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Case Details (Sorted by Vaccination Date)

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VAERS ID:331553 (history)  Vaccinated:2008-11-06
Age:3.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-06, Days after onset: 0
Location:Pennsylvania  Entered:2008-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: HERE FOR FLU SHOT ONLY
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE AS OF YET
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA375AA1IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: SO FAR, SHE HAS HAD NONE

VAERS ID:331568 (history)  Vaccinated:2008-11-06
Age:3.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-06, Days after onset: 0
Location:Minnesota  Entered:2008-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500569P0IN 
Administered by: Public     Purchased by: Public
Symptoms: Accidental exposure
SMQs:
Write-up: Went to give the child the flumist (nasal), and child jolted head back as spraying - small amount of flumist sprayed into child''s eye. We immediatelty flushed with water. Patient did not have any effects.

VAERS ID:331573 (history)  Vaccinated:2008-11-06
Age:16.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-06, Days after onset: 0
Location:Oklahoma  Entered:2008-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Rash~Hep B (no brand name)~2~4~In Patient
Other Medications: none
Current Illness: none
Preexisting Conditions: Hepatits B vaccination
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0652X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2727AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pruritus, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Pt. has had an adverse reaction the hepatitis B shot in the past that consisted of a rash with an onset of 10 minutes after administration. Pt. received HPV shot and meningoccal today. I waited 15 minutes between adminstration of each vaccine to check for reactions. The meningococcal vaccine was adminstered first with no reaction. After 15 minutes the HPV vaccine was adminstered and patient had some localized itching at the injection site and some slight itching on her face but did not report any problems swallowing or breathing. After 15 minutes the patient left the office with instructions to call if itching increased. After one hour the patient''s mother called in complaining of increased itching by the patient. The patient was informed to come in and per Dr. a 4mg/ml 1 ml dose of dexamethasone sodium phospate was injected in the gluteus muscle. The patient was held at the office for one hour and reported feeling better with less itching. The patient was sent home with instructions to go to the ER if any signs of trouble breathing or swallowing were found.

VAERS ID:331686 (history)  Vaccinated:2008-11-06
Age:23.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-07, Days after onset: 1
Location:Connecticut  Entered:2008-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paxil, Ortho-tricycline
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Public     Purchased by: Unknown
Symptoms: Asthenia, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Developed a slight fever and weakness as well as headaches.

VAERS ID:331687 (history)  Vaccinated:2008-11-06
Age:47.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-07, Days after onset: 1
Location:New York  Entered:2008-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: chantix
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2768AA UNLA
Administered by: Public     Purchased by: Private
Symptoms: Dyspnoea, Heart rate increased, Pyrexia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: 6 hours after getting the flu shot I Developed a fever that rose to 103 degrees. I had difficuly breathing and my heartrate was faster than normal and I was wheezing.

VAERS ID:331706 (history)  Vaccinated:2008-11-06
Age:32.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-07, Days after onset: 1
Location:Mississippi  Entered:2008-11-07
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: Cancer, Asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Dyspnoea, Feeling abnormal, Feeling of body temperature change, Hyperhidrosis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: On Nov. 6th I was administered the flu vaccine at my job....It was given to me around 6:30am..around 3:30pm - 4:30pm I started breaking out in sweat. I was hot then cold...My teeth was knocking I was so cold. My temp. got up to 101 before I started taking tylenol. The symptoms last about 3:30pm til about 8:30pm when I finally feel asleep. I felt awful. My wife tells me I was having a diffcult time breathing in my sleep.

VAERS ID:331878 (history)  Vaccinated:2008-11-06
Age:52.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-10, Days after onset: 4
Location:New Mexico  Entered:2008-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fatigue~ ()~NULL~10~In Patient
Other Medications:
Current Illness: No
Preexisting Conditions: History of fatigue with Tetanus vaccine.earliest recollection is at 10 years 0f age---noy sure what tetanus shot was given.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Condition aggravated, Fatigue, Headache, Induration, Influenza like illness, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Lymphadenopathy, Nausea, Pain, Pyrexia
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)
Write-up: Flu-like symptoms to include fever, headache, body aches, nausea, extreme tiredness, pain, redness, swelling, hard knot the size of an Olympic medal at injection site, chills, swollen lymph glands, all of which began late in the day the injection was given (11:00 in the morning) and lasting for two full days, fatigue and arm soreness, redness and knot lasting into the third day. (today)

VAERS ID:331882 (history)  Vaccinated:2008-11-06
Age:37.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-10, Days after onset: 4
Location:Texas  Entered:2008-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: was not sick or showing signs of illness prior to vaccine. No one in household was sick either.
Preexisting Conditions: allergy to codeine and codone
Diagnostic Lab Data: no lab test were done after the reaction
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0 LA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Cough, Fatigue, Feeling cold, Lacrimation increased, Ocular hyperaemia, Palpitations, Pyrexia, Throat irritation, Throat tightness, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Lacrimal disorders (narrow), Hypersensitivity (broad)
Write-up: Got the flu shot around 5pm and around 8:30pm started feeling a little tickle in my throat. The tickle started getting worse and i started coughing a lot. Then it seemed like my throat was closing up. I also started shivering and felt extremely cold (chills). I began vomiting, my heartbeat was racing, my eyes were real red (on the white part) and watery. I was also wheezing when i exhaled. I took two capsules of Benadryl and after about 20 minutes my throat felt better. I was breathing better. I still had chills and now had a fever of 101.8. Most of the symptoms subsided but I have remained tired and fatigued feeling. I have also had low grade fever off and on for 3 days now. I went to see the doctor on Friday and she believes I did indeed have an allergic reaction to the flu shot. I am also allergic to codeine and codone.

VAERS ID:331896 (history)  Vaccinated:2008-11-06
Age:67.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-10, Days after onset: 4
Location:Oklahoma  Entered:2008-11-10
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Quadrupal bipass 9 yrs. ago, Back surgery 5 yrs. ago, In early July had stone removed from bladder. 1 1/2 months ago had basal cell CA removed from forehead. Allergic to Loratab
Diagnostic Lab Data: Had blood test for infection and neg.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICSU2772AA4IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0886F0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Asthenia, Balance disorder, Blood test normal, Chills, Discomfort, Erythema, Headache, Hypersensitivity, Inflammation, Malaise, Musculoskeletal stiffness, Oedema peripheral, Pain, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Received telephone call from patient at 9:00 a.m. He states he had a flu and pneumonia shot 11/6/08 at 10:30 a.m. in his left arm. He states he had a sever reaction to his shot per ER. He is ok this morning. He is a little sore and red. Thursday a little after lunch his left arm became swollen, stiff and sore. Later he developed weakness and was not feeling well, "feeling fluish". Had headache, sick, dull, arm swollen and red from the shoulder down. Started chilling late in the afternoon and evening. States very uncomfortable, and lackadaisical. Did not want to eat. Took Advil and went to bed. When he got up in the night he was unstable on his feet. Friday the redness extended down his arm to his armpit and was light pink and swollen and very sore. Stayed in bed till 10 a.m. with a headache. Did not eat breakfast. Ate very little lunch just did not feel like eating. Arm still bright pink. Called CDC hot line at 6 p.m. It said if you have a reaction that last past 24 hours you need to see the MD. He said it was too late to see anyone that night. Saturday morining arm is still inflamed. Called clinic and they told him to call the Nurse hot line. They refered him to an MD. So midmorning he went to the ER. This is 48 hours after immunizations. They said no infection. Allergic reaction. Since he had taken the flu shot in the past with out reaction it was probably the pneumonia vaccine. Gave him a steroid shot in the hip. Told him not to take the penumonia vaccine again or it could kill him. Gave him Rx for steroids to get filled on Sunday if not improved. Sunday morning he was a little better. Arm still pink but better. Monday (today) his arm is norm color and he is feeling much better. Just wanted to let us know he had a severe reaction to the pneumonia shot. I told him I would report it to VAERS.

VAERS ID:331900 (history)  Vaccinated:2008-11-06
Age:8.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Male  Submitted:2008-11-10, Days after onset: 3
Location:Arizona  Entered:2008-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2734HA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: REDNESS, SWELLING, WARMTH AND TENDERNESS AT INJECTION SITE THE DAY AFTER INFLUENZA VACCINE ADMINISTERED.

VAERS ID:331901 (history)  Vaccinated:2008-11-06
Age:40.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-10, Days after onset: 4
Location:North Carolina  Entered:2008-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0399X2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Injection site swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: (1) Pain up and down arm during injection (2)generalized urticaria beginning one hour after injection - including face, lips, and chest, for several days after injection (3) pain and swelling at injection site for several days after injection

VAERS ID:331906 (history)  Vaccinated:2008-11-06
Age:18.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Female  Submitted:2008-11-10, Days after onset: 3
Location:Idaho  Entered:2008-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Seasonale,Xyzal, Nasonex,Ventolin
Current Illness: none
Preexisting Conditions: Allergic Rhinitis, History Pneumonia
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR2550AA0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1382U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Erythema, Local reaction, Pyrexia, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Localized swelling, tenderness, erythema, fever and chills.

VAERS ID:331980 (history)  Vaccinated:2008-11-06
Age:7.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Male  Submitted:2008-11-10, Days after onset: 3
Location:Washington  Entered:2008-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2829AA4IMLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: (L) deltoid. Symp started 11/7/08. Redness swelling itching spread from top of shoulder down toward elbow. Pt given Benadryl symp. resolved by 11/9/08.

VAERS ID:331924 (history)  Vaccinated:2008-11-06
Age:49.0  Onset:2008-11-08, Days after vaccination: 2
Gender:Female  Submitted:2008-11-11, Days after onset: 3
Location:Wisconsin  Entered:2008-11-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: allopurinol, cephalexin monohydrate, evista, indomethacin, lasix, synthroid
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Called drs office on Monday. Told that hives were unlikely. Decided against going to urgent care after doing personal research and realizing that hives can be a reaction and that nothing else had changed in my lifestyle. Treated sites wi
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERNOT KNOWN0UNLA
Administered by: Public     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives developed on my left elbow on Saturday afternoon. More hives appeared on my inner forearm on Sunday morning.

VAERS ID:332080 (history)  Vaccinated:2008-11-06
Age:4.0  Onset:2008-11-08, Days after vaccination: 2
Gender:Male  Submitted:2008-11-08, Days after onset: 0
Location:Virginia  Entered:2008-11-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PULMICORE; ALBUTEROL
Current Illness: None
Preexisting Conditions: No allergies; Past Hx of ear infections; Allergic rhinitis; Bronchospasm
Diagnostic Lab Data:
CDC 'Split Type':
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DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2799AA4IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2754AA3IMLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site rash, Rash erythematous, Rash macular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red, blotchy, itchy rash over the site of DAPTACEL injection over the lateral aspect of the R thigh. Treated with local care, antihistamines as necessary.

VAERS ID:332096 (history)  Vaccinated:2008-11-06
Age:12.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Female  Submitted:2008-11-12, Days after onset: 5
Location:North Carolina  Entered:2008-11-12
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: n/a
Preexisting Conditions: Allergy to penicillin
Diagnostic Lab Data: Neurological exam given by doctor.
CDC 'Split Type':
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HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB294BA2IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Facial pain, Facial palsy, Hypoaesthesia facial, Hypoaesthesia oral, Neurological examination, Oral herpes, Sensory loss, Similar reaction on previous exposure to drug
SMQs:, Peripheral neuropathy (narrow), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (broad)
Write-up: After final dose of both Hepititis A Vaccine, and HPV Vaccine my daughter awoke the following morning; (less than 24hrs) with complete paralysis of the left side of her face. Unable to smile on left side, close left eye completely, unable to stick out tongue or move it side to side. Complained of numbness and pain on left side of face. Prior to this, after last doses; my daughter complained that she was having problems with her tongue and taste buds, had one incident of severe pain in her ear which lasted one day, complained of stomach pain unrelated to anything, general aches and pains, and headaches. I called the doctor''s office after assessing the situation and brought her in to be evaluated. The doctor felt it was unrelated to the vaccines and diagnosed her with Bell''s Palsy. She provided patient with a neuroligical examination and a prescription of Prednisone and Acyclovir. She took the Acyclovir for 5 days and is still taking the steroids with no benefits or improvements. She will be rechecked on 11/17/08. 11/19/08-records received-office visit 11/7/08-C/O tingling of tongue and can not move left side of face, cold sore left corner of mouth some decrease in sensation on left side of face. cannot completely close left eyelid. DX:Bell''s Palsy. Possibly related to herpes. Office visit 11/14/08-after 2nd Gardasil vaccine C/O sudden onset of ear pain that resolved same night. Bell''s Palsy appeared day after 3rd dose of Gardasil. At time of this office visit symptoms improving.

