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Case Details (Sorted by Vaccination Date)

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VAERS ID: 294666 (history)  
Age: 54.0  
Gender: Female  
Location: Indiana  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-10-29
   Days after onset:0
Entered: 2007-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2494AA / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Niacin 500mg, Flonase, Atanolol, Allegra
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: MD examined patient and found a diffuse rash pruitic in nature and spreading. Treated with DepoMedrol 80mg IM in office and observed for 30 minutes. Rash resolving following injection and observation.
CDC Split Type:

Write-up: Patient presented here for over-all rash following a flu shot given where she is employed.


VAERS ID: 294844 (history)  
Age: 32.0  
Gender: Female  
Location: California  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-10-30
   Days after onset:1
Entered: 2007-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest discomfort, Chills, Cough, Dyspnoea, Fatigue, Feeling of body temperature change, Hyperhidrosis, Pain, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zovia
Current Illness: none
Preexisting Conditions: allergic rhinitis, anxiety with air travel
Diagnostic Lab Data: none
CDC Split Type:

Write-up: SUBJECTIVE: Patient is a 32 Y female presenting for first visit with provider after transfer of care from Dr. to me with concerns of reaction to flu vaccine. States she received flu vaccine at 1:30pm yesterday at a pharmacy and then she developed symptoms at 10:00pm before bed that involved coughing and dyspnea and chest tightness and wheezing, hives on chest. Took some benadryl and was able to lie down and then felt hot and chilled. NO temp taken but she felt sweaty. Today she feels fatigued and achey. Denies a history of asthma but gets allergies. No recent URI or allergy symptoms the past few days, gets allergies in the spring and summer. No prior adverse events reported. No history of egg allergy. Pt had no symptoms today and appears well so no treatment was given. Attempted to contact the vaccine administrator and was transferred to voice mail where a message was left indicating pt''s name and reaction and my intent to file VAERS report. I do not have any of the information on what brand or lot number was given.


VAERS ID: 295034 (history)  
Age: 66.0  
Gender: Male  
Location: American Samoa  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:2
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Military       Purchased by: Unknown
Symptoms: Asthenia, Injection site pain, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None, this was a check-up
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: I received the pneumonia vaccination on 10-29-07.When I arrived home a short time later my body began to ache all over, I developed a fever that increased from 99.1 to 101.7 over the next several hours. I was so weak that I had to lay down. I stayed in bed until 10-31. The soreness around the injection area was much more severe than stated for the "after effects", it is now 2 days later and my arm is still extremely sore.


VAERS ID: 295038 (history)  
Age: 61.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-10-31
   Days after onset:1
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER U2492AH / - RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Anorexia, Asthenia, Chills, Dyspnoea, Feeling abnormal, Headache, Hyperhidrosis, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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:

Write-up: Received shot at 3:10 PM on Monday Oct 29th woke up during the night with very bad headache, took Tyneol. In the morning every muscle ached, felt week and short of breath. Slept most of the day.Kept breaking out with sweats and then chills, no appitite no energy to get sometime to eat. Felt so bad I wish I would die. Today is day 2 and I am able to get up and move around some as soon as I move I break out in a sweat. I am hoping that this is the end


VAERS ID: 295041 (history)  
Age: 77.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:2
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2505AA / - LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Feeling abnormal, Pain in extremity
SMQs:, Dementia (broad), Tendinopathies and ligament disorders (broad)

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: allergic to CT scan dye
Diagnostic Lab Data:
CDC Split Type:

Write-up: After flu shot complained she "felt funny", pain in both arms, BP 140/90, heart rate 88 irregular. Gave juice & nitro without relief. Ambulance to ER. spoke to her 7 hours later at home said didn''t have a heart attack but needs stress test and already had appt with heart dr 11-1-07.


VAERS ID: 295144 (history)  
Age: 1.55  
Gender: Male  
Location: Kentucky  
Vaccinated:2007-10-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B049AA / 3 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2502AA / - LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABV149AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08700H / 3 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Incorrect dose administered, No adverse reaction
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was given 0.5 ml of influenza vaccine instead of 0.25 ml. Called CDC was told dose counts and possible positive local reaction. 10-31-07 no reaction per parents.


VAERS ID: 295184 (history)  
Age: 62.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:3
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 79720 / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0964U / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Erythema, Pain in extremity, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unable to inquire. She stated she had to attend to a student and needed to go.
Current Illness: States she was not ill at time of injection.
Preexisting Conditions: Dust animal pollen mold allergies. Receives weekly allery injection. Received last allergy injection on Monday 10/29/07. Unable to inquire site of allergy injections. She stated she had to attend to a student and needed to go.
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10/29/07-woke up at night (does not know time) left bicep hurt. Left Bicep became red & hot. 10/30/07- Left Bicep became swollen.


VAERS ID: 295263 (history)  
Age: 8.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-10-31
   Days after onset:1
Entered: 2007-11-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 13280 / 0 LL / IM
VARCEL: VARICELLA (VARILRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB21AA / 1 LL / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flu vaccine V2440AA Sanofi given right lower thigh
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: 6 x 6cm area of erythema and induration to left anterior thigh at injection site with extended area of erythema (extending toward inner thigh) measuring a total of 10cm - no palp inguinal nodes, no systemic symptoms


VAERS ID: 295321 (history)  
Age: 12.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-11-02
   Days after onset:3
Entered: 2007-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1335U / 1 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Induration, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: STREP THROAT
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: AREA RED APPROX. 10 CM WITH 5CM INDURATION AREA WARM AND SWOLLEN. MOTRIN EVERY 4-6HRS AND BENADRYL 50 MG EVERY 6 HRS AND ICE PRN.


VAERS ID: 295555 (history)  
Age: 1.55  
Gender: Female  
Location: Ohio  
Vaccinated:2007-10-29
Onset:0000-00-00
Submitted: 2007-10-29
Entered: 2007-11-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B070AA / 0 LL / IM
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500488P / 0 - / IN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB200AA / 0 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF108AA / 0 RL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0232U / 0 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08679E / 0 LL / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Incorrect drug dosage form administered, Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient was given FluMist nasal spray today at age 18 mos (Vaccine is recommended starting at age 24 mos).


VAERS ID: 295567 (history)  
Age: 1.8  
Gender: Male  
Location: Ohio  
Vaccinated:2007-10-29
Onset:0000-00-00
Submitted: 2007-10-29
Entered: 2007-11-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500488P / 0 - / IN

Administered by: Public       Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)

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:

Write-up: Patient was given FluMist nasal spray today at age 21 mos. (Vaccine is recommended starting at 24 mos.)


VAERS ID: 295601 (history)  
Age: 0.6  
Gender: Male  
Location: New York  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:2
Entered: 2007-11-05
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B127AA / 2 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2474AA / 0 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0257U / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08700C / - LL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Crying, Local reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Crying, fever, increased crying with movement of legs no redness. Localized reaction to Imm.


VAERS ID: 295706 (history)  
Age: 43.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-06
   Days after onset:8
Entered: 2007-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1175F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Nausea, Pyrexia, Sleep disorder
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Plavix, Norvase, Baby Asprin, Advil
Current Illness: None
Preexisting Conditions: Chronic Cardiac problems had 2 surgeries in 2007.
Diagnostic Lab Data: No labs done. No blood drawn.
CDC Split Type:

Write-up: Administered vaccine on 10/29/07 at 1129 to right deltoid area. Employee states she was unable to sleep due to pain/swelling at site and she also had a fever. Site was tender and warm to touch. Employee returned to work the following day but was naseated and had a headache. She was taken to the E.R. for evaluation due to several cardiac surgeries she had had during this year.


VAERS ID: 295769 (history)  
Age: 72.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:3
Entered: 2007-11-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2445AA / - RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amitriptyline; Keflex; Dicyclomine; Premarin; Hydrochlorothiazide; Levothyroxine; Metoprolol; Prazosin; Prednisone; Verapamil CR;
Current Illness: None
Preexisting Conditions: Hypothyroidism, Hyperlipidemia, Ankylosing spondylitis, HTN
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Erythema and induration over biceps area.


VAERS ID: 295819 (history)  
Age: 5.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:2
Entered: 2007-11-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2289AA / 3 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0872 / 3 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1273U / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOTRIN prn
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 3-4 hours after vaccines administered, grandmother noted swelling of left upper arm, redness and warm to the touch. Symptoms persist x 2 days.


VAERS ID: 295822 (history)  
Age: 0.56  
Gender: Female  
Location: California  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2007-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC218124BA / 2 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Rash erythematous, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Broke out in red rash to face in afternoon after receiving vaccine in am. Rash spread to rest of body by the evening. Benadryl given in clinic.


VAERS ID: 295827 (history)  
Age: 80.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:3
Entered: 2007-11-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0733U / - RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Sulfa; Trilisate; Lisinopril; Zocar; Depomedrol; Triamicinolone; Asthma; COPD; CVA; Hypercholesterolemia; HTN; migraines
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Day of injection had right arm pain. Next day had swelling, increased pain, and redness from shoulder to elbow. 3rd day having decreased redness and swelling continues with pain. Will continue to monitor for possible infection.


VAERS ID: 295888 (history)  
Age: 50.0  
Gender: Female  
Location: Alabama  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-10-31
   Days after onset:1
Entered: 2007-11-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 79282 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Rash erythematous, Streptococcus identification test, Streptococcus identification test negative
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: allergic peanuts, chocolate, cats
Diagnostic Lab Data: Rapid Strep - Negative
CDC Split Type:

Write-up: Rash developed approximately 24 hours after vaccine, multiple erythematous patches, raised. Located on neck, chest, abdomen, arms, upper legs. One brief episode of shortness of breath.


VAERS ID: 296058 (history)  
Age: 81.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-07
   Days after onset:9
Entered: 2007-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - LA / UN
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0740U / - RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSAMAX; LIPITOR; VASOTEC; DIOVAN; COUMADIN
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA00145

Write-up: Information has been received from a certified medical assistant concerning an 81 year old female who on 29-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 657767/0740U) in the right deltoid. Concomitant vaccination administered on that day included a dose of Pneumovax 23 (MSD) in the left arm. Other concomitant drug therapy included alendronate sodium (MSD), valsartan (DIOVAN), warfarin sodium (COUMADIN), enalapril maleate (VASOTEC) and atorvastatin calcium (LIPITOR). On that same day, the patient experienced pain, redness and swelling in her right arm. The patient was seen by the physician. The patient was noted to be recovering. There was no product quality complaint. Pain, redness and swelling were considered to be disabling by the reporter. Additional information has been requested.


VAERS ID: 296075 (history)  
Age: 0.2  
Gender: Female  
Location: Kentucky  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-10-30
   Days after onset:0
Entered: 2007-11-08
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2607AA / 0 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1158F / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 21009 / 0 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 853981 / 0 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 05084 / 0 UN / UN

Administered by: Private       Purchased by: Private
Symptoms:
SMQs:

Life Threatening? No
Died? Yes
   Date died: 2007-10-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nystatin
Current Illness: constipation, thrush
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death. 12/17/07 Reviewed autopsy report which states COD as SIDS. Patient found in crib lying on back & unresponsive. 12/17/07 Received vax record & medical records which confirm vax dose & lot #s as reported. Patient had thrush & was constipated during office visit 10/29/07, otherwise, healthy.


