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Found 508628 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:462268 (history)  Vaccinated:2012-08-17
Age:18.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-08-17, Days after onset: 0
Location:Missouri  Entered:2012-08-17
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURC3976AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURUH4242AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Blood glucose normal, Fall, Gaze palsy, Head injury, Headache, Loss of consciousness, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (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), Accidents and injuries (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: 8-17-12 at 09:40 patient received tdap and MCV-4, after receiving vaccine pt. alert & oriented. Walked approx. 65 ft. to front office and was talking to staff. At approx. 9:45 father reports pt''s eyes rolled back into head, Pt. felt after becoming unconscious hitting head on floor, B/P 107/55 BS=104, HR-55, Pt. regained consciousness - talking oriented. C/O headache and tingling to neck. Transported via ambulance to hospital.

VAERS ID:462269 (history)  Vaccinated:2012-08-17
Age:12.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-17, Days after onset: 0
Location:Michigan  Entered:2012-08-17
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: Seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB515AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0420AE2IMRA
Administered by: Public     Purchased by: Public
Symptoms: Blindness, Dizziness, Hypotonia, Pallor
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Client very anxious prior to vaccines given. After administering vaccines client became pale and c/o feeling dizzy and loss of vision. Client became limp and lowered to floor with knees elevated. Client remained conscious and talking. Cool compress applied and juice given.

VAERS ID:462286 (history)  Vaccinated:2012-08-17
Age:3.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-08-17, Days after onset: 0
Location:Kentucky  Entered:2012-08-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: Allergic to trees, peanuts and garlic. Mom states had severe anaphylaxis to allergy testing 3-4 months ago but unsure what he was allergic to.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3944AA3IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB586BA1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives noted around mouth, chin, forehead, cheeks and arms. Pt scratching. Admin. epinephrine 0.15 mL LD @ 1135 am. Rash improved at 1138, pt transported to ER by EMS.

VAERS ID:462319 (history)  Vaccinated:2012-08-17
Age:18.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-17, Days after onset: 0
Location:Minnesota  Entered:2012-08-17
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: amoxicillin erythromycin- asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0597Z0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Nausea, dizzy and then vomited within minutes of receiving the vaccination, resolved quickly after she vomited, applied ice to face/neck, she lay on the floor for recovery, sipped water.

VAERS ID:462368 (history)  Vaccinated:2012-08-17
Age:12.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-08-17, Days after onset: 0
Location:California  Entered:2012-08-17
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
TDAP: TDAP (ADACEL)SANOFI PASTEURU3957CA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Hypoaesthesia, Immediate post-injection reaction
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Numbness in left arm immediately after intramuscular injection.

VAERS ID:462329 (history)  Vaccinated:2012-08-17
Age:16.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-18, Days after onset: 0
Location:Texas  Entered:2012-08-18
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: Urine sample Blood sample Strep test Pregnancy test
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Private
Symptoms: Asthenia, Blood test, Chills, Headache, Musculoskeletal stiffness, Myalgia, Nausea, Pain in extremity, Pregnancy test, Pyrexia, Streptococcus test, Syncope, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Painful arm; headache; chills; fever of 100.2; stiff neck; nausea; fainting; overall muscle aches; weakness.

VAERS ID:462376 (history)  Vaccinated:2012-08-17
Age:71.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-08-17, Days after onset: 0
Location:Pennsylvania  Entered:2012-08-18, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.05665AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Patient reported vomiting twice and feeling lightheaded. Patient also reported feeling hot and sweating. Patient ate some food and felt better later that afternoon. Patient also started taking ARICEPT the same morning as the ZOSTAVAX was administered.

VAERS ID:462342 (history)  Vaccinated:2012-08-17
Age:1.3  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-19, Days after onset: 2
Location:Virginia  Entered:2012-08-19
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: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 3 LA
Administered by: Unknown     Purchased by: Private
Symptoms: Diarrhoea, Frequent bowel movements, Injection site erythema, Injection site induration
SMQs:, Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Injection site hard and red, loose, watery stools 5 or 6 times a day.

VAERS ID:462441 (history)  Vaccinated:2012-08-17
Age:8.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-20, Days after onset: 3
Location:New York  Entered:2012-08-20
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
HEPA: HEP A (VAQTA)MERCK & CO. INC.H0101451IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Incorrect dose administered, Pain in extremity, Wrong drug administered
SMQs:
Write-up: Mother brought child to Doctor to get Varicella #2. Instead Doctor gave her Hep A #2. She just received her Hep A #2 three weeks earlier from Dr. Then he wanted to give client her 2nd Varicella and her mother woudn''t allow it. Mother stated client stated she had more pain in Left arm due to 3rd Hep !. Told mother to give Ibruprofen as needed, maybe use a cool compress on area and move the arm around.

VAERS ID:462447 (history)  Vaccinated:2012-08-17
Age:18.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-20, Days after onset: 3
Location:Michigan  Entered:2012-08-20
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1524AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt was seated during administration. Within 5 minutes patient became pale and light headed. Pt was reclined on table with feet elevated. After 20 minutes, patient felt better to leave.

VAERS ID:462469 (history)  Vaccinated:2012-08-17
Age:1.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-20, Days after onset: 2
Location:North Carolina  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diaper rash; Using Nystatin ointment QID
Preexisting Conditions: No known allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1896AA0SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF636663IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0470AE0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Patient received MMR, varicella & PREVNAR 13 vaccines on 8/17/2012. Parent noted local reaction "rash" 8/18/2012. Patient seen in office 8/19/2012 - left thigh at injection site red, firm, slightly tender. No fluctuance, blanches well. About 3 cm in diameter. Treatment: MOTRIN, BENADRYL, cool compresses per dr.

VAERS ID:462478 (history)  Vaccinated:2012-08-17
Age:58.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Male  Submitted:2012-08-20, Days after onset: 2
Location:Maryland  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Denies
Preexisting Conditions: Allergic to PCN, tetracycline PMH: HTN, osteoarthritis, basal cell skin CA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0408AA0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Headache, Injection site cellulitis, Injection site discolouration, Injection site erythema, Injection site pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Pt states that she woke up to find redness @ right arm approx 1.5 x 2 inches in size. By that evening it was 2.5 X 3 inches in size. By next Am, redness was 5 X 6 inches, "about the size of a lemon", between her elbow and underarm. Stated it looked like cellulitis, had a black dot in the center, was very itchy. c/o headache. Went to facility, was given Benadryl and Prednisone. Also used ice, hydrocortisone cream and Advil.

VAERS ID:462484 (history)  Vaccinated:2012-08-17
Age:29.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-20, Days after onset: 3
Location:Minnesota  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4470AA0ID 
Administered by: Private     Purchased by: Private
Symptoms: Burning sensation, Contusion, Erythema, Pain, Pruritus, Skin warm, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow)
Write-up: Welt, redness, hot to touch 3"x3" area with smooth edge. "Felt on fire" painful to touch - started day of vaccine. Today heat is resolved, area very itchy & pink in color - feels bruised.

VAERS ID:462493 (history)  Vaccinated:2012-08-17
Age:16.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-20, Days after onset: 3
Location:California  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Per father child has no medical illnesses
Preexisting Conditions: nkda
Diagnostic Lab Data: unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0020AE0IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0325AE0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13051 SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4253AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4090CA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0072730SCRA
Administered by: Public     Purchased by: Public
Symptoms: Cold sweat, Dizziness, Gaze palsy, Pallor, Skin discolouration, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Clammy palms, dizziness, dusty color skin, paleness, unresponsive, eyes rolled.

VAERS ID:462496 (history)  Vaccinated:2012-08-17
Age:55.0  Onset:2012-08-20, Days after vaccination: 3
Gender:Male  Submitted:2012-08-20, Days after onset: 0
Location:New Mexico  Entered:2012-08-20
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0363AE SCRA
Administered by: Other     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash on right side of chest, not raised or itching.

VAERS ID:462548 (history)  Vaccinated:2012-08-17
Age:11.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-08-20, Days after onset: 3
Location:Utah  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4287AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4247AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Cellulitis Rt arm red and hot to touch 8/19/12 ROCEPHIN 1000 mg given. Will start taking oral Cephalexin 500mg Bid x 10 days.

VAERS ID:462606 (history)  Vaccinated:2012-08-17
Age:11.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Male  Submitted:2012-08-20, Days after onset: 2
Location:North Carolina  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Anxiety disorder
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB549CA0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA110640UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURAC52B09413A0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0065310UNRA
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: Varicella was given on 8-17-12. On 8-18-12 developed redness and swelling at site. Mom took to urgent care on 8-19-12 and was given BENADRYL and prednisone. Arm better 8-20-12.

VAERS ID:462623 (history)  Vaccinated:2012-08-17
Age:0.3  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Texas  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Infant TYLENOL
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B114DA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH562AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH133010SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9152450IMLL
Administered by: Public     Purchased by: Public
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 8/20/12 - father of child called to report child developed generalize rash later in the day after receiving her immunization. He reported child is alert, active and without fever. States plans to take infant to doctor today.

VAERS ID:462546 (history)  Vaccinated:2012-08-17
Age:67.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-21, Days after onset: 3
Location:California  Entered:2012-08-21
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: Allergies: dust, grass, pollen, ragweed; asthma; injury to TMJ; leg tendonitis; difficulty with (24 mo) ankle sprain; "reflux"
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR  SYRAR
Administered by: Public     Purchased by: Private
Symptoms: Fatigue, Injection site erythema, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Arm felt warm, fatigue, swollen arm & redness at site of injection 6 inch diameter (lasting 2 days). On the third day I applied a cold compress from the freezer. On day 4 arm is still slightly swollen & mild soreness.

VAERS ID:462646 (history)  Vaccinated:2012-08-17
Age:12.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-21, Days after onset: 3
Location:Minnesota  Entered:2012-08-21
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: So far, rapid strep test was negative. Dr. saw her for follow up and refused flu test as it is likely to show positive based on Friday''s vaccine administration.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal pain upper, Cough, Fatigue, Feeling abnormal, Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Streptococcus test negative
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Started with complaints about a stomach ache, headache, and tiredness on Saturday. She slept for a couple hours during the day and started to run a temperature in the evening of close to 100 degrees. By Sunday morning, her temperature was over 101 with a slight cough, upper respiratory (runny nose), slight sore throat and felt poorly. Monday and Tuesday, her fever was 102-103. We are now at Tuesday afternoon. She went to the dr. Tuesday a.m. and so far strep is ruled out using a rapid test, awaiting long test results.

VAERS ID:462692 (history)  Vaccinated:2012-08-17
Age:33.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-21, Days after onset: 3
Location:Massachusetts  Entered:2012-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness
Preexisting Conditions: Allergies - NEURONTIN, LYRICA, trazodone; Fibromyalgia.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH713AB0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Day 1 - Pt no reaction to vaccines (received FLUZONE (R)/PNEUMOVAX (L)). Day 2 - Evening - Fever, swelling, redness on left of arm. Day 3/4 - Pt went to MD - MD admitted Pt due to swelling on arm. Day 5 - Came to pharmacy with KEFLEX prescription.

VAERS ID:462712 (history)  Vaccinated:2012-08-17
Age:11.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Male  Submitted:2012-08-20, Days after onset: 2
Location:Iowa  Entered:2012-08-21, 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: Cold symptoms - cough/stuffy nose x2 wks
Preexisting Conditions: Allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB642CA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4284AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4335AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site vesicles
SMQs:
Write-up: Mom called 8/18/12 reporting (L) arm at injection site had 2-3 blisters noted 8/18/12. Tdap & MENACTRA given in LD on 8/17/12.

VAERS ID:462734 (history)  Vaccinated:2012-08-17
Age:3.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-08-21, Days after onset: 4
Location:Kentucky  Entered:2012-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted
Preexisting Conditions: Previous egg allergy - cleared by allergist in 8-12
Diagnostic Lab Data: Allergy test 8-12 - No longer allergic to eggs
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH721AB2UNUN
Administered by: Private     Purchased by: Private
Symptoms: Allergy test negative, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash appeared covering body after flu vaccine was administered. No respiratory distress. O2 sat 97%. BENADRYL given. Directed to give BENADRYL Q 6 hours PRN. Mom to call allergist and consult regarding future flu vaccines.

VAERS ID:462741 (history)  Vaccinated:2012-08-17
Age:68.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-21, Days after onset: 4
Location:California  Entered:2012-08-21
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 HIGH-DOSE)SANOFI PASTEURU4489AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Anaphylactic reaction, Dry mouth, Dry throat, Dyspnoea, Foreign body, Nausea, Sensation of foreign body
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: On 8/17/12 vaccine admin. at 420pm. No signs of ADE or distress noted while present. Later that evening pt complained of "sick to stomach" which progressively worsened to dry, sandy mouth and throat. At 8pm, the symptoms worsened & involved difficulty breathing so she went to the ER at hospital to be treated for anaphylaxis. Pt reported the incident to the pharmacy on 8/21/12 at 1:10p when requesting a list of ingredients in the vaccine for her allergist.

VAERS ID:462757 (history)  Vaccinated:2012-08-17
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-21
Location:Washington  Entered:2012-08-21
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
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110470IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Headache, Influenza like illness, Injection site erythema, Injection site macule, Injection site reaction, Injection site warmth, Local reaction, Pallor, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Local reaction below injection site to (L) upper arm 4 in diameter - red, blanching, macular area, mild warmth. Experienced low grade fever day after injection & mild flu like s/s - headache/dizziness.

VAERS ID:462821 (history)  Vaccinated:2012-08-17
Age:40.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-22, Days after onset: 4
Location:Minnesota  Entered:2012-08-22
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: Fibromyalgia; Anxiety; Panic attacks; Myalgia; De Quervain''s disease
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4046AH0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Cough, Dizziness, Dyspnoea, Headache, Musculoskeletal stiffness, Nausea, Oropharyngeal pain, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: Patient reported on 8/21/12 that after receiving Tdap on 8/17/12 in (Lt) Deltoid pt reports on 8/18/12 had a fever of 102.9, headache body aches, nausea, dizziness, cough, sore throat, stiffness, and hard time breathing. Reports all symptoms went away within 48 hours after onset.

VAERS ID:462865 (history)  Vaccinated:2012-08-17
Age:33.0  Onset:2012-08-20, Days after vaccination: 3
Gender:Female  Submitted:2012-08-22, Days after onset: 2
Location:Arizona  Entered:2012-08-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pneumonia presumed bacterial lobar
Preexisting Conditions: cardiomyopathy from unknown agent
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH105B0110IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Itching, red, painful raised rash over the right upper arm just distal to IM injection site.

VAERS ID:462881 (history)  Vaccinated:2012-08-17
Age:11.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Wisconsin  Entered:2012-08-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CT scan; Lab work (Istat)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636E0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4349AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B075BA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram, Convulsion, Laboratory test
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 received 3 separate injections on 8/17/12 and on Saturday 8/18/12 mom was driving with patient when patient had a seizure and was brought to emergency room for evaluation.

VAERS ID:462935 (history)  Vaccinated:2012-08-17
Age:6.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-22, Days after onset: 5
Location:Arizona  Entered:2012-08-22
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
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193CA UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0233AE1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1212AA1UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Red bump on RT arm where vaccine was given, rash.

VAERS ID:462920 (history)  Vaccinated:2012-08-17
Age:4.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-08-23, Days after onset: 6
Location:Texas  Entered:2012-08-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild seasonal allergies
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 4SYRLL
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Similar reaction on previous exposure to drug
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Large circular reaction at site of seasonal flu vaccine injection (left thigh). Area about 3" diameter. Red, warm to touch, slightly raised and firm. Similar reaction to last year''s flu vaccine, but we forgot about it until this reaction.

VAERS ID:462977 (history)  Vaccinated:2012-08-17
Age:61.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-23, Days after onset: 5
Location:Montana  Entered:2012-08-23
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
TDAP: TDAP (ADACEL)SANOFI PASTEURU4393BA IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.P0562AE0SCLA
Administered by: Public     Purchased by: Private
Symptoms: Arthralgia, Herpes zoster, Injection site erythema, Injection site pruritus, Lymphadenopathy, Myalgia, Rash, Urticaria, Vaccination site rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Awakened 8/18/12 by severe itching of shingles vaccination site. Raised welt 2 inches in diameter, sore joints, muscles, lymph notes under arm were swollen - 8/19 rash on arm, raised, welt at vaccination site increased to 5" x 2 1/2" 5/23, welt gone rash still on arm and itching has subsided. Denies any fever during this time.

VAERS ID:463097 (history)  Vaccinated:2012-08-17
Age:47.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-17, Days after onset: 0
Location:Michigan  Entered:2012-08-24, Days after submission: 7
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: Anxiety
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH711AA IMUN
Administered by: Unknown     Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient was dizzy, felt like fainting. However, she remained conscious & was talking. She felt OK after 10 minutes.

VAERS ID:463101 (history)  Vaccinated:2012-08-17
Age:39.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-24, Days after onset: 7
Location:Minnesota  Entered:2012-08-24
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR  IDAR
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Area very swollen, red, itchy, painful for 5 days after. Unable to sleep on arm for 5 days. HDC cream applied often, but site still itchy and very painful.

