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Found 596268 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:436826 (history)  Vaccinated:2011-10-03
Age:26.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Ohio  Entered:2011-10-05
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) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA627CA1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Localised oedema, Pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Localized pain, edema, and erythema

VAERS ID:436835 (history)  Vaccinated:2011-10-03
Age:37.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Pennsylvania  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH462AC0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral, Pain, Paraesthesia, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Left arm swollen, red and itching. Pain/w numbness and tingling.

VAERS ID:436840 (history)  Vaccinated:2011-10-03
Age:29.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Florida  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: (R) hand infected cat bite; Lymphangitis
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
DT: DT ADSORBED (DECAVAC)SANOFI PASTEURU3748EA IMLA
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: (L) arm deltoid area redness, visible swelling, increased warm, tenderness to palpation. Tx: ALEVE, cool compresses.

VAERS ID:436899 (history)  Vaccinated:2011-10-03
Age:1.5  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Kentucky  Entered:2011-10-05
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Blood work. Not exactly sure what all they drew but know that WBC was normal. They said all bloodwork was normal. Chest xray was normal. Urinalysis was normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4027AA3UNRL
Administered by: Unknown     Purchased by: Private
Symptoms: Blood test normal, Chest X-ray normal, Irritability, Pain, Pyrexia, Urine analysis normal, Vaccination complication, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Fine when she went to sleep at 9:00 PM. Gave Tylenol before sleep just to help with fever and aching from shot. No fever upon going to bed. Starting whining in her sleep around 1:10 or so. Never woke. After 20 minutes or so went upstairs to check on her. She sat up, threw up, and had a temp of 105.4 rectally. Stripped her of clothing. Tried to give Tylenol, but couldn''t keep down. Took to ER. Told them I thought was flu shot reaction but they wanted to run tests just to make sure wasn''t coincidence that something else wasn''t going on. Did bloodwork, chest xray, and urine. All came back negative. Fever came down with rectal tylenol. Pediatrician says its a reaction to flu shot.

VAERS ID:436966 (history)  Vaccinated:2011-10-03
Age:41.0  Onset:2011-10-05, Days after vaccination: 2
Gender:Female  Submitted:2011-10-06, Days after onset: 1
Location:Colorado  Entered:2011-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUH505AB0IDLA
Administered by: Unknown     Purchased by: Private
Symptoms: Agitation, Diarrhoea, Formication, Nausea, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: fever, very runny nose, sore throat, aches, agitated feeling, diarrhea, feeling nauseous, crawling skin

VAERS ID:436967 (history)  Vaccinated:2011-10-03
Age:57.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 3
Location:Indiana  Entered:2011-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: The patient did not report any illness at the time of vaccination
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN56506A IMLA
Administered by: Other     Purchased by: Private
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient reported inability to lift her left arm due to excruciating pain, limited range of motion. Took a pain pill on Monday night.

VAERS ID:436974 (history)  Vaccinated:2011-10-03
Age:66.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-06, Days after onset: 2
Location:New Mexico  Entered:2011-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: HTN HRT
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH453AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Arthralgia, Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: REDNESS SWELLING ARTHRALGIA

VAERS ID:436996 (history)  Vaccinated:2011-10-03
Age:69.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-06, Days after onset: 2
Location:Illinois  Entered:2011-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Systemic allergic rxn to something in yard on 10-3
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11001010IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site haematoma, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient has bruising and swelling at injection site. Recommended ice, topical BENADRYL, and ALLEGRA. Followed up with patient the next day and swelling has gone down.

VAERS ID:437287 (history)  Vaccinated:2011-10-03
Age:45.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-07, Days after onset: 3
Location:Utah  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU41069BA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Hypersensitivity, Hypoaesthesia, Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Skin warm
SMQs:, Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Upper arm went red from the shoulder down to the elbow hot to the touch very sore at the site. I also had numbness for 2 hours on the right side of my body. 5 days later started with a lacy type allergic reation on the RT arm. Still having redness and pain at the sight. Redness and a hard knot 2-3 inches around the site.

VAERS ID:437308 (history)  Vaccinated:2011-10-03
Age:56.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:North Carolina  Entered:2011-10-07, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH475AA IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1056AA SCRA
Administered by: Other     Purchased by: Other
Symptoms: Headache, Injection site erythema, Injection site nodule, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Nodule at injection site (Right arm). Redness at injection site (Right arm). Warmth at site (Right arm). Fever. Headache.

VAERS ID:437319 (history)  Vaccinated:2011-10-03
Age:48.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-07, Days after onset: 3
Location:New York  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3976AA IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Employee reports fever on 10/4/11, and swelling/pain of (L) deltoid area, (L) trapezius area, and swollen glands (L) axilla. States no history of similar reaction to Tetanus vaccination in past. States range of motion is intact but very painful.

VAERS ID:437329 (history)  Vaccinated:2011-10-03
Age:49.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 4
Location:Texas  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: TX20110070PU
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AC2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: VAXC @ 8:30, NOTICED RX @ 12:30 PIMPLE LIKE RASH (ITCHY) DEVELOPED RIGHT, BACKSIDE (TRUNK) NEAR WAISTLINE. USED BENADRYL, ANTI ITCH CREAM. NO KNOWN RXS TO PREVIOUS FLU VACCINES

VAERS ID:437393 (history)  Vaccinated:2011-10-03
Age:44.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-07, Days after onset: 3
Location:Kentucky  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy
Preexisting Conditions: None
Diagnostic Lab Data: CBC; Chem 12; Gave script for MEDROL DOSE PACK
CDC Split Type:
Vaccination
Manufacturer
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Dose
Route
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dyspnoea, Erythema, Full blood count, Laboratory test, Swelling face, Tenderness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Noticed swelling & redness under left eye & cheek. Later became SOB took BENADRYL resolved SOB. Swelling & redness continued with tenderness.

VAERS ID:437434 (history)  Vaccinated:2011-10-03
Age:56.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-07, Days after onset: 3
Location:Pennsylvania  Entered:2011-10-07
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH460AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site haematoma, Injection site rash, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Pt. developed rash, warm to touch, bruise, redness near site of injection.

VAERS ID:437440 (history)  Vaccinated:2011-10-03
Age:0.79  Onset:2011-10-04, Days after vaccination: 1
Gender:Male  Submitted:2011-10-06, Days after onset: 2
Location:Minnesota  Entered:2011-10-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKA; umbilical hernia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3754AA2IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4176BA0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9160061IMLL
Administered by: Private     Purchased by: Unknown
Symptoms: Lethargy, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 24 hours after receiving vaccines pt. developed temp 102 degrees F. Pt was lethargic, but responded to TYLENOL. 48 hours after vaccines, fever was gone, but pt. had fine rash all over his body. Pt acting normal with usual ADLs.

VAERS ID:437441 (history)  Vaccinated:2011-10-03
Age:30.0  Onset:2011-10-05, Days after vaccination: 2
Gender:Female  Submitted:2011-10-07, Days after onset: 2
Location:California  Entered:2011-10-07
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: Pregnant (33 wks, 4 days)
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11063P0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cold sweat, Maternal exposure during pregnancy, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypoglycaemia (broad)
Write-up: Patient felt nauseous and vomited several times through the day (10/05/11) with some diarrhea on the second day after the flu shot. Patient is afebrile and appears well at urgent appointment on 10/06/11, but felt clammy yesterday. Patient was given ZOFRAN prescription and return if worsens. Patient is pregnant (33 wks, 4d) but did not have these complaints before the shot. Patient returned from a 2 week trip earlier this week where a couple people had upset stomach and diarrhea, but none with her severity.

VAERS ID:437442 (history)  Vaccinated:2011-10-03
Age:51.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Male  Submitted:2011-10-07, Days after onset: 3
Location:Arizona  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11012011UNLA
Administered by: Public     Purchased by: Public
Symptoms: Activities of daily living impaired, Diarrhoea, Hypoaesthesia, Injection site mass, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: 10-3-11 - Flu vaccine give (L) deltoid. 10-4-11 - Lump at injection site, numbness (L) arm to 4-5th fingers, nausea & vomiting & diarrhea x 2 days. Lost 2 work days.

VAERS ID:437353 (history)  Vaccinated:2011-10-03
Age:31.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-08, Days after onset: 5
Location:California  Entered:2011-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec D, calcium vitamins, Centrum multi-vitamin, B12 complex vitamin
Current Illness: No
Preexisting Conditions: Migraines, Environmental allergies (dust, mold, pollen)
Diagnostic Lab Data: The doctor performed a nerve test and verified that I did not have Bell''s palsy by assessing my nerves and reflexes
CDC Split Type:
Vaccination
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Route
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FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA673AA0IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Hypoaesthesia, Nerve conduction studies normal, Paraesthesia, Paraesthesia oral, Reflex test normal, Vaccination complication
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: The shot was admininstered in my left arm. Around noon, I had tingling in the left side of my face and slight numbness and then had tingling in my toungue and lips. My tongue was tingling until around 6:00pm and the tingling slightly subsided. The following day, my lips were tingling. I went to the urgent care facility and they determined that it was an adverse reaction to the flu shot and recommended for me to take Benadryl. The influenza 07/26/2011 shot that I had received was the GlaxoSmithKline lot # AFLLA673AA in my left deltoid via IM.

VAERS ID:437358 (history)  Vaccinated:2011-10-03
Age:72.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Male  Submitted:2011-10-08, Days after onset: 4
Location:California  Entered:2011-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Compromised immune system (hypothyroidism and all the associated ailments (elevated LDL and blood pressure, DC, depression, etc.), and successful brachytherapy for PCa a decade ago.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Influenza
SMQs:
Write-up: Flu symptoms for three days, starting 24 hours after vaccination. Never had a reaction to a seasonal flu shot before.

VAERS ID:437375 (history)  Vaccinated:2011-10-03
Age:84.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Male  Submitted:2011-10-09, Days after onset: 6
Location:Virginia  Entered:2011-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: Cipro allergy
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED04649221A IMRA
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Injection site nodule, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt went to walk away from getting flu vaccination. She said her arm was hurting, we looked and she had a large knot on her arm where the vaccine was given. We held ice and I observed her for one and one-half hours. She did not exhibit any signs of an allegic reaction. We have been using the pharmaject when giving flu shots this year. I believe that it was the device that may have bruised her arm. We also let her medical doctor know of the reaction.

VAERS ID:437389 (history)  Vaccinated:2011-10-03
Age:44.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-10, Days after onset: 6
Location:Florida  Entered:2011-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: I went to facility to have a finer laceration stitched.
Preexisting Conditions: Adverse/allergic rxn to ACE inhibitors. Kindey tranplant patient. I am immunosuppressed.
Diagnostic Lab Data: I am going to call the doctor today to see what treatment is.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Erythema, Induration, Mass, Pain, Swelling, Type III immune complex mediated reaction
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red painful swelling ~3CM diameter. It is now Day 7, and the swelling is still there with a hard bump. I believe this to be an Arthus rxn. I have never had a Type III reaction to a vaccine before. And certainly no painful red area with a hard bump 7 days post injection.

VAERS ID:437454 (history)  Vaccinated:2011-10-03
Age:11.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-07, Days after onset: 3
Location:Michigan  Entered:2011-10-10, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4103AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: None

VAERS ID:437482 (history)  Vaccinated:2011-10-03
Age:87.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-10, Days after onset: 7
Location:Kansas  Entered:2011-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Client had same reaction last year client, family or facility did not report to nursing staff.~Vaccine not specified (no brand n
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA686AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Vaccine positive rechallenge, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: One hour after administration client transferred to hospital for severe vomiting. Hospitalized for overnight observation by the facility she is living.

VAERS ID:437495 (history)  Vaccinated:2011-10-03
Age:43.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-10, Days after onset: 6
Location:Washington  Entered:2011-10-10
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
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4104AA0IJLA
Administered by: Public     Purchased by: Other
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Oedema peripheral, Pain, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Soreness at injection site, but on the 2nd day after the injection the pain is now down to my elbow but mostly in my armpit. My armpit is swollen and so tender that even putting deodorant on hurts. Sharp pains, than throbbing. Today is day 4 after injection and pains and swelling still in my armpit and at injection site. At day 8 all symptoms are mostly gone.

VAERS ID:437510 (history)  Vaccinated:2011-10-03
Age:64.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-08, Days after onset: 4
Location:Washington  Entered:2011-10-10, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1101301 IMLA
Administered by: Other     Purchased by: Public
Symptoms: Pruritus, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on both side of body. Itchiness.

VAERS ID:437523 (history)  Vaccinated:2011-10-03
Age:11.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Male  Submitted:2011-10-06, Days after onset: 3
Location:California  Entered:2011-10-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Reactive airway disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT445AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Disorientation, Loss of consciousness, Yellow skin
SMQs:, Torsade de pointes/QT prolongation (broad), Cholestasis and jaundice of hepatic origin (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: After pt was informed he had been vaccinated, he developed a yellowish pallor & passed out for a few seconds. He was initially disoriented to place. He declined food & blood pressure monitoring, he drank water. He did not c/o difficulty breathing. He left at 4:35 w/his mom.

VAERS ID:437524 (history)  Vaccinated:2011-10-03
Age:59.0  Onset:2011-10-05, Days after vaccination: 2
Gender:Unknown  Submitted:0000-00-00
Location:Washington  Entered:2011-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1101301 IMUN
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0659AA0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Local reaction, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Local reactions: itching, redness. Pharmacist suggested to ice the area & use BENADRYL if needed.

VAERS ID:437528 (history)  Vaccinated:2011-10-03
Age:16.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Washington  Entered:2011-10-10
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
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0477AA2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Fall, Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Patient fainted about 10 minutes after receiving the injection. She struck her head when she fell.

VAERS ID:437571 (history)  Vaccinated:2011-10-03
Age:65.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 2
Location:California  Entered:2011-10-10, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: mild fatigue~Influenza (Seasonal) (no brand name)~0~0.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Dyspnoea, Fatigue, Muscular weakness, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)
Write-up: After the FLUARIX vaccine about 10 min. later started feeling weak, drowsy & sleepy - muscles felt weak, tired. Had about 5 min. of shortness of breath. The weakness, fatigue & drowsiness lasted about 2 1/2 hrs.

VAERS ID:437645 (history)  Vaccinated:2011-10-03
Age:58.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Male  Submitted:2011-10-11, Days after onset: 8
Location:Louisiana  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: cerebal palsy
Preexisting Conditions: cerebal palsy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMRA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Pain, Staphylococcal infection, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pain, swelling, redness, patient received staph infection. Patient is now taking Keflex, doxycycline and laratabs.

VAERS ID:437677 (history)  Vaccinated:2011-10-03
Age:43.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 8
Location:Missouri  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported to me by patient.
Preexisting Conditions: After the client returned to the health department at approximately 3:00 PM 10/3/11, she stated she never had problems with the flu injection in the past, but ever since she had a heart stent placed last year it seems that she is allergic to everything.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH463AC1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Body temperature increased, Ocular hyperaemia, Sensation of foreign body
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Glaucoma (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient stated the symptoms started all at once at approx. 1:30 PM with bilateral eye redness and a feeling that food was sticking in her throat. The next day I called to check on her and she reported that she developed a 105 degree F temperature over night, which had resolved by the time I talked to her around 10:30 AM 10/4/2011.

VAERS ID:437726 (history)  Vaccinated:2011-10-03
Age:80.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 8
Location:Michigan  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted on screening sheet
Preexisting Conditions: None noted on screening sheet
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH452AB IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Hot flush
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: C/o facial heat/redness. Vital signs stable. Given water and chair. Twenty minutes later, flushing fading. Fifteen minutes later, left clinic without complaint.

VAERS ID:437729 (history)  Vaccinated:2011-10-03
Age:8.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Male  Submitted:2011-10-11, Days after onset: 7
Location:North Carolina  Entered:2011-10-11
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: Sulfa drugs, hives Asthma episodes
Diagnostic Lab Data: No testing done.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH460AC IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Within a day following Fluzone injection in left deltoid, redness, warmth, itching and swelling present in left upper arm. Took Benadryl for relief. Seen by her pediatrician on 10/5/11 per triage advice given the previous evening. Physician diagnosed cellulitis in upper left arm. He prescribed Cephalexin 250mg tid x 10 days and loratadine 10mg bid. Recovered.

VAERS ID:437732 (history)  Vaccinated:2011-10-03
Age:4.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-11, Days after onset: 7
Location:Texas  Entered:2011-10-11
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: TX20110072PU
Vaccination
Manufacturer
Lot
Dose
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Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B171CA0 LL
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   LL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9166000 RL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: RED INDURATED AREA TO THIGHS, WARM TO TOUCH

VAERS ID:437773 (history)  Vaccinated:2011-10-03
Age:51.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-11, Days after onset: 7
Location:Colorado  Entered:2011-10-11
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
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4163AA IDUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 4" large red area recommended oral BENADRYL.

VAERS ID:437778 (history)  Vaccinated:2011-10-03
Age:58.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-11, Days after onset: 7
Location:California  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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Dose
Route
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1100901 IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema, Eye swelling, Skin exfoliation, Swelling face
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient woke up the next morning with a red, swollen face. Eyes swollen. Pt given BENADRYL & prednisone. Pt recovered & has some residual flaking skin. No reaction at injection site.