VAERS ID: 296090 (history)  
Age: 49.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-08
   Days after onset:10
Entered: 2007-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2487AA / 0 LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Injection site bruising, Skin induration, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Avelox, Demulen, Prilosec
Current Illness: Otitis Media
Preexisting Conditions: Penicillin Drug Allergy
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Marked bruising at injection site = 3cm in diameter. Redness, swelling, firm warm tissue below injection site - area approx 10 cm x 8cm - Symptoms resolving


VAERS ID: 296128 (history)  
Age: 1.25  
Gender: Female  
Location: Georgia  
Vaccinated:2007-10-29
Onset:2007-11-08
   Days after vaccination:10
Submitted: 2007-11-08
   Days after onset:0
Entered: 2007-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C27658A / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2457DA / 0 RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB186AA / 0 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0306U / 0 RL / SC

Administered by: Private       Purchased by: Private
Symptoms: Cellulitis
SMQs:

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:

Write-up: CELLULITIS LEFT LEG


VAERS ID: 296137 (history)  
Age: 0.5  
Gender: Female  
Location: Mississippi  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-10-30
   Days after onset:0
Entered: 2007-11-08
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B126BB / 2 LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 1354013D / 2 RA / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 006706 / - - / PO

Administered by: Public       Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: MS7030

Write-up: FEVER 102


VAERS ID: 296143 (history)  
Age: 37.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-10-31
   Days after onset:1
Entered: 2007-11-08
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Axillary mass, Contusion, Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor, Vit C, multi vitamins
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Right deltoid swollen and red. Some bruising noted. Two knots noted under axilla. arm very sore and painful to lift arm for two days. Onset day after injection. Applied heat pads at home.


VAERS ID: 296483 (history)  
Age: 40.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-11-07
   Days after onset:8
Entered: 2007-11-12
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA296GA / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Burning sensation, Erythema, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Red, Burning, itching; Benadryl - Still have intermitted burning and tingling


VAERS ID: 296538 (history)  
Age: 13.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-12
   Days after onset:14
Entered: 2007-11-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Convulsion, Dizziness, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA01247

Write-up: Information has been received from a physician concerning a 13 year old female who on 29-OCT-2007 was vaccinated with Gardasil intramuscularly. On 29-OCT-2007 after standing up from the examination table, the patient felt light headed. The patient was placed on a chair and fainted shortly thereafter. Seizure activity started after the patient had been unconsciousness approximately 10 seconds and lasted approximately 5-10 seconds. The patient regained unconsciousness. Vital signs were taken which were normal. The patient was observed for 20 minutes. An EEG was ordered (results not reported) and the patient was release with her mom. On 29-OCT-2007 the patient recovered from the seizure and fainting. Upon internal review seizure was determined to be an other important medical event. Additional information is expected.


VAERS ID: 296591 (history)  
Age: 61.0  
Gender: Female  
Location: New York  
Vaccinated:2007-10-29
Onset:2007-10-31
   Days after vaccination:2
Submitted: 2007-11-13
   Days after onset:13
Entered: 2007-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2529AA / 1 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0200U / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ambien 10 mg, Patanol 0.1%
Current Illness:
Preexisting Conditions: allergy to iodine, allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:

Write-up: Large right arm area swelling to elbow. Pain into the hand.


VAERS ID: 296646 (history)  
Age: 69.0  
Gender: Male  
Location: California  
Vaccinated:2007-10-29
Onset:2007-11-09
   Days after vaccination:11
Submitted: 2007-11-13
   Days after onset:4
Entered: 2007-11-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2523AA / - UN / IM
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0461U / - UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None that he has reported to us. Please confirm with MD.
Diagnostic Lab Data: Please call Dr. for info about tx.
CDC Split Type:

Write-up: Patient requested and received a flu & zostavax R vaccines on 10/29/2007. On 11/12/2007 he went to his primary care physician for painless rashes that have started on 11/9/2007.


VAERS ID: 296651 (history)  
Age: 74.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:16
Entered: 2007-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2505AA / 4 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Dry mouth, Gingival pain, Irritable bowel syndrome, Lip swelling, Pharyngolaryngeal pain, Retching, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Imodium, Lisinoprel, Viactiv, vit. D, Evista, Tums, aspirin EC
Current Illness:
Preexisting Conditions: Allergies: latex, wool, Prednisone. Medical conditions: irritable bowel symptoms, osteoporosis, hypertension, history-malignant neoplasm gastrointestinal tract.
Diagnostic Lab Data:
CDC Split Type:

Write-up: I wish to report a reaction to the flu shot administered around 2:00 p.m. on October 29--something much worse than just feeling like I have caught a cold. I was at Bell Choir practice (7:00-8:00 p.m. on Monday) and my throat became excruciatingly sore--like a burning furnace. A cough drop was of no help at all; however by the next morning my throat felt back to normal. I tried to talk to my daughter and granddaughter on the way home and couldn''t get more than two words out and then gagging. This continued all the way home--some 15-20 miles. I didn''t try talking and the problem disappeared by the next morning. My mouth became exceedingly dry and my lips swelled. The inside of my lower lip still feels "spongy" and the gums continue to hurt when I brush my teeth--especially the lower teeth. This has not disappeared. (I had a thorough dental exam and teeth cleaning on October 4 and there were no problems then).


VAERS ID: 296855 (history)  
Age: 0.5  
Gender: Male  
Location: Florida  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-11-05
   Days after onset:6
Entered: 2007-11-15
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2797AA / 2 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF219AA / 2 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0273 / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08702E / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1052U / 2 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: EEG, MRI normal 11/28/07-records received-CBC with WBC of 23.9 attributed to seizure activity. Platelets 521, ANC 16730, neutrophils 67, lymphocytes 23. Glucose 198.
CDC Split Type:

Write-up: Afebrile seizure, within 24 hour of vaccines administration.11/28/07-records received for DOS 10/30-10/31/07 DC DX: seczure disorder seconardy to vaccine acministration, most likely rotavirus. Seizure lasted approximately 18 minutes described as staring episode and shaking of upper and lower extremities. No postictal state. No fever. EEG and MRI of brain normal. Rash on right axillary area.


VAERS ID: 299835 (history)  
Age: 13.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:16
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 85581061U / 0 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Head injury, Heart rate decreased, Hypotension, Laceration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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: Blood pressure, 10/29/07, 30/60; Arterial blood O2, 10/29/07, 100%; Respiratory rate, 10/29/07, 53
CDC Split Type: WAES0711USA00091

Write-up: Information has been received from a physician concerning a 13 year old female, who on 29-OCT-2007 was vaccinated with her first dose of Gardasil vaccine, IM (lot# 658558/1061U). Concomitant therapy included influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 29-OCT-2007, the patient fainted after she stood up after receiving the vaccination. The patient developed a small cut to her lip and hit her head as she fainted. The patient''s blood pressure an heart rate were low. While the patient recovered, she was observed for about an hour and a half until her blood pressure and heart rate returned to normal range. Subsequently, the patient recovered from fainting, small cut to lip, low blood pressure, low heart rate and hitting her head as she fainted. The patient sought medical attention in the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007; 1/7/2008. Information has been received from a physician concerning a 13 year old female who on 29-OCT-2007 was vaccinated with her first dose of GARDASIL IM (Lot# 658558/1061U). Concomitant therapy included influenza virus vaccine (unspecified) in the left deltoid (lot# 80822) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 29-OCT-2007 the patient fainted after she stood up after receiving the vaccinatinon. This never occurred before with vaccines for this patient. The patient developed a samll cut to her lip and hit her head as she fainted. The patient''s blood pressure and heart rate were low (BP = 90/60 and HR= 53). The patient complained of dizziness. She was diaphoretic, weak and cold to the touch. While the patient recovered, she was observed for about an hour and a half until her blood pressure and heart rate returned to normal range. Subsequently on 10-OCT-2007 the patient recovered from fainting, small cut to lip, low blood pressure, low heart rate and hitting her head as she fainted, weakness, cold to touch and being diaphoretic. The patient sought medical attention in the office. No additional information is expected.


VAERS ID: 297163 (history)  
Age: 26.0  
Gender: Female  
Location: California  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-11-07
   Days after onset:8
Entered: 2007-11-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1786BA / - LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Hypokinesia, Injection site pain, Joint range of motion decreased
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling
Other Medications: Aderall; Oral Contraceptives
Current Illness: injury
Preexisting Conditions: allergic Bactrim
Diagnostic Lab Data: none
CDC Split Type:

Write-up: pain in left deltoid can''t raise arm, turn steering wheal sleep on that side. Pinpoint pain posterolat aspect of deltoid. Limited range of motion, Rx for Naproxen Sodium 500mg one twice a day with food


VAERS ID: 297296 (history)  
Age: 2.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2007-10-29
Onset:0000-00-00
Submitted: 2007-10-29
Entered: 2007-11-19
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U252AA / - LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Otitis Media
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None reported.


VAERS ID: 297317 (history)  
Age: 87.0  
Gender: Male  
Location: Michigan  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-11-07
   Days after onset:8
Entered: 2007-11-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR PMCU2501AA / 8 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blood pressure decreased, Food intolerance, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~In Patient
Other Medications: Lupron, Coreg + Trental.
Current Illness: Prostate Cancer + HTN
Preexisting Conditions: Allergic to codeine Has HTN + prostate cancer
Diagnostic Lab Data:
CDC Split Type:

Write-up: Was taken by ambulance to ER on 10-30-07 with BP of 100/20 and vomiting. He was in the ER for 6 hrs and was given IV therapy. CLIENT STATES HE ATE SOME OLD LUNCH MEAT + STARTED VOMITING SHORTLY AFTER.


VAERS ID: 297364 (history)  
Age: 0.0  
Gender: Female  
Location: Iowa  
Vaccinated:2007-10-29
Onset:2007-10-31
   Days after vaccination:2
Submitted: 2007-11-20
   Days after onset:20
Entered: 2007-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80435 / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Contrast media allergy, Full blood count normal, Joint swelling, Oedema peripheral, Pitting oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: knee pain x 3 months~Tdap (Adacel)~1~49.80~In Patient
Other Medications: Zyflo, Zyrtec, Nasonex, estrogen patch, vitamin D, calcium, albuterol PRN
Current Illness: none
Preexisting Conditions: asthma, autonomic neuropathy, allergic to: Ceclor, Flagyl, Amantadine, x-ray dye
Diagnostic Lab Data: CBC, ERS drawn 11/16/07 normal
CDC Split Type:

Write-up: Moderate to severe generalized joint pain, pitting edema in lower legs, slight edema to joints at base of great toes, index fingers and thumbs, and slight edema of knees. This started on 10/31/07 is is still present today. Examined by Dr. 11/16/07.


VAERS ID: 298147 (history)  
Age: 43.0  
Gender: Male  
Location: Virginia  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-29
   Days after onset:31
Entered: 2007-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U24655A / 9 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications/ OTC nyquil afrin nasls spray for relief of symptoms of previous weeks'' illness.
Current Illness: Undiagnosed Upper respiratory Illness symptoms x 1 week prior to vaccine. symptoms were resolved at the time of vaccine.
Preexisting Conditions: food allergies: strawberries, rasberries, animal allergies: cats, guinea pigs
Diagnostic Lab Data:
CDC Split Type:

Write-up: flu vaccine was administerd by Rn of L deltoid. No bleeding or redness occured at injection site immediately post injection. Approx 3 hours post injection employee began experiencing pain of L upper arm. Pain moved to L elbow area the next day.Pain is only present when the arm is moving . No pain noted present when the arm is fully extended, or after arm is flexed . Arm hurts only on initial movement. Duration of symptoms, 37 days.Employee sought medical consult with Occupation health physician. Employee referred to private physician for further evaluation and treatment of ongoing symptoms


VAERS ID: 300363 (history)  
Age: 50.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-12-14
   Days after onset:46
Entered: 2007-12-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Back pain, Dizziness, Muscular weakness, Sensation of heaviness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)

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: 200704190

Write-up: Initial report received on 06 December 2007 from a health care professional. A 50-year-old female patient, with no illness at the time of vaccination, had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, and route and site of administration not reported, on 29 October 2007. Seven hours post-vaccination, the patient experienced heaviness in her arms, weakness in her legs, a backache in the lumbar and dorsal spines, a loss of appetite, and dizziness. She was examined in a physician''s office, and physical therapy was ordered. Relevant diagnostic testing was unknown, and past medical history was not provided. At the time of this report, the patient had not recovered.


