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Case Details (Sorted by Vaccination Date)

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VAERS ID:296514 (history)  Vaccinated:2007-11-13
Age:13.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-11-13, Days after onset: 0
Location:Illinois  Entered:2007-11-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.106142IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Cyanosis, Gaze palsy, Grand mal convulsion, Pallor
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: APPROX 1-2 MINUTES PATIENT BECAME PALE, CONTINUED TO BECOME INCREASINGLY PALE EYES ROLLED BACK AND PATIENT STARTED TO HAVE GRAND MAL SEIZURE LASTING APPROX 5 SECONDS. CIRCUMORAL CYANOSIS NOTED. PATIENT NEUROLOGICALLY APPROPRIATE POST SEIZURE. BLOOD PRESSURE 102/40 IMMEDIATELY POST, 128/52 10 MINUTES POST.

VAERS ID:296636 (history)  Vaccinated:2007-11-13
Age:27.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Male  Submitted:2007-11-14, Days after onset: 1
Location:Arizona  Entered:2007-11-14
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: Father of patient claims to be healthy.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1391U PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Accidental exposure
SMQs:, Medication errors (narrow)
Write-up: Father of patient was holding child who had just received an oral dose of Rotateq. The child coughed and fluid from his mouth made contact with the father''s eye. Unsure if fluid was just saliva or vaccine. Eye flushed at eye wash station. Father did not have any complaints of pain or burining in the eye. Father showed copy of package insert and denies allergy to any ingredients listed. Call placed to Merck. Spoke with physician who recommended observation for now. Most likely will not contract rotavirus as it requires oral transmission and Dad has probably had the virus at some time in the past. Could have local reaction at site of splash. Needs to observe for irritation, swelling, eye pain, visual changes. If any concerning sx, needs to seek medical care. This information relayed to father. Informed that we would be doing a VAERS report. Dad verbalized understanding.

VAERS ID:296704 (history)  Vaccinated:2007-11-13
Age:15.0  Onset:2007-11-14, Days after vaccination: 1
Gender:Male  Submitted:2007-11-14, Days after onset: 0
Location:Washington  Entered:2007-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: trileptal, seroquel
Current Illness: none
Preexisting Conditions: diabetes
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS80956 IMGM
Administered by: Unknown     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: vaccination was given in the evening. the following AM she had a rash on face and over torso

VAERS ID:296710 (history)  Vaccinated:2007-11-13
Age:1.5  Onset:2007-11-14, Days after vaccination: 1
Gender:Female  Submitted:2007-11-14, Days after onset: 0
Location:Idaho  Entered:2007-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: diarrhea for 2 weeks
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B049AA3IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2459MA2IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0526U0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47442D3IMLL
Administered by: Private     Purchased by: Private
Symptoms: Abasia
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)
Write-up: pt unable to walk 24 hours after vaccine, attempted to stand and could not bear weight, after, 36 hours after vaccine was administerd pt able to walk

VAERS ID:296791 (history)  Vaccinated:2007-11-13
Age:11.0  Onset:2007-11-14, Days after vaccination: 1
Gender:Female  Submitted:2007-11-15, Days after onset: 1
Location:Pennsylvania  Entered:2007-11-15
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: allergic to erythromyacin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  IMLA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal pain upper, Chills, Dizziness, Erythema, Headache, Injection site swelling, Pain, Pallor, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever of 100.1 10:30 am 11/14/07 sent home from school. Fever rose to 103.5 by 12:00 pm 11/14/07 extreme chills redness of entire body then extremely pale aching body dizziness headache stomachache. Contacted doctor was told to give motrin/ tylenol and put her in a tepid bath.Gave her soup and tea for stomachache. I did that and fever subsided for a few hours. it then returned 103.2 along with all the symptoms listed above, again i called the doctor at 6:00 pm 11/14/07 was told to give more tylenol and get her back in the bath. Gave her tea and a 1/2 bagel.The fever subsided again until 11:00 pm and again the symptoms returned 102.3, again I put her back in the bath and gave more tylenol. Gave tea and toast for stomachache. Symptoms again subsided until 3:30 am 11/15/07 101.9 i then gave her more tylenol and a cup of tea to settle her stomach. 7:00 am 11/15/07 fever returned and the shot area is very swollen chills are again back and fever is 100.4 i gave her more tylenol tea and a small amount of plain yogurt to try and settle her stomach also an ice pack was applied to the swollen area. 8:27am 11/15/07 fever is returning it is 100.9 and she is jhaving chills and stomachache headache.

VAERS ID:296814 (history)  Vaccinated:2007-11-13
Age:26.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Male  Submitted:2007-11-15, Days after onset: 2
Location:California  Entered:2007-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none (per client)
Current Illness: Client stated he had a seizure at 20 years old.
Preexisting Conditions: unknown
Diagnostic Lab Data: none at present time; still trying to contact the client for a follow up.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA054AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Dizziness, Loss of consciousness, Petit mal epilepsy
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: flu vaccine administered in left deltoid at 0954 and at 0955 became light headed and sat down. At 10:05a client was in and out of conciousness and had a petite mal seizure lasting approx. 30 seconds in duration (paramedics on site). Was transported to Hospital

VAERS ID:296820 (history)  Vaccinated:2007-11-13
Age:7.0  Onset:2007-11-15, Days after vaccination: 2
Gender:Female  Submitted:2007-11-15, Days after onset: 0
Location:Wisconsin  Entered:2007-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANTUS, NOVOLOG
Current Illness: TYPE 1 DM
Preexisting Conditions: ALLERGIC TO CINNAMON
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2502AA1IMLL
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0200U0IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1343U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site reaction, Local reaction
SMQs:
Write-up: LOCALIZED REACTION ON RIGHT THIGH 7X7 CM LARGER ON DAY 2 THAN DAY ONE POST INJECTION TREATED WITH ZYRTEC 10 MG PO DAILY FOR A WEEK

VAERS ID:297311 (history)  Vaccinated:2007-11-13
Age:0.6  Onset:2007-11-13, Days after vaccination: 0
Gender:Male  Submitted:2007-11-13, Days after onset: 0
Location:Massachusetts  Entered:2007-11-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B129AA2IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR072774AA0UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUROF92AA2IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.B70193A2IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1192U6PO 
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: fever after vaccine on 11/13/07

VAERS ID:297320 (history)  Vaccinated:2007-11-13
Age:1.3  Onset:0000-00-00
Gender:Male  Submitted:2007-11-13
Location:Michigan  Entered:2007-11-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2477DA0IMLL
TDAP: TDAP (ADACEL)SANOFI PASTEURC2644AA3IMRL
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Irritability, Medication error, Vomiting, Wrong drug administered
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: PHN gave Tdap instead of Dtap. see attached MICR and Immz. flow sheet. Dr Notified by phone at 1615. 11/14 TC from Dr''s office Re what vaccine given on 11/14/07; 11/15/07 PHN called Dr''s office - child seen PA Temp of 101 deg; throwing up for 12 hours (7p to 7Am) on 11/13/07 fussy. getting Oral Tylenlol

VAERS ID:297324 (history)  Vaccinated:2007-11-13
Age:17.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-11-15, Days after onset: 2
Location:Louisiana  Entered:2007-11-19, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none noted~ ()~~0~In Patient
Other Medications: None
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: None
CDC Split Type: LA071104
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0273-24SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2407AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Immediate post-injection reaction, Loss of consciousness, Malaise, Nausea, Posturing, Tonic clonic movements, Unresponsive to stimuli, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Patient with Apprehension noted prior to 1st dose, pt received 3 dose, HPV (2nd) Followed by IPV, pt with complaint of "not feeling good", passed out immediately after, had tonic-clonic movement and posturing noted, Lasted 30 seconds, responsive after 3rd Ammonia inhalant, alert x3, with c/o "eyes; see Back; Feeling Funny ", patient with urinary incontinence during event. Placed supine on Floor with legs Elevated, Released to Father 30 min Later. Patient Ambulatory. Follow-up with parent 3 Hrs Later, pt home Resting with complaint of nausea, No other events reported.

VAERS ID:297422 (history)  Vaccinated:2007-11-13
Age:0.17  Onset:2007-11-15, Days after vaccination: 2
Gender:Male  Submitted:2007-11-16, Days after onset: 1
Location:North Carolina  Entered:2007-11-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 12/3/07-records received-CT and EKG negative. CBC BMP normal. EEG results pending.
CDC Split Type: NC07114
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B130AA IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0259U IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH870143A IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0533U PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms:
SMQs:
Write-up: Possible seizure admitted to hospital for workup. 12/3/07-records received for DOS 115/15-11/16/07-Overnight observation-Assessment:choking episode. Family member observed child foaming at mouth, gasping for air. Suctioned his nose as it appeaded he was not catching his breath and strangling on saliva. Seemed to have some loss of muscle tone. No color changes no shaking or eye deviation.

VAERS ID:297424 (history)  Vaccinated:2007-11-13
Age:2.0  Onset:2007-11-14, Days after vaccination: 1
Gender:Male  Submitted:2007-11-19, Days after onset: 5
Location:Arizona  Entered:2007-11-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ocuflox; Tamiflu; Carvedilol; Captopril; Protonix; Reglan
Current Illness: None
Preexisting Conditions: Developmental delay NOS; Blindness/Low Vision; Prim Cardiomyopathy Nec; GERD; 6/23/08-records received-PMH:congenital dilated cardiomyopathy, developmental delay, G-tube dependent and gastroesophageal reflux.
Diagnostic Lab Data: 6/23/08-records received-Lumbar puncture, MRI showed focal edema and cytotoxic change in mid left thalamus an acute change. Atrophic appearance of right mesial temporal lesion w ith dilatation of temporal horn, EEg show some seizure activit
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2474CA2IMLL
Administered by: Private     Purchased by: Private
Symptoms: CSF culture negative, Chest X-ray abnormal, Convulsion, Electroencephalogram abnormal, Loss of consciousness, Nuclear magnetic resonance imaging abnormal, Respiratory syncytial virus serology, Status epilepticus
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Per hospital admission note - admitted on 11/17/07 for acute loss of consciousness. 6/23/08-records received for DOS 11/15-11/24/07-DC DX: seizure disorder. Presented with nonconvulsive status epilepticus demonstrated on EEG.

