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Case Details (Sorted by Vaccination Date)

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VAERS ID:329616 (history)  Vaccinated:2008-10-22
Age:15.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-22, Days after onset: 0
Location:Vermont  Entered:2008-10-22
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: Chronic functional abdominal pain
Diagnostic Lab Data: CT Head
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2829AA0IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB247AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU273AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B020AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Grand mal convulsion, Scan brain
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had clonic / tonic seizure lasting aproximately 60 seconds.

VAERS ID:329660 (history)  Vaccinated:2008-10-22
Age:11.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Male  Submitted:2008-10-22, Days after onset: 0
Location:Iowa  Entered:2008-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no illnesses
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2797BA IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024DB IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dyspnoea, Lip swelling, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: patient received flu shot and boostrix vaccines. He came back to office about 30 minutes after leaving. His lips were swelling up and his tongue was swelling up. He was having some difficulty breathing.

VAERS ID:329789 (history)  Vaccinated:2008-10-22
Age:30.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-23, Days after onset: 1
Location:Wisconsin  Entered:2008-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Isotrenin
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Hyperhidrosis, Palatal oedema, Pharyngeal oedema, Tachycardia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Extreme and uncontrollable coughing (this started about 2 hours and 15 minutes after administration of vaccine), wheezing, tachycardia, sweating, swelling of the uvula and back of throat. An insurance nurse line was called and the nurse instructed us to call 911. My husband took me to the ER at the closest hospital. I was there for about 3 hours and received oxygen, an epi pen, steroids, and breathing treatments.

VAERS ID:329808 (history)  Vaccinated:2008-10-22
Age:5.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-23
Location:New York  Entered:2008-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none known
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAG20B16AB0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAO 492-23IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0266X3SCLA
Administered by: Unknown     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: IPV vaccine given in error (also gave Kinrix)-- no adverse effects

VAERS ID:329815 (history)  Vaccinated:2008-10-22
Age:3.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-23, Days after onset: 1
Location:Illinois  Entered:2008-10-23
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: Has asthma .
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2769AA IM 
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Tremor, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Mother called health dept. about child having elevated temp of 102 and uncontrollable shaking for 3-4 hours after receiving the flu shot on 10-22-08 . Took the child to the Dr. on 10-23-08 and Dr . instructed mom to not get the child the second flu shot this season since this was probably a reaction to the flu vaccine .

VAERS ID:329818 (history)  Vaccinated:2008-10-22
Age:10.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-10-23, Days after onset: 0
Location:Pennsylvania  Entered:2008-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: None
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2811AA3IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0519X2IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site reaction, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt had localized uticarial reaction at site of vaccine administration in right deltoid.

VAERS ID:329819 (history)  Vaccinated:2008-10-22
Age:85.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-23, Days after onset: 1
Location:Massachusetts  Entered:2008-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: no
Preexisting Conditions: no allergies, other medical conditions unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA191AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient received a flu immunization intramuscularly in Left arm at public flu clinic on 10/22/08. Reports severe increased swelling, redness and pain at site, requiring cold compresses and Acetaminophen

VAERS ID:329836 (history)  Vaccinated:2008-10-22
Age:34.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-10-23, Days after onset: 0
Location:Florida  Entered:2008-10-23
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) (NO BRAND NAME)UNKNOWN MANUFACTURER?0IDLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Systemic reaction: low-Grade fever, chills, severe muscle aches and splitting headache. Symptoms began just about 24 hrs after the vaccine.

VAERS ID:329837 (history)  Vaccinated:2008-10-22
Age:37.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-23, Days after onset: 1
Location:Alabama  Entered:2008-10-23
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) (NO BRAND NAME)UNKNOWN MANUFACTURER 9IMRA
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Abdominal pain upper, Headache, Injection site pain, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (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), Eosinophilic pneumonia (broad)
Write-up: severe pain on and around injection site. fever up to 101.4. muscle aches, stomach cramps, headache

VAERS ID:329839 (history)  Vaccinated:2008-10-22
Age:6.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Male  Submitted:2008-10-23, Days after onset: 1
Location:Oregon  Entered:2008-10-23
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TRIAMINIC cough/cold; albuterol neb Tx at 11:50
Current Illness: Bronchitis
Preexisting Conditions: Demerol allergy
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1190X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Bronchitis, Erythema, Eyelid oedema, Hypersensitivity, Injection site induration, Rash generalised, Swelling face, Vaccination complication, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Pt received vaccine and developed facial swelling and rash within 30 minutes. Wheezing and stomach pain as well. Pt was given 12.5 mg oral BENADRYL 0.5mg albuterol with Neb, and 5 mg Dexamethasone injection. His rash had resolved and only mild swelling around eyes by 3:30pm same day. Breathing had normalized. 11/3/08 Reviewed PCP medical records of 10/22/08. FINAL DX: bronchitis; allergic reaction to varicella vaccine. Records reveal patient experienced cough, nasal congestion & runny nose x 6 days on day of vaccination. Dx w/bronchitis. Tx w/nebs, antibiotics & cough syrup. Returned to office wheezing, rash all over, facial & eyelid swelling, ears red, injection site induration. Tx w/antihistamine, nebs, steroids & d/c to home on same.

VAERS ID:329853 (history)  Vaccinated:2008-10-22
Age:26.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-23, Days after onset: 1
Location:Utah  Entered:2008-10-23
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 PASTEURU2809AA0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Chest discomfort, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives, facial swelling and chest tightness occurred within 24 hours. Treated with Benadryl OTC at home and Benadryl 50mg IM at clinic.

VAERS ID:329854 (history)  Vaccinated:2008-10-22
Age:42.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-23, Days after onset: 1
Location:Oregon  Entered:2008-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WELLBUTRIN; CLARITIN; PROZAC; SYNTHROID; dust mite; dust; dogs; cats; fleas
Current Illness: baseline allergies
Preexisting Conditions: tetracyclines; CODEINE; Sulfa drugs
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA159AA UNLA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Had flu vaccine about 0900. Went back to work area. Because increased SOB almost shivered. Realized "things weren''t right" without 15" of injection. Used Albuterol inhaler. Stayed in work area till increased SOB x 2 about 12:00. Came back to RN work area. Sent to health clinic. Given PO BENDARYL. Coworker brought inhaler. Used 2nd time. Back to baseline by 1300.

VAERS ID:329875 (history)  Vaccinated:2008-10-22
Age:53.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-23, Days after onset: 1
Location:Minnesota  Entered:2008-10-24, 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: METFORMIN;Hydrochlorothiazide;LEXAPRO; LAMICTAL;SYMBICORT; Albuterol; SONATA; XANAX;SIMVASTATIN
Current Illness: Asthma, Diabetic, High Blood Pressure
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA173AA0IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Dyspnoea, Pallor
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Received flu vaccine at around 11:15 am. Started having difficulty breathing, poor color. Was given 0.3 mL Epinephrine @ 11:51 am. B/P 142/78 P - 90. She appeared to improve slightly; was taken to E.R. for further eval

VAERS ID:329904 (history)  Vaccinated:2008-10-22
Age:43.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-22, Days after onset: 0
Location:Pennsylvania  Entered:2008-10-24, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPROL; Flecainide
Current Illness: None
Preexisting Conditions: Frequent PVCs
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2789EA2IMUN
Administered by: Unknown     Purchased by: Private
Symptoms: Chills, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: 5 hours after vaccine had uncontrollable chills. Temp was 103 7-8 hrs after vaccine. 1 hour after taking Motrin 600 mg had localized soreness 3 hours afterwards. The next day, felt better - feel she has low grade fever (approximately 99-100). No other sxs. Fever up to 101 the following evening.

VAERS ID:329981 (history)  Vaccinated:2008-10-22
Age:55.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-10-24, Days after onset: 1
Location:Tennessee  Entered:2008-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrocortisone, Florinef, Synthroid, Premarin, Prevacid
Current Illness:
Preexisting Conditions: Addison''s Disease - Possible yellow food dye
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Cough, Dizziness, Dysphonia, Dyspnoea, Eye swelling, Lip swelling, Pain, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Flu shot @ 4:00 - Coughing at 7:00 - difficulty breathing 7:45 - hoarseness, hives, weakness, dizziness, lips and gums stinging - lips, eyes swollen

VAERS ID:330017 (history)  Vaccinated:2008-10-22
Age:62.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-10-24, Days after onset: 1
Location:Texas  Entered:2008-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: KENALOG, RELAFEN
Current Illness: Lupus
Preexisting Conditions: Penicillin, Sulfa
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA175AA0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Eye swelling, Oedema peripheral, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Red, swollen face, eyes, fingers next day after vaccination - given BENADRYL EVERY 6 hrs

VAERS ID:330020 (history)  Vaccinated:2008-10-22
Age:7.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Male  Submitted:2008-10-23, Days after onset: 0
Location:New Jersey  Entered:2008-10-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU275UAA3UNLA
Administered by: Private     Purchased by: Unknown
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: (+) erythema, (+) swelling, mild tenderness to site

VAERS ID:330028 (history)  Vaccinated:2008-10-22
Age:78.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-23
Location:California  Entered:2008-10-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension; Interstitial Lung Disease; DM
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0868X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling of Left arm/ (L) chest wall, Erythema, Itching.

VAERS ID:330138 (history)  Vaccinated:2008-10-22
Age:14.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Male  Submitted:2008-10-27, Days after onset: 5
Location:Texas  Entered:2008-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2952BA4IMLA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: None

VAERS ID:331012 (history)  Vaccinated:2008-10-22
Age:45.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-29, Days after onset: 7
Location:Wisconsin  Entered:2008-10-31, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2755AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chest pain, Chills, Conjunctivitis, Headache, Myalgia, Nausea, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad)
Write-up: States approximately two hours after receiving flu vaccine noted "fever, chills, seizing chest pain, horrible sore throat, headache, conjunctivitis, muscle aches, nausea and conjunctivitis. Went to clinic for eval. Symptoms subsided within 12 hours except conjunctivitis.