VAERS ID: 302399 (history)  
Age: 69.0  
Gender: Male  
Location: California  
Vaccinated:2007-10-29
Onset:2007-11-09
   Days after vaccination:11
Submitted: 2007-12-21
   Days after onset:42
Entered: 2007-12-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified), cyclophosphamide (+)
Current Illness: Arrhythmia, Bipolar disorder
Preexisting Conditions: Myocardial infarction
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA02605

Write-up: Information has been received from a registered nurse concerning a 69 year old male with arrhythmia and bipolar disorder and a history of myocardial infarction and no allergies who on approximately 29-OCT-2007 was vaccinated with a dose of zoster vaccine live(Oka/Merck). Concomitant therapy included cyclophosphamide (+) doxorubicin, blood pressure medication, stomach medication and bipolar medication. On 09-NOV-2007 the patient developed shingles. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.


VAERS ID: 302653 (history)  
Age: 17.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-10-29
Onset:2007-11-02
   Days after vaccination:4
Submitted: 2007-11-07
   Days after onset:5
Entered: 2008-01-14
   Days after submission:68
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80958 / 6 UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Respiratory allergies
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Client received Influenza vaccine 10/29/07. Reported to HD 11/7/07 after office visit with MD. Stated she started with rash on her abdomen 11/2/07 that looks like small mosquito bites. Continued to spread. Hives type rash noted on abdomen and pelvic area today with itching. Was put on Medical Doze Pack by MD. Denies allergies to eggs. Client to discuss with her allergist prior to next flu shot.


VAERS ID: 304787 (history)  
Age: 15.0  
Gender: Female  
Location: Maine  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2008-02-12
   Days after onset:106
Entered: 2008-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Dizziness, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: birth control
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Numbness in arm felt numb light headed whole body.


VAERS ID: 310016 (history)  
Age: 79.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-10-29
Onset:2007-11-12
   Days after vaccination:14
Submitted: 2008-04-18
   Days after onset:157
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80684 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dysphagia, Gait disturbance, Guillain-Barre syndrome, Movement disorder, No reaction on previous exposure to drug, Surgery, Tracheostomy
SMQs:, Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Demyelination (narrow), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 92 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: PMH: HTN, CAD, depression, tubular adenoma s/p resection & serial colonoscopies, chronic alcoholism x 20 yrs, recent recurrent episodes of aspiration pneumonia, ex-smoker, weight loss of approx 15 lbs in a month.
Diagnostic Lab Data: 12/8/07-2/4/08 Hospital LABS: WBC 21K (H), plts as low as 106. CXR revealed LLL abscess. Chest CT scan abnormal. Head CT revealed chronic-appearing lacunar infarcts in basal ganglia. ESR 94 (H), CRP 12 (H). EMG/NCS incomplete but abnormal. Pleural fluid revealed complex peripneumonic effusion bordering on empyema. Lung biopsy, cytology inconclusive. Swallowing study grossly abnormal. Prealbumin 5 (L). Troponin elevated. AST 611 (H), ALT 405 (H). Blood c/s (+) Enterobacter. Sputum c/s (+) for acinetobacter baumannii, stenotrophomonas maltophila & VRE. Echocardiogram revealed severe global LV systolic dysfunction w/ ejection fraction 10-15%. 2/17-2/21/2008 Hospital LABS: WBC 19.6 (H), neutros 86%. CXR revealed bilateral infiltrat
CDC Split Type: MA20080544

Write-up: We received from a health care professional via the Medical Communication the following information on 07 APR 2008: A 79-year-old man, born on 03 OCT 1928, was vaccinated with Fluvirin, batch-no. 80684, i.m. on 29 OCT 2007. On 12 NOV 2007 the patient started to have problems. He had trouble walking, swallowing and could not move legs at onset of symptoms. Patient was hospitalised for evaluation, and received tracheotomy as result of difficulties. Over the past three months the patient has had some improvement in leg movement and swallowing. Previous vaccination(s) was (were) well tolerated. Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data. We have not enough medical details to assess the case definitely. Expectedness assessment according to SPC/US label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. 5/2/08 Reviewed hospital medical records for 12/8/2007-2/4/2008. FINAL DX: severe dysphagia; chronic aspiration; LLL abscess; congestive cardiomyopathy, possibly related to alcoholism; septic shock; cardiogenic shock; shocked liver syndrome; urinary retention w/catheter; hyponatremia; thrombocytopenia. Records reveal patient experienced weakness w/falls, fatigue, anorexia, decreased oral intake, cough & secretions w/food or liquids, bilateral leg edema w/bluish discoloration all progressing to the inability to walk over approx 2 weeks. Denied alcohol for past 10 days. Ischial pressure ulcers noted on admission along w/peripheral neuropathy likely noted to be related to alcohol abuse. Consults: wound care, neuro, cardio, ID, palliative care, uro. Developed tachycardia, hypotension, worsening infiltraes & sepsis. Transferred to ICU by 12/11/07 on pressors, antibiotics, TPN, thoracentesis & BiPap, never intubated. PEG tube inserted. Improved minimally & transferred to rehab facility on continued IV antibiotics. Patient refused PT/ST/OT or further neuro w/u but accepted PT at transfer. 5/2/08 Reviewed hospital medical records for 2/17-2/21/2008. FINAL DX: aspiration pneumonia secondary to severe dysphagia; dysphagia; poor nutrition; diarrhea secondary to poor oral absorption of PEG feeds; abdominal pain secondary to tube feeds; HTN; depression; Stage II sacral decubitus. Records reveal patient experienced severe resp distress & hypotension due to recurrent aspiration while at rehab facility. Tx w/IV antibiotics & supplemental O2. Improved minimally & transferred back to rehab facility. Patient returned to hospital 2/21-2/27/2008. FINAL DX: aspiration; neuromuscular disease unknown etiology. Records reveal patient readmitted for gen weakness & altered mental status. Transfused for anemia. Intubated & on mechanical ventilation. Neuro consult done & suspected chronic inflammatory demyelinating polyneuropathy. Recommended transfer to higher level of care for further neuro w/u. 4/29/08 Reviewed hospital medical records for 2/27-3/21/2008. FINAL DX: motor/sensory axonal neuropathy of unclear etiology; muscle fibrosis c/w possible muscular dystrophy; aspiration pneumonia, resolving; left anterior uveitis left eye, resolving; multiple electrolyte abnormalities; anemia related to chronic disease & poor nutrition. Records reveal patient experienced approx 5 mos of progressive weakness, dysphagia & weight loss. Now had PEG feeding tube. Had 2 previous admits in outlying hospitals. Intubated & in neuro ICU. Exam revealed left eye w/corneal clouding & ptosis. Areflexic. Severe atrophy bilateral LEs. Increased tone right side. Unable to walk due to weakness. Consults by rheum, ID, ophthalmo & neuro. All rheumatology testing was neg. Trached 3/7/08. Transferred for further rehabilitation. .


VAERS ID: 310054 (history)  
Age: 48.0  
Gender: Female  
Location: New York  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2008-04-18
   Days after onset:172
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2451AA / 10 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
SMQs:, Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lotrel - Vitamins
Current Illness: denied
Preexisting Conditions: Hypertension, Migraines, Back surgery L2 + L3. Nodule on parathyroid gland removed 12-07.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Sore right arm immediately after vaccination. Couldn''t lift arm. Still taking NSAIDS and physical therapy. Notified Employee Health re: above 4-1-08. Spoke with "patient" 4-18-08 to file report.


VAERS ID: 310805 (history)  
Age: 56.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2008-04-21
   Days after onset:175
Entered: 2008-04-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80683 / 0 RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0554U / 0 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Verapamil; HCTZ; Amitriptyline; Singulair; Proventil; Advair; Lyrica; Spiriva; Glucophage; Prilosec; Atrovent; Lisinopril; Nasonex; Naprosyn
Current Illness: upper respiratory infection; asthma exacerbation
Preexisting Conditions: Allergy to penicillin, hay fever, asthma, HTN, fibromyalgia, DM Type 2
Diagnostic Lab Data:
CDC Split Type:

Write-up: Persistent left arm pain at site of vaccination. Pain has lasted 6 months. 6/11/08-records received for DOS 10/29/07-6/2/08-on date of vaccine C/O 3 days of nasal congestion, fatigue, chills/sweats and cough. DX:pharyngitis. URI/asthma.11/7/07, 11/19/07, 11/28/07, 12/5/07,12/19/07, 1/2/08,1/16/08-Follow-up for persistent cough. Unable to work, wheezing, cough keeps her up at night, myalgia, sinusitis, new onset of type 2 diabetes mellitus. 3/12/08 first complaint of left arm pain status post pneumovax. Unable to work due to wheezing retired from job 1/16/08. 6/2/08-cough continues, unable to life arm overhead. Left shoulder pain. Follow-up: Left shoulder pain persists - unclear if this pain is related to the PNEUMOVAX. Left arm pain has resolved.


VAERS ID: 313749 (history)  
Age: 72.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2008-05-16
   Days after onset:200
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1092U / - - / SC

Administered by: Other       Purchased by: Other
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)

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: WAES0711USA06884

Write-up: Information has been received from a licensed practical nurse concerning a patient who on 29-OCT-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported as a medical error, another nurse grabbed the wrong vaccine. No adverse experience was reported. A product quality complaint was not involved. Follow-up information has been received concerning a 72-year-old female who was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). The reason for the confusion was that one nurse pulled the vaccine out of the refrigerator and drew it up. That nurse was called away and another nurse took it and administered it. Additional information is not expected. This is one of several reports received from the same source.


VAERS ID: 314193 (history)  
Age: 76.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2008-05-16
   Days after onset:200
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1092U / - - / SC

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)

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: WAES0710USA06080

Write-up: Information has been received from a licensed practical nurse concerning a patient who on 29-OCT-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported as a medical error, another nurse grabbed the wrong vaccine. No adverse experience was reported. A product quality was not involved. Follow-up information has been received concerning a 76-year-old male patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). The reason for the product confusion was that one nurse pulled the vaccine out of the refrigerator and drew it up. That nurse was called away and another nurse just took it and administered it. Additional information is not expected. This is one of several reports received from the same source.


VAERS ID: 323458 (history)  
Age: 65.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2008-07-30
   Days after onset:275
Entered: 2008-08-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0964U / 0 - / SC

Administered by: Other       Purchased by: Other
Symptoms: Injection site irritation, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZETIA; SYNTHROID; TOPROL XL TABLETS
Current Illness: Hypertension; Hypercholesterolaemia; Hypothyroidism
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA06522

Write-up: Information has been received from a physician, concerning a 65 year old female patient with hypertension, hypercholesterolaemia and hypothyroidism, who on 29-OCT-2007 was vaccinated SQ in the right upper arm, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot # 658555/09364U). Concomitant therapy included ZETIA, TOPROL XL TABLETS, and SYNTHROID. On 29-OCT-2007, a few hours after administration of the vaccine, the patient developed a "golf ball sized" area of warmth and irritation at the injection site. She called the office, and was prescribed BENADRYL and cold compresses. The patient subsequently recovered (duration not specified). This is one of three reports from the same source. Additional information has been requested.


VAERS ID: 384595 (history)  
Age: 0.51  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2007-10-29
Onset:2009-04-21
   Days after vaccination:540
Submitted: 2010-04-02
   Days after onset:346
Entered: 2010-04-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1390U / 2 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Vomiting projectile~Rotavirus (no brand name)~3~0.50~Sibling|Watery diarrhoea~Rotavirus (no brand name)~3~0.50~Sibling
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA00543

Write-up: Information has been received from a registered nurse concerning a 23 month old male who on 27-JUN-2007 was vaccinated with a first dose of ROTATEQ. On 27-AUG-2007 the patient received a third dose of ROTATEQ (lot # 657668/1390U). On 21-APR-2009 the patient developed vomiting that lasted 24 hours, followed by watery diarrhea that lasted for 4 days, the patient also experienced fever. The patient had recovered. Follow up information has been received from the registered nurse concerning a male patient, who on 21-APR-2009 experienced vomiting for 24 hours, then he had watery diarrhea that lasted for 4 days, the patient also had fever. Subsequently, the patient fully recovered. The patient''s sister also had an adverse event after vaccination with ROTATEQ (WAES # 0905USA00018). This is one of two reports from the same source. No further information is available.