VAERS ID:463131 (history)  Vaccinated:2012-08-17
Age:81.0  Onset:2012-08-20, Days after vaccination: 3
Gender:Female  Submitted:2012-08-24, Days after onset: 4
Location:Illinois  Entered:2012-08-24
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: UNKNOWN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)
Write-up: PT STARTING DEVELOPING A BRUISE ABOUT 3 DAYS AFTER SHOT GIVEN, BRUISE HAS NOT GONE AWAY YET 8-24-12 3:12PM.

VAERS ID:463199 (history)  Vaccinated:2012-08-17
Age:45.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-22, Days after onset: 5
Location:Montana  Entered:2012-08-24, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma; Internal birth defects
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0259AE SCLA
Administered by: Public     Purchased by: Private
Symptoms: Diarrhoea, Nausea, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: 08/22/12 - reported nausea/vomit/diarrhea and rash evening post vaccination, rash cleared up but returned 1-2 days later, continued to have N/V/D, c/o sore throat. Denial respiratory issue immediately following vaccination but use of inhaler for asthma times 1 during week. Encouraged patient to seek medical assessment with her doctor she verbalized that she would.

VAERS ID:463229 (history)  Vaccinated:2012-08-17
Age:5.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Male  Submitted:2012-08-20, Days after onset: 2
Location:West Virginia  Entered:2012-08-24, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC218329BA2IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB515AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site rash, 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), Hypersensitivity (narrow)
Write-up: Swelling, redness, rash (L) arm & shoulder; mild fever (antibiotics) PO BID x 10 days.

VAERS ID:463233 (history)  Vaccinated:2012-08-17
Age:15.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-23, Days after onset: 6
Location:Texas  Entered:2012-08-24, 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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA SYRAR
Administered by: Private     Purchased by: Public
Symptoms: Dyskinesia, 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), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Within 5 minutes of GARDASIL deltoid injection child had a brief loss of consciousness with body jerking < 1 min. Blood pressure was normal/ V.S. nl. She recovered completely. No postictal state.

VAERS ID:463190 (history)  Vaccinated:2012-08-17
Age:55.0  Onset:2012-08-19, Days after vaccination: 2
Gender:Female  Submitted:2012-08-24, Days after onset: 5
Location:Unknown  Entered:2012-08-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0422AE0SCRA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site pain, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt said liquid hurt when it went in her arm. Swollen in 2 days - MD said to treat w/ heat called RpH on 8/24/12 & we told her to ice the area.

VAERS ID:463259 (history)  Vaccinated:2012-08-17
Age:12.0  Onset:2012-08-19, Days after vaccination: 2
Gender:Male  Submitted:2012-08-27, Days after onset: 8
Location:Florida  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: Tree nuts, Eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA1SYRRA
Administered by: Public     Purchased by: Other
Symptoms: Blister, Hypersensitivity, Rash erythematous, Vaccination complication
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow)
Write-up: Red bumps, rashy with some blistering break out on arms, under arms, hands and legs. Went to his Physician''s office and saw the N.P. We thought it was his eczema flare up, so she treated with Steroids for 6 days. After the 2nd day of steroids, noticed progression of the bumps and blistering spreading to face and more bumps in the same areas as noted. Went back to Physician''s office and saw N.P., as well as Drs. Dr. determined after discussion that he had an allergic reaction to the immunization, most likely the HEP A and HPV4 shots given on 6/11/12 and 8/17/12. He said NOT to get the 3rd immunization which was to be administered in December to complete the series. Patient also had the TDAP and MCV4 vaccinations administered on 6/11/12, but Dr. believed the reaction was from the HPV4 vaccine.

VAERS ID:463295 (history)  Vaccinated:2012-08-17
Age:37.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-20, Days after onset: 2
Location:Missouri  Entered:2012-08-27, Days after submission: 7
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 BIOLOGICALSAHAVB554AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: On 8/17 - patient fainted when shot was given. No adverse effects noted. On Sat AM - woke up with small spot on bridge of nose - rash spread to arms, legs, hands, face & trunk. Does not itch. No other swelling noted. No temperature. Advised to call MD.

VAERS ID:463296 (history)  Vaccinated:2012-08-17
Age:11.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Male  Submitted:2012-08-20, Days after onset: 2
Location:Colorado  Entered:2012-08-27, 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: Asthma; Obesity
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0420AE0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4096AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B079BA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swollen 3" x 2" diameter, red, hot to touch. Seen by Dr. given instructions to watch for increased swelling, redness, fever.

VAERS ID:463298 (history)  Vaccinated:2012-08-17
Age:77.0  Onset:2012-08-19, Days after vaccination: 2
Gender:Female  Submitted:2012-08-20, Days after onset: 1
Location:New Mexico  Entered:2012-08-27, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0171AE0UNRA
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Two mornings after injection patient woke and the area was red, raised, swollen & itching. Area was approx 1 1/2" x 4" patient used ice & used hydrocortisone cream & ibuprofen. The swelling stopped but remained itchy.

VAERS ID:463352 (history)  Vaccinated:2012-08-17
Age:31.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-22, Days after onset: 4
Location:Kansas  Entered:2012-08-27, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B065AA IMRA
Administered by: Public     Purchased by: Other
Symptoms: Diarrhoea, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: 8/20 - Pt reports having nausea, HA, body aches, et diarrhea starting on 8/18 till 8/20. Denies needing doctor''s care at this time. Pt says rest at home has helped.

VAERS ID:463424 (history)  Vaccinated:2012-08-17
Age:37.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-27
Location:California  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: Per pt no illness
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081BA IMUN
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0256AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: Patient didn''t report any symptoms, spoke to pt for a follow up, pt said she saw the doctor and she is fine, she didn''t have any questions to pharmacist.

VAERS ID:467662 (history)  Vaccinated:2012-08-17
Age:  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-27, Days after onset: 10
Location:New York  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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA008387
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
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 female patient of unknown age. The patient was vaccinated IM with dose 1, 0.5 ml GARDASIL (Lot number not reported) in July 2011. On 17-AUG-2012, the patient received IM, dose 2, 0.5 ml GARDASIL (Lot number not reported). No adverse effect was reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.

VAERS ID:468927 (history)  Vaccinated:2012-08-17
Age:56.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Unknown  Submitted:0000-00-00
Location:California  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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1706AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 8/18/12 Swelling and pain in left arm. Patient went to see MD. Patient Dx cellulitis. Patient was given a rx for cephalexin 500mg on 8/18/12 - rx filled on 8/19/12.

VAERS ID:463442 (history)  Vaccinated:2012-08-17
Age:70.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-08-22, Days after onset: 5
Location:Florida  Entered:2012-08-28, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0257AE0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Acne, Erythema, Injection site rash, Rash, Rash pustular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient has large, flat rash at injection site and many small red pimple/pustules on arms and neck.

VAERS ID:463486 (history)  Vaccinated:2012-08-17
Age:73.0  Onset:2012-08-19, Days after vaccination: 2
Gender:Female  Submitted:2012-08-20, Days after onset: 1
Location:Georgia  Entered:2012-08-28, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12041010IMRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0242AE0SCLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Red swollen itchy rash around injection site (ZOSTAVAX) -$g recommended cold compress and BENADRYL.

VAERS ID:463489 (history)  Vaccinated:2012-08-17
Age:1.1  Onset:2012-08-24, Days after vaccination: 7
Gender:Male  Submitted:2012-08-27, Days after onset: 3
Location:California  Entered:2012-08-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB527CA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1450AA0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0697AE0SCLL
Administered by: Public     Purchased by: Public
Symptoms: Blister, Rash, Rash erythematous, Rash maculo-papular
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt. developed a red, maculopapular rash with few vesicles throughout face, chest, back & extremities.

VAERS ID:468101 (history)  Vaccinated:2012-08-17
Age:4.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 11
Location:Unknown  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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA009067
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1251AA1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse concerning a child who on 17-AUG-2012, was vaccinated with a dose of M-M-R II (lot# 1251AA, exp 01-AUG-2013). The nurse stated that the child might have been vaccinated with improperly stored M-M-R II. M-M-R II was exposed to 68 F for 9 hours and then on Wednesday last week "on 15-AUG-2012", the temperature went to 48F for 1 hour. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:463417 (history)  Vaccinated:2012-08-17
Age:15.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-29, Days after onset: 12
Location:Wisconsin  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: Unknown
Preexisting Conditions: Presyncope to blood draw
Diagnostic Lab Data: 08/17/2012, Blood pressure, Increased
CDC Split Type: WAES1208USA010653
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0555AE0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Blood pressure increased, Convulsion, Dyskinesia, Headache, Musculoskeletal stiffness, Pallor, Posture abnormal, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: This spontaneous report as received from a nurse refers to a 15 years old female patient. The patient''s medical history included vagal response to blood draw. The patient had no pertinent medical history or drug reactions/allergies. The patient was vaccinated with the first dose GARDASIL (vaccination, site, route and strength unspecified) (Lot Number reported as 0555AE, Expire date 14-DEC-2014 waiting for verification) on 17-AUG-2012. No other co-suspects were reported. Concomitant medications included ZOLOFT, PROVENTIL HFA inhaler and clonazepam. The nurse reported that a patient had an episode of syncope and seizure following the first vaccination with GARDASIL on 17-AUG-2012. The nurse reported that about 5 minutes after vaccination while sitting down the patient threw her head back, body stiffened and became unresponsive making mouth noises, with tonic motions of the upper extremities. The patient became pale and ashen. The whole syncope / seizure event lasted about 2 minutes. The patient had a headache and stomach ache following the syncope/seizure event and her blood pressure was reported to have increased on 17-AUG-2012. The patient was treated with ice to the back of the neck and given juice and water. The outcome was reported as recovered/resolved after about 45 minutes on 17-AUG-2012 and left the office. The nurse reported the patient reported remembering everything that happened during the syncope/seizure event. The patient had sought medical attention via office visit. Upon internal review, seizure was considered to be an medically significant event. Additional information has been requested.

VAERS ID:463493 (history)  Vaccinated:2012-08-17
Age:70.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-21, Days after onset: 3
Location:Massachusetts  Entered:2012-08-29, 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.0073AE SCRA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: Patient developed cellulitis from reaction to injection - placed on antibiotic - KEFLEX per MD. Seen on 8/20/12.

VAERS ID:463527 (history)  Vaccinated:2012-08-17
Age:64.0  Onset:2012-08-19, Days after vaccination: 2
Gender:Female  Submitted:2012-08-27, Days after onset: 8
Location:Michigan  Entered:2012-08-29, 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 reported
Preexisting Conditions: None reported
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0097790SCLA
Administered by: Other     Purchased by: Private
Symptoms: Ear pain, Lymphadenopathy, Mass, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 8-19-12 --$g earache glands swollen 8/21/12 - Doctor visit no diagnosis. 8-23-12 bumps & rash in hair - not itchy, painful, lump in middle of head. Stabbing pain 8-24-12 - Doctor visit "doesn''t look like shingles" take MOTRIN for pain antibiotic KEFLEX begun 8-28-12.

VAERS ID:463587 (history)  Vaccinated:2012-08-17
Age:40.0  Onset:2012-08-23, Days after vaccination: 6
Gender:Female  Submitted:2012-08-30, Days after onset: 7
Location:Texas  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: none
Preexisting Conditions: none
Diagnostic Lab Data: CBC and WNV negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081BA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia, Asthenia, Diarrhoea, Fatigue, Full blood count normal, Headache, Nausea, Pyrexia, West Nile virus test negative
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: I received this shot on 8/17/12 Lot number AC52B081BA exp 2/15/2014. Thursday, August 23 2012, 2 AM, I woke up with joint aching, fever and severe headache. I started taking 600mg of Advil every 4-5 hours with relief. This continued thru Friday, so I called the pharmacist and she recommend I visit the clinic. West Nile Virus is in this area, so we were concerned that my symptoms of 6-7 days later may not be due to the shot. I visited the clinic and had labs drawn- WNV was negative, CBC normal. I continued to depend on the Advil and started developing nausea Friday, waking up to diarrhea on Saturday. Major fatigue and weakness. It took me thru Tuesday to be back to normal. My bowels are still very loose. Energy is back and headache is gone.

VAERS ID:463704 (history)  Vaccinated:2012-08-17
Age:12.0  Onset:2012-08-19, Days after vaccination: 2
Gender:Male  Submitted:2012-08-27, Days after onset: 8
Location:North Dakota  Entered:2012-08-30, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4079AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0607AE1SCRA
Administered by: Public     Purchased by: Other
Symptoms: Blister, Pruritus, Rash erythematous, Scab, Skin lesion
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Received #2 varicella vaccine on 8-17-12. On 8-14-12 began having vesicle filled lesions to arms, chest & legs, on 8-27-12. Continues to have lesions to these areas with itching. Taking BENADRYL prn - doing okay no fever or cough. 8/28/12 - saw client areas were clustered raised red rash - no vesicle noted. Still has lesions to legs. One scabbed area to leg on 8-30-12.

VAERS ID:463757 (history)  Vaccinated:2012-08-17
Age:18.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Maryland  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: Normal ECG; CXR; CBC; Metabolic profile
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0101231UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chest X-ray, Chest pain, Electrocardiogram normal, Full blood count, Metabolic function test, Musculoskeletal chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Chest pain several hours after vaccine - seen at local ED - ECG, CXR normal. Some chest wall tenderness to palpation. Discharged home. Seen in office 1 week later with normal exam.

VAERS ID:463910 (history)  Vaccinated:2012-08-17
Age:23.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-08-31, Days after onset: 14
Location:Texas  Entered:2012-08-31
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
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110640IMLA
Administered by: Public     Purchased by: Private
Symptoms: Fatigue, Myalgia, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Pt states after getting shot on Friday am her arm became sore that night. Pt states her whole body became sore on Sunday & her muscles hurt all over, but she had no fever, but felt tired. She was advised to call her pvt dr she stated she was using ADVIL for relief & hot showers. 8/21/12 telephone call made to pt with no answer, mom received pt per phoned on 8/23/12 states dr advised if not better in 3 days to come in but pt better now.

VAERS ID:463926 (history)  Vaccinated:2012-08-17
Age:67.0  Onset:2012-08-20, Days after vaccination: 3
Gender:Female  Submitted:2012-09-01, Days after onset: 12
Location:Colorado  Entered:2012-09-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: All codeine; Penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0169AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 3 days after vaccination patient got a rash on her leg (8/20/12), patient went to walk-in. Clinic 9/1/12 & MD diagnosed it as shingles.

VAERS ID:464039 (history)  Vaccinated:2012-08-17
Age:  Onset:2012-08-17, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-04, Days after onset: 18
Location:Connecticut  Entered:2012-09-04
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:
CDC Split Type: WAES1208USA012459
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: This spontaneous report was received from a healthcare worker who on 17-AUG-2012 was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL (route unknown) (lot # H009826, expiration date on 11-FEB-2014). On 17-AUG-2012, the patient developed a redness reaction behind the arm and across the chest. The patient was taken to an unspecified hospital for an unspecified amount of time and was given unspecified antibiotics to treat the event. The outcome of the event was unknown. The relatedness for the event was unknown for PNEUMOVAX 23. Additional information has been requested.

VAERS ID:467965 (history)  Vaccinated:2012-08-17
Age:  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-09-04, Days after onset: 18
Location:Unknown  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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA008133
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Information has been received from a healthcare worker concerning a female patient of unknown age. On 17-AUG-2012, the patient was vaccinated with the second dose of GARDASIL (lot #, dose and route were not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date in the last year, in 2011, the patient received the first dose of GARDASIL and on 17-AUG-2012, she got the second dose. No treatment information was reported. The patient''s outcome was unknown. Additional information has been requested.

VAERS ID:464244 (history)  Vaccinated:2012-08-17
Age:38.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-20, Days after onset: 2
Location:Nevada  Entered:2012-09-06, Days after submission: 17
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
TDAP: TDAP (ADACEL)SANOFI PASTEURU4046AB0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Chills, Dyspnoea, Headache, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Fever, headache, achy body, chills, shortness of breath.

VAERS ID:464336 (history)  Vaccinated:2012-08-17
Age:14.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-08-23, Days after onset: 5
Location:Illinois  Entered:2012-09-06, Days after submission: 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: Ex preterm infant
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURERAHAVB549DA UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3837AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEUR44137AA UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0097691UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large red patch at the injection site. (R) post arm.

VAERS ID:467925 (history)  Vaccinated:2012-08-17
Age:  Onset:2012-08-17, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-06, Days after onset: 20
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: WAES1208USA008236
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: Information has been received from a physician concerning a patient of unknown gender and age. On 22-APR-2011, the patient vaccinated with a dose of GARDASIL, intramuscular, (dose and lot number were not provided). On 17-AUG-2012, the patient was vaccinated with a dose of GARDASIL. No known adverse effects. Additional information has been requested.

