2007, at 9:00 the patient experienced pain, tenderness, and redness of the right leg. The patient was given Tylenol by his (a nurse in a pediatric outpatient department) for some relief from pain and swelling. The patient sought medical attention through a pediatric office visit on 03-DEC-2007. Remarkable exam findings included an alert, non-ill appearance with large erythema of right leg at the anterior thigh with swelling. There was no induration, drainage or purulence, but 2 small pimples

VAERS ID:323412 (history)  Vaccinated:2007-11-30
Age:76.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2008-07-30, Days after onset: 242
Location:Florida  Entered:2008-08-06, 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: vitamins (unspecified); zinc (unspecified)
Current Illness: Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA00333
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1381U0SC 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a Certified Medical Assistant concerning a 76 year old male patient with drug allergy to triazolam who on 30-NOV-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659147/1381U. Concomitant therapy included influenza virus vaccine (unspecified), vitamins (unspecified) and zinc (unspecified). On 30-NOV-2007, the patient developed injection site redness, swelling, warmth and pain. Medical attention was sought by the patient. At the time of this report patient had not recovered. No other information was available at this time. Additional information has been requested.

VAERS ID:336116 (history)  Vaccinated:2007-11-30
Age:74.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-04, Days after onset: 4
Location:Nevada  Entered:2008-11-13, Days after submission: 345
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: "Water Pill"; "Pill for Diabetes"
Current Illness:
Preexisting Conditions: The patient was taking medication for diabetes and a "water pill."
Diagnostic Lab Data:
CDC Split Type: 200704171
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU053AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Confusional state
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: Initial report received on 04 December 2007 from the patient''s family member. A 74-year-old female patient had received an injection of FLUZONE SV 2007-2008, lot number U253AA (not a valid sanofi pasteur lot number) on either 04 November 2007 or 30 November 2007. Per the reporter, at an unspecified time post-vaccination, the patient experienced confusion. She turned the wrong way going to the store and was unable to balance her checkbook. The reporter indicated that this was abnormal for the patient. An appointment was scheduled for medical examination. At the time of this report, the patient had not recovered.

VAERS ID:335591 (history)  Vaccinated:2007-11-30
Age:22.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2008-11-17, Days after onset: 353
Location:Colorado  Entered:2008-11-25, 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: TDAP vaccine (Non-GSK)
Current Illness: Unknown
Preexisting Conditions: The subject received a TDAP vaccine (ADACEL) four days prior to administration of TWINRIX, which was her first vaccine ever (the subject had not previously been vaccinated with any childhood vaccines). ADACEL was administered on 26 November 2007 in the left arm. The subject experienced fever and chills the day after administration of ADACEL. It was reported that the subject is
Diagnostic Lab Data: Unk
CDC Split Type: A0698421A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS0499U0SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.AHABB100AA0IMLA
Administered by: Public     Purchased by: Other
Symptoms: Chills, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of nausea in a 22-year-old female subject who was vaccinated with TWINRIX, (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (Merck) administered on 30 November 2007, subcutaneously, in the right arm. Previous vaccination included ADACEL (TDAP) given on 26 November 2007 in the left arm. The subject experienced chills and fever one day following vaccination with ADACEL. These events were said to have resolved. On 30 November 2007 the subject received 1st dose of TWINRIX at 1.0 ml, intramuscularly in the right arm. On 30 November 2007 (at 19:30), about 3 to 4 hours after vaccination with TWINRIX (and MMR vaccine), the subject experienced nausea, vomiting and fever. The events reportedly resolved by 02 December 2007.

VAERS ID:337479 (history)  Vaccinated:2007-11-30
Age:2.0  Onset:2007-12-07, Days after vaccination: 7
Gender:Male  Submitted:2009-01-15, Days after onset: 405
Location:Indiana  Entered:2009-01-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None at the time
Current Illness: Possibly double-ear infection and earlier that month had sinusitis
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB229AA2UNLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB139BA0UNLL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0831F0UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Febrile convulsion
SMQs:, Neuroleptic malignant syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had a febrile seizure with a temperature of 106.8 degrees and rising 7 days post MMRV shot. He''d had a double-ear infection as well at the time of the seizure, but I can''t remember if he had that prior to immediately prior to vaccination or not. He also had subsequent febrile seizures. Initial seizure was 12/7/06.

VAERS ID:340616 (history)  Vaccinated:2007-11-30
Age:22.0  Onset:2008-12-01, Days after vaccination: 367
Gender:Female  Submitted:2009-02-13, Days after onset: 74
Location:Unknown  Entered:2009-02-18, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: No Relevant Data~ ()~~0~In Patient
Other Medications: HORMONAL CONTRACEPTIVES
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Pap test, 12/??/08, - Abnormal; Cervix HPV DNA assay, 12/??/08, - was positive for high risk HPV
CDC Split Type: WAES0901USA01978
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Papilloma viral infection, Smear cervix abnormal, Viral DNA test positive
SMQs:
Write-up: Information has been received from a Nurse Practitioner concerning a 22 year old female virgin patient with no pertinent medical history no drug reactions or allergy who on 07-JUN-2007 was vaccinated with first dose of GARDASIL vaccine (lot # not reported) 0.5ml, intramuscularly. On 09-AUG-2007 patient received second dose of GARDASIL vaccine (lot # not reported) 0.5ml, intramuscularly and on 30-NOV-2007 she received third dose of GARDASIL vaccine (lot # 659439/1267U) 0.5ml, intramuscularly. Concomitant therapy included hormonal contraceptives (unspecified). Patient was virgin prior GARDASIL vaccination. In December 2008 the patient had an abnormal pap and DNA test was positive for high risk HPV. Patient sought medical attention was seen in the office. This is one of two reports from the same source. Additional information has been requested.

