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Found 505988 cases in entire database

Case Details (Sorted by Vaccination Date)

This is page 1709 out of 2024

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VAERS ID:464335 (history)  Vaccinated:2012-08-25
Age:77.0  Onset:2012-08-26, Days after vaccination: 1
Gender:Female  Submitted:2012-08-30, Days after onset: 4
Location:New York  Entered:2012-09-06, 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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1241AA0UNLA
Administered by: Other     Purchased by: Public
Symptoms: Cellulitis, Inflammation, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Inflammation & swelling noticeable after 24 hours, worsened overnight. Patient saw her doctor and was diagnosed with cellulitis and given Cephalexin at 48 hours post.

VAERS ID:472641 (history)  Vaccinated:2012-08-25
Age:72.0  Onset:2012-09-26, Days after vaccination: 32
Gender:Male  Submitted:2012-10-25, Days after onset: 29
Location:New Jersey  Entered:2012-10-31, 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; HBP; cholesterol
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH714AB UNRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Rash - stated end of September - itchy red patches in right arm - area of vaccination.

VAERS ID:463464 (history)  Vaccinated:2012-08-26
Age:77.0  Onset:2012-08-27, Days after vaccination: 1
Gender:Female  Submitted:2012-08-28, Days after onset: 1
Location:New York  Entered:2012-08-28
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)SANOFI PASTEURUH715AA IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Erythema, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Localized redness on left arm. Pt states area is warm and tender.

VAERS ID:463454 (history)  Vaccinated:2012-08-26
Age:4.0  Onset:2012-08-27, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 2
Location:Texas  Entered:2012-08-29
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: n/a
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMAR
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal pain, Diarrhoea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: 8/27 Complained abdominal pain AM and PM 8/28 Watery diarrhea starting 2 AM Fever 100 F 8 AM, ibuprofen given

VAERS ID:463528 (history)  Vaccinated:2012-08-26
Age:37.0  Onset:2012-08-27, Days after vaccination: 1
Gender:Female  Submitted:2012-08-28, Days after onset: 1
Location:Oregon  Entered:2012-08-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Trees, grass, mold
Diagnostic Lab Data: Measured rash & bump
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH732AA UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4383AA0UNRA
Administered by: Other     Purchased by: Other
Symptoms: Abscess, Feeling hot, Pruritus, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red rash, hot, abscess, given prescription for antibiotics (KEFLEX), itchy.

VAERS ID:468561 (history)  Vaccinated:2012-08-26
Age:61.0  Onset:2012-08-26, Days after vaccination: 0
Gender:Female  Submitted:2012-09-05, Days after onset: 10
Location:Unknown  Entered:2012-09-05
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:
CDC Split Type: WAES1208USA012277
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0421AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Paraesthesia oral
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with no known reactions or allergies. The patient was subcutaneously vaccinated with ZOSTAVAX (lot # 671901/0421AE, Exp date: 21-MAR-2013, dose/frequency unspecified) on 26-AUG-2012. It was reported that the patient experienced immediate tingling of the lower lip after administration of ZOSTAVAX on 26-AUG-2012. The patient declined the suggestion that she went to a local emergency room for evaluation. The patient took oral BENADRYL and left the pharmacy. The pharmacist contacted the patient for follow-up later in the day and she had fully recovered without additional symptoms. Additional information is not expected.

VAERS ID:464416 (history)  Vaccinated:2012-08-26
Age:29.0  Onset:2012-08-26, Days after vaccination: 0
Gender:Female  Submitted:2012-09-08, Days after onset: 13
Location:Tennessee  Entered:2012-09-08
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
Preexisting Conditions: NKDA; No medical conditions noted
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4467AA IDLA
Administered by: Other     Purchased by: Other
Symptoms: Administration site pain, Injection site erythema, Injection site swelling, Rash generalised, Rash macular
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pt was administered Fluzone intra-dermal vaccine. About 30 min after administration - pt came back to pharmacy w/ a lot of redness on the upper arm and a raised area where the medication was administered. Approximately another 15 min later, pt came back to pharmacy again w/ red, blotchy patches on skin from neck down to legs. Pt reported no itching, no severe allergic reactions, only slight pain at site of administration. Pt was administered 25 mg liquid Benadryl and 500 mg Tylenol. Within 30-45 min after treatment - all redness was gone. Pt reported no other problems post-vaccination.

VAERS ID:464822 (history)  Vaccinated:2012-08-26
Age:31.0  Onset:2012-08-27, Days after vaccination: 1
Gender:Female  Submitted:2012-09-11, Days after onset: 15
Location:Virginia  Entered:2012-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Burn
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR748 UNLA
Administered by: Private     Purchased by: Private
Symptoms: Pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pt with (L) arm pain, paresthesia and pain with motion. No swelling.

VAERS ID:463277 (history)  Vaccinated:2012-08-27
Age:12.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-27, Days after onset: 0
Location:Minnesota  Entered:2012-08-27
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: no tests performed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1171AA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0679AE1SCLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC5ZB094AA0IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0073AE0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: Zostavax vaccine given instead of varicella vaccine. Per MDH there should be no problems, pt should develop rash in 10-14 days and be seen by a provider to document. If no rash, then needs to have booster of varicella in 3 months.

VAERS ID:463287 (history)  Vaccinated:2012-08-27
Age:12.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-27, Days after onset: 0
Location:Pennsylvania  Entered:2012-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER    
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fainted.

VAERS ID:463291 (history)  Vaccinated:2012-08-27
Age:11.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-27, Days after onset: 0
Location:Texas  Entered:2012-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4375AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4137AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Gait disturbance, Hypoaesthesia, Pain in extremity, Paraesthesia, Tremor, Weight bearing difficulty
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Pt reports shortly after receiving vaccines, she began having pain in toes, currently 7/10. Pt reports pain is bilaterally lower extremities, up to upper thigh. Pt reports she doesn''t feel she can hold her own weigh and when she tries to walk, she feels like she is going to fall. PT reports numbness and tingling, tickling. Pt reports she has also been shaking in lower extremities. Pt denies any weakness in arms or face, Denies any difficult breathing. Pt reports she has been able to urinate following vaccine. Pt denies any changes in voice or hearing.

VAERS ID:463372 (history)  Vaccinated:2012-08-27
Age:13.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-08-27, Days after onset: 0
Location:Wisconsin  Entered:2012-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB605CA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0420AE0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Dyskinesia, Posture abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: 8-27-12 at 11:32 am. HAVRIX given in left delt then GARDASIL given in right delt. Patient''s head dropped down immediately & I laid him back he jerked a couple times & wake.

VAERS ID:463392 (history)  Vaccinated:2012-08-27
Age:5.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-08-28, Days after onset: 1
Location:Wisconsin  Entered:2012-08-28
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: Question if he had allergic reaction to immunizations 02/18/11
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0367AE1SCLL
Administered by: Unknown     Purchased by: Private
Symptoms: Eyelid oedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Hives all over body, swollen eye lids. No difficulty breathing.

VAERS ID:463406 (history)  Vaccinated:2012-08-27
Age:11.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 1
Location:California  Entered:2012-08-28
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4254AA IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B094BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0072741SCLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site anaesthesia, Injection site pruritus
SMQs:
Write-up: Itchiness and numbness around vaccine site.

VAERS ID:463407 (history)  Vaccinated:2012-08-27
Age:33.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 1
Location:Nevada  Entered:2012-08-28
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
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER 2IMRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Immediate post-injection reaction, Induration, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Itchiness and red skin began immediately. A large welt or hive appeared within a few hours and has continued. This "hive" is hard to the touch.

VAERS ID:463428 (history)  Vaccinated:2012-08-27
Age:0.5  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-08-28, Days after onset: 1
Location:Virginia  Entered:2012-08-28
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1150AA0SCLA
Administered by: Private     Purchased by: Public
Symptoms: Loss of consciousness, Rash generalised
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Child was given Varicella immunization. Child broke out in a rash all over his body and passed out. Epipen was used. 911 called. Transported to ER.

VAERS ID:463431 (history)  Vaccinated:2012-08-27
Age:29.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 1
Location:Arkansas  Entered:2012-08-28
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: Seasonal allergies; Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0020AE0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Received TB Skin test and Hep B vaccine - reported numbness left hand radiating up arm approximately 5 minutes after receiving Hep. B injection.

VAERS ID:463452 (history)  Vaccinated:2012-08-27
Age:61.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-27, Days after onset: 0
Location:Kentucky  Entered:2012-08-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH712AB0UNRA
Administered by: Unknown     Purchased by: Private
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: At approximately 130pm on 8/27/12 the pt received a flu shot. At about 215pm it was brought to my attention that the pt was passed out in her car. EMS was called and I stayed with the patient until they arrived. Pt eventually walked home.

VAERS ID:463470 (history)  Vaccinated:2012-08-27
Age:13.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 1
Location:Oregon  Entered:2012-08-28
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 PASTEURUH716AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1495AA2IMRA
Administered by: Public     Purchased by: Private
Symptoms: Convulsion, Cyanosis, Loss of consciousness, Pallor, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Seizure activity of brief duration, she turned pale, blue lips & passed out for 2-3 min. Ambulance was called and transported to ER. Was released from ER after a couple hours. ER assumed vasovagal .

VAERS ID:463480 (history)  Vaccinated:2012-08-27
Age:88.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 1
Location:Texas  Entered:2012-08-28
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
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AB0IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0105150IMUN
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site discomfort, Injection site induration, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient had a reaction to PNEUMOVAX at injection site. Pt said there was hardness around injection site and a lot of discomfort.

VAERS ID:463481 (history)  Vaccinated:2012-08-27
Age:11.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-08-27, Days after onset: 0
Location:Pennsylvania  Entered:2012-08-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH718AB2IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110660IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B094BA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Immediate post-injection reaction, Injection site urticaria, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt was given Tdap (BOOSTRIX) in (R) arm. Pt had immediate hive at injection site (right arm). Redness area measured 12 cm in length x 7 cm wide with welt measuring 6 cm in length. Pt was given 25 mg of BENADRYL 30 mg. Prednisone immediately. Pt waited 20 minutes & was given ice for the affected area. After 20 minutes the welt decreased & pt left w/instructions to call us if he needs to.

VAERS ID:463415 (history)  Vaccinated:2012-08-27
Age:4.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Male  Submitted:2012-08-29, Days after onset: 1
Location:Illinois  Entered:2012-08-29
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: He was diagnosed with sensory processing disorder at 2 1/2 yrs old. Also had same reaction in thigh to vaccine at 18 months.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: His entire upper arm is hot and red and slightly swollen. Haven''t contacted Dr yet since I have read it''s a typical reaction but after reading blogs about filing one of these I figured I should since he was diagnosed on the autism spectrum..

VAERS ID:463457 (history)  Vaccinated:2012-08-27
Age:4.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:Tennessee  Entered:2012-08-29
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 (TRIPEDIA)SANOFI PASTEURU3497CA4IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB515AA1IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1873AA1SCRL
Administered by: Public     Purchased by: Public
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pt. received DTAP vaccine 8-27-12. Came in today with large red rash, warm to touch (swollen) near injection site.

VAERS ID:463465 (history)  Vaccinated:2012-08-27
Age:12.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-29, Days after onset: 2
Location:Texas  Entered:2012-08-29
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204521 IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4137AA IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.A11064 IMRA
Administered by: Public     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:
Write-up: Gave Zostavax instead of Varciella vaccine to a 12 year old. Patient also received Influenza, HPV, TDAP, MCV4 that day. Mother only signed one of the consent forms of the three she filled out. 0.5mL IM Zostavax in the right deltoid.

VAERS ID:463468 (history)  Vaccinated:2012-08-27
Age:65.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:Pennsylvania  Entered:2012-08-29
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IDLA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Erythema & pain at site of injection which developed in 6 hours, fever of 101.6, severe mylagia & arthralgia, headache. Most severe symptoms lasted 24 hours. Myalgia & arthralgia still present after 36 hours. Treated with Aleve & ice to injection site.

VAERS ID:463506 (history)  Vaccinated:2012-08-27
Age:11.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-29, Days after onset: 2
Location:Illinois  Entered:2012-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Cyanosis, Extrasystoles, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt had 2 syncopal episodes with in minutes of each other, the first being 1 min. after tdap given (L) deltoid. As NP was listening to apical pulse noted app. 10 sec pause in heart beat & pt. was cyanotic but then recovered. 911 was notified & pt was taken to hospital.

VAERS ID:463521 (history)  Vaccinated:2012-08-27
Age:10.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:Nevada  Entered:2012-08-29
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0071691SYRRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling around injection site itching, fever.

VAERS ID:463524 (history)  Vaccinated:2012-08-27
Age:4.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:California  Entered:2012-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tb test (PPD)
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196EA4UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0078AE2UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0071202UNRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Rash papular
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: (L) deltoid with erythema & mild induration. Diffuse papular rash.

VAERS ID:463535 (history)  Vaccinated:2012-08-27
Age:5.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Male  Submitted:2012-08-29, Days after onset: 0
Location:Idaho  Entered:2012-08-29
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4182AA3IMRL
Administered by: Unknown     Purchased by: Public
Symptoms: Erythema, Feeling hot, Local reaction, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Local reaction-redness, warmth and swelling.

VAERS ID:463537 (history)  Vaccinated:2012-08-27
Age:5.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:Idaho  Entered:2012-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none noted
Preexisting Conditions: none noted
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193B0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0516AA1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0097831SCRL
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: "Tennis ball sized inflammed and red area at the site of the vaccination; temp 100.3; evaluated in office today 08/29/2011 and redness is 5x6cm and hot and indurated, nontender at site of injection.

VAERS ID:463539 (history)  Vaccinated:2012-08-27
Age:60.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-08-29, Days after onset: 0
Location:California  Entered:2012-08-29
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, EXCEPT PHYSICAL EXAM AND VITAL SIGNS. PT INSTRUCTED TO TAKE OTC BENADRYL AND OR ZYRTEC, AND OTC ANALGESIC FOR PAIN. COOL COMPRESSES. ER PRECAUTIONS DISC AND TO RETURN THE FOLLOWING DAY FOR RECHECK.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.00069AE SCRA
Administered by: Public     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: HEADACHE, LOCALIZED RASH INDURATION, REDNESS, WARMTH, AND ITCHING OVER THE INJECTION SITE.

VAERS ID:463548 (history)  Vaccinated:2012-08-27
Age:9.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-08-29, Days after onset: 2
Location:Texas  Entered:2012-08-29
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 other than asthma.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4481CA4IMLA
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: Started with red area size of quarter (at site of flu injection on L deltoid) on evening of 8-27-12. On 8-28-12 Parent noted L deltoid area swollen and red over large area. 8-29-12 L deltoid reddened area with 100mm X 85mm and swollen.

VAERS ID:463594 (history)  Vaccinated:2012-08-27
Age:11.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:Idaho  Entered:2012-08-29
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1745AA IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4341AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4196AA IMLA
Administered by: Military     Purchased by: Military
Symptoms: Abdominal discomfort, Dizziness, Erythema, Fatigue, Headache, Skin warm
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: 1 Day post-little redness, upset stomach, tiredness, headache, light headedness, spot hot to touch. 2 day post-fist sized redness along w/day 1 symptoms.

VAERS ID:463540 (history)  Vaccinated:2012-08-27
Age:62.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-08-29, Days after onset: 0
Location:California  Entered:2012-08-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204521 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Patient complained of lower back pain and difficulty breathing which began 2 days after the vaccine. Patient was told to go to ER if having difficulty breathing.

VAERS ID:463601 (history)  Vaccinated:2012-08-27
Age:77.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:Ohio  Entered:2012-08-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4490AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Inflammation, Pain in extremity, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: It looks like a patient has a cellulitis on the bicep. Patients arm was red and inflamed. It was painful and warm to the touch instructed to take BENADRYL & go to ER. Patient came in 2 hour after vaccine.

VAERS ID:463663 (history)  Vaccinated:2012-08-27
Age:0.5  Onset:2012-08-29, Days after vaccination: 2
Gender:Male  Submitted:2012-08-30, Days after onset: 1
Location:Oklahoma  Entered:2012-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMLG
HBPV: HIB POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLG
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMLG
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema, Rash generalised, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Broke out in rash from head to toe and skin became very red and warm to touch. Child was not as active as usual.

VAERS ID:463738 (history)  Vaccinated:2012-08-27
Age:69.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Male  Submitted:2012-08-30, Days after onset: 2
Location:Ohio  Entered:2012-08-30
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: Penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0255AE0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 24 hours after injection pt developed large red area up his arm. Area is red, raised and hard underneath. Counseled pt to apply ice and call us tomorrow with condition of red area.

VAERS ID:463739 (history)  Vaccinated:2012-08-27
Age:11.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-30, Days after onset: 2
Location:Tennessee  Entered:2012-08-30
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.0555AE0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4286AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4384AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Started 10.5 x 9.5 cm area of tenderness and erythema. No fever. (L) arm suppcare treatment.

VAERS ID:463742 (history)  Vaccinated:2012-08-27
Age:6.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-08-30, Days after onset: 1
Location:Tennessee  Entered:2012-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Strep throat 8/22/2012
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B213BA0SYRLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0071411SYRLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left thigh injection sites measure 15 cm x 11.5 cm with erythematous firm cellulitis/indurated.

VAERS ID:463744 (history)  Vaccinated:2012-08-27
Age:69.0  Onset:2012-08-30, Days after vaccination: 3
Gender:Female  Submitted:2012-08-30, Days after onset: 0
Location:Maryland  Entered:2012-08-30
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: COMPAZINE allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0567AC0SCUN
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site pruritus, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, blister, itching, numbness at site of injection.

VAERS ID:463779 (history)  Vaccinated:2012-08-27
Age:1.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-08-27, Days after onset: 0
Location:Pennsylvania  Entered:2012-08-31, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1067AA SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Small wheel appeared under injection within 5 minutes of injection. Treated with 1/2 tsp of BENADRYL. Parents and pt left within another 5 minutes of treatment of BENADRYL.

VAERS ID:463856 (history)  Vaccinated:2012-08-27
Age:52.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-31, Days after onset: 4
Location:New Mexico  Entered:2012-08-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: PCN; KEFLEX
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0106560SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Swelling, redness, large hive 4x5.

