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Case Details (Sorted by Vaccination Date)

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VAERS ID: 434808 (history)  
Age: 48.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-19
   Days after onset:0
Entered: 2011-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA666CA / 4 LA / -

Administered by: Unknown       Purchased by: Private
Symptoms: Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: C/o chest pain and blood stools previous to her appointment at the Center today. Had gone to the ER previous to vaccine appointment, and had a normal EKG, lab work, which results were not available.
Preexisting Conditions: Diabetic/ hypertensive/ h/o pulmonary embolism/ asthma
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient slumped over in wheel chair while waiting for a ride home a few minutes after receiving a Flulaval dose. This patient has a history of frequent LOC in office before and after appointments. She is greeted at the entrance with a wheel chair. Incident occurred at 10:00am and by 10:05 she was conversing with a provider. BP was 120/72 times 2, pulse 88 and 100, pulse ox 92 and 95, blood sugar 146. Skin was warm and dry, color pale initially, then color improved quickly. No respiratory difficulty. Diagnosed with pseudo syncopal episodes. Was wheeled back to an exam room to be observed by a nurse and Dr. and discharged when her ride home arrived.


VAERS ID: 434972 (history)  
Age: 65.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:1
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH458AB / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0595AA / - RA / IM

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

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

Write-up: swollen and redness from shoulder to elbow


VAERS ID: 434987 (history)  
Age: 47.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-19
   Days after onset:0
Entered: 2011-09-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED N58106 / 0 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Cough, Pain, Respiratory tract congestion, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VICODIN; Ferrous sulfate; Vitamin D; MP magnesium; AMBIEN
Current Illness:
Preexisting Conditions: Allergy sulfonamide; Aortic valve insufficiency; Cervical radiculitis; Hyperlipidemia; Iron deficiency anemia; Low back pain
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1 1/2 after vaccination - congestion, wheezing, coughing, chills, aching and vomiting.


VAERS ID: 434988 (history)  
Age: 0.61  
Gender: Male  
Location: Ohio  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:1
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3893AA / 2 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB976AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E97569 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0063AA / 2 - / PO

Administered by: Private       Purchased by: Public
Symptoms: Irritability, Lethargy, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Dry cough for 1 wk
Preexisting Conditions: Torticollis; Plagiocephaly
Diagnostic Lab Data:
CDC Split Type:

Write-up: C/o lethargy & fever & vomiting within hours of vaccine. Temp up to 103 degrees & fussiness. Tx with TYLENOL/MOTRIN.


VAERS ID: 435002 (history)  
Age: 11.0  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:1
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT426AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3927AA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth, Local reaction
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: Methylcobalamin inj; Nystatin 2 po TID
Current Illness:
Preexisting Conditions: Autistic disorder; OCD; Aspergers syndrome
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had a local reaction to flu vax on (R) deltoid. Injection site was very red and hot to the touch size approx 4 1/2 x 3 inches.


VAERS ID: 435006 (history)  
Age: 21.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-19
Onset:2011-09-20
   Days after vaccination:1
Submitted: 2011-09-20
   Days after onset:0
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 11031P / - UN / IM

Administered by: Public       Purchased by: Private
Symptoms: Erythema, Skin warm, Swelling face
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKMA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling to her left cheek, redness, and warm to touch. Denies nausea, vomiting, diarrhea.


VAERS ID: 435012 (history)  
Age: 24.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-09-19
Onset:0000-00-00
Submitted: 2011-09-20
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3976AA / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (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:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Erythema at injection site, injection site pain, mild itching at site. Started after injection and continues to day after.


VAERS ID: 435014 (history)  
Age: 50.0  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:1
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 90658/Q2038 / 0 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Chills, Eye swelling, Fatigue, Lacrimation increased, Pain, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Lacrimal 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:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Scratchy throat, watering swollen eyes. Extreme fatigue, body chills and aches.


VAERS ID: 435016 (history)  
Age: 51.0  
Gender: Male  
Location: Georgia  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:1
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1101301 / - LA / IM

Administered by: Other       Purchased by: Private
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:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt got a rash on arms, chest, and back. I gave him Diphenhydramine 25 mg to take 1 to 2 tablets to take by mouth every 4 to 6 hours. He will call his doctor.


VAERS ID: 435019 (history)  
Age: 42.0  
Gender: Female  
Location: Missouri  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:1
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 9874408 / 0 RA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Induration, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (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: warfarin simvastatin ranitidine
Current Illness: no
Preexisting Conditions: h/o PE with factor V Leiden on chronic anti-coagulation
Diagnostic Lab Data:
CDC Split Type:

Write-up: induration and pain in right shoulder and arm


VAERS ID: 435075 (history)  
Age: 30.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-19
Onset:2011-09-20
   Days after vaccination:1
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT448AA / - LA / UN

Administered by: Public       Purchased by: Private
Symptoms: Ophthalmological examination abnormal, Periorbital oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Optic nerve disorders (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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Eye exam - other than edema: normal
CDC Split Type:

Write-up: Patient developed (L) periorbital edema one day after vaccine administration.


VAERS ID: 435321 (history)  
Age: 38.0  
Gender: Female  
Location: Kansas  
Vaccinated:2011-09-19
Onset:2011-09-20
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB207BA / 3 UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Chills, Feeling hot, Hyperhidrosis, Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Pruritus, Rash macular, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (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: None
Current Illness: None
Preexisting Conditions: Allergy to PCN & Erythromycin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Client received TWINRIX at health department on 9-19-2011 approximately at 4:30pm. At approx. 3am on 9-20, she woke up feeling hot and having chills. She had itching on her head, armpits, lips, labia and could feel "blotchy hives" on her back. She did not have any tightness of the throat at that time. She took BENADRYL at that time and again at 11-11:30am on Tuesday. She felt ok all day Wednesday and then woke up at 3am on Thursday feeling hot and sweating. She had swelling of her lips with tingling and numbness. She took a BENADRYL at that time. Patient called me late morning and I returned her call about 1:30pm. She asked me if she could take anything else to help with the reaction. I told her to take either generic CLARITIN or ZYRTEC. She thought she had some at home so took a ZYRTEC at approximately 1:30-2:00 pm. She also reported that her throat felt tight with that lasting until about mid afternoon. I called patient about 7pm and asked how she was doing and she told me that she had taken a ZYRTEC and that all of her swelling was gone along with the itching. She said she was "up and going and does not feel bad at all". She also reported that her swelling had completely resolved.


VAERS ID: 435323 (history)  
Age: 67.0  
Gender: Male  
Location: Georgia  
Vaccinated:2011-09-19
Onset:2011-09-20
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0595AA / 0 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site cellulitis, 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril
Current Illness: None
Preexisting Conditions: None as per patient but currently taking one month trial of Lisinopril for slight increase in blood pressure
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Left bicep region was red, swollen and hot 9/22/11. Cellulitis below injection site (injection site left deltoid; cellulitis site left bicep region) - This occurred one to two days post PNEUMOVAX injection in left deltoid. Treatment: KEFLEX 500mg Q6 hours x 10 days, moist head to area and elevation of extremity.


VAERS ID: 435357 (history)  
Age: 48.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-09-19
Onset:2011-09-20
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:3
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA621BA / - LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Erythema, Pruritus, Skin 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? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hyzaar, Aldactone, Zocor, Krill Oil tablets, Vitamin D
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Morning after vaccination noted raised, reddened, itchy area on (R) foot. The following day she had more of the above described areas on her legs & as of 9/22/11 she had more areas on arms, as well as a few noted on her trunk. Area immediately surrounding injection site was clear with no redness or itching reported or noted.


VAERS ID: 435496 (history)  
Age: 0.52  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-09-19
Onset:2011-09-21
   Days after vaccination:2
Submitted: 2011-09-23
   Days after onset:2
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 - / PO

Administered by: Unknown       Purchased by: Private
Symptoms: Abdominal pain, Candida nappy rash, Crying, Culture stool, Decreased appetite, Diarrhoea, Erythema, Faeces discoloured, Frequent bowel movements, Haematochezia, Irritability, Lethargy, Pain of skin, Somnolence, Ultrasound abdomen normal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: None
Diagnostic Lab Data: ultrasound and stool culture
CDC Split Type:

Write-up: 9/21/11: severe abdominal pain that came on and subsided in waves, inconsolable crying, lethargy, disinterest in food, sleepiness, fussiness, significant blood in stool; symptoms grew worse over course of four hours and then began to improve somewhat; was taken to ER where ultrasound was performed at 10:00 PM that did not detect blockage 9/22/11: Numerous green stools throughout day indicative of diarrhea; took her to pediatrician for follow-up exam following ER visit; submitted stool sample for culture testing 9/23/11: Return of inconsolable crying in the afternoon around 3:30 PM, diarrhea worsened, persistent diarrhea caused severe and painful red diaper rash accompanied by yeast infection; treated with frequent hydration with nursing and anti-fungal/petroleum jelly applied to bottom to aid diaper rash


VAERS ID: 435520 (history)  
Age: 52.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-25
   Days after onset:6
Entered: 2011-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 11052P / - LA / -

Administered by: Other       Purchased by: Private
Symptoms: Abdominal pain upper, Chills, Headache, Hyperhidrosis, Injection site swelling, Malaise, Nausea, Pain in extremity, Rash macular
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid daily and Nexium as needed and inhaler as needed
Current Illness: No I was not ill at time of shot but got so then evening and still am today on 9/25/11 and I am looking for help. Been to urgent care 3 times.
Preexisting Conditions: Aasthma mostly have some allergies not much.
Diagnostic Lab Data: Oral and IV antibiotics given as well a steroid injection and a bag of fluid and nausea medicine.
CDC Split Type:

Write-up: I knew my arm was sore but expected that from the flu shot. But when my arm was blotchy red and the site was swelling larger by early Tuesday or late Monday the 19th, I was concerned because of swelling and the pain my arm was in was almost unbearable. Striking pain and swelling just got bigger. I phoned the place where I got it right away as well as my medical providers nurse advice. All told me to be seen so I did go to urgent care where I went for 9---22, 23, 24 and here I am today still sick with this, pain in my arm, red, still swollen and my head hurts like crazy and my stomach nausea and the chills and sweats keep coming. I am very worried almost scared really. Never had this before. Physical, emotional and financial costly to me but mostly I just want help in getting this GONE and being alive without side effects and I am searching out help. Called the company who produced the vaccine and they won''t help unless my primary care doctor is seeing me which I tried to get into and couldn''t so I have seen consistently for the last 3 days Dr. at urgent care. It is unknown at this time 7 days in how long this will last and or the side effects and final outcome. I just want to live and even though I am considered High risk due to asthma and should get the flu shot I won''t again unless my doctor insists.


VAERS ID: 435630 (history)  
Age: 50.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-26
   Days after onset:7
Entered: 2011-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3976AA / 0 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Lymphadenopathy
SMQs:, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None noted
Current Illness: None noted
Preexisting Conditions: None aware of
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Large R axillary lymph nodes noted, tenderness at injection site, erythema at injection site, palpated enlarged lymph nodes.


VAERS ID: 435831 (history)  
Age: 2.0  
Gender: Female  
Location: Virginia  
Vaccinated:2011-09-19
Onset:2011-09-22
   Days after vaccination:3
Submitted: 2011-09-22
   Days after onset:0
Entered: 2011-09-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4184BC / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Febrile convulsion, Pyrexia, Urine analysis normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), 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: None
Current Illness: Insect bites
Preexisting Conditions: None
Diagnostic Lab Data: Urinalysis was done & negative
CDC Split Type:

Write-up: Child received vaccine for flu on 9/19 at approx 10:30 AM. She had a febrile seizure 9/22 at approx 4:30 AM. Fever started "tactile" the morning following vaccine & first documented fever 9/21/11 about 1600.


VAERS ID: 435843 (history)  
Age: 0.51  
Gender: Male  
Location: South Carolina  
Vaccinated:2011-09-19
Onset:0000-00-00
Submitted: 2011-09-26
Entered: 2011-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F25578 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0777AA / 2 - / PO

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

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: Fever of 105.8 degrees F.


VAERS ID: 435845 (history)  
Age: 68.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:1
Entered: 2011-09-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH458AC / 0 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Blood pressure, Cough, Dysphonia, Dyspnoea, Oxygen saturation, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

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

Write-up: Cough, difficulty breathing, wheezing, & hoarseness began 3 hrs. after high dose Flu shot administered. Treated at hospital emergency room.


VAERS ID: 435851 (history)  
Age: 25.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:1
Entered: 2011-09-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 11034P / 0 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATROVENT inhaler
Current Illness: None
Preexisting Conditions: History of asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1:15 pm Seasonal flu vaccine recipient rec''d vaccine. 1:20pm C/o itching and redness at site (right deltoid) and upper back area. 1:20pm BENADRYL 50 mg IM given per MD order. 1:40 pm itching and redness subsided.


VAERS ID: 435965 (history)  
Age: 1.28  
Gender: Unknown  
Location: Unknown  
Vaccinated:2011-09-19
Onset:0000-00-00
Submitted: 2011-09-26
Entered: 2011-09-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / - UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201108893

Write-up: Initial report was received from a health care professional on 20 September 2011. A one-year-old patient (gender not reported) had received on 19 September 2011 FLUZONE (lot number, route and site of administration not reported) and PENTACEL (lot number, route, and site of administration not reported) and four to six hours later experienced febrile seizures. The patient was evaluated in the ER (emergency room) by the reporting physician. Treatments were not reported. No further information was available at the time of the report. The patient''s outcome was not reported. Documents held by sender: none.


VAERS ID: 435992 (history)  
Age: 57.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-19
Onset:2011-09-21
   Days after vaccination:2
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA691AA / - RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0630AA / 0 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: 2002 Lt axilla lymph nodes removed; Breast cancer lumpectomy (Lt) 1998
Diagnostic Lab Data:
CDC Split Type:

Write-up: Lt upper arm redness, swelling, pain, decreased mobility & warm to touch. Fever 102 degrees F. Treatment: AUGMENTIN.


VAERS ID: 436069 (history)  
Age: 79.0  
Gender: Male  
Location: Tennessee  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-28
   Days after onset:9
Entered: 2011-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH459AB / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Injection site pain
SMQs:, Guillain-Barre syndrome (broad), 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: See attached list.
Current Illness: COPD; HTN
Preexisting Conditions: codeine; sulfa; NEURONTIN; See attached list
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pain at injection site - no c/o chills, fever, pain other areas - but did have severe weakness - says got better after 2-3 days - never had flu shot to hurt like that ever.


VAERS ID: 436177 (history)  
Age: 0.76  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:2
Entered: 2011-09-29
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4119AA / 0 RL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1047AA / 2 LL / UN

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Ear infection
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? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had seizure & ER found pt with ear infection that evening.


VAERS ID: 436179 (history)  
Age: 65.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-19
Onset:2011-09-22
   Days after vaccination:3
Submitted: 2011-09-23
   Days after onset:1
Entered: 2011-09-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0615AA / - UN / SC

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

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: Heart disease
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient went to another pharmacy on 9-22-11 complaining of chills, redness at site of injection and swelling. Pt. went to primary care physician on 9-23-11 and got a script for some antibiotic because the physician said the site of injection was infected.


VAERS ID: 436185 (history)  
Age: 60.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:3
Entered: 2011-09-29
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED N55906 / - LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Blood test normal, Cardiac enzymes, Cardioversion, Dizziness, Electrocardiogram normal, Heart rate increased, Liver function test, Renal function test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Cardiac labs; EKG''s normal; liver & renal panel
CDC Split Type:

Write-up: Pt returned to flu shot clinic just 45 minutes after receiving vaccination with c/o feeling dizzy & feeling heart beat fast. Employee taken to ED for eval. Pt''s pulse - 226. Employee reports normal blood work & 3 EKG''s, but did receive cardioversion in ED. Not admitted. Employee returned to work next day.