VAERS ID: 295500 (history)  
Age: 0.49  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-05
   Days after onset:7
Entered: 2007-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Apnoeic attack, Apparent life threatening event, Cyanosis, Hypertonia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Diphenhydramine
Current Illness: Gastroesophageal Reflux Disease
Preexisting Conditions: Intrauterine Growth Retardation, Low Birth Weight, Urinary Tract Infection, Enterococcus
Diagnostic Lab Data: 29 October 2007: Physical examination was normal.
CDC Split Type: B0485708B

Write-up: This male subject was enrolled in the prophylactic double-blind study. On 13 August 2007 and 29 October 2007, he received the 1st and 2nd dose of 10-valent pneumococcal-protein D conjugate vaccine (10-Pn-PD-DiT) or control Engerix B (IM R thigh) and co-administration of either Infanrix Hexa or Infanrix-IPV/Hib (IM L thigh). Other vaccinations also included: Bacillus Calmette-Guerin vaccine (BCG)(unknown manufacturer) on 04 May 2007 and hepatitis B vaccine (unknown manufacturer) on 03 May 2007. The subject had been randomized to receive the control Engerix B and co-administration of Infanrix-IPV/Hib. The subject''s past medical history included urinary tract infection due to enterococcus faecalis from 29 May 2007 to 07 June 2007. Medical conditions at the time of the event included gastroesophageal reflux disease with onset date of 01 September 2007. Concomitant medication included diphenhydramine hydrochloride from 29 August 2007 to 01 September 2007. On 29 October 2007, 12 hours after the 2nd dose of Blinded vaccine, this six-month-old subject developed minor apparent life threatening event. The subject was hospitalised and the event was life-threatening. The subject was treated with domperidone, ranitidine hydrochloride, salbutamol sulphate, salmeterol xinafoate and fluticasone propionate. The event improved on an unspecified date. The investigator considered that there was a reasonable possibility that the minor apparent life threatening event may have been caused by investigational product and that the event was possibly due to the medical condition, gastroesophageal reflux. Relevant risk factors were noted as low birth rate and intrauterine growth retardation. Investigator comments: On 29 October 2007, the subject presented with an apneic pause for less than ten seconds. He had cyanosis and hypertonia. The episode finished with stimulation. Then, he presented three similar episodes. The first episode was two hours after feeding. The subject went to the emergency room and was subsequently admitted to the hospital. The apparent life-threatening event episode occurred 12 hours after study vaccine dose two. Between 01 September 2007 and 29 October 2007, the subject did not present with any other episodes of an apparent life-threatening event. Physical examination was normal. Investigator comments received on 31 October 2007: The apparent life-threatening event episode could be related to any of the vaccines administered on 29 October 2007.


VAERS ID: 295841 (history)  
Age: 12.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-06
   Days after onset:8
Entered: 2007-11-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bradycardia, Convulsion, Postictal state, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0710MEX00019

Write-up: Information has been received from a physician concerning a 12 year old male who on 29-OCT-2007 was vaccinated with Gardasil. The patient has familiar history of diabetes mellitus and patient''s mother with antecedent of vagotonic syndrome. There was no concomitant medication. On 29-OCT-2007 while the patient was receiving the vaccination, the patient experienced vagotonic syncope followed by convulsive crisis and bradycardia and was admitted in the emergency room for 3 hours. After convulsive crisis (duration and characteristics are unknown) postictal period was of approximately 40 minutes. The patient was treated with 2 doses of dexamethasone 1 mL each. Subsequently, the patient recovered from vagotonic syncope, convulsive crisis and bradycardia. The patient is in good conditions. The reporter felt that vagotonic syncope, convulsive crisis and bradycardia were related to therapy with Gardasil. By internal revision was considered that the syncope vasovagal is other medical event. Additional information has been requested.


VAERS ID: 297533 (history)  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-11-20
   Days after onset:22
Entered: 2007-11-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0354U / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Bradycardia, Convulsion, Dyskinesia, Electrocardiogram, Electroencephalogram, Loss of consciousness, Mydriasis, Resuscitation, Syncope, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: electrocardiogram Comment: results unknown; electroencephalography Comment: results unknown
CDC Split Type: WAES0711USA02386

Write-up: Initial information received on 30-Oct-2007. Information has been received from a pediatrician concerning a 19 year old female patient, who on 29-OCT-2007 was vaccinated IM in the left arm with the first dose of Gardasil. On 29-OCT-2007, the patient experienced syncope convulsion, circulatory collapse, unconsciousness, dyskinesia circumoral and bradycardia. Two to three minutes post vaccination, the patient experienced a convulsive syncope, collapsed and became unconscious for a short time. Perioral dyskinesia was observed as well as mydriasus and bradycardia. The patient was spontaneously recovered after 10 minutes. She was given a salt solution IV. After the event the patient mentioned to the pediatrician that in the morning she already was vaccinated with three different travel vaccines into the same arm. The case is closed. The follow up information received on 08-Nov-2007, indicated that the patient was admitted to hospital for observation and the situation was assessed as life threatening. It was also added that 2-3 minutes post vaccination the patient experienced apnoea of about one minute during the convulsive syncope with tonic convulsions. The physician started mouth to mouth ventilation and after 2 inspirations, spontaneous breathing restarted. Concomitant therapy included rabies virus vaccine (human diploid) (TOLLMUT-IMPFSTOFF), MENINGITEC, TYPHIM VI and STAMARIL. The patient was not vaccinated with other vaccines the same day as previously reported but had numerous vaccinations in the days before. She did not experience adverse reactions after three vaccines. In the hospital ECG and EEG were performed the results were not mentioned but reportedly an anaphylactic reaction and an epileptic seizure was ruled out. The reporter considered syncope convulsive and circulatory collapse to be life threatening. No further information is available.


VAERS ID: 297780 (history)  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-11-11
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2007-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Gastroenteritis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0711USC00024

Write-up: Information has been received from an investigator concerning a 17-week-old male, with no relevant medical history, who entered study title as stated above. The patient was vaccinated with his first and second doses of blinded therapy on 28-SEP-2007 and 29-OCT-2007. There was no concomitant medication. Report reached the clinician on 12-NOV-2007 from an aunt who stated that the baby had diarrhoea and fever the night of 10-NOV-2007. On the morning of 11-NOV-2007, the baby died due to acute gastroenteritis while on the way to the hospital. The death was 13 days past dose 2 of study therapy. A Verbal autopsy was to be done. The reporting investigator felt that acute gastroenteritis, an important medical event, was of severe intensity and was possibly related to study therapy. Additional information has been requested.


VAERS ID: 299541 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-12-12
   Days after onset:44
Entered: 2007-12-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1536F / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure decreased, Convulsion, Electrocardiogram normal, Electroencephalogram normal, Grand mal convulsion, Hyperventilation, Loss of consciousness, Syncope, Syncope vasovagal, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: electroencephalography 29Oct07 Comment: normal; electrocardiogram 29Oct07 Comment: normal; orthostatic hypotension measurement 29Oct07 Comment: normal
CDC Split Type: WAES0712USA01277

Write-up: Initial and follow up information has been received from a physician, concerning a 12 year old (previously reported as 13 year old) female patient who on 29-OCT-2007, was vaccinated IM in the left upper arm with the first dose of Gardasil (lot #1536F; batch NG01520). About 3 minutes after vaccination, she experienced an orthostatic collapse with a short period of loss of consciousness, as well as decreased blood pressure and unresponsiveness to verbal stimuli for a few minutes. During this time, she experienced a "generalized convulsion" for about 10 to 20 seconds. Following the convulsion, the patient hyperventilated (duration not specified). she subsequently recovered, however, she was hospitalized for monitoring. An electroencephalogram (EEG), electrocardiogram (ECG) and Schellong''s test were normal. She was diagnosed with vasovagal syncope and hyperventilation following vaccination. The hospital stay was without incident, and she was released on the next day, 30-OCT-2007. This file is closed. Other business partner numbers include: E2007-08576.


VAERS ID: 302227 (history)  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2008-01-09
   Days after onset:72
Entered: 2008-01-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER A21081 / - UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER A21081 / - UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A21081 / - UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 26897 / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apathy, Convulsion, Crying, Depressed level of consciousness, Hemiparesis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None provided
CDC Split Type: PLWYEH01960408

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional via a regulatory authority regarding a 4-month-old male who experienced uncontrollable crying, convulsions, left hemiparesis and was apathetic, hardly reactive and was reluctant to keep in touch with others. The patient received a dose on 29-Oct-2007. Relevant medical history was not provided. Concomitant medications were not provided. The child was administered the Prevenar vaccine on 29-Oct-2007 at 12:00 pm. Around 6:00 pm that evening, he experienced a 30 minute episode of inconsolable crying. Two hours later, 8:00 pm, he experienced his first episode of unilateral convulsions followed by unilateral left hemiparesis. The child was hospitalized. The episodes of the convulsions reappeared again several times after 9:00 pm. He was treated with unspecified medications. The child was also apathetic, reluctant to keep in touch with others and hardly reactive. After a few days, the child was in good general condition but still observed at the hospital. Outcome was reported as recovering. No additional information was available at the time of this report.


VAERS ID: 302943 (history)  
Age: 24.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2008-01-16
   Days after onset:78
Entered: 2008-01-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1401F / 0 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diagnostic procedure, Injection site pain, Lumbar puncture, Lymphadenopathy, Tendon pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: L Thyrox; iodine
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA07052

Write-up: Information has been received from a gynecologist concerning a 24 year old female with no relevant medical history or on-going diseases who on 29-OCT-2007 was vaccinated in the upper left arm (route not reported) with the 1st dose of the Gardasil (Batch: NG00010, lot#1401F). Concomitant therapy included levothyroxine Na (L THYROXIN) and iodine. On 30-OCT-2007, post vaccination, the patient complained of pain at the injection site. On 31-OCT-2007, the patient developed swelling of lymph nodes in the left axilla, left groin and in the left adductor canal. At the time of reporting the patient also complained of tendon pain of the left arm with painful inner rotation. Medication with Ibuprofen was started. The patient had recovered from all symptoms after about 14 days. After an interval free of complaints the pain in the arm reoccurred. The patient was admitted into the hospital for diagnostics test (neurological apartment), including lumbar puncture. Results are pending. Symptoms were ongoing at the time of reporting. Other business partners numbers include E2007-08078 (0). Additional information is not expected.


VAERS ID: 303177 (history)  
Age: 27.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2008-01-18
   Days after onset:81
Entered: 2008-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture negative, C-reactive protein increased, Cellulitis, General physical health deterioration, Injection site erythema, Injection site pain, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Trisomy 8
Diagnostic Lab Data: WBC count 13; serum C-reactive protein 20; blood culture Comment: negative
CDC Split Type: WAES0801USA03193

Write-up: Information has been received from a health care authority concerning a 27 year old male with a history of trisomy 8 who on 29-OCT-2007 was vaccinated with Pneumovax 23 (Lot# not reported). That same day the patient developed fever and injection site pain. On 30-OCT-2007 he also developed injection site redness and reduced general condition. On an unspecified date the patient developed and was diagnosed with cellulitis of the upper arm. On an unspecified date the patient was hospitalized. Laboratory results from an unspecified date revealed: serum C-reactive protein test: 20 - 11; white blood cell count 13-12 and negative blood cultures. At the time of this report the fever had resolved and it was reported the patient was recovering from the other events. Other manufacturer #s included E2008-00271. No further information is available.