VAERS ID:463884 (history)  Vaccinated:2012-08-27
Age:70.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-30, Days after onset: 2
Location:Ohio  Entered:2012-09-01, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0242AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Influenza like illness, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient developed a large (approximately 5" diameter) rash, and severe flu-like symptoms - she said could barely get out of bed the next day.

VAERS ID:463882 (history)  Vaccinated:2012-08-27
Age:61.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-09-01, Days after onset: 5
Location:Florida  Entered:2012-09-02, 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: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204701A IMLA
Administered by: Other     Purchased by: Private
Symptoms: Chest pain, Chills, Cough, Fatigue, Nausea, Oropharyngeal pain, Rhinorrhoea, Throat irritation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Chills, excessive fatigue, runny nose, scratchy throat, sore throat (09/02/12), nausea (intermittent), pain in chest when coughing.

VAERS ID:463915 (history)  Vaccinated:2012-08-27
Age:70.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-30, Days after onset: 2
Location:Vermont  Entered:2012-09-03, 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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0239AC0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Reddened area ~3"-4" long ~2" wide warm to touch.

VAERS ID:463943 (history)  Vaccinated:2012-08-27
Age:75.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-09-03, Days after onset: 5
Location:Texas  Entered:2012-09-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0170AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Mass, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient presented 2 days after immunization with swelling and hard mass (small) in her arm. Told to take Ibuprofen & BENADRYL and go to MD if getting worse.

VAERS ID:463921 (history)  Vaccinated:2012-08-27
Age:12.0  Onset:2012-08-30, Days after vaccination: 3
Gender:Male  Submitted:2012-08-31, Days after onset: 1
Location:Texas  Entered:2012-09-04, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Platelets - 8000
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0325AE1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4241AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3976AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0065371SCRA
Administered by: Private     Purchased by: Public
Symptoms: Ecchymosis, Idiopathic thrombocytopenic purpura, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow)
Write-up: 2 days -ecchymosis all over body. Idiopathic thrombocytopenia purpura.

VAERS ID:463942 (history)  Vaccinated:2012-08-27
Age:0.2  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:California  Entered:2012-09-04, Days after submission: 6
Life Threatening? No
Died? Yes
   Date died: 2012-08-28
   Days after onset: 0
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
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4184AB0UNLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC109BB1UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF654410UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0052AE0PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Bed sharing, Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)
Write-up: Baby was found dead in parents bed (she sleeps in parents bed). She was on the side with face down in the memory foam mattress. This happened on 8-28-12. Day after she received her 2 months vaccines on 8-27-12. Most probably a case of SIDS.

VAERS ID:464040 (history)  Vaccinated:2012-08-27
Age:55.0  Onset:2012-08-30, Days after vaccination: 3
Gender:Female  Submitted:2012-09-02, Days after onset: 3
Location:Virginia  Entered:2012-09-04, 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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1169AA0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia, Erythema, Oedema peripheral, Pain, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: Pt. received PNEUMOVAX vaccine 8/87/12. Pt. called 8/31/12 stating arm was swollen & red. Condition continued to worsen to severe swelling, redness, pain, tenderness and joint pain. PCP told pt. cold compresses & ibu for treatment.

VAERS ID:464042 (history)  Vaccinated:2012-08-27
Age:41.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:Pennsylvania  Entered:2012-09-04
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)SANOFI PASTEURUTAA70BA UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1743AA UNLA
Administered by: Private     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:464126 (history)  Vaccinated:2012-08-27
Age:10.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-29, Days after onset: 2
Location:Virginia  Entered:2012-09-05, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1799AA1UNLA
Administered by: Military     Purchased by: Military
Symptoms: Cold sweat, Fall, Fatigue, Feeling abnormal, Heart rate increased, Hyperhidrosis, Loss of consciousness, Malaise, Pallor, Thinking abnormal, Tinnitus, Visual impairment
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), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient rec''d vaccine in clinic office. As we were leaving tx room, pt told mother she did not feel well. We sat down in pt waiting area. Mother then witnessed pt turned pale & fall over side of chair (passed out). Pt recovered (woke up) w/in 60 sec & complained she could "not think" felt like bubbles in her head & vision was "black". Mother called for assistance. Pt was pale, clammy, sweaty. Pt did not really remember where she was or what had happened corpsman then helped mother transport pt back to clinic tx area where pt was placed in recliner chair and Pulse ox & BP were monitored. Initial O2 sats mid 90''s BP OK, HR increased. Continued to monitor pt for next 45 minutes. Color returned w/in 15 min of incident. Pt was released to mothers call 45 min after vaccination - all vitals were normal. Pt continued to be very "foggy" in her head all day - she was profoundly tired & complained of ringing in ears. Pt was fully recovered the following day.

VAERS ID:464138 (history)  Vaccinated:2012-08-27
Age:22.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-09-05, Days after onset: 8
Location:Indiana  Entered:2012-09-05
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1575AA0UNRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Injection site pain, Local reaction, Pain in extremity, Pruritus, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Sore at site the day after vaccination. X2 days had itchiness, redness, swelling 2 inches below vacc. site with warmth to touch. No blister. Sts entire arm was painful on 8-28-12. States it was a local reaction only - no fever or other generalized symptoms reported.

VAERS ID:464166 (history)  Vaccinated:2012-08-27
Age:64.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:Virginia  Entered:2012-09-05, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergic rhinitis; HTN; Depression; GERD; Increased lipids
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0468AE0SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: On pt. (R) arm, 1 1/2 x 1 1/2 inch area, redness, swollen & warm to touch. Advised pt to take BENADRYL as needed, apply cortizone Cr and apply cool compresses to the site.

VAERS ID:464191 (history)  Vaccinated:2012-08-27
Age:66.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Unknown  Submitted:0000-00-00
Location:Maine  Entered:2012-09-05
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: Hyperthyroidism
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4493AA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Feeling abnormal, Injection site erythema, Injection site warmth, Pyrexia, Tenderness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Notices tenderness after shot AM 8/29 Really not feeling good. Red & hot at the site about a dollar size area told to take TYLENOL & cold pack by doctor There was a fever 8/29 but gone on 8/30 and has been gradually better since.

VAERS ID:467940 (history)  Vaccinated:2012-08-27
Age:  Onset:2012-08-27, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-05, Days after onset: 9
Location:Unknown  Entered:2012-09-05
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:
CDC Split Type: WAES1209USA000619
Vaccination
Manufacturer
Lot
Dose
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not reported) one year ago, in approximately August 2011. No other co-suspects were reported. No concomitant medications were reported. On 27-AUG-2012 the patient was getting the second dose of GARDASIL. No adverse effects reported. The outcome was unknown at the time of report. It was unspecified if the patient had sought medical attention. Additional information has been requested.

VAERS ID:464251 (history)  Vaccinated:2012-08-27
Age:17.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-31, Days after onset: 3
Location:New York  Entered:2012-09-06, 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: HA; Nausea
Preexisting Conditions: Asthma; Tree nut; Sesame seed; Cat; Dogs; Environmental allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0325AE0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0106490IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3857BC1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Inflammation, Injection site warmth, Local reaction
SMQs:
Write-up: Large local inflammatory reaction in right deltoid. Warm to touch.

VAERS ID:464261 (history)  Vaccinated:2012-08-27
Age:61.0  Onset:2012-08-30, Days after vaccination: 3
Gender:Female  Submitted:2012-09-06, Days after onset: 7
Location:Tennessee  Entered:2012-09-06
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: Insomnia; Anxiety; Migraines; DDD/spinal stenosis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1254AA0SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Blister, Pruritus, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Blistering rash on bilateral legs, abd, and back - mild. No documented fever, no SOB, no other symptoms. Recommended to do OTC anti-histamines for itching.

VAERS ID:464267 (history)  Vaccinated:2012-08-27
Age:16.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-09-06, Days after onset: 10
Location:Ohio  Entered:2012-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB605BA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0109150IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4345AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Gaze palsy, Immediate post-injection reaction, Loss of consciousness, Muscle twitching
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Immediately after receiving Gardasil, Patient''s eyes rolled back, her whole body started twitching and she passed out. Lasted 15 seconds.

VAERS ID:464283 (history)  Vaccinated:2012-08-27
Age:1.0  Onset:2012-09-03, Days after vaccination: 7
Gender:Female  Submitted:2012-09-06, Days after onset: 3
Location:Indiana  Entered:2012-09-06
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: Streptococcal Test-negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0075AE0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF940013IMGM
Administered by: Unknown     Purchased by: Private
Symptoms: Crying, Lymphadenopathy, Pyrexia, Rash generalised, Rhinorrhoea, Streptococcus test negative, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Patient presents with complaint(s) of fever 102-103 fevers, rash all over, lymph node in groin the size of a pea x 3 days. 102.4 fever in office. Onset three days ago. No real rhinorrhea-other than when crying. Had an appointment for well visit but was fine. MMR given in left leg at that time. Now with enlarged lymph node left femoral/inguinal-no inflammation-non-tender. Vomits with Ibuprofen-no Acetaminophen yet today 9/6/12. Plan: Treat to cover strep in light of pharyngitis. Strongly suspect sequelae to MMR vaccination - does not follow course of events or characteristics of rash of roseola. Monitor closely in light of high fever. Coun/Edu: Discussed viral exanthem vs. sequelae of MMR vaccine-handout re: MMR vaccination with possible rash/fever within 7-12 days of vaccination. Discussed cover for strep in light of pharyngitis and recent increase in strep pharyngitis seen. Symptomatic treatment and usual course discussed. Reviewed fever and pain control with tylenol. Instructed to call or return for: --Symptoms not improved in 2 days, --Worsening symptoms, --New, unexplained symptoms develop.

VAERS ID:464318 (history)  Vaccinated:2012-08-27
Age:12.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Male  Submitted:2012-08-30, Days after onset: 2
Location:Texas  Entered:2012-09-06, 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
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0368AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0963AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4022AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B066AA5IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1091AA1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: At 1710 - 08/28/12 - Mother reported "pea & golf ball sized bumps" on back of (R) arm; No fever; Child "felt fine"; red area on back of (R) arm; stated ice "makes it swell more"; instructed to see a healthcare provider; stated would "go tomorrow if worse" 8/29/12 at 1115 - mother states son "felt fine" & "sent to school"; states redness & swelling "from his shoulder to elbow"; states going to see doctor after school 8/29/12 at 1645 - in hospital ER; red area triangular in shape on back of (R) arm warm to touch, measures 10cm x 10cm at widest areas; no fever; no pain or discomfort; given antibiotics & told to take BENADRYL to use ice packs by ER healthcare provider.

VAERS ID:464349 (history)  Vaccinated:2012-08-27
Age:61.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-29
Location:Delaware  Entered:2012-09-06, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0242AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt presented with rash, indicated receiving tx for possible cellulitis.

VAERS ID:464353 (history)  Vaccinated:2012-08-27
Age:5.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Male  Submitted:2012-08-29, Days after onset: 0
Location:Georgia  Entered:2012-09-06, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH712AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0073281SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: (L) tricep area swollen, red and warm to touch. Approx. 3 1/2 cm in length 4 cm width. Arm circumference 20 cm (R) arm 19 cm. Mother was told by the school''s bus driver that child''s arm was swollen.

VAERS ID:464356 (history)  Vaccinated:2012-08-27
Age:39.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-09-06, Days after onset: 10
Location:Texas  Entered:2012-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UTI 8/22/12
Preexisting Conditions: Hypothyroidism; Osteopenia
Diagnostic Lab Data: Patient signed consent on 8/27/12 stating no previous flu shot reactions. She then stated on 8/28/12 that she did have a previous reaction in 2010.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH732AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Eye pruritus, Fatigue, Ocular hyperaemia, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad)
Write-up: By 5 PM on 8/27/12, patient felt tired, had itchy eyes, also red eyes. Low-grade fever, patient states 101 degrees. Chills, body aches.

VAERS ID:464358 (history)  Vaccinated:2012-08-27
Age:68.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-09-06, Days after onset: 10
Location:Ohio  Entered:2012-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0105150UNLA
Administered by: Private     Purchased by: Private
Symptoms: Chest pain, Injection site cellulitis, Pain in extremity
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: (L) upper arm cellulitis - (L) arm pain - down fingers & across chest - started on KEFLEX 500mg 1 QD x 7 days. ROCEPHIN 1 gm IM - ALEVE - ADVIL - heat/ice - VICODIN 5/500 1 po Q 4-6hrs. # 20 ER --$g 600 mg CLEOCIN - BACTRIM also added.

VAERS ID:464488 (history)  Vaccinated:2012-08-27
Age:37.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-08-29, Days after onset: 0
Location:Pennsylvania  Entered:2012-09-06, 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: Sore throat
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.8653AE0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling, (L) arm pain, tenderness in underarm. 8-27-12- went to urgent care.

VAERS ID:464489 (history)  Vaccinated:2012-08-27
Age:40.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:Pennsylvania  Entered:2012-09-06, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0653AE UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, arm soreness, swelling, warmness. Ibuprofen for treatment.

VAERS ID:468744 (history)  Vaccinated:2012-08-27
Age:67.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-09-06, Days after onset: 8
Location:Kentucky  Entered:2012-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA001266
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0567AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient was vaccinated with ZOSTAVAX (lot # reported as 0567AE. Exp date 14-APR-2013, dose/frequency and route were unspecified) on 27-AUG-2012 in the afternoon. Pharmacist reported that the patient called the pharmacy this morning, 29-AUG-2012, to report that she noticed that she had developed an "injection site reaction", including "mild pain and the surrounding area was raised slightly warm to the touch". The patient had not contacted the physician who prescribed ZOSTAVAX. VZVIP packet not offered because the pharmacist stated that she didn''t think the patient was experiencing a rash. The patient had sought medical attention via consulting pharmacist. No treatment was given for the adverse event. The outcome was reported as not recovered/not resolved. Additional information is not expected.

VAERS ID:464288 (history)  Vaccinated:2012-08-27
Age:17.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-09-07, Days after onset: 11
Location:Indiana  Entered:2012-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA001201
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Dizziness, Fatigue, Gait disturbance, Injection site pain, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This spontaneous report was received from a female consumer concerning her 17 years old daughter with no pertinent medical history or drug reactions. The patient was vaccinated with dose 1 GARDASIL on 14-JUN-2012. On 27-AUG-2012, the patient was vaccinated with the second dose of GARDASIL. No other co-suspects were reported. There was no concomitant medication. On 27-AUG-2012, approximately 1 minute after received the second dose, the patient had seizure (medically significant) in the physician''s office. The consumer mentioned her daughter did not have a history of seizures. The reporter mentioned that her daughter was retained in the physician''s office for 2 hours following the vaccine administration. When the patient was sent home from the physician''s office, she felt lightheaded, dizzy, and fatigued and had difficulty walking to the parking lot where her mother''s car was parked. The consumer stated her daughter vomited in the physician''s parking lot and "looked extremely pale". The patient continued to feel extremely fatigued and that she had soreness in the arm where she received GARDASIL. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.

VAERS ID:464393 (history)  Vaccinated:2012-08-27
Age:0.4  Onset:2012-09-04, Days after vaccination: 8
Gender:Male  Submitted:2012-09-07, Days after onset: 3
Location:Illinois  Entered:2012-09-07
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4260AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451371IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB252A1PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea 7-8 times a day for 3 days, vomiting 1 time.

VAERS ID:464512 (history)  Vaccinated:2012-08-27
Age:63.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-31, Days after onset: 4
Location:New Jersey  Entered:2012-09-07, 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: PCN
Diagnostic Lab Data: Temp in office 98.9, no signs of infxn
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Pt received flu shot from local pharmacy on 8/27 & has had 5 days of chills, myalgias & fevers up to 101 in absence of any other causes.

VAERS ID:464740 (history)  Vaccinated:2012-08-27
Age:0.4  Onset:2012-09-05, Days after vaccination: 9
Gender:Female  Submitted:2012-09-06, Days after onset: 1
Location:Utah  Entered:2012-09-07, 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: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B344CA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH625AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF940011IMLL
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Had vomiting and diarrhea 8 days after receiving Rotavirus vaccine. No treatment needed.

VAERS ID:468827 (history)  Vaccinated:2012-08-27
Age:65.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-09-07, Days after onset: 9
Location:Unknown  Entered:2012-09-07
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:
CDC Split Type: WAES1209USA001383
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0071AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with no pertinent medical history or any drug reactions/allergies. The patient was vaccinated subcutaneously with ZOSTAVAX (lot number 0071AE, expiration date 03-APR-2013) on 27-AUG-2012. No other co-suspects were reported. Concomitant medications included simvastatin, XALANTAN and FOSAMAX. On 29-AUG-2012 the patient experienced warm, pink area around the injection site after receiving ZOSTAVAX. The patient had contacted pharmacist for medical attention. No treatment or any laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.

VAERS ID:466789 (history)  Vaccinated:2012-08-27
Age:60.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-09-08, Days after onset: 11
Location:Unknown  Entered:2012-09-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA001257
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Induration, Pruritus, Upper extremity mass
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: This spontaneous report as received from a 60 years old female consumer refers to herself. The patient had none pertinent medical history. The patient had none drug allergies. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported) on "Monday", 27-AUG-2012. Concomitant medications included: metoprolol tartrate. It was reported that then "the next night", on 28-AUG-2012 the patient had some itching. On the morning of 29-AUG-2012 the patient then noticed a hard lump on her arm about 3 to 4 inches in diameter. The patient was going to a medical clinic on 29-AUG-2012 to treat this adverse event and had no specific doctor that she saw. No treatment was given. No lab diagnostics studies was performed. The adverse event did not improve. The outcome was reported as not recovered. Additional information is not expected.

VAERS ID:468846 (history)  Vaccinated:2012-08-27
Age:78.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-09-09, Days after onset: 13
Location:Missouri  Entered:2012-09-09
Life Threatening? No
Died? No
Permanent Disability? No
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: WAES1209USA002389
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a physician refers to a female patient of 78 years old (as reported). The patient was vaccinated with 0.65 ml ZOSTAVAX (lot# was reported as 00768ae, exp. not available) subcutaneously on right arm on 27-AUG-2012. There were no other immunizations provided at the time of ZOSTAVAX. It was reported that the patient was seen in the office with a swollen right arm at the injection site one week after receiving ZOSTAVAX. The adverse event onset date was reported as On 27-AUG-2012. The outcome of patient was unknown. Additional information is not expected.