VAERS ID: 436203 (history)  
Age: 74.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-24
   Days after onset:5
Entered: 2011-09-29
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / - UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Abdominal distension, Asthenia, Chills, Diarrhoea, Myalgia, Rhinorrhoea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (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: TUSSIN adult chest congestion syrup as needed at night; ICY HOT roll on as needed; melatonin 3 at PM to sleep; LORTAB 7.5 for pain as needed; ATIVAN 1 mg at night; ATARAX 2 at night 25 mg; CELEBREX 1- 200 mg in A.M.; loperamide 2 mg 2 as n
Current Illness: Gout; arthritis; scleroderma; pulmonary embolism
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chills - severe, vomiting, dirr, abdom. swelling, weakness, runny nose, muscle aches.


VAERS ID: 436292 (history)  
Age: 9.0  
Gender: Male  
Location: California  
Vaccinated:2011-09-19
Onset:2011-09-21
   Days after vaccination:2
Submitted: 2011-09-28
   Days after onset:7
Entered: 2011-09-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH464AA / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4104BA / - LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

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

Write-up: None stated.


VAERS ID: 436878 (history)  
Age: 44.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-10-05
   Days after onset:16
Entered: 2011-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 11093P / - RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Full blood count, Hypoaesthesia, Inflammation, Injection site pain, Muscular weakness, Oedema peripheral, Pain in extremity, Ultrasound Doppler
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), 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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: CBC and venous Doppler
CDC Split Type:

Write-up: Patient felt pain at the onset of injection. There is swelling, inflammation, numbness in the right arm along with pain and weakness. Patient was treated with ibu 600mg and awaiting blood work to start antibiotic levaquine 500mg. CBC and venous Doppler was ordered by his MD.


VAERS ID: 436984 (history)  
Age: 66.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2011-09-19
Onset:0000-00-00
Submitted: 2011-10-04
Entered: 2011-10-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blister, Erythema, Herpes zoster, Immediate post-injection reaction, Pain
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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201109378

Write-up: Initial report was received 27 September 2011 from a health care professional which involved a cluster of two patients who experienced events after receiving FLUZONE HIGH-DOSE. This case captures one patient. The other patient has been captured in case number 2011-09379. A 66-year-old male patient had received an injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 19 September 2011 and he developed "soreness right after". A few days later, blistering developed consisting of two clustered spots of vesicles on an erythematous base developed on the left deltoid; no fever, no chills. The patient was diagnosed with shingles and received VALTREX as corrective treatment. Outcome was not reported. Documents held by sender: None.


VAERS ID: 437019 (history)  
Age: 67.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2011-09-19
Onset:2011-09-22
   Days after vaccination:3
Submitted: 2011-09-22
   Days after onset:0
Entered: 2011-10-06
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100201 / 0 LA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1174Z / 0 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Dizziness, Eructation, Hiccups, Loss of consciousness, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (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: None
Preexisting Conditions: penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Evening after pt received vaccines, he woke up with arm pain, cough and burping/hiccups. Pt took aspirin and returned to bed without problems. The next day pt was at coffee shop felt dizzy and lost consciousness. He woke up surrounded by pan medicine. Pt saw his PCP the next day.


VAERS ID: 437070 (history)  
Age: 2.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2011-09-19
Onset:2011-09-20
   Days after vaccination:1
Submitted: 2011-10-06
   Days after onset:16
Entered: 2011-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4159BB / 2 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0190AA / 0 LL / SC

Administered by: Unknown       Purchased by: Public
Symptoms: Erythema, Local reaction, Local swelling, Skin warm
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: no
Preexisting Conditions: Prematurity
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Mother noted increased redness, swelling and area warm to touch; was advised to use cool compresses and monitor. Child was seen by physician 9/21/11; recommended po Benadryl and cool compresses.Was seen again on 09/29/11: slowly resolving local reaction; no further followup recommended.


VAERS ID: 438187 (history)  
Age: 65.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-09-19
   Days after onset:0
Entered: 2011-10-13
   Days after submission:24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH457AA / 0 LA / UN

Administered by: Public       Purchased by: Public
Symptoms: Injection site pain, Lacrimation increased, Ocular hyperaemia, Oropharyngeal pain, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Lacrimal disorders (narrow)

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: Patient had injection site pain, sore scratchy throat, red, watery eyes. Symptoms occurred 3-4 hrs post inj. Treated with BENADRYL & TYLENOL. Felt better by evening.


VAERS ID: 439895 (history)  
Age: 72.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-09-19
Onset:2011-09-20
   Days after vaccination:1
Submitted: 2011-10-25
   Days after onset:35
Entered: 2011-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / - - / IM

Administered by: Other       Purchased by: Other
Symptoms: Cough, Homeopathy, Injection site pain, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), 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: Synthroid 1 po Daily BP med-patient could not remember name
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 9/20- arm soreness at injection site 9/21- runny nose and cough self administered homeopathic treatment


VAERS ID: 440849 (history)  
Age: 36.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-10-31
   Days after onset:42
Entered: 2011-11-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA691AA / - RA / UN

Administered by: Other       Purchased by: Private
Symptoms: Pain
SMQs:

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

Write-up: 9/19/11 sharp shooting pain, feels like getting another shot in area.


VAERS ID: 441328 (history)  
Age: 65.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-19
Onset:2011-09-21
   Days after vaccination:2
Submitted: 2011-11-03
   Days after onset:43
Entered: 2011-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH459AB / - LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (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:
Other Medications:
Current Illness: No illness
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had soreness and pain on left shoulder for over a month, she went to the doctor and got pain medicine and compress.


VAERS ID: 441711 (history)  
Age: 3.0  
Gender: Female  
Location: Illinois  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-11-08
   Days after onset:50
Entered: 2011-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR E1032 / 2 RL / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Arthritis, C-reactive protein normal, Full blood count normal, Pyrexia, Rash, X-ray of pelvis and hip normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Arthritis (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:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Complete blood count; CRP and hip x-rays - normal
CDC Split Type:

Write-up: Arthritis - Developed hip and knee pain, fever and rash intermittently about 3 weeks after the initiation of the vaccine series. Seen by rheumatologist and treated with NSAIDS.


VAERS ID: 443085 (history)  
Age: 45.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-09-19
Onset:2011-10-19
   Days after vaccination:30
Submitted: 2011-11-19
   Days after onset:31
Entered: 2011-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / IJ

Administered by: Other       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

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: Shot hurt right away, worse by the minute never got better seen DR on 11/02/11 (2 weeks later) was put on Mobic for the first 5 days was getting better then by the last 3 days was coming back. Pain in shoulder struggle getting dressed & brushing hair. Getting another visit to Dr this next week. Lucky I ask for in my left arm. Shot was given high is shoulder have never had pain immediately after like this and then did not go away. I now can not lift my arm over my head to get dressed without severe pain. The only relief was with the Mobic and that was only the first 5-7 days.


VAERS ID: 444220 (history)  
Age: 46.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-19
Onset:2011-09-28
   Days after vaccination:9
Submitted: 2011-12-02
   Days after onset:65
Entered: 2011-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLU636BA / - LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Blood creatine phosphokinase increased, Electromyogram, Guillain-Barre syndrome, Hepatic enzyme increased, Laboratory test, Muscle atrophy, Muscle enzyme increased, Muscle spasms, Myalgia, Neuropathy peripheral, Nuclear magnetic resonance imaging, Sciatica, Spinal X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Eosinophilic pneumonia (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: Graves disease in July tx with radiation in August
Preexisting Conditions: Allergy PCC; sulfa; codeine
Diagnostic Lab Data: EMG r/o Guillain Barr to muscles; 40-50 lab test done; spinal x-ray & MRI; CPK elevated; liver enzymes elevated
CDC Split Type:

Write-up: Muscle breakdown, muscle enzymes elevated along with liver enzymes, muscle pain with muscle spasms & sciatica to legs. Peripheral neuropathy along with Guillain Barr to vision. Was on prednisone 2 weeks, no improvement. Tizanidine for pain/muscle relaxer.


VAERS ID: 445912 (history)  
Age: 71.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-11-21
   Days after onset:63
Entered: 2011-12-20
   Days after submission:29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100401 / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pruritus, Rash macular
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: SYNVISC; BENICAR; Fish oil; Vit D; Calcium; Prednisone; Eye vitamin
Current Illness: None
Preexisting Conditions: Penicillin; Benzocaine; BIAXIN
Diagnostic Lab Data: None
CDC Split Type:

Write-up: After 3 hours of receiving vaccine intense itching and redness (9/26) and blotchiness on upper arm & legs. Pt went to Urgent Care received Prednisone (5-day), ATARAX; saw Dermatologist (9/26) and received Prednisone (9-day), ATARAX, LIDEX cream; 2nd Dermatologist (10/7, 10/14, 10/21) continued ATARAX and LIDEX and other medications stopped except BENICAR - Symptoms have not improved over entire body.


VAERS ID: 446260 (history)  
Age: 0.51  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-12-08
   Days after onset:80
Entered: 2011-12-23
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B300 / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 916007 / 2 UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Diphenhydramine HCl
Current Illness: Unknown
Preexisting Conditions: The subject had no relevant medical history and no history of adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0946697A

Write-up: This case was reported by a physician and described the occurrence of fever in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (Pfizer) given on 19 September 2011. Concurrent medications included BENADRYL. On 19 September 2011 at 10:00 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left leg. On 19 September 2011 (14:00), 4 hours after vaccination with PEDIARIX, the subject experienced fever. On the morning of 20 September 2011, one day following vaccination with PEDIARIX the subject developed a rash. The physician considered the events were clinically significant (or requiring intervention). It was noted that the subject required multiple visits to the physician''s office. Fever resolved 3 days after onset on 21 September 2011 and rash resolved 3 days after onset on 22 September 2011. Attribution of the events to vaccination with PEDIARIX was not reported.


VAERS ID: 573344 (history)  
Age: 35.0  
Gender: Female  
Location: Illinois  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2015-04-09
   Days after onset:1298
Entered: 2015-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB986AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Broke out in hives from neck on down.


VAERS ID: 589454 (history)  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2015-08-04
   Days after onset:1415
Entered: 2015-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 1 UN / UN

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: WAES1507USA010449

Write-up: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 11-APR-2011, the patient was vaccinated with a dose of VAQTA (lot#, dose and route were not reported) by an unspecified physician. Then another dose of VAQTA was administered on 19-SEP-2011 by an unspecified physician (Inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.


VAERS ID: 605808 (history)  
Age: 61.0  
Gender: Male  
Location: D.C.  
Vaccinated:2011-09-19
Onset:2011-09-20
   Days after vaccination:1
Submitted: 2015-10-29
   Days after onset:1500
Entered: 2015-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad), 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: No major illness
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme shoulder pain and lack of ability to rotate shoulder. Flu shot was given very high up on the arm near shoulder. Physical therapy and cortisone shots to no avail. Told tear in rotator. Considered surgery and set a date for it, but needed to cancel. 11 months after pain began, I woke up one day and it was gone. The reason I am writing this now, is that no one believed that the flu shot caused my problems. I read a story this week in the newspaper which mirrored all my problems. So I am reporting this because I do not want to see people suffer because shots are being administered improperly.


VAERS ID: 437696 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-10-11
   Days after onset:22
Entered: 2011-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA087AC / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyskinesia, Loss of consciousness, Musculoskeletal stiffness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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: No jerking with stiffness previously observed by parent.
Diagnostic Lab Data: UNK
CDC Split Type: B0752162A

Write-up: This case was reported by the regulatory authority (GB-MHRA-ADR 21272696) and described the occurrence of loss of consciousness in a 13-year-old female subject who was vaccinated with CERVARIX. No previous history of jerking with stiffness. On 19 September 2011 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 19 September 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced loss of consciousness, stiffness of limb and jerky movements. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 19 September 2011, the events were resolved. Loss of consciousness, stiffness of upper limbs, jerking movements. Medically significant: child prone to fainting in stressful situations but no jerking with stiffness previously observed by parent.


VAERS ID: 438741 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-10-17
   Days after onset:28
Entered: 2011-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA083DA / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure increased, Dizziness, Malaise, Paraesthesia, Peripheral coldness, Rash, Rash macular, Tachycardia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Vestibular disorders (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:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Allergy to feathers; Cat allergy
Diagnostic Lab Data: UNK
CDC Split Type: B0753236A

Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-ADR 21277619) and described the occurrence of feeling unwell in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included allergy to feathers and cat allergy. On 19 September 2011 the subject received an unspecified dose of CERVARIX (intramuscular). Approximately 10 minutes after vaccination with CERVARIX, the subject experienced feeling unwell, dizziness, blotchy rash on neck, tingling around neck and face, tachycardia, increased blood pressure and peripheral coldness in hands and legs. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were was unspecified. Verbatim Text: 10 minutes after vaccination patient felt unwell ? dizzy ? blotchy rash on neck ? tingling around neck and face. Hands and legs cold ? tachycardia ? elevated blood pressure.


VAERS ID: 439930 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2011-10-25
   Days after onset:36
Entered: 2011-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA079DB / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Epilepsy
Diagnostic Lab Data: UNK
CDC Split Type: B0755770A

Write-up: This case was reported by a regulatory authority (# GB-MHRA-ADR 21290853) and described the occurrence of arm swollen in a 12-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included epilepsy. On 19 September 2011 the subject received unspecified dose of CERVARIX (intramuscular). On 19 September 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced arm swollen, feeling sick and high temperature. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. Verbatim Text: Very swollen arm. Also felt sick, had high temperature and swollen arm for twenty four hours.


VAERS ID: 444626 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2011-09-21
   Days after vaccination:2
Submitted: 2011-12-05
   Days after onset:75
Entered: 2011-12-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NM26350 / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Headache, Mass, 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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1111USA03610

Write-up: This case was received from the Health Authority on 23-NOV-2011 ref 2011-008001. This case was medically confirmed. A 17 year old female patient, with no medical history of concomitant medications, received an injection of GARDASIL (Lot # NM26350) IM on 19-SEP-2011. On 21-SEP-2011, two days post vaccination, the patient experienced a headache and lumps on limbs and a rash around her mouth. The patient was treated with antihistamines only. The duration of the events was one week and the patient recovered on an unreported date. The events were considered medically important as they required intervention. Headache, lumps on limbs and a rash around her mouth were considered to be other medical events by the Health Authority. Other business partner numbers include: E2011-07417. No further information is available.


VAERS ID: 447776 (history)  
Age: 29.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2011-09-21
   Days after vaccination:2
Submitted: 2012-01-20
   Days after onset:121
Entered: 2012-01-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0121AA / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Endotracheal intubation, Epilepsy, Intensive care
SMQs:, Angioedema (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EPILIM; TEGRETOL
Current Illness: Epilepsy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1201USA02378

Write-up: Case received from the Health authority 11-JAN-2012 under the reference number GB-MHRA-ADR-21433843. Case medically confirmed. A 29 year old female patient received an injection of MMR II (batch number NP34150, Lot # 667967/0121AA), 1ml (to be checked with HA), IM, on 19-SEP-2011. On 21-SEP-2011, two days post vaccination, the patient was admitted to the Intensive Treatment Unit with epileptic seizures. The patient was known to have epilepsy but had been seizure-free for the previous 18 months on medication. The patient was taking concomitant EPILIM, 500mg and TEGRETOL 500mg for epilepsy. The patient needed intubation and was discharged from hospital seven days later. At the time of reporting the patient was recovering. The event was considered serious due to hospitalisation and life-threatening. Other business partner numbers include E2012-00212. A lot check has been initiated. Additional information has been requested.


VAERS ID: 453054 (history)  
Age: 0.19  
Gender: Male  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2012-04-02
   Days after onset:196
Entered: 2012-04-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / - UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Diarrhoea, Rash macular, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012079059

Write-up: This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number DE-PEI-PEI2012009186. A 2 month-old male patient of an unspecified ethnicity received PREVENAR, intramuscular on 19Sep2011, ROTATEQ, via an unspecified route of administration on 19Sep2011, INFANRIX HEXA, intramuscular on 19Sep2011. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 19Sep2011, few hours after vaccination, the patient presented with pronounced small spotted-maculated exanthema on whole body, vomiting, abdominal pain, and mushy stool. The patient was hospitalized and treated with Glucose-Elektrolytinfusion. Therapeutic measures were taken as a result of the events, pronounced small spotted-maculated exanthema on whole body, vomiting, abdominal pain, and mushy stool, and included treatment with Glucose-Elektrolytinfusion. The patient was discharged on 20Sep2011. The clinical outcome of the events, pronounced small spotted-maculated exanthema on whole body, vomiting, abdominal pain, and mushy stool, was recovered on an unknown date.