VAERS ID:343023 (history)  Vaccinated:2007-11-30
Age:24.0  Onset:2007-12-12, Days after vaccination: 12
Gender:Female  Submitted:2009-03-30, Days after onset: 473
Location:Unknown  Entered:2009-03-31, 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: Lactose intolerance
Diagnostic Lab Data: ultrasound, 01/31/08, 7w5d, reason for test: Dates; diagnostic laboratory, 01/31/08, routine laboratory tests for pregnancy; diagnostic laboratory, 01/31/08, negat; Cystic fibrosis screening; serum alpha-fetoprotein, 02/28/08 within, screen
CDC Split Type: WAES0803USA01775
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein, Arrested labour, Caesarean section, Cephalo-pelvic disproportion, Drug exposure during pregnancy, Laboratory test normal, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female with a history of lactose intolerance and 1 miscarriage who on 30-NOV-2007 was vaccinated with a 1st dose of GARDASIL (lot# 659055/1522U). Concomitant therapy included prenatal vitamins. Subsequently, 2 to 3 weeks after getting her vaccination the patient became pregnant (LMP 12-dec-2007). It was reported that on 31-JAN-2008 the patient has an ultrasound, routine obstetrical diagnostic tests, and cystic fibrosis screening (results negative). It was reported that on 28-FEB-2008 the patient had serum alpha-fetoprotein test (results within range). No adverse event was reported. Follow up information was received from a charge nurse who stated that the patient delivered a healthy and normal male, at term, on 16-SEP-2008. It was reported that the patient''s labor progressed to second stage, when she had an arrest of descent and was diagnosed with CPD for this birth. It was reported that the patient had a cesarean section. The reporter stated that the patient had an uncomplicated prenatal course, with the usual pregnancy related complains, nothing more. No further information is available.

VAERS ID:440308 (history)  Vaccinated:2007-11-30
Age:53.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Male  Submitted:2011-10-26, Days after onset: 1425
Location:Montana  Entered:2011-10-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Fatigue & depression; Chronic pain
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS80682 IMLA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Arthritis
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow)
Write-up: Joint pain, arthritis.

VAERS ID:446223 (history)  Vaccinated:2007-11-30
Age:1.0  Onset:2007-12-10, Days after vaccination: 10
Gender:Female  Submitted:2011-12-22, Days after onset: 1473
Location:Mississippi  Entered:2011-12-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2011030580
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Cerebellar ataxia, Miosis
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)
Write-up: This medically confirmed spontaneous report (initial receipt 13-Dec-2011) concerns a 1-year old female patient, who had no pertinent medical history, drug reactions / allergies or taking any concomitant medication. On 30-Nov-2007 the patient received flu vaccine. On the same day she also received dose 1 of VARIVAX injection and dose 1 of MMR. Ten days later, the patient was unable to walk and had ''pinpointing''. She developed cerebella ataxia and was taken to an ER (Emergency Room) with no significant finding. The ataxia resolved within 5 to 7 days after onset. The event outcome was recovered. The patient has since received a second MMR on 06-Dec-2011 with no problems to report. The reporter considered events to be serious as the events caused significant disability / incapacity.

VAERS ID:451942 (history)  Vaccinated:2007-11-30
Age:28.0  Onset:2008-10-09, Days after vaccination: 314
Gender:Male  Submitted:2012-03-16, Days after onset: 1254
Location:Unknown  Entered:2012-03-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Insulin pump
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: (Email sent 3/16/12) This patient did have testing done through the Repository and was NEG prior to his diagnosis, but positive after. I am not prepared to explain what that means right now as our group is reviewing these cases in detail. I think it supports that something (possibly vaccines) between his NEG antibody tests in June 2004 and his Dx of DM/POS antibody tests in 2008 triggering his diabetes. Once we have reviewed and analyzed the antibody results, I will try to have write a statement/explanation that can be shared with each patient. If there Is a question of LOD or service connection, this may help this patient.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONS 3UNUN
Administered by: Military     Purchased by: Military
Symptoms: Activities of daily living impaired, Antibody test positive, Arthralgia, Asthenia, Back pain, Dehydration, Fatigue, Gait disturbance, Headache, Hypoaesthesia, Loss of consciousness, Nausea, Paraesthesia, Thirst, Type 1 diabetes mellitus, Viral infection, Vision blurred, Vomiting, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vasculitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: 32 yo patient who states he "was in really good health" until he was dx''d with Type I DM on Oct. 9th, 2008. He now is insulin dependent and has an insulin pump. He heard that the development of Type I DM may be related to receipt of Anthrax Vaccine(s). Patient received AVA #1 on 28 Oct 2004, AVA #2 on 24 JUN 2007, AVA #3 on 28 JUN 2007 and AVA #4 on 30 NOV 2007. The patient is sure that he received an additional dose of Anthrax (not documented in DEERS). My knees (L$gR) and lower back really began to bother me during my 2nd deployment x 14 months (JAN2007 to 13FEB08). Seen and I began taking 800 mg. Ibuprofen "like it was candy" and had difficulty just walking around I began to have daily headaches (no prior hx migraines, HTN or HA''s). I figured it was just all the dust and dirt and just "sucked it up" and took whatever I could find to relieve my joint/back pain and headaches- TYLENOL, MOTRIN, ALEVE. Patient PCS''d to camp in FEB 2008. His knee and back pain continued and he saw providers about his back and knee pain. MRI of knees. The patient was seen for a "Viral Syndrome: (N/Vx1, weak) on Sep. 8th of 2008 and was told he was "dehydrated" and given fluids and PHENERGAN. The patient believes that he was experiencing sx of diabetes at the time, but did not know it- he was attending an extremely demanding Advanced Leadership Course AUG/SEP2008 "always trying to advance and be the best I could be." I felt run down and worn out, but attributed this to the physical demands of the Advance Leadership Course he was taking. I felt thirsty ALL the time and it seemed like nothing could quench my thirst. Patient lost from 165 to 147 lbs without dieting. Was tired all the time- no energy. Felt numbness and tingling in his hands and feet. His Supervisor at the Course noticed the patient''s fatigue and said "Are you alright? were you out partying or something?" Patient managed to graduate from the course "somehow" on 25SEP08. On Saturday 04OCT08 he noticed that his "vision was a little off- blurry." Patient returned to his work on Monday 06OCT08- was cleaning his equipment, but just had no strength or energy and his vision was more blurry. On 08OCT08 he had to drive in a rental vehicle with another person. His vision was so blurry that he had to ask the other person to drive. Patient called his sister, who is a nurse, who advised him to get checked by MD. Patient was seen by Surgeon on 09OCT08 and went to hospital for labs. Two hours later his doctor told the patient he had diabetes, but he was not sure which type yet. The patient was hospitalized from 09OCT08 to 12OCT08 and given fluids and insulin and stabilized. Patient was then referred to Internal Medicine. Sx could not be controlled with Metformin. Referred to Endocrinology, who formally dx''d patient as having DM-Type I. Most recent visit with Dr. was at the end of AUG 2009. Patient has had an insulin pump x 2 months and his glucose control is improving. Patient states: "My lifestyle has completely changed- I no long have a career doing what I love (Communications Engineer); I no longer have the energy for health to do the activities that I used to do- I passed out trying to mow the lawn last week; I do not know my future and where I will be after the corps lets me go." Patient is facing a MEB and has been told he cannot continue his service with this dx. He has been in the service since 1997. He denies any family hx of DM1, but MGM (obese) has DM2 and denies any other personal hx of other chronic illness. He request that this VAERS report be filed and would like to know if causality can be established for his DM Type 1 s/p Anthrax vaccines/Live Intranasal FLUMIST Vaccines.