VAERS ID:330968 (history)  Vaccinated:2008-10-22
Age:28.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-02, Days after onset: 11
Location:Colorado  Entered:2008-11-02
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':
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Feeling abnormal, Feeling cold, Gait disturbance, Pain, Paraesthesia oral, Tremor
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: On October 22, 2008 I got the Influenza Vaccine at approximately 10:30 am. Around 1:30 I started feeling dizzy and cloudy. By 3:00 pm I was feeling sore and shaky and around 4 pm I started getting very cold. I was freezing and no matter how many blankets I wrapped around myself I was still cold. My temperature spiked to 103.7 and I was still freezing and unable to move. I couldn''t breath and my tongue felt odd. By 6:30 I was unable to walk at all, my husband threw me in a cold shower and brought my temperature down at which time I took allergy pills and Tylenol and my temperature fell down to 99.9, but it kept spiking up to 101 to 103 for another 30-45 minutes at which point my temperature stabilized and I was able to move around again. I believe it was an allergic reaction as the next day I was completely fine.

VAERS ID:331030 (history)  Vaccinated:2008-10-22
Age:40.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-03, Days after onset: 11
Location:Michigan  Entered:2008-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAF1HA3648A0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Generalized Erythematous pruritic rash on arms, legs, torso.

VAERS ID:331041 (history)  Vaccinated:2008-10-22
Age:62.0  Onset:2008-10-29, Days after vaccination: 7
Gender:Male  Submitted:2008-11-03, Days after onset: 5
Location:Tennessee  Entered:2008-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Steroid injection for chronic sinusitis 10/3/08; HTN; Cholesterol.
Current Illness: No
Preexisting Conditions: NKDA; dust mites. PMH: HTN, Acid reflux, ulcer, appendectomy, laminectomy, cataract removal
Diagnostic Lab Data: Blood work; EKG; CXR; echocardiogram; scan . Labs and Diagnsotics: Echo (+) for mild concentric hypertrophy and diastolic dysfunction. Stress test WNL. CT heart (+) for calcified granuloma with calcified mediastinal lymph nodes. CXR WNL.
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2768AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Atrial fibrillation, Blood chloride decreased, Blood potassium decreased, Chest X-ray normal, Chest discomfort, Computerised tomogram abnormal, Echocardiogram abnormal, Fatigue, Full blood count, Haemoglobin increased, Heart rate irregular, Hypokalaemia, International normalised ratio increased, Malaise, Prothrombin time prolonged, Throat irritation, Thyroxine decreased, White blood cell count increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Cardiac arrhythmia terms, nonspecific (narrow)
Write-up: Several days experienced fatigue. Not feeling well. Tuesday night - sensation of flutter in throat and chest. Got better. Wed. night - flutter sensation and felt heart beat. Diagnosed w/ atrial fibrillation. IV Heparin. Converted on the 30th, started on COUMADIN. 12/15/2008 ER records received for DOS 10/29-30/2008 with DX: Atrial Fibrillation with rapid ventricular rate. Hypokalemia. Pt presented with c/o irregular heartbeats and chest discomfort. PE (+) for irregularly irregular heartbeat. Admitted for medication mgmt.

VAERS ID:331043 (history)  Vaccinated:2008-10-22
Age:66.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-27, Days after onset: 5
Location:California  Entered:2008-11-03, Days after submission: 7
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: High cholesterol; Sleep apnea; Allergic rhinitis; osteopenia Allergy: codeine.
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2793EA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Anaphylactic reaction, Blood pressure decreased, Chest discomfort, Conjunctivitis, Cough, Dyspnoea, Eye discharge, Eye swelling, Feeling hot, Hypersensitivity, Hypotension, No reaction on previous exposure to drug, Orthostatic hypotension, Oxygen saturation decreased, Pain in jaw, Rhinitis, Scleral hyperaemia, Tongue disorder
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Conjunctival disorders (narrow), Osteonecrosis (broad), Scleral disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow)
Write-up: 3 hours after FLUVAX: developed dyspnea, cough, conjunctivitis, rhinitis, ST so came to doctor''s office. When in office, became hypotensive. Dx:anaphylaxis and treated with IM BENADRYL and Epinephrine. Ambulance pt to hospital and given IV TAGAMET and recovered. 11/7/08 Reviewed ER medical records of 10/22/2008. FINAL DX: acute allergic reaction; conjunctivitis Records reveal patient experienced eye discomfort & swelling, heat, chest tightness, cough & jaw discomfort approx 2 hours s/p vaccination. RTC & tx w/epi, IM benadryl. BP at that time 80/50 & transported to ER. Improving by the time arrived in ER. Exam in ER revealed dramatic swelling & crusting of eyes, scleral injection, tongue cramping. Pulse ox initially was 91% & BP supine 130/76, standing 106 systolic. No reaction to previous flu shots.

VAERS ID:331048 (history)  Vaccinated:2008-10-22
Age:49.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-10-27, Days after onset: 4
Location:Maryland  Entered:2008-11-03, 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: Blood Pressure; Thyroid
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA159AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Induration, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Erythema induration 5x8 cm diam noted 24 hours after injection. Pt noted little itching also Px reported to health unit 48 hour after administration of vaccine, Diphenhydramine and KEFLEX given

VAERS ID:331116 (history)  Vaccinated:2008-10-22
Age:3.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-10-24, Days after onset: 1
Location:Pennsylvania  Entered:2008-11-03, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: allergic rhinitis
Diagnostic Lab Data:
CDC 'Split Type':
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UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Otitis media, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever 24-36 hours after immunization given. Tmax 101.5 Also night otitis media

VAERS ID:331146 (history)  Vaccinated:2008-10-22
Age:7.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-03, Days after onset: 12
Location:Missouri  Entered:2008-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None; patient had been diagnosed in 09/18/08 with right ear infection, recurrent pneumonia and cough; was started on Albuterol H
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2805AA4IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1679U0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic shock, Breath sounds abnormal, Cough, Cyanosis, Dyspnoea, Face oedema, Fall, Hypersensitivity, Immediate post-injection reaction, Oxygen saturation decreased, Oxygen supplementation, Respiratory distress
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Patient received immunizations and immediately began coughing, developed cyanosis, severe respiratory distress, and oral and facial edema. Oxygen sats at first assessment 55-60 percent, BP 120/90, HR 160. Was alert and able to talk with difficulty. Lung fields decreased aeration bilaterally. Oxygen cannula and Albuterol nebulization administered. Epi pen applied (lot 7EM841, exp 07/09). Pt responded immediately, pulse ox increased to 100%. Patient transferred to ER by ambulance. 11/11/2008 MR received for ER visit 10/22/08 with DX: Allergic Reaction-serum, anaphylactic shock. Immediately after receiving vax pt began coughing, became SOB, fell to the ground and turned blue. TX with epipen and nebs and transferred to ER via EMS. Upon arrival in ER sx had resolved.

VAERS ID:331150 (history)  Vaccinated:2008-10-22
Age:47.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-03, Days after onset: 12
Location:California  Entered:2008-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: BASIC ALLERGIES TO ANIMAL HAIRS, USE TO TAKE ALLERGY INJECTIONS. STOPPED INJECTIONS OVER 15 YEARS AGO...OTHERWISE HEALTHY CONDITION
Diagnostic Lab Data: SORE THOAT/EAR PAIN/ NASAL DRIP ALMOST IMMEDIATE. 10/23/08 SORE THROAT/EAR/START OF NASAL CONGESTION W/HEADACHE, EYES WATERY & HURT-BURNING, SOME DIZZYNESS...2-3 TIMES I FELT LIKE THE ONSET OF A FEVER FOLLOWED BY CHILLS...10/24/08 NASAL CON
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.B/FLORIDA/4/2002IN 
Administered by: Unknown     Purchased by: Public
Symptoms: Chest pain, Chills, Dizziness, Dysphonia, Dyspnoea, Ear pain, Eye irritation, Eye pain, Fatigue, Headache, Lacrimation increased, Nasal congestion, Oropharyngeal pain, Pain, Pallor, Pyrexia, Respiratory tract congestion, Seasonal allergy, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: SORE THROAT WITH EAR PAIN, FEVERISH & CHILLS ON&OFF, EYES HURT, DIZZY, TIRED, CONGESTION, HAY FEVER SNEEZING, HEADACHES, SHORTNESS OF BREATH, CHEST PAINS, BODY ACHES...LASTED OVER A WEEK...STAYED IN BED ON DAY 3 & 4(SUNDAY...PLANNED ON ER VISIT ON MONDAY, IF COULD NOT GET OUT OF BED), TIRENESS, SORE THROAT, & SNEEZING LINGERED TO DAY 10-11 OF DAY OF FLUMIST.

VAERS ID:331181 (history)  Vaccinated:2008-10-22
Age:49.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-10-28, Days after onset: 5
Location:Iowa  Entered:2008-11-03, 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: Unknow
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA366BA IMRA
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 10/23/2008 @ 13:00 2 1/4 cm x 2 1/2 cm reddened slightly swollen, slightly warm to touch @ injection site. No fever aches/pain.

VAERS ID:331203 (history)  Vaccinated:2008-10-22
Age:67.0  Onset:2008-10-24, Days after vaccination: 2
Gender:Female  Submitted:2008-11-03, Days after onset: 10
Location:Florida  Entered:2008-11-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0810USA05147
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Eye swelling, Headache, Lip swelling, Throat irritation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 67 year old female who on 22-OCT-2008 was vaccinated with a dose of PNEUMOVAX 23 IM. Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unspecified). On 24-OCT-2008 the patient experienced headaches, swelling of the lips and eyes, itchy throat, and hives all over. The patient went to the ER and was admitted for observations. The patient was released on 26-OCT-2008 and re-admitted on 27-OCT-2008. The patient had been there since because of the hives. She was being treated with MEDROL, BENADRYL and famotidine (MSD). Additional information has been requested.