VAERS ID:332121 (history)  Vaccinated:2008-11-06
Age:3.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Male  Submitted:2008-11-12, Days after onset: 5
Location:Minnesota  Entered:2008-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: runny nose
Preexisting Conditions: occasional wheezing during winters - nebs used
Diagnostic Lab Data: Blood draw on 11/07/08 & again on 11/08/08. All cell counts were normal.
CDC 'Split Type':
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2789BA2IMLA
Administered by: Public     Purchased by: Private
Symptoms: Full blood count normal, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received flu shot on 11/06/08. The next day (11/07/08) around 11 am, left arm was hot, red, painful and swollen to 1 inch above elbow. Saw dr around 1 pm and was placed on antibiotics, Benedryl and Tylenol. On 11/08/08 swelling spread into the chest area and down past the elbow of left arm. Area was hot, red and painful. Saw Dr.at 11 am on 11/08/08. Placed on steroid medication.

VAERS ID:332142 (history)  Vaccinated:2008-11-06
Age:13.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-12, Days after onset: 6
Location:California  Entered:2008-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: ADMINISTERED ADULT ONLY
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA178AA IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0650X0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Incorrect dose administered
SMQs:
Write-up: NONE

VAERS ID:332144 (history)  Vaccinated:2008-11-06
Age:4.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-12, Days after onset: 6
Location:California  Entered:2008-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: ADULT USE ONLY ON INFLUENZA
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B087BA4IMLA
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA178AA IMRA
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURA04903IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1079K1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0135K1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: NONE

VAERS ID:332203 (history)  Vaccinated:2008-11-06
Age:26.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Female  Submitted:2008-11-08, Days after onset: 1
Location:Georga  Entered:2008-11-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUREJN234A0UNUN
Administered by: Public     Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Headache, Myalgia, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad)
Write-up: Headache Vomiting & Nausea Dizziness Muscle Pain Difficulty Breathing no wheeze. Given EPI PEN x1, IV ATIVE & MORPHINE for symptomatic treatment

VAERS ID:332587 (history)  Vaccinated:2008-11-06
Age:26.0  Onset:2008-11-08, Days after vaccination: 2
Gender:Female  Submitted:2008-11-17, Days after onset: 9
Location:Florida  Entered:2008-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO-TRICYCLINE LOW
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE LABS: CT scan c-spine revealed disk herniation C5-C6; disk bulging C6-C7.
CDC 'Split Type':
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89685 IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Computerised tomogram abnormal, Intervertebral disc protrusion, Muscle spasms, Musculoskeletal pain, Neck pain, Pain in extremity, Rash, Sensation of heaviness, Sleep disorder, Soft tissue disorder, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dystonia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: CLIENT STATED THAT THE FIRST TWO DAYS AFTER THE FLU SHOT, SHE HAD "A RASH AND MY ARM FELT HEAVY. THERE WAS SOME PAIN, BUT NOT ALOT." SHE THEN GOES ON TO SAY THAT THE THIRD DAY AFTER THE FLU SHOT SHE HAD A SHARP BURNING PAIN THAT RADIATED UP HER RIGHT NECK AND DOWN HER RIGHT ARM. SHE SAID THAT SHE TOOK TYLENOL, USED THE COLD COMPRESSES, TOOK HOT SHOWERS, BUT DID NOT GET ANY RELIEF AND CANNOT SLEEP. SHE DID NOT TAKE HER TEMPERATURE SO SHE IS NOT AWARE OF A FEVER. SHE CALLED OUR OFFICE BEFORE GOING TO SEE A DOCTOR. ENCOURAGED HER TO SEE HER PRIMARY CARE PHYSICIAN. SHE SAID THAT SHE DOES NOT HAVE ONE SHE WOULD HAVE TO GO TO THE ER. 2/5/09 Received ER medical records of 11/21/2008. FINAL DX: cervicalgia; pain in limb Records reveal patient experienced right side neck & shoulder pain x several weeks. Exam noted sever muscle spasm of right posterior neck & severe soft tissue tenderness of right upper neck. Tx w/steroids & pain meds. Phone f/u revealed patient improved on 11/24/08.

VAERS ID:332590 (history)  Vaccinated:2008-11-06
Age:10.0  Onset:2008-11-11, Days after vaccination: 5
Gender:Male  Submitted:2008-11-17, Days after onset: 6
Location:California  Entered:2008-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0~In Patient|none~ ()~~0~In Sibling
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500546P1IN 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Impetigo, Rash, Staphylococcal infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 11/06/2008 received FluMist at Flu Clinic/Exercise. 11/11/08-noticed slight rash on rt. side of upper lip, during weekend spread to outer left side of nostril. MOC took child to clinic on 11/17/08, rash dx. as staph infection (impetigo) given medication and instructions to stop spread, also told to report it to Public Health.

VAERS ID:332636 (history)  Vaccinated:2008-11-06
Age:39.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-17, Days after onset: 11
Location:Wisconsin  Entered:2008-11-17
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: Unknown
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED02749111A IMLA
Administered by: Public     Purchased by: Private
Symptoms: Feeling hot, Hypertension, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow)
Write-up: 45 minutes after AFLURIA complained of feeling hot and nauseated. RN checked vitals: BP 144/100 pulse 72 skin warm and dry. Appears fine. Was talking on telephone when RN arrived for assessment. Voicemail left at pt''s home 11/14.

VAERS ID:332637 (history)  Vaccinated:2008-11-06
Age:52.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-17, Days after onset: 11
Location:Wisconsin  Entered:2008-11-17
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: Unknown
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR02749111A IMLA
Administered by: Public     Purchased by: Private
Symptoms: Body temperature increased, Discomfort, Injection site erythema
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient returned to flu clinic about 2 hours after injection of flu vaccine, complaining of discomfort and increased temperature. Per RN assessment, revealed mild redness around site.

VAERS ID:332650 (history)  Vaccinated:2008-11-06
Age:65.0  Onset:0000-00-00
Gender:Female  Submitted:2008-11-12
Location:Louisiana  Entered:2008-11-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': LA081102
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2356CA0IMLA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2848AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0961U0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: No adverse event reported by patient from DTAP administration.

VAERS ID:332653 (history)  Vaccinated:2008-11-06
Age:72.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-10, Days after onset: 4
Location:Minnesota  Entered:2008-11-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Calcium+D; COSAMIN DS; ADVIL; Keflex; SYNTHROID/LEVOXYL; PRINIVIL/ZESTRIL; Ocuvite; ZOCOR; Total Heart; Total Liver D-Tox; TYLENOL PM
Current Illness: None
Preexisting Conditions: Sulfa, Doxycycline
Diagnostic Lab Data: None
CDC 'Split Type':
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0742X1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Immunization given 11/6/08, very painful arm during night w/ rash. AM pt noted hot to touch. Evaluated by MD on 11/7/08- erythema, heat, swelling, tenderness at injection site and distally down right arm. Temperature 36.4. 11/10/08 Pt reports much better.

VAERS ID:332654 (history)  Vaccinated:2008-11-06
Age:  Onset:2008-11-10, Days after vaccination: 4
Gender:Unknown  Submitted:2008-11-17, Days after onset: 7
Location:California  Entered:2008-11-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; INSULIN R (INSULIN HUMAN); Lisinopril
Current Illness: Diabetes; Hepatic cirrhosis; Hypertension; Hyperlipidaemia
Preexisting Conditions:
Diagnostic Lab Data: chest x-ray; WBC count, 39,000
CDC 'Split Type': WAES0811USA01734
Vaccination
Manufacturer
Lot
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1076X IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest X-ray, Pneumonia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Information has been received from a physician concerning a patient with diabetes, cirrhosis, hypertension and hyperlipidaemia and no allergies, who on 06-NOV-2008 or 07-NOV-2008, was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23 (lot # 662599/1076X). Concomitant therapy included INSULIN R, LIPITOR and Lisinopril. On 10-NOV-2008 the patient went to the ER and was hospitalized for pneumonia. Laboratory diagnostics includes a white blood cell count of 39,000 and a chest x-ray. Additional information has been requested.

VAERS ID:332691 (history)  Vaccinated:2008-11-06
Age:47.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-18, Days after onset: 12
Location:Ohio  Entered:2008-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2768AA2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pain in extremity, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Patient received vaccine from Student Nurse on 11/6/08. Instructor present and cosigned paperwork. Patient contacted HD on 11/18/08 at 9:00am and reported that she has had pain in arm since vaccination. She stated that she saw her private Physician who informed her that she was not sure what was wrong with the injection site but that it could be infected and could potentially be Staph. Dr. prescribed Bactrum. Patient stated that she is beginning to lose the use of her arm and that the arm surface is pink and warm to the touch. Advised patient to keep in contact me the Health Department.

VAERS ID:332699 (history)  Vaccinated:2008-11-06
Age:52.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Female  Submitted:2008-11-18, Days after onset: 11
Location:Mississippi  Entered:2008-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: aleve, tylenol, and benadryl
Current Illness: none knkown
Preexisting Conditions: none known by client
Diagnostic Lab Data:
CDC 'Split Type': MS112008
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2802AA1IMRL
Administered by: Public     Purchased by: Public
Symptoms: Auricular swelling, Chills, Flushing, Local swelling, Musculoskeletal stiffness, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Took flu shot 11/6/08. Next morning woke up with flushed face and swelling of rt side of neck and stiffness. Used heating pad to neck all day. Neck "went down". Small node felt in right side of nectk. Client also reported chills all next day but never took temperature. Took tylenol and benadryl on 11/8 started noticing swelling and itching at ear lobes, temporal areas and under jaws. Small area 2 inch by 1 inch of pale rash at right side of face by ear on 11/13/08. Still complaining 11/13/08. Has not seen doctor but instructed to do so

VAERS ID:332703 (history)  Vaccinated:2008-11-06
Age:1.3  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-18, Days after onset: 12
Location:Illinois  Entered:2008-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: singulair, pulmocort
Current Illness: no acute illness
Preexisting Conditions: reactive airway disease
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN3IMUN
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUNKNOWN1IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had shots at 10am, had tylenol throughout the day, at 8pm crawled up in my lap did not feel real warm and started to seize, pt seizure last 8-10 minutes from the time that we called the ems until they carried him to the ambulance.

VAERS ID:332705 (history)  Vaccinated:2008-11-06
Age:26.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-18, Days after onset: 12
Location:Utah  Entered:2008-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Not known. PMH: fx bones, ulnar collateral ligament repair, reactive lymph nodes-neck
Diagnostic Lab Data: dental x-rays, MRI. Labs and Diagnostics: Head MRI WNL.
CDC 'Split Type':
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500545P IN 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Facial pain, Insomnia, Nuclear magnetic resonance imaging brain normal, Pain, Pain in jaw, Paraesthesia, Sinusitis, Tenderness, Toothache, Trigeminal neuralgia, X-ray dental
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Demyelination (broad), Depression (excl suicide and self injury) (broad), Osteonecrosis (broad)
Write-up: Within a couple hours of receiving the flumist vaccine, client experienced pain in the R upper jaw, he thought it was something related to a tooth. Pain continued to get more intense and dental visit showed no problem with his teeth. Pain continued to increase until it felt as though he had electric shocks in the upper R facial area. Was diagnosed with a sinus infection , but antibiotics did not help. Client was not sleeping and was in severe pain. Was hospitalized for the pain and an MRI was done- diagnosed with trigeminal neuralgia and is now on Tegretol and ibuprofen. The Tegretol has provided relief for the pain, but still has a dull ache. 12/01/08 MR received for DOS 1112-13/2008 with D/C DX: Trigeminal Neuralgia. Pt initially presented to dentist with c/o R-sided upper teeth pain. No problems found but Rx Z-pak for possible sinus infection. Pain worsened, disturbing sleep. Pain is sharp, lancinating near R ear, cheek and eye. (+) maxillary tenderness. PE WNL except for severe pain and crying. Tx with pain meds and Tegretol with some improvement.