VAERS ID: 356647 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-11-26
   Days after vaccination:28
Submitted: 2009-09-04
   Days after onset:647
Entered: 2009-09-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Activities of daily living impaired, Arthralgia, Bedridden, Chills, Condition aggravated, Fatigue, Hallucination, Headache, Hyperhidrosis, Influenza like illness, Malaise, Musculoskeletal stiffness, Oropharyngeal pain, Petechiae, Photophobia, Pyrexia, Rash, Rheumatoid arthritis, Still's disease adult onset, Vomiting, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hallucination
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA04428

Write-up: Information has been received on request by the company from the agency via public case details form concerning a 16 year old female patient who on 11-MAY-2007 was vaccinated with the first dose of GARDASIL (Lot number 655742/0138U and Batch number J0799) intramuscular, on 12-JUN-2007 with the second dose of GARDASIL and on 29-OCT-2007 with the third dose of GARDASIL (Lot number not reported). On 26-NOV-2007 the patient experienced rheumatoid arthritis and still''s disease adult onset. The first episode of illness resulted in general malaise and flu like symptoms and progressed to cyclical pattern of fevers/chills/sweats several times, during 24 hours period. This first episode of illness resolved around 09-DEC-2007 and patient recovered. The patient was taken to a medical centre during this illness. The second episode of illness was very severe and began on 22-DEC-2007 and again started with malaise and flu like symptoms progressing to a continuous cycle if fevers/chills/sweats with no break between the cycles. The patient had severe abdominal and joint pain, sore throat, headache, vomiting and was incapacitated and continually bedridden and unable to attend to ADL''s such as showering and eating for two weeks. The patient also suffered from hallucinations and lost 6 kg. The patient again attended a medical centre for treatment. In January 2007, the patient was admitted to the hospital for 5 days under specialist care. The patient was then referred to another specialist (Rheumatologist) and registered and had been under their care since February 2008. A firm diagnosis had not been reached to date, however the specialist had started that it appeared to resemble adult onset still''s disease. It was unsure if the following information was relevant, but the patient the patient suffered a mild fever after the first dose of GARDASIL in May 2007. The patient also suffered an illness in mid July 2007. The symptoms of the illness involved high fever, severe headache, neck stiffness, extreme aversion to light, vomiting and petechie, and GP was given for treatment. This illness was resolved satisfactorily after one week. The patient received ongoing treatment by rheumatologist for chronic inflammatory disorder. Currently, the patient was taking medications: Prednisolone, methotrexate, NAPROSYN, folic acid, STEMETIL and calcium supplement. The patient had to resign from her part time job in January 2008 as her illness was so debilitating. The patient managed to complete grade 12. The last year despite repeated absences from school and was currently studied at university. She continually battles extreme fatigue and joint pain and suffered intermittent relapses that resulted in the return of symptoms such as fevers, chills, sweats, headache, sore throat and rashes. At the time of reporting on 04-JUL-2009, the patient had not yet recovered. The agency considered that all the symptoms were possibly related to therapy with GARDASIL. The original reporting source was not provided. Rheumatoid arthritis and still''s disease adult onset were considered to be disabling. No further information is available.


VAERS ID: 428104 (history)  
Age: 53.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-11-08
   Days after vaccination:10
Submitted: 2011-07-25
   Days after onset:1354
Entered: 2011-07-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adverse reaction, Death, General physical condition abnormal, Myopathy, Polymyositis
SMQs:, Rhabdomyolysis/myopathy (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 2009-03-05
   Days after onset: 483
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1107USA02547

Write-up: Information has been received regarding a case in litigation from a lawyer concerning a 53 year old male who was vaccinated on 29-OCT-2007 with the first dose of HBVAXPRO (lot/batch number not reported). Approximately ten days post vaccination he presented with severe symptoms that lead to hospitalization on 10-JAN-2008; he was discharged on 30-JAN-2008 with diagnosis of myopathy. On 04-SEP-2008 due to aggrevation of his condition, the patient was again admitted to the hospital from which he was discharged with diagnosis of polymyostitis. Successively the patient''s condition kept progressively aggravating requiring further hospitalizations. Patient''s date of death reported 05-MAR-2009 (no further information reported). It was reported that the outcome of the event of polymyostitis was fatal. Case was medically confirmed. No further information is expected.


VAERS ID: 531417 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-29
Onset:0000-00-00
Submitted: 2014-05-21
Entered: 2014-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal pain, Abortion spontaneous, Anxiety, Aphagia, Apnoea test, Arrhythmia, Arthralgia, Arthritis, Arthropathy, Asthenia, Asthma, Axillary pain, Back pain, Balance disorder, Borrelia test negative, Bronchitis, C-reactive protein normal, Cardiac stress test normal, Chest pain, Colonoscopy abnormal, Cough, Crying, Diarrhoea, Disturbance in attention, Dizziness, Drug hypersensitivity, Dysphagia, Dyspnoea, Ear pain, Electrocardiogram normal, Emotional distress, Endoscopy upper gastrointestinal tract abnormal, Fatigue, Fibromyalgia, Gastritis, Genital pain, Grip strength decreased, Heart rate increased, Heart rate irregular, Hypermobility syndrome, Hypoaesthesia, Impaired work ability, Injected limb mobility decreased, Injection site reaction, Insomnia, Irritable bowel syndrome, Joint crepitation, Joint injury, Joint lock, Joint swelling, Limb injury, Local swelling, Loss of employment, Malaise, Maternal exposure before pregnancy, Medical device complication, Menorrhagia, Mood altered, Musculoskeletal discomfort, Musculoskeletal stiffness, Myalgia, Myositis, Nasopharyngitis, Nausea, Oropharyngeal pain, Pain, Pain in extremity, Palpitations, Pharyngeal oedema, Pharyngitis, Plantar fasciitis, Pruritus genital, Pyrexia, Rash, Respiratory tract infection, Rheumatic disorder, Rhinitis, Skin discolouration, Skin operation, Streptococcus test negative, Stress, Suture insertion, Swelling, Syncope, Tenderness, Tendon pain, Tendonitis, Tremor, Urinary tract infection, Viral infection, Vitamin D, Vomiting, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives (unspecified)
Current Illness: Asthma; Immunisation
Preexisting Conditions: Injury; Lactose intolerance; Vulval abscess; Tenderness; 02/14/2007, Bronchitis; Gastritis
Diagnostic Lab Data: Test in Sep-2009 ECG showed basic rhythm and average frequency at 89 min. Stress test was normal; Sleep apnoea test was unremarkable; 11-Mar-2014 Colonoscopy and Gastroscopy showed small gap in the cardia; 10/18/2010, Body temperature, 37.8 degrees C; Borrelia test, negative; 01/22/2013, C-reactive protein, $g5; 01/22/2013, Streptococcus test, Strep A negative; 11/05/2012, Vitamin D, 48
CDC Split Type: WAES1404SWE007203

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control# E2014-02768) on 16-MAY-2014. Case received from a non-health professional via company representative on 21-Mar-2014. The primary reporter was a consumer (relative of the patient), who is the neighbour of a relative of the company representative. A 22-year-old female patient with no reported medical history, had received an injection of GARDASIL (batch number not reported) via unspecified route of administration in unspecified site of administration on unspecified date, and later on post vaccination, she developed rheumatic pain, feeling unwell, rash on abdomen and pain. It was reported that the events started more than one year ago, and the patient is continuously feeling unwell. The patient has had several medical contacts, but the reporter is not aware of details. At the time of reporting, the patient had not recovered. According to the reporter, the reaction was probably not related to vaccination, whereas the family of the patient think the events are related to vaccination. Follow up received from consumer via company representative on 26-Apr-2014. The patient provided her date of birth. She was vaccinated with GARDASIL (0.5 ml) on 07-Jul-2007. She describes the following symptoms: heart problem, the heart sounded irregular; "ECG went down instead of up", muscle inflammation in left arm, which persisted for 1/2 year, joint problems, swollen joints, chronic pain and she has been treated with asthma medicine (not further specified). Her general practitioner has sent referrals to several hospitals. No further information specified. Follow up information received from the patient via company representative on 12-May-2014. The patient was provided copies of the medical records, case is medically confirmed. The patient received the second GARDASIL dose i.m. (0.5 ml) in the right upper arm on 20-Sep-2007. The first dose was given in the left arm. The patient was vaccinated with D1 TWINRIX (1 ml, other MFR) in the left upper arm on 04-Oct-2007 and D2 TWINRIX (0.5 ml, other MFR) i.m. in the left upper arm 29-Oct-2007. The patient sought medical care on 13-Mar-2008 due to muscle pain after the GARDASIL vaccination. According to medical records: she had muscle pain in both arms, but mainly the right arm. Both the arms were tender when palpated (mainly right arm). No signs of inflammation in the skin. Assessed as myalgia and possible inflammation after vaccination. The pain started after the first dose mainly in the right arm. She had pain after the second dose as well. She was prescribed Enterota VOLTAREN (50 mg x 2, other MFR, recommended for at least one month.), TERRACORTRIL with polymyxin (5ml, other MFR), Naproxen (Astra Zeneca, 250mg) and HERACILLIN (750 mg x2, other MFR). 18-Mar-2008 she still had a muscle pain localized in the upper arm muscles (proximally) but not in the shoulder. It was difficult for her to use the arm appropriately, especially when lifting the arm. She had contact tenderness as well. VOLTAREN had no effect and caused her stomach problems. She was told to use IPREN (other MFR) instead when needed. 01-Apr-2008 she was referred to a physical therapist and she started to have pain in the proximal thigh muscles ventrally. She had reduced strength in right hand. Laboratory test was unremarkable. 17-Sep-2008 Medical records on 17-Sep-2008: The patient sought medical attention. The reason is throat pain. Also slight cold and cough. Had it the last week. Uncertain about elevated temperature but has the last days started having diarrhea and a mild nausea. No vomiting. She received the diagnosed acute bronchitis and was prescribed AMIMOX (750 mg x 2, other MFR) and Cocillana-etyfin (other MFR, oral). Medical record on 05-Nov-2008 she had pain in left front foot, increasing pain and loading pain. She received Diklofenak (50 mg) for pain and Omeprazole for gastritis. Diagnosed with Plantar fasciitis. She had pharyngitis in Mar-2009. In May-2


VAERS ID: 295132 (history)  
Age: 48.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:1
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2499AA / - RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0803U / - LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Injected limb mobility decreased, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Swelling of arm (right) + redness. Pt unable to lift. Advil, Benadryl, Dr. gave 2 Rx''s Darvocet and Bactrim D.S.


VAERS ID: 295137 (history)  
Age: 54.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2007-10-31
   Days after onset:0
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2514AA / 2 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Eye irritation, Eyelid oedema, Headache, Ocular hyperaemia, Pharyngolaryngeal pain, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Corneal disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10/30/07 8:30 pm Fluzone 0.5ml/IM administered. 10/31/07 0130 - Progressive headache, sniffles, sore throat and burning of eyes. Sclera and conjunctiva very red, moist with mild eyelid edema observed at 0645 am. Denies SOB or rash.


VAERS ID: 295183 (history)  
Age: 53.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:2
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2516AA / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0991U / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: C-reactive protein normal, Corneal dystrophy, Fatigue, Headache, Musculoskeletal chest pain, Pain, Red blood cell sedimentation rate increased, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Congenital, familial and genetic disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Toprol XL 50mg 1/4 tab bid, Detrol LA 4mg 1 qd, Aldactone 25mg prn, Flexeril 10mg prn, ASA 81mg 1 qd, Lexaprol 20mg 1 qd, Anusol HC supp 25mg bid prn, Coumadin qd, Rythmol 150mg 1 tid, Fosomax 35mg 1 q week, Chantix, Calcium 600mg, Vitamin
Current Illness: No illness
Preexisting Conditions: A Fib/A flutter, osteoarthritis C-spine, urge incontinance, fibromyalgia, RSD, hyperlipidemia, diverticulosis, corneal dystrophy, anxiety, tobacco abuse, RLS, osteopenia, neurological sx possible microemboli related
Diagnostic Lab Data: Patient received Solu-Medrol 125mg at appointment on 10-31-07. Lab work was done. WBC: 11.9, Sed rate: 34, hsCRP: 2.595 all other lab work was normal
CDC Split Type:

Write-up: Patient received flu & pneumo vaccine on 10-30-07. Came to office on 10-31-07 with generalized pain whole body and fatigue which started 10-30-07 in the afternoon after getting flu/pneumo. Slight headache. Started in arms, now whole body. Positive rib pain with movement. No fever or nausea. Has had flu shot previously with no problems.