VAERS ID:331207 (history)  Vaccinated:2008-10-22
Age:26.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-30, Days after onset: 8
Location:Wisconsin  Entered:2008-11-04, 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: Adderall; Welbutrin; Apri; Loratidine; Manalt
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2739AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dysphagia, Paraesthesia, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (broad)
Write-up: Tight throat, tingly, difficult swallowing. Benadryl 25mg IM given.

VAERS ID:331234 (history)  Vaccinated:2008-10-22
Age:33.0  Onset:2008-10-27, Days after vaccination: 5
Gender:Female  Submitted:2008-11-04, Days after onset: 8
Location:Kentucky  Entered:2008-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
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YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF426AA0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pruritus, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt reported with 3 - 4 cm circular area of erythema, no bruising, neg for cellulitis, neg for infection, c/o of itching and tender to palpation. Pt states she noticed tenderness and swelling 5 days post vaccine for yellow fever.

VAERS ID:331290 (history)  Vaccinated:2008-10-22
Age:13.0  Onset:2008-10-25, Days after vaccination: 3
Gender:Female  Submitted:2008-11-04, Days after onset: 10
Location:New Mexico  Entered:2008-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: sibling w/(+)GABS 10 /18
Diagnostic Lab Data: ASO (-); Blood culture (-); RF (-); (+) Rapid test for strep; Many others LABS: Urgent care labs of 10/10/26/08: WBC 38,300, PMNs 92%. ESR 70(H). Hospital labs of 10/28-31/08: WBC 31,900, PMNs 93%. ESR 124(H). CRP 7.3(H). ASO neg. RA factor 19(H). Echocardiogram abnormal & c/w mild carditis w/min mitral & tricuspid regurg. EKG WNL. WBC 21,900, neutros 80%, lymphs 18%. ESR 120(H). CRP 6.1. ASO & antiDNAse B neg. CXR & hand x-rays WNL.
CDC 'Split Type':
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500560P0IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.0381X0UNLL
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2730AA0UNRL
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B027AA5UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0994X0UNLL
Administered by: Private     Purchased by: Public
Symptoms: Arthralgia, Arthritis, Blood culture negative, C-reactive protein increased, Carditis, Chest X-ray normal, Echocardiogram abnormal, Electrocardiogram normal, Joint range of motion decreased, Joint swelling, Lymphocyte percentage decreased, Mitral valve incompetence, Myalgia, Neutrophil percentage increased, Pharyngitis streptococcal, Pyrexia, Rash, Rash pruritic, Red blood cell sedimentation rate increased, Rheumatoid factor increased, Streptococcus identification test, Streptococcus identification test positive, Tricuspid valve incompetence, Urticaria, White blood cell count increased, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: Hives like rash at day 3-4D, Fever day 5, Joint and muscle pain debilitating by day 5, Admitted to hospital 10-28-08. WBC 32,000, ESR 70 - 124, CRP 7.3. 1/26/09 Reiceived hospital medical records for 10/28-10/31/2008. FINAL DX: not available on d/c summary available Records reveal patient experienced migratory joint pain, fever & migrating pruritic rash. Had recent strep throat. Tx w/IV antibiotics, NSAIDS & antihistamines. Improved by d/c to home on continued oral PCN & w/outpatient cardio & rheum consults. 2/3/09 Received Rheum & ID consults. Rheum consult of 11/14/2008: FINAL DX: arthritis, carditis, fever, ?Still''s disease Records reveal patient exp (+)GABS 10/26 after rash developed on 10/24. Rash has waxed & waned since. Remained on PCN & NSAID. Exam revealed swollen wrists w/decreased ROM. Labs & x-rays ordered. Patient was being f/u by cardio. ID consult of 11/18/2008: FINAL DX: fever, arthritis, rheumatic fever doubtful Records reveal review of extensive medical records w/o definitive diagnosis. Referred back to cardio & rheum clinics.

VAERS ID:331319 (history)  Vaccinated:2008-10-22
Age:26.0  Onset:2008-10-26, Days after vaccination: 4
Gender:Female  Submitted:2008-10-29, Days after onset: 3
Location:Pennsylvania  Entered:2008-11-05, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Anxiety d/o
Diagnostic Lab Data:
CDC 'Split Type':
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TDAP: TDAP (ADACEL)SANOFI PASTEURC3030AA IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Body temperature increased, Diarrhoea, Injection site erythema, Injection site induration, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: 9.5 x 7 cm induration, erythema at injection site R arm N/V/D. Tmax 101 degrees.

VAERS ID:331326 (history)  Vaccinated:2008-10-22
Age:73.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-27, Days after onset: 5
Location:Connecticut  Entered:2008-11-05, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Seasonal allergy
Preexisting Conditions: Asthma as a child
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2751AA12UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site rash, Similar reaction on previous exposure to drug
SMQs:, Hypersensitivity (narrow)
Write-up: pt. came to office 2 days past vaccination with large raised area at site of injection (per nurse who observed pt. was advised to go to her MD. There were no other systemic indications 10/27 spoke with Pt. who did not see MD after all. She is ok. Pt. states had a reaction (similar) to the pneumonia shot last year. I advised to get flu shots by MD in future.

VAERS ID:331374 (history)  Vaccinated:2008-10-22
Age:34.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-05, Days after onset: 14
Location:Nebraska  Entered:2008-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to Penicillin
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2760AA IMUN
Administered by: Public     Purchased by: Private
Symptoms: Injection site haematoma, Injection site pruritus, Injection site swelling, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Lg. hematoma at injection site, itching swelling at inj site, vomiting, nausea, fever 103 degrees F.

VAERS ID:331384 (history)  Vaccinated:2008-10-22
Age:4.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Male  Submitted:2008-10-24, Days after onset: 1
Location:Iowa  Entered:2008-11-05, 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: No
Current Illness: No
Preexisting Conditions: Allergy-PCN
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B084AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA09963SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0664X1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1142X1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pallor
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Mom noticed red area on if upper arm the day after vaccinations. Took child to MD the next day 10/24/08. 5cm circular area on Lt upper arm with blanching. Warm to touch. Tender. No fever. Continue to monitor.

VAERS ID:331460 (history)  Vaccinated:2008-10-22
Age:1.0  Onset:2008-11-05, Days after vaccination: 14
Gender:Female  Submitted:2008-11-05, Days after onset: 0
Location:California  Entered:2008-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT27850A1UNRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB238AA1UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0356X1SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC734591UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1792U SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration, Injection site reaction, Scab
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 3 cm induration and central crusting at injection site, of VARICELLA, no blisters.

VAERS ID:331536 (history)  Vaccinated:2008-10-22
Age:11.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Male  Submitted:2008-11-06, Days after onset: 15
Location:New Mexico  Entered:2008-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma. Allergic to Augmentin
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2833AA3IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB246AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2683AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Feeling cold, Feeling hot, Hot flush, Injection site pruritus, Injection site warmth, Malaise
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Patient said he did not feel good around 4pm the day of vaccination. Around 9pm patient said he was hot. His face, ears, neck and shoulders were very red and hot to the touch. He was then saying he was having hot/cold flashes. He said his arms around the injections sites were hot and itching.

VAERS ID:331551 (history)  Vaccinated:2008-10-22
Age:70.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Male  Submitted:2008-11-06, Days after onset: 14
Location:Iowa  Entered:2008-11-06
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: COPD
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89622 IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Infection, Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: PT. RECEIVED VACCINATION ON 10/22/08. CALLED PHARMACY ON 10/23/08 AND STATED THAT THEY HAD PAIN AT INJECTION SITE AND REDNESS DOWN TO ELBOW AREA. PHARMACIST INSTRUCTED TO KEEP AN EYE ON IT FOR A DAY OR TWO AND TO REPORT IF THE REACTION DIDN''T RESOLVE IN A COUPLE DAYS. PT. ENDED UP GOING TO DOCTOR ON 10/27/08 FOR TREATMENT AND RECEIVED ANTIBIOTIC FOR INFECTION. PT REPORTED LATER IN THE WEEK THAT THE PAIN AND SITE WERE IMPROVING WITH CONTINUED ANTIBIOTIC TREATMENT.

VAERS ID:331560 (history)  Vaccinated:2008-10-22
Age:26.0  Onset:2008-10-24, Days after vaccination: 2
Gender:Female  Submitted:2008-11-06, Days after onset: 13
Location:Florida  Entered:2008-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Cough, Fatigue, Influenza like illness, Injection site pain, Malaise, Oropharyngeal pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Coworker and I were administered flu shot on 10/22/08. From what I read, symptoms should not be occuring, but both of us are experiencing the same symptoms: flu like symptoms, fatigue, sore throat, dry cough, slight fever. Both of us just do not feel well and normally do not fall ill. No one else in the office has received the shot or nasal spray, has fallen ill, or become infected by either of us. Also, site of injection was usually sore compared to the previous 5 years I have received the flu shot.

VAERS ID:331571 (history)  Vaccinated:2008-10-22
Age:30.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-06, Days after onset: 14
Location:Minnesota  Entered:2008-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Apri, celexa, minocycline, prevacid
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0619X0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Cellulitis, Chills, Headache, Influenza like illness, Malaise, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Cellulitis of the left arm, encompassing the entire upper arm. Flu like symptoms such as fever, chills, body aches, malaise, headache and nausea. Given clyndamycin 300mg four times a day for 10 days and bactrim twice a day for 15 days, also vicodin for pain.