VAERS ID:332771 (history)  Vaccinated:2008-11-06
Age:56.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-19, Days after onset: 13
Location:New Hampshire  Entered:2008-11-19
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: Percodan; Meclomen; Toradol
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2751AA4IMLA
Administered by: Other     Purchased by: Private
Symptoms: Aphthous stomatitis, Oedema mouth
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Received FLUZONE (L) deltoid 11/06/08 @ 4PM. Over a period of 2 hours felt "vaccine move from upper arm to shoulder to cheek." Following morning cheek swollen and mouth full of canker sores. Saw MD 11/7/08. Advised not to have FLUZONE again.

VAERS ID:332783 (history)  Vaccinated:2008-11-06
Age:84.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-19, Days after onset: 13
Location:Ohio  Entered:2008-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: none that I am aware of
CDC 'Split Type':
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2839AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
SMQs:
Write-up: Her physician called to report that her flu shot resulted in the inability to move her entire arm, but the condition is improving. Her arm was very sore and tender and the doctor thought maybe the injection had been given too high on her arm.

VAERS ID:332799 (history)  Vaccinated:2008-11-06
Age:3.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-19, Days after onset: 13
Location:California  Entered:2008-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA178AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: ADMINISTERED ADULT ONLY ON FLU

VAERS ID:332929 (history)  Vaccinated:2008-11-06
Age:31.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-20, Days after onset: 14
Location:South Carolina  Entered:2008-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRENATAL VITAMINS
Current Illness: NONE
Preexisting Conditions: PREGNANCY 27 WEEKS
Diagnostic Lab Data: WENT TO NURSES STATION AT WORK TO HAVE CHECKED OUT
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2839AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Hypoaesthesia, Injection site erythema
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: NUMBNESS IN HANDS AND ARMS, REDNESS AT SITE OF INJECTION

VAERS ID:332942 (history)  Vaccinated:2008-11-06
Age:60.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Female  Submitted:2008-11-21, Days after onset: 14
Location:Colorado  Entered:2008-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: REDNESS, SWELLING~Influenza (no brand name)~UN~~In Patient
Other Medications: UNKNOWN
Current Illness: NONE.
Preexisting Conditions: HYPOTHYROID
Diagnostic Lab Data: NONE.
CDC 'Split Type':
Vaccination
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0204X0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blister, Erythema, Oedema peripheral, Pruritus generalised, Tenderness
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: L-ARM: SHOT GIVEN - RED, TENDERNESS, SWELLING; NOTICED THE NEXT DAY; GOT WORSE IN THE NEXT 24-36 HOURS. R-ARM: NOTHING GIVEN - BLISTERS (2) ON FOREARM HALF WAY UP; FULL BODY ITCHYNESS. PATIENT CHOSE NOT TO BE SEEN - CALL THE CLINIC TO REPORT INCIDENT.

VAERS ID:332981 (history)  Vaccinated:2008-11-06
Age:49.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-18, Days after onset: 12
Location:Maryland  Entered:2008-11-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2806AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Cough, Dysphonia, Dyspnoea, Eye discharge, Ocular hyperaemia, Pharyngeal oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Difficulty breathing (chest felt tight/ heavy) Coughing, hoarseness, Throat felt swollen. Eyes became extremely red and filled with pus. This occurred approx. 4 hours after FLUZONE. Treated by paramedics (given oxygen) taken to hospital ER.

VAERS ID:333009 (history)  Vaccinated:2008-11-06
Age:57.0  Onset:2008-11-09, Days after vaccination: 3
Gender:Female  Submitted:2008-11-21, Days after onset: 12
Location:Nebraska  Entered:2008-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra D, Synthroid, Pre-pro, Aleve
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Audiogram
CDC 'Split Type':
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA365AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Audiogram abnormal, Headache, Hypoacusis, Oropharyngeal pain, Rhinitis, Tinnitus
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hearing impairment (narrow)
Write-up: 3 days after vaccine administer, developed headache, sore throat, rhinitis, tinnitis. Tinnitis persisted 2 weeks later; audiogram documents diminished hearing as compared to 2006 testing.

VAERS ID:333019 (history)  Vaccinated:2008-11-06
Age:5.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-21, Days after onset: 15
Location:Minnesota  Entered:2008-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra, albuterol PRN, Pulmicort or QVAR BID
Current Illness: None
Preexisting Conditions: Asthma, environmental allergies. No known food allergies.
Diagnostic Lab Data: Blood allergy testing for egg negative.
CDC 'Split Type':
Vaccination
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DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B084BB4IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2803AA3IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0664X1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1007X1SCLL
Administered by: Private     Purchased by: Public
Symptoms: Allergy test negative, Malaise, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: About 15 minutes after receipt of immunizations, pt developed swelling and rash of eyes, face, lips. Rash on trunk of body. General sense of "I don''t feel good."

VAERS ID:333027 (history)  Vaccinated:2008-11-06
Age:0.5  Onset:2008-11-11, Days after vaccination: 5
Gender:Male  Submitted:2008-11-21, Days after onset: 10
Location:Hawaii  Entered:2008-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol HFA
Current Illness: diarrhea and emesis
Preexisting Conditions: reactive airway disease. PMH: none
Diagnostic Lab Data: see #7 Labs and Diagnsotics: Abd X-ray (+) for BO. Abd US (+) for IS. Barium enema (+) for IS.
CDC 'Split Type':
Vaccination
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Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC2IBI43AA2IMLL
HIBV: HIB (PROHIBIT)SANOFI PASTEURUF505AB2IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC22832IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.047OX0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal X-ray, Barium enema, Barium enema abnormal, Cyanosis, Decreased appetite, Dehydration, Enema administration, Hypophagia, Intussusception, Irritability, Lethargy, Pyrexia, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt received Pediarix, Hib, PCV, and rotavirus vaccines on 11/6/08. On 11/17 he was admitted for intussusception. He was discharged 11/19 after successful reduction by barium enema. 11/26/2008 MR received for DOS 11/17-19/2008 with D/C DX: Intussusception. Diarrhea. Pt presented to ER with 5 day hx of diarrhea, irritabily, ear grabbing, fever and decreased appetite and 1 day hx of vomiting everything eaten. En route to ER vomited, turned blue and appeared to have stopped breathing, but quickly recovered. Upon admission appeared dehydrated. initially thought to be AGE. Pt remained lethargic and unable to take po. IS dx by X-ray and US. Reduced by barium enema with immediate improvement in pt condition.

VAERS ID:333043 (history)  Vaccinated:2008-11-06
Age:49.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-12, Days after onset: 6
Location:Wyoming  Entered:2008-11-21, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Food allergy to sage
Diagnostic Lab Data: Symptoms had subsided by the time she was seen by MD so no medication was given. MD recommended Benadryl at home but patient didn''t need it.
CDC 'Split Type':
Vaccination
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Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89745 IMUN
Administered by: Other     Purchased by: Private
Symptoms: Diarrhoea, Dyspnoea, Hypersensitivity, Pharyngeal oedema, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Pseudomembranous colitis (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Pt called the store and reported that she was having allergic reaction including hives, diarrhea, possible swelling in the throat and some difficulty breathing. Pharmacist on duty advised her to go to the ER. Pt did go to walk in clinic but by the and she was seen, symptoms were gone and no treatment was needed or given.

VAERS ID:333066 (history)  Vaccinated:2008-11-06
Age:34.0  Onset:2008-11-18, Days after vaccination: 12
Gender:Female  Submitted:2008-11-19, Days after onset: 1
Location:Arizona  Entered:2008-11-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: HTN
Diagnostic Lab Data:
CDC 'Split Type':
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VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0392X0SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Fatigue, itch at injection site, sore, red. 2 cm area erythema at injection site, no induration, no cellulitis - otherwise nl exam.

VAERS ID:333180 (history)  Vaccinated:2008-11-06
Age:22.0  Onset:2008-11-12, Days after vaccination: 6
Gender:Female  Submitted:2008-11-25, Days after onset: 13
Location:Minnesota  Entered:2008-11-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin, vitamin C
Current Illness:
Preexisting Conditions: Allergy to dust and mold. Asthma. Type I diabetes.
Diagnostic Lab Data: Contacted emergency nurse line late night, instead of going into urgent care or emergency. Was directed to monitor hives and their spread. Was told to go to emergency if hives spread to palms, soles of feet, or if throat started to close up
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Chills, Injection site pain, Injection site urticaria, Pain in jaw, Pruritus, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Osteonecrosis (broad), Hypersensitivity (narrow)
Write-up: Initial large hives on the arm of the injection between shoulder and elbow, spreading down to forearm after two days. Extremely itchy and painful. Treated with anti-itch cream and oatmeal paste. Pain radiated up from injection site and into jaw, causing pain similar to toothache. Treated with OTC pain relievers. Fever and chills followed after two or three days of initial onset. Reaction subsided around/after November 18-19th, 2008.

VAERS ID:333269 (history)  Vaccinated:2008-11-06
Age:34.0  Onset:2008-11-09, Days after vaccination: 3
Gender:Male  Submitted:2008-11-25, Days after onset: 16
Location:Kansas  Entered:2008-11-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2802AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2998BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Fatigue, Hypoaesthesia, Injection site pain, Musculoskeletal stiffness, Oedema peripheral, Paraesthesia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: Received flu vaccine and Tdap on same day - reports soreness at Tdap injection site for a couple days but has had shoulder stiffness since then. Denies redness, edema, numbness or tingling in arm just stiff and tired at end of day especially when raising arm above head.

VAERS ID:333275 (history)  Vaccinated:2008-11-06
Age:2.0  Onset:0000-00-00
Gender:Male  Submitted:2008-11-25
Location:North Carolina  Entered:2008-11-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
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DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3201AA0IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA110921SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0908X0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC683091IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0972X0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: no adverse event

VAERS ID:333284 (history)  Vaccinated:2008-11-06
Age:78.0  Onset:2008-11-13, Days after vaccination: 7
Gender:Male  Submitted:2008-11-25, Days after onset: 12
Location:Florida  Entered:2008-11-25
Life Threatening? Yes
Died? Yes
   Date died: 2008-12-20
   Days after onset: 37
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypertension, hyperlipidemia, benign prostatic hypertrophy PMH: obesity, kidney stones,
Diagnostic Lab Data: LABS: Brain biopsy. CSF: WBC 141( H), lprotein 135(H), glucose 161(H), c/s (+) strep grp B & S. simulu. Initial CT brain scan, MRI brain & CXR WNL. Later CT brain revealed bilateral SDHs. Paracentesis fluid: WBC 1822(H), lymphs 5%(H), polys 95%(H), c/s (+) candida. CBC, ammonia, B12, folic acid, ESR, TSH WNL. LFTs (H). Sodium 133. UA abnormal. Blood c/s (+)E.faecal, E. coli, S. Eeider, candida. Urine c/s (+) E. coli & candida. Sputum c/s(+) psuedomonas & Strep Grp B. EEG c/w diffuse encephalopathy, no seizures. CT abdomen & renal US (+) multiple nonobstructing bladder & kidney stones. US doppler of LEs neg.
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA209AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal cavity drainage, Abdominal symptom, Acute respiratory distress syndrome, Amnesia, Asthenia, Biopsy brain, Blood culture positive, CSF culture positive, CSF glucose increased, CSF protein increased, CSF white blood cell count increased, Candidiasis, Cellulitis, Computerised tomogram abnormal, Confusional state, Culture urine positive, Diabetes mellitus, Dialysis, Disorientation, Dizziness, Dysphagia, Electroencephalogram abnormal, Encephalitis, Endotracheal intubation, Escherichia infection, Fall, Gastrointestinal tube insertion, Hospice care, Hypernatraemia, Intensive care, Lethargy, Liver function test abnormal, Lumbar puncture, Malaise, Mechanical ventilation, Multi-organ failure, Nephrolithiasis, Peritoneal fluid analysis abnormal, Plasmapheresis, Pseudomonas infection, Pyrexia, Rash, Renal failure acute, Sepsis, Sputum culture positive, Streptococcus identification test positive, Syncope, Thrombocytopenia, Ultrasound abdomen abnormal, Urinary tract infection, Urine analysis abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad)
Write-up: Started with confusion and disorientation abou 3-4 days afterwards which developed into a full bown encephalitis. Presently in an intensive care unit at Medical Center. 1/6/09 Received hospital medical records of 11/13/08-12/20/2008 FINAL DX: No d/c summary dictated. Consults mention multisystem organ failure, fever, cellulitis, UTI, acute renal failure, syncope Records reveal patient being treated for UTI x approx 1 week. Developed confusion, weakness, malaise, dizziness, fever, fall w/amnesia, lethargy, rash mostly over LEs. Fever 101.5 in ER. ID, Neuro, Uro, Nephro, Pulmo, Heme consults done. Developed diabetes, dysphagia, hypernatremia, drug induced thrombocytopenia, liver encephalitis, polymicrobial sepsis w/feeding tube disruption, intra-abdominal infection & acute respiratory distress. Admitted ICU & intubated. LP done. Tx w/IV antibiotics, antivirals, antiseizure meds, steroids, PEG tube feeding, plasmapheresis, dialysis. Continued downhill course & transferred to hospice on 12/20/08.