VAERS ID:437780 (history)  Vaccinated:2011-10-03
Age:3.0  Onset:2011-10-07, Days after vaccination: 4
Gender:Male  Submitted:2011-10-11, Days after onset: 4
Location:Colorado  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No illness documented
Preexisting Conditions: Eye anomaly; med allergy to amoxicillin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH470AD0IMLA
Administered by: Public     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site infection, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Influenza (IM) administered on 10/03/11. Developed rash & redness, pus, to site on 10/07/11. Diagnosed with cellulitis. Treated on 10/07/11 with KEFLEX 250 po TID x10 days.

VAERS ID:437930 (history)  Vaccinated:2011-10-03
Age:61.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Male  Submitted:2011-10-12, Days after onset: 8
Location:Washington  Entered:2011-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Achilles tendinitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dysphonia, Eye pruritus, Fatigue, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Itchy eyes, sore throat, hoarseness, tiredness lasting eight days (so far).

VAERS ID:437938 (history)  Vaccinated:2011-10-03
Age:4.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-12, Days after onset: 8
Location:Alaska  Entered:2011-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B064A4IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURE09500SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: The patient developed a 1.5cm circular area of erythema and warmth at the injection site.

VAERS ID:438004 (history)  Vaccinated:2011-10-03
Age:75.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Male  Submitted:2011-10-07, Days after onset: 3
Location:North Carolina  Entered:2011-10-12, 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: Thrombocytopenia; Polyuria
Preexisting Conditions: Allergic-steroids, Cipro, Metronidazole, Diclofenac, AMOXIL
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AC IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1158Z0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Flu injection on 10/3/11 Lt deltoid and PNEUMOVAX on Rt deltoid. 10/4/11 returned to clinic c/o rash around the injection. Redness & warmth anterior left deltoid new site of flu injection (8 x 4). Dx with cellulitis. Started Cefdinir 10/6/11 Area increasing pt came in for injection of ROCEPHIN 10/6/11.

VAERS ID:438002 (history)  Vaccinated:2011-10-03
Age:45.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-12, Days after onset: 9
Location:Virginia  Entered:2011-10-13, 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:
Current Illness: Fibromyalgia; Back pain
Preexisting Conditions: Allergic to ibuprofen; PCN
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH462AA3UNLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Pain, Psychomotor hyperactivity, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: The afternoon after vaccine, fever, body aches, chills, hives over entire body, felt hyper.

VAERS ID:438028 (history)  Vaccinated:2011-10-03
Age:33.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-03, Days after onset: 0
Location:Arizona  Entered:2011-10-13, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH470AD0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash erythematous, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt developed several small hives on body approximately 2 hours post influenza vaccine. 1 on foot, 2 on knee, 1 on side of right hip. All approx cm across with 5-7 cm red rash surrounding.

VAERS ID:438051 (history)  Vaccinated:2011-10-03
Age:57.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 4
Location:Washington  Entered:2011-10-13, 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: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3872BA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Body temperature increased, Injection site erythema, Injection site induration
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Td clinic 10/5/11 (L) arm upper deltoid with 17x22 cm area of erythema, induration onset 8-12 hours after Tdap. T 101. No pain.

VAERS ID:438052 (history)  Vaccinated:2011-10-03
Age:4.0  Onset:2011-10-05, Days after vaccination: 2
Gender:Male  Submitted:2011-10-05, Days after onset: 0
Location:Nevada  Entered:2011-10-13, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B102A44UNLA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1494Z3UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURE083013UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1575Z1UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0338AA1UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swollen (L) arm 7 3/4" w/ pain. Unswollen (R) arm 6 3/4. No fever. After cold compresses/swollen has gone down.

VAERS ID:438273 (history)  Vaccinated:2011-10-03
Age:60.0  Onset:2011-10-05, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:Kentucky  Entered:2011-10-13
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: Asthma; heart disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AB0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1200AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Infection, Oedema peripheral, Rash erythematous
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt called on 10/5 in the morning complaining of red rash on her arm below the site of injections, arm was swollen to the elbow and difficult to move. Advised pt to see MD - she was seen and MD thought the condition was an infection and prescribed KEFLEX. She is to return to MD on 10/10/2011.

VAERS ID:438263 (history)  Vaccinated:2011-10-03
Age:69.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-14
Location:South Carolina  Entered:2011-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Diabetes
Diagnostic Lab Data: MD did x-ray & determined pt. has inflammation & bone spur
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT440AA IJLA
Administered by: Other     Purchased by: Other
Symptoms: Exostosis, Inflammation, Pain, X-ray abnormal
SMQs:
Write-up: Patient received INLFUENZA injection in her left arm. She is stating she has had continued pain since she received injection.

VAERS ID:438681 (history)  Vaccinated:2011-10-03
Age:52.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-17, Days after onset: 14
Location:Wisconsin  Entered:2011-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Slight nausea
Preexisting Conditions: Chronic rhinitis, hypothyroidosis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMRA
Administered by: Other     Purchased by: Public
Symptoms: Chills, Headache, Myalgia, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Muscle aches, with mild fever, headache, & chills lasting 2 days. Developed rash over belly, chest, and arms after 1 day, which lasted for 2 days.

VAERS ID:438764 (history)  Vaccinated:2011-10-03
Age:7.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Male  Submitted:2011-10-05, Days after onset: 1
Location:Colorado  Entered:2011-10-17, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH453AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Oedema peripheral, Vaccination site erythema, Vaccination site pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 6 yo male developed temp to 104. 2; arm swelling, erythematous tenderness at vaccine site within 24 hours of injection. Temp persisted x 72 hours. Treated for possible cellulitis with BACTRIM. Also received ibuprofen, TYLENOL, BENADRYL.

VAERS ID:439146 (history)  Vaccinated:2011-10-03
Age:36.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-13, Days after onset: 10
Location:Minnesota  Entered:2011-10-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None known
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA682AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Dizziness, Headache, Pain
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: On 10/4/11, this employee reports feeling dizziness, headache & general body aches after receiving flu shot on 10/3/2011. She received flu shot at approx 1130AM, worked her shift until 2PM & started H/A so intense she called husband to drive her home as she was unable to walk. On 10/4/11, employee reports feeling better but still has dull H/A. Injection site free of redness/swelling. On 10/5/11, employee reports feeling fine, no H/A or dizziness.

VAERS ID:439156 (history)  Vaccinated:2011-10-03
Age:0.65  Onset:2011-10-05, Days after vaccination: 2
Gender:Female  Submitted:2011-10-19, Days after onset: 14
Location:Missouri  Entered:2011-10-19
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: MO201111
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT41L4BA0UNLL
Administered by: Public     Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: When Mom changed child''s pajamas, she noticed several spots that appeared to be hives. Child scratched her belly. 10/19/11-Follow up-Child ok. At ER, told most likely not shot, given Benadryl.

VAERS ID:439253 (history)  Vaccinated:2011-10-03
Age:77.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-13, Days after onset: 10
Location:Florida  Entered:2011-10-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Yes~Influenza (Seasonal) (no brand name)~1~76.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: Diabetes Type II
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Chills, Eye discharge, Eyelid margin crusting, Eyelid oedema, Eyelid pain, Feeling hot, Injection site reaction, Myalgia, Nausea, Oropharyngeal pain, Pain, Purulent discharge
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Started with sore throat - next overheated then severe chills - temp. 100.6 - eyelids swelled then pus-like and crusting on lashes. Blood pressure 179/108, Pulse 96 (normal is 126/62, 73 Pulse). Very nauseated, muscle pain all over body and at injection site and etc. Gone in 24 hrs, except body aches and eyelids for 4 days.

VAERS ID:439264 (history)  Vaccinated:2011-10-03
Age:22.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-09, Days after onset: 6
Location:Idaho  Entered:2011-10-19, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: None taken
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT480AA IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Approximately 3-4 hours after receiving FLUZONE, the patient reported to E.R. with complaints of chest pain and difficulty breathing. Patient was successfully treated with an extended steroid therapy course and BENADRYL.

VAERS ID:439274 (history)  Vaccinated:2011-10-03
Age:83.0  Onset:2011-10-05, Days after vaccination: 2
Gender:Male  Submitted:2011-10-13, Days after onset: 8
Location:Nebraska  Entered:2011-10-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH453AB IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt. complains that two days after receiving flu shot that his left arm started itching and he noticed a rash developing where shot was given (rash size of quarter). He reports he applied hydrocortisone cream and takes BENADRYL at night. He shows up at pharmacy on 10/12/11 10:46 with a rash at same site as large as a fist but no itching as of this date.

VAERS ID:439441 (history)  Vaccinated:2011-10-03
Age:60.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 3
Location:North Carolina  Entered:2011-10-20, Days after submission: 14
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: Allergic to LEVAQUIN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0730AA0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt came to us asking if normal reaction. She had 3 inch diameter red swollen itchy area around vaccination area. She bought ZYRTEC & hydrocortisone cream 1%.

VAERS ID:439447 (history)  Vaccinated:2011-10-03
Age:39.0  Onset:2011-10-05, Days after vaccination: 2
Gender:Male  Submitted:2011-10-06, Days after onset: 1
Location:Virginia  Entered:2011-10-20, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Med allergy to amoxicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1824IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt received anthrax 3 Oct 11 in (L) arm. Did not start having a side effect until 5 Oct 11. Pt has redness down (L) arm and hot to touch.

VAERS ID:439526 (history)  Vaccinated:2011-10-03
Age:36.0  Onset:2011-10-20, Days after vaccination: 17
Gender:Female  Submitted:2011-10-22, Days after onset: 2
Location:Illinois  Entered:2011-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH464AA1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Abortion spontaneous, Foetal heart rate abnormal, Maternal exposure during pregnancy, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: I was 5 weeks pregnant when I had the mercury-free flu shot. At 7 weeks pregnant, an ultrsound found no fetal heartbeat and the fetus measured 5 weeks pregnant. Doctor confirmed miscarriage of pregnancy.

VAERS ID:439538 (history)  Vaccinated:2011-10-03
Age:61.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Male  Submitted:2011-10-23, Days after onset: 19
Location:Ohio  Entered:2011-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Mobility decreased, Muscular weakness, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)
Write-up: Could not raise arm over shoulder height weakness when reaching for anything in upper arm, slow motion ability after a certain distance was reached, very painful when touched, but does not seem related to muscles, can''t reach behind my self, or reach up without extreme thought process before doing the deed.

VAERS ID:439716 (history)  Vaccinated:2011-10-03
Age:54.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-17, Days after onset: 13
Location:Oregon  Entered:2011-10-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH453AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0454AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site abscess, Injection site erythema, Injection site swelling, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling, redness at pneumonia site, blistering, abscess. Received antibiotics at ER 10 days after vaccination.

VAERS ID:439720 (history)  Vaccinated:2011-10-03
Age:91.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-10, Days after onset: 7
Location:Connecticut  Entered:2011-10-24, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH436AC UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA UNLA
Administered by: Other     Purchased by: Private
Symptoms: Drug administered at inappropriate site, Musculoskeletal stiffness, Pain in extremity
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)
Write-up: Pt received PNEUMOVAX and Influenza shots in left arm. 1 1/2 hr post immunization pt complained of pain and arm stiffness. The next morning family brought her to ER. ER MD says one of the shots too high. Treat with analgesics and ice. Patient called several days later to relate story.

VAERS ID:439722 (history)  Vaccinated:2011-10-03
Age:80.0  Onset:2011-10-06, Days after vaccination: 3
Gender:Female  Submitted:2011-10-12, Days after onset: 6
Location:New Mexico  Entered:2011-10-24, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0399Z0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Infection, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: The pt received a PNEUMOVAX shot +2 days later (approximately) called the RX stating a red hot swollen infected looking arm, she was advised to take APAP, measure, and call if it gets larger.

VAERS ID:439739 (history)  Vaccinated:2011-10-03
Age:51.0  Onset:2011-10-07, Days after vaccination: 4
Gender:Male  Submitted:2011-10-12, Days after onset: 5
Location:Pennsylvania  Entered:2011-10-24, Days after submission: 12
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: Asthma; Allergies; Elevated Lipids; HTM
Diagnostic Lab Data: CBC, CMP, Lyme (normal)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH463AB1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Borrelia test negative, Burning sensation, Full blood count, Headache, Injection site pain, Metabolic function test, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Headache, rash, joint pain, burning sensation (especially around injection site).

VAERS ID:439764 (history)  Vaccinated:2011-10-03
Age:19.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-15, Days after onset: 11
Location:Massachusetts  Entered:2011-10-24, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN57307 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Arm was swollen, red, puffy.

VAERS ID:439826 (history)  Vaccinated:2011-10-03
Age:69.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-24
Location:California  Entered:2011-10-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0615AA0SCRA
Administered by: Other     Purchased by: Public
Symptoms: Pruritus, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Severe itching. Varicella-like rash.

VAERS ID:439918 (history)  Vaccinated:2011-10-03
Age:57.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-25, Days after onset: 22
Location:Kansas  Entered:2011-10-25
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:
CDC Split Type: KS2011006
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR6H4SSAD IMLA
Administered by: Public     Purchased by: Public
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: IMMEDIATE BRUISING TO AREA AROUND INJECTION. BY NEXT AFTERNOON THERE WAS A RAISED AREA 4X2 AT INJECTION SITE THAT WAS VERY WARM TO TOUCH AND SORE.

VAERS ID:440018 (history)  Vaccinated:2011-10-03
Age:30.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-25, Days after onset: 22
Location:Florida  Entered:2011-10-25
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: Seasonal Allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH498AB2IMRA
Administered by: Private     Purchased by: Other
Symptoms: Cough, Eye discharge, Eye irritation, Fatigue, Headache, Injection site pain, Ocular hyperaemia, Pain, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Corneal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Cough. Fatigue. Body Aches. Sore Throat. Red, burning eyes with discharge. 102 degree fever for 12 hours. 99.5 degree mild fever for one week. Headache. Pain at injection site. Nasal Drainage.

VAERS ID:440142 (history)  Vaccinated:2011-10-03
Age:44.0  Onset:2011-10-10, Days after vaccination: 7
Gender:Female  Submitted:2011-10-26, Days after onset: 16
Location:Maryland  Entered:2011-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Lupus
Diagnostic Lab Data: Provider exam given with no lab test perfomed.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT424AA0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Limited mobility in left arm with tenderness at injection site. Numbness with tingling to finger tips.

VAERS ID:440407 (history)  Vaccinated:2011-10-03
Age:43.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-10-27, Days after onset: 23
Location:Minnesota  Entered:2011-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: X-ray done, no bone irregularities. No MRI done. Diagnosed with tendonitis and bursitis.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALS 0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Bursitis, Mobility decreased, Musculoskeletal pain, Tendonitis, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (narrow)
Write-up: Intense shoulder pain, weakness, limited mobility. Went to physician, received Vicodin for pain and sling for arm referred to orthopaedic specialist. Diagnosed with tendonities and bursitis in right shoulder.

VAERS ID:440861 (history)  Vaccinated:2011-10-03
Age:4.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-11-01, Days after onset: 28
Location:Texas  Entered:2011-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: ALLERGIC TO AMOXICILLIN
Diagnostic Lab Data: N/A
CDC Split Type: TX20110077
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B178DA IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT465AA IMRL
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC)MERCK & CO. INC.0790Z SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH916303 IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0574AA SCRL
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: TREATMENT: PREDNISOLONE AND CLINDAMYCIN SUSPENSIONS. SITE WHERE INJ. WAS GIVEN WAS RED, PAINFUL AND WARM.

VAERS ID:444528 (history)  Vaccinated:2011-10-03
Age:57.0  Onset:2011-11-01, Days after vaccination: 29
Gender:Male  Submitted:2011-12-05, Days after onset: 34
Location:Connecticut  Entered:2011-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH453AC IMLA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Cough, Eye irritation
SMQs:, Anaphylactic reaction (broad), Corneal disorders (broad)
Write-up: 24 hrs after vaccination developed "deep cough, chills, eye burning", stayed in bed for 3-4 days. Feeling fine now. Never checked temperature.

VAERS ID:444893 (history)  Vaccinated:2011-10-03
Age:65.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-12-08, Days after onset: 65
Location:Massachusetts  Entered:2011-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Loratadine 10mg PO qDay Clonazepam 0.5mg PO BID Citalopram 20mg PO qDay Zolpidem 5 mg PO qhs Singulair 10mg qDay Levothyroxine 25mcg PO qDay Advair 250/50mcg 1 puff BID Pericolace 1 tab PO BID Motrin 600mg PO q6h Hydromorphone 2mg
Current Illness: Pt was post-operative day #5 after a urogyn surgery. Post-op course was complicated by hypotension, followed by aggressive fluid rescusitation, followed by pulmonary edema and ICU admission. Afebrile.
Preexisting Conditions: Asthma Seasonal Allergies Hypothyroidism Low Back Pain Anxiety/Depression Hyperlipidemia
Diagnostic Lab Data: None. ID and Derm followed pt while in house and pt was treated with IV vancomycin and Keflex and Bactrim as outpatient.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT492AA0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0985AA0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Induration, Pyrexia, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt returned to the hospital 2 days after being discharged with fever. She had a large indurated, erythematous region on her left arm. Over several hospital days, the erythematous area expanded, was warm to the touch, and remained indurated. The patient was seen by infectious disease and started on IV vancomycin. By hospital day #5, her symptoms had greatly improved and she was discharged home.