VAERS ID: 295186 (history)  
Age: 72.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2007-11-01
   Days after onset:1
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0963U / 0 LA / IM
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0888U / 0 LA / SC

Administered by: Unknown       Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Latex sensitivity per patient
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s left arm was erythemic, swollen, and warm. The patient comlained of slight pain and tenderness in the area. The affected area covered the top part of her arm. Patient has taken Tavist and is using Benadryl cream.


VAERS ID: 295199 (history)  
Age: 23.0  
Gender: Male  
Location: Washington  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:2
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV111 / 3 RA / SC
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500496P / 5 - / IN

Administered by: Military       Purchased by: Military
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: observation
CDC Split Type:

Write-up: pain in arm, swelling/itching of R upper arm. cold pack/motrin


VAERS ID: 295219 (history)  
Age: 56.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:2
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2499AA / 10 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0803U / 1 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Injection site pain, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt experienced pain in upper arm 4 hours post vaccination. 8 hours post, pt also experienced red rash and generalized swelling in an approximate radius of 12 inches from the injection site and swelling/rash extending down the arm to a point about 2 inches past the elbow. Pt self treated with BenadrylMotrin until 48 hours post vaccination at which time she was seen at a medical clinic. She received prescriptions for hydroxyzine and for a medrol dose pack.


VAERS ID: 295221 (history)  
Age: 37.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:2
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / 3 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Asthma, Blood test normal, Chest discomfort, Computerised tomogram normal, Diarrhoea, Electrocardiogram normal, Hypersensitivity, Nausea, Palpitations, Pyrexia, Syncope, Throat tightness, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen lo
Current Illness: None
Preexisting Conditions: Asthma, spina bifida oculta, reaction to aspirin (nosebleeds), latex allergy PMH: asthma, well controlled.
Diagnostic Lab Data: EKG, blood tests, urinalysis all came back okay LABS: EKG showed sinus tachycardia. CT of abdomen/pelvis WNL. WBC 11.9 (H), neutros 94.2 (H), lymphs 4.1 (L). UA sp grav 1.009 (L) w/few bacteria.
CDC Split Type:

Write-up: Received vaccine at 11:45 am on October 30. Around 1 or 1:30 pm felt like something lodged in throat, followed by tightness in chest and racing heart. Wasn''t sure if it was a reaction, but it got worse and was followed by diarrhea and nausea, and asthma attack. By 3:30 pm I collapsed in bathroom and coworkers called an ambulance to take me to ER. I was given anti-nausea medicine en route and at ER. After meeting with doctor and tests administered, including EKG and blood tests, I was given Benadryl and the throat felt better. I was also prescribed Prednisone for 5 days. I left the ER at about 7 pm. I had to go back to ER at around 11pm due to stomach pains and fever of 101. I wasn''t seen until after 1 am and they did a cat scan of stomach area and found nothing wrong and determined it was probably more of the allergic reaction, so I left at around 2:30 am. 11/2/07 Received t/c from patient/reporter. States she is feeling somewhat better & able to return to work partial day. Still on steroids & benadryl. Has appt w/allergist next week as she has had flu shots many times in past w/o any problems. 11/30/07 Reviewed ER medical records which reveal patient experienced gradual onset of throat tightness & abdominal pain & cramps beginning several hours after flu vax. She had an asthma attack w/subsequent SOB, wheezing & dry cough followed by nausea, diarrhea, malaise & weakness. Had received flu shots in past w/o problems. Tx w/antihistamine & symptoms completely resolved. D/C to home but returned to ER 7 hours later w/worsening RLQ abdominal pain & temp of 101 w/urinary frequency & decreased UO. FINAL DX: acute allergic reaction to influenza vaccine & RLQ abdominal pain, resolving. Per 60 day follow up I had allergy tests done after this event to see if I had afood allergy but everything came back negative so it must have been the flu shot only that caused it. Follow-up Information 14-NOV-2008: Abstaining from flu shots indefinitely.


VAERS ID: 295231 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2007-10-30
Onset:2007-11-01
   Days after vaccination:2
Submitted: 2007-11-01
   Days after onset:0
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2440AA / 3 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Large area of erythema on Rt. deltoid approximately 5 inches long by 4 inches wide. Treatment with Benadryl and cool compresses.


VAERS ID: 295237 (history)  
Age: 9.0  
Gender: Male  
Location: Texas  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:1
Entered: 2007-11-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500487P / - - / IN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1336U / 1 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Cough, Dyspnoea, Face oedema, Flushing, Lacrimation increased, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Lacrimal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: Amoxicillin Allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: cough, facial flushing/edema, wheezing, SOB epiphora.


VAERS ID: 295244 (history)  
Age: 50.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2007-11-01
   Days after onset:1
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2500AA / - LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Flushing, Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TST; Cyotonel 50mg
Current Illness: Hypothyroidism
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Flu shot given at approx 10am within 24 hr (L) arm red, swellign, warm to touch throbbing pain. H/A yesterday and felt flushed. Today slightly better.


VAERS ID: 295249 (history)  
Age: 45.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:2
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 79718 / 4 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Colonoscopy, Dysphonia, Pallor, Palpitations, Presyncope, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None recent colonoscopy - normal
CDC Split Type:

Write-up: Injection given at 2:30pm - 9:00pm while at home patient became very pale, heart palpitations almost fainted - ready to call 911 feeling passed 10-15 minutes later - became hoarse and throat tightened up for 15 minutes then was o.k.


VAERS ID: 295261 (history)  
Age: 3.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2007-11-01
   Days after onset:1
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB18219A / 0 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08702H / 3 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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:

Write-up: Patient woke up day after, thigh at injection site red swollen warm to touch and blances. Gave 12.5mg IM Benadryl


VAERS ID: 295322 (history)  
Age: 36.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-02
   Days after onset:3
Entered: 2007-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA316BA / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control Pills
Current Illness: None
Preexisting Conditions: None Known
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Patient reports that she broke out in a rash, three hours after receiving the flu vaccine. Rash was on face, arms, and neck. It appeared as small raised red bumps that did not itch or cause any other discomfort. Vaccine administrator recommended that the patient see her primary care physician. To date the patient has not seen a physician.


VAERS ID: 295324 (history)  
Age: 35.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2007-11-02
   Days after onset:2
Entered: 2007-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2769AA / - LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Erythema, Headache, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left arm reddened and swollen. Warm to touch.Has had a headache since administration


VAERS ID: 295326 (history)  
Age: 14.0  
Gender: Unknown  
Location: California  
Vaccinated:2007-10-30
Onset:2007-11-01
   Days after vaccination:2
Submitted: 2007-11-02
   Days after onset:1
Entered: 2007-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1005U / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0495U / 1 LA / SC

Administered by: Public       Purchased by: Unknown
Symptoms: Erythema, Injection site reaction
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: REDNESS AND BUMP ON SHOT AREA


VAERS ID: 295331 (history)  
Age: 8.0  
Gender: Male  
Location: Florida  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-02
   Days after onset:3
Entered: 2007-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500486PIN / 1 - / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Croup infectious
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: has history of "seasonal asthma", patient has cough variant asthma. PMH: Similar illnesses/events several times in past. NKDA.
Diagnostic Lab Data: Labs and Diagnostics: CXR with "streaky interstitial pattern bilaterally with steeple sign.
CDC Split Type:

Write-up: Croup began the evening he received the flumist vaccine. 11/09/2007 MR received for DOS 10/31/2007 for D/C DX of Croup. Pt presented to ER with abrupt onset of inspiratory stridor which responded quickly to racemic epinephrine and steroids. Transfered to current facilty where pt has not required any additional epi. Discharged on steroid taper. PE (+) respiratory stridor, otherwise WNL. Impression: Croup


VAERS ID: 295333 (history)  
Age: 13.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-10-30
Onset:2007-11-01
   Days after vaccination:2
Submitted: 2007-11-02
   Days after onset:1
Entered: 2007-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500491P / 0 - / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2538AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2862AA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blister, Erythema, Skin lesion, Tenderness
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. awoke 11/01/2007 approximately 0700 to discover 1cm bulla-appearing lesion on L upper arm which had a small rim of erythema surrounding it. Entire area of upper arm tender to touch.


VAERS ID: 295339 (history)  
Age: 51.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-02
   Days after onset:3
Entered: 2007-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB431AA / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN
Current Illness: NO
Preexisting Conditions: DEGENERATIVE BONE DISEASE
Diagnostic Lab Data: NO
CDC Split Type:

Write-up: Received Tdap on 10/30/2007. Later that evening, patient experienced extreme pain in her arm, fever 101 F, swelling, and redness. Reports left leg pain, but has a history of backpain. Today, no fever present, redness at injection site and area of Width 9 cm X Length 8 cm which is warm/painful to touch and swelling present below injection site. Patient prescribed Cipro 500 mg one tablet twice a day for 7 days for cellulitis.


VAERS ID: 295346 (history)  
Age: 0.25  
Gender: Male  
Location: Minnesota  
Vaccinated:2007-10-30
Onset:2007-11-02
   Days after vaccination:3
Submitted: 2007-11-02
   Days after onset:0
Entered: 2007-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2459NA / 0 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Diarrhoea, Discomfort, Inappropriate schedule of drug administration
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow)

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:

Write-up: Child is uncomfortable and having diarrhea. Was seen back in Clinic on November 2nd. CDC adverse effects for vaccines were reviewed with mother.Mother was informed that child was given flu shot earlier than the 6 month recommended age.


VAERS ID: 295409 (history)  
Age: 28.0  
Gender: Female  
Location: Nevada  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2007-11-01
   Days after onset:1
Entered: 2007-11-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2504AA / - LA / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Injection site erythema, Musculoskeletal stiffness, Pain in extremity, Skin warm
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain and stiffness of left deltoid warm erythematous circular area measures 5cm approximately 4cm inferior to the injection site.


VAERS ID: 296995 (history)  
Age: 1.0  
Gender: Male  
Location: Missouri  
Vaccinated:2007-10-30
Onset:2007-11-08
   Days after vaccination:9
Submitted: 2007-11-15
   Days after onset:7
Entered: 2007-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2473GA / 0 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0184U / 0 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 354007F / 3 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0675U / 0 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vesicles to vaccine site of Left upper outer arm with continued redness.


VAERS ID: 297005 (history)  
Age: 66.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2007-11-05
   Days after onset:5
Entered: 2007-11-15
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1381U / 0 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Erythema, Induration, Local reaction, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Diovan, HCT, Floxapen, meloxicam, floxopen, Vicodin
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Exagerates Local reaction with erythema, induration Also arthralgia, fever. symptoms of Fever, arthralgia resulted 11/5. Arm pain much better and still improving 11/8/07


VAERS ID: 298733 (history)  
Age: 26.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:1
Entered: 2007-12-04
   Days after submission:34
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 417011C / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Joint stiffness, Lymphadenopathy, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Tomatoes, pollen, migraines, asthma
Diagnostic Lab Data:
CDC Split Type: TX0798

Write-up: Soreness noted after receiving shot. 3 hours after receiving shot felt lymph nodes on (L) arm swelling. Next morning noticed stiffness in joints (shoulder). (L) arm, slight stiffness in (R) shoulder, felt tingling in (L) arm and fingers. No shortness of breath, alert.


VAERS ID: 300100 (history)  
Age: 49.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-10-30
Onset:2007-11-01
   Days after vaccination:2
Submitted: 2007-11-07
   Days after onset:6
Entered: 2007-12-17
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80433 / 0 UN / IM

Administered by: Public       Purchased by: Private
Symptoms: Blister, Pruritus generalised, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Received Fluvirin vaccine on 10/30/07. Began to experience over entire body itchiness. This was on 11/1/07. On 11/2/07 a raised hive-like rash developed with blisters on (L) arm. Took own Diprolene ointment and advised employee health who advised OTC Benadryl.