VAERS ID:331672 (history)  Vaccinated:2008-10-22
Age:39.0  Onset:2008-11-01, Days after vaccination: 10
Gender:Female  Submitted:2008-11-06, Days after onset: 5
Location:Iowa  Entered:2008-11-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: None
Preexisting Conditions: Allergy to Biaxin and Augmentin - Rash PMH: migraine, venous insufficiency, right knee arthritis, chicken pox, herpes zoster.
Diagnostic Lab Data: Lyme disease/sed rate LABS: CBC & chemistry WNL.
CDC 'Split Type': IA08015
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2763AA4UNLA
Administered by: Private     Purchased by: Private
Symptoms: Borrelia burgdorferi serology, Conjunctival hyperaemia, Facial palsy, Full blood count, Headache, Hypoaesthesia facial, Laboratory test, Oedema peripheral, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow)
Write-up: Facial numbness w/drooping. Bells palsy. Predisone/CT scan. 11/14/08 Reviewed PCP medical records of 9/11-11/06/2008. FINAL DX: Bell''s palsy Records reveal patient experienced intermittent redness & inflammation of conjunctivae bilaterally. Right calf also swollen & painful w/equivocal Homan''s. Referred to ophtho & vein center. RTC 11/1/08 w/numbness/tingling left face w/HA x 2 days. Tx w/steroids.

VAERS ID:331905 (history)  Vaccinated:2008-10-22
Age:41.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-10, Days after onset: 18
Location:North Carolina  Entered:2008-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA380AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Patient administered flu vaccine in left upper arm. Post vaccine administration patient c/o pain radiating down left arm which she described as "tingling". Pain worse with certain movements of left arm. Treatment is with abupropin and rest.

VAERS ID:331920 (history)  Vaccinated:2008-10-22
Age:26.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-10, Days after onset: 18
Location:Arizona  Entered:2008-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': AZ0819
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB128AB IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0427U SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1490F SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Client stated on 11/5/08 - that the next day after the immunizations-she traveled with friends and suddenly could not breath. She was treated at hospital. States was given epinephrine and fluids and placed on prednisone. Dr. told her it not a vaccine reaction.

VAERS ID:332035 (history)  Vaccinated:2008-10-22
Age:17.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-04, Days after onset: 13
Location:Oklahoma  Entered:2008-11-12, 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: 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 PASTEURU2811AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 10/31/08 by 5:30 L Deltoid red, swollen, tender, hot to touch from elbow to shoulder. Pain increase to point, client unable to use L arm rest of the evening/night. For next 2 days, deltoid warm, red, tender. 11-01-08 - Resolved. Client used TYLENOL for pain.

VAERS ID:332041 (history)  Vaccinated:2008-10-22
Age:1.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-10-27, Days after onset: 4
Location:Indiana  Entered:2008-11-12, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2759AA0 LL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0917X0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC683123IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1000X0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: PT. had large knot on left thigh one day after she received shots. Area was larger than a quarter, red, hard, and hot to the touch. Did not seem painful for pt. Was told to give antihistamine and use cold compresses as needed.

VAERS ID:332115 (history)  Vaccinated:2008-10-22
Age:47.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-12, Days after onset: 20
Location:South Carolina  Entered:2008-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nortrel, Zoloft, Imitrex prn
Current Illness: none
Preexisting Conditions: Migraine headaches
Diagnostic Lab Data: none
CDC 'Split Type': SC 0820
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2828AA5IMLA
Administered by: Public     Purchased by: Public
Symptoms: Condition aggravated, Eyelid oedema, Headache, Migraine, Nausea, Ocular hyperaemia, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Slight HA, sore arm. Awoke next AM feeling nauseous, upper eyelids swollen, and eyes bloodshot. Did precipitate her migraines, X 2-3 days. Other than migraines, other symptoms gone after 24 hours.

VAERS ID:332118 (history)  Vaccinated:2008-10-22
Age:71.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-12, Days after onset: 20
Location:Virginia  Entered:2008-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no new
Current Illness: none
Preexisting Conditions: sertraline
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS87877 IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Rash maculo-papular, Skin exfoliation, Stevens-Johnson syndrome, Urticaria
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: received flu vaccine 10/22/08. Next day had eruption that spread to entire body, at first urticarial, then maculopapular, involving mouth and eyes, followed by extensive exfoliation, c/w stevens-johnson syndrome

VAERS ID:332178 (history)  Vaccinated:2008-10-22
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-11-07
Location:New Jersey  Entered:2008-11-12, 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: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791DA IMUN
Administered by: Other     Purchased by: Private
Symptoms: Discomfort, Injected limb mobility decreased, Pain in extremity
SMQs:
Write-up: I had discomfort for 10 days. I was unable to lift my arm for almost a week. I am relieved to hear that others experienced the same symptoms. The arm is still sore. I would like to know if the shot was administered correctly or if it was the vaccine.

VAERS ID:332236 (history)  Vaccinated:2008-10-22
Age:  Onset:0000-00-00
Gender:Male  Submitted:2008-11-07
Location:New Jersey  Entered:2008-11-12, 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: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791DA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Feeling abnormal, Joint range of motion decreased, Pain in extremity, Sleep disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: I''m, still experiencing very strong pain that limits the movement of my arm while I''m at work and that wakes me up repeatedly at night. The hot compresses help very temporarily and the pain returns minutes later. ADVIL doesn''t seem to mute the pain either. The pain is an intense, sharp ache that travels down my upper arm but not past my elbow. The pain is always there and is aggravated by movement of my arm. Changing positions at night causes intense pain if I have been, in any degree, sleeping on the affected arm. If I haven''t been sleeping on it changing positions still causes enough pain to wake up and delay my returning to sleep. At work I leave my left arm ( the affected arm) resting on my desk and mostly use my right to do anything that might require me to lift my left. I will use the left in some cases ( because I can''t spend my day using one arm solely) but with sharp, aching pain as being the price paid. My pain has been consistent and extreme and it began within 12 hours of FLUZONE. Monday, while at work, I felt dizzy and disconnected(similar to how you might feel after taking strong pain medication). It went away and it may or may not be connected to the FLUZONE but I thought I''d mention it anyway. I have considered going to the doctor but have hesitated because I don''t have the available finances to be paying the doctor to tell me what you already have suggested. I''ve been trying the suggestions previously given, without success. I hope something comes of this investigation because I''m beyond ready to have this be over. At least if I stay healthy this winter it may be worth it but at this point, as the pain radiates from my shoulder, that''s highly debatable.

VAERS ID:332238 (history)  Vaccinated:2008-10-22
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-11-07
Location:New Jersey  Entered:2008-11-12, 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: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791DA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Activities of daily living impaired, Arthralgia, Hypokinesia, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: I still have a large amount of pain when I move that arm in a certain directions and I have been using mostly my right arm since the shot. It is difficult to put on a coat or a shirt. I have to bend totally over to take one off or put one on. Driving is ok. I cannot lift anything with that arm either. There has not been any swelling, bruising or redness in the area of the shot. It feels like it is the joint or the muscle itself. It even aches and has sharp pain occasionally when I am not using it. I have an appt. with a Dr. on another matter on Thursday and intend to ask him what is wrong. I have been applying warm packs and letting the shower run on it to no avail. I cannot take any aspirin, Tylenol or Advil for the pain.

VAERS ID:332239 (history)  Vaccinated:2008-10-22
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-11-07
Location:New Jersey  Entered:2008-11-12, 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: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791DA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Pain in extremity
SMQs:
Write-up: Arm pain

VAERS ID:332240 (history)  Vaccinated:2008-10-22
Age:  Onset:0000-00-00
Gender:Male  Submitted:2008-11-07
Location:New Jersey  Entered:2008-11-12, 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: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791DA IMUN
Administered by: Other     Purchased by: Private
Symptoms: Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: I think that the work you do to bring the flu shot to the office is a great benefit and I do appreciate it as much as I do the heart test. I have to tell you though that I couldn''t possibly risk another 2 weeks of pain like I received from this last shot. Youch! It''s very surprising to me and I have to believe that it''s more a case of misplaced shot than a new mix of vaccine. I''m just guessing really, but my shot was near the top of my shoulder and my pain is sort of in the shoulder itself-not the muscle. Please don''t interpret this as a complain in any way 9 I do complain about it as I explain to her why she''s raking the leaves and splitting the wood (not really)). I continue to appreciate the effort and concern that you and the company put forth regarding out health. I just wanted to share my experience with you in the even that you continue your dialog with the nurse.

VAERS ID:332241 (history)  Vaccinated:2008-10-22
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2008-11-07
Location:New Jersey  Entered:2008-11-12, 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: unknown
Preexisting Conditions: unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791DA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Joint range of motion decreased, Pain in extremity
SMQs:, Arthritis (broad)
Write-up: This is the 6th year I received the flu shot and I have never had a experience like the one I had this year. Within hour of the shot I had radiating pain throughout my upper arm. The pain was very deep and was felt in my armpit and down my side. Every time I moved my left arm it was painful. I thought it was unusual, but I expected it to go away within 24 hours. That was not the case. The pain continued for almost a week. The injection site was also sore to touch for a week also.

VAERS ID:332230 (history)  Vaccinated:2008-10-22
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-11-07
Location:New Jersey  Entered:2008-11-13, 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: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791DA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: I, too, had discomfort after the shot but I didn''t think to tell anyone about it because I though I was the only one. My arm was quite sore and hot at the injection site and it hurt a lotto raise my arm. That lasted for about 4 or 5 days but I did not go to the Dr. about it cause I thought it would go away by itself, which it did and now it is fine.

VAERS ID:332237 (history)  Vaccinated:2008-10-22
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-11-07
Location:New Jersey  Entered:2008-11-13, 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: unknown
Preexisting Conditions: unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791DA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Fatigue, Hypokinesia, Injection site pain, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Regarding FLUZONE, I had never had one before so I was not aware that there was anything unusual about the after affects. I did feel somewhat like after a tetanus shot-sore at the site of the injection, muscles sore-unable to lift arm above shoulder level, and tired and achy all over. That went away after four days, but then came back a day later for three more days. Now I just have some muscle soreness left.