VAERS ID:464870 (history)  Vaccinated:2012-08-17
Age:27.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-09-09, Days after onset: 23
Location:West Virginia  Entered:2012-09-11, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Consulted MD on 2 occasions and is medicated.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH71AA5IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: Shoulder to fingertips numb and tingling - very painful in shoulder joint.

VAERS ID:468856 (history)  Vaccinated:2012-08-17
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2012-09-11
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: WAES1209USA00013
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with MMR II (Lot number not provided) subcutaneously into anterior lateral thigh and VARIVAX (Merck) (vaccination site, route and strength unknown) (Lot number not provided) at the same time on 17-AUG-2012 (reported as "one week ago"). No concomitant medications were reported. On an unknown date in August 2012 the patient experienced rash after receiving MMR II and VARIVAX (Merck) at the same time. No treatment information was reported. The outcome of rash was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.

VAERS ID:464899 (history)  Vaccinated:2012-08-17
Age:13.0  Onset:2012-09-08, Days after vaccination: 22
Gender:Female  Submitted:2012-09-12, Days after onset: 4
Location:Michigan  Entered:2012-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0459AE0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: #1 GARDASIL administered on 8-17-12, no reaction local or systemic - broke out in hives 9-8-12. ER visit - record sent.

VAERS ID:465035 (history)  Vaccinated:2012-08-17
Age:18.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-09-13, Days after onset: 27
Location:Unknown  Entered:2012-09-13
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: 08/17/2012, Chest X-ray, normal, within normal limits; 08/17/2012, Electrocardiogram, within normal limits; 08/17/2012, blood work, normal, within normal limits
CDC Split Type: WAES1209USA000871
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anxiety, Blood test normal, Chest X-ray normal, Chest pain, Electrocardiogram normal
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a physician concerning an 18 year old male patient. The patient had no pertinent medical history and no known drug allergies. There were no concomitant medications. On 11-JUN-2012, the patient was vaccinated with the first 0.5 ml intramuscular dose of GARDASIL (lot # not reported), and on 17-AUG-2012, the patient received the second 0.5 ml dose of GARDASIL, intramuscularly. On 17-AUG-2012, "the same evening he received the second dose", the patient experienced chest pain and went to the emergency room. An Electrocardiogram (ECG), a chest x-ray and an unspecified "blood work" were performed. Physician reported that the chest x-ray and the ECG were "within normal limits" and results from the patient''s blood work were also "within normal limits". On an unspecified date, the patient was discharged from the emergency room with a diagnosis of chest pain of unknown origin versus anxiety, "since all his diagnostic studies were within normal limits. At the time of the report, the patient''s outcome for chest pain and anxiety was reported as "fully recovered". Additional information has been requested.

VAERS ID:469165 (history)  Vaccinated:2012-08-17
Age:64.0  Onset:2012-08-19, Days after vaccination: 2
Gender:Female  Submitted:2012-09-16, Days after onset: 28
Location:Unknown  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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA004509
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a 64 years old female patient. The patient was vaccinated with ZOSTAVAX on approximately 17-AUG-2012, "3 weeks go". Lot# and route were unspecified. On approximately 19-AUG-2012, "2-3 days after vaccination", the patient developed a spot on her arm and a spot on her chest. No medical treatment was prescribed. The outcome of patient was unknown. It was unspecified if the patient sought medical attention or not. Additional information has been requested.

VAERS ID:465246 (history)  Vaccinated:2012-08-17
Age:61.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-09-11, Days after onset: 25
Location:Louisiana  Entered:2012-09-17, Days after submission: 6
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 25 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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0097790SCLA
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Endotracheal intubation, Intensive care, Neck pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Arthritis (broad)
Write-up: Spouse notified pharmacy (9/4/12) that patient began experiencing neck pain on night of 8/17/12. Progressed into breathing issues, ER, intubation, and patient is still currently in ICU.

VAERS ID:470451 (history)  Vaccinated:2012-08-17
Age:63.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-09-21, Days after onset: 35
Location:California  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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA009202
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:
Write-up: This spontaneous report as received from a physician refers to a 63 years old male patient. The patient was vaccinated with (Merck) VARIVAX (lot number, dose and route not reported) on 17-AUG-2012, accidentally. The patient''s relevant medical history, concomitant medications, and past drug history were unknown. No other co-suspects were reported. No concomitant medications were reported. The patient was supposed to have been administered ZOSTAVAX, but was accidentally given (Merck) VARIVAX. It was unknown if there was any relevant laboratory data. As of 17-AUG-2012, the outcome of the patient receiving the (Merck) VARIVAX instead of ZOSTAVAX was unknown, and it was unknown if the consumer to receive an unknown dose of (Merck) VARIVAX. Additional information has been requested.

VAERS ID:466175 (history)  Vaccinated:2012-08-17
Age:0.2  Onset:2012-08-26, Days after vaccination: 9
Gender:Male  Submitted:2012-09-17, Days after onset: 22
Location:Florida  Entered:2012-09-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: (+) hemoccult on 9-13-12
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.H0110511IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0380AE0PO 
Administered by: Private     Purchased by: Private
Symptoms: Haematochezia, Mucous stools, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad)
Write-up: Patient seen in office for c/o blood in stool with mucus 8 days after vaccine administered. Lab confirmed one positive hemoccult on 9-13-12. No medications ordered.

VAERS ID:466329 (history)  Vaccinated:2012-08-17
Age:65.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-25
Location:Maryland  Entered:2012-09-25
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.0566AE0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Neuralgia
SMQs:, Peripheral neuropathy (narrow)
Write-up: PT REPORTED ON 9/25/2012 THAT HE HAD NERVE PAIN AND HAD SPOKEN TO 2 DRS WHO SAID IT WAS A RESULT OF THE ZOSTAVAX VACCINATION. BOTH DR''S SAID TO INFORM PHARMACY, WHO SHOULD REPORT SIDE EFFECT.

VAERS ID:470711 (history)  Vaccinated:2012-08-17
Age:70.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-25
Location:Massachusetts  Entered:2012-09-25
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: WAES1208USA010979
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCRA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: This spontaneous report as received from a nurse refers to a 70 years old female patient. On 17-AUG-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot: not reported). The nurse stated from physician''s office that the patient was using ZOSTAVAX and on an unspecified date experienced cellulitis (also reported as cellulites) to the right arm. The patent was put on treatment KEFLEX. The patient sought medical attention office visit. At the time of the report, the outcome of cellulitis to the right arm was unknown. Additional information has been requested.

VAERS ID:470847 (history)  Vaccinated:2012-08-17
Age:83.0  Onset:2012-09-10, Days after vaccination: 24
Gender:Female  Submitted:2012-09-26, Days after onset: 16
Location:Unknown  Entered:2012-09-26
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: Penicillin (unspecified)
Diagnostic Lab Data:
CDC Split Type: WAES1209USA005120
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0364AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to an 83 years old female patient with drug allergy to penicillin. On about 25 days ago, approximately on 17-AUG-2012, the patient was vaccinated with ZOSTAVAX (lot# reported as 0364AE, exp 16-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. the Pharmacist reported that patient called the pharmacy and complained of rash around her bra strap on her trunk and burning sensation around rash after receiving ZOSTAVAX about 25 days ago. Patient noticed rash started appearing yesterday, 10-SEP-2012. There were no treatment and no laboratory information for the event. The patient had sought medical attention by spoke to the pharmacist. The outcome was reported as not recovered. Additional information is not expected.

VAERS ID:470861 (history)  Vaccinated:2012-08-17
Age:70.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-09-26, Days after onset: 39
Location:Unknown  Entered:2012-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastrooesophageal reflux disease
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA006212
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCAR
Administered by: Other     Purchased by: Other
Symptoms: Rash, Skin warm, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a 70 year old female consumer with acid reflux who reported she received an injection of the ZOSTAVAX for "shingles" on 17Aug2012 and "right the next day she started to experience side effects, however, she is still experiencing a rashy and hot feeling on that arm. She mentioned she also started feeling a little wheezing. Concomitant medication included: omeprazole. The consumer refused to provide her health care professional information and mentioned that she will contact her health care professional." The patient did indicate that she had the vaccine administered at a pharmacy. It was reported the patient did not seek medical attention. Additional information has been requested.

VAERS ID:471140 (history)  Vaccinated:2012-08-17
Age:  Onset:2012-08-17, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-28, Days after onset: 42
Location:Unknown  Entered:2012-09-28
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: WAES1208USA010533
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Product name confusion, Wrong drug administered
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information was received from a pharmacist regarding three patients who were inadvertently administered LIQUID PEDVAXHIB subcutaneously on 17AUG2012 as the vaccine "was mistaken for a meningococcal vaccine because Haemophilus b Conjugate Vaccine has Meningococcal Protein Conjugate in its name." The pharmacist noted all patients experienced "more pain in the injection site than normal." The pharmacist did not have any specific patient information on any of these patients. No further information was provided. Additional information has been requested.

VAERS ID:471149 (history)  Vaccinated:2012-08-17
Age:  Onset:2012-08-17, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-28, Days after onset: 42
Location:Unknown  Entered:2012-09-28
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: WAES1208USA010531
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0599AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a pharmacist regarding to a patient of unknown age and gender. On 17-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot # 672932/0599AE, expiration date 22-JUN-2013). No other co-suspects were reported. No concomitant medications were reported. On 17-AUG-2012, after received ZOSTAVAX, the patient had redness and a raised bump around the injection site after received ZOSTAVAX. The patient did not receive treatment for the adverse event. The patient call to pharmacy for medical attention. The patient did not recover from the adverse events. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:468664 (history)  Vaccinated:2012-08-17
Age:12.0  Onset:2012-08-19, Days after vaccination: 2
Gender:Female  Submitted:2012-10-10, Days after onset: 52
Location:Texas  Entered:2012-10-10
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: No diagnosis yet, and doctors will not report to the CDC or VAERS, keep laughing it off and acting like maybe patient''s hands and feet are all asleep, patient says sensation is not the same as limbs falling asleep but numb and painful. Blood work completed and c protein levels are elevated they are currently treating patient with 1200 mg of Advil/Motrin daily to keep the swelling and inflammation at bay.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Public
Symptoms: Blood test, C-reactive protein increased, Hypoaesthesia, Inflammation, Oedema peripheral, Paraesthesia
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Hands and feet started swelling, went numb, tingling sensation.

VAERS ID:469259 (history)  Vaccinated:2012-08-17
Age:64.0  Onset:2012-08-21, Days after vaccination: 4
Gender:Female  Submitted:2012-08-23, Days after onset: 2
Location:Washington  Entered:2012-10-11, Days after submission: 49
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: GERD; HTN; Hyperlipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4136BA0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Rash papular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Vaccine given 8/17, noticed 4 days later, (R) arm swollen, warm, tender to touch, firm. No fever no chills raised papular rash noted, skin intact.

VAERS ID:475800 (history)  Vaccinated:2012-08-17
Age:82.0  Onset:2012-08-18, Days after vaccination: 1
Gender:Male  Submitted:2012-09-03, Days after onset: 16
Location:California  Entered:2012-11-09, Days after submission: 67
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no medical history and concomitant medication was not reported. The patient''s history of adverse event to previous vaccination and corrective treatments were not reported.
Diagnostic Lab Data: None
CDC Split Type: 201207799
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Fatigue, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Initial report received from a healthcare professional on 20 August 2012. A 82-year-old male patient, whose had no medical history and concomitant medications was not reported, had received intramuscular dose of FLUZONE HD vaccine in left deltoid (lot number: U4489AA) on 18 August 2012. The reported stated that, the patient presented with nausea, vomiting, short of breathing (SOB) and fatigue on 17 August 2012. The patient had no relevant diagnostic tests/laboratory data. The outcome of the event was unknown. List of documents held by sender: none.

VAERS ID:476573 (history)  Vaccinated:2012-08-17
Age:13.0  Onset:2012-09-24, Days after vaccination: 38
Gender:Female  Submitted:2012-11-09, Days after onset: 46
Location:Unknown  Entered:2012-11-09
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: WAES1211USA000133
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1016Z1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Chest pain, Fatigue, Headache, Laboratory test, Pain
SMQs:, Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This spontaneous report as received from a nurse refers to a 13 years old female patient. No medical history of concomitant conditions were reported. It was reported that the patient had no known allergies. The nurse reported that the patient received the first dose of GARDASIL on 12-JUN-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The second dose was received on 17-AUG-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The route of administration and anatomical location were not reported. No co-suspects or concomitant medications were reported. The patient developed fatigue with whole body pain, but mostly abdominal and back pain on 24-SEP-2012. About a week later the patient experienced a headache with worsening of the pain (whole body pain but mostly abdominal and back pain) and a burning sensation (discomfort) in the chest. Fatigue was reported as a significant disability or incapacity because the patient was unable to attend school for the last month due to fatigue. The patient was evaluated for a urinary tract infection and Rocky Mountain Spotted Fever. No results were provided. The patient had an emergency room visit in the first week of October which was pain related. No treatment information was provided and the patient did not recover from the events. The reporter relatedness for fatigue, burning sensation (discomfort) in the chest, headache, whole body pain but mostly abdominal and back pain is unknown for GARDASIL. No further information was provided. Additional information has been requested.

VAERS ID:484393 (history)  Vaccinated:2012-08-17
Age:20.0  Onset:2012-08-20, Days after vaccination: 3
Gender:Male  Submitted:2013-02-13, Days after onset: 177
Location:Unknown  Entered:2013-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Type 1 diabetes mellitus
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1302USA004465
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Other     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: This spontaneous report as received from a Medical Assistant via a Company Representative refers to a 20 year old male patient with type I Diabetes. On 17-AUG-2012, the patient was vaccinated intramuscularly (IM) with a dose of PNEUMOVAX23 (Lot #, and dose not reported). Concomitant medications were not reported. On 20-AUG-2012, while on PNEUMOVAX23, the patient had a seizure. The patient sought Medical Attention; he was admitted to an unspecified hospital (date unknown) for an unspecified length of time. Patients outcome was reported as recovered (stop date not reported). The relatedness between the event and PNEUMOVAX23 was unknown. Additional information has been requested.

VAERS ID:485718 (history)  Vaccinated:2012-08-17
Age:11.0  Onset:2012-08-19, Days after vaccination: 2
Gender:Male  Submitted:2013-02-27, Days after onset: 192
Location:South Carolina  Entered:2013-02-27
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4285AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, swollen and warm to touch, area was the size of golf ball at top and baseball at the bottom.

VAERS ID:498977 (history)  Vaccinated:2012-08-17
Age:  Onset:2012-08-17, Days after vaccination: 0
Gender:Unknown  Submitted:2013-08-09, Days after onset: 357
Location:Unknown  Entered:2013-08-09
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: WAES1307USA007222
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 08-SEP-2011 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route and lot number was not reported). The patient received the second, the third and the fourth dose of GARDASIL on 10-JUL-2012, 17-AUG-2012, 24-MAY-2013 respectively (strength, doses, routes and lot numbers were not reported). No adverse effects was reported. Additional information has been requested.

VAERS ID:502653 (history)  Vaccinated:2012-08-17
Age:56.0  Onset:2012-08-31, Days after vaccination: 14
Gender:Female  Submitted:2013-09-09, Days after onset: 374
Location:Minnesota  Entered:2013-09-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Same as above~Influenza (Seasonal) (Fluvirin)~UN~56.00~Patient
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 DIAGNOSTICS  SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis, Surgery
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (narrow)
Write-up: Several weeks post vaccine L shoulder pain inject. site. Spread to shoulder upper arm (pain). Restricted shoulder movement/increased pain. Primary care Dr. sent me to PT, MRI, surgeon; diagnosed adhesive capsulitis. Surgery 6/5/12. PT 6/13-9/13. Improved, still pain with some shoulder restriction. PT says several women in for therapy after flu vaccine. Same vaccine 2011: exercises per primary care dr - most pain gone, most restriction gone by 2/12. Advised no flu shot arm.

VAERS ID:505630 (history)  Vaccinated:2012-08-17
Age:58.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2013-09-18, Days after onset: 397
Location:Michigan  Entered:2013-10-02, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Calcium with vitamin D; Guar gum; Aspirin; Metronidazole; Fish oil; Pravastatin; Stool softener; Loratadine
Current Illness: Allergy to Ceclor; Allergy to Cipro; Bactrim Allergy
Preexisting Conditions: No adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0995165A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080AA UNLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a physician and described the occurrence of injection site pain in a 58-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to ceclor, allergy to cipro and bactrim allergy. Concurrent medications included Calcium with vitamin D, Benefiber, Aspirin, Metronidazole, Fish oil, Pravastatin, Stool softener and CLARITIN. On 17 August 2012 at about 17:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left arm). On 17 August 2012, within hours of vaccination with BOOSTRIX, the subject experienced injection site pain and painful to move arm. The physician reported the subject had continuing pain at the injection site from her BOOSTRIX vaccine. The site is not tender to the touch, but whenever she moves her arm it pulls at the site. This has been continuing since the date of injection. The pain has improved slightly since the injection. At the time of reporting the injection site pain and painful to move arm were improved. The physician considered the events were probably related to vaccination with BOOSTRIX.

VAERS ID:529812 (history)  Vaccinated:2012-08-17
Age:13.0  Onset:2012-08-22, Days after vaccination: 5
Gender:Female  Submitted:2014-04-30, Days after onset: 616
Location:Texas  Entered:2014-04-30
Life Threatening? Yes
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: Xray ultrasounds bloodwork Cat scans urine test over and over poop test scan after scan all of these over and over and over
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0420AE0SYRUN
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Blood test, Chest pain, Computerised tomogram, Fatigue, Incomplete course of vaccination, Malaise, Stool analysis, Ultrasound scan, Urine analysis, Vomiting, X-ray
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Stomach and sternum pain fatigue vomiting lots of vomiting and has had vomiting everyday 3-4 sometime 10 times a day ever since for the past 2 years she has been to multiple hospitals and doctors and specialist she has been put on several different medications that do not calm it down she carries a bucket around at school she missed more days from school then she went all dr excused because that''s how many times I have had to take her to the doctor and nothing is helping her she was a very healthy athletic girl that didn''t miss school until a few days after she received the injection she has been fatigued and sick every single day since we did not finish the injections because I new that what made her sick I took her back to the same dr a few days later and told them that''s what made her sick and they said it couldn''t have and no one told me that I could report it and I no they didn't report it because they said I was wrong but Im not wrong I know what made my child sick Im very worried about my daughter and I want someone to give her something that reverses the injection right away because its ruining my daughters life I want someone to call me and tell me what Im supposed to do to help her now.

VAERS ID:555759 (history)  Vaccinated:2012-08-17
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-11-12
Location:Unknown  Entered:2014-11-12
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: 08/17/2012, Pregnancy test urine, Positive, Twice
CDC Split Type: WAES1208USA008735
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This spontaneous prospective pregnancy report as received from a Nurse Practitioner for VARIVAX (Merck), a Pregnancy Registry product, refers to a 15 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with VARIVAX (Merck) (lot # not reported) on 17-AUG-2012. It was reported that the patient may be pregnancy. The Nurse Practitioner did not know the date of the patient''s first dose of VARIVAX (Merck). The Nurse Practitioner provided a urine pregnancy test for the patient which was positive for pregnancy. The test was repeated and was found to be positive for pregnancy. No adverse experience has been reported or observed. No other co-suspects were reported. There were no concomitant medications were reported. The patient with an LMP of July 2012 ("late July") and EED of approximately 07-MAY-2013. The patient was exposed to VARIVAX (Merck) during trimester 1. The patient sought unspecified medical attention. Follow up information has been received on 11-NOV-2014. A phone call was placed to the reporting nurse who was no longer at facility. The facility was unable to share the patient information without a signed consent form. Reporter information has been updated. Additional information is not expected.

VAERS ID:564982 (history)  Vaccinated:2012-08-17
Age:1.1  Onset:2014-08-10, Days after vaccination: 723
Gender:Female  Submitted:2015-02-13, Days after onset: 187
Location:Pennsylvania  Entered:2015-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: Specimen Date: 08/10/2014; Source: lesion; Test: VZV DNA (Any Specimen) - PCR; Result: Positive
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0UNUN
Administered by: Unknown     Purchased by: Other
Symptoms: Heart transplant, Herpes zoster, Polymerase chain reaction, Rash, Varicella virus test positive
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Dx with Herpes Zoster in one dose varicella vaccine recipient. Treated with IV acyclovir. Unilateral rash, one dermatome. Rash lasted <4 weeks. Also given topical Bactrim. Heart transplant recipient in September 2013.

VAERS ID:464168 (history)  Vaccinated:2012-08-17
Age:2.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Female  Submitted:2012-09-05, Days after onset: 19
Location:Foreign  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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209AUT000930
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERH007539 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Pallor, Screaming
SMQs:, Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Case received from the Health Authorities on 31-Aug-2012 under the reference number AT-BASGAGES-121679. Case reported as serious (due to other medically important condition). Case medically confirmed. Initial source was a physician. A 24-month-old female patient (weight, height: not reported) with no relevant medical history reported, had received a dose of mumps, M-M-RVAXPRO, batch number H007539) via subcutaneous route and and not reported site of administration on 17-Aug-2012. No concomitant medication was reported. On the same day, the female patient experienced pallor and creaming after injection. The patient recovered within 1-2 days. The case is closed.

VAERS ID:464169 (history)  Vaccinated:2012-08-17
Age:2.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-09-05, Days after onset: 19
Location:Foreign  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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209AUT000928
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURERH007539 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Pallor, Screaming
SMQs:, Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Case received from the Health Authority on 31-Aug-2012 under the reference number AT-BASGAGES-121678. Case reported as serious (due to other medically important condition). Case medically confirmed. Initial source was a physician. A 24-month-old male patient (weight, height: not reported) with no relevant medical history reported, had received a dose of MMRVAXPRO (batch number H007539) via subcutaneous route and not reported site of administration on 17-Aug-2012. No concomitant medication was reported. On the same day, the male patient experienced pallor and severe screaming after injection. The patient recovered within 1-2 days. The case is closed.

VAERS ID:465394 (history)  Vaccinated:2012-08-17
Age:30.0  Onset:2012-08-27, Days after vaccination: 10
Gender:Female  Submitted:2012-09-18, Days after onset: 22
Location:Foreign  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: Immunisation
Preexisting Conditions: Asthma; Multiple sclerosis
Diagnostic Lab Data:
CDC Split Type: WAES1209DEU007154
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)
Write-up: Case was received from an internist on 12-Sep-2012. Case was forwarded by another company (Novartis Vaccines, case number S2012DE06798). Case is medically confirmed. A 30-year-old female patient with a medical history of multiple sclerosis (patient was in a relapse free period at the time of vaccination) and ashtma, received a dose of PNEUMOVAX23 (lot-no. not reported) IM on 17-Aug-2012. The patient had been vaccinated with BOOSTRIX (GSK, lot number not reported) IM on 04-Jul-2012. Ten days after the PNEUMOVAX 23 vaccination and seven weeks after the BOOSTRIX vaccination, on 27-Aug-2012, the patient experienced an exacerbation of multiple sclerosis (no further details were provided). At the time of reporting the patient had not recovered. Concomitantly the patient was treated with cortisone.

VAERS ID:465991 (history)  Vaccinated:2012-08-17
Age:2.0  Onset:2012-08-17, Days after vaccination: 0
Gender:Male  Submitted:2012-09-21, Days after onset: 35
Location:Foreign  Entered:2012-09-21
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: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209AUT008458
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERH007539 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Pallor, Screaming
SMQs:, Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Case received from the Health Authority on 18-Sep-2012 under the reference number AT-BASGAGES-121677. Case reported as serious (due to other medically important condition). Case medically confirmed. Initial source was a physician. This case is linked to the reference case E2012-04833 (same reporter, same vaccine) and linked to sibling case E2012-05739. A 24-month-old male patient (weight, height: not reported) with no relevant medical history reported, had received a dose of M-M-RVAXPRO (batch number H007539) via subcutaneous route and not reported site of administration on 17-Aug-2012. No concomitant medication was reported. On the same day, the male patient experienced pallor and severe screaming after injection. The patient recovered within 1-2 days. The male patient is a sibling of the male patient in case E2012-05739, the two boys are part of a triplet.

VAERS ID:470170 (history)  Vaccinated:2012-08-17
Age:14.0  Onset:2012-09-11, Days after vaccination: 25
Gender:Female  Submitted:2012-10-17, Days after onset: 36
Location:Foreign  Entered:2012-10-17
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:
Diagnostic Lab Data: Brain MRI (date unknown): showed hypersignal in gray nuclei.
CDC Split Type: WAES1210FRA007807
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Clonus, Cyanosis, Dystonia, Encephalitis, Hyperhidrosis, Hypertonia, Loss of consciousness, Metabolic disorder, Nuclear magnetic resonance imaging brain abnormal, Psychomotor retardation, Renal failure acute, Seizure like phenomena, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tumour lysis syndrome (broad)
Write-up: Case received from the Health Authorities on 12-Oct-2012 under reference ST20120815. Case medically confirmed. a 14-year-old female patient had received a dose of GARDASIL (batch number not reported) via intramuscular route on 17-Aug-2012. On 11-Sep-2012, she experienced acute encephalitis with perioral cyanosis, loss of consciousness, dystonia of the face followed by seizure-like episode and sweats, tachycardia, hypertonia and clonus. Symptoms regressed on an unspecified date but a mild psychomotor retardation persisted, accompanied with acute kidney failure, which spontaneously regressed. The pediatrician did not known whether psychomotor retardation was pre-existing or not. Suspicion of metabolic disorder was evoked. A brain MRI performed on an unspecified date showed hypersignal in gray nuclei. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the adverse event: "suspicion of metabolic disorder" which was mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C1 S1 I1) according to the country''s method of assessment.

VAERS ID:473958 (history)  Vaccinated:2012-08-17
Age:0.1  Onset:2012-08-18, Days after vaccination: 1
Gender:Female  Submitted:2012-11-12, Days after onset: 86
Location:Foreign  Entered:2012-11-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Family and personal medical history: not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201210401
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20911001D SCUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA11009 IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG99671 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotonia, Hypotonic-hyporesponsive episode, Somnolence
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Case received from the Health Authorities on 06 November 2012 (HA''s number PLURPLOCR20120917004). A 01-month-old female patient, with no reported medical history, had received an intramuscular dose of ACT-HIB (batch number G99671, site of administration not reported), an intramuscular dose of EUVAX B (batch number UVA11009, site of administration not reported) and a subcutaneous dose of DTP (other manufacturer, batch number 20911001D, site of administration not reported) on 17 August 2012. On 18 August 2012, the patient experienced hypotonic-hyporesponsive episode. More than 24 hours post-vaccination, she presented somnolence with flaccid of upper right hand (mobility persisted). The symptoms has resolved gradually to 20 August 2012. The patient recovered on 20 August 2012. The Health Authorities coded "hypotonic-hyporesponsive episode", "somnolence" and "flaccidity muscle".

VAERS ID:475228 (history)  Vaccinated:2012-08-17
Age:0.3  Onset:2012-10-25, Days after vaccination: 69
Gender:Male  Submitted:2012-11-21, Days after onset: 27
Location:Foreign  Entered:2012-11-21
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: Alanine aminotransferase, 25Oct2012, 37IU/L; Albumin, 25Oct2012, 4.7g/dL; Aspartate aminotransferase, 25Oct2012, 45IU/L; Barium enema, 25Oct2012, Positive for a c; Basophils, 25Oct2012, 0.0%; Bilirubin total, 25Oct2012, 0.5mg/dL; Blood urea nitrogen, 25Oct2012, 7.5mg/dl; Body temperature, 25Oct2012, 36.8Deg.C; C-reactive protein, 25Oct2012, 0.1mg/dL; Creatine phosphokinase, 25Oct2012, 251IU/L; Echography, intra-abdominal; Eosinophils, 25Oct2012, 0.0%; Hematocrit, 25Oct2012, 38.7%; Hemoglobin, 25Oct2012, 13.0g/dL; Lactate dehydrogenase, 25Oct2012, 392IU/L; Lymphocytes, 25Oct2012, 43.5%; Monocytes, 25Oct2012, 4.5%; Neutrophils, 25Oct2012, 52.0%; Platelet count, 25Oct2012, 36.4x10^4/mm3; Protein total, 25Oct2012, 6.4g/dL; Red blood cell count,
CDC Split Type: B0841837A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA429BA1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal mass, Alanine aminotransferase normal, Aspartate aminotransferase normal, Barium enema abnormal, Basophil percentage, Blood albumin normal, Blood bilirubin normal, Blood creatine phosphokinase increased, Blood creatinine decreased, Blood lactate dehydrogenase increased, Blood urea normal, C-reactive protein normal, Echography abnormal, Eosinophil percentage decreased, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Lymphocyte percentage increased, Monocyte percentage, Neutrophil percentage decreased, Platelet count decreased, Protein total normal, Red blood cell count normal, Ultrasound abdomen abnormal, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 5-month-old male subject who was vaccinated with ROTARIX liquid formulation (GlaxoSmithKline). Previous vaccination included live attenuated human rotavirus vaccine (GlaxoSmithKline) given on 9 July 2012. On 17 August 2012, the subject received 2nd dose of ROTARIX liquid formulation (1.5 ml, oral). On 25 October 2012, 69 days after vaccination with ROTARIX liquid formulation, the subject experienced invagination of intestine. The subject was hospitalised. On 26 October 2012, the event was resolved. The physician considered the event was related to vaccination with ROTARIX liquid formulation. Although the invagination of intestine occurred 2 months after the second vaccination, the causal relationship to ROTARIX could not be denied. Follow-up information received on 5 November 2012: Subject details were added. On 25 October 2012 in the morning, the subject experienced bloody stool. The subject''s mood remained unchanged. On 25 October 2012 at around 11:00, the subject visited another hospital, where intussusception was suspected, and he was referred to the reporter''s hospital. On 25 October 2012 at 14:00, the subject visited the pediatric department of the reporter''s hospital. Ultrasound revealed positive target sign. 25 October 2012 at 15:00, the intussusception was reduced with high contrast enema (Positive for a crab claw sign). The subject was hospitalized for observation. On 25 October 2012, result for alanine aminotransferase was 37 IU/L, for albumin was 4.7 g/dL, for aspartate aminotransferase was 45 IU/L, for basophils was 0.0%, for bilirubin total was 0.5 mg/dL, for blood pressure systolic was 92 mmHg, for blood urea nitrogen was 7.6 mg/dL, for body temperature was 36.8 Deg.C, for C-reactive protein was 0.1 mg/dL, for creatine phosphokinase was 251 IU/L, for eosinophils was 0.0%, for haematocrit was 38.7%, for haemoglobin was 13.0 g/dL, for lactate dehydrogenase was 392 IU/L, for lymphocytes was 43.5%, for monocytes was 4.5%, for neutrophils was 52.0%, for platelet count was 36.4 x 10^4/mm3, for protein total was 6.4 g/dL, for red blood cell count was 472 x 10^4/mm3, for serum creatinine was 0.15 mg/dL, for white blood cells was 15200 cells/mm3. On 26 October 2012 in the morning, the bloody stool was resolved. The subject began to take orally. On 26 October 2012 at 13:00, the subject was discharged from the hospital. The reporter considered that intussusception was related to vaccination with ROTARIX. The intussusception occurred 2 months after the vaccination of ROTARIX, but the causal relationship to ROTARIX could not be ruled out. The subject was a 5-month-old infant with a low risk for intussusception, and when the incidence rate of intussusception in other children vaccinated with ROTARIX was considered, it was considered that the involvement of ROTARIX should be fully invested. The risk for developing intussusception within 6 months after oral administration of ROTARIX should be examined. Follow-up information received on 12 November 2012. Family history of intussusception or intestinal abnormality was not reported. The subject did not have a history of any intra-abdominal surgery. No congenital intestinal malformation was observed. Visible intussusception or soft tissue mass on plain abdominal X-ray was not confirmed. Niveau and distended intestinal loops on plain abdominal X-ray was not confirmed. Intussusception findings with enema of air or contrast medium were confirmed. Nonspecific abnormalities on plain abdominal X-ray were not confirmed. Visible intussusception or soft tissue mass on abdominal ultrasound was confirmed. Findings of intra-abdominal mass accompanied by specific characteristics, was confirmed. (specific characteristics which were confirmed by echography after the intestinal regulation to have been reduced by water enema: The target sign or donut sign on the transverse section image, and the pse

VAERS ID:484337 (history)  Vaccinated:2012-08-17
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-11
Location:Foreign  Entered:2013-02-12, Days after submission: 1
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:
Current Illness:
Preexisting Conditions: The patient''s personal and family medical history was unknown.
Diagnostic Lab Data: A faecal test was conducted on 10 January 2013. Results were negative for shigella, giardia and cryptosporidium. There were no results for salmonella typhi.
CDC Split Type: 201301426
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG0461 UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial test negative, Diarrhoea, Giardia test negative, Irritable bowel syndrome, Typhoid fever, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Case received from an Healthcare professional through the local affiliate on 30 January 2013. TYPHIM batch number G0461-2 was identified as at-risk of an antigen (purified Vi capsular polysaccharide) content below specifications. This batch was recalled on 25 September 2012. A 32-year-old female patient, with an unknown personal and family history, has received a dose of TYPHIM VI (lot number: G0461-2, route of administration unknown) in the left arm concomitantly with an intramuscular dose of HAVRIX (other manufacturer) in the right deltoid on 17 August 2012. After vaccination, the patient travelled to another country. During this period, she informed that she was hospitalised from 28 November 2012 to 03 December 2012 and was diagnosed with typhoid fever. She was treated with antibiotics. Vaccination failure was suspected. On her return, she presented to the clinic on 07 January 2013 with diarrhoea. A faecal test was conducted on 10 January 2013. Results were negative for shigella, giardia and cryptosporidium. The nurse informed that there were no results for salmonella typhi. The doctor diagnosed post-infectious irritable bowel syndrome. The patient declined to provide the clinical reports from the hospital. List of documents held by sender: none.

VAERS ID:484342 (history)  Vaccinated:2012-08-17
Age:0.2  Onset:0000-00-00
Gender:Male  Submitted:2013-02-12
Location:Foreign  Entered:2013-02-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201301776
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER139P2002A0UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER139P2002A0UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER139P2002A0UNUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURH11560UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURERASPNA124BA0UNUN
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURERQROLA450BA0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Hypotonic-hyporesponsive episode, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (narrow), Hypersensitivity (broad)
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 04 February 2013 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A male patient (born on 17 June 2012), whose medical history and concomitant therapies were not reported, had received first dose of IMOVAX POLIO vaccine (lot number: H1156, route and anatomical site of administration was not reported), first dose of PENTA vaccine (Manufacturer other, lot number: 139P2002A, route and anatomical site of administration was not reported), first dose of VORH vaccine (Manufacturer other, lot number: QROLA450BA, route and anatomical site of administration not reported) and first dose of Pneumo 10 vaccine (Manufacturer other, lot number ASPNA124BA, route and anatomical site of admnistration was not reported) on 17 August 2012. On an unspecified date post-vaccination, the patient experienced Pain, Redness, Heating, Hypotonic hypo responsive episode and Fever <39.5 degrees C. The outcome of the event was recovered without sequelae. The resolution was reported as "indefined". The action regarding next vaccinations is reported as Contraindication with scheme change. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Documents held by sender: None.

VAERS ID:484667 (history)  Vaccinated:2012-08-17
Age:0.2  Onset:0000-00-00
Gender:Male  Submitted:2013-02-15
Location:Foreign  Entered:2013-02-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, less than 39.5
CDC Split Type: B0867524A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER14530590UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSQROLA450BA0UNLA
UNK: PNEUMO (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSASPNA155AB0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypotonic-hyporesponsive episode, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (narrow)
Write-up: This case was reported by a healthcare professional (National Immunization Program) and described the occurrence of hypotonic-hyporesponsive episode in a 4-month-old male subject who was vaccinated with SYNFLORIX (GlaxoSmithKline), ROTARIX liquid formulation and dtpa-hib (non-gsk). On 17 August 2012 the subject received 1st dose of SYNFLORIX (unknown), 1st dose of ROTARIX liquid formulation (unknown), 1st dose of DTP-Hib (Non-GSK) (unknown). At an unspecified time after vaccination with DTPa-Hib (Non-GSK), ROTARIX liquid formulation and SYNFLORIX, the subject experienced hypotonic-hyporesponsive episode and fever (less than 39.5 deg. C). The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.

VAERS ID:484953 (history)  Vaccinated:2012-08-17
Age:0.2  Onset:0000-00-00
Gender:Male  Submitted:2013-02-19
Location:Foreign  Entered:2013-02-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, less than 39.5 d
CDC Split Type: B0867554A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS139P20020UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERH11560UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSQROLA450BA0UNUN
UNK: PNEUMO (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSASPNA124BA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypotonic-hyporesponsive episode, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (narrow)
Write-up: This case was reported by a healthcare professional (National Immunization Program) and described the occurrence of hypotonic-hyporesponsive episode in a 2-month-old male subject who was vaccinated with SYNFLORIX (GlaxoSmithKline), ROTARIX, dtpw-hbv-hib vaccine (non-gsk) and poliomyelitis vaccine inactivated (non-gsk). On 17 August 2012 the subject received 1st dose of SYNFLORIX (unknown), 1st dose of ROTARIX (unknown), 1st dose of DTPw-HBV-HIB vaccine (Non-GSK) (unknown), 1st dose of Poliomyelitis vaccine inactivated (Non-GSK) (unknown). At an unspecified time after vaccination with DTPw-HBV-HIB vaccine (Non-GSK), Poliomyelitis vaccine inactivated (Non-GSK), ROTARIX and SYNFLORIX, the subject experienced hypotonic-hyporesponsive episode, fever (less than 39.5 deg. C), injection site redness, injection site pain and injection site warmth. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. This is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.

VAERS ID:500214 (history)  Vaccinated:2012-08-17
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2013-08-23
Location:Foreign  Entered:2013-08-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid
Current Illness: Immunisation
Preexisting Conditions: Pregnancy, The patient had one previous pregnancy to full term with no birth defects or miscarriages.
Diagnostic Lab Data: A seronegative test result confirmed the patient was susceptible to rubella.
CDC Split Type: WAES1210GBR013932
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This case of pregnancy follow-up was reported by the Health Protection Agency on 18/Oct/2012, HPA Ref: 562. This case is medically confirmed. A 31 year old female patient received dose 1 of MMRVAXPRO, batch not reported on 17/Aug/2012. The patient was taking a concomitant medication of folic acid on an unreported date. The patients LMP date was 18/Jul/2012. The patient did not experience an adverse effect. A seronegative test result confirmed the patient was susceptible to rubella and this was the reason for vaccination. The patient had one previous pregnancy to full term with no birth defects or miscarriages. Follow up received from the PHE on 15-Aug-2013: The patient''s EDD was 24-Apr-2013. On an unreported date post vaccination the patient experienced a miscarriage at eight weeks after her LMP. The products of conception were not examined. It was not known if the foetus was normal. The patient outcome was not reported. Upon internal medical review the events were considered to be medically significant.

VAERS ID:537756 (history)  Vaccinated:2012-08-17
Age:6.0  Onset:2012-09-22, Days after vaccination: 36
Gender:Male  Submitted:2014-07-25, Days after onset: 671
Location:Foreign  Entered:2014-07-25
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: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1407CHN010919
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.S18250IMAR
Administered by: Other     Purchased by: Other
Symptoms: Bronchitis, Chest discomfort, Confusional state, Induration, Local swelling, Night sweats
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report was received from a regulatory authority (HA # 2187741) refers to an approximately 6 year old male patient. No current condition and historical drug was reported. On 17-AUG-2012 the patient was vaccinated with PNEUMOVAX 23 dose 1, 0.5 ml, (Batch # S1825; expiry date unknown) vaccination dose intramuscular in the deltoid in a routine way. Other suspect reported as Poliomyelitis Vaccine in Dragee Candy, Live. Was given as routine vaccine. No concomitant medication was reported. On 22-SEP-2012, the patient experienced bronchitis (hospitalization). Final diagnosis was reported as other. Localized swelling was reported as more than 5.0 and localized induration as $g= 2.5 and hospitalization as yes. It was reported that the patient experienced chest distress after vaccination, with swelling and induration of the arm, night sweat. The patient was in minor confusion, but has recovered. The patient had no fever. Adverse event primary category was reported as undetermined (other). Adverse event category was reported as coincidental event. Other diagnosis was reported as bronchitis. Serious AEFI or not and cluster AEFI was mentioned as no. The outcome of bronchitis was reported as resolving. The outcome of localized swelling and localized induration was unknown. The causality between PNEUMOVAX 23 and event was not reported. According to local regulation serious AEFI definition, this case was not assessed as serious by agency, although it resulted in hospitalization. Original reporter for the case was unknown. Additional information is not expected as there is no expected information for agency and we are unable to do follow up for this report.

VAERS ID:462868 (history)  Vaccinated:2012-08-18
Age:61.0  Onset:2012-08-21, Days after vaccination: 3
Gender:Female  Submitted:2012-08-22, Days after onset: 1
Location:Washington  Entered:2012-08-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No known or reported illnesses
Preexisting Conditions: None disclosed
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0171AE0SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 3 inch by 6 inch red, raised, inflammed tissue at surrounding injection site. Patient kept dermatologist appointment, was given 10mg cetirizine and topical clobetasol. On 8/22 reaction had significantly subsided.

VAERS ID:462981 (history)  Vaccinated:2012-08-18
Age:73.0  Onset:2012-08-19, Days after vaccination: 1
Gender:Female  Submitted:2012-08-23, Days after onset: 4
Location:Virginia  Entered:2012-08-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4493AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1706AA IMRA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Red warm tender left arm 8x3cm. Red warm tender right arm 12x3cm. KEFLEX 500mg 1Q6 hours x1 wk. BACTRIM DS 2 BID x1wk. ZYVOX 600mg 1 BID x7 days.

VAERS ID:463300 (history)  Vaccinated:2012-08-18
Age:65.0  Onset:2012-08-19, Days after vaccination: 1
Gender:Female  Submitted:2012-08-20, Days after onset: 1
Location:California  Entered:2012-08-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No (physical)
Preexisting Conditions: Allergy: Ibuprofen; GERD; Hypothyroidism; Depression; Hypercholesterolemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1418AA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Hearing impaired, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (narrow), Hypersensitivity (narrow)
Write-up: 8-19-12 - soreness, redness, heat & swelling at site. "Hearing sounds like underwater". 8-20-12 - redness at site resolved into raised bumps soreness decreased. No SOB no fever.

VAERS ID:463301 (history)  Vaccinated:2012-08-18
Age:49.0  Onset:2012-08-20, Days after vaccination: 2
Gender:Female  Submitted:2012-08-20, Days after onset: 0
Location:California  Entered:2012-08-27, Days after submission: 7
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 PASTEUR6130130IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness of injection site (about 1.5 inches radius).

VAERS ID:463308 (history)  Vaccinated:2012-08-18
Age:42.0  Onset:2012-08-18, Days after vaccination: 0
Gender:Female  Submitted:2012-08-20, Days after onset: 2
Location:California  Entered:2012-08-27, Days after submission: 7
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 INTRADERMAL)SANOFI PASTEURUT4470AA0IDLA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Headache, Injection site erythema, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad)
Write-up: Redness of injection site (about 1.5 inches radius). Headache. Dizziness. Soreness of arm.

VAERS ID:467665 (history)  Vaccinated:2012-08-18
Age:60.0  Onset:2012-08-18, Days after vaccination: 0
Gender:Female  Submitted:2012-08-27, Days after onset: 9
Location:Unknown  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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA009109
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a female patient of 60 years old. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneously left arm, lot # not reported) on 18-AUG-2012 and had injection site reaction. Pharmacist stated the patient came into pharmacy today (20-AUG-2012), with hard, red, sore bump and rash at injection site of left arm. No other co-suspects were reported. No concomitant medications were reported. At the time of report the outcome was reported as not recovered/not resolved. The patient sought medical attention via coming into the pharmacy. Additional information is not expected.

VAERS ID:468105 (history)  Vaccinated:2012-08-18
Age:63.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-28
Location:Unknown  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: Vitamin D (unspecified); fluticasone
Current Illness: Drug hypersensitivity
Preexisting Conditions: Sulfa, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1208USA010237
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0073AE SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Muscle twitching
SMQs:, Dyskinesia (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report was received from a pharmacist concerning a 63 year old female patient with sulfa allergy, who on 18-AUG-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX in her left arm (lot number reported as 0073AE, expiration date were not provided) (route was not provided). No other co-suspects were reported. Concomitant medications included vitamin D (unspecified) and fluticasone. The pharmacist stated that the patient developed a red, itchy rash on her left arm at the injection site after receiving ZOSTAVAX. The area of the rash was about 1 inch by 2 inches in size. The patient also told the pharmacist that her left thumb had been twitching. This started at unspecified time after she received ZOSTAVAX. The patient was given BENADRYL as treatment. Additional information has been requested.

VAERS ID:468765 (history)  Vaccinated:2012-08-18
Age:61.0  Onset:2012-08-18, Days after vaccination: 0
Gender:Female  Submitted:2012-09-06, Days after onset: 19
Location:Virginia  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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA011500
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0097790SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a licensed practitioner nurse reporting on a 61 years old female patient with no pertinent medical history and no drug reactions/allergies who on 17-AUG-2012, was vaccinated with a dose of ZOSTAVAX (lot# H009779, exp March 2013, dose and route not reported). It was reported that on 18-AUG-2012, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The patient developed an injection site reaction described as a 2x2 inch red, swollen area at the injection site that was warm to the touch without rash, but a little bit itchy during an office visit on 20-AUG-2012. The patient was treated with ice packs, BENADRYL and OTC cortisone cream (unspecified). At the time of the report, the patient was recovering from adverse events. The patient sought medical attention-office visit. The relatedness for 2x2 inch red, little bit itchy, out rash, warm to touch and swollen area at injection site were unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:464831 (history)  Vaccinated:2012-08-18
Age:49.0  Onset:2012-08-18, Days after vaccination: 0
Gender:Female  Submitted:2012-08-30, Days after onset: 12
Location:Massachusetts  Entered:2012-09-11, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: X-ray on 8/30
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12041010UNRA
Administered by: Other     Purchased by: Other
Symptoms: Discomfort, Mobility decreased, Pain in extremity, X-ray
SMQs:, Parkinson-like events (broad)
Write-up: Pt received vaccine on 8/18/12 and on 8/29 called to say her arm was aching. She could not find a comfortable position to sleep and could hardly raise her arm. She saw MD 8/30/12.

VAERS ID:470458 (history)  Vaccinated:2012-08-18
Age:  Onset:2012-08-18, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-21, Days after onset: 34
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: WAES1209USA008598
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0217AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a patient (id# 746) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 18-AUG-2012. Lot# was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.

VAERS ID:466057 (history)  Vaccinated:2012-08-18
Age:70.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-22
Location:Indiana  Entered:2012-09-23, 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:
Diagnostic Lab Data: WBC = 1.0
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURLU4490AA0IMUN
Administered by: Other     Purchased by: Public
Symptoms: Dysstasia, Malaise, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad)
Write-up: Could not stand, sick, hospital had WBC 1.0.

VAERS ID:466061 (history)  Vaccinated:2012-08-18
Age:78.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-23
Location:Indiana  Entered:2012-09-23
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: WBC = 25
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4490AA IMUN
Administered by: Other     Purchased by: Public
Symptoms: Asthenia, Malaise, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Sick, very weak - hospital visit. WBC = 25.

VAERS ID:470647 (history)  Vaccinated:2012-08-18
Age:5.0  Onset:2012-08-18, Days after vaccination: 0
Gender:Male  Submitted:2012-09-24, Days after onset: 37
Location:Ohio  Entered:2012-09-24
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: WAES1209USA006120
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cough, Laboratory test, Nasopharyngitis, Wrong drug administered
SMQs:, Anaphylactic reaction (broad)
Write-up: This spontaneous report was received from a consumer concerning her 5 years old male son who on 25-APR-2012 was vaccinated with MMR II (dose and lot number not reported). The patient''s mother reported that by mistake was given another dose of MMR II on 18-AUG-2012. The intention was to have the child get the VARIVAX (Merck) vaccine that day. The mother was reporting that the child had been tested twice for autism and had had a cold and cough since getting the second vaccine. The mother did not want to continue to report and chose to answer no further questions. The patient sought medical attention. At the time of the report, the patient''s outcome was unknown. The relatedness for the adverse events were unknown for MMR II. Additional information is not expected.

VAERS ID:471320 (history)  Vaccinated:2012-08-18
Age:66.0  Onset:2012-08-18, Days after vaccination: 0
Gender:Female  Submitted:2012-09-29, Days after onset: 42
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: WAES1208USA011338
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.5663AE SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report was received from a doctor of pharmacy refers to a 66 years old female patient who on 18-AUG-2012, was vaccinated with a dose of ZOSTAVAX (lot number 5663AE, Exp. Date: 21-MAR-2013) (dose and route not reported). No concomitant medications were reported. The pharmacist reported that on 18-AUG-2012, the patient developed red, swollen, raised and sore area at the injection site after receiving ZOSTAVAX. BENADRYL, TYLENOL and MOTRIN were given as a treatment for the experience. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The relatedness for red, sore, raised and swollen area at the injection site was unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:463973 (history)  Vaccinated:2012-08-18
Age:21.0  Onset:2012-08-19, Days after vaccination: 1
Gender:Female  Submitted:2012-09-04, Days after onset: 16
Location:Foreign  Entered:2012-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0826132A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133CB0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of headache in a 21-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 18 August 2012, the subject received 1st dose of CERVARIX (intramuscular, unknown). On 19 August 2012, 1 day after vaccination with CERVARIX, the subject experienced headache, sleepless, arthralgia, tiredness and nausea. The subject was hospitalised for 3 days. The subject was treated with vitamin and cerebral vasodilator. At the time of reporting, the outcome of headache was unspecified. Nausea, arthralgia, tiredness and sleepless were improved. The physician considered the events were almost certainly related to vaccination with CERVARIX.

VAERS ID:469756 (history)  Vaccinated:2012-08-18
Age:0.2  Onset:2012-08-18, Days after vaccination: 0
Gender:Female  Submitted:2012-10-15, Days after onset: 58
Location:Foreign  Entered:2012-10-16, 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: The patient had no past medical history and unknown family history. The patient was born with no delivery complications and does not have concomitant disease. The patient never presented adverse events in previous vaccinations.
Diagnostic Lab Data:
CDC Split Type: 201209236
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLG
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURG1275 SYRLG
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Crying, Feeding disorder neonatal, Injection site erythema, Injection site swelling, Loss of consciousness, Pallor, Peripheral coldness, Pyrexia, Skin warm
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Functional lactation disorders (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Initial report was received from a non-healthcare professional through the local affiliate on 02 October 2012. A two-month-old female patient had received a primary dose one injection in the thigh (vastus lateralis) of IMOVAX POLIO, lot number G1275-1 and a primary dose one injection in the thigh (vastus lateralis) of "hole cell pentavalent vaccine (DTP+HIB+HB)" (manufacturer and lot number not reported). A few hours later the patient presented body heat, swelling and intense redness in the lower limbs. She became worse and had no strength to cry. The patient was taken to the emergency room and when she arrived, she was unconsciousness, pale and cold. As corrective treatment, an antipyretic injection was administered, because the patient had a fever of 38 degrees Celsius. The patient remained under observation for one hour. The patient also started to cry too much, stopped breastfeeding and her legs were very red a few hours after the vaccines. There was no need for hospitalization and the patient recovered the same day. The physician believed the reactions were possibly related to the pentavalent vaccine and suggested that the patient did not receive this anymore. The patient received a dose of ASANA127BA (other manufacturer) and a doe of meningococcal vaccine, lot number 543011A (other manufacturer) on 18 September 2012 and presented fever. The patient had no past medical history and unknown family history. The patient was born with no delivery complications and does not have concomitant disease. The patient never presented adverse events in previous vaccinations. The patient''s outcome was recovered. Documents held by sender: None.

VAERS ID:483857 (history)  Vaccinated:2012-08-18
Age:2.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-07
Location:Foreign  Entered:2013-02-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201301620
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEURC3873C0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: This initial case repot is part of a batch of reports associated with several products that was received on 30 January 2103 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A female patient (age reported as 2-years-old), whose medical history and concomitant therapies were not reported, had received her 1st booster dose of PENTACEL, lot number C3873C (invalid lot #), (route and anatomical) site of administration not reported) on 18 August 2012. On an unspecified date post-vaccination the patient experienced pain redness, and heat. The patient''s outcome was recovered ("cure") with no sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Documents held by sender: None.

VAERS ID:484195 (history)  Vaccinated:2012-08-18
Age:0.5  Onset:0000-00-00
Gender:Male  Submitted:2013-02-11
Location:Foreign  Entered:2013-02-12, 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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201302189
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotonic-hyporesponsive episode
SMQs:, Hypotonic-hyporesponsive episode (narrow)
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 30 January 2013 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A male patient, age reported as "6-month-28-day-old", whose medical history and concomitant therapies were not reported, had received his second dose of DIPHTHERIA, TETANUS, POLIO, ACELLULAR PERTUSSIS AND Hib Vac, lot number 3059, (route and anatomical site of administration not reported) on 18 August 2012. On an unspecified date post-vaccination the patient experienced a hypotonic hyporesponsive episode. The patient''s outcome was recovered without sequelae. The case was assessed as serious by the Ministry of Health. The patient was not hospitalized. Documents held by sender: None.

VAERS ID:484218 (history)  Vaccinated:2012-08-18
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-12
Location:Foreign  Entered:2013-02-12
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: B0866908A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA679AA0SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site abscess, Injection site warmth
SMQs:
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site abscess in a 4-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 18 August 2012, the subject received 1st dose of FLUARIX (unknown route and injection site). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site abscess and injection site warmth. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting, the events were resolved without sequelae. This report is one of several cases received as part of a line-listening, each containing minimal information. No further information was expected. Case was closed.

VAERS ID:484334 (history)  Vaccinated:2012-08-18
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2013-02-11
Location:Foreign  Entered:2013-02-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201301885
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER14530580UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER14530580UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER14530580UNUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURH70460UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abscess, Skin warm
SMQs:
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 30 January 2013 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A female patient (age reported as "02-month-03-day-old"), whose medical history and concomitant therapies were not reported, had received her 1st dose of IMOVAX POLIO, lot number H7046, (route and anatomical site of administration not reported) and 1st dose of PENTAVALENT vaccine (other manufacturer, lot number 1453058, route and anatomical site of administration not reported) on 18 August 2012. On an unspecified date post-vaccination the patient experienced local hot abscess. The patient''s outcome was recovered without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. Documents held by sender: None.

VAERS ID:484516 (history)  Vaccinated:2012-08-18
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-13
Location:Foreign  Entered:2013-02-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201302051
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER11102021UNUN
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 04 February 2013 by the Sanofi Pasteur affiliate who received the report from the foreign Ministry of Health. A female patient (age reported as "4-year-old") whose medical history and concomitant therapies were not reported, had received her second booster dose of DTP vaccine manufacturer unknown, lot number "1110202", (route and anatomical site of administration not reported) concomitantly with her second booster dose of MMR vaccine manufacturer unknown (lot number, route and anatomical site of administration not reported) and her second booster dose of Influenza vaccine manufacturer unknown (lot number, route and anatomical site of administration not reported) on 18 August 2012. On an unspecified date post-vaccination the patient experienced headache, vomiting, fever (< 39.5 degrees C). The patient''s outcome was recovered without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The MOH indicated that the resolution of the case was indefined. The evolution was reported as "schedule maintained". Documents held by sender: None.

VAERS ID:484565 (history)  Vaccinated:2012-08-18
Age:3.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-14
Location:Foreign  Entered:2013-02-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0867167A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA679AC SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site abscess, Injection site warmth
SMQs:
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site abscess in a 3-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 18 August 2012, the subject received an unspecified dose of FLUARIX (administration site and route unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site abscess and injection site warmth. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.

VAERS ID:484574 (history)  Vaccinated:2012-08-18
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2013-02-14
Location:Foreign  Entered:2013-02-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0867172A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER14530590UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER14530590UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER14530590UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Hypotonic-hyporesponsive episode
SMQs:, Hypotonic-hyporesponsive episode (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of hypotonic-hyporesponsive episode in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline) and DTP-HBV-Hib (non-gsk). On 18 August 2012, the subject received 1st dose of ROTARIX (oral, batch number not provided) and 1st dose of DTP-HBV-Hib vaccine (Non-GSK) (unknown). At an unspecified time after vaccination with DTP-HBV-Hib vaccine (Non-GSK) and ROTARIX, the subject experienced hypotonic-hyporesponsive episode. The subject was hospitalized and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting, the event was resolved. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.

VAERS ID:463285 (history)  Vaccinated:2012-08-19
Age:24.0  Onset:2012-08-20, Days after vaccination: 1
Gender:Male  Submitted:2012-08-27, Days after onset: 7
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
TDAP: TDAP (ADACEL)SANOFI PASTEURC4137AA IM 
Administered by: Private     Purchased by: Private
Symptoms: Muscle spasms, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad)
Write-up: Muscle spasm in back, fever, arm pain.

VAERS ID:463327 (history)  Vaccinated:2012-08-19
Age:43.0  Onset:2012-08-19, Days after vaccination: 0
Gender:Female  Submitted:2012-08-19, Days after onset: 0
Location:Illinois  Entered:2012-08-27, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0184AE SCLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080AA IMRA
Administered by: Other     Purchased by: Private
Symptoms: Loss of consciousness, Syncope, Vomiting
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt had 2 immunizations - Tdap administered in (R) arm, then MMR administered in her (L) arm. Pt fainted and vomited after second immunization. Husband brought pt back to consciousness while I called 911. Pt was OK after recovering and did not want further treatment from Emergency personnel.

VAERS ID:463355 (history)  Vaccinated:2012-08-19
Age:72.0  Onset:2012-08-20, Days after vaccination: 1
Gender:Female  Submitted:2012-08-21, Days after onset: 1
Location:Texas  Entered:2012-08-27, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204101 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0556AE0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad)
Write-up: 8/21/12 Extreme soreness in left arm, difficult to move. Called again at 2:30 pm 8/21/12, she was feeling better. Advised to keep putting ice & taking TYLENOL.

VAERS ID:464142 (history)  Vaccinated:2012-08-19
Age:60.0  Onset:2012-08-21, Days after vaccination: 2
Gender:Female  Submitted:2012-09-05, Days after onset: 15
Location:Georgia  Entered:2012-09-05
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0442AE SCRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site cellulitis
SMQs:
Write-up: PATIENT CONTRACTED CELLULITIS ON ARM AT INJECTION SITE.

VAERS ID:464226 (history)  Vaccinated:2012-08-19
Age:36.0  Onset:2012-08-20, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:New Jersey  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: Chronic D2
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH711AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site joint pain, Injection site reaction, Musculoskeletal stiffness, Neck pain
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Pain/stiffness neck/shoulder of vaccinated arm - progressively got worse. Saw MD 1 week later - MD gave Tramadol - not f/u yet.

VAERS ID:468167 (history)  Vaccinated:2012-08-19
Age:63.0  Onset:2012-08-20, Days after vaccination: 1
Gender:Male  Submitted:2012-09-11, Days after onset: 22
Location:Florida  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:
CDC Split Type: WAES1209USA000273
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Pain in extremity
SMQs:
Write-up: This spontaneous report as received from a 63 years old male pharmacist refers to himself. The patient had none pertinent medical history. The patient had none drug allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) subcutaneously on 19-AUG-2012. Concomitant medications were reported as none. It was reported that the patient''s arm was sore and he had a headache on 20-AUG-2012. The patient did not seek medical attention. No treatment was given. Lab diagnostics studies performed were reported as none. The patient was recovered on 22-AUG-2012. Additional information has been requested.

VAERS ID:465890 (history)  Vaccinated:2012-08-19
Age:16.0  Onset:2012-09-20, Days after vaccination: 32
Gender:Female  Submitted:2012-09-21, Days after onset: 1
Location:Maine  Entered:2012-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0555AE1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Abdominal discomfort, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: PT SEEMS TO GET SICK TO HER STOMACH AND NAUSEOUS FOR 2-3 DAYS.

VAERS ID:467072 (history)  Vaccinated:2012-08-19
Age:71.0  Onset:2012-08-20, Days after vaccination: 1
Gender:Female  Submitted:2012-08-20, Days after onset: 0
Location:California  Entered:2012-09-28, Days after submission: 39
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) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4991AA IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: 3-4" swelling at inj. site, hot, raised, red, itchy. Hives on arms, legs & torso. - Treated with ATARAX, prednisone & Clobetasol.

VAERS ID:467790 (history)  Vaccinated:2012-08-19
Age:53.0  Onset:2012-08-19, Days after vaccination: 0
Gender:Female  Submitted:2012-10-05, Days after onset: 47
Location:New York  Entered:2012-10-05
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: Imitrex
Diagnostic Lab Data: Yellow Fever Vaccination
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH287AA1 RA
Administered by: Public     Purchased by: Other
Symptoms: Fatigue, Pain, Rash pruritic, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Swelling, body aches, itchy rash, fatigue.

VAERS ID:469500 (history)  Vaccinated:2012-08-19
Age:51.0  Onset:2012-08-19, Days after vaccination: 0
Gender:Male  Submitted:2012-09-20, Days after onset: 32
Location:New York  Entered:2012-10-12, Days after submission: 22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4470BA IDUN
Administered by: Other     Purchased by: Private
Symptoms: Pain in extremity
SMQs:
Write-up: On 8/19/2012 patient received an Intradermal injection of FLUZONE vaccine. Patient came back to the pharmacy on 9/20/2012 complaining of pain in the left arm since receiving the vaccine.

VAERS ID:469649 (history)  Vaccinated:2012-08-19
Age:56.0  Onset:2012-08-19, Days after vaccination: 0
Gender:Female  Submitted:2012-10-14, Days after onset: 56
Location:Minnesota  Entered:2012-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AA IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB520AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA SCLA
Administered by: Other     Purchased by: Public
Symptoms: Diarrhoea, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow)
Write-up: 8/19/12 - gave pt PNEUMOVAX, HAVRIX & FLUZONE, in evening pt reported arm swelling at site of SQ PNEUMOVAX w/fever and diarrhea. Pt went to ER but did not fill Rx. 8/21 - went to Urgent Care told to take BENADRYL any given Rx for steroid but did not take. 8/22/12 - saw Primary. Given triamcinolone cream.

VAERS ID:462475 (history)  Vaccinated:2012-08-20
Age:29.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-20, Days after onset: 0
Location:Virginia  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE INDICATED.
Preexisting Conditions: NONE.
Diagnostic Lab Data: HEENT EXAM, B/P, SPO2, PULSE.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH2193 IN 
Administered by: Military     Purchased by: Military
Symptoms: Dyspnoea, Ear, nose and throat examination, Nausea, Tachycardia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: TACHYCARDIA, DIFFICULTY BREATHING, NAUSEA.

VAERS ID:462497 (history)  Vaccinated:2012-08-20
Age:74.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-20
Location:Kentucky  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: 2 doses mixed in same syringe; no symptoms at this time
Preexisting Conditions: Hypertension
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0070AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:
Write-up: None at this time.

VAERS ID:462534 (history)  Vaccinated:2012-08-20
Age:19.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-20, Days after onset: 0
Location:Virginia  Entered:2012-08-20
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 known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12041010IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA100530IMUN
Administered by: Other     Purchased by: Private
Symptoms: Balance disorder, Blood pressure decreased, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fainted, loss of balance, decreased BP vasovagal response.

VAERS ID:462577 (history)  Vaccinated:2012-08-20
Age:18.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Nevada  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0131AE1IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081AA1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Fall, Muscle twitching, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient received vaccine & had syncope - fell to floor & started twitching, lasted about 10 seconds. 911 was called.

VAERS ID:462613 (history)  Vaccinated:2012-08-20
Age:4.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-20, Days after onset: 0
Location:Virginia  Entered:2012-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4186AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13303UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pruritus, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Became itchy at vaccine site & developed x 2 hours. On (R) arm.

VAERS ID:462533 (history)  Vaccinated:2012-08-20
Age:18.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-20, Days after onset: 0
Location:New Hampshire  Entered:2012-08-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0131AE IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt fainted and was seen by a NP and sent home with mother and father.

VAERS ID:462651 (history)  Vaccinated:2012-08-20
Age:0.2  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-21, Days after onset: 1
Location:California  Entered:2012-08-21
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: GERD
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B329BA IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH561AA IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF92473 IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB214A PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Crying, Injection site erythema, Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad)
Write-up: Started crying at 230 pm, gave Tylenol dose. At about 330 pm right thigh red and inflamed thigh to knee. Took directly to ED. By the time they arrived, no redness or swelling present, took 15 min by car. Examined and sent home. Continued to cry uncontrollably until 630pm that evening.

VAERS ID:462713 (history)  Vaccinated:2012-08-20
Age:16.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-21, Days after onset: 0
Location:Georgia  Entered:2012-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1261AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Nausea, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Pt experienced nausea, emesis, rash within 2-3 hrs of injection. No fever or chills - tx''ed with OTC BENADRYL. Symptoms continued. Rx''ed with ZOFRAN.

VAERS ID:462716 (history)  Vaccinated:2012-08-20
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-21
Location:Texas  Entered:2012-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4253AA1UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B071AA1UNLA
Administered by: Public     Purchased by: Public
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: Patient received vaccines and discovered after that patient had received same vaccines 5/2012. No adverse events.

VAERS ID:462759 (history)  Vaccinated:2012-08-20
Age:20.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-21, Days after onset: 0
Location:Texas  Entered:2012-08-21
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: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA110640IMUN
Administered by: Other     Purchased by: Private
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Experience itching, rash, after 12 hours of administration of MENVEO and hives.

VAERS ID:462760 (history)  Vaccinated:2012-08-20
Age:94.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-21, Days after onset: 0
Location:Washington  Entered:2012-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetic
Preexisting Conditions: Allergies to opioids
Diagnostic Lab Data: Anecdotal mention of abnormally low glucometer readings.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4483AA IMUN
Administered by: Other     Purchased by: Private
Symptoms: Blood glucose decreased, Vertigo
SMQs:, Vestibular disorders (narrow)
Write-up: Declining blood glucose. Vertigo. Symptoms were relayed by the patient''s daughter-in-law.

VAERS ID:462776 (history)  Vaccinated:2012-08-20
Age:1.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-22, Days after onset: 2
Location:Texas  Entered:2012-08-22
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: Failure to thrive
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451373IMLL
Administered by: Private     Purchased by: Private
Symptoms: Vomiting projectile
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)
Write-up: 8-20-12 PM projectile vomiting, "few times".

VAERS ID:462806 (history)  Vaccinated:2012-08-20
Age:14.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-22, Days after onset: 1
Location:North Carolina  Entered:2012-08-22
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: none
Diagnostic Lab Data: PT SEEN IN OFFICE TREATED WITH 2TSP OF BENADRYL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB522BA IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4240AA IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Pruritus, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: HOT, ITCHY, 2 INCHES IN DIAMETER, SWOLLEN. NO TREATMENT.

VAERS ID:462809 (history)  Vaccinated:2012-08-20
Age:22.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-22, Days after onset: 1
Location:Georgia  Entered:2012-08-22
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: NKA
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B087CB0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0065341SCRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Local reaction, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Localized reaction to back of right arm 5cm by 4cm raised hot to touch and red.

VAERS ID:462851 (history)  Vaccinated:2012-08-20
Age:27.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-22, Days after onset: 2
Location:Ohio  Entered:2012-08-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: unknown
Diagnostic Lab Data: Was given IV fluids at hospital.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC061AA2IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEUREU4137AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Chest discomfort, Dyspnoea, Nasal congestion, Pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Aches, nasal congestion, feeling of heaviness on chest, difficult to take deep breaths.

VAERS ID:462857 (history)  Vaccinated:2012-08-20
Age:11.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Male  Submitted:2012-08-22, Days after onset: 1
Location:Mississippi  Entered:2012-08-22
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: MS12016
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0420AC1 RA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3841AA0 LA
Administered by: Public     Purchased by: Private
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: L arm started swelling around 7:30 08/21/12 a.m. Swollen to the size of silver dollar.

VAERS ID:462862 (history)  Vaccinated:2012-08-20
Age:42.0  Onset:2012-08-22, Days after vaccination: 2
Gender:Male  Submitted:2012-08-22, Days after onset: 0
Location:Pennsylvania  Entered:2012-08-22
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: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0105150IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Tenderness erythema and swelling at the injection site.

VAERS ID:462880 (history)  Vaccinated:2012-08-20
Age:16.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Male  Submitted:2012-08-22, Days after onset: 1
Location:Massachusetts  Entered:2012-08-22
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: ADD; Allergy to shellfish (anaphylaxis)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS110511IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Upper (L) arm deltoid muscle red & swollen and warm (baseball size -$g softball size in redness) slight tenderness to touch. No drainage. Treatment: 50 mg BENADRYL q 6 hours x 24 hours then as needed, cold compresses. If no better will start BACTRIM.

VAERS ID:462929 (history)  Vaccinated:2012-08-20
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2012-08-22
Location:California  Entered:2012-08-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1769AA SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0418AE SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Received KINRIX & MMR IM (L) arm on 8/20/12 --$g pain 8/21/12 --$g red 8/22/12 --$g I put patient on KEFLEX, TYLENOL on 8/22/12.

VAERS ID:462931 (history)  Vaccinated:2012-08-20
Age:61.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-22, Days after onset: 1
Location:Pennsylvania  Entered:2012-08-22
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 PASTEURUH730AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0653AE IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pain, swelling, redness in left arm.

VAERS ID:462937 (history)  Vaccinated:2012-08-20
Age:30.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-20, Days after onset: 0
Location:New Jersey  Entered:2012-08-22, 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: None
Preexisting Conditions: Cinnamon; Black pepper
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1542AA1SCLA
Administered by: Other     Purchased by: Private
Symptoms: Flushing, Paraesthesia oral, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (broad)
Write-up: Face flushed, tongue "feeling thick", eyes feeling foggy -$g evaluated by MD. Given 50mg BENADRYL IM -$g EMS called. Patient observed and monitored -$g IV access placed 20g to right hand -$g patient transferred to hospital.

VAERS ID:462939 (history)  Vaccinated:2012-08-20
Age:1.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Male  Submitted:2012-08-22, Days after onset: 1
Location:Louisiana  Entered:2012-08-22
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 BIOLOGICALSAHAVB605BA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH574AA3IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0183AE0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF654413IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0070830IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Area of erythema about 5 cm in diameter, non tender, no drainage.

VAERS ID:462969 (history)  Vaccinated:2012-08-20
Age:68.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-22, Days after onset: 2
Location:Delaware  Entered:2012-08-22
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: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204101 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The patient presented back to the pharmacy 2 days after receiving a flu & pneumonia shot. He complained of redness & swelling near the injection site and chills and fatigue suggested treatment was to ice the area and return to pharmacy if not resolved in 2 days.

VAERS ID:462919 (history)  Vaccinated:2012-08-20
Age:4.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-23, Days after onset: 2
Location:Texas  Entered:2012-08-23
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: TX120042PU
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193CA4IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: L delt area red swollen, warm to touch-Dad brought child in, and mom pick her up next day. Noticed it was red-child c/o arm hurting-Advised to put ice on/off - Tylenol for pain - if got worse to see PCP.

VAERS ID:462968 (history)  Vaccinated:2012-08-20
Age:13.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-22, Days after onset: 2
Location:North Carolina  Entered:2012-08-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA; NKA; Anemia, unspecified
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0306AE0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: In clinic reporting pain, itching, redness and increased warmth to upper right arm - localized to vaccine site, that began the same evening the vaccine was administered. Patient & parent report gradual increase in these symptoms over past two days, with development of rash to site only. No fever nor difficulty breathing; no seizure activity.

VAERS ID:462995 (history)  Vaccinated:2012-08-20
Age:54.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-23, Days after onset: 2
Location:Kentucky  Entered:2012-08-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: NONE AT PRESENT
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)SANOFI PASTEURU3919BA0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Approx. 2 inch red circular area R. Deltoid. Area is hard and warm to touch. Told to treat with cold compress to area and Tylenol prn pain. Avoid heavy lifting.

VAERS ID:462997 (history)  Vaccinated:2012-08-20
Age:0.5  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-23, Days after onset: 2
Location:New Mexico  Entered:2012-08-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: NO
Diagnostic Lab Data: None determine by the provider seen.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B33OCE2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451192IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0277AE2PO 
Administered by: Military     Purchased by: Military
Symptoms: Injection site irritation, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Mild bumps and irritation of both thighs.

VAERS ID:463010 (history)  Vaccinated:2012-08-20
Age:12.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-23, Days after onset: 3
Location:Nevada  Entered:2012-08-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB522BA1IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081AA4IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Laboratory test
SMQs:, Arthritis (broad)
Write-up: Joints aching at 4:00pm quite a bit of pain. 900mg''s 600mg''s. Called nurse hotline, ER - under observation. Labs. Hx of Guillain-Barre. 8/21/2012 (Well/still sore).

VAERS ID:463021 (history)  Vaccinated:2012-08-20
Age:57.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-23, Days after onset: 3
Location:Arizona  Entered:2012-08-23
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: transplant recipient
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4492BA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1706AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, 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: Injection site pain, redness, and swelling. Fever for two days following. As of 8/23/12 still red and sore, no fever and not as painful.

VAERS ID:463043 (history)  Vaccinated:2012-08-20
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2012-08-23
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 PASTEURUH712AA0UNLA
Administered by: Other     Purchased by: Military
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Red area the size of a silver dollar around injection site. No other symptoms.

VAERS ID:463044 (history)  Vaccinated:2012-08-20
Age:86.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-22, Days after onset: 2
Location:Ohio  Entered:2012-08-23, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness around site, & itching told to ice and BENADRYL cream called Dr - they will call patient.

VAERS ID:463064 (history)  Vaccinated:2012-08-20
Age:11.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Male  Submitted:2012-08-22, Days after onset: 1
Location:Washington  Entered:2012-08-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4024AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4329AA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt came in Monday 8/20/12 for 3 immunizations had MENACTRA in (R) arm, HPV & Tdap in (L) arm. Pt noticed swelling, redness, & slight pain 24 hours later. Dr gave pt prednisone.

VAERS ID:463072 (history)  Vaccinated:2012-08-20
Age:42.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-22, Days after onset: 2
Location:Massachusetts  Entered:2012-08-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4470BA0SYRRA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site swelling, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red swollen arm around injection site. Pain upon exertion. Radiates heat - cellulitis appearance.

VAERS ID:463048 (history)  Vaccinated:2012-08-20
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-24
Location:Delaware  Entered:2012-08-24
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.1152AA0SCAR
Administered by: Private     Purchased by: Private
Symptoms: No adverse event
SMQs:
Write-up: Administered Varicella vaccine to patient who had chickenpox as a child. Patient had no reaction was made aware of incident.

VAERS ID:463085 (history)  Vaccinated:2012-08-20
Age:11.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-23, Days after onset: 3
Location:Florida  Entered:2012-08-24, 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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AB0UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB54CA0UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0106490UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4393BA0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site urticaria, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hive reaction centered around right arm. Hives on face. BENADRYL Allergy, inj (50m/1ml) 0.5 ml IM. MENACTRA Sanofi Pasteur (L) U3906AA.

VAERS ID:463087 (history)  Vaccinated:2012-08-20
Age:4.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-24, Days after onset: 4
Location:Arizona  Entered:2012-08-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4186AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH134013IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0367AC1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0110741SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site urticaria, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Within 5 minutes of receiving vaccine, patient''s (L) shoulder was red, swollen & had hives. BENADRYL given & ice applied. This halted the spread. Monitored x 20 min. & released home. Phone update next day - no further spread, but had fever of 104. (area of DTaP injection).

VAERS ID:463088 (history)  Vaccinated:2012-08-20
Age:27.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-22, Days after onset: 2
Location:Ohio  Entered:2012-08-24, 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: Allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR 0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Had headache, myalgias, joint pain and fever for 102 degrees F oral.

VAERS ID:463103 (history)  Vaccinated:2012-08-20
Age:0.3  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-24, Days after onset: 3
Location:South Carolina  Entered:2012-08-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ACL sprain left knee
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4149AA IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Induration, Local reaction, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Minor local reaction - erythema, induration and itching.

VAERS ID:463198 (history)  Vaccinated:2012-08-20
Age:76.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-22, Days after onset: 1
Location:Washington  Entered:2012-08-24, 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
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1477AA0IMLA
Administered by: Public     Purchased by: Private
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: Morning after immunization, pt presented with very swollen, red, hot, full upper arm (L). She went to primary Dr, got Doxycycline 100, then that night, reaction spread. So went to ER and prescribed KEFLEX 500. Doing better.

VAERS ID:463202 (history)  Vaccinated:2012-08-20
Age:60.0  Onset:2012-08-23, Days after vaccination: 3
Gender:Female  Submitted:2012-08-24, Days after onset: 1
Location:California  Entered:2012-08-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B085CA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: BOOSTRIX given on 8/20/12. Pt referred to pharmacy on 8/23/12 reporting itching & rashes on both arms, left chin & neck. Pt given Diphenhydramine 25 mg - 2 stat, 1-2 q 4-6 h prn.

VAERS ID:463234 (history)  Vaccinated:2012-08-20
Age:11.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-24, Days after onset: 3
Location:Indiana  Entered:2012-08-24
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1860AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4030AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B060BA0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Headache, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: (L) deltoid area red, swollen, "$g 1/2 dollar size". No fever, fatigue - able to attend school. No N/V/D. Headache on 8/21. Mom concerned of reddened area.

VAERS ID:463237 (history)  Vaccinated:2012-08-20
Age:78.0  Onset:2012-08-23, Days after vaccination: 3
Gender:Male  Submitted:2012-08-24, Days after onset: 1
Location:Idaho  Entered:2012-08-24
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: Hypertension
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4335AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Large red area covering upper arm. Patient went to Dr''s office and received prescription for KEFLEX 500mg #40 1 qid.

VAERS ID:463240 (history)  Vaccinated:2012-08-20
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2012-08-23
Location:Minnesota  Entered:2012-08-24, 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: Transposition of great vessels
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH21080IN 
Administered by: Private     Purchased by: Private
Symptoms: Contraindication to vaccination
SMQs:
Write-up: FLUMIST given within 1 week of having received MMR and Varicella vaccines. Patient was on aspirin therapy.

VAERS ID:463247 (history)  Vaccinated:2012-08-20
Age:82.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Massachusetts  Entered:2012-08-24
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4181AA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythema and swelling of (L) deltoid on morning 8/20/12 says erythema/swelling started within hours of inj. worse on Tues/Wed with pruritus but better now.

VAERS ID:467664 (history)  Vaccinated:2012-08-20
Age:  Onset:2012-08-20, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-26, Days after onset: 6
Location:Unknown  Entered:2012-08-26
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: WAES1208USA008786
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0731AA UNUN
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 an expired ZOSTAVAX (lot #670980/0731AA, expire date 17-AUG-2012) (vaccination site unknown) on 20-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.

VAERS ID:463258 (history)  Vaccinated:2012-08-20
Age:16.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-27, Days after onset: 7
Location:Tennessee  Entered:2012-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough, runny nose, neck pain for 1 day prior No fever, CBC WNL
Preexisting Conditions: None
Diagnostic Lab Data: None performed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0097461IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Erythema, Eyelid oedema, Headache, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: C/O HA, dizziness, nausea, erythematous face on and off, face puffy under eyes. 50mg of Benadryl administered in the office and was some better after 1 hour. Pt called back the next day 8/21 stating they went to the ER and was given more Benadryl and a anti-nausea med. Much better after second dose of Benadryl and anti-nausea med.

VAERS ID:463263 (history)  Vaccinated:2012-08-20
Age:57.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-27, Days after onset: 6
Location:Iowa  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: No
Preexisting Conditions: Penicillin
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: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Patient reported a rash around the site of administration that was not getting any better.

VAERS ID:463269 (history)  Vaccinated:2012-08-20
Age:65.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-27
Location:California  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: ATIVAN; Citalopram HBR; Tramadol HCL; JUNEL
Current Illness: Anxiety; Depression
Preexisting Conditions: Phenytoin allergy; Phenytoin sodium; Phenytoin sodium extended
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4149AA4IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Erythema, swelling & warmth around site. Generalized pruritus without rash.

VAERS ID:463317 (history)  Vaccinated:2012-08-20
Age:5.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-21, Days after onset: 0
Location:Iowa  Entered:2012-08-27, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B213AA IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0412AE1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0069511SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Rash (R) thigh MMR & Varicella administered SQ.

VAERS ID:463349 (history)  Vaccinated:2012-08-20
Age:11.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:North Carolina  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: She has dx of Allergic rhinitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4481AA2IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0131AE0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4021AD0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081AA0IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site rash, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: One day after Tdap, Meningococcal, Flu and HPV vaccine were given, patient had itching and appearance of multiple small bumps on both deltoid area.

VAERS ID:463359 (history)  Vaccinated:2012-08-20
Age:0.2  Onset:2012-08-24, Days after vaccination: 4
Gender:Male  Submitted:2012-08-27, Days after onset: 3
Location:Wisconsin  Entered:2012-08-27
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: Normal electrolytes & glucose
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B165BA0UNLL
Administered by: Private     Purchased by: Public
Symptoms: Blood electrolytes normal, Blood glucose normal, Convulsion, Dyskinesia, Irritability, Postictal state, Somnolence, Staring
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had starting spell with associated head jerking for 1 minute. Postictal (irritable & drowsy) for 1 hr after event. Seen in local Emergency dept with negative workup. Symptoms c/w seizure.

VAERS ID:463427 (history)  Vaccinated:2012-08-20
Age:11.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-22, Days after onset: 2
Location:Arizona  Entered:2012-08-27, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4253AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4106AA5IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Injection site rash, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Mother called in reports: Rt. arm with rash at injection site & shoulder area, c/o arm hurts, lightheadedness, nausea intermittently, c/o nausea 20 minutes after left clinic. Mother denies giving Ibuprofen or MOTRIN, has applied Hydrocortisone ointment to rash without noticeable change. Denies fever, signs of infection at injection site.

VAERS ID:468926 (history)  Vaccinated:2012-08-20
Age:42.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-21, Days after onset: 1
Location:California  Entered:2012-08-27, 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: PCN
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0414AE1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local reaction, Oedema peripheral, Tenderness, Vaccination complication
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: (L) arm, erythema, swelling, tender to touch. Local Rxn to vaccine.

VAERS ID:463390 (history)  Vaccinated:2012-08-20
Age:53.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-28, Days after onset: 8
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: No
Preexisting Conditions: No
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLA
Administered by: Public     Purchased by: Other
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Five minutes after I received the shingles vaccine Zoster, I had a headache which lasted for the next 10 days. Two days (48 hours) after I received this vaccine, I had redness, soreness, swelling, and itching at the site of the injection and I vomited on 8/22/2012 because of the intense headache.

VAERS ID:463391 (history)  Vaccinated:2012-08-20
Age:19.0  Onset:2012-08-24, Days after vaccination: 4
Gender:Male  Submitted:2012-08-28, Days after onset: 4
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: no
Preexisting Conditions: tinea corporis
Diagnostic Lab Data: neg test for West Nile, neg blood culture, normal WBC and platelets followed in hospital by neurologist and infectious disease
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0101230IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4341AA1IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Blood culture negative, Computerised tomogram head normal, Delirium, Drug screen negative, Hypoaesthesia, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Platelet count normal, West Nile virus test negative, White blood cell count normal
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad)
Write-up: Transient delirium and numbness of lower extremities, patient neg CT of head, neg MRA and MRI and neg LP and neg drug screen.

VAERS ID:463410 (history)  Vaccinated:2012-08-20
Age:64.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-28, Days after onset: 7
Location:Kansas  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: HRT, trazadone, antidepressant, aspirin
Current Illness: end of a cold
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Public     Purchased by: Private
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: My arm became swollen to the size of a baseball and was hot to the touch. It has a red spot about one inch long and 3/4 of an inch wide.

VAERS ID:463421 (history)  Vaccinated:2012-08-20
Age:12.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-24, Days after onset: 4
Location:Vermont  Entered:2012-08-28, 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: Asthma; Allergy to Amox. BENADRYL
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0414AE1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Induration, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Erythema 14cm x 8cm, induration, tender and hot to touch. Treated with BENADRYL.

VAERS ID:463448 (history)  Vaccinated:2012-08-20
Age:60.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Male  Submitted:2012-08-24, Days after onset: 3
Location:Ohio  Entered:2012-08-28, 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: HTN; gout
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0468AE0SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt. experienced redness, swelling, aching, and itching at the injection site approximately 24 hours after receiving the injection. Pt. treated by applying ice and taking TYLENOL for pain and BENADRYL for itching. Redness and swelling were reduced by - 96 hr after injection pt. still experiencing itching/aching in the evening.

VAERS ID:468076 (history)  Vaccinated:2012-08-20
Age:13.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-28, Days after onset: 8
Location:Unknown  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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA008608
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a 13 years old patient. The patient was vaccinated with ZOSTAVAX (Lot# unspecified) on 20-AUG-2012, instead of the intended (Merck) VARIVAX. At the time of this report, the patient had just received the dose of ZOSTAVAX; for that reason, the reporter did not know if the patient was experiencing any adverse effects. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.

VAERS ID:463553 (history)  Vaccinated:2012-08-20
Age:55.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Male  Submitted:2012-08-29, Days after onset: 9
Location:California  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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4149AA IMAR
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Induration, erythema, swelling & warmth around injection site. 2nd pt to have same with this lot.

VAERS ID:463579 (history)  Vaccinated:2012-08-20
Age:60.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-28, Days after onset: 7
Location:Maine  Entered:2012-08-29, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3974AA IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0562AE0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: (R) upper arm. Within 24 degrees of receiving vaccine, pt reports area around site with increase redness, tenderness to touch & low grade fever. By day 3, redness area increasing in size. Pt had appt & treated with KEFLEX as questioning cellulitis vs allergic reaction.

VAERS ID:463583 (history)  Vaccinated:2012-08-20
Age:63.0  Onset:2012-08-24, Days after vaccination: 4
Gender:Female  Submitted:2012-08-29, Days after onset: 5
Location:Hawaii  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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0467AE0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Fever 102 degrees, nausea, diarrhea from 8/24/12 till current. Nurse notified & will have pt. go in for check.

VAERS ID:468184 (history)  Vaccinated:2012-08-20
Age:56.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-29, Days after onset: 8
Location:Unknown  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: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA010395
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC528079CA0IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0564AE0SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report was received from a register nurse concerning a 56 year old female patient with not pertinent medical history or drug/reactions allergies who on 20-AUG-2012 was vaccinated with a dose of ZOSTAVAX, subcutaneous in her right arm (lot number reported as 0564AE, expiration date 21-MAR-2013) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, intramuscular in her left arm. No other co-suspects were reported. The nurse stated that on 21-AUG-2012, the patient developed a 2 inch red area and lump around the injection site where the ZOSTAVAX was administered. The patient was given warm or cold compresses. At the time of the report, the patient was recovering form the events. Additional information has been requested.

VAERS ID:463659 (history)  Vaccinated:2012-08-20
Age:35.0  Onset:2012-08-24, Days after vaccination: 4
Gender:Female  Submitted:2012-08-27, Days after onset: 3
Location:Florida  Entered:2012-08-30, 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: New patient
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4393BA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Induration, Pruritus, Rash, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Left deltoid rash x 2 d. Rash is "not painful but warm to touch". Patient noticed area of induration & pruritus.

VAERS ID:463661 (history)  Vaccinated:2012-08-20
Age:62.0  Onset:2012-08-30, Days after vaccination: 10
Gender:Male  Submitted:2012-08-30, Days after onset: 0
Location:Florida  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: NKDA. No signficant medical conditions.
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0071AE0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Burning sensation, Rash erythematous
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: Patient developed blistery, erythematous rash to right T12 dermatome. Patient reports slight burning sensation on right arm and right thigh region. Patient denies pain. Adverse effect is reported in 1-6% of patients according to package insert.

VAERS ID:463667 (history)  Vaccinated:2012-08-20
Age:1.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Male  Submitted:2012-08-30, Days after onset: 9
Location:Oklahoma  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: No illness reported on review prior to vaccinations.
Preexisting Conditions: No prior illness, birth defects, no medical conditions or prior reactions to vaccines. Allergic to Amoxicillin- Generalized body rash
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4129AA IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAV0591AA IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0078AE SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF53370 IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H006539 SCLA
Administered by: Public     Purchased by: Public
Symptoms: Blister, Erythema, Oral mucosal blistering, Rash, Skin exfoliation, Swelling, Tongue blistering
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Onset of redness and swelling with tiny clear fluid filled blisters, around mouth, on tongue, bilateral hands/digits and feet. Reported 4-5 larger blisters with creamy yellow fluid around mouth and on chin. Fine rash on upper and lower extremities. No fever. Received instruction by pcp to give children Benadryl by second dose rase was improved. Mom reports as of today (8-30-12) that hand and feet are peeling.

VAERS ID:463762 (history)  Vaccinated:2012-08-20
Age:60.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-27, Days after onset: 6
Location:Idaho  Entered:2012-08-31, 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: B/P controlled with meds
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0169AE0SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 8/20/12- Received Imm. 8/21/12 3:00 AM work up with throbbing, hot, sore (L) arm at injection site - continued to lump at site - 8/22 - reddened area moved to elbow, hotter arm, lump soreness continues.

VAERS ID:463795 (history)  Vaccinated:2012-08-20
Age:10.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Male  Submitted:2012-08-31, Days after onset: 10
Location:Nevada  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 reported
Preexisting Conditions: none
Diagnostic Lab Data: UNKNOWN
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B281BA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1630AA SCRA
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: PER MOTHER, REDNESS AND SWELLING AT INJECTION SITE WITH BLISTER LIKE LESIONS, AFEBRILE; SEEN BY MD ON 8/23/12. TX WITH ANTIBIOTICS AND DX WITH CELLULITIS.

VAERS ID:463849 (history)  Vaccinated:2012-08-20
Age:2.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-08-24, Days after onset: 3
Location:Oregon  Entered:2012-08-31, 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: Constipation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1647AA1IMLL
Administered by: Private     Purchased by: Public
Symptoms: Auricular swelling, Oedema peripheral, Rash, Rash erythematous, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pt. woke up 2 days ago, a day after receiving hepatitis a, with swollen red patches on her arms, legs. By she arrived at the ER 8/21/12 her hands, legs and knees were swollen, ears were swollen as well. She went to ER and was given diphenhydramine and oral steroid. The rash went away, but the next day they appeared as little dots on the face that later became a confluent hive. She went back, to ER, 8/22/12 and was given a prescription for oral steroids for 3 days, today is first day of that. Didn''t clear up until today 8/23. No respiratory symptoms. No fever. No lip swelling, no vomiting.

VAERS ID:463922 (history)  Vaccinated:2012-08-20
Age:29.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-09-04, Days after onset: 15
Location:Minnesota  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: Lump & redness
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4136AA UNRA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Mass
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Tdap was given on 8/20/12 - states that since that time area was red & a large lump, since then currently noting a pea sized lump.

VAERS ID:463989 (history)  Vaccinated:2012-08-20
Age:55.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Male  Submitted:2012-09-04, Days after onset: 14
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: no
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB538AA0IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Round, red, painful 1" diameter reaction at injection site. Lasted for 24 hours, gone at 36 hours.

VAERS ID:468569 (history)  Vaccinated:2012-08-20
Age:  Onset:2012-08-20, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-04, Days after onset: 15
Location:North Carolina  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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA008737
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  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 ZOSTAVAX (dose, route and lot number not provided) on 20-AUG-2012, which had expired 18-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.

VAERS ID:464059 (history)  Vaccinated:2012-08-20
Age:1.0  Onset:2012-08-22, Days after vaccination: 2
Gender:Male  Submitted:2012-09-05, Days after onset: 14
Location:Michigan  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: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA011726
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Febrile convulsion, Laboratory test
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This spontaneous report was received from a physician refers to a 1 year old male patient without any medical history and drug reactions/allergies. The patient was vaccinated SQ with single 0.5 ml dose of M-M-R II (lot# not reported) on 20-AUG-2012. Second suspect medications included VARIVAX (Merck) (dose, route, lot# not reported) and concomitant therapy included PREVNAR 13 (dose, route, lot# not reported) on 20-AUG-2012. On 22-AUG-2012 the patient developed a febrile seizure after concomitant administration of VARIVAX (Merck) and M-M-R II. The patient was taken to the ER for the event, and given ROCEPHIN. Unspecified test was performed (result not reported). The AE was improved. At the time of reporting, the patient had recovered on an unspecified date. Upon internal review, febrile seizure was considered as an other important medical event. Additional information has been requested.

VAERS ID:464189 (history)  Vaccinated:2012-08-20
Age:53.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Male  Submitted:2012-08-23, Days after onset: 2
Location:Illinois  Entered:2012-09-06, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sjogrens Syndrome
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12041012UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 UNRA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Erythema of right arm. Fever of 48 hrs duration.

VAERS ID:464224 (history)  Vaccinated:2012-08-20
Age:61.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-08-31, Days after onset: 11
Location:Illinois  Entered:2012-09-06, 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:
Preexisting Conditions: HTN per pt
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: Private
Symptoms: Activities of daily living impaired, Arthralgia, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad)
Write-up: Radiating pain built for days in left arm following vaccine administration. Pt is debilitated cannot exercise, open car door, difficulty dressing. Pt complains of weakness & pain from elbow to shoulder, not specific at administration site. Recommend neurologist as has no GP.

VAERS ID:464720 (history)  Vaccinated:2012-08-20
Age:1.3  Onset:2012-08-23, Days after vaccination: 3
Gender:Male  Submitted:2012-09-10, Days after onset: 18
Location:Alabama  Entered:2012-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI Sx - no fever
Preexisting Conditions:
Diagnostic Lab Data: U/A; U/C (-); RST (-); WBC, 7.7; HgB, 12; HCT, 37; Platelet count, 249; 63% lymph
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0681AE0SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0064620SCLL
Administered by: Private     Purchased by: Private
Symptoms: Culture urine negative, Haematocrit normal, Haemoglobin normal, Laboratory test normal, Lymphocyte percentage increased, Platelet count normal, Pyrexia, Rash, Streptococcus test, Urine analysis, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Began with fever/rash 2-3 day after vaccines better then return of sx 9/1 - 9/4 also has URI sx - which began before vaccine.

VAERS ID:464633 (history)  Vaccinated:2012-08-20
Age:56.0  Onset:2012-08-29, Days after vaccination: 9
Gender:Female  Submitted:2012-09-04, Days after onset: 6
Location:Ohio  Entered:2012-09-11, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Calcium Citrate with D; Flax seed oil; Balanced B; Diltiazem ER; Pravastatin; RYTHMOL; ALDACTONE
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: All labs WNL; CT of head normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0071AE0SCAR
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram head normal, Hyperhidrosis, Laboratory test normal, Nausea, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: 1 week after vaccine extreme vertigo, had nausea, diaphoresis - seen in ER, adm.

VAERS ID:464796 (history)  Vaccinated:2012-08-20
Age:33.0  Onset:2012-08-23, Days after vaccination: 3
Gender:Male  Submitted:2012-08-23, Days after onset: 0
Location:Colorado  Entered:2012-09-11, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None/preventative
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB185AA0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081AA UNLA
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Patient reported no adverse event. Vaccine was expired and administered to patient. After speaking with health department vaccine specialist, it was determined patient would need a duplicate vaccine in date.

VAERS ID:464824 (history)  Vaccinated:2012-08-20
Age:62.0  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AA2UNLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Immediate post-injection reaction, Muscle spasms, Nasopharyngitis
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Lightheaded immediately. Severe muscle cramps in legs and back from 10pm to 5am. Cold like symptoms day after.

VAERS ID:464913 (history)  Vaccinated:2012-08-20
Age:62.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-03
Location:South Carolina  Entered:2012-09-11, 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: Vitamin D; Diuretic; Cholesterol rx
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0073AE0SCUN
Administered by: Other     Purchased by: Private
Symptoms: Hyperaesthesia, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient complained of sensitivity on head that started 2nd or 3rd day following ZOSTAVAX shot & quit couple of days ago. Also reported red rash on upper chest that only itched if he touched it, which started 2nd or 3rd day following the shot is still present.

VAERS ID:468310 (history)  Vaccinated:2012-08-20
Age:0.4  Onset:2012-08-20, Days after vaccination: 0
Gender:Female  Submitted:2012-09-13, Days after onset: 24
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: WAES1208USA010775
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1270Z1UNUN
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 4 months old female patient. The patient was vaccinated with the second dose of lot # (669072/1270Z expiration date 16-AUG-2012) ROTATEQ (dose and route not reported) on 20-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that they administered expirated ROTATEQ to child on 20-AUG-2012. No adverse effects were reported. Additional information has been requested.

VAERS ID:469108 (history)  Vaccinated:2012-08-20
Age:71.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-09-13, Days after onset: 23
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: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA000311
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRAR
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SYRAR
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 71 years old female patient. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported) on 20-AUG-2012. If this was the first time the patient had gotten ZOSTAVAX could not be confirmed. Concomitant mediations included: INFLUENZA (unspecified) (manufacturer unknown) vaccinated in the opposite arm on 20-AUG-2012. It was reported that on 21-AUG-2012, "the following day", the patient had developed redness, swelling and warmth at the injection site. The patient came to the pharmacy on 23-AUG-2012 and said that the injection site reaction had gotten larger and there were still redness, warmth and swelling. No rash had been reported. And there was no injection site reaction in the arm vaccinated with the flu vaccine. The patient sought for unspecified medical attention. Treatment given was reported as none. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information is not expected.

VAERS ID:469324 (history)  Vaccinated:2012-08-20
Age:63.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-09-17, Days after onset: 27
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA010885
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0565AE0SCAR
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a female patient with unspecified age, with no pertinent medical history or drug reactions / allergies. The pharmacist stated that the patient was vaccinated subcutaneously in the triceps with 0.65 ml dose ZOSTAVAX on 20-AUG-2012. No other co-suspects were reported. Concomitant therapies included "a lot" (therapies unspecified). On 21-AUG-2012 the patient experienced at injection site a knot that was the size of a fist, hot to the touch, redness and heat spreading to the elbow. The reaction was worse at the time of report. The patient would saw the primary care physician in 2 days. At the time of report, the patient had not recovered. The patient call the pharmacist for medical attention. The patient would be put ice on affected area. There were not diagnostic test performed. Additional information has been requested.

VAERS ID:469838 (history)  Vaccinated:2012-08-20
Age:1.4  Onset:2012-08-29, Days after vaccination: 9
Gender:Male  Submitted:2012-09-19, Days after onset: 21
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: WAES1209USA001106
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0045AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a Bachelor of Science in Nursing (B.S.N.), concerning a 16 months old male child. The patient had no pertinent medical history and no known drug allergies. On 20-AUG-2012, the patient was vaccinated subcutaneously with a dose of (Merck) VARIVAX (lot #: 0045AE; Expiration date: 20-DEC-2013). There were no concomitant medications reported. On 29-AUG-2012, the patient developed "three spots on him". No treatment was given for the event. No lab diagnostic studies were performed. The patient sought medical attention through phone call to office. At the time of the report, the patient''s outcome for the three spots on him was not recovered/not resolved. Additional information has been requested.

VAERS ID:465733 (history)  Vaccinated:2012-08-20
Age:68.0  Onset:2012-08-21, Days after vaccination: 1
Gender:Female  Submitted:2012-09-20, Days after onset: 30
Location:North Carolina  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4170AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling and pain at inj. site.

VAERS ID:470399 (history)  Vaccinated:2012-08-20
Age:  Onset:2012-08-20, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-21, Days after onset: 32
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: WAES1209USA008599
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0493AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, 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 improperly stored PNEUMOVAX 23 on 20-AUG-2012. Lot# was reported as 0493AE, expiration date: 08-DEC-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6 C for total of 19 hours (2 excursions), -4.8 C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA00725, 1209USA008597, 1209USA008598, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.

VAERS ID:470703 (history)  Vaccinated:2012-08-20
Age:66.0  Onset:2012-08-22, Days after vaccination: 2
Gender:Female  Submitted:2012-09-24, Days after onset: 33
Location:Unknown  Entered:2012-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; ZESTRIL; vitamins (unspecified); CALTRATE; NASONEX
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA000341
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0423AE0SCRA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Rash, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a licensed practical nurse concerning a 66 years old female patient with no drug reaction/allergies and no pertinent medical history, who on 20-AUG-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not reported) (lot # 0423AE, Exp: 02-APR-2012 - in validation process). No other co-suspects were reported. Concomitant medications included montelukast sodium, ZESTRIL, multivitamin, CA