VAERS ID:297425 (history)  Vaccinated:2007-11-13
Age:2.0  Onset:2007-11-17, Days after vaccination: 4
Gender:Male  Submitted:2007-11-19, Days after onset: 2
Location:Arizona  Entered:2007-11-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Magnesium Sulfate; Ferrous Sulfate; Reglan; Poly-Vi-Sol; Protonix; Prograf; Sirolimus; Valcyte
Current Illness: None
Preexisting Conditions: Compl Heart Transplant; Strabismus; GERD; Microcephalus; Infectious mononucleosis; Developmental delay; Feeding problem 6/27/08-records received-PMH:Cardiac transplant secondary to cardiomyopathy 2/06, congenital dilated cardiomyopathy, G-tube feed, seizure disorder. 37 week twin.
Diagnostic Lab Data: 6/27/08-records received-EEG subclinical seizure acitivty without any obvious seizure activitiy. Urine culture negative, blood culture negative, CT no acute pathology, abnormal appearance of lateral ventricles with dilatation of frontal horms and prominent frontal CSF space as well and cerebellar atrophy. BMP normal range.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2474CA2IMLL
Administered by: Private     Purchased by: Private
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Per hospital admission notice - admitted 11/15/07 for seizures. 6/27/08-records received for DOS 11/17-11/25/07-DC DX: Global developmental delay. Presented with status epilepticus with some desaturation at home, generalized tonic-clonic seizures and decreased responsiveness per parent. Cough and nasal congestion noted. Known seizure disorder.

VAERS ID:297452 (history)  Vaccinated:2007-11-13
Age:  Onset:2007-11-14, Days after vaccination: 1
Gender:Unknown  Submitted:0000-00-00
Location:Unknown  Entered:2007-11-20
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: insomnia allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Herpes zoster, Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: pt given 1st (L) arm Gardasil then developed shingles (L) shoulder (L) upper ant chest and trunk approx 4 hours after Gardasil injection.

VAERS ID:297457 (history)  Vaccinated:2007-11-13
Age:57.0  Onset:2007-11-16, Days after vaccination: 3
Gender:Female  Submitted:2007-11-19, Days after onset: 3
Location:Massachusetts  Entered:2007-11-20, 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: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2524AA UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1229F0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: increased swelling pain given Levaquin 750 11/19/07 better/can use hand slightly/not as red

VAERS ID:297518 (history)  Vaccinated:2007-11-13
Age:20.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-11-21, Days after onset: 8
Location:Missouri  Entered:2007-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Desogen
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.052240IMRA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Pt got dizzy after Gardasil injection. Given ammonia pellet and juice, rested in clinic for 20 minutes. Left alerted and oriented. BP 100/60 Pulse 66 Resp 16 even and unlabored.

VAERS ID:297559 (history)  Vaccinated:2007-11-13
Age:0.4  Onset:2007-11-14, Days after vaccination: 1
Gender:Female  Submitted:2007-11-15, Days after onset: 1
Location:Idaho  Entered:2007-11-23, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Normal CBC, Chem 7, Blood Cx, CSF Cx.Labs and Diagnostics (11/14/07): CBC WNL except platelets of 98,000. Chemistry WNL with glucose . Head CT normal. LP with normal CSF. CSF culture (-). Blood culture (-). WBCs 15.4 on 12/05/07. EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B130AA1UNRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0676U1UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB53981H1UNLL
Administered by: Private     Purchased by: Unknown
Symptoms: Blood culture negative, Blood glucose increased, CSF culture negative, Clonus, Computerised tomogram normal, Convulsion, Excessive eye blinking, Febrile convulsion, Full blood count normal, Laboratory test normal, Myoclonus, Platelet count increased, Postictal state, Pyrexia, Scan brain, White blood cell count increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Prolonged Seizure less than 24 hours after administration. 12/17/2007 MR received for DOS 11/14-15/2007 with D/C Dx: Seizure, prolonged. Hx of recent admin of routine 4 month vaccinations. Fever, resolved. ER record also received for 12/05/2007 with DX: Pediatric fever with likely febrile seizure. On 11/14/07 infant presented to ER with generalized seizure activity. Clonic seizure activity and blinking continue despite initial dose of Diastat. VS WNL including a temp of 98.7''F. No further seizure activity but temp went up to 102''F 1 day post seizure. Infant returned on 12/5/07 with recurrent seizure. Pt had temp of 100.8''F. Pt continued with some myoclonic jerking then became post ictal. EEG to be obtained at a later time.

VAERS ID:297843 (history)  Vaccinated:2007-11-13
Age:66.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:California  Entered:2007-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: cheratussin, Azmacort, Xopenex, benzonatate, Mirapex, prednisone, azithromycin, fluoxetine, Topamax
Current Illness: Recovering from URI, no fever
Preexisting Conditions: Milk allergy, asthma, arthritis, hyperlipidemia, mild osteopenia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2504AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Bronchitis, Cough, Dyspnoea, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Recovering well from URI with bronchitis. Following IZZ c/o worsening cough & shortness of breath evening of IZZ until 3 d later visited clinic for same. No sx improvement with Xopenex x2. Have on prednisone taper & Zithromax.

VAERS ID:297855 (history)  Vaccinated:2007-11-13
Age:0.5  Onset:2007-11-14, Days after vaccination: 1
Gender:Female  Submitted:2007-11-27, Days after onset: 13
Location:Ohio  Entered:2007-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN
Current Illness: Ear infection diagnose one week prior
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B074AA2IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF120AA2IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08690B2IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0667U2PO 
Administered by: Public     Purchased by: Public
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Approximately 24 hrs. after receiving vaccines, mother stated that child developed fine red rash on both legs, back, abdomen and arms. No fever. Child taking Amoxicillin for ear infection x 1 week and this is first time on Amoxicillin

VAERS ID:297903 (history)  Vaccinated:2007-11-13
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2007-11-22
Location:Illinois  Entered:2007-11-27, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2510AA1UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0964U1UNRA
Administered by: Other     Purchased by: Private
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Pain in right arm

VAERS ID:297916 (history)  Vaccinated:2007-11-13
Age:4.0  Onset:2007-11-14, Days after vaccination: 1
Gender:Male  Submitted:2007-11-16, Days after onset: 2
Location:California  Entered:2007-11-27, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cortisone Creme
Current Illness: None
Preexisting Conditions: Allergies: Bactrim, Trees, Cats, Grass
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2473BA1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The patient came in on 11-15-07 with his left arm all swollen and red from the shoulder bone all the way down to his elbow. It was also hot and Mom said that his elbow started to swell on 11-14-07 at night.

VAERS ID:298195 (history)  Vaccinated:2007-11-13
Age:17.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-11-21, Days after onset: 8
Location:Massachusetts  Entered:2007-11-29, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266N0 LA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2484AA0 RA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Patient''s brother came into office stating patient had passed out in car - when staff personnel arrived, patient more alert and oriented - pale - brought back to office. Lying down blood pressure 105/74 x 2 - observed - color good

VAERS ID:298207 (history)  Vaccinated:2007-11-13
Age:0.17  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-11-13, Days after onset: 0
Location:Alabama  Entered:2007-11-29, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B125BB0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF603AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54014D0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0972U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)
Write-up: Patient was fussy in the afternoon following vaccination. Seen in office to recheck; mild swelling in thigh that had Pediarix/HIB. Plan to space out next vaccines.

VAERS ID:298210 (history)  Vaccinated:2007-11-13
Age:17.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Male  Submitted:2007-11-28, Days after onset: 15
Location:North Dakota  Entered:2007-11-29, 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: Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2382BA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Malaise, Pallor, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mother related he came home and was very pale and didn''t feel well. Developed bumpy, itchy rash on arm where immunization was given. Mom gave him Benadryl and symptoms passed in approx. 4 hours.

VAERS ID:298233 (history)  Vaccinated:2007-11-13
Age:6.0  Onset:2007-11-15, Days after vaccination: 2
Gender:Unknown  Submitted:2007-11-15, Days after onset: 0
Location:Washington  Entered:2007-11-29, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: mild asthma, nocturnal enuresis
Preexisting Conditions: mild asthma, nocturnal enuresis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB213AA1IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1359U1SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site papule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: L thigh redness of 1cm diameter & small papular lesion in center. No fever. These occurred about 48 hrs after shot. No treatment.

VAERS ID:298937 (history)  Vaccinated:2007-11-13
Age:19.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Male  Submitted:2007-11-27, Days after onset: 14
Location:Minnesota  Entered:2007-12-06, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Denies
Diagnostic Lab Data: He hasn''t wanted to go to the doctor. I continue to rec. that as he still doesn''t feel good (11/27/07).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2511AA2IMRA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Fatigue, Lethargy, Pain, Pallor, Pharyngolaryngeal pain, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Mom reported the evening of the shot (shot given at 210 PM) he experienced dizziness "all the time" and his color was bad. He''s achy and also had a sore throat. Dizziness and paleness continued about a couple days so that''s why she called us 11-16-07. He did go back to work, but very groggy and tired - lethargic.

VAERS ID:298952 (history)  Vaccinated:2007-11-13
Age:60.0  Onset:2007-11-19, Days after vaccination: 6
Gender:Male  Submitted:2007-11-28, Days after onset: 9
Location:Vermont  Entered:2007-12-06, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prozac 20 mg
Current Illness: None
Preexisting Conditions: Sulfa drugs-headache
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1080U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: red rash 5 cm diameter, appeared 6 day/after shot given Noticed reaction same day-not reported x 6 days

VAERS ID:298994 (history)  Vaccinated:2007-11-13
Age:60.0  Onset:2007-11-14, Days after vaccination: 1
Gender:Female  Submitted:2007-11-15, Days after onset: 1
Location:Texas  Entered:2007-12-06, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0963U0  
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 5 inch band (below injection site) of redness and swelling, cold compress applied night of 11/14/07. 11/15 - patient said getting better, swelling gone down.