VAERS ID:333344 (history)  Vaccinated:2008-11-06
Age:14.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-25, Days after onset: 19
Location:Connecticut  Entered:2008-11-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA03557
Vaccination
Manufacturer
Lot
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Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a nurse concerning a female patient who 2 weeks ago, on approximately 06-NOV-2008, was vaccinated with a dose of GARDASIL. The patient experienced syncope and seizure-like symptoms after receiving the vaccine. The patient experienced the symptoms while she was still at the physician''s office. The patient sought medical attention through an office visit. Subsequently, the patient recovered. Upon internal review seizure-like symptoms was determined to be another important medical event. Additional information has been requested.

VAERS ID:333379 (history)  Vaccinated:2008-11-06
Age:  Onset:2008-11-06, Days after vaccination: 0
Gender:Unknown  Submitted:2008-11-26, Days after onset: 20
Location:Indiana  Entered:2008-11-26
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxepin, benadryl, chlortrimetron
Current Illness: None
Preexisting Conditions: Severe life threatening allergic reactions to PCN.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791BA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURUF455AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Feeling hot, Flushing, Swollen tongue, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: within minutes of receiving vaccines became hot/flushed and developed hives over body and experienced swelling of tongue. Has history of severe allergic reactions ands carries treatment medications with her. She took benadryl, doxepin, and chlortrimeton. Symptoms resolved without taking epinephrine as well.

VAERS ID:333472 (history)  Vaccinated:2008-11-06
Age:45.0  Onset:2008-11-16, Days after vaccination: 10
Gender:Male  Submitted:2008-11-26, Days after onset: 10
Location:Pennsylvania  Entered:2008-12-01, Days after submission: 5
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: The patient had no concurrent illnesses, but did have a history of heartburn at the time of vaccination on 06 November 2008.
Diagnostic Lab Data: Blood work was drawn and an magnetic resonance imaging (MRI) of the brain was ordered; however the results of both tests were not provided.
CDC 'Split Type': 200803691
Vaccination
Manufacturer
Lot
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU27751AA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Facial palsy, Hypoaesthesia oral, Nuclear magnetic resonance imaging brain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Initial report received on 20 November 2008 from a physician. A 45-year-old male patient, with no concurrent illnesses, and a history of heartburn, had received a first deltoid injection of FLUZONE SV 2008-2009 (lot number U27751AA, not a valid Sanofi Pasteur lot number) on 06 November 2008 at 16:00 pm. Approximately nine or 10 ten days (also reported as nine days) after receiving the FLUZONE, the patient experienced numbness around the right side of his mouth. Approximately two days later, the patient was evaluated by his physician and diagnosed with Bell''s palsy. The patient was treated with Prednisone and Famciclovir. Blood work was drawn and a magnetic resonance imaging (MRI) of the brain was ordered; however the dates of service and results of both tests were not provided. At the time of this report, the recovery status of the patient was "unknown." Documents held by sender: None

VAERS ID:333656 (history)  Vaccinated:2008-11-06
Age:51.0  Onset:2008-11-08, Days after vaccination: 2
Gender:Female  Submitted:2008-11-14, Days after onset: 6
Location:Illinois  Entered:2008-12-02, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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TDAP: TDAP (ADACEL)SANOFI PASTEURC3031AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injection site induration, Injection site mass, Injection site pain, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: PM on 11/7/08 - Site sore with small lump felt AM on 11/8/08 - 1 1/2 by 2 inch hard lump at injection site and arm sore, PM on 11/8/08 - Same size area, but arm hurt from elbow to neck with Rt shoulder sore. 11/10/08 - area smaller and arm less sore by 11/14/08 almost gone, arm achy, arm remains swollen and sore.

VAERS ID:333762 (history)  Vaccinated:2008-11-06
Age:58.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Female  Submitted:2008-11-11, Days after onset: 4
Location:Ohio  Entered:2008-12-03, Days after submission: 22
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: 10/22/08-records received-PMH: HTN and CAD. Allegies to latex, penicillins, shellfish and iodine.
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contusion, Facial palsy, Joint injury, Oedema peripheral, Rhinorrhoea
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Flu vaccination on 11/6 - 11/9 -$g developed B1ell''s palsy. 12/22/08-records received for ED visit 11/7/08-C/O foot pain status post injury 11/6/08. Pain with walking. PE: rhinorrhea. Assessment right ankle contusion. Edema. no record of hospitalization.

VAERS ID:333917 (history)  Vaccinated:2008-11-06
Age:65.0  Onset:0000-00-00
Gender:Male  Submitted:2008-12-01
Location:California  Entered:2008-12-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS899940IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1124X0IMUN
Administered by: Other     Purchased by: Private
Symptoms: Pneumonia primary atypical
SMQs:
Write-up: Walking pneumonia a week later hospitalized for 4 days.

VAERS ID:334267 (history)  Vaccinated:2008-11-06
Age:1.3  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-10, Days after onset: 4
Location:California  Entered:2008-12-09, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENADRYL, on 11/9/08
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
RUB: RUBELLA (MERUVAX II)MERCK & CO. INC.1198X0SCUN
Administered by: Private     Purchased by: Private
Symptoms: Rash, Rash erythematous, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 15 month old boy given MEURAVAX II on 11/6/08. About 3 hours after the injection, developed spots, slight welt-like rash on cheeks and evolved coalesced appearing. Over next 4 days rash progressed from face down to trunk extremity. Examined on 11/10/08. Positive generalized erythematous macular papular rash. No lymphadenopathy, no fever.

VAERS ID:334416 (history)  Vaccinated:2008-11-06
Age:4.0  Onset:2008-11-10, Days after vaccination: 4
Gender:Female  Submitted:2008-11-12, Days after onset: 2
Location:Ohio  Entered:2008-12-09, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2849AC UNLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site induration, Injection site warmth, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Urticaria, itching, irregular rash on left thigh not continuous to site, started 11-10-08. First few days hard hot @ site.

VAERS ID:334477 (history)  Vaccinated:2008-11-06
Age:2.0  Onset:0000-00-00
Gender:Female  Submitted:2008-11-14
Location:Wisconsin  Entered:2008-12-09, Days after submission: 25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2761AA2IMLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Rash on left thigh only (fine, red, sl). Fluzone given left thigh, 7 days prior. Child was not ill.

VAERS ID:334493 (history)  Vaccinated:2008-11-06
Age:39.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-12, Days after onset: 6
Location:Massachusetts  Entered:2008-12-09, Days after submission: 27
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: ADHD- Asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURPU2877AA0IMUN
Administered by: Private     Purchased by: Public
Symptoms: Injection site cellulitis, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt presented with increased swelling of (L) deltoid where MENACTRA was given. Prescribed CEPHALEXIN 500 mg 1-TID x 10 day for cellulitis.

VAERS ID:334522 (history)  Vaccinated:2008-11-06
Age:0.9  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-14, Days after onset: 8
Location:Oklahoma  Entered:2008-12-09, Days after submission: 25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Not symptomatic at the time of vaccination - but was (+) for virus
Preexisting Conditions: None
Diagnostic Lab Data: Patient was positive for parainfluenza virus
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3201AA0UNUN
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2794BA0UNUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB618AA1UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC222830UNUN
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Parainfluenzae virus infection, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Fever and seizure approx 12hrs after immunizations.

VAERS ID:334535 (history)  Vaccinated:2008-11-06
Age:20.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-07, Days after onset: 1
Location:Virginia  Entered:2008-12-09, Days after submission: 32
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: Pancreatitis, PCN, Patient consulted with physician before getting shot.
Diagnostic Lab Data: CBC
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA197A UNLA
Administered by: Military     Purchased by: Other
Symptoms: Full blood count, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives with itching.

VAERS ID:334560 (history)  Vaccinated:2008-11-06
Age:41.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-13, Days after onset: 7
Location:Maine  Entered:2008-12-09, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMBIEN
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2828AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Eye pruritus, Ocular hyperaemia, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad)
Write-up: Employee came in with complaints of red itchy eyes - feel a tickle in throat - questions difficulty/itchy throat - developed these signs at 13:00 given flu shot at 09:00

VAERS ID:334658 (history)  Vaccinated:2008-11-06
Age:19.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-12, Days after onset: 6
Location:California  Entered:2008-12-09, Days after submission: 27
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: AMOXICILLIN; PEDIAZOLE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS899870IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Developed rash/bumps/spots all over body

VAERS ID:336683 (history)  Vaccinated:2008-11-06
Age:19.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 36
Location:Alabama  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA01667
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a 19 year old female who on 06-NOV-2008 or 07-NOV-2008 was vaccinated with the first dose of GARDASIL. The physician reported that the patient received another vaccine on the same date on the other arm, but the name and manufacturer of that vaccine was unspecified. After receiving the vaccination, the patient''s arm was swollen about 6 inches and was very red. The physician reported that the patient has recovered and would not be receiving any more dose of GARDASIL. The patient sought medical attention. Additional information has been requested.

VAERS ID:336740 (history)  Vaccinated:2008-11-06
Age:20.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 36
Location:Pennsylvania  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure 11/06/08 - 76/40 blood pressure 11/06/08 - 92/58 at discharge
CDC 'Split Type': WAES0811USA01143
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure decreased, Dizziness, Nausea, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a health professional concerning a 20 year old female patient who on 06-NOV-2008 was vaccinated with the first dose of GARDASIL vaccine (lot # 661044/0548X), intramuscularly in her right deltoid at 13:10. The health professional reported that after the vaccine was given, at 13:13, the patient became dizzy, nauseous and her blood pressure decreased to 76/40. At 13:15, the patient was given cold compress. Upon discharge, the patient''s blood pressure raised to 92/58. The health professional reported that the patient experienced a vasovagal reaction. On 06-NOV-2008, the patient recovered. The patient sought medical attention. No further information is available.

VAERS ID:336899 (history)  Vaccinated:2008-11-06
Age:0.2  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 36
Location:Virginia  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute follicular conjunctivitis
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA03734
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Private     Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received form a medical assistant concerning a 55 day old female with a history of acute ocular conjunctivitis who on 06-NOV-2008 was vaccinated with ROTATEQ vaccine. Unspecified medical attention was sought. Subsequently, on 06-NOV-2008, the patient recovered from vomiting. Additional information has been requested. 03/05/09 This is in follow-up to report(s) previously submitted on 12/12/2008. Information has been received from a medical assistant concerning 55 day old female with a history of acute ocular conjunctivitis who on 06-NOV-2008 was vaccinated with ROTATEQ. The patient vomited 2 minutes after receiving ROTATEQ. Unspecified medical attention was sought. Subsequently, on 06-NOV-2008, the patient recovered from vomiting. Follow up information was received that the patient with illness of acute follicular conjunctivitis at the time of vaccination spit up along with milk 30 seconds after the vaccine ROTATEQ was given. No further information is available.