VAERS ID:445144 (history)  Vaccinated:2011-10-03
Age:27.0  Onset:2011-10-05, Days after vaccination: 2
Gender:Female  Submitted:2011-12-12, Days after onset: 68
Location:Ohio  Entered:2011-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1345Z0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient stated that her left arm became red, swollen and hurt at the injection site. She took TYLENOL for the pain. Patient stated that she had the vaccine on 10/3/11 and just remember to call me on 12/9/11.

VAERS ID:449863 (history)  Vaccinated:2011-10-03
Age:84.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 123
Location:New Jersey  Entered:2012-02-20, Days after submission: 17
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: Flu like symptoms. There were no concomitant vaccinations. The subject refused to provide concomitant medications. She had no allergies. The subject had received flu shots in the past and had experienced flu-like symptoms every year following vaccination.
Diagnostic Lab Data: UNK
CDC Split Type: A0949920A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA669AA SYRRA
Administered by: Private     Purchased by: Public
Symptoms: Burning sensation, Erythema, Extensive swelling of vaccinated limb, Influenza like illness, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a consumer (also the subject) and described the occurrence of extensive swelling of vaccinated limb in a 84-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject''s medical history included flu like symptoms following previous flu shots. The subject reported that she had received flu shots for several years, but had never experienced such a reaction. Concurrent medical conditions included hypertension. On 3 October 2011 at 13:30 the subject received a dose of FLULAVAL (unknown route, right arm). The lot number was reported as AFFLLA669AA from the reporter; however, based on a safety lot number review, the lot number was updated to AFLLA669AA. On 3 October 2011, less than one day after vaccination with FLULAVAL, the subject experienced extensive swelling of vaccinated limb, arm burning upon injection, itching near injection site and erythema near injection site. The subject reported that the extensive swelling, burning and redness occurred at the inner aspect of her right arm (arm of vaccination), but not at the site of the injection. The size of her arm had doubled. She also experienced flu-like symptoms. At the time of reporting the outcome of the events was unspecified.

VAERS ID:450802 (history)  Vaccinated:2011-10-03
Age:4.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Male  Submitted:2011-10-07, Days after onset: 4
Location:Pennsylvania  Entered:2012-02-23, Days after submission: 139
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: MEDI0013681
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.501111P IN 
Administered by: Other     Purchased by: Other
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: A non-serious spontaneous report of nosebleed has been received from a health professional concerning a four-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune''s FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 03-Oct-2011. On 03-Oct-2011, 12 hours after receiving FLUMIST, the patient experienced a nosebleed. The outcome of event nosebleed was resolved.

VAERS ID:450806 (history)  Vaccinated:2011-10-03
Age:52.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 2
Location:Wisconsin  Entered:2012-02-23, Days after submission: 141
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: MEDI0013662
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.501092P IN 
Administered by: Public     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of administration of FLUMIST to a 59 year old was received from a health professional concerning a 52-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 03-Oct-2011, a 52-year-old patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.

VAERS ID:451696 (history)  Vaccinated:2011-10-03
Age:45.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2012-03-13, Days after onset: 162
Location:Maryland  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nasonex, vitamins
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: MRI done on 3/8/2012 showed bursitis in shoulder.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURVT433AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bursitis, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: Severe shoulder pain lasting over 5 months now. Lots of PT and ibuprofen did not completely remove pain. Better now, but still hurts. MRI done 3/8/2012 revealed bursitis. Not sure what to try next.

VAERS ID:452508 (history)  Vaccinated:2011-10-03
Age:62.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-15
Location:Unknown  Entered:2012-03-27, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 12-5-12, cortisone injection in between these two dates, I was given several different pain medicines
Current Illness:
Preexisting Conditions: I''m a light smoker which has nothing to do with the adverse effects I encountered with the flu shot
Diagnostic Lab Data: On 1-12-12, I again returned to the doctor as the pain had increased to unbearable. He asked that the following tests be done and they were that day. Chest x-ray and shoulder x-ray. They showed no problems. On 1-20-12, a MRI was done with no contrast. All the above tests showed no signs of rotator cuff tear or injury. On 1-25-12, I was seen at an orthopedic office and given a cortisone injection and arm exercises to try to increase my range of motion.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Chest X-ray normal, Insomnia, Joint range of motion decreased, Limb discomfort, Musculoskeletal discomfort, Musculoskeletal pain, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity, X-ray limb normal
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: On 10-03-11, I was given a FLUARIX -36+ month - PF latex - flu shot within a week, I began having discomfort and stiffness in my arm and shoulder. Prior to the flu shot I had no injuries, issues or problems with my left arm. As it got worse, on 11-28-11, I went to the doctor regarding the increased pain in my arm and shoulder. The constant throbbing and the pain limited my abilities to use my arm and was getting only about 2 hours of sleep a night due to this situation. On 12-14-11, I again returned to the doctor as the pain was increasing even more and my range of motion was very limited at that point. It was difficult to dress or do anything that required use of my left arm. On 1-12-12, I again returned to the doctor as the pain had increased to unbearable. He ask that the following tests be done and they were that day. Chest x-ray and shoulder x-ray. They showed no problems. On 1-20-12, a MRI was done with no contrast. All the above tests showed no signs of rotator cuff tear or injury. On 1-25-12, I was seen at orthopedics and given a cortisone injection and arm exercises to try to increase my range of motion. Because I had no prior issues or injury to my left arm before the flu shot, I began and extensive internet research regarding side effects to the flu shot. I was stunned at the information I found and the problems I''ve encountered are ?not? uncommon. The flu shot is so recommended by doctors, pharmacies, insurance companies and media, but no where were there any warnings about possible side affects! I truly believe all the problems I''ve had with my left arm - the pain, suffering, loss of motion etc. was ?all caused by the flu shot? I received. Currently my out of pocket expenses total $532.00. This includes doctor visits, x-rays, MRI and medicines, not to include the pain and suffering - and not knowing that the pain will ever truly go away and/or that I''ll have full use and range of motion in that arm. At a minimum, I should be reimbursed for ?all of pocket expenses? due to this fiasco. If I or others would have been provided the possible side affects - this could have been avoided as I would have never agreed to have the shot in the first place.

VAERS ID:453634 (history)  Vaccinated:2011-10-03
Age:  Onset:2011-10-03, Days after vaccination: 0
Gender:Unknown  Submitted:2012-03-23, Days after onset: 172
Location:New Jersey  Entered:2012-04-10, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA00452
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a physician concerning an infant who on 03-OCT-2011, was vaccinated with a dose of ROTATEQ (lot # and dose not reported). The physician reported that on 03-OCT-2011 the patient vomited shortly after receipt of the vaccine. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.

VAERS ID:453418 (history)  Vaccinated:2011-10-03
Age:68.0  Onset:2011-11-15, Days after vaccination: 43
Gender:Male  Submitted:2012-04-11, Days after onset: 147
Location:Florida  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: Blood tests
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0  
Administered by: Public     Purchased by: Private
Symptoms: Blood test, Genital herpes, Skin lesion
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Lesions on penis. Diagnosed with herpes but there was no sexual contact with anyone.

VAERS ID:458792 (history)  Vaccinated:2011-10-03
Age:11.0  Onset:2012-01-15, Days after vaccination: 104
Gender:Female  Submitted:2012-07-07, Days after onset: 173
Location:Kentucky  Entered:2012-07-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None. Other than being up set at the time because she was getting a shot, she was perfectly healthy.
Preexisting Conditions: Only common allergies and an allergy to amoxicillin and sulfa. None of these came into play at the time of vaccine.
Diagnostic Lab Data: Normal thyroid testing Normal vitamin levels Normal testing for auto-immune disorders/diseases Condition still ongoing
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMAR
Administered by: Unknown     Purchased by: Other
Symptoms: Blood alkaline phosphatase abnormal, Blood test normal, Immunology test normal, Madarosis, Thyroid function test normal
SMQs:, Liver related investigations, signs and symptoms (broad), Biliary system related investigations, signs and symptoms (broad), Periorbital and eyelid disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Noticed that eyelashes were totally gone and at eye exam February 23, 2012 asked doctor about what she thought may have caused it. Told it could be possibly allergy related or that rubbing the eyes could make them fall out. Went to doctor in March 2012 about eyelashes and the fact that one eyebrow had started to fall out as well. Took her for bloodwork to check for thyroid issues which was negative and we were told that if it got worse to call. By the end of the week the eyebrow was totally gone and the other eyebrow had started to fall out. Called Dr. back and was immediately referred to Dermatologist. Saw dermatologist in April 2012 and he also ordered more bloodwork to screen for vitamin deficiencies or any auto-immune disorders/diseases. Also started her on Protopic topical gel twice daily as an attempt to stimulate hair growth. Went back to Dr. for a check up in June 2012 and both eyebrows were gone at this point. Bloodwork was normal, only abnormality was her akaline phosphatase which the pediatrician said was from her growing and not to worry about it. At this appointment I asked dermatologist specifically if the Gardasil vaccine could have cause this reaction. He stated that he didn''t think so, however, he also stated that he is not a "medical maintenance" physician and only practices dermatology. In our research to see if there have been any additional cases of hair loss related to Gardasil, we have found that there are others who have had the same experience that we are having and that their children are also misdiagnosed as having alopecia areata. This began 3-4 months after the third Gardasil vaccine which is exactly what is being reported by others and in each case all of the children were healthy and had normal bloodwork during the course of this reaction.

VAERS ID:461382 (history)  Vaccinated:2011-10-03
Age:62.0  Onset:2011-10-10, Days after vaccination: 7
Gender:Female  Submitted:2012-06-18, Days after onset: 252
Location:Idaho  Entered:2012-08-08, Days after submission: 51
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVAIR; COMBIVENT
Current Illness: Allergy to hydrocodone; Bronchial infection; Chronic obstructive pulmonary disea; Smoker
Preexisting Conditions: The subject had no concomitant vaccines. The subject had never received any previous flu shots. The subject stated the last vaccine she had was the pneumonia vaccine 8 years ago and she had not experienced any adverse events following previous vaccines. The subject reported having hives and stomach pain reaction to nabumetone and an allergy to hydrocodone which she discovered after vaccination. Follow-up via consumer 27 March 2012: The subject reported experiencing events following an increase in ADVAIR dose to 250/50 about a year and a half ago. The subject only reported taking one dose of ADVAIR at the increased strength and decreased to her usual strength of 100/50 as she reported the increased dose to be "too strong" causing shakiness,
Diagnostic Lab Data: Nuclear magnetic resonance ima, 20Jan2012, no injury to sho; X-ray, 2012, no damage
CDC Split Type: A0970247A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Private     Purchased by: Private
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Insomnia, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity, X-ray normal
SMQs:, Dementia (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a consumer (also the subject) and described the occurrence of injection arm pain in a 62-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to hydrocodone and smoker. Historic vaccination included pneumonia vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on an unspecified date. Concurrent medications included ADVAIR and COMBIVENT. On 3 October 2011 at 15:15 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 10 October 2011, 7 days after vaccination with FLUARIX, the subject experienced injection arm pain, injection site movement impairment ("loss of range of motion, could not move him, complete loss of mobility"), not sleeping and inability to perform daily activities ("could not dress, cook"). The subject stated that 1 week after the vaccination she developed significant pain in her left arm and loss of motion. She denied any injection site immediate reaction from the vaccination. According to the subject, she continued to worsen to the point of complete loss of mobility in the injected arm. She stated she could not sleep, dress, cook or move her arm. The subject reported that she was only able to get 2 hours of sleep a night for 3 months. The subject saw her physician on 14 December 2011 and again on 12 January 2012 for "continued problems". An X-ray demonstrated no physical damage or tears in her arm. The subject had a magnetic resonance imaging (MRI) on 20 January 2012 and again no injury to the shoulder or arm was seen. The subject saw an orthopedist on 25 January 2012 who treated her with a cortisone injection, pain medications and range of motion exercises. According to the subject, the cortisone injections stopped the pain and the exercises have made a very small improvement in the range of motion. The subject noted that she is not certain if she will ever be able to have full range again like this on the internet and is angry over the loss of function and money". The subject indicated that she has not pursued legal action at this time, but may proceed for reimbursement. The subject stated she reported her events to the FDA. At the time of reporting, the injection site arm pain was resolved as of 25 January 2012 and the injection site movement impairment and not sleeping were improved. The outcome for inability to perform daily activities was unknown. Follow-up information was received via the consumer on 27 March 2012. It was reported that the subject still had ongoing issues following vaccination with FLUARIX. She noted pain in her arm described as severe pain with certain arm movements and "loss of range of motion". The subject noted still not having full use of her arm. She reported that her condition may require additional cortisone shots and therapy. This subject has received ADVAIR concurrently. For details concerning events associated with ADVAIR use, please see case A0912059A.

VAERS ID:462214 (history)  Vaccinated:2011-10-03
Age:0.53  Onset:2012-08-15, Days after vaccination: 317
Gender:Female  Submitted:2012-08-16, Days after onset: 1
Location:Vermont  Entered:2012-08-16
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: Received 3 vaccinations of DTap
Diagnostic Lab Data: Nasal swab PCR
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 2  
Administered by: Private     Purchased by: Other
Symptoms: Pertussis, Polymerase chain reaction
SMQs:
Write-up: Co-worker called to state that child was diagnosed with whooping cough. Both mother and child placed on Zithromax and a nasal swab was done of child on 08/15/2012.

VAERS ID:475811 (history)  Vaccinated:2011-10-03
Age:48.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Male  Submitted:2011-11-24, Days after onset: 52
Location:Alabama  Entered:2012-11-09, Days after submission: 351
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 medical history. The patient did not have illness at time of vaccination. It was not reported if the patient had experienced adverse event following prior vaccination. It was unknown if the patient had received concomitant therapy.
Diagnostic Lab Data: Not reported
CDC Split Type: 201109644
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT445AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Case received from a Healthcare Professional on 05 October 2011 under the reference number 11-0721. A 48-year-old male patient, with unknown medical history, had received his intramuscular dose of FLUZONE (batch number UT445AA) in the left deltoid on 03 October 2011. The patient did not have illness at time of vaccination. It was not reported if the patient had experienced adverse event following prior vaccination. It was unknown if the patient had received concomitant therapy. On 03 October 2011, the patient experienced nausea and diarrhea. He recovered on an unspecified date.

VAERS ID:504062 (history)  Vaccinated:2011-10-03
Age:58.0  Onset:2011-10-11, Days after vaccination: 8
Gender:Female  Submitted:2013-09-24, Days after onset: 714
Location:Ohio  Entered:2013-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: Post herpetic neuralgia; Herpes zoster
Diagnostic Lab Data:
CDC Split Type: WAES1110USA02095
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Post herpetic neuralgia
SMQs:
Write-up: Information has been received from a 58 year old female consumer with drug reactions/allergies of sulfa who on 03-OCT-2011 was vaccinated with a dose of ZOSTAVAX (lot #, dose and frequency were not provided). Concomitant medication included "Anti-depressant and sleeping pill". The consumer reported that she experienced "unusual side effect" after receiving ZOSTAVAX. She reported that on 11-OCT-2011, she experienced post herpetic neuralgia (PHN) coming back and stated that "Neuralgia came back to the exact same location where she had it, on the right side of crown of her head to the hair line". She had a recent episode of shingles in June 2011 (also reported as no pertinent medical history) but she stated she had gotten over shingles completely with no PHN at the time of the ZOSTAVAX administration. She reported that the PHN was not as severe as before and she had been managing it with over the counter (OTC) medications (unspecified). The patient had sought medical attention by calling health department where she received ZOSTAVAX. No lab diagnostics study was performed. Her physician stated her on LYRICA 50 mg twice daily for 4 weeks. At the time of report, the outcome of the adverse event was unknown. Follow up information has been received from the consumer. On 17-SEP-2012 the patient developed a red rash in the area around her right eye. On 18-SEP-2013 she had a scratchy feeling in the right eye. On 19-SEP-2013 she was diagnosed with shingles and started taking acyclovir tablets. The outcome of shingles was not provided. Additional information is not expected.

VAERS ID:437699 (history)  Vaccinated:2011-10-03
Age:12.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 8
Location:Foreign  Entered:2011-10-11
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: B0752947A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA083EB SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a school Nurse and described the occurrence of passed out in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 3 October 2011 the subject received unspecified dose of CERVARIX (1 injection, injection). On 3 October 2011, immediately after vaccination with CERVARIX, the subject experienced passed out. This case was assessed as medically serious by GSK. At the time of reporting, the event was resolved.