VAERS ID:299034 (history)  Vaccinated:2007-11-30
Age:  Onset:2007-12-02, Days after vaccination: 2
Gender:Female  Submitted:2007-12-06, Days after onset: 4
Location:Foreign  Entered:2007-12-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory test 02Dec07 Comment: other values were normal; appendiceal surgery Comment: normal; WBC count 02Dec07 15000; serum C-reactive protein 02Dec07 180; WBC count 03Dec07 12000; serum C-reactive protein 03Dec07 250; body te
CDC Split Type: WAES0712USA01345
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Appendicectomy, Body temperature increased, C-reactive protein increased, Flank pain, Laboratory test, Pyrexia, Surgery, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a health professional concerning a female (age not reported) with no medical history who on 30-NOV-2007 was vaccinated with Gardasil (lot# unknown); route and site of administration were not reported). On 02-DEC-2007 (2 days later) after vaccination the patient experienced a fever of 39 degrees celcius and abdominal pain in the right flank. The patient went to the hospital. On 02-DEC-2007, tests showed white blood cells at 15000 and serum C-reactive protein test (CRP) was 180. Other results were normal. On 03-DEC-2007, the patient had white blood cells at 12000 and serum C-reactive protein test (CRP) was 250. Pain in the right flank persisted. The patient had a fever of 38.6 degrees celcius. Surgery was performed, however nothing was found. The appendix was normal. On 04-DEC-2007, pain and fever had resolved. The patient remained in the hospital at the time of reporting. Additional information is not expected. Other business partners included are: E2007-08870.

VAERS ID:299138 (history)  Vaccinated:2007-11-30
Age:  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2007-12-07, Days after onset: 7
Location:Foreign  Entered:2007-12-10, 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: Unknown
Current Illness: Feeling unwell
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712AUS00003
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Disorientation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician via CSL as part of a business agreement concerning a female who was initially vaccinated with the first dose of Gardasil (date unspecified) and tolerated it well. On 30-NOV-2007 the patient was vaccinated with the second dose of Gardasil. The patient felt a little unwell before the second dose of Gardasil was given. Subsequently she fainted, had a seizure, immediately following that was disorientated for 2-3 minutes and had to lie down for 2 hours. Upon internal review seizure has been considered an other important medical event. Additional information has been requested.

VAERS ID:300079 (history)  Vaccinated:2007-11-30
Age:81.0  Onset:2007-12-03, Days after vaccination: 3
Gender:Male  Submitted:2007-12-14, Days after onset: 11
Location:Foreign  Entered:2007-12-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Blopress; Flutide; Meptin; Norvasc; Theolong; Zyloric
Current Illness: Hypertension; Asthma
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01543
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Inflammation, Malaise, Pneumonia
SMQs:, Eosinophilic pneumonia (broad)
Write-up: Information has been received from a physician concerning an 81 year old male with hypertension and asthma, who on 30-NOV-2007 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included amlodipine besylate (NORVASC), candesartan cilexetil (BLOPRESS), allopurinol (ZYLORIC), procaterol hydrochloride (MEPTIN), theophylline (THEOLONG) and fluticasone propionate (FLUTIDE). On 01-DEC-2007 the patient experienced anorexia and malaise. On 03-DEC-2007, the patient presented to the reporting physician again, because the symptoms were severe. Inflammation in the left lung was observed. The patient developed pneumonia. At the time of the report, the patient was hospitalized in another hospital. The outcome of the pneumonia was unknown. The physician did not assess the relationship between the vaccine and pneumonia. The physician considered that pneumonia was serious due to hospitalization. No further information is available.