VAERS ID:336900 (history)  Vaccinated:2008-11-06
Age:0.3  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-12-12, Days after onset: 36
Location:Massachusetts  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA03654
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0595X1PO 
Administered by: Other     Purchased by: Other
Symptoms: Rash macular
SMQs:, Hypersensitivity (narrow)
Write-up: This is in follow-up to report (s) previously submitted on 12/12/2008. Information has been received from a physician concerning an "around 4 months old" male who on an unspecified date, was vaccinated with the second dose of ROTATEQ vaccine, 2ml, oral (lot# not provided). Subsequently the patient experienced blotchy redness in face and around lips. It was reported that the patient had no reaction after first dose of ROTATEQ vaccine (lot# 663033/0894X) and the physician had decided not to administer the third dose. The patient''s mother has not contacted the office since the last visit so the doctor is assuming that there have been no further problems. The doctor would be seeing the patient again in 2 weeks. Unspecified medical attention was sought. Additional information has been requested. Follow up information has been received from the physician reporting that the 17 week old male with no medical history or drug allergy received his second dose of ROTATEQ 2ml oral (lot# 661582-0595X) on 06-NOV-2008. On 06-NOV-2008, the nurse had just started to administer vaccine, the tube was just touching the patient''s mouth and had started to transfer contents when a few pink/red blotches were noted on the patient''s face. They resolved quickly. No vomit or respiration difficulty was reported. The physician instructed the nurse to try again and same rash appeared. The patient was observed in office for 30 minutes. No respiration and no rash noted before the patient left. Additional information is not expected.

VAERS ID:335422 (history)  Vaccinated:2008-11-06
Age:75.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Male  Submitted:2008-12-13, Days after onset: 36
Location:Florida  Entered:2008-12-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Chest x-ray; EKG; blood tests - all normal
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1541U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Body temperature increased, Chest X-ray normal, Chest pain, Cough, Electrocardiogram normal, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: The day following vaccination, I experienced very sore throat and worst cough I can recall in past 30 years. Three days later I called the vaccine provider and was told that my symptoms could not have come from vaccines and must be coincidental cold. Sore throat subsided, but cough continued and even got worse. No serious fever -- maximum 100-101 deg F. After suffering for 10 days, I finally saw a doctor (11/17/08) who said I did not have either pneumonia or pleurisy and gave Rx for Azithromycin. He said pain in chest muscles was due to strain of coughing so hard. Cough cleared after 5 days, but pain in chest continued and became more severe. On 12/3/08, I saw same doctor again. Pain has gradually diminished during past 10 days, and 12/10 was first day I felt I could resume most of my normal activities. Still have twinges of pain in rib cage and shoulder blades with any quick motion. I have had mild chronic bronchitis for many years, but have never experience anything like the past 5 weeks. It may have been just coincidence, but I will never risk having another pneumonia or flu vaccination.

VAERS ID:335497 (history)  Vaccinated:2008-11-06
Age:51.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-12-08, Days after onset: 32
Location:Utah  Entered:2008-12-17, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2772AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0224X0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Activities of daily living impaired, Body temperature fluctuation, Chills, Livedo reticularis, Pain, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dementia (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Approx 12hrs after pneumonia vaccine was given to me in (L) arm, it began to swell, and it was very tender to touch and mottling. I had a temperature that would come and go- at one point it reached 102.5. Body chills and achiness that were unexplained. These signs and symptoms lasted for about 4 days and loss of work.

VAERS ID:335574 (history)  Vaccinated:2008-11-06
Age:51.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-17, Days after onset: 11
Location:New Jersey  Entered:2008-12-18, Days after submission: 31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AVANDIA, BID
Current Illness:
Preexisting Conditions: NIDDM (non insulin dependent diabetes mellitus)
Diagnostic Lab Data: Allergic, CIPRO
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS891260IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Facial redness and pruritis.

VAERS ID:337532 (history)  Vaccinated:2008-11-06
Age:3.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-11-06, Days after onset: 0
Location:Minnesota  Entered:2008-12-18, Days after submission: 42
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007466
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Accidental exposure
SMQs:
Write-up: A non-serious spontaneous report of "FLUMIST got in her eye" was received from a registered nurse concerning a three-year-old female. Medical history and concomitant medications were not reported. On 06-Nov-2008, during administration of FLUMIST, the patient moved and experienced exposure of the vaccine into her eyes. The reporter inquired about what to expect from this exposure. The reporter states that the medication error occurred at another clinic and no additional information is available, however, the nurse did submit a VARES report for this case. There was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.

VAERS ID:337534 (history)  Vaccinated:2008-11-06
Age:1.9  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-07, Days after onset: 1
Location:Nebraska  Entered:2008-12-18, Days after submission: 41
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007463
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.IN500560P IN 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: A non-serious spontaneous report of administration to a 23-month-old was received from a nurse. The patient received FLUMIST on 06-Nov-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.

VAERS ID:335741 (history)  Vaccinated:2008-11-06
Age:66.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Female  Submitted:2008-12-02, Days after onset: 25
Location:Nebraska  Entered:2008-12-19, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: sore lymphnodes~Influenza (no brand name)~1~55~In Patient
Other Medications: ALENDRONATE 20mg; HYDROCLOROTHIAZINE 12.5mg; Calcium; Multivitamin, Aspirin, CHOLINE 250; ENABLEX 2.5 mg
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2755AA UNLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.18206 UNRA
Administered by: Private     Purchased by: Other
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
SMQs:
Write-up: Shingles shot (right arm) when I awoke the next morning, the arm was extremely sore. Unable to move it (including combing hair, brushing teeth). It was worse when I walked, as I could feel the skin on my arm move with each step. This lasted only 1 day. Took TYLENOL for pain. Mild ache the evening of vaccination.

VAERS ID:336656 (history)  Vaccinated:2008-11-06
Age:1.4  Onset:0000-00-00
Gender:Female  Submitted:2009-01-02
Location:Massachusetts  Entered:2009-01-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500569P0IN 
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: As part of flu clinic 17 mo was given FLUMIST approved for equal to or greater than 2 year olds. No reactions.

VAERS ID:337054 (history)  Vaccinated:2008-11-06
Age:51.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2009-01-06, Days after onset: 61
Location:Michigan  Entered:2009-01-12, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED0254911A IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain at injection site for 2 months.

VAERS ID:337211 (history)  Vaccinated:2008-11-06
Age:48.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2009-01-12, Days after onset: 67
Location:New York  Entered:2009-01-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HCTZ 25mg qd; Lipitor 10mg one qd.
Current Illness: None
Preexisting Conditions: Allergies: Morphine
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS886350UNRA
Administered by: Public     Purchased by: Private
Symptoms: Chest pain, Dyspepsia, Dyspnoea, Eructation, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: 45 minutes after injection - developed bilat. chest pain and around to back. Short of breath. Took Benadryl 50mg PO and felt better in 5-10 min. Also had a lot of indigestion and belching.

VAERS ID:338585 (history)  Vaccinated:2008-11-06
Age:13.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2009-01-16, Days after onset: 71
Location:California  Entered:2009-01-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none None
Diagnostic Lab Data: Unknown Labs and Diagnostics: CBC WNL. CRP (-). LP with normal cell count, protein and glucose. CSF cx (-). MRI of lumbar, throacic and sacral spine (+) for L4-5 disc bulge. EBV IgG and IgM (+) Labs and Diagnostics: EMG/NCS WNL but limited due to intolerance. BS 128. CO2 19. Neurological examination, not Guillain Barre
CDC 'Split Type': WAES0812USA02603
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0652X2UNLA
Administered by: Private     Purchased by: Other
Symptoms: Areflexia, Asthenia, Back pain, Blood glucose increased, C-reactive protein normal, CSF culture negative, Carbon dioxide abnormal, Dyskinesia, Dyspnoea, Electromyogram normal, Epstein-Barr virus antibody positive, Fatigue, Full blood count normal, Headache, Hypoaesthesia, Hypokinesia, Local reaction, Lumbar puncture normal, Malaise, Muscular weakness, Nerve conduction studies normal, Neurological examination, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging abnormal, Peripheral sensory neuropathy, Pyrexia, Sensation of heaviness, Sensory disturbance, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dyskinesia (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 13 year old female patient who was vaccinated with the third dose of GARDASIL vaccine (lot# was not available) on unspecified date and played a "vigorous volleyball" using the same arm where she received the vaccine the following day after receiving the vaccine. There was no concomitant medication. The physician reported that on 06-NOV-2008 the patient experienced "serious malaise after vaccination" and on 17-NOV-2008, the patient brought to the hospital and was admitted for a "couple of days", Lab diagnostics Studies Performed included neurological tests when the patient was in the hospital including MRI. The patient sought medical attention through the physician. At the time of report the patient was recovering. Additional information has been requested. 2/23/09 MR received for DOS 11/15-xxxx with DX: S1 distribution sensory neuropathy. Lower extremity weakness and altered sensation. No D/C information available. Pt presented with 1 wk hx of weakness and fatigue. Had local reaction to recent HPV vax 11/6/08 with fever. Pt describes heaviness of extremities and difficulty lifting them. Low grade temp with mild intermittant H/As, numbess in foot and toes and low back pain. Seen by outpt neurologist and found to be areflexic. Instucted to go to ER with worsening sx. Presented for eval following an episode of dyspnea which self-resolved. Neuro exam (+) for loss of sensation on the back and decreased in extremities. DTRs and strength WNL. Abdominal reflexes absent. Admitting DX: S1 sensory neuropathy. LE weakness and altered sensation. 2/26/09 Neurology consult received dated 11/14/08 with DX: Generalized weakness with depressed ankle jerks. S/P Vaccination. R/O GBS despite normal NCS/EMG. PE (+) for decreased strength, depressed reflexes in upper extremities and ankles, normal sensation. Instructed to go to ER for further progression of sx which pt did. This is in follow-up to report (s) previously submitted on 1/16/2009. Follow up information received on 23-FEB-2009 stated that the patient with no medical history or allergies, reeived the third dose of GARDASIL vaccine (lot # 661768/0652X) into the left deltoid on 06-NOV-2008 at 10:00. The patient experienced severe fatigue, malaise and feeling of weakness. The patient was admitted on a hospital and was hospitalized foe 2 days. Laboratory diagnostic studies included unspecified laboratory procedures and a magnetic resonance image (MRI). It was also reported that per neurology Guillain Barre Syndrome was excluded. The patient gradially recovered on 26-NOV-2008. No further information is available.

VAERS ID:338443 (history)  Vaccinated:2008-11-06
Age:65.0  Onset:2008-11-16, Days after vaccination: 10
Gender:Male  Submitted:2009-01-27, Days after onset: 72
Location:Pennsylvania  Entered:2009-01-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity; Diabetes mellitus; Asthma; Hypolipidaemia; Gout
Preexisting Conditions:
Diagnostic Lab Data: magnetic resonance, Left shoulder; suggested degenerative changes
CDC 'Split Type': WAES0811USA02650
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER8488B IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1161X IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Information has been received from a physician concerning a 65 year old male who on 05-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot #661577/1161X). On 05-NOV-2008 the patient experienced tenderness, swelling and pain at the injection site. The pain became severe and stemmed from the shoulder up through the neck. The patient sought unspecified medical attention. Subsequently, the patient recovered from the adverse events. Follow-up information received from the physician indicated that the patient with asthma, hypolipidaemia, gout, diabetes mellitus and allergies to erythromycin and niacin received a dose of PNEUMOVAX 23 (Lot #661577/1161X) IM into the left arm on 06-NOV-2008 (previously reported by the physician as 05-NOV-2008). Concomitant therapy included influenza virus vaccine (unspecified) IM into the right arm on 06-NOV-2008. The patient experienced pain at injection site on 16-NOV-2008, 10 days after the vaccination. The patient also had difficulty ROM (range of motion). On 14-JAN-2009, one magnetic resonance imaging (MRI) of the left shoulder was performed. The changes on MRI suggested degenerative changes. The patient had an orthopedic evaluation after the MRI. The reporter considered tenderness, swelling and pain at the injection site, pain severe and stemmed from the shoulder up through the neck, difficulty ROM to be other important medical events. Additional information has been requested.