VAERS ID:464558 (history)  Vaccinated:2012-08-27
Age:40.0  Onset:2012-08-30, Days after vaccination: 3
Gender:Male  Submitted:2012-09-10, Days after onset: 11
Location:Illinois  Entered:2012-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None stated
Diagnostic Lab Data: None reported by Pt''s physician
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA734AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Influenza, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: H/A, fever. Dx''ed Post Influenza Syndrome.

VAERS ID:464588 (history)  Vaccinated:2012-08-27
Age:1.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-09-11, Days after onset: 15
Location:Michigan  Entered:2012-09-11
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Private
Symptoms: Diet refusal, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Fever of 100-102 for 4-5 days, refusal to eat, ended up in a rash on day 5.

VAERS ID:464818 (history)  Vaccinated:2012-08-27
Age:12.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-08-29, Days after onset: 0
Location:Ohio  Entered:2012-09-11, Days after submission: 13
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: CK 445, BMP WNL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0101AE0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4169AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood creatine phosphokinase increased, Metabolic function test normal, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: GARDASIL vaccine administered and within 2 days right arm painful and weak. Pt did not have weakness or pain in any other extremities. No dark urine. Treated with OTC pain relievers, increased fluids.

VAERS ID:464825 (history)  Vaccinated:2012-08-27
Age:11.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Arizona  Entered:2012-09-11
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.D101AE UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11041 UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3976AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling on (L) shoulder.

VAERS ID:464838 (history)  Vaccinated:2012-08-27
Age:16.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-09-03, Days after onset: 7
Location:Texas  Entered:2012-09-11, 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: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH1223 IMUN
Administered by: Other     Purchased by: Private
Symptoms: Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fainted & nauseated after immunization.

VAERS ID:468287 (history)  Vaccinated:2012-08-27
Age:  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-09-11, Days after onset: 15
Location:Unknown  Entered:2012-09-11
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:
CDC Split Type: WAES1209USA002312
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0659AA0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report was received from a register nurse concerning a male patient of unknown age who on 27-AUG-2012 was vaccinated with an expired dose, 0.65 ml dose subcutaneous ZOSTAVAX, lot number 670547/0659AA, expiration date 04-AUG-2012. No adverse events were reported. This is one of several reports received from the same source (other MAARS number 1209USA002305). Additional information had been requested.

VAERS ID:468836 (history)  Vaccinated:2012-08-27
Age:68.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-11
Location:Unknown  Entered:2012-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydroxychloroquine sulfate; Prednisone
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA001157
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0565AE SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a 68 years old female patient with no known allergies. The patient was vaccinated SC into back of unspecified arm with 0.65 ml ZOSTAVAX (lot # not reported) on 27-AUG-2012. Concomitant medications included hydroxychloroquine sulfate and low dose prednisone. In August 2012 the patient experienced adverse reaction. The patient came to the pharmacy on 29-AUG-2012 with a large red bump, size of a plum, warm to touch, at the injection site of unspecified arm. No treatment was given. No laboratory test was done. At the time of reporting, the patient had not recovered for the events. Additional information has been requested.

VAERS ID:464975 (history)  Vaccinated:2012-08-27
Age:98.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Male  Submitted:2012-09-13, Days after onset: 16
Location:California  Entered:2012-09-13
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: Atrial fibrillation; Hypertension
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Flank pain, Musculoskeletal pain, Musculoskeletal stiffness, Oropharyngeal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Pain from lower foot to up right side to shoulder; stiff neck 3 days; extreme sore throat to present.

VAERS ID:469075 (history)  Vaccinated:2012-08-27
Age:60.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-09-13, Days after onset: 16
Location:Ohio  Entered:2012-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA001265
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SYRAR
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SYRAR
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a physician refers to a 60 years old female patient. The patient was vaccinated with ZOSTAVAX (1 vial dose, injection, lot# was unknown) on 27-AUG-2012. Other suspect therapies included PNEUMOVAX 23 (lot# was unknown) on 27-AUG-2012. On 28-AUG-2012 the patient experienced swelling and inflammation, about 10x5cm in size, of the injection site, from after receiving ZOSTAVAX and PNEUMOVAX 23 in the same deltoid area. The patient sought unspecified medical attention, an anti-inflammatory was given for the adverse events. Additional information has been requested.

VAERS ID:465099 (history)  Vaccinated:2012-08-27
Age:11.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-09-14, Days after onset: 18
Location:Arizona  Entered:2012-09-14
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: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH715AA0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4341AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4383AA0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Pt. felt nausea and lightheaded immediately after immunizations.

VAERS ID:465110 (history)  Vaccinated:2012-08-27
Age:71.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-09-10, Days after onset: 14
Location:Montana  Entered:2012-09-14, 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:
Preexisting Conditions: Hypertension
Diagnostic Lab Data: None by physician
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Pain
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Some allergic activity begins evening of vaccine received 8/27/12 continue through 9/10/12. Symptoms - itching, redness from site of injection down to elbow. Mild/moderate pain. Has no known allergy to vaccine components.

VAERS ID:468315 (history)  Vaccinated:2012-08-27
Age:0.1  Onset:2012-08-27, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-14, Days after onset: 18
Location:Massachusetts  Entered:2012-09-14
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:
CDC Split Type: WAES1209USA000126
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a physician refers to a 32 days old patient. The patient was vaccinated with the first dose of oral ROTATEQ (lot number, route, dose not reported) on 27-AUG-2012, 10 days before 6 weeks old. No other co-suspects or concomitant medications were reported. The patient was not experiencing any known symptoms. No treatment information was reported. Additional information has been requested.

VAERS ID:469179 (history)  Vaccinated:2012-08-27
Age:  Onset:2012-08-27, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-14, Days after onset: 18
Location:California  Entered:2012-09-14
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:
CDC Split Type: WAES1209USA005130
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first dose of 0.5 ml VAQTA 25/0.5 U/ml (lot number not reported) on 02-APR-2012 and the second dose on 27-AUG-2012. No other co-suspects or concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.

VAERS ID:465164 (history)  Vaccinated:2012-08-27
Age:51.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-09-16, Days after onset: 18
Location:New Jersey  Entered:2012-09-16
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: Diabetic
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMRA
Administered by: Public     Purchased by: Other
Symptoms: Chills, Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Right arm red, swollen, hot to the touch, has chills.

VAERS ID:465176 (history)  Vaccinated:2012-08-27
Age:65.0  Onset:2012-08-30, Days after vaccination: 3
Gender:Male  Submitted:2012-09-16, Days after onset: 17
Location:Texas  Entered:2012-09-16
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: Granulomera-red blotches down arms; High Cholesterol; DM; Hypertension; High triglyceride
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1203801 IMRA
PPV: PNEUMO (PNU-IMUNE)PFIZER/WYETHH010515 IMRA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Migraine, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Migraine in the evening of the 8/27/12, red hot swollen arm. Seen Dr. for cellulitis. Was given Prednisone and Bactrim.

VAERS ID:465177 (history)  Vaccinated:2012-08-27
Age:12.0  Onset:2012-08-31, Days after vaccination: 4
Gender:Female  Submitted:2012-09-16, Days after onset: 16
Location:New Jersey  Entered:2012-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE ~ NOT SURE OF DATE OF BIRTH, DIDN''T HAVE THAT INFORMATION
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMRA
Administered by: Public     Purchased by: Other
Symptoms: Bacterial infection, Body temperature increased, Diarrhoea, Erythema, Feeling hot, Injection site erythema, Nausea, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Warm and achy, temp 101, right arm hot and red, nauseous, diarrhea. Right arm was red from the shoulder to the elbow. Went to Urgent care. Dr. diagnosis bacterial infection. Prescribed Keflex.

VAERS ID:465390 (history)  Vaccinated:2012-08-27
Age:74.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-09-17, Days after onset: 20
Location:Ohio  Entered:2012-09-17
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) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4490AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Malaise, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, swollen area that spread to elbow after vaccine. Hot to touch & patient did not feel well next day.

VAERS ID:469319 (history)  Vaccinated:2012-08-27
Age:29.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-17, Days after onset: 21
Location:Unknown  Entered:2012-09-17
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:
CDC Split Type: WAES1209USA001321
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0907Z SCUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse concerning a 29 year old patient of unknown gender, who on 27-AUG-2012 was vaccinated with a dose of M-M-R II 0.5 ml, SQ, rHA, lot # (667246/0907Z) that had expired on 09-JUL-2012. No adverse effects reported. Additional information has been requested.

VAERS ID:465417 (history)  Vaccinated:2012-08-27
Age:1.0  Onset:2012-09-03, Days after vaccination: 7
Gender:Male  Submitted:2012-09-18, Days after onset: 15
Location:Pennsylvania  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy to milk protein
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0325AE0UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0076AE0UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH9182423UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0186AE0UNRL
Administered by: Private     Purchased by: Public
Symptoms: Acne, Dermatitis diaper, Diarrhoea, Pyrexia, Rash generalised, Varicella post vaccine, Viral rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Approx. 9/3/12 my son spiked a fever under 101*. During this time he had one LARGE episode of vomiting. On 9/4/12 he cont.d'' with fever of 101* started with diarrhoea and what looked to me like diaper rash. 9/5/12 low grade fever and rash ALL over his body. This includes inside his mouth, ears, diaper area, in his hair, his eye lids. 9/6/12 I took him to the Hospital they said it was a viral rash which was also said by Dr. By evening the rash had DOUBLED, raised, and my son was in agony!! I took him to my husbands pediatrician. He confirmed that the rash was indeed a case of the chicken pox. He prescribed him acyclovir. I also gave him Tylenol and Benadryl per Dr. He still has SOME pimples. They no longer bother him and are still fading.

VAERS ID:465429 (history)  Vaccinated:2012-08-27
Age:5.0  Onset:2012-09-06, Days after vaccination: 10
Gender:Male  Submitted:2012-09-18, Days after onset: 12
Location:Georgia  Entered:2012-09-18
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: Egg white allergy by blood test.
Diagnostic Lab Data: None yet.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Other
Symptoms: Abnormal behaviour, Cough, Decreased appetite, Fatigue, Headache, Myalgia, Pyrexia, Retching, Sleep disorder, Vomiting, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad)
Write-up: Fever up to 100.5 continues, dry cough to wet cough causing sleep disturbances severity progrssing to gagging and vomiting at times. Complaints of severe headache, muscle aches in arms/legs/abdomen. Lack of appetite, 2lb weight loss in 2 weeks. Continued fatigue, change of behavior and disruption of behavior patterns.

VAERS ID:465447 (history)  Vaccinated:2012-08-27
Age:37.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-09-18, Days after onset: 21
Location:Kentucky  Entered:2012-09-18
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS122202 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad)
Write-up: The morning after the vaccination, the patient states, "she has trouble raising her arm above her head, and there are severe pains radiating from her shoulder. It takes some time before the pain resides."

VAERS ID:465534 (history)  Vaccinated:2012-08-27
Age:1.5  Onset:2012-09-02, Days after vaccination: 6
Gender:Female  Submitted:2012-09-13, Days after onset: 11
Location:Illinois  Entered:2012-09-18, 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:
Diagnostic Lab Data: Urine analysis/negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Irritability, Listless, Pyrexia, Rash generalised, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Patient had a high fever - over 104 degrees as documented by ER doctor using temporal thermometer. From day 6/7 to 10) she was listless and drowsy and extremely irritable. Treatment could only be for fever - TYLENOL & ADVIL. Followed with rash all over body on day 10.

VAERS ID:465600 (history)  Vaccinated:2012-08-27
Age:71.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-09-19, Days after onset: 22
Location:Michigan  Entered:2012-09-19
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4492BA0IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Activities of daily living impaired, Lethargy, Nausea
SMQs:, Acute pancreatitis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Extreme lethargy with bouts of nausea. The lethargy lasted a full week where she was unable to cook a meal with out sitting down to rest her eyes.

VAERS ID:465617 (history)  Vaccinated:2012-08-27
Age:31.0  Onset:2012-09-13, Days after vaccination: 17
Gender:Female  Submitted:2012-09-19, Days after onset: 6
Location:California  Entered:2012-09-19
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: Blood test
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
VARCEL: VARICELLA (VARILRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Public     Purchased by: Unknown
Symptoms: Blood test, Fatigue, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Write-up: High Fever, fatigue, heart palpitation.

VAERS ID:465626 (history)  Vaccinated:2012-08-27
Age:51.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Male  Submitted:2012-09-19, Days after onset: 22
Location:New Hampshire  Entered:2012-09-19
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: NKA; NMC
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0242AE0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt got "red circle" at injection site that lasted few days, but also got "hard lump" under skin. He said it still feels sore, like a bruise several weeks after immunization.

VAERS ID:465663 (history)  Vaccinated:2012-08-27
Age:0.4  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-09-19, Days after onset: 23
Location:Kansas  Entered:2012-09-19
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: Seizure
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4222AA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451351IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0050AE1PO 
Administered by: Private     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient was observed by parents to have a seizure. Pt was taken to ER. This clinic referred pt. to Neuro clinic and ordered EEG.

VAERS ID:469877 (history)  Vaccinated:2012-08-27
Age:  Onset:2012-08-27, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-19, Days after onset: 23
Location:Unknown  Entered:2012-09-19
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:
CDC Split Type: WAES1209USA006345
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of hepatitis b vaccine (manufacturer unknown) (lot number not reported, expired date 27-APR-2012) on 27-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.

VAERS ID:465767 (history)  Vaccinated:2012-08-27
Age:61.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-09-20, Days after onset: 22
Location:Oklahoma  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204501 IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0070AE SCRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 2 days after flu vaccine was administered, the area around injection site was swollen, red and hot. Also had streaking of red down her arm and around injection site. Saw physician and started on Keflex

VAERS ID:470250 (history)  Vaccinated:2012-08-27
Age:78.0  Onset:2012-09-04, Days after vaccination: 8
Gender:Female  Submitted:2012-09-20, Days after onset: 16
Location:Missouri  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA003206
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a physician refers to a 78 years old female patient. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous) on 27-AUG-2012. Lot number 00768AE was an invalid lot number for ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. Physician reported patient seen in the office with a swollen right arm at the injection site one week after receiving ZOSTAVAX on 04-SEP-2012. Reporter noted there were no other immunizations provided at the time of ZOSTAVAX administration. The outcome of swollen right arm at the injection site was unknown. The patient went to physician''s office and sought medical attention. Additional information is not expected.

VAERS ID:465886 (history)  Vaccinated:2012-08-27
Age:67.0  Onset:2012-09-06, Days after vaccination: 10
Gender:Male  Submitted:2012-09-21, Days after onset: 15
Location:California  Entered:2012-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Check up with kidney specialist
Preexisting Conditions: Spinal surgery 3 years ago
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Asthenia, Back pain, Balance disorder, Malaise, Skin tightness
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: Started experiencing problems around 9/6 or 9/7. First thought they were related to recovery from surgery. Tightness in arm, stomach, hands, pain in back, weakness, imbalance, joint pain. Increased in severity. Has not been feeling well for about 2 weeks. Will contact doctor today.

VAERS ID:470405 (history)  Vaccinated:2012-08-27
Age:16.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-09-21, Days after onset: 25
Location:Unknown  Entered:2012-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA001031
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H009779 UNUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: This spontaneous report as received from health care worker referring a 16 year old patient of unknown age who was vaccinated with a dose of ZOSTAVAX (lot # H009779, Exp 27-MAR-2013) (dose and route not reported) on 27-AUG-2012 inadvertently instead of VARIVAX. No adverse effects reported. Additional information not expected.

VAERS ID:466105 (history)  Vaccinated:2012-08-27
Age:65.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-09-24, Days after onset: 27
Location:Georgia  Entered:2012-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: HTN
Diagnostic Lab Data: None, BP med increased with good result.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Blood pressure increased, Condition aggravated, Personality change
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Hypertension (narrow)
Write-up: Seen at ER 8/27/2012 due to hand laceration received Tdap. Days following had increased BP, and change in personality. Last tetanus x 8-10 yr ago without incident states arm did not "get sore" like all other times.

VAERS ID:466270 (history)  Vaccinated:2012-08-27
Age:17.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-08-29, Days after onset: 2
Location:North Carolina  Entered:2012-09-25, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURUH286AA1IMUN
Administered by: Public     Purchased by: Unknown
Symptoms: Feeling abnormal, Headache, Insomnia, Myalgia, Pain in extremity, Spinal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Meningococcal (MCV4P) given 8/27/12. Mother reported that he felt bad that night. Sore arm, the next day patient had headache, muscle pain, difficulty sleeping, and his spine "killing" him. Mom has been giving him ADVIL every 4-6 hrs for pain. Called mom on 8/29/12 reports son still feels bad with same symptoms. These symptoms lasted for 5 days f/u with mom on 9/10/12. Patient is at college & doing fine now.

VAERS ID:470869 (history)  Vaccinated:2012-08-27
Age:64.0  Onset:2012-08-30, Days after vaccination: 3
Gender:Female  Submitted:2012-09-26, Days after onset: 27
Location:North Carolina  Entered:2012-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA007464
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0423AE0SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site vesicles
SMQs:
Write-up: This spontaneous report as received from a healthcare worker refers to a 64 year old female patient. The patient was vaccinated subcutaneously in unspecified arm with 0.65 ml ZOSTAVAX (lot number 672675/0068AE, expiration date 12-SEP-2013) on 27-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. Three days later, on approximately 30-AUG-2012 the patient experienced a "huge water blister the size of a lemon, at the injection site". The outcome of adverse event was reported as recovered. The patient called for office medical attention. Additional information has been requested. This is one of several reports received from the same source.

VAERS ID:466697 (history)  Vaccinated:2012-08-27
Age:0.2  Onset:2012-08-28, Days after vaccination: 1
Gender:Male  Submitted:2012-09-27, Days after onset: 30
Location:Texas  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted
Preexisting Conditions: None noted
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12038011IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0105151IMRA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Neck pain, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Next day stinging pain in arm, thought it was a spider bite. Became more painful in arm & neck. Had red streaking and went to hospital. Started on Benadryl & steriods. Better now.

VAERS ID:466801 (history)  Vaccinated:2012-08-27
Age:39.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-09-28, Days after onset: 30
Location:Georgia  Entered:2012-09-28
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
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD 0PO 
Administered by: Other     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Skin eruption on right side of forehead. Acyclovir and mupirocin ointment.