VAERS ID:300727 (history)  Vaccinated:2007-11-13
Age:16.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 31
Location:Massachusetts  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0711USA02913
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a "16 year old" female with no pertinent medical history who on 13-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM. Concomitant therapy included MENACTRA (lot# unknown). On 13-NOV-2007 the patient fainted after receiving GARDASIL. Medical attention was sought. No additional information was provided. Additional information has been requested.

VAERS ID:300736 (history)  Vaccinated:2007-11-13
Age:12.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 31
Location:Unknown  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA03139
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: No reaction on previous exposure to drug, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a mother concerning her 12 year old daughter who on 09-May-2007 was vaccinated into the left arm with a first dose of Gardasil. On 13-Nov-2007, the patient was vaccinated with a third dose of Gardasil. Concomitant suspect vaccination on the same day included Vaqta. On 14-Nov-2007 the patient fainted. She "came out of it shaking or tremoring (whole body) and almost fell off the table". She was given orange juice and was told to lie down. The patient was in the office. On 13-Nov-2007, the patient recovered. The patient had no problems with the first and second dose of Gardasil. Additional information has been requested.

VAERS ID:301186 (history)  Vaccinated:2007-11-13
Age:25.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-12-10, Days after onset: 27
Location:Wisconsin  Entered:2007-12-28, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS811110IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Medication error, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Patient required 2 injections; 1st injection given with no flu vaccine in syringe; 2nd injection had flu vaccine drawn up - was given.

VAERS ID:302536 (history)  Vaccinated:2007-11-13
Age:0.35  Onset:2008-01-02, Days after vaccination: 50
Gender:Male  Submitted:2008-01-11, Days after onset: 9
Location:California  Entered:2008-01-11
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Abdominal U/S: transverse colon intussusception. Labs and Diagnostics: Abd US (+) for IS. Barium enema (+) for IS at level of hepatic flexure.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B0621IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.6376U1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01261IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54015D1IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1392U1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Barium enema abnormal, Diarrhoea haemorrhagic, Enema administration, Intussusception, Irritability, Oral intake reduced, Ultrasound abdomen abnormal, Urine output decreased, Vomiting
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Developed 1 d hx of fussiness and vomiting and found to have intussusception and reduced by barium enema. 01/23/2008 Vax record received and Rotateq Lot # updated. It appears that the reported lot # was for the 9/18/07 dose not the 11/13/07 dose. 5/30/2008 MR received for DOS 1/2-3/2008 with DX: Intussusception. Infant presented to local hospital with belly pain, vomiting and bloody diarrhea. Pt had been feeding poorly and had fewer wet diapers. Reduced by Barium enema and admitted for o/n obs.

VAERS ID:302636 (history)  Vaccinated:2007-11-13
Age:25.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Male  Submitted:2007-11-15, Days after onset: 2
Location:Georgia  Entered:2008-01-14, Days after submission: 60
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: None
CDC Split Type: GA07083
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURPMCU2524AACP1IMRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness around injection site, rash developed. Client c/o itching without relief after taking Benadryl. Saw MD 11-15-07, gave him a shot for itching and a Rx for Motrin & Benadryl.

VAERS ID:303374 (history)  Vaccinated:2007-11-13
Age:0.3  Onset:0000-00-00
Gender:Male  Submitted:2007-12-11
Location:Michigan  Entered:2008-01-23, Days after submission: 43
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B015AA0IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0500U0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08720SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB70143A0IMLL
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: Infant was given Rotateq at 15 wks. of age. Next visit due Jan. 08. There has been no contact with or from family.

VAERS ID:305372 (history)  Vaccinated:2007-11-13
Age:1.3  Onset:2007-11-14, Days after vaccination: 1
Gender:Male  Submitted:2008-02-21, Days after onset: 99
Location:Virginia  Entered:2008-02-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2516AA0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0500U1IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1470F0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700K2IMRL
Administered by: Military     Purchased by: Military
Symptoms: Grand mal 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Fever with tonic clonic seizures lasting 30 seconds and occurring at 3 AM on November 14, 2007. Paramedics were called to the house, child recovered, advised follow up.

VAERS ID:313332 (history)  Vaccinated:2007-11-13
Age:24.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 182
Location:New York  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: Sulfonamide allergy
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA00214
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1265U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Influenza like illness, Injection site pain, Pain, Sleep disorder
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 24 year old female with a history of sulfonamide allergy who on 13-NOV-2007 was IM vaccinated with her first dose of GARDASIL (lot number 659435/1265U). On 14-JAN-2008 the patient was IM vaccinated with her second dose of GARDASIL (lot number 659435/1265U). On 29-APR-2008 the patient received her third dose of GARDASIL (lot number 660389/1968U) intramuscularly. Concomitant therapy included APRI. On 13-NOV-2007 the patient experienced injection site pain. On 14-JAN-2008 the patient experienced injection site pain. On 29-APR-2008 the patient experienced body aches, felt like she had the flu and barely slept overnight. The patient''s body aches, flu-like symptoms and difficulty sleeping persisted. The patient sought medical attention by calling the office. The patient was told to drink fluids and take TYLENOL. The patient missed work due to her symptoms. Additional information has been requested.

VAERS ID:314659 (history)  Vaccinated:2007-11-13
Age:2.0  Onset:2007-11-17, Days after vaccination: 4
Gender:Male  Submitted:2008-05-29, Days after onset: 193
Location:Arizona  Entered:2008-06-03, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations: No adverse effect~Influenza (Fluzone)~2~2~In Patient
Other Medications: magnesium sulfate 4%, ferrous sulfate, REGLAN, POLY-VI-SOL, PROTONIX, PROGRAF, sirolimus, VALCYTE
Current Illness:
Preexisting Conditions: The patient had no illness at the time of vaccination and had received a prior dose of FLUZONE on 10 October 2007. The patient had a past medical history of complete heart transplant (16/Feb/2006), strabismus, gastroesophageal reflux disease, microcephalus, infectious mononucleosis, general social family, development delay NOS and feeding problem (g-tube - oral aversion). The pat
Diagnostic Lab Data: EEG, showed nearly continuous seizures; Follow-up EEG, showed some continued electrographic seizures
CDC Split Type: 200801661
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2474C2IMLL
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Electroencephalogram abnormal, Epilepsy, Hyperreflexia, Hypotonia, Loss of consciousness, Status epilepticus
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Initial report was received 20 May 2008 from a health care professional. Additional information was received 22 May 2008 from the same health care provider. A two-year-old male patient, who was an identical twin born at 32 weeks gestation, had received a third dose, left thigh intramuscular injection of FLUZONE No-preservative 2007-2008, lot number UT247CA, on 13 November 2007 and four days later, on 17 November 2007, he was admitted to the hospital with an admitting diagnosis of acute loss of consciousness. According to the reporter, the patient had no concurrent illness at the time of vaccination. The patient had previously received a second dose, intramuscular right thigh injection of FLUZONE SV, lot number UT504AA, on 10 October 2007 with no reported adverse events. The patient had a history of complete heart transplant, strabismus and cortical visual impairment, gastroesophageal reflux disease, microcephalus, infectious mononucleosis, general social/family, development delay and feeding problems. The patient also had a history of infectious mononucleosis which had resolved with Valcyte therapy (dates not provided). The patient had been receiving concomitant medications which included Magnesium Sulfate 4%, Ferrous Sulfate 15mg/0.6mL, REGLAN 5 mg/Ml, POLY-VI-SOL, PROTONIX 40 mg, PROGRAF 5 MG/Ml, sirolimus 1 mg/mL and VALCYTE 450 mg/tabs. According to medical records received, the patient was admitted to the hospital''s critical care unit on 17 November 2007 with an admitting diagnosis of acute loss of consciousness. According to a VAERS report filled by the reporter on 19 November 2007, the patient had been admitted on 15 November 2007 for seizures; however, this patient has a twin sibling (case 2008-01680) who had been hospitalized on 15 November 2007 with an admitting diagnosis of seizure. The following information will include information obtained from medical records received from the reporter. The patient had been seen by his neurologist for a follow-up evaluation on 22 April 2008 with a chief complaint of

VAERS ID:317267 (history)  Vaccinated:2007-11-13
Age:52.0  Onset:2008-01-15, Days after vaccination: 63
Gender:Male  Submitted:2008-05-05, Days after onset: 110
Location:Massachusetts  Entered:2008-06-24, Days after submission: 50
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes, Hypertension; Increased triglycerides
Preexisting Conditions: NKA
Diagnostic Lab Data: MRI, blood work
CDC Split Type: MA0809
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA050AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Blood test, Movement disorder, Nerve injury, Nuclear magnetic resonance imaging, Viral infection
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Accidents and injuries (narrow)
Write-up: Mid January, pt developed "curling" of the three middle fingers associated with the ulnar nerve (ring, small and middle). The fingers can''t be opened straight on exam must be held open. MRIs 3/28/08. Neurologist told pt that based on the blood work, it was a viral infection of the ulnar nerve related to the flu vaccine.

VAERS ID:322956 (history)  Vaccinated:2007-11-13
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2008-07-30
Location:Unknown  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA02953
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0990U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a medical assistant concerning a patient who on 13-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 658673/0990U). Subsequently the patient experienced injection site pain and swelling. Unknown medical attention was sought. The patient''s outcome was unknown. No product quality complaint was involved. This is one of the multiple patient report from the same source. Additional information has been requested.

VAERS ID:325989 (history)  Vaccinated:2007-11-13
Age:15.0  Onset:2008-04-01, Days after vaccination: 140
Gender:Female  Submitted:2008-06-14, Days after onset: 74
Location:Unknown  Entered:2008-08-18, Days after submission: 65
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0807USA01904
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Headache, Hypoaesthesia, Vaccine positive rechallenge
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a physician concerning a 15 year old female who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 659180/1758U, route and site of administration not reported) and on 11-APR-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (Lot # 659435/1265U, route and site of administration not reported). The physician reported that the patient had numbness in her top right foot, headaches and severe abdominal pain with her first and second doses of GARDASIL vaccine (yeast). She will not receive dose 3. She reported this to the physician on 08-JUL-2008 after her mom saw "news reports of GARDASIL vaccine (yeast) problems." No additional AE information reported. At the time of the report, it was unknown if the patient had recovered from the numbness in her top right foot, headaches and severe abdominal pain. The patient sought medical attention, was seen by physician. Additional information has been requested.