VAERS ID:332372 (history)  Vaccinated:2008-10-22
Age:48.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Male  Submitted:2008-10-29, Days after onset: 7
Location:Michigan  Entered:2008-11-14, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Celiac disease
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA364BA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Generalized pruritis-1hr-after vaccination-lasted approx. 5hrs until took Benadryl.

VAERS ID:332376 (history)  Vaccinated:2008-10-22
Age:76.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-24, Days after onset: 2
Location:Virginia  Entered:2008-11-14, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS87950 IMRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt experienced itching & redness on the arm vaccine was administered. Not at the administration site but along the forearm. She didn''t know if she got poison ivy or if this was a reaction.

VAERS ID:332426 (history)  Vaccinated:2008-10-22
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-11-14
Location:New Jersey  Entered:2008-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791DA IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: Shoulder Pain

VAERS ID:332506 (history)  Vaccinated:2008-10-22
Age:0.3  Onset:2008-11-07, Days after vaccination: 16
Gender:Male  Submitted:2008-11-10, Days after onset: 3
Location:Texas  Entered:2008-11-17, Days after submission: 7
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none PMH: mild viral URI few weeks prior.
Diagnostic Lab Data: Barium enema LABS: abdominal US c/w IS. Contrast enema reduced. Blood & stool c/s neg.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2955BA1UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF441AA1UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA08361UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC69205B1UNLL
Administered by: Private     Purchased by: Unknown
Symptoms: Barium double contrast, Blood culture negative, Cold sweat, Culture stool negative, Diarrhoea, Enema administration, Haematochezia, Intussusception, Nausea, Pallor, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow)
Write-up: Intussusception (barium enema diagnosed). Reduced with air contrast enema. Recovered without incident. Presented with vomiting & hematochezia. 12/02/08 Reviewed hospital medical records of 11/08/2008. FINAL DX: Intussusception, enema reduced. Records reveal patient experienced loose stools x 2 days that became bloody & nausea/vomiting, clammy, pale. Admitted overnight for observation s/p enema reduction of IS. D/C to home.

VAERS ID:334817 (history)  Vaccinated:2008-10-22
Age:11.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Male  Submitted:2010-06-08, Days after onset: 594
Location:Texas  Entered:2008-11-17, Days after submission: 567
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0810USA04326
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Pain in extremity, Wrong drug administered
SMQs:, Guillain-Barre syndrome (broad)
Write-up: Information has been received from a registered nurse concerning an 11 year old male who on 22-OCT-2008 was vaccinated with a dose of GARDASIL vaccine, IM. No problems reported. Follow up information was received from a physician who reported that the patient came into the office for Tdap vaccine (unspecified), MENACTRA and VARIVAX (Oka/Merck) and he mistakenly received GARDASIL. The physician reported that the child experienced some soreness in his arm and weakness, but nothing adverse. The physician stated the the child was fine. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2008. Information has been received from a registered nurse concerning an 11 year old male who on 22-OCT-2008 was vaccinated with a dose of GARDASIL 0.5 mL, IM. No problems reported. Follow up information was received from a physician who reported that the patient came into the office for MENACTRA and VARIVAX and he mistakenly received GARDASIL. The physician reported that the child experiened some soreness in his arm and and weakness, but nothing adverse. The physician stated that the child was fine. Additional information has been requested.

VAERS ID:332737 (history)  Vaccinated:2008-10-22
Age:11.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-18, Days after onset: 27
Location:Washington  Entered:2008-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.6570X IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2683AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2997AA IMRA
Administered by: Public     Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Anorexia, Bacterial infection, Burning sensation, Cellulitis, Contusion, Crying, Dizziness, Erythema, Genital pain, Headache, Pallor, Pruritus genital, Rash, Skin discolouration, Swelling, Vulvovaginal discomfort
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: 10/22/08 after my daughter received the vaccinations at a little after 10:00 AM, my daughter started to tell me that she was itching around her pelvic/vaginal area and on the same day as the shot early morning she had just got her PMS before going to the Dr.''s office. I did not think it was serious because I thought that it might of been the pad that was making her feel uncomfortable. I remembered seeing my daughter''s face was very pale, but again I did not think of anything serious nor read the allergic reactions vaccination handouts that was provided to me from the Medical Assistant GRA 93777-initials. And after the appointment, she also had a dentist appointment on the same day and she had two fillings done & 2 sealants. It finally got my attention after hearing my daughter acting abnormal, like constantly scratching and crying because her itching was burning and I asked her describe to me what they look like. She told me it was red and color purple around her vagina and that it was bruising and swollen, also it was spreading all over her bottom everywhere, between her legs. I was very scared to look at it but I told her that I would make a Dr''s appointment and I also asked her if she would like to be taken into the emergency room and she refused to because she could not handled the pain anymore. I called her Dr.''s office on 10/27/08 and asked for the earliest appointment available in the later afternoon so I can have her stepfather take her to see the Dr. I even mentioned to the gentlemen that it was very weird that she has all these rashes right after she received the vaccinations. So the appointment was scheduled on 10/30/08 4:45 p.m. to see the doctor and she diagnosed her as rash & nonspecific skin eruption and on the same day they offered her a flu shot which she agreed to have. The Dr. provided a rash cream for antifungal bacterial infection around the vagina. At the same time I''ve been so worried and feel very helpless to see my daughter having to go through this pain, especially having her to tell me

VAERS ID:332864 (history)  Vaccinated:2008-10-22
Age:83.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-02, Days after onset: 10
Location:Maryland  Entered:2008-11-20, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; TRICOR; ZIAC
Current Illness: None
Preexisting Conditions: High cholesterol; Hypertension. PMH: HTN, hyperlipidemia
Diagnostic Lab Data: X-Ray showed tendonitis and inflammation in right shoulder. There was also previous scar tissue. Labs and Diagnostics: Shoulder X-ray (+) for calcification along proxima R humerus. X-ray humerus (+) for likely calcific tendonitis of supr
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA381AA0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Inflammation, Injected limb mobility decreased, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Tenderness, Tendonitis, X-ray limb abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Osteonecrosis (broad), Arthritis (broad)
Write-up: Severe pain and limitation in movement in upper right arm and shoulder. Pain has slowly decreased over a period of 2 weeks and range of motion is improving. Patient sought care at a hospital and was given pain medication and recommended for physical therapy. 10/24/08 ER record dated 10/31/08 received with DX: Calcific Tendonitis. Pt presnted with 9 day hx of shoulder pain since receiving flu shot. PE (+) for tenderness, limited ROM, and weak arm abduction past 90''.

VAERS ID:332866 (history)  Vaccinated:2008-10-22
Age:7.0  Onset:2008-10-28, Days after vaccination: 6
Gender:Male  Submitted:2008-11-03, Days after onset: 6
Location:Louisiana  Entered:2008-11-20, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA~ ()~~0~In Patient
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': LA081103
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0662X1SC 
Administered by: Public     Purchased by: Unknown
Symptoms: Rash erythematous, Rash pruritic, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Itchy rash beginning on 10/28/08 progressively getting worse + face, upper ext. trunk and small amount right thigh 11/3/08 in clinic. Rash red, slightly raised. Reports itches. Plans to see private MD today.

VAERS ID:333162 (history)  Vaccinated:2008-10-22
Age:47.0  Onset:2008-11-15, Days after vaccination: 24
Gender:Male  Submitted:2008-11-24, Days after onset: 9
Location:Ohio  Entered:2008-11-24
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 12/26/08-records received-PMH: HTN, HPL and history of MI x 2 s/p PTCA of RCA and mid LCX.
Diagnostic Lab Data: Please contact the patient''s physician for additional information. 12/26/08-records received-Lumbar puncture protein 108. EMG test demonstrated absent Fan d H reflexes suggestive of acute inflammatory demyelinating polyneuropathy affecting both lower extremities and to lesser extent bilateral upper extremities.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Areflexia, Asthenia, Blood product transfusion, CSF protein increased, Demyelinating polyneuropathy, Dysgeusia, Electromyogram abnormal, Facial palsy, Facial paresis, Guillain-Barre syndrome, Lumbar puncture abnormal, Paraesthesia, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Taste and smell disorders (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow)
Write-up: 47 WM never-smoker with HTN and h/o MI x 2 (12/97 and 4/98) s/p PTCA of RCA and mid LCX, and family history of early cardiovascular disease, who presents to clinic as a transfer from Medical Center with concern for GBS secondary to recent influenza vaccine administration on 10/22/08. He had been in his usual state of health from that point until 11/15/08, at which time he developed bilateral paresthesias of his toes, then fingers, then the following day a continuous sensation of Left$gRight LE progressive strength deficit, beginning in the feet, up to the knees, to the hips. n 11/19/08, he developed Left-sided facial weakness and diminished sense of taste. Diagnosis of GBS. Please contact M.D. for additional information. 12/26/08-records received for DOS 11/20-11/25/08-DC DX: Guillain-Barre syndrome. Presented on 11/19/08 with C/O bilateral toe and finger paresthesias later progressing throughout day to include feet, knees and hips. Developed left-sided facial weakness and diminished sense of taste. Treated with IVIG. PE: absent patellar, Achilles and triceps reflexes. Complete left upper and lower facial paralysis consistent with cranial nerve 7 distribution. Discharged to rehabilitation facility.

VAERS ID:333318 (history)  Vaccinated:2008-10-22
Age:54.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Male  Submitted:2008-11-24, Days after onset: 33
Location:Illinois  Entered:2008-11-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA192AA IMUN
Administered by: Public     Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:
Write-up: 11/24 - reported pain/hurt through out arm since shot given on 10-22-08. Has not taken anything as of yet. Saw doctor within last few days - MD said it could take up to 3 months to get better.

VAERS ID:333928 (history)  Vaccinated:2008-10-22
Age:0.2  Onset:0000-00-00
Gender:Male  Submitted:2008-11-26
Location:Ohio  Entered:2008-12-04, 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
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: None. Pt. received both PEDIARIX and Hep B (single dose) on 10-22-08.