VAERS ID:301118 (history)  Vaccinated:2007-11-30
Age:32.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-27
Location:Foreign  Entered:2007-12-27
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: colostomy
Diagnostic Lab Data: Bilirubin 2007 28IU; Folate 2007 normal; Liver function test 2007 normal; Renal function test 2007 normal; Thyroxine 2007 normal; Vitamin B12 normal
CDC Split Type: B0499644B
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB374AC UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood bilirubin increased, Blood folate normal, Gilbert's syndrome, Influenza like illness, Liver function test normal, Musculoskeletal stiffness, Paraesthesia, Renal function test normal, Thyroxine normal, Vitamin B12 normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Parkinson-like events (broad), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of flu like symptoms in a 32-year-old female subject who was vaccinated with Engerix B for prophylaxis. Follow-up information was received from a Regulatory Authority. The subject''s medical history included colostomy in infancy. For tolerance to previous vaccination, please refer to case B0499644A. On 30 November 2007 the subject received 2nd dose of Engerix B (unknown, unknown deltoid. In 2007, less than one month after vaccination with Engerix B, the subject experienced flu like symptoms, pins and needles which radiated up her legs as well as leg stiffness. She continued to go to work. Blood tests for B12, folate, thyroxine, renal and liver were all normal except that her bilirubin was slightly elevated at 28 (normal range 2-19) but the doctor felt that this was probably Gilbert syndrome. The doctor felt that this reaction should resolve in 8-10 weeks. He considered the events to be probably related to the vaccination. In the report received from the Regulatory Authorities, it was mentioned that the subject had been vaccinated on 22 November 2007 and experienced paresthesia. The regulatory authorities considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.

VAERS ID:303934 (history)  Vaccinated:2007-11-30
Age:0.3  Onset:2007-11-30, Days after vaccination: 0
Gender:Unknown  Submitted:2008-01-28, Days after onset: 59
Location:Foreign  Entered:2008-01-30, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Similar symptoms (oedema, redness of the face and forearms) occurred after previous vaccination (unspecified).
Diagnostic Lab Data:
CDC Split Type: 200800192
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURERZ0906002 UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ1046 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Immediate post-injection reaction, Rash erythematous, Rash macular, Restlessness
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: A 04-month-old patient (gender not reported), with no reported medical history, presented with macular rash, erythematous skin rash and weeping on 30 November 2007 the day she/he received Imovax Polio*, lot Z1046-1, DTP vaccine, lot Z0906002 and Hiberix*, lot A72CA331A, both from another manufacturers. He/she was vaccinated in this order. 1-2 minutes after the last injection (Hib vaccine), redness of the skin appeared. During vaccinations the child was crying very much and was restless. The red patches appeared also on the head, lower limbs and the chest. The redness has gone very quickly - insignificantly - lasted for 3-5 minutes. The red patches lasted longer (on the head and lower limbs) and the patient was referred to the hospital in a good health status. According to the hospital information card, similar symptoms (oedema, redness of the face and forearms) occurred after previous vaccination. The patient had recovered within an unspecified time frame.

VAERS ID:304210 (history)  Vaccinated:2007-11-30
Age:18.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-01, Days after onset: 63
Location:Foreign  Entered:2008-02-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Bronchitis asthmatic
Diagnostic Lab Data: WBC count 26; WBC count 4-31; WBC count 2-9; WBC count 4; body temp 40.0; pulse oximetry 96; serum C-reactive protein 21; serum C-reactive protein 232-332-48; serum creatinine 96.5-51; urine culture Comment: no growth; blood culture Comment
CDC Split Type: WAES0801USA05396
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood creatinine, Blood culture negative, Body temperature increased, C-reactive protein, Culture urine negative, Diarrhoea, Headache, Injection site pain, Oxygen saturation, Pyrexia, Respiratory rate, Vomiting, White blood cell count
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received by an authority concerning an 18 year old woman with a history of bronchitis asthmatic who on 30-Nov-2007 was vaccinated with PNEUMOVAX 23 (name and batch number of the vaccines unknown, parenteral). Secondary suspect therapy included influenza virus vaccine (unspecified), purified antigen (lot # not reported). On 30-Nov-2007 the same day as the vaccination patient felt pain at the injection site reaction. On 01-Dec-2007 the patient developed a fever of 40 (no unit reported). On 02-Dec-2007 the patient experienced diarrhea and vomiting. On an unspecified date the patient had a headache. The laboratory/diagnostic results are as follows: serum C-reactive protein test was 21 and 232-332-48 (no unit reported), Creatinine was 96.51 (no unit reported), urine culture had no growth, oxygen saturation measurement was 96 (no unit reported), blood culture had no growth, respiratory rate measurement was 36 (no unit reported) white blood cell count was 26; 4-31; 2-9 and 4 (no unit reported). According to the health authority the event involved or prolonged inpatient hospitalization. The outcome was recovering/resolving at the time of report. Case is closed. Additional information is not expected. Other business partners included are: E200800562.

VAERS ID:306169 (history)  Vaccinated:2007-11-30
Age:15.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-28, Days after onset: 90
Location:Foreign  Entered:2008-02-29, 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: Weight abnormal
Preexisting Conditions: Amenorrhoea
Diagnostic Lab Data: ultrasound 30?Nov07 Comment: Vaccination arm (slight bone defect); laboratory test Comment: Blood work up was normal (not specified)
CDC Split Type: WAES0802USA05480
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1358F0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Injection site pain, Medication error, Skeletal injury, Ultrasound scan abnormal, Wrong technique in drug usage process
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health professional concerning a 15 year old female patient who was underweight for her height and had a history of amenorrhoea. On 30-NOV-2007 patient was vaccinated in the deltoid (route not reported) with a first dose of Gardasil (batch # NG01510) (lot # 1358F). The patient had no concomitant therapy. During the vaccination, the patient experienced violent pain at the site of injection and the vaccinator felt a contact with the patient''s bone. The physician consequently pulled the needle a few centimeters back and completed the injection. The patient subsequently complained of pain at the site of injection on an unspecified date, which led the physician to perform ultrasound of the vaccinated arm. Ultrasound showed a slight "bone defect". Blood work up (not specified) was normal and magnetic resonance imaging (MRI) of the arm was scheduled. The physician considered that the event was caused by her own vaccination error and was not related to the vaccine itself. The outcome was unknown. The reporter considered the events to be an other important medical event. The other business partner''s number included: E200801494. Additional information is not available.