VAERS ID:326672 (history)  Vaccinated:2007-11-13
Age:18.0  Onset:0000-00-00
Gender:Male  Submitted:2008-05-20
Location:New Jersey  Entered:2008-09-09, 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: Hayfever, lactose intolerant. No illness at the time of the vaccinations.
Diagnostic Lab Data: CAT Scan- swollen nasal passages.
CDC Split Type: 200801532
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2234A UNUN
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram abnormal, Fatigue, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial report received from parent of a patient on 13 May an 18 year old, male patient (with a medical history of hayfever and lactose intolerance) developed low grade fever, body aches, fatigue after he received MENACTRA (lot number U2234AA, route and site of administration not provided), Tetanus vaccine and TB Test (manufacturer, lot number, route and site of administration not provided) on 13 November 2007. He was seen at the Medical Center ER X 2 and given antibiotics (CIPRO, AUGMENTIN, AVALOX) with no response. His CAT Scan showed swollen nasal passages. He did not have any illness at the time of vaccination. At the time of the report, he had not recovered.

VAERS ID:326788 (history)  Vaccinated:2007-11-13
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-15
Location:Colorado  Entered:2008-09-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0808USA00626
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dysmenorrhoea, Menorrhagia, Menstrual disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Information has been received from a medical assistant concerning a 16 year old female with no known pertinent medical history and drug reaction, who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 28-JAN-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). On 04-AUG-2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot # 650391/0063X), 0.5 ml, via intramuscularly route. There was no concomitant medication. The medical assistant was reported that the patient experienced heavy and difficult periods after received GARDASIL vaccines (yeast). The patient also reported to had more severe cramps with menstruation than before. The patient was seen by a nurse. At the time of the report the patient had not recovered. Additional information has been requested.

VAERS ID:376406 (history)  Vaccinated:2007-11-13
Age:22.0  Onset:2007-11-25, Days after vaccination: 12
Gender:Female  Submitted:2010-01-10, Days after onset: 777
Location:Massachusetts  Entered:2010-01-10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma, ADHD
Diagnostic Lab Data: 3/10/08 UTI 3/11/08 Food Allergies (IgE testing) 4/22/08 Overactive Bladder (misdiagnosis) 5/25/08 Reactive Arthritis or Ankylosing Spondylitis 3/10/09 Mediator Release Test
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Activities of daily living impaired, Allergy test, Bladder disorder, Dry eye, Fatigue, Micturition urgency, Musculoskeletal stiffness, Myalgia, Pollakiuria, Skin laceration, Somnolence, Tendon pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Hypoglycaemia (broad)
Write-up: About a week after the first shot I started to have Achilles pain which I had never had before. Several weeks later, I started having problems controlling my bladder. I had increased frequency and urgency. I had to start wearing diapers because I kept losing control. Muscle soreness also increased all over my body. My body was very stiff. I was a collegiate athlete and suddenly I felt like a prisoner trapped in my own body, unable to move. After each shot, my symptoms worsened. I became increasingly tired all of the time and only wanted to sleep during the day. My eyes were also extremely dry and I would get cuts all over my hands-signs of arthritis.

VAERS ID:296696 (history)  Vaccinated:2007-11-14
Age:28.0  Onset:0000-00-00
Gender:Female  Submitted:2007-11-14
Location:Michigan  Entered:2007-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U0IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, Medication error
SMQs:, Medication errors (narrow)
Write-up: none, realized too late that client too old to have HPV

VAERS ID:296702 (history)  Vaccinated:2007-11-14
Age:29.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 0
Location:Texas  Entered:2007-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: allergic to penicillin and codiene
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA029AA1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Erythema, Pruritus, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rec.''d shot at 11:40 a.m. Noticed adverse event at 1:00 p.m. c/o burning and itching of the face. Stated that she felt her face swelling. 3:00 p.m. Reported to the school nurse. c/o itching and facial burning. Minimum amount of redness noted. temp - 98.4 / pulse -72 & regular. No difficulty breathing. 4:05 p.m. To ER with a family member.

VAERS ID:296707 (history)  Vaccinated:2007-11-14
Age:75.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 0
Location:Texas  Entered:2007-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2499AA0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cold compress therapy, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: PATIENT EXPERIENCED SWELLING AT INJECTION SITE, NO PAIN OR ITCHING OR REDNESS. PATIENT WAS ASKED TO BE OBSERVED FOR 40 MINUTES AND THE SWELLING DECREASED SLIGHTLY. PATIENT WAS CONTACTED 2 HOURS LATER, THE SWELLING HAD SUBSIDED SLIGHTLY MORE. PATIENT WAS ADVISED TO USE COOL COMPRESSES AT THE INJECTION SITE AND TO TAKE BENADRYL AND OR TYLENOL. PATIENT''S PRIMARY CARE PHYSICIAN (MEDICAL NURSE) WAS INFORMED OF THE REACTION. THE DR. WAS FAXED THE COPY OF THE VACCINE ADMINISTRATION CONSENT FORM.

VAERS ID:296795 (history)  Vaccinated:2007-11-14
Age:55.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Male  Submitted:2007-11-15, Days after onset: 0
Location:New York  Entered:2007-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol, Jenuvia, Lipitor, Prevocid, ''a water pill''
Current Illness: Has been feeling run down and tired because of increased work schedule and lack of sleep. Only sleeping about 4 hours per night
Preexisting Conditions: Adult Onset Diabetes, Arthritis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2473BA IMUN
Administered by: Public     Purchased by: Unknown
Symptoms: Diarrhoea, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Client received flu vaccine injection at 4:45pm on 11/14/2007. He awoke at 4:30am on 11/15/2007 feeling nauseous and dizzy. He had diarrhea. The symptoms lasted for 90 minutes. He then felt better and returned to bed.

VAERS ID:297001 (history)  Vaccinated:2007-11-14
Age:1.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Male  Submitted:2007-11-15, Days after onset: 0
Location:Missouri  Entered:2007-11-15
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
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0865U0SCLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH308702F3IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0597U0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Left thigh with 2x3 cm raised red lesion

VAERS ID:297008 (history)  Vaccinated:2007-11-14
Age:5.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Male  Submitted:2007-11-16, Days after onset: 1
Location:Indiana  Entered:2007-11-16
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 (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B056CA4IMLA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2489AA2IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR4069-23IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0416U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1349U1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Cold compress therapy, Erythema, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mother states left arm red, swollen, tender to touch. Recommended cool compresses or ice to site with Tylenol or Ibuprophen for symptomatic relief. Mother to call physician on 11/18/2007 of no improvement.

VAERS ID:297016 (history)  Vaccinated:2007-11-14
Age:54.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Male  Submitted:2007-11-16, Days after onset: 2
Location:Arkansas  Entered:2007-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLAO53AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received the flu shot (FluLaval, Lot # AFLLA053AA) at our health fair. He developed swelling of the tongue with in six hours of taking the shot. He had no previously known allergies to the vaccine components or contraindications to receiving the shot. He called the employee health nurse(this writer) the next morning and reported the swollen tongue. He was advised to see the doctor. The doctor told him he had an allergic reaction to the flu vaccine. She gave hime a steroid shot and advised him to get OTC Allegra as an antihistamine. This morning (the 16th and two days after receiving the shot) he is back at work and reporting the the swelling has greatly decreased. This writer does not know if the treating physician made a report of this episode.

VAERS ID:297017 (history)  Vaccinated:2007-11-14
Age:60.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Female  Submitted:2007-11-16, Days after onset: 1
Location:Ohio  Entered:2007-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1088U0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Acne
SMQs:
Write-up: The client has a pusy pimple on the middle finger of her left hand. She stated that it was not painful. She noticed the pimple on November 15, after recieving the vaccine on November 14.

VAERS ID:297439 (history)  Vaccinated:2007-11-14
Age:4.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Male  Submitted:2007-11-16, Days after onset: 1
Location:Utah  Entered:2007-11-20, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2436AA2UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red, swollen deltoid, from shoulder to elbow but decreased a lot in redness and size with Benadryl.

VAERS ID:297444 (history)  Vaccinated:2007-11-14
Age:6.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Male  Submitted:2007-11-19, Days after onset: 5
Location:Arizona  Entered:2007-11-20, 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: Concerta, Lovastatin, Singulair
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2461BA5UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Mother states pt''s arm became red and warm to touch at injection site on the evening of 11-14-07. Mother states a large red, warm area on his (R) arm was present in the am on 11/15/07, mother also noted and rash around the red area and took pt to the ER-the ER gave the pt Benadryl and sent home Mother states today 11-19-07 that the swelling, redness and heat is gone.

VAERS ID:297472 (history)  Vaccinated:2007-11-14
Age:32.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-16, Days after onset: 2
Location:Pennsylvania  Entered:2007-11-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Paxil CR
Current Illness: None
Preexisting Conditions: Anxiety
Diagnostic Lab Data: None at present
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0379U2UNLA
Administered by: Private     Purchased by: Other
Symptoms: Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: 1/2 h after receiving vaccine developed pain and primarily "pinpricks" and tingling from top of shoulder to all left fingertips worse with movement.

VAERS ID:297643 (history)  Vaccinated:2007-11-14
Age:3.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Male  Submitted:2007-11-21, Days after onset: 6
Location:New Mexico  Entered:2007-11-23, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Normal exam, pt alert & playful
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2457EA1IMUN
Administered by: Public     Purchased by: Other
Symptoms: Aggression, Decreased appetite, Enuresis, Speech disorder
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (narrow)
Write-up: Per mom, bedwetting, decreased appetite, mumbling, speech deficit, increased temper tantrums.

VAERS ID:297863 (history)  Vaccinated:2007-11-14
Age:54.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Male  Submitted:2007-11-27, Days after onset: 12
Location:California  Entered:2007-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lotrel, Diovan
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS811080IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Furuncle, Hypersensitivity, Skin lesion
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Strong allergic reaction: breakout of skin throughout most of body, boils, legions.