VAERS ID: 456381 (history)  
Age: 0.55  
Gender: Male  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2012-04-01
   Days after vaccination:195
Submitted: 2012-05-29
   Days after onset:58
Entered: 2012-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Rotavirus infection, Rotavirus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Rotavirus test positive, Apr2012, positive
CDC Split Type: D0075746A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of Rotavirus infection in a 13-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s twin brother also experienced Rotavirus infection post complete vaccination with two doses of ROTARIX at the same time. For further information please see case D0075733A. On 14 June 2011 the subject received the first dose of ROTARIX (oral). On 19 September 2011 the subject received the second dose of ROTARIX (oral). Approximately nine months post vaccination with the first dose of ROTARIX and approximately six months post vaccination with the second dose of ROTARIX, on an unknown date in April 2012, the subject experienced Rotavirus infection (vaccination failure). This case was assessed as medically serious by GSK criteria. Rotavirus infection was confirmed by Rotavirus test positive. At the time of reporting the outcome of the event was unspecified. Follow-up information has been requested.


VAERS ID: 456385 (history)  
Age: 0.55  
Gender: Male  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2012-04-01
   Days after vaccination:195
Submitted: 2012-05-29
   Days after onset:58
Entered: 2012-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Rotavirus infection, Rotavirus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Rotavirus test positive, Apr2012, positive
CDC Split Type: D0075733A

Write-up: This case as reported by a physician via a sales representative and described the occurrence of Rotavirus infection in a 13-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s twin brother also experienced Rotavirus infection post complete vaccination with two doses of ROTARIX at the same time. For further information please see case D0075746A. On 14 June 2011 the subject received the first dose of ROTARIX (oral). On 19 September 2011 the subject received the second dose of ROTARIX (oral). Approximately nine months post vaccination with the first dose of ROTARIX and approximately six months post vaccination with the second dose of ROTARIX, on an unknown date in April 2012, the subject experienced Rotavirus infection (vaccination failure). The subject was hospitalised for four days from 16 April 2012 to 19 April 2012. Rotavirus infection was confirmed by Rotavirus test positive. At the time of reporting the outcome of the event was unspecified. Follow-up information has been requested.


VAERS ID: 458979 (history)  
Age: 0.34  
Gender: Male  
Location: Foreign  
Vaccinated:2011-09-19
Onset:0000-00-00
Submitted: 2012-07-10
Entered: 2012-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / PO
PPV: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / PO

Administered by: Other       Purchased by: Other
Symptoms: Hypotonic-hyporesponsive episode
SMQs:, Hypotonic-hyporesponsive episode (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0812440A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of hypotonic-hyporesponsive episode in a 4-month-old male subject who was vaccinated with SYNFLORIX (GlaxoSmithKline) and ROTARIX. On 19 September 2011 the subject received unspecified dose of SYNFLORIX (unknown route of administration and batch number). On the same day, the subject also received ROTARIX (GlaxoSmithKline, oral), DTaP-Hib (non-GSK) and OPV (non-GSK). Those 3 vaccines were reported as concomitant vaccines. At an unspecified time after vaccination with SYNFLORIX, the subject experienced hypotonic-hyporesonsive episode. The subject was hospitalised (no information about the period of hospitalisation was provided) and the healthcare professional considered the event was disabling. At the time of reporting the event was resolved with unspecified sequelae. This report is one of cases received as part of a line-listing, each one containing minimal information. No further information can be obtained; therefore this case has been closed. Follow-up information received later on: ROTARIX was also considered as suspect vaccine.


VAERS ID: 459010 (history)  
Age: 0.34  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:0000-00-00
Submitted: 2012-07-10
Entered: 2012-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
PPV: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA080BA / - UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA291BA / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0812622A

Write-up: This case was reported by a healthcare professional (National Immunization Program) via another manufacturer (Fiocruz) and described the occurrence of febrile seizure in a 4-month-old female subject who was vaccinated with SYNFLORIX (GlaxoSmithKline), ROTARIX. Concurrent vaccination included DTPA-HIB (non-GSK manufacturer) given on 19 September 2011; ROTARIX (manufacturer unspecified;oral) given on 19 September 2011. On 19 September 2011 the subjects received unspecified dose of SYNFLORIX (unknown route). At an unspecified time after vaccination with SYNFLORIX, the subject experienced febrile seizure. The subject was hospitalised. At the time of reporting the event was resolved. Follow up information received on 26 June 2012: ROTARIX liquid formulation was also considered as suspect. This report is one of cases received as part of a line-listing, each one containing minimal information. No further information can be obtained; this case has therefore been closed.


VAERS ID: 460944 (history)  
Age: 11.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-09-19
Onset:0000-00-00
Submitted: 2012-08-02
Entered: 2012-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Borrelia test negative, Chest X-ray normal, Chest pain, Condition aggravated, Electrocardiogram normal, Epstein-Barr virus test negative, Mobility decreased, Musculoskeletal chest pain, Mycoplasma test, Viral test negative
SMQs:, Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Pulmonary X-ray was normal. ECG showed no signs of cardiac explanation to the pain. Laboratory status, Borrelia, TBE (Tick-borne encephalitis), mycoplasma and EBV which showed normal values (dates not reported).
CDC Split Type: WAES1208SWE000730

Write-up: Case received from a Health Care Professional via the Health Authorities in a foreign country on 25-Jul-2012 under the reference number 122719. Case medically confirmed. An 11-year-old male patient received an injection of MMRVAXPRO (batch number not reported) on 19-Sep-2011 and approximately two weeks post vaccination, the patient experienced worsened chest pain. The pain was described as a square down to the arch and was superficial. He had difficulties to get up from the bed because of the chest pain. Due to increased pain, the patient was admitted to the hospital. Investigations carried out: Pulmonary X-ray was normal. ECG showed no signs of cardiac explanation to the pain. Laboratory status, Borrelia, TBE (Tick-borne encephalitis), mycoplasma and EBV which showed normal values (dates not reported). Interpretation of the pain was musculoskeletal and was treated with CITODON, NAPROXEN and even NSAID gel. The patient was previously essentially healthy without any known allergy. He was vaccinated against flu (PANDEMRIX). In September 2010, onset of headache which is described as a continuous pressing "as a cap", even vomiting a few times and dizziness of rotational character. No fever or other symptoms of infection. Even light sensitivity. Treated with ibuprofen and paracetamol without effect. Neurological status showed nothing abnormal, no neck stiffness and no rash. Examination of lab status (blood, differential, CRP, ESR, Glucose, ALAT, electrolytes, creatinine, albumin) showed no abnormalities. Examination by ENT and ophthalmologist could not give any explanation to the headache either. Borrelia tests, lumbar puncture and CT brain, later also MRI angiography did not show anything which could explain the headache. Treated with CITODON. More than a month later slowly progress but later deterioration with pronounced light sensitivity. The headache was judged as tension headache with migraine elements, eventual even psychosomatic elements. In mid-December 2010 there was a pronounced improvement, no residual effects of headaches. Approximately in March 2011, the patient experienced extreme fatigue. He fell asleep in the middle of activities and had also chest pain. The Health Authority coded fatigue and headache as well as chest pain. The company regarded fatigue and headache as medical history as these symptoms began prior to the vaccination with MMRVAXPRO. Contradicting information in the HA report: the outcome was reported as unknown as well as recovered. Stated in the narrative: At spring 2012, the patient felt good except of periods of unexplained fatigue which lasted a half to one day. He was then so tired that he had difficult to wake up. The health authority assessment: No evidence for narcolepsy in this case. However, fatigue is assessed as possibly related, despite his debut over a year after vaccination with PANDEMRIX, since we would have judged so if the diagnosis narcolepsy had been verified then. The headache is not assessable on the basis of much time between vaccination with PANDEMRIX and the onset of symptoms. Time correlation between chest pain and vaccination with MMRVAXPRO therefore possibly related.


VAERS ID: 468560 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:0000-00-00
Submitted: 2012-10-09
Entered: 2012-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Foetal exposure during pregnancy, Jaundice neonatal, Phototherapy
SMQs:, Congenital, familial, neonatal and genetic disorders of the liver (broad), Congenital biliary disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (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: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210GBR004030

Write-up: This case was reported by the agency on 04/Oct/2012, agency Ref: 524. This case is linked to mother report E2011-08424. This case is medically confirmed. A female patient of unreported age who was a neonate received MMRVAXPRO, batch NN09260, transplacentally on 19/Sep/2011. On an unreported date the patient experienced neonatal jaundice which required single phototherapy for 58 hours. The patient outcome was not reported. The patient''s mother''s medical history included one previous pregnancy to full term, the baby experienced a birth defect of kernicterus in the neonatal period, cerebral palsy, glucose 6 phosphate dehydrogenase deficiency and hyperbilirubinaemia. The patient''s mother had not experienced any miscarriages. The patient''s mother experienced a complication of anaemia secondary to beta thalassemia. The patient''s mother did not experience a pregnancy complication, labour complication, pregnancy illness or medical condition. The patient''s mother underwent only routine diagnostic tests. The patient was born on an unreported date weighing 3.8kg at 40 weeks gestation with no abnormalities, cutaneous skin scarring, limb hypoplasia, eye abnormalities, neurological deficits, cardiac abnormalities, microcephaly or intrauterine growth retardation.


VAERS ID: 494159 (history)  
Age: 64.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2013-05-01
   Days after vaccination:590
Submitted: 2013-06-13
   Days after onset:43
Entered: 2013-06-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR G0563 / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Typhoid fever
SMQs:

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: The patient had a medical history of high cholesterol and hypertension.
Diagnostic Lab Data:
CDC Split Type: E201304312

Write-up: This case was received from a health care professional in the foreign via another company on 31-May-2013. The TYPHIM batch was identified as at-risk of an antigen content below specifications. Batch recall in Sept 2012. This case is medically confirmed. A 66 year old female patient received dose one of TYPHIM VI (batch number G0563, expiry 09-2013), IM, site not reported, on 19-Sep-2011. In May 2013, 20 months post vaccination, the patient experienced typhoid. The patient had a medical history of high cholesterol and hypertension. The patient was taking concomitant unspecified statins, high blood pressure medication and eye drops. The patient saw the GP on 29-May-2013. The patient recovered on an unreported date. Upon internal review the event was considered to be medically significant.


VAERS ID: 495154 (history)  
Age: 0.23  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:2011-09-19
   Days after vaccination:0
Submitted: 2013-06-25
   Days after onset:645
Entered: 2013-06-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB143A / 0 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F36225 / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adverse drug reaction, Crying, Decreased eye contact, Dyskinesia, Dystonia, Electroencephalogram abnormal, Encephalopathy, Gaze palsy, Hypertension, Hypochloraemia, Hypotonia, Infantile spasms, Metabolic alkalosis, Muscle spasms, Weight increased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Hypertension (narrow), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: EEG (unknown date): compatible with epileptogenic encephalopathy
CDC Split Type: 2013185883

Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 208100. A hospital physician (contactable through Regulatory Authority only) referred that a 12-week-old female patient received first dose of PREVENAR 13 (Lot # F36225) intramuscular on 19Sep2011 at 09:00 and first dose of INFANRIX HEXA (Lot # A21CB143A) intramuscular on 19Sep2011 at 09:00. The patient medical history was not reported. Concomitantly she received a food supplement (DIKOVIT DK) and unspecified milk enzymes. The patient experienced inconsolable crying on 19Sep2011 and gradual psychomotorial involution followed by crisis with spasms in flexion on 20Sep2011. The patient was visited at the emergency room where appeared in good general condition, afebrile, normotensive, hypotonic, continue aimless movements at the level of limbs and trunk, inability to connect with and to follow with eyes, did not bring hands in the midline, did not grasp objects. Objectivity cardio-thoracic-abdominal unscathed. EEG was performed which was found to be compatible with epileptogenic encephalopathy during which the patient showed brief episode of generalized hypertonia and revulsion of the eyeballs, (such episode occurred even earlier, mainly on awakening and only after immunization). The child was then hospitalized. In the light of the initial EEG, apparently compatible with West syndrome was undertaken treatment with synacthen depot, gradually decreased to the light of the initial improvement of the EEG. During this treatment had reported symptoms attributed to probable side effects related to the drug regimen used (such as hypertension, metabolic alkalosis, hypochloremia, and weight gain). At the suspension of the drug the clinical and laboratory returned within normal limits. On 14Nov2011 due to the persistence of the crisis oral therapy with DEPAKOTE was started progressively increased up to 100mg twice daily. The patient returned home on 03Dec2011l, with reduction of chaotic dystonic movements, the patient brought hands on the midline and limb traction appeared to be more symmetrical. The diagnosis of West Syndrome was stated on 08Nov2011. The outcome of the events was reported as unknown.


VAERS ID: 629623 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-19
Onset:0000-00-00
Submitted: 2016-02-19
Entered: 2016-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Cognitive disorder, Fatigue, Headache, Pyrexia, Skin striae
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1602IRL009236

Write-up: Information has been received from Sanofi Pasteur (MSD) (SPM) (MFR control number IE-1577272925-2016001389) on 18-FEB-2016. This case was received from the health authority on 16-FEB-2016 under reference number IE-HPRA-2016-025878. Initial report was received by the RA on 01-FEB-2016 from a member of the public (patient''s mother and also a HCP) which concerns a 13 year old female patient who experienced Fatigue, Arthralgia, Skin striae, Abdominal pain, Pyrexia, Headache and Cognitive disorder following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: Nil. The patient was vaccinated with 3 doses of GARDASIL via IM route, including one dose received on 19-SEP-2011 (only one vaccination date provided). Approximately 4 weeks post vaccination, the patient experienced chronic fatigue, joint pains, stretch marks, severe headaches, reduced cognition, abdominal pain and pyrexia. The reporter indicated that the patient has had multiple hospital admissions and multiple GP and consultant visits. At the time of reporting the patient''s symptoms were persisting. The patient outcome was reported as not recovered/not resolved.


VAERS ID: 435009 (history)  
Age: 72.0  
Gender: Female  
Location: Vermont  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:0
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR 49281038965 / - LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Buttock crushing, Dizziness, Fall, Head injury
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Forteo, Ambien
Current Illness: no
Preexisting Conditions: osteoporosis, irregular heartbeat
Diagnostic Lab Data:
CDC Split Type:

Write-up: After check-out I was looking over the sales slip and re-arranging items in cart. I took one step backwards and tripped over the "barrier" cone in front of the customer service desk. I fell over backwards, landing on right buttocks and head. It''s possible that I fell as result of dizziness from the vaccine shot, but more likely that I was simply not watching my step. I''m in good physical shape and in fact just before the vaccine I participated in an aerobics class. Alerted doctor''s office and advised to use ice on buttock injury.


VAERS ID: 435021 (history)  
Age: 29.0  
Gender: Male  
Location: Montana  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:0
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 444011A / - RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: NA
Preexisting Conditions: NA
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: After receiving immunization, donor had LOC for 60 sec.


VAERS ID: 435035 (history)  
Age: 74.0  
Gender: Male  
Location: Colorado  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:0
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100401 / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0614AA / - RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Renal pain
SMQs:

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

Write-up: Gave pt PNEUMOVAX & FLUVIRIN in opposite arms. Within 5 min. pt was complaining of kidney pain. He walked around about 5 more min., & said it passed & he had no pain anymore.


VAERS ID: 435040 (history)  
Age: 67.0  
Gender: Male  
Location: Arizona  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:0
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH477AD / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Angioedema, Dysphonia, Laryngitis, Lip oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: metoprolol
Current Illness:
Preexisting Conditions: NKDA; No prior food/environmental allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Angioedema lips, hoarseness/laryngitis. Epi - 0.3mg IM (R) deltoid 5.12 PM.