VAERS ID:308888 (history)  Vaccinated:2007-11-30
Age:20.0  Onset:2008-01-31, Days after vaccination: 62
Gender:Female  Submitted:2008-04-03, Days after onset: 62
Location:Foreign  Entered:2008-04-04, 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: JASMINE (DROSPIRENONE (+) ETHINYL ESTRAD unk - unk
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Neurological examination normal - no sensory or motor deficit; diagnostic laboratory test tendon reflexes normal; electromyography normal; ultrasound soft tissue of left deltoid area - no haematoma or subcutaneous anomalies.
CDC Split Type: WAES0803USA04706
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1358F1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Electromyogram normal, Injected limb mobility decreased, Injection site erythema, Myalgia, Myositis, Neurological examination normal, No reaction on previous exposure to drug, Paraesthesia, Paresis, Ultrasound scan normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a physician concerning a 20 year old female who on 30-NOV-2007 was vaccinated with her first dose of GARDASIL (Lot #1358F; Batch #NG01510) in the right arm. It is noteworthy that the patient had not experienced any adverse effects after receiving the first dose of GARDASIL in the right arm. On 29-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (Lot #0484U; Batch #NG29160) intramuscularly in the left arm. Concomitant therapy included drospirenone (+) ethinyl estradiol (JASMINELLE). On 31-JAN-2008, 48 hours after her vaccination, the patient experienced discreet erythema at the site of the injection and functional impairment of the whole arm associated with myalgia and paraesthesia. An ultrasound and an electromyogram (on an unspecified date) of the upper left arm did not reveal anything. The patient fully recovered 6 days later. Follow up information was received on 19-MAR-2008 through the pharmocovigilance form from the physician. This case was upgraded to serious (events considered serious by the reporter). Concomitant therapy of drospirenone (+) ethinyl estradiol (JASMINELLE) was considered not suspect by the reporter. Complete functional impairment of the left upper arm limb was associated with paresis and paraesthesia of the same arm. The three adverse events resolved on 07-FEB-2008. Functional impairment was reported a severe, paresis and paresthesia were reported as moderate. Laboratory diagnostic test on an unspecified date were as follows: an electromyogram of the left upper limb did not reveal anything, an ultrasound of the soft tissues of the left upper deltoid did not find any visible anomalies in the deltoid area, no haematomas and no subcutaneous anomalies were found, a neurological exam was normal, there were no sensory or motor deficits, and tendon reflexes were normal. Myositosis was suggested by the reporter as a possible diagnosis, however creatine kinase was not tested. The patient received corrective treatment with Ibuprofe

VAERS ID:316493 (history)  Vaccinated:2007-11-30
Age:14.0  Onset:2008-05-01, Days after vaccination: 153
Gender:Female  Submitted:2008-06-17, Days after onset: 47
Location:Foreign  Entered:2008-06-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA02188
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Migraine, No reaction on previous exposure to drug, Paraesthesia, Weight decreased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from a physician (who received the information from a patient''s mother) concerning a 14 year old female who on 30-NOV-2007 was vaccinated with the first dose of GARDASIL (lot# not reported), which was well tolerated. On 03-JAN-2008 the patient was vaccinated intramuscularly into the upper arm with the second dose of GARDASIL (lot# not reported). In the beginning of May 2008, the patient developed paresthesia, migraine and weight loss and was hospitalized for diagnostics. No reports on findings were made available to the reporter. The events were ongoing at the time of reporting. The physician noted that according to the patient''s mother "the symptoms improve while her daughter listens to loud music via an MP3 player". The reporting physician does not see a causal relationship to the vaccination. Other business partner numbers included: E2008-05224. No further information is available.

VAERS ID:352858 (history)  Vaccinated:2007-11-30
Age:18.0  Onset:2007-11-30, Days after vaccination: 0
Gender:Female  Submitted:2009-07-31, Days after onset: 608
Location:Foreign  Entered:2009-07-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Bronchial asthma
Diagnostic Lab Data: Blood culture, Dec2007, No growth; Body temperature, 01Dec2007, 40deg. C; C-reactive protein, Dec2007, 232; C-reactive protein, Dec2007, 332; C-reactive protein, Dec2007, 48; C-reactive protein, 01Dec2007, 21; Creatinine, Dec2007, 96; Creat
CDC Split Type: B0505423A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood creatinine normal, Blood culture negative, Body temperature increased, C-reactive protein increased, Culture urine negative, Diarrhoea, Headache, Injection site pain, Oxygen saturation normal, Pyrexia, Respiratory rate increased, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a regulatory authority (# NO-NOMAADVRE-FHI-2008-5077) and described the occurrence of diarrhea in a 18-year-old female subject who was vaccinated with Influenza virus vaccine (manufacturer unspecified) and Pneumococcal polysaccharide vaccine. The subject''s medical history included bronchial asthma. On 30 November 2007, the subject received unspecified dose of Influenza vaccine (parenteral, unknown) and unspecified dose of Pneumococcal polysaccharide vaccine (parenteral, unknown). On 30 November 2007, less than one day after vaccination with Influenza vaccine and Pneumococcal polysaccharide vaccine, the subject experienced injection site pain. On 01 December 2007, she experienced fever. On 02 December 2007, she experienced, vomiting and diarrhea. On an unspecified date she experienced headache. The subject was hospitalised. Laboratory tests were performed and showed the following: C-reactive protein: 232-332-48-21; Oxygen saturation: 96%; Body Temperature: 40.0 deg. C; Blood culture: negative; Creatinine: 96-51; White blood cells count: 26.4-31.2-9.4; Urine culture: No growth; Respiratory rate: 36. At the time of reporting the events were improved. The regulatory authority reported that the events were possibly related to vaccination with Influenza vaccine and Pneumococcal polysaccharide vaccine. Despite several attempts, no additional information could be obtained; therefore the case has been closed.