VAERS ID:338444 (history)  Vaccinated:2008-11-06
Age:49.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2009-01-27, Days after onset: 82
Location:Pennsylvania  Entered:2009-01-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Rhinitis allergic; Asthma
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA02652
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1161X IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Information has been received from a physician concerning a 49 year old male with asthma and allergic rhinitis who on 06-NOV-2008 was vaccinated with PNEUMOVAX 23 (lot number 661577/1161X) intramuscularly in the right arm. On 06-NOV-2008 the patient developed tenderness, swelling and pain at the injection site after receiving the dose of PNEUMOVAX 23. The pain became severe and stemmed from the shoulder up through the neck. The patient recovered after stopping therapy. Follow up information was received from the physician. The physician stated that on 06-NOV-2008 post vaccination the patient developed erythema, warmth and pain at the injection site. On 08-NOV-2008 the pain stemmed from shoulder through the neck. The patient was treated with MEDROL and VICODIN. On 14-NOV-2008 the patient''s symptoms and signs resolved. There were no additional diagnostic tests. The physician felt the patient''s injection site pain, erythema, warmth, and pain from shoulder through the neck were other important medical events. Additional information is not expected.

VAERS ID:338466 (history)  Vaccinated:2008-11-06
Age:62.0  Onset:2008-11-09, Days after vaccination: 3
Gender:Male  Submitted:2009-01-28, Days after onset: 80
Location:North Carolina  Entered:2009-01-28
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypercholesteremia; CHF; HTN; COPD; Obesity; DM; h/o A Fib 2/2/09-records received-PMH:paroxysmal atrial arrhythmias and systemic hypertension syncope, dyslipidemia, GERD, morbid obesity,emphysema, congestive heart failure, pancreatitis, degenerative arthritis, mild valvular regurgitation and COPD. Smoker.
Diagnostic Lab Data: Glucose SERUM, 156 mg/dL; Urea Nitrogen SERUM, 13 mg/dL; Creatinine SERUM, 0.8, mg/dL; Sodium SERUM, 134 mmol/L; Potassium SERUM, 3.2 mmol/L; Chloride SERUM, 96 mmol/L; Calcium SERUM, 7.7 mg/dL; Carbon Dioxide SERUM, 30 mmol/L; Anion Gap SERUM, 11 mmol/L; Osmalality Calculated SERUM, 272; GFR SERUM, $g90; Myoglobin SERUM 19347 ng/mL; Hepatic Function Panel Site/Specimen, 26 Nov 2008, 0531 Units Ref Rng; Albumin SERUM, 2.5 g/dL; Bilirubin Direct SERUM, 0.4 mg/dL; Bilirubin SERUM, 1.1 mg/dL; Alkaline Phosphatase SERUM, 130, U/L; Alanine Aminotransferase SERUM, 583 U/L: Aspartate Aminotransferase SERUM, 1972 U/L; Protein SERUM, 4.0 g/dL; Myoglobulin SERUM, 21560 ng/mL 2/2/09-records received-Elevated CK 20,000 and elevated liver functions test
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Military     Purchased by: Military
Symptoms: Alanine aminotransferase increased, Anion gap normal, Arthralgia, Aspartate aminotransferase increased, Asthenia, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood calcium decreased, Blood chloride decreased, Blood creatine phosphokinase increased, Blood creatinine normal, Blood glucose abnormal, Blood potassium decreased, Blood sodium decreased, Blood urea normal, Carbon dioxide normal, Echocardiogram abnormal, Hypokalaemia, Lethargy, Liver function test abnormal, Myalgia, Myoglobin blood increased, Oedema, Protein total decreased, Rhabdomyolysis, Transaminases increased, Urine output decreased
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Arthritis (broad), Tumour lysis syndrome (broad)
Write-up: Retiree who received flu and ZOSTAVAX vaccine on 11/6/08 began to notice lethargy, myalgias, arthralgias that gradually grew worse. Was seen in ER and admitted to civilian hospital with dx of rhabdomylosis 2/2/09-records received for DOS 11/28-12/10/08-DC DX:Rhabdomyolysis. Secondary to influenza vaccination. Elevated transaminases. Three days prior to admission C/O severe muscle aches, weakness and decreased urine output. Edema.

VAERS ID:340024 (history)  Vaccinated:2008-11-06
Age:5.0  Onset:2008-11-08, Days after vaccination: 2
Gender:Female  Submitted:2009-01-29, Days after onset: 82
Location:Illinois  Entered:2009-02-19, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: cellulitis
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3201AA0UNRA
HEP: HEP B (FOREIGN)MERCK & CO. INC.162242UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0985X1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0533X1UNLA
Administered by: Other     Purchased by: Other
Symptoms: 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)
Write-up: Upper arm with erythema, length of deltoid positive warmth, positive swelling given 10 days KEFLEX 250 mg every 12.

VAERS ID:340360 (history)  Vaccinated:2008-11-06
Age:11.0  Onset:2008-12-25, Days after vaccination: 49
Gender:Female  Submitted:2009-02-19, Days after onset: 56
Location:Unknown  Entered:2009-02-23, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: She does have allergies PMH: asthma, seasonal allergies.
Diagnostic Lab Data: LABS: Blood c/s, CRP, PT/PTT all WNL.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activated partial thromboplastin time, Arthropod bite, Blood culture negative, C-reactive protein normal, Chest pain, Contusion, Dysgeusia, Erythema, Hypoaesthesia, Lymphadenopathy, Pharyngitis streptococcal, Prothrombin time normal, Pruritus, Purpura, Tenderness, Upper respiratory tract infection, Urticaria
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Taste and smell disorders (narrow), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: My daughter had the vaccine GARDASIL and now her arm is bruising up looks really nasty and she saying she''s got numbness of the arm and Dr. don''t think it''s the GARDASIL I''m very worried, she does allergies but Dr. did say shot was ok for her. 3/18/09 Received vac records & PCP medical records of FINAL DX: purpuric rash LUE; allergies; urticaria Records reveal patient experienced good health on day of #1 & #2 HPV vaccines. RTC 1/15/09 w/rash, redness, itching & bruising LUE which had started in wrist area & moved up arm. Dx w/insect bite (spider) LUE. Tx w/IV antibiotic & antihistamine. RTC 2/2/09 w/URI & pain left arm. Dx w/strep throat & URI. Tx w/antibiotics. Seen in ER 2/3/09 for probable insect bite LUE & enlarged bilateral axillary lymph nodes. Tx w/continued antibiotics & antihistamines. RTC 2/19 w/purpuric rash left arm & 2/24 w/bruising & tenderness of both arms, chest pain & taste alteration. Dx w/allergies & urticaria. Tx w/antihistamines.

VAERS ID:340779 (history)  Vaccinated:2008-11-06
Age:93.0  Onset:2009-01-05, Days after vaccination: 60
Gender:Female  Submitted:2009-02-10, Days after onset: 36
Location:Oregon  Entered:2009-02-26, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDNISONE 1/2 mg qod
Current Illness:
Preexisting Conditions: Arthritis
Diagnostic Lab Data:
CDC 'Split Type': OR200909
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1416X0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia
SMQs:, Arthritis (broad)
Write-up: 2/9/09 Call from pt that she had acute joint pain during the night Jan 5, 09. Her doctor told her it was due to the shingles shot. Was on 1/2 mg PREDNISONE qod for arthritis on 11/6/08.

VAERS ID:342768 (history)  Vaccinated:2008-11-06
Age:17.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2009-03-13, Days after onset: 126
Location:Michigan  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO
Current Illness: Pregnancy NOS (LMP = 10/5/2008) Smoker
Preexisting Conditions: Depression
Diagnostic Lab Data: ultrasound 11/??/08 - 5 weeks and 6 days gestation at time of vaccine; ultrasound 11/16/08 - 7 weeks gestation; serum alpha-fetoprotein 01/21/09 - negative
CDC 'Split Type': WAES0901USA04179
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Muscle spasms, Pregnancy test negative, Ultrasound scan, Vomiting
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a Licensed Practical Nurse (L.P.N.) for GARDASIL, a Pregnancy Registry product, concerning an 18 year old pregnant female smoker with no drug allergies who received her second dose of GARDASIL on 06-NOV-2006. Date of initial dose was unspecified. No details about the first or second dose of GARDASIL are known as another office administered them. Concomitant therapy included LEXAPRO which was discontinued on 16-nov-2008. An ultrasound showed patient was 5 weeks and 6 days pregnant at time of GARDASIL administration (LMP: 05-OCT-2008). Follow-up information was received from the a physician concerning the 18 year old white female smoker with no previous pregnancies and a history of depression who on 06-NOV-2008 was vaccinated with a dose of GARDASIL though a clinic. The patient had a LMP of 05-OCT-2008, became pregnant and had an EDD of 04-JUL-2009. On 16-NOV-2008 ultrasound was done in the emergency room due to vomiting and cramping the ultrasound indicated 7 weeks gestation and on 21-JAN-2009 serum alpha-fetoprotein test negative. The patient sought medical attention by visiting the physician''s office. Additional information has been requested.

VAERS ID:341925 (history)  Vaccinated:2008-11-06
Age:19.0  Onset:2008-11-26, Days after vaccination: 20
Gender:Female  Submitted:2009-03-17, Days after onset: 110
Location:Oregon  Entered:2009-03-17
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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB251BA1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2843AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1190X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Optic neuritis, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad)
Write-up: Menactra, Varivax, and Havrix administered on 11/6/08. Pt. noted abrubt onset of blurred vision in left eye on 11/26/08. Seen by a neuro-ophthalmologist, diagnosed with optic nueritis on 12/5/08. Follow-up shows some recovery of vision, though still signifigant blurred vision.

VAERS ID:349853 (history)  Vaccinated:2008-11-06
Age:18.0  Onset:2008-12-01, Days after vaccination: 25
Gender:Female  Submitted:2009-06-23, Days after onset: 203
Location:Massachusetts  Entered:2009-06-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri-cycle
Current Illness: None.
Preexisting Conditions: Allergy to amoxicillin and cefzil.
Diagnostic Lab Data: MRI of left foot- revealed bursitis and bone marrow edema to left calcaneus and talus. CT scan of left foot- normal. X-rays (twice) of left leg/foot- normal. Blood work- normal.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X1UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Blood test normal, Bone marrow oedema, Bursitis, Computerised tomogram normal, Dysstasia, Erythema, Joint swelling, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendon pain, X-ray normal
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: Swelling of both ankles, purple/red color on heals. Extreme pain in left ankle/ achillies tenden/ lower leg. Began December 08- Present. Can not stand or put pressure on left foot without pain. Gardasil Dose #1 9/20/07 Lot# 1060U Site RA

VAERS ID:355537 (history)  Vaccinated:2008-11-06
Age:  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-24, Days after onset: 18
Location:Georga  Entered:2009-08-13, Days after submission: 261
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': MEDI0007493
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, Underdose
SMQs:
Write-up: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.