VAERS ID: 305504 (history)  
Age: 23.0  
Gender: Male  
Location: Texas  
Vaccinated:2007-10-30
Onset:0000-00-00
Submitted: 2008-02-20
Entered: 2008-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 2 UN / SC
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500488P / 0 - / IN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB431AA / 1 UN / IM
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER AHAVB109EA / 1 UN / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 0 UN / ID

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain, Biopsy colon abnormal, Biopsy intestine abnormal, Clostridial infection, Clostridium difficile toxin test positive, Colitis, Computerised tomogram abdomen abnormal, Diarrhoea, Full blood count abnormal, Gastroenteritis, Inflammatory bowel disease, Injection site pain, Nausea
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 51 days
   Extended hospital stay? No
Previous Vaccinations: reaction to childhood vaccines (large limb after DTaP/MMR; fevers, local reactions after most vaccine); burning; pain at previou
Other Medications: None at time of immunizations
Current Illness: None
Preexisting Conditions: Hx of LBP; NKDA
Diagnostic Lab Data: C diff (Toxin A), 11/26/07, positive; 12/11/07, positive (2nd specimen obtained at 2215 on 12/11/07 was NEG); 12/17/07, NEG; 12/31/07, NEG; labs, 13 Jan 2008, pathology report, hospital; SPECIMEN Rectosigmoid, R) and L) Colon Biopsies, all three specimens show an active colitis with the left and rectosigmoid colon biopsies showing a moderate degree of activity while the right shows a more mild degree, however all pieces in all of the biopsies are affected and there are few foci of surface exudate, the overall appearance suggests an infectious colitis; the possibility of ulcerative colitis cannot be excluded, no granulomas are identified, no dysplasia is seen; 24 Jan 2008, pathology report, hospital, Random Colon Biopsy, microscopic descript
CDC Split Type:

Write-up: Healthy 24 year old preparing for deployment. Symptom onset on 31 Oct 2007 (within 24 hours post-vaccinations: Pan at AVA vaccination site, nausea, diarrhea (every time he ate it ''went through'' him). Presenting complaint to Clinic on day 16 post-vaccination: 2 week history of abdominal cramping and diarrhea. Diagnosed as gastroenteritis and treated with IVFs, Bentyl, Lomotil, Acidophilus. Temporarily felt better after taking meds, but symptoms returned after 2-3 hours. Admitted to hospital with Diagnosis: Infectious Colitis secondary to C. diff, LUE. Admission date: 26 Nov 2007, Discharge Date: 18 Dec 2007. Upon discharge, symptoms had improved but not completely resolved. Worsened in early Jan and patient re-admitted on 5 Jan with discharge on 5 Feb. Working dx is inflammatory bowel disease and pt was discharged on oral steroids. 3/7/08 Received hospital medical records for 11/26-12/18/2007 admission which reveal: FINAL DX: infectious collitis secondary to c. difficile secondary to debilitated immunity; RUE thrombophlebitis. HPI: Patient experienced bloody diarrhea x 1 mo w/pain & abdominal cramping. Patient passed out & came to ER. Tx w/IVF, IV & oralantibiotics. GI & ID consults done. PICC line inserted for IV/TPN nutrition but removed due to basilic vein thrombophlebitis. Gradually improved & d/c to home w/GI clinic f/u. 1/20/2010 SCE ECDE rolo with Biopsy ripoas -FBS 09 02/05/2010 Diagnosed with Ulcerative Colitis.


VAERS ID: 309167 (history)  
Age: 26.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2008-04-08
   Days after onset:161
Entered: 2008-04-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1448U / 0 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Central nervous system inflammation, Clumsiness, Computerised tomogram abnormal, Dysaesthesia, Gait disturbance, Headache, Hypoaesthesia, Lumbar puncture abnormal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Drug hypersensitivity
Preexisting Conditions: records received 4/28/08-asthma
Diagnostic Lab Data: computed axial positive for inflammation; magnetic resonance c-spine-with inflammatory lesion; magnetic resonance brain-with inflammatory lesion; spinal tap abnormal 4/28/08-records received-MRI brain no evidence of significant demyelinating lesions, quesitonable signal noticed in posterior corpus callosum. MRI cervical spine revealed T2 lesion in high spinal cord. MRI of thoracic and lumbar spine essentially negative. Lumbar puncture revealed normal protein, cell count, myelin based protein and oligoclonal band positive with findings consistent with demyelinating disease. EMG/NCV showed no evidence of peripheral neuropathy.
CDC Split Type: WAES0803USA04168

Write-up: Information has been received from a physician concerning a 26 year old female with an allergy to DEMEROL who was vaccinated in December 2007 with her first dose of Gardasil (lot# not reported). The patient had severe headaches after receiving this vaccine. In February 2008 the patient was vaccinated with her second dose of Gardasil (lot# not reported). Subsequently the patient experienced neurological symptoms within the first couple of weeks after receiving the vaccine. The patient was referred to a neurologist and she had either a cat scan or MRI. The test was positive for inflammation. The patient''s outcome was not reported. Follow-up information was received from a physician. The patient had no pertinent medical history or no family history of adverse reactions in siblings. There was no illness at the time of vaccination. The patient was vaccinated with her first dose of Gardasil on approximately 30-OCT-2007. On 30-OCT-2007 the patient developed severe headaches "right after the vaccination". On 14-JAN-2008 the patient was vaccinated with a second dose of Gardasil (lot# 659653/1448U) in the deltoid. There was no concomitant medications at the time of the vaccine. On 08-MAR-2008 the patient developed progressive dysesthesias and numbness of limbs and trunk, clumsiness of hands and gait and was hospitalized. On an unspecified date magnetic resonance imaging of c-spine showed an inflammatory lesion and MRI of the brain revealed one other inflammed spot. A lumbar puncture was abnormal. The physician reported that this is all consistent with an acute central nervous system inflammatory condition which occurred about 2 to 3 weeks after the second Gardasil. At the time of reporting the patient had not recovered from the CNS inflammation. The reporter felt that central nervous system inflammation was disabling. Additional information is not expected. 4/28/08-records received for DOS 3/9-3/15/08- DC DX: Transverse myelitis. Admitted with paresthesia in limbs. Symptoms gradually getting worse and moved over to trunk.


VAERS ID: 309792 (history)  
Age: 80.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-30
Onset:2007-11-04
   Days after vaccination:5
Submitted: 2008-03-26
   Days after onset:143
Entered: 2008-04-16
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1080U / - UN / UN

Administered by: Other       Purchased by: Private
Symptoms: Herpes zoster, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA05178

Write-up: Information has been received from a registered nurse concerning an approximate 70-year-old female who in approximately February 2008, was vaccinated with a dose of Zostavax (Oka/Merck). In approximately February 2008, it was reported the patient was on vacation and experienced a rash 10 days after vaccination and called the doctors office to let them known about it. The rash was over her entire body and the patient was going to follow-up with a doctor where she was vacationing. At the time of the report the patient''s status was unknown. Additional information has been requested. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a registered nurse concerning an 80 year-old female with no known allergies who on 30-OCT-2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 658602/1080U). Concomitant therapy included an unspecified influenza vaccine "within the last 4 weeks". On 07-NOV-2007, the patient was on vacation and broke out in a rash on 04-NOV-2007 (also reported as 10 days after vaccination) and called the doctors office to let them know about it. The rash was over her entire body but especially on her face and arms. The patient stated that "it looks like chicken pox before it blisters to heads" and "I have shingles". She did not complain of pain or itching. She stated that she felt fine. The patient was going to follow-up with a doctor where she was vacationing the next day. At the time of the report the patient''s status was unknown. In follow up the registered nurse indicated that they were unable to follow up with the patient because she did not answer her telephone on vacation for the next 3 days and her other telephone number was disconnected. Additional information is not expected.


VAERS ID: 322945 (history)  
Age: 35.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-30
Onset:0000-00-00
Submitted: 2008-07-30
Entered: 2008-08-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - - / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: WAES0711USA02460

Write-up: Information has been received from a registered nurse concerning a 35 year old female who on 30-OCT-2007 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine, (lot # "0099U") and concomitantly was vaccinated with influenza virus vaccine (unspecified). It was reported that the patient experienced soreness and pain up her arm but not at the injection site, with a rash or redness of the blood vessels of her hands and wrists. She was treated with ibuprofen and ice. It was not known if the patient had received a pneumococcal 23 v polysaccharide vaccine in the past. The patient sought unspecified medical attention by phone. At the time of the report, it was unknown if the patient recovered. The nurse reported on two other patients that experienced adverse events after receiving pneumococcal 23v polysaccharide vaccine (0711USA02461 and 0711USA00610). The patient worked with 45 persons that were vaccinated during a vaccine clinic at their company. A total of 45 persons received the influenza virus vaccine (unspecified) and 12 persons received pneumococcal 23v polysaccharide vaccine. There have been no other adverse symptoms reported. Additional information has been requested.


VAERS ID: 347265 (history)  
Age: 14.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2007-10-30
Onset:2007-11-21
   Days after vaccination:22
Submitted: 2009-05-26
   Days after onset:551
Entered: 2009-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80433 / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dysphagia, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscular weakness, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Demyelination (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 10 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Medical records from Hospital included (will be faxed to VAERS) 5/27/09-records received- WBC 12.5. Positive mono spot. Positive EVB titers. Respiratory culture positive for haemophilus influenza and streptococcus pneumonia.LFTs elevated with ALT of 187 and AST of 80. Lumbar puncture protein 240, glucose 72, 4 nucleated cells. 6/26/09 Hospital records and DC summary recieved. DOS 12/02/07 to 01/04/08. LABS and DIAGNOSTICS: Lumbar Puncture - protein 240, glucose 72, 4 nucleated cells, 0 red blood cells. EBV Titers (+). Haemophilus Influenza Culture (+). Strep pneumonia Culture (+). CT Head - No Evidence of Acute Intracranial Hemorrhage or Hydrocephalus. Chest X-Ray - Lungs mildly hypoinflated, mild vascular prominence. CDC - WBC 12.5 (H), H
CDC Split Type: SC0915

Write-up: Several weeks (end of November) after getting flu vaccine, client began experiencing weakness in legs with numbness in feet and toes. He began walking with a cane and 2 days later he was in a wheelchair. Family took client to the ER when he couldn''t swallow. Admitted to hospital on December 3rd, 2007, and diagnosed with Guillian-Barre Syndrome. He was on life support X 17 days and in ICU X 1 month. Transferred to rehab center. 5/27/09-records submitted with report-Presented on 12/2/08 with 10 day history of increasing weakness and numbness of feet which made an ascending pattern up entire body. 4 days prior began with feelings of breathlessness and day before presenting to ED C/O trouble with swallowing and muffled speech. Elevated BP on admission 148/99 and subsequent transient increase in BP. Treated with IVIG. Mechanical ventilation required with intubation and subsequent extubation. NG feedings. DX: Guillain-Barre syndrome. One month hospitalization. Office visit follow up 1/23/09 residual weakness on both sides of face, CN VII focally affected R$gL. 6/26/09 Hospital records and DC summary recieved. DOS 12/02/07 to 01/04/08. Assessment: Ascending paralysis, probable Guillain-Barre. Patient presented with ascending numbness and weakness. Nausea and vomitjng. Numbness in feet. Difficulty swallowing liquids. Unable to walk or sit up on his own. DTR''s absent. Stregnth diminished upper and lower extremities. Fever, headache. Sedation/Analgesia dependence. Agitation with respiratory distress. Hypertension. IVIG administered. Transferred to rehabilitation facility. ICD-9 Codes: 357.0, 518.81, V46.11, 707.03, 292.0, 304.01, 112.0, 401.9, 075, 726.87, 041.5, 564.00, 110.5


VAERS ID: 457961 (history)  
Age: 1.06  
Gender: Female  
Location: Colorado  
Vaccinated:2007-10-30
Onset:2011-12-15
   Days after vaccination:1507
Submitted: 2012-06-21
   Days after onset:188
Entered: 2012-06-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Blister, CSF test abnormal, Herpes zoster, Immunology test normal, Meningitis, Polymerase chain reaction, Varicella virus test positive, White blood cell count increased
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Facial nerve VI zoster & meningitis (70 WBC) facial lesions & CSF PCR (+) YZV -$g sent to CDC
CDC Split Type:

Write-up: Facial nerve zoster & meningitis (70 WBC) facial vesicles & CSF (+) PCR VZV -$g sent to CDC, confirmed OKA strain. Limited immune evaluation normal.