VAERS ID:466955 (history)  Vaccinated:2012-08-27
Age:52.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-08-31, Days after onset: 4
Location:New Mexico  Entered:2012-09-28, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: PCN; KEFLEX
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0106560SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Swelling, redness, large hive 4 x 5.

VAERS ID:470003 (history)  Vaccinated:2012-08-27
Age:1.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-29, Days after onset: 33
Location:Unknown  Entered:2012-09-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA002049
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H010428 SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report as received from an Office manager registered nurse refers to a patient of 1 years old. The office manager reported that on 27-AUG-2012, the received 0.5 ml dose of GARDASIL injection 120 Y (Lot#H010428; exp. date: 20-JAN-2012) inadvertently. No adverse effects reported. The outcome of the event was unknown. The event was not related to GARDASIL. Additional information has been requested.

VAERS ID:467168 (history)  Vaccinated:2012-08-27
Age:74.0  Onset:2012-09-06, Days after vaccination: 10
Gender:Female  Submitted:2012-09-24, Days after onset: 18
Location:Ohio  Entered:2012-10-01, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H010470SCUN
Administered by: Other     Purchased by: Public
Symptoms: Blister, Pain in extremity, Pruritus, Pyrexia, Rash generalised, Rash macular
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 10 days after receiving vaccine developed blotches of rash on left side arms, legs, back, hairline rash turned into blisters, and are itching. Also low grade fever after rash was gone arm hurt for about a week.

VAERS ID:467232 (history)  Vaccinated:2012-08-27
Age:55.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-09-27, Days after onset: 30
Location:Ohio  Entered:2012-10-01, 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:
Diagnostic Lab Data: MRI pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AB IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling and pain left upper arm.

VAERS ID:467230 (history)  Vaccinated:2012-08-27
Age:0.3  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-02, Days after onset: 35
Location:California  Entered:2012-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4184AA1IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC1098B1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9182451IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB268A1PO 
Administered by: Public     Purchased by: Unknown
Symptoms: Atonic seizures, Convulsion, Hypotonia, Intensive care, Laboratory test normal, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: mo female had immunization on 8/27/12. Healthy at the time. Had fever <101 that night. Next day appeared well breast fed, no fever, then went limp. Call the ambulance - hospital. Received ATIVAN. Dx afebrile atonic seizure. Transferred to major hospital, admitted. Septic work up done, all negative. 3 days in hospital. Came to office on 9/11/12. This child received vaccines on 8/27/12 and had an afebrile seizure the following day and was hospitalized in ICU and regular unit for three days. Unable to get lot # for vaccines.

VAERS ID:468991 (history)  Vaccinated:2012-08-27
Age:67.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Male  Submitted:2012-09-22, Days after onset: 25
Location:Florida  Entered:2012-10-10, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None; Saw my Dr, Dx reaction; Screen patients over 65 to flu shot very, very closely.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR 0IDAR
Administered by: Other     Purchased by: Unknown
Symptoms: Diarrhoea, Monoplegia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Noninfectious diarrhoea (narrow)
Write-up: 27 Aug 12 5:00 PM shot administered. 28 Aug 12 3:00 AM awoke with 104.7 fever, legs were paralyzed for a few minutes. 103 fever most of the day. 6:00 PM uncontrollable diarrhea, no notice, no pain. 29 Aug 12 Fever 101, diarrhea ended about 6:00 PM. 30 Aug 12 Better.

VAERS ID:469420 (history)  Vaccinated:2012-08-27
Age:33.0  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-10-13, Days after onset: 45
Location:North Carolina  Entered:2012-10-13
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS120420 IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injected limb mobility decreased, Movement disorder, Pain, Pain in extremity
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad)
Write-up: Sharp, excruciating pain to right arm when lifting arm above shoulder level. Can''t move arm at all on 9/12/12. Saw physician who consulted with neuro MD, who said it''s not nerve damage or a bad batch of vaccine. Prescribed anti-inflammatory med from doctor. It helped while on it but she is finished with med and it''s painful again. Sees physician for follow-up next week. Will call again.

VAERS ID:469529 (history)  Vaccinated:2012-08-27
Age:67.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-15
Location:Michigan  Entered:2012-10-15
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) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4490AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Drug administered at inappropriate site, Immune system disorder, Mobility decreased, Muscle atrophy, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: After patient received flu shot she had tissue damage, muscular atrophy and the loss of normal use of her left arm due to pain. Her doctors diagnosed that the injection site was too high in the rotary cuff causing destructive immune activity. She is undergoing extended physical therapy at this time.

VAERS ID:469785 (history)  Vaccinated:2012-08-27
Age:41.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-10-14, Days after onset: 48
Location:Massachusetts  Entered:2012-10-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Bipolar disorder; Autism; hypertension; hypothyroidism; hypercholesterolemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AC0IMAR
Administered by: Other     Purchased by: Public
Symptoms: Pain in extremity
SMQs:
Write-up: Patient has ongoing pain in his arm since receiving the FLUZONE immunization on 8/27/12.

VAERS ID:470100 (history)  Vaccinated:2012-08-27
Age:23.0  Onset:0000-00-00
Gender:Male  Submitted:2012-10-11
Location:Illinois  Entered:2012-10-16, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: None
Diagnostic Lab Data: Got x rays done no results yet
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRAR
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, X-ray
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Shot was administered August 27, 12 and whole arm including area where shot was administered hurts unable to move/sleep on arm at times and painful. Taking nabumetone 750mgs for possible infection.

VAERS ID:470300 (history)  Vaccinated:2012-08-27
Age:35.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-10-18, Days after onset: 52
Location:Oklahoma  Entered:2012-10-18
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0360AE1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Patient was seen on 10/16/2012 and was diagnosed with pregnancy. She had been given a Varicella vaccine on 08/27/2012. She was asked at that time if any chance for pregnancy and was denied. Stated last menses was 08/22/2012.

VAERS ID:475626 (history)  Vaccinated:2012-08-27
Age:56.0  Onset:2012-09-30, Days after vaccination: 34
Gender:Female  Submitted:2012-10-20, Days after onset: 20
Location:Texas  Entered:2012-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: 1984, Brain neoplasm
Diagnostic Lab Data:
CDC Split Type: WAES1210USA003688
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Herpes zoster, Oropharyngeal pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a consumer refers to a 56 years old female patient. The patient''s medical history included brain tumor (in 1984). The patient was vaccinated by her physician with ZOSTAVAX on 27-AUG-2012. Information regarding dose, frequency, or route was not provided. No other co-suspects were reported. Concomitant medications included PROVIGIL, VIIBRYD, NEXIUM, hydrocodone and PLAVIX. On 30-SEP-2012, 35 days after onset of therapy, the patient experienced sore throat, fever, and then broke out on her bottom with a rash, and was then diagnosed with shingles by her gynecologist. The patient received treatment with acyclovir. A blood test was performed (result not provided). The patient was not hospitalized. The event did not improve and the outcome for shingles was reported as not recovered/not resolved. A reporter causality for shingles was not provided for ZOSTAVAX. Additional information has been requested.

VAERS ID:470644 (history)  Vaccinated:2012-08-27
Age:38.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-22, Days after onset: 55
Location:Florida  Entered:2012-10-22
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 blood pressure, anxiety.
Diagnostic Lab Data: None yet due to no insurance.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR  IDAR
Administered by: Unknown     Purchased by: Private
Symptoms: Activities of daily living impaired, Erythema, Feeling abnormal, Pain, Pruritus, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Hypersensitivity (broad)
Write-up: Itching and raised redness, but then a day later it was a sharp pain just under where the shot was given, and STILL if I raise my arm it feels like it is going to crack deep inside my upper arm, I can''t brush my hair, or lift anything over my head the pain is just to much. I am not sure if this shot has given me arthritis, or tendonitis. I do not have any insurance right now so I can''t go back to see the Dr but I have never had a problem with my arm before. This is going on three months now. I can''t even sleep on my side due to this upper arm pain.

VAERS ID:471773 (history)  Vaccinated:2012-08-27
Age:14.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Virginia  Entered:2012-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: syncope~Hep A (no brand name)~0~13.00~Patient
Other Medications: None
Current Illness: None; Well visit
Preexisting Conditions: Nasal allergy - not current problem
Diagnostic Lab Data: EKG -$g atrial flutter
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.H010451IMUN
Administered by: Private     Purchased by: Private
Symptoms: Arachnoid cyst, Atrial flutter, Electrocardiogram abnormal, Head injury, Hypersensitivity, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: 8/23/2011 -$g Hep A #1 given - BP decreased, nausea - $g resolved after G''ade/ 8/27/2012 -$g Hep A #2 given - syncope, head bang on floor, BP ok but weak, at 1229, nauseated - $g in atrial flutter lasting for $g 1 hour. CT - minor or arachnoid cyst. Cardiac evaluation - normal neuro eval - normal $g$g allergic reaction.

VAERS ID:472333 (history)  Vaccinated:2012-08-27
Age:12.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-10-31, Days after onset: 65
Location:Pennsylvania  Entered:2012-10-31
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: Kidney and bladder ultrasounds, bloodwork, urinalysis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood test, Blood urine present, Haematuria, Ultrasound bladder, Ultrasound kidney, Urine analysis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Tubulointerstitial diseases (broad)
Write-up: Blood in urine.

VAERS ID:474114 (history)  Vaccinated:2012-08-27
Age:29.0  Onset:2012-09-03, Days after vaccination: 7
Gender:Male  Submitted:2012-09-10, Days after onset: 7
Location:Georgia  Entered:2012-11-09, Days after submission: 60
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s ongoing illness /medical history/ risk factors and adverse event to previous vaccinations were not reported. The patient had no concomitant vaccines or medication. Corrective treatments were not reported.
Diagnostic Lab Data: Lab investigations were not reported.
CDC Split Type: 201208078
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4463BA IDRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contusion, Injection site haematoma, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial information received from a Health care professional on 04 September 2012. A 29-year-old male patient whose medical history and concomitant medication were not reported received an intradermal dose of FLUZONE ID vaccine (Batch lot number UT4463BA) (Expiry date 26 March 2013) in right arm on 27 August 2012. The reporter stated that on the 03 September 2012, the patient had bruising down length of upper right arm, beginning into right forearm and slightly swollen right arm. Laboratory details and corrective treatment were not reported. Outcome of the event was unknown. Documents held by sender: none.

VAERS ID:474121 (history)  Vaccinated:2012-08-27
Age:  Onset:2012-08-27, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-06, Days after onset: 10
Location:Unknown  Entered:2012-11-09, Days after submission: 64
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s ongoing illness /medical history/ risk factors and adverse event to previous vaccinations were not reported. The patient had no concomitant vaccines or medication. Corrective treatments were not reported.
Diagnostic Lab Data: Lab investigations were not reported.
CDC Split Type: 201208035
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR  IDUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Feeling abnormal, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Dementia (broad), Hypersensitivity (narrow)
Write-up: This case is linked with the case# 2012-08034 (0). Initial information received from a health care professional on 29 August 2012. A patient (unknown age and gender) whose medical history and concomitant medication were not reported received an intradermal dose of FLUZONE ID vaccine (Batch lot number, anatomical position and dose: not reported) on 27 August 2012. It was reported that the patient who was 1 of the 12 employees had a funny feeling at the time of the injection and later in the afternoon. Also the patient had welts, it was mosquito bite size to 1/2 dollar size and some were red. Laboratory details and corrective treatment were not reported. Outcome of the event was not reported. Documents held by sender: none.

VAERS ID:474194 (history)  Vaccinated:2012-08-27
Age:57.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2012-09-06, Days after onset: 10
Location:Pennsylvania  Entered:2012-11-09, Days after submission: 64
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; LIPITOR
Current Illness:
Preexisting Conditions: The patient''s history included diabetes and elevated cholesterol.
Diagnostic Lab Data: Not Reported
CDC Split Type: 201208008
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4463BA IDAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Initial report received from a healthcare professional (pharmacist) on 29 August 2012. A male patient with medical history of diabetes and elevated cholesterol and no reported concomitant medications received intradermal FLUZONE (batch number: UT4463BA) in the deltoid on 27 August 2012. On 27 August 2012, after vaccination the patient experienced large red, rash, itching area around injection site on arm and lump at injection site. At the time of this report, the events had not resolved. Documents held by sender: none.

VAERS ID:479857 (history)  Vaccinated:2012-08-27
Age:76.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-12-27, Days after onset: 122
Location:Georgia  Entered:2012-12-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Alprazolam; Ibuprofen; Atenolol; LASIX; MAXZIDE; Metformin; NIASPAN ER; PREVACID; Simvastatin; SYNTHROID; Nystatin-triamcinolone cream; KLOR-CON; Meclizine
Current Illness:
Preexisting Conditions: From follow-up information on 20 December 2012, it was unknown if the patient had any illness at the time of vaccination. The patient had an allergy to atorvastatin calcium where she experienced myalgia. Medical history included type II or unspecified type diabetes mellitus without mention of complication, not stated as uncontrolled and essential hypertension, benign.
Diagnostic Lab Data: Not reported
CDC Split Type: 201209450
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Oedema peripheral, Skin discolouration
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Initial report was received from a consumer, who was also the patient, on 09 October 2012. A 76-year-old female patient had received a dose one intramuscular injection in the right deltoid of FLUZONE (lot number unknown) on 27 August 2012 and the same day the patient''s left fingers got swollen and turned black and blue which then went all the way up her hand. The patient''s little finger was still swollen at the time of the report. The patient''s past medical history was unknown. The patient''s outcome was not recovered. Follow-up information was received from a healthcare professional on 20 December 2012. Due to the new information received, this case has been upgraded to serious. The finger does not feel to be infected. Treatment included MEDROL 4 mg dose pack) and continued antibiotic therapy with a follow-up in ten days. It was unknown if the patient had any illness at the time of vaccination. Medical history type II or unspecified type diabetes mellitus without mention of complication, not stated as uncontrolled and essential hypertension, benign. Concomitant medications included alprazolam, ibuprofen, atenolol, LASIX, MAXZIDE, metformin, NIASPAN, PREVACID, simvastatin, SYNTHROID, nystatin-triamcinolone cream, KLOR-CON and meclizine. Outcome remained not recovered. Documents held by sender: None.

VAERS ID:480494 (history)  Vaccinated:2012-08-27
Age:59.0  Onset:2012-10-01, Days after vaccination: 35
Gender:Female  Submitted:2013-01-07, Days after onset: 98
Location:Texas  Entered:2013-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Actibvella 1 po QD (low dose hormone - estrogen/Progesterone); B12 1000 mcg QD; Multivitamin 1 QD
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: Thyroid function tests- normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC5280878C IMRA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB231BA0IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG05080IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Alopecia, Thyroid function test normal
SMQs:
Write-up: On August 27th I went to a travel clinic prior to trip abroad. Had Twinrix vaccine, Typhoid Vaccine, and Tdap vaccine. My hair began falling out. I first noted this in the shower - as I pulled fingers through hair - large amounts would come out. I am 59 years old and have NEVER had hair come out like this. The hair came out diffusely - there were not particular bald spots perse. I stopped frequent hair washing and was afraid to even brush hair. I am a physician and after a few weeks of this - had my thyroid functions tested - normal. I did not have any life "changes" associated with hairloss - stress, hormone changes, dietary changes, illnesses etc. I began looking on web and found association with Hepatitis B vaccine. (could not find association with Typhoid or Tdap) I then had a second Twinrix shot November 5, 2012. It has only been in the past 2-3 weeks that I have noticed the hair loss has lessened. Given the time line and lack of any other events the only factor I can attribute the hair loss to is the vaccine. I am reluctant to get my third shot - due in 2 months.

VAERS ID:481176 (history)  Vaccinated:2012-08-27
Age:48.0  Onset:2012-09-04, Days after vaccination: 8
Gender:Male  Submitted:2013-01-11, Days after onset: 129
Location:Massachusetts  Entered:2013-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: WELLBUTRIN
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: EMG - Demyelinating sensorimotor polyneuropathy
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1873AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram abnormal, Immunoglobulin therapy, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)
Write-up: Early September tingling in hands & feet. Symptoms moved up body. Muscle weakness end of September that became progressive * DX CIDP treatment IVIG.

VAERS ID:485064 (history)  Vaccinated:2012-08-27
Age:10.0  Onset:2012-09-04, Days after vaccination: 8
Gender:Female  Submitted:2012-09-04, Days after onset: 0
Location:Tennessee  Entered:2013-02-20, Days after submission: 169
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: 2012SE69794
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH2140 IN 
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Headache, Nausea, Oropharyngeal pain, Pain, Pneumonia streptococcal, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Aug-2012. The patient experienced weakness which started on 12-Sep-2012 and body aches, strep pneumoniae, nausea, sore throat, fever and headache which started on 04-Sep-2012. The patient recovered from the event of body aches, strep pneumoniae, nausea, sore throat, fever, headache and weakness on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune from medical representative on 16-Nov-2012: new event, new reporter, lot number and expiration date. Summary of follow-up information received by AstraZeneca/MedImmune 26-Nov-2012 from HCP was provided new event: Weakness the outcome of events changed to recovered. Corrected report 06-Dec-2012 reporter tab corrected.

VAERS ID:487000 (history)  Vaccinated:2012-08-27
Age:45.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Male  Submitted:2013-03-15, Days after onset: 200
Location:Wisconsin  Entered:2013-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Azithromycin, ceftriaxone, acetaminophen with codeine
Current Illness: Hospitalized with fever and possible pneumonia
Preexisting Conditions: No known drug allergies, had allergy listed to tomatoes
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1743AA IMLA
Administered by: Military     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient received pneumonia vaccine per hospital protocol. She had previously had fevers and after the vaccine was given she had fever spike and had swelling at injection site and hives on neck and arm. She was treated with acetaminophen and then ibuprofen. Symptoms subsided and at discharge her only instruction was to apply ice to the site if soreness continued.