VAERS ID:356644 (history)  Vaccinated:2008-11-06
Age:0.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Male  Submitted:2009-09-04, Days after onset: 300
Location:Unknown  Entered:2009-09-08, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Circumcision
Preexisting Conditions:
Diagnostic Lab Data: urine bilirubin test, 11/10/08, Neonatal bilirubin: 9.5 ug/dL; urine bilirubin test, 11/07/08, Neonatal bilirubin: 12.6 ug/dL
CDC 'Split Type': WAES0908USA04685
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia, Breast feeding, Chest X-ray normal, Constipation, Cough, Crying, Dermatitis atopic, Dry skin, Dyspnoea, Dysuria, Eczema, Erythema, Faeces hard, Flatulence, Food intolerance, Full blood count, Infrequent bowel movements, Irritability, Rash, Rash papular, Respiratory syncytial virus bronchiolitis, Rhinitis, Skin exfoliation, Umbilical granuloma, Umbilical hernia, Upper respiratory tract congestion, Upper respiratory tract infection, Urine bilirubin increased, Weight increased, Wheezing
SMQs:, Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician via medical records concerning a 7 day old male who on 06-NOV-2008 was vaccinated with a first dose of Hep B (manufacturer unknown). On 06-NOV-08 the baby was circumcised. On 07-NOV-2008 the baby was 3 days old, and the mother reported that she was unsure if the baby had urinated and had concerns. The baby was questionably crying with urination. The mother did some nursing but wanted to change to ENFAMIL for convenience. The patient''s neonatal bilirubin was 12.6 mg/dL. On 10-NOV-2008 a laboratory test was performed and the result indicated that Neonatal bilirubin 9.5 ug/dl. On 18-NOV-2008 the baby was reportedly to have had no bowel movement in the past 24 hours, no emesis or fever. The baby had wet diapers 4-5 per day. The baby was breastfed with ENFAMIL FE with occasional breastfeeds. He was diagnosed with constipation, reducible umbilical granuloma/hernia and weight gain. Pediatric glyceric supplement and silver nitrate were applied to the umbilical. On 11-DEC-2008 the mother complained the baby congested for 2 weeks (approximately 27-NOV-2008) and experienced rash for 2 weeks on and off, erythema dry rash on cheek and neck. The baby was assessed as upper respiratory infection and atopic dermatitis. The plan was hydrocortisone 2.5% cream everyday to face and back of neck with follow up in 5 days. On 16-DEC-2008 the mother complained that the baby was gassy, irritable, was crying, straightening like a board. Dry rash was noticed on his face. The assessment was formula intolerance. "LACROPUE" was prescribed. On 22-DEC-2008 the patient was hospitalized due to respiratory syncytial virus bronchiolitis. On 26-DEC-2008 the patient was discharged. On 29-DEC-2009 generalized papular rash was noticed. The baby still coughed but no fever. The assessment was upper respiratory infection, formula intolerance and rash. "NEO DM" was given. On 05-JAN-2009 the baby was fed well, taking 4 OZ every 3 hours. The baby still coughed, the sign and symptoms of upper respiratory infection

VAERS ID:367157 (history)  Vaccinated:2008-11-06
Age:58.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2009-03-03, Days after onset: 117
Location:Utah  Entered:2009-11-12, Days after submission: 254
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 had no illness at the time of vaccination on 06 November 200. It was "unknown" if the patient had any pre-existing medical conditions or use of other medications. It was "unknown" if the patient had received any other vaccinations within four weeks prior to 06 November 2008. From information received 09 March 2009, the patient had not been ill at the time of vaccination
Diagnostic Lab Data: Not reported. From information received 09 March 2009, laboratory or diagnostic testing had not been performed.
CDC 'Split Type': 200803511
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2761A IMLL
Administered by: Public     Purchased by: Public
Symptoms: Cough, Dysphonia, Eyelid oedema, Local swelling, Ocular hyperaemia, Pain
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Initial report received on 07 November 2008 from a nurse. A 58-year-old male patient with no concurrent illnesses and "unknown" past medical history, had received an intramuscular left deltoid injection of Fluzone SV 2008-2009 (lot number U2761AA) on 06 November 2009 at 11:30am. Approximate four and a half hours post-vaccination, around 16:00 pm, the patient''s eyelids were swollen , the sclera in his eyes were reddened, his neck was swelling. The patient had body aches and had developed a cough, and his voice was hoarse. The patient was treated with Benadryl by the nurse and was subsequently examined by a physician. Results of that examination were not provided. It was not reported whether any diagnostic tests or laboratory data were performed. At the time of this report, it was "unknown" if the patient had recovered. Follow up information was received on 09 February 2009 from a health care professional. The patient recovered. The date of recovery was not provided. Follow up information received 09 March 2009 from a health care professional. There had been no laboratory or diagnostic tests performed and the patient had no sick exposures; however the patient was also a health care professional. The patient self medicated with Benadryl x2 which began to reverse the symptoms. According to the reporter, the patient had not experienced any difficulty breathing and they had completely recovered on the same day of vaccination. Follow up information was received 27 March 2009 from a health care professional. The patient was an anesthesiologist who self medicated with Benadryl to treat the event, and he had not had a doctor''s visit (previously reported as having been examined by a physician). A diagnosis had not been determined for the event and no additional information was provided.

VAERS ID:367579 (history)  Vaccinated:2008-11-06
Age:46.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-18, Days after onset: 12
Location:New Jersey  Entered:2009-11-12, Days after submission: 359
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a history of allergies to penicillin, trees and mold. He denied other medical conditions. Concomitant medications included asthma inhaler (to be used as needed) and multivitamins. The patient denied having any illness at the time of vaccination, denied receiving any other vaccination on the same day as or within four weeks of receiving FLUZONE and denied experiencing adverse events following prior vaccinations. The patient had previously received FLUZONE annually.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 200803510
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2810A UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Erythema, Eye pruritus, Fatigue, Pharyngeal oedema, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Initial report received from a consumer on 07 November 2008. A 46-year-old male patient had received a dose of FLUZONE (lot number U2810AA, route and site of administration not reported) on 06 November 2008 and within one hour, his eyes became itchy, face became red and he felt like his throat was closing. The patient used his asthma inhaler with some benefit. The patient also complained of fever of 102 degrees Fahrenheit, chills and vomiting that evening. On the day of the report, patient outcome was "not recovered". The patient reported feeling better although "not great", and indicated that he felt very tired. Documents held by sender: none

VAERS ID:374999 (history)  Vaccinated:2008-11-06
Age:0.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2009-12-26, Days after onset: 415
Location:Texas  Entered:2009-12-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Public     Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Immediate Rash on his cheek. Has never gone away and has since spread all over his body.

VAERS ID:399243 (history)  Vaccinated:2008-11-06
Age:14.0  Onset:2008-11-12, Days after vaccination: 6
Gender:Female  Submitted:2010-08-04, Days after onset: 629
Location:Massachusetts  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: endoscopy, no results provided; biopsy, no results provided; diagnostic laboratory, no results provided
CDC 'Split Type': WAES1001USA00561
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Biopsy, Diarrhoea, Endoscopy, Laboratory test, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a registered nurse concerning a 14 year old female patient who on 06-Nov-2008 was vaccinated with a first IM dose of GARDASIL (Lot # 661044/0548X) into her right arm. On 30-Dec-2008 the patient was vaccinated with as second IM dose of GARDASIL (Lot # 661703/0651X) into her left arm and on 16-APR-2009 was vaccinated with a third dose of GARDASIL (Lot # 661952/1129X) into her right arm. Since the patient received the third dose of GARDASIL she has had really bad abdominal pain on and off. The pain has worsened and been more persistent now since she finished the vaccination series. She also has had emesis and diarrhea. The patient was seen by a gastroenterologist (GI). An endoscopy with a biopsy and "lots of lab work" had been performed with no results provided. No further information is available.

VAERS ID:460064 (history)  Vaccinated:2008-11-06
Age:75.0  Onset:2012-07-06, Days after vaccination: 1338
Gender:Female  Submitted:2012-07-18, Days after onset: 12
Location:Illinois  Entered:2012-07-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1207USA003872
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: This spontaneous report as received from a 75 year old female patient with high blood pressure and with no drug reaction or allergies. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX on 06-NOV-2008 (Lot# and dose not reported). No other co-suspects were reported. Concomitant medications were reported as blood pressure pill, name unknown. On 06-JUL-2012 the patient experienced shingles. The shingles started on her right upper hip and had gone around her mid section and back. The patient had contacted her physician and had a diagnosed case of the shingles. She had been treated with valacyclovir hydrochloride 1mg. No lab diagnostics studies performed. At the time of this report the patient was recovering. Additional information has been requested.

VAERS ID:344227 (history)  Vaccinated:2008-11-06
Age:1.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2009-04-15, Days after onset: 159
Location:Foreign  Entered:2009-04-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 06Nov2008, 41.3deg C
CDC 'Split Type': B0569641A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA20CA429B3IMLA
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA429B3IMLA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA20CA429B3IMLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH301533UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Convulsion, Loss of consciousness, Pyrexia, Respiration abnormal, Staring
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), 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)
Write-up: This case was reported by a regulatory authority (NL-LRB-86231) and described the occurrence of unconscious in a 1-year-old male subject who was vaccinated with INFANRIX-Polio-HIB (GlaxoSmithKline), (non-gsk) PREVENAR. The subject had no relevant medical history and no concomitant medication. On 6 November 2008, the subject received 4th dose of INFANRIX-Polio-HIB (intramuscular, unknown injection site), 4th dose of PREVENAR (intramuscular, unknown injection site). On 6 November 2008, less than one day after vaccination with INFANRIX-polio-HIB and PREVENAR, the subject experienced fever (41,3 deg C) which lasted more than 3 days. Two days after the vaccination, the subject experienced unconsciousness, convulsion, staring, abnormal respiration for 10 minutes. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The regulatory authority reported that the events were unlikely to be related to vaccination with INFANRIX-polio-HIB and PREVENAR. No further information could be obtained from regulatory authority about this report; the case has been closed.

VAERS ID:350740 (history)  Vaccinated:2008-11-06
Age:32.0  Onset:2008-11-07, Days after vaccination: 1
Gender:Female  Submitted:2009-06-19, Days after onset: 223
Location:Foreign  Entered:2009-06-25, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BELLARA Indication for use was Contraception. Dosage was Daily Dose Quantity: 1, Daily Dose Unit: U, Oral
Current Illness:
Preexisting Conditions: Pregnant: No.
Diagnostic Lab Data:
CDC 'Split Type': 200814464
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED098610201 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Reports received from a General Practitioner on 17-Dec-2008: A 32-year old female patient (initials: KM, date of birth: 29/6/1976) received 0.5 mL AFLURIA (lot-number 0986-10201) on 06-Nov-2008 by intramuscular injection for influenza prophylaxis. She received influenza prophylaxis yearly since 2004, including BEGRIVAC last year, without any adverse experiences. The patient was also taking concomitant BELLARA for contraception, 1 tablet/day by mouth. On the next day (07-Nov-2008) she experienced painful swelling and redness at injection site for 4-5 days on a path 5x5 cm, which was treated using cooling measures locally. The patient recovered by 11-Nov-2008. The company considered the events to be highly probably related to the suspect drug. Information derived from this AE report does not change the current safety of the product.

VAERS ID:350381 (history)  Vaccinated:2008-11-06
Age:41.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2009-06-29, Days after onset: 234
Location:Foreign  Entered:2009-06-29
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0792747A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA198AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Agitation, Obstructive airways disorder, Respiratory disorder, Stridor, Tachycardia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority (# V0900150) and described the occurrence of stridor in a 41-year-old female subject who was vaccinated with FLUVIRAL (GlaxoSmithKline). On 6 November 2008 the subject received unspecified dose of FLUVIRAL (unknown). On 6 November 2008, 45 minutes after vaccination with FLUVIRAL, the subject experienced stridor, airway obstruction, respiratory disorder, agitation and tachycardia. The subject visited the emergency room. The regulatory authority reported that the events were life threatening. At the time of reporting the events were resolved.

VAERS ID:350533 (history)  Vaccinated:2008-11-06
Age:35.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2009-06-30, Days after onset: 235
Location:Foreign  Entered:2009-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0792693A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA204AA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dysgeusia, Feeling of body temperature change, Hypersensitivity, Oedema mouth, Stupor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (# V0809467) and described the occurrence of stupor in a 35-year-old female subject who was vaccinated with FLUVIRAL (GlaxoSmithKline). On 6 November 2008 the subject received 1st dose of FLUVIRAL (unknown). On 6 November 2008, one hour after vaccination with FLUVIRAL, the subject experienced taste perversion, vomiting, mouth edema and temperature changed sensation. At an unspecified time after vaccination with FLUVIRAL, the subject experienced stupor and allergic reaction. The subject was hospitalised. At the time of reporting the events were resolved.