VAERS ID:510833 (history)  Vaccinated:2007-11-30
Age:21.0  Onset:2008-06-04, Days after vaccination: 187
Gender:Male  Submitted:2013-10-31, Days after onset: 1975
Location:Foreign  Entered:2013-10-31
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Scaphoid fracture
Preexisting Conditions: No known relevant medical history
Diagnostic Lab Data: Nuclear magnetic resonance ima, 2012, see lab text; Nuclear magnetic resonance ima, 2013, see lab text; 2012, MRI: several cerebral hypersignals with rare black holes; 2013, MRI: almost identical to the previous one
CDC Split Type: B0934730A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB101CA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Dysstasia, Fatigue, Inappropriate schedule of drug administration, Micturition urgency, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (broad)
Write-up: This case was reported by the foreign regulatory authority (MP20131020) and described the occurrence of multiple sclerosis in a 21-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline) and ENGERIX B adult (GlaxoSmithKline). The subject belonged to an association. Concurrent medical conditions included right scaphoid fracture on 18 June 2009. The subject had no known relevant medical history. On 31 August 2005 (batch HAB286A6, intramuscular, injection site unknown), 28 February 2006 (batch HAB286A6, intramuscular, injection site unknown, more than 1 month after the first dose) and 23 October 2006 (batch AMABB041DA as reported, AHABB041DA as data entry, intramuscular, injection site unknown; more than 6 months after the second dose), the subject received the 3 prime vaccination doses of TWINRIX adult. On 23 November 2006 (batch AMABB070AC as reported, AHABB070AC as data entry, intramuscular, injection site unknown), the subject received an extra dose of TWINRIX adult. On 30 November 2007, the subject received one dose of ENGERIX B adult (batch AHBVB101CA, intramuscular, unknown). On 04 June 2008, the first symptoms occurred with hands and foot paresthesia. A severe fatigue was noticed mainly during hot weather, with some urgent urination. The subject experienced dizziness triggered by head movements, after more than 30 minutes of footing, standing position became impossible. In 2012, a MRI showed several cerebral hypersignals with rare black holes. In 2013, a new MRI was almost identical to the previous one. Remittent multiple sclerosis was diagnosed. The subject had no significant motor disabling. Initiation of treatment was planned in August or September 2013. The regulatory authority reported that the events were disabling. At the time of reporting, the multiple sclerosis was unresolved. According to the foreign method of assessment, the regulatory authority assessed the causal relationship of vaccination with TWINRIX adult and ENGERIX B adult with the reported events as dubious.

VAERS ID:303014 (history)  Vaccinated:2007-12-01
Age:0.8  Onset:2007-12-01, Days after vaccination: 0
Gender:Male  Submitted:2008-01-17, Days after onset: 47
Location:Foreign  Entered:2008-01-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801ISR00009
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Information has been received from a physician concerning an approximately 6 week male infant who in December 2007, was vaccinated with Rotateq, first dose out of three. In December 2007, a day after the injection, the patient experienced hematochezia which lasted for three days. Subsequently, the patient recovered from hematochezia. The reporter felt that hematochezia was related to therapy with Rotateq. Hematochezia is considered to be an Other Important Medical Event. No further information is available.

VAERS ID:303298 (history)  Vaccinated:2007-12-01
Age:  Onset:2007-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-01-22, Days after onset: 52
Location:Foreign  Entered:2008-01-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: X-ray ??Dec07 Normal; serum c-reactive protein ??Dec07 slightly increased; sedimentation ??Dec07 slightly increased
CDC Split Type: WAES0801USA02757
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood creatinine increased, C-reactive protein increased, Erythema, Mobility decreased, Musculoskeletal pain, Oedema, Red blood cell sedimentation rate increased, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad)
Write-up: Information has been received from a health professional concerning a female patient who in December 2007, was vaccinated IM into deltoid with a second dose of GARDASIL. No problem was encountered during injection. 48 hours after vaccination, the patient experienced pain in the shoulder. Pain worsened over a week with the occurrence of mobility impairment of the upper limb. The shoulder was described as red and oedematous on palpation. X-ray was normal, sedimentation rate and serum c-reactive protein (CRP) test were slightly increased. the patient was seen in rheumatology on 11-JAN-2008; results were awaited. The reporting physician considered the event disabling for over 6 days, repercussion on the patient''s job. The outcome was not reported. The other business partner numbers include: E2008-00196 additional information is not expected.