VAERS ID:297959 (history)  Vaccinated:2007-11-14
Age:78.0  Onset:2007-11-16, Days after vaccination: 2
Gender:Female  Submitted:2007-11-27, Days after onset: 11
Location:Florida  Entered:2007-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: s/p Left Breast Bx (post-op)
Preexisting Conditions: DM II, COPD, PVD, HTN, CKD II, acute MI, depression/ anxiety
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1382U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient presented to office on 11/19/07 c/o "swollen red area after receiving pneumo shot" on 11/14/07 Pt was seen by physician assistant. Left deltoid area was tender and erythema present. Keflex 500mg TID x 10 days was ordered and cold compresses. 11/19/07 following visit-condition resolved.

VAERS ID:298073 (history)  Vaccinated:2007-11-14
Age:5.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-15, Days after onset: 1
Location:North Carolina  Entered:2007-11-27, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Cough
Preexisting Conditions: Allergic rhinitis
Diagnostic Lab Data:
CDC Split Type: NC07117
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2479BA1IMLL
Administered by: Private     Purchased by: Public
Symptoms: Angioedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Angioedema within 2 hours of vaccine involving hands/feet/elbow/knees. Urticaria as well within 10-15 hours, extensive case.

VAERS ID:298041 (history)  Vaccinated:2007-11-14
Age:8.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-15, Days after onset: 1
Location:Pennsylvania  Entered:2007-11-28, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURV2502AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Medication error
SMQs:, Medication errors (narrow)
Write-up: PT given influenza vaccine on 11/12/07. Second influenza vaccination given on 11/14/07 due to miscommunication between physician and nurse.

VAERS ID:298046 (history)  Vaccinated:2007-11-14
Age:7.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Male  Submitted:2007-11-16, Days after onset: 1
Location:Georgia  Entered:2007-11-28, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2476HA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1120U2UNLA
Administered by: Public     Purchased by: Public
Symptoms: Blister, Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Arm swollen and red, vesicle x 2 on arm.

VAERS ID:298047 (history)  Vaccinated:2007-11-14
Age:34.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Maine  Entered:2007-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Decreased hearing, sciatica, pre-diabetes, hyperlipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS81110 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.108460IMRA
Administered by: Private     Purchased by: Private
Symptoms: Anorexia, Cellulitis, Fatigue, Malaise, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Write-up: Local cellulitis (resolving), palpations, malaise, loss of appetite, fatigue.

VAERS ID:298051 (history)  Vaccinated:2007-11-14
Age:54.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Female  Submitted:2007-11-20, Days after onset: 5
Location:Wisconsin  Entered:2007-11-28, 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: albuterol inhaler, buspirone, cyclobenzaprine, Nexium, primrose oil, flaxseed oil, Advair
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2450AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Localized cellulitis 2 days after influenza vaccine. Red, hot to touch, four inch area on L deltoid.

VAERS ID:298199 (history)  Vaccinated:2007-11-14
Age:48.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-21, Days after onset: 7
Location:Pennsylvania  Entered:2007-11-29, 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: Calen SR, mobic, Nortriptyline, dyazide
Current Illness: none
Preexisting Conditions: Allergy: Vicodon; PMH, Fibromyalgia
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Left upper arm, swelling, pain, erythema starting within 2 hours of immunization and continuing to worsen for 48 hrs. Also, lymphadenopathy, left axilla - erythema $g6" - treated with antihistamine, NSAIDS, ice improved but not completely resolved at 1 week follow-up

VAERS ID:298218 (history)  Vaccinated:2007-11-14
Age:2.0  Onset:0000-00-00
Gender:Female  Submitted:2007-11-28
Location:Massachusetts  Entered:2007-11-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU1813AB3UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF172AA3UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAD1702UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0185U0UNLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHA47300F3UNRL
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Stomatitis
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Temp increased 102 in Day 13 and mild viral stomatitis on trunk on Day 14 after MMR

VAERS ID:298342 (history)  Vaccinated:2007-11-14
Age:0.2  Onset:2007-11-23, Days after vaccination: 9
Gender:Female  Submitted:2007-11-24, Days after onset: 1
Location:Oregon  Entered:2007-11-30, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2749AA0UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF188AA0UNRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURC48880UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHA01690UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1192U0PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema multiforme, Urticaria
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives/erythema multiforme whole body.

VAERS ID:298715 (history)  Vaccinated:2007-11-14
Age:59.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-26, Days after onset: 12
Location:South Carolina  Entered:2007-12-04, 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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2526AA2IM 
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1380U0IM 
Administered by: Private     Purchased by: Private
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Same day as shots developed fever, chills, body aches, swelling at sit of pneumovax.

VAERS ID:298886 (history)  Vaccinated:2007-11-14
Age:13.0  Onset:2007-11-25, Days after vaccination: 11
Gender:Female  Submitted:2007-12-06, Days after onset: 11
Location:Unknown  Entered:2007-12-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature 27Nov2007 39.4C, Body temperature 27Nov2007 38.6C, White blood cells 27Nov2007 17.1 Rash diagnosed as macropapular with hives.
CDC Split Type: B0497683A
Vaccination
Manufacturer
Lot
Dose
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Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Body temperature increased, Headache, Malaise, Myalgia, Rash, Rash papular, Serum sickness, Urticaria, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: This female subject was enrolled in the prophylactic open study 107682 (HPV-018). On 02 April 2007, the subject received the 1st dose of HPV 16 and 18 (IM left upper deltoid), the dose of Aventis Pasteur''s Menactra (IM, right lower deltoid) and the dose of Boostrix (IM right upper deltoid). On 08 May 2007 and 14 November 2007, the subject received the 2nd and 3rd dose of HPV (IM left upper deltoid). On 25 November 2007, 11 days after the 3rd of HPV 16-18, seven months after the 1st dose of Boostrix and seven months after the 1st dose of Menactra, this 13-year-old subject developed febrile rash. The subject was hospitalised. The subject was treated with adrenaline, diphenhydramine hydrochloride and corticosteroid. The event was unresolved at time of reporting. The investigator considered there was no reasonable possibility that the febrile rash may have been caused by Boostrix or Menactra but the investigator considered that there was a reasonable possibility that the febrile rash may have been caused by HPV 16-18. Investigator Comments: On 21 November 2007, the subject stated she had headache, muscle pain and weakness. On 25 November 2007, the rash started on legs during the evening. On 26 November 2007, the subject came to clinic with a rash covering most of her body. Given Epinephrine and told to take Benadryl. Return to clinic on 27 November 2007 in AM. On 27 November 2007, the rash was worse, subject had temperature of 39.4 C and general malaise. She was sent to hospital ER for evaluation where she was admitted. Per mother, the subject was given a steroids IV and discharged with Prednisone and Motrin. Information received on 28 November 2007 following a phone call with her grandmother; the subject had a temperature of 38.6 C yesterday afternoon. She stated that she was admitted for 3 days of treatment. The doctors there felt it was related to the HPV vaccine. The subject was feeling better and the rash has decreased. On 28 November 2007, the subject was going to be discharged in this afternoon. She stated that the ER doctor diagnosed "serum sickness".

VAERS ID:299306 (history)  Vaccinated:2007-11-14
Age:45.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Female  Submitted:2007-11-16, Days after onset: 1
Location:Florida  Entered:2007-12-11, Days after submission: 25
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2506AA0IM 
Administered by: Military     Purchased by: Unknown
Symptoms: Erythema, Local reaction, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Flu shot right deltoid 11/14. Within 24 hours had local reaction, redness, itching, some whole body hives. No anaphylaxis, no shortness of breath.

VAERS ID:299403 (history)  Vaccinated:2007-11-14
Age:1.4  Onset:0000-00-00
Gender:Female  Submitted:2007-12-06
Location:Tennessee  Entered:2007-12-12, 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: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2435AA1UNRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB181AA0UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR205273UNLL
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B016BA3UNRL
Administered by: Private     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: No adverse side effects reports mother. Was given Tdap vaccine instead of DTaP vaccine by mistake.

VAERS ID:300085 (history)  Vaccinated:2007-11-14
Age:0.5  Onset:2007-11-26, Days after vaccination: 12
Gender:Male  Submitted:2007-12-14, Days after onset: 18
Location:Texas  Entered:2007-12-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Clavicle fracture; sniffles
Diagnostic Lab Data: diagnostic laboratory, 11/26?/07, high white blood count; lower GI series X-ray, 11/26?/07; ultrasound, 11/26?/07 1/16/08-records received-successful reduction of intussusception
CDC Split Type: WAES0712USA02142
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC2607AA2UNLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2460BA0UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF192AA2UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB0870282UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1460U2PO 
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Barium enema, Dehydration, Enema administration, Haematemesis, Haematochezia, Intussusception, Irritability, Mucous stools, Pain, Ultrasound scan, White blood cell count increased, X-ray, X-ray with contrast lower gastrointestinal tract
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but

VAERS ID:300064 (history)  Vaccinated:2007-11-14
Age:3.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Male  Submitted:2007-12-18, Days after onset: 33
Location:California  Entered:2007-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2511AA2IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0495U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 6X6 CM AREA OF LOCAL REDNESS AND TENDERNESS AT VACCINE SITE

VAERS ID:300889 (history)  Vaccinated:2007-11-14
Age:  Onset:2007-11-15, Days after vaccination: 1
Gender:Female  Submitted:2007-12-14, Days after onset: 29
Location:New York  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA04143
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a female (age not reported) who on 14-Nov-2007 was vaccinated with the second dose of Gardasil (lot not reported). "Within 24 hours" of vaccination, the patient experienced diarrhea. It was reported that the patient sought unspecified medical attention on 15-Nov-2007. Subsequently, the patient recovered from diarrhea. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow up information was received on 18-JAN-2008. The nurse reports that the above incident was most likely related to a question and if this was possible to occur with GARDASIL vaccine. She states that the diarrhea was most likely not related to GARDASIL vaccine. She also does not remember who the patient was and therefore she cannot complete the B form.