VAERS ID: 480526 (history)  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2012-12-26
   Days after onset:1884
Entered: 2012-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1212USA008424

Write-up: This spontaneous report as received from a registered nurse refers to a patient of unknown age who on 23-DEC-2003 was vaccinated with the first doses of VARIVAX (Merck) and MMR II (dose, lot number and route not reported). No concomitant medications were reported. The patient''s second dose of MMR II was administered on 24-OCT-2007 and the second dose of VARIVAX (Merck) was administered on 30-OCT-2007. No adverse effect reported. Patient''s outcome unknown. Additional information is not expected.


VAERS ID: 530629 (history)  
Age: 14.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-10-30
Onset:2014-04-12
   Days after vaccination:2356
Submitted: 2014-05-12
   Days after onset:30
Entered: 2014-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2505AA / 2 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2277AA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pain, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses noted.
Preexisting Conditions: History of allergy to amoxicillin and asthma
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash began on right anterior lower trunk. Started itchy and had become sharp, pin point pain.


VAERS ID: 571348 (history)  
Age: 0.34  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-30
Onset:0000-00-00
Submitted: 2015-03-17
Entered: 2015-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1503USA001048

Write-up: This spontaneous report as received from a physician''s assistant refers to a 4 month old female patient. There was no pertinent medical history, drug reactions/allergies and concomitant medication provided. On 21-JUL-2007, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose 0.5 ml, route, therapy type, lot # and expiration date were not reported). On 29-AUG-2007, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose 0.5 ml, route, therapy type, lot # and expiration date were not reported). On 30-OCT-2007, the patient was vaccinated with the third dose of RECOMBIVAX HB (dose 0.5 ml, route, therapy type lot # and expiration date were not reported). No adverse effect was reported. Additional information has been requested.


VAERS ID: 296842 (history)  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-15
   Days after onset:16
Entered: 2007-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA301AD / - RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure decreased, Erythema, Feeling abnormal, Heart rate increased, Malaise, Oedema peripheral, Skin warm, Syncope, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: Blood pressure 30Oct2007 under 100/60mmHg; Blood pressure 30Oct2007 130/80mmHg; Heart rate 30Oct2007 120/min; Heart rate 30Oct2007 120-130/min
CDC Split Type: B0494521A

Write-up: This case was reported by a physician and described the occurrence of edema of arm in a 26-year-old female subject who was vaccinated with (Alpharix, GlaxoSmithKline) for prophylaxis. A year before the subject beneficied of the same type of vaccination, she moreover tolerated perfectly. The subject did not experience any adverse event after previous vaccinations. On 30 October 2007 the subject received unspecified dose of Alpharix (intramuscular, right deltoid). On 30 October 2007, immediately after vaccination with Alpharix, the subject presented a large edema of arm, redish and warm at the external side of the right arm. She was in a lipothymic conditions. Therefore the physician told her to lie down and stayed her bedside for half an hour. Her vital parameters were watched closely The subject''s blood pressure decreased initially under 100/60 mmHg. The subject received methylprednisolone sodium succinate (Solu-medrol) then Levorenine (epinephrine). The subject''s heart rate was 120/130/min. Then she developed a generalised urticaria and felt more and more bad althought the preservation of the vitals signs included heart rate 120/min and blood pressure 130/80mmHg. At the end of the afternoon the subject was allowed to leave the hospital. The symptomatology was completely amended. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved.


VAERS ID: 297545 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-30
Onset:2007-11-01
   Days after vaccination:2
Submitted: 2007-11-21
   Days after onset:20
Entered: 2007-11-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA301AF / 0 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Injection site reaction, Myalgia, Oedema peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0054989A

Write-up: This case was reported by a physician and described the occurrence of severe myalgia in a 14-year-old female subject who was vaccinated with Influsplit SSW 2007/2008 (GlaxoSmithKline). On 30 October 2007 the subject received the first dose of Influsplit SSW 2007/2008 (0.5 ml, intramuscular, right deltoid). Approximately two days post vaccination with Influsplit SSW 2007/2008, on 01 November 2007, the subject experienced injection site reaction and swelling of the right upper arm. The event was resolved after about three days. Approximately six days post vaccination with Influsplit SSW 2007/2008, around 05 November 2007, the subject experienced severe myalgia and severe back pain. The subject visited the emergency ward of a hospital. The subject stayed in hospital for an unknown period of time for diagnostics, including internal, neurological and orthopaedic examinations. At the time of follow-up reporting, on 15 November 2007, the events were improved. The reporting physician considered that the events were probably related to vaccination with Influsplit SSW 2007/2008. No further information will be available.


VAERS ID: 297547 (history)  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-21
   Days after onset:22
Entered: 2007-11-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypokinesia, Hypotonia, Pallor
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: b0496052a

Write-up: This case was reported by a regulatory authority (foreign Regulatory Agency # 78773) and described the occurrence of decreased responsiveness in a 3-month-old female subject who was vaccinated with Infanrix (GlaxoSmithKline). On 30 October 2007, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site), lot not provided. On 30 October 2007, less than one day after vaccination with Infanrix, the subject experienced decreased responsiveness with muscle hypotonia and pallor. The subject was hospitalised for 48 hours for observation. A diagnosis of pallor crisis was made. On 31 October 2007, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix.


VAERS ID: 298443 (history)  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2007-11-30
   Days after onset:30
Entered: 2007-12-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Multiple sclerosis relapse, Myelitis transverse, Optic neuritis
SMQs:, Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cyproterone acetate/ethinyl estradiol
Current Illness: Multiple sclerosis
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711AUS00143

Write-up: Information has been received from a physician via CSL as part of a business agreement concerning a 21 year old female with multiple sclerosis who on 30-OCT-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included ESTELLE 35. On 31-OCT-2007 the patient experienced rapid consecutive relapse of multiple sclerosis characterised by transverse myelitis and optic neuritis. At the time of reporting on 29-NOV-2007, the patient had partly recovered. Additional information is not expected.


VAERS ID: 300441 (history)  
Age: 0.8  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2007-12-19
   Days after onset:49
Entered: 2007-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB21833 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: B0499912A

Write-up: This case was reported by a physician and described the occurrence of generalized rash in a 9-month-old male subject who was vaccinated with Engerix B pediatric for prophylaxis. On 30 October 2007, the subject received the 3rd dose of Engerix B pediatric (intramuscular, unknown). On 31 October 2007, one day after vaccination with the 3rd dose of Engerix B pediatric, the child developed a generalized rash and generalized urticaria. The physician considered the event was clinically significant (or requiring intervention). The subject was treated with Loratadin, mepredinsone and Fenistil. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with Engerix B pediatric.


VAERS ID: 302131 (history)  
Age: 60.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-30
Onset:2007-10-31
   Days after vaccination:1
Submitted: 2008-01-09
   Days after onset:70
Entered: 2008-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 09102 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Atrial fibrillation, Chest pain, Neck pain
SMQs:, Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol; Aspirin; Rosuvastatin calcium
Current Illness: Unknown
Preexisting Conditions: Not stated.
Diagnostic Lab Data: UNK
CDC Split Type: B0501782A

Write-up: This case was reported by a regulatory authority and described the occurrence of neck pain in a 60-year-old male subject who was vaccinated with Influenza vaccine for prophylaxis. Concurrent medications included Atenolol, Aspirin and Rosuvastatin calcium (Rosuvastatin). On 30 October 2007 the subject received unspecified dose of Influenza vaccine (.5 ml, intramuscular). On 31 October 2007, at an unspecified time after vaccination with Influenza vaccine, the subject experienced neck pain, chest pain and paroxysmal atrial fibrillation. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 1 November 2007, the events were resolved. Verbatim Text: Pains in neck, chest pain, also paroxysmal atrial fibrillation.


VAERS ID: 303311 (history)  
Age: 1.4  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-30
Onset:2007-11-01
   Days after vaccination:2
Submitted: 2008-01-21
   Days after onset:81
Entered: 2008-01-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2695A / - LL / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Electroencephalogram normal, Febrile convulsion, Off label use, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None reported
Diagnostic Lab Data: EEG was normal
CDC Split Type: E200800164

Write-up: Case initially received on 10-Jan-08. Case reported by HA (HA reference number PEI2007013441) through Sanofi Pasteur. This is a misuse case (off label use). It was reported that a 16-month-old female patient was vaccinated with a dose of Covaxis (lot# C2695AA) into the left thigh on 30-Oct-07. On 01-Nov-07 the patient experienced urticaria (approx. 3.00 p.m.) and a febrile seizure for 30 minutes (approx. 6.00 p.m.). She was admitted to hospital, the situation was considered to be life-threatening. Nothing was reported about treatment, EEG was normal. The patient recovered completely within an unspecified time.


VAERS ID: 319298 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-30
Onset:2008-04-01
   Days after vaccination:154
Submitted: 2008-07-15
   Days after onset:105
Entered: 2008-07-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0859F / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Nuclear magnetic resonance imaging, Paraesthesia, Peroneal nerve palsy
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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: magnetic resonance imaging, 26Jun08, Comment: MRT results pending
CDC Split Type: WAES0807USA01693

Write-up: Information has been received from an internist concerning a 15 year old female who on 21-AUG-2007 was vaccinated with a first dose of GARDASIL (batch# not reported) and was well tolerated. On 30-OCT-2007 the patient received a second dose of GARDASIL (batch# NE29660, lot# 654740/0859F). About 6 months after the second vaccination, approximately April 2007 and prior to the third dose, the patient had experienced a short episode of paresthesia in the leg which had resolved. On 07-MAY-2008 the patient received a third dose (batch# NNH15190/lot# 1114U) intramuscularly into the deltoid muscle. On 23-MAY-2008 the patient developed paresthesia in the face and leg and experienced peroneal paralysis. On 26-JUN-2008, MRI was performed but the results were pending at the time of reporting. The patient had not recovered. The reporter considered paralysis peroneal, paresthesia foot, paresthesia lower limb and facial paresthesia to be other important medical events. Other business partner numbers included: E2008-06192. Additional information is not available.


VAERS ID: 413412 (history)  
Age: 1.3  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-30
Onset:2007-11-01
   Days after vaccination:2
Submitted: 2010-12-22
   Days after onset:1147
Entered: 2010-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pruritus, Wound haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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: B0689674A

Write-up: This case was reported by the Foreign regulatory authority (reference BX20101011) and described the occurrence of injection site pruritus in a 16-month-old female subject who was vaccinated with combined INFANRIXQUINTA (GlaxoSmithKline) and PREVENAR (non-gsk). Medical conditions were unspecified. On 30 October 2007, the subject received an unspecified dose of INFANRIXQUINTA (batch unknown, intramuscular, unknown thigh) and an unspecified dose of PREVENAR (batch unknown, intramuscular, unknown other thigh). In November 2007, the subject presented with injection site pruritus on left thigh. it was unknown if it was injection site of INFANRIXQUINTA or PREVENAR. Pruritus was almost permanent with sometimes bloody scratching lesions. Events resolved spontaneously and suddenly in July 2010. There were no other general or local phenomena during all this periode. Other vaccines were administered in other injection sites without the same tolerance problem. The regulatory authority reported that the events were clinically significant (or requiring intervention). Causal relationship of vaccination with INFANRIX HEXA and PREVENAR and the reported events was assessed as probably, according to the Foreign method of imputability.


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