VAERS ID: 435041 (history)  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:0000-00-00
Submitted: 2011-09-20
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA664BA / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age
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:
CDC Split Type:

Write-up: FLULAVAL 0.5ml given IM to 17 y/o. Vaccine is approved for 18 years and above only. No data on children''s group.


VAERS ID: 435042 (history)  
Age: 56.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:0
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0730AA / 0 RA / SC

Administered by: Other       Purchased by: Private
Symptoms: Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tizanidine; Lorazepam
Current Illness: None
Preexisting Conditions: Allergies to BACTRIM, FLEXERIL, NSAIDS
Diagnostic Lab Data:
CDC Split Type:

Write-up: ZOSTAVAX administered at 4:30 PM. Pt went home and called to report throat closure at 5:45 PM. No NEOMYCIN allergies. Advised pt to call 911.


VAERS ID: 435071 (history)  
Age: 1.12  
Gender: Female  
Location: Missouri  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:0
Entered: 2011-09-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB481AB / - LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1642Z / - RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. E008907 / - LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site reaction
SMQs:

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: Developed 2mm x 6mm white raised area above injection site 10 min after injection (Lt outer arm).


VAERS ID: 435073 (history)  
Age: 68.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH468AB / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dyspnoea, Malaise, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), 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: Allergy~Tetanus Toxoid, adsorbed (no brand name)~UN~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 4 hours after shot pt stated he had shortness of breath, tongue swelling and general malaise that he contacted his doctor about.


VAERS ID: 435100 (history)  
Age: 38.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH476AA / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Dizziness, Electrocardiogram, Inflammation
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: I currently take Omnaris, Astelin, Pataday (eye drops), and birth control pills.
Current Illness: No
Preexisting Conditions: Seasonal Allergies, Vasomotor Rhinitis
Diagnostic Lab Data: The ER did an EKG, chest X-Ray, and blood work. I was released with the doctor stating I had inflammation in my chest, a condition he wrote down as Costochondritis. However, I did not have any of the chest pains or inflammation prior to having the injection.
CDC Split Type:

Write-up: About 15 minutes after the injection I began to feel some tightness and pain in my chest. About 30 minutes to an hour after the injection I started having really bad chest pains in the center to right portions of my chest, especially when taking a deep breath, which the tightness was making me feel like I needed to take in a some deeper breaths. About 2 hours after the injection I went to the ER because the pain in my chest was becoming more severe, and when I stood up from my desk I began to feel light headed.


VAERS ID: 435112 (history)  
Age: 19.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0306AA / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Admin injection to LA IM at 10:30am; at 10:55am LA: noted 3cm hard swollen area at injection site. No signs/symptoms noted of any resp distress. Scheduled with Dr. for further evaluation and final disposition.


VAERS ID: 435125 (history)  
Age: 68.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100201 / 1 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1150Z / 0 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injected limb mobility decreased, Pain in extremity
SMQs:, Tendinopathies and ligament 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: arthritis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 2 hr after shot, pt developed strong pain in (R) arm she called pharmacy & we advised that is normal side effect & told her to try TYLENOL or ibuprofen. The following morning we spoke again & she described pain as "extreme" and stated she could barely lift her arm. She was advised to contact MD.


VAERS ID: 435156 (history)  
Age: 46.0  
Gender: Male  
Location: Arizona  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-21
   Days after onset:0
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Public       Purchased by: Private
Symptoms: Abdominal pain, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: diabetes, hypertension, membranous nephropathy, seizure disorder, hairy cell leukemia in remission, hyperlipidemia, coronary artery disease
Diagnostic Lab Data:
CDC Split Type:

Write-up: extreme nausea, intractable vomiting, abdominal pain


VAERS ID: 435164 (history)  
Age: 55.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / - - / SC

Administered by: Public       Purchased by: Other
Symptoms: Dizziness, Eructation, Injection site erythema, Injection site haematoma, Injection site pruritus, Injection site swelling, Nausea, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (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: Fluzone(seasonal+H1N1combination) vaccine given subcutanously
Current Illness: no
Preexisting Conditions: Seasonal allergies (hayfever), HTN, hypothyroidism.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Initally itching, redness+swelling @ site. (Icepack applied to injection site with hematoma) Followed by feeling dizzy, faint, lightheaded. BPS 186. Took Benadryl 25 mg. Approx 15 min later increase in feeling dizzy, faint, and also nausea with belching+general body tremors.


VAERS ID: 435165 (history)  
Age: 54.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cough, Pharyngeal oedema, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: none
Preexisting Conditions: allergic to Penicillin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: coughing, swollen throat, vomiting


VAERS ID: 435166 (history)  
Age: 1.01  
Gender: Male  
Location: Guam  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4114AA / 0 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB472BA / 0 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH218AA / 3 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0398AA / 0 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1699Z / 0 RL / SC

Administered by: Military       Purchased by: Military
Symptoms: Cyanosis, Febrile convulsion, Resuscitation
SMQs:, Anaphylactic reaction (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)

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

Write-up: Pt turned blue, CPR ADMINISTERED, transported by ambulance. DIAGNOSED AS FEBRILE SEIZURE


VAERS ID: 435182 (history)  
Age: 65.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100201 / 1 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1150Z / 0 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injected limb mobility decreased, Pain in extremity
SMQs:, Tendinopathies and ligament 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: Arthritis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 2 hr after shot, pt developed strong pain in (R) arm she called pharmacy & we advised that is normal side effect & told her to try TYLENOL or ibuprofen. The following morning we spoke again & she described pain as "extreme" and stated she could barely lift her arm. She was advised to contact MD.


VAERS ID: 435184 (history)  
Age: 68.0  
Gender: Male  
Location: Georgia  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:0
Entered: 2011-09-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature, Diarrhoea, Dyspnoea, Headache, Nausea, Pain, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOCOR - 40 mg; PLAVIX 75 mg
Current Illness: None
Preexisting Conditions: Multiple myeloma 1-2011/remission
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache - achy - N & V - Temp 99.5. Diarrhea - SOB - (1st symptom SOB) N & V x 2 episodes. Diarrhea x 5-6 episodes.


VAERS ID: 435186 (history)  
Age: 28.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA6039A / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Rash macular, Rash pruritic
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amitriptyline
Current Illness: None
Preexisting Conditions: Allergy to tramadol
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pr developed SOB and pruritic macular rash appx 10 hrs after flu vaccine. Symptoms responded to BENADRYL.


VAERS ID: 435187 (history)  
Age: 26.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLAG65AA / 1 LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Muscle tightness
SMQs:, Dystonia (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:
CDC Split Type:

Write-up: Patient noticed muscle tightness in neck and shoulders several hours after receiving vaccination. Was told to take acetaminophen for relief.


VAERS ID: 435191 (history)  
Age: 6.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-21
   Days after onset:0
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AD / 1 LA / UN

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

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: Swelling to area where Influenza vaccine was administered.


VAERS ID: 435200 (history)  
Age: 49.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH460AA / 2 UN / JET

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Unknown
Current Illness: None known
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was given the FLUZONE 11-12 vaccine IM via the pharmajet needles system. Patient developed a baseball size "welt" on the area she was given the shot. The welt was red, swollen and warm to the touch. Watching the patient for possible cellulitis.


VAERS ID: 435201 (history)  
Age: 26.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT450AA / - LA / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Injection site erythema, Tenderness
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: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Slightly raised 3cm wide red circle at injection site. Approx. 12hrs after vacc. (patient was sleeping so may have been sooner). Tender to touch. Vacc. time Tues about 5:30pm 9/20/11. Noted on waking Wed 9/21/11 7am.


VAERS ID: 435224 (history)  
Age: 4.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B196BA / 0 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0487AA / 2 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0405AA / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916599 / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0410AA / 1 RL / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site mass
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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 inch knot in area Varicella vaccine was given with some redness


VAERS ID: 435249 (history)  
Age: 27.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / - RA / IM

Administered by: Military       Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: SWOLLEN RED WELTS AT INJECTION SITE VERY PAINFUL AND HARD TO TOUCH, CANT MOVE ARM


VAERS ID: 435295 (history)  
Age: 45.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH477AB / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest X-ray, Cough, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

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

Write-up: Shortness of breath, wheezing, cough. Treated in the Emergency Room.


VAERS ID: 435300 (history)  
Age: 20.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3111BA / - LA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Asthenia, Computerised tomogram normal, Dehydration, Head discomfort, Headache, Posture abnormal, Somnolence
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: NONE
Preexisting Conditions: PKU
Diagnostic Lab Data: CT scan was negative according to patient no results were sent to our office for follow up. Patient reports she was told her "brain shrank" and that was cause of pain. She was also told she was dehydrated and IV fluids were administered.
CDC Split Type:

Write-up: Patient begun complaining of feeling like head was heavy and she was weak. She complained of feeling a "vice like" pressure to occipital region of skull 7/10 on pain scale that worsened over a 10 minute period. Patient then became increasingly drowsy and felt she couldn''t keep head upright. She was sent to ER for evaluation.


VAERS ID: 435301 (history)  
Age: 65.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH457AA / - LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Chills, Headache, Night sweats
SMQs:

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

Write-up: C/O headache and extreme night sweats, that required a change of bedding and chills. Began evening of vacination, much better the next day.


VAERS ID: 435304 (history)  
Age: 73.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0619AA / 0 LA / -

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Pain, Pruritus, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Red swelling about 4 inches in diameter. Patient complained of soreness and itching. Advised to use lanocane.


VAERS ID: 435308 (history)  
Age: 5.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / - - / IN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / - - / SC

Administered by: Private       Purchased by: Public
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)

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

Write-up: rash to injection site


VAERS ID: 435317 (history)  
Age: 2.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / 3 LL / IM

Administered by: Public       Purchased by: Other
Symptoms: Gait disturbance, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: leg swelling~Influenza (Seasonal) (Fluzone)~2~1.25~Patient
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Large degree of swelling of left thigh at site of injection accompanied by pain, limp and fever. Swelling measured ~ 7 x 12 cm 48 hours after vaccine administration, not warm or tender at that time, no fluctuance.


VAERS ID: 435325 (history)  
Age: 59.0  
Gender: Female  
Location: New Mexico  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100121 / - LA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0614AA / - RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Urticaria, Vaccination site pain
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt presented with red welts that were itchy. Not at injection site (underarm). Complained that vaccine hurt much more then normal 2 days later.


VAERS ID: 435326 (history)  
Age: 1.79  
Gender: Male  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3841AA / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH184BB / 0 RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB517CA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916006 / 0 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Body temperature increased, Febrile convulsion, Grand mal convulsion
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: Multiple ER visits.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt vaccinated 9/20. The next day he was eating at church & had a seizure. TC generalized approximately <5 min. Upon arrival to ER temperature was 104 degrees F. Dx: febrile seizure. Sun. at hospital.


VAERS ID: 435387 (history)  
Age: 0.21  
Gender: Female  
Location: Washington  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3896AB / 0 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB977BA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E89952 / 0 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0256AA / 0 - / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Body temperature increased, Decreased appetite, Hypotonia, Lethargy
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), 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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Limp, lethargy, T 103 degrees, decreased appetite -called aid car - referred to PCP. Lasted 45 min. Occurred 6-7 hr after shots. Exam normal in office.


VAERS ID: 435455 (history)  
Age: 12.0  
Gender: Female  
Location: Illinois  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0786Z / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Computerised tomogram head, Full blood count, Metabolic function test, Urine analysis, VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: None
Diagnostic Lab Data: U/A; BMP; CBC; CT head
CDC Split Type:

Write-up: One day after first GARDASIL patient developed Bell''s Palsy.


VAERS ID: 435469 (history)  
Age: 77.0  
Gender: Male  
Location: Tennessee  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100201 / - LA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1174Z / - RA / UN

Administered by: Other       Purchased by: Unknown
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? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes; HTN
Diagnostic Lab Data:
CDC Split Type:

Write-up: Significant redness, swelling and soreness size of softball but flat right arm.


VAERS ID: 435604 (history)  
Age: 1.26  
Gender: Male  
Location: Tennessee  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B107AA / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4119AA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1443Z / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916971 / 3 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Laboratory test normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: See attached
CDC Split Type:

Write-up: Received immunizations listed below at routine well check. Presented to ED with fever/seizure activity approximately 10 hours after vaccination. Initial w/u negative, d/c''d home. Returned 12 hours later with 2-3 more episodes of seizure activity.


VAERS ID: 435329 (history)  
Age: 36.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-21
   Days after onset:0
Entered: 2011-09-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH464AA / 0 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Pyrexia, Skin warm
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? 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: Redness at shot area. Warm to touch. Low grade fever.


VAERS ID: 435336 (history)  
Age: 16.0  
Gender: Male  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4104AA / - AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Injection site rash
SMQs:, Angioedema (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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: After given patient ADACEL, pt started to have allergic reaction (rash localize where inject medication). Pt seem alright in term of breathing and alert. Advise Mom to give patient ice-pack around rash area.


VAERS ID: 435350 (history)  
Age: 62.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:2
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1066Z / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
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: Unknown
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Awoke with tender, red, swollen left arm at area where injcetion was given. Limited range of motion.


VAERS ID: 435366 (history)  
Age: 71.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-23
   Days after onset:3
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0744AA / 0 LA / -

Administered by: Unknown       Purchased by: Private
Symptoms: Erythema, Skin warm
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:
Current Illness: NONE
Preexisting Conditions: DEMEROL, TYLENOL
Diagnostic Lab Data: nONE
CDC Split Type:

Write-up: 11CMX12CM AREA OF ERYTHEMA, WARMTH OVER THE LATERAL ASPECT OF THE LEFT ARM THIS REACTION STARTED WITH IN 24 HOURS OF THE VACCINE.


VAERS ID: 435402 (history)  
Age: 13.0  
Gender: Female  
Location: Wyoming  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:2
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0627AA / 0 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0692AA / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 114004AA / 0 LA / IM

Administered by: Public       Purchased by: Private
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccinated 9-20-11. Reports that on 9-21-11 fever of 104.1. Continued for 3 days. No other symptoms.


VAERS ID: 435412 (history)  
Age: 11.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 2011-09-23
   Days after onset:1
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501103P / 0 - / IN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB481AB / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3518AA / 0 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0675AA / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Inflammation, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pruritus, redness, elevation on back of (L) arm on 9/23/11. By reference of mother the inflammation have diminished. Area hard to touch: diameter 1/2 inch, no redness. On S/Q tissue.


VAERS ID: 435413 (history)  
Age: 51.0  
Gender: Female  
Location: Alaska  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH453AC / - UN / IM
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0253AA / - UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Local reaction
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D
Current Illness:
Preexisting Conditions: See attached document
Diagnostic Lab Data: None - just a large local reaction on the skin
CDC Split Type:

Write-up: 5 cm large local reaction at injection site.


VAERS ID: 435476 (history)  
Age: 63.0  
Gender: Female  
Location: Kansas  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-23
   Days after onset:3
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 444011A / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic 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: NA
Current Illness: NA
Preexisting Conditions: NA
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: PATIENT COMPLETED PLASMA DONATION AT 14:46 ON 09/20/2011 AND RECEIVED A RABIES BOOSTER VACCINE POST PLASMA DONATION AT 16:21. PER CSL GUIDELINES, PATIENT WAS REQUIRED TO WAIT AT CENTER 20MIN AFTER VACCINE ADMINISTRATION AND RELEASED WITHOUT ANY SYMPTOMS OF REACTION AT 16:41. PATIENT STATES SHE FELT DIZZY AND LIGHTHEADED THAT EVENING WHILE SHE WAS AT HOME AND LASTED GREATER THAN 30 MIN BUT LESS THAN 1 HOUR. PATIENT UNSURE OF SPECIFIC LENGTH OF TIME OF SYMPTOMS. PATIENT STATES TODAY (9/23/11) THAT SHE IS FEELING BETTER AND HAS NOT HAD ANY FURTHER PROBLEMS.


VAERS ID: 435484 (history)  
Age: 22.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:2
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - RA / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Bumps on Arm~Hep B (no brand name)~UN~13.50~Patient
Other Medications:
Current Illness: No
Preexisting Conditions: Thimerisol and Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Bumps around the area (right bicep) of injection, becoming more prevalent each day.