VAERS ID:303510 (history)  Vaccinated:2007-12-01
Age:36.0  Onset:2007-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-01-24, Days after onset: 54
Location:Foreign  Entered:2008-01-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: In 1997, the subject experienced a first psoriasis episode around one month after the first injection of Engerix B Adult (unspecified batch reference) (B0504398A). Familial history of chronic psoriasis in a cousin since her birth.
Diagnostic Lab Data: UNK
CDC Split Type: B0504398B
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNRA
Administered by: Other     Purchased by: Other
Symptoms: Psoriasis, Vaccine positive rechallenge
SMQs:
Write-up: This case was reported by a physician and described the occurrence of psoriasis flare up in a 36-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. The subject included no past medical history of psoriasis. In 1997, the subject experienced a first psoriasis episode around one month after the first injection of Engerix B Adult (unspecified batch reference) (See case B0504398A). She did not present new psoriasis flare up from the one in 1997 to the second one in December 2007. Concomitant drug included prazepam (Lysanxia) for depression which was stopped on 14 January 2008. Familial medical history included a chronic psoriasis in a cousin since her birth. In December 2007, the subject received the second dose of Engerix B Adult (20 mcg, unknown batch reference). In 2007, around three weeks after the vaccination, the subject experienced a psoriasis flare up. At the time of reporting, the outcome of the event was unknown. This case was assessed as medically serious by GSK. The reporter''s causality assessment was unknown.

VAERS ID:303642 (history)  Vaccinated:2007-12-01
Age:0.3  Onset:2007-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-01-25, Days after onset: 55
Location:Foreign  Entered:2008-01-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had no past medical condition of neurological disorder (at clinical examination) and no past medical condition of convulsion. The delivery by her mother was normal.
Diagnostic Lab Data: Body temperature 38.5 Celsius deg; Scan Abnormal
CDC Split Type: B0503690A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Febrile convulsion, Pyrexia, Scan abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of febrile convulsion in a 4-month-old female subject who was vaccinated with Infanrixquinta, Engerix B and Prevenar for prophylaxis. The subject had no past medical condition of neurological disorder (at clinical examination) and no past medical condition of convulsion. The delivery by her mother was normal. Around end of December 2007 - beginning of January 2008, the subject received a 1st dose of Infanrixquinta (batch number not available), a 1st dose of Engerix B (batch number not available) and a 1st dose of Prevenar (batch number not available). One day after vaccinations, the subject developed febrile convulsion, which quickly resolved. The subject was hospitalised. At the admission, fever was a t28.5 degrees Celsius. Scan revealed an abnormality (NOS). The subject initiated as treatment with Depakine. The physician considered the event was possibly related to vaccination with Infanrixquinta, Engerix B and Prevenar.

VAERS ID:303712 (history)  Vaccinated:2007-12-01
Age:21.0  Onset:2007-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-01-25, Days after onset: 55
Location:Foreign  Entered:2008-01-28, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Rectorrhagia; Mucous stools; Abdominal pain
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA03204
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0275U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Colonoscopy abnormal, Condition aggravated, Enterocolitis haemorrhagic, Histology abnormal, Mucous stools, Rectal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Noninfectious diarrhoea (broad)
Write-up: Information has been received from a physician concerning her 21 year old daughter who was recently diagnosed with hemorrhagic rectocolitis who in November 2007 (also reported as early December 2007) was vaccinated IM into the thigh with a first dose of Gardasil (Lot# 0275U; Batch# NF54050). It was reported that late in January 2007, the patient received a dose of Vaxigrip. Three weeks later, she experienced rectorrhagia, mucous stools and abdominal pain. In May 2007, as symptoms persisted, a colonscopy was performed. The macroscopic and histologic aspect of rectal lesion lead to a diagnosis of haemorrhagic rectocolitis, with isolated rectal impairment (Also confirmed by imaging and biopsy). Approximately 15 days to 3 weeks after the first vaccination with Gardasil, the patient experienced another flare of the disease with the same symptoms as in May 2007. She was hospitalized and received corrective treatment with mesalazine (PENTASA), which was inefficient. A one month treatment with IV corticosteroids, triamcinolone (KENACORT) was started. Her symptoms regressed, however, at the time of this report, the patient had not recovered. It was also reported that hospital physician did not consider the vaccine as the triggering factor, however the reporter did not wish to continue the vaccination. Other business partner numbers include: E200800276. No further information is available.

VAERS ID:303924 (history)  Vaccinated:2007-12-01
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-29
Location:Foreign  Entered:2008-01-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Paralysis
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA04277
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Condition aggravated, Fall, Fatigue, Gait disturbance, Paralysis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a healthcare professional concerning a 17-year-old female who in December 2007, was vaccinated with her second 10.0 mcg dose of Recombivax HB. The patient was vaccinated because of her training to become a health care professional. A few days after the first dose of Recombivax HB was administered, she developed an increasing tiredness in her arms and legs. After some time symptoms of paralysis developed, she experienced difficulty in walking and fell. The problems of paralysis were aggravated when she received the second dose. The general practitioner (GP) was consulted, she was sent to a neurologist and hospitalized. The third dose will not be administered. Other company numbers included: E200800381. Additional information has been requested.

VAERS ID:304199 (history)  Vaccinated:2007-12-01
Age:18.0  Onset:2007-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-02-01, Days after onset: 62
Location:Foreign  Entered:2008-02-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypersensitivity
Preexisting Conditions: Asthma; Gastrooesophageal reflux
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05392
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Bronchitis, Condition aggravated, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Information has been received from a health authority concerning an 18 year old female with allergy and a history of asthma and gastrooesophageal reflux who in December 2007, was vaccinated with a first dose of Gardasil. In December 2007, five hours post vaccination the patient experienced a severe asthmatic attack, fever, and nausea. Two days later the patient developed bronchitis. The patient was treated with antibiotics. Subsequently, the patient recovered five days afterwards. The reporter felt that the events were serious for an other important medical event. Other business partner numbers include E2008-0060. Additional information has been requested.