VAERS ID:437705 (history)  Vaccinated:2011-10-03
Age:12.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 8
Location:Foreign  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0752948A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA083EB SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a school Nurse and described the occurrence of passed out in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 3 October 2011 the subject received unspecified dose of CERVARIX (1 injection, injection). On 3 October 2011, immediately after vaccination with CERVARIX, the subject experienced passed out. This case was assessed medically serious by GSK. It was reported that the subject was taken to hospital for observation. At the time of reporting the event was resolved.

VAERS ID:437706 (history)  Vaccinated:2011-10-03
Age:  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 8
Location:Foreign  Entered:2011-10-11
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: B0752949A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA083EB SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a school Nurse and described the occurrence of passed out in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On 3 October 2011 the subject received unspecified dose of CERVARIX (1 injection, injection). On 3 October 2011, immediately after vaccination with CERVARIX, the subject experienced passed out. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved.

VAERS ID:437707 (history)  Vaccinated:2011-10-03
Age:  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 8
Location:Foreign  Entered:2011-10-11
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: B0752950A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA083EB SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a school Nurse and described the occurrence of passed out in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On 3 October 2011 the subject received unspecified dose of CERVARIX (1 injection, injection). On 3 October 2011, immediately after vaccination with CERVARIX, the subject experienced passed out. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved.

VAERS ID:437708 (history)  Vaccinated:2011-10-03
Age:  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 8
Location:Foreign  Entered:2011-10-11
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: B0752951A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA083EB SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a school Nurse and described the occurrence of passed out in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On 3 October 2011 the subject received unspecified dose of CERVARIX (1 injection, injection). On 3 October 2011, immediately after vaccination with CERVARIX, the subject experienced passed out. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved.

VAERS ID:438504 (history)  Vaccinated:2011-10-03
Age:3.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-13, Days after onset: 10
Location:Foreign  Entered:2011-10-14, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0754974A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 4IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest pain, Hyperhidrosis, Neck pain, Pain in extremity, Pallor, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a nurse via a regulatory authority (# NL-LRB-128378) and described the occurrence of vasovagal reaction in a 3-year-old female subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline). Concomitant medication was not reported. The subject had no known medical history and no known past drug therapy. On 3 October 2011, the subject received 5th dose of INFANRIX-IPV (.5 ml, intramuscular, unknown site of injection, batch number not provided). On 3 October 2011, directly after vaccination with INFANRIX-IPV, the subject experienced pain in her left hand and on the chest. On 3 October 2011, 5 minutes after vaccination with INFANRIX-IPV, while the subject was walking outside, she collapsed. She looked very pale and was perspiring a lot. Ambulance was called and came. Vasovagal reaction was diagnosed. She has not been unconscious. After 20 minutes she was completely recovered. Later, the subject also complained about pain in her neck. This case was assessed as medically serious by GSK. On 3 October 2011, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX-IPV. Further details will be provided by the Reporting Authority whenever available.

VAERS ID:438592 (history)  Vaccinated:2011-10-03
Age:1.5  Onset:2011-10-04, Days after vaccination: 1
Gender:Male  Submitted:2011-10-14, Days after onset: 10
Location:Foreign  Entered:2011-10-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Underlying diseases: febrile convulsion, common cold. The patient was 3308g weight at the time of birth. The patient''s body temperature was 37.1 before vaccination.
Diagnostic Lab Data: No data
CDC Split Type: 201109789
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURERJE15A3SCRA
HIBV: HIB (ACTHIB)SANOFI PASTEURG12313SCLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH10L04A3SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blister, Condition aggravated, Febrile convulsion, Nasopharyngitis, Pharyngeal erythema, Pyrexia
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial report received from a physician via Health Authorities (#HIB-273) through the affiliates on 07 October 2011 under local reference number A201100631. An 18-month-old male patient with a medical history of underlying diseases of febrile convulsion and common cold presented with febrile convulsion on 04 October 2011 the day after he had received a fourth subcutaneous dose of ACTHIB (manufacturer Sanofi Pasteur, Lot No. G1231) in the left upper arm, a fourth subcutaneous dose of PREVENAR (Other Manufacturer, Lot No. 10L04A) in the left upper arm, and a fourth dose of DPT (Other manufacturer, Lot No. JE15A) in the right upper arm on 03 October 2011. The patient was 3308g weight at the time of birth. The patient''s body temperature was 37.1 degrees C before the vaccination. On 04 October 2011, the patient developed pyrexia of 38-39 degrees C late at night. Then, the pyrexia went up further and brought on febrile convulsion. At around 4:00 a.m., the patient visited another hospital. Diagnosis of common cold and febrile convulsion was made. At 9:00 a.m., the patient was seen at this hospital. Physical findings revealed pharynx redness of, vesicle and pyrexia. Considering there was no redness or swelling on the arm where the vaccination was given, the events seemed to have occurred due to common cold in its incubation period. As of 06 October 2011, the patient has not recovered from the event. The physician''s comment: The patient developed febrile convulsion after receiving the vaccination with ACTHIB, PREVENAR, and DPT. According to the physician, this case was not serious and not related to ACTHIB. The company upgraded the case as serious according to internal procedures due to significant medical condition.

VAERS ID:438766 (history)  Vaccinated:2011-10-03
Age:0.2  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-17, Days after onset: 14
Location:Foreign  Entered:2011-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0754941A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Apnoea, Bradycardia, Cardiac function test normal, Foaming at mouth, Laboratory test normal, Mechanical ventilation, Pallor, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of apnea in a 2-month-old female subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), ROTARIX and PREVENAR (non-GSK). The subject was not premature. Before vaccination the subject was in good health. On 3 October 2011, the subject received 1st dose of INFANRIX HEXA (unknown route of administration, lot number not provided), 1st dose of ROTARIX (unknown route of administration, lot number not provided) and 1st dose of PREVENAR (unknown route of administration). On 3 October 2011, few minutes after vaccination with INFANRIX HEXA, PREVENAR and ROTARIX, the subject experienced apnea, bradycardia, pallor and foam in mouth. The subject was immediately taken to the emergencies and was hospitalised (for 2 days). Apnea stopped after reanimation at the emergencies. The bradycardia stopped after the child received oxygen. Ventilation of the subject was performed. The child stayed pale for several hours. The physician did not think that this was an anaphylactic shock. The physician thought it was a vagal hyperreactivity. Physician decided to perform some investigations. All heart tests were normal. Other investigations will be performed in the next days. At the time of reporting the events were resolved.

VAERS ID:440706 (history)  Vaccinated:2011-10-03
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2011-10-28
Location:Foreign  Entered:2011-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0757344A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B199AB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Localised infection, Product quality issue
SMQs:
Write-up: This case was reported by a physician and described the occurrence of arm infection in a 6-year-old male subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline). On 3 October 2011, the subject received an unspecified dose of INFANRIX-IPV (administration site and route unknown). The reporter had a doubt regarding the lot number. In October 2011, less than one month after vaccination with INFANRIX-IPV, the subject experienced an extended infection on upper arm. The subject was hospitalised. The subject was treated with high dose of Antibiotics. At the time of reporting, the event was improved. This case was associated to a pharmaceutical product complaint as 2 other similar cases which were reported by the same reporter: B0757346A & B0757348A. Further information has been expected.

VAERS ID:440928 (history)  Vaccinated:2011-10-03
Age:49.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-31, Days after onset: 28
Location:Foreign  Entered:2011-11-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2011030189
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Neuropathy peripheral, Pain, Pain in extremity, Vaccination site pain
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: This health authority report (initial receipt: 26-Oct-2011) concerns a 49-year old female patient. On 03-Oct-2011 the patient received a dose of influenza vaccine in deltoid. On 03-Oct-2011, the same day as vaccination, the patient experienced vaccination site soreness. On 05-Oct-2011, two days post vaccination, she had severe pain in the arm and suspected nerve aggravation. She also had a severe pain in the vaccinated deltoid radiating up into the neck and down to the thumb and forefinger. She could not move her arm without severe pain. The General Practitioner was querying nerve aggravation. It was unknown if the events were treated. The patient had not recovered at the time of reporting. The outcome for ''vaccination site soreness'' was unknown. Action taken with drug was not applicable. Rechallenge was unknown. The reporter considered events to be serious as the events was considered medically significant.

VAERS ID:441146 (history)  Vaccinated:2011-10-03
Age:52.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Male  Submitted:2011-10-31, Days after onset: 28
Location:Foreign  Entered:2011-11-02, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type: PHFR2011GB05747
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX10146 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHFR2011GB05747 is an initial spontaneous report from a nurse received on 04 Oct 2011, with follow-up report from a nurse, received on 20 Oct 2011. This report refers to a 52 year old male patient. The patient''s medical history included asthma. Concomitant medications were not reported. The patient came for a surgery on 03 Oct 2011 (it was not clearly reported as whether he underwent surgery) and he received MENVEO (batch; X10146, Exp. Aug 2013) as routine vaccination on 03 Oct 2011 at unspecified dose. After the patient had received vaccination, he advised that he had already received some vaccination from another clinic earlier in the week. On checking the patient''s documentation from the other clinic, it was confirmed that the patient already had received MENVEO (no batch number available). The reporter inquired any information on the consequences of receiving 2 doses of MENVEO in 1 week. The reporter stated that at no point did the patient mention that he had already received MENVEO. The patient had forgotten what vaccinations he had received and thought they were different vaccinations. No adverse events were reported. The patient and his family were advised to monitor any changes. The patient''s wife confirmed a few days later that the patient had not experienced any adverse events as a result of the second dose of MENVEO. The reporter assessed this case as serious - medically significant. Outcome was reported as recovered, and causality was assessed as not suspected. Follow-up information received on 20 Oct 2011: case upgraded. Patient details, history, suspect drug details, event seriousness, outcome and causality updated.

VAERS ID:441153 (history)  Vaccinated:2011-10-03
Age:12.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-11-02, Days after onset: 30
Location:Foreign  Entered:2011-11-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, Unknown
CDC Split Type: B0757548A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA082AI IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Malaise, Oedema peripheral, Paraesthesia
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-EYC 00073266) and described the occurrence of hand swelling in a 12-year-old female subject who was vaccinated with CERVARIX. On 3 October 2011 the subject received unspecified dose of CERVARIX (intramuscular). On 3 October 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced hand swelling and felt sick. As the swelling did not subside, the subject was advised to go to General Practitioner (GP). The subject attended walk in centre and her arm was put in a sling and advised to see GP next day if no improvement. Her hand was still swollen and she also experienced a tingling sensation in left arm. The subject had an urgent appointment at GP surgery. The GP referred the subject to hospital where the patient had a blood test and was put on a course of antihistamines. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 4 October 2011, the events were resolved. Verbatim Text: Swelling to left hand and felt sick. Swelling did not subside. Patient advised to go to General Practitioner (GP). Patient attended walk in centre, arm put in sling and advised to see GP next day if no improvement. Hand still swollen and tingling sensation in left arm. Patient had an urgent appointment at GP surgery. GP referred patient to hospital where the patient had a blood test and was put on a course of antihistamines. Advised against continuing the Human papillomavirus (HPV) vaccinations.

VAERS ID:441282 (history)  Vaccinated:2011-10-03
Age:16.0  Onset:2011-10-08, Days after vaccination: 5
Gender:Female  Submitted:2011-11-03, Days after onset: 26
Location:Foreign  Entered:2011-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Torticollis
Diagnostic Lab Data: UNK
CDC Split Type: B0758980A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Liver disorder, Pyrexia
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of liver disorder in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included torticollis. Concurrent vaccination included CERVARIX (GlaxoSmithKline, intramuscular) 1st and 2nd doses given on an unspecified dates. On 3 October 2011, the subject received 3rd dose of CERVARIX (intramuscular, unknown deltoid). Lot number not provided. On 8 October 2011, 5 days after vaccination with CERVARIX, the subject experienced fever. On 12 October 2011, the subject developed liver disorder. The subject was hospitalised. On 14 October 2011, the symptoms were improved and she was discharged from hospital. On 18 October 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:441689 (history)  Vaccinated:2011-10-03
Age:49.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-11-04, Days after onset: 32
Location:Foreign  Entered:2011-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No information reported
Diagnostic Lab Data: UNK
CDC Split Type: B0758071A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNAR
Administered by: Other     Purchased by: Other
Symptoms: Neck pain, Neuralgia, Pain, Pain in extremity, Vaccination site pain
SMQs:, Peripheral neuropathy (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by the foreign regulatory authority and described the occurrence of neuralgia in a 49-year-old female subject who was vaccinated with Influenza vaccine. On 3 October 2011 the subject received unspecified dose of Influenza vaccine. On 3 October 2011, the same day as the vaccination, the subject experienced vaccination site soreness in the deltoid. On 05 October 2011, she had severe pain in the vaccinated deltoid radiating up into the neck and down to the thumb and fore finger. She could not move her arm without severe pain. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. Verbatim Text: This case was received from a Pharmacist on 06-Oct-11 under the reference number 07124. This case is medically confirmed. A 49 year old female patient with an unreported medical history and concomitant medication received a dose of an influenza vaccine (batch number not reported) route in the deltoid on 03-Oct-11. On 03-Oct-11, the same day as the vaccination, the patient experienced vaccination site soreness and two days post vaccination had severe pain in the arm and suspected nerve aggravation. Initially the patient had injection site soreness in the deltoid. On 05-Oct-11, she had severe pain in the vaccinated deltoid radiating up into the neck and down to the thumb and fore finger. She cannot move her arm without severe pain. The General Practitioner is querying a nerve aggravation. The reporter considered the events of suspected nerve aggravation and severe pain to be serious and has reported these events to the agency. At the time of reporting the patient has not recovered.

VAERS ID:441845 (history)  Vaccinated:2011-10-03
Age:13.0  Onset:2011-10-07, Days after vaccination: 4
Gender:Female  Submitted:2011-11-08, Days after onset: 32
Location:Foreign  Entered:2011-11-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory test, 10Oct11, blood test: normal
CDC Split Type: WAES1111USA00476
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN124500IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Hypoaesthesia, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by the agency on 28-OCT-2011, Ref: 2011-007474. This case was medically confirmed. A 13 year old female patient with unreported medical history who was not taking any concomitant medications received dose 1 of GARDASIL (batch G005569; lot#NN12450), 0.5 mL intramuscularly on 03-OCT-2011 (side not reported). On 07-OCT-2011, 4 days post vaccination, the patient experienced numbness in the thumb and little finger and decreased power in the left arm. The patient underwent blood tests in hospital on 10-OCT-2011 and was informed that these were normal. At the time of reporting to the agency the patient still had decreased power in her left arm and had not recovered. The agency considered the case to be serious as an other medically important condition. Other business partner numbers include E2011-06671.

VAERS ID:441964 (history)  Vaccinated:2011-10-03
Age:12.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-11-09, Days after onset: 37
Location:Foreign  Entered:2011-11-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin; Int./long-acting insulin; Cetirizine hydrochloride
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0759335A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA082CC021 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (GB-MHRA-ADR 21312515) and described the occurrence of swollen lips in a 12-year-old female subject who was vaccinated with CERVARIX. Concurrent medications included NOVORAPID, LEVEMIR and CETIRIZINE. On 3 October 2011 the subject received unspecified dose of CERVARIX (intramuscular). On 3 October 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced swollen lips and hive. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 16 October 2011, the events were resolved. Verbatim Text: Hives, swollen lips.

VAERS ID:443266 (history)  Vaccinated:2011-10-03
Age:74.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-11-22, Days after onset: 49
Location:Foreign  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin; Bisoprolol; Frusemide; Thyroxine sodium
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Polymerase chain reaction, HSV negative
CDC Split Type: B0762138A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: CSF lymphocyte count abnormal, Confusional state, Encephalitis, Polymerase chain reaction, Viral test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (GB-MHRA-ADR 21342278) and described the occurrence of encephalitis in a 74-year-old female subject who was vaccinated with Influenza vaccine. Concurrent medications included Aspirin, Bisoprolol, Frusemide and LEVOTHYROXINE. On 3 October 2011 the subject received unspecified dose of Influenza vaccine. On 4 October 2011, 1 day after vaccination with Influenza vaccine, the subject experienced encephalitis (confirmed by lymphocytes in Cerebrospinal fluid). Herpes simplex virus polymerase chain reaction negative and confusion. The subject was hospitalised. At the time of reporting the events were unresolved. Verbatim Text: Encephalitis (confirmed by lymphocytes in Cerebrospinal fluid). Herpes simplex virus polymerase chain reaction negative. Medically significant - still markedly confused.

VAERS ID:443891 (history)  Vaccinated:2011-10-03
Age:74.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2011-11-24, Days after onset: 51
Location:Foreign  Entered:2011-11-28, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetylsalicylic acid; Bisoprolol; Frusemide; Levothyroxine
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CSF cell count, Significant, the finding of lymphocytes in the cerebrospinal fluid; Polymerase chain reaction, Normal, HSV negative
CDC Split Type: PHFR2011GB006543
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: CSF lymphocyte count increased, Confusional state, Encephalitis, Herpes simplex serology negative, Polymerase chain reaction
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Case number PHFR2011GB006543 is an initial spontaneous report from health care professional via the health authority (MHRA ADR 21342278) received on 14 Nov 2011. This report refers to a 74-year-old female patient. This poly medicated patient received influenza virus vaccine seasonal (manufacture and batch no: unknown) on 03 Oct 2011. On 04 Oct 2011, the patient developed encephalitis, which was confirmed by the finding of lymphocytes in the cerebrospinal fluid examination. Lab value results of polymerase chain reaction revealed a negative result for herpes simplex virus. At the time of reporting, the patient was still markedly confused but her condition was improving. The reporter considered the events to be medically significant. A causality assessment was not provided.