VAERS ID:487022 (history)  Vaccinated:2012-08-27
Age:1.9  Onset:2012-09-02, Days after vaccination: 6
Gender:Male  Submitted:2013-03-17, Days after onset: 196
Location:Colorado  Entered:2013-03-17
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: At birth, patient had an ASD and multiple VSD''s. At 3 months old, he had open heart surgery/cath procedure to repair the largest VSD. Since then, the other holes have been closing on their own.
Diagnostic Lab Data: No doctor can explain any of patient''s symptoms or problems.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLG
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLG
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLG
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLG
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLG
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal pain upper, Cough, Food allergy, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Patient developed increasingly worse skin rashes over his entire body. He also is running fevers on and off. He has a raspy wet cough that won''t go away. He has mysterious stomach aches unrelated to eating. He has become allergic to more foods with more severe reactions.

VAERS ID:488874 (history)  Vaccinated:2012-08-27
Age:4.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2013-04-10, Days after onset: 226
Location:New York  Entered:2013-04-10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Epilepsy - seizures
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.C234AA UNUN
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Day 0 after injection my daughter''s body was having slight seizures. Got worse until hospitalized. Up to 20 seizures a day for 10 days. Checked into hospital. Diagnosis epilepsy.

VAERS ID:492930 (history)  Vaccinated:2012-08-27
Age:14.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-28
Location:Florida  Entered:2013-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1305USA011690
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 27-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (route, anatomical location and dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:498106 (history)  Vaccinated:2012-08-27
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-30
Location:Unknown  Entered:2013-07-30
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: Multiple sclerosis
Preexisting Conditions:
Diagnostic Lab Data: Serology test, Negative, No antibodies
CDC Split Type: WAES1307USA001651
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Antibody test negative, Serology test
SMQs:
Write-up: This spontaneous report as received from a nurse refers to a female patient between 18 and 19 years old with multiple sclerosis. On 02-JUL-2013, the patient received the first vaccination with the VARIVAX (Merck) and on 27-AUG-2012 the second vaccination. On an unknown date, the result of serologic testing for immune response after administration of VARIVAX (Merck) showed that the patient had no antibodies. Additional information has been requested.

VAERS ID:501786 (history)  Vaccinated:2012-08-27
Age:24.0  Onset:2012-08-30, Days after vaccination: 3
Gender:Male  Submitted:2013-09-05, Days after onset: 371
Location:California  Entered:2013-09-09, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject has a history of penicillin allergy, night sweats and fever.
Diagnostic Lab Data:
CDC Split Type: 201309218
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR   UN
Administered by: Military     Purchased by: Military
Symptoms: Chest pain, Electrocardiogram normal, Lymphadenopathy, Night sweats, Pyrexia, Troponin I increased
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This study case was received from the investigator in a trial on 28 August 2013. A 24 year-old male subject with a past medical history of penicillin allergy had received on 27 August 2012 a ACAM2000 (lot number, route and site of administration not reported) and an Anthrax vaccine (lot number, route and site of administration not reported) and on 30 August 2012 was found to have possible myopericarditis. The investigator notes stated the subject had an onset during physical exertion of fever, chest pain and night sweats three days post vaccination which resolved on second day. The subject saw a medic and was diagnosed with "swollen glands". On 12 September 2012, the subject had a Troponin I of <0.10 ng/mL and a normal ECG. The subject''s clinical evaluation was negative on 12 September 2012 and was returned to full duty. Treatments included aspirin. No further information was available at the time of the report. The subject''s outcome was recovered 31 August 2012. According to the investigator the event of possible myopericarditis was possibly related and the severity of the event was mild. Documents held by sender: medical records.

VAERS ID:505633 (history)  Vaccinated:2012-08-27
Age:69.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2013-09-18, Days after onset: 387
Location:Rhode Island  Entered:2013-10-02, 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: Unknown
Preexisting Conditions: It was unknown if the subject had concomitant medications. The subject had no relevant medical history.
Diagnostic Lab Data: UNK
CDC Split Type: A0992047A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AA UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B051AA UNRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Dysphonia
SMQs:, Anticholinergic syndrome (broad), Parkinson-like events (broad), Vestibular disorders (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of dizziness in a 69-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) FLUZONE. On 27 August 2012 at 12:35 the subject received a dose of BOOSTRIX (.5 ml, unknown, right arm) and on 27 August 2012 the subject received a dose of FLUZONE (details unknown). On 27 August 2012, within hours of vaccination with BOOSTRIX and FLUZONE, the subject experienced dizziness and on 29 August 2012, 2 days after vaccination with BOOSTRIX and FLUZONE, the subject experienced hoarseness. According to the pharmacist, the subject experienced the dizziness when she turned over while lying in bed the evening of the vaccinations, 27 August 2012. On 29 August 2012, the subject was told that she sounded hoarse while talking on the phone. At the time of reporting the dizziness was resolved and the hoarseness was unresolved. The lot number was reported as AC2B081AA by the reporter, but was corrected to AC52B081AA based on the BOOSTRIX rules for the vaccine batch numbering system.

VAERS ID:506120 (history)  Vaccinated:2012-08-27
Age:0.3  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2013-09-30, Days after onset: 399
Location:New York  Entered:2013-10-04, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had no concomitant medications, no concomitant vaccines on the same date, no relevant medical history and no adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0992416A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALS 1UNLL
Administered by: Other     Purchased by: Other
Symptoms: Drug administered at inappropriate site, Drug administered to patient of inappropriate age, Injection site swelling, Wrong drug administered
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a physician and described the occurrence of swelling injection site in a 4-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On the morning of 27 August 2012, the subject received a dose of KINRIX (.5 ml, unknown route, left thigh) as the 2nd dose in series and experienced wrong vaccine administered and vaccine administered at inappropriate site. The subject was younger than the indicated age for KINRIX. KINRIX is indicated to be used as the fifth dose in the DTaP series and the fourth dose in the IPV series. The preferred site for injection is the deltoid. On 29 August 2012, 2 days after vaccination with KINRIX, the subject experienced swelling injection site. The swelling was less than a centimeter 3 days post vaccination. The subject was "mistakenly given KINRIX on 27 August 2012 for the second dose in the primary series. The subject went to an alternate physician (reporter) 3 days later with swelling less than or approximately a centimeter at injection site. The subject had no fever or other discomfort. The physician refused to provide contact information for follow-up. At the time of reporting the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with KINRIX.

VAERS ID:522428 (history)  Vaccinated:2012-08-27
Age:54.0  Onset:2012-09-01, Days after vaccination: 5
Gender:Female  Submitted:2014-02-11, Days after onset: 528
Location:Unknown  Entered:2014-02-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 2012, Medical observation normal, "Clean bill of health"
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA003832
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0423AE0SCRA
Administered by: Other     Purchased by: Other
Symptoms: Cardiac failure congestive, Cardiac pacemaker insertion, Fatigue, Fluid retention, Gait disturbance, Injection site erythema, Local reaction, Malaise, Pyrexia, Viral infection, Weight increased
SMQs:, Cardiac failure (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Information was received from a 54 year-old female patient who in September 2012, following a routine physical which resulted in a "clean bill of health," was vaccinated with a single dose of ZOSTAVAX (dosage and route of administration not provided). In September 2012, shortly after administration, the patient developed an enlarged red spot at the injection site. She followed with her healthcare provider twice and was advised that she had a local reaction to the vaccine and was advised to use BENADRYL. She developed a fever "shortly after." The following week, the patient "became very ill." She experienced severe fatigue, difficulty in walking and was hospitalized for one week. The patient had "gained 20 lbs. of water weight and her ''ES'' was ''down to 15''." The patient reported that two weeks after receiving ZOSTAVAX, she received a diagnosis of congestive heart failure as a result of viral infection, "possibly brought on by the vaccine." At an unspecified time after, the patient had a pacemaker installed. Upon internal review, pacemaker installed was determined to be medically significant. Additional information has been requested.

VAERS ID:552577 (history)  Vaccinated:2012-08-27
Age:81.0  Onset:0000-00-00
Gender:Female  Submitted:2014-10-17
Location:Unknown  Entered:2014-10-17
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: CIPRO, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1410USA007327
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0467AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a currently 83 female patient. Patient with drug reactions/allergies: CIPRO (unspecified reaction). On 27-AUG-2012 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose 0.65 ml, lot number 0467AE, expiration date 04-APR-2013) subcutaneous. There was no concomitant medication reported. On an unknown date the patient experienced what might possibly be a case of shingles. The pharmacist did not observe the patient''s skin of discuss the symptoms with patient in any details. The patient sought for medical attention and was prescribed famciclovir on 30-SEP-2014. The pharmacist reported that the patient returned to the pharmacy on 14-OCT-2014 (today) to report that her condition did not improve after her course of famciclovir. It was reported that the patient had not consulted with her prescriber physician about the fact that the famciclovir did not help her "rash" resolved at the time of this report. The outcome of the event was not recovered. This is one of two reports from the same source. Additional information has been requested.

VAERS ID:554816 (history)  Vaccinated:2012-08-27
Age:26.0  Onset:2012-11-11, Days after vaccination: 76
Gender:Female  Submitted:2014-11-20, Days after onset: 739
Location:Unknown  Entered:2014-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA004311
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Emotional distress, Exposure during pregnancy
SMQs:, Depression (excl suicide and self injury) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a 26 year old female Licensed practical nurse (L.P.N.), concerning herself. The patient had no pertinent medical history and no known drug allergies or reactions. In August 2012 "approximately two weeks ago", the patient was vaccinated with a dose of 0.5 ml VARIVAX (Merck) injection, 0.5 ml single dose (route was not reported) (lot # was not reported). Subsequently in August 2012, "at approximately the same time", between two menstrual cycles, the patient became pregnant with a last menstrual period (LMP) of approximately 27-AUG-2012 and an estimated delivery date (EDD) on 03-JUN-13. The patient did not seek medical attention. At the time of the report, the patient''s outcome was unknown. Follow up has been received from licensed practical nurse regarding herself on 05-NOV-2014. This spontaneous report was prospective pregnancy report. On 27-AUG-2013 (reported as 2 weeks ago), the patient was vaccinated with VARIVAX (Merck). The patient became pregnant with LMP of 26-AUG-2012 and EDD of 02-JUN-2013. Initial exposure to VARIVAX (Merck) was at 2 weeks(s). On approximately 11-NOV-12, at 11 weeks gestation, the patient miscarried (medically significant). The pregnancy outcome was spontaneous abortion. Patient became very emotional and did not wanted to discuss any details concerning this report. The outcome of received a dose of VARIVAX and must have conceived a child at approximately the same time was recovered. The outcome of Miscarried at 11 weeks was unknown. Outcome of became emotional was unknown. The causality of Miscarried at 11 weeks with VARIVAX (Merck) and became emotional was unknown. Upon internal review, event spontaneous abortion was considered medically significant. Additional information is not expected.

VAERS ID:464667 (history)  Vaccinated:2012-08-27
Age:14.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-09-11, Days after onset: 15
Location:Foreign  Entered:2012-09-11
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: Blood pressure, 27Aug2012, 90/70mmHg; Blood pressure, 27Aug2012, 102/60mmHg; Heart rate, 27Aug2012, 60bpm
CDC Split Type: B0828808A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162CA1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pallor, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a regulatory authority (HPV-970) and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Before vaccination, her body temperature was 35.6 deg C. On 27 August 2012 the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, unknown deltoid). On 27 August 2012, 5 minutes after vaccination with CERVARIX, the subject experienced syncope, vagal reaction and facial pallor. The regulatory authority reported that the events were clinically significant (or requiring intervention). Blood pressure was 90/70 mmHg without disturbed pulse 60 bpm. Subsequently, blood pressure was 102/60 mmHg. On 27 August 2012, the events were resolved. The regulatory authority reported that the events were related to vaccination with CERVARIX.

VAERS ID:465300 (history)  Vaccinated:2012-08-27
Age:14.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 21
Location:Foreign  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 27Aug2012, 94/60
CDC Split Type: B0830666A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cold sweat, Pallor, Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of vagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 August 2012, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, unknown injection site). On 27 August 2012, approximately 5 minutes after vaccination with CERVARIX, the subject experienced cold sweat and pale lips. The symptoms were not considered to be those of anaphylaxis but were considered to have occurred because of vagal reaction. The physician considered the events were clinically significant (or requiring intervention). On 27 Aug 2012, blood pressure was 94/60. On 27 August 2012, the events were resolved. The 2nd vaccination was already scheduled. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:466052 (history)  Vaccinated:2012-08-27
Age:0.3  Onset:2012-08-30, Days after vaccination: 3
Gender:Female  Submitted:2012-09-21, Days after onset: 22
Location:Foreign  Entered:2012-09-24, 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: Not reported
Diagnostic Lab Data: Infection count, thrombocytes and INR taken on an unspecified date showed normal values.
CDC Split Type: E201205964
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER0131A IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR699150IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Henoch-Schonlein purpura, International normalised ratio normal, Laboratory test normal, Petechiae, Platelet count normal
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: Case received from the Health Authorities in a foreign country via other company on 11-Sep-2012 under the reference numbers DK-DKMA-ADR 21831498, DK-DKMA-EFO3203 and DKSSI0105325. Case medically confirmed. A 3-month-old female patient (weight 5.5 kg, height 58 cm) had received an injection of ACTHIB (dose 1, i.m. batch number 69915 (incomplete) in combination with DI-TE-KI-POL (dose 1 batch number 0131A, i.m) on 27-Aug-2012 and later on 30-Aug-2012 she developed allergic purpura, petechiae around both knees and symmetrical redness around medial malleoli and soles. The patient also received a PREVENAR 13, on 27-Aug-2012, considered as concomitant medication. The patient did not receive any other medication. Laboratory test was taken on an unspecified date for infection count, thrombocytes and INR showed normal values. Stated in the HA report: only DITEKIPOL/ACTHIB was suspect. At the time of reporting, the outcome was not yet recovered. No causality assessment was provided. No further information expected.

VAERS ID:466752 (history)  Vaccinated:2012-08-27
Age:0.0  Onset:2012-08-28, Days after vaccination: 1
Gender:Female  Submitted:2012-09-27, Days after onset: 30
Location:Foreign  Entered:2012-09-27
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: B0832355A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, Clonic convulsion, Oxygen saturation decreased, Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician via a regulatory authority (176141) and described the occurrence of absence seizures in a 3-day old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and hepatitis B immunoglobulin. The subject was born from a HBsAG positive mother. On 25 August 2012, the subject received unspecified dose of Hepatitis B immune globulin (300 iu, intramuscular, unknown injection site, batch number not provided). On 27 August 2012, the subject received unspecified dose of ENGERIX B (intramuscular, unknown injection site, batch number not provided). On 28 August 2012, 1 day after vaccination with ENGERIX B, 3 days after vaccination with Hepatitis B immune globulin, the subject experienced absence seizures, generalized clonic seizures, bradycardia and desaturation. The subject was hospitalised. The subject was treated with phenobarbitone. At the time of reporting the events were improved. The regulatory authority reported that the events were possibly related to vaccination with ENGERIX B and Hepatitis B immune globulin.

VAERS ID:467006 (history)  Vaccinated:2012-08-27
Age:73.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-28
Location:Foreign  Entered:2012-10-01, 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: EUTHYROX; EXODUS; LIPIBLOCK; PANTOGAR; REDUCOFEN; Rosuvastatin calcium; VANNAR
Current Illness:
Preexisting Conditions: High cholesterol; Hypothyroidism; Reflux esophagitis, Patient underwent a esophageal operation due to reflux; Endometrial polyp (Uterine polyp), Patient underwent an hysterectomy due to endometrial polyp; Blood triglycerides increased; Anxiety; Hair loss; Respiratory depth increased, Problem in the respiratory airway (lung) due to reflux; Asthma
Diagnostic Lab Data: 28-AUG-2012, Body temperature, 38 Centigrade
CDC Split Type: 2012213887
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH918033D IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug administration error, Erythema, Influenza like illness, Injection site erythema, Injection site oedema, Injection site pain, Lung infection, Pain, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: This 73-year-old female of an unspecified weight and height, started to receive pneumococcal 13 (lot number [918033D]) 1 dose intramuscular on 27Aug2012 at 0.5 ml, single (one dose). The physician reported that the patient used the vaccine incorrectly and did not known exactly what happened, because the vaccine was not applied at he clinic. The patient had a medical history of high cholesterol, hypothyroidism, gastroesophageal reflux (patient underwent a esophageal operation due to reflux) and high triglycerides, all these conditions were ongoing. The medical history also included uterine polyp (patient underwent an hysterectomy due to endometrial polyp), anxiety, hair loss, respiratory problems due to reflux and severe asthma. Concomitant medications included EUTHYROX for hypothyroidism, EXODUS for anxiety, LIPIBLOCK for weight loss, aminobenzoic acid, calcium pantothenate, cysteine, keratin, saccharomyces medicinalis, PANTOGAR for hair loss, REDUCOFEN and rosuvastatin calcium for cholesterol and triglycerides control, and budesonide, VANNAIR for respirator problems due to reflux, all the concomitant medicines started on unknown dates, were ongoing as of 29Aug2012. Concomitant medications also included budesonide (strength 400 ug) plus formoterol at 12 ug 12/12 hours. The reporter informed that soon after the vaccination (left arm) the site got painful and the patient almost did not sleep due to pain in arm. Later (on an unspecified day of Aug2012) the patient had pain in the body, similar to flu-like illness, but she did not have coryza. On 28Aug2012 at night the patient had fever of 38 degreesCelsius. On 29Aug2012 the patient did not have a significant improvement and redness in the left arm appeared, near to the site of administration; the redness had an extension of 4cm of width. On an unknown date the patient had repeated pulmonary infection. The physician reported that there was erythema, edema and pain at the site of vaccine administration. The physician said that the erythema improved in 7 days. The reporter believed that the redness was due to malpractice of the professional that administered the vaccine. He informed that the professional was undecided at the moment of application, she applied the product in an incorrect manner, without angulation and deeply, the professional staggered at the moment of application. The patient had a medical appointment scheduled for 30Aug2012. The outcome of the events "fever of 38 Celsius degrees", site (left arm) got painful / patient almost did not sleep at night due to the pain", and "pain in body, similar to flu-like illness" was not recovered. The outcome of the remaining events was unknown. Follow-up attempts completed. No further information expected.

VAERS ID:472113 (history)  Vaccinated:2012-08-27
Age:19.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Unknown  Submitted:2012-10-02, Days after onset: 36
Location:Foreign  Entered:2012-10-02
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:
CDC Split Type: WAES1209USA001496
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 3IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: Information has been received from medical assistant concerning a 19 years old patient, who was administered 3 doses of LIQUID PEDVAXHIB in childhood, and was inadvertantly administered a dose of LIQUID PEDVAXHIB on 27-AUG-2012. No adverse effects reported. Additional information has been requested.