VAERS ID:301055 (history)  Vaccinated:2007-11-14
Age:4.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Male  Submitted:2007-12-29, Days after onset: 45
Location:Massachusetts  Entered:2007-12-26, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2437AA1IM 
Administered by: Private     Purchased by: Public
Symptoms: Cough, Pyrexia, Respiration abnormal, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vaccine at 0900 a.m. At night, fever from 102 to 104 degrees F. Developed cough, wheeze, respiration distress. Sent by 911 to emergency department for wheezing.

VAERS ID:301499 (history)  Vaccinated:2007-11-14
Age:30.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1105SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per authority direction.

VAERS ID:301533 (history)  Vaccinated:2007-11-14
Age:20.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1102SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse reaction
SMQs:, Medication errors (narrow)
Write-up: Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per agency direction.

VAERS ID:301576 (history)  Vaccinated:2007-11-14
Age:36.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: HTN, Hyperlipidemia, Allergy - Iodine, shellfish
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV110 SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per milvax direction.

VAERS ID:301886 (history)  Vaccinated:2007-11-14
Age:35.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Male  Submitted:2007-11-14, Days after onset: 0
Location:Ohio  Entered:2008-01-08, Days after submission: 55
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: Codeine allergy
Diagnostic Lab Data: BP 153/79, pulse 80
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA319AA0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Blood pressure, Erythema, Heart rate normal, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 1st time patient received flu shot. Itching, redness face, little on top of chest, none on arms/back or body. BP 153/79, pulse 8. Gave Benadryl 50 mg, advised q 6 hours x2 days, then see MD. Gave pt. Benadryl if continues.

VAERS ID:301887 (history)  Vaccinated:2007-11-14
Age:20.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Male  Submitted:2007-11-14, Days after onset: 0
Location:Ohio  Entered:2008-01-08, Days after submission: 55
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: NKDA
Diagnostic Lab Data: BP 128/71, Pulse 105; Recheck 113/74, Pulse 85
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA307AA0UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Blood pressure, Dizziness, Flushing, Heart rate increased, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypersensitivity (broad), Hypoglycaemia (broad)
Write-up: 1st time patient received Flu shot. BP 128/71. Pt felt dizzy/shaking, flushed. 5 min recheck BP gave O.J. and crackers. BP 113/74, 85 pulse, felt ok. Gave cold compress. Patient had not eaten upon further conversation.

VAERS ID:301890 (history)  Vaccinated:2007-11-14
Age:23.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 0
Location:Ohio  Entered:2008-01-08, Days after submission: 55
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: Sulfa allergy
Diagnostic Lab Data: BP 12/79, pulse 99; recheck 125/79, pulse 89
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA294EA UNLA
Administered by: Other     Purchased by: Private
Symptoms: Blood pressure, Dizziness, Feeling hot, Heart rate normal, Hyperhidrosis, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Patient has had flu shot in past. Hot, sweating, shaking, dizzy. BP 120/79, pulse 99. 10 min later recheck 125/79, pulse 89. Cold compress, orange juice, crackers given.

VAERS ID:301893 (history)  Vaccinated:2007-11-14
Age:23.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 0
Location:Ohio  Entered:2008-01-08, Days after submission: 55
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: N/A
Diagnostic Lab Data: BP 141/93, Pulse 93; 5 min later 125/83, EMS 110/74
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA294EA0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Blood pressure increased, Dizziness, Flushing, Heart rate, Heart rate increased, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Patient''s first time getting flu shot. Patient felt flushed, dizzy, nauseated 5-10 minutes after flu shot. BP 141/93, Pulse 93. Recheck 5 min, 125/83, Pulse 83. Called corporate. Found out patient had not eaten yet, gave crackers, orange juice. Patient felt better. Cold compress applied.

VAERS ID:302496 (history)  Vaccinated:2007-11-14
Age:71.0  Onset:2007-11-16, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:Nevada  Entered:2008-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Spiriva
Current Illness: COPD
Preexisting Conditions:
Diagnostic Lab Data: Mild wheezing/ Laryngitis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS80687  RA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Chest discomfort, Laryngitis, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Laryngitis, tight chest, wheezing, weakness. RX: Spiriva

VAERS ID:302497 (history)  Vaccinated:2007-11-14
Age:  Onset:2007-11-29, Days after vaccination: 15
Gender:Male  Submitted:2008-01-11, Days after onset: 43
Location:Tennessee  Entered:2008-01-11
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: DM, HTN, Hyperlipidemia, Diabetic Neuropathy
Diagnostic Lab Data: HgB1C 6.6, ESR 13, WBC 7.8, Vit D -T- 12 cc) Hct-40.7
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2524AA3IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989U0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Asthenia, Glycosylated haemoglobin, Haematocrit decreased, Joint swelling, Red blood cell sedimentation rate normal, Vitamin D deficiency, White blood cell count normal
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Has arthralgias/weakness with evidence of joint swelling in hand. Arthralgias included neck/shoulder/arms/hands.

VAERS ID:303669 (history)  Vaccinated:2007-11-14
Age:23.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 62
Location:Ohio  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA03096
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health professional concerning a 23 year old white female (70 in., 199 lb.) with no pre-existing allergies, birth defects or medical conditions who on 14-NOV-2007 (at 15:30) was vaccinated with her initial dosage of Gardasil (lot # 659437/1266U), IM, in the left deltoid. On 14-NOV-2007 (at 15:30) the patient felt lightheaded, got dizzy and passed out. It was reported the patient recovered from the event on the same day. It was reported the patient had no illness at the time of vaccination. Additional information is not expected.

VAERS ID:304109 (history)  Vaccinated:2007-11-14
Age:16.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2008-01-25, Days after onset: 72
Location:Vermont  Entered:2008-02-01, Days after submission: 7
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: Yaz
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Labs EKG - Seen by cardiologist ER LABS: CBC, chemistry, cardiac enzymes, UA all WNL. Hospital LABS: EKG revealed bracycardia. Echocardiogrm WNL. Stress test WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0929U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2182AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Bradycardia, Cardiac enzymes normal, Cardiac stress test normal, Cardiovascular disorder, Dizziness, Echocardiogram normal, Electrocardiogram, Eye movement disorder, Fatigue, Feeling hot, Full blood count normal, Gaze palsy, Hypotonia, Intensive care, Laboratory test, Laboratory test normal, Loss of consciousness, Nausea, Oxygen supplementation, Pallor, Syncope, Syncope vasovagal, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)
Write-up: Immediately after shots - became Faint with pulse 50; Next Am had syncopal episode -$g ER -$g hosp Adm. with significant bradycardia -$g cardiac work-up; now on Atenolol. 2/1/08 Reviewed ER medical records of 11/15/07 which reveal patient experienced feeling lightheaded, warmth & nauseated. Felt faint, lost consciousness & collapsed for approx 1 min witnessed by parent. Recovered at the scene. In ER placed on O2. Had additional episodes of syncope w/HR 30''s while laying on gurney in ER. Noted to have eye twitching, pallor & eyes rolling back in head, flaccid. Awoke immediately but was very tired. Transferred to higher level of care. FINAL ER Dx: syncope of unknown cause. 2/8/08 Reviewed hospital medical records which reveal patient admitted to PICU 11/15-11/16/2007. Cardio consult done. Syncopal episodes felt to be neurocardiogenic w/significant cardioinhibitory component, resulting in secondary bardycardia/asystole & syncope. Tx w/meds & hydration & d/c to home w/cardio f/u. FINAL DX: syncope, probably neurally-mediated syncope; periods of marked bradycardia.

VAERS ID:304458 (history)  Vaccinated:2007-11-14
Age:58.0  Onset:2007-11-26, Days after vaccination: 12
Gender:Female  Submitted:2008-02-06, Days after onset: 72
Location:North Carolina  Entered:2008-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA298BA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injected limb mobility decreased, Muscular weakness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Muscle soreness and weakness upon certain movements especially at night. Extreme weakness in a week or so post injection for 4-5 days. Has abated some but still limits movement.

VAERS ID:306015 (history)  Vaccinated:2007-11-14
Age:22.0  Onset:2007-11-16, Days after vaccination: 2
Gender:Female  Submitted:2008-02-14, Days after onset: 90
Location:New Jersey  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05746
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1265U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Rash
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 22 year old white female who on 14-NOV-2007 was vaccinated with a dose of Gardasil (lot# 659435/1265U). On 16-NOV-2007 the patient felt dizzy. On 17-NOV-2007 the patient developed rash. On 19-NOV-2007 the patient''s rash subsided. The outcome of dizziness and nausea were unknown. Additional information has been requested.

VAERS ID:306473 (history)  Vaccinated:2007-11-14
Age:44.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2008-02-29, Days after onset: 107
Location:Ohio  Entered:2008-03-05, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Illness at the time of vaccination, other medications, and past medical history were not known. From new information received on 22 February 2008 the patient did not have any illnesses or pre-existing medical history prior to vaccinations on 14 November 2007. The patient also had no other vaccine administered within four weeks of 14 November 2007.
Diagnostic Lab Data: Not reported
CDC Split Type: 200800533
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2529AA IMUN
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Follow-up was requested on this cluster and information was received for one of the vaccine recipients (unclear if additional patients were involved) on 22 February 2008 from the original reporter who is a health care professional. This case will be the case of reference for that patient who is a 44-year-old female patient, who had no concurrent illnesses, or pre-existing medical history, and who had received an intramuscular dose of FLUZONE 2007-2008 (lot number U2529AA) on 14 November 2007. The time of vaccination was unknown, and the site of administration of the Fluzone vaccine was not reported. That night following vaccination, the patient woke up "felt warmness in her face" and self medicated with Tylenol. The following morning, the patient''s face was swollen and red, and she self medicated with two Benadryl. The symptoms did not resolve and she presented to the emergency room with itching in her arms and a rash on her face. She was treated with Zyrtec and Prednisone. Final diagnosis was not provided. At the time of this report, the patient had recovered. After medical review of this case, the case was upgraded to serious.