VAERS ID: 435574 (history)  
Age: 44.0  
Gender: Female  
Location: Illinois  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-23
   Days after onset:3
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1101401 / 0 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1111Z / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site swelling, Pyrexia, Vomiting
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonazepam; Buprenorphine
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Onset day of vaccination continuing and worsening until next day. Vomiting, injection site swollen, fever. Patient was recommended fluid intake (electrolytes), BENADRYL.


VAERS ID: 435576 (history)  
Age: 65.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:2
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH436AB / 0 RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0453AA / - RA / UN
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0364AA / - LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site papule, 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Shellfish, tape-adhesive -$g no anaphylaxis
Diagnostic Lab Data: None
CDC Split Type:

Write-up: At injection site large papular red bump with excess swelling - hard & warm to touch.


VAERS ID: 435587 (history)  
Age: 73.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:2
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH452AB / 0 LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Erythema, Flushing, Headache, Injection site erythema, Injection site nodule, Injection site warmth
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: Similar.~Influenza (Seasonal) (no brand name)~UN~72.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccination 9/20/11. Reported redness on arm 9/21/11 stated there was a hard nodule at injection site, the arm was red onto the elbow and hot to touch. The patient reported 9/23/11 that she was flushed & had a headache. Was going to physician at 2pm. At this time, 9/23/11, the patient reported taking an expired prescription of Prednisone 20mg 1/2 tablet at 4pm then a full tablet at 7pm on 9/22/11. Otherwise only Aspirin & TYLENOL.


VAERS ID: 435672 (history)  
Age: 67.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:2
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0811AA / 0 RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Arthralgia, Chills, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), 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: ACTONEL; enalapril; Ranitidine
Current Illness: None
Preexisting Conditions: NASH; hyperlipidemia; hx of PUD
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chills, myalgias, arthralgias, severe headache, possible cellulitis of RUE.


VAERS ID: 435674 (history)  
Age: 79.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:2
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0595AA / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Axillary pain, Erythema, Musculoskeletal pain, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), 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? 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: Red hives & pain around the shoulder area & under the arm of injection site.


VAERS ID: 435507 (history)  
Age: 62.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-24
   Days after onset:4
Entered: 2011-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0895AA / - LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Dyspnoea, Hyperhidrosis, Muscle spasms
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

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

Write-up: Sweating, shortness of breath, sweating, back spasms. 911 called. Patient refused transport, reported feeling better.


VAERS ID: 435509 (history)  
Age: 77.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-24
   Days after onset:4
Entered: 2011-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - - / -

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

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

Write-up: Dx''d by PCP with cellulits


VAERS ID: 435555 (history)  
Age: 36.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2011-09-20
Onset:2011-09-23
   Days after vaccination:3
Submitted: 2011-09-23
   Days after onset:0
Entered: 2011-09-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV286 / 1 LA / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 0 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR G0181 / 0 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
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: Same as above~Anthrax (no brand name)~UN~33.00~Patient
Other Medications:
Current Illness: No
Preexisting Conditions: No (including NO latex allergy)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Day after shot had mild swelling & tenderness at site. 3 days after shot, had developed approx. 6 inch x 6 inch erythema/swelling & itching. Located a few inches distal to the injection site.


VAERS ID: 435556 (history)  
Age: 65.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-24
   Days after onset:4
Entered: 2011-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100101 / - RA / UN
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0616AA / - LA / SC

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

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

Write-up: 6" diameter inj. site rxn - redness, swelling, pain, tenderness. 4 days after inj.


VAERS ID: 435563 (history)  
Age: 27.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-25
   Days after onset:4
Entered: 2011-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100401 / 0 AR / IM

Administered by: Other       Purchased by: Public
Symptoms: Dyspnoea, Pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

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

Write-up: Pt. husband states pt. has shortness of breath, aching, symptoms onset next day.


VAERS ID: 435584 (history)  
Age: 91.0  
Gender: Male  
Location: Arizona  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-24
   Days after onset:4
Entered: 2011-09-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH458AC / 0 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pain in extremity, Urine output decreased
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Chronic kidney disease (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLOMAX; PROSCAR; CIPRO
Current Illness:
Preexisting Conditions: Prostate Hypertrophy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient said the evening of vaccination he had redness on his face and right side of body. His arms & legs were sore and he had a decrease in urination. He reported to MD next day.


VAERS ID: 435618 (history)  
Age: 68.0  
Gender: Female  
Location: South Dakota  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-26
   Days after onset:6
Entered: 2011-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH452AC / - LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Feeling cold, Injection site pain
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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient describes injection as "excruciating" pain -- she has never had pain with previous flu shots. She also reports that she felt "freezing cold" during the administration and for the next day and a half, but does not thing she had a fever.


VAERS ID: 435689 (history)  
Age: 46.0  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-20
Onset:2011-09-23
   Days after vaccination:3
Submitted: 2011-09-26
   Days after onset:3
Entered: 2011-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB944BB / 1 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Asthenia, Cardiac monitoring normal, Chest discomfort, Chest pain, Dizziness, Dyspnoea, Hyperhidrosis, Hypertension, Malaise, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Pt states he was seen on the 23 for scheduled BP check as he has high BP. Was dizzy, SOB, chest pain and pressure, and sweaty. He was "down for 5 hours on the couch:. Sent to Er and was there at hospital for 5 hours but cardiac was ruled out. Still not feeling well on 9/26, is dizzy and weak and has been reading that this could happen from hours to days after hep b shot. States had 1 dizzy spell 2 weeks after first HEP B but did not share this with staff at the time of 2nd shot. States has followup apt with PA for this week


VAERS ID: 435701 (history)  
Age: 63.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-23
   Days after onset:3
Entered: 2011-09-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AA / - RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0882Z / 0 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Hyperlipidemia; NKDA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Injection site swollen, tender, warm 4 x 4.5 inches, fever 101.1, H/A.


VAERS ID: 435787 (history)  
Age: 37.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-21
   Days after onset:0
Entered: 2011-09-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0046AA / 0 LA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3899AA / 0 LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Headache, Laboratory test, Lip swelling, Neck pain, Pharyngeal oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Arthritis (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: PPD
Current Illness: None
Preexisting Conditions: Allergy to Tetracycline
Diagnostic Lab Data: Had lab test done but not sure for what no results available yet
CDC Split Type:

Write-up: C/o pain in headache & neck pain, swelling in throat & lips morning after vaccine. Consult with PHN and family physician - instructed to take BENADRYL.


VAERS ID: 435800 (history)  
Age: 69.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-27
   Days after onset:7
Entered: 2011-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA671AA / - LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic fatigue syndrome (chronic, 18 years)
Preexisting Conditions: Amoxicillin Atrial fibrillation, mild hypertension (both controlled with meds)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vomiting -- extreme -- for 4 hours


VAERS ID: 435801 (history)  
Age: 23.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-26
   Days after vaccination:6
Submitted: 2011-09-27
   Days after onset:1
Entered: 2011-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA628BA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3298AA / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: N/A
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient describes swelling, pain and itching at site to right arm.


VAERS ID: 435810 (history)  
Age: 38.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:2
Entered: 2011-09-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1622Z / 0 LA / SC

Administered by: Public       Purchased by: Other
Symptoms: Injection site cellulitis, Injection site erythema, 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:
Current Illness: Acute pancreatitis; Hypokalemia
Preexisting Conditions: Latex; REGLAN; Nitrofurantoin; Nystatin; PCN; Prochlorperazine; Talc; Adhesive; Beeswax; CIPRO; CARDIZEM; Erythromycin base; pollen; Lactobacillus
Diagnostic Lab Data: Pt refused lab work - Dr. aware
CDC Split Type:

Write-up: At injection site to Lt arm lg reddened area, warm to touch noted. Measures 11cm wide by 14cm long. Dr. aware and monitoring - believes cellulitis, will start on Abx today.


VAERS ID: 435813 (history)  
Age: 28.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2011-09-20
Onset:0000-00-00
Submitted: 2011-09-20
Entered: 2011-09-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3921BA / - RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

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: None stated.


VAERS ID: 435835 (history)  
Age: 30.0  
Gender: Female  
Location: Iowa  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:1
Entered: 2011-09-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT447AA / 0 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Limb discomfort, Local reaction
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: CELEXA; prenatal vitamin
Current Illness: None reported
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: S: The patient is a nurse who works in recovery. She had a flu vaccine in her left arm a few days ago. She had noticed that where the immunization was given there has been warmth and erythema. It has felt firm. It has been sore. She says that the firmness and soreness have decreased. It does not hurt too much moving her left arm around. She denies fever, chills, nausea, vomiting, headache, shortness of breath, or facial or throat swelling. She took ibuprofen times one. She has used some heat on her left arm. O: Midway down the lateral posterior aspect of the left upper arm, there is approximately a 4-cm-diameter area of erythema. It is slightly warm. I detect no fluctuance here. There are no gross signs of infection. It is slightly tender to palpation. She expressed slight discomfort with resisted left upper extremity examination maneuvers but has full range of motion in the left upper extremity. Her lungs are clear. Her heart examination is normal. A: Local reaction status post influenza vaccination. P: We discussed that this is not an uncommon occurrence with ''flu vaccination. The are no overt signs of infection or any signs or symptoms that she has had an allergic reaction to the vaccine. I directed her for reference to again look at the influenza vaccination information sheet provided by the CDC. (1) We discussed physical modalities to do. (2) She should try to stretch her left arm. (3) We discussed some medication she can take for the next one to two days. (4) At this juncture, she is fine with being discharged to full duty. (5) I did want her to continue to watch the area for worsening signs of pain, redness, and swelling, as well as any allergic reaction type symptoms. (5) Otherwise, I will discharge her from the clinic today. She may return P.R.N.


VAERS ID: 435838 (history)  
Age: 66.0  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH457AA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Diarrhoea, Dizziness, Muscle spasms, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sinus congestion - ear pain & dry cough - tinnitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt experienced dizziness, nausea, vomiting, cramps and diarrhea until he went to bed last night. Symptoms began.


VAERS ID: 435868 (history)  
Age: 37.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-09-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA664AA / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Fatigue, Headache, Injection site erythema, Injection site rash, Injection site swelling, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Pt. on NEXIUM & ATIVAN
Current Illness:
Preexisting Conditions: Allergic to PCN; Sulfa drugs; PHENERGAN; Chipotle
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. states after vaccination had headache, tired aches over body. Rash appeared on chest, back tops of arms. Site reaction with redness swelling. 9-02-11 pt. c/o of only rash still present today & just tired. Pt. instructed to use ice pack on arm for site rxn. & watch rash for 2 more days if no improvement contact PCP.


VAERS ID: 435883 (history)  
Age: 7.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 2011-09-27
   Days after onset:5
Entered: 2011-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH445AA / 2 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Eyelid ptosis
SMQs:, Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VYVANSE 30 (off all asthma meds)
Current Illness: Sl URI
Preexisting Conditions: 36 wk preemie with Sm ASD & bil PA stenosis; RSV at 2 mos of age; asthma; GERD; ADHD & dyslexia; T & A bil PETS 5/05
Diagnostic Lab Data: None done; 9/27/11 Spoke with mom. Still with some drooping of Lt eyelid on & off. Has f/u appt scheduled 9/29/11.
CDC Split Type:

Write-up: Pt had flu vaccine 9/20/2011 when he had his annual well child check up. He had URI sx at that time. MOC called 9/22 that Lt eyelid was droopy today. Seen evening of 9/22 in the office. Mild left ptosis, sl decrease nasolabial fold Lt side of face eye brows & eyelids symmetrical. NL strength U & L extremities dx ptosis ? early Bells Palsy.


VAERS ID: 435903 (history)  
Age: 1.26  
Gender: Male  
Location: Missouri  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 2011-09-27
   Days after onset:5
Entered: 2011-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC143146AA / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4184BA / 2 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB533CA / 0 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1443Z / 2 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None; well child
Preexisting Conditions: ? PCN allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: (Lt) lateral thigh with about 4 x 4 cm induration & about 6-7 cm x 6 cm redness surrounding inject. site. Positive swelling began 9-22-11. Tx includes: BENADRYL x 1-2 d; ibuprofen PRN; warm packs/baths to area. To call PRN if increases.


VAERS ID: 435925 (history)  
Age: 90.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-27
   Days after onset:7
Entered: 2011-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH475AA / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shaking, tremor, fever after 3 hours of flu shot. Went to emergency room, IV treatment of antibiotics & discharged with levofloxacin prescription.


VAERS ID: 436084 (history)  
Age: 40.0  
Gender: Male  
Location: Virginia  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-26
   Days after onset:6
Entered: 2011-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AC / - RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Dysphonia, Injection site erythema, Injection site induration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Vestibular disorders (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: PRILOSEC OTC
Current Illness: None
Preexisting Conditions: Pre-existing allergy to some component of KENALOG
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately 1.5 hours following vaccine administration, client reported feeling faint, lightheaded. Noted raspiness in voice. Pulse, blood pressure WNL client conscious, responsive. Epinephrine given, 0.3 mg IM via auto injection. Additional care provided at hospital ER - epinephrine and BENADRYL. 12 hours after injection, client noticed induration and erythema at injection site.


VAERS ID: 435979 (history)  
Age: 10.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0420AA / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Muscular weakness, Thinking abnormal, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: 1 DIFLUCAN taken 9/19/11 150 mg tablet
Current Illness: Yeast infection
Preexisting Conditions: None per client''s mom
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within minutes of vaccination, client felt "faint & dizzy". (Given juice and client ate crackers). Client observed for 20 minutes. She had complaints of legs feeling "wobbly". She also had tremors of her arms. Client''s mom said she is still having difficulty moving her legs. They feel "wobbly". Also client feels her head is in a "whirlpool". Client to see her doctor. This is approximately 15 hours following immunization.


VAERS ID: 435981 (history)  
Age: 13.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-28
   Days after onset:7
Entered: 2011-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH460AA / 0 RA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0628AA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1561Z / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3712AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3837BA / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0448AA / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Eye swelling, Oedema peripheral, Skin warm, Swelling face, Visual impairment
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Mother states (R) arm swelled & hot to touch. Eyes & face also had swelling. Pt c/o problems with vision due to swelling. Taken to hospital ER where pt was given TYLENOL & instructed to do BENADRYL at home. No testing or other meds were done. Pt remained afebrile & total recovery after 3 days.


VAERS ID: 435998 (history)  
Age: 29.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-28
   Days after onset:8
Entered: 2011-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS - / - RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral, Pruritus, Pruritus generalised, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (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: Oral contraceptive Phentermine
Current Illness: No
Preexisting Conditions: Not physician diagnosed, but I do have an allergy to Beef.
Diagnostic Lab Data: I spoke with my Doctor''s office on the phone but did not go in.
CDC Split Type:

Write-up: I started itching on my hands and arms. Then I started getting hives. The itching and hives spread quickly to my entire body. I had some swelling in my right arm. I took 2 Benadryl almost immediately. Symptoms started improving slightly in about an hour. Symptoms were completely gone by about 8:00 PM.


VAERS ID: 436012 (history)  
Age: 61.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-09-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2011-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3927BA / 0 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left upper arm swollen, red, itchy. Physician prescribed KEFLEX.


VAERS ID: 436046 (history)  
Age: 65.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-28
   Days after onset:7
Entered: 2011-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3898BA / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pruritus, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolol PO for A-fib. PPD skin test administered same day:0 mm
Current Illness: None
Preexisting Conditions: A-fib treated with Metoprolol. NKDA.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Itching, followed by redness, warmth, swelling down to elbow.


VAERS ID: 436123 (history)  
Age: 92.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-28
   Days after onset:8
Entered: 2011-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH436AC / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Bronchitis, Dyspnoea, Sepsis, Throat tightness, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: COPD; Chronic kidney disease; NKDA; NKFA
Diagnostic Lab Data:
CDC Split Type:

Write-up: High dose flu vaccine given 9/20/11. Complaints of shortness of breath and feeling of throat closing and vomiting 9/20/11 (Admitted to hospital with diagnosis of sepsis). Discharged 9/22/11. Diagnosis Bronchitis. Office visit recheck 9/27/11 without complaints.