VAERS ID:334105 (history)  Vaccinated:2008-10-22
Age:  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-06, Days after onset: 14
Location:Washington  Entered:2008-12-05, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 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 PASTEURU2808AA UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Rash papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Fine papular rash covering entire trunk and arms, itchy.

VAERS ID:334540 (history)  Vaccinated:2008-10-22
Age:77.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Male  Submitted:2008-11-18, Days after onset: 26
Location:Alabama  Entered:2008-12-09, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2803AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1384U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling, and tenderness around injection site. (L) arm.

VAERS ID:334545 (history)  Vaccinated:2008-10-22
Age:72.0  Onset:0000-00-00
Gender:Male  Submitted:2008-11-17
Location:Unknown  Entered:2008-12-09, Days after submission: 22
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) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Back pain, Chills, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad)
Write-up: Fever chills Lower Back muscles aches

VAERS ID:334837 (history)  Vaccinated:2008-10-22
Age:95.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-12-08, Days after onset: 46
Location:Connecticut  Entered:2008-12-10, 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: NORVASC; Aspirin; XALATAN; PRILOSEC; ZOLOFT; Vitamins (unspecified)
Current Illness: Retirement; Non-smoker; Hypertension; Anaemia; Osteoarthritis; Hypocholesterolaemia; Hyponatraemia; Depression; Headache; Osteop
Preexisting Conditions: Cerebrovascular accident; Transient ischaemic attack
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0810USA05186
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1076X0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Atelectasis, Chills, Condition aggravated, Cough, Dyspnoea, Erythema, Hypertension, Hyponatraemia, Local reaction, Oedema peripheral, Pleural effusion, Pyrexia, Urinary tract infection, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 96 year old female who in October 2008 was vaccinated with PNEUMOVAX (Lot# 662599/1076X, therapy date, route, site unknown). "In the last 10 days", approximately 19-OCT-2008, the patient developed severe local reactions in the injection arm. She experienced welts and swelling on the arm. She also developed a fever and had trouble breathing. She sought medical attention and was hospitalized for the fever but has since been released. A lot check is requested for PNEUMOVAX lot # 662599/1076X. At the time of this report on 29-OCT-2008, the patient was recovering. This is one of several reports received from the same source. Follow-up information was received from the physician and medical records that the patient was a 95 year old female with hypertension, anaemia, depression, headache, osteoporosis, hyponatraemia, hypocholesterolaemia and osteoarthritis and a history of cerebrovascular accident and transient ischaemic attack who on 22-OCT-2008 was vaccinated with PNEUMOVAX on left deltoid (Lot# 662599/1076X, therapy route unknown). Concomitant therapy included NORVASC, aspirin, ZOLOFT, PRILOSEC, XALATAN and multivitamin. The patient retired and had no smoking or drinking. On 23-OCT-2008 the patient experienced chills, cough, dyspnea and redness of upper extremity. She sought medical attention and was hospitalized for 2 days from 23-OCT-2008 to 25-OCT-2008. At the hospital, the patient was started prior to admission on nitrofurantoin for urinary tract infection. Discharge summary reported principal diagnosis as "small left pleural effusion atelectasis". Other diagnoses included: "transient febrile, Pneumovax, Redness of upper extremity status post pneumonia injection, urinary tract infection, hyponatremia, hypertension". A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the research center and was released. No further information

VAERS ID:335093 (history)  Vaccinated:2008-10-22
Age:6.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-06, Days after onset: 14
Location:Washington  Entered:2008-12-11, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2808AA UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Pruritus, Rash, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Fine papular rash covering entire trunk and arms, itchy

VAERS ID:335106 (history)  Vaccinated:2008-10-22
Age:35.0  Onset:2008-10-28, Days after vaccination: 6
Gender:Female  Submitted:2008-12-10, Days after onset: 43
Location:Washington  Entered:2008-12-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERAL ER; APRI OCP; EFFEXOR XR; NEURONTIN; PRILOSEC; SEROQUEL; WELLBUTRIN XL
Current Illness: NONE
Preexisting Conditions: Bipolar; depression; ADD
Diagnostic Lab Data: Brain MRI 11/5/08, head CT 10/30/08.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0906X2SCRA
Administered by: Public     Purchased by: Public
Symptoms: Computerised tomogram, Headache, Nuclear magnetic resonance imaging brain
SMQs:
Write-up: Pt was given 2nd MMR booster 10/22/08. Developed severe headache 10/28/08. Has slightly improved but not back to baseline as of 12/10/08.

VAERS ID:336738 (history)  Vaccinated:2008-10-22
Age:23.0  Onset:2008-10-26, Days after vaccination: 4
Gender:Female  Submitted:2008-12-12, Days after onset: 47
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0811USA01307
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Menstruation delayed
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a 23 year old female with no drug reaction/allergies, who on 22-OCT-2008 was vaccinated with the first dose of GARDASIL vaccine. There was no concomitant medication. Patient mentioned that she was supposed to have her period on 26-OCT-2008, but until now she had not had her menstrual period yet. Patient noted that she had not done any pregnancy testing. The patient sought medical attention. No further information is available.

VAERS ID:336804 (history)  Vaccinated:2008-10-22
Age:14.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 51
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00541
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site reaction, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a medical assistant concerning a 14 year old female patient who on 23-APR-2008 was vaccinated with the first dose of GARDASIL, on 23-JUN-2008 she received the second dose of GARDASIL and on 22-OCT-2008 the patient received the third dose of GARDASIL 0.5 ml, I.M. in right deltoid. The medical assistant reported that after the third dose of HPV vaccine, the patient developed an injection site reaction. The patient experienced pain at the injection site and massaged the area that evening. The patient still had what was described as "BB size hard knot" at the injection site with discomfort. At the time of the report, the patient had no recovered. The patient sought medical attention at the office. Additional information has been requested. Follow up information has been received on 12-FEB-2009 from a health care professional who reported that the patient is a 14 year old female student who no known allergies or pertinent medical history (Weight 125 lb and heighth 62 in). On 22-OCT-2008 was vaccinated intramuscularly into her left deltoid with 0.5 ml of the third dose of GARDASIL (Lot# 660359/1968U). There was no concomitant medication. On 04-NOV-2008 the patient developed a small bb size hard knot at the injectio site. Sore to touch. On an unspecified date the patient recovered. There was no illness at the time of vaccination. In further follow-up received from the health care professional and medical records, it was reported that on 04-NOV-2008, the patient complained of a knot still on the arm. No further information is available. All available medical records will be provided upon request.

VAERS ID:336805 (history)  Vaccinated:2008-10-22
Age:  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 51
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00535
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a nurse practitioner concerning a female patient who on 22-OCT-2008, was vaccinated with the third dose of GARDASIL. The nurse practitioner reported that the patient experienced small knot at the injection site after getting the third dose of GARDASIL. The nurse stated that the patient did not experienced any AE on the first and second dose of GARDASIL. At the time of the report the outcome was

VAERS ID:337539 (history)  Vaccinated:2008-10-22
Age:4.0  Onset:2008-10-26, Days after vaccination: 4
Gender:Female  Submitted:2008-11-03, Days after onset: 8
Location:Unknown  Entered:2008-12-18, Days after submission: 45
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007367
Vaccination
Manufacturer
Lot
Dose
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Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500555P IN 
Administered by: Military     Purchased by: Other
Symptoms: Asthma, Chest discomfort, Cough
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: A non-serious, spontaneous report of acute asthma exacerbation, chest tightness and cough was received from a military nurse concerning a four year-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient''s past medical history includes asthma. No concomitant medications have been reported for this patient. The patient received FLUMIST on 22-Oct-2008. On 26-Oct-2008 the child experienced coughing and acute exacerbation attack of asthma and was taken to the emergency room. The child was seen at the clinic on 27-Oct-2008 and 31-Oct-2008 for continuing symptoms of coughing and chest tightness. As of 03-Nov-2008 the child was stable with no symptoms.

VAERS ID:335770 (history)  Vaccinated:2008-10-22
Age:71.0  Onset:2008-11-13, Days after vaccination: 22
Gender:Female  Submitted:2008-12-19, Days after onset: 36
Location:California  Entered:2008-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Mucinex Tessalon 1 week course of Prednisone began 10-28-2008.
Current Illness: Cough for 1 month
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1214X0SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Pain
SMQs:
Write-up: Lancinating pain above right ear and foreheadbeginning 11/13/08.