VAERS ID:467616 (history)  Vaccinated:2012-08-27
Age:13.0  Onset:2012-09-04, Days after vaccination: 8
Gender:Female  Submitted:2012-10-04, Days after onset: 30
Location:Foreign  Entered:2012-10-04
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: B0834199A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162DA1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Suicide attempt
SMQs:, Suicide/self-injury (narrow)
Write-up: This case was reported by a physician and described the occurrence of attempted suicide in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on 25 July 2012. On 27 August 2012, the subject received 2nd dose of CERVARIX (0.5 ml, intramuscular, unknown injection site). On 4 September 2012, 8 days after vaccination with CERVARIX, the subject attempted to suicide. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting, the event was resolved. The physician considered the event was related to vaccination with CERVARIX.

VAERS ID:468231 (history)  Vaccinated:2012-08-27
Age:1.6  Onset:2012-08-30, Days after vaccination: 3
Gender:Male  Submitted:2012-10-08, Days after onset: 39
Location:Foreign  Entered:2012-10-08
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: Platelet count, 12Sep2012, 100.10E9/L; Platelet count, 21Sep2012, 21.10E9/L
CDC Split Type: B0834110A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSYHAVB440BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased, Purpura, Skin haemorrhage
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of idiopathic thrombocytopenic purpura in a 20-month-old male subject who was vaccinated with HAVRIX JUNIOR (GlaxoSmithKline). On 27 August 2012, the subject received an unspecified dose of HAVRIX JUNIOR (0.5 ml, intramuscular, unknown injection site). On 30 August 2012, 3 days after vaccination with HAVRIX JUNIOR, the subject experienced hemorrhagic spots on the two knee joints. In September 2012, half month after vaccination with HAVRIX JUNIOR, the subject experienced purpura on the two knee joints. The final diagnosis was idiopathic thrombocytopenic purpura. The subject was hospitalised. The platelets count was 100X10E9/L on 12 September 2012 and 21X10E9/L on 21 September 2012. At the time of reporting, the events were unresolved.

VAERS ID:474378 (history)  Vaccinated:2012-08-27
Age:5.0  Onset:2012-09-17, Days after vaccination: 21
Gender:Male  Submitted:2012-11-15, Days after onset: 59
Location:Foreign  Entered:2012-11-16, 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: In history the patient was vaccinated with: INFANRIX HEXA (GSK, lot-no. not reported) on 15-Aug-2007, INFANRIX HEXA (GSK, lot-no. not reported) on 20-Sep-2007, INFANRIX HEXA (GSK, lot-no. A21CA296A) on 22-Nov-2007 and INFANRIX HEXA (GSK, lot-no. A21CA420A) on 25-Sep-2008. Toleration was not reported.
Diagnostic Lab Data:
CDC Split Type: E201208517
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC3963AB UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bordetella test positive, Pertussis, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Case of vaccination failure was received from the Health Authorities on 07-Nov-2012 (reference number PEI2012055773). Case is medically confirmed. A 5-year-old male patient received a booster dose of COVAXIS (lot-no. C3963AB) on 27-Aug-2012. Three weeks later, on 17-Sep-2012, he developed pertussis (severe clinical manifestation, no symptoms reported). The infection was biologically confirmed on 24-Sep-2012 with positive B. pertussis DNA (PCR). Duration and outcome were not reported. This case was considered as a vaccination failure by the initial reporter. In history the patient was vaccinated with: on 15-Aug-2007, INFANRIX HEXA (GSK, lot-no. not reported) on 20-Sep-2007, INFANRIX HEXA (GSK, lot-no. A21CA296A) on 22-Nov-2007 and INFANRIX HEXA (GSK, lot-no. A21CA420A) on 25-Sep-2008. Toleration was not reported. CASE IS CLOSED.

VAERS ID:475748 (history)  Vaccinated:2012-08-27
Age:1.6  Onset:2012-09-06, Days after vaccination: 10
Gender:Male  Submitted:2012-11-30, Days after onset: 85
Location:Foreign  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Caesarean section; Premature baby; Posture abnormal
Diagnostic Lab Data: 24-OCT-12 EMG: the patient does not cooperate. No transmission alterations of the neuromuscular plaque. Electroneurographic evidence within normal limits. 26-OCT-12: first EEG performed, sleep recording discretely organized with a few unusual elements but no evident paroxysmal anomalies. Several myoclonus without electrical correlation during sleep. 26-OCT-12: brain MRI within normal limits. 01-NOV-12 CSF exam: clear, protein 30, glucose 56, cells 0. Negative for enterovirus and West Nile Virus. 03-NOV-12 MRI rachis, brain and encephalic trunk, with and without contrast: within normal limits. 16-NOV-12 MRI rachis, brain and encephalic trunk, with and without contrast: onset of extensive bilateral symmetric signal alterations in the limbic s
CDC Split Type: WAES1211ITA006441
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER1053AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, CSF cell count normal, CSF glucose increased, CSF protein normal, Cycloplegia, Dyspnoea, Electroencephalogram normal, Electromyogram normal, Electroneuromyography, Encephalopathy, Endotracheal intubation, Enterovirus test negative, Eyelid ptosis, Fatigue, Immunoglobulin therapy, Intensive care, Laboratory test normal, Muscular weakness, Myoclonus, Nuclear magnetic resonance imaging brain abnormal, Posture abnormal, Psychomotor retardation, Pyrexia, Speech disorder developmental, West Nile virus test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Chronic kidney disease (broad)
Write-up: Case received from Health Authority (case n. 181366) through agency (local case n. IT581/12). Initial case received on 13-NOV-12. Case medically confirmed. A 19-month-old male patient was vaccinated on 27-AUG-2012 with one dose of M-M-RVAXPRO (batch n. H001859) i.m.. On 06-SEP-12 he presented with high fever that persisted for 3 days. On 20-SEP-12 he was evaluated by his pediatrician that referred him for neuropsychiatric consultation on 24-SEP-12. He was hospitalized. At the time of reporting he had not yet recovered. The case is closed. Follow-up (clinical report) received from HA on 22-NOV-12: The patient was born premature at 35 weeks through C-section. At age 4 months and 6 months and 25 days the patients pediatrician advised psychiatric consultation due to deviation of the head to the left; the mother did not follow the advise. The patient has a family history positive for strabismus. He acquired the seated position at 9 months and started crawling at 11 months, at 18 months he was not able to walk. Following the febrile reaction on 06-SEP-12 he was admitted to the hospital from 20-SEP-12 to 24-SEP-12 due to deviation of the head to the left. During admission no acute neurological symptoms were detected but a condition becoming more and more evident in reference to the expected child development was identified. The patient was discharged with the diagnosis of psychomotor retardation and language retardation. No remedial therapy was administered, the child was referred for psychomotor rehabilitation. An ophthalmology consultation performed on 11-OCT-12 revealed cycloplegia; another ophthalmology consultation performed on 23-OCT-12 revealed worsening of the symptoms (tiredness following muscular strain, asthenia, difficulty in bulbar elevation, variable ptosis). The patient is admitted again to the hospital on 23-OCT-12: myasthenia is suspected. Investigations performed: see lab comments screen. The patient was treated with MESTINON until 30-OCT-12 without benefit. On 01-NOV-12 the patient was started on treatment with aspecific immunoglobulins for 4 days. On 05-NOV-12 due to the worsening of his condition and difficulty breathing he was transferred to pediatric intensive care and intubated. As of 22-NOV-12 he was still hospitalized and being treated with methylprednisolone and i.v. immunoglobulins 10 G X 2. Results from an MRI rachis, brain and encephalic trunk, with and without contrast performed on 16-NOV-12 did not provide clear indications as they could be compatible with both encephalitis or mytochondrial encephalitis (specifically polymerase-gammopathy). Considering the overall clinical evidence, the most likely diagnostic conclusion is for an immuno-mediated encephalopathy as supported by an infectious disease specialist who suggested that the m-m-r vaccination may have a role in triggering such a disease. A CSF test was scheduled for 23-NOV-12 to search for anti-dna autoantibodies, anti-neurotransmitter autoantibodies, lactate and piruvate. No further information is available at this time. The case is closed.

VAERS ID:476285 (history)  Vaccinated:2012-08-27
Age:0.9  Onset:2012-08-29, Days after vaccination: 2
Gender:Female  Submitted:2012-12-03, Days after onset: 96
Location:Foreign  Entered:2012-12-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood test (no date provided): normal, no result provided; C-reactive protein (CRP) (no date provided): normal, no result provided; Blood electrolytes (no date provided): normal, no result provided; Blood glucose (no date provided): normal, no result provided; Blood transaminase (no date provided): normal, no result provided; Blood bilirubin (no date provided): normal, no results provided; Blood creatinine (no date provided): normal, no results provided; Blood nitrogen, (no date provided): normal, no results provided; Blood total protein (no date provided): normal, no results provided; Blood pH, (no date provided): 7.15; BE (no date provided): -12.5 mEq/L; Urinalysis (no date provided): ++ leukocytes; Urinalysis (no date provided): (control
CDC Split Type: 2012266195
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB171A IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF83420 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial test negative, Base excess negative, Blood bilirubin normal, Blood creatinine normal, Blood electrolytes normal, Blood glucose normal, Blood pH decreased, Blood test normal, Blood urea normal, C-reactive protein normal, Culture stool negative, Diarrhoea, Gastroenteritis, Protein total normal, Rotavirus test negative, Transaminases, Urine analysis normal, Vaccination complication, Vomiting, White blood cells urine positive
SMQs:, Acute pancreatitis (broad), Lactic acidosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow)
Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 179383. A pharmacist (contactable through Regulatory Authority only) reported that a 10-month-old female patient received a dose of PREVENAR 13 (Lot F83420, Exp. Date 31Jul2014) intramuscular on 27Aug2012, 0.5 ml, single dose and a dose of INFANRIX HEXA (Lot A21CB171A, Exp. Date 31Jan2014) intramuscular on 27Aug2012 at 1 DF, both as vaccination. Relevant medical history and concomitant medications were unknown. The patient experienced diarrhoea and vomiting on 29Aug2012. The patient was initially seen in the Emergency Room, then was hospitalized on 29Aug2012 and discharged on 31Aug2012 in good general conditions. At the entrance, the patient showed vomiting, diarrhea and fever with weight loss and metabolic acidosis, and during the hospitalization she was rehydrated intravenously and then orally, with a progressive clinical improvement. Relevant tests were normal: blood test, C-reactive protein (CRP), blood electrolytes, blood glucose, blood transaminases, blood bilirubin, blood creatinine, blood nitrogen, and blood total protein. Were instead altered the following tests: blood gas analysis: pH 7.15, BE -12.5 mEq / L, urinalysis: ++ leukocytes, while at the control test they were negative. The diagnosis made at discharge was gastroenteritis. However, with a revaluation of the case together with the pediatrician, the reporter noted that there remained a suspicion of an adverse reaction to the two vaccines reported, as culture test on the stools were negative for rotavirus, salmonella, shigella and campylobacter, moreover the results for urine tests, while showing the presence of leukocytes, did not suggest any differential diagnosis for the symptoms reported. Follow-up (27Nov2012): New information reported from Health Authority includes: patient''s clinical course; laboratory data and reporter''s comment.

VAERS ID:489394 (history)  Vaccinated:2012-08-27
Age:0.1  Onset:2012-08-27, Days after vaccination: 0
Gender:Unknown  Submitted:2013-04-16, Days after onset: 232
Location:Foreign  Entered:2013-04-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported. No post-vaccinal reaction in the past.
Diagnostic Lab Data: Not reported
CDC Split Type: 201304938
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA110091IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG99670IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Lividity
SMQs:
Write-up: Case received from the Health Authorities through the local affiliate on 09 April 2013 under the reference number N1023/2012. A 28-day-old patient (gender not reported), with no post-vaccinal reaction in the past, had received the 1st intramuscular dose of ACTHIB (batch number G9967-1) in the left site (exact date of administration not reported), concomitantly with the 2nd intramuscular dose of EUVAX B (other manufacturer, batch number UVA11009) in the right site (exact site of administration not reported) on 29 August 2012 at 02:30pm. On 29 August 2012 at 02:30pm, during vaccination, the patient''s lower limbs turned livid up to the fingers. Lividity resolved quickly. The patient was referred to a consultation outpatient clinic and was hospitalized for 1 day. The patient completely recovered on an unspecified date. She was currently in good health status. The Health Authorities considered the reaction as "a mild-post-vaccinal reaction". The report stated that the vaccines were stored properly in a refrigerator at 6-8 degrees C and that an aseptic technique was maintained during the vaccination. There was also a correct technique of vaccination. It was also mentioned that, in the opinion of an employee, the adverse post-vaccination reaction did not occur as a result of non-considering contraindications for the vaccination. In the given area, 18 people have been vaccinated with the same vaccine lot of ACT-HIB, and 14 people with the same vaccine lot of EUVAX B. Upon internal review, this case was considered as a misuse case since the vaccine was administered at inappropriate age. Documents held by sender: none.

VAERS ID:495527 (history)  Vaccinated:2012-08-27
Age:0.4  Onset:2012-11-14, Days after vaccination: 79
Gender:Female  Submitted:2013-06-28, Days after onset: 225
Location:Foreign  Entered:2013-06-28
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: Exanthema subitum
Diagnostic Lab Data: Plain Abdominal Radiograph/Air or Liquid Contrast Enema: Plain abdominal radiograph showing a visible intussusceptum or soft tissue mass: No. Plain abdominal radiograph showing fluid levels and dilated bowel loops: No. Demonstration of invagination of the intestine by air or liquid contrast enema: Yes. Plain abdominal radiograph showing non-specific abnormalities: No. Abdominal Ultrasound: Abdominal Ultrasound showing a visible intussusceptum or soft tissue mass: Yes. Demonstration of an intra-abdominal mass with specific characteristic features (target sign or doughnut sign on transverse section and a pseudo-kidney or sandwich sign on longitudinal section) that is proven to be reduced by hydrostatic enema on post-reduction ultrasound: Not
CDC Split Type: B0883315A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA428CA1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Adenovirus infection, Crying, Enema administration, Intussusception, Ultrasound abdomen abnormal, X-ray abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Depression (excl suicide and self injury) (broad)
Write-up: This female subject was enrolled in a study. On 21 July 2012 and 27 August 2012, she received the 1st and 2nd dose of ROTARIX PO. The subject''s medical history included exanthema subitum. On 14 November 2012, 79 days after the 2nd dose of ROTARIX, this seven-month-old subject developed intussusception. The event resolved on 16 November 2012. The investigator considered that there was no reasonable possibility that the intussusception may have been caused by ROTARIX. Comments: Follow-up information was received on 19 June 2013: Clinical course: 14 November 2012: The subject experienced intussusception. Intermittent crying occurred. Adenovirus infection was noted. Does the subject have a history of any of the following: Is there a family history of intussusception or bowel abnormalities: No. Previous intra-abdominal surgery: No. Congenital intestinal malformation: No. Intestinal polyps: no. Meckels diverticulum: No. Intestinal vascular malformations: No. Cystic fibrosis: No. Hirschsprung disease: No. Other gastrointestinal malformation and dysfunction: No. Intussusception: No. Treatment received/ Outcome: None - spontaneously resolved: No. Resolved by liquid contrast/hydrostatic water/air enema: Yes. Required surgical reduction but no resection: No. Required surgical resection: No. Complications radiological procedure: No. Did the child survive?: Yes. No further information available.

VAERS ID:501071 (history)  Vaccinated:2012-08-27
Age:53.0  Onset:2013-08-27, Days after vaccination: 365
Gender:Male  Submitted:2013-09-01, Days after onset: 5
Location:Foreign  Entered:2013-09-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nasonex; Reactine; Received the Shingles vaccine.
Current Illness: None
Preexisting Conditions: Dust mite and tree allergies; Allergic to minocycline
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  IDLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Noticed large "egg" at injection site and redness. Some discomfort. Continued for days.

VAERS ID:501102 (history)  Vaccinated:2012-08-27
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-09-02
Location:Foreign  Entered:2013-09-02
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: Unspecified examination in a brain surgery department and a prefectural hospital (date unknown): no abnormality was found
CDC Split Type: WAES1308JPN014926
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Gait disturbance, Hypoaesthesia, Laboratory test normal, Muscular weakness, Nasopharyngitis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Initial information has been received from a physician concerning a female patient in her 10''s. On 27-AUG-2012, she received the third GARDASIL intramuscular (IM) injection drug (injection site and lot number not provided). No concomitant medication was reported. On 29-SEP-2011, the patient received the first GARDASIL IM injection drug (at A hospital). On an unspecified date, the patient received the second GARDASIL IM injection drug (at A hospital). On 27-AUG-2012 as mentioned above, the patient received the third GARDASIL IM injection drug (at A hospital). On an unspecified date, 5 days after the third vaccination, the patient had cold symptoms and then numbness, gait disturbance and weakness of limbs. On an unspecified date, the patient visited a department of brain surgery and a prefectural hospital, where no abnormality was found. The patient then left the symptoms untreated. In NOV-2012, the patient complained of only cold symptoms at A hospital. In APR-2013, the patient presented to B hospital because symptoms such as numbness, gait disturbance and weakness of limbs appeared again. At the time of this report, the outcome of the numbness gait disturbance, cold symptoms and weakness of limbs was unknown. Reporter''s comment: A hospital: I did not know details about the patient''s symptoms because she complained of only cold symptoms when visited our hospital in NOV-2012. Her symptoms (numbness, gait disturbance and weakness of limbs) were reported by the B hospital after her 3 vaccinations. I have never seen her symptoms, so I can do nothing about them. B hospital: The GARDASIL is suspected to be related to the symptoms. The reporting physician assessed that the numbness, gait disturbance and weakness of limbs were related to GARDASIL. The reporting physician did not assess the causal relationship of the cold symptoms with GARDASIL. The reporting physician assessed the numbness, gait disturbance and weakness of limbs as serious (disability). The reporting physician did not assess the seriousness of the cold symptoms. Further information has been requested.