VAERS ID: 436127 (history)  
Age: 73.0  
Gender: Male  
Location: Alabama  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-28
   Days after onset:8
Entered: 2011-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH459AA / 0 UN / IM

Administered by: Other       Purchased by: Public
Symptoms: Chills, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Iprat-Albut 0.5-3 mg/inh; Lorazepam 0.5mg; Gabapentin 100mg; Alprazolam 1mg
Current Illness:
Preexisting Conditions: COPD
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chill & hard to breath -$g pt doesn''t have BENADRYL at home (so, asked him to use his breathing medications for COPD & call 911).


VAERS ID: 436105 (history)  
Age: 51.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 2011-09-23
   Days after onset:1
Entered: 2011-09-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH478AA / - LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Activities of daily living impaired, Diarrhoea, Epistaxis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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 reported
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vomiting & diarrhea started at 12:30 am 9/22/11. Also a nose bleed. Missed 1 day of work.


VAERS ID: 436165 (history)  
Age: 1.15  
Gender: Female  
Location: Maine  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-29
   Days after onset:8
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB517CA / 0 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Rash generalised, Rash maculo-papular
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: None
Current Illness: Mild runny/stuffy nose x 2-3d
Preexisting Conditions: Heart murmur - likely Still''s
Diagnostic Lab Data: None
CDC Split Type:

Write-up: At 9/26/11 office visit, mom reports woke with rash the day following immunization. Dr. described as fine maculopapular rash all over body. BENADRYL recommended. (Mom denied any SOB, wheezing or swelling of face or lips).


VAERS ID: 436187 (history)  
Age: 53.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-09-29
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0453AA / 0 LA / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Oxycodone
Current Illness:
Preexisting Conditions: Not known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe pain in arm, spreading to elbow, went to ER - Dr dx cellulitis, got antibiotic.


VAERS ID: 436236 (history)  
Age: 39.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-29
   Days after onset:9
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 1152216 / 0 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Chest discomfort, Chills, Eye discharge, Feeling hot, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Breastfeeding at the time?? Taking prenatal vitamins.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tightness in chest, nauseas, vomiting (6 times), hot, severe weakness, severe chills, eye mucus. Lastest until 09/21/2011 5:00 am


VAERS ID: 436241 (history)  
Age: 0.16  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-29
   Days after onset:9
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 0 LL / IM

Administered by: Private       Purchased by: Other
Symptoms: Decreased appetite, Hypotonia, Micturition disorder, Mobility decreased, Screaming, Urine output decreased
SMQs:, Acute renal failure (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Child has not received any other vaccines leading up to the Pentacel vaccine.
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Pediatrician was notified, but she did not request any tests. Sanofi Pasteur was notified - The Pasteur medical team recommended no more combo vaccines and raised concerns about the DTAP component of the vaccine.
CDC Split Type:

Write-up: Atypical screaming for 4-5 hours, no appetite for 17 hours, urinated only twice in 20 hours, severe limpness of arms and legs (child moved shoulders, but could not raise arms. Arms hung limp at sides of body).


VAERS ID: 436243 (history)  
Age: 2.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-23
   Days after onset:3
Entered: 2011-09-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4184BB / - RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Rash generalised, Rash maculo-papular
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:
Current Illness: Urinary frequency
Preexisting Conditions: NKDA; Asthma; Allergic rhinitis; Impetigo
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash all over the body maculopapular.


VAERS ID: 436267 (history)  
Age: 5.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2011-09-20
Onset:2011-09-24
   Days after vaccination:4
Submitted: 2011-09-29
   Days after onset:5
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - RA / -

Administered by: Unknown       Purchased by: Other
Symptoms: Arthralgia, Decreased appetite, Headache, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: High fever, lethargy~Measles + Mumps + Rubella (no brand name)~~2.25~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: ADHD, PDD-NOS, Hx of Henoch Schonlein Purpura
Diagnostic Lab Data: Has doctor appointment with immunologist November 9th. As of today, Sept. 29th, still have headaches and joint pain.
CDC Split Type:

Write-up: Began with headache, several hours later, high fever began (104 degrees), lethargic, loss of appetite and joint pain.


VAERS ID: 436286 (history)  
Age: 71.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-29
   Days after onset:9
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH439AA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Diarrhoea, Nausea, Pain, Sensation of foreign body, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

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

Write-up: N/V, achy, chills, some diarrhea, lump in throat.


VAERS ID: 436298 (history)  
Age: 30.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-29
   Days after onset:8
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAV520AA / 0 LA / IM
JEV1: JAPANESE ENCEPHALITIS (IXIARO) / INTERCELL AG JEV10F54E / 0 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1163Z / 0 LA / SC
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS 473011C / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood culture negative, Body temperature increased, C-reactive protein increased, Erythema, Local reaction, Lymphocyte morphology abnormal, Lymphocyte percentage decreased, Neutrophil count, Pain in extremity, Red blood cell sedimentation rate increased, Ultrasound scan normal, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (broad), Malignant lymphomas (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma; h/o pneumonia; Allergy to dairy, latex, Amoxicillin
Diagnostic Lab Data: U/S (L) arm negative for fluid collection; 9/22 WBC=10.48, 69S/18L/3AtyL; 9/23 WBC=8.87, 74S/20L; B cx negative; ESR 51, CRP=127.3
CDC Split Type:

Write-up: 1 day after immunization, pt developed red area (L) arm, red & sore. The following day, she noted temp 100. Appearance more c/w local rxn 6.5 x 10 cm oval well circumscribed, but increased over next 24 hours, on Ibuprofen/ice pack. Treated 9/23 & 9/24 with IV Vanco/ceftriaxone with much improvement by 9/25. Switched to oral Dicloxacillin.


VAERS ID: 436513 (history)  
Age: 0.34  
Gender: Male  
Location: Illinois  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-10-03
   Days after onset:13
Entered: 2011-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTIPV: DT + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: Blood in multiple stools for 2 days.
CDC Split Type:

Write-up: Blood in stool.


VAERS ID: 436614 (history)  
Age: 50.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-10-03
   Days after onset:13
Entered: 2011-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1101301 / - LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site pain
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: Unknown
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 9/29 she reported that she developed soreness starting from site of injection through the elbow 4 to 5 days. The symptoms disappeared for 3-4 days then started again. I asked her to see a dr. She said I will be fine & I am leaving to another country for 2 weeks & I will call you back after I return.


VAERS ID: 436618 (history)  
Age: 13.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-03
   Days after onset:12
Entered: 2011-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS 0565Z / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A10034 / 0 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: 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: None.
Current Illness: None noted.
Preexisting Conditions: Food allergies to shellfish, chocolate, oranges, tree nuts and bananas. This information provided when parent called about HIVES.
Diagnostic Lab Data: None. Parent did not seek medical attention.
CDC Split Type:

Write-up: On 3 Oct 2011, parent called to say that the child had hives all over body starting next day. She gave him Benadryl for 3 days. He did not have any trouble breathing or any other symptoms. Temperature remained normal. Parent also reported at this time that child has food allergies to shellfish, chocolate, oranges, Tree nuts, and bananas. Parent reports that child did not have any of these around this time but that the Hives is the same reaction he has to his food allergies.


VAERS ID: 436714 (history)  
Age: 33.0  
Gender: Female  
Location: Colorado  
Vaccinated:2011-09-20
Onset:2011-09-23
   Days after vaccination:3
Submitted: 2011-10-04
   Days after onset:11
Entered: 2011-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLUA625BA / 0 RA / UN

Administered by: Public       Purchased by: Other
Symptoms: Multiple sclerosis relapse, Pain of skin, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Optic nerve disorders (broad), Demyelination (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Interferon beta-1a; Unknown
Current Illness: Multiple sclerosis
Preexisting Conditions: The subject had previously received flu shots with no documented reactions and had no history of adverse events following previous vaccinations. The subject had a history of multiple sclerosis and no known allergies.
Diagnostic Lab Data: UNK
CDC Split Type: A0946702A

Write-up: This case was reported by a health care professional and described the occurrence of multiple sclerosis flare in a 33-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included multiple sclerosis. Concurrent medications included REBIF and unknown concurrent medications. On 20 September 2011 at 11:00 the subject received 1st dose of FLULAVAL at 0.5 ml in the right arm. On 23 September 2011, 3 days after vaccination with FLULAVAL, the subject experienced multiple sclerosis flare and was hospitalized overnight. The subject also experienced itching arms, hips and legs with onset 23 September 2011. Painful welts on the arms, legs and hips was also reported (onset date not specified). The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events was unspecified. The subject was discharged from the hospital on 24 September 2011.


VAERS ID: 436828 (history)  
Age: 48.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-10-05
   Days after onset:15
Entered: 2011-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Other
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Seasonique
Current Illness: Resolving URI (mild)
Preexisting Conditions: Latex, Sulfa, Gluten Intolerance, Asthma
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Severe pain at injection site after 45 minutes, about three hours later developed fever 101 with chills, general malaise. Following morning arm red hot swollen, erythema circumfirential from top of shoulder to elbow. Continued with significant pain to area until 9/23/11. Treated with antihistamine (Claritin 10mg) and Ibuprofen 600mg TID.


VAERS ID: 436871 (history)  
Age: 1.72  
Gender: Female  
Location: Illinois  
Vaccinated:2011-09-20
Onset:2011-10-01
   Days after vaccination:11
Submitted: 2011-10-04
   Days after onset:3
Entered: 2011-10-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3895AA / 3 RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0156Z / 0 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E97564 / 3 RL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0412AA / 0 LL / UN

Administered by: Private       Purchased by: Public
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)

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: Possible infection dm. 21 month 1 day old female presents with c/o rash on left thigh where had varicella vaccine 10 days ago.


VAERS ID: 436874 (history)  
Age: 61.0  
Gender: Male  
Location: New York  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-30
   Days after onset:10
Entered: 2011-10-05
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4114DA / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cough, Lethargy, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

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

Write-up: Cough, nausea, lethargy.


VAERS ID: 436884 (history)  
Age: 55.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2011-09-20
Onset:0000-00-00
Submitted: 2011-10-05
Entered: 2011-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA673AA / - LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown. Previous vaccination history unknown. Client saw PMD 9/28/11 for another issue, PMD advised her to report reaction to our office. 10/4/11 c/o persistent redness and swelling, redness on inside of arm in elbow area. Welt below injec
Current Illness: none reported
Preexisting Conditions: none reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left upper arm welt, Redness and swelling, soreness on movement, sore to the touch. Reported on 9/29/2011.


VAERS ID: 437031 (history)  
Age: 1.01  
Gender: Male  
Location: Washington  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-10-03
   Days after onset:13
Entered: 2011-10-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4114AA / 0 LL / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB481BB / 0 RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0008AA / 0 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0340AA / 0 RL / SC

Administered by: Other       Purchased by: Public
Symptoms: Dyskinesia, Hypotonia, Irritability, Pyrexia, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), 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: None known
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Irritability, fever to touch. Apparently asleep. 3-4 jerking movements of arms and one leg. Then limp and unresponsive for 5 min. Acetaminophen suppository. Responsive within seconds.


VAERS ID: 437034 (history)  
Age: 31.0  
Gender: Female  
Location: Virginia  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-04
   Days after onset:13
Entered: 2011-10-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH463AB / 0 UN / IM

Administered by: Public       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Musculoskeletal pain, Neck pain, Pain in extremity, Pallor, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt felt dizzy after receiving the flu shot, but went home. Later that day, she felt weak/pale & felt pain in her legs (heels), wrist, neck. Next am, she had fever (102 F) & pain in her shoulders & knees. Also head headache. She went to see her PMD for follow-up.


VAERS ID: 437047 (history)  
Age: 78.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-27
   Days after onset:6
Entered: 2011-10-06
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH436AC / - LA / UN

Administered by: Other       Purchased by: Public
Symptoms: Erythema, Feeling hot, Injection site erythema, Swelling, Tenderness
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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient describes redness starting about 2 inches below the injection site and extending all the way down the arm. She stated warmth, tenderness, and limited swelling. Her MD recommended BENADRYL. She noted recovery on 9-22-11.


VAERS ID: 437057 (history)  
Age: 4.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 2011-10-06
   Days after onset:14
Entered: 2011-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B121B / 4 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E0204 / 3 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1045Z / 1 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0925Z / 1 LA / SC

Administered by: Public       Purchased by: Other
Symptoms: Injection site pain, 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:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: TX20110065

Write-up: MOM OF PATIENT BROUGHT CHILD IN RA IM. WARM TO TOUCH AND TENDER TO TOUCH. CHILD AFEBRILE 98.2. MOM STATES THAT SHE IS TAKING CHILD TO PHYSICIAN FOR FOLLOW UP. INSTRUCTED MOTHER CONTINUE APPLY COOL TOWELS TO ARM. 9-30-11 MOM STATES "SHE I FINE, THE DOCTOR GAVE ME SOME CREAM TO PUT ON IT AND ITS GONE."


VAERS ID: 437124 (history)  
Age: 0.34  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2011-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Infantile spitting up, Irritability, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shots 445?pm by 11pm fever of 102.5. Next day very fussy, clingy, throwing up/spit up, tired & diarrhea. Low grade fever the following day, fussy & little appetite, throw up/spit up for six days.


VAERS ID: 437189 (history)  
Age: 70.0  
Gender: Male  
Location: New York  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-28
   Days after onset:8
Entered: 2011-10-06
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Multi-vit; PRAVACHOL; Vit D; SAW PALMETTO
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccination 3:30pm. By 10:30pm - chills, shivering, eventually vomiting at 1:00 AM. Extreme leg pain.


VAERS ID: 437208 (history)  
Age: 68.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-06
   Days after onset:15
Entered: 2011-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH436AA / 0 LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Injection site reaction
SMQs:

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

Write-up: Allergic type reaction in muscle area of injection.


VAERS ID: 437183 (history)  
Age: 46.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 2011-09-30
   Days after onset:8
Entered: 2011-10-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100101 / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dehydration, Immune system disorder, Influenza like illness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad)

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

Write-up: Patient received vaccination 9/20/11 -$g had MD appt next day & found out she had a compromised immune system. Patient reported flu like symptoms on Saturday 9/24. Patient went to hospital & treated for dehydration & released.


VAERS ID: 437309 (history)  
Age: 4.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-10-07
   Days after onset:17
Entered: 2011-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS C3944AA / 5 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR G11451 / 3 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0402AA / 1 LL / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0345AA / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, 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: N/A
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: TX20110067PU

Write-up: EDEMA 5CM X 4CM REACTION L THIGH, REDNESS AND SWELLING HOT WHERE DTAP WAS GIVEN


VAERS ID: 437324 (history)  
Age: 35.0  
Gender: Male  
Location: New York  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-07
   Days after onset:16
Entered: 2011-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA681AA / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad), 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:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe Pain on shoulder / neck on side of injection site. Did not regain full motion without pain for over a week. Treated neck and shoulder with ice.


VAERS ID: 437338 (history)  
Age: 75.0  
Gender: Male  
Location: Missouri  
Vaccinated:2011-09-20
Onset:2011-09-28
   Days after vaccination:8
Submitted: 2011-10-07
   Days after onset:9
Entered: 2011-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH463AA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain
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: Provigil 200mg T Daily; Finastenide 5mg T Daily; ProAir HFA (Albuterol) emergency only-not used; fluticasone propionate nasal spray 50 mcg prn; asmanex twisthaler 220 mcg 2 puffs each nostril; hydrochlorothiazide 25 mg 1/2 po in AM; levothy
Current Illness:
Preexisting Conditions: COPD
Diagnostic Lab Data:
CDC Split Type: MO201110

Write-up: Wednesday 9/28/11-dull pain #2 on scale 1-10. Left shoulder proximal to deltoid site of influenza injection given 9/20/11. 9/28/11 by 11:00 pm intensity increased to #10 on scale 1-10. Related to pain of rotator cuff as in Hx. Not sure if related to flu shot or participation in "Old Timers Baseball Game: 9/25/11. Improved by Friday 9/30/11 and resolved completely by 10/4/11.