VAERS ID:337889 (history)  Vaccinated:2008-10-22
Age:26.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-10-29, Days after onset: 6
Location:Washington  Entered:2008-12-19, Days after submission: 51
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': 200814234
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED03549111A0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad)
Write-up: Report received from ZLB Plasma Center 0n 27-Oct-2008. A 26 year-old female (S.L. / DOB 08-AUG-1982) received AFLURIA (CSL influenza vaccine, lot 03549111A) on 22-Oct-2008 at 13:27. On 20-Oct-2008, patient was given two doses IM of HEPATITIS vaccine, lot 0398x. At the time of her AFLURIA vaccination, patient had no illness. Patient had no pre-existing allergies, concomitant medications or medical conditions. On 23-Oct-2008 at 9:30am, approximately 20 hours after receiving AFLURIA, patient complained of nausea, malaise, and muscle pain. Per the reporter, the patient recovered. Additional information had been requested. Assessment: No serious criteria mentioned. Causality: Possible. Follow-up information was received on 28-Oct-2008 from ZLB Plasma Center on 28-Oct-2008. The patient''s symptoms resolved in about 48 hours. She did not contact her primary care physician (PCP) and was not treated for her symptoms. Patient is not pregnant. No additional information is expected. No change is assessment. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:337896 (history)  Vaccinated:2008-10-22
Age:54.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-29, Days after onset: 7
Location:California  Entered:2008-12-19, Days after submission: 51
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: Allergy to penicillin; Allergy to THIMERISOL
Diagnostic Lab Data:
CDC 'Split Type': 200814217
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED01149111A0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Dysphonia, Ear discomfort, Electrocardiogram normal, Pharyngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Report received from RN who is also the patient on 23-Oct-2008. An adult female (BLH) received AFLURIA on 22-Oct-2008 (the patient was unsure if dose was from pre-filled syringe or vial). The patient experienced chest tightness, swelling or throat, and ears clogging 2 hours post-vaccination. She took 25 mg BENADRYL and felt better 30 minutes later. She went to the ER and received a SOLU-MEDROL shot and received prescription for PREDNISONE 20 mg twice daily for 5 days. The patient reported she feels much better today (23-Oct-2008) and her symptoms are basically gone. Patient reports history of allergy to penicillin and THIMERISOL. Awaiting further information. No serious criteria mentioned. Causality: Possible. Follow-up information received on 24-Oct-2008 from an RN (not the patient who is also a RN). RN confirmed that this 54 year-old female received a single dose syringe of AFLURIA IM to the left arm on 22-Oct-2008 at 8:00am. Lot administered: 01149111A. At 11:00am on 22-Oct-2008, patient experienced chest discomfort and her voice became hoarse. She has no prior allergic reactions to flu shots or allergies to the preservatives for the vaccine. She was evaluated and treated in the emergency department. Her EKG was normal (date/time not provided). Patient took 25 mg PO BENADRYL for 5 days, SOLUMEDROL IM, and PREDNISONE PO. Per the RN, patient has fully recovered. It is not known if patient received any other vaccinations within 4 weeks prior to receiving AFLURIA. No further information is expected. No change in assessment. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:337213 (history)  Vaccinated:2008-10-22
Age:65.0  Onset:2008-11-01, Days after vaccination: 10
Gender:Male  Submitted:2008-12-23, Days after onset: 52
Location:Unknown  Entered:2008-12-29, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA00697
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCAR
Administered by: Other     Purchased by: Other
Symptoms: Varicella
SMQs:
Write-up: Information has been received from a pharmacist concerning a 65 year old male patient with no pertinent medical history who on approximately 22-OCT-2008 ("approximately 2 weeks ago") was vaccinated with ZOSTAVAX (Oka/Merck) (lot number not available) SC into the arm. There was no concomitant medication. On approximately 01-NOV-2008 ("10-14 days after vaccination") the patient experienced chickenpox. The patient could not remember if he had ever had chickenpox. After stopping therapy the patient recovered from chickenpox. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:336420 (history)  Vaccinated:2008-10-22
Age:37.0  Onset:2008-11-22, Days after vaccination: 31
Gender:Female  Submitted:2008-12-23, Days after onset: 31
Location:Massachusetts  Entered:2009-01-02, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA367LA0UNLA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERD916X0SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling, redness, induration, warmth in posterior upper arm (triceps area); occurred one mo. after vaccine.

VAERS ID:337043 (history)  Vaccinated:2008-10-22
Age:53.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-28, Days after onset: 37
Location:Minnesota  Entered:2009-01-12, Days after submission: 45
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Avalide, Synthroid, MVI Calcium, Atenol, ASA, Welbutron
Current Illness:
Preexisting Conditions: Allergy to Sulfa, Macrodantin
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 4 Inch redness at injection site that lasted 4 days- 0 raised - some pain with palpation - itching on 3 of 4.

VAERS ID:337848 (history)  Vaccinated:2008-10-22
Age:0.3  Onset:2008-12-22, Days after vaccination: 61
Gender:Male  Submitted:2009-01-21, Days after onset: 30
Location:Unknown  Entered:2009-01-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': R0001587A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Other     Purchased by: Other
Symptoms: Bronchiolitis, Cough, Dehydration, Otitis media, Pyrexia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: This male subject was enrolled in the study 110870 (MenACWY-TT-057). On 27 August 2008, 22 October 2008 and 23 December 2008, he received the 1st, 2nd and 3rd dose of combined (Hib-MenCY-TT, IM L thigh) and (PEDIARIX, IM right thigh). On 22 December 2008, 61 days after the 2nd dose of PEDIARIX, 61 days after the 2nd dose of Hib-MenCY-TT, this six-month-old subject developed broncholitis. On 08 January 2009, 16 days after the 3rd dose of PEDIARIX and Hib-MenCY-TT, he developed dehydration. The subject was hospitalised. The events were unresolved at the time of reporting. The investigator considered that there was a reasonable possibility that the bronchiolitis may have been caused by PEDIARIX and Hib-MenCY-TT and that the events were possibly due to viral infection. The investigator considered that there was no reasonable possibility that the dehydration may have been caused by PEDIARIX and Hib-MenCY-TT. Relevant risk factors: sibling with asthma. Investigator comments: On 1/5/09 subject presented with 2 week history of cough, diagnosed with bronchiolitis and treated with ALBUTEROL. The subject returned on 1/7/09 with worsening symptoms and fever and was diagnosed with OM, brronchiolitis and treated with OMNICEF antibiotic and ORAPRED. Returned to clinic on 1/9/09, unable to keep his meds down and became dehydrated. Hospitalized for for management of bronchiolitis and dehydration.

VAERS ID:338296 (history)  Vaccinated:2008-10-22
Age:58.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-24, Days after onset: 2
Location:Kansas  Entered:2009-01-26, Days after submission: 94
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None; BP, 109/66; P, 56
CDC 'Split Type': KS200820
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2810AA0IMUN
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Chills, Disturbance in attention, Dysgraphia, Eye pain, Headache, Heart rate decreased, Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad)
Write-up: Headache, weakness, decreased concentration, writing illegible, chills, stiffness lower extremities, muscle aching, fever 101 (although this was taken after client took hot bath for chills), eyes aching, nausea.

VAERS ID:339281 (history)  Vaccinated:2008-10-22
Age:62.0  Onset:2008-12-03, Days after vaccination: 42
Gender:Female  Submitted:2009-02-09, Days after onset: 68
Location:Maryland  Entered:2009-02-09
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypertension, and hypothyroidism, chronic back pain s/p mva PMH:panic attack
Diagnostic Lab Data: RPR=non-reactive, Lyme disease=negative, CSF studies as well as serum protein electrophoresis unremarkable other than CSF protein of 77 and WBC of 1. CSF cytology was unremarkable. MRI of head showed mild chronic ischemic microangiopathy and possible empty cellar syndrome. MRI of cervical spine showed changes of cervical spondylosis with bulging of disc osteophyte complex at the c3-c4 and c4-c5 and c5- c6 interspace where there is extrinsic pressure of the thecal sac and extrinsic pressure of the spinal cord at the c-4 to c-5 and c5-c6 interspaces where there is spinal stenosis. Spinal cord itself appears normal. ANA is 146 high and SSA 146 is high. LABS: CT brain WNL. EMG/NCS abnormal & c/w GBS
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2832AA2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody increased, Areflexia, Asthenia, Back pain, Blood product transfusion, Borrelia burgdorferi serology negative, Burning sensation, CSF cell count normal, CSF protein increased, CSF white blood cell count, Cerebral microangiopathy, Cervical spinal stenosis, Computerised tomogram normal, Cough, Diarrhoea, Electromyogram abnormal, Electrophoresis protein, Fatigue, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Influenza, Intensive care, Intervertebral disc protrusion, Lumbar puncture, Muscular weakness, Nausea, Nerve conduction studies, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity, Paraesthesia, Protein urine present, Sensory loss, Spinal osteoarthritis, Syphilis test negative, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Cerebrovascular disorders, not specified as haemorrhagic or ischaemic (broad), Chronic kidney disease (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow)
Write-up: 12/3/08 pt started with "strangled cough" and body aches. 12/12/2008 Had severe vomiting and diarrhea- extremely weak and barely could walk-no stool cultures done. Pt prescribed anti-nausea and anti-diarrheal med. 12/17/2008 Pt achy, tired, and cough returned. 12/21-12/22/2008 Couldn''t walk up steps describes legs feeling like jelly. 12/23/08 extreme pain in back and all extremities, but pain only at night. 12/24/2008 Burning electrical pain continued but only at pm. 12/26/08 pt to emergency room-no reflexes present in lower extremities. Admitted to ICU. Seen by neurologist and diagnosed with Guillain Barre Syndrome. Pt had lumbar puncture, MRI, nerve conduction tests. Given IVIG for total of 5 days. 2/6/09 Pt still has residual weakness and compacted feeling in hands. 2/11/09 Received hospital medical records of 12/26-12/31/2009. FINAL DX: Guillain Barre syndrome; cervical spinal stenosis Records reveal patient had stomach flu approx 2 wks prior to admit w/N/V/D that resolved after 3 days. Developed weakness/numbness of limbs, difficulty walking, & pain in her back x 3 days prior to admit. Neuro consult done. Areflexia & loss of sensation of legs. LP done. Tx w/IVIG x 5 day w/improvement. D/C to home w/outpatient PT. 2/16/09 Received CSF results.

VAERS ID:339780 (history)  Vaccinated:2008-10-22
Age:53.0  Onset:2008-10-24, Days after vaccination: 2
Gender:Female  Submitted:2008-12-01, Days after onset: 38
Location:Connecticut  Entered:2009-02-18, Days after submission: 79
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No
Diagnostic Lab Data: EMG-neg
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2745AA4IMLA
Administered by: Public     Purchased by: Private
Symptoms: Arthralgia, Electromyogram normal, Erythema, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: On 10/24/08 pt. presented to office c/o pain L deltoid w/ radiation of pain to elbow. Area of erythema measured 1.5x2 cm. Normal remainder of exam. Redness + swelling resolved but pain to elbow from mid-deltoid persisted.