VAERS ID:308363 (history)  Vaccinated:2007-11-14
Age:44.0  Onset:2007-11-20, Days after vaccination: 6
Gender:Female  Submitted:2008-03-21, Days after onset: 121
Location:Maine  Entered:2008-03-27, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None. PMH: Partial thyroidectomy.
Diagnostic Lab Data: Complete book workup; CT chest; EMG left arm all normal. Labs and Diagnsotics: NCS normal. EMG normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2502AA UNUN
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Allergy to vaccine, Anal fissure, Asthenia, Blood test normal, Brachial plexus injury, Burning sensation, Chest discomfort, Chills, Computerised tomogram normal, Cough, Decreased appetite, Dermal cyst, Diarrhoea, Dizziness, Dyspnoea, Ear pain, Electromyogram normal, Fatigue, Feeling abnormal, Food poisoning, Headache, Hypoaesthesia, Impaired work ability, Inflammation, Injected limb mobility decreased, Injection site pain, Insomnia, Lymphadenopathy, Malaise, Mobility decreased, Muscular weakness, Myalgia, Nasal congestion, Nasopharyngitis, Nausea, Neck pain, Nerve conduction studies normal, Neuropathy peripheral, Pain, Pain in extremity, Photophobia, Pyrexia, Rectal fissure, Rectal haemorrhage, Rhinorrhoea, Scar, Sigmoidoscopy, Sinus congestion, Somnolence, Stomach discomfort, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Injection site soreness-worsened within 2 weeks. Low grade fever for 2 weeks, fatigue, malaise, did not feel right-left arm pain 9 on 10 scale for weeks...see attached journal. As of March 21 2008 arm still sore and weak. November 14, 2007 Had annual flu shot. Experienced injection site tenderness that evening and next day. Nothing unusual. Have received about 8 consecutive flu shots in the past. Arm soreness progressively got worse over the next week and 1/2. Peaked at 10 days. Pain 9.5 on 10 scale. Deltoid, bicep and tricep pain; deep ache, burning. Adduction, abduction of arm in all planes difficult and very painful. Supine position most uncomfortable; hard to get a nights sleep. Simple things like driving, taking shirt off, reaching for something; very difficult and painful. Ran low fever for two weeks. Self/Home remedies: Tried ibuprofen, no relief. Heat therapy; no relief (possibly worse). Chiropractic visit; gentle range of motion; no relief. Took old prescription Flexeril one night to help pain and sleep; no pain relief but I slept. Hot bath; no relief. Analgesic rub (Biofreeze); no relief. Saw massage therapist on Dec 5; relief during visit only. November 26: Went back to doctor''s office on Monday, November 26 as a walk-in asking to see a doctor about an adverse reaction I was having. Saw Dr. He read the insert on the vaccine package about side effects and questioned whether I could have brachial plexus neuropathy. Recommended I have blood work done at hospital to check protein levels and scheduled an appointment for Dec. 7, 2007 (when results would be in 10-14 days). He told me to keep the arm moving so it wouldn''t seize up. Have been doing light workout for past two weeks to keep muscles moving and to avoid atrophy. Chest press, upright row, deltoid raises (very difficult), low row, tricep and bicep exercises. Week of December 1, 2007 Pain is reduced to 5 or 6 on the scale. Simple movements still painful and awkward. Night time seems worse. Don''t feel that I am progressing to get better. Plateau? Chronic pain affecting me; just need arm to stop hurting and work right. Exhausted at days end. December 7, 2007 Appointment with Dr. to go over blood panel results. The blood work was excellent. No issues. Dr. ordered a CT scan. Had CT scan that afternoon. December 10, 2007 Called Dr. for CT results. Scan showed swollen lymph glands left side of chest. All else looked good. Nothing on scan to point directly to shoulder pain. Dr. scheduled appointment for December 13 at which time he went over the results in depth of CT scan and prescribed Vicodin for pain. He referred me to Dr. (neurologist) and we scheduled an appointment for mid Jan. 2008. December 14, 2007 Saw Reiki practitioner to work on my arm. Results were minimal. Slight improvement in ROM that day and next. Pain did not improve. Very discouraging. December 18, 2007. Pain is persistent and not improved. Having trouble sleeping and performing job. Simple movements like removing shirt, tucking in shirt and opening car door very painful. Called Dr. to prescribe a pain med that wouldn''t give me insomnia like the Vicodin on advice of pharmacist who said that it affects some people in that manner. Dr. prescribed Percocet. I am continuing to work the muscles in a light manner, with no weights, to keep the muscles from atrophy. December 20, 2007 Saw massage therapist to work on arm. This form of therapy seems to offer the most immediate relief and comfort, even though it is only temporary. I''m going with it though...it''s a few hours of relief and I''ll take anything at this point. Also, starting with head congestion today. Feels like a cold coming on. December 21, 2007 Full blown cold or virus happening. Severe head congestion, fever, chills, body aches. Feel awful...good thing I got the flu shot. Ha ha ha. December 24, 2007 All of the above symptoms with unproductive cough and weakness. Ears hurt. Appetite

VAERS ID:309752 (history)  Vaccinated:2007-11-14
Age:  Onset:2007-11-23, Days after vaccination: 9
Gender:Female  Submitted:2008-03-26, Days after onset: 123
Location:Texas  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: WAES0712USA00328
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1411U SCUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a pharmacist concerning a female with no pertinent medical history or drug allergies who on 14-NOV-2007 was vaccinated SC with one dose of Zostavax (Oka/Merck) (lot# 658839/1411U). There was no concomitant medication. On 23-NOV-2007 the patient developed shingles. The patient was seen by the physician for medical attention. No labs or diagnostic studies were performed. The patient was treated with acyclovir. The patient was recovering. There was no prodcut quality complaint.

VAERS ID:309774 (history)  Vaccinated:2007-11-14
Age:84.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Female  Submitted:2008-03-26, Days after onset: 131
Location:Arizona  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: atenolol; LIPITOR; ACTONEL
Current Illness: Sulfonamide allergy; Penicillin allergy; Drug hypersensitivity
Preexisting Conditions: Hives
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01720
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Herpes virus infection, Injection site erythema, Injection site pruritus, Pyrexia
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning an 84 year old female with sulfonamide allergy, penicillin allergy and allergy to MACROBID and a history of getting hives every year who on 14-NOV-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included atenolol, LIPITOR and ACTONEL. On 15-NOV-2007, The consumer reported that her arm got red and itchy at the injection site. She also had a high fever and diarrhea. On 01-DEC-2007 the patient broke out with herpes on her buttocks but " " this happens about once a year when I am under stress" It was reported that the patient recovered about three days after it started." The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:310198 (history)  Vaccinated:2007-11-14
Age:65.0  Onset:2007-12-26, Days after vaccination: 42
Gender:Female  Submitted:2008-03-26, Days after onset: 90
Location:Texas  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: ZYRTEC; PROZAC; BENICAR
Current Illness: Hypertension
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA08809
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 65 year old female with hypertension who on approximately 14-NOV-2007 six weeks ago was vaccinated with a dose of ZOSTAVAX. Concomitant drug therapy included ZYRTEC, BENICAR and PROZAC. On approximately 26-DEC-2007 the patient developed a rash across both sides of her left arm. The rash had no blisters and no pain, but was itchy. It was unknown whether medical attention was sought. The outcome was unknown. Additional information is not expected.

VAERS ID:312797 (history)  Vaccinated:2007-11-14
Age:19.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Female  Submitted:2008-05-14, Days after onset: 180
Location:Unknown  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: LOESTRIN
Current Illness:
Preexisting Conditions: Allergic reaction to antibiotics
Diagnostic Lab Data:
CDC Split Type: WAES0804USA00354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received concerning a 19 year old female with a history of allergic reaction to antibiotics who on 14-NOV-2007 was vaccinated IM in the deltoid with the first dose of GARDASIL (658560/1062U). Concomitant therapy included LOESTRIN. On 15-NOV-2007 the patient experienced nausea, vomiting, fever, chills and headache. Additional information received from NSC call (14-APR-2008): The caller states that she continues to receive letters from WPS about WAES 0804USA00354. The caller does not know who the WPS letter was addressed to. The caller was unable to locate the SR associated with this WAES #. The caller states that she has returned a previous letter from WPS and does not want to receive any more letters. Additional information is not expected.

VAERS ID:316869 (history)  Vaccinated:2007-11-14
Age:20.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 211
Location:Unknown  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: thyroid function test, negative
CDC Split Type: WAES0805USA03483
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1210U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Thyroid function test normal, Vaccine positive rechallenge, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Medication errors (narrow)
Write-up: Information has been received from a physician assistant concerning a 20 year old female with pertinent medical history reported as none and drug allergies not specified, who on 14-NOV-2007 was vaccinated with the first dose of GARDASIL (lot # 655154/1210U). Concomitant therapy included YAZ. The second dose of GARDASIL (lot # 655327/1287U) was given on 16-JAN-2008. Between these two doses the patient gained 15 pounds. The third dose of GARDASIL (lot # 0152X), was given on 07-MAY-2008. Between the second and third dose the patient gained 25 pounds. She gained a total of 40 pounds in about 5 to 6 months. On an unspecified date, the patient sought medical attention by her primary care provider and had thyroid tests completed which were reported as negative. At the time of reporting, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:323008 (history)  Vaccinated:2007-11-14
Age:65.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Male  Submitted:2008-07-30, Days after onset: 258
Location:Unknown  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA04212
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0985F1UN 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a registered nurse concerning a 65 year old male with no reported medical history who on approximately 14-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #655291/0985F). On 14-NOV-2007 the patient developed an injection site reaction which included pain, swelling and redness. This was the patient''s second dose of pneumococcal 23v polysaccharide vaccine. The patient sought medical attention with an office visit and recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:323832 (history)  Vaccinated:2007-11-14
Age:52.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 258
Location:Georgia  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Penicillin allergy, Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA02829
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1345U UNLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site discolouration, Injection site irritation, Injection site pain, Injection site swelling, Neck pain, Pain in extremity, Sleep disorder
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a 52 year old female consumer with penicillin and erythromycin allergies and no pertinent medical history who on 14-NOV-2007 was vaccinated (route not reported) in left arm with a "1ml dose" of pneumococcal 23v polysaccharide vaccine (Batch 657042, lot#1345U). Concomitant therapy included influenza virus vaccine (unspecified). On 14-NOV-2007, post vaccination, the patient experienced pain and a burning sensation on the left arm which was the injection site right after receiving the pneumococcal 23v polysaccharide vaccine. The patient reported that the injection site became swollen, up to half the size of an egg and turned purple, then green and later yellow. This lasted for a week or more. The patient reported that she wakes up at night because her arm hurts and the pain now travels up to her neck. Per patient, to date, the swelling is gone but the pain and burning are still there. The patient did not receive medical attention and no diagnostic lab test were performed. At the time of this report the patient had not removed. Additional information has been requested.