VAERS ID: 437490 (history)  
Age: 44.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-10
   Days after onset:19
Entered: 2011-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS 678AA / 17 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0441Z / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Decreased appetite, Diarrhoea, Gastric disorder, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
SMQs:, Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multi vitamin calcium Celexa 20 mg qd
Current Illness: none
Preexisting Conditions: arthritis
Diagnostic Lab Data:
CDC Split Type:

Write-up: Warm, red, indurated & ithcy at site of MMR injection site - lasted approx. 6 days. 10/02/2011 6:00 AM developed diarrhea which lasted approx. 4 days - improved for approx. 3 days and resumed on 10/9. Yellow stools - primarily liquid - has not checked temp - does not believe she is running a fever; has loss of appetite and "stomach rumbling" - does not know anyone else with similar symptoms; can keep small amounts of food and liquids down - does not think she is dehydrated.


VAERS ID: 437792 (history)  
Age: 0.1  
Gender: Male  
Location: Tennessee  
Vaccinated:2011-09-20
Onset:2011-09-24
   Days after vaccination:4
Submitted: 2011-10-05
   Days after onset:11
Entered: 2011-10-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB977CA / 1 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Bed sharing, Cardiac arrest, Death neonatal, Intensive care, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? Yes
   Date died: 2011-09-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: PICU treatment
CDC Split Type:

Write-up: Infant reportedly co-sleeping. Found nonresponsive. EMS took to ER - 24 hr in PICU - arrested and died.


VAERS ID: 437825 (history)  
Age: 57.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-26
   Days after onset:5
Entered: 2011-10-12
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1474Z / 0 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), 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: Hydrochlorothiazide; atenolol
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: VZV given on 9/20/11 - next day red, swelling (L) posterior arm with increased redness, induration 9/22/11. Hot to touch, itching approx size 2x2.


VAERS ID: 438043 (history)  
Age: 33.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-27
   Days after onset:7
Entered: 2011-10-13
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Rash, Swelling face, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash, hives, swelling of face.


VAERS ID: 438208 (history)  
Age: 57.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-14
   Days after onset:23
Entered: 2011-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AA / - AR / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Penicillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Slight fever, dizziness, headache.


VAERS ID: 438619 (history)  
Age: 48.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 2011-09-22
   Days after onset:0
Entered: 2011-10-17
   Days after submission:25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3082BA / 0 LA / IM
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3002105 / 0 - / PO

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Nodule
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: ARIMIDEX 1mg QD; LUPRON inj Q mos; Omeprazole 20mg PRN
Current Illness: None
Preexisting Conditions: ASA; ADVIL; Breast CA with lung metastasis
Diagnostic Lab Data:
CDC Split Type:

Write-up: Slight redness on injection site. Approx dime size nodule.


VAERS ID: 438790 (history)  
Age: 1.47  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2011-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR 2028718 / - LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AD / - RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS UH265AA / - LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916600 / - RL / IM

Administered by: Public       Purchased by: Public
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:
Other Medications: gave .2cc BENADRYL IM
Current Illness:
Preexisting Conditions: Allergic to red food colorings
Diagnostic Lab Data:
CDC Split Type:

Write-up: Lt cheek rash, bump on chin. Lt forehead small area on rash. Fine rash, above rt eye, would not scratching.


VAERS ID: 439065 (history)  
Age: 69.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2011-10-19
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100201 / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1111Z / - RA / IM

Administered by: Other       Purchased by: Public
Symptoms: 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pravastatin; multi vitamin; vit C
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient experience swelling & rash around injection site & nearly entire (R) upper arm.


VAERS ID: 439267 (history)  
Age: 94.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-20
Onset:2011-10-14
   Days after vaccination:24
Submitted: 2011-10-17
   Days after onset:3
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Died? Yes
   Date died: 2011-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CAD; HTN; Arthritis; Confusion/delirium
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 439558 (history)  
Age: 29.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-24
   Days after onset:33
Entered: 2011-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 04949221A / 9 UN / IM
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / 0 UN / OT

Administered by: Military       Purchased by: Military
Symptoms: Fatigue, Joint stiffness, Muscular weakness, Rash erythematous
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), 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: none
Current Illness: none noted
Preexisting Conditions: Allergic to Septra and sulfa based drugs. Reaction-rash
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Bilateral hand weakness, joint stiffness in the hands and elbows, fatigue, petechiae on right arm/chest.


VAERS ID: 440085 (history)  
Age: 61.0  
Gender: Female  
Location: Vermont  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2011-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AA / 0 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0614AA / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Chest pain, Musculoskeletal pain, Myalgia, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), 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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme muscle soreness on Right arm w/in min of rec. Pain spread to shoulder, neck, chest, back by mid-afternoon. Resolved after 9 days.


VAERS ID: 440106 (history)  
Age: 72.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-09-30
   Days after onset:9
Entered: 2011-10-26
   Days after submission:26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH39AA / 0 UN / UN

Administered by: Other       Purchased by: Public
Symptoms: Pain
SMQs:

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: Arthritis
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt called on 9/30/11 stating after receiving flu vaccine on 9/20/11, she had body aches throughout body. States she has arthritis but she doesn''t know if its the vaccine or her current disease state causing the pain.


VAERS ID: 440120 (history)  
Age: 48.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-20
Onset:2011-09-23
   Days after vaccination:3
Submitted: 2011-10-17
   Days after onset:24
Entered: 2011-10-26
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA651AA / 3 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia
SMQs:, Arthritis (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: Type I DM; Hashimoto''s Thyroid; HLD; OA; Gastroparesis; Gluten intolerance
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe joint pain.


VAERS ID: 440128 (history)  
Age: 21.0  
Gender: Female  
Location: Delaware  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-21
   Days after onset:1
Entered: 2011-10-26
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0841AA / 1 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Excoriation, Laceration, Lip injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Transported to medical center for eval.
CDC Split Type:

Write-up: Fainted - serapes on side of face, abrasions on left forehead, under left eye, corner of left nare & neck. Cut on bridge of nose & inside of upper lip.


VAERS ID: 440200 (history)  
Age: 4.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-26
   Days after onset:35
Entered: 2011-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B171 / 4 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0104AA / 1 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0461AA / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site inflammation, Injection site reaction, Injection site swelling, Injection site warmth, Yellow skin
SMQs:, Cholestasis and jaundice of hepatic origin (broad), Extravasation events (injections, infusions and implants) (broad), 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: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type: AR1124

Write-up: Phone call from mother stating child''s Left upper arm is swollen and feverish. States lookes inflamed with yellowish skin on top, area 4 1/2 inches long and 4 1/2 inches wide. States has used ice packs and ibuprofen. Mother told to take to MD if continues.


VAERS ID: 441016 (history)  
Age: 69.0  
Gender: Unknown  
Location: New York  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2011-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0595AA / - LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Contusion, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (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: Patient complained of arm swelling and bruising.


VAERS ID: 441292 (history)  
Age: 36.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-11-03
   Days after onset:44
Entered: 2011-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH471AA / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Chest discomfort, Chills, Cough, Feeling abnormal, Formication, Pain, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Dementia (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:
Other Medications: none
Current Illness: no
Preexisting Conditions: allergy to codeine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt reports she received injection at approx 3:30 pm. At about 6:30 pm began to have chest pressure, a cough, aching, chilling, and skin itching. At about 2:30 AM felt very bad. "Felt like I had a fever and my skin was crawling". 9/21/11 pt reports she is broke out in a hivey rash on stomach and back.


VAERS ID: 441693 (history)  
Age: 72.0  
Gender: Female  
Location: Mississippi  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-11-07
   Days after onset:48
Entered: 2011-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AC / 0 LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain
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: Unknown
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain in left arm from shoulder to elbow. Pain continuous. Difficulty raising arm.


VAERS ID: 442070 (history)  
Age: 12.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-26
   Days after onset:35
Entered: 2011-11-09
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3765AA / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
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:
Current Illness: None
Preexisting Conditions: Allergic rhinitis only
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Local redness at injection site swelling, pain, mild cellulitis vaccine given on 9/20/2011 & symptoms started 9/21/2011.


VAERS ID: 442163 (history)  
Age: 31.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-11-11
   Days after onset:52
Entered: 2011-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 04949221A / 1 RA / -

Administered by: Military       Purchased by: Military
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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: Severe Lesion and prolonged sickness for several months.~Smallpox (Dryvax)~1~22.67~Patient
Other Medications: none
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within a few hours, patient began to have pain and numbness in elbow and last 2 fingers (pinky and ring). Patient researched common symptoms and did not think much of it. About a week and a half later, the pain in fingers was mostly gone. Currently, the pain in upper right arm, mostly in elbow, is constant and progressively getting worse. It is almost two month after the shot, and the level of pain increases with each day.


VAERS ID: 442526 (history)  
Age: 0.34  
Gender: Male  
Location: Maryland  
Vaccinated:2011-09-20
Onset:2011-10-19
   Days after vaccination:29
Submitted: 2011-11-08
   Days after onset:20
Entered: 2011-11-15
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3980AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916975 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0064AA / 1 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Intussusception, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: See hospital report
CDC Split Type:

Write-up: On 10-19-11 developed vomiting diagnosed with intussusception requiring surgery. On 11-2-11 again developed intussusception that resolved without surgery.


VAERS ID: 442566 (history)  
Age: 11.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-11-15
   Days after onset:56
Entered: 2011-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 0 LA / -
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 RA / -

Administered by: Military       Purchased by: Military
Symptoms: Altered state of consciousness, Oedema peripheral, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: impetigo dx on forearm, rx mupurocin
Preexisting Conditions: obesity, eczema
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had onset of hand swelling, which progressed to whole body swelling within a few minutes. Mom became very concerned, gave him liquid Benadryl, then drove him to the ER. Pt was having altered consciousness by triage in the ER and was unable to see or hear, then slumped in his chair. Pt was given steroids, and was sent home with a course of Prednisone for 14 days.


VAERS ID: 443408 (history)  
Age: 18.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-11-11
   Days after onset:52
Entered: 2011-11-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501103P / 0 - / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3840AA / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B058BA / - RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Blood glucose normal, Bundle branch block right, Electrocardiogram abnormal, Sinus bradycardia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Conduction defects (narrow), 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: None
Current Illness: None
Preexisting Conditions: Child had asthma; Gynecomastia
Diagnostic Lab Data: 9-20-11 Glucose 80 after syncope episode. 12 lead EKG sinus bradycardia 56, incomplete RBBB.
CDC Split Type:

Write-up: Patient received an intranasal FLUMIST, Tdap IM and MCV4 IM. He had a brief syncope episode (possible vaccine reaction) after receiving IM vaccines, sent to ER via EMS.


VAERS ID: 443135 (history)  
Age: 68.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 2011-11-16
   Days after onset:55
Entered: 2011-11-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH462AA / - RA / IJ

Administered by: Public       Purchased by: Unknown
Symptoms: Cellulitis
SMQs:

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: The patient was already hospitalized (reason not reported) prior to vaccination.
Diagnostic Lab Data: Not reported
CDC Split Type: 201111123

Write-up: Initial report received from a health care professional on 14 November 2011. This reporter also reported another adverse event, which was captured in case number 2011-09213 and 2011-11124. A 68-year-old female patient received a right arm injection (route not reported) of FLUZONE, sanofi pasteur Inc. lot number UH462AA, on 20 September 2011. The patient''s medical history and concomitant medications were not reported. The patient was given the FLUZONE vaccine at the time of discharge from the hospital on 20 September 2011. Two days later on 22 September 2011, the patient presented to the Emergency Department (ED) with cellulitis of the right arm. The patient was treated with intravenous ANCEF and given a prescription for KEFLEX. The patient was re-checked the following day and showed significant improvement. The outcome was reported as recovered. Documents held by sender: None.


VAERS ID: 443220 (history)  
Age: 1.03  
Gender: Male  
Location: Ohio  
Vaccinated:2011-09-20
Onset:2011-11-18
   Days after vaccination:59
Submitted: 2011-11-21
   Days after onset:3
Entered: 2011-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Public       Purchased by: Private
Symptoms: Injection site rash, Rash erythematous, Rash vesicular
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 at the time of vaccination
Preexisting Conditions: no preexisting conditions
Diagnostic Lab Data: He went to the Dr on 11/21 at 11:00 AM. They diagnosed it as a Zosters rash. They admitted that it could of come from his vaccination since he''s not been exposed to anybody with chicken pox or shingles.
CDC Split Type:

Write-up: In the early morning of 11/18 I noticed rash on the left leg of patient. It was raised and red, but not oozing or seeping. The rash did not go away over the weekend, and in fact seemed to spread by Monday, 11/21 when we took him to the Dr.


VAERS ID: 443482 (history)  
Age: 25.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-11-23
   Days after onset:63
Entered: 2011-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA684AA / - RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dyspnoea, Eye discharge, Pyrexia, Throat irritation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Unknown
Current Illness: eyes were red (pink eye)
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Itchy throat, difficulty breathing, slight fever and green drainage to both eyes. Advised Benadryl.


VAERS ID: 444320 (history)  
Age: 1.26  
Gender: Female  
Location: North Dakota  
Vaccinated:2011-09-20
Onset:0000-00-00
Submitted: 2011-12-02
Entered: 2011-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0140AA / 0 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0472AA / 0 LL / SC

Administered by: Private       Purchased by: Private
Symptoms: Rash morbilliform
SMQs:, 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: AMOXICILLIN
Current Illness: SINUSITIS
Preexisting Conditions:
Diagnostic Lab Data: NA
CDC Split Type: ND1135

Write-up: MEASLES LIKE RASH


VAERS ID: 444556 (history)  
Age: 18.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2011-09-20
Onset:2011-11-29
   Days after vaccination:70
Submitted: 2011-12-05
   Days after onset:6
Entered: 2011-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501096P / - - / IN
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB227AA / - - / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3842AA / - - / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR AC52B073AA / - - / IM

Administered by: Military       Purchased by: Military
Symptoms: Neisseria test positive, Pneumonia
SMQs:, Eosinophilic pneumonia (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, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: 12/2: positive lab for nessieria meningitidis.
CDC Split Type:

Write-up: Visit sickcall for afebrile pneumonia.


VAERS ID: 444686 (history)  
Age: 0.99  
Gender: Male  
Location: West Virginia  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-12-06
   Days after onset:77
Entered: 2011-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4114BA / 0 UN / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB498AA / 0 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH168AA / 3 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E55587 / 3 UN / IM

Administered by: Public       Purchased by: Private
Symptoms: Convulsion, Crying, Dyskinesia, Pyrexia, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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:
Current Illness:
Preexisting Conditions: Genetic disorder Propionic acidemia
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, seizure (unresponsive and jerking), odd cry.


VAERS ID: 444954 (history)  
Age: 56.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-12-08
   Days after onset:79
Entered: 2011-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA638AA / - LA / -

Administered by: Other       Purchased by: Other
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Pain
SMQs:, Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

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

Write-up: Severe burning sensation when vaccine administered. Started having a deep ache in the arm that night, radiated from the shoulder to the elbow. Lasted several days. Have had pain intermittently since, worse yesterday and today. Very sore to the touch. Painful if moved certain ways.


VAERS ID: 445208 (history)  
Age: 55.0  
Gender: Male  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-23
   Days after vaccination:3
Submitted: 2011-12-12
   Days after onset:80
Entered: 2011-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U4088AA / 0 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Antinuclear antibody, Injection site pain, Injection site reaction, Polyarthritis, Seroma
SMQs:, Systemic lupus erythematosus (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (narrow)

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

Write-up: Initial large painful seroma at site of injection. Several days later followed by the onset of severe polyarticular inflammatory arthritis unimproved with steroids, somewhat improved with adalimumab (Humira.)


VAERS ID: 445586 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-20
Onset:2011-11-24
   Days after vaccination:65
Submitted: 2011-12-15
   Days after onset:21
Entered: 2011-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV284 / 0 RA / IM
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / 0 LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Maternal exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

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: Positive pregnancy test on 11/24/2011
CDC Split Type:

Write-up: Patient received Smallpox on 08/23/2011 and 2 doses of anthrax vaccine one on 08/23/2011 and the other on 09/20/2011. Deployed and returned because she had a positive pregnancy test on 11/24/2011. Patient''s first pregnancy.