VAERS ID:376306 (history)  Vaccinated:2008-11-06
Age:13.0  Onset:2008-12-01, Days after vaccination: 25
Gender:Female  Submitted:2010-01-08, Days after onset: 403
Location:Foreign  Entered:2010-01-08
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: Unk
CDC 'Split Type': B0574614A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA021BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Thirst, Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-ADR 20428075) and described the occurrence of type 1 diabetes mellitus in a 13-year-old female subject who was vaccinated with (CERVARIX). On 06 November 2008 the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular). On 01 May 2009, approximately 176 days after vaccination with CERVARIX, the subject experienced type 1 diabetes mellitus and at an unknown time the subject experienced thirst. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Mother informed nursing team child become increasingly thirsty after 1st HPV Vaccine and has now been diagnosed with Type 1 diabetes (Reported to team as per reaction start date). Follow-up information received on 07 January 2010 (via healthcare professional): On an unknown date in December 2008, 25 days after vaccination with CERVARIX, the patient experienced type 1 diabetes mellitus.

VAERS ID:393035 (history)  Vaccinated:2008-11-06
Age:1.3  Onset:2008-11-09, Days after vaccination: 3
Gender:Male  Submitted:2010-07-16, Days after onset: 613
Location:Foreign  Entered:2010-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0665667A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Ataxia, Cough, Dysstasia, Gait disturbance, Pyrexia, Reflex test normal, Rhinorrhoea, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad)
Write-up: This male subject was enrolled in Novartis study V70P5, a phase III, randomized, observer blind, controlled, multi-center clinical study to evaluated the efficacy, safety and immunogenicity of one and two intramuscular doses of Influenza vaccine (FLUARIX or AGRIPPAL) versus control vaccines (ENCEPUR or MENJUGATE) in unprimed healthy subject aged 6 to 72 months. On 09 November 2008, three days after the 1st dose of FLUARIX, this 16-month-old subject developed ataxia with walking. The event was clinically significant (or requiring intervention). The event resolved on 20 November 2008. The investigator considered that there was a reasonable possibility that the ataxia with walking may have been caused by FLUARIX. The subject will be withdrawn from the study due to the SAE. Narrative received from Novartis: Case previously recorded as MA2008-2853. Initial - 12 NOV 2008: In study V70P5 (agency no. 2007-003786-41) a 16-month-old male received the first i.m. injection of the investigational medicinal product according to the study protocol on 6 NOV 2008. 3 days later (on 08 NOV 2008) the subject developed fever up to 40 C. On the following day fever was gone but the subject became unsure to walk and stand. Situation continued so that the subject was brought to the paediatrician (11 NOV 2008). Pediatrician''s assessment: "walking ataxia", normal reflexes, no signs of encephalitis. Outcome: AE persisting. Follow up needed. Outcome assessment will be updated as soon as possible. Assessment: Seriousness criterion: medically significant. Causality (investigator''s and sponsor assessment): probably related. The differential diagnosis can be manifold, no straight forward neurological workup occurred. Diagnosis not yet substantiated. Due to close time relationship an association with the vaccination cannot be excluded. The reported event is unexpected according to current IB. Follow-8p #1 - 14 NOV 2008: Following information was added: No further symptoms but walking ataxia still persists. Symptoms approved during the week (mother observed some normal walking patterns, but the gait appeared sometimes still ataxic). Normal childhood development so far, no trauma, no congenital anomalies. Some signs of an upper airway infection (running nose and cough) on the day of report. Assessment: unchanged. Addendum: The subject has been unblinded on 17 NOV 2008. Subject received not a Novartis Vaccines & Diagnostics vaccine but only INFLUSPLIT SSW (Manufacturer GSK) as a Flu control. Assessment: unchanged. Follow-up #2 - 21 NOV 2008. Following information was added: Symptoms disappeared. Subject recovered completely on 20 NOV 2008. Normal walking since then. Subject will be withdrawn from the study. Assessment; unchanged.

VAERS ID:416222 (history)  Vaccinated:2008-11-06
Age:69.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Female  Submitted:2011-02-04, Days after onset: 820
Location:Foreign  Entered:2011-02-04
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0696393A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMAR
Administered by: Other     Purchased by: Other
Symptoms: Death, Erythema, Rash, Swelling, T-cell lymphoma
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Malignant tumours (narrow), Hypersensitivity (narrow), Malignant lymphomas (narrow)
Write-up: This case was reported by a consumer and described the occurrence of t-cell lymphoma in a 69-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 6 November 2008, the subject received an unspecified dose of FLUARIX (intramuscular, administration site unknown, batch number not provided). On 6 November 2008, less than one day after vaccination with FLUARIX, the subject experienced swollen, rash and erythema. In May 2010, 18 months after vaccination with FLUARIX, the subject experienced t-cell lymphoma. On an unspecified date, the subject died, cause of death is not specified. It was unknown whether an autopsy was performed.

VAERS ID:456371 (history)  Vaccinated:2008-11-06
Age:0.3  Onset:2008-12-11, Days after vaccination: 35
Gender:Male  Submitted:2012-05-25, Days after onset: 1260
Location:Foreign  Entered:2012-05-29, Days after submission: 4
Life Threatening? No
Died? Yes
   Date died: 2009-04-07
   Days after onset: 116
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Familial risk factor
Preexisting Conditions: Torticollis
Diagnostic Lab Data: Ultrasound, 3 normal antenatal ultrasounds performed during pregnancy
CDC 'Split Type': WAES1011USA03505
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  SYRUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  SYRUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0UN 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Brain neoplasm, Death, Hydrocephalus, Investigation abnormal
SMQs:, Tumours of unspecified malignancy (narrow)
Write-up: Case received from the health authorities on 15-SEP-2010 under the reference number 200900220. Case medically confirmed. A 3 month old male patient had received the first dose of ROTATEQ (batch number not reported), an injection of diphtheria toxoid, tetanus toxoid, pertussis vaccine (unspecified), hepatitis B virus vaccine (unspecified), poliovirus vaccine inactivated (unspecified), Hib conj vaccine (unspecified carrier) (batch number not reported, manufacturer unknown) and an injection of PREVENAR (batch number not reported, other manufacturer) on 06-NOV-2008 and, on 11-DEC-2008 he developed brain tumor. The patient had a personal medical history of torticollis and a family history of different organ neoplasia in his uncle, aunt, cousin and grandmother. The patient was hospitalized on 11-DEC-2008. Aetiological investigations were performed and revealed grade III glial brainstem tumor. The tumor was considered to be unresectable. Hydrocephalus was treated with external derivation. Palliative therapy was decided in December 2009, the patient was hospitalized on the day of his death. The patient died from brain tumor on 07-APR-2009. The investigator considered that brain tumor was not related. The sponsor considered that brain tumor was unlikely related to the study drug. Follow-up information received through the final clinical study report provided by the sponsor of the study, hospital on 11-MAY-2012 under the reference number 200900220: According to the sponsor, the event was possibly related to vaccination. Upon internal review, a corrective version was created on 23-MAY-2012 to correct a suspect vaccine. In the information received on 11-MAY-2012 it was specified that the patient had received on 06-NOV-2008 a dose of INFANRIXQUINTA (batch number not reported, other manufacturer) instead of a dose of diphtheria toxoid, tetanus toxoid, pertussis vaccine (unspecified), hepatitis B virus vaccine (unspecified), poliovirus vaccine inactivated (unspecified), Hib conj vaccine (unspecified carrier) (batch number not reported, manufacturer unknown) as previously reported. Other business partner numbers include E2010-07349. No further information is available.

VAERS ID:469079 (history)  Vaccinated:2008-11-06
Age:13.0  Onset:2008-12-01, Days after vaccination: 25
Gender:Male  Submitted:2012-10-11, Days after onset: 1409
Location:Foreign  Entered:2012-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic rhinopathy; Allergy to normal immunoglobulin; Familial risk factor; Migraine; Neurodermatitis
Preexisting Conditions: Adenotomy; Phimosis correction surgery
Diagnostic Lab Data: UNK
CDC 'Split Type': D0077233A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB188AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Anti-platelet antibody, HIV test negative, Haematoma, Hepatitis A virus test, Hepatitis B test negative, Hepatitis C test negative, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Laboratory test normal, Petechiae, Platelet count decreased, Skin haemorrhage, Skin irritation, Thrombocytopenia, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2012046954) and described the occurrence of idiopathic thrombocytopenic purpura (ITP) in a 13-year-old male subject who was vaccinated with HAVRIX 720 Junior (GlaxoSmithKline). The subject was born spontaneously after pregnancy without complications with a weight of 4150 gram and a height of 52 cm. Previous development had been normal. The subject''s medical history included adenotomy in 2007 and phimosis correction surgery in 2006. Concurrent medical conditions included allergic rhinopathy, migraine (about one episode per months) and neurodermatitis. Familial risk factors included neurodermatitis, asthma and allergic rhinitis of the subject''s mother as well as atopic dermatitis of the subject''s older brother and the subject''s maternal grandmother. The subject''s father was completely healthy. Concomitant medications included CETIRIZIN as needed for the treatment of allergic rhinitis. On 06 November 2008 the subject received the first dose of HAVRIX 720 Junior (0.5 ml, intramuscular, left deltoid). Approximately four weeks post vaccination with HAVRIX 720 Junior, on an unknown date in December 2008, the subject experienced symptomatic thrombocytopenia and was diagnosed with idiopathic thrombocytopenic purpura (ITP). Recurrent symptoms of thrombocytopenia / idiopathic thrombocytopenic purpura (ITP) included petechiae, skin bleeding, scratching of self and hematoma. Platelet count was as low as 15 G/l on 11 April 2009 and 12 G/l on 03 September 2010 whereas normal range was between 140 and 340 G/l. All other laboratory parameters including inflammatory parameters have been more or less within normal range. Serology has showed no signs of current viral infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV). The results of determination of anti-platelet autoantibodies, performed in September 2010, have not been provided. At first, in December 2008, the subject was not treated for the events. Since January 2009 the subject has been hospitalised repeatedly for about two days each time for an unknown total time. Each time the subject was treated with normal Immunoglobulins (e.g. GAMUNEX). During first or second course of treatment with normal immunoglobulin, in January 2009 or March 2009, respectively, the subject showed signs of possible allergy to normal immunoglobulin with epigastric pain and vomiting. Since April 2009 the subject was treated with normal immunoglobulin after having received pre-treatment with 4 mg FENISTIL intravenously. The subject was did no longer experience any complications when being treated with normal immunoglobulin. The subject was hospitalised and treated with dimethindene maleate (intravenous; 4 g) followed by normal immunoglobulin (intravenous; 20 g; GAMUNEX) at least in April 2009, in December 2009 and in September 2010. Each time at first thrombocytopenia and the symptoms improved and platelet count increased post treatment with normal immunoglobulin but symptomatic thrombocytopenia did recur each time after some time without any new exposure to a vaccine. At the time of reporting, about four years later, on 25 September 2012, the events were still unresolved. Platelet count, determined in August 2012, still showed thrombocytopenia (exact value not readable because of bad copy of excerpt of lab data). The vaccination course with HAVRIX 720 Junior was discontinued. No further information will be available.

VAERS ID:522309 (history)  Vaccinated:2008-11-06
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2014-02-07
Location:Foreign  Entered:2014-02-10, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2014033035
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Measles post vaccine, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This is a spontaneous report received from a contactable physician via the Foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2014006389. A 3-month old female patient of an unspecified ethnicity received the first dose of PREVENAR 7 and the first dose of INFANRIX HEXA both via an unspecified route of administration for prophylactic vaccination on 06Nov2008. The patient''s medical history and concomitant medications were not reported. After vaccination the patient developed fever and measles post vaccine. The patient''s twin sister did not have reactions after receiving the vaccinations. The clinical outcome of the fever and measles was unknown. No follow-up attempts needed. No further information expected.

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