VAERS ID:444749 (history)  Vaccinated:2011-10-03
Age:1.1  Onset:2011-10-10, Days after vaccination: 7
Gender:Male  Submitted:2011-12-03, Days after onset: 54
Location:Foreign  Entered:2011-12-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA00070
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0053Z SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Circulatory collapse, Cyanosis, Hyperhidrosis, Livedo reticularis, Peripheral ischaemia, Pyrexia, Rash, Rash papular, Respiratory disorder
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Case received from a health care professional via Health Authority on 23-NOV-2011, under the reference # 113865). Case medically confirmed. A 13 months old male patient had resolved an injection of MMR (lot # 667056/0053Z, Batch # NP14650), 0.5 ml, on 03-OCT-2011 and later on 10-OCT-2011 he developed fever. Two days later on 12-OCT-2011, he developed chills and peripheral ischemia and on 13-NOV-2011, rash. The patient developed fever on 10-OCT-2011, but was otherwise unaffected. Two days later, he had severe chills and sweating after receiving fever-reducing drugs (not specified). The chills turned into failing circulation with blue marbled fingers, toes and mouth. He had, according to the mother, an irregular breathing. Ambulance was called, in the ambulance he had given oxygen and epinephrine (adrenaline, does not reported). He recovered quickly. On 13-OCT-2011, he experienced papular rash over the trunk and back. He recovered after one day in hospital. The patient was previously healthy. Upon medical review the company judged relevant to code the following adverse events: Respiration irregularity (verbatim: irregular breathing), sweating and fever which were mentioned by the Health Authority in the narrative, but no coded. The patient recovered from the rash on 14-OCT-2011 and from the other events on an unspecified date. According to the reporter the reactions were possibly related to vaccination. Other business partner number include: E2011-07380. No further information is available.

VAERS ID:444878 (history)  Vaccinated:2011-10-03
Age:  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-12-07, Days after onset: 65
Location:Foreign  Entered:2011-12-07
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: Body temperature, 03Oct2011, 38.5deg C; White blood cells urine, 03Oct2011, positive
CDC Split Type: B0767210A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146BA0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Pyelonephritis acute, Pyrexia, White blood cells urine positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Chronic kidney disease (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of acute pyelonephritis in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On 3 October 2011, at 16:0, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, right deltoid). On 3 October 2011, at 19:50, 3 hours after vaccination with CERVARIX, the subject experienced fever (38.5 deg C). At 21:00, the subject visited the reporting physician hospital. Acute pyelonephritis and costovertebral arthralgia were diagnosed. The physician considered the events were clinically significant (or requiring intervention). Relevant test showed presence of white blood cells in urine. The subject was treated with CALONAL. The subject left for home. On 4 October 2011, in the morning, fever was resolved. At the time of reporting, the outcome of acute pyelonephritis and costovertebral arthralgia was unspecified. According to the physician, it was unknown if fever was related to CERVARIX, it was probably related to acute pyelonephritis.

VAERS ID:447164 (history)  Vaccinated:2011-10-03
Age:12.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2012-01-10, Days after onset: 99
Location:Foreign  Entered:2012-01-11, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1201USA00710
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM263500IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: This case was received from the health authority on 03-JAN-2012. IMB REF 2011-008837. This case is medically confirmed. A 12 year old female patient who was not taking any concomitant medication received the first dose of GARDASIL (lot number NM26350, batch number NP26080), 0.5 ml, IM, on 03-OCT-2011. On 03-OCT-2011, the same day as vaccination, the patient experienced a sore arm. The patient was treated with paracetamol. The patient recovered on an unreported date, seven days later. The patient reported the reaction to the reporter on 28-NOV-2011 when she came for her second dose. She had no problem after the second dose. The IMB considered the event to be serious: as it was medically important and required intervention. Other business partner numbers include E2012-00027.

VAERS ID:455498 (history)  Vaccinated:2011-10-03
Age:17.0  Onset:2011-10-04, Days after vaccination: 1
Gender:Female  Submitted:2012-05-11, Days after onset: 220
Location:Foreign  Entered:2012-05-14, 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: WAES1205USA01022
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM263500IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: This case was received from the Health Authority on 03-MAY-2012, IMB REF 2012-011131. This case is medically confirmed. A 17 year old female patient, with no concomitant medication and no reported medical history, received the first dose of GARDASIL (lot # NM26350, batch # NP26080), 0.5 ml, IM, site not reported, on 03-Oct-2011. On 04-Oct-2011, one day post vaccination, the patient developed a rash at the site of the injection. The patient was treated with antihistamines. The reaction lasted for two days and resolved completely. The patient refused further doses of GARDASIL. The IMB considered the event to be medically significant. Other business partner number include E2012-02911. Additional information is not expected.

VAERS ID:486738 (history)  Vaccinated:2011-10-03
Age:0.2  Onset:0000-00-00
Gender:Male  Submitted:2013-03-12
Location:Foreign  Entered:2013-03-12
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: Convulsion; Crying; Fever; Refusal to eat
Diagnostic Lab Data: UNK
CDC Split Type: B0873319A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Autopsy, Brain oedema, Cardio-respiratory arrest, Death, Hepatic congestion, Hyperhidrosis, Hypotonia, Pallor, Peripheral coldness, Pulmonary congestion, Pulmonary haemorrhage, Pulmonary oedema, Renal haemorrhage, Renal tubular necrosis, Renal venous congestion, Spleen congestion, Sudden infant death syndrome, Toxicologic test abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Renovascular disorders (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of sudden infant death in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), DTP-Hep B-Hib (non-gsk) and OPV. No family history of metabolic disorders/inborn errors of metabolism, of any cardiac problem, of epilepsy and convulsions, of non accidental injury in child and of non accidental injury in siblings. The subject had no known allergies, no episodes of cyanosis, stop breathing or apnea, no gastroesophageal reflux, no convulsions, no sleep disorder, no past surgery and no other medical conditions. Following last vaccinations (it was unknown which vaccines were administered), the subject experienced crying, fever (39.9 deg.C) and convulsions. He also refused to eat. It was unknown if there was a history of mistreatment prior to contact with social worker. 2 weeks before vaccination, the subject was not exposed to contagious disease, no infection, no loud breathing or snoring during sleep, no vomiting, no appetite change, no diarrhea or stool change, no dyspnea, no abnormal crying, no lethargy. He only had fever and excessive sweating during sleep. His twin brother had fever and convulsion that evolved favorably. Please see case B0873315A for details regarding this case. The 18-year-old subject''s mother didn''t smoke. During pregnancy, there was no maternal illness or complication, she didn''t smoke, she didn''t take any medication during pregnancy and breast feeding. She gave birth at 37 weeks of gestation of 2 boys (twins). Birth weight: 3.200kg, length: 51 cm. Apgar score: 8 at 1st minute, 9 at 5th minute and 10 at 10 minutes. There were no birth defects, no fetal distress. The subject was not breast fed. The evolution of the growth and weight since birth was normal. On 3 October 2011, the subject received 1st dose of ROTARIX (oral, batch number not provided), an unspecified dose of DTP-Hep B-Hib (unknown) and an unspecified dose of OPV (oral). His last meal was at 8 pm (milk). 12 hours after vaccination with DTP-Hep B-Hib, OPV and ROTARIX, the subject experienced cardiopulmonary arrest, flaccidity, pallor generalized, sweating and skin cold. The subject died from sudden infant death and post vaccinal reaction. The subject was found dead in his bed where he slept with his mother and brother. He was placed face up and was found also in this position. An autopsy was performed and showed cardiopulmonary arrest, brain edema, cardiac congestion, congestion of kidney, extensive intraparenchymal hemorrhage, hepatic congestion, lung congestion, pulmonary edema, pulmonary hemorrhage, renal hemorrhage, spleen congestion and tubular necrosis. The toxicology study showed the presence of phospine that could be contained in pesticides, not existing in the mentioned vaccines.

VAERS ID:486868 (history)  Vaccinated:2011-10-03
Age:0.2  Onset:2011-10-03, Days after vaccination: 0
Gender:Unknown  Submitted:2013-03-13, Days after onset: 527
Location:Foreign  Entered:2013-03-13
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Heart rate, 03Oct2011, 40 beats per min; Toxicologic test, No presence of phosphine
CDC Split Type: B0873315A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 0SYRUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, Convulsion, Feeling cold, Hypotonia, Hypoxia, Pallor, Pyrexia, Respiratory failure, Resuscitation, Toxicologic test normal
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Convulsions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of convulsion syndrome in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline), DTP-HepB-Hib (manufacturer unspecified) and OPV (manufacturer unspecified). On 3 October 2011, the subject received 1st dose of ROTARIX (oral, unknown batch number), 1st dose of Penta vaccine (unknown route, site of injection and batch number), 1st dose of OPV (oral, unknown batch number). On 3 October 2011, 12 hours after vaccination with OPV, Penta vaccine and ROTARIX, the subject experienced cold feeling, flaccidity and pallor generalized with a heart rate of 40 per minute. The subject was hospitalised and the physician considered the events were life threatening. The subject received oxygen and cardiopulmonary resuscitation manoeuvres in a medical center. The subject''s airway was free. The subject was then referred to hospital with a diagnostic of respiratory insufficiency secondary to bradycardia and hypoxemia. At the hospital, the subject was diagnosed with convulsive syndrome and febrile syndrome, both under evaluation. A forensic toxicology study was done and did not reveal any presence of phosphine. The subject evolved well and was discharged in good health condition. At the time of reporting, the events were resolved. This case is linked to B0873319A (Twin''s brother who experienced adverse event after the same vaccination).

VAERS ID:489407 (history)  Vaccinated:2011-10-03
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-15
Location:Foreign  Entered:2013-04-15
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1304GBR006272
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Depression, Irritability, Lethargy, Menorrhagia, Pain
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)
Write-up: This case was received from the health authority in the foreign country on 08-Apr-2013. GB-MHRA-ADR 22066991. This case is not medically confirmed as it was reported by a consumer. A 14-year old female patient, with no reported medical history or concomitant medication, was vaccinated on 03-Oct-2011 with an injection of HPV (manufacturer and batch no. unknown; route, dose and site of administration not reported) and on an unreported date she experienced sore, was irritable, lethargic, had anaemia and showed worrying signs of depression. It was reported that changes in her health occurred within three days of the jab. The patient had been for X-rays and seen the doctor many times however nothing had been found which explained this situation. Heavy periods were lasting months at a time. She had small break of week or so and then it started again. It was unknown hot to get this period to stop. Corrective treatment included co-cyprindiol but it was stated that nothing stopped this bleeding. Even though on the pill and not having seen day break, this period was on its 4th week at the time of reporting. The patient had seen many different healthcare professionals since getting this jab. The reporter stated that the jab could not be given to teenage girls. Not enough information was given and the reporter did not feel enough research went into this. At the time of reporting the patient had not recovered from heavy periods. The outcome was unknown for anaemia, cramps, depressed, irritable, lethargic and sore. The MHRA considered this case to be serious due to disability and as an other medically important condition.

VAERS ID:489338 (history)  Vaccinated:2011-10-03
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-16
Location:Foreign  Entered:2013-04-16
Life Threatening? No
Died? No
Permanent Disability? Yes
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: B0882204A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Depressive symptom, Dysmenorrhoea, General physical health deterioration, Irritability, Lethargy, Menorrhagia, Menstruation irregular, Pain, X-ray
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), Fertility disorders (broad), Hypoglycaemia (broad)
Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-EYC 00099741) and described the occurrence of heavy menstrual bleeding in a 14-year-old female subject who was vaccinated with HPV2. On 3 October 2011 the subject received an unspecified dose of HPV2. At an unspecified time after vaccination with HPV2, the subject experienced heavy menstrual bleeding which lasted months at a time, irritability, lethargy, anemia, depressive symptom, menstrual cramp which lasted up to five months at a time and pain. The patient has a small break of a week or so then starts menstrual bleeding again. The patient had tried a few mini pills however the bleeding continued. Within 3 days of vaccination with HPV2 the patient had experienced changed in her health. X-rays had been performed (results unspecified). The regulatory authority reported that the events were disabling. At the time of reporting the heavy menstrual bleeding was unresolved and the outcome of all other events was unknown. Verbatim Text: The patient has been for X-rays and seen the doctor many times however nothing has been found which explains the situation. Heavy periods lasting months at a time. Has small break of week or so then starts again. Has tried a few mini pills now but nothing stops this bleeding. Sore, irritable, lethargic, anaemia and shows worrying signs of depression. No get up and go left in the patient when the patient was a bubbly teenager. Changes in health within three days of this jab. Unknown how to get this period to stop. Even though on the pill and not having seven day break, this period now on its 4th week!! The patient has seen many different healthcare professionals since getting this jab. Lethargic, depressed, excessive bleeding and cramps lasting up to five months at a time. Jab should not be given to teenage girls. Not enough information was given and I don''t feel enough research went into this.

VAERS ID:436777 (history)  Vaccinated:2011-10-04
Age:33.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Ohio  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Pregnant
Diagnostic Lab Data: None - has first prenatal visit 10/5/11
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11094PA0IMLA
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.501094P0IN 
Administered by: Public     Purchased by: Private
Symptoms: Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Pregnant female (approximately 2 months) given 1/2 dose of nasal flu vaccine prior to nurse noting that recipient pregnant. Flu immunization completed with approved for pregnant women vaccine.

VAERS ID:436788 (history)  Vaccinated:2011-10-04
Age:59.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-05, Days after onset: 0
Location:Ohio  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1150Z0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain, redness and swelling at injection site. Patient states severe pain.

VAERS ID:436790 (history)  Vaccinated:2011-10-04
Age:29.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Colorado  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: stomach pain X5days~Influenza (Seasonal) (no brand name)~1~27.25~Patient
Other Medications:
Current Illness: Mild cold/cough
Preexisting Conditions: Chronic Asthma and Sinusitis; environmental allergies. Allergy to Vicodin and Zyrtec
Diagnostic Lab Data: EKG; Decadron, Claritin, Aceteminophen administered
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  IJUN
Administered by: Public     Purchased by: Other
Symptoms: Chest discomfort, Dizziness, Electrocardiogram, Headache, Muscle tightness, Musculoskeletal pain, Pain, Pruritus, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Dystonia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pain, swelling, and extreme itching distal to injection site; shoulder pain; headache; dizziness; lightheaded; chest tightness, back tightness.

VAERS ID:436794 (history)  Vaccinated:2011-10-04
Age:44.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Georgia  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: feeling ill (can''t recall symptoms~Influenza (Seasonal) (no brand name)~UN~42.00~Patient|feeling ill~Influenza (Seasonal) (no br
Other Medications:
Current Illness: Some allergy symptoms: congestion, occasional sneezing, itchy eyes, occasional dull headache. I believe due to ragweed allergy which is in bloom now.
Preexisting Conditions: Seasonal allergies, low-thyroid, mild depression, dry eye, chronic conjunctivitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 4IJRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal discomfort, Fatigue, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Began with headache which got continually worse and was eventually accompanied by mild nausea and some fatigue. At 5:30 took Advil 400 mg. Headache did not respond so 1 hour later I took 1 Percocet 7.5 mg (I had left over from a foot surgery in June). Severe headache continued to persist along with mild nausea. At 10:00pm I took 2 Tylenol and tried to go to bed. Headache was keeping me awake so at 12:30 I took an oxcodone 7.5 mg (prescribed from another foot surgery the year before). I was finally able to get to sleep. Woke up this morning (10/5) with stomach upset and mild body aches. Headache is better. Almost not present now.

VAERS ID:436820 (history)  Vaccinated:2011-10-04
Age:29.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Michigan  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN551050IJRA
Administered by: Other     Purchased by: Other
Symptoms: Headache, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Around 10PM in the evening on 10/04/2011, I begun to have hives on the back of both my arms. This cleared up by morning, however, when I woke up 7AM on 10/05/2011, I had hives on my abdomen. They disappeared by 10AM on 10/05/2011. I have also had a headache since the shot.

VAERS ID:436822 (history)  Vaccinated:2011-10-04
Age:45.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:North Carolina  Entered:2011-10-05
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: No
Diagnostic Lab Data: Lab work and EKG...monitor my heart and blood pressure
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Cardiac monitoring, Dysphonia, Dyspnoea, Electrocardiogram, Heart rate increased, Heart rate irregular, Laboratory test, Pain, Ventricular extrasystoles
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)
Write-up: Rapid irregular heart rate. PVCs body aches and headache hoarsness and shortness of breath due to the PVC...lasted on into midnite and went to ER...Took Tylenol and Xanax

VAERS ID:436862 (history)  Vaccinated:2011-10-04
Age:71.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-05, Days after onset: 1
Location:California  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergic to Amoxicillin/w Augmentin, Vicodin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS 1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad)
Write-up: Fast Heart Beat, Dizziness, (200 beats a minute Blood Pressure 95/65

VAERS ID:436863 (history)  Vaccinated:2011-10-04
Age:51.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-05, Days after onset: 0
Location:Pennsylvania  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA673AA0 LA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Pain
SMQs:
Write-up: I am unable to lift my left arm without excrutiating pain.