VAERS ID:340314 (history)  Vaccinated:2008-10-22
Age:13.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2009-02-13, Days after onset: 114
Location:New York  Entered:2009-02-18, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0901USA04442
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0560X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Initial information has been received from an office staff member and follow up information has been received from a nurse concerning a female patient who in approximately January 2009 was vaccinated with the first dose of GARDASIL (lot # not available). The patient became lightheaded and went to the emergency room after receiving the vaccine (approximately January 2009). The patient becoming lightheaded was considered another important medical event by the reporter because the patient went to the emergency room. Additional information has been requested. In the follow-up the nurse stated that the vaccine was ordered by a nurse practitioner. The patient was 13 year old and was vaccinated with the first dose of GARDASIL (Lot # 659055/05060X) on 22-OCT-2008. The nurse reported that within 5 minutes of receiving the vaccination, the patient became dizzy and lightheaded. The patient complained of shortness of breath. The nurse practitioner evaluated the patient and had her transported to the emergency room. The patient was evaluated in the emergency room. The patient was wheezing and was given a breathing treatment. The patient was not admitted to the hospital. The patient had recovered and the following day returned to school. The patient becoming lightheaded was considered another important medical event by the reporter because the patient went to the emergency room. Additional information is not expected.

VAERS ID:341425 (history)  Vaccinated:2008-10-22
Age:14.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2009-02-26, Days after onset: 127
Location:California  Entered:2009-03-10, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0229X1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Vaccine positive rechallenge
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Dizzy episode after 1st GARDASIL 8/18/08. Dizzy episode after 2nd GARDASIL 10/22/08. See attached.

VAERS ID:342636 (history)  Vaccinated:2008-10-22
Age:37.0  Onset:2008-11-08, Days after vaccination: 17
Gender:Female  Submitted:2009-03-13, Days after onset: 124
Location:Virginia  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC 'Split Type': WAES0902USA01120
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Information has been received from a 37 year old female with no allergy and medical history who on 18-AUG-2008 was vaccinated with a first dose of GARDASIL. On 22-OCT-2008, the patient was vaccinated with a second dose of GARDASIL. Concomitant therapy included oral OCELLA. On 08-NOV-2008 the patient experienced severe itching all over her body, mainly on her chest, back, stomach and all pressure points. On 13-NOV-2008 the patient was put on oral steroids. On 25-NOv-2008, the patient recovered from the events. The steroids did not work completely and received a second oral steroid which did help the itching. Additional information has been requested.

VAERS ID:345560 (history)  Vaccinated:2008-10-22
Age:62.0  Onset:2008-12-22, Days after vaccination: 61
Gender:Male  Submitted:2009-03-27, Days after onset: 94
Location:Unknown  Entered:2009-04-08, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA04552
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Genital herpes
SMQs:
Write-up: Information has been received from a 62 year old male who "about 8 weeks ago" was vaccinated with single dose of series of ZOSTAVAX (Oka/Merck) and now the patient has genital herpes. At time of the report the patient''s genital herpes outcome was unknown. The patient sought unspecified medical attention. Additional information has requested.

VAERS ID:351968 (history)  Vaccinated:2008-10-22
Age:54.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2008-11-25, Days after onset: 33
Location:North Carolina  Entered:2009-07-14, Days after submission: 230
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 reported.
Diagnostic Lab Data: None reported.
CDC 'Split Type': 200803357
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA380AA IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB132AC UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3030A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial information was received on 27 October 2008 from a health care professional. A 54 year old female received an intramuscular left deltoid injection of FLUARIX (manufacturer GSK, lot number AFLUA3808AA) on 21 October 2008. On 22 October 2008 she received an intramuscular left deltoid injection of ADACEL (lot number C3030AA) and TWINRIX (manufacturer GSK, lot number AHABB132AC) given in the right deltoid. The patient noted that she received the Td injection in 2003. On 23 October 2008 the patient had a "big local reaction" at the injection site (arm not specified). The patient also had an indurated area which was red, swollen and measured at 7.25 x 7.5 cm. The patient stated that at one point it was larger than 7.25 x 7.5 cm. The patient was seen by her physician. The patient was not recovered at the time of the report. Follow-up information received on 24 November 2008 from a health care professional. The patient''s reaction was at the site of the ADACEL injection in the left deltoid. She was re-evaluated in the clinic on an unspecified date and treated with over the counter ADVIL and warm soaks. She recovered from the events on 04 November 2008. List of Documents held by Sender: None.

VAERS ID:355327 (history)  Vaccinated:2008-10-22
Age:8.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Male  Submitted:2008-11-07, Days after onset: 16
Location:Illinois  Entered:2009-08-13, Days after submission: 278
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Used
Current Illness:
Preexisting Conditions: No known allergies or history of hypersensitivity.
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007331
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500550P IN 
Administered by: Private     Purchased by: Other
Symptoms: Inflammation, Pruritus, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: A non-serious, spontaneous report of inflammation of the face iwth swelling and itching was received from a nurse, concerning an eight year-old male patient, subsequent to FLUMIST. The patient was not taking any concomitant medications. The patient has no known allergies or history of hypersensitivity. The patient received FLUMIST, nasal on 22-Oct-2008 for flu vaccinations. Twelve hours after administration of FLUMIST, the child experienced inflammation of the face with swelling and itching. There was no report of difficulty breathing or swelling of the tongue or throat. The nurse advised the parent to administer the patient diphenhydramine by mouth. The symptoms were ongoing at time of reporting on 24-Oct-2008 The outcome of the events is unknown.

VAERS ID:355336 (history)  Vaccinated:2008-10-22
Age:  Onset:2008-10-24, Days after vaccination: 2
Gender:Female  Submitted:2008-10-30, Days after onset: 6
Location:Wisconsin  Entered:2009-08-13, Days after submission: 287
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': MEDI0007352
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Upper respiratory tract congestion
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad)
Write-up: A non-serious, spontaneous report of fever, congestion, muscle aches and sore throat was received from a consumer, concerning an adult female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 22-Oct-2008. Forty-eight hours after administration the patient experienced symptoms of low grade fever, congestion, muscle aches and sorer throat. The symptoms were ongoing at the time of reporting on 30-Oct-2008.

VAERS ID:355553 (history)  Vaccinated:2008-10-22
Age:17.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-18, Days after onset: 27
Location:West Virginia  Entered:2009-08-13, Days after submission: 267
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007527
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500553P IN 
Administered by: Other     Purchased by: Other
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: A non-serious spontaneous report of administration of FLUMIST to a 17-year old pregnant female was received from a nurse practitioner concerning a 17-year old female patient. The patient received a single dose of FLUMIST on 22-Oct-2008. The reporter''s clinic was not aware of the pregnancy until 18-Nov-2008. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable.

VAERS ID:359672 (history)  Vaccinated:2008-10-22
Age:69.0  Onset:2008-10-22, Days after vaccination: 0
Gender:Female  Submitted:2009-09-15, Days after onset: 328
Location:California  Entered:2009-10-06, 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:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89880 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0619X IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:
Write-up: Pt did not report until 9/4/09 when she came to another Walgreens for a flu shot. She complained of soreness on R arm, resulting from PNEUMOVAX she received on 10/22/08. She said to other pharmacist that the soreness has always been there, still havaday it hasn''t gone away - still has soreness.

VAERS ID:364890 (history)  Vaccinated:2008-10-22
Age:0.9  Onset:2008-10-22, Days after vaccination: 0
Gender:Male  Submitted:2009-11-04, Days after onset: 378
Location:Texas  Entered:2009-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: EAR INFECTION
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type': TX090064PU
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2783EA0IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Pallor, Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: ACCORDING TO FAMILY, ABOUT 15-20 MINUTES AFTER RECEIVED INFLUENZA IMMUNZATION ON 10/22/08, DEVELOPED RASH. WENT TO ER AND WAS TOLD ALLERGIC REACTION AND PRESCRIBED BENADRYL, PREDNISONE. WHEN SEEN IN FOLLOWUP ON 10/23/08 HAD SPLOTCHY, BLANCHING ERYTHEMATOUS RASH ON FACE, CHEST, UPPER EXTREMITIES.

VAERS ID:367572 (history)  Vaccinated:2008-10-22
Age:45.0  Onset:2008-11-18, Days after vaccination: 27
Gender:Female  Submitted:2008-11-20, Days after onset: 2
Location:Nebraska  Entered:2009-11-12, Days after submission: 357
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: The patient had no illness at the time of vaccination
Diagnostic Lab Data: None reported
CDC 'Split Type': 200803674
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2797B IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site atrophy, Injection site induration, Injection site necrosis
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Injection site necrosis - Injection site atrophy. Initial report was received on 19 November 2008 from a health care professional in the USA. A 45 year old female patient received a left deltoid intramuscular injection of FLUZONE No Preservative 2008-2009 (lot number U2797BA) on 22 October 2008. On 18 November 2008 the patient noticed that she had a red, dime sized indentation on the left deltoid where she had the injection. The area was not inflamed or painful. The nurse stated that the area looked like tissue necrosis. The patient is scheduled to visit with her doctor on 19 November 2008. The patient was not recovered at the time of the report. List of Documents held by Sender: None.

VAERS ID:392350 (history)  Vaccinated:2008-10-22
Age:30.0  Onset:2008-10-23, Days after vaccination: 1
Gender:Female  Submitted:2010-06-14, Days after onset: 599
Location:North Carolina  Entered:2010-07-02, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0755836A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA380AA UNLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Induration, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of induration in a 30-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 22 October 2008 the subject received a dose of FLUARIX at 0.5 ml in the left arm. One day later, on 23 October 2008, a 2 cm by 2 cm area of induration was reported. Additionally, at an unspecified amount of time following administration of FLUARIX, the subject developed arm redness and swelling. The redness was unresolved at the time of reporting and the outcome of induration and swelling were unknown. The subject was treated with warm compresses and was advised to apply warm compresses 4 times daily for the next few days. Follow-up information was received on 12 December 2008, via healthcare professional, who reported the events resolved on an unknown date. The reporting healthcare professional considered the events related to vaccination with FLUARIX.

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