VAERS ID:323841 (history)  Vaccinated:2007-11-14
Age:60.0  Onset:2007-11-16, Days after vaccination: 2
Gender:Female  Submitted:2008-07-30, Days after onset: 256
Location:Maryland  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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA06049
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0990U IMRA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a certified medical assistant concerning a 60 year old female who on 14-NOV-2007 was vaccinated IM into the right deltoid with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658673/0990U). On 16-NOV-2007 the patient came into the office with hot, painful, large swelling at the injection site and she felt dizzy. It was also reported that the patient was improving. The patient sought medical attention. The physician requested a lot check. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.

VAERS ID:324571 (history)  Vaccinated:2007-11-14
Age:34.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-11-16, Days after onset: 2
Location:Maryland  Entered:2008-08-15, Days after submission: 272
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sinusitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0006199
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Eye pain, Headache, Pain in jaw, Sinus headache, Toothache
SMQs:, Glaucoma (broad), Osteonecrosis (broad)
Write-up: A non-serious report was received by a pharmaceutical company representative concerning a 34-year-old female. The patient had a history of sinusitis and had been under treatment since 12-Nov-2007. No drug history was reported for this patient. The patient received FLUMIST late on 14-Nov-2007. Within hours she experienced increased sinus, teeth, jaw, eye pain and headache. The teeth, jaw and eye were the most uncomfortable. Outcome for the reported adverse events was not reported. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor''s comment is not applicable.

VAERS ID:325318 (history)  Vaccinated:2007-11-14
Age:9.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2008-08-14, Days after onset: 273
Location:Missouri  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypersensitivity
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA03685
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise, Pyrexia, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from an office manager on 17-JUL-2008 concerning a 9 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL and on 14-NOV-2007 was vaccinated with the second dose of GARDASIL and "is sick". Specific symptoms unspecified. The patient sought medical attention, by phone and was coming into the office on 18-JUL-2008. At the time of the report the patient was not recovered. The patient''s sibling with the same initials also had an adverse experience after vaccination with GARDASIL. (WAES # 0807USA03678). Additional information has been requested. This is in follow-up report (s) previously mentioned on 8/14/2008. Follow-up information has been recieved from the physician, who reported that the patient, went to the office to received her third dose of GARDASIL and was "sick" per parents - left without being seen and returned for third dose at a later date. Her second dose had runny nose and fever in July 2008 were related to the vaccine. Eight months lapsed between the second dose and illness. No additional information is expected.

VAERS ID:336864 (history)  Vaccinated:2007-11-14
Age:19.0  Onset:2007-11-25, Days after vaccination: 11
Gender:Female  Submitted:2008-12-12, Days after onset: 383
Location:Pennsylvania  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Urinary tract infection; Kidney infection; Papanicolaou smear abnormal; Termination of pregnancy - elective
Diagnostic Lab Data: Ultrasound, 03/19/08, normal limit 12 wk 7 days; Ultrasound, 04/26/08, anatomy - 18 wk 1 day with echogenic fetal kidneys; Ultrasound, 05/06/08, Echogenic fetal kidney-anatomy screen: 0 problems; Diagnostic laboratory, ?/?/08, everything wa
CDC Split Type: WAES0803USA03041
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Constipation, Diagnostic procedure, Drug exposure during pregnancy, Premature labour, Ultrasound scan abnormal, Ultrasound scan normal, Urine human chorionic gonadotropin positive, Vaginitis bacterial
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow-up information has been received from a registered nurse and a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with a history of urinary tract infections, kidney infections, a previous pregnancy with an elective abortion, and an "abnormal pap with cryo" in December 2006, who on 14-NOV-2007 was vaccinated with her first dose of GARDASIL. On 21-JAN-2008, the patient was vaccinated with her second dose of GARDASIL. There was no concomitant medication. Subsequently, the patient became pregnant. No adverse symptoms were reported. The registered nurse stated that the patient was 12 weeks pregnant as of 18-Mar-2008. On an unspecified date, the patient took a urine pregnancy test which was positive. The date of last menstrual period was 23-DEC-2007 and the estimated delivery date was 28-SEP-2008. On 19-MAR-2008, the patient had a pelvic ultrasound with the normal result. On 25-MAR-2008 the patient had a maternal serum alpha-fetoprotein test for first trimester screening which was negative. On 26-APR-2008, the patient had an ultrasound for "anatomy" with "Echogenic Fetal Kidneys", results not provided. The dose of GARDASIL were administered at another site while the patient attended college. The patient sought unspecified medical attention in the office. On 10-OCT-2008, the nurse practitioner reported that the patient had her baby at the end of September or beginning of October. She did not have the patient''s chart available at the moment so she wasn''t sure of the exact date. She also reported that "nothing ever came of that" about the echogenic fetal kidneys that were seen during the 18 week 1 day anatomy scan on 26-APR-2008. The patient had undergone some genetic counseling/testing but everything was normal with the baby. There were no congenital anomalies and the baby was healthy when it was born. Follow-up information has been received from a completed questionnaire from a Certified Registered Nurse Practitioner. Other medication used d

VAERS ID:344447 (history)  Vaccinated:2007-11-14
Age:14.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2009-04-20, Days after onset: 522
Location:Florida  Entered:2009-04-20
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: lo-ogesterl, vitamins, metanx, glucophase, prozac, trazadone, spironlactone
Current Illness: hypoglycemia, PCOS, depression
Preexisting Conditions: mold, cockroaches, smoke, dust, dust mites, trees, grass,perfume allergies PCOS, blounts, hypoglycemia, PMH: exudative pharyngitis, metabolic syndrome w/hirsutism, Type II DM w/peripheral neuropathy, metromenorrhagia, morbid obesity, Blount''s disease w/left tibial lengthenins & reshaping via cage, left gastrocnemius contracture, bronchitis, URI, sleep apnea, restless leg syndrome, insomnia, congenital liver disease, hives, allergic rhinitis, bipolar w/recurrent depression, panic attacks. Allergy: trees, dust, pollen, mold. OCPs. Family hx: sibling bipolar, migraines. HPV #2, lot # 03894, given 1/18/08, LA; HPV#3, lot #1970U, given 5/14/08, RA. 6/15/09 Received consultant medical records of 1/29/08-5/26/2009. Obesity, Type II diabetes.
Diagnostic Lab Data: EKG, Holter Monitor, EEG, Sleep Studies, Heavy Metal test, CBC, Urinalysis, Upper GI, Stool sample, Hepatitis test, CBC, metobolic study, Cat Scans, MRI, Has seen neurologist, pulmonary doctor, podiatrist, endocrinologist, tons on blood work. Has had blood in urine. LABS: CBC, ESR, ANA, TSH, echocardiogram, Holter monitor, EEG WNL. AST/ALT 47/62(H). EKG W/sinus tachycardia. 6/15/09 Received consultant medical records of 1/29/08-5/26/2009. LABS and Diagnostics: EEG - WNL. CT Head - Normal. "Slightly abnormal'' Holter.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERU24767GA2UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0389U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Amenorrhoea, Blood heavy metal test, Blood urine present, Chest pain, Cold sweat, Dysarthria, Fatigue, Gastritis, Haematochezia, Headache, Hepatitis viral test, Immediate post-injection reaction, Insomnia, Malaise, Metabolic function test, Mobility decreased, Monoplegia, Muscular weakness, Neuropathy peripheral, Nuclear magnetic resonance imaging, Pallor, Paraesthesia, Pyrexia, Similar reaction on previous exposure to drug, Sinusitis, Sleep apnoea syndrome, Sleep study, Stool analysis, Syncope, Urine analysis, Vomiting, X-ray with contrast upper gastrointestinal tract
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: fever, vomiting,malise, headache could not get out of bed for 2 weeks after 1st shot. Developed periphreal neurapathy within 30 days of 1st shot. However it took 3 months to diagnose. Gastritis several times. Migraines constantly, fainting with muscle weakness...can not use legs for hours after faintinf, bloody stools, paralysis in right arm immediately after third vaccine. Pallor, clamminess, amennorhea no period since first vaccine. fatigue, insomnia, sleep apnea, chest pain, pins and needle sensations throughout extremities, sinusitis several times, pins and needles feelings in stomach, fevers on and off, slurred speech. She has been very ill since first vaccine and in a lot of pain. 5/1/09 Received vaccine & PCP medical records of 11/14/06-1/9/2009. FINAL DX: none provided Records reveal patient experienced shooting paine & numbness of extremities 2 wks prior to HPV #1 & flu shot. RTC w/recurrent depression, left plantar fasciitis, migraine HAs. Seen in ER 3/13/08 for HA & dx w/ethmoid sinusitis, tonsillitis & URI. RTC w/viral gastroenteritis, right CTS, recurrent allergic rhinitis. 8/18/08 w/spells x 3-4 yrs which had increased in frequency x 3 wks; dx w/presyncopal episodes. Seen in ER w/dx gastroenteritis. Referred to Neuro for syncope. Missed several days of school. RTC for LBP s/p fall, gastritis w/bloody stools. 6/15/09 Received consultant medical records of 1/29/08-5/26/2009. Pulmonology records reveal patient experienced sleep disturbance, obstructive sleep apnea, increasing obesity, nasal congestion, and allergic rhinitis. Residual cough. Low bloodpressure. ENT - intranasal mucosal edema and clear drainage, deviated septum, mouth and oral cavity small, enlarged tonsils, redundant pharyngeal mucosa, obese neck. Tonsillectomy / Adenoidectomy. Neurology - patient c/o burning in feet, dizzeness, fainting spells, clamminess, sweating, shooting pains in wrists /ankles, difficulty focusing / concentrating. Examination is unremarkable. Ophthalmologic evaluation reports some loss of peripheral vision.

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