VAERS ID:436875 (history)  Vaccinated:2011-10-04
Age:66.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Florida  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH458AC IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Cold sweat, Influenza like illness, Nausea, Neck pain, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: (PM) arm ache radiating to back and neck cold sweat, n/v, flu like symptoms. Patient''s husband will contact MD on 10/5/11.

VAERS ID:436876 (history)  Vaccinated:2011-10-04
Age:56.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Louisiana  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1100201 IJUN
Administered by: Unknown     Purchased by: Private
Symptoms: Nerve injury
SMQs:, Accidents and injuries (narrow)
Write-up: Pt thought I hit a nerve when injecting flu vaccine.

VAERS ID:436877 (history)  Vaccinated:2011-10-04
Age:0.17  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Illinois  Entered:2011-10-05
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: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3867AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF255780IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0920AA0PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left leg with swelling and redness

VAERS ID:436882 (history)  Vaccinated:2011-10-04
Age:65.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Massachusetts  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Shingles outbreak~Zoster (no brand name)~1~60.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER   RA
Administered by: Unknown     Purchased by: Other
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Increasing arm pain, searing quality, radiation of pain down from shoulder to fingers, numbness/tingling in fingers, marked stiffness of shoulder. Unable to move/lift arm.

VAERS ID:436885 (history)  Vaccinated:2011-10-04
Age:71.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Minnesota  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: Allergies: Sulfa Medical Condition: COPD 496
Diagnostic Lab Data: No tests. Injection site examined by physician. Patient told to elevate arm and apply ice. Patient dismissed. Patient to call or follow up with primary if symptoms worsen
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1071AA1IMLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pain, swelling, redness, warmth.

VAERS ID:436886 (history)  Vaccinated:2011-10-04
Age:56.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-05, Days after onset: 1
Location:Virginia  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: We have all hospital reports blood work and EKG results if needed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   RA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure increased, Blood test, Electrocardiogram, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow)
Write-up: Rapid Heart beat and elevated blood pressure. Duration 4 hours.

VAERS ID:436903 (history)  Vaccinated:2011-10-04
Age:52.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Virginia  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: high blood pressure
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR492810011500IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Chills, Dizziness, Syncope, Thirst
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: At bedtime, generally lightheaded for 5 minutes, shivering about 2 minutes before sudden fainting that lasted no more than 1/2 minute. Thirst, weakness, and continued shivering lasting 25 minutes while drinking water and 5 oz of Gatorade. More comfortable as symptoms subsided and slept comfortably.

VAERS ID:436914 (history)  Vaccinated:2011-10-04
Age:80.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-05, Days after onset: 0
Location:Louisiana  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0453AA UNLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: PNEUMOVAX vaccination Lt upper arm swelling & pain to lt upper arm.

VAERS ID:436918 (history)  Vaccinated:2011-10-04
Age:20.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-04, Days after onset: 0
Location:California  Entered:2011-10-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4052AD1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Axillary pain, Back pain, Chills, Fatigue, Headache, Injection site pain, Muscle contracture, Neck pain, Restlessness
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: 10/4/11 approx. started feeling tired, headache, neck and back pain, felt like muscles contracting, pain in injection side and to armpit, chills temps not taken, restless through the night.

VAERS ID:436925 (history)  Vaccinated:2011-10-04
Age:52.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Male  Submitted:2011-10-05, Days after onset: 0
Location:Colorado  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No known illness
Preexisting Conditions: Allergic to bee stings
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT443AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B072EA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Multiple muscle & joint pain. Taking ASA.

VAERS ID:436939 (history)  Vaccinated:2011-10-04
Age:44.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-05, Days after onset: 1
Location:New York  Entered:2011-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None performed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1101601 SYRLA
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site oedema, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Itching, pain, edema at injection site immediately after injection. Increased in severity after several minutes. Was seen m ER within 30 minutes, given BENADRYL and discharged home within 1 hour.

VAERS ID:436941 (history)  Vaccinated:2011-10-04
Age:41.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 1
Location:Georgia  Entered:2011-10-05
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) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFFLLA674AA0IJLA
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Three (3) hours after injections welts/hives appeared on face and neck.

VAERS ID:436905 (history)  Vaccinated:2011-10-04
Age:38.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-06, Days after onset: 2
Location:Unknown  Entered:2011-10-06
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) (FLUZONE)SANOFI PASTEURUH453AB IMLA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Oedema peripheral, Rash, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives, rash, swollen hands/achy joints

VAERS ID:436960 (history)  Vaccinated:2011-10-04
Age:55.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 2
Location:Michigan  Entered:2011-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No.
Preexisting Conditions: Allergic to Sulfa drugs and shellfish, like mussels and clams.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMLA
Administered by: Other     Purchased by: Private
Symptoms: Asthenia, Chills, Hypokinesia, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Could not raise arms, chills, body aches, 101 fever. All eased the next day, but recurred the following evening. As of reporting 10/06/2011, still feel weak and achy in arms.

VAERS ID:436965 (history)  Vaccinated:2011-10-04
Age:3.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 2
Location:Ohio  Entered:2011-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: strep test negative urine culture sent
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSU4159BB2IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH390AA3IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF255784IMLL
Administered by: Unknown     Purchased by: Private
Symptoms: Culture urine, Headache, Pyrexia, Streptococcus test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: fever headache and vomiting

VAERS ID:436999 (history)  Vaccinated:2011-10-04
Age:55.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-05, Days after onset: 1
Location:Florida  Entered:2011-10-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA672AA UNRA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Myalgia, Pyrexia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Flu-like symptoms from 5-20 hours post vaccination (shaking chills, fever to 100.7 degrees, muscle and joint pain, fatigue).

VAERS ID:437487 (history)  Vaccinated:2011-10-04
Age:30.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-10, Days after onset: 6
Location:Washington  Entered:2011-10-10
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: BMP, CBC: all values within normal limits.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA625BA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Full blood count normal, Induration, Local reaction, Metabolic function test normal, Pain, Pyrexia, Tenderness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Low grade fever, local reaction; erythema and induration measuring 12 cm x 6 cm, pain and tenderness.

VAERS ID:437499 (history)  Vaccinated:2011-10-04
Age:69.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-10, Days after onset: 6
Location:New York  Entered:2011-10-10
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: penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH436AA0UNLA
Administered by: Military     Purchased by: Unknown
Symptoms: Body temperature increased, Chills
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Severe, uncontrollable shivering. Temp: 100.5. Duration: 50 minutes. Rx; TYLENOL.

VAERS ID:437515 (history)  Vaccinated:2011-10-04
Age:42.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-10, Days after onset: 6
Location:Minnesota  Entered:2011-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN55906 IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Hypoaesthesia, Paraesthesia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Numbness and Tingling sensation that started on the side injection was given. Right shoulder into neck, tongue and head, eventually moved throughout entire body. Also sensation of tremoring through body.

VAERS ID:437517 (history)  Vaccinated:2011-10-04
Age:34.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-10, Days after onset: 6
Location:Virginia  Entered:2011-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: dermatitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)SANOFI PASTEURLU4178BBA6IMLA
Administered by: Public     Purchased by: Private
Symptoms: Condition aggravated, Dermatitis
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Dermatitis

VAERS ID:437529 (history)  Vaccinated:2011-10-04
Age:5.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Male  Submitted:2011-10-07, Days after onset: 2
Location:California  Entered:2011-10-10, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN569070IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large local are of redness (palm size) around site of flu shot (L) deltoid) resolved w/in 48 hours.

VAERS ID:437540 (history)  Vaccinated:2011-10-04
Age:29.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-10, Days after onset: 5
Location:Oklahoma  Entered:2011-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Client denied feeling ill day of immunizations and client completed the adult screening questionnaire before immunizations were administered and questionnare was reviewed/discussed before immunizatons were administered. Public health nurse advised client to go to E.R. due to s/s and pain.
Preexisting Conditions: ASTHMA AND HODGKIN''S LYMPHOMA STAGE 4 IN 2007 & 2010, RECEIVED STEM CELL TRANSPLANT JULY 5, 2010 AND CONTINUES TO BE IN REMISSION PER LETTER FROM BLOOD AND MARROW TRANSPLANT PROGRAM. CLIENT BROUGHT TO IMMUNIZATION APPOINTMENT A PRESCRIPTION & A LETTER FROM MD ORDERING THE IMMUNIZATIONS THAT WERE ADMINSTERED ON OCT 4, 2011.
Diagnostic Lab Data: BLOOD AND URINE TESTING-DIAGNOSED WITH UTI & DEHYDRATED. CLIENT REPORTS WAS GIVEN I.V.FLUIDS, I.V.ROCEPHIN, I.V.ZOFRAN, I.V. MORPHINE, I.V. DILAUDID, I.V. TRAMADOL AND ORAL POTASSIUM, NO MEDS WERE ISSUED FOR HOME USE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH455AA IMRA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVCOO4AA1IMRA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0058Z IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURE03301 SCLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0884Z IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3922AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood test, Bone pain, Dehydration, Dizziness, Headache, Nausea, Pain, Pain in extremity, Pyrexia, Urinary tract infection, Urine analysis abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: ON 10-5-2011 DIZZY, ARMS SORE, FEVER OF 101-104 DEGREES, WITH TYLENOL 2 DEGREES LESS. ON THURSDAY 10-06-11 FEVER OF 104, BODY ACHES AND BONE PAIN, DIZZY, HEADACHE, NAUSEA, AND VOMITING BEGAN THURSDAY NIGHT. WENT TO ER ON FRIDAY OCT 7TH, 2011 AT 5PM.

VAERS ID:437565 (history)  Vaccinated:2011-10-04
Age:28.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-10, Days after onset: 5
Location:Michigan  Entered:2011-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness or symptoms of imminent illness.
Preexisting Conditions: Latex sensitivity- causes skin itching. Latex condom allergy.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Cough, Decreased appetite, Fatigue, Nausea, Oropharyngeal pain, Pain, Rhinorrhoea, Sneezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: On 10/4/2011 @ 9:30 PM, I began feeling nausea. On 10/5/2011, I had symptoms including: severely sore throat, nausea, loss of appetite, runny nose. 10/6/2011, symptoms: all of above plus coughing, sneezing & fatigue. 10/7/2011 symptoms: all of above plus body aches. Saw doctor 10/7/11, who prescribed " Tamiflu" capsules and "Phenergan" cough syrup.

VAERS ID:437593 (history)  Vaccinated:2011-10-04
Age:7.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-10, Days after onset: 6
Location:Pennsylvania  Entered:2011-10-10
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: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH471AA6IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1110Z0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site vesicles, Papule
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Small raised papule on upper (R) forearm with mild erythema on 10/6/11. Mom repots on PM of 10/4 child developed blister at site of injection that was painful, itchy. Blister burst exuding watery material, no pus, no fever, no other complaints.

VAERS ID:437631 (history)  Vaccinated:2011-10-04
Age:45.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 7
Location:Virginia  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: n/a
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH462AA IMLA
Administered by: Military     Purchased by: Private
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea and Vomiting

VAERS ID:437636 (history)  Vaccinated:2011-10-04
Age:60.0  Onset:2011-10-11, Days after vaccination: 7
Gender:Female  Submitted:2011-10-11, Days after onset: 0
Location:Virginia  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3935AA IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Fatigue, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site warmth, Local reaction, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Reports local site reaction x1 week, redness, warm and tender to touch, approximate 3 inches round. Complained of feeling tired yesterday 10/10/11. Reports shooting pains, numbness and tingling in right arm that started last night. Woke up this morning with additional warm, red irregular erythematic area on inside of right upper arm approximately 3-4 inches that is oblong in shape. Denies fever. Referred to PCP.

VAERS ID:437662 (history)  Vaccinated:2011-10-04
Age:41.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-10, Days after onset: 6
Location:Florida  Entered:2011-10-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IJUN
Administered by: Private     Purchased by: Private
Symptoms: Abasia, Activities of daily living impaired, Back pain, Dizziness, Dysstasia, Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site rash, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Headache, nausea, redness at injection site along with itching, hard, sore bump. Body aches, back ache, could not stand or walk, lightheaded & dizzy, symptoms lasted more than 72 hrs - missed 2 days of work.

VAERS ID:437664 (history)  Vaccinated:2011-10-04
Age:81.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 7
Location:Florida  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Sinus allergies; high blood pressure; thyroid; anxiety
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
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FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRA
Administered by: Other     Purchased by: Public
Symptoms: Chills, Dizziness, Fatigue, Headache, Increased upper airway secretion, Injection site pain, Nasal congestion, Productive cough, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hurt during administration. Felt dizzy waited 20 minutes. Went home still felt light headed, chills, fever and headache eventually developed. Took ADVIL. Next couple of days was fatigued, chills, stuffy nose, fever, cough with phlegm until Friday. Weekend felt fatigued/tired. Today feeling better. Has never had problems with flu or any vaccine before.

VAERS ID:437691 (history)  Vaccinated:2011-10-04
Age:26.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 2
Location:New York  Entered:2011-10-11, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11020012IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Adverse reaction, Injection site erythema, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: At on 10/4/11 at 8:51 am pt received INFLUENZA vaccine. On 10/6/11 at 6:46 am pt called on-call RN c/o her arm is now red; warm with rash about size of egg where she had her flu shot. Called & pt needing MD appt at 3:30 with dr. Dx reaction, 10/11/11 resolved.

VAERS ID:437714 (history)  Vaccinated:2011-10-04
Age:66.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Male  Submitted:2011-10-07, Days after onset: 2
Location:New York  Entered:2011-10-11, Days after submission: 4
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
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11004010UNAR
Administered by: Other     Purchased by: Public
Symptoms: Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient came in after receiving flu vaccine on 10/4/2011. Patient came in Friday 10/7/11 morning reporting swelling bump where vaccine administered. Bump is fluid filled, 1/2cm diameter, 2 mm height. No treatment provided. Instructed patient to put on antibiotic if bump breaks and opens up.

VAERS ID:437715 (history)  Vaccinated:2011-10-04
Age:3.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 7
Location:Pennsylvania  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH455AC2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Localized shot reaction (R) UE with surrounding redness.

VAERS ID:437727 (history)  Vaccinated:2011-10-04
Age:35.0  Onset:2011-10-08, Days after vaccination: 4
Gender:Female  Submitted:2011-10-11, Days after onset: 3
Location:Georgia  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Reported
Preexisting Conditions: None Reported
Diagnostic Lab Data: N/ A
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED13849111A IMLA
Administered by: Military     Purchased by: Military
Symptoms: Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient noted erythematous blotches on upper anterior thighs. Not itching. The next morning round, erythematous patches developed on posterior aspect of upper arms. Not itching.

VAERS ID:437728 (history)  Vaccinated:2011-10-04
Age:36.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-11, Days after onset: 7
Location:Maryland  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Test results are pending.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
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FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Laboratory test, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: The patient started having a burning sensation and pain in left arm after receiving the influenza vaccine on 4 Oct 11.

VAERS ID:437775 (history)  Vaccinated:2011-10-04
Age:49.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-11, Days after onset: 7
Location:Hawaii  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No (illness at home nasal symptoms - daughter)
Preexisting Conditions: Unknown; (NDA = not allergic to eggs)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH462AB1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Muscular weakness, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 10/4/11 Client rec''d flu vaccine with incident (L) deltoid. 10/7/11 Client returned c/o sl fever day after vaccine, feels tired, body aches, both arms feel weak since vaccine (stated went jogging after vaccine given, daughter at home with nasal congestion). Client on TYLENOL/ referred to PMD BP 160/80 T 97.9.

VAERS ID:437781 (history)  Vaccinated:2011-10-04
Age:2.0  Onset:0000-00-00
Gender:Male  Submitted:2011-10-11
Location:Minnesota  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
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DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B250BA IMRL
Administered by: Public     Purchased by: Unknown
Symptoms: No adverse event
SMQs:
Write-up: No adverse events, noted or tx. needed.

VAERS ID:437782 (history)  Vaccinated:2011-10-04
Age:22.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-11, Days after onset: 6
Location:Minnesota  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1102501 IMLA
Administered by: Other     Purchased by: Public
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Vaccine administered 10/4/11. Patient reported seizure within 24 hours. Hospitalized overnight for observation.

VAERS ID:437858 (history)  Vaccinated:2011-10-04
Age:80.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-11, Days after onset: 6
Location:North Carolina  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1100101 IMRA
Administered by: Other     Purchased by: Private
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Malaise, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Pt experienced shortness of breath, fatigue, nausea, tightness of chest and overall sick feeling for 1 week.

VAERS ID:437786 (history)  Vaccinated:2011-10-04
Age:47.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 2
Location:Texas  Entered:2011-10-12, Days after submission: 6
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
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AB0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Local swelling, Swelling face, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 4 hours after vaccine given pt started having tongue, face and neck swelling. She called ambulance and was taken to ED. Pt also states that she had a recent tick bite on her face and just had eaten red meat, she read an article regarding meat allergies after tick bites.