VAERS ID:501481 (history)  Vaccinated:2012-08-27
Age:23.0  Onset:2012-09-03, Days after vaccination: 7
Gender:Female  Submitted:2013-09-04, Days after onset: 366
Location:Foreign  Entered:2013-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: MALONETTA
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Examinations and laboratory tests: MRI showed myelitis to TH6-TH8. Lumbar puncture showed no signs of sclerosis.
CDC Split Type: WAES1309DNK001381
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Lumbar puncture normal, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal
SMQs:, Demyelination (narrow)
Write-up: Case received from health care professional via the Health Authorities on 26-Aug-2013 under the reference number 22218521 and EFO6612. Case medically confirmed. A 23 year old female patient had received an injection of GARDASIL (dose 1, batch number not reported, intramuscular route, site not reported) on 27-Aug-2012. She had also concomitant medication MALONETTA (other MFR) and later on (03-Sep-2012) she developed myelitis transverse. The patient was hospitalized due to the adverse event (dates not reported). She went through vaccination program without any further problems. Examinations and laboratory tests: MRI showed myelitis to TH6-TH8. Lumbar puncture showed no signs of sclerosis. No relevant medical history reported. At the time of reporting, the outcome was recovering.

VAERS ID:514013 (history)  Vaccinated:2012-08-27
Age:22.0  Onset:2012-08-27, Days after vaccination: 0
Gender:Female  Submitted:2013-11-19, Days after onset: 449
Location:Foreign  Entered:2013-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Diarrhoea; Abdominal pain
Diagnostic Lab Data: Examination for intestinal diseases revealed no findings.
CDC Split Type: WAES1311DNK007473
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN12630 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Alopecia, Arthralgia, Asthenia, Blister, Chest discomfort, Contusion, Decreased appetite, Disturbance in attention, Dyspnoea, Facial pain, Fatigue, Infection, Laboratory test normal, Menstrual disorder, Migraine, Muscular weakness, Myalgia, Nausea, Oral mucosal blistering, Pain, Pyrexia, Rash, Sensory disturbance, Sleep disorder, Syncope, Visual impairment, Vomiting, Vulvovaginal mycotic infection, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Case received from a consumer or other non health care professional via the Health Authority on 11-Nov-2013 under the references DK-DKMA-ADR 22295565 and DK-DKMA-EFO7337. Case is not medically confirmed. A 22-year-old female patient (weight 50 kg, height 169 cm), had received the unspecified dose number in series of GARDASIL (batch number G007714, lot number NN12630, exp 23-SEP-2013) via intramuscular route in not reported site of administration on 27-Aug-2012 and later on the same day she developed severe migraine-like headache, fever, infections, vaginosis fungal, menstrual disturbances, severe abdominal pain and cramps, daily nausea, appetite loss, weight loss, skin problems with rashes, buds and wound, joint and muscle pain, sensory disturbances, reduced strength in body and limbs, pain in body and limbs, intermittent pain by touch of skin, sleeping problems, large bruises without punch, tiredness, without energy, daily fainting, concentration memory difficulty, cases od palpitations and chest tightness, intermittent vomiting, breathing difficulty, visual disturbance, frequent facial pain, blisters / blisters in the mouth, and hair loss. The patient was treated with antibiotics for half a year. The patient had no other medications. The patient underwent several clinical examinations in various hospitals since Aug-2012, along with the symptoms showing up. She was now completely investigated and was declared without known disease. Therefore HPV vaccine was suspected to cause the events. Patient''s medical history included periodic abdominal pain and diarrhoea. Examination for intestinal diseases revealed no findings. At the time of reporting, the patient had not recovered.

VAERS ID:538066 (history)  Vaccinated:2012-08-27
Age:16.0  Onset:2012-09-01, Days after vaccination: 5
Gender:Female  Submitted:2014-07-30, Days after onset: 697
Location:Foreign  Entered:2014-07-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1407JPN011564
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0564AA1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Bedridden, Headache, Hyperventilation, Lymphadenopathy, Memory impairment, Photophobia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad)
Write-up: Initial information has been received from a physician via the regulatory authority concerning a 16 year old female patient who on 27-AUG-2012 was vaccinated with GARDASIL injection drug, intramuscular, dose unknown, (batch/lot# 9QN05R/0564AA) (expiry date unknown) for the second time. Information including underlying/ concomitant diseases and medical history was not obtained. According to the medical questionnaire for vaccination, special notes including patient''s primary disease, allergy, vaccination and disease within recent one month, medications currently taken, history of past adverse reaction and growth state was unknown. There were no special notes for family history. The body weight at birth was 2780g. Other concomitant medications were not reported. On 11-JUN-2012, the patient received GARDASIL injection drug, intramuscular, dose unknown (batch/lot# 9QN03R/0277AA) (expiry date unknown) for the first time in other hospital. On an unspecified date, the patient had swollen lymph nodes and headache. On 27-AUG-2012, the patient received GARDASIL injection drug, intramuscular, dose unknown, (batch/lot# 9QN05R/0564AA) (expiry date unknown) for the second time in other hospital. On an unspecified date, the patient had hyperpnoea attack. In September 2012, the patient presented with photophobia and memory impairment (she developed brain dysfunction). On 11-MAR-2013, the patient received GARDASIL injection drug, intramuscular, dose unknown, (batch/lot # 9QN07R/0788AA) (expiry date 05-JUN-2014) for the third time in other hospital. In September 2013, the patient started having weakness. On 25-FEB-2014, the patient presented to the reporting hospital. At the time the report, the outcome of brain dysfunction was not recovered/resolved. The patient tended to be bedridden recently. Reporter''s comment; Not provided. The reporting physician considered that brain dysfunction was serious due to possible disability (also reported as medically significant). The reporting physician considered that brain dysfunction was related to GARDASIL with no other causative factors. Information has been received for a direct report from the regulatory authority regarding a case provided by the physician. Additional information has been requested.

VAERS ID:463384 (history)  Vaccinated:2012-08-28
Age:1.4  Onset:0000-00-00
Gender:Male  Submitted:2012-08-28
Location:Minnesota  Entered:2012-08-28
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
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193DA IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF94001 IMRL
Administered by: Public     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: Not Applicable

VAERS ID:463485 (history)  Vaccinated:2012-08-28
Age:48.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 0
Location:Ohio  Entered:2012-08-28
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: Sulfa; TRICOR; peanuts
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDPS8406 UNLA
Administered by: Other     Purchased by: Private
Symptoms: Paraesthesia oral, Rash
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Pt came back after 20 min w/ a lacertine rash & lip tingling. She did not think she was allergic to any of the ingredients & had said no to all questions. Known sulfa, TRICOR, & peanut allergy. Our nurse practitioner briefly saw her & recommended OTC BENADRYL, pt took 2 of them (50 mg).

VAERS ID:463455 (history)  Vaccinated:2012-08-28
Age:12.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 0
Location:Michigan  Entered:2012-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none known
Preexisting Conditions: none known
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H010649 IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4345AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema, Skin warm, Swelling, Upper extremity mass
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, warm to the touch, swollen, lump in arm. Area of reaction is larger than injection site.

VAERS ID:463497 (history)  Vaccinated:2012-08-28
Age:17.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 0
Location:D.C.  Entered:2012-08-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0022AE0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13400IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1026AA1SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA101300IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B085BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0316AE0SCRA
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Loss of consciousness, Nausea, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: See page 2. 1250- Became pale and lost consciousness briefly - did not fall and was able to walk to the bed. Skin pale but dry. 1255 B/P 90/70 P-64 130 B/P 100/70 P- 64 1205 - BP 100/70 P-74 Awake oriented, but continued to feel weak and nauseous. Transported to hosp at 1310.

VAERS ID:463498 (history)  Vaccinated:2012-08-28
Age:16.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Male  Submitted:2012-08-28, Days after onset: 0
Location:New Jersey  Entered:2012-08-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC093BA UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB605AA UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH1305 UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076BA UNLA
Administered by: Public     Purchased by: Public
Symptoms: Seizure like phenomena, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Syncopal episode with seizure-like activity of the extremities for 3-5 seconds.

VAERS ID:463532 (history)  Vaccinated:2012-08-28
Age:47.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-08-29, Days after onset: 1
Location:Pennsylvania  Entered:2012-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no, none
Preexisting Conditions: none
Diagnostic Lab Data: Considered going to the hospital -- that''s how strong the low back and stomach pain were, but I didn''t feel up to driving.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4181AA0 LA
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal pain upper, Back pain, Chills, Cold sweat, Fatigue, Feeling hot, Headache, Hyperhidrosis, Pain, Peripheral coldness, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Symptoms began with headache, fatigue and stomach pain but increased with time. I was able to go out the day of the vaccination. However, as the evening wore on, the stomach pain became intense and low back pain began. During the night both intensified. By morning I had body aches, chills and a fever of 100.9 (ear). My hands were cold and clammy and then hot. I fell asleep for four hours, awakening covered in sweat but the stomach and low back pain, as well as the other symptoms, are now subsiding, a little more than 24 hours later.

VAERS ID:463536 (history)  Vaccinated:2012-08-28
Age:4.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 0
Location:New York  Entered:2012-08-29
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: speech delay
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Inflammation, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Injection site very swollen, red, warm. Local inflammatory reaction, not infectious process.

VAERS ID:463589 (history)  Vaccinated:2012-08-28
Age:12.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Male  Submitted:2012-08-30, Days after onset: 2
Location:Illinois  Entered:2012-08-30
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: Morbid obesity
Diagnostic Lab Data: N/A Pt given Benadryl and precautions of when to RTC. Sx are improving, but have not completely resolved.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA0IMLA
MEN: MENINGOCOCCAL (MENOMUNE)SANOFI PASTEUR    
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B077AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Local site reaction - erythematous and edematous at site of varicella vaccine. Per pt report, onset of reaction was shortly after vaccine administration. Pt presented to clinic 2 days after administration with an edematous and erythematous area around the injection site measuring 8.5 cm x 8.5 cm, with mild tenderness. Per pt report, reaction has been improving - now with less edema, erythema, and tenderness than at onset.

VAERS ID:463665 (history)  Vaccinated:2012-08-28
Age:48.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-08-30, Days after onset: 1
Location:California  Entered:2012-08-30
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: Multiple Sclerosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204101 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Induration, Injection site pain, Injection site warmth, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: At site: soreness, later that night soreness and swelling increased, site hot, redness an inch below injection site. Size of redness/induration: 2 x 3 inches.

VAERS ID:463701 (history)  Vaccinated:2012-08-28
Age:11.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-08-30, Days after onset: 2
Location:Washington  Entered:2012-08-30
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4079AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081BA0UNRA
Administered by: Private     Purchased by: Public
Symptoms: Contusion, Erythema, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Fever, redness, swelling (size of a lemon), bruising.

VAERS ID:463703 (history)  Vaccinated:2012-08-28
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2012-08-30
Location:Colorado  Entered:2012-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4053AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076DA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Drug administration error, No adverse event
SMQs:
Write-up: On 8/28/12 FLUMIST was sprayed into right eye, when child suddenly moved. 1/2 of full dose was sprayed into eye. Eye was wiped with tissue. No adverse effects after 10 minutes. Call to mother 48 hours later indicated no eye or other health problems. Child was not revaccinated against flu,

VAERS ID:463756 (history)  Vaccinated:2012-08-28
Age:67.0  Onset:2012-08-30, Days after vaccination: 2
Gender:Male  Submitted:2012-08-30, Days after onset: 0
Location:New York  Entered:2012-08-30
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)SANOFI PASTEURUH715AA IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Malaise, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Weak, sick, can''t use his right hand, feels like "it''s paralyzed"

VAERS ID:463750 (history)  Vaccinated:2012-08-28
Age:0.3  Onset:2012-08-28, Days after vaccination: 0
Gender:Male  Submitted:2012-08-30, Days after onset: 2
Location:Ohio  Entered:2012-08-31, 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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4297AA1UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH9182451UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0058AA1PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Local swelling and redness at shot. (Rt) and (Lt) shot site within 24 hours of vaccination. No Rx needed.

VAERS ID:463801 (history)  Vaccinated:2012-08-28
Age:5.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Male  Submitted:2012-08-31, Days after onset: 2
Location:Alaska  Entered:2012-08-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none noted
Preexisting Conditions: none noted
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B138AA4IMRA
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURH13051 IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1023AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1411AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling w/ tenderness to arm from injection site to just below elbow. Low grade temp.

VAERS ID:463815 (history)  Vaccinated:2012-08-28
Age:28.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-08-31, Days after onset: 2
Location:Wisconsin  Entered:2012-08-31
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0611AE0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Injection site reaction, Rash vesicular, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: 17cm X 10cm area of swelling/redness. Vesicular rash around site appearing 8/30/2012.

VAERS ID:463821 (history)  Vaccinated:2012-08-28
Age:1.3  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-08-31, Days after onset: 3
Location:Ohio  Entered:2012-08-31
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: No laboratory or tests were done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLL
Administered by: Unknown     Purchased by: Private
Symptoms: Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: My 15 month daughter was given 2 shots on 8/28/2012. (Hib and DTaP). My daughter spiked a temperature of 102.9 *F and was told by the Drs office to go to the ER. She was taken to the ER where they gave her 5 ML of ibuprofen to bring the fever down. on 8/31/2012, she broke out in a rash all over her body. Again, the Dr was called and we were told to take her to the ER.

VAERS ID:463827 (history)  Vaccinated:2012-08-28
Age:47.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-09-01, Days after onset: 3
Location:Washington  Entered:2012-09-01
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: allergies-septra, erythromycin, levaquin, lidocaine, amoxicillin, medical tape, prednisone, versed, spiriva, phenergan and several anti-depressants. conditions- asthma, chronic facial pain, seizures, migraines, sleep apnea, endometriosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Aphagia, Arthralgia, Asthenia, Body temperature increased, Dizziness, Erythema, Feeling abnormal, Feeling hot, Hyperhidrosis, Nausea, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: All over and joint aches, weakness, nausea, dizzy, sweating, temperature of 101 after Tylenol, unable to eat and redness and heat in a 2 inch raised stripe around my arm. Had the shot not oral where some of these are listed. Felt like/ wanted to die took Tylenol every 3 hours and forced fluids.

VAERS ID:463835 (history)  Vaccinated:2012-08-28
Age:64.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-09-02, Days after onset: 4
Location:Florida  Entered:2012-09-03, 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: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain lower, Chills, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Extreme lower abdominal pain, headache fever 100, chills. Duration 48 hours.

VAERS ID:463982 (history)  Vaccinated:2012-08-28
Age:75.0  Onset:2012-08-31, Days after vaccination: 3
Gender:Female  Submitted:2012-09-04, Days after onset: 4
Location:Virginia  Entered:2012-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: hyperthryroid, hypertension Allergies: Codeine and Kenalog
Diagnostic Lab Data: Was seen in office by NP on 09/04/2012 and was advised to take Claritin and Zantac during day and take Benadryl at bedtime. Apply warm compresses to area and to return to clinic in not better in 4-6 days.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4383AA0IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site erythema, Injection site reaction, Local swelling, Pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Localized swelling and pain- reddened area approx size of a softball with welping at injection site.

VAERS ID:464010 (history)  Vaccinated:2012-08-28
Age:30.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-09-04, Days after onset: 6
Location:Michigan  Entered:2012-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None.
Preexisting Conditions: Type 2 diabetes controlled by diet & weight. Depression.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0556AE0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3974AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Chest discomfort, Contusion, Cough, Induration, Injection site pain, Pyrexia, Skin warm, Somnolence
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Per phone message on 8/31/12 @ 12:51PM: (Patient says) 24 hrs after the vaccine she had a 102 fever, a funny cough, and her chest felt heavy. Went to bed the entire day. The right arm is warm to touch. hard and bruised. Fever is gone and feels better. Denies itching at the site. On 9/4/12 @ 9:38AM Patient says vaccine site is now just tender to touch.

VAERS ID:464026 (history)  Vaccinated:2012-08-28
Age:69.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Male  Submitted:2012-09-04, Days after onset: 7
Location:Georgia  Entered:2012-09-04
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 cholesterol, depression, glaucoma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4493AA IMRA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Dyskinesia, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad)
Write-up: Chills, sweating, jerking starting when went to bed that evening and continued for 3 days.

VAERS ID:464081 (history)  Vaccinated:2012-08-28
Age:59.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-09-02, Days after onset: 5
Location:Arizona  Entered:2012-09-05, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Underdose
SMQs:
Write-up: Administering FLUZONE in (L) deltoid muscle & vaccine liquid squirted back out, the injection did not go in.

VAERS ID:464147 (history)  Vaccinated:2012-08-28
Age:12.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Male  Submitted:2012-09-05, Days after onset: 8
Location:Alaska  Entered:2012-09-05
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
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B078AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Feeling hot, Injection site reaction, Muscle swelling, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling of deltoid muscle from top of shoulder down to mid humerus. No swelling palpable on inferior, inner upper arm. Hot, swollen, tender. No axilla nodes palpated.

VAERS ID:464155 (history)  Vaccinated:2012-08-28
Age:27.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-09-05, Days after onset: 8
Location:Indiana  Entered:2012-09-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dizziness, nausea, and chills.
Preexisting Conditions:
Diagnostic Lab Data: Nothing yet.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MM: MEASLES + MUMPS (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Private
Symptoms: Activities of daily living impaired, Hypoaesthesia, Influenza like illness, Injection site inflammation, Injection site swelling, Injection site warmth, Lower extremity mass, Nasopharyngitis, Pain in extremity, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Numbness and itchiness all over arms and legs. Lasted over 24 hours. One week after on left arm (where Tdap was inserted) a raised red inflamed area appeared and radiated heat. Area was approximately 3" in diameter. The next day, a flu-like cold appeared accompanied by numbness, tingleness and pain shooting through arms and legs. Small lumps found in legs along tibialis anterior and around ankle area. The pain makes it hard to perform normal ADL''s.

VAERS ID:464162 (history)  Vaccinated:2012-08-28
Age:49.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Male  Submitted:2012-08-28, Days after onset: 0
Location:Illinois  Entered:2012-09-05, Days after submission: 8
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: HTN; Cholesterol; Migraine; Diabetes
Diagnostic Lab Data: Recommended pt to see MD ASAP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS264701 UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1420AA UNLA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Left arm redness, swelling and pain, it also feels warm to the touch. Pt tried some ice, it didn''t help. Recommended pt to see MD ASAP.