VAERS ID:304655 (history)  Vaccinated:2007-12-01
Age:0.3  Onset:2007-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-02-08, Days after onset: 69
Location:Foreign  Entered:2008-02-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA01139
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Somnolence, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a health care professional concerning a 3 month old female who in December 2007 (exact date not reported), was vaccinated with her first dose of ROTATEQ (batch #, lot # not reported). Concomitant vaccination administered on that same day included a dose of PREVNAR. Later that day, the patient experienced vomiting (afternoon and night), somnolence and fainting episodes. The patient was sent to the hospital directly from the ER, but she was not admitted to the hospital. No significant medical findings were noted. The patient recovered that same day. The event was considered medically relevant an other important medical event by the reporter. Other business partner numbers include: E2007-00727. No further information is available. Case is closed.

VAERS ID:304885 (history)  Vaccinated:2007-12-01
Age:24.0  Onset:2007-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-02-13, Days after onset: 74
Location:Foreign  Entered:2008-02-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypersensitity; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0802USA02234
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Hypersensitivity, Malaise, Palatal oedema, Throat irritation, Tonsillitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a healthcare professional, concerning a 24 year old female patient with hypersensitivity (not specified) and drug hypersensitivity to paracetamol, who in December 2007, was vaccinated with the first dose of Gardasil (lot # not reported). Two to three hours after vaccination, she experienced general malaise. That evening, she developed dyspnea, itchy throat and uvula edema. She went to emergency services and was diagnosed with an allergic reaction to the vaccine. Treatment included URBASON, and the patient''s symptoms improved. The next day, she experienced similar symptoms, and was diagnosed with tonsillitis. No further information was reported. The healthcare professional considered one or more of the events to be serious as an other relevant medical event. Other business partner numbers include: E2008-01029.

VAERS ID:305011 (history)  Vaccinated:2007-12-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Foreign  Entered:2008-02-15, 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: WAES0802USA02742
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure increased, Hypertensive crisis
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)
Write-up: Information has been received from a consumer, concerning her daughter (age not specified) with no reported medical history, who in December 2007, was vaccinated with the first dose of GARDASIL (lot # not reported). Subsequently (date of onset not specified). the patient experienced a hypertensive crisis, described as elevation of blood pressure within minutes, of unknown etiology. Investigations included neurology, cardiology and ophthalmology, though a diagnosis was not determined. In January 2008, the second dose of GARDASIL (lot # not reported) was administered. At the time of this report, hypertensive crisis (elevation of blood pressure within minutes) had not resolved. The event of hypertensive crisis was considered to be serious as an other important medical event. Other business partner numbers include E2008-00751.

VAERS ID:305365 (history)  Vaccinated:2007-12-01
Age:0.4  Onset:2007-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-02-21, Days after onset: 82
Location:Foreign  Entered:2008-02-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Previous vaccination included the 1st dose of Infanrix-IPV/Hib (GlaxoSmithKline; unknown; unknown) given when she was 2 months old without any adverse event and Prevnar (Wyeth Labs; unknown; unknown) given 15 days prior to the day of report again without any adverse event.
Diagnostic Lab Data: UNK
CDC Split Type: B0504350A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site oedema, Injection site rash, Porphyria, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Congenital, familial and genetic disorders (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of thrombocytopenia purpura in a 5-month-old female subject who was vaccinated with Infanrix-IPV/Hib (GlaxoSmithKline). Previous vaccination included the 1st dose of Infanrix-IPV/Hib (GlaxoSmithKline; unknown; unknown) given when she was 2 months old without any adverse event and pneumococcal vaccine, unspecified (Wyeth Labs; unknown; unknown) given 15 days prior to the day of report again without any adverse event. In December 2007, the subject received the 2nd dose of Infanrix-IPV/Hib (unknown, unknown thigh, lot number not provided). In December 2007, few hours after vaccination with Infanrix-IPV/Hib, the subject presented oedema and porphyric rash at the injection site (thigh). The infant recovered after two days with no sequale and without any treatment. In December 2007, the events resolved. The pediatrician did not actually see the event as the parents reported it after it had abated, but the parents took a photo which they were going to send to the pediatrician. The pediatrician does not know whether the event is related to the vaccine. She expected to examine the photo taken by the parents before she comes to a conclusion and before she proceeds to the third dose of Infanrix-IPV/Hib. This case was assessed as medically serious by GSK. Follow up information received on 08 February 2008: The parents of the child took photos of the event and sent it to the pediatrician who diagnoseed thrombocytopenic purpura. She still can not provide a causality assessment and she was uncertain as to whether she will continue with the 3rd dose of Infanrix-IPV/Hib. Follow up information received on 14 February 2008: The subject had no relevant medical history. The subject was not hospitalised. The events did not require any blood transfusion, platelets transfusion, platelets transfusion, Gamma globulin or corticosteroid.

VAERS ID:310281 (history)  Vaccinated:2007-12-01
Age:15.0  Onset:2008-04-01, Days after vaccination: 122
Gender:Female  Submitted:2008-04-17, Days after onset: 16
Location:Foreign  Entered:2008-04-21, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA02303
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, No reaction on previous exposure to drug, Tonic clonic movements
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: Information has been received from a health professional concerning a 15 year old female patient who in December 2007 (exact date not reported), was vaccinated with the second dose of GARDASIL. On an unreported date, four months after the second dose, the patient experienced a seizure (tonic/clonic episode). The patient was referred to accident and emergency. It was not known if the patient was kept in hospital overnight. Subsequently, the patient recovered. It was also reported that the patient received the first dose of GARDASIL without any adverse events. It has not been reported if the patient was receiving any concomitant medication. The reporter considered the seizure to be a serious reaction due to other medically important reason. Other business partner numbers include: E200803272 and 67359. No further information is available.

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