VAERS ID:437815 (history)  Vaccinated:2011-10-04
Age:1.56  Onset:2011-10-05, Days after vaccination: 1
Gender:Male  Submitted:2011-10-12, Days after onset: 7
Location:Indiana  Entered:2011-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: gastroesophageal reflux, exercise induced bronchospasm.
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
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DTAP: DTAP (DAPTACEL)SANOFI PASTEURU3497BA3 RA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH454AA2IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAUB533CA1 LA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness of right upper arm that persisted for over a week.

VAERS ID:437899 (history)  Vaccinated:2011-10-04
Age:8.0  Onset:2011-10-06, Days after vaccination: 2
Gender:Male  Submitted:2011-10-12, Days after onset: 6
Location:Virginia  Entered:2011-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sore throat
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT472AA5IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site reaction
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Localized erythema on L shoulder at injection site 8cm round-non tender, No discharge. No fever.

VAERS ID:437907 (history)  Vaccinated:2011-10-04
Age:39.0  Onset:2011-10-06, Days after vaccination: 2
Gender:Female  Submitted:2011-10-12, Days after onset: 6
Location:Texas  Entered:2011-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT451AA IMLA
Administered by: Public     Purchased by: Other
Symptoms: Eyelid ptosis, Hypoaesthesia oral, Paraesthesia oral, VIIth nerve paralysis
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Bells Palsy (per patient), Pt complains of L eye droop, numbness and tingling to mouth.

VAERS ID:438286 (history)  Vaccinated:2011-10-04
Age:11.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-06, Days after onset: 2
Location:California  Entered:2011-10-13, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.501092P3IN 
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4052AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC39478A0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Local swelling, Pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling, pain, redness 6 x 8 cm (R) deltoid.

VAERS ID:438289 (history)  Vaccinated:2011-10-04
Age:46.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-04, Days after onset: 0
Location:Virginia  Entered:2011-10-14, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Dust mites
Diagnostic Lab Data: None at this time.
CDC Split Type:
Vaccination
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.501088P0IN 
Administered by: Public     Purchased by: Public
Symptoms: Accidental exposure, Eye irrigation
SMQs:, Medication errors (narrow)
Write-up: Patient was inadvertently sprayed with FLUMIST on (R) side of face and possibly (R) eye when student was attempting to deliver intranasal mist in (R) nostril. Eye was immediately flushed with eye rinse by RN. No swelling or redness noted before or after eye rinsing. Both nostrils effectively sprayed with FLUMIST by RN. No irritation of eye when client left clinic around 10AM.

VAERS ID:438400 (history)  Vaccinated:2011-10-04
Age:44.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-14, Days after onset: 10
Location:Minnesota  Entered:2011-10-14
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 known
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH462AB IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Limb discomfort, Middle insomnia, Neuropathy peripheral, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad)
Write-up: First report on 10/6/11. Initially slight discomfort in right arm, then awakened by the pain twice during night. Worse 24 hours later, applied ice and took ibuprofen and Benadryl but not much relief. Reports intermittent shooting pains from shoulder to thumb, limited range of motion, painful to move arm. Has had previous influenza vaccines without any problem. Gradually worse by 48 hrs later. Observed redness 4 inches laterally at injeciton site low on the R deltoid along with some swelling. Attempted range of passive motion but met with complaints. Recommended call own provider for treatment. F/U phone call 10/12/11 she went to NP who prescribed antibiotic for infection and suggested referral to neurologist if continues. She states still having pains but able to go to work. Recommended see another provider for additonal meds to quiet nerve irritation but she declined.

VAERS ID:438403 (history)  Vaccinated:2011-10-04
Age:4.0  Onset:2011-10-06, Days after vaccination: 2
Gender:Male  Submitted:2011-10-14, Days after onset: 8
Location:Texas  Entered:2011-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic Rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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Dose
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DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184AA IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0104AA SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0111AA SCLL
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient complaining of large, red, whelp on Right Thigh, and went to Urgent Care Center and recieved antibiotics at that time on 10/06/2011. The patient went back to Urgent Care Center 10/11/2011 was informed to continue prescribed antibiotics and also gave the patient Ora Pred.

VAERS ID:438407 (history)  Vaccinated:2011-10-04
Age:33.0  Onset:2011-10-10, Days after vaccination: 6
Gender:Female  Submitted:2011-10-14, Days after onset: 4
Location:Texas  Entered:2011-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11093P0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: 10/10/11 Woke up & noticed that she had numbness in 3 fingers on her R hand, a spot above her R knee & the ball of her R foot. States that the numbness has been progressing since then and now affects the entire right side of her body. NO weakness or pain.

VAERS ID:438475 (history)  Vaccinated:2011-10-04
Age:59.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-14, Days after onset: 9
Location:Kansas  Entered:2011-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hx DVT; Depression; Hyperlipidemia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AB1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4103AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injected limb mobility decreased, Nausea, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pain to (R) arm et decreased ROM 1 day after Tdap. Pain worse with movement. Nausea 2 days after administration. Tx: Ice/heat/ibuprofen/TYLENOL F/U PRN. No associated redness, swelling, warmth, numbness or tingling.

VAERS ID:438487 (history)  Vaccinated:2011-10-04
Age:61.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-14, Days after onset: 9
Location:Washington  Entered:2011-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Oral HSV; hyperlipidemia; GERD
Diagnostic Lab Data: CBC; BMP; normal pm 10/8/11
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT427AA UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Fatigue, Full blood count normal, Metabolic function test normal, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Dizziness, nausea, fatigue, few episodes vomiting x 3 - 4 d.

VAERS ID:438523 (history)  Vaccinated:2011-10-04
Age:71.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-14, Days after onset: 10
Location:Texas  Entered:2011-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH455AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Eye swelling, Fatigue, Nasal congestion
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt in the past has had previous reaction to neomycin as extreme fatigue, but did not think it even was a possible allergy. With this flu shot patient experienced eye swelling, nose swelling, & difficulty breathing & fatigue 40 minutes after receiving the shot. Pt took 4 BENADRYL to stop reaction for several days. Swelling/difficulty breathing resolved in one day. Fatigue resolved in one week.

VAERS ID:438526 (history)  Vaccinated:2011-10-04
Age:69.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-15, Days after onset: 11
Location:New Mexico  Entered:2011-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11021010IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1066Z0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site rash, Mobility decreased, Pain
SMQs:, Parkinson-like events (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pt. felt achy, stayed in bed for about day. 1 day later developed a spreading rash near site of injection.

VAERS ID:438631 (history)  Vaccinated:2011-10-04
Age:55.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Georgia  Entered:2011-10-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1102501 UNLA
Administered by: Other     Purchased by: Military
Symptoms: Injection site erythema, Injection site haematoma, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient called to let us know about a small bruise surrounded by a red, warm, circular area (about 3 inches) at the site.

VAERS ID:438533 (history)  Vaccinated:2011-10-04
Age:11.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-17, Days after onset: 12
Location:Virginia  Entered:2011-10-17
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: Allerigic to Cillin drugs. Born with Transposition of Great Vessels corrected by arterial switch at birth Wilms Tumor age 2.5. Rt Kidney removed/chemo 9 months.
Diagnostic Lab Data: Follow up at Peds office. Vision spell not happening during visit. Eye test okay at visit. Spells continued however so Spoke with Cardiologist referred to Opt. to evaluate. Opthomologist: blurred vision spell happened at appt. Could not read everything.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR    
HEPA: HEP A (VAQTA)MERCK & CO. INC.    
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
MEN: MENINGOCOCCAL (MENOMUNE)SANOFI PASTEUR    
Administered by: Unknown     Purchased by: Private
Symptoms: Laboratory test normal, Reading disorder, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)
Write-up: Periodic Blurry Vision will not stop.

VAERS ID:438602 (history)  Vaccinated:2011-10-04
Age:57.0  Onset:0000-00-00
Gender:Male  Submitted:2011-10-14
Location:Massachusetts  Entered:2011-10-17, 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: No
Preexisting Conditions: PNEUMOVAX experienced allergic reaction
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED04749211A UNUN
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Chills, Dizziness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Light headed, weak, chills, temp 101, soreness in arm, took ADVIL to eliminate fever 200 mg. Went away as quickly as it came on, gone by afternoon. Now she is doing well.

VAERS ID:438651 (history)  Vaccinated:2011-10-04
Age:58.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-17, Days after onset: 13
Location:Michigan  Entered:2011-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH453AD0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Patient called to report right arm pain after injection & continuing for last 2 weeks. Pain comes & goes.

VAERS ID:438808 (history)  Vaccinated:2011-10-04
Age:16.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-14, Days after onset: 10
Location:New York  Entered:2011-10-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: chills, vomiting~Meningococcal Conjugate (Menactra)~1~12.00~Patient|chills, vomiting~Tdap (Boostrix)~1~12.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data: CXR; CBC; CMP; U/A; Urine preg - all normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0132AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Chest X-ray normal, Cough, Full blood count normal, Injection site pain, Metabolic function test, Pregnancy test urine negative, Urine analysis normal, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt given PNEUMOVAX 10/4/2011 - within 24 hours developed T201, vomiting, severe pain at injection site & cough.

VAERS ID:438816 (history)  Vaccinated:2011-10-04
Age:69.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-10, Days after onset: 6
Location:West Virginia  Entered:2011-10-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations: ~Tetanus Toxoid (no brand name)~UN~0.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: Nicotine dependence; Depression; Allergies: Tetanus, AVELOX, Zmax, Lidocaine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH458AB IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Pt. presented back to doctor office 2hr after vaccination - temp 98.1, BP 140/80, HR - 135, O2 - 92% on room air. Pt placed on O2 at 3L. Vitals monitored continuously. Given SOLUMEDROL 125 mg IM. Given 50mg BENADRYL IM. Given albuterol breathing treatment. Transported to ER. Pt stayed overnight. Discharged in stable condition.

VAERS ID:438824 (history)  Vaccinated:2011-10-04
Age:60.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-18, Days after onset: 14
Location:Massachusetts  Entered:2011-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No known allergies. High cholesterol - surgery for coradiv blockage in artery
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AB0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Temperature spiked to 102 degrees. Fever, chills, bodyaches, sweats, fatigue.

VAERS ID:438829 (history)  Vaccinated:2011-10-04
Age:39.0  Onset:2011-10-07, Days after vaccination: 3
Gender:Female  Submitted:2011-10-18, Days after onset: 11
Location:Pennsylvania  Entered:2011-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Was 6 weeks Pregnant and on 10/7/11 started feeling ill and miscarried the baby on 10/9/11
Preexisting Conditions: ALLERGIES: CODEINE, MORPHINE, DARVOCET, PERCOCET, KEFLEX, PAXIL, TYLENOL,
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1131P0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Malaise, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: MISCARRIED THE BABY ON SUNDAY 10/9/11 AT 2PM

VAERS ID:438836 (history)  Vaccinated:2011-10-04
Age:54.0  Onset:2011-10-10, Days after vaccination: 6
Gender:Male  Submitted:2011-10-18, Days after onset: 8
Location:New Jersey  Entered:2011-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Rash~Influenza (Seasonal) (Fluvirin)~UN~54.50~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Had same reaction this time last year approximately 5 days after flu shot reaction. Went to family physician who prescribed over-the-counter antihistamines.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS110423 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on sides and back of torso and under arms.

VAERS ID:438861 (history)  Vaccinated:2011-10-04
Age:24.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 2
Location:Tennessee  Entered:2011-10-18, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN551050UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Asthma, Body temperature increased, Condition aggravated, Fatigue, Headache
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Approximately 3 hrs after receiving shot, had sudden severe asthma attack. Felt fatigued, increased body temperature, and headache for the next day and a half.

VAERS ID:439234 (history)  Vaccinated:2011-10-04
Age:63.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-10-06, Days after onset: 2
Location:Unknown  Entered:2011-10-20, Days after submission: 14
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: Type 2 diabetes; High blood pressure
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Cyproheptad 4mg Tab Teva. Methylpred 4 Mg Pak Qual. Several hours after receiving the flu vaccine severe itching started requiring medication for relief.

VAERS ID:439236 (history)  Vaccinated:2011-10-04
Age:49.0  Onset:2011-10-10, Days after vaccination: 6
Gender:Female  Submitted:2011-10-20, Days after onset: 10
Location:Connecticut  Entered:2011-10-20
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: HUMIRA; ARAVA; PLAQUENIL; Methotrexate
Current Illness:
Preexisting Conditions: RA; B12 deficiency
Diagnostic Lab Data: Abnormal LFTs
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA686AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Liver function test abnormal, Muscular weakness, Paraesthesia, Protein total increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Numbness, tingling, paraesthesias, elevated protein proximal muscle weakness.

VAERS ID:439365 (history)  Vaccinated:2011-10-04
Age:40.0  Onset:2011-10-06, Days after vaccination: 2
Gender:Male  Submitted:2011-10-20, Days after onset: 14
Location:Unknown  Entered:2011-10-20
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: ALLERGY TO PCN
Diagnostic Lab Data: LABS ORDERED, MRI SCHEDULED. SYMPTONS TREATED.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2893IMRA
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.501096P1IN 
Administered by: Military     Purchased by: Military
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: NUMBNESS AND TINGLING TO FACE, HEAD, BILATERAL HANDS AND FEET.

VAERS ID:439385 (history)  Vaccinated:2011-10-04
Age:50.0  Onset:2011-10-15, Days after vaccination: 11
Gender:Female  Submitted:2011-10-20, Days after onset: 5
Location:Oregon  Entered:2011-10-20
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: Clarithromycin; Asthma; DM II
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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Dose
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HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB944CA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0011AA0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Fatigue, Headache, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt called 10/19/1 & complained she developed low grade fever, headache, fatigue & rash - red over face & chest, 10/15/11. She cancelled FU appt as she was feeling better.

VAERS ID:439404 (history)  Vaccinated:2011-10-04
Age:81.0  Onset:2011-10-07, Days after vaccination: 3
Gender:Female  Submitted:2011-10-20, Days after onset: 13
Location:Pennsylvania  Entered:2011-10-20
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: Hypothyroidism
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN57307 IMRA
Administered by: Other     Purchased by: Private
Symptoms: Nausea, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea/vomiting. Body aches.

VAERS ID:439369 (history)  Vaccinated:2011-10-04
Age:57.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Male  Submitted:2011-10-21, Days after onset: 16
Location:Connecticut  Entered:2011-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported.
Preexisting Conditions: None reported.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11053P IMLA
Administered by: Public     Purchased by: Other
Symptoms: Chills, Cough, Lethargy, Nasal congestion, Viral infection
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)
Write-up: Patient reported chills, nasal congestion, lethargy and coughing starting 10/05/2011 and did not resolve within two weeks. Patient evaluated and appears to have viral illness. Patient has reported that she feels viral illness is related to vaccine.

VAERS ID:439580 (history)  Vaccinated:2011-10-04
Age:0.54  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-21, Days after onset: 16
Location:Georgia  Entered:2011-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: dry skin
Preexisting Conditions: reflux; preterm infant
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS 2UNRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4197CA0UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH7255792UNLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Tiny bumps, rash on thighs (anterior lateral) Left $g right which was noticed 1-2 days after vaccines administered.

VAERS ID:439542 (history)  Vaccinated:2011-10-04
Age:54.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-23, Days after onset: 19
Location:South Carolina  Entered:2011-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: GI Reflux Interstitial Cystitis
Diagnostic Lab Data: Numerous labs, and retinal studies
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LA
Administered by: Unknown     Purchased by: Private
Symptoms: Blindness unilateral, Immune system disorder, Laboratory test, Retinal function test abnormal, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad)
Write-up: Acute onset blurred vision/vision loss in left eye approximately three hours after receiving flu shot. Also, severe immune response occurred with systemic symptoms. Was urgently referred to retinal specialist and then rheumatologist on 10/5/2011. Under strict monitoring and treatment currently. Had to be placed on disease-modifying agents and steroids. Vision remains impaired along with systemic symptoms.

VAERS ID:439741 (history)  Vaccinated:2011-10-04
Age:62.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-17
Location:Maine  Entered:2011-10-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: High BP; COPD; Cauda Equina
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0751AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt called Rx dept to ask about the "red hard egg" at the injection site. She did report that it was less red today than yesterday. She did not report a fever.

VAERS ID:439743 (history)  Vaccinated:2011-10-04
Age:1.69  Onset:2011-10-15, Days after vaccination: 11
Gender:Female  Submitted:2011-10-17, Days after onset: 2
Location:Florida  Entered:2011-10-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4149CA2UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0346AA0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0100AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash all over body.

VAERS ID:439779 (history)  Vaccinated:2011-10-04
Age:24.0  Onset:2011-10-07, Days after vaccination: 3
Gender:Female  Submitted:2011-10-13, Days after onset: 6
Location:Pennsylvania  Entered:2011-10-24, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Spondylolysis; spondylolisthesis
Diagnostic Lab Data: Per ER visit
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA677AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Eyelid oedema, Oedema peripheral, Oropharyngeal pain, Pain, Photophobia, Pyrexia, VIIth nerve paralysis, Vaccination complication, Vision blurred
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Student presents on 10-7-11 at 10:15 a.m. with c/o of awakening with blurred vision (L) eye, photophobia, (L) eyelid edema, bilateral hands edema, ST, fever, general body aches. Student referred to ER where she was dx with Bell''s Palsy & reaction to flu shot administered 10-4-11. She was treated with Prednisone 60mg daily x6 days & decrease by 10mg daily x 5 days.

VAERS ID:439864 (history)  Vaccinated:2011-10-04
Age:32.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Male  Submitted:2011-10-24, Days after onset: 19
Location:Texas  Entered:2011-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
Administered by: Military     Purchased by: Military
Symptoms: Activities of daily living impaired, Cough, Influenza like illness, Injected limb mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Dementia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Flu like symptoms started (cough) took THERAFLU, severe shoulder pain, unable to move left arm took TYLENOL but did not help. Went to doctor on 10/17 no guidance given. Went to another doctor on 10/24 who is referring to orthopedic doctor for testing. Specified that might be issues with administration. Pain has diminished a bit over time but still not able to use arm. Needs help dressing and other activities that require use of arm (driving).

VAERS ID:444287 (history)  Vaccinated:2011-10-04
Age:36.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Illinois  Entered:2011-12-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: Cellulitis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1100401 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1150Z IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient was treated in the emergency room twice for severe pain/swelling and cellulitis at the injection site.

VAERS ID:444852 (history)  Vaccinated:2011-10-04
Age:68.0  Onset:2011-10-06, Days after vaccination: 2
Gender:Male  Submitted:2011-12-07, Days after onset: 62
Location:Kentucky  Entered:2011-12-07
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: anemia, HTN, Anxiety
Diagnostic Lab Data: n/a
CDC Split Type: KY1118
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI440AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Confusional state, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)
Write-up: Pt states " shaking, chills and confusion started 2-3 day after injection and last a less than 24 hours.

VAERS ID:444857 (history)  Vaccinated:2011-10-04
Age:62.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Male  Submitted:2011-12-07, Days after onset: 63
Location:Texas  Entered:2011-12-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASCORBATE CALCIUM (VITAMIN C ORAL) Take 500 mg by mouth two(2) times daily. aspirin (BAYER) 325 mg tablet Take 325 mg by mouth every day. Cholecalciferol, Vitamin D3, (VITAMIN D) 5,000 unit Tab Take by mouth
Current Illness: NO
Preexisting Conditions: DM, CAD, hx of CVA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNGM
Administered by: Private     Purchased by: Other
Symptoms: Chest discomfort, Computerised tomogram normal, Headache, Hypoaesthesia, Hypoaesthesia oral, Nuclear magnetic resonance imaging abnormal, Photopsia, Spinal disorder
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Retinal disorders (narrow)
Write-up: On 10/5 around 5:30pm went to a historical marker at the cemetary. Patient had an acute episode of flash in eyes, headache and then numbness in both arms and legs and feet and also heaviness of chest that felt like patient was pulling down to the ground. Made it back to car, sat there for a while and returned back baseline. The next day had 3 episodes. The following day, lasting 10-15 minutes each. Patient had episodes 10/5-9 daily, occasionally it is numbness and tingling, face, mouth, hands, feet and feet. On 10/10 woke up feeling fine had a more severe reaction, thought was having a stroke, called 911 but was still very aware and precise. Patient was evaluated by CT scan and everything was negative. Numbness involves the entire body, and is not unilateral. Was seen by Family doctor and was given Valtrex x 10d - finished on 10/23. Was seen by neurology and was told has cervical spine problems. Had an MRI and has a lot of cervical disease. Was seen by Dr. yesterday and there is extensive disease. Patient did a lot of heavy lifting. Does have cervical disease but it does not explain the numbness in face and mouth. These days it has not been occurring on face and mouth anymore. The pt still is having episodes 2-3 x a day.

VAERS ID:445008 (history)  Vaccinated:2011-10-04
Age:51.0  Onset:2011-10-31, Days after vaccination: 27
Gender:Male  Submitted:2011-12-08, Days after onset: 38
Location:Colorado  Entered:2011-12-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril at hosp; Reeon Vit D 1000-2000 unit/d.
Current Illness: Mild periph neuropathy LE
Preexisting Conditions: None
Diagnostic Lab Data: NL lab; (-) CT of head; (-) Carotid U/S
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA668BA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram head, Computerised tomogram normal, Dysarthria, Guillain-Barre syndrome, Headache, Hypertension, Hypoaesthesia, Laboratory test normal, Paraesthesia, Paraesthesia oral, Swelling face, Ultrasound Doppler, Ultrasound scan normal, VIIth nerve paralysis, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Hypertension (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Pt. developed bilat numbness tingling hands/feet (digits), then poor focus , HA, 2d later, (L) cheek swollen, (R) facial droop, (R) side of tongue tingling: slurred speech. Seen at ER 11/2/11 & admitted & evaluated also HTN, presumed Guillain-Barre.

VAERS ID:445126 (history)  Vaccinated:2011-10-04
Age:51.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Male  Submitted:2011-12-09, Days after onset: 65
Location:California  Entered:2011-12-12, 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:
Diagnostic Lab Data:
CDC Split Type: 2011030127
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0614AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This medically confirmed spontaneous report (initial receipt: 13-Oct-2011) concerns a 51 year old male patient, who had no pre-existing allergies, birth defects or medical conditions. On 04-Oct-2011 the patient received an unidentified "flu vaccine" into the right arm. On the same day at 14:21 the patient also received 0.5 mL of PNEUMOVAX 23 injection (lot number 0614AA) intramuscularly into left arm deltoid for vaccination. On 05-Oct-2011, after vaccination, the patient developed an infection in the left arm, a 99.4 degree F (Fahrenheit) fever, and decreased range of motion. The patient''s left arm was hot, red and swollen from the deltoid to the elbow ("all the way") when seen by a doctor on 06-Oct-2011. Redness was noted on the left upper chest wall. The deltoid down to his elbow was painful. The patient was diagnosed with cellulitis and prescribed doxycycline 100 mg twice daily for 7 days. On a follow up call to the patient, the arm had improved. It was reported that the patient had no reaction to the unidentified "flu vaccine" that was administered to the right arm. The event outcome was recovered. The reporter stated that the dose of PNEUMOVAX 23 given was one of the two final doses from the multi dose vial. Follow-up (18-Nov-2011): additional AE term, PNEUMOVAX 23 vaccination time, event summary description, AE onset date, no pre-existing allergies, birth defects or medical conditions.

VAERS ID:445130 (history)  Vaccinated:2011-10-04
Age:50.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Male  Submitted:2011-12-09, Days after onset: 66
Location:California  Entered:2011-12-12, 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:
Diagnostic Lab Data:
CDC Split Type: 2011030113
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0614AA IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth, Joint range of motion decreased, Nausea, Pain in extremity, Staphylococcal skin infection
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This medically confirmed spontaneous report (initial receipt: 13-Oct-2011) concerns a 50 year old male patient, who had no pre-existing allergies, birth defects, medical conditions or illness at time of vaccination. On 04-Oct-2011 the patient received an unidentified "flu vaccine" into the right arm. On the same day at 16:33 the patient also received 0.5 mL of PNEUMOVAX 23 injection (lot number 0614AA) intramuscularly into left arm deltoid for vaccination. On 04-Oct-2011 at around 22:30 to 23:00, the patient complained of left arm painful, red and hot to touch. On examination his left deltoid area was hot, red and swelling. The redness extended from shoulder to elbow. He had decreased range of motion. The patient had some nausea and low grade flu-like symptoms (temperature of 98.4 degrees F (Fahrenheit)) when seen by a doctor on 06-Oct-2011. The patient was diagnosed with staphylococcal infection of skin and prescribed doxycycline 100 mg twice daily for 7 days. It was reported that the patient had no reaction to the unidentified "flu vaccine" that was administered to the right arm. On 11-Oct-2011 the patient was seen again during a ''care visit'' where the nurse noted the reaction had resolved and there were no residual effects. The event outcome was recovered. The reporter stated that the dose of PNEUMOVAX 23 given was one of the two final doses from the multi dose vial. Follow-up (18-Nov-2011): additional AE terms, PNEUMOVAX 23 vaccination time, event summary description, AE onset date, no pre-existing allergies, birth defects, medical conditions or illness at time of vaccination.

VAERS ID:445153 (history)  Vaccinated:2011-10-04
Age:26.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 3
Location:Indiana  Entered:2011-12-12, Days after submission: 66
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: allergic to PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH467AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Bronchospasm, Headache, Hyperhidrosis, Nausea, Pain, Pallor, Pulse abnormal, Pulse pressure decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Approx 1 hr after injection had bronchospasms, developed generalized body aches, headache. At approx 1300 became nauseous, diaphoretic, pale. BP: 90s/40s, weak thread pulse - near syncope. Temp 100.8. Next morning symptoms resolved.

VAERS ID:445297 (history)  Vaccinated:2011-10-04
Age:42.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-12-08, Days after onset: 65
Location:Texas  Entered:2011-12-13, 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:
Diagnostic Lab Data: N/A to date
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA618AB20UNAR
Administered by: Unknown     Purchased by: Other
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)
Write-up: Severe arm/shoulder pain (from onset to 1 month later), immobility in arm movement limited (2 months), dull, aching pain (to present).

VAERS ID:445300 (history)  Vaccinated:2011-10-04
Age:50.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-12-08, Days after onset: 65
Location:Texas  Entered:2011-12-13, 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: None
Preexisting Conditions: PCN; BACTRIM
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA618AB0UNRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site joint pain, Mobility decreased
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Upper right arm/shoulder pain. Difficult to pull up arm. Comes and goes in intensity of pain.

VAERS ID:445329 (history)  Vaccinated:2011-10-04
Age:53.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-12-13, Days after onset: 70
Location:Indiana  Entered:2011-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None Known
Preexisting Conditions: Allergies to Penicillin, Erythromycin, cats, dogs, seasonal allergies
Diagnostic Lab Data: MRI-showed thickening at injection site per patient report
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH438AB IMRA
Administered by: Public     Purchased by: Private
Symptoms: Immune system disorder, Injection site pain, Injection site swelling, Muscle disorder, Nuclear magnetic resonance imaging abnormal, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Patient recieved Fluzone influenza vaccine on 10/04/2011 IM right deltoid. Called health department on 12/09/2011 to report has been experiencing pain in right arm from shoulder to elbow ever since flu vaccine 2 months ago. Reports no redness or swelling after injection. Reports has seen two doctors and had an MRI done which did not show anything that showed thickening at injection site. Said doctor told patient that body''s immune system had attacked the flu vaccine and it was an immune reaction which would take time to heal. Has been treated with a round of steroids, which patient reports made the pain a little better. Reports arm hurts daily and takes ibuprofen every day. Has tried both hot and cold compresses. Encouraged patient to call doctor to let doctor know it is still hurting. Patient says not using the right arm much and thinks the muscle in the right arm looks like it is smaller than the muscle in the left arm. Has recieved yearly doses of Fluzone vaccine since at least 2007 without any problems.

VAERS ID:445605 (history)  Vaccinated:2011-10-04
Age:39.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-10-11, Days after onset: 6
Location:Illinois  Entered:2011-12-15, Days after submission: 65
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: As above.~Influenza (Seasonal) (no brand name)~UN~38.00~Patient
Other Medications:
Current Illness: ?None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Chest pain, Chills, Dyspnoea, Fatigue, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Fatigue, nausea, muscle aches, chills, intermittent chest pain, SOB, denies rash, no vomiting. Advise f/u with PCP.

VAERS ID:445995 (history)  Vaccinated:2011-10-04
Age:40.0  Onset:2011-10-10, Days after vaccination: 6
Gender:Female  Submitted:2011-12-21, Days after onset: 72
Location:Florida  Entered:2011-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall 20mg
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A - will be headed to the doctor to determine cause as well as solution.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRRA
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  JETLA
HEPAB: HEP A + HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRRA
Administered by: Unknown     Purchased by: Private
Symptoms: Activities of daily living impaired, Back pain, Injection site joint pain, Insomnia, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: I had shots for the flu, Hep, Tetanus and MMR. Three shots in right arm and one in left arm. Extreme pain continued in right arm/shoulder. Can not lift heavy items, very difficult to dry hair, get dressed, pick up groceries. Arm "pops" or "cracks" when moved to certain positions. Difficult to sleep at night - continuous throbbing pain, starting in arm going into shoulder, back, neck and sometime leg.

VAERS ID:446515 (history)  Vaccinated:2011-10-04
Age:53.0  Onset:2011-11-14, Days after vaccination: 41
Gender:Male  Submitted:2011-12-30, Days after onset: 46
Location:Ohio  Entered:2011-12-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XYZAL 5MG, DEXILANT 30MG, ALBUTEROL HFA 90MCG, LIPITOR 20MG
Current Illness: none noted
Preexisting Conditions: GERD, joint pain, hyperlipidemia, hypertension, tobacco use, osteoarthritis, impaired fasting glucose,
Diagnostic Lab Data: office visit to date
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA668AA IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: None other than pain, was seen in office 11/21/2011 states 2-3 pain as dull ache in left lateral upper arm, with numbness, no fever, redness seen again 12-29, dull ache rated 2, no numbness redness, fever, tingling, or loss of sensation, normal range of motion, no edema.

VAERS ID:446664 (history)  Vaccinated:2011-10-04
Age:65.0  Onset:2011-10-05, Days after vaccination: 1
Gender:Female  Submitted:2011-12-28, Days after onset: 84
Location:Oregon  Entered:2012-01-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonidine; HCTZ
Current Illness: None
Preexisting Conditions: Hypertension; Obesity; Pre-diabetes
Diagnostic Lab Data: CBC; ESR grossly normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3947BA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Full blood count normal, Injection site erythema, Injection site rash, Injection site vesicles, Rash erythematous, Red blood cell sedimentation rate normal
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Developed red, blistering rash at injection site 1-2 days after injection, spread to trunk, other arm.

VAERS ID:447115 (history)  Vaccinated:2011-10-04
Age:15.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2012-01-05, Days after onset: 93
Location:Ohio  Entered:2012-01-10, 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 has no reported past medical history, is taking no concomitant medications and illness at the time of vaccination was denied. The patient had a TD nine years ago.
Diagnostic Lab Data: The patient had blood tests including "WBC and connective tissue" results not reported.
CDC Split Type: 201110871
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DECAVAC)SANOFI PASTEURU3421DA SYRLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Blood test, Facial pain, Fatigue, Feeling abnormal, Gait disturbance, Laboratory test, Lymphadenopathy, Mononucleosis heterophile test negative, Myalgia, Pain in extremity, Pallor, Pyrexia, Streptococcus test negative, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Initial report was received on 08 November 2011 from a health care professional with additional information received on 11 November 2011 from a consumer who is also the patient''s parent. A 15 year-old female patient with no reported past medical history had received on 04 October 2011 a left deltoid injection of DECAVAC, lot number U3421DA (route of administration not reported) and an unspecified amount of time later the day of vaccination, experienced leg pain, swollen lymph glands, left thigh muscle pain, paleness, fatigue, felt feverish (temperature was not taken or documented) and a feeling that the left side of the face was bruised with no overt sign. The patient was evaluated by a physician. Diagnostic tests included a negative strep test and a negative mono test. No treatments were prescribed. It was reported some signs and symptoms were resolving. No further information was available at the time of the report. The patient''s outcome was not recovered. Follow-up information was received on 30 December 2011 from a consumer who is also the patient''s parent who reported that the patient can not walk for long. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. According to the parent, the patient has been experiencing leg and muscle pain since October. The patient is an organist and has a difficult time with the pedals. The parent states that all other symptoms have resolved except the leg and muscle pain. The patient has been treated with acupuncture and has seen a chiropractor. The patient had not been on any medications but the patient underwent some "blood tests" including WBC and connective tissue (results were not reported). The patient has a referral to see a physiatrist. According to the patient''s mother, the patient was not hospitalized. No further information was available at the time of the event. The patient''s outcome was not recovered. Documents held by sender: none.

VAERS ID:447184 (history)  Vaccinated:2011-10-04
Age:85.0  Onset:2011-10-13, Days after vaccination: 9
Gender:Female  Submitted:2012-01-06, Days after onset: 85
Location:Pennsylvania  Entered:2012-01-11, 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: LIPITOR; atenolol; lorazepam; levothyroxine; PRILOSEC
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0746AA1SCLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness at injection site that went away in 2 weeks after administration after adding ice pack to the redness site.

VAERS ID:447233 (history)  Vaccinated:2011-10-04
Age:43.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-11-23, Days after onset: 50
Location:Alabama  Entered:2012-01-11, Days after submission: 49
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None known
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT441AA IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Diarrhoea, Rash
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: FLUZONE received 10/04/2011 - developed diffuse rash w/in 4 hours; reports diarrhea (8-10 liquid stools) w/in 8 hours. No fever - resolved.

VAERS ID:447374