VAERS ID: 445688 (history)  
Age: 50.0  
Gender: Female  
Location: Maryland  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-12-16
   Days after onset:87
Entered: 2011-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH467AA / 0 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site nodule
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: Synthroid Buspar Vitamin D Multiple Vitamin Tabs Antabuse Toprol XL Nitrostat Ginkoba
Current Illness: No
Preexisting Conditions: Problem List: Skin Tags Callus, left foot Congenital deafness ANA positive Palpitations Fatty liver disease GERD Conjunctivitis, Allergic
Diagnostic Lab Data: area examined at 12/6/11 office visit
CDC Split Type:

Write-up: Later in evening at home pt. noticed 1cm firm nodule at injection site.


VAERS ID: 447670 (history)  
Age: 79.0  
Gender: Male  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2012-01-12
   Days after onset:114
Entered: 2012-01-20
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT423AA / 0 RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0595AA / - LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B07 / - RA / UN

Administered by: Military       Purchased by: Unknown
Symptoms: Injection site pain
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: EFFEXOR XR; STRATTERA; SALAGEN; AVODART; Fentanyl Patch; DILAUDID; NEXIUM; Clonazepam; AMBIEN or SEROQUEL; ZOFRAN, Metoclopramide or Promethazine; Simvastatin; Lactulose; LOMOTIL; GAVISCON Extra Strength; Calcium w/vitamin D; Multivitamin;
Current Illness: Chronic pain
Preexisting Conditions: Penicillin (Rash); DEMEROL (nausea); IV contrast dye - suffocation; Total Knee Replacements with metal parts in both knees March 2010
Diagnostic Lab Data:
CDC Split Type:

Write-up: Needed vaccinations prior to cochlear implant surgery. As clinic location is distant from home, I had all 3 needed injected at the same time. Rt. upper arm had Tdap & influenza injections as is still remarkably painful after nearly 4 months.


VAERS ID: 447880 (history)  
Age: 74.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2012-01-20
   Days after onset:121
Entered: 2012-01-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH458AC / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood pressure increased, Chronic obstructive pulmonary disease, Condition aggravated, Heart rate increased, Injection site erythema, Pruritus, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Baby ASA; LANOXIN; ATIVAN; DIOVAN; LASIX
Current Illness:
Preexisting Conditions: No illness at time of vaccination; Allergies: PLAVIX and Sulfa; New information received on 07 Jan 2012: Additional medical history of COPD
Diagnostic Lab Data: BP increased 170/100, pulse increased 120, and pulse oximeter reading of 90%.
CDC Split Type: 201109168

Write-up: Initial non-serious report received from a healthcare professional on 21 September 2011 under the local reference number 11-0601. A 74-year-old female patient who had many medications for years and allergies to PLAVIX and Sulfa had received a "lasted" intramuscular dose of FLUZONE HIGH-DOSE (batch number UH458AC) in the left deltoid on 20 September 2011. The patient had no illness at time of vaccination. The patient had no other vaccination within 4 weeks prior to 20 September 2011. On 21 September 2011 in the afternoon, the patient was seen by the physician for local redness on left arm with injection site "larger than a half dollar" with a rash over entire body, BP increased 170/100, pulse increased 120, and pulse oximeter reading of 90%. The patient required a doctor visit. At the time of the report, the patient had not recovered. Follow-up information received on 17 January 2012. Due to the following information, the case was upgraded from non-serious to serious: Concomitant medications included Baby ASA, LANOXIN, DIOVAN, ATIVAN and LASIX. The reporter clarified that the rash was from head to toe with terrible itching. The duration site was approximately 4 x 6 inches of erythema (adverse event coding updated to reflect size of vaccination reaction). The patient had recovered after treatment with steroids (one week later, the rash improved). Seventeen days after vaccination (which was on 17 October 2011), the patient was hospitalized due to COPD exacerbation. The reporter was not sure if this was aggravated by her reaction to the FLUZONE vaccine. Diagnostic tests/laboratory data or treatments for the COPD were not reported. Hospital discharge date not reported. At the time of this report, the patient had recovered (date not reported).


VAERS ID: 450413 (history)  
Age: 6.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:2
Entered: 2012-02-23
   Days after submission:154
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Private       Purchased by: Other
Symptoms: Rash generalised, Urticaria, Vaccination error
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (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: Concomitant Drug(s) Not Reported
Current Illness: Egg allergy; 2) milk allergy
Preexisting Conditions: At the time of vaccination patient was not ill; FLUMIST successfully administered in 2009 and 2010.
Diagnostic Lab Data:
CDC Split Type: MEDI0013573

Write-up: A non-serious spontaneous report of FLUMIST administered to patient with history of egg allergy, rash over body and hives over body has been received from a non-health professional concerning a six-year-old female, subsequent to FLUMIST. The patient''s past medical history included egg allergy in 2007 and milk allergy in 2008. The patient was not ill at the time of vaccination. No concomitant medications have been reported for this patient. The patient received FLUMIST on 20-Sep-2011. The patient had previously received FLUMIST in 2009 and 2010. On 21-Sep-2011 at 6:30 PM, the rash and hives began then at 7:00 PM diphenhydramine was administered. On 22-Sep-2011 at 7:00 AM, the rash subsided. The outcome of FLUMIST administered to patient with history of egg allergy, rash and hives was resolved on 22-Sep-2011.


VAERS ID: 451657 (history)  
Age: 54.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2012-03-06
   Days after onset:168
Entered: 2012-03-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 0 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Blepharospasm, Headache, Injection site pain, Injection site warmth
SMQs:, Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES1110USA01452

Write-up: Information has been received from a 54 year old female with no pertinent medical history and no drug reaction/allergies who was vaccinated (approximately 20-SEP-2011) with RECOMBIVAX HB 10 mcg/mL. There was no concomitant medication. The patient reported that following administration of the first dose of RECOMBIVAX HB, on approximately 20-Sep-2011 ("approximately three weeks ago"), she experienced injection site soreness and warmth within hours following the vaccination. The patient also reported that she began to develop headaches approximately two days after receiving the vaccine (on approximately 22-Sep-2011), and a twitch in left lower eyelid approximately one week following the vaccination (on approximately 27-SEP-2011). No lab diagnostics studies were performed. The patient did not seek medical attention. No treatment given for the events. At the time of reporting, the patient was recovering from all reported adverse events. Follow up information has been received from the physician who said this was not one of his patients. Additional information has been requested.


VAERS ID: 451660 (history)  
Age: 0.4  
Gender: Male  
Location: New Jersey  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-12-28
   Days after onset:99
Entered: 2012-03-09
   Days after submission:72
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4002AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1317 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 916973 / - RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Irritability, Local swelling
SMQs:, Angioedema (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No concurrent illnesses, no known allergies, no concomitant medications.
Diagnostic Lab Data: None
CDC Split Type: 201109211

Write-up: Initial report received on 22 September 2011 from a nurse. This case involves one 4-month old patient who is part of a cluster of 3 patients from the same reporter, and with the same vaccines administered. Information regarding the other 2 patient who are also 4 months old have been captured in case number 2011-09210. A 4-month-old male patient (dates of birth unknown) who had no concurrent illnesses, and no known allergies had received a second intramuscular right leg injection of ACTHIB (lot number UH409AA, sanofi pasteur SA lot number G1317-1), and a second intramuscular left leg injection of DAPTACEL (lot number C4002AA), and an intramuscular right leg injection of PREVNAR (Wyeth, lot number 916973) on 20 September 2011 and the following day the patient was brought back to the office with swollen right foot that started the same day of vaccination. The patient required medical evaluation and was advised to take TYLENOL for the swelling and irritability. It was reported "med RX not available for demographics". No relevant diagnostic tests and or laboratory data were performed. Twenty-five gauge, 5/8 inch (15.875 mm) needled were used for the vaccinations. The patient recovered on an unspecified date. Documents held by sender: None.


VAERS ID: 453637 (history)  
Age: 0.2  
Gender: Unknown  
Location: Unknown  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2012-03-29
   Days after onset:191
Entered: 2012-04-10
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Infrequent bowel movements
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Hirschsprung''s disease
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA00690

Write-up: Information has been received from a certified nurse practitioner concerning an 8 week old patient with a history of Hirschsprung''s disease that was repaired (unspecified repair), who "about two weeks ago" on approximately 20-SEP-2011 was vaccinated with a dose of ROTATEQ (dose, route and lot # not reported). The nurse reported that about two weeks ago, on approximately 20-SEP-2011 the patient developed slowed down bowel movements and a loss of appetite after receiving ROTATEQ. The development of slowed down bowel movements and loss of appetite occurred shortly after the vaccine was administered. The patient sought unspecified medical attention. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 455248 (history)  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-09-20
Onset:2011-09-22
   Days after vaccination:2
Submitted: 2012-03-12
   Days after onset:172
Entered: 2012-05-09
   Days after submission:58
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR D1101 / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Anxiety, Arthropod bite, Decreased appetite, Heart rate increased, Muscle twitching, Palpitations, Paraesthesia, Stress
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (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:
Preexisting Conditions: The patient had no illness at the time of vaccination. It was unknown if the patient had any past medical history or took any concomitant medications. Follow-up 05 March 2012. the physician noted a lot of anxiety and suggested talking to a counselor about stress.
Diagnostic Lab Data: Not reported
CDC Split Type: 201109376

Write-up: Initial report was received from a consumer on 27 September 2011. A female patient had received the first dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 20 September 2011 and three days later on 22 September 2011 experienced a rapid heart rate tat lasted for two hours. The patient had received the second dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 23 September 2011 and later that day experienced rapid heart rate. The patient took BENADRYL and the rapid heart rate lasted one and a half hours. The patient also experienced muscle twitching after the second dose. The patient had received the third dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 27 September 2011 and later that day experienced rapid heart rate that lasted one and a half hours. No other vaccinations were given within four weeks and the patient had no illness at the time of vaccination. It was unknown if the patient had any past medical history or took any concomitant medications. No further information was available at the time of the report. The patient''s outcome was not reported. Follow-up information was received from a consumer on 05 March 2012. On 27 September 2011, the patient was seen in follow-up with concern that she may be having an allergic reaction to the vaccination. The physician stated that the symptoms were relatively mild and recommended continuing the vaccination. On 10 October 2011, the patient as seen again for heart palpitations, loss of appetite and legs tingling. She thought she had Lyme disease due to a tick bite " weeks ago". The physician noted a lot of anxiety and suggested talking to a counselor about the stress. The patient outcome was reported as recovered/resolved. Documents held by sender: none.


VAERS ID: 460089 (history)  
Age: 1.03  
Gender: Male  
Location: New York  
Vaccinated:2011-09-20
Onset:2012-06-01
   Days after vaccination:255
Submitted: 2012-07-25
   Days after onset:54
Entered: 2012-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0605AA / 0 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Pruritus, Rash, Scab, Varicella post vaccine
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:
Other Medications: No other medications
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1206USA05119

Write-up: Information has been received from a nurse concerning a 21 month old male who on 20-SEP-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot# 670102/0605AA), (0.5mL, Subcutaneously). In around June 2012, the patient experienced chicken-pox and the physician believes the child got chicken-pox from his grandmother, who received ZOSTAVAX (Merck) (Lot#, dose and route not reported). The patient sought medical attention by an unspecified way. The adverse event was improving. At the time of reporting, the patient was recovering. Follow up information has been received from the physician concerning the 22 month (previous reported as 21 month) old male patient with no pre-existing allergies, birth defects, medical conditions and no illness at time of vaccination who on 20-SEP-2011 at 11:12 was vaccinated with the first dose of VARIVAX (Merck) (Lot# 670102/0605AA), IM (previously reported as subcutaneously) into the right thigh. The physician stated that patient experienced rash for 15 days and itchy started on shoulder and spread scabbed over. No relevant diagnostic tests were performed. At the time of the report, the patient had recovered from rash and itchy. Outcome of chicken pox was unknown. The physician also stated that the patient''s grandmother had shingles (MARRS case #1207USA005119). Additional information has been requested.


VAERS ID: 481169 (history)  
Age: 49.0  
Gender: Female  
Location: Iowa  
Vaccinated:2011-09-20
Onset:2011-10-13
   Days after vaccination:23
Submitted: 2012-11-30
   Days after onset:414
Entered: 2013-01-10
   Days after submission:41
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED N55105 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Musculoskeletal pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), 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: Albuterol; Antihypertensives
Current Illness: Penicillin drug allergy; SULFA drug allergy
Preexisting Conditions: Fibromyalgia; COPD (Chronic pulmonary obstructive disease); High blood pressure; GERD
Diagnostic Lab Data:
CDC Split Type: 2011030087

Write-up: Description of Event or Problem: This medically confirmed spontaneous report (initial receipt 13-Oct-2011) concerns a female patient who had a history of fibromyalgia, COPD (Chronic pulmonary obstructive disease), high blood pressure, GERD (Gastroesophageal reflux disease), penicillin allergies and SULFA allergies. Concomitant medications included salbutamol and anti-hypertensives. Upon follow up it was reported that the patient had no other illness at time of vaccination, pre-existing allergies, birth defects or medical conditions. On 20-Sep-2011 at 19:30 the patient received AFLURIA (batch number: N55105) injection intramuscularly into her left arm at a dose of 0.5 mL. On 13-Oct-2011 the patient called the pharmacist stating she has experienced arm pain, had difficulty/decreased range of motion of her left arm and had difficulty sleeping due to the pain after receiving AFLURIA. She also reported injection site reaction resulting in sore arm and shoulder. It hurt to move arm and raise above her head. The event outcome was recovered on 20-Oct-2011. The reporter considered events as non serious. Follow up (01-May-2012) : time of vaccination, lot number, additional AE terms, event outcome, medical history, reporter''s causality assessment. Follow-up (17-Jul-2012) : further adverse events detail and recovery date.


VAERS ID: 488637 (history)  
Age: 65.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-20
Onset:2011-11-27
   Days after vaccination:68
Submitted: 2013-04-07
   Days after onset:496
Entered: 2013-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT480AA / - RA / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB942AC / 0 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Atrial fibrillation, Cardiac pacemaker insertion, Heart rate increased, Laboratory test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow)

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: None
Preexisting Conditions: None
Diagnostic Lab Data: Many more tests and many more episodes of fast heart rate. Now have a pacemaker and A-FIB and many drugs.
CDC Split Type:

Write-up: Heart rate went to 170 went to ER was admitted over night. Heart rate was converted back to normal.


VAERS ID: 592500 (history)  
Age: 0.74  
Gender: Male  
Location: California  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2015-09-02
   Days after onset:1442
Entered: 2015-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U14119CA / - - / -

Administered by: Private       Purchased by: Other
Symptoms: Food allergy, Hypersensitivity, Pyrexia, Rhinorrhoea
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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:
Other Medications: Tylenol once the fever got high
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Allergy to eggs and many other food and environmental
CDC Split Type:

Write-up: Started with a runny nose then turned into a 103+ fever. Called our pediatrician''s after care nurse line on 9/25/2011.


VAERS ID: 607259 (history)  
Age: 65.0  
Gender: Male  
Location: Alabama  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2012-03-08
   Days after onset:169
Entered: 2015-11-03
   Days after submission:1335
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0811AA / 1 GM / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema multiforme, Pain in extremity, Peripheral swelling, Vaccination site induration
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (narrow), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None, routine follow up appointment with PCP.
Preexisting Conditions: HTN; dyslipidemia; DJD; diverticulosis; Allergies: ZOCOR, PRAVACHOL, LIPITOR
Diagnostic Lab Data:
CDC Split Type:

Write-up: Erythema multiforme and induration of vaccinated area, (R) arm soreness/swelling. Diphenhydramine, amoxicillin/clavulanate 875 mg BID.


VAERS ID: 436197 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-20
Onset:2011-09-20
   Days after vaccination:0
Submitted: 2011-09-29
   Days after onset:9
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
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