VAERS ID:464186 (history)  Vaccinated:2012-08-28
Age:2.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-08-30, Days after onset: 1
Location:North Carolina  Entered:2012-09-05, 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
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4274AA2SYRLL
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Within 24hrs of vaccination (the next am) pt had about 1 1/2 cm area of raised, fine erythema at our (L) thigh injection site with T 99.1 ear. Checked in office 8/30/2012.

VAERS ID:467942 (history)  Vaccinated:2012-08-28
Age:0.4  Onset:2012-08-28, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-05, Days after onset: 8
Location:Unknown  Entered:2012-09-05
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:
CDC Split Type: WAES1209USA001154
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1268Z1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a 5 months old patient. The patient was vaccinated with dose 1 ROTATEQ, oral (lot # not reported) on 04-JUN-2012. On 28-AUG-2012 the patient experienced received an expired second dose of ROTATEQ (lot # 669070/1268Z, expiration date 13-AUG-2012). No adverse symptoms reported. Additional information has been requested.

VAERS ID:464227 (history)  Vaccinated:2012-08-28
Age:11.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Male  Submitted:2012-08-29, Days after onset: 1
Location:Louisiana  Entered:2012-09-06, Days after submission: 8
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
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074CA0UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient developed 2x1 cm area of redness & swelling at injection site.

VAERS ID:464268 (history)  Vaccinated:2012-08-28
Age:1.1  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-09-06, Days after onset: 8
Location:Missouri  Entered:2012-09-06
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: Allergies-seasonal
Diagnostic Lab Data:
CDC Split Type: MO201207
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH131AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0233AE0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF657323IMRL
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)PFIZER/WYETH0080AE0SCRL
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Hard knot, redness, swelling, warmth to right upper thigh.

VAERS ID:464334 (history)  Vaccinated:2012-08-28
Age:4.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-08-30, Days after onset: 2
Location:Nebraska  Entered:2012-09-06, 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: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B213AA UNRL
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH2108 IN 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0118981UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0071701UNRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: MMR given on 8/28/12. Redness began at injection site and spread over left thigh. Area of redness was outlined 8/30/12. Patient given a dose of oral steroids and asked to return on 8/31/12 for evaluation.

VAERS ID:467922 (history)  Vaccinated:2012-08-28
Age:16.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Female  Submitted:2012-09-06, Days after onset: 8
Location:Unknown  Entered:2012-09-06
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:
CDC Split Type: WAES1209USA001168
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: This spontaneous report as received from a consumer refers to her 16 years old daughter. The patient was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported) on 28-AUG-2012. On 29-AUG-2012 the patient experienced nausea, dizziness and headache, 24 hours after therapy. The outcome of nausea, dizziness and headache was reported as not recovered/not resolved. Additional information is not expected.

VAERS ID:464668 (history)  Vaccinated:2012-08-28
Age:55.0  Onset:2012-09-06, Days after vaccination: 9
Gender:Female  Submitted:2012-09-08, Days after onset: 2
Location:Minnesota  Entered:2012-09-10, 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: None
Preexisting Conditions: Anxiety; CTS; DM; Elevated chol; High BP; Depression; RA; POD.
Diagnostic Lab Data: Was given KEFLEX x 500 tid x 10 days.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AA IMRL
TDAP: TDAP (ADACEL)SANOFI PASTEURU4329AA1IMLL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: L deltoid, warm-red. No fever, area of redness, 8 cm x 3 cm.

VAERS ID:464758 (history)  Vaccinated:2012-08-28
Age:1.3  Onset:2012-09-04, Days after vaccination: 7
Gender:Female  Submitted:2012-09-06, Days after onset: 2
Location:Michigan  Entered:2012-09-10, 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: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4129AA3IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH120012SCLL
Administered by: Private     Purchased by: Public
Symptoms: Diarrhoea, Frequent bowel movements
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Onset of diarrhea - Sept 4, 2012. Very loose frequent stools vaccinated on 8/28/12 DAPTACEL & IPV stools are returning to normal on 9/10/12. Used probiotic.

VAERS ID:464828 (history)  Vaccinated:2012-08-28
Age:4.0  Onset:2012-09-01, Days after vaccination: 4
Gender:Male  Submitted:2012-09-04, Days after onset: 3
Location:Colorado  Entered:2012-09-11, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None known Pt to see MD this p.m.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184AA IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1426Z1SCRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHE94498 IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0340AA1SCLL
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Diarrhoea, Headache, Urine output decreased, Urticaria
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: MOC reports pt developed "hives" over entire body, fever (to 103.2 before TYLENOL), headache and diarrhea 4 days after vaccination. States urine output also down on day 4, intake and output now reported per usual temp elevated to touch, hive reduced to trunk per MOC at time of this report.

VAERS ID:464856 (history)  Vaccinated:2012-08-28
Age:76.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-09-04, Days after onset: 7
Location:Wisconsin  Entered:2012-09-11, 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: No
Preexisting Conditions: Bee sting allergy; Hypertension; Osteoporosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B079BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Skin warm
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: 8/28 immediately upon administration of Tdap Pt. expressed pain & arm felt numb, hot & full from shoulder to hand & into the muscle. Through out day her arm was sore but could move it, 8/29 arm more difficult to move in morning. On 8/30 & 8/31 arm was "so-so". On 9/1 it hurt and 9/2 had problem lifting arm & can''t feel pressure on arm. 9/4 continues to be unable to lift arm. Has medical appt. 9/4/12 in afternoon.

VAERS ID:468295 (history)  Vaccinated:2012-08-28
Age:5.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-11, Days after onset: 14
Location:Unknown  Entered:2012-09-11
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:
CDC Split Type: WAES1208USA012213
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report as received from a nurse practitioner refers to a 5 years old patient. On 18-AUG-2012 the patient was vaccinated with a dose of ZOSTAVAX in error. On 31-JUL-2012 the patient was vaccinated with a dose of VARIVAX (Merck). It was unknown if the patient sought medical attention or not. No adverse effect has been observed or reported. Additional information has been requested.

VAERS ID:464879 (history)  Vaccinated:2012-08-28
Age:67.0  Onset:2012-08-30, Days after vaccination: 2
Gender:Female  Submitted:2012-09-12, Days after onset: 13
Location:Illinois  Entered:2012-09-12
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCLA
Administered by: Unknown     Purchased by: Public
Symptoms: Back pain
SMQs:, Retroperitoneal fibrosis (broad)
Write-up: Vaccine was given approx. 1 month after recovery from Shingles. Shingles pain in the back returned after the vaccine was administered.

VAERS ID:468312 (history)  Vaccinated:2012-08-28
Age:11.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-09-13, Days after onset: 16
Location:Virginia  Entered:2012-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA000911
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This spontaneous report as received from a registered nurse refers to a 11 years old female patient who on 28-AUG-2012 was vaccinated with the first dose of GARDASIL (lot # and dose was not reported). No other co-suspects were reported. Concomitant medications included: diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) te). On 28-AUG-2012, the patient fainted. It was given liquid (gingerale) to the treatment of the adverse event. No lab test was performed. The patient sought unspecified medical attention. At the time of the report, the outcome of fainted was reported as recovered/resolved on 28-AUG-2011. Additional information is not expected.

VAERS ID:469023 (history)  Vaccinated:2012-08-28
Age:76.0  Onset:2012-08-30, Days after vaccination: 2
Gender:Female  Submitted:2012-09-13, Days after onset: 14
Location:Unknown  Entered:2012-09-13
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:
CDC Split Type: WAES1209USA001079
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0169AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report was received from a registered pharmacist refers to a 76 years old female patient with no pertinent medical history and no drug reactions or allergies who on 28-AUG-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 671779/0169AE, Exp. Date: 06-MAR-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included CRESTOR and methotrexate. The pharmacist reported that a patient developed a reaction at the injection site consisted of red, swollen and warm area after receiving ZOSTAVAX. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for patient developed a reaction at the injection site consisted of red, swollen and warm area warm unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:465055 (history)  Vaccinated:2012-08-28
Age:6.0  Onset:2012-08-29, Days after vaccination: 1
Gender:Male  Submitted:2012-09-12, Days after onset: 14
Location:Washington  Entered:2012-09-14, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4050AA2IMRL
Administered by: Private     Purchased by: Public
Symptoms: Convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Fever (102 degrees) & seizure within 36 hours of administration of vaccine. No prior seizures ever.

VAERS ID:465192 (history)  Vaccinated:2012-08-28
Age:2.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-05
Location:Colorado  Entered:2012-09-14, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC
Current Illness: None
Preexisting Conditions: Several episodes of OM; a few episodes of cough/wheeze
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4488EA1IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.0100AE0IMRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site pruritus, Injection site rash, Rash papular
SMQs:, Hypersensitivity (narrow)
Write-up: Large area of papular rash at site of vaccine, spreading over left upper thigh, inguinal region, and over left side of abdomen, over the 7-8 days after vaccine administration mild pruritus using hydrocortisone cream at site.

VAERS ID:469177 (history)  Vaccinated:2012-08-28
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2012-09-14
Location:Unknown  Entered:2012-09-14
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:
CDC Split Type: WAES1208USA012291
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0657AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Subcutaneous, 0.65 ml, lot # (670613/0657AA), expiration date 04-AUG-2012) on 28-AUG-2012. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. At the report time the outcome was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.

VAERS ID:469197 (history)  Vaccinated:2012-08-28
Age:74.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 17
Location:Unknown  Entered:2012-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Iodine allergy
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA000348
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1786AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Mass
SMQs:, Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a doctor pharmacy refers to a 74 years old female patient with iodine allergy and no pertinent medical history who on 28-AUG-2012, was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (lot # 672752/1786AA, exp 08-SEP-2012). There was no concomitant medication. The pharmacist stated that 28-AUG-2012 the patient immediately experienced swelling which was described as "a 2 inch lump". There was no treatment given. At the time of the report, the patient had not recovered. The relatedness for swelling which was described as "a 2 inch lump" is unknown for PNEUMOVAX 23. Additional information has been requested.

VAERS ID:465148 (history)  Vaccinated:2012-08-28
Age:61.0  Onset:2012-08-31, Days after vaccination: 3
Gender:Female  Submitted:2012-09-16, Days after onset: 16
Location:Texas  Entered:2012-09-16
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  IMLA
Administered by: Public     Purchased by: Other
Symptoms: Body temperature increased, Erythema, Injection site pain, Mass, Rash macular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Extremely sore in deltoids, temp 102, red with splotchs about 4x4 inches with and round with a lump the size of a golfball. Had to see her Dr. twice

VAERS ID:465151 (history)  Vaccinated:2012-08-28
Age:72.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-09-16, Days after onset: 19
Location:Florida  Entered:2012-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness
Preexisting Conditions: Allergy to sulfa drugs
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCLA
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Pain, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: On the evening after vaccine was given, the patient experienced itching and stinging. She also noticed that it was severely swollen and bruised.

VAERS ID:465376 (history)  Vaccinated:2012-08-28
Age:1.0  Onset:2012-09-07, Days after vaccination: 10
Gender:Female  Submitted:2012-09-08, Days after onset: 1
Location:Massachusetts  Entered:2012-09-17, Days after submission: 9
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
HEPA: HEP A (VAQTA)MERCK & CO. INC.0271AE0IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0075270SCRL
Administered by: Private     Purchased by: Unknown
Symptoms: Decreased appetite, Injection site erythema, Injection site induration, Injection site rash, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: Right anterior thigh red, raised, hard enlarging. Fever 99-100, cranky, decreased appetite. Rx KEFLEX 250/5ml oral suspension 1/2 tsp TID x10 days.

VAERS ID:469365 (history)  Vaccinated:2012-08-28
Age:68.0  Onset:2012-09-02, Days after vaccination: 5
Gender:Female  Submitted:2012-09-17, Days after onset: 15
Location:Kansas  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA004519
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abnormal sensation in eye, Eye swelling, Herpes zoster, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Corneal disorders (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report was received from a 68 years old female patient. The patient was vaccinated with ZOSTAVAX one dose injection on 28-AUG-2012. Lot# and route were unspecified. Concomitant medication included lisinopril (manufacturer unknown). On 02-SEP-2012 the patient experienced shingles. On 04-SEP-2012, the patient developed a rash all over the left side of her face. On 05-SEP-2012, the reactions became much worse. The patient said it felt like "there are millions of needles in her eye" and her left eye was almost completely swollen. In addition, her "left ear feels like there is stinging in it". On 06-SEP-2012, the patient went to her physician and was prescribed medications. They were: acyclovir, gabapentin, and hydrocodone acetaminophen 7.5-325m. The patient still had shingles and was not recovered yet. No lab diagnostic study was performed. Additional information has been requested.

VAERS ID:465539 (history)  Vaccinated:2012-08-28
Age:52.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 17
Location:California  Entered:2012-09-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Aspirin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4329AA IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:469535 (history)  Vaccinated:2012-08-28
Age:63.0  Onset:2012-08-28, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 21
Location:Unknown  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA000717
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0660AA0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse reporting on a patient of unknown age and gender who on 28-AUG-2012, was vaccinated with an expired dose of ZOSTAVAX (lot # 670820/0660AA, exp 04-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. The nurse stated that no symptoms were reported. Additional information has been requested.

VAERS ID:469561 (history)  Vaccinated:2012-08-28
Age:30.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-18
Location:Unknown  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA001115
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0556AE0SYRRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction
SMQs:
Write-up: Information has been received from a pharmacist concerning a patient of unknown age and sex. The patient''s pertinent medical history and drug allergies were not reported. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and frequency were not reported) (lot # and expiration date were not reported). It was reported that on an unknown date patient "asked the pharmacist what an injection site reaction was" since she patient experienced some type of reaction below the injection site, unspecified what type of reaction, unspecified what site. It was unknown if patient sought medical attention. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:465706 (history)  Vaccinated:2012-08-28
Age:35.0  Onset:2012-09-03, Days after vaccination: 6
Gender:Female  Submitted:2012-09-14, Days after onset: 11
Location:Florida  Entered:2012-09-20, 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:
Preexisting Conditions: The patient has a history of diabetes, hypothyroid and is allergic to codeine - rash.
Diagnostic Lab Data: Not reported
CDC Split Type: 201208415
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AD IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cheilitis, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Initial report was received on 10 September 2012 from a health care professional. A 35 year-old female patient with a diabetic, hypothyroid and allergy to codeine - rash history had received on 28 August 2012 (also reported as 28/08/2012) an intramuscular right deltoid injection of FLUZONE, lot number UH719AD. On 03 September 2012 (also reported as 03/09/2012), the patient developed a 104 fever and a rash on torso, hands, face and lips. The patient was evaluated by her primary care physician on 07 September 2012 (also reported as 07/09/2012) and was treated with Prednisone for three days. No further information was available at the time of the report. The patient''s outcome was unknown. Documents held by sender: None.

VAERS ID:470204 (history)  Vaccinated:2012-08-28
Age:1.1  Onset:2012-08-28, Days after vaccination: 0
Gender:Male  Submitted:2012-09-20, Days after onset: 23
Location:Indiana  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA000410
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0422AE SCLL
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: This spontaneous report as received from a health worker refers to a 12 months old male patient. The patient was inadvertently vaccinated with ZOSTAVAX (lot#: 0422AE, expiration date: 27-MAR-2013, 0.65 ml, subcutaneous, left leg) instead of VARIVAX (Merck) today(on 28-AUG-2012). No adverse effects reported at this time. No other co-suspects were reported. No concomitant medications were reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.

VAERS ID:465858 (history)  Vaccinated:2012-08-28
Age:0.6  Onset:2012-08-30, Days after vaccination: 2
Gender:Female  Submitted:2012-09-14, Days after onset: 15
Location:North Carolina  Entered:2012-09-21, Days after submission: 7
Life Threatening? No
Died? Yes
   Date died: 2012-09-02
   Days after onset: 3
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: Recent otitis media - TM''s normal 8/28/12
Diagnostic Lab Data: Extensive evaluation at hospital
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4186AA2IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0293AE2IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0130AE2IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13302SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF636652IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0033AE2PO 
Administered by: Private     Purchased by: Public
Symptoms: Apnoeic attack, Autopsy, Brain death, Cyanosis, Death, Hypoxic-ischaemic encephalopathy, Intensive care, Multi-organ failure, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic cerebrovascular conditions (narrow), 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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Tumour lysis syndrome (broad)
Write-up: Vaccines given 8/28/12, 850am. Catastrophic event about 6pm 8/30/12. Found by family to be apneic, blue, unresponsive. To ER then to Hosp PICU. Hypoxic ischemic encephalopathy & multisystem organ failure. Brain dead & expired 09/02/12. Law enforcement & DSS notified - autopsy pending. No indication that death related to immunizations.

VAERS ID:466178 (history)  Vaccinated:2012-08-28
Age:47.0  Onset:2012-08-30, Days after vaccination: 2
Gender:Female  Submitted:2012-09-18, Days after onset: 19
Location:Colorado  Entered:2012-09-24, 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: Started Sulfamethoxazole TMP 8/28; see attached; Hydroxyzine HCl; Fluticasone Propionate; PULMICORT; SINGULAIR; SYMBICORT; VENTOLIN; Citalopram Hydrobromide; Atorvastatin Calcium; ZETIA; Hydrochlorothiazide; Lisinopril; BD Pen Needle Mini;
Current Illness: Polynephritis
Preexisting Conditions: Type 2 Diabetes; Asthma; Hyperlipidemia; Hypertension
Diagnostic Lab Data: Urticaria & allergic reaction
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH730AB IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Hypersensitivity, Local swelling, Pruritus, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: See attached. Received FLUZONE Pres-Free injection on August 28, 2012, in the left deltoid area. On Tues, August 29 had quarter size swollen area, with about half dollar size red area, low grade fever of 100.5. Wed, August 30 woke up with hives everywhere. Neck and face were bright red just about purple looking. Started taking BENADRYL when that did not work was told to try Cetirizine came to see dr on August 31, he had her stop the Cetirizine and put her on Hydroxyzine 50 mg three times a day. After two days on medication hives resolved. Then on Sept 10 the itching started again. She was in to see dr on Sept 11, and was treated with Hydroxyzine 50 mg again. Patient stated that 24hrs after being on Hydroxyzine hives and itching gone. See it to